 |
| Cardiovascular Biomarker Investigation and Risk Assessment in Chronic Kidney Disease (CardIACK) |
| Patients with CKD (Chronic Kidney Disease) are at a high risk of developing heart disease.The risk of developing heart disease rises by 600% when kidney function drops to less that 15%, when compared against a kidney function of more than 60%. Heart disease is the most common cause of death in patients with CKD. As CKD progresses, so does heart disease and vice versa. Effective management of heart disease in CKD requires early diagnosis.
Our research, aims to develop a panel of 'biomarkers' to help predict early heart disease in CKD patients. Biomarkers could be of different types. They could be chemical substances in the blood, structurally altered genes or stiffness of blood vessels. In combination, these biomarkers are capable of predicting heart disease even before it becomes clinically evident. Identification of 'biomarkers' will enable early identification of high risk patients. We can subject the high risk
patients to rigorous diagnostic tests and therapeutic intervention, which we believe will be life saving to a large number of CKD patients.
Our study will be done in two phase. In the initial phase, we will study the difference in biomarker load between mild and advanced CKD in 300 patients. The next phase will be, a follow up phase involvling 500 patients over 5 year period, to study the relationship of biomarker load and occurrence of heart disease as CKD progresses. This will enable us to develop a panel of disease predictive biomarker. The study is being undertaken by CardIACK study research group, comprising of clinical scientists, kidney doctors and heart doctors. It will be performed at Manchester Royal Infirmary, kidney disease department and Bedford House Medical Centre, GP Surgery. The study is currently being funded by CMMC Trust Renal fund. For the future, we plan to apply for a British Heart Foundation grant. |
This is a translational research taking medicine from bench to bedside. The study aims to develop a panel of
cardiovascular biomarkers, which would facilitate early subclinical diagnosis of heart disease in CKD patients. This will
enable the clinician to risk stratify patients, subjecting the high risk group to early diagnostic tests and appropriate
intervention.
As it is widely known that the there is an exponential risk of adverse cardiovascular events and death as CKD progresses,
successful development of prognostically useful cardiovascular biomarkers will have significant impact on reducing
cardiovascular morbidity and mortality in the CKD population. This will in effect be instrumental in delaying or even, halting
progression of CKD.
At an individual level, the study will involve few non invasive clinical tests on all participants and a MR Scan of the heart for
a subgroup of patients.
Each participant will have routine targetted clinincal examination including a Blood Pressure check. If a high blood
pressure is detected in a participant, with no diagnosis of hypertension the GP and the participant's Consultant will be
alerted about the findings which will prompt diagnosis of an important undiagnosed problem.
Smoking is highly prevelant in CKD population. Although we are aware of the deleterious effects of smoking, no tests are
available on a routine scale, to reveal the effects of smoking on blood vessels. In our study, each participant will have
pulse wave velocity measured. This test is highly sensitive is detecting arterial stiffness in smokers.The increased risk of
cardiovascular disease with raised arterial stiffness is well documented. A diagnosis of arterial stiffness in smokers who do
not have any obvious heart disease might convince them of the potential risk of smoking. This could possibly provide them
the conviction to quit smoking.
A subgroup of participants will have Cardiac MR Scan which is highly sensitive and precise study of Left Ventricular
hypertrophy. If such a change is detected it will be related to participants GP and Consultant, highlighting the need for a
tight blood pressure control. |
RMG/09/095
20/08/09
19/08/14
ReGrouP |
 |
| Pathways to prevention and prediction of cardiovascular disease and associated disability in older men: the British Regional Heart Study |
| not available |
|
RMG/09/094
01/01/10
31/12/11
ReGrouP |
|
| Analysis of clinical data routinely collected in Salford |
| In summary, routinely collected data has the potential to answer questions of real clinical importance but is currently under utilised. If we can identify better ways of providing care for people with chronic conditions we could potentially improve their care and reduce the development of potential problems. |
|
RMG/09/089
24/07/09
NHS SalfoR+D (joint study) |
|
| Exploration of FM system use with hearing aids in the home setting by early identified deaf children |
| For chldren with hearing impairments, the benefits of frequency modulation (FM) system use with hearing aids in overcoming the difficulties associated with distance, reverberation and signal to noise ratio (SNR) have long been established. However, the fitting of FM systems at a very young age (<12 months) has previously never been explored. With rapid technological advancements and the recently established Newborn Hearing Screening Program, many previous
limitations on the use of FM systems with infants can now be overcome. This research is part of a PhD studying three areas of FM use with infants a) identification of optimal FM use with early identified hearing impaired pre−school children, b) characterising the acoustic environment of pre−school children and c) the language acquisition of early identified hearing impaired children using FM systems. The research is a longitudinal study over a period of 12 months with a prospective cohort design. The study will incorporate a single intervention group of approximately 10 families of infants who have been identified with hearing impairment prior to 6 months of age. They will be provided with the latest FM technology (Inspiro transmitter and ml10i receivers) in addition to the amplification technology their child is currently fitted with at their local audiology department. Regular contact will be maintained with parents throughout the study with data being collected over the duration of the study. |
The potential benefits to participants would be access to the latest amplification technology not normally accesible for
pre−school hearing impaired children,
regular contact with an audiological professional including regular mointoring of devices, extensive support on use and
maintenance of aids and language evaluations.
Also by using the FM systems an improved quality of communication for parents of deaf children with their heairng
impaired child would be expected which may improve language acquisition due to better signal detection. |
RMG/09/087
10/07/09
30/04/10
ReGrouP |
|
| A 26 week placebo−controlled, randomised, double−blind, parallel group study of the efficacy and safety of 2PX (topical strontium chloride hexahydrate) in patients with pain due to osteoarthritis of the knee. |
| This trial will be conducted as a multi−centre, randomised, double−blind, parellel−group study, in patients with chronic, moderate to severe osteoarthritis pain of the knee. The investigational therapy in this study is 2PX (10% strontium chloride hexahydrate) solution for topical administration and will be compared to placebo ((vehicle; identical to the test article without the 10% strontium chloride hexahydrate).The study will last for approximately 26 weeks and will include a total of 7 study visits at the investigational site. |
There may or may not be direct medical benefit to the participant apart from the potential of reliving discomfort of pain.
The expected benefit of taking part in the study is predicted to be similar to that of getting commonly used therapy without
being on study.
The results of this study may be of value for the future treatment of patients with knee pain due to osteoarthritis. |
RMG/09/079
26/06/09
29/11/09
ReGrouP |
|
| COMPARISON OF A BASAL PLUS ONE INSULIN REGIMEN (INSULIN GLARGINE/INSULIN GLULISINE) WITH A BIPHASIC INSULIN REGIMEN (INSULIN ASPART/INSULIN ASPART PROTAMINE 30/70) IN TYPE 2 DIABETES PATIENTS FOLLOWING BASAL INSULIN OPTIMISATION - LanScape |
| Controlling diabetes is complex and focuses on controlling blood sugar levels. Treatment tends to start with lifestyle
changes (diet and exercise) then treatments such as Oral Anti−diabetic tablets (OADs) and insulin injections.
In medical practice, its common to start with long−acting insulin called basal insulin. It controls fasting blood sugar levels
and is usually given once a day. An example of a basal insulin is Lantus®. A Basal plus one regimen is where an injection
of ‘fast acting’ insulin is added to the regimen before the biggest meal of the day.
Alternatively patients may be prescribed a biphasic insulin regimen. Biphasic insulin is a mixture of intermediate and fastacting insulin and it provides a rapid lowering effect on blood glucose levels followed by a prolonged effect that controls the blood glucose levels for the rest of the day and is usually injected before a meal. |
|
RMG/09/078
05/08/09
04/04/11
ReGrouP |
|
| Users' Perceptions of Communication Aid Design |
| “Augmentative and Alternative Communication (AAC) are the words used to describe extra ways of helping people who
find it hard to communicate by speech or writing. AAC helps them to communicate more easily.” [ISAAC, 2008]
Many people use Voice Output Communication Aids to help them to communicate – these are devices that ‘provide a
voice’ for the user. Communication aids are a key tool in the AAC field but little previous research has looked at what
users think about the use of communication aids. The aim of this project is to investigate what users require from these
devices and how they can be improved. The overall project is split into two parts: interviews with communication aid users
in South Yorkshire and a questionnaire sent nationally to users, carers, and professionals.
This objective of this project is to allow users to influence the design of future communication aids by understanding what
contributes to the perceived success and dignity of use of these devices. |
There are no direct clinical benefits to participants and they will not be offered any incentives. However participants will be
contributing to the future design of communication aids and will be offered the opportunity to receive the plain−English
results of the project. |
RMG/09/075
11/06/09
11/05/10
ReGrouP |
|
| An Exploration of the Experience of Group Therapy for School-Aged Children who Stammer.
|
| Background
Stammering is a communication disorder affecting 1.2% of school−aged children. In addition to physical ‘symptoms’ of
stammering, the child often experiences feelings such as fear, shame and embarrassment. These can lead to many
aspects of his life (e.g. social life; education; relationships; career choices) being shaped around a negative view of himself
as ‘a stammerer’ (Guitar, 1998). Access to successful therapeutic interventions is therefore paramount.
Rationale
The use of group therapy for school−aged children who stammer is a well recognised element of Speech & Language
Therapy (SLT) service provision and is widely recommended to SLTs in the UK (e.g. Stewart and Turnbull, 2007).
However, there is currently very little research into the use of this intervention.
Aim of Study
This study aims to increase the body of research evidence which guides SLTs in their decision making about group
therapy provision for school−aged children who stammer. As there is no consensus in the literature on what should be
considered to be successful therapeutic outcomes, this study will not measure outcomes of group therapies in order to
determine their value. Instead, the study aims to investigate the experience of group therapy from the perspective of the
participants i.e. children who stammer, their parents and SLTs.
The following research questions will be addressed:
• What are children’s, parents’ and therapists’ experiences of group therapy?
• What role does the participation in group therapy play in the management of stammering in school−aged children?
• To what part of the group process do participants attribute change?
• How might a therapeutic group environment facilitate change in the school−aged child’s experience of stammering?
Methodology
This study will employ a qualitative (rather than a quantitative) design as this will be useful for investigating participants’
experiences (Smith 2008). A series of in−depth, semi−structured interviews will be conducted with children, parents and
SLTs about their experiences of group therapy for children who stammer.
This study forms part of a PhD research project and is funded by Leeds Metropolitan University. |
There will be no direct benefit to participants at this stage. However, the results of the research may inform Speech and
Language Therapy practice and could therefore have an indirect impact on participants in the future.
Although the intention of the research is not to directly benefit the participants, they may find it interesting and enjoyable to
discuss the topic in depth. This process may help them to clarify their own understanding of the topic. |
RMG/09/072
22/06/09
22/12/09
ReGrouP |
|
| Genetics of Pernicious anaemia |
| Purpose −
To identify specific genetic variants underlying Pernicious anaemia.
Design and methodology −
The research will take the form of case−controlled association studies. These techniques have been used
succesfully to identify genetic variants associated with a number of common diseases.
Individuals with Pernicious aneamia (PA) will be identified approached and recruited by principal investigators from
haematology departments predominantly in the North West of England and from the Pernicious Anaemia Society.
From each subject clinical data plus a blood sample (5−10ml EDTA)or mouthwash for DNA isolation will be collected.
DNA extraction and storage will take place in the Regional Molecular Genetics Laboratory at St Mary's Hospital,
Manchester. DNA will be securely stored only identifiable by a unique barcode/lab reference number and not
immediately traceable to clinical or demographic data. Demographic details and clinical data relating to the diagnosis of PA will also be collected and stored on the PI's computer in a password protected database. No patient
identifiable data (e.g name, address) will be stored with the clinical data.
We plan to do an association study where common gene variants (single nucleotide polymorphisms, SNPs) will be
selected based on functional effect on the encoded protein (cSNPs) or haplotype tagging SNPs (tSNPs) to cover the
whole gene using information from the HapMap project. We will use SNPs previously associated with autoimmune
disease. Additional variants will be selected based on their potential importance to disease pathogenesis.The
frequency of these genetic variants will be compared between cases and healthy controls to establish statistical
evidence of association with PA. A number of statistical strategies are available for analysis of the generated data.
If variant(s) in a gene are identified that may be important in PA (ie the association has been replicated in an
independent PA cohort) these will need to be verified using a number of strategies.
Firstly, in silico analysis would be performed to determine the potential effect of the variant on protein function or RNA
transcription.
A number of techniques could then be employed to assess the functional relevance of the gene and its variant.
Functional analysis to determine the effect of the gene change on the RNA (eg alterations to transcript splicing,
nonsense mediated decay) or protein product will be designed dependent upon the nature of the variant/gene
identified. In addition, cell culture studies using over− & /or under− expression of the relevant gene and its
downstream effects may be performed. |
To contribute to the overall understanding of Pernicious anaemia. There will be no direct benefit for the
participants. No clinical genetic test results will be generated. |
RMG/09/071
29/09/09
31/08/14
ReGrouP |
|
| Health care professionals reactions to integrating 'everyday emotional tools' into daily practice |
| Primary health care professionals such as Practice Nurses, Health Visitors, Physiotherapists, Dieticians, and District
Nurses, frequently care for people with long−term physical health problems, who are known to experience more emotional
and mental health problems than the rest of the population, with adverse effects on their quality of life and control of their
condition. These professionals receive little training in recognition and management of mental health problems and
express low confidence in their abilities, though recognise the importance of this aspect of their work.
This study is using the opportunity offered by an educational project to try to gain a better understanding of the problems
which these professionals experience in integrating emotional work into their practice. The workshops were designed on
the basis that the professionals have many skills appropriate to emotional work with patients, which they do not recognise,
and that adding simple tools could allow them to do this work with greater confidence. Those attending two linked
workshops will be invited to be interviewed by a medical student researcher not involved in the teaching. The interview will
explore their experience of applying the tools in practice, to check their usefulness and how it felt to engage in work of an
emotional nature alongside the other demands of consultations. Transcripts of interviews will be subject to Discourse
Analysis, which seeks common themes in the way interviewees talk about the subject being discussed. This method has
been shown to assist in understanding people’s ‘inner world’, and is of particular value in clarifying situations where there
may be barriers to change which are less obvious. The outcome of the research will be used by the Manchester Primary
Care Mental Health Education and Training Group, which ran the workshops, in designing future educational work. |
Research participants may find it beneficial to have a 1:1 opportunity to discuss their reactions to implementing the
training. There is evidence that management of mental health problems and dealing with stress associated with long−term
physical health problems is a high educational priority for practitioners such as the participants so this extra 'arm' to the
intervention is potentially therapeutic to them. |
RMG/09/061
02/06/09
22/08/09
ReGrouP |
|
| An evaluation of primary care prescribing behaviour in a Practice Based Commissioning Cluster in Greater Manchester following the introduction of a computer-based prescribing support system (ScriptSwitch) |
| The formation of Practice Based Commissioning (PBC) Groups in Primary Care is integral to the Goverment strategy to
improve health care provision and choice for local patients (DH 2006). Resource utilisation directed by local clinicians now
underpins local health care decisions, resources spent on prescribed medicines as with other interventions, need to be
both evidence based and cost−effective. A computer based prescribing support tool (ScriptSwitch) may help optimise
health care through prescribed treatments. The benefits and drawbacks of IT based prescribing support needs careful
local evaluation, integral to this evaluation is determining the views of local clinicians and system users. The relative
interplay of ScriptSwitch amongst other influences on prescribing behaviour is unknown, this evaluation will help to define
the perceived importance of the system mongst local clinicians in the GPCARE PBC Cluster |
As commisioners of the ScriptSwitch system, the participants can influence the usefulness and operation of the clinical
decision support system.
The ScriptSwitch system allows local adaptation to respond to local agreements on prescribing decisions.
The level of information provided to prescribers via ScriptSwith can also be varied so as to provide a suitable level of text
in order to facilitate good decision making.
By undertaking the study, we can gain valuable insights into GPs perceptions of benefits and drawbacks of the system
which at the moment may not be communicated back to the Medicines Managment Team effectively.
By including only relevent levels of information, this can improve the acceptability of the decision support system and may
improve quality and cost−effective prescribing for patients. |
RMG/09/060
14/08/09
24/02/10
ReGrouP |
|
| Qualitative evaluation of the Personal Health Record (PHR) |
| The aim of this pilot study is to investigate the effects of patient use of web−based PHR clinical components in the home
and general practice settings. The outcomes of this study of a PHR integrated into a healthcare management workflow will
concern: (1) patient and primary care clinical staff attitudes and behaviour, (2) effects of demographic and valuegraphic
factors on PHR use and non−use. Discussion will focus on recommendations for PHR content, structure and modes of
use, aimed at improving effectiveness of future PHR design, implementation and evaluation. |
A greater understanding of the benefits/disadvantages of their PHR with regard to patient involvement in their healthcare
and their GP/nurse attitude to its use in the consultation. |
RMG/09/059
05/06/09
31/07/11
ReGrouP |
|
| Can the quality assessment of dental radiographs be improved by modification of the present quality grading system? |
| Dental practitioners have to grade the x−ray films they take and regularly perform an audit
The x−ray quality grades are
1. Excellent 2. Diagnostically acceptable 3. Unacceptable
The National Radiological Protection board (now part of the Health Protection Agency) set targets for
radiographic quality
Not less than 70% of films should be graded as Excellent
Not greater than 20% of films should be graded as Diagnostically acceptable
Not greater than 10% of films should be graded as Unacceptable
Research has repeatedly shown that these targets are often not reached (and this is my personal experience).
Dentists have to be self−critical when auditing their own x−ray films. If they honestly grade their films, the targets
are very hard to meet.
I wish to test a more “user friendly” grading system which would include excellence but also for allow minor
faults.
X−ray quality audit is important as dentists can miss pathology or make a wrong diagnosis from poor quality
films. Patients can suffer because of this
I think dentists are discouraged from regular audit because the present grading system is awkward to use
I hope to produce with this research a better quality grading system where minor film faults can be admitted to
without such faults producing such depressingly poor audit results. The present grading system encourages
dentists to “ignore or not notice” film faults in order to reach the quality targets.
The Health Protection Agency states that around 19 million x−ray films are taken annually inside the mouth.
Demographically, even a small improvement in x−ray film audit should could nationally make a very great
improvement in treatment outcomes for patients by reduction of x−ray exposure and correct diagnosis. |
Dential practitioners should improve their skills in the quality assessment of radiographs by the practice
gained in this study. |
RMG/09/055
15/05/09
15/11/09
ReGrouP |
|
| A phenomenological study exploring the experiences of people living with bronchiectasis |
| A phenomenological study exploring the experiences of people living with bronchiectasis
Bronchiectasis is a chronic respiratory disease that is characterised by dilatation of the airways and sputum production
with a vicious cycle of infection and inflammation. Sufferers of the disease present with a productive cough and recurrent
infections, and the management of the condition primarily involves controlling these symptoms. As with most chronic
diseases, treatment strategies for bronchiectasis rely on sufferers managing their own condition but very little is known
about self−management strategies for bronchiectasis (Lavery et al, 2007). A trial exploring the experience of having
bronchiectasis is needed to begin to understand the implications the disease has for sufferers’ lives. The research
question that needs addressing is how do people with bronchiectasis experience the disease and the symptoms
associated with it?
A qualitative research project using a phenomenological tradition of enquiry is proposed to explore the experience of living
with bronchiectasis. The data will be gathered by audio−recording semi−structured interviews with eight people who have
been diagnosed with bronchiectasis. The interviews will take place in the participants' homes and will last between one
and two hours. The interviews will be transcribed and relevant statements will be located and formulated into a
non−repeating list. Meanings will be explored from these statements and these will be synthesised into common
themes. To ensure trustworthiness of the data analysis, it will be peer−reviewed by two colleagues with clinical and/oresearch experience. The themes from all the interviews will be explored and amalgamated into a general description of
what it is like to live and cope with bronchiectasis. The themes and descriptions will be reported in a manner to incorporate
the participants’ experience of living with bronchiectasis and discuss the important themes they highlight regarding the
management and coping with the disease. |
|
RMG/09/054
10/06/09
31/01/10
ReGrouP |
|
| Managing the menopause: women's experiences and primary care practice |
| Part of a broader NIHR RfPB funded study of women’s experiences of the menopause involving qualitative interviews with
40−50 women aged around 45−60 in the UK (there is existing MREC approval for the interviews with women). We plan to
explore GP and practice nurse management of women’s health in primary care, with a particular focus on supporting
women through the menopause. Tape recorded qualitative interviews (15−20 minutes duration) will be conducted with 30
GPs and practice nurses drawn from practices in three Primary Care Trusts which are characterised by high, medium and
low HRT prescribing rates. Using a clinical scenario and a series of questions, practice staff will be asked to describe what
they would ask women, in what circumstances they would recommend treatment or referral, and if so what they would
suggest. Staff views on potential resources that could help them in the consultation will also be sought during the
interviews.
The qualitative research findings will contribute to an understanding of women’s experiences of menopause and how this
might be better managed by women themselves and in primary and secondary care, for those who choose to consult. The
findings will also be used to inform the development of resources, including training packages, for primary care staff. |
|
RMG/09/052
07/05/09
07/11/09
ReGrouP |
|
| A quantitative observational study (with embedded waiting list control between−group analysis) to assess
the effect of targeted mobilization of the C0−C3 segments on the intensity, frequency and duration of
migraine (with and without aura). |
| PURPOSE: To assess the effectiveness of mobilization of the upper 3 segments of the neck on migraine headache.
DESIGN: Prospective cohort (Observation Study) with embedded control group.
THEORECTICAL FRAMEWORK: The gold standard in clinical trials is the randomised controlled trial (RCT). Robustly
designed RCTs are the only way of assuring that the observed effect is attributed to the intervention. However RCTs need to
have sufficient numbers to detect differences between groups (should a true difference exist). This is established using a
sample size calculation which requires information derived from data which can either be taken from well designed trials or
observation data.
In the case of the present study, no data exist informing us of treatment effect (which is central to calculating a sample size)
and making a “power calculation” for a RCT would be largely guesswork. Estimates tend to be based on conservative data
which frequently produce high numbers and this can often make the cost of trials prohibitive.
We propose in this study, to conduct an adequately powered observation study (pre−test/post−test) to enable us to have
data on treatment effect size in order to conduct an adequately powered RCT at a later date. We also propose to randomise
half of the group to a “waiting list control” group. This means that half of the group’s treatment will be delayed and their
baseline data measured three times prior to treatment. This will provide us with a control group. This is very important
because it allows us to make a more accurate judgement of how the treatment has affected the patients. The study (as a
RCT) is likely to be underpowered (depending upon the observed treatment effect size) but the power and integrity of the
observational study will be maintained. Observation studies are very important as they help to provide important information
about how potent a treatment might be. This is called the treatment effect. Once the level of treatment effect is know, it is
possible to estimate more accurately how many patients would be required in order to conduct a randomised controlled trial.
This approach is recommended by the Medical Research Council (MRC) as a method of developing trials in complex
interventions (1). The benefit of having a control group embedded within the observational study is that if the treatment effect
is large enough, then it is possible that we can demonstrate a difference between the control and the intervention group and
so the need for a larger, more expensive study can be avoided.
METHODOLOGY: Following inclusion into the study, patients will undergo some measures aimed at establishing a base
level for their migraine headache. The measures that will be incorporated are:
PRIMARY OUTCOME MEASURE
− The Headache Score (Appendix 1): This score has been used previously and gives an indication of the intensity, duration
and frequency of headaches at any given time. This score will be used daily within the headache diary (see below) to give a
sense of how the headache has been over any one day. Average scores of the headache diary will be weekly by the
researchers and used to assess the effect of the treatment.
SECONDARY OUTCOME MEASURES
−The Headache Diary: This will be a log of the patient’s headaches and actions taken to overcome them. Times of day that
headaches occur will be incorporated and level of severity monitored using a pain scale. The level of medication used will
also be recorded (since there will be no restriction use of medication between groups. This will give the researchers more
specific information about the nature and pattern of headache suffered by individuals.
−SF36 (Appendix 2): It is believed that patient who suffer migraines suffer negatively in terms of quality of life and restriction
on activities for fear of provoking an attack. This assesses quality of life.
− Hospital Anxiety and Depression Scale (Appendix 3): Depression is not uncommon amongst migraine sufferers. It is
believed that this is in relation to the uncertainty surrounding migraine attacks and frequency. This scale will be used to
monitor changes in levels of anxiety and depression.
These measures will be undertaken by the patient themselves and there will be no participation by the researchers in their
administration.
All patients will complete the measures at baseline.
Following baseline measurement, participants will be assessed and treated by a physiotherapist in the private sector (free of
treatment charge). They physiotherapists will make a judgement as to whether the patients are suitable to undertake
mobilization of the neck and whether the patient’s headache can be reproduced. If the headache can be reproduced, then
the patient will be entered onto the study and allocated into control and intervention groups.
METHOD OF ALLOCATION
A random sample from patient volunteers will be drawn from 3 sources. The sample will be allocated to control and
intervention groups by means of minimisation (21−23). The minimisation factors will be: age, sex, diagnosis (migraine with
aura and migraine without aura) headache score at baseline, source of recruitment and number of years of headache
disorder (chronicity). Allocation will be made using the “Minim” software package (22) and will be conducted by the lead
researcher.
BLINDING
Treating therapists will see all participant included in the study. However, they will not be aware of who has been allocated to
the “waiting list control” group. Also, since the outcome measures are posted back to the research team no influence in
terms of the outcomes recorded could be made by the research team. While the principle investigator will know the allocation
of patients (since he will allocate patients using the minimisation programme) the research assistant will not be aware of the
allocation status. Consequently this constitutes a double blind trial when measured against the four levels of blinding
possible to achieve (24).
The control group will undertake these measures on 2 further occasions prior to undertaking treatment:
1. Once at 3 months from inclusion onto study
2. Once at 6 months from inclusion onto study
The intervention group will complete the battery of tests once more before treatment:
1. Once at 3 months (just prior to treatment)
Following treatment, the control and intervention groups will then complete these measures a further five times:
1. Post treatment
2. At one month
3. At three months
4. At six months
5. At one year
The difference in the timing of the treatment will allow half of the group to be delayed in order to have a control group in the
study. However, all patients will receive the treatment. A summary of the recruitment and treatment timing can be seen in the
flow charts in appendix 4
PARTICIPIPATION OF PATIENT GROUP IN STUDY DESIGN
The design of this study has been considered by the Migraine Action Group (http://www.migraine.org.uk/) who have agreed
to assist in acting as an intermediary for the recruitment of patients on their data base (please see attached letter of support). |
In clinical practice, it has been shown that this technique is highly effective in the amelioration of migraine. These effects are
frequently considerable with some sufferers experiencing remition from migraine attacks for years. |
RMG/09/050
26/06/09
26/11/09
ReGrouP |
|
| Integration of Anonymised Health Care Data Across Multiple Sites |
| The population will consist of all residents of areas in which their healthcare providers have signed up to participate in the
North West e−Health (NWeH) Federation. Initially this will be all residents of Salford. It is intended that residents of
Stockport, the Wirral, Western Cheshire, Manchester and Liverpool will be included over the course of the following 3
years. Ultimately, it is our aim that much of the Northwest's population will be included by year 5 of the project.
As data needs to be collected on entire populations, there are no inclusion or exclusion criteria for people. However, data
on HIV/AIDS, pregnancy terminations and all mental and sexual health conditions will be excluded.
The data stored by each healthcare provider is a pseudonymised form of all routinely collected patient data which includes
demographics (year of birth, gender and partial postcode), blood test results, complications, conditions, prescriptions and
treatments. No data will be specifically collected from patients in order to populate the database, only data that is already
routinely captured will be used. The data that is provided to researchers is a fully anonymised extract of the data including
only the data items required for their research. |
|
RMG/09/049
22/05/09
22/05/12
NHS SalfoR+D (joint study) |
|
| A COST BENEFIT ANALYSIS OF PALIVIZUMAB PROPHYLAXIS IN INFANTS WITH BRONCHOPULMONARY DYSPLASIA |
|
|
RMG/09/044
20/04/09
19/04/11
ReGrouP |
|
| A qualitative study of the emotional needs of people with a diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD). |
| Anxiety, depression and feeling of panic or low mood are very common in people who also suffer from long term conditions
such as chronic obstructive pulmonary disease (COPD). This study aims to understand how COPD affects the life of the
patient, and in particular how it affects their ability to cope and how they feel about themselves and their everyday
functioning. It will involve in−depth interviews and completion of a questionnaire with 12−16 people who have a diagnosis
of moderate to severe COPD and where the clinician has recognised that the patient has some associated psychological
symptoms. We want to find out how these needs may be better met by the National Health Service so that we can design
and put in place better systems of care to meet them. |
|
RMG/09/043
01/05/09
31/12/09
ReGrouP |
|
| A multicenter, randomised, double−blind, active−controlled, parallel group, 2−arm study to investigate the effect of estradiol valerate/dienogest compared To Microgynon on hormone withdrawal associated symptoms in otherwise
Healthy women after 6 cyc |
| Oral contraceptives are the most common method of reversible birth control. Despite the continuous reduction in hormone
content since oral contraceptive introduction almost 40 years ago, side effects continue to affect compliance. These symptoms often occur in the hormone−free interval. Shortening the hormone−free interval from 7 to 4 or 2 days could
decrease the number of days with symptoms. Adding oestrogen during the typical 7 hormone−free days also could provide
better ovarian suppression and reduce symptoms.
The aim of this study is to reduce hormone−withdrawal associated symptoms, namely headache and pelvic pain whilst
taking oral contraceptives.
The study will compare the effects of a novel compound, SH T00658ID/Drug A, to Microgynon/Drug B, a well−established
oral contraceptive. Drug A should demonstrate superiority to Drug B with primary regard to
• hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22−28
Secondary, comparisons of Drug A to Drug B should demonstrate an improvement of:
• bloating or swelling, breast tenderness, nausea or vomiting during the hormone free interval,
• change in frequency and intensity of hormone related symptoms
• pain killer consumption
The duration of the study will be approximately 16 months involving 1100 patients, with 880 receiving treatment
(approximately 75 study centres in 9 countries). Study drug administration will extend over a total of 168 days (i.e. 6 cycles
of 28 days each).
Administration of Drug A or Drug B will be randomly assigned. Tablets are encapsulated for blinding purposes. There will
be no pill−free interval between the consecutive cycles of the study medication. Study treatment for all patients will cease
upon completion of the trial.
A reduction in those symptoms, named previously, could further improve acceptance and long−term use, with increased
tolerance and non contraceptive benefits of oral contraceptives. |
The aim of this study is to reduce hormone−withdrawal associated symptoms, namely headache and pelvic pain whilst
taking oral contraceptives. Other oral contraceptive−associated symptoms including nausea, vomiting, breakthrough
bleeding and spotting, bloating and breast tenderness may also be reduced for the women assigned to the study drug,
during the study. |
RMG/09/042
12/05/09
30/01/11
ReGrouP |
|
| Ingenious Hypercare |
| Patients with hypertension will be recruited from the Glasgow Blood Pressure Clinic. These patients (index patients) will attend BHF Glasgow Cardiovascular Research Centre (BHF GCRC) for a number of non−invasive investigations to examine their heart and blood vessels. We will also take blood and urine samples and take a detailed medical and family history. Most importantly, we will collect blood for DNA extraction to investigate the genetics of hypertension.
This is a family−based study. We will therefore also recruit hypertensive and normotensive first−degree relatives of index patients. In these subjects we will also collect blood for DNA extraction to examine transmission of hypertension−related genes within the family. Depending on clinical criteria we will also conduct non−invasive investigations to examine their heart and blood vessels similar to those in index patients.
We will also recruit spouses of index patients as non−related control subjects who share the environment with index patients. Spouses will undergo the same examinations as index patients. All study participants will be seen at BHF GCRC for their study visit. As they will be provided with a 24−hour ambulatory blood pressure monitor, study participants will return on the following day to hand in their monitor. Another urine sample will be collected at this time. This second visit within 24 hours can also be used to complete examinations if not done on the previous day. The project also includes a longitudinal aspect to examine changes in blood pressure and related phenotypes over time. We will therefore re−invite all study participants after 2 and 4 years to repeat the tests. |
Patients with hypertension will benefit from a detailed assessment of cardiovascular risk. These data will be
fed back to the Hypertension Clinic and to GPs.
Unaffected family members will also undergo detailed assessment of cardiovascular risk. These data will be
fed back to their GP. |
RMG/09/041
08/05/09
13/04/13
ReGrouP |
|
| Feasibility, acceptability and barriers to management of unexplained oro−facial pain. |
| Purpose
To explore the views of stakeholders including patients, general practitioners (medical and dental) and secondary
care practitioners (dental hospital consultants) on the feasibility, acceptability and barriers to management of
unexplained oro−facial pain.
Methods
Study design
A qualitative study using semi−structured interviews with stakeholders (patients and dental and health care
providers).
Study participants and recruitment
A sample of general practitioners (medical and dental) will be recruited from primary care organizations in the North
West of England. All practitioners will be sent a letter inviting them to participate and requesting suitable times and
contact numbers for face to face / telephone interviews. Secondary care practitioners (dental hospital consultants)
and patients will be recruited from specialist facial pain clinics at the Manchester Dental Hospital. Secondary care
clinicians will be approached via e−mail and patients will be identified and approached by their secondary care
consultant who will then pass on their details to the researchers. The researcher(s) will contact the patient and send
information sheets if they are willing to take part. Patients and clinicians will be given at least 24 hours to read and
assimilate the contents of the information sheet following which they will be contacted by the researcher(s) to arrange
an interview if they are willing to participate. Written consent will be obtained at the time of interview by the
researcher(s).
Participants will be purposively sought to provide a range of views. Data collection and analysis will continue until no
new items (range of views) emerge from the interview. It is anticipated that 15 patients and 15 healthcare providers
will be recruited.
Semi−structured interview
The interviewer will adopt a flexible framework for questioning, using open questions to elicit data from participants
and probing to focus on relevant details. Topics will cover experiences and understanding of unexplained oro−facial
pain, experiences and understanding of physical and psychological management of oro−facial pain, and barriers to
delivery of services.
Data Analysis
Digital audio−recordings of interviews will be transcribed and emerging themes and categories identified. In this way,
analysis will take into account the experiences of stakeholders. The development of the coding framework will be
informed by accumulating data and developed and refined through discussions between the full research team and
applied systematically to further data. Thematic categories identified in initial interviews will be explored and tested
and disconfirmatory evidence sought. Finally, the major categories will be integrated and refined to generate our
findings from the data. Cycling between data and the developing analysis, the use of authors from different
disciplinary backgrounds, and presentation of relevant transcripts are established procedural sources of
trustworthiness of analysis. |
The current research is exploring views of stakeholders and therefore information from the current project
whilst not having immediate benefit, will inform a future intervention which itself may have long−term benefits.
The potential long−term benefit to research participants is an early diagnosis of the symptoms that comprise
unexplained chronic oro−facial pain. This in turn ensures that primary health care providers do not allow their
patients to fall victim to the cycle of 'multiple referrals' as referral and management is appropriate at the
outset. This as research has shown compounds the problem.
The study also aims to explore the barriers facing primary health care providers in relation to those patients
who present with unexplained oro−facial pain. A psychological intervention may serve to give a more
desired outcome than one based on correction of mechanical dysfunction which tends to be irreversible and
not improve symptoms in many cases.
All stakeholders will eventually benefit from the information collected in this investigation. Primary health
care providers will gain an enhanced knowledge of this syndrome, enabling them to achieve a better quality
of life for their patients.
Patients will benefit from their primary health care provider having a greater understanding of their pain,
which will subsequently assist pain management. |
RMG/09/038
21/05/09
31/12/10
ReGrouP |
|
| CV181−057 − A multicentre, randomized, double−blind, Phase 3b trial to evaluate the efficacy and safety of saxagliptin added to Insulin Monotherapy or to Insulin in combination with Metformin in subjects with Type 2 Diabetes who have
inadequate gly |
| There are two million people in the UK with Type 2 diabetes. Type 2 diabetes may lead to damage to the eyes, the
kidneys or the nerve endings leading to risk of amputation. It is also associated with cardiovascular events such as heart
attack or stroke. Treatment to reduce blood sugar levels minimises the risk of developing these complications. Currently
available treatments may cause low blood sugar, weight gain and swelling without adequately reducing blood sugar
levels. The study will measure the effect of the study drug saxagliptin on decreasing high blood sugar levels.
Patients with Type 2 diabetes currently treated with insulin or insulin in combination with Metformin with poorly controlled
blood sugar levels will receive either saxagliptin or placebo (dummy drug) in addition to their current treatment. The aim
of this study is to show that the decrease in blood sugar levels will be greater in those treated with saxagliptin in addition to
current treatment to those receiving placebo in addition to current treatment.
435 patients who consent to take part in this 56 week study will receive either saxagliptin or placebo (two patients to
saxagliptin for every one to placebo); will record their daily self blood glucose (finger prick test), their daily treatment doses
and maintain diet and exercise management. They will also undergo physical examination, blood, urine, and heart
function tests at study visits. The study will comprise a screening period, a short term treatment phase of 24 weeks and a
long term treatment phase of a further 28 weeks. Patients will attend a maximum of 15 study visits. A rescue procedure
will be followed for any patient with increased blood sugar levels.
The research will be funded by Bristol−Myers Squibb and patients will be recruited in the UK from hospitals in England and
Wales. |
|
RMG/09/028
16/04/09
16/07/10
NHS SalfoR+D (joint study) |
|
| The effect of FES on gait variability under dual-task conditions, in post-stroke drop foot subjects. |
| Each year stroke affects 174 − 216 people per 100,000 population in the UK. Of these, approximately 20% will
be affected by a drop foot − its presence impeding activities of daily and independent living. Stroke survivors are
up to six times more likely to fall, due to gait impairment, reduced balance and cognitive deficits.
Functional Electrical Stimulation (FES) addresses drop foot by using electrical impulses to create movement in
the muscles that lift the foot. FES improves walking speed and energy consumption during gait. However, users
of FES do not rate these effects as highly as those of reduced effort of walking, reduced risk of falls, and
increased confidence and independence. Furthermore, FES has been reported as reducing the amount of
concentration that is needed to walk.
To date no studies have quantified the effect of FES on the attention given to walking, nor on the effect on falls.
This study will use a novel design to address these two outcomes. Gait variability, collected using a motion
capture system, will be measured to assess fall risk. A dual−task methodology will be applied to assess
attention. This method involves a task that tests memory being performed whilst walking.
The participants will be assessed in terms of their fall history and fall risk. Participants will be asked about any
fall or near fall events during the course of the study and be assessed regarding their fear of falling.
Descriptive data about medical conditions, stroke history and use of any other walking devices will be collected.
The participants will also be described in terms of their general cognitive abilities. During the course of the study,
data concerning use of and the effect of FES will be collected, as well as an overall measure of daily functioning. |
Participants will be contributing to improved understanding of the effects of FES, which will potentially
improve patient care. |
RMG/09/027
02/06/09
01/06/10
NHS SalfoR+D (joint study) |
|
| A study into the role of the Public Health Assistant practitioner (PHAP) in addressing cardiovascular health inequalities in Salford. |
| The 'Evaluation of a Local Enhanced Pilot Project' aims to examine what works in terms of addressing
cardiovascular health inequalities in Salford. Heart disease is recognised as a major public health issue around
the globe. Approximately 10,533 people in Salford suffer with heart disease. A characteristic feature of heart
disease is that it is not evenly distributed within communities, but that more poor people or people who live in
disadvantaged areas are affected in comparison to those living in more affluent areas. The UK government has
decided that tackling heart disease inequalities is to be one of its top priorities and has required all Primary Care
Trusts to develop strategies to address them. One strategy to address such health inequalities is to introduce
the role of the Public Health Assistant Practitioner or PHAP. |
The opportunity to present their views as to the effectiveness of the PHAP role in addressing cardiovascular
disease in Salford. These findings will be used to inform the report which will underpin the evaluation of this
pilot service project in Salford. The benefit to the research participants is manifest in that fact that these views
could help shape the development of future cardiovascular health services in Salford. |
RMG/09/026
22/05/09
11/09/10
ReGrouP |
|
| Professional identity, image and reputation in pharmacy |
| The main purpose of this research is to gain insight, using qualitative methods, into professional identity, image and
reputation in pharmacy. Pharmacists’ jobs have changed in recent years, with pharmacists being expected to take on new
roles which require new skills and activities. In such a time of change, the professional identity of pharmacists, and other
staff or patients’ expectations of pharmacists, is likely to change. Consequently, it would be beneficial to identify how
pharmacists see their own professional identity, and also how they are perceived by other healthcare professionals and by
their patients, to identify to what extent different stakeholders share similar views, and find out what differences in opinion
exist. The study will use qualitative interviews with pharmacists to explore their perceptions of their own professional
identity and image, i.e. how they define themselves in their professional roles and how they believe others see them.
Interviews will also be undertaken with pharmacy support staff, doctors, nurses and patients and other users of community
pharmacies, to investigate the professional reputation of pharmacists, that is, how these ‘others’ perceive pharmacists. |
|
RMG/09/023
02/04/09
02/03/10
ReGrouP |
|
| Best Interests: Implementation of the Mental Capacity Act (2005) in palliative care multidisciplinary teams |
| In recognition of vulnerable adults in England and Wales who may experience lack of mental capacity the Department of
Constitutional Affairs (DCA) introduced the Mental Capacity Act (MCA) (2005), implemented in 2007. The MCA
potentially affects over two million vulnerable people, including palliative care patients, some of whom may experience a
lack of mental capacity in the course of their illness, treatment and care.
There is a lack of research on the implementation of the MCA (2005) since available literature is primarily practice
guidelines rather than research. This study proposes to evaluate how are palliative care patients, who lack decision
making capacity, protected by the multidisciplinary team implementation of the MCA in regards to patients' 'best
interests'. The aim of this research is to generate knowledge that will inform best practice in the care of palliative care
patients.
