Warwick Clinical Trials Unit:
Methodology Research
www.warwick.ac.uk/go/ctu
Selected Publications
Overview
Bridle C. (2003). Systematic reviews in health psychology: How and
why they should be conducted. Health Psychology Update, 12(4), 3-13
Bridle C, Murphy S, Kainth A. (2009). Methodological issues in health
behaviour intervention research: Bridging the research-practice
chasm. Annals of Behavioral Medicine, 36(3), 22-32.
Bridle C, Riemsma RP, Pattenden J, et al. (2005) 'Systematic review
of the effectiveness of health behavior interventions based on the
transtheoretical model' Psychology & Health 20 (3), 283 – 301.
Systematic Review
Good quality research about the effects of health care
interventions can help clinicians and policy-makers to
make decisions. However, it can be difficult to identify the
research relevant to a particular question from the
overwhelming quantity of published literature, and
individual research studies often vary in quality, have
conflicting results and fail to contextualise their findings.
Systematic reviews (SRs) use explicit, reproducible
methods to identify, evaluate and synthesis relevant
research in order to provide concise evidence-based
answers to sharply defined empirical questions.
SRs examine results from studies in order to improve the
accuracy of estimates of effectiveness, and to investigate
discrepancies between individual studies. Scientifically
rigorous methods minimise the risk of bias.
Politically, SRs are important because DoH R&D strategy
concentrates on the utilisation of research findings rather
than on the generation of original research which, though
useful, is