In this study, qualitative methods will be used to explore how multidisplinary teams implement the MCA as regards 'best
interests' of the patient. The purposeful sample is two separate multidisciplinary teams where the best practice model
'palliative care' is being utilised. Methods of non−participant observation of the two teams and individual interviews with
members of the teams will be used. Observation of team meetings will include only meetings regarding patients with a
diagnosis of a life threatening illness who have a temporary or permanent loss of decision making capacity. Interviews
will include all members of the multidisciplinary teams.
Analysis of the ethnographic data collected during team observations will include thematic analysis of fieldnotes to identify
topic categories and patterns of practice. Content analysis will be used to analyse the written transcripts of audiotaped
individual interviews. Analyses from the two sources of data will be merged to provide cohesive results regarding team
implementation of the MCA in relation to patients' best interests. |
There is no direct benefit anticipated to research participants. However, health care professionals may value and enjoy
the opportunity to discuss approaches to the team practices. It is anticipated that the final results of the study may be of
interest to participants and other professionals involved in care of palliative care patients lacking mental capacity. |
RMG/09/022
09/04/09
31/10/09
ReGrouP |
|
| Experiences of the GP-patient relationship and management in chronic illness: qualitative study of GPs & patients in primary care. |
| The importance of the doctor−patient relationship has been emphasised in British general practice for over fifty years.
However, despite its continuing significance in contemporary primary care, tensions occur. In particular, doctor−patient
relationship may be difficult, especially when patients have complex, on−going or chronic illnesses or needs. Secondly, the
many scientific advances of recent years are often not able to solve such illnesses or needs, and this may be focussed in
the patient’s relationship with their doctor in primary care. Thirdly, UK NHS policy encourages GPs both to follow
guidelines about treatment and to be guided by patients’ wishes – another potential tension for doctor−patient relationship
in primary care.
Previous work carried out by the applicant suggests that for patients with long−term diffuse or chronic problems, holding
work is an important potential outcome or method of management. Holding work has been defined as establishing and
maintaining a trusting, constant, reliable doctor−patient relationship that offers on−going support rather than cure. It
describes doctor−patient relationships when patients have long−term needs which are related to the experience of
complex and chronic problems.
This study aims to explore GPs’ and patients’ experiences of the management of chronic illness in primary care, with a particular focus on investigating the place of holding work in managing people with complex and ongoing problems.
Previous work in this area has focussed on doctors' views, particularly GPs in semi−rural settings. This study will focus on
urban settings and investigate the views of both patients and doctors. Audio−taped interviews will be undertaken with pairs
of patients and GPs. Transcripts of the interviews form the data for analysis. |
|
RMG/09/015
16/03/09
31/12/09
ReGrouP |
|
| Investigation into the different amounts of physical activity undertaken by males and females and the perceived barriers to undertaking physical exercise. |
| This project will investigate the levels of physical activity undertaken by males and females both working within NHS
Heywood, Middleton and Rochdale and living within the Borough of Rochdale. 100 subjects aged between 21−65 will be
selected using quota sampling, 50 male and 50 female participants will be recruited.
Participants will complete an anonymous long form International Physical Activity Questionnaire (IPAQ) along with socio−demographic information such as age, gender, family status, ethnic minority and occupation. The IPAQ is a
validated questionnaire suitable for use with adults aged 15 to 69. The IPAQ has been subject to extensive reliability and
validity testing across 14 sites in 12 countries.
The consent form distributed with the IPAQ will ask participants if they would like to be involved in one of the two focus
groups and will be asked to leave contact details. The focus groups will have a maximum of 10 participants. Male
participants will take part in one focus group and female participants will take part in another. The focus groups will
ascertain the perceived barriers to undertaking exercise and will last for approximately 30 minutes. |
|
RMG/09/013
06/03/09
06/06/09
ReGrouP |
|
| A 24−week, international, multi centre, randomised, double−blind, double−dummy, parallel group, phase IV clinical trial
investigating changes in back pain in postmenopausal women with an osteoporosis related vertebral fracture(s) treated
with eithe |
| Osteoporosis is a disease in which bones become fragile due to low bone mineral density (thinning of the bone) and
therefore more likely to break or collapse (fracture). Some postmenopausal women suffer from back pain because they
have one or more of such fractures in their spine (vertebral fractures).
The medications used in this trial are already on the market and are approved for the treatment of osteoporosis.
The purpose of this trial is to investigate whether the study drug PTH(1−84) (Preotact ®), in addition to its known effect on
osteoporosis, also can reduce back pain caused by osteoporosis related vertebral fractures in postmenopausal women.
The two active treatments given in the trial (PTH(1−84) and alendronate (Fosamax®) will be compared in order to evaluate
their effects (good or bad) on reduction of such back pain.
Approximately 300 post menopausal women aged 50 and above suffering from back pain due to at least one such fracture
will participate in the trial. They will randomly (by chance) be assigned to either one of the two treatment groups below:−active PTH(1−84) and a placebo alendronate
or
− active alendronate and placebo PTH(1−84)
A placebo is a dummy drug that looks like the study drugs, being tested, but has no active ingredients.
Participants will receive either of the treatments for 24 weeks (+/− 2 weeks) and will be involved in the trial for a maximum
of 32 weeks, they will also be given daily calcium and vitamin D supplements throughout the whole trial period.
The participants will be required to attend 6 planned out−patient visits including lab visits.
During the trial the following tests will be performed:
− Blood tests
− Spinal X−ray
− DXA scan (bone mineral density measurement)
The participants will be asked to assess and report the intensity of their back pain on a daily basis to a telephone based
diary system.
At some of the visits the participants will also be asked to complete questionnaires about their physical disability and
quality of life. |
|
RMG/09/011
28/05/09
28/11/10
ReGrouP |
|
| The predictors of foot ulceration in people with rheumatoid arthritis (RA). |
| commonly occur on the toes, the sole of the foot or over bunions. We have found that a third of people with RA who have
ulcers on the foot will have more than one, and around half will have ulcers that will heal and then recur. Unlike diabetes,
there is no evidence to guide the identification and treatment of foot ulceration in people with RA. The aim of this research
is to identify factors that predict which people with RA are at risk of ulceration in order to target care more effectively. We
aim to recruit 150 people with RA who have open foot ulceration and 300 people with RA who have never had a foot ulcer
with the assistance of clinical collaborators at 7 sites throughout the UK. We will examine both groups and assess
Many people with RA experience foot problems, and around one in ten will develop an ulcer on the foot. Ulcers whether they have any problems with their circulation or the feeling in their feet and how high the pressure is underneath
their feet when they are walking. These are all known risk factors for foot ulcers in people with diabetes and therefore it
makes sense to check if these are equally important in patients with RA. In our study, we will also assess how active the
arthritis is in both groups, measure foot deformity and ask what medication people are taking. We will ask both groups to
complete two questionnaires: one which looks at the impact of foot problems on the individual and one which assesses
people’s ability to carry out self care. The information gained from the two groups – those affected by ulcers and those
not − will be compared by a statistician using the latest computer technology. The analysis will tell us which factors are
linked with an increased chance of developing a foot ulcer |
|
RMG/09/008
11/03/09
11/02/12
ReGrouP |
|
| Detecting primary open angle glaucoma in a GP setting |
| Patients attending a north Manchester GP practice (Collegiate Medical Centre) who are over 50 yrs of age will be invited to
participate. Other than age there will be no other selection criteria. Selected patients will be given an information sheet
describing the project and what is involved if they agree to participate. Those agreeing to participate will be asked to sign a
consent form and will then undergo a visual field test conducted by a specially trained Healthcare worker. Total test time
(both eyes) is approximately 5 minutes. During the test patients will be presented with a series of patterns which include
either 2, 3 or 4 lights and asked to report the number they see. Most patients will be presented with only 7 patterns to each
eye although in approximately 10% of cases the number of patterns will be increased to 20. The number of patterns is
increased when 1 or more of the stimuli in the preceeding 7 paterns has been missed. Patients who fail the screening test will enter an already established pathway for suspect glaucoma cases seen by optometrists within Central Manchester.
This pathway starts with the patient being referred to one of 12 specially trained optometrists working within the community. These optometrists have been trained at Manchester Royal Eye Hospital and, since 2001, have been reviewing all suspect glaucoma referrals from all other optometrists. They perform a series of diagnostic tests including a measurement of the inraocular pressure, a measurement of the visual field and an examination of the optic nerve head. The results from these tests are used to decide whether or not the patient meets the referral guidlines of Manchester Royal Eye Hospital. If they meet the guidlines they are referred directly to the Hospital otherwise they are advised that they do not have glaucoma but should continue to have regular eye examinations at their optometrist.
Results from all examinations conducted by these specially trained optometrists are sent to Manchester PCT for payment
and subsequently to the hospital for audit purposes. These results would be made available to the researchers. |
No risks, only burden is the additional time required to conduct the test. |
RMG/09/005
31/03/09
01/04/10
ReGrouP |
|
| Attachment in Adults with Intellectual Disabilities; The Development and Preliminary Validation of a New Criterion Q Sort Scale |
| Research suggests that early attachment relationships are highly predictive of later relationships; therefore, securely attached infants are more likely to be securely attached adults. However, as yet a there has not been a measure developed specifically for this population of people (Janssen et al 2002) with research relying on measures validated for a normative population. We are therefore, proposing to develop such a measure using Q sort methodology as our basis.
In the Q sort method the participant is given a set of statements previously developed. The participant sorts the statements into piles that represent the degree to which that characteristic or statement is true to the question being asked. Here the question being asked is how much the statement represents secure attachment in those with Intellectual disababled person according to the participants views. This type of method has been used to develop scales such as the Adult Attachment Q sort (Kobak 1989), The Marital Q sort (Kobak and Hazan, 1991), The Attachment Q sort for use with Autistic children (Rutgers et al 2007), The Adult Attachment Behaviour Q set (Wampler et al 2004) and the Maternal Behaviour Q set (Pederson and Moran 1995a). |
There will be no direct benefit to the participant when taking part however we hope that completing the Q sorts will give participants chance to discuss their own ideas about attachment and ultimately lead to the development of a new psychometric measure that participants and the wider psychological community can utilise in their work. |
RMG/08/134
09/02/09
09/01/10
ReGrouP |
|
| A qualitative study of patients' and primary care practitioners' understanding of empowerment within the management of chronic disease. |
| Empowerment has been defined by patients with diabetes in a number of ways; enabling people to take control of their lives; contribute to decision−making with professionals in the management of their condition, and deal positively with uncomfortable emotions. Empowerment has been defined as both a process and an outcome. However, little is known about how patients' and practitioners' understand empowerment in relation to chronic disease management, and how they think it can best be brought about.
The aim of the study is two−fold.
1. Understand the meaning of empowerment from the perspective of patients, and to understand factors that support or hinder empowerment.
2. Understand the meaning of patient empowerment from the perspective of primary care practitioners, and to understand factors that support or hinder their ability to empower their patients.
Developing a better understanding of empowerment will assist in the development of relevant interventions to assist both patients and professionals. It will also assist in the development of measures of empowerment, to enable the effects of such interventions to be tested. This research represents the first stage in a postgraduate project designed to develop and validate an instrument to measure empowerment in patients with chronic disease in primary care. |
Patients may benefit from talking through their experiences of living with a long term condition. |
RMG/08/133
10/03/09
09/03/10
ReGrouP |
|
| Understanding the factors influencing the prescribing decisions of nurse and pharmacist non-medical prescribers - An exploratory study |
| Historically in the United Kingdom (UK) only doctors and dentists were legally able to prescribe medicine to patients. Since
1994, however, major developments have taken place which has enabled prescribing by a number of other health care
professionals (HCPs) including: nurses, pharmacists, radiographers, physiotherapists, chiropodists/podiatrists and
optometrists. Since these HCPs are not considered to be medically trained, unlike doctors and dentists, the term
‘non−medical’ is often used to describe their prescribing.
Analysis of primary care data (primary care is a term used for the activity of a health care provider who acts as a first point
of consultation for the community i.e. GPs, practice nurses) in England shows that non−medical prescribing is rapidly
increasing. This increase reinforces the need to understand more about the prescribing behaviour of non−medical
prescribers. Research has found that prescribing decisions are influenced by a wide range of factors and are not always
driven by purely therapeutic motives. However, the vast majority of this research has focused on doctors prescribing and it
is uncertain how this literature can be applied to non−medical prescribers. Research is therefore required to fill this gap in
current knowledge. The overall research question posed by this study is the following: What are the factors influencing the
prescribing decisions of nurse and pharmacist non−medical prescribers’ working in primary care?
This small exploratory study is intended to be the first step in a larger programme of work. It is hoped that this study will
help refine the research question, help generate objectives and contribute to the research design of future research. A
small number of nurse and pharmacists prescribers working in primary care will be asked to take part in an in−depthinterview in which they will discuss their role, use of prescribing and the factors which they believe influence their
prescribing decisions. |
|
RMG/08/132
22/01/09
22/09/09
ReGrouP |
|
| An Oberservational Follow-Up Study of Patients Previously Enrolled in Exubera Controlled Clinical Trials. |
| Ongoing safety review of Exubera has indicated that lung cancer occurred in a few more patients who were taking
Exubera than patients who were taking other medications for diabetes. Therefore this study aims to evaluate whether
participants previously treated with Exubera in controlled clinical trials are more likely to die from lung cancer
compared to participants treated with a comparator (a comparator is a drug or placebo which the study drug is
compared against).
This is an observational study in which patients will be followed−up for 2 years and lung cancer mortality rates will be
recorded. Mortality rate was determined to be the most appropriate endpoint for this study as lung cancer screening
is invasive and does not detect early lung cancer so is of limited benefit to the patient. In addition two years was
determined to be an appropriate follow up period as all cases of lung cancer in the Exubera clinical programme were
observed after a mean exposure period of 14 months and within 2 years of randomisation.
The study is designed to obtain data from the largest available source of Exubera treated patients, the clinical trial
population, with minimal effort on the part of the investigator and patients. In addition this study design allows clinical
trial data already obtained to be combined with data obtained in this study and will provide data prior to Exubera
exposure, including history of diabetes, details of smoking history, details of other medications and past medical
history. |
|
RMG/08/129
23/01/09
01/04/12
NHS SalfoR+D (joint study) |
|
| The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes. A 26-week, randomised, open-label, parrallel-group, multicentre, multinational trial with a 26-week e |
| The aim of this study is to investigate the effect of insulin detemir in combination with liraglutide and metformin compared
to liraglutide and metformin in subjects with type 2 diabetes
Both liraglutide and insulin detemir are liquids that are administered by an injection under the skin (subcutaneous).
Liraglutide and insulin detemir will be provided to patients in injection pens.
A planned total of 940 subjects from the following countries will take part in the study: Belgium, Canada, France, Germany,
Italy, The Netherlands, Spain, the UK and the US.
Subjects will be asked to attend a total of 13 clinic visits and be available for 22 telephone contacts if allocated to the
randomised arm or 10 clinic visits in the non randomised arm over a period of 67 weeks. This includes a screening period
of 2 weeks a run in period of 12 weeks and a randomised period of 52 weeks. |
|
RMG/08/127
01/03/09
31/03/11
NHS SalfoR+D (joint study) |
|
| A within patient, placebo controlled, proof of concept trial to assess the efficacy of Juvista in improving the appearance of existing scars that are 2-6 months old. |
| Renovo, a biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2−6
months old using Juvista. Juvista has not previously been administered to pre−existing scars without surgical revision, but
it is thought that some beneficial effects seen with Juvista in previous trials may also be seen when administered to
existing scars whilst the scar is maturing. This proof of concept study will therefore investigate the effect of Juvista in
Caucasian male and female patients when administered to scars that are between two and six months old.
Scarring in the skin can vary hugely between individuals; therefore the most reliable way to assess the efficacy of an
improvement of scar appearance is to use a model where each patient acts as their own control. A placebo (a dummy
treatment with no active ingredient)will also be used for this trial as there are currently no approved pharmaceuticals for
the improvement of scarring.
A total of 40 patients will be equally allocated to one of two dosing groups. Patients who enter the study will have linear
scars resulting from broken skin (e.g. trauma, surgery) between 7 and 20cm in length, as well as meeting other specific
criteria. The scar to be treated will be divided into two equal segments. Each segment will receive an intradermal injection
of Juvista or placebo on Day 0 and 24 hours after Day 0.
The measure of change in scar appearance will be performed using colour analysis which will assess the change in colour
between the Juvista treated segments versus the placebo treated segment of the scar, with reference to the surrounding
skin within each patient. |
|
RMG/08/124
08/01/09
08/02/10
ReGrouP |
|
| Evaluation of 'Find and Treat' Cardiovascular Screening Programme, Ashton, Leigh and Wigan Primary Care Trust |
| Cardiovascular disease (CVD) is the biggest cause of mortality and poor life expectancy in Wigan. The control of known
risk factors is a proven means of reducing the burden of CVD at the population level. The ‘Find and Treat’ CVD screening
programme in Ashton, Leigh and Wigan PCT, uses GP records to construct a CVD risk score in those aged 50−74. Those who have a 10 year risk of 20% (‘high risk’) or more, and those who have incomplete records are invited for a screening interview. Measurements of CVD risk factors are recorded and appropriate advice and treatment given.
The aims of the evaluation study are to:−
1. Examine the effectiveness of the programme in reducing morbidity and mortality from CVD and from other circulatory
diseases. This will be investigated using anonymised data files in relation to the screening, and data linked to morbidity
and mortality statistics.
2. Evaluate the effectiveness of treatment regimens and support with lifestyle change in reducing risk factors for CVD. Anonymised data files for a sample of screened and unscreened, high and low risk patients will be used to analyse
changes in risk factor profiles. A questionnaire will be sent to these four groups to analyse information on health beliefs
and changes in lifestyle factors.
3. Monitor and assess procedures for recording CVD risk factors in practice based databases. The completeness and
accuracy of screening protocols and record completion will be examined. Views of practice staff will be used to evaluate
the effectiveness of the screening procedures.
This knowledge will be important for reducing CVD morbidity and mortality. The last evaluation of a community based intervention for CVD risk took place in East London in the 1970’s. There have since been marked improvements in treatment for CVD and lifestyle interventions for CVD risk factors |
|
RMG/08/123
03/03/09
03/03/12
ReGrouP |
|
| A double-blind, double-dummy, parallel group, randomised study to compare the efficacy and tolerability of oxycodone / naloxone prolonged release (OXN PR) and codeine / paracetamol in the treatment of moderate to severe chronic low back pain or pain |
| Oxycodone is a pain killer that belongs to a class of drugs known as opioids (morphine is another opioid). Oxycodone
was launched in the UK in January 2000 as a prolonged release formulation (Oxycontin®) and is authorised for the
treatment of moderate to severe pain.
Although highly effective, a common side effect of the use of opioids is constipation. Constipation can be very
uncomfortable for the patient and in some cases it can be so severe that patients opt to discontinue therapy.
Oxycodone / naloxone prolonged release (OXN PR) tablets have been developed in order to combine the analgesic effect
of oxycodone with the opioid antagonistic property of the drug naloxone which prevents the onset of opioid−induced
constipation without altering the analgesic effect of oxycodone.
OXN PR was launched in Germany in 2007.
The purpose of this study is to demonstrate that OXN PR is as good as the commonly used analgesic, codeine /
paracetamol combination tablets, in the treatment of pain associated with low back pain or osteoarthritis. |
|
RMG/08/118
23/01/09
23/01/11
ReGrouP |
|
| Role transition to qualified nurse: experiences of children's community nurses. |
| The purpose of this study is to investigate the experiences of newly qualified nurses who are making the role
transition from student nurse to working as a children's community nurse. A children's community nurse cares
for ill children in a community setting rather than in hospital. The purpose of the study is to find out how
newly qualified children's nurses experience transition and the circumstances that facilitate or inhibit this role
transition. The intention is to describe and interpret what happens in the clinical practice setting, how the
nurses see their actions and the context in which their actions take place (Mason 2002). This study will help
illuminate these nurses experiences in order to highlight good practice and help education and practice to
enhance the transition for newly qualified children's nurses in the future.
A qualitative methodology using ethnographically orientated methods appears to best suit the aim of this
study by providing detailed theoretical descriptions of how they interpret their experiences and the meaning
of transition from their perspective (Glaser & Strauss 1967, Willis 1977, Hammersley & Atkinson 1995).
The participants of the study will be the consenting newly qualified children's nurses employed as a result of
the expansion of CCN teams in Greater Manchester, East Cheshire and High Peak Primary Care Trusts.
Within this locality the Primary Care trusts are Oldham, Bury, Heywood, Middleton and Rochdale, Trafford,
Stockport, Manchester,Salford, Bolton, Ashton Leigh & Wigan, and Tameside & Glossop. |
|
RMG/08/114
26/01/09
26/03/11
ReGrouP |
|
| The Genetic Basis of Familial Epilepsy in Wales. |
| Idiopathic epilepsy has a strong genetic basis and at present 12 genes have been described in the literature
that cause the various seizure phenotypes. These are often found in rare families that have clear inheritance patterns and
large pedigrees, but the scientific consensus is that many more gene associations lie undiscovered. This is not surprising
since there are many biological candidates that can trigger an unhappy brain into seizure. Despite this success in rare
families, the majority of cases the inheritance is complex and largely resistant to classical genetic approach. However, it is
important to ensure that all monogenetic epilepsy genes are found before launching into expensive and time−consuming
complex genetic / genomic analysis. This project will attempt to identify other epilepsy genes that are an important cause of
epilepsy in Wales. |
There are no immediate or direct benefits for participants taking part in the study. In rare circumstances the samples
collected may yield information which could be used in a clinical setting. For example, if a specific gene change is identified
in a family then it may be possible to offer genetic testing to interested family members.In this instance the project genetic counsellors will inform consenting participants of the findings. All further care and responsibility for these families will then transfer to a clinical medical genetics team so that a clear distinction is made between the research project and the clinical duty of care. |
RMG/08/109
23/12/08
23/12/11
ReGrouP |
|
| Long-term (3years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapuetic doses (2.557.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An interna |
| The main aim of this study is to confirm, in the long-term, the absence of any toxic effect of a drug, called ivabradine, on the retina when administered to patients with chronic stable angina. Ivabradine has been developed for the treatment of stable chronic angina. It mainly works by lowering the heart rate by a few beats per minute. This reduces the heart’s need for oxygen especially in situations when an angina attack is more likely to happen. In this way, ivabradine helps to control and reduce the number of angina attacks in patients suffering from angina pectoris.
(text taken form PIS) |
|
RMG/08/108
10/03/09
30/11/13
ReGrouP |
|
| Learning disability staff responses to allegations of sexual abuse: the influence of claimant gender, multiple allegations and perceived sexuality. |
| Research shows that the prevalence of sexual abuse is higher within learning disabilities than in the general
population (Bailey, 1997). A report commissioned in 2001 by Voice UK, Respond and Mencap estimates that
people with learning disabilities may be as much as four times more likely to become victims of abuse, and
are the most ‘at risk’ group within society (‘Behind Closed Doors’, 2001). Other figures suggest that the
prevalence rates within the learning disabled population could be as much as 95% (Matich−Maroney, 2003),
depending on the definition of sexual abuse used. In addition there is considerable evidence to suggest that
the majority of the victims of sexual abuse are female. Brown & Turk (1994) found that 73% of victims were
female and only 27% male.
Despite the high prevalence rates, very few perpetrators of sexual abuse against somebody with a learning
disability will ever be convicted of the crime (Cooke & Davies, 2001). One study estimates that only 6% of
cases of alleged sexual abuse of people with learning disabilities end in prosecution (Brown et al.,1995). The
reasons why this may be the case include reluctance of the Crown Prosecution Service to prosecute when
the victim is vulnerable (for instance has an enduring mental health problem or learning disability), poor
communication skills, a dependence on others for personal/intimate care and a poor comprehension of
sexual activity and what it involves (Peckham, 2007). The common denominator within these possibilities is
the victim themselves. There is very little research which examines the impact others, for example those
close to the victim, may have on the outcome of sexual abuse allegations. The judicial process which (may or
may not) take place has to be initiated somewhere, and this is highly likely to be by the person who receives
the allegation of abuse. When a person makes such an allegation, attribution theory tells us that there will be
certain factors which affect our appraisal/ assessment of it and subsequently, our emotional and behavioural
response to it. This means that different types of allegation may bring about differential effects on how
individuals and organisations respond.
The aim of the research is to examine whether this is the case, which factors may influence the outcome for
the victim, and why. The limited amount of research which exists in this field justifies the use of null
hypotheses.
The hypotheses being tested are as follows:
1. There will be no significant effect of claimant gender on the attribution styles, emotional responses and
helping behaviour of staff.
2. Responses to adults making a repeated allegation of sexual abuse will produce similar responses to those
making a first allegation.
3. There will be no effect of perceived sexuality of the claimant (promiscuous vs. asexual) on responses of
staff.
In order to do this, a mixed method design will be employed. The first part will involve administering
questionnaires via post to potential participants (identified as such by their current employment within
learning disability services). The questionnaire will comprise a vignette or scenario which outlines a situation
in which an adult service user alleges that they have been abused by another person. This will be followed by
13 questions, to be answered along a rating scale. This data will be analysed quantitatively and will directly
test the above hypotheses. The design is a 2x2x2 factorial analysis of variance (ANOVA): |
|
RMG/08/103
26/01/09
26/07/09
ReGrouP |
|
| Study ID: NN304-3573. A multicentre, open label, non-randomised, non-interventional study to evaluate the safety of self-titration in insulin-naïve people with Type 2 diabetes treated with insulin detemir and oral antidiabetic agents. The SOLVE St |
| The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid
late stage complications of diabetes. Self−titration (where patients adjust insulin dosage themselves) offers the potential
for better blood glucose control than titration only at clinic visits.
In recent years treatment of Type 2 diabetes in the UK has moved from hospitals to GP surgeries or local clinics. People
with Type 2 diabetes, in general, have not been trained in self−titration to the same degree as people with Type 1
diabetes. Less experience in self−titration could impact the level of blood glucose control and outcome for these people.
The main objective of the study is to assess the safety of self−titration in people with Type 2 diabetes on antidiabetic
tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose
adjustment, clinic visits, and time spent on training in self−titration.
An observational, non−interventional study design has been chosen. This means that patient data are collected following
routine clinical management |
|
RMG/08/098
19/11/08
18/04/10
ReGrouP |
|
| A randomized, double-blind, placebo-controlled, parallel group study to determine whether, in patients with type 2 diabetes at high risk of cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal |
| The null hypothesis to be tested is that the hazard ratio for primary efficacy variable is equal to 1, versus the
alternative hypothesis that hazard ratio is not equal to 1. If the hypothesis can be rejected it will show that aliskiren is
superior to placebo on top of conventional therapy.
Aliskiren is a Renin−Angiotensin−System (RAS) blocking agent. Previous studies with other RAS blocking agents
have shown a separate renal benefit for patients with diabetic nephropathy and cardiovascular benefit in patients at
high risk for cardiovascular events. It is hoped that the study will show both renal and cardiovascular benefits to this
group of patients.
Participants will be randomly allocated aliskiren or placebo in addition to their current conventional treatment. The
placebo arm is justified as all participants will continue to be treated with their conventional treatment as prescribed
by their doctor.
The study is planned to start in the UK in Nov 2007, recruitment to the study will be open until January 2010. Data
will be monitored and collected on an ongoing basis and analysed at regular intervals for safety and efficacy
assessments. Participants will remain on study (and on study treatment) until the required number of cardiovascular
and renal endpoints have occured, at which point all participants will be asked to stop treatment in line with a
common study end date. Database lock will occur once all data is clean and in the study database. The final study
report will be completed within one year following last patient last visit.
Participants will have to attend regular (3 monthly) study visits potentially for 4 years or more. This is more than
would be required by standard care, however this regular care may show some beneficial effects for the participants.
If the study doctor thinks that the patient may be suitable to enter the study, the patient will be invited to discuss the
study and the study will be explained to the pateint as part of the informed consent process. Should the patient wish
to enter the study and gives their written informed consent they will enter the screening phase of the study.
Screening may last from 4 to 12 weeks and will involve 2 to 4 visits to the clinic or surgery.
At the first screening visit the following will be carried out − an assessment of the patient's eligibility to enter the study,
full medical history, full physical examination, vital signs (blood pressure and pulse), height & weight measurements,
recording of medications already being taken, blood samples and a pregnancy test for women of child bearing
potential.
At the second screening visit the patient's eligibility will be re−assessed as will the vital signs and the recording of
medications. In the week prior to this visit participants will have been asked to collect 3 first morning void urine
samples, patients will be asked to take these to the visit. Blood samples will be taken.
Should the concentration of serum creatinine differ by 20% or more between visits 1 and 2, |
|
RMG/08/096
20/11/08
19/04/14
ReGrouP |
|
| Placental regulation of insulin-like growth factor bioavailability and fetal growth in diabetic pregnancy |
| STUDY 3: How is the level / activity of alkaline phosphatase altered in diabetic pregnancy?
Our hypothesis predicts that the level / activity of alkaline phosphatase will be low in pregnancies complicated
by growth restriction and enhance in pregnancies associated with macrosomia. this will be tested by
comparing the alkaline phosphatse level / activity in samples from (i) women with diabetes who give birth to
babies with growth problems (ii) women with diabetes who give birth to normal birthweight infants and (iii)
women without diabetes who give birth to normal birthweight infants.
Subject suitable for participation in study 3 include:
(i) women aged 18 years or older who deliver a singleton infant with a birthweight between the 10th and 90th
centiles in weeks 38−42 of gestation;
(ii) women with type I or type II diabetes aged 18 years or older who deliver a singleton infant with a
birthweight between the 10th and 90th centiles in weeks 38−42 of pregnancy;
(iii) women with type I or type II diabetes aged 18 years or older who deliver a singleton infant with a
birthweight below the 10th or above the 90th centile in weeks 38−42 of pregnancy.
These women will be identified during the antenatal clinics of St Mary's Hospital (normal pregnancy and pregnancies complicated by diabetes) or Hope Hospital (pregnancies complicated by diabetes) and told
about our research project by the dedicated research midwife / clinical research fellow. The potential
participants will also be given an appropriate information sheet and will be asked to consider participating in
this study. At an approprite point before the delivery of their infant (as judged by the clinical staff responsible
for their care) they will be asked if they have had sufficient time to read the information sheet and if so,
whether they consent to taking part in our study. If consent is given then,we will collect data regarding
smoking history, weight gain, proteinuria, blood pressure, and where appropriate, type and control of
diabetes. Following delivery of the baby, mode of delivery, placental weight and sex of the infant will be
recorded and anthropometric measurements (length, weight, head circumferance, triceps and subscapular
thickness and upper arm circumferance) of the infant will be made. We shall also obtain a sample of amniotic
fluid and maternal and umbilical cord blood. The placenta and samples will be transported to the laboratory
and that will be the end of the subject's participation in the study. |
|
RMG/08/090
10/11/08
30/06/11
Salford Royal Foundation Trust |
|
| Do cancer patients receive timely and appropriate information? |
| The research will be qualitative using a phenomenological approach. The rationale for using this approach
is because the researcher is aiming to capture people's perceptions of their experiences of receiving
information throughout their cancer journey. Alfred Schulz describes phenomenological assumptions as,
"things (phenomena)are real to the extent and ways in which they are experienced and acted upon; however,
if two persons percieve the same thing in different ways, then for each the thing is different". The researcher
aims to study the perceptions of cancer patients based on experience.
The sample will be 6 participants, the reason for the small scale study is because timescales are restricted
due to the study being part of an MSc. The research design will include semi structured interviews with
cancer patients/survivors aged of 18 years and above. The reason for the choice of age range is that the
researcher's role encompasses adults and she is not knowledgeable in addressing the needs of children with
cancer.
The 6 participants will be interviewed individually and anonymously, tape recorded semi−structured
interviews will be conducted in a PCT building. However, if the participant is unable to attend the planned
venue the researcher will suggest conducting the interview in the participant's home if they provide consent.
The tape recordings will be transcribed and destroyed after transcription. The transcripts will subsequently be
shared with the participants to establish accuracy. Any significant themes emerging will be compared to the
literature review to enhance validity. Themes and concepts emerging will be identified using a research framework, coded, compared and contrasted with each other. |
|
RMG/08/088
12/11/08
12/07/09
ReGrouP |
|
| Is there a difference in gleno-humeral subluxation in sitting and standing insubject with hemiplegia following stroke |
| Stroke affects up to 216 people per 100,000 in the UK annually (Royal College of Physicians – 2004) and its
survivors account for a large proportion of the disabled population. Shoulder subluxation (ie a gap in the
shoulder joint caused by separation of the two joint surfaces)is a common symptom following stroke –
occurring in up to 75% of patients (Turner−Stokes and Jackson, 2002). This occurs because the
glenohumeral(shoulder) joint is mainly held in place by muscles and their tendons – notably the rotator cuff
(Wilk, Arrigo and Andrews, 1997). Following a stroke these muscles become paralysed or weak as a result
of a decrease in the motor output from the brain(Shepherd and Carr, 1998). This leads to inferior subluxation
(dropping of the head of humerus away from the shoulder). This is evident as the arm hangs dependant
under the influence of gravity when people are sitting or standing. The rotator cuff muscles are predominantly
slow oxidative (tonic) in nature,this enables ongoing postural support without fatigue. This is one of the main
mechanisms keeping the gleno−humeral (shoulder) joint in place. This stability is lost in some people
following stroke and this study aims to measure whether changing posture (moving from sitting to standing)
influences shoulder joint stability by altering the amount of anti−gravity activity that is required. The positions
of sitting and standing are to be used as subluxation would be evident and measurable in both of these
postures but may vary as standing requires greater postural control and anti−gravity activity than sitting.
There may therefore be a measurable difference in subluxation between the two − if this hypothesis is
supported then this would suggest that shoulder stability can be influenced by altering base of support and
centre of gravity (as occurs when moving from sitting to standing.
Current practice for this problem includes the use of external supports to realign the gleno−humeral joint eg
by use of slings, strapping and supports. These have been studied in depth but without firm conclusions
made regarding effectiveness (Morley, Clarke, English and Helliwell, 2002, Turner−Stokes and Jackson,
2002) |
|
RMG/08/087
09/10/08
09/05/09
ReGrouP |
|
| District nurses and their provision of palliative care. An ethnographic study. |
| Palliative care is provided to those who have life−threatening illness, and can be offered from early in the course of an illness through to death and bereavement (1). Whilst care can be given in any settings, most of those needing palliative care spend much of their last year at home, and home is the preferred place of care and death (2). Community palliative care services are therefore important to the way patients and their carers experience the palliative phase of illness.
Community palliative care is delivered both by those who specialise in its provision (such as hospice services, or Macmillan nurses), and those who are generalists (such as district nurses or general practitioners), but who nevertheless provide most palliative care to patients. Whilst there is much research investigating aspects of specialist community palliative care provision such as referral issues, equity of access to services, and the quality and outcomes of care, the evidence base regarding patients cared for by generalists is scant (3−6). The scarcity of research into this area is surprising given that many more palliative care patients are cared for in the community by general services such as district nursing than specialist
services (7). |
|
RMG/08/086
08/10/08
07/10/10
ReGrouP |
|
| UK study of Childhood, teenage and Young Adult Brain tumours (UK CYAB): A pilot study |
| This is a charity funded pilot study aiming to establish processes and procedures for a full national study of risk
factors for brain tumours in children, teenagers and young adults. The pilot project will collect questionnaire
and medical information from parents and patients and controls as well collecting blood samples and/or buccal
mouth scrapes from study particpants. |
|
RMG/08/079
20/10/08
28/02/10
ReGrouP |
|
| Low Level Laser Therapy for Carpal Tunnel Syndrome |
| Low level laser therapy is a therapeutic tool with growing popularity in medicine. The effect on human tissue is not heat mediated as in surgical laser but it is rather through a mechanism taking place at the cellular levels reducing inflammation and enhancing healing process. Clinical trials as well as laboratory studies have shown this modality to reduce pain, oedema and inflammation associated with different pathological conditions affecting the muscles and nerves.
Carpal tunnel syndrome is a condition in which a nerve called "median nerve" is trapped at the wrist due to local oedema causing pain, tingling and even weakness of the hand. In this study, low level laser therapy will be applied on hands with carpal tunnel syndrome to find out whether or not it could help curing this condition or at least alleviating it. This research will be very useful for the scientific community and for the patients with carpal tunnel syndrome and the questions asked are of
huge importance to further understand this therapeutic tool and make the best of its applications. |
|
RMG/08/078
15/11/07
15/12/09
ReGrouP |
|
| Beyond Return to Work: A longitudinal study of psychosocial factors, workplace adjustments and support associated with effective return to work for cancer survivors |
| Past research has provided a useful insight into the return to work patterns of cancer patients. However, many of the findings that have been presented are based on studies conducted in the USA and Scandinavia. Thus, there is a need to consider patients from the UK. Further to this, existing research investigating post return to work has predominantly focused on changes in survivors' work capacity / ability associated with physical / cognitive impairment. Consequently, the proposed study aims to go beyond this and consider how psychosocial well−being may change over time following return to work. This would enable both psychosocial well−being and subsequent post return to work behaviours to be mapped (i.e. withdrawal from the work force, sickness / absenteeism, change in employment).
Aims and objectives:
1) To examine the prevalence and impact of depression among cancer survivors returning to work
2) Investigate whether workplace adjustments, and support from colleagues and managers, buffer the effect
of depression on return to work and over time
3) To explore whether self−efficacy (confidence in resuming work tasks and managing health) buffers the
effects of depression on return to work over time |
|
RMG/08/075
24/12/08
31/12/10
ReGrouP |
|
| Cognitive-Behavioural Therapy for Bipolar Disorder: A Case Series |
| Bipolar disorder (previously known as manic depression) is a severe mental health problem characterised by significant fluctuations in people’s mood, involving periods of depression and periods of mania during which the individual becomes elevated and/or highly irritable. These periods of mood fluctuation also involve extreme changes in the way people think and behave. For example, during depression individuals may feel hopeless and suicidal, withdraw from social activities and have difficulty functioning resulting in a neglect of self−care and basic needs. During mania, individuals may experience delusional beliefs, become highly distractible and prone to engaging in high−risk activities such as excessive spending or drug−taking. Both mood states can result in significant impairment in work, social or daily functioning and may result in
hospitalisation. Furthermore, individuals with bipolar disorder usually experience a chronic course of the illness due to multiple relapses, causing them significant long−term disability.
Cognitive−behavioural strategies have been previously used with bipolar disorder, and there are a number of existing therapy manuals which have been found to be useful in managing symptoms and preventing relapse. However, an integrative model−driven approach has previously not been developed for this disorder, and current understanding of the specific psychological processes and mechanisms involved in bipolar disorder are limited. A recent cognitive model proposes that people with bipolar disorder experience extreme mood changes as a result of the multiple and conflicting appraisals they hold about changes in their internal state. These appraisals lead to the use of certain behaviours that subsequently exacerbate mood changes. The use of this cognitive model has to date been reported in three published case studies (Mansell & Lam, 2003; Mansell, 2007 & Mansell et al, 2007b) and has been found to be very useful from
client reports. However, a new 12−session course of cognitive behaviour therapy based on the model has
now been developed and it is necessary to evaluate this model−based therapy in a case series and to elicit
feedback from clients on its strengths and areas for improvement. |
|
RMG/08/069
24/11/08
24/06/10
ReGrouP |
|
| Empathy in Adult Offenders and Non Offenders with Disabilities |
| This study is a quantitative project. Two independent groups of people with learning disabilities will be studied: offenders
and non−offenders. They will be matched on variables of age, gender, ethnicity and verbal ability.
This study will employ standardised assessments to investigate verbal ability, cognitive empathy and affective empathy in
offenders and non−offenders with learning disabilities. The study will also examine whether there is a significant relationship between age, gender, verbal ability, autism and empathy.
Two carefully selected questionnaires and two brief vignettes will be used to explore both cognitive and affective empathy,
as previous studies within the general population have found cognitive empathy to have a stronger negative relationship with
offending than affective empathy (Jolliffe & Farrington,2004). Only two types of offenders (violent and sex offenders) will also be recruited, so that it will be possible to explore differences in empathy between them, and hence the appropriateness of standard empathy training for both types of offences. |
|
RMG/08/066
03/11/08
31/08/09
ReGrouP |
|
| From Legitimate peripheral participation to full participation? Investigating the career paths of mature physiotherapy students in a context of changing NHS employment opportunities |
| Until recently NHS staff shortages meant that physiotherapy students were assured of an NHS post as a
physiotherapist on graduating. This is no longer so. Statistics showed that only 15−20% of the 1,523
graduates in 2005 found such jobs: in 2006 just 12% of the 2,238 graduates found a permanent
physiotherapy junior post. This is happening in the context of the current crisis of funding in the NHS, the
restructuring of the service through Agenda for Change and widening participation in initial training. There is,
however, no robust evidence about what other physiotherapy graduates did next or about their longer−term
prospects of entering the profession. Contradictions are evident here. Despite policy and practice measures
intended to help staff the NHS (including an increase in student numbers promoted by the government),
anecdotal evidence of mid−course dropout and non−physiotherapy destinations suggest resources in initial
training (£73 million in 2005) may be being wasted. This may also lead to a fall in recruitment to
physiotherapy degrees, threatening a future recurrence of staff shortages. |
|
RMG/08/063
01/09/08
30/10/09
ReGrouP |
|
| A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 1356 (5.0 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient gl |
| Type 2 diabetes (T2D) accounts for 90 95% of all cases of diabetes and is an increasingly prevalent disease
with an estimated 180 million affected people worldwide. The incidence of T2D is expected to double during
the next 20 years, and the high frequency of complications leads to a significant reduction in life expectancy.
In patients with T2D, the insulin produced by their pancreatic beta cells does not work properly (known as
insulin resistance), and in order to keep blood glucose levels under control, the beta cells have to increase
their production of insulin over time. Eventually, the beta cells cannot keep up with this increased insulin
demand. Glucose control continues to deteriorate progressively over time and after the failure of diet and
exercise alone, a new intervention with oral glucose lowering agents is generally needed every 3 4 years
to retain good glucose control.
A range of oral glucose lowering agents are currently available with different mechanisms of action, but to
date, none of these can prevent the progressive failure of the pancreatic beta cells, and many patients with
T2D eventually require insulin injections in addition to, or instead of, oral agents to control their blood
glucose. Furthermore, some of these oral glucose lowering agents (such as insulin secretagogues) increase
the production of insulin via a mechanism that does not involve glucose (i.e. it is glucose independent), and
so carry a risk of lowering the blood glucose too much (hypoglycaemia) due to inappropriate insulin secretion. |
|
RMG/08/059
30/07/08
30/11/10
ReGrouP |
|
| GETGOAL−L: A randomized, double−blind, placebo−controlled, 2−arm parallel−group, multicenter study with a 24−week main treatment period and an extension assessing the efficacy and safety of AVE0010 in patients with Type 2 diabetes insufficiently cont |
| The purpose of the GETGOAL−L study is to see whether adding AVE0010 to basal insulin(insulin given to provide continuous background levels throughout the day) can help to improve the treatment of patients with type 2 diabetes over a period of 24 weeks when compared to placebo (dummy medication). In this study patients who are also being treated with metformin in addition to their insulin can also participate. At the end of this study there is an extension period where patients who complete the first 24 weeks can continue to be treated until the last patient in the study has started treatment. |
AVE0010 may help to improve the body's natural response to blood sugar by enhancing the production and action of the body's own insulin with a low risk of hypoglycemia and may also help to reduce the patient's requirement for injectable insulin. Improved blood glucose control (HbA1c) will lead to a much lower risk of developing the complications of diabetes that can afect the eyes, nerves, kindneys and circulatory system of people with diabetes. In addition, AVE0010 may lead to a reduction of appetite and weight loss, which in Type 2 diabetes is expected to have added positive effects on health. |
RMG/08/057
21/07/08
27/07/10
NHS SalfoR+D (joint study) |
|
| Manchester Community Asthma Study Phase 2 |
| This study aims to find out if children who had BCG vaccination in infancy have less chance of having asthma
and allergies when they are older. It will also look at whether the dose of BCG vaccination makes a difference
to the chances of asthma and allergies.
Asthma and allergies in children have become more common in recent years but the reason for this is not
clearly understood. Early infancy appears to be an important stage in the development of the immune system
and some researchers believe infections and/or vaccinations in early life might change how the immune
system develops.
BCG vaccination, given to babies to protect against tuberculosis (TB), might also reduce the risk of later
asthma and allergies by altering how the immune system reacts. Our earlier work has shown that children
given BCG vaccination as young babies were less likely to experience wheeze.
Central Manchester is one of a few areas in the UK where BCG vaccination is routinely given to young
babies. In 1994, at St Mary's hospital in Manchester, 857 children were given an incorrect dose of BCG
vaccination by mistake, which meant that they received five times the normal dose. Follow up checks of
these babies did not find any serious adverse effects. When the error was discovered the hospital
discontinued its policy of infant BCG vaccination. Eighteen months later, the policy was changed again and
BCG vaccination for children born at this hospital was re introduced. This high dose vaccination and the
later change to the BCG vaccination policy has provided a unique opportunity to look for an association
between BCG vaccination in babies and asthma/allergies. |
|
RMG/08/054
06/10/08
06/04/11
ReGrouP |
|
| Investigation of Environmental, Lifestyle and Genetic Risk Factors for Prostate Cancer in Younger Men |
| The aim of the study is to investigate the role of lifestyle, environmental and dietary factors in the development of prostate cancer. In addition, we would like to explore if the effect of these factors is affected by patient¡¦s genetic makeup. The following 5 hypotheses will be tested in a collaborative case−control study covering selected regions ofthe Great Britain:
1. prostate cancer may be associated with certain aspects of diet (e.g., high fat consumption, selenium or
other trace elements)
2. prostate cancer may be caused by environmental factors, e.g., x−rays, physical activity
3. prostate cancer may be caused by occupational exposures
4. sexual behaviour may be a contributory factor in prostate cancer
5. prostate cancer may be caused by a genetic predisposition to the disease which interacts with the above
factors.
These hypotheses will be tested in a collaborative case−control study covering selected regions of Great Britain. Relevant information for hypotheses 1−4 will be obtained principally using a postal−questionnaire and a toenail clipping sample. Hypothesis 5 will be tested using 20 mls of blood from cases and controls. Blood samples will be stored and analysed at the Institute of Cancer Research/The Royal Marsden NHS Trust and toenail samples will be stored at Nottingham University. |
|
RMG/08/051
20/06/08
20/06/13
ReGrouP |
|
| Exploring what recovery from psychosis in primary care means for service-users with a diagnosis of psychosis and for general practitioners. |
| This research study is focused on practical issues, and it is ultimately envisaged that the findings of this study might be applied to primary care settings within the United Kingdom’s National Health Service (NHS). The study is interested in exploring the experiences of GPs and SUs in the context of their interactions in real−world primary care settings. A qualitative research methodology facilitates the collection of the participants’ rich and varied experiences of such naturalistic settings. This exploratory research data could not be collected through the use of experimental quantitative methodology as it would be based in an artificial environment.
In−depth interviews will be used as the main tool of data collection. In contrast to structured interviews, the in−depth interview allows for the participant’s subjective interpretations to flow. The in−depth interview has a certain number of pre−defined topics of interest that all participants will talk about. However, these scheduled, exploratory, open−ended questions will be supplemented with further relevant, probing questions (Powell & Single, 1996). |
Research participants may or may not experience some benefit from taking part in the interviews. These sessions may give GPs the opportunity to impart their knowledge and experience related to providing services for service−users with a diagnosis of psychosis. In the case of service−users, they may benefit by being able to relate their thoughts, opinions, and experiences to the research team. Similarly, the focus groups will allow GPs and SUs to communicate their experiences to each other directly, without the possible hindrance of doctor−patient consultation roles necessarily coming into play. Also, focus groups provide an opportunity for research participants to hear about other service users’ and general practitioners’ thoughts and experiences in a way that they may find helpful. |
RMG/08/050
12/09/08
31/12/09
ReGrouP |
|
| Management of Asthma in School Age Children on Therapy |
| The main research objective is to determine, in 6−14 year old children who have asthma which is uncontrolled on their current regime of low−dose inhaled corticosteroids, whether their control can be improved by adding in a long−acting beta2 agonist (salmeterol) or a leukotriene receptor antagonist (montelukast) as measured by a reduced number of exacerbations requiring treatment with oral corticosteroids over a 48 week period. |
|
RMG/08/039
16/06/08
30/11/10
ReGrouP |
|
| Randomised controlled trial of a web-based cognitive behavioual intervention for psoriasis |
| Psoriasis is a chronic inflammatory skin disease affecting approximately 2−3% of the population. The condition is incurable at this stage and the course is recurrent, with periods of remission. It is believed to be a genetic disease, with the genetic tendency thought to be triggered by various environmental factors including infection, skin trauma, certain medications and stress. Previous research has shown that psoriasis patients report a high incidence of psychological distress (e.g. anxiety, excessive worry, depression) with studies reporting psychological disturbance in 30−40% of patients. The condition also causes considerable social and occupational impairment.
Given the proportion of distressed patients, only a few studies have investigated the effectiveness of psychological interventions designed to reduce distress and improve social functioning in psoriasis patients, with cognitive behavioural interventions showing the most promising results. To date, three studies have evaluated the effectiveness of cognitive behavioural interventions with psoriasis patients with some positive results in terms of reductions in psoriasis symptom severity and psychological distress. The current study builds and improves on these studies. It will employ more rigorous scientific methodology, use a broader recruitment strategy and offer cognitive behaviour therapy (CBT) in a web−based format. This method allows participants to complete the study in privacy, at their own convenience and makes the treatment more broadly accessible. Other research has shown that the results obtained via internet administration replicate those of more traditional paper−and pencil questionnaires and face to face therapies. The proposed study is an area of potentially great importance for the treatment of psoriasis. Stronger evidence for the utility of CBT in adddition to standard care in psoriasis could inform the development of more effective and integrated clinical practice in this area. The proposed study is also the first that we know of to evaluate a WCBT program designed to address the psychosocial needs of psoriasis patients. There is potential for this program to be made available to a broad spectrum of people with psoriasis. |
|
RMG/08/032
14/08/08
14/08/09
ReGrouP |
|
| Improving the delivery of care for patients with diabetes through understanding optimised team work and organisation in primary care. |
| Purpose:
The aim of this study is to identify individual, team and organisational factors that predict the implementation
of best practice for patients with diabetes cared for in primary care. The study has four objectives:
1. To measure the attributes of individual health care professionals (HCPs), care teams and their
organisation in primary care
2. To measure the organisational structure in primary care
3. To measure the process of care, markers of biochemical control, and QOF scores
4. To identify configurations of care provision that are associated with high quality care (this will be done by
relating the findings generated from objectives 1 & 2 to objective 3).
Design:
Questionnaire survey and telephone interview s will be used to collect data from complete teams of primary
care HCPs involved in the provision of diabetes care, including general practice administrative staff.
The study will generate the following predictor variables:
Individuals’ cognitions about clinical behaviours, clinical conditions, work, team and organisational setting
measured by questionnaire (Objective 1).
Organisational structure and function measured by telephone structured interview (Objective 2).
And the following dependent variables:
Self−reported clinical behaviours relating to teams of clinicians, and biochemical and physiological
measurements (e.g. blood pressure, glycated haemoglobin, serum cholesterol) that are the consequence of
the clinical behaviours but include consequences of patient physiology and behaviour (Objective 3).
Relationships between predictor and dependent variables will be examined using correlation, standard
multiple regression analysis and structural equation modelling (SEM). |
The results of the study will allow them to understand what elements of their behavior (as individuals and as
a team) are associated with higher quality care for their patients with diabetes. Higher quality care will be
indicated by higher rates of performance of behaviors (measuring blood pressure)and by better levels of
control of the clinical and biochemical variables (blood pressure, glycated
haemoglobin). |
RMG/08/031
02/05/08
31/08/10
ReGrouP |
|
| An investigation into the forms and functions of self attacking in depression, persecutory delusions and voice hearing as compared to non-psychiatric controls. |
| BACKGROUND AND RATIONALE
It is likely that symptoms such as persecutory delusions and negative voice hearing are subserved and maintained by
a tendency to attack the self with hating and persecutory thoughts. Such thoughts have been found to be associated
with the level of distress in people with depression, and in students showing a tendency to experience symptoms
resembling persecutory delusions. The current research therefore aims to assess the level of self hating thoughts in
people with two different types of psychotic symptoms: A)those who experience persecutory delusions and B)those
who hear negative auditory hallucinations (voices). The principal hypotheses, respectively, are that people who have
persecutory delusions or who hear negative voices will report higher levels of self hating thoughts than people with
depression and a healthy comparison group.
PARTICIPANTS
The study aims to recruit people with psychosis from secondary community mental health services and inpatient
units, early intervention services and from voluntary groups such as ‘The Hearing Voices Network’ across the north
west of England. People with depression will be recruited from primary care services, community mental health care
teams and voluntary groups across the northwest of England. The healthy comparison groups will be recruited in
order to match the clinical groups as closely as possible on the variables of age and sex.
In terms of inclusion criteria, the occurrence of negative voice hearing and persecutory delusions will be assessed
using the Psychotic Symptoms Rating Scale (PSYRATS)(a brief structured interview) and current anxiety and
depression will be screened for using the Hospital Anxiety and Depression Scale (HADS)(a short self−report
measure). Self hating thoughts will be measured using the Forms of Self Criticising/Attacking and Self−Reassuring
Scale, which includes a specific subscale for ‘Hated Self’. All these measures are well validated and are often used
within routine clinical practice. |
There are no obvious immediate benefits to the people who choose to participate in this study. It is possible
that the participants might benefit from having the opportunity to discuss and perhaps learn more about their
own experience of hearing voices or persecutory delusions and be signposted to relevant services and
support networks where appropriate. Each participant will also be provided with an information sheet on
compassionate mind therapy. |
RMG/08/030
12/05/08
01/04/10
ReGrouP |
|
| The effect of liraglutide compared to sitagliptin, both in combination with metformin, in subjects with type 2 diabetes. |
| Type 2 diabetes, which is characterised by insulin resistance, impaired insulin secretion, increased hepatic
glucose production, and often obesity, is a progressive disease. Oral anti−diabetic drugs (OADs), as
monotherapy or in combination therapy, initially lower blood glucose effectively but after some years' duration
of the disease, a deterioration of glycaemic control (i.e. control of blood glucose levels) and a marked decline
in ß−cell function usually develops. Some people have already considerably reduced ß−cell function at the
time of diagnosis with type 2 diabetes. The existing treatment strategies for type 2 diabetes are still not
satisfactory. Subjects not adequately treated with metformin, diet and exercise will inevitably receive either
insulin secreting agents or insulin itself. The consequence is an increased risk of experiencing
hypoglycaemia (low blood glucose level) and drug related weight gain.
To stimulate the production and release of insulin as well as improving the function of the insulin producing
cells in the pancreas, the body produces another hormone called Glucagon−Like Peptide 1 (GLP−1). GLP−1
also slows the passage of food through the gut, resulting in a slower rise in blood glucose after a meal and
increasing the sensation of fullness. Liraglutide is a modified form of this GLP−1 hormone which is
developed aiming for once daily subcutaneous injections.
The rationale for this trial is to demonstrate that by adding liraglutide or sitagliptin to existing metformin
therapy (blood glucose lowering agent)an equal improvement in the glycaemic control of the participating
subjects is achieved.
In this clinical trial, the effect of liraglutide is being compared to that of sitagliptin. Sitagliptin is an oral
Dipeptidyl peptidase 4 (DDP4) inhibitor which is already approved for the treatment of type 2 diabetes
patients to improve glycaemic control. The action of both liraglutide and sitagliptin rely on enhancing the
stimulation of GLP−1 receptors but as each drug does this differently, it is expected that they will have
different profiles of clinical efficacy and safety. Through previous phase 2 trials with liraglutide, it has been suggested that liraglutide has a greater control effect on glycaemic control (as measured by a reduction in HbA1c and FPG) than that of sitagliptin. Furthermore, sitagliptin has been shown to be weight neutral whereas treatment with liraglutide has been linked to significant weight loss.
The purpose of this trial therefore is to perform a direct comparison of both liraglutide and sitagliptin and
address any differences between the two drugs, when added to metformin therapy |
All trial participants will benefit from frequent contact to the trial doctor who will monitor the subjects health
including diabetes control continuously. In addition, the subject will receive trial medication and equipment for
blood sugar testing (including lancets and strips) free of charge. The blood sugar meter can be kept by the
subject after the trial ends.
The subject’s condition may not improve, or may worsen, while participating in this research trial. The
subject may not receive any benefit from his/her participation. Additionally, it is possible that some
discomfort or bruising may occur when blood samples are taken. However, all care will be taken to minimise
this and by participating in this trial, the subject will be contributing to the development of knowledge
concerning the treatment of their diabetes. |
RMG/08/028
05/06/08
16/04/09
NHS SalfoR+D (joint study) |
|
| EPA-Cardiovascular: International observational study of cardiovascular prevention and risk management in primary care |
| The aim of the study is to describe and compare quality of cardiovascular prevention and risk management in
primary care in 11 European countries (Austria, Belgium, Finland, France, Germany, Israel, Netherlands,
Slovenia, Spain, Switzerland and the UK). This application is just for interviews and questionnaires within the
UK, other countries will handle the interviews and questionnaires individually.
The study has a cross−sectional observational design. It is partly internationally comparitive (focused on
description and comparison of countries) and partly trans−national descriptive and explorative (focused on
factors in patients, professionals and practices across countries).
The study in the UK focuses on patients and health professionals attached to 36 general practices. The
practices will be selected as part of a stratified random sample, based on practice size and socio−economic
deprivation |
No direct benefit. Indirect benefits include the identification of the level of quality of cardiovascular care in
each country and the potential for identifying a minimum standard of care. |
RMG/08/022
07/08/08
06/08/09
ReGrouP |
|
| Identification of effective working models using dental therapist in dental practice teams |
| This study will be undertaken in three phases over three years.
The three phases are:
• Phase 1: Case studies.
The case study part of the research comprises of a multiple exploratory case study of dental practices. Both quantitative and qualitative data will collected from each case study practice including: documentary evidence, non−participant observation, interviews, Diaries and day sheets. • Phase 2: Generalisability to other practices: focus groups, and questionnaire to dental team members Focus groups will be held with dentists, dental therapists, PCT and policy makers and mixed stakeholders.
• Phase 3: Implementation study
An implementation study to investigate the changes in the dental team which take place after employing a dental therapist will be undertaken. Baseline data before a dental therapist is added to the team, will be collected, and then one year later, comparative data will be collected.
Study Procedures
Phase 1: Case studies
Yin summarises the essence of case study research in that it is an investigation which relies on multiple sources of evidence, with data needing to converge in a triangulating fashion (1). Several different data collection techniques and approaches to data analysis are employed to give a detailed picture of the
‘case’. The ‘case’ here is identified as an individual dental practice, and this part of the research will build upa detailed picture of the dental practice.
1.1 Study propositions
At the outset of a case study, study propositions are identified (1). These are addressed by the gathering of different types of data within the case. The study propositions guiding data collection in the case studies are as follows:
1. What are the key factors which influence the decision to employ a dental therapist or not?
2. Has the new dental contract changed how roles/tasks are distributed in the dental team?
3. Can dental therapists make economic sense in the dental practice team?
• With respect to productivity
• Efficiency
• Profit
4. What are the characteristics of practices and practitioners which employ dental therapists?
5. How are tasks distributed in dental practice teams?
6. What role do dental therapists take in teams where they are viewed to make economic sense?
7. Does the incorporation of dental therapists in the dental team influence patient satisfaction?
1.2 Identification of practices
Eight dental practices identified in the North West Strategic Health Authority area. All will be large dental practices (defined as dental practices with a contract value above £400,000). Within these eight practices, four will have at least one dental therapist while the other four do not have dental therapist. In addition, to
have the case studies comparable, the research intends to choose practices with similar features, including contract value, size of dental teams, accommodation and location, etc. The practices will be identifies in collaboration with Cumbria and Lancashire dental public health team based in Preston PCT. The practices will all be those who are happy to take part in the research outlined to them at the outset.
1.3 Data collection
The 8 practices chosen in this study will be visited once a week each for a research period of four weeks. Multiple types of data collection will be employed to collect both quantitative and qualitative data in this case study. This study includes five types of data collection:
1) Documentary evidence: analysing available reports and paperwork relating to job descriptions, meetings about employing dental therapists.
2) Non−participant observation: relating to accommodation useage; roles undertaken by the dental;sub−cultures; operations managements.
3) Interviews: Semi−structured interviews will be conducted with practice principals/owners as well as other members of dental team. The interviews with dentists and dental therapists will be taped and transcribed.
The other interviews (with dental nurses and practice managers will be undertaken using note−taking by the interviewer.
4) Day sheet: a day sheet is designed to collect some quantitative data to calculate the productivity, efficiency and practice profit. Each team member (dentist, therapist, and hygienist) will be asked to filling in one sheet each day for a period of four weeks. They will be asks to place a tick for each patient seen to detail their broad category of care given.
5) Patient satisfaction: a questionnaire using validated questions relating to Dental Visit satisfaction will be given to a random sample of patients from each dental practice.
Patient satisfaction questionnaire
item validated questionnaire using the Dental Visit Satisfaction Scale (2) will be given to 30 consecutive patients attending a dentist and 30 consecutive patients attending an appointment with the dental therapist (where one is employed) prior to their treatment in each dental practice. Parents
will be invited to complete the questionnaire on behalf of their child, if the appointment is for a child. The invitation to take part in the study, and consents will be given out at the reception desk. Only data on the gender of the patient and the date of the appointment will be collected. No patient identifiers at all will be
collected. Patients will be invited to reply by posting in the sealed box in the waiting area, or by posting directly to the research team if they prefer.
1.5 Data handling procedures
Data from the all dental practices will be coded so that the practices remain anonymous. The data from each practice will be summarised so that individuals within the dental practice will not be identified. Audio−taped interviews will be transcribed within 3 weeks and the tape destroyed. Information sheets will be
given to all participants within the dental practice and appropriate consents collected.
1.6 Analysis
In this study, the unit of analysis is a single dental practice. It is therefore a system of action rather than an individual or group of individuals. Case studies are multi−perspectival analyses and therefore the researcher will consider not just the voice and perspective of the actors (members of the dental team), but of the relevant groups of actors and the interaction between them. Qualitative data will be analysed using the NVIVO software package, and quantitative data using SPSS computer software.
Phase 2: Generalisability to other practices: focus groups and questionnaire to dental team members in practices employing a dental therapist |
The participating dental teams will benefit from being able to discuss their roles with the research team and
issues relating to the cost and productivity of dental teams in relation to dental therapists.
Models which give the optimal team performance will be identified and research participants will have the
opportunity to discuss these findings in detail with the PCT and the research team, those benefiting the way
they run their practice. |
RMG/08/019
18/04/08
18/03/11
ReGrouP |
|
| Comparative analysis of how local system factors affect progress tackling health inequalities |
| The purpose of the planned research is to establish what attributes of Spearhead areas are associated singly or in combination with better or worse outcomes regarding progress with narrowing health inequalities. Consequently, there are seven objectives for the planned research:
1. To establish the recent trend in the relative gap between each Spearhead area and the national trends for premature mortality from circulatory diseases and cancers and for teenage conceptions. These are the three outcomes with which the project will be concerned.
2. To derive a theoretically, empirically and practically informed list of attributes and descriptors regarded as likely to be associated with these outcomes.
3. To survey every Spearhead PCT in England to gather data on these attributes.
4. To analyse these data using Qualitative Comparative Analysis (QCA), a technique that enables patterns of association between attributes and outcomes to be identified.
5. To undertake a longitudinal analysis using existing QCA data for North West England (from a previous study) to explore causal attribution in more depth.
6. To explore causation further by engaging practitioners in workshops to discuss results from the analysis.
7. To enable PCTs and their partners to use the results to identify how they might improve and from which
PCTs they might learn in order to make more progress with tackling health inequalities. All Spearhead PCTs in England and their partner organisations represented on local health partnerships will be invited to participate in the study, with initial contact being organised through SHAs and Government Offices. Meetings will be held with regional Directors of Public Health to brief them on the project and engage their assistance with approaching the PCTs and health partnerships. Each PCT area in England generally has a designated person leading on tackling circulatory diseases, cancers and teenage conceptions respectively (the three outcome areas the study is focusing on). Each of these leads, together with Directors
of Public Health (in a coordinating capacity) will be approached to take part in the study. An analysis will be undertaken of the most recent health inequality trends, based on three year rolling averages for each Spearhead local authority area over the past 5 years in the relative gap for under−75 deaths in circulatory diseases and cancers and for teenage conceptions. |
Tackling health inequalities is one of the key priorities of the NHS operating framework (Department of Health, 2006b). The recent commissioning framework for health and well−being identifies reducing health inequalities as ‘an overarching goal’ and emphasises tackling circulatory diseases and cancers as the two biggest contributors to the gap in life expectancy between the national average and the Spearhead areas with the worst health and deprivation (Department of Health, 2007, p. 71). Tackling teenage pregnancy is central to the Government’s work to prevent health inequalities, child poverty and social exclusion (DfES, 2007). Despite the priorities given to them, progress with narrowing these inequalities is slow; it will be a challenge to meet the 2010 targets and to continue improvements beyond this date (Department of Health, 2006a). For circulatory diseases and cancers the focus to 2010 is on high impact interventions, especially smoking cessation services and secondary prevention in primary care. While these place the NHS in the lead role, partnerships with other bodies, especially local government, are essential. This is both to maximise the effectiveness of these interventions, such as providing health checks at community events, and to pursue primary prevention through, for example, housing, employment and income−maximisation programmes. However, no studies have been identified that present strong comparative evidence about the effect on defined outcomes of local attributes and how they combine. Our aim is to address this by providing local decision−makers in the NHS and partner organisations with much more targeted information about the
strategic−level changes likely to achieve more progress with their health inequality targets. In addition, this project will potentially benefit research participants through the possibility of establishing learning partnerships. These will require participants removing their consent to anonymity in exchange for more targeted learning opportunities, based on findings that are expected to point to where attributes could be developed because of their association with a better outcome. It will be possible to communicate directly to PCTs and their partners in areas making less progress with tackling health inequalities where there are other areas with similar contexts making better progress, and from which they could learn. In this respect, the method enables the specific factors both missing in the less successful areas and present in comparable
areas to be identified and shared. |
RMG/08/017
01/07/08
07/11/09
ReGrouP |
|
| A 52-week international, multi-centre, randomised, parallel-group, double-blind, active-controlled phase III study with a 52-week extension period to evaluate the efficacy and safety of dapagliflozin in combination with metformin compared with sulpho |
| Type 2 diabetes is characterised by dysfunction of the cells in the pancreas that produce insulin (beta cells) and also resistance to insulin leading to elevated blood glucose (hyperglycaemia). Chronic hyperglycaemia is associated with damage to blood vessels leading to complications such as heart attack, stroke and
damage to the eyes, kidneys and nerves. There are many treatment regimens for type 2 diabetes but many of them focus on reducing glucose levels by either:
− stimulating insulin secretion
− reducing the resistance to insulin
− inhibiting absorption of glucose in the intestine, or
− substituting insulin
However these treatments have limited efficacy and also induce side effects such as low blood sugar(hypoglycaemia), fluid retention (oedema) and weight gain. Thus there is a need for novel antidiabetic treatment strategies. Intestinal and renal reabsorption of glucose are mediated through sodium−glucose transporters (SGLT) and two specific SGLT transporters, SGLT1 and SGLT2 have been identified as major transporters of glucose in humans. SGLT1 is found in the gastrointestinal tract, heart, skeletal muscle, liver, lung and kidney. SGLT2 is localised almost exclusively in the kidney, in particular in a region of the kidney where >90% of renal glucose reabsorption occurs. People who have a mutation of SGLT2 present with glucose in their urine (glucosuria) as a result of a reduction in the reabsorption of glucose in their kidney. However they have normal blood glucose values. From the information that is available, it appears that these patients have a normal life span and the majority of them have no abnormalities associated with hyperglycaemia; they only demonstrate increased excretion of glucose in their urine. Therefore by inhibiting SGLT2 it may be possible to reduce high blood glucose levels as less glucose will be reabsorbed by the kidney and more will be excreted in the urine. |
Participants who enter this study will be inadequately controlled diabetics. Therefore it is possible that these
patients will demonstrate an improvement in their diabetes control. However some participants will already
have good glycaemic control and therefore may not benefit from the study. The range of patients allowed to
enrol in the study was selected to reflect the real life situation.
Patients may also benefit from an increased frequency of visits to their doctor and the opportunity to review
their condition, thus impacting on their quality of life. |
RMG/08/012
03/04/08
03/04/11
ReGrouP |
|
| Improving outcomes in chronic conditions through effective self-management: exploratory trial of the WISE model in primary care |
| Although we have tested most of the components of the WISE model, these components have not been integrated into a single training intervention for use in primary care. The current study is designed to develop a training intervention to implement the WISE model in primary care, to test the acceptability and feasibility of the intervention and to provide preliminary data on its effectiveness. This will allow us to refine and adapt the intervention further, before testing its cost−effectiveness in a larger randomised controlled trial (which will be the subject of a separate future ethics application). The research is thus in line with the MRC framework for the development of complex interventions.
Research process
To complete development of a training intervention for primary care teams to improve the quality of
care for patients with chronic diseases; We have developed most aspects of the training intervention through previous empirical work and extensive development over the last 12 months. We will complete the development process by seeking the views of relevant stakeholders in primary care (patients, clinicians and managers). This phase will identify potential
problems which might make the intervention difficult to adopt in practice.
Two focus groups of 4−8 participants will be conducted. One will involve patients with long−term conditions, while the other will involve professionals (including both clinical and management stakeholders). Each focus group will begin with the presentation of the basic WISE model, followed by information about specific interventions which are included. The focus group facilitator will use the discussion to assess attitudes to the intervention, and to identify potential problems. The groups will be audiotaped and transcribed. The results of the focus groups will be used to further refine our training intervention to make itas acceptable as possible. |
Patients should receive improved self−management support from the practice. |
RMG/08/010
03/03/08
01/09/09
ReGrouP |
|
| An exploratory study of the causation and management of aggression in residential care facilities for people with dementia |
| Sample: A sample of all nurses and other care staff working in three Dementia Care Units situated within Independent Sector Care Homes will be employed for Stage One of the study. These Units will be within the North West SHA geographical area. This number of Units will allow for sufficient representative information to be collected while facilitating the practicalities of data collection. It is anticipated that a sample of up to eight members of staff from each Unit will be required for follow−up interviews in Stage Two of the study. This is to ensure that the range of staff including permanent and temporary staff and qualified and unqualified staff will be represented (n=24). A sample of relatives to represent long term/respite care residents, aggressive/non aggressive residents and self−funded/state−funded residents will be sought for focus groups. Data Collection: In Stage One of the study, the views of nursing and other care staff as to the causes and management of aggression will be surveyed using the Management of Aggression in People with Dementia Questionnaire (MAPDAQ), an adapted version of the Management of Aggression and Violence Attitude Scale (MAVAS: Duxbury, 2003), employed in similar studies in acute in−patient settings. Staff in each participating unit will also be asked to complete a critical incident form, the Aggression in Residential Care Incident Form
(ARCIF), an adaptation of the Modified Staff Observation of Aggression Scale (MSOAS: Duxbury, 2002). This classifies each incident in terms of the cause of the aggression, and how the incident was managed. An ARCIF form will be completed for each incident involving aggression over a three month period. This length
of time has been identified as sufficient to allow for potential fluctuations in staff and the potential range of interventions that may be used, some of which will be less frequent than others dependent upon situations. Previous work has shown that a longer period of data collection of this nature is less likely to provide
accurate information, as staff can become indifferent to the research and unreliable in completing incident forms. MAPDAQ and ARCIF will be piloted prior to commencement of data collection and revised accordingly. |
We anticipate that the findings of our study will benefit people with dementia in residential care settings by
identifying more clearly what is current practice in this field of care, and in so doing will assist nurses and
other care staff to reflect on and improve the quality of their practice. Findings will be fed into future staff
training initiatives. Our study should also provide the impetus for future research to identify, test out and
disseminate good practice in aggression management. Relatives and informal carers will benefit by sharing
their views regarding the identified problems and their management. |
RMG/08/009
04/04/08
04/04/09
ReGrouP |
|
| A case-controlled study to identify risk factors for venous ulceration |
| Patients with a history of venous ulceration will be identified from the clinics of collaborating leg ulcer clinics in the Greater Manchester area. They will be provided with a questionnaire and covering letter (serving as the information sheet), by post or at the leg ulcer clinic. The researcher will go through the questionnaire with the patient at their appointment or over the telephone to ensure that they have understood the questions and answered them fully. Patients will only be contacted by telephone if they have given permission The participant is asked to identify a suitable control participant. There will be no further interventions. Control volunteers will be identified by patients with leg ulcers. They will be sent an information leaflet regarding the study and invited to book an appointment at the leg ulcer clinic to complete the questionnaire and go through their answers with the researcher. Where this is not practical, a telephone interview will be scheduled.
Where the leg ulcer patient is unable to provide the name of a suitable control volunteer, or the named person is unable or unwilling to participate, their GP will be asked to identify an age and sex−matched patient without a history of leg ulceration. These patients will be sent the same information and asked to contact the clinic for a suitable follow−up appointment. |
None − the aim of the research is to devise strategies to prevent leg ulcers in patients in the future. |
RMG/08/006
05/03/08
31/08/10
ReGrouP |
|
| The Oldham Model: clinical preventive care pathways in primary dental care |
| Purpose of the research:
To decribe the consequences of implementing a model of contracting in general dental practice which is based on adherence to clinical preventive care pathways. Methods:
This is a multi−method research undertaken on case study dental practices which have implemented the new Sampling of dental practices: The new system will be evaluated in a newly established practice in Oldham (Glodwick), and also in 3 other established practices in Oldham and Salford. The existing practices will be identified as those willing to transfer to contracting based on the clinical care pathway principle. Within each dental practice the following data will be collected:
1. Quarterly reports with process and health outcome data Using the dental practices IT system, in liaison with the dental practice and the PCT, analysis of activity data will be undertaken and reported quarterly.
2. Cost, productivity and skill mix data Data related to the cost efficiency, productivity and roles of the dental team members will be collected. The data will be collected using the existing dental practice IT system, and day sheets completed for a 4 week period to give a cross−sectional picture of activity. Following the interviews with dental team members, outlining tasks undertaken, a short questionnaire will be given to dental team members asking them to rate
on a scale 0−7, a) how important the task is to their job, b) how much time relative to their other tasks, the tasks takes c) how difficult they consider the task to be relative to other tasks.
3. Team members' perception of the new system Interviews with dental team members will be audiotaped and transcribed and cover how they perceive the
benefits and drawbacks of the new system. Topics for discussion will include issues relating to autonomy and control, and explore reasons for the variance of patients from care pathways.
4. Dentists' values and job satisfaction Evidence exists which shows that innovations are most successful when they fit closely with the user’s value
system. In order to capture this, accepted psychometrically accepted measures of job−satisfaction, goals and values will be used and dentists asked to complete a few questions on a questionnaire, and to take part in a diary study which records a few key indicators such as well−being daily for 10 working days.
5. Patients' satisfaction
Interviews with up to 30 dental patients will be undertaken in each of the participating dental practices. Interviews will be audio−taped and transcribed, and analysed thematically. Purposive sampling will be undertaken and sampling completed when data saturation is achieved. |
The research participants will be able to discuss their experience of the new system and regular reporting to
the PCTs will mean that any problems and concerns with the new may be highlighted at an early stage.
Dental practice principals are involved in a project steering group guiding the research, as are
representatives from the SHA and PCTs. |
RMG/08/002
06/10/08
05/10/10
ReGrouP |
|
| How do nurse lecturers in Higher Education Institutions engage with clinical practice? A case study of one School of Nursing and its partner NHS and Non- NHS Organisations |
| Purpose of the research:To explore how nurse lecturers, working as an Academic in Practice (AiP) in one Higher Education Institution School of Nursing engages in clinical practice with its partner NHS and Non− NHS Organisations.
All lecturers in the School of Nursing have a compulsory clinical practice component to their role and are assigned to a particular Academic in Practice (AiP)Team within one of is eighteen partner NHS and non− NHS practice organisations. The range of practice organisations span primary and secondary care and Non− NHS organisations for example prisons and private hopsitals. Prisons and private hospitals are not sampled as part of this study. Within each practice organisation there are individual practice placement areas, with individual AiP’s being allocated one or more individual practice area to engage within, usually within one particular organisation. Each AiP Team is managed by an AiP Lead. This person is a nurse lecturer. Methodology: Case study methodology used for this study allows for data to be collected and analysed within
multiple ‘mini’ case study sites, whilst at the same time maintaining the overall wider picture of the actual case, which in this case is one School of Nursing and its partner NHS and Non−NHS organisations. This means that four AiP Teams can be studied in the context of the practice organisation in which they work. The descriptive data generated as a result of undertaking the study provides an opportunity to describe how and why nurse lecturers engage in clinical practice with its partner NHS and Non− NHS Organisations from the perspectives of nurse lecturers themselves and from practitioners and students working in clinical practice and Strategic Health Authority. |
|
RMG/07/136
01/02/08
01/02/12
ReGrouP |
|
| A study to investigate the impact on residential and nursing home admissions of an evidence based screening tool on a population of older people living in their own homes and referred to Adult Care Services for the initial contact assessment process |
| The main methods of the pilot will involve recruiting older people living in their own homes who have an Initial Contact Assessment Process for a new referral to Adult Care Services. Potential participants will be contacted and given information about the research and asked to consent for their details to be shared with Bury Primary Care Trust and their GP. 900 participants will be recruited in total, over a 28 month period. This equates to about thirty−two participants per month.
Initially, general practices in Bury will be invited to enter a Locally Enhanced Service Agreement with the PCT
to provide this service − deliver the screening and follow up. Patients registered with practices that do not
choose to enter the Locally Enhanced Service Agreement will form the group for comparison. |
|
RMG/07/135
20/02/08
31/05/10
ReGrouP |
|
| Optimising the conservative treatment for patellofemoral pain syndrome- a pilot study |
| Pain underneath and around the kneecap is described as a ‘common’ condition, affecting about 25% of the population. It is well known that patients suffering from kneecap pain usually undergo long periods of conservative treatment, with physiotherapists mainly shouldering this burden. Physiotherapy has traditionally been a mixture of some clinicians using specific, tailored treatments based on their examination and analysis of the patient’s problem and others using a ‘generalised’ approach giving the patient all forms of therapy modalities in the belief that at least one of them will be beneficial. Clearly, this 'hit and miss' approach has implications on time and resources both to patients and physiotherapists. Although it is still unclear what really causes this condition, some experts are beginning to understand that patients can be separated into several clear groups with different characteristics of their knees, legs and muscles that may cause their kneecap problem. All previous studies on this subject have grouped together the patients without using sub
classification. We believe that we have the expertise and resources to conduct the first ever study to attempt sub classification leading to the appropriate treatment and see if this makes any difference to the outcome of patients with kneecap pain. |
|
RMG/07/128
14/07/08
30/06/09
ReGrouP |
|
| Perceptions of bonding, maternal sensitivity and mentalizing ability in mothers with psychosis, depression and in mothers with no psychiatric difficulties. |
| The principal research objective is to determine whether levels of maternal sensitivity, bonding and mentalizing ability vary in mothers with psychosis and depression when compared to non−clinical controls. This study is particularly interested in levels of maternal sensitivity in these mother−infant relationships as observed in the CARE index video. Maternal sensitivity is the ability to correctly identify and respond to infant cues, and as such it is associated with nurturing and sensitive mother−infant relationships and attachment.
Mentalizing/theory of mind ability refers to a person's ability to correctly determine the intentions and behaviours of others, in this case their infants. We are interested in whether mothers with psychosis have impaired mentalizing ability compared to mothers with depression and non−clinical controls. As deficits in mentalizing ability have been found in individuals with psychosis, it is likely that this could influence these mothers when relating to their infants. The study is also interested in whether group differences are observed using the CARE index measure of maternal sensitivity. This is an assessment of the mother−baby interaction based on a 5 minute video−clip. It will allow us to assess maternal perceptions of the mother−infant relationship, i.e. their perception of how they bonded with their baby and how well they are attached. The findings from this will contribute to developments in psychological treatments for women with depression and psychosis, notably Cognitive Behavioural Therapy (CBT). This is important because at present the psychological processes that contribute to maternal sensitivity remain poorly understood. To our knowledge, to date, no study has assessed maternal
sensitivity across these three groups of mothers. |
|
RMG/07/125
14/02/08
31/01/10
ReGrouP |
|
| Research regarding health professionals` and the public`s views on patient held health records |
| The purpose of the planned research is to gain an informed picture regarding potential users` views of patient held records. Focus groups of the general public have highlighted issues of concern e.g. fears about security. Approval is sought to carry out semi−structured interviews to discuss these concerns with experts who have had experience of using or developing patient−held record devices. |
|
RMG/07/124
04/12/07
30/12/10
ReGrouP |
|
| Does the use of a knee block influence hip deformity, functional ability and pain in children with bilateral cerebral palsy? Key words: Cerebral palsy, children, posture, knee block, hip migration, hip dislocation, sitting ability, pain, randomised |
| A randomised controlled trial will be carried out over a five year period. Participants will be randomised to a control group or an intervention group. Both groups will use orthogonal modular wheelchair seating. This will include: ramped seat base, backrest, lateral pelvic and thoracic supports, pelvic belt and foot supports. A head rest, chest harness and tray will be optional.
The intervention group will use an appropriately adjusted knee block and sacral pad whereas the control group will use the seating without a knee block and sacral pad. The CAPSII seat (Active Design) and the GILL3 (RMS) modular wheelchair seats have been identified as suitable modular seats, and the subjects will be free to choose between these two seating systems. Outcome Measures include: hip migration percentage, lower limb joint range, sitting ability on the Chailey scale and pain score on the paediatric pain profile. The Null Hypothesis is that there is no difference in outcome measures when using the seat with or without a knee block/sacral pad. |
|
RMG/07/122
01/02/08
31/01/13
ReGrouP |
|
| A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination with Metformin compared with Sulphon |
| There is an unmet need with the current pharmacological treatment of type 2 diabetes. Despite available drugs with different mechanisms of actions, many patients are not reaching glycaemic control goals. Some insulin secretagogues have Significant side effects such as hypoglycaemia, weight gain and insulin resistance.This 52+52-week Phase III clinical study investigates the safety and efficacy of saxagliptin in combination with metformin compared with glipizide (sulphonylurea) in combination with metformin in patients with type 2 diabetes. The study is required to demonstrate that saxagliptin is effective in the treatment of type 2 diabetes and at least as effective as other antidiabetic medication. |
|
RMG/07/121
13/12/07
13/12/10
ReGrouP |
|
| ASCEND: A randomised 2x2 factorial study of aspirin versus placebo, and of omega-3 fatty acid supplementation versus placebo, for primary prevention of cardiovascular events inpeople with diabetes |
| Patients with diabetes will be identified from 3 sources: centrally held and general practice-held diabetic registers and trial databases. Suitable individuals will be sent an invitation letter from the local doctor (GP or diabetologist) enclosing an Information Leaflet (B17-1) and a brief Screening Questionnaire (B15-1) to determine eligibility and seek consent (with a Freepost envelope for replying). Eligibility for the pre-randomisation placebo Run-in will be based on information provided on the completed Screening Questionnaire (i.e. diagnosis of diabetes, no history of diagnosed occlusive arterial disease, no contraindication to regular aspirin and signed consent to participate). Patients who are not eligible will be thanked for completing the questionnaire, but will not proceed further. Pre-randomisation Run-in: 2 months of placebo treatment (and optional blood sampling) |
|
RMG/07/110
21/11/07
21/11/12
ReGrouP |
|
| Large Scale IS Collaborations: A Case Study Investigation of the Effect of Implementing a Single Patient Administration System |
| The research is concerned with large scale Information Systems collaborations and the development, implementation and use of such systems in the NHS. In particular, it is concerned with the effects of implementing a generic, standardised IT system and the impact upon, and attitudes of those who are expected to utilise such systems. To this extent, the research wishes to explore how the realities of multiple stakeholder groups combine to form an Information Systems' identity.
The research will attempt to explore the multiple perspectives which are associated with a particular 'thing'. That is to say that one thing (in this case an Information System) can represent different things to different groups/people. In attempting to do so, the research aims to identify the critical success factors for the implementation of large, Public Sector Information Systems which require the collaborative efforts of a number of different parties |
|
RMG/07/106
05/12/07
31/03/09
ReGrouP |
|
| A qualitative exploration of financial concerns, advice, support and coping in people diagnosed with cancer and their carers. |
| The financial issues that can beset people diagnosed with cancer and their families have recently been highlighted in the national press and by voluntary organisations, but, apart from some work on disability benefits, there is little research literature on this topic. As the body of knowledge is so scanty in this area, an exploratory qualitative study using in−depth
conversational interviews is proposed. This project will map the territory for the first time and identify key issues for practice, policy and further research. Patients will be accessed through health professionals in primary and secondary care, and through cancer self−help/support groups. Data will be collected using audio−recorded in−depth conversational interviews
with a purposive sample of approximately 40 people treated for/living with cancer and, where appropriate, their carers. Participants will be offered the choice of a face−to−face or telephone interview and, if the latter is chosen, where they prefer to be interviewed; it is anticipated that most will choose to be interviewed in their own/the patient's home. Patients and carers will be interviewed once only, and will be interviewed separately unless they express a wish to the contrary. |
There will be no direct benefits to participants, but they may perceive benefits such as being given the opportunity to talk and be listened to by an experienced researcher. Where appropriate, the researcher will direct participants to sources of information and support as indicated by the interview. |
RMG/07/102
03/12/07
03/07/09
ReGrouP |
|
| A psychological autopsy study of homicide followed by suicide |
| In cases of homicide followed suicide there is no opportunity to assess the perpetrator to establish his/her state of mind at the time of the offence, or to ask them directly why the events occurred, unlike other homicide cases. The lack of detailed clinical information in the literature means there is a gap in our understanding of these tragic events. By employing a psychological autopsy methodology the mental and psychosocial features of the deceased can be characterised. The psychological autopsy method is used to reconstruct the lifestyle and personality of the deceased and involves collecting detailed information from a number of different sources. In this study we aim to examine data from the police investigation files, the coroner (including transcripts of the inquest where possible) and access the deceased medical records. We also aim to interview the General Practitioner and a relative or friend of the perpetrator. |
|
RMG/07/098
05/10/07
30/09/12
ReGrouP |
|
| A qualitative study of participation in health care amongst disadvantaged groups |
| To explore the experiences of participation in health care, perceived barriers to participation and beliefs about effective ways of overcoming these barriers, amongst patients with a background of lower socio−economic status. To answer these questions:
(i) What experience of participating in health care have patients from lower socio−economic backgrounds had?
(ii) What are their attitudes to participating in health care?
(iii) Why do they have these attitudes, what are their beliefs?
(iv) Are there any perceived barriers to participation?
(v) How could these barriers, if present, be overcome? |
|
RMG/07/087
01/09/07
31/08/10
ReGrouP |
|
| Preparing undergraduate nurses as future health promoters |
| This research aims to identify the opportunities for student nurses and qualified practitioners to promote health through education and other interventions they encounter in their placement/workplaces and to Identify factors, which might facilitate or hinder this. |
This research provides an Opportunity to investigate differentiated means of curricular delivery and assessment of skills in practice and of the issues around appropriateness of practice placement areas to broaden the students’ exposure to
those practicing public health. |
RMG/07/083
03/09/07
03/04/10
ReGrouP |
|
| Assessing the attitudes and behaviours of medical students in clinical practice: the supervisors perspective. |
| The purpose of this study is to deepen understanding of the assessment of medical students behaviours and attitudes and the process which tutors go through in order to do this. The assessment of professionalism in undergraduate medical students is of increasing importance to those involved in medical education, to regulatory bodies such as the General Medical Council and to wider society. That medical students and future doctors behave in a
manner which is professional is essential to the safety of patients and to the quality of care which they receive. |
|
RMG/07/080
01/09/07
01/09/09
ReGrouP |
|
| Hidden Pain? Self injury and people with learning difficulties |
| This proposal seeks to understand the experiences of people with learning difficulties who self−injure, and those who support them. The research will identify how to better support individuals who self−injure. It will do this by: 1. Exploring the experiences of men and women with learning difficulties for whom self−injury is an issue, in particular why they might self−injure and what helpful responses to them at these times might be. 2. Finding out from people that support them (both professionals and family members) their understandings of why the person might self−injure and what they perceive to be the needs of people with learning difficulties who self−injure. 3. Identifying the barriers and needs that must be addressed so that people with learning difficulties can access appropriate, positive support in addressing their self−injury. 4. Identifying ideas and then producing resources for training and policy development which would enable people with learning difficulties to get the positive support they need. |
|
RMG/07/073
24/07/07
24/07/09
ReGrouP |
|
| Knowledge of sexually transmitted infections and sexual health amongst hetrosexual/bisexual men aged between thirty five and sixty five - is there a need for more targeted health promotion? |
| In this study we are interested in what men understand about sexually transmitted disease are how they are transmitted. We need to find out if men need some specific information that will encourage them to use condoms and how we can prevent the spread of infections. We will be focuses on men who have sex with women and men who have sex with both men and women that are aged between 35 and 65 because this age group have not been targeted before and we know little about their understanding of sexually transmitted infections. Although we know that the number of infections within this group of men are raising .
The study will use both questionnaires and one to one interviews methods. The men that we approach will work within the Wigan area. We will use the findings from the study to help us improve the services and information to help men over the age of to improve and maintain the sexual health and reduce the number of infections. |
|
RMG/07/072
28/02/08
30/09/09
ReGrouP |
|
| Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects |
| This study compares two HIV treatment regimens:
Kivexa + Efavirenz once daily and Truvada + Efavirenz once daily
Kivexa is a combination tablet containing Abacavir and Lamivudine.
Truvada is a combination tablet containing Tenofovir and Emtircitabine.
Patients will be randomised into either arm of the study. The study is not blinded so both the patient and
research staff will know which treatment the patient is receiving. |
|
RMG/07/069
14/09/07
30/01/11
ReGrouP |
|
| Acceptability and feasibility of vaccinating school-attending adolescent girls against human papillomavirus (HPV) |
| A vaccine that protects against HPV types 16 and 18 (Cervarix, manufactured by GSK) has been shown to be equally effective and safe. This is the vaccine we shall be using. GSK has applied to the European Agency for the Evaluation of Medicinal Products for marketing authorisation for this vaccine, and an EU licence is anticipated in June 2007. We are applying for ethical permission in advance of marketing authorisation approval, as otherwise, it will be impossible to deliver the vaccine in September. There is no intention to continue with the research unless approval is obtained (and we undertake to send a letter of confirmation to
the ethical committe following marketing approval, if this is recommended). In the UK the Joint Committee on Vaccines and Immunisation has yet to state its policy on vaccination but is widely expected to introduce school vaccination of 11 year old girls. However, the vaccine is expensive (about £250 for three doses) and the relative costs of different strategies and vaccines are currently being assessed by the Department of Health (DOH). Hence the urgency to proceed this year with the vaccination programme.
As HPV 16 and 18 are associated with increased risk of progression to cervical cancer, preventive vaccines could have a significant public health impact by reducing type−specific HPV infection and the cervical changes that can lead to cancer. However, HPV is a sexually transmitted infection (STI) and vaccination
could face problems of public acceptance as it will be the first STI vaccine to be routinely administered. The main target groups for HPV vaccination will be (pre) − adolescent girls. In clinical trials antibody levels following vaccination were at least two−fold higher among 10−14 year olds compared with 15−25 year old
women − a relative immune advantage that could translate into longer protection. The vaccine should also be given prior to the onset of sexual activity as the vaccine is not known to protect women already exposed to HPV. Parental consent for adolescent vaccination would be required, which some may refuse. Anticipating the level of refusal is critical for determining future policies for preventive vaccines. A Finnish epidemiological model predicts that vaccinating 90% of girls before sexual debut could decrease cervical cancer incidence by 91%.High coverage depends on vaccine acceptability and ability to reach a high proportion of the target group. Our group has conducted a baseline survey in Manchester of parental attitudes to HPV vaccination which indicates that about 80% of parents would be in favour of vaccination (Brabin et al, Vaccine 2006), but acceptability has not yet been assessed within the context of a population−based vaccine programme. The proposed pilot will allow the vaccine to be offered for the first time in a context where uptake, acceptability and feasibility issues can be properly monitored and assessed before probable routine introduction. |
The information provided from this study will be critical for determining the potential impact of adolescent
HPV vaccination, and its role within a UK national strategy for HPV prevention. It will also identify potential
logistic issues related to delivering a three−dose HPV vaccine through secondary schools, which is a
This is a post−licensing study and involves a partnership with GSK, which has agreed to provide the vaccine
and vaccination−related costs. The study has been discussed with Dr. David Salisbury, the Director of
Immunisation, Department for Health, has indicated that the results will be of considerable interest in
developing DOH policies. |
RMG/07/065
11/09/07
11/09/09
ReGrouP |
|
| Nutrition as a modifiable causal factor in antisocial behaviours |
| We propose to carry out a randomised, placebo−controlled, double−blind administration of nutritional supplements or
placebo with monitoring of disciplinary incidents, diet, psychological and psychophysiological measures to objectively assess the strength of any relationship between nutritional status and antisocial behaviour, and to identify how such effects might be mediated. |
In our previous study (Gesch et al, 2002) we found that a significant proportion of the prison population made poor food
choices, resulting in a significant proportion falling below the government's recommended reference nutrient intakes.
In the long term this compromised nutritional status could lead to poor health.
The active supplementation is designed to ensure that all participants achieve the government's reference nutrient intakes. |
RMG/07/064
20/07/07
31/05/10
ReGrouP |
|
| The impact of ethnicity on communication within general practice teams:a qualitative interview and
observation study |
| There is a need for exploratory research to examine the role of ethnic diversity within general practice teams. For this reason this study will examine the impact of ethnic diversity within teams, and the effect it has on team processes including the exchange of information and knowledge of alternatives. Specifically, the study aims to explore the relationship between the ethnic composition of general practice ‘teams’ (structure), team process attributes such as information sharing and interdependent working, and outcomes (innovation). Ethnic diversity usually relates to the racial, religious, or national origin of a group of individuals. This exploratory study will examine the way that ethnic origin of general practice team members impacts on team innovation and innovative team practices, by examining team processes. Diversity can be defined broadly to include characteristics including cultural practices, behaviours and values. However, for the purposes of this investigation, the analysis will be limited to the ethnic origin of general practice team members to examine specifically the impact that it has on the process and outcome variables. Although ethnic origin will not be the only attribute which directly affects teamwork, it is anticipated that it will have a significant influence. |
|
RMG/07/058
01/07/07
01/08/09
ReGrouP |
|
| Children with delayed language development: Does temperament make a difference? |
| − This study will evaluate the temperament and language profiles of a cohort of young children referred to speech
and language therapy.
− It will seek to identify any relationships which exist between temperamental traits and language skills.
− This study will evaluate the stability of temperament and progress made in language development after one year.
− The study will compare the language progress of children and their main−carers(usually parents) whose
temperament profiles have a similar profile (good fit), with those who have different profiles from each other (poor fit)
Participants: A cohort of 250 children and main carers will be recruited to the study by invitation via their local speech and language therapist. The inclusion criteria for participants are:
a. children will have been referred to the speech and language therapy services because of delayed language
development.
b. children will be aged between 2;06−4;06 years at their entry into the study.
c. children will be monolingual english speakers
The exclusion criteria are:
a. children will have no identified learning disability or significant sensory impairment.
b. main carers will have no known significant disability which would prevent them from reporting on the child's
behaviour and personal details.
Procedure: Measures of child language, child temperament and adult temperament will be collected via published assessments from children and their main carer at entry to NHS speech and language therapy (SLT) services and again 12 months later. Background information will be collected through carer interview relating to risk factors identified in the literature for developmental language difficulty. |
|
RMG/07/057
20/07/07
20/07/10
ReGrouP |
|
| Evaluation of Teenage Health Demonstration Sites |
| The Department of Health (DH) have commissioned this research to evaluate the extent to which the new government funded initiative to enhance services providing information advice and guidance about health issues for young people (teenage health demonstration sites) has an impact on the development of local services and on young people. Four sites have been selected by the DH to receive funding to develop services. The study design is a process evaluation using mixed methods to collect quantitative and qualitative data from young people, service staff and other stakeholders at each of the four sites. There are five main components:
1) questionnaire survey of young people attending local services
2) questionnaire survey of service staff
3) interviews with young people, service staff and other stakeholders
4) observation of service delivery and staff training
5) Record of service delivery |
|
RMG/07/055
27/11/07
01/07/09
ReGrouP |
|
| Guided self help for eating disorders in primary care: a research project |
| The study aims to evaluate a guided self help pack for eating disorders that has been developed by the
Huddersfield Eating Disorders team. It aims to establish whether the pack reduces the core
psychopathology of the eating disorders as compared with a waiting list control group. The study will also
measure the therapeutic alliance between people using the guided self help and the professionals guiding
them through it. This will establish whether the alliance formed has any impact on treatment gains and/or
attrition from the study.
Design:
The research is a randomised controlled trial. There are two groups and participants will be randomly
assigned to one. The two groups are: the guided self help group and the waiting list control group. |
|
RMG/07/054
19/06/07
01/09/09
ReGrouP |
|
| A follow-up programme for patients using Symbicort Turbuhaler maintenance and reliever therapy in normal clinical practice |
| This will be a 12−month, observational, non−comparative, follow−up programme for patients previously prescribed SMART. The decision to treat patients in this manner will precede the decision to include the patient in the programme. The programme is designed to reflect normal clinical practice and not a clinical study and therefore patients will be treated as per clinical practice, ie, the patient will receive instructions for use of Symbicort as maintenance and reliever therapy according to the approved label.
There will be 2 visits to clinic for the patient; visit 1 (enrolment) and a follow−up visit after 12 months. Between these
visits the patient should be treated and assessed according to normal clinical practice. |
|
RMG/07/045
21/05/07
21/02/10
ReGrouP |
|
| Self-management of multiple medicines for patients with type 2 diabetes and cardiovascular disease: A six month follow-up survey. |
| The purpose of this research is to understand the relationship between self−management, the regimen
prescribed and perceptions of illness and treatment (in patients managing multiple medicines for T2D and CVD). |
The findings of this investigation will be used in the future to improving healthcare professionals' awareness
of multiple medicines self−management and the perceptions which drive it. Furthermore, all the work
described within this application will contribute towards a PhD awarded by the University of Manchester. |
RMG/07/044
10/07/07
10/07/09
ReGrouP |
|
| Adherence to PTH(1-84) treatment in Europe. A non-interventional cohort study collecting safety information and examining reasons and predictors for adherence to PTH(1-84) treatment in Usual Clinical Settings |
| This project aims to describe "adherence" (and the main factors influencing adherence) to PTH(1−84) treatment when
prescribed in a normal clinical setting. The term "adherence" covers both "compliance" (i.e. whether the patient takes the treatment as prescribed by the physician) and "persistence" (i.e. the time from treatment initiation to discontinuation) to treatment. |
|
RMG/07/030
16/04/07
16/04/13
ReGrouP |
|
| Evaluation of long-term conservative treatment in patients with tennis elbow (lateral epicondylitis): A randomised, assessor- blinded controlled trial. |
| The proposed study will be a prospective randomised, assessor−blinded, trial. All patients referred with tennis elbow to the Trust will be assessed by the chief investigator in a standardised manner according to defined eligibility criteria. Written informed consent will be gained prior to randomisation into one of 3 groups: physiotherapy rehabilitation (home exercise programme), injection or ultrasound. |
Through this study one will gain an increased knowledge about tennis elbow and what is the most beneficial management for this problem. |
RMG/07/008
01/07/06
01/10/09
ReGrouP |
|
| Women with Epilepsy preparing for pregnancy: A Qualitative analysis of the preception and communication of risk information |
| The studies primary purpose is to develop a knowledge base of the needs of women with epilepsy (WWE) preparing for pregnancy. WWE are presented with information when attending for routine epilepsy review. Some women actively request additional information when preparing for pregnancy. However, others rely on the offer of counselling from their family doctor, neurologist or epilepsy specialist; and for this group, some women choose to take−up this offer and others present during pregnancy unaware of potential risks. Much of the information provided within routine epilepsy review has a risk component, either relating to the health of the woman with epilepsy or that of her unborn child, and it is how she considers, uses, or, is influenced by, trusts and either acts on, or, disregards this information that is of primary purpose of this research. This is a pragmatic study and was developed through a process of consultation with epilepsy specialist, and through professional experience of reviewing women with epilepsy within The Mersey Regional Epilepsy Clinic. |
To inform care delivery and service development for women with epilepsy preparing for pregnancy. The
research question addresses the perceptions of risk information in women with epilepsy preparing for
pregnancy. The proposed study reflects recommendations for research into perceptions of risk information,
made by the Clinical Guidelines and Evidence review for the Epilepsies: diagnosis and management in adults
and children in primary and secondary care, London: Royal College of General Practitioners (2004). |
RMG/07/006
21/02/07
01/02/10
ReGrouP |
|
| Effectiveness of speech and language therapy intervention for children with pragmatic language impairments: an
interdisciplinary study |
| Children with pragmatic language impairment (CwPLI) have difficulty with the interpersonal use of language in social contexts. These children are typically verbose, have poor turn−taking skills, difficulty staying on topic, problems in comprehending discourse and difficulty in developing conversational skills. Additional problems of social cognition, social participation and mental health have also been reported. These communication difficulties pervade the child's social interactions and require facilitation so as to improve inclusion in social and educational activities.
A significant proportion of services in UK educational speech and language therapy (SLT) are directed to the amelioration of such pragmatic difficulties. However, there is little existing high−quality evidence, which would stand rigorous methodological scrutiny, that pragmatic and language processing ability in CwPLI can be enhanced or that interventions have significant positive functional outcomes. In our Manchester group's earlier work a single case series study indicated a strong signal of potential change as a result of intervention for CwPLI and reported appropriacy of quantitative outcome measures. The way forward is to carry out a study which incorporates a randomised controlled trial using appropriately robust methodology, a manualised intervention, a well−defined group and outcome measures which will have the potential to inform policy and practice.
Project objectives
•To ascertain the effects of an intensive manualised social communication therapy for a group of CwPLI in a small−scale randomised controlled trial
•To explore mediating and moderating variables through multilevel analysis
•To ascertain views of CwPLI, their parents and teachers on the experience and value of an intervention. |
|
RMG/06/134
16/02/07
30/03/11
ReGrouP |
|
| Unplanned hospital admissions of older people (75+): the impact of governance and incentives |
| This study will look at the ways in which social services, hospitals and community health services work together to finance,
organise and deliver services, and particularly how this affects the use of hospital services by people aged 75 or older.
Finding the best ways for these organisations to work together would help to make sure that older people get the right
services provided by the right people in the right place at the right time.
Nine councils spread across England have been brought together as part of the government’s Innovation Forum. They are
aiming to reduce the number of days that older people spend in hospital by providing alternative services that are at least as
good and which improve the lives of older people. Most people want to avoid going in to hospital or staying longer than is
necessary, and many efforts are being made to develop alternative services.
The councils in this study want to lower the total number of days that older people spend in hospital by 20% over a three
year period. In each council the local Primary Care Trust(s) and the hospital trust(s) have agreed on this target and on ways
to achieve it.
The study will ask these questions:
• What achievements have been made in lowering hospital bed use by older people?
• How do health and social services staff – together with housing providers, charities and others – work together to run
services that are alternatives to hospital care?
• What changes have been made in these 9 areas so that they can have fewer emergency admissions to hospital?
The research will take 2 years to complete and will include activities to ensure that people working in the health and social
services are aware of the findings |
|
RMG/06/118
24/01/07
31/05/09
ReGrouP |
|
| A Recent History of the NHS in Manchester and Salford |
| The study will be based at the Centre for the History of Science, Technology and Medicine at Manchester University which has long−established connections to many local hospitals including the MRI, Christies' and Hope Hospital. It will also collaborate with the National Primary Care Research Development Centre at Manchester University which has both national and local connections to the primary care sector.
There will be three phases of the study:
i) the first phase,lasting for 1 year, involves 'mapping' the structures, issues and personnel in the North West Region/Manchester & Salford, through 20 or so interviews with key managers, clinicians and other health service professionals. Patients' associations will also be included in this overview. Preparatory work has already identified a number of key figures and secured their consent for future interviews.
ii) the second phase, lasting for 3 years, will involve interviewing personnel in one or two hospitals (a teaching hospital and one other), and a few primary−care practices, so as to reconstruct the ways in which policy changes and other organisational shifts have impacted on work patterns, and especially on patient care. Around 50 subjects will be interviewed including more managers and politicians.
iii) the third phase, lasting for 1 year, will be the writing−up period. A maximum of 10 further interviews will take place during this time. |
|
RMG/06/110
06/11/06
06/11/11
ReGrouP |
|
| A qualitative study on the effect of long term mental ill health on the achievements and goals of older adults |
| • Identify participant
• Explanation and information about study
• Inform interested parties (as identified with participant) e.g. wardens, neighbour
• Consent from participant
• Complete CV (interview 1)
• Permission to approach family/ friends
• Explanation and consent with family and friends
• Interview 2 (CV and effect of mental illness)
• Interview 3 (effect of mental illness of life now)
• Interviews with family/ friends (their perspective) |
|
RMG/06/106
05/03/07
01/05/10
ReGrouP |
|
| Assessing Communication Therapy in the North West (The ACT NoW study) |
| Purpose:
The purpose is to determine the effectiveness, cost effectiveness and service users' views of an intervention delivered to people with aphasia or dysarthria after stroke by NHS speech and language therapists. These will be compared with outcomes for participants allocated to our attention control group who will be offered the same amount of time and attention but delivered by ACT NoW visitors rather than by therapists. The therapy to be evaluated will be delivered by NHS S&L therapists (not by research therapists). The intervention is a consensus−based document of best practice standards, equivalent to an enhanced version of what NHS therapists could offer with further training and resources (time and equipment). The intervention starts soon after stroke and runs as a 16
week programme, with up to three contacts a week. The programme is structured (for replication) yet flexible for tailoring to the specific needs and wishes of participants as well as allowing for differences among the participating centres. Many participants will be discharged to primary care before the 16 week programme ends. The programme will continue to be delivered on an out−patient, day hospital or domiciliary care basis, as required.
Design:
There are three research methods in the study
1. A randomised controlled trial of communication therapy by NHS speech and language therapists versus attention
provided by ACT NoW visitors.
2. A qualitative study based on interviews with 30 people purposively sampled from the trial (15 from each arm of the trial). In addition, there will be 10 interviews with carers (5 from each arm of the trial).
3. Health economic evaluation of the order and value of preferences for the process and outcomes found in the intervention and control groups.
Methodology:
A flow chart is attached with the study protocol, which shows what happens and when. In brief, all those admitted to hospital with a stroke are screened (briefly assessed) for eligibility. Those eligible are invited to participate in the study. All consenting/assenting participants are randomly assigned to either the intervention arm or the attention control arm. External randomisation will be used with concealed allocation. Randomisation is stratified to take account of diagnosis/severity of condition as well as recruitment centre, to ensure both arms of the trial are balanced at the start of the study. Participants
allocated to the trial will receive up to 16 weeks' contact with a S&L therapist or a trained visitor (control group). Approximately 6 months post−randomisation, researchers will conduct outcome assessments. These will be used to compare outcome between the two groups. In addition, the 40 qualitative interviews (30 patients and 10 carers) will also take place. Some health economics data (resource use) will also be collected from patient records or by the researchers at the
interview. [Note − The health economics evaluation of preferences and values is not conducted with these research participants but instead is a societal perspective from non−NHS members of the public.] After these six−month outcome assessments, participants from both groups exit the study. They may then access standard NHS therapy services at current practice levels (i.e. not the research therapy/intensity)or voluntary services. The researcher will provide the participant with locally relevant information on services and will alert the NHS therapists that this person has now exited the trial.
Patient involvement
During our feasibility study (04/MRE03/30) we worked collaboratively with previous service users and carers to design the study, test our procedures and develop the materials needed. All our qualitative and quantitative methods are tailored specifically for use with people with communication problems after strokes and their carers. We set up a user group which met regularly. Our strategy of employing recruitment materials geared toward specific problems encountered by persons suffering from language comprehension problems (modified aphasia friendly information booklet and simplified pictorial
information) proved successful in the feasibility study.
We have worked closely with service user representatives (Speakeasy and The Stroke Association) in designing our study procedures and materials. We will continue to do this throughout the main study. Our management group includes two service user representatives. Previous service users and carers (who have formed the ACT NoW Research User Group), will continue to work with us as planners and collaborators, rather than as participants of research. |
|
RMG/06/075
01/10/06
31/10/10
ReGrouP |
|
| Why Do Practitioners Work in Deprived Areas? Identifying Affinity Factors for Urban Deprived General Practice |
| The study will used mixed−methods, employing qualitative interviews and a questionnaire survey with GPs and practice nurses in both deprived and non−deprived areas. Such a design was chosen as it will provide both breadth and depth of information regarding the characteristics that distinguish those working in urban deprived general practice from those working in non−deprived areas.
Participants: The study will involve GPs and practice nurses in the northwest of England, a region that offers a great deal of diversity in terms of the socioeconomic status of its patient populations. General practices will be selected from a database held at the National Primary Care Research & Development Centre at the University of Manchester (www.primarycaredb.org). The numbers of practices needed will be dependent on achieving the required sample size for each stage of the study, and in each professional (GP versus nurse) and deprivation (high verus low) group. Timeline: Set−up Mar−Jun 2006; Qualitative interviews and analaysis Jul−Apr 2007; Questionnaire survey and analysis Apr−Oct 2007; 7. Interpretation and reporting Oct 2007−Mar 2008.
Qualitative interviews: Approximately 20−30 one−to−one interviews will be conducted with GPs and nurses at their general practice or another location of their choice. Interviewees will be sent a brief proforma in advance of the interviews to collect information regarding age, sex, ethnicity, qualifications and previous employment. This will give more time to, and help direct, the collection of more in−depth information during the interview itself. Issues to be covered in the interviews will include: reasons for early occupational choices; factors influencing previous and current practice location; aspects of their job they find most enjoyable, rewarding and difficult; and their attitudes towards their job, such as what they consider to be the essence of their role. Significant events and brief scenarios will be used for some of these; for example, practitioners might be asked to describe a specific situation that made them feel good about being a GP/nurse, or one that that they found particularly hard to deal with.
Questionnaire survey: The survey will involve approximately 1000 GPs and nurses, stratified by deprived versus non−deprived areas. It is anticipated that the questionnaire will include standardised measures of values (e.g. the Schwartz Values Questionnaire), work orientation (e.g. Calnan’s work orientation scale) and job satisfaction (e.g. the Warr−Cook−Wall job satisfaction scale), as well as questions on socio−demographic, background, practice and job characteristics. However, the specific content of the questionnaire will be developed during the course of the study in response to findings from the
literature and the qualitative interviews. The questionnaire will initially be piloted with approximately 10 GPs prior to the survey. Participants in the survey will be sent a package through the post, which will include a covering letter, an information sheet, the questionnaire and a reply−paid envelope. A second pack will be sent to non−responders after three weeks. After a further three weeks, non−responders will be contacted by telephone to ensure that the questionnaire has been received − experience with previous surveys involving GPs has shown that questionnaires do not always reach the intended recipient possibly through errors in the recorded contact details for the general practice. Following this and if the practitioner agrees, a third and final questionnaire will be sent through the post. |
|
RMG/06/065
06/07/06
31/12/09
ReGrouP |
|
| Preschool Autism Communication Trial (PACT) |
| The PACT intervention targets core social interactive and language/communication impairments in autism. Its rationale is that children with autism require a style of carer communication precisely adapted to these impairments and that they respond to this with enhanced communicative and social development. The intervention firstly aims to and increase parental sensitivity and responsiveness adapted to the autistic disorder and reduce intrusive or mistimed parental responses. Then it applies systematic communication training strategies to further develop the child's communication ability. The main hypothesis is that the addition of a systematic, theory based preschool family intervention, targeted on known core social communication impairments in autism, will result in significant improvement in autism−specific symptoms compared to treatment as usual (TAU ). Secondary hypotheses are that 1) this improvement will be mediated by changes in specific aspects of parent−child communication targeted by the treatment, 2) general language development will be accelerated, 3)
teacher−observed child adaptation will be improved.
Why is this the most important question? On current evidence the treatment to be studied here (the ‘PACT’ treatment) is the most theoretically well founded and evidence−based candidate treatment available for the enhancement of existing services for autism. Additionally, it is of an intensity (1.5 hr/wk therapist time for six months for the primary treatment) that makes it feasible to include into NHS care. Therefore we consider that a comparison of the effectiveness of the PACT treatment against routine NHS care is the most appropriate research question at this stage. Such a design will best guide policy and clinical decisions on how to develop existing UK autism services. The design is a 3 site 2 arm single (rater) blinded Randomised Controlled Trial of the study treatment against treatment as usual, evaluated on standard autism and behavioural instruments and including health economic analysis. Trial sites spread in the North East, North West, and South East of the UK will enhance the generalisability of the study findings. This design has been chosen as the most rigorous way of testing the effectiveness of the intervention. In the 6 month start up stage of the study, assessors will be trained on the current best practice core evaluation protocol for
autism along with specific instruments for this trial. Speech and language therapists will be trained to treatment fidelity using video practice treatment sessions independently rated by the lead clinician. Parallel field work will be also be done to refine an autism specific service−use interview for the economic evaluation.
We will then recruit children of 2−5 yrs with defined core autistic disorder to the trail following referral from specialists in the local areas. After informed consent and baseline assessment, families will be randomised on three sites around the UK to receive either the PACT social communication intervention in addition to treatment as usual (TAU) or TAU alone. After an initial home visit for engagement, orientation and explanation of the treatment process, families will attend bi−weekly 3 hr clinic sessions for 6 months. In each of these a new videotape of parent−child play is made and then watched and discussed in detail with parents in terms of progress since last session, fidelity to treatment goals and planning next steps. Detailed goals for the next period are written. Parents undertake to spend 30 minutes daily between clinic sessions practising predefined strategies at home and they make a daily record of achievement. The pace of work is individualised to the family’s specific needs and progress and interim goals are reached before moving to the next stage. At the end of this 6 month primary treatment there will be an interim assessment for all families in the Trial (both arms) looking at parent child interaction and reviewing their use of services. For families in the trial arm, following the six month primary intervention, there is a second 6 month period in which there are monthly booster sessions. These focus on consolidation and generalisation of treatment gains into everyday routines. At 12 months after beginning of treatment children in both arms will be assessed using measures already used at baseline, focussing on autistic symptoms, language and behaviour using standardised methods. The study will include also the collection of information which will allow assessment of the impact of the child's disbility on the family and the costs of all the
treatments and service use to families. This will enable a calculation of the cost effectiveness of the treatment. All the assessments will be undertaken by independent researchers who are 'blind' to the treatment allocation of the family. Steps are taken on the assessments to prevent families revealing treatment status to researchers. This is the best way of avoiding researcher bias in the results. Some assessments will be conducted at home and some in a professional child health care setting. Design of the trial has been undertaken in collaboration with the National Autistic Society and the research director of the
Society is a collaborator on the Trial. Trial sites are spread in the North East, North West, and South East of the UK and this will enhance the generalisability of the study findings. Additionally, we have undertaken a series of focus groups with parents of Autistic children, run with independent expert help.
These focused on what parents feel they want from a treatment for their chilren in the preschool years and on what dimensions we should measure change. The results of these focus groups (along with others that we will undertake with parents and teachers in the start up phase of the study)will be used to develop a measure of family functioning to be used in the trial. |
|
RMG/06/064
13/07/06
13/08/09
ReGrouP |
|
| A Phenomenological study to determine whether the introduction of Health Action Plans have resulted in health gains for people with learning disabilities living in England. |
| This research intends to discover both a local and a national perspective on the impact of one aspect of the policy document
Valuing People (DOH 2001a).The study will follow a phenomological approach. Phenomenology is concerned with
understanding and interpreting a person’s experience (Polit et al 2001). It suggests that reality is complex and an
understanding cannot be gained simply by observation or questioning alone. More in−depth analysis, probing and
interpretation are required. Whilst phenomological enquiry is subjective in nature, there are two schools of thought to the
process. Descriptive phenomenology looks at identifying what we, as people, know (Husserl 1962 as cited by Polit et al
2001)and interpretive phenomenology−Hermeneutics −(Heidegger 1962 as cited by Polit et al 2001)focuses on how
individuals describe and understand their experience (Crotty 1998).
Whilst different aspects of a phenomenon can be studied following a single approach to research (Parahoo 1997), a more
comprehensive picture can emerge by using a combination of methods. Denzin (1989) refers to one form of this process as
method triangulation. Indeed with the growing emphasis in nursing to move away from the softer qualitative approach the
incidence of combined approaches is increasing.(Copnell 1998, Shih 1998). Therefore a qualitative approach using focus
groups and a quantitative approach using questionnaires will be undertaken.
The study sample will be purposive in nature to allow for the recruitment of participants with particular characteristics and will
be broad enough to include variations in perspectives and views(Silverman 2001).
Qualitative Data Collection:
Two focus groups will be arranged, one for PWLD and one for HF from social care providers.This will enable a local
perspective to determine best practice and inform future service implementation of the policy document Valuing People(DOH
2001a).
Participants will be recruited with the support of learning disability social care managers.Appropriately designed information
will be provided to potential participants to inform them of the nature of the study.Once participants have been identified I will
contact them to confirm consent.
For the focus group for PWLD this will involve a visit to both confirm understanding and eligibility of inclusion and enable the
particpant to become familiar with the researcher prior to the group taking place(Walsmsley et al 2003).
Data collection will consist of semi−structured taped interviews to gain participants perceptions of their involvement in and
any potential health benefits identified as a result of the introduction of HAP. The focus groups will last for one hour, although
an additional half hour has been allocated for the PWLD group as previous experience indicates that participants may need
to take a short break during the session. Participants will be reminded that they can withdraw from the focus group at any
time.
A colleague will assist with the focus groups to monitor taping equipment and will also make field notes during the interview.
Participants will be asked to verify data transcription to ensure accuracy of reporting. Data will be analysed using a thematic
analysis approach.
In order to reduce the risk of researcher bias the colleague and myself will make post interview notes immediately following
the groups These will allow material for reflection, critical examination of my role and assumptions, bias and influence during
supervision with my academic supervisor.
Quantitative data collection
HF Questionniare.As discussed as Valuing People (DOH 2001a) is a policy that relates to England only potential participants
are all practising Health Facilitators that have completed Health Action Plans in England.As there is currently no active
register of these participants it is difficult to estimate the number of responses that are likely to be recieved. In order to
maximise the chance of a good response rate letters and information discussing the project will be sent around:
I. Regional and National Learning Disability Networks
II. Learning Disability Practice
III. The RCN Bulletin
IV. Valuing People Networks
Interested parties will then complete and return the questionnaire to the researcher either via email or post.
Pilot: A pilot of the questionnaire design will be undertaken prior to distribution. The pilot group will be selected on
convenience and ease of access criteria. Following any amendments the questionnaire will circulated as above. If no
amendments are required the pilot group will be included in the research analysis.
It is intended that analysis will be achieved by using an SPPS package.
It is anticpated that this study, including analysis will occur between July 2006 and July 2008 |
|
RMG/06/049
01/07/06
30/09/09
ReGrouP |
|
| Changing Cultures and Performance in Local Health Care Economies(ve1) |
| Given the diversity of views and approaches to understanding and assessing organisational culture and organisational performance, and the intrinsic complexity of any relationships, this study proposes to adopt a multi−method approach, integrating both qualitative and quantitative approaches in order to examine these relationships in both breadth (through national quantitative survey) and depth (through three in−depth case studies). Both strands of research will be fully integrated, and each will support and inform the other.
We are keen to involve key stakeholders at all stages of the project is supported by an advisory committee comprising key stakeholders.
A) National quantitative survey:
In order to capture the breadth of any associations between cultural dynamics, inter−organisational relationships and health care performance we aim to conduct national quantitative surveys of staff at different levels of hierarchy in both English acute Trusts and PCTs using a validated culture−rating instrument (the Competing Values Framework, CVF). In addition, culture and performance data related the some randomly selected GP practices will also be collected. The reason for collection of data at this level is justified below. We propose to collect culture data at two time points (at about six months and two years in to the proposed project). This would yield three cultural data points for the analysis of senior management team culture in acute Trusts (as we already
have base line data for most organizations) and two new dataset for staff lower down the hierarchy in acute Trusts and PCTs/GP practices. These culture data will then be linked to a pre−existing comprehensive and robust national performance data set (with current and historical data). The combined dataset will be used to explore (longitudinally) culture/performance associations at organisational level, as well as to investigate the inter−organisational contingencies for
performance in local health care economies. We propose to send the CVF questionnaire to all participants with a covering letter written on official headed paper and a pre−paid business franked addressed envelope for its return. A reminder letter will be sent to all nonresponders four weeks after posting the questionnaire.
A−1) In all English acute trusts, the CVF questionnaire will be sent for board level managers. We will also seek to collect data from all clinical directors (or equivalent) and the highest−ranking non−clinician within each directorate. A−2) In all English PCTs, cultural assessment data using the CVF will be collected for board level managers. It is necessary bear in mind that despite the administrative structure GP practices still operate fairly autonomously from their
PCTs and the relationship is more of a networked one than a hierarchical or bureaucratic one. It is the practices that have primary responsibility for delivering primary care services and therefore should be the focus of attention for any culture−performance links. For these reasons, we think that the most important quantitative research questions to address in primary care are:
1) Is there a relationship between the culture of PCT managers (unlike acute trusts, managers represent the majority of PCT
employees) and their local practices?
2) Is there a relationship between the culture of general practices and their performance?
3) Is there a relationship between the culture of PCT managers and the culture of their local acute trusts?
4) To what extent is the culture of PCTs and practices stable, and how does it change over time?
To address these questions, we survey all senior PCT managers (using Binleys) and as many middle managers as possible, using the Competing Values questionnaire. This will be undertaken in a sample of 50−70 PCTs. We will also choose a random sub−sample of 15 of these 50−70 PCTs and select a random sample of 10 practices in each, stratified according to practice size. All of the staff in these 150 practices will then be asked to complete the CVF
questionnaire. This will include the GPs, practice nurses and administrative staff and past experience suggests there will be about 15 people in each practice. We will therefore be surveying about 2250 front line staff in the primary care sector.We will examine the relationship between practice culture and practice performance by using routinely available performance data from the Quality and Outcomes Data associated with the new practice contract. These data include information about clinical performance, patient experience and practice organization, all of which are now routinely available at a practice level. The analyses will be hypothesis driven, drawing on previous work and the ongoing case study work in the new project. Hypotheses will be developed and tested in a number of areas: on the nature of any contingent relationships; on the presence and nature of lags; on the effects of cultural ‘balance’ and cultural congruence on performance; on the influence of the stage in the performance life−cycle the organisation finds itself; and on the interconnectedness of trusts’ culture(s) and B) Case studies:
The quantitative national survey will provide identification of patterns of association between trust clusters, inter−organisational relationships and (organisational and local health economy) performance, and show the extent to which these patterns are replicated across the country. The case study work builds on this to tease out the nature and contingencies of any such linkages. The case study work proposes to explore the organisational dynamics in three health care organisations undergoing significant organisational change. In this way, the study will add considerable depth and insight into what are undoubtedly complex, multi−faceted and recursive relationship heavily dependent on context. Each case study will have as its centre of investigation as a sentinel organisation with a reasonable 'cultural gradient' (or likelihood of one); that is, an organisation where there is a reasonable expetation of significant ongoing cultural shift both planned and emergent. Investiagtion of organisations influx in this way are more likely to be revealing of the complex, contested and recrusive nature of the linkage between aspects of culture and aspects od performance. The case studies sampled will be determined once the project is underway but will include:
• a sentinel organisation with a clinically focused or ‘bottom up, organisational change− for example an organisation which is implementing a clinically focused National Services Framework (NSF)
And two selected from the following:
• a sentinel organisation that is undergoing major restructuring and leadership change,
• a sentinel organisation undergoing turnaround,
• a sentinel organisation transitioning to Foundation status.
It is important to note that identification of the organisation undergoing significant change is simply the way in to our case studies. Each ‘case’ for study actually comprises the local health care economy surrounding the single organisation− i.e. the key acute and primary care organisations, Strategic Heath Authority, and local Social Services Department(s) which acting together and separately deliver care to a community. Where appropriate the perspective of regulatory and other statutory bodies (e.g. National Patient Safety Agency, CHAI) will be drawn. Different data collection strategies will be recruited in the case studies as followed: 2−1) Quantitative methods: Within each health care Trust relevant to the local health economy we will collect culture data at all levels of the hierarchy and across professional groups using diverse sources of evidence. Quantitative data will be provided by use of the CVF questionnaire completed by a stratified sample of about 250 staff in each acute Trust and staff at all levels and across different staff groups in PCTs. The intention is to use these quantitative data in a qualitative rather than statistical sense (i.e. to provide a broad overview of extant cultures at different levels and across different professional groups in the organisation) and thereby contribute another source of evidence to be triangulated against the ethnographic and qualitative evidence. 2−2) Obsevation methods:
To allow prolonged observation of cultures’ in situ’ and ‘thick description’ of prevailing (sub) cultures, researchers will be based in each sentinel organisation for about 6 weeks in each of the three years (a total of over 4 months on−site observation over the lifetime of the project). We use non−participant observation of meetings, fieldwork notes and records of spoken communications.
2−3)Open and semi−structured interviews:
We will interview between 30−40 people in each sentinel organisation, at all level of the hierarchy.
2−4) Review of Documents:
The above mentioned data resources will be complemented by a content/discourse analysis of internal documents, reports
and formal mission statements; the completion of diaries by key staff.
These sources of evidence will be triangulated with information provided by key external stakeholders (from the SHA, local
Social Services, regulatory and other agencies) to generate a ‘360 degree’ understanding of the
cultures−relationships−performance dynamics in each health care economy. Interim project reports will be produced at the behest of SDO to a format and schedule that best suits their and other stakeholder needs. It is expected that a substantial interim report documenting the quantitative analysis of the national
culture−performance survey and emerging themes from the case study analysis could be produced at c 18 months. We would expect to share (through formal reports and informal dialogue) interim findings with the successful research team(s) funded under SDO call OC1. We have provided project timetable as below:
Months 1−5
· Seek ethics committee approval.
· Select case study sites and sentinel organisations.
· Preparation and piloting of national postal questionnaires.
· Negotiate access to case−study organisations.
· Obtain and review background reports and documentation on case study sites.
6−11
· Begin fieldwork in case study organisations
· Conduct first national quantitative survey in acute trusts and PCTs
· Processing and analysis of quantitative culture data linked to CHE performance data.
· Identification of emerging themes from quantitative and qualitative dataanalysis anddevelopment of new hypotheses to test and exploration of ‘disconfirming’ cases. 12−24
· Interim report prepared for SDO
· Continuation of case study fieldwork, qualitative data collection and analysis.
. Second national quantitative survey of acute Trusts and PCTs
. Integration of quantitative and qualitative data
25−36 · Dynamic modelling of culture−performance linkages in organisations and across health economies.
· Continuation of case−study fieldwork, qualitative data collection and analysis.
· Analysis and report writing |
|
RMG/06/041
09/05/06
09/07/09
ReGrouP |
|
| MAAS and IFWIN: age 8 follow up |
| Asthma and other allergic disorders are the most common chronic childhood diseases in the UK. Improved understanding of individuals at risk would facilitate better targeting of intervention, treatment and resources in primary and secondary care.
The cohort has already attracted international recognition as a 'landmark' study and has to date produced 12 peer reviewed papers with 47 abstracts being presented at national and international conferences. References in appendix 1. |
|
RMG/06/037
03/05/06
03/09/10
ReGrouP |
|
| Is surgery or conservative treatment better in the treatment of frozen shoulder |
| People with a true frozen shoulder who have not had prior significant treatment will be offered entry to the study when they are referred to WWL Trust either by dierect consultant referral or via the Tier 2 physiotherapy programme.It is current practice that all pts reffered to Tier 2 physiotherapy services are seen by one of the study specialist shoulder physiotherapists. |
|
RMG/05/134
01/09/05
01/09/09
ReGrouP |
|
| A comparison of automated technology and manual cervical screening |
| The routine cervical screening of 100,000 women in Greater Manchester will be randomly allocated by general practice to one of two liquid based systems; SurePath or ThinPrep, both of which are approved for liquid based cytology and will be used approximately 50:50 across England. The randomisation of practices involves stratification for deprivation index. Following receipt of the cytology sample at the Manchester Cytology Centre, slides will be randomly allocated in batches of 50 to either manual reading alone or manual reading followed by automated reading. ThinPrep slides for automated reading are read in the 'ImagerR' system and SurePath slides in the Focal Point system. The slides will be handled in such a way that the cytoscreener will not know which slides are to be subsequently re-read in the automated system. In all cases therefore slides will at least be read and is currently standard practice in every aspect including rapid review.
The design will enable through matched readings a direct comparison of manual and automated systems, a comparison of one automated system versus the other and thirdly the contribution of the ranking module of the Focal Point particularly its ability to predict accurately which smears are negative and which would safely be set aside as requiring no further reading. The diagnositc performance of these systems have clear implications for the cost effectiveness of cervical screening and a detailed cost analysis is part of the study. We wish to use reflex testing of the cytological material using HPV in cases of
borderline cytology. This is because we know from widely accepted research data that HPV testing will increase the sensitivity to detect underlying CIN in this group compared with repeated follow up cytology. Though this is still standard NHS
practice, it may change following publication of the NHS pilots of HPV triage in mildly abnormal smears. All women with any grade of dyskaryosis will be referred for colposcopy at their local clinic. Following reflex testing, women who are HPV+ve will be referred for colposcopy and those who are HPV negative will be returned to routine call/recall if a new smear at
12 months is normal. The study will run for 4 years; 6 month to set up, 24 months to screen 100,000 women,
12 months to complete the collection of clinical outcomes and economic analysis and 6 months to complete the analysis of the data and write the report. |
|
RMG/05/120
08/02/06
08/07/09
ReGrouP |
|
| A randomised, double-blind, placebo controlled trial of Vitamin D supplementation in the management of symptomatic knee osteoarthritis |
| The study's hypothesis is, therefore, to determine whether vitamin D supplementation can reduce the rate of disease progression and improve symptoms in participants with knee OA. In total, 800 participants with knee OA will be studied in a 3 year, randomised, double−blind, placebo−controlled trial of cholecalciferol 800 IU daily or placebo. The primary outcome measure will be radiological progression with secondary endpoints being symptoms and quality of life assessments.
Sub−studies will examine the effect of vitamin D supplementation on subchondral bone assessed using dual energy X−ray absorptiometry and magnetic resonance imaging, muscle mass and strength, and proprioception. As Vitamin D supplementation is safe and cheap, any proven benefit in the management of OA will have important relevance to healthcare in the elderly.
Type of design: Randomised, double−blind, placebo controlled trial. The major measures to minimise bias in this trial are remote randomisation and double blinding to treatment allocation. In addition, analysis and grading of all knee radiographs will be conducted blind.
Disease/patients studied: Ambulatory patients aged over 50 years of both sexes with knee pain on 16 or more days in the month prior to screening will be invited to participate.
Trial treatments − intervention and control:
Participants will be randomised to receive oral vitamin D 800 IU (as cholecalciferol) daily or matching placebo. Participants will receive treatment packs at 6 monthly intervals for a total of 3 years. Duration: Patients will be reviewed at baseline, 3 months, 6 months and then at 6 monthly intervals for a total of 3 years. For more details and the sequence of trial see attached flow chart. Data will be recorded on case report forms (CRF's), the top copy/original should be sent to the MRC CTU for data entry and a copy kept at the local centre. .Ancillary studies: An ancillary study to assess the role of genetic factors in OA is planned. Separate consent for this sub−study will be obtained from participants. Other ancillary studies will be: Bone Mineral Density: BMD will be measured by dual energy X−ray absorptiometry (DXA) using a study approved densitometer (Hologic or Lunar). BMD measurements will be made at the lumbar spine (L1 to L4), hip, and whole body. The latter measurement will include assessment of body composition. Proximal tibial BMD will also be measured to give
information on subchondral bone changes. Measurements will be made at baseline and at 1 and 3 years. Magnetic Resonance Imaging (MRI):Imaging of the signal knee will be made using a study approved MRI machine. Baseline assessment will be made using T1 and T−2 weighted fat−saturated images to evaluate for presence of bone marrow oedema. Cartilage volume will also be measured. MRI data will be acquired at baseline and at the end of the study period. Muscle Strength:Assessment of by Hand grip and quadriceps muscle strength at will be measured baseline, 1 and 3 years. Hand grip strength will be measured in both right and left hands. Quadriceps muscle strength will also be assessed in each leg from the supine position.
Proprioception: Static postural sway and proprioception will be assessed at baseline, and then at 1 and 3 years.Cognition and depression: Cognitive ability and depression severity will be measured using the Mini−mental State Examination and the Beck Depression Inventory. These questionnaires will be issued at baseline, 12 and 36 months. |
|
RMG/05/115
03/02/06
01/07/11
ReGrouP |
|
| A long-term, post treatment, safety follow-up, multi-centre study in patients with type 2 diabetes mellitus from the GALLANT, GALLEX or ARMOR Studies |
| Patients who fulfil the following criteria will be enrolled into this study in the UK.
EITHER:
Group 1 − patients who had a pre−defined laboratory or clincal finding. That is:
− received any randomised treatment within GALLANT or GALLEX and met a handling−plan related discontinuation criteria.
− met a criterion for entering a handling plan, or remained in a handling plan at the last treatment visit in GALLANT or
GALLEX.
− showed an increase in creatinine >50% from baseline to the last treatment visit in GALLANT or GALLEX.
− showed a decrease in Hb <2.5 g/dL from baseline to the last treatment visit in GALLANT or GALLEX.
These patients will participate in both a short−term and a long−term follow−up.
OR
Group 2 − patients who received at least 24 weeks of any randomised treatment in GALLANT or GALLEX without meeting any safety related criteria. These patients will participate only in the long−term follow−up. If a patient completes one of the GALLANT studies but does not wish to participate in a GALLEX study, they will be invited to participate in G−PLUS, however the GALLEX study will take a preference. Patients in both groups will be followed over a period of 24 months. This will include a visit to clinic at 12 and 24 months plus 4 telephone contacts. Patients in group 1 will have an additional visit to clinic at 12 weeks. During the telephone contacts, concomitant medications and medical events will be collected. At clinic visits, physical examinations will be performed. At the 12−week visit, for patients in group 1, adverse events, laboratory tests, weight and cardiac evaluation will be undertaken. In addition, patients who had new or worsening CHF during GALLANT or GALLEX will have a 6−minute walk test, an electrocardiogram (ECG) and an echocardiogram performed at visit 2. They will also be assessed for worsening of their CHF at the 12 and 24 month clinic visits. Serious Adverse Events will be collected for group 1 patients up to and including visit 2 only. |
|
RMG/05/072
14/11/05
31/05/11
ReGrouP |
|
| Epidemiology of unexplained functional disorders (EPIFUND) |
| Chronic, medically unexplained symptoms are common in the adult population of most countries of Western Europe and the USA. Those relating to the musculoskeletal system and the gastrointestinal (GI) tract are particularly common and are often disabling, with both representing considerable health and socio-economic costs to the community.The baseline EPIFUND study, set up to examine risk factors for the onset of Chronic Widespread Pain, Lower Back Pain and Functional Gastrointestinal Disorders , was conducted from 2001 to 2002. All subjects who participated and who agreed to further contact by the study team were followed up 15 months later. The study has contributed a wealth of information to our understanding of the aetiology of these common disabling symptoms. However, although we have identified a number of factors that strongly predict symptom onset, we are still only able to identify a small proportion of all new cases. This indicates that there are number of other risk factors that we have not measured. In the current application we propose to follow up subjects in the study for a second time to assess the impact of a range of new risk factors in symptom onset and persistence. |
The overall aim of the EPIFUND follow-up study will be to further our knowledge of the aetiology and persistence of CWP, LBP and GI disorders |
RMG/05/050
06/09/05
06/12/09
ReGrouP |
|
| The effect of position on arterial oxygen saturation in adults with severe and profound learning and physical disabilities |
| Research Design - A within subject cross-sectional clinical study will be undertaken following a pilot study. As the study involves the use of a common clinical intervention and outcome measures, and the principle investigator collecting the data is experienced in handling and position people with severe and profound physical and learniing disabilities only tow patients will be used in the pilot |
|
RMG/05/048
05/08/08
30/04/09
ReGrouP |
|
| The Million Women Study: Detailed Investigation of Susceptibility to Disease |
| The case study approach will be used, as it is the method of choice to investigate contemporary phenomena over which the researcher has little control (Yin, 2003).The study will be multi−case design, comprising three cases. Limiting the number of cases to three ensures the study is achievable within the resource and time constraints of the study.
The following factors will be considered in selecting cases, so meeting recommended criteria for qualitative sampling (Miles
and Huberman, 1994):
• At least one community matron will be in post for a minimum of three months prior to the start of the study, to ensure a rich
collection of data can be achieved.
• Geographical diversity will be sought by selecting a cases from inner city, urban and suburban/rural locations
• Feasibility of the case site, for example anticipated ease of access into the primary care trust, travelling distances for the
researcher.
• Existing procedures for research consent from service users and staff.
The Director of Nursing will be the first point of contact for potential case sites, as she will be a key access point to the PCT. The proposed study will be presented to the meeting of directors of nursing. Each director will be contacted to determine interest in participating in the study. If agreement is given preliminary information to assist in selection of the case sites will be sought, for example the number of matrons in post, size of organisation. Three cases will be selected from those expressing interest, using criteria for qualitative sampling to guide selection (Miles and Huberman, 1994), as highlighted
earlier. Formal consent and access to the organisation will be sought through the relevant research and governance
procedures for each site Preliminary discussions will be held with those directly involved, eg community matrons and their managers, to discuss the
study and give the opportunity to adapt and develop the study design in light of any aspects they raise. Representatives from the Patients Forum will be contacted to discuss the study and seek their views, in particular regarding involvement of service
users. Data for case studies is drawn from many sources of evidence (Yin 2003) as detailed below (further information can be seen
in the proposal (attachment 2)).
− Documents, eg job descriptions, minutes of meetings, reports and policies
− Archival records, eg statistics,caseload figures and profiles, reflective diaries
− Observation, eg time with community matron to see work environment
− Interviews, eg with community matron, service users and key contacts e.g. GP
− Meetings with groups associated with the community matron role
Recruitment of patients : purposive sampling will be used to select around 5 patients from each site, which can reflect a range of experience and perspective of the community matron’s role. Recruitment will be undertaken through the community matron in order to protect the confidentiality of patients. The community matron will have an introductory letter (attachment 3) and information sheet (attachment 4) to discuss the study with prospective participants which will also serve as written information for the patient to keep. This describes the voluntary nature of participation and withdrawal at any time, that any decision to participate or otherwise would not affect their care, with confirmation that the confidentiality of participants would be protected. The information sheet will be given with a consent form (attachment 5). Barriers to involvement would be considered in each setting and the PCT’s public involvement officer and diversity officer consulted in light of their local knowledge, if specific arrangements are needed, for example the availability of interpreters. Recruitment of staff and managers: Individuals to be invited to participate in interviews will be identified initially by the community matron and manager to provide a purposive sample. These will not be determined before the start of the study. An introductory letter (attachment 6), written information sheet (attachment 7) and consent form (attachment 8) will be sent to individuals. In addition the study will be advertised in the staff newsletter and notice boards should any individuals wish to
present themselves. Permission to attend meetings would be sought from the chair, with the information sheet (attachment 7) about the study sent to members prior to the meeting.
Pilot study: A pilot case study will be undertaken in a PCT outside of the selected cases. The pilot case will be selected on convenience and ease of access criteria. It will be used to clarify the approach, check sampling and recruitment methods and develop relevant questioning (Yin, 2003), in addition to highlighting any unexpected practical issues within the case study design which need to be addressed. |
|
RMG/05/039
24/11/05
31/03/14
ReGrouP |
|
| The Drug-Induced Arrhythmia Risk Evaluation (DARE) Study |
| Cases of ventricular proarrhythmia will be recruited throughout England over a 5-year period from junior and consultant hospital doctors including cardiologists. Three research nurses will cover England. They will arrange appointments with patients to discuss the study, genetic testing and consent. If consent is given then a full interview will follow. Hospital and GP records will also be examined. In-hospital deaths due to drug-induced arrhythmias will be included. A panel of cardiologists will screen all cases recruited to ensure appropriate inclusion.
The epidemiological study will utilise a population-based and individually matched control. The GP responsible for each included case will be asked to select and approach the 12 best age and sex matched individuals from his/her patient list to act as controls. The 4 controls closest in age to the index case that respond within 4 weeks will be interviewed. The panel will also screen controls. Follow-up data will be examined using statistical survival modelling.
The genetic study (conducted at St. George's [SGH] will include the first 100 recruited proarrhythmia cases who are white, Northern European, >16 years old and have provided blood samples. DNA will be extracted and PCR (Polymerase Chain Recation) undertaken utilising already designed primers to amplify the coding regions of the implicated cardiac ion channel genes. High throughput base sequencing will then directly identify any base changes relative to the published sequences. If detected they will then be looked for in controls. Two separate control groups will be examined; a population-based ethnically and sex matched control and a drug-challenged control matched for sex and left ventricular function. Logistic regression will be used to estimate the odds ratio between proarryhthmia and the overall mutation rate as well as for each gene and mutation depending on numbers. Separate analyses will be carried out adjusting for specified clinical variables. All data, samples and results will be anonymously stored and kept secure and confidential. |
For the epidemiological case control study the main endpoints are clinical features of risk for proarrhythmia. For the follow-up study the main endpoints are mortality, cardiovascular mortality and cardiovascular morbidity. For the genetic study the main endpoint is mutation nad polymorphism carriage. |
RMG/05/022
01/07/03
28/02/12
ReGrouP |
|
| An investigation into two orthotic devices, their usage patterns, user perceptions and their effects on effort. |
| The proposed study forms the first of a two-part project investigating and comparing the effectiveness of two orthoses: the ankle foot orthosis (AFO) and functional electrical stimulation (FES), for hemiplegic stroke patients with drop foot. In particular, the study will focus on the under-researched areas of patient views of their orthoses and on the effects, that wearing an orthosis, has on physical and cognitive aspects of effort. Information gathered from this study will also be used to inform the second part of the project – an experimental, quantitative comparison of the effect of the two orthoses on gait and function. |
|
RMG/04/105
01/04/04
01/08/09
ReGrouP |
|
| National confidential enquiry into suicide and homicide by people with mental illness-psychological autopsy study |
|
|
RMG/03/006
01/10/03
31/03/09
ReGrouP |
|
| European Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondilitis: Assessment of pain relieve, gastrointestinal symptoms, adherence and health resource consumption |
| This is a multinational, multicentre, observational, retrospective and prospective study which will include patients with
arthritic disorders that have been initiated with a new nonsteriod antiinflammatory (NSAID) treatment within 2-12
weeks of enrolment and are at risk of developing dyspeptic symptoms and serious gastrointestinal complications.
The aim of this study is to find out how patients with osteoarthitis, rheumatoid arthritis and ankylosing spondilitis
receiving NSAIDtherapy are managed in real clinical practice, how patients comply with their treatment and how
satisfied they are.
There are 3 study visits over a period of 6 months. Patients who agree to participate in to the study and give their
informed consent will complete 4 or 5 questionnaires, depending on the treatment the participant is receiving at each
visit. Information regarding patient disease characteristics will be collected from medical records including diagnostics
tests performed and therapies received by the patients.
Patients will undergo clinical assessments and receive medical care as per normal practice. No experimental
intervention or medication will be given as part of the study.
Overall, approximately 3600 patients will be recruited across Europe, and approximately 400 patients will be recruited
in the UK from approximately 40 sites. |
|
2010/238
07/10/10
30/09/11
Not Available |
|
| Evaluating Balint Groups For Foundation Doctors: A Mixed Method Approach |
| The study is looking at any benefits or limitations of foundation year doctors attending a balint style case discussion
group. A foundation year doctor is a postgraduate medical trainee undertaking the compulsory two year foundation
program prior to obtaining full General Medical Council registration. Balint case discussion groups aim to look at the
doctorpatient relationship and how to make the most of this partnership whilst supporting the groups members.
Medical training is a largely objective endeavour: a Balint type case discussion group, encourages a more subjective
assessment of the doctorpatient relationship. The phrase 'patient centered medicine' has been coined to describe
this approach. Balint groups are well established in General Practice and Psychiatry postgraduate
training, with the purpose of providing psychological skills to enable trainees to function more effectively. The effects of using Balint Case Groups at
earlier stages of the postgraduate training using foundation year doctors has not been studied previously. Given the
popularity of case discussion groups within these specialities, it is proposed that exposing doctors to this style of
learning in their careers may lay the foundations for more patient centered medicine.
In this study both qualitative and quantitative methods will be used to assess the effect of Balint groups on Foundation
doctors functioning: the qualitative methodology will involve selecting a purposive sample and conducting semistructured
interviews with participants to uncover people's views and perspectives. This will be complimented by
quantitative techniques delivered via questionnaire. |
|
2010/235
04/10/10
03/10/11
Salford Royal Foundation Trust |
|
| The role of basic emotions in binge eating behaviours within a treatment seeking obese population. |
| The current study seeks to examine the specific role of emotions within binge eating behaviours in an obese population.
Research examining binge eating within an obese population has suggested that specific emotions may have a role in
the origins of these behaviours (Chua et al., 2004; Ganley, 1989). Despite this, research in this area has not
progressed to consider the literature which exists about 'normal' emotional processing. In other words, literature which
is derived from the study of individuals who have more adaptive emotional patterns rather than disordered ones. Within
this, is the 'basic emotions' perspective, which suggests that there are five basic emotions, from which complex
emotions and emotional disorders, such as depression, are derived (Power & Dalgleish, 2008).
Recent research within the field of eating disorders has begun to consider the role of basic emotions in eating
disorder psychopathology. Specifically, some research has suggested that individuals may feel threatened by certain
emotions and thus may suppress them, this in turn may lead to specific eating disordered behaviours (Ionnou & Fox,
2009).
The current study hopes to build on this work, examining these processes within a binge eating obese population.
Specifically the study hopes to investigate whether individuals feel threatened by certain emotional states, and whether
this in turn limits their ability to express these emotions; finally considering whether this leads them to engage in binge
eating behaviours.
The study will therefore recruit participants from weight management and bariatric services and will administer
questionnaires. The data from these questionnaires will then be inputted into a statistical package and analysed using
multiple regression analyses. |
|
2010/223
NHS SalfoR+D (joint study) |
|
| Can skeletal image reporting be taught online: perceptions of experienced reporting radiographers? |
| Reporting of skeletal radiographs is a complex process relying upon clinical skill and comprehensive knowledge and
understanding of the theories and concepts underpinning practice. Traditionally, this has been taught using a blend of
classroom based learning and workplace clinical practice. The direct and indirect costs of staff development are
widely reported, with implications for service sustainability a particular feature of geographically distant locations. A
national shortage of radiologists to supervise workplace experience and support academic learning has challenged
heath professionals to investigate alternative mechanisms to deliver reporting programmes.
In response, a blended learning solution has been developed for radiology, combining traditional models with elearning
techniques and delivering the entire core curriculum through an interactive electronic learning platform.
Despite the growing demand, radiography has been resistant to such progression. Recent analysis of UK reporting
programmes failed to identify any delivering in this format. Similar to radiology, an interactive e-Iearning resource
supporting development of image interpretation skills is being developed for radiography, its focus on basic skills
across the range of healthcare professions, inclUding radiographers, but not extending to the level undertaken by
skilled reporting radiographers.
Given the progress in radiology, this study aims to explore the perceptions of reporting radiographers to online skeletal
reporting education in order to answer the research question, "Radiographer skeletal image reporting: can it be taught
online?" by means of a short online questionnaire, as part of a mixed methods study.
E-Iearning could allow easier access to skeletal reporting education for radiographers. More radiographers
performing this extended role will reduce radiologists' workload and improve patient experience by having reports
available qUicker, allowing treatment to commence sooner. For clinical managers, maintenance of service will be
easier and the financial burden of staff development reduced. For Higher Education Institutions, they could attract
more students from a wider geographical area. |
|
2010/217 ET
27/08/10
26/10/10
Salford Royal Foundation Trust |
|
| Reducing visceral sensitivity in IBS patients by noninvasive cortical and lumbosacral magnetic stimulation |
| Irritable bowel syndrome (IBS) is a common gut problem, affecting some 15% of adults. It is difficult to treat and costs
the National Health Service a lot of time and money. The main problem for irritable bowel syndrome (IBS) patients is
abdominal pain. Non−invasive magnetic stimulation is a safe technique for stimulating nerves and has been shown in
some previous studies to reduce pain sensation in the arm. After having determined the best magnetic stimulation
rates to alter pain sensation in healthy volunteers, we now wish to use the same stimulation techniques over specific
areas of the head and spine to alter sensation and pain experienced in the lower abdomen of IBS patients. |
|
2010/212GI
04/10/10
03/10/12
Salford Royal Foundation Trust |
|
| An evaluation of the Baby Triple P Positive Parenting Programme in women with Postnatal Depression (PND) |
| It is widely accepted that depression in the postnatal period leaves the mother vulnerable to subsequent episodes of
depression, and acts as a risk factor for poor socioemotional
and cognitive development of the baby. Importantly,
Postnatal Depression (PND) has a negative impact on the relationship between the mother and baby. For example,
mothers who suffer with depression have marked difficulties responding to their babies and act as poor models for
problem solving compared with healthy mothers. Studies have shown a predictive link between early PND and
problems much later in development. Early effective treatment of PND is therefore paramount.
The Baby Triple P Positive Parenting Programme (Baby TP) is an intensive parent training involving active skills training
in four core areas, including developing a positive relationship, responding to baby, teaching new skills and
behaviours and survival and partner support skills. It has been developed to enhance the knowledge, skills and
confidence of parents of babies, specifically during the transition to parenthood. Baby TP is a variant of the
internationally recognised and effective parenting programme Triple P.
No study to date has examined the effectiveness of Baby TP in the treatment of women with PND. The research will
evaluate Baby TP in a community sample of first time mothers diagnosed with mild to moderate PND. Mothers with
PND have difficulties responding and developing a positive relationship with their baby, it is therefore predicted that
mothers who receive Baby TP in addition to Treatment as Usual (TAU) will report significant improvements in maternal
mood, parenting confidence and the motherbaby relationship based on selfreport and assessorrated
measures from baseline to posttreatment and followup assessments. This study is unique because for the first time the impact
of Baby TP on the relationship between the mother and the baby will be observerrated using the CARE Index. |
|
2010/210
01/10/10
01/10/12
ReGrouP |
|
| Qualitative study of the views of the General Practitioners on the Collaborative Care Model for the treatment of depression in Primary Care setting |
| Depression is a common mental health problem in primary care setting. It is largely managed by General Practitioners
(GPs)except for the severe end of the spectrum. The General Practitioners refer patients with depression to the
Psychiatrists in secondary care, when depression is of severe degree and/or not manageable in the primary care
setting.
A primary care service based on the "Stepped/Collaborative care model" was established about 3 years ago in Central
Salford area to enhance the care given by the General Practitioners to patients with depression in primary care setting
with support from a Consultant Psychiatrist who provides specialist overview and supervision. This primary care
service team includes a Consultant Psychiatrist,a General Practitioner with a special interest in mental health, case
managers who provide care according to an agreed protocol in liaison with GP,a specialist nurse who provides extra
input to certain patients and supervision and advice to case managers as required and a Cognitivebehavioural
therapist(CBT therapist) who provides specialist psychological supervision.
The aim of our Qualitative study is to explore the views of the General Practioners in Salford concerning this innovative
form of mental health care ie the colloborative care model for common mental illnesses particularly depression. |
|
2010/209
21/09/10
31/08/11
ReGrouP |
|
| A retrospective study to investigate the application of HER2 testing in advanced gastric cancer using semiquantitative immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). |
| The chemotherapy drug Herceptin, better known for its application in breast cancer, has recently been licensed for use
in advanced gastric cancer. The drug is only effective in tumours that overexpress the epithelial surface receptors,
HER2. To identify suitable candidates for this drug, gastric tumours must be screened to establish their receptor
status and whether the tumour would be susceptible to the Herceptin.
This study aims to examine the use of two methods currently employed for the screening of breast tumour HER2
expression and investigate their application to gastric tumour tissue.
immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are clinically used for the identification of the
HER2 receptor and HER2 receptor gene expression respectively in breast tissue. In this study the same techniques
will be applied to gastric tissue to determine if the same concordance between the two techniques can be achieved.
The aim of the project is to tailor these techniques to achieve a standard scoring system so that the same results are
attained from IHC as FISH. This will enable the use of this test diagnostically at SRFT, saving money from unnecessary
referral of work outside the hospital. |
|
2010/204can
16/09/10
15/11/10
Salford Royal Foundation Trust |
|
| Early Detection of Lung Cancer in High Risk Populations Exposed to Occupational and Environmental Risk factors (This is a substantial amendment to the project with title "Incidence, Prevalence, and Biology of Progressive Bronchial Dysplasia in Two Di |
| This study aims to assess the frequency of precancerous airway lesions in patients at high risk for lung cancer and monitor the behaviour of these abnormal areas over time. We will compare the effectiveness of two autofluorescence bronchoscopy systems, one in combination with narrow band imaging (manufactured by Olympus and Xillix Technologies) in the detection of these abnormal lesions. We will also explore the utility of tissue specimens to refine the risk, in addition to patient characteristics, and use molecular biological tools, to identify key genes/gene or protein expression which play a role in lung cancer development. |
|
2010/203
13/09/10
30/06/12
ReGrouP |
|
| Developing a Cortical Auditory Evoked Potential Assessment Tool for Infants With Auditory Neuropathy Spectrum Disorder. |
| Auditory Neuropathy Spectrum Disorder (ANSD) is a type of hearing impairment. The hearing level of patients with
ANSD can vary from near normal to profound hearing impairment. However, the key feature of ANSD is a difficulty in
processing speech. It is not possible to test speech listening ability in babies. Whilst ANSD can be diagnosed very
early in babies in the Neonatal Intensive Care Unit through the Newborn Hearing Screening Programme, there is little
information that can be gathered from the usual Audiological assessments until these infants are at least 6 months
old. Therefore, management of ANSD is very difficult due to the lack of information available to the Audiologist whilst the
infant is very young.
In the management of infants with ‘typical’ sensorineural hearing loss, decisions about treatment, such as hearing aid
settings, are made based on hearing levels measured with a test called the Auditory Brainstem Response (ABR).
However, this technique cannot be used to measure hearing levels in babies with ANSD. Therefore, research is
needed to develop assessment tools which may offer more information for the early treatment of these patients.
This study aims to find out if Cortical Auditory Evoked Potentials (CAEPs), recorded in sleeping infants with ANSD, are
able to predict speech listening ability at one year of age. CAEPs measure the brain's response to different sounds.
This study will first look at whether it is possible to get a clear CAEP response in sleeping infants with normal hearing.
This will then be repeated and compared to infants with ANSD. |
|
2010/200
27/08/10
01/06/12
NHS SalfoR+D (joint study) |
|
| A TwoPart Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin |
| The aim of this study is to assess the variability in various parameters associated with an isoglycaemic clamp procedure in healthy volunteers and patients with Type 1 Diabetes Mellitus. An isoglycaemic clamp is a method by which the length and strength of action of insulin can be measured. At the same time an infusion of glucose is also administered and the amount of glucose used by the body reflects the activity of the insulin. The rate at which glucose given is varied to maintain a set level of sugar in the blood that can be analysed and the effectiveness of the insulin determined.
This study has two parts – part I in diabetic patients and part II in healthy volunteers. Both parts of the study have the same overall study design and the 2 parts may occur simultaneously or in any sequence. Two sites will participate in this study: ICON San Antonio in the USA (Part I) and ICON Manchester, UK (Parts I and II). Each part may be conducted at one or both centres. The patients involved in this study will not receive any benefit from taking part.
This will be an open label study using a marketed form of insulin. Each participant will take part in a screening visit, two study periods and a follow up visit. At the study visits each participant will undergo an isoglycaemic clamp procedure which will last for 30 hours. This procedure requires a high degree of accuracy in order to be able to assess the action of the insulin when using a new product. This study will therefore look at the accuracy obtained using a marketed product to show that this tool will be efficient, accurate and reproducible when looking at a new compound. |
|
2010/198vas
02/09/10
Not Available |
|
| Homelessness and access to Primary Care |
| The proposed project is for a small scale exploratory qualitative study that considers the access to primary care by
homeless individuals. The research will be taking place in Manchester centre. This piece of research was prompted
by The Manchester LINk homelessness campaign. The aim of the research is to consider both those barriers that
may exist within homeless individuals in respect of primary care and those factors that are inherent within the primary
care service itself – training, legislation, attitudes and awareness. Primary care for the most part will be considered as
accessing general practitioners. The research population will be homeless individuals, members of the Manchester
NHS (The Patient, Public Involvement and Patient Experience Team for which I have access to through my involvement
with Manchester LINk) and G.P. (through Manchester Local Medical Committee) and G.P. receptionist staff.
Key questions are as follows
1.) Do the street homeless avoid services due to internal perceptions they have about accessing services?
2.) Questions about stigma and labelling theory of homelessness.
3.) The levels of NHS staff training and support in relation to homelessness?
4.) Questions regarding flagship NHS services, supporting vulnerable individuals in relation to other primary care
services.
Methods employed in the study will be: focused interviews (homeless individuals, support staff and NHS staff);
documentary/textual analysis (policy information, NHS protocols etc.) and literaturebased
research (aligning themes
to theory). Within this Masters study I hope to explore access issues, from both the perspective of homeless
individuals and the practitioner point of view, unpacking the concept of social exclusion along the way. |
|
2010/196
13/09/10
16/11/10
ReGrouP |
|
| Motivating young women to take up cervical screening at first invitation |
| The UK has a high quality cervical screening programme which has been key to reducing mortality from cervical
cancer. Yet in recent years, coverage among the female population has dropped below 80%, and is as low as 50%
amongst young women below 30 years of age in some parts of the country. Women who do not respond to this first
invitation put themselves at risk of cervical cancer. Interventions are urgently needed to reverse this downward trend in
cervical screening uptake and to target women when they are first invited.The main aim of the research is to investigate
whether key information, provided to young women prior to their first cervical screening invitation, can increase their
readiness to engage with cervical screening.The research is qualitative and will determine key motivational
messages, as well as the format in which these should be communicated to young women. Focus group discussions
will be conducted in two sites – in Manchester, England where women are invited for screening at age 25, and in
Aberdeen, Scotland where young women are first called at age 20. Due to this younger screening age, most Scottish
screening invitations will, in future, be sent to young women who will have been offered Human papillomavirus (HPV)
vaccine to prevent cervical cancer. Theoretically the study will determine key messages that move young women from a
stage of "precontemplation" (neither engaging, or planning to engage with screening" to "contemplation" (not
engaging in it, but considering it). These key messages will be incorporated into a leaflet specifically designed for
young women to receive just before their first formal screening invitation. |
|
2010/192
10/08/10
28/02/11
ReGrouP |
|
| Recovery from Day and Short Stay Surgery |
| The present United Kingdom Government has a target of 75% of all elective surgery to be undertaken on a
day case basis by 2010 (Department of Health 2000). Moreover, it has been widely predicted that all elective
surgery will ultimately be undertaken on a day−case basis in the years to come (Baskerville 2007). Such
changes signal the demise of many aspects of traditional physical pre and post−operative nurse care once
deeply embedded in the character of in−patient surgical nursing (Mitchell 2007). For example, “I remember
during my surgical training (Professor Sir Ara Darzi − National adviser on Surgery) in the early 1980’s patients were kept in bed after a hernia operation.” (Darzi 2007 p.2). This situation has now dramatically changed and the British Association of Day Surgery has recently stated that 95% of Inguinal Hernia repairs are currently undertaken on a day−case basis in the United Kingdom (BADS Council 2007).
The amount and variety of surgical procedures possible within the day surgery setting is growing continuously (Lieske et al. 2007, Toftgaard 2007). This inexorable growth is due largely to −
a) the greater use of minimal access surgery which considerably reduces the physical assault on the body (Cuschieri 1991)
b)advances in anaesthesia permitting patients to recovery quicker (Raeder 2006)
c) the public’s desire to undergo day surgery as it is more compatible with 21st Century lifestyles(Lieske et al. 2007).
Furthermore, the increasing complexity of surgical procedures able to be undertaken on a day−case basis continues to grow (Lacquiere et al. 2006, Grimsley et al. 2007, Nishimori et al. 2007). Moreover, further technological advances indicate even greater expansion. “In the next ten years, endoluminal surgery − entering the body through its natural 'holes', such as the throat − will become the standard method of treating many complex cases." (Darzi 2007 p.7). In the near future many patients will therefore have no wounds and thereby experience a minimal amount of pain following their day surgery as the majority of surgical pain arises from the incised skin (Prewett et al. 2008). With new technology continually eliminating many issues of limited post−operative immobility, pain management, wound management together with a very brief hospital stay − what will be the future focus for elective surgical nursing (Hallett 2007)? |
|
2010/190
15/09/10
14/03/12
Salford Royal Foundation Trust |
|
| A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial of Ustekinumab, a Fully Human anti-IL 12/23p40 Monoclonal Antibody, Administered Subcutaneously, in SUbjects with Active Psoriatic Arthritis ahd Previously Treated with Biologi |
| This study will evaluate a new drug called ustekinumab at two dose levels compared with a dummy preparation which looks the same as the test substance. This drug will be tested in subjects with active psoriatic arthritis (PsA), a condition which causes inflammation in and around the joints, usually in people who already have the skin condition psoriasis. The study will enroll approximately 300 subjects. The subjects will be randomly assigned to either treatment with a 45mg dose of ustekinumab, a 90mg dose of ustekinumab or dummy treatment. Subjects assigned to the dummy treatment will transfer at Week 24 to receive ustekinumab at either of the two dose levels with the last dose being administered at Week 40; Subjects in the 45mg/90mg dose groups will receive ustekinumab at Week 1 with the last dose at Week 40. All subjects will be regularly reviewed to measure the effectiveness of the study drugs from the start of the study through to Week 52. The safety measurements will be continued through to Week 60. |
|
2010/187DERM
18/08/10
13/05/12
Not Available |
|
| Pharmacogenetics to predict side effects and response to treatment in cancer |
| Pharmacogenetics is the study of genes (inherited instructions in cells in the body)which may be responsible for drug side
effects and how different people respond to drugs. Recent studies have identified a number of changes in a variety of
genes which have been shown to be important in predicting side effects or good response to treatment. This project
concentrates specifically on genes that may predict side effects and outcome to drugs used in cancer treatment.
Traditionally chemotherapy has been very toxic with a range of side effects including increased risk of infection due to
damage to the immune system, vomiting and diarrhoea.
We plan to collect blood and cancer tissue samples to study why some individuals are at higher risk of problems associated
with cancer treatment. We will study genes important in drug metabolism (handling of drugs in the body) to determine if
they can predict good or poor outcomes to medication to tailor more effective and less toxic treatments in the future.
Therefore, the main research question is: can we identify genes that indicate how individuals will respond to cancer
treatment. |
|
2010/185can
27/09/10
01/11/11
Salford Royal Foundation Trust |
|
| A randomized, double blind, placebo controlled, parallelgroup, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome |
| The prevalence of type 2 diabetes has increased to epidemic proportions worldwide and people with diabetes have an increased risk of cardiovascular diseases and complications leading to a decreased life expectancy. Intensive blood glucose control in diabetes decreases the risk of complications related to vascular disease. Lixisenatide belongs to the class of Glucagonlike peptide 1 (GLP1) receptor agonists and is being developed for the treatment of patients
with type 2 diabetes.
The main aim of this study is to investigate the effect of Lixisenatide on cardiovascular outcomes as compared to placebo using various outcome tests. This will be studied in patients with type 2 diabetes who have experienced an acute coronary syndrome (ACS), i.e. a specific form of angina or heart attack, between 5 days and 12 weeks before the screening visit. Eligible patients will be randomly assigned to Lixisenatide or placebo treatment groups and the study will comprise 3 periods:
1 the screening and run in period where eligible patients will be identified and trained to self inject the placebo.
2 the double blind treatment period where the patient will be randomly assigned to receive either Lixisenatide or placebo for approximately 14 to 41 months (median duration of 23.5 months). After randomization the dose of the study drug will be increased to the specified higher dose over a two week period if tolerable. The patient will then be asked to attend site at regular intervals for visits that will alternate with telephone contacts by the site personnel every
68 weeks.
3 a followup safety phone call performed 3 days after treatment completion.
It is hoped that this research study can show that this new experimental medication, Lixisenatide, may improve the cardiovascular outcomes for these patients. |
|
2010/184vas
23/09/10
06/06/14
Not Available |
|
| Does HPV vaccination for girls encourage under-screened mothers to attend for cervical screening? |
| The national HPV vaccination programme now routinely vaccinates all 1213 year old girls. The potential for HPV
vaccination to reverse a downward trend in cervical cancer prevention is critical. There are many reasons women do
not attend for cervical screening. Information provided to parents and daughters with the HPV vaccination invitation
could raise awareness amongst mothers, increase understanding of HPV and the screening process or impact on
screening uptake by reminding mothers to attend for a smear test. In November 2010, we propose to conduct a survey and in depth interviews of mothers whose daughters have recently been invited for vaccination to investigate the following research questions:
1. What is the association between mothers’ screening histories and acceptance of daughters’ HPV vaccination?
2. Does daughters’ vaccination invitation alter mothers’ intentions to attend for cervical screening?
3. What are the factors associated with a mother’s change in intention to attend for cervical screening?
Two Northwest PCTs will be asked to send a questionnaire to mothers of all 1213
year old girls eligible for the HPV vaccine in school year 2010/11. The short questionnaire will ask about mothers’ screening history, whether they have
chosen to vaccinate their daughter and whether the vaccination or other recent events have resulted in them changing
their intentions to attend for screening in the future. From the questionnaire returns 2030
women, who have agreed to a further interview, representing both positive and
negative attitudes to future screening, will be invited for an audio recorded indepth
interview at a convenient location. These interviews will focus on the motivational determinants of protective behaviour (cervical screening, and its
interplay with HPV vaccination), in particular attitudinal, social support and selfefficacy
expectations (Ajzen 1991). |
|
2010/182
18/08/10
01/08/11
ReGrouP |
|
| Do Rumination and Corumination Independantly Predict Onset of Depressive Symptoms when controling for each other and Attachment Style in Chronic Disease? A Longitudanal Study. |
| Repetitively thinking (ruminating) and talking (coruminating)
about problems, without getting to a solution can lead to
depressive symptoms in healthy people. Chronic disease also increases the risk of depression. This may be
because people tend to ruminate and coruminate
about it.
This study aims to better understand the relationship between rumination, corumination
and depression in chronic
disease. Willing participants will be asked to answer questionnaires about their mood, thoughts, closest relationship and conversations following a hospital appointment and again 3 months later. Participants will be recruited from chronic disease clinics for diabetes and coronary heart disease. Patients’ capacity
to decide whether to participate will be assessed at their outpatient appointment. Those who have capacity and are interested in participation will receive an invitation to join the study, information sheet, consent form and questionnaire battery following their outpatient appointment. They will be asked for a contact phone number. Willing participants' capacity will be confirmed and their questions addressed by phone. They will be asked to complete and return the
consent form and questionnaires by post. The initial data will be analysed for correlations between rumination (Ruminative Thought Style Questionnaire), corumination (CoRumination Questionnaire) and depression (Hospital Anxiety and Depression Scale) when controlling for the related concept of relationship quality (Relationship Questionnaire, Distress Disclosure Index). 3 months later participants will be sent follow up questionnaires to complete and return. These results will be analysed to assess how well rumination and corumination predict the onset of depressive symptoms after 3 months, the direction of the relationship between rumination, corumination, relationship quality and depression. Better understanding the relationship between rumination, corumination
and depression may lead to new avenues for intervention to prevent and treat depression in chronic disease. |
|
2010/181
14/07/10
14/01/11
NHS SalfoR+D (joint study) |
|
| Development of a treatment schedule of upper limb interventions employed by occupational therapists with service users following Stroke |
| Previous stroke therapy research studies have failed to accurately record occupational therapy interventions due to a
lack of appropriate documentation. As a result it has been difficult to draw conclusions from these studies.
Occupational therapists currently record their interventions in a variety of ways, there is usually a reliance on
description of the intervention and it is therefore difficult to concisely and accurately summarise interventions. In order
that upper limb (hand and arm) interventions can be effectively studied, it is essential that a method of documenting
upper limb interventions used by occupational therapists is developed. This type of documentation is often referred to
as a treatment schedule.
The aim of this study is to develop an upper limb treatment schedule to standardise the documentation of upper limb
interventions used by occupational therapists working with stroke survivors. Once developed the treatment schedule
will complement a previously developed physiotherapy treatment schedule and will allow an accurate record of upper
limb interventions. This study is part of a larger project and the treatment schedule will be used in a second study that
will aim to establish the effectiveness of a selected upper limb intervention (constraintinduced
movement therapy).
A series of interviews and two facilitated group discussions with experienced occupational therapists in the NorthWest
of England will be used to collect the data. This data will be transcribed and analysed by two independent researchers
and will inform the development of the treatment schedule. The generalisablity of this locally agreed treatment
schedule will be tested through a questionnaire completed by a sample of occupational therapists based in the United
Kingdom. This phase will indicate to what extent the treatment schedule is appropriate for use in stroke services
throughout the United Kingdom.
It is anticipated that it will take 14 months to complete this study. |
|
2010/179
20/07/10
31/08/11
ReGrouP |
|
| Multiprofessional Communities of Practice in Healthcare |
| It has been suggested that healthcare organisations are more likely to implement their objectives and achieve
sustainable change if the communities of practice (CoPs) are formed from within. A CoP is a group of people who
share a concern, a set of problems, or a passion about a particular topic, and who deepen their understanding and
knowledge of this area by interacting on an ongoing basis. The CoP approach is being increasingly used in healthcare
as a strategy to promote partnership working, collaborative learning and knowledge mobilisation. In turn, this raises
the question whether CoPs can be deliberately created and managed to achieve a set of desired aims.
While previous research has predominantly focused on unidisciplinary CoPs and knowledge transfer between
communities, this study will explore the development of multiprofessional and multiagency
CoPs and the process of
knowledge sharing within them. It will explore how knowledge sharing within a multiprofessional and multiagency
CoP is influenced by different professional and organisational roleidentities
of its members as well as by multiple
boundaries between different sectors, organisations and occupational groups.
The study will look at three interconnected teams working within the Greater Manchester CLAHRC (Collaboration for
Leadership in Applied Health Research and Care). Underpinned by the philosophical assumptions of critical realism,
the project will deploy a case study as a research methodology. It will include the following methods: (1) Analysis of
documents produced by the CLAHRC; (2) Observation of team meetings and other activities performed by the
participants; (3) Indepth interviews with the participants of the CLAHRC projects.
This research project will aim to reveal some of the mechanisms which govern the functioning of heterogeneous
communities of practice in healthcare organisations. Understanding these mechanisms is critical for the identification
of barriers to joint working, making collaboration more effective and achieving sustainable organisational change |
|
2010/178
02/08/10
19/09/12
NHS SalfoR+D (joint study) |
|
| Headache and Posttraumatic Stress Disorder: What is the relationship? |
| Both migraine and PTSD commonly occur in the general population at significant costs to society (Steiner et al, 2003)
(Seedat et al, 2005) (Ferrari, 1998). The links between adverse life events and ill health and, more specifically, abuse
and headaches, is well recognised (Felitti et al, 1998). Indeed, research suggests that there is a great deal of overlap
of patients with migraine headaches and patients with PTSD (de Leeuw, 2005). Yet, little is known of the character and
type of headaches that people with PTSD tend to suffer. This study will chart the selfreported
headache features of a sample population of asylumseekers
diagnosed with PTSD. The aim of the study is to establish whether there is a
pattern to the headaches experienced by sufferers of PTSD. |
|
2010/177
07/07/10
31/05/11
ReGrouP |
|
| Living with Chronic Obstructive Pulmonary Disease (COPD) |
| The research aims to gain a greater understanding of individual's experience of living with Chronic Obstructive
Pulmonary Disease (COPD) and how they express this. There is much research that has measured COPD patients
quality of life and functioning through outcome measures (Sodergren et al, 2002, Sewell and Singh, 2001, Puhan et al,
2007), however, the researcher wishes to use visual research (photograph elicitation) to enable the participants to lead
the research by identifying the main themes in living with COPD, coping with the condition and expressing their
experiences of COPD. This would be conducted within the Ashton, Leigh and Wigan district where COPD patients
would be recruited from the researcher's clinical caseload (adults from 18 years and above). The participants will be
asked to take 10 photographs each that express how they live with COPD. The researcher will be providing digital
cameras for this purpose. Following this the researcher will discuss with each participant the meaning of their
photographs. Finally, a focus group will be held to discuss the main themes identified from these discussions. This
will be conducted within the Ashton Leigh and Wigan community and it is anticipated the study will take 12 months in
total. |
|
2010/176
13/09/10
02/09/11
ReGrouP |
|
| Exploring diversity within the sex industry: an investigation into the structure and composition of sex markets in Britain |
| The research will investigate, primarily through a webbased survey of government or voluntary projects seeking to
support sex workers, the approximate distribution of sex work and sex markets in Britain (including broad occupational
classification and estimate of proportion of male/female/transgender workers in each subsector).
Through a review
of the literature it will also consider how these different forms of work are treated in current UK legislation and policy. |
|
2010/172
06/07/10
30/09/10
ReGrouP |
|
| A study to describe the resource use and patient pathways associated with the management of Chronic Obstructive Pulmonary Disease (COPD) in clinical practice. |
| Chronic Obstructive Pulmonary Disease (COPD) is a disease characterised by chronic obstruction of airflow in the
lungs, interfering with normal breathing and causing shortness of breath. It is the thought to be the fourth most
common cause of death worldwide. It predominately affects adults over the age of 40 and is strongly linked to smoking
and exposure to occupational pollutants. Treatment and management of COPD represent a significant burden to the
NHS.
The primary aim of this study is to quantify the resoruce use associated with the routine management of patients with
COPD and the management of disease exacerbations in a real world setting. In addition to this, patient pathways and
treatment algorithms will be described.
COPD is a progressive disease and the study will involve approximately 500 patients with varying stages of COPD
(mild, moderate and severe) from 10 GP practices in England. This is a non-interventional study and therefore patients
will not participate directly but will be asked for their consent for their medical records to be used for the purpose of this
research.
Data on numbers of visits to the GP and hospital, and all investigations and treatments received for COPD over the last
3 years will be collected retrospectively from the medical notes of the consenting patients. The 10 GP practices will be
selected to include a representative mixture socio-economic and geographical factors. |
|
2010/171
26/07/10
31/12/10
ReGrouP |
|
| A Multinational, multicentre, randomised, parallel group study performed in subjects with Relapsing Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40mg administered three times |
| Multiple Sclerosis (MS) is a chronic, inflammatory condition which leads to damage of the central nervous system, causing disability at various degrees and rates in different patients. Copaxone® (glatiramer acetate)(GA) is a disease modifying drug that has been licensed for use in RelapsingRemitting
multiple sclerosis (RRMS) patients.
The current dosing regimen requires daily injections of 20mg GA. This research will investigate a new dosing regimen of three injections per week of 40mg GA. The study will involve approximately 1350 subjects from participating countries including Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Romania, Russia, South Africa, Turkey, Ukraine, UK and the USA. Approximately sixteen (16) patients will be invited to participate from four (4) UK centres. The study will consist of a 30 day screening period followed by a 12 month doubleblind, placebocontrolled
treatment phase during which patients will be expected to attend approximately 3 monthly for five (5) visits. Subjects completing the 12 month doubleblind
treatment phase will be offered the opportunity to participate in an openlabel extension phase where they will be treated with 40mg GA until the new dose strength becomes commercially available. It is expected that a new dosing regimen for GA will improve convenience of treatment by allowing fewer injections, provide reduced burden and increase treatment compliance in RRMS patients. It is also expected that there will be fewer sideeffects that are normally associated with daily subcutaneous (under the skin) injections. Overall, the aim of this research is to provide a safer, more convenient treatment for RRMS patients. |
|
2010/160neuro
26/08/10
31/05/15
Salford Royal Foundation Trust |
|
| Barriers to quitting smoking experienced by White adult males using an NHS Stop Smoking Service |
| Research question: What are the barriers to quitting smoking experienced by White adult males that do not achieve 4
week quit when accessing the NHS Tameside and Glossop Stop Smoking Service (SSS)?
Purpose of research: Around 18% of all deaths amongst those aged 35 years and over are estimated to be attributable
to smoking, as well as being responsible for over half of the difference in risk of premature death between social
classes. As the purpose of the NHS SSS is to support smokers to quit, it is important that they understand barriers in
quitting experienced by smokers that use the SSS to aid their quit attempts.
Research methods: During this research, three focus groups will be conducted, with between six and ten men in each
group. Participants will be recruited via the SSS using the following inclusion criteria: White adult males that have
given permission to be contacted again by the SSS; they should also have started a cessation programme from
2008/09 onwards, but have not achieved a 4 week quit as defined by the SSS monitoring guidance.
The focus groups will be audio recorded and transcripts will undergo framework analysis to identify themes emerging
from the group discussions.
Costs of research: The focus groups will be held in community venues provided by a local social housing provider, and
NHS Tameside and Glossop will cover costs associated with the research. |
|
2010/159
27/07/10
31/08/11
ReGrouP |
|
| Newly Qualified Clinical Psychologists’ Perspectives on Resilience: A Qualitative Study. |
| This study aims to gain an understanding of how newly qualified clinical psychologists understand the concept of
resilience, their experiences of the process of developing resilience, and how they maintain resilience.
Research suggests that healthcare professionals experience significantly higher levels of stress compared to the
general population. Research into resilience amongst healthcare professionals is primarily quantitative, focuses on
nursing, and does not address the process of developing resilience. More specifically, using primarily quantitative
approaches, research to date tends to focus on the nature of resilience as opposed to experiences which may have
contributed towards its development – which may be a lifelong process.
Related research amongst a clinical psychologist population has used quantitative approaches assessing stress
levels (with data indicating clinical psychologists experience significant levels of stress). Trainee clinical psychologists
find themselves in a stage of adjustment to new responsibilities, and given the experiences required to become a
trainee clinical psychologist, and the stresses of training, are likely to come armed with many experiences enabling
them to manage the adjustment.
There is thus a lack of qualitative research into resilience generally, and none in a clinical psychologist population.
Similarly, there is a lack of research into the process of developing resilience, identification of which may help identify
experiences which may be useful in training programmes to help promote the development of resilience.
A sample of between 1015
newly qualified clinical psychologists will be individually interviewed, guided by
Interpretative Phenomenological Analysis (IPA) either in their place of work or in the Division of Clinical Psychology at
The University of Liverpool, to gain insight in to their understanding of resilience, and how they have developed and
maintained it. Interviews will last around an hour and be recorded and transcribed for subsequent data analysis. |
|
2010/155
20/07/10
30/04/11
ReGrouP |
|
| A Phase III, randomized, comparative, openlabel study of intravenous Iron Isomaltoside 1000 (Monofer®)
administered by infusions or repeated bolus injections in comparison with oral Iron Sulphate in subjects with nondialysis dependent chronic kidney |
| The main objective of the study is to determine the effects of an investigational drug Iron Isomaltoside 1000 (Monofer®)
in subjects not in dialysis who have Chronic Kidney Disease (NDDCKD)
(a renal disease characterized by
progressive loss of renal function over a period of months or years) and with Iron Deficiency Anaemia (IDA) (Anaemia
is a condition characterized by deficiency of blood).
Clinical safety data is present for Iron Isomaltoside 1000 (Monofer®) but needs to be supplemented with effectiveness
data in subjects with iron deficiency anemia requiring parenteral (administered by intravenous or intramuscular
injection) iron therapy. NDDCKD
associated with IDA is one such condition where subjects require parenteral iron therapy.
IDA is often associated with many chronic diseases such as renal diseases, cancer, infections (e.g. AIDS and
malaria), chronic heart failure and inflammatory bowel disease. It is also common in elderly people who do not have
any obvious symptoms of chronic disease. The mechanism behind anaemia in chronic disease is complex. Currently,
parenteral iron is used in subjects with anaemia associated with chronic kidney disease treated with haemodialysis
and erythropoiesis stimulating agents (ESA’s, i.e. epoetin or darbepoetin). Studies have shown that parenteral iron
therapy may be superior to oral supplementation in such subjects.
A total number of approximately 350 subjects will be randomized (like flipping a coin) in a ratio of 2:1 to either Iron
Isomaltoside 1000 (Monofer®) or oral Iron Sulphate. The subjects randomized to Iron Isomaltoside 1000 (Monofer®)
will be equally divided into groups A1 (administered as intravenous infusions) & A2 (administered as intravenous
bolus injections).
Subjects will at the trial hospital clinic be given intravenous infusions or repeated bolus injections of Iron Isomaltoside
1000 (Monofer®) or
subjects will twice daily swallow a tablet of oral iron sulphate at home for 8 weeks. |
|
2010/151VAS
02/09/10
01/05/12
Salford Royal Foundation Trust |
|
| An investigation into the experience of making the transition from trainee to qualified clinical psychologist. |
| Background: The transition from trainee to qualified clinical psychologist is often accompanied by significant difficulties in adjusting to the new role. Cheshire (2000; 2002) found that many newly qualified psychologists felt "very low" and demoralised at different times during the first eighteen months postqualification,
with some considering leaving the profession. Increased professional stress has further reaching consequences as it is associated with reduced quality of care to clients (e.g. FirthCozens, 1993). Understanding the experience of qualifying as a clinical psychologist, and what factors facilitate a smooth transition are therefore likely to be beneficial to clinicians and their clients.
Aims:
To gain an understanding of:
• The experience of making the transition from trainee to qualified clinical psychologist.
• The meaning this transition holds (e.g. Loss? Change in status/responsibility? Etc.)
• What facilitates a smooth transition, and what makes it more difficult. Questions will focus on both personal attributes (e.g. Personal expectations, previous experiences etc.) and external/social factors (e.g. Social support, workload, supervision etc.)
Summary of Procedure:
Recruitment: The 2006-2009 cohort that qualified in 2009 from the University of Liverpool D.Clin.Psychol course (N =20) will be contacted with written details of study via University of Liverpool administrative staff and contacts at local NHS Trusts. Potential participants will be asked to respond if they are eligible and interested in taking part. (Please see A171 for inclusion criteria). It is intended that approximately 12 people will participate (including 2 for the pilot study).
Method: A semistructured interview will be used to elicit rich data whilst ensuring specific areas of enquiry are covered. Interviews will be recorded and transcribed for analysis. The interviews will be transcribed by an approved transcriber at the University of Liverpool.
Analysis: Interpretative Phenomenological Analysis (IPA) (i.e. Identification of superordinate and subthemes using an iterative approach) |
|
2010/150
21/06/10
31/12/10
ReGrouP |
|
| Preliminary psychometric evaluation of a questionnaire to measure empowerment in primary care patients with longterm conditions |
| We are seeking ethical approval to conduct preliminary testing of a questionnaire developed to measure empowerment in patients with long term conditions in primary care. Current health policy states that GPs and nurses are required to support selfcare to help patients’ become empowered to self manage and achieve better outcomes. To check that health professionals are able to empower their patients, we need to be able to measure empowerment. There are a number of questionnaires, but none have been developed specifically for patients in the UK with long term conditions.In previous research, we spoke to people with different long term conditions about their feelings of being in control. We also spoke to doctors and nurses about how they tried to achieve empowerment.
Being empowered involved having a strong sense of self, having as much conditionrelated knowledge as desired, having personal control outside of the consultation, making decisions with your doctor, and enabling fellow patients who may be coping less well. We devised questions to capture these different beliefs and feelings and incorporated these into a questionnaire. We have done some preliminary testing of this questionnaire to make sure it is understandable and acceptable. We would now like a lot more patients with long term conditions to complete our questionnaire. This will enable us to see whether the tool is actually measuring what it sets out to measure (that is, whether the tool is valid) and whether the measure gives consistent scores over time (that is, whether the tool is reliable). We will invite three practices previously recruited for our work, situated in the North West of England. We propose a postal survey, with practitioners' selecting respondents from the chronic disease registers. We aim to recruit approximately 300 respondents in total in order to perform preliminary survey anlayses. |
|
2010/147
21/06/10
31/08/10
ReGrouP |
|
| Does polymorphism of BDNF gene affect Oesophageal Pain Thresholds? |
| Gullet pain is common. Many people suffer pain that does not respond to acid suppressing medicines and the cause is unknown despite tests. There is evidence that these patients are more sensitive in the gullet, compared to those without symptoms. A person's genes might influence how sensitive the gullet is. We want to test how sensitive a person's gullet is and test them to see if they have a certain gene which is present in one third of healthy people. We
know that this gene (BDNF) is important in the gut and the workings of the nervous system. If the link is proven this could improve understanding why some people suffer with symptoms of these disorders, while others don’t. It could lead to other studies as well as exciting developments in future treatments. |
|
2010/146 GI
13/07/10
12/07/11
Salford Royal Foundation Trust |
|
| Understanding movement problems of ataxic gait. |
| To identify the movement problems of ataxic gait and explore the relationships between the problems and their effects on function. Ataxia is a neurological condition that causes uncoordinated movement which affects activities of daily living, such as walking. Ataxia can be seen in many conditions such as Spinocerebellar Ataxia, Freidrich’s Ataxia, Multiple Sclerosis, Stroke, Peripheral Vascular Disease and Neuronopathies.
We do not have a full understanding of what causes the uncoordinated movement and why people with ataxia have difficulty with walking and balance. Physiotherapy is one way of treating and managing walking problems but we want to know what causes the uncoordinated movement so we can develop more effective physiotherapy treatments.
Hence, a detailed analysis of walking needs to be carried out.
Consultant neurologists and stroke physicians based at Hope Hospital; and their clinical teams will identify patients who have ataxia, are able to walk 10m independently or with an assistive device, able to stand independently for 20seconds, are over 18 years of age and able to give informed consent. This study will take place in the Podiatry Clinic and last around 2 hours. Assessments of ataxia severity, walking speed, standing balance, number and type of falls, leg strength, leg sensation, fatigue, pain and eye movement will be taken. The testing procedure involves well developed tests and equipment that are widely used in clinical and movement science research. Information collected will be analysed and help us to develop more effective treatments.
This work is supported by the University of Salford and is run through the Centre for Health, Sport and Rehabilitation Sciences Research. Participant’s expenses for travel will be reimbursed. |
|
2010/145NEURO
10/08/10
09/08/12
Salford Royal Foundation Trust |
|
| Illness perceptions in mothers with depression after childbirth |
| One in seven women experience depression after childbirth (postnatal depression) which is characterised by low mood, anxiety, disturbed sleep and eating patterns, poor concentration, low selfesteem and low energy levels. It is suggested that mothers with postnatal depression do not always seek professional help as they can be concerned about having their baby taken away from them. To help mothers seek support from professionals, it is essential that professional staff have an understanding of mothers’ beliefs about having this type of depression. The study aims to discover how mothers with postnatal depression view their illness and what beliefs they hold about it, determining what common sense model or representation mothers have of postnatal depression. Determining illness beliefs is very important, as research strongly suggests that illness beliefs have a significant impact on coping and managing with the illness. A questionnaire called the Illness Perception Questionnaire (IPQR) has been created to measure people's feelings and beliefs about having a physical illness. There have been studies which have adapted the IPQR to explore illness beliefs in depression and schizophrenia. This study aims to use the IPQR to measure mothers' feelings and beliefs about having postnatal depression. For this purpose the IPQR will be modified so that it is applicable to postnatal depression. The study will test aspects of the reliability (consistency) and validity of the IPQR modified for use with postnatal depression. The study also aims to explore if mothers' beliefs about their depression have any influence on how severe their symptoms of depression are and if illness beliefs are different for mothers who have experienced depression before. |
|
2010/144
16/08/10
01/09/11
ReGrouP |
|
| Evaluating the implementation of the Mental Health National Service Framework: process and impact |
| The Mental Health National Service Framework (NSF) was published in 1999 and set out to improve the quality of provision for people experiencing mental health problems through developing community services. The Mental Health NSF included an explicit focus on implementation including roles, structures and preparation necessary to facilitate implementation. It led to the development of Local Implementation Teams (LITs) as well as additional investment of
resources and an annual process of review. An examination of the literature reveals an absence of research that focuses on understanding implementation of
mental health policy. This study is concerned with exploring both how the Mental Health NSF has been implemented in a local area and the impact that it has had on the lives of people with a serious mental illness living in that area. By doing this, the research should contribute to improving the quality of services and the quality of lives of people with a diagnosis of mental illness. This is mainly a qualitative study. The first phase of the study involved interviews with key people engaged in the development and implementation of the Mental Health NSF to explore issues related to overall conception, vision and implementation. The second phase provides a detailed study of NSF implementation in two case study sites. The case studies will involve interviews with LIT members, local providers, clinicians and other staff and mental health service users about their experience of implementing the Mental Health NSF. A questionnaire will also be circulated to a wider group of stakeholders in order to understand how the local mental health system works. It will also involve reviewing key papers and reports and examining data on investment in mental health services to understand what changes have taken place as a consequence of the Mental Health NSF. |
|
2010/142
06/07/10
31/12/10
ReGrouP |
|
| Perspectives on Prescribing Influences amongst Nonmedical Prescribers |
| The overall aim of this programme of work is to understand the factors influencing the prescribing decisions of nurse
and pharmacist nonmedical
prescribers. This study aims to build on initial findings from a small exploratory study completed between March and August 2009. The exploratory work helped to explore some of the influences on the prescribing decisions of nonmedical prescribers. This study aims to build on this knowledge by exploring the
viewpoints held by prescribers with regards to the factors that influence their prescribing decisions. Whilst the exploratory study provided some initial data on this matter, due to the nature of the technique it was difficult to clearly differentiate perspectives amongst prescribers. In contrast the Qmethod provides a systematic means to identify perspectives in relation to a topic whilst still maintaining the depth of qualitative research techniques. In this study the
qmethod exercise will be facilitated by the internet. To be eligible for the study participants must be working in primary or community care and be using independent and/or supplementary prescribing. It is anticipated that the final sample will comprise 60 nurse and pharmacist prescribers. During the exercise participants will be asked to sort a number of statements depending on the extent of their agreement with the statement in relation to the prescribing decisions they make. Participants will also be asked to provide a few details regarding their role and use of prescribing. It is hoped that this study will provide a means to look at different view points or perspectives held by nonmedical prescribers in relation to influences on prescribing decisions. |
|
2010/141
15/06/10
31/12/10
ReGrouP |
|
| A study to investigate the feasability and acceptability of the use of the Dementia Care Mapping tool on an acute neurorehabilitation ward |
| Person centred care involves valuing patients, treating them as individuals, considering the world from their
perspective and providing a positive social environment. National Health Service guidance states that these are
important aspects of care for people receiving treatment for brain injury on neurorehabilitation wards. However,
currently, there is no method to check the quality of person centred care on neurorehabilitation wards, or to help staff
improve their person centred care.
Dementia Care Mapping (DCM) is a method to check and improve person centred care in Dementia settings. It
involves trained individuals observing a care setting such as a hospital ward. They pay particular attention to staff and
patient interactions and patient wellbeing. Following this, the trained individuals feedback the results to staff, so that
staff can use this information to improve person centred care. This would aim to improve the experiences of patients
accessing services. There is some evidence that this method is suitable for use in other clinical settings, but to date it
has not been used on neurorehabilitation wards.
This research aims to see if DCM is an effective technique to improve person centred care on a neurorehabilitation
ward and whether any adaptations would need to be made to the method to use it in this setting. Q sort methodology
will be used to obtain feedback from patients and staff on what it was like to be observed and how they found the
process overall. Staff and patients will also be asked to give their ideas about how the tool may be adapted further in
the future. It is hoped that staff and patients will find the adapted tool useful and a positive experience; however, ideas
regarding improvements to the process will be used to highlight further recommendations for the use of this tool on a
neurorehabilitation unit. |
|
2010/139NEURO
10/09/10
09/11/10
Salford Royal Foundation Trust |
|
| A 4 month, open-label, multi-centre study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis |
| Multiple Sclerosis (MS) is the most common disabling disease of the Central Nervous System (brain and nerves of the spinal cord) in young adults. The cause of MS is unknown. It is an autoimmune disease, where the white blood cells (lymphocytes) start to attack the nerves and parts of the brain.
There are several types of MS the most common type is known as relapsing remitting MS (RRMS). Patients with RRMS have repeated acute episodes of neurological symptoms(relapses), which are followed by a complete or partial recovery (remission). |
|
2010/137neuro
15/07/10
14/02/12
Salford Royal Foundation Trust |
|
| The effects of prescribed exercise to health when delivered within a Primary Care Trust environment |
| The effects of prescribed exercise to health when delivered within a Primary Care Trust environment How to engage individuals and populations in becoming more active is evidently a key question today in public health. The main aim of the study is to investigate the role of an exercise intervention when delivered within a primary health care setting in improving adherence rates for the treatment of obesity. Further objectives of the study are to both provide
evidence and determine the effectiveness of a 12 week exercise referral scheme. The weight management referral service was set up to encourage the early identification of overweight and obese patients. Hindley is known to be an area with high deprivation levels. Therefore the scheme will help to reduce the burden of chronic disease within the area, thereby reducing health inequalities between Hindley and other areas. Indeed, the weight management scheme at Pennygate Medical Centre is unique in offering patients the opportunity to exercise in a primary care trust facility within the borough of Ashton, Leigh and Wigan. Patients recruited onto the study will be identified and selected by the doctors. To be included, all participants are required to have a BMI > 30 (or 28 in Asian population) or BMI > 25 with comorbidities. The number of participants will be one group of 20. The mode of aerobic activity will include rowers, cycles, cross-trainers and treadmills. On testing days, before and after the 12 week exercise programme, the following measurements are required: a fasting lipid profile using blood samples taken by the nurses at Pennygate Medical Centre. Body fat percentage will be analysed using a handheld bioelectrical impedance analyser. Blood pressure will be assessed using an upper arm blood pressure monitor. A physical activity questionnaire will be used to measure the amount of physical activity performed weekly, as well as a questionnaire to assess mood. |
|
2010/136
15/07/10
31/12/10
NHS SalfoR+D (joint study) |
|
| Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in subjects with active axial spondyloarthritis (Axial SpA) Protocol Number AS001 |
| This study aims to determine if the Certolizumab Pegol, a TNFa-antagonist (Cimzia®), is a safe and suitable treatment for patients with active axial spondyloarthritis (SpA).
Axial SpA is the name given to a group of chronic or long-lasting diseases that affect the spine and the sacroiliac joints (where the spine meets the pelvis), which may lead to fusion of the spine. The most well acknowledged subset of the axial SpAs is ankylosing spondylitis (AS). About 1 in 1000 people in the UK develop AS at some point in their life. Those in their 20s and 30s are affected most often. Men are two to three times more likely than women to have
spondyloa rthritis.
Conventional treatment of AS has included nonsteroidal anti-inflammatory drugs (NSAlDs) and physiotherapy. NSAlDs reduce inflammation and ease the pain, but sometimes have unacceptable side effects, especially in the gastrointestinal tract. The introduction of TNF-antagonists represents a major advance in the drug treatment of AS, and preliminary data support their efficacy in axial SpA. Currently there is no approved treatment for patients with axial SpA.
Early data support that TNF-antagonists may work as well if not better for treatment of all axial SpA rather than just AS only. The therapeutic response to currently available TNF-antagonists is variable in AS. This is also true for tolerability and is in keeping with the well known idiosyncratic response to traditional disease-modifying antirheumatic drug (DMARDs). Therefore, there remains a medical need for additional effective TNF-antagonists for the treatment of AS, and an approved treatment for axial SpA. Thus, the benefit this study is the potential efficacy and future availability of a new TNF-antagonist treatment for axial SpA, which includes those diagnosed with AS.
For each SUbject, the study will last a maximum of 171 weeks, and approximately 315 SUbjects across 100 sites worldwide will take part in this research. |
|
2010/134derm
13/09/10
02/09/14
Not Available |
|
| Focus groups using parents of children with a learning disability |
| The purpose of this study is to explore parents’ experiences of accessing health services. To discuss the positive and negative experiences parents and their child have had. |
|
2010/127
28/06/10
30/11/10
ReGrouP |
|
| A 52 week treatment, multicenter, randomized, doubleblind, parallelgroup, active controlled study to evaluate the effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and open label tiotropium (18 μg o.d.) on COPD exacerbations in patients with s |
| Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs characterized by airflow limitation which is not fully reversible. Frequent COPD exacerbations (worsening of symptoms)reduce the patients quality of life and lung function which can lead to ill health, hospitalization and deaths. Therefore effective management of COPD includes both prevention and treatment of their exacerbations. QVA149 is a fixed dose, dry powder combination of two
medications indacaterol (QAB149) and glycopyrronium bromide (NVA237) which is being developed as an inhaled medicine for the treatment of COPD. Current data indicates that these drugs can reduce the rate of COPD exacerbations. Both medicines on their own are effective in providing longterm bronchodilation in terms of improvement in symptoms but the possible beneficial effects of them as a fixeddose combination has to be demonstrated. Currently, there is no fixeddose combination of these two long acting medicines. Tiortopium is a similar long acting medicine which is already on the market and is being used to compare the new treatments to. If a patient gives consent to take part, they will be randomly assigned to one of three treatment groups.
QVA149 (the combination)
NVA237
Open label Tiotropium
130 UK patients will be recruited at approx 14 sites and remain in the study for a 12 month period. 2000 patients will be
recruited globally into the study. Patients will attend a maximum of 14 study visits. |
|
2010/126ET
04/06/10
03/06/12
Salford Royal Foundation Trust |
|
| Phase 3, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects with Adult -Onset Active and ProQressive Arthritis(PsA) |
| This study aims to determine if Certolizumab Pegol, a TNFa-antagonist (Cimzia®), is a safe and suitable treatment for patients with adult-onset Psoriatic Arthritis (PsA).
Psoriasis is a long-term (chronic) scaling disease of the skin, which affects 2% - 3% of the UK population. It appears as red, raised scaly patches known as plaques. Plaques most commonly appear on the elbows, knees and scalp. It can be itchy, but is not usually painful. 10% to 20% of people will develop psoriatic arthritis. More than 50% of patients with PsA experience progressive, erosive arthritis, accompanied with pain, fatigue and functional impairment. The
combination of both joint and skin symptoms of PsA can have a profound impact on a patient's function, well-being and quality of life.
Therapeutic approaches for PsA have focused on a similar etiology underlying both Rheumatoid Arthritis (RA) and PsA and treatment for PsA has traditionally included nonsteroidal anti-inflammatory drugs (NSAIDs) and data support their efficacy in the treatment of peripheral arthritis. The TNFa-antagonists (there are 4 registered in Europe for PsA) have improved the signs and symptoms of peripheral arthritis in PsA and accompanying psoriatic skin disease. In addition,
all have demonstrated improvement in functional status and patient quality of life as well as showing diminished progression of joint damage on X-ray. However, for reasons of loss or lack of efficacy or intolerance to these currently available TNFa-antagonists, there remains a need for additional TNFa-antagonists as therapeutic options for patients with PsA, as observational data support that failure of an initial TNFa-antagonist does not prevent the response to another one.
For each SUbject, the study will last a maximum of 171 weeks, and approximately 390 subjects across 100 sites worldwide will take part in this research. |
|
2010/125DERM
13/09/10
02/09/14
Salford Royal Foundation Trust |
|
| Polo−like Kinase 1 mediated oesophagogastric cancer development, it's prognostic significance and potential therapeutic target. |
| We will aim to collect a small number of paired biopsies from approximately 110 patients with Oesophageal
cancer attending for routine endoscopy and/or curative/palliative surgical treatment. The paired biopsy's will
be taken from the area of cancer and adjacent non−tumour tissue, so the patients own normal tissue is the
control. We will also collect a small number of entirely normal controls (approximately 30 patients) to assess
baseline PLK1 expression.
We will perform immunohistochemistry and colocalisation of PLK1 in tumour tissue. This enables us to
determine the expression of active PLK1 protein in the tissues and to compare it to tissue taken from normal
patients. This will show us if PLK1 is overproduced in cancerous cells.
We will also perform RT−PCR (Reverse transciptase polymerase chain reaction) examination of PLK1 RNA
expression in oesophagogastric snap frozen biopsy samples (University of Manchester, Life Science section,
Prof AD Sharrocks team – Collaboration). This is a more direct method to assess the levels of PLK1 genes in
cancerous cells.
Furthermore, we will utilise cancer cell line models (laboratory grown cancer cells) to study the association of
PLK1 expression with proliferation related genes and oncogenes (e.g. PCNA−LI = proliferating cell nuclear
antigen−labelling index) and tumour suppressor genes (e.g. p53). This will allow us to study how PLK1
contributes to cancer formation and will give us more information about what PLK1 does in cancerous cells.
We will observe the effect of PLK1 gene depletion on the growth of cancer cell line (e.g. MKN45 cells) via
inhibition by siRNA (expression of PLK1 mRNA and protein –RT−PCR/Western blot, morphological change of
microtubules and mitosis phenotype in MKN45 cells will be observed by immunofluoresence staining and
laser confocal microscopy, expression levels of cyclin B/caspase 3). This will allows us to assess the effect
on cancer development of removing the PLK1 protein and will give us information about how useful a cancer
target plk1 is. We hope this reveals whether or not drugs targeting PLK1 will be successful in this cancer
We will look for co−association between FoxM1 and Plk−1 overexpression in cancer samples. We will
examine whether a forkhead protein is responsible for recruiting Plk−1 to target genes (as suggested from
the yeast study) in cancer cell lines (see relevant recent publication by A Sharrocks et al in Nature, nov
2006). This will show us how PLK1 is "turned on" to contribute to the development of cancer. |
|
2010/123 CAN
06/09/10
01/11/11
Salford Royal Foundation Trust |
|
| Appraisals and coping in nonepileptic attack disorder (NEAD) |
| Nonepileptic attack disorder (NEAD) is a disorder characterised by episodes which resemble epileptic seizures, but has a psychological rather than physical cause. It is increasingly recognised as a clinical problem, with up to 20% of patients being referred to epilepsy centres experiencing nonepileptic attacks. NEAD poses significant challenges for health professionals, particularly as the psychological mechanisms of the condition remain poorly understood.
There are many reasons why people can develop NEAD. Previous research has investigated the role of childhood abuse and attachment styles in the development of NEAD. Such experiences can affect how we relate to others and how we think about the world, particularly during times of stress. It could be argued that NEAD sufferers cope in this way (i.e. having seizures) when faced with stressful situations, but we are unsure why these people respond to stress
in this way.
A person’s response to stress is determined by the person’s interpretation of the stressful event (i.e. their appraisal) and the subsequent coping strategy selected. We predict that NEAD patients will interpret situations as more threatening and stressful, and will therefore use more maladaptive coping strategies. This study will investigate how NEAD patients respond to stress by measuring how they relate to others, their appraisals and coping strategies. |
|
2010/122 NEURO
06/07/10
05/11/11
Salford Royal Foundation Trust |
|
| A double-blind, randomized, multi-centre, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis |
|
|
2010/121
19/07/10
15/07/14
Salford Royal Foundation Trust |
|
| What is the impact of knowledge gained through Medicine Use Reviews (MURs) in adult asthma patients? |
| During a MUR consultation, the areas of patient’s knowledge needing improvement are highlighted to the patient. The
pharmacist then makes a list of recommendations and an action plan is agreed on with the patient in order to address
the issues raised. As a result, the patient gets better understanding of their condition and its management which,
hopefully ultimately results into improved control of their asthma. To date, studies, articles and reports have primarily
focused on the revelation of problem areas and how they have been dealt with and how patients have benefited from
the MUR, mainly by having improved knowledge of condition and treatment. No study has been found that has
measured and quantified this improvement resulting from MURs, or evaluated whether or not the patient still recalls
and follows the points covered during the consultation, six months after the MUR, thereby assessing the longer term
effectiveness and impact of the MUR. This study has the potential to raise interest in more research into ways to
improve the value of MURs.
In this study, knowledge, asthma control, inhaler technique, Peak Expiratory Flow Rate (PEFR), and compliance will be
evaluated before and six months after MUR. By reviewing after 6 months the study will also assess level of application
of the recommendations and impact on asthma control. It will be limited to eligible adult patients with Asthma Control
Test (ACT) score of less than 20. These participants will be recruited from 13 Rowlands Pharmacy shops in Greater
Manchester. This study is part of a MSc. Project and is being funded by the Pharmacy Practice Research Trust (PPRT)
of the Royal Pharmaceutical Society Of Great Britain (RPSGB). |
|
2010/118
14/09/10
30/04/11
ReGrouP |
|
| An investigation into reproducibility of Arterial Spin Labelling (ASL) between scanners, and into modifying ASL methodology to increase sensitivity in inferior brain regions |
| Arterial Spin Labelling (ASL) is an Magnetic Resonance Imaging (MRI) technique for measuring the blood flow in the brain. It is increasingly being used in functional MRI, and to investigate various disease processes (e.g. MS, depression, dementia, etc). It is noninvasive, and involves no exposure to ionising radiation. There have been studies looking at how reproducible the measurements are over time, and between scanners of the same type. This study will look at how reproducible the ASL measurement is between scanners using different methodologies and of different manufacture. A separate part of the study will aim to improve the sensitivity of the ASL measurement in inferior regions of the brain, where signal is lost due to magnetic susceptibility effects. |
|
2010/116NEURO
05/05/10
31/10/10
Salford Royal Foundation Trust |
|
| A formative evaluation of CLAHRCs: Institutional entrepreneurship for service innovation |
| This project will evaluate Collaborations for Leadership in Applied Health Research and Care (CLAHRCs), funded by the National Institute for Health Research, in the early stages of their development. It will identify the institutional conditions (e.g. policy, regulation and performance indicators; professional roles and cultures; organisational boundaries, such as between commissioners and providers) that help or obstruct the process of implementing research evidence in practice in the NHS. Following this, it explores the role of "institutional entrepreneurship" in promoting more effective knowledge transfer: i.e. how individuals and groups transform these institutional conditions to promote change. The project will use case studies of selected CLAHRCs to inform analysis and solutions to the challenges of implementing research evidence in healthcare.
The project will begin by reviewing all nine commissioned CLAHRCs, before selecting the four most suitable sites for detailed case study. We will research the process of institutional change using complementary approaches. Social network analysis will enable us to map relationships and patterns of knowledge exchange within the CLAHRCs. From this, we will identify areas of these networks where knowledge exchange is effective and areas where it appears
problematic in relation to the work of institutional entrepreneurs. This will inform indepth case analysis through qualitative methods, including interviews and observations.The study will engage all relevant stakeholders, including policy makers, clinical practitioners, NHS managers, applied health researchers, and service users, all of whom will also be represented on an advisory committee. Overall, the aim is to contribute to the more effective implementation of research evidence into practice by understanding institutional entrepreneurship, and offering formative lessons for CLAHRCs and other initiatives. This might include, for example:
how to bring managers, clinicians and researchers together in implementing evidence; how to communicate innovations to diverse groups; how to reconcile different groups’ competing interests. |
|
2010/111
NHS SalfoR+D (joint study) |
|
| A Phase III, multicentre, double-blind, randomised, placebo-controlled study to confirm the safety and efficacy of subcutaneous bioresorbable afamelanotide Implants in patients with erythropoietic protoporphyria (EPP) |
| Erythropoietic protoporphyria (EPP) is a genetic disorder in which impaired ferrochelatase activity results in
the accumulation of its substrate, protoporphyrin. There are two main clinical manifestations of
protoporphyrin: cutaneous phototoxicity and hepatobiliary disease. Phototoxicity is the more common of
these and it usually presents in early childhood as intolerance to sun−exposure with patients experiencing
severe burning pain in the skin most often on the face and hands. It may last for several days and may be
accompanied by swelling and redness on sun exposed areas.
Accumulation of protoporphyrin IX in the skin is responsible for cutaneous photosensitivity leading to (i) pain,
(ii) swelling, (iii) discrete scarring and (iv) formation of ulcers. In the presence of light at 410 nm,
protoporphyrin IX generates reactive oxygen species resulting in the typical phototoxic reactions.
Protoporphyrin IX is eliminated exclusively via the liver. When the capacity of the biliary excretion pathway is
exceeded, excess protoporphyrin IX may result in the formation of gallstones or cholestatic liver damage. |
|
2010/110derm
29/04/10
28/01/11
NHS SalfoR+D (joint study) |
|
| Management of breast cancer for women aged 70+ in Greater Manchester: The role of patient choice in the surgical treatment decision. |
| Research demonstrates that older breast cancer patients are less likely to receive surgery for operable breast cancer compared to younger post menopausal women. The Cancer Reform Strategy states that the only acceptable criteria for older people not having clinically appropriate treatment are patient choice and poor health. This study will investigate the role of patient health and choice in the surgical treatment decision for older women with breast cancer from the
perspective of both the patient and their surgeon. It will also help determine which health measures best predict post surgical complications and quality of life for older breast cancer patients.
We will follow the treatment of 550 patients aged ≥70 years with operable breast cancer and interview them regardingtheir surgical choices and general health. We will also ask surgeons to tick one of five responses, of a standard measure of decision making, immediately following the consultation in which the surgical decision was taken. As a result, we will attain a measure of who took primary responsibility for the treatment decision as agreed by both patient and surgeon. This will help to identify whether the difference in surgery between older and younger patients is due to older patients choosing not to have surgery. Knowing the extent to which older people's experience of nonstandard treatment is due to patient choice and poor health will help to establish whether older women are unduly receiving suboptimal treatment and provide evidence to encourage change in practice. Measures identified as accurate predictors of post surgery complications and quality of life could be considered for future use in clinical settings to help make treatment decisions. |
|
2010/107CAN
13/07/10
31/01/13
Salford Royal Foundation Trust |
|
| Improving skin barrier function in psoriasis |
| Our clinical and scientific research has identified defective skin barrier function as a major problem in chronic inflammatory skin diseases. Psoriasis is a common, incurable chronic skin condition with high morbidity and there remains a significant unmet clinical need for developing therapies that are acceptable to patients and offer some measure of prophylactic action. Skin barrier function is deficient in psoriasis and allows entry of allergens and pathogenic microorganisms into the skin which stimulates inflammatory responses characteristic of the condition.
Current clinical studies in atopic dermatitis (AD) suggest that administration of a naturally occurring molecule that is involved in skin barrier formation improves barrier function in AD. We therefore propose to conduct a pilot study on the effect of topical application of the same naturally occurring molecule on skin barrier function in psoriasis. |
|
2010/104DERM
08/06/10
07/06/11
Salford Royal Foundation Trust |
|
| Development and Validation of a Questionnaire Measure to Assess the Supervisory Relationship from the Supervisor's Perspective |
| Clinical supervision is the formal provision, by senior/qualified health practitioners, of an intensive relationshipbased
education and training that is casefocused, and which supports, directs and guides the work of colleagues’ (Milne,
2007). Clinical supervision is an essential component of many health and social care professions including clinical
psychology. Research suggests that the relationship between a supervisor and their supervisee is one of the most
important aspects of the supervision process and outcome. However there are currently very few good ways to assess
this relationship formally. This study aims to develop and validate a measure for supervisors to complete which will
assess the relationship they have with their supervisee. The study will involve supervisors of clinical psychology
trainees filling out a number of online questionnaires about their supervision experience. Supervisors will be asked if
they wish to complete a similar set of questions a few weeks after the first set, and if they agree will be contacted again
by email to ask them to do so. It is hoped that the study will be completed by July 2010. |
|
2010/102
13/05/10
31/12/10
NHS SalfoR+D (joint study) |
|
| Suppression of disease activity and improved vascular function in Systemic Lupus Erythematosus and Rheumatoid Arthritis (Formerly: Effects of Biological Agents on Inflammation and Vascular Function in Rheumatoid Arthritis (RA) and Systemic Lupus Ery |
| Patients with rheumatic diseases, in particular rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE, Lupus)
have significantly increased chances of developing diseases of the heart and cardiovascular system, leading to increased
morbidity (ill health) and mortality. This does not appear to be entirely explained by well known risk factors such as
smoking and high blood pressure and would appear to be related to the diseases themselves. This study aims to examine
whether part of this increased risk of cardiovascular disease is related to the level of inflammation present, and whether
certain drugs improve this risk by controlling inflammation. We aim to assess patients with both RA and SLE who are to
start either usual therapy for the first time or who have severe enough disease to warrant newer "biologic therapies". We
will assess their cardiovascular function before and after using these therapies to see whether any changes can be
detected, and whether this is due simply to better control of their disease (and hence inflammation) or possibly related to
the type of drug used. |
|
2010/098
26/05/10
25/05/11
Salford Royal Foundation Trust |
|
| Safety and efficacy of Calcipotriol plus Betamethasone dipropionate gel in adolescent patients (aged 12 to 17 years) with scalp psoriasis |
| Psoriasis is a common skin disease characterised by thickened, red and scaly patches of skin which may itch. It is
more common on the body and the limbs but is also found on the scalp, face and occluded areas, e.g. armpits. The
scalp is one of the most common sites for psoriasis, causing psychological and social incapacity. Involvement of the scalp has been reported to occur in 5379%
of psoriasis patients.
LEO80185 gel is a combination product containing calcipotriol 50 mcg/g & betamethasone dipropionate 0.5 mg/g developed for topical treatment of scalp psoriasis. The results from five phase 3 studies in adults (4 in UK, 1 in USA) have showed that LEO 80185 gel is significantly more effective than using betamethasone dipropionate in gel vehicle, calcipotriol (in the gel vehicle or as the marketed scalp solution) & the gel vehicle alone in the treatment of scalp
psoriasis. LEO 80185 gel has marketing approval in many countries for the treatment of scalp psoriasis in adults. No studies with this product have been conducted in patients under 18 years of age. The study is being undertaken as a postmarketing commitment to the FDA.
This study will run in the UK & France, where 70 participants will be recruited. The main purpose of this study is to assess the safety of calcipotriol & betamethasone dipropionate gel in adolescent patients with scalp psoriasis. This study will be openlabel with no comparator. The study will involve an 8 week treatment period for eligible patients, during which study medication will be applied once daily. Participants will attend 2 screening visits followed by 5 visits
for assessment of their psoriasis. Participants may then have a 2 week follow up period if they have adverse events ongoing at the end of their treatment that have a possible/probable/unknown relationship to the gel. |
|
2010/096derm
11/05/10
30/06/12
Salford Royal Foundation Trust |
|
| A Methodology Study to Assess the Variability of and Effect of Hormone Therapy on (i) Putative Androgen Regulated Gene Expression in Hair Samples and (ii) Circulating Tumour Cell Numbers and Androgen Receptor Expression in Patients with Prostate Canc |
| AstraZeneca is conducting a research study in patients with prostate cancer. There is no investigat ional drug being given in this study . This study is being carried out to aid the development of drugs for the treatment of prostate cancer.
Hair follicles that are actively growing share many properties with tumour cells and clinical studies of experimental drugs often include looking at the effect of drugs on hair follicles . Circulating tumour cells (CTCs) are cells that have detached from the prostate cancer and circulate in the bloodstream. There is growing interest in the possibility of measuring the levels of these cells before and after treatment to help assess the effect of treatment.
Patients in this study will be recruited into 4 groups. Group 1 will cons ist of patients with early stage prostate cancer receiving no hormonal therapy. Group 2 will consist of patients with advanced prostate cancer already receiving treatment to reduce male hormone levels . Group 3 will consist of patients with advanced prostate cancer already receiv ing treatment to reduce their male hormone and who are also receiving the anti-androgen tablet Casodex® (bicalutamide). Group 4 will consist of pat ients with newly diagnosed advanced prostate cancer requiring hormonal treatment but not currently receiving hormonal treatment.
Patients will be recruited from 2 clinical centres in the UK. If patients consent to participation in the study, patients in Groups 1, 2 and 3 will be asked to attend for 2 visits. At both visits hair samples (hair pluck) will be taken from the temporal region of the scalp and blood samples will be taken for the CTC assessments. Patients in Group 4 will be asked to attend for 1 vis it, at which blood samples will be taken for CTC assessments. No hair samples will be taken
from patients in Group 4. |
|
2010/092can
02/06/10
01/08/10
Salford Royal Foundation Trust |
|
| Emotional Reactions to Traumatic Brain Injury: How do Brain-Injured Survivors Respond to and Make Sense of Their Experiences? |
| This study aims to explore emotional reactions to Traumatic Brain Injury (TBI), particularly those relating to intrusive symptoms of Post Traumatic Stress Disorder (PTSD), and how TBI survivors make sense of these experiences. There is considerable debate in the literature about how PTSD can be conceptualised in the TBI population, considering the impact of the TBI on consciousness and memory. Some studies, for example, argue that disturbed consciousness around the traumatic event prevents memories from being encoded and that PTSD cannot therefore occur. However, others argue that PTSDlike
reactions can occur, for example, triggered by traumatic memories surrounding the event.
This study will therefore explore, using a qualitative methodology, the posttraumatic experiences of those who have had a TBI and how they have made sense of these experiences in the context of their memory for the traumatic event. Ten to fifteen participants will be recruited from a Neuropsychology department, having experienced a mild to moderate TBI in the last six months to two years. They will participate in approximately hourlong interviews, which will then be
transcribed and analysed using Interpretative Phenomenological Analysis (IPA) in order to look for themes. It is hoped that interviewing TBI survivors about their experiences will lead to increased awareness of how PTSD can be conceptualised in this population and therefore have important implications for treatment. |
|
2010/090ET
12/05/10
30/07/11
Salford Royal Foundation Trust |
|
| Can the S 100B assay replace computed tomography head Scans to Rule Out traumatic brain Injury (SSROI), in adults within 3 hours of apparently minor head injury? |
| Every day in the NHS hundreds of patients undergo a CT brain scan after attending the emergency department with an apparently mild head injury. For every 20 scans done a brain injury will only be detected on one. Patients often have to be admitted to a ward whilst awaiting their scans which is inconvenient for them and costly to the NHS. Earlier studies have suggested that a blood test, if done within 3 hours of head injury and shown to be negative, could mean that many
of these patients could be safely discharged without the CT hence avoiding unnecessary radiation and waiting. The blood test is for S100B which is a protein only normally found in the blood if brain injury has occurred.
In this study at Salford Royal we will be (1) determining exactly what proportion of adults with minor head injury present early enough to have the blood test, (2) Check that all the patients with a negative s100B test have a negative brain scan and hence whether the test is safe and is a good cost investment for the NHS. If we can do the study in Salford we will apply for funding for a multicentre study |
|
2010/089INJ
19/04/10
18/07/10
Salford Royal Foundation Trust |
|
| Barriers & Influences affecting Innovation within SCH |
| This study focuses on the barriers and influences which affect SCH’s ability to become an organisation where
innovation becomes mainstream. According to David Nicholson, NHS Chief Executive (2009), a tough financial period
will follow where the only way to connect quality and productivity gains will be through innovation. Mulgan et al, (2006)
suggest in their government white paper that without innovation, public services costs rise faster than the rest of the
economy and the inevitable pressure to contain costs will have a detrimental affect on quality. Donahue (2005) points
out that since public organisations touch the interests of so many stakeholders and are often entrusted with socially
important tasks, innovation in this sector is crucial. According to Mulgan et al, (2005) innovation should not be seen as
an added burden but a core activity to increase responsiveness of services to local and individual needs and keep up
with public expectations. All Salford Community Health staff will be eligible to become volunteers in the study by either
completing an anonymous questionnaire(300 will be randomly distributed via email with an anonymous return box)by
participation in a focus group (x7 with 10 participants each) or through semi structured interview (10 participants)The
reaseach will be undertaken during a 4 week period using Salford Community Health staff sites. |
|
2010/088
18/05/10
31/12/10
ReGrouP |
|
| The utility of elastase inhibitors in skin care products for photoaged skin |
| The purpose of this study is to investigate whether cosmetic skincare products, currently under development by Kao Corporation, can positively effect biomarkers of photoageing and/or ageing in healthy volunteers. We will use a model system to mimic longterm use, by applying the products under lightand
waterproof dressings for up to 12 days.
Samples of skin will be taken and assessed in the laboratory for changes in the distribution of biomarkers in the treated skin. |
|
2010/085derm
30/03/10
29/11/10
Salford Royal Foundation Trust |
|
| A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017)
in Subjects with Relapsing Multiple Sclerosis. |
| MUltiple Sclerosis (MS) is a chronic disease of the central nervous system (CNS). Although there is still no cure for MS. effective therapies are available to modify the disease course andtreatexacerbations, such as interferon beta and Copaxcne (glatiramer acetate).
Biogen Idee (the sponsor) is developing BIIB017 for MS. BIIB017 was well tolerated at doses ranging from 63 mcg to 188 mcg in Phase 1 studies. BIIB017 with a longer half-life and greater exposure to IFN ~-1 a compared to Avonex (a drug with over 10 years of established efficacy andsafety) is being developed to reduce side-effects (e.q., flu-like symptoms), while increasing convenience and improving treatmentcompliance,
The study is examining the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in patients with RMS after 1 year. This pivotal Phase 3 study will determine the efficacy and safety of 1 dose of BIlB017 (125mcg SCi and two dosing frequencies (every 2 weeks and 4 weeks) of 8118017 to treat Relapsing Multiple Sclerosis (RMS) patients over the course of 2 years, All subjects will receive a (SC) injection (self administration) of study treatment (either
BIIB017 or placebo) every 2 weeks.
Potential patients are screened for the followlnq cnteria: Aged 18 to 55 years old, Confirmed diagnosis of relapsing MS, "Expanded Disability Status Scale (EDSS) score between 0.0 and 5,0, and at least 2 relapses within the last 3 years with at least one of these relapses having occurred within the past 12 months prior to randomization. Patients will keep a diary of their MS symptoms, do questionnaires, visit hospital to give blood/urine samples as well as less frequent
tests as ECG to assess their well being over the course of the study. The UK is aiming to recruit circa 45 patients over approximately 5/6 hospitals in the country |
|
2010/084neuro
03/06/10
02/06/14
Salford Royal Foundation Trust |
|
| A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects With Essential Hypertensi |
| High Blood Pressure (Hypertension) is the most common cause of preventable death in developed nations.
Uncontrolled hypertension greatly increases the risk of heart disease, brain disease, and kidney failure. As the
population ages, the incidence of hypertension will continue to increase if effective preventive measures are not
implemented. Despite the availability of antihypertensive agents, hypertension is not adequately controlled; only about
one in three patients successfully keep blood pressure normal.
This study will compare the safety and tolerability of TAK491plus chlorthalidone (TAK491CLD) fixed dose
combination to olmesartan medoxomilhydrochlorothiazide
fixeddose
combination.
To be eligible to take part in this trial amongst other factors, the patient must be willing to discontinue current
antihypertensive medications on Day 14
to Day 1.
The patient must be 18 or over and either treatment naive or who
require a change to their current antihypertensive therapy.
It is estimated that approximately 800880
randomised patients will take part in this study. The study will be conducted
in approximately 112 sites in United States, Canada and Europe.
Initially patients will undergo a Screening Visit to confirm that they are eligible to participate in the study. All participants
will receive the study drug for up to 52 weeks. The dose of the study drug may be gradually increased throughout the
study so that a target blood pressure value can be reached for each participant.
Throughout the treatment period of the study, participants will be required to visit the research site for 11 visits. At these
study visits participants will be required to undergo certain study procedures including physical examinations, vital sign
measurements (blood pressure, heart rate, weight and height), electrocardiograms (monitoring of the heart), and
blood and urine samples taken for clinical laboratory tests.
It is hoped the results form this study will help in the future treatment of patients with hypertension.
A62. |
|
2010/081
26/03/10
25/03/12
ReGrouP |
|
| CHOICE(Choosing Health Options in Chronic Care Emergencies) Developing effective strategies to reduce unscheduled care in chronic disease qualitative study. |
| People with chronic physical illnesses often seek medical help as emergency care, for example from hospital
emergency departments or from walkin
centres or outofhours
GP services in the evenings or at weekends. It is likely
that reasons other than the severity of the physical illness are implicated in this. In particular, we already know that
about 2025%
of people with chronic physical illness also have marked anxiety or depression, which is associated
with increased need for emergency care, and about 50% of people who seek frequent emergency care have
depression. These emotional difficulties often do not receive the attention they merit. In this research project we want
to identify psychosocial factors, as well as cultural and servicerelated
factors, which may result in increased use of
emergency care in people with 4 chronic conditions: diabetes, asthma, chronic obstructive airways disease and
coronary heart disease.
In this qualitative study, we will interview patients who use emergency care, familymembers
who are involved in theirdecisions to use care, patients who tend not to use emergency services, practitioners who provide emergency care
and practitioners who provide routine care for patients with these conditions. We will analyse these participants'
accounts in order to identify processes, potentially amenable to change, that which influence patients' use of
emergency care. |
|
2010/079
05/05/10
05/05/13
ReGrouP |
|
| An Investigation into Users' Experience of Foot Orthoses in a Population of Patients with Low Back Pain |
| To investigate the patient experience of foot orthoses fitted for the purpose of helping reduce their symptoms of low
back pain. Patients will be identified by a consultant as being appropriate for such intervention. The patient will have
given verbal and written consent to take part in the study. They will have been diagnosed with mechanical low back
pain. An RMDQ (Roland & Morris) and L+H questionnaire will already have been completed by the patient to assess
their disability scale. The patient will then see me for a biomechanical assessment and a 'Gaitscan' (pressure plate
analysis) which will be used to design an orthotic prescription for them. These orthotics will be manufactured by an
external lab and the patient will attend 34
weeks later for them to be fitted. The patient will then be given appropriate
advice and will be reviewed 34
months later. At the review appointment the patient will be asked to complete the
RolandMorris
disability questionnaire for a second time and an interview will take place. This will be an open digitally
recorded interview, conversational style where the patient experience will be discussed. It may be semi structured if
patients are struggling to communicate their experience. The research question is an important one as currently there
is no consensus as to whether this population of patients benefit from orthoses fitted into their shoes. It could be
considered an expensive treatment modality by some depending on the type of orthoses chosen and if they do not help
the patient then this is money that could be spent elsewhere within the healthcare setting. However, if they do help it
could be considered cost effective as it is widely reported how costly low back pain can be within the wider economy. |
|
2010/078
15/07/10
15/01/11
ReGrouP |
|
| A case control study to assess cardiovascular risk in idiopathic inflammatory myopathy (IIM). Version 1.0 |
| The aim of this study is to establish whether myositis sufferes are at increased risk of developing coronary heart disease (CHD) as a result of their condition.
We already know that patients with related diseases, such as rheumatoid arthritis and lupus, have a higher chance of developing CHD, compared to those who don't. In order to establish whether the same is true for myositis, we would like to perform a pilot study, comparing the cardiovascular risk factors of 30 patient's from Salford Royal's adult myositis clinic, with a group of 30 healthy controls.
Participant would be invited along to the Wellcome Trust Clinical Research Facility (WTCRF), where all the necessary tests would be performed at a 'one off' study visit. Participants would be asked to bring along a friend of the same gender and roughly the same age, who would then comprise the 'healthy control' comparison group.
The study would involve a consultant clinician completing a 'heart disease questionnaire' for each of the participants.
A single blood sample would be taken to check their blood sugar levels and cholesterol, and if they had myositis, disease activity would also be assessed.
The non invasive diagnostic testing would include an ultrasound of the blood vessels of the neck, checking for narrowing of the arteries, and a special blood pressure test, looking for the early signs of atherosclerosis (build up of fat in the blood vessels). An electrocardiogram (ECG) would be performed, and if they have myositis, an ultrasound test of their heart, called an echo, would also be performed.
If the study demonstrated that patients with myositis had more chance of developing CHD, than those in the control group, this would have implications for their future clinical care, requiring monitoring for CHD, and early intervention when appropriate.
This study will be funded by the WTCRF Small Grants Award Scheme |
|
2010/077derm
14/04/10
13/12/11
Salford Royal Foundation Trust |
|
| Impact of Herpes Zoster and Post Herpetic Neuralgia on Health Related Quality of Life: Crosssectional Epidemiological Study in Patients Seen by Physicians in the UK. |
| Herpes zoster (HZ) also known as shingles is a condition that can lead to longterm
debilitating complications, which
may adversely affect a patients quality of life, where HZ affects the eye it is known as Herpes Zoster Opthalmicus
(HZO). The most common and debilitating complication of HZ is postherpetic
neuralgia (PHN) a pain affecting the
nerves of the skin and causing symptoms such as spontaneous aching or burning; paroxysmal shooting pains, pain
from stimuli which normally don't illicit pain and hyperalgesia. It has been shown that PHN can have a negative impact
on patients quality of life and lead to poorer physical and social functioning, interfering with activities of daily living,
including work, sleep and enjoyment of life. Although it is well documented that HZ and PHN pain can have a
substantial impact on patients Health Related Quality of life (HRQoL), there is a lack of convincing data within the UK to
document the patient HRQoL burden specific to HZ and PHN. This study is therefore a non interventional study in
which HRQoL data will be collected from patients with a recent diagnosis of HZ and patients currently suffering from of
PHN in order to help inform the scientific community involved in the development of treatments and prophylactic
vaccines to combat HZ. |
|
2010/064
19/03/10
31/10/10
ReGrouP |
|
| Saying "no" to patients: how guidelines are used by GPs to justify decisions and actions |
| Some GPs find saying “no” to patients’ requests difficult, and “demanding” patient encounters are an important source
of stress and burnout in GPs. The influence of consumerism and a narrowing of the knowledge gap between doctors
and their patients – particularly through the growth of Internet use have
contributed to doctors' perception that
patients have become more demanding in recent decades.
Over the same period a large number of clinical guidelines have been published covering many aspects of practice to
help guide best practice and manage demand. Many studies have demonstrated barriers to the implementation of
guidelines in general practice and have explored GPs' attitudes towards their use. Despite initial lack of enthusiasm,
GPs appear to have incorporated the use of guidelines into routine clinical practice.
Rationing decisions may seem to conflict with the ideal of patientcentred
medicine, which does not take into account
the needs of the wider population, even if such benefits are improbable or limited. Given the principles of explicitness
and fair resource allocation, it remains important for GPs to be able to effectively and sensitively decline services
where they are not indicated or likely to be of limited benefit. The principle of explicitness would suggest that guidelines
ought to be cited when explaining such decisions within the consultation.
No study has yet explored GPs’ accounts of how they are able to successfully decline to provide a particular request
made by a patient within the consultation, or their views regarding the explicit use of guidelines to facilitate this
decisionmaking
and action. The study proposed will do this by using focus groups of fully trained and trainee GPs
followed by individual interviews. The data collected will be analysed using recognised methods and the study written
for publication in peerreview
journals. The study has importance for training of future GPs. |
|
2010/063
28/05/10
28/05/11
ReGrouP |
|
| TOP: Tysabri Observational Program |
| TOP (Tysabri Observational Program) is an observational study looking at the long term safety and efficacy in patients with relapsing remitting multiple sclerosis being treated with natalizumab in the clinical practice setting. Patients who are drug naive to natalizumab and who meet local prescribing criteria are eligible to be enrolled and will be observed at routine outpatient clinic visits for up to 5 years. Between 3,000 and 5.000 patients will be enrolled worldwide. The
primary endpoint will assess long term safety (incidence and pattern of Serious Adverse Events) in patients receiving natalizumab during the observation period. The secondary endpoints are to assess long term efficacy as determined by physician's assessment of disability progression and the occurrence of relapses. Patient data will also be compared with that of a matching cohort of patients in another independent observational study, who are being treated
with a disease modifying therapy. |
|
2010/061Neuro
21/05/10
20/08/17
Salford Royal Foundation Trust |
|
| People with Long Term Conditions: Guided information for people with long term conditions implementing selfcare support in diabetes, heart and kidney disease |
| CLAHRC (Collaboration for Leadership in Applied Health Research and Care) is a collaboration between 19 NHS
trusts in Greater Manchester area and the University of Manchester. The overall aim of the programme is to develop,
evaluate and implement a selfcare
informational and social support strategy for people with diabetes, heart and
kidney disease. To become active partners in chronic condition management, people need relevant information which
clearly explains management options including selfmanagement
and is integrated with both the chronic condition
support provided by health services and the everyday lives of people living with a chronic condition. This theme will
develop a coordinated
programme of research for adapting and implementing a patientcentred
information based
strategy as part of a guided selfmanagement
approach. The programme will focus on engaging people who are most
socially disadvantaged. Research will be undertaken to elicit the needs, social and health contexts and receptivity of
socially disadvantaged people with vascular conditions in order that information can be developed, integrated and
evaluated within an existing evidenced based approach to guided selfmanagement
support. Supplementing this
informational strategy, this study will also identify attributes of networks (e.g. directed, mutual ties, homophily)
implicated in self care and explore the manner in which household and work place composition impact on the
management of long term conditions.
More specifically, the study will:
• Identify the ranges of social economic and cultural resources that individuals draw on in responding to long term
health conditions.
• Assess lay peoples’ systems of support and access to resources which influence engagement with services,
information and coping strategies.
• Identify how community social capital resources (e.g., economic, cultural, political, symbolic) is used (in positive and
negative ways) for pursuing personal and collective goals linked to long term condition management.
• Consider the ways in which networks and lay knowledge contribute to and inform the design of effective self care
interventions. |
|
2010/056
21/04/10
30/09/13
ReGrouP |
|
| Better patient-orientated management of functional GI disorders |
| Some patients with functional lower GI symptoms (sometimes known as irritable bowel syndrome/IBS) have
symptoms that are well controlled and they cope well with them. Other patients have symptoms that are more difficult to
control and they suffer considerable ill health, becoming regular healthcare users.
If we can predict which patients are likely to do worse in terms of their functional GI symptoms it might be possible to
manage these patients differently, thus altering the course of their illness and improving their quality of life.
To see if this is possible we propose to perform three related studies. In the first study (Study 1: The GP Read Code
Study) we will find out how General Practitioners (GPs), in the ‘real world’, classify patients with functional lower GI
symptoms in terms of the Read codes they use to code consultations (and hence retrieve information about patients
with chronic diseases at a later date). This information will be useful not only to ensure potential cases are not missed
in this study, and to allow good followup,
but also for future studies on functional lower GI symptoms in primary care.
In the second Study (Study 2: The Risk Assessment Study) we will use a short questionnaire to see if we can
categorise patients with functional lower GI symptoms into high or low risk of developing ongoing problems. We will
assess the usefulness of this risk assessment questionnaire for predicting healthcare utilisation and burden of
symptoms/degree of distress.
In the third study (Study 3: Intervention Study) we will assess whether we can intervene in the group of people predicted
to do worse using the questionnaire in Study 2 to reduce their healthcare utilisation and improve their burden of
symptoms/distress (using a selfmanagement
booklet and the possibility progressing to cognitive behavioural therapy
[CBT] and/or hypnotherapy.) |
|
2010/053
07/04/10
30/09/12
ReGrouP |
|
| A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial of Ustekinumab, a Fully Human anti IL 1223p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis |
| This study will assess the effect of the new drug ustekinumab in subjects who have active psoriatic arthritis despite current or previous disease treatment with modifying antirheumatic drugs (DMARDs) and/or nonsteroidal antiinflammatory drugs (NSAIDs). Approximately 600 subjects aged 18 to 99 years (excluding pregnant or nursing women, and men and women planning a pregnancy) will be randomly allocated to one of three groups who will receive treatment with ustekinumab at a dose of 45 mg or 90 mg, or placebo. Ustekinumab will be given by subcutaneous injection at Weeks 0 and 4 and followed by repeat dosing every 12 weeks with the last dose at Week 88. Subjects randomised to placebo will crossover to active therapy at Week 24 and will receive ustekinumab at Weeks 24 and 28 followed by 12 weekly repeat dosing with the last dose at Week 88. Subjects in all three groups are expected to be treated for a total of 100 weeks (approximately 2 years). The effectiveness of ustekinumab will be assessed up to Week 100 and the safety of ustekinumab through to Week 108. |
|
2010/051derm
08/06/10
07/06/12
Salford Royal Foundation Trust |
|
| A cooperative inquiry to explore how knowledge transfer associates facilitate the implementation of research in the NHS to improve patient / client care |
| Research is notoriously difficult to put into practice. There are many reasons for this, not least, the type of evidence, the receptiveness of staff to the evidence, the organisational structures and culture, the level of research education of clinicians, and whether and how the implementation is facilitated. This project is part of a larger study (Collaboration for Leadership in Applied health Research and Care, CLAHRC, for Greater Manchester) which aims to implement
evidence base practice in four chronic disease areas: chronic kidney disease, diabetes, stroke and heart disease.
In this part of CLAHRC, there will be eight projects facilitated by eight knowledge transfer associates who will work closely with an academic and clinical lead. There is a dearth of research on how to best facilitate (ie assist or support) the implementation of research findings. The project aims therefore to explore how the knowledge transfer associates actually facilitate the implementation of research to improve patient care. A cooperative inquiry is proposed using qualitative research methods. A cooperative inquiry has been chosen as research participants become coresearchers in the research process leading to research findings which are highly relevant and have an immediate impact. The knowledge transfer associates will pass through a series of phases. They begin by
proposing statements on how they think they facilitate change and then through cycles of reflection and practice revise and refine them. They will make diary entries of their own experiences of trying to facilitate the implementation of research and will share them in regular critical reflective meetings. There will be two important outcomes: 1) the development of theory on the process and outcomes of facilitation, and 2) the personal and practical development of facilitatory skills of the individuals concerned as they reflect on their own and each others’ practices |
|
2010/050et
12/04/10
10/09/11
Salford Royal Foundation Trust |
|
| Evaluation of a capacity and best interests process tool as an effective tool for aiding professionals to make capacity and best interest decisions. |
| The purpose of this research is twofold. Firstly to evaluate, amongst service professionals assessing capacity, the use of a capacity and best interests assessment form that has been recently developed. This form was designed to help
professionals fulfill their statutory responsibilities under the Mental Capacity Act (MCA). Secondly, the research aims to
provide detailed information relating to the actual experience, challenges and difficulties faced by professionals
undertaking capacity assessment within the MCA framework. This research will help identify the future training and
support needs of professionals.
Professionals invited to take part in this study would include NHS employees who undertake capacity assessments as
part of their clinical work and would likely include medical doctors, nurses and allied health professionals. |
|
2010/044
10/03/10
29/10/10
ReGrouP |
|
| A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab |
| The primary aim of the study is to compare NHS resource utilisation in Crohn’s Disease patients at 12, 18 and 24 months after the introduction of infliximab with resource utilisation during the 12 months prior to the initial infusion. This study is designed as a retrospective audit of Crohn’s Disease patients’ using medical records, although information could also be collected from electronic sources (e.g. hospital electronic databases). Hospital centres will be selected from across the UK and will be representative of care facilities providing care to Crohn’s Disease patients. It is intended to recruit a minimum of 20 physicians, each located at a different centre across the UK, in order to achieve a minimum sample of 400 patients.
Candidate physicians will be asked to complete paper case report forms on all Crohn’s Disease patients who are managed at their centre and meet the study inclusion criteria. Physicians who treat Crohn’s Disease with infliximab will be eligible to participate in the study. It is assumed that they will consist primarily of Gastroenterologists, though general physicians (hospitalbased) with an interest in Crohn’s Disease may also be included. |
|
2010/043GI
22/03/10
21/11/10
Salford Royal Foundation Trust |
|
| The COAP (Care of Ataxia Patients) study: An evaluation of service provision for people with ataxia |
| People with longstanding
conditions that affect different parts of the body often require access to many healthcare
services from specialist centres, local hospitals and general practitioners. Healthcare should ideally be provided in a
manner that provides seamless and timely care between the different services. ‘Ataxia’ is a symptom that may result
from a number of conditions and can affect a persons’s balance and coordination, mobility, speech, swallowing and
vision. Ataxia not only results in significant physical, social and psychological disability but presents a substantial
economic burden.
It has been suggested that care for people with ataxia in the Greater Manchester area is patchy, unstructured
and uncoordinated
but this has not yet been shown in a research study. Guidelines produced at a national level by clinical
experts recommend that people with ataxia should be seen in a specialist centre and list service standards that aim to
improve patients’ quality of life. Implementing these recommendations for all people with ataxia may have a significant
impact on healthcare resources.
This 2year
study will be based in Greater Manchester and use interviews with adult patients, their carers andhealthcare professionals to explore their experiences and to describe what it is like living with ataxia and how services
are currently provided. Crucially, views on the main patient benefits possible from specialist service provision will be
explored. It will also measure the cost of providing current services compared to those recommended by the
guidelines. A survey will see if there is any variation in the services available for people with ataxia across the UK. This
study will suggest how services for people with ataxia can be improved. These lessons may be transferable to
services for people with other conditions such as Parkinson’s diseases |
|
2010/040 NEURO
15/03/10
15/03/12
NHS SalfoR+D (joint study) |
|
| RealWorld Assessment of LongTerm Infliximab Therapy for Psoriasis (REALITY) |
| This is an observational, multicentre study of infliximab in subjects with plaquetype psoriasis. Approximately 100 sites and up to 1000 subjects will be recruited across the world. Each subject will participate in the study for a maximum of 50 weeks from the time the subject signs the Informed Consent Form (ICF) through to the final contact.
The study will assess the clinical response in realworld practice of longterm maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population.
Suitable subjects who the physician has chosen to treat with infliximab in accordance with local clinical practice will be enrolled into the trial.
It is expected that they will receive infliximab infusions at Week 0, Week 2, and Week 6 followed by maintenance infusions at Week 14, Week 22, Week 30, Week 38, and Week 46 as per the Summary of Product Characteristics (SPC) of the drug.
The study consists of 4 scheduled visits (Baseline/Week 0, Week 14, Week 30 and Week 50 FollowUp. Additional assessment visits can be scheduled at the discretion of the physician. Psoriasis Activity and Severity Index (PASI) score will be collected at all visits including any additional assessment visits and Dermatology Life Quality Index (DLQI) scores will be collected at Baseline/Week 0 and Week 50 FollowUp visits
Optimal response will be defined as a change in PASI score from Baseline of ≥75% A subject who has an adequate but not optimal response at any additional assessment visit between Week 23 and Week 49 or a subject who has an adequate but not optimal response at the Week 30 or Week 50 scheduled visits will
be invited to participate in an interventional study (P05315) focusing on dose optimisation. |
|
2010/039derm
10/03/10
09/07/11
Salford Royal Foundation Trust |
|
| The role of Multidrug Transporters in causing Pharmacoresistance in Epilpesy |
| • A third of people with epilepsy continue to have seizures despite treatment with antiepileptic drugs.
• The ‘drug transporter hypothesis’ states that an increased expression of multidrug transporters (MDTs) occurs in
seizuregenerating areas of the brain (seizure focus). These MDTs transport antiepileptic drugs away resulting in lower
levels of the drugs where they are needed most.
• There are hundreds of human MDTs, but studies in epilepsy have so far focused only on a small number of these
and have produced conflicting results.
• The questions we want to answer are: Can MDTs contribute to treatment failure in epilepsy? If so, which MDTs?
• Some patients with drugresistant
epilepsy have the seizure focus surgically removed from their brains.
• We will identify which MDTs are overexpressed in these surgically removed seizure foci.
• This discovery will allow us to develop new strategies for treating refractory epilepsy with current antiepileptic drugs and to develop newer antiepileptic drugs which are not transported by the implicated MDTs. |
|
2010/034 NEURO
06/05/10
05/05/13
Salford Royal Foundation Trust |
|
| Do alterations in cutaneous vascular biology identify those patients with psoriasis who have increased risk of cardiovascular comorbidity? |
| Psoriasis is a common skin disease which confers immense suffering on those it afflicts. Recent work indicates that psoriasis is an independent risk factor for ischaemic heart disease. The growth of new blood vessels, a process known as angiogenesis, may be a key causative factor for both psoriasis and heart disease.
A key promoter of angiogenesis, a protein called vascular endothelial growth factor (VEGF), is produced in the skin and is found in increased amounts in ischaemic heart disease (atherosclerosis) and in patients with psoriasis. On the basis of our previous research we believe that VEGF may be particularly relevant to the development of psoriasis in some patients. It is this group of patients with psoriasis who may be at greatest risk of developing heart disease.
This study will determine the magnitude of the increased risk of heart disease in patients with psoriasis. It will also identify key risk factors and investigate the biological pathway for the development of heart disease in these patients. The project will use an integrated research approach and translate findings from studies of the function of genes and cells into improved identification and management of heart disease in patients with psoriasis. |
|
2010/030
27/08/10
26/01/13
Salford Royal Foundation Trust |
|
| A prospective, multi-centre, randomized, open-label, parallel, comparative study to evaluate effects of AQUACEL® Ag dressing and Urgotul® Silver dressing on healing of Chronic Venous Leg Ulcers.
|
| A prospective, multi-eentre, randomized, open-label, parallel, comparative study to evaluate effects of AQUACEl® Ag
dressing and Urgotul® Silver dressing on the healing of Chronic Venous leg Ulcers. Subjects in both groups will be
followed to complete healing or to a maximum of 8 weeks. SUbjects will be treated with the silver version of each
dressing (in accordance with randomization) for 4 weeks and the non-silvered version for the remaining 4 weeks. |
|
2010/029
29/07/10
04/01/11
ReGrouP |
|
| Grazax Asthma Prevention (GAP) Study Final Version 30/06/2009 |
| It is well established that seasonal allergic rhinitis (hay fever) is a risk factor for the development of asthma and
therefore treating the allergic reaction to grass pollen that results in hay fever could represent a means to prevent the
development of asthma. Very few previous trials have addressed this possibility and therefore, the present trial aims at
investigating the effect of this treatment on the risk of developing asthma in childhood. The trial population comprises
of children aged 5 to 12 years, diagnosed with grass induced rhinoconjunctivitis (hay fever) without any asthma. The
aim of the trial is to investigate if 3 years continuous treatment with Grazax can delay or prevent the onset of asthma
symptoms compared to those on placebo treatment. Three years treatment is the recommended treatment period. The
study will continue for two further years after treatment is completed to enable the long term benefit of therapy to be
assessed. During the 5 years of the study, the patients will visit the clinic approximately 15 times. Half the patients will
receive active treatment with Grazax and half will receive placebo. All patients will have access to optimal standard hay
fever treatment throughout the study. As the aim of the study is to ascertain if the onset of asthma can be delayed in the
active group, respiratory symptoms and lung function will be closely monitored throughout. If a patient develops
asthma, they continue in the study receiving optimal asthma medication and disease management. The study will be
performed in secondary care, in paediatric allergy clinics or designated research units. |
|
2010/025
13/04/10
02/08/15
ReGrouP |
|
| A double blind randomised placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of AT1001 in patients with Fabry Disease and AT1001-responsive GLA mutations |
| This Phase 3 study will evaluate the efficacy, safety and pharmacodynamics of the study drug, AT1001, in patients with Fabry disease who have a confirmed GLA mutation which is responsive to AT1001. The primary objective of this study is to compare the effect of AT1001 versus placebo on kidney GL3
levels. GL3 is a fatty substance which builds up in the kidney, heart, skin, and blood vessels as a result of having Fabry disease. The total duration of the study will be for 15 months. This is a multicenter, international study with approximately 4 UK sites taking part. |
|
2010/022ET
09/03/10
08/04/11
Salford Royal Foundation Trust |
|
| Bury Health Survey 2010 |
| The survey will collect information on a wide range of topics including perceptions of health status, long term and recent morbidity and health risk behaviour in order to assess its prevalence within the local population. The research will allow NHS Bury to gain further awareness of locally based needs and address them through careful service planning and targeting areas that require specific action. By looking at wellbeing within the borough, NHS Bury will be able to provide enhanced services that are responsive to local needs, that meet high standards in healthcare, which are set nationally enabling us to address health inequalities within the community. |
|
2010/014
05/03/10
31/10/10
ReGrouP |
|
| Measurement of plasma RANTES (CCL5) as a potential biomarker for patients at risk of stroke |
| We wish to undertake further analysis on plasma samples obtained as part of a previous research project from participants with known risk factors for stroke and cerebrovascular disease and from a number of healthy volunteers.
Previously we compared levels of specific inflammatory markers (proteins within blood plasma) between the two groups. The inflammatory markers measured in the earlier project were ones known at the time to be associated with risk of stroke. However, since completion of the study there is now evidence from animal models that a different inflammatory marker, RANTES, may be important in the development of atherosclerosis leading to development of stroke and cerebral ischaemia.
We do not intend to recruit further participants or contact the previous participants to seek their consent for this analysis. Consent taken from participants and healthy controls at the time allowed for further inflammatory marker analysis by members of the University of Manchester group. The analysis will be carried out by colleagues at the University of Manchester Faculty of Life Sciences, with anonymised samples being transferred under the supervision ofDr Stephen Hopkins, to the temporary custodianship of Dr Adam Denes.
This study will provide an opportunity to establish if the findings from the animal models can be replicated in humans; without the need for further patient recruitment. The success of this study may provide justification for further exploration within human subjects. |
|
2010/012 Neuro
04/05/10
03/10/10
Salford Royal Foundation Trust |
|
| Alternative providers of primary care in the English National Health Service: a study of commissioning, organisation and operation. |
| The focus of the study is on
• The commissioning by Primary Care Trusts (PCTs) of primary care from organisations other than traditional general
medical practices. Such nontraditional
organisations may include (though are not limited to) corporate commercial
providers, ‘chains’ of general practices under single ownership, social enterprises and secondary care foundation
trusts. We use the term Alternative Providers of Primary Care (APPC) to denote such organisations.
• The operation of APPCs in order to understand how they are organised and operated in the provision of primary
medical care to the NHS. |
|
2010/010
16/02/10
31/03/11
ReGrouP |
|
| An extension trial comparing the safety and efficacy of NN5401 plus meal-time insulin aspart for the remaining meals with insulin detemir plus meal-time insulin aspart in type 1 diabetes |
| The aim of this study is to confirm the long term safety and tolerability of a new insulin product called SIAC (Soluble Insulin Analogue Combination) in people with type 1 diabetes.
This is a 26 week extension to an ongoing study (NN5401-3594, CAS reference 09/H1 01 0/34) which is looking at the effectiveness of this new insulin in controlling subjects' blood sugars. Subjects who consent to participate in the extension study will continue to receive treatment with either SIAC once daily
plus insulin aspart or insulin detemir plus insulin aspart as previously randomly allocated in trial NN5401-3594. In this research study, SIAC (a combination of both short and lon'g acting insulins) is injected with the main meal of the day, while a marketed short acting insulin (insulin aspart) is injected at the other two mealtimes. The safety and blood sugar controlling effect of this treatment regimen is compared to a commonly used treatment regimen of long acting insulin (insulin detemir) injected once a day in the evening, along with the short acting insuHn (insulin aspart) at each of the three mealtimes. All insulins are liquids administered by subcutaneous (under the skin) injection and will be provided to patients in injection pens.
Between 335 and 528* subjects with Type 1 diabetes from the following countries will participate in the study:
Denmark, Poland, Romania, France, United Kingdom, Russian Federation, Israel, Australia and the United States.
• depending on how many sUbjects complete the NN5401-3594 study.
Subjects will be asked to attend a total of 9 clinic visits and be available for 7 telephone contacts dUring the study. This includes a one week screening period, a treatment period of 26 weeks and a follow-up of one week. |
|
2010/009vas
02/02/10
22/04/11
Salford Royal Foundation Trust |
|
| The transition of assistant practitioners in primary care (version 2) |
| Assistant practitioners (APs) are relatively new higher level support workers; they were introduced into the healthcare
workforce from about 2003. National workforce plans predict that APs will play an increasingly important part in many
healthcare teams, and their numbers are increasing. Being relatively new, research information about APs is scarce.
The few studies that exist indicate that APs make a positive contribution to patient services, but there has been little
investigation into how the APs make the transition into their new roles after completion of their training, and what their
support and development needs are. To embed and sustain these new roles within the workforce for the long term,
these issues require further indepth
investigation.
This study will investigate the process of transition into new AP roles within primary care, and will explore the following:
whether APs experience similar problems to nurses or therapists during the transition period; if they require similar
support to enable them to apply their learning back in the workplace; the influence of working in a uniprofessional or
multiprofessional team; and their career aspirations.
A case study methodology will be used to explore the transition of APs within NHS Bolton, a primary care trust in
Greater Manchester. The main data collection method will be semistructured
interviews; all APs working within the
Bolton health economy will be invited to participate. These will be followed by a focus group of 510
APs who will be
invited to act as a reference group to verify the findings of the research and develop a model for the preceptorship of
future APs(preceptorship refers to a period of support which attempts to ease transition into a new role). The study
forms the final two years of a professional doctorate being undertaken by the Chief Investigator. |
|
2010/007
05/02/10
31/03/11
ReGrouP |
|
| Blood Oxygen Level Dependent (BOLD) responses during emotional and cognitive processing in dysphoric and nondysphoric participants and their modulation by a pharmacological probe of serotonin function. |
| This study aims to improve understanding of how people with low mood and negative feelings (known as 'dysphoric') may be different from people with normal mood and feelings (nondysphoric) when responding to a variety of social and emotional information. The study will look at the patterns of activity in peoples’ brains in situations (presented as a battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results from this study will help to
gather information about the effectiveness of the various tests being used in this study in detecting any changes due to treatment with an antidepressant.
Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the other half of volunteers will be healthy volunteers. It is hoped that the results of this study will provide guidance for assessing effectiveness of new medicines and potentially help with the treatment of depression. |
|
2010/005 IMJ
25/02/10
24/02/11
Salford Royal Foundation Trust |
|
| A non-interventional, observational, post authorisation safety study of subjects treated with lenalidomide |
| Multiple myeloma is an incurable cancer affecting plasma cells. Plasma cells are a form of white blood cell (the cells which fight infection as part of a person’s immune system), which initially develops within the bone marrow. Lenalidomide is a licensed drug, which when used in combination with another drug, dexamethasone, can be used to treat multiple myeloma in adult patients. Lenalidomide is a type of immunomodulatory medicine; medicines which can
stimulate or suppress the activity of the immune system. Previous clinical studies have shown that the most significant side effect associated with lenalidomide treatment is neutropenia (an abnormally low number of neutrophil granulocytes – a type of white blood cell) and thrombocytopenia (an abnormally low number of platelets – cells involved in the clotting of blood). This study aims to investigate the sideeffects of lenalidomide treatment in greater detail, while also comparing the sideeffects of lenalidomide treatment with those of alternative multiple myeloma treatments.
This is a 'noninterventional', 'observational' study. The decision to treat the participants’ multiple myeloma will already have been made by a doctor in accordance with their normal clinical practice prior to the decision to enter the participant into this study. The participant will be treated for multiple myeloma at all times in accordance with normal clinical practice and no additional procedures will be required during the course of the study. It is intended that
approximately 3000 consenting participants will be recruited to take part in this study, from around 300 sites across the European Union.
Two groups of patients will be recruited to participate within this study:
1) 1500 patients with multiple myeloma who are commencing treatment with lenalidomide
2) 1500 patients with multiple myeloma who have received at least one previous therapy and are commencing a new therapy, which is not lenalidomide
The sideeffects of multiple myeloma treatment will be documented as they occur and it is hoped that the findings of this study will improve patient care in the future. |
|
2010/002 CAN
21/04/10
20/04/13
Salford Royal Foundation Trust |
|
| Study OMB110911. A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil Monotherapy in previously untreated patients with Chronic Lymphocytic Leukemia |
| The primary objective of this study is to compare the time from first receiving study treatment until disease progression or death (progression−free survival) of subjects taking ofatumumab (a new monoclonal antibody which targets Chronic Lymphocytic Leukaemia cells) added to chlorambucil (a chemotherapy of the alkylating agent class) with subjects taking chlorambucil alone for the treatment of previously untreated (front line) Chronic Lymphocytic Leukaemia (CLL).
Chlorambucil is a therapy currently approved for frontline treatment of CLL. The addition of ofatumumab to chlorambucil is being investigated in this open−label randomised study, to see if it offers a more effective therapy with limited additional toxicities. Secondary objectives include an evaluation of subjects' overall well−being and quality of life. Approximately 444 eligible subjects, at least 101 in the UK, will be stratified and randomised in a 1:1 ratio to receive either
ofatumumab as monthly iv infusions (300mg on day 1 and 1000mg on day 8 of cycle 1; 1000mg on day 1 of subsequent 28−day cycles) together with oral chlorambucil (10mg/m2 on Days 1−7 of each 28−day cycle) or the same dose of oral chlorambucil alone. All subjects will receive 3 cycles of treatment and their disease will be assessed. Dependent on a subject's response, they may receive further treatment up to a maximum of 12 cycles.
Subjects' response will be measured by blood samples, lymph node examination, spleen and liver measurement and assessment of clinical symptoms performed monthly throughout the treatment phase and at one month post treatment and then every 3 months for up to 5 years. A bone marrow examination and CT scan will be performed to confirm complete remission at least 3 months after end of treatment.
Safety assessments will be performed on a regular basis including haematology, biochemistry and adverse events. |
|
2009/263CAN
05/02/10
04/12/17
Salford Royal Foundation Trust |
|
| A qualitative investigation of patients and therapists views of rehabilitation of the upper limb post stroke, in order to inform the design of an advanced Functional Electrical Stimulation (FES) rehabilitation tool. |
| After stroke, many people cannot use their affected hand and arm, and this has considerable impact on their quality of life. Recovery of function over the rehabilitation period is often poor and approximately 50% of patients are left with long term arm problems. Functional Electrical Stimulation (FES) is a low cost solution which could significantly enhance rehabilitation treatment options for stroke patients.
The proposed research is part of a larger project the object being to create a prototype muscle stimulation system (the FES Rehab Tool) for hand and arm therapy after stroke. We also plan to demonstrate a hybrid system based on the new FES Rehab Tool and an existing rehabilitation robot (iPAM).
There are three stages to the larger project; Stage 1 involves gathering patients and practitioners views in order to inform the design of the system. Stage 2 – development of the system itself and stage 3 is a proof of concept exploratory trial of the advanced FES Rehabilitation Tool.
The views of patients with upper limb deficits following stroke are essential to this process and will be sought during stages 1 and three of the project. Permission is being sought to run the patient advisory group. |
|
2009/260NEURO
24/02/10
23/02/13
Salford Royal Foundation Trust |
|
| Repair of extracellular matrix by topical retinoids. |
| The purpose of this study is to investigate whether the topical application of retinoids (derivatives of vitamin A) can repair agerelated changes to the skin in healthy volunteers. Retinoids will be applied under waterproof dressings for up to 4 days. Samples of skin will be taken and assessed in the laboratory for changes in the structures and distribution of agerelated biomarkers. |
|
2009/256DERM
14/04/10
31/12/12
Salford Royal Foundation Trust |
|
| Psychological predictors of depression in people with long term conditions |
| This study aims to identify which psychological processes are associated with depression in people with Long Term Conditions. Depression is common in people with chronic physical illness (or Long Term Conditions, as they are now called), but seldom receives appropriate treatment because: i) the treatment of the physical condition is prioritised and ii) conventional psychological treatments for depression are expensive, difficult to access and also may be less effective
in people with Long Term Conditions. There is a need to develop novel psychological treatments that are inexpensive, deliverable by nonspecialist staff, appropriate for the needs of people with Long Term Conditions.
This study aims to determine which psychological processes are associated with depression in people with Long Term Conditions. This preliminary research will contribute to the subsequent development for novel psychological treatments for people with Long Term Conditions.
For this study, we will recruit patients with heart disease, diabetes, chronic lung disease, and rheumatoid arthritis from outpatients departments in local hospitals. Over 1 year we will identify 35 patients with each of the above Long Term Conditions and write to them before a planned visit to the outpatients. Interested patients will complete questionnaires (about 20 mins) and computerised psychological tests (15 mins) in a private environment whilst waiting to be seen in hospital, at their homes or a mixture of the 2, as preferred by the patient.
A small subgroup of patients who are found to depressed (about 20 in total) will be invited to take part in an interview assessment, where they will have the opportunity to talk about how they think about their illness and how this affects them emotionally. This interview will take about 30 mins and will be conducted separate from the questionnaire assessments at a time and place of the patients choosing. |
|
2009/254 NEURO
01/02/10
31/12/10
Salford Royal Foundation Trust |
|
| Patients’ opinions of a client centered approach in nutrition |
| Dietetics used to be based on prescriptive advice giving but counselling skills strategies are now being used and
considered essential skills. The use of counselling skills in nutrition support practice is still marginal and evidence of
their effectiveness is lacking. Previous studies have explored Dietitians' perception of the use of counselling skills in
the past but this study aims to explore patients’ opinions and satisfaction of their use as opposed to a more
prescriptive approach to nutrition support. Outpatients who have attended 1 or more appointment with a Trafford
Dietitian for nutrition support, meet the inclusion criteria and have been discharged less than 1 month before will be
invited to take part in the study. 3060
minutes audiorecorded
interviews will be conducted and typed into a word
document for analysis. The researcher will aim to confirm information from previous studies, answer questions raised
in the literature but also learn about the patients’ experiences and satisfaction. This should inform practice and in
particular the shift between prescriptive nutrition support towards a more patientcentred
practice. The results and
analysis will take the form of a dissertation as part of the researcher’s Masters. |
|
2009/253
04/05/10
31/12/10
ReGrouP |
|
| A 26week randomised, confirmatory, controlled, open label, multicentre, multinational treattotarget trial comparing the efficacy and safety of soluble insulin basal analogue (SIBA) 200 U/ml and insulin glargine, both injected once daily in combinatio |
| The aim of this study is to compare the gloucose lowering effect of Soluble Insulin Basal Anallogue (SIBA) 200 U/ml with that of insulin glargine both in combination with metformin +/a DPP4 inhibitor in Type 2 diabetic patients who need to start insulin. In UK DPP4 inhbitors are not licensed for use with insulin so if subjects are taking these on entry to the study these will be stopped at randomisation (along with any other OADs, apart from metformin).
A planned total of 450 patients from the following countries will take part: France, Ireland, United Kingdom, Russia, Ukraine, South Africa, Canada and United States of America.
Subjects will be asked to attend a total of 15 clinic visits and 14 telephone contacts during the study. This includes a 1week screening period, a 26 week treatment period and a 1 week follow up period. |
|
2009/241vas
26/01/10
14/10/10
NHS SalfoR+D (joint study) |
|
| Individual finger grip strength after injury or surgery. |
| In cases of hand injuries or diseases, the grip strength assessment is one of the most reliable and valid tools in
assessing the effectiveness of treatment. All medical devices used for measuring the grip strength indicate only
total grip strength of all four fingers. However, in clinical practice, it has been recognised that there is need for
higher level of precision in the form of measurement of individual finger grip strength. So, recently the new device called DIGITS−grip has been developed which measures grip strength of all fingers separately and indicates total grip strength also. Studies with this device on normal hands have been reported.
Our study is aiming to see if this new instrument is reliable and valid in comparison to 'gold standard' Jamar dynamometer. This will be first study to evaluate recovery pattern of grip strength in fingers after injury or fractures and after operation on fingers due to other reasons. And we are also aiming to confirm the results of previous studies.
One hundred participants with injuries and fractures in the hand and sixty participants having specific elective operations will be recruited for the study. The study includes detailed protocol for measuring the grip strength of both hands (normal and affected) using two devices during each routine clinical follow−up visits to hospital. Reliability and validity of the instrument, recovery of grip strength of fingers after injury or operation, normal relative contribution of individual finger strength towards total grip strength and user− friendliness of devices will be analysed using appropriate statistical methods. The clinical importance of this study arises from the necessity to guarantee that assessment instruments being used in the clinic are valid and reliable. Whether individual finger strength deficits occur following injury or operation and, if present, whether it has any clinical significance is not known. So, the objective information derived from this study will be used to suggest variations in hand rehabilitation therapy and introduce the concept of single−digit grip strength as a routine in hand rehabilitation. |
|
2009/236 INJ
05/02/10
04/10/10
Salford Royal Foundation Trust |
|
| A Randomized, Multicenter, DoubleBlind, Parallel, PlaceboControlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study) |
| JNJ28431754 (canagliflozin) is an experimental drug being tested to see if it may be useful in treating Type 2 Diabetes Mellitus. This study will compare the possible effects (both good and bad) of canagliflozin to those of placebo (a dummy pill) on the heart and circulatory system in patients whose diabetes is not well treated with standard diabetes therapies. The study is designed to see if canagliflozin is safe and well tolerated in patients with Type 2 Diabetes
Mellitus, and potentially to see if it may reduce the risks that diabetes poses to the heart and circulatory system. There are 3 treatment groups in this study : Canagliflozin 100mg (active treatment), canagliflozin 300mg (active treatment), or placebo once daily. Patients allocated to receive active treatment may, later in the study, be switched to the other dose of active treatment, depending upon an initial assessment of the data whilst the study is ongoing.
The study is expected to take up to approximately 8 years. For each patient the minimum treatment length is expected to be 104 weeks, continuing until the study ends (including a maximum of approximately 37 visits and 4 phone calls).
The exact duration of the study is not known, since it will be determined by the data the study generates. Visits will bemore frequent in the initial stages of the study but after approximately the first 6 months will be only every 13 weeks, until the end of the study. |
|
2009/234vas
22/03/10
21/05/18
Salford Royal Foundation Trust |
|
| Evaluation of epidermal cell proliferation by dansyl chloride labelling of the skin: Study of the pretreatment duration |
| The objective of this study is to determine the effect of skin moisturisation on the turnover of skin cells in the epidermis. Subjects will be asked to use a specific moisturiser for up to 4 weeks before labelling the skin with a nontoxic fluorescent dye, the disappearance of which can be monitored over the following 3 weeks. |
|
2009/232derm
09/03/10
31/12/10
Salford Royal Foundation Trust |
|
| A 10-Year, Post-marketing, Observational, Registry of HUMIRA® (adalimumab) in Adult Patients With Chronic Plaque Psoriasis (Ps) (The ESPRIT Study). |
| This protocol describes a Post−Marketing, Observational Registry that will evaluate the longterm safety and effectiveness of HUMIRA® (adalimumab) as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis, who are candidates for systemic therapy (treatment that affects the body's whole system) or phototherapy (light therapy). This registry is part of a postmarketing commitment from Abbott Laboratories to the FDA and European Medicines Evaluation Agency (EMEA).
The participating physicians, with regard to countries and sites, will be representative of the dermatologists who prescribe HUMIRA® for patients with psoriasis in North America and Europe, Canada and Australia. Similarly, the patients selected for enrolment in the registry will be representative of the population for which HUMIRA® is used to treat psoriasis in the participating countries.
The patients will receive commercial HUMIRA® that will be prescribed per their local prescribing information. The data collected in this registry will be complementary to those from the preregistration studies of HUMIRA® inpsoriasis. The management of the patients in this registry will reflect the use of HUMIRA® in current clinical practice.
The participating physician is free to determine the appropriate therapy for each patient and make treatment choices as deemed clinically necessary. Patients who consent to participate in the registry will be followed for up to 10 years, providing important longterm safety and effectiveness data on HUMIRA® in psoriasis patients.
Patients in the study will not directly benefit from participating, however information from the study may help provide psoriasis sufferers better treatment in the future. Patients will consent to the study to provide information at some of their regular clinical visits on their psoriasis symptoms, any illness and changes in medication. The study physician will also complete a short questionnaire. |
|
2009/230DERM
08/04/10
07/04/23
Salford Royal Foundation Trust |
|
| An Investigation into the Attitudes and Behaviours of Consumers and Caregivers in the Preparation, Handling, Storage and Feeding of Powdered Infant Formula Inside and Outside the Home |
| − PURPOSE OF RESEARCH:
The purpose of the cumulative research study is to investigate attitudes and behaviours of parent and
caregivers when handling, preparing and storing powdered infant formula inside and outside of the home. In
addition the study will determine sources and perceptions of current hygiene and safety information
concerned with powdered milk formula. |
|
2009/229
22/01/10
31/03/10
NHS SalfoR+D (joint study) |
|
| Factors Influencing the Decision to Prescribe |
| Historically in the United Kingdom (UK) only doctors and dentists were legally able to prescribe medicine to patients.
However, since 1994 major developments have taken place which has enabled prescribing by a number of other
health care professionals (HCPs) including: nurses, pharmacists, radiographers, physiotherapists,
chiropodists/podiatrists and optometrists. As these HCPs are not considered to be medically trained, unlike doctors
and dentists, the term ‘nonmedical’
is often used to refer to their prescribing.
The first study in this programme of work aimed to identify and explore the factors influencing the prescribing decisions
of nonmedical
prescribers. The findings indicated that nonmedical
prescribers not only need to make treatment
choices but also need to decide whether they should issue a prescription or take responsibility for making a
prescribing decision for a patient at all. This finding has not been previously identified in the medical prescribing
literature and offers new insights into the differences between medical and nonmedical
prescribing that have not been
previously discussed.
This study aims to expand on the preliminary findings of study one by furthering the understanding of the factors that
influence whether nonmedical
prescribers issue a prescription or take responsibility for making a prescribing
decision for a patient. This is a particularly important issue to understand as nonmedical
prescribers have the legal
authority to prescribe any licensed medicine from the British National Formulary. This study will comprise a purposively
selected sample of nurse and pharmacist prescribers. A group of participants will initially take part in a semistructured
interview. In these interviews participants will be asked to bring examples of prescribing scenarios and describe them
indepth.
The findings from the interviews will then be anonymised and presented to participants in a minigroup
setting who will be asked to discuss them through their own experiences. |
|
2009/227
11/01/10
30/11/10
ReGrouP |
|
| Observational study of treatment outcomes in early diffuse systemic sclerosis (SSc)in Europe |
| At present there is no known cure for systemic sclerosis (SSc) often termed 'scleroderma'. People with the 'diffuse'
form of the disease often have a particularly aggressive illness, and are at high risk of developing lung, kidney and
heart involvement especially in its first 3 years. 'Diffuse' means that skin thickening is widespread, spreading from the
fingers, feet and face to involve upper arms, thighs, or trunk. A number of different drugs with effects on the immune
system (called 'immunosuppressants') are currently used by doctors in the treatment of early diffuse scleroderma, but
all have major side effects and may not even be helpful. Ideally these drugs should be tested in what are termed
randomised controlled trials. However, such trials are difficult and very expensive to run, and both patients and their
physicians are frequently not willing to have their therapy chosen at random. Our objective is, by the careful recording
and analysis of the effects of routine therapy, to examine the effectiveness of different immunosuppressant drugs
currently favoured by doctors treating scleroderma. This approach, applied in a multicentre European study, will allow
recruitment of large numbers of patients using a practical, affordable study design. Each patient entering the study
commences one of three recommended immunosuppressant drugs(reflecting current clinical practice)or, conversely,
decides with his/her doctor not to commence immunosuppressant therapy. She/he is then carefully followed up for 12
years with any changes in therapy carefully documented. The effectiveness of different treatments will then becompared. Using modern and complex statistical techniques, it is possible to adjust for different patient characteristics
at baseline and for any changes in therapy. |
|
2009/225 RHEUM
12/07/10
11/08/14
Salford Royal Foundation Trust |
|
| Comparison of a photographic and a clinical dental examination:Phase 3 |
| Primary Care Trust Dental Services regularly conduct surveys in schools as part of Department of Health requirements.
These surveys help to monitor the dental health of children and assist in the planning of future dental services. Caries
data collected this way can be used for evaluating water fluoridation schemes. However dental teams could be
influenced in the way they collect the data if they are aware of the fluoridation status of the residence of subjects. This
could potentially create bias. If dental teams could examine photographs of subjects, rather than perform clinical
examination of subjects it could overcome the problem of bias
This study will help to find out whether examining photographs of children's teeth gives the same results as examining
the children themselves.
Two groups of children, one aged 5 years and the other 10/11 (Year 6), attending primary schools in Rochdale will be
eligible to take part in the study. These age groups have been selected as they are internationally recognised as the
ages at which information about dental decay is usually collected.
The children will have a clinical examination of their teeth (a "dental inspection") at school by 5 dentists. They will also
have up to 8 photographs taken of of their teeth at the same time. (There will be no photographs of the face taken).
Some of the participating children, in both age groups, and on a separate occasion, will be selected at random to say
what they thought of the inspection method and the photographic method of obtaining information about their teeth.
These children will meet in small groups and will give their views with or without the aid of a puppet, according to age
group. |
|
2009/223
10/12/09
30/06/10
ReGrouP |
|
| AN EXAMINATION OF THE UNDERSTANDING OF 'CATASTROPHIC REACTION' IN RELATION TO THE SELF AFTER BRAIN INJURY: AN INTERPRETATIVE PHENOMENOLOGICAL ANALYSIS (IPA) |
| The study aims to better understand the phenomena of ‘catastrophic reaction’ and 'self' following brain injury. The
term ‘catastrophic reaction’ was first observed and documented by Goldstein, (1959) and is associated with the 'self's'
lost ability to successfully undertake a task or tasks. The phenomenon is described as an acute anxiety state followed
by an initial avoidance of the ‘lost’ activity. Over time, the 'self' increasingly avoids activities associated with the lost
skill thereby further restricting and reducing their potential for successful rehabilitation.
The project seeks to achieve its aims by asking people with brain injuries about their own experiences and how they
have made sense of these. In gaining an insight into these processes, increasingly effective ways of managing and
even preventing the restriction and debilitation of avoidance/nonengagement
can be found.
Further, the study will seek to construct a theoretical framework setting out tentative stages of reconstruction of ‘self’
following brain injury. This will add to existing knowledge and enable the development of more clinically and costeffective
rehabilitation programmes to reduce the suffering of people with brain injuries and their families.
The proposed qualitative research will utilise semistructured
interviews to explore the above which will be analysed
using interpretative phenomenological analysis (IPA),
IPA is a method of analysing texts and is chosen because it explores an experience from the perspective of the person
who has experienced it. Thus it can provide powerful indications of how interventions or treatments might be
experienced (and therefore improved) from the perspective of the participant. Further, the material is contemporary
and relevant to the individual engaging with the research. The approach is personcentred
and has the capacity both
to deal with the idiosyncrasies of the individual experience together with those elements shared by others. |
|
2009/220
11/03/10
11/02/11
ReGrouP |
|
| Assessing the use of different samples for Norovirus testing during community outbreaks of gastroenteritis. |
| Institutions in the community, such as care homes, often suffer outbreaks of diarrhoea and vomiting. The most
common cause is a virus called norovirus, though there are many other causes. Given there are many causes, it is
important to confirm what is causing the outbreak. Identifying the cause normally involves the collection of a faecal
sample. Collecting faecal samples in community settings is difficult for a number of reasons. This means the cause of
an outbreak of gastroenteritis is often never known. Given the majority of outbreaks are caused by norovirus, improving
the identification of norovirus is one strategy to identify the cause of more outbreaks.
Norovirus testing has in recent years improved significantly. We believe it is now possible to swab faeces or vomit, as
opposed to collect a faecal sample in a pot, and test these samples for norovirus. It is hoped swabbing faeces or vomit
will allow samples to be collected more easily in the community allowing the cause of more outbreaks to be confirmed.
We therefore plan to compare testing swabs of faeces and vomit with the routine practicetesting
a faecal sample in a
pot. In an outbreak, the standard medical response will occur. Part of that response includes an investigator (usually
an infection control nurse) visiting to obtain information on cases and faecal specimens on up to 5 cases.
As part of this research study, patients/carers will collect swabs of faeces and vomit from those who have submitted
standard faecal samples, and who consent to participate. This is a non invasive test. The faeces sample will be
processed as usual as well as an aliquot stored along with the swabs. Study samples will be anonymised and sent to
Liverpool University for testing. Collection will continue until samples from 72 patients are obtained. |
|
2009/217
03/03/10
03/04/11
ReGrouP |
|
| A 24 week, multicentre, randomised, double-blind, placebo-controlled, parallel-group, international phase III study with a 24-week extension period to evaluate the safety and efficacy of Dapagliflozin 10mg daily in patients with type 2 diabetes who h |
| In type 2 diabetes the level of blood sugar is above normal. Since many patients with type 2 diabetes do not achieve
treatment goals with current therapies, there is a need for new treatments, especially those that do not cause low
blood sugar or weight gain.
Dapagliflozin is an experimental drug that works differently than other known drugs: it causes sugar from the blood to
be excreted in the urine. This study aims to investigate how dapagliflozin can control blood sugar in patients with type
2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of
dapagliflozin on weight and blood pressure will also be studied.
Approximately 430 patients from North and South America and three European countries will take part. About fifty
patients will be recruited from the UK. Men and women aged 18 years or older with type 2 diabetes may be eligible.
Only patients who are not receiving treatment for type 2 diabetes, or those who currently receive metformin, sitagliptin
or vildagliptin can be enrolled. Eligible patients will be screened by a blood test and only those who need additional
therapy will be enrolled.
Patients in the study will be divided into two groups. Both groups will receive background drug treatments but in only
one group (50% of all patients) dapagliflozin will be added on to background treatment. The other group will receive
an inactive placebo pill. There are fourteen study visits over a one year and three months period. At the visits patients
will be asked to give blood samples for routine blood tests. At three visits during the study, blood samples will be taken
before and after a liquid meal to compare blood sugar before and after meals. Other assessments will include urine
tests, ECG, and physical examinations. |
|
2009/213
19/01/09
19/01/12
ReGrouP |
|
| International Survey in MS Cost of Illness and Unmet Need |
| This is a noninterventional observational study to collect data on treatment experience, costs and health outcomes from patients with Multiple Sclerosis (MS). The study will take place in UK, France, Germany, Spain, Italy and Canada. Data will be captured for this study via a secure, simple web based questionnaire that patients can access either in the clinic or by using their personal computer in their own home. The aim of the study is to determine the true cost of MS to government health departments / NHS, to determine what health resources are used in each country, patient treatment preferences in MS and assess the health outcomes (such as quality of life, fatigue).
Approximately 250300 treated or untreated adult patients with MS, including at least 250300 patients with relapsing MS (RRMS – RelapsingRemitting
MS and SPMS – Secondary Progressive MS), will be recruited at approximately 6 sites in the UK. It is estimated considerably more than 300 patients will be initially considered in order to obtain the 300 required patients in the study. Patients will be identified by their health care professional at their clinic if they have
had at least one visit to the clinic during 2008. Eligible patients will be selected according to the inclusion and exclusion criteria. They will be asked either at their next routine clinic appointment or by telephone if they are willing to participate and their informed consent will be sought when they access the web based questionnaire. They will not be able to complete the web based questionnaire until consent has been given and electronically recorded. Selected patients will be assigned a unique study ID provided by i3 Innovus. Each ID has a unique password with which the webbased questionnaire can be accessed.
The study will not influence any treatment decision nor induce any study/specific investigations. |
|
2009/212 NEURO
04/03/10
03/10/10
Salford Royal Foundation Trust |
|
| Non−attendance at hepatitis C testing and treatment appointments |
| Hepatitis C is a bloodborne disease which can be acquired by sharing needles. It causes scarring of the liver and can
ultimately lead to liver failure and death. It is the main reason for liver disease around the world and information given in
the Hepatitis C Action Plan (2004) is that "around 200, 000 people in England are chronically infected with hepatitis C". It is
estimated that there are more than 1000 drug users who are receiving treatment via the Manchester Drug Service and
have active hepatitis C infection (2006).
It is possible to treat hepatitis C. The treatment is effective 55−90% of the time. However, more than 70% of clients of
Manchester Drug Service do not attend appointments where testing for hepatitis C is carried out, or where treatment for
hepatitis C is offered.
In this study, we will interview 30 people who have been given appointments for hepatitis C testing or treatment after
accessing Manchester Drug Services. The interview will explore the reasons why this group do not go to appointments and
seek to identify ways in which future health services can be designed to improve attendance at appointments for testing
and treatment of hepatitis C. |
|
2009/210
03/03/10
03/09/10
ReGrouP |
|
| An exploration of the factors influencing the food intake and eating habits of partners of enterally fed adults |
| The aim of the study is to explore the factors influencing the food intake and eating habits of partners of adults who are
being tube fed (enterally fed). More than 24,000 adults per annum are enterally fed in the UK, the main causes being
head and neck cancer and long term neurological conditions. Increasingly enterally fed people live at home and
therefore partners play a vital role in supporting them, needing to address not only the practical aspects of managing
the feeding system but the wider implications of the effects of having a member of the family who is unable to eat. A
small study we have undertaken suggested that supporting a person being enterally fed has a significant impact on
partners’ food intake and this study is designed to explore this issue in more detail.
A qualitative approach using interviews and food diaries will be used. Participants will be partners of adults receiving
nothing by mouth who are living at home, with a diagnosis of head and neck cancer or a neurological condition.
Participants will be identified via dietetic departmental records and invited by letter to participate. They will be asked to
participate in one interview to explore the experience of supporting someone being enterally fed and how this affects
their eating. They will then be asked to keep a food diary for one week to provide insights into their eating
patterns/habits and food and drink intake. This will be discussed at a follow up interview where perceived changes in
eating habits and social dining issues will also be explored. All interviews will: last 12
hours; take place where
possible in participants' homes, and, be digitally recorded. Interviews will be transcribed verbatim, summarised and
returned to the participant for member checking. Data will be analysed thematically. |
|
2009/209
10/02/10
31/01/14
ReGrouP |
|
| Factors Influencing Infant Feeding Choice in Bolton: Parents’ Views, Experiences and Support Needs |
| Breastfeeding has a number of wellestablished
health benefits for babies and protects infants from a number of
illnesses including gastroenteritis,
respiratory infection, atopic disease and the prevention of otitis media and type 1
diabetes mellitus in childhood. The Department of Health wants to increase rates of breastfeeding to improve child
health and reduce inequalities in child health. However, breast feeding rates across Bolton are very low and rates are
declining. In 2008/09 only 24% of women were breastfeeding their baby at 68
weeks old. This is a decline in
breastfeeding rates from 2007/08 when breastfeeding rates were 31.62%. In this study we want to increase our
understanding of how parents (mothers and fathers/partners) make decisions about infant feeding choices, the factors
and issues that shape these decisions and the factors that hinder breastfeeding initiation and duration among
mothers living in Bolton. In addition, we plan to find out about parents’ breastfeeding information and support needs
and the views of service users, health professionals and service providers on ways to improve and develop the
appropriateness and accessibility of breastfeeding service provision. |
|
2009/205
15/01/10
31/07/10
ReGrouP |
|
| Genetic Analysis of Risk Factors for the Development of Diabetic Complications. |
| In subjects with type 1 diabetes, the detection of abnormal amounts of albumin in the urine (termed microalbuminuria)
is highly predictive of the consequent risk for the development of diabetic nephropathy, and may be independently
linked to the risk for cardiovascular disease. Microalbuminuria becomes evident in around 16% of children and
adolescents with type 1 diabetes around the time of puberty. The appearance of microalbuminuria is related to the
metabolic control of diabetes, but there is also evidence to suggest that there may be a genetic predisposition. Our
previous studies of adolescents with diabetes suggest that by longitudinal analysis of metabolic control, coupled with
the rate of change in albumin excretion as subjects go through puberty, may give us a measure of the underlying
genetic susceptibility. We plan to complement our ongoing longitudinal studies of 500 children in the Oxford region,
by recruiting a further 1,000 children from East Anglia, Birmingham and Bristol. Children and adolescents aged
10−18 years will be recruited for annual assessment of urinary protein excretion rates and regular assessment of
glycaemic control as judged by HbA1c over a minimum period of 3 years. Data regarding family histories of
cardiovascular disease, hyperlipidaemia and diabetes will be obtained from the parents, together with direct
measurements of parental lipids and urinary albumin excretion rates in order to determine whether microalbuminuria
in the probands relates to other heritable traits in the parents. Blood samples will also be taken from the children and
their parents for extraction of DNA which will be used to examine association between candidate genes, the genetic
susceptibility for microalbuminuria and the relationship with associated phenotype in the parents. The identification
of genetic factors linked to the risk of diabetic complications would permit earlier detection and prevention in those most at risk |
|
2009/202
26/11/09
01/10/12
NHS SalfoR+D (joint study) |
|
| Social Marketing Insight into Men's Mental Health |
| NHS Heywood, Middleton and Rochdale would like to gain insight into attitudes to and behaviour around mental health
issues (focusing on the neurotic rather than psychotic) in men aged 2035.
This is in order to inform a social
marketing project to raise awareness of the signs and symptoms of mental health problems and encourage men to
recognise those and get help when it's needed, therefore targeting the following behavioural goals: for target men to
recognise when they have a problem with their mental health and for target men to seek support to improve their
mental health |
|
2009/200
11/01/10
10/02/10
ReGrouP |
|
| Survey of patients of Non-Medical Prescribers |
| This research is part three of a service evaluation over the North West of England looking at Non Medical Prescribers
(NMPs), their role and scope; two previous surveys of NMPs and Doctors have already taken place. This part asks
patients what they think about the service provided by NMPs.
The questionnaire has been developed by a team including NHS senior managers, researchers, prescribing course
leaders of 8 North Western Universities and advisors as part of the service evaluation. Approval for a user group to be
involved in the development and piloting of the survey was included in the service evaluation approval: users comments
and feedback have helped develop the questionnaire to a finished state. The questionnaire will be administered to at
least 300 patients and a maximum of 600 in total, by their NMP in the three NHS zones in the North West (Cheshire and
Mersey; Lancashire and Cumbria; Gtr. Manchester). 10 NMPs in each zone will each recruit from their patient list up to 20
patients. Over a designated period (usually 2 months) they will invite every patient who meets the recruitment criteria and
is treated in their NMP role, to fill in the survey until they have recruited approximately 10−20 patients (they will not know
who sends back the survey). We expect a return rate of about 40−50% (so some NMPs may ask up to 50 patients and
stop after a short time while others will not treat as many and need a longer time period). Patients excluded (not invited to
participate) will be: children, those unable to consent or particularly vulnerable (according to judgement by the NMP on
site), those dealing with a sudden serious and sensitive issue that the questionnaire might upset (judgement on site), those
compromised by physical disability making it painful for them to write. Patients will self complete the surveys at home and
send them in a prepaid envelope to the co−ordinating university for analysis.
The questionnaire is appended. |
|
2009/199
19/02/10
19/05/10
ReGrouP |
|
| Speech and Language Therapists' Approaches to Communication Assessment and Intervention with Children and Adults with Profound and Multiple Learning Disability (PMLD) |
| People with profound and multiple learning difficulties (pmld) have profound intellectual impairment compounded
by one or more of vision or hearing impairment, physical disability and epilepsy. Consequently, severe
communication difficulties are very common, making it difficult for this group to interact and make their needs
and wants known.
There is no consensus on approaches to speech and language therapy (SLT) with this group. A review by
Goldbart, (2005) found six types of intervention. Of these, four involved working directly with the client with pmld
and two involved working through carers or modifying the environment.
There is only limited evidence supporting the effectiveness of any of these approaches. It is also unclear what
intervention approaches SLTs typically use and what informs their decision−making regarding assessment and
intervention.
This research aims to:
• find out what assessment and interventions SLTs use when they work with people with PMLD
• find out what things influence SLTs’ choice of communication assessment and intervention approaches for
people with pmld.
• determine the frequency of use of different communication assessments and intervention approaches by SLTs
with children or adults with pmld, and
It will also provide up to date information on SLT service provision around communication for people with PMLD.
In order to access the largest number of SLTs a survey has been devised, asking SLTs about their current
practice in assessment and intervention and the reasons for their choices.
The Royal College of Speech and Language Therapists (RCSLT) is assisting with the distribution of letters
inviting participation. Interested participants will be sent the questionnaire which will be analysed quantitatively
and qualitatively.
The findings will be made available to participants and other SLTs in an article in the RCSLT Bulletin and
disseminated through journal papers and conference presentations. |
|
2009/198
13/11/09
30/04/11
ReGrouP |
|
| Effect of auditory deprivation and its rehabilitation on cortical activations and connectivity |
| Deafness occurs in certain inherited conditions and also increases with age. It is a common condition which has a huge social impact on the person and on his or her family. Rehabilitation can be in the form of amplification or using visual cues, i.e., sign language or lip reading.
Rehabilitation can also be successfully provided by a cochlear implant, which involves surgery to place it in the ear. This works by converting sound into an electrical signal which stimulates the hearing nerve. This in turn sends signals to the brain to process. Our knowledge of how the brain processes these signals from the auditory nerve is being improved by newer imaging techniques. At present cochlear implant success is measured on how successful patients understand speech. Studies have shown this success rate is variable. Poor outcome is associated with a prolonged period of deafness prior to cochlear implantation. Why this is the case is still not fully understood.
Imaging the brain and assessing the function of the hearing areas in patients who are awaiting a cochlear implant will help our understanding of how the brain has adapted in its processing of sound. This will helpinform patients on how successful the surgery can be and predict the outcome. Hence giving the patient a
more informed choice on whether they wish to go through with the procedure or not.
Patients who have neurofibromatosis experience hearing loss over time due to benign growths on both hearing nerves which stop the nerves from working.
In these patients hearing rehabilitation can only be provided by placing an auditory brainstem implant. This involves a significant brain operation. The outcome from this procedure is variable and at best improves the patients perception to environmental sounds. Using the above forms of imaging, the brain function especially in the hearing and visual areas will help provide information on how sound is processed. This will help to decide if and when to provide an auditory brainstem implant and aim to predict outcome and in doing so then will allow patients to make an informed decision on whether they would like to consider this option. |
|
2009/197
16/12/09
15/12/10
Salford Royal Foundation Trust |
|
| A phase I, multi-centre, double-blind, placebo controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female subjects fulfilling the criteria for Major Depressive Disorder |
| This study is divided into two parts. Part one of the study will assess the effect of a single intravenous (IV) dose of ketamine compared to saline on the Blood Oxygen Level Dependent (BOLD) on the brain area BA25 using functional Magnetic Resonance Imaging (fMRI) in participants meeting the criteria for Major Depressive Disorder (MDD).
Part 2 of the study will look at this but this time participants will receive either ketamine or AZD6765 or placebo, administered intravenously. The study will also assess whether a single dose of ketamine or AZD6765 improves symptoms of depression as assessed from MontgomeryAsberg Depression Rating Scale (MADRS) total score. Whether a single IV dose of ketamine and AZD6765 alter the responses on the Emotional Test Battery of Behavioural Tasks (ETB). To assess whether a single dose iv infusion of ketamine or AZD6765 alter the effects of emotional processing on the BOLD signal in various brain areas. |
|
2009/192
11/12/09
31/12/10
Salford Royal Foundation Trust |
|
| Is touch an effective therapeutic intervention impacting on health and well being? An examination of the use of Touch within movement - psychotherapy practice for learning disabled adults. |
| In the NHS and traditionally in psychotherapy, a nontouch
policy is the general rule for infection control and to protect
the professional from litigation and the client from the possibility of receiving abusive touch. The arts therapies however
use touch effectively as an integral aspect of the therapeutic process. This conflict, with the call for more research
across nursing and psychotherapy in learning disability contexts, is the backdrop for this study. Lack of effective
intervention and inadequate communication underlie public concern for the care of learning disabled adults as
patients. This study will contribute to the ongoing
debate of the negative effects of a predominantly nontouch
culture
and the impact of touch deprivation on health for this client group.
The study will question and identify how touch therapy may reduce the negative impact of the symptoms of anxiety,
behaviour, self injury, grief, etc, on the participants' quality of life.
The study is hosted by the Adult Learning Disability Services of Oldham Primary Care Trust in NHS premises and
therapy rooms. The participants are learning disabled adults referre
|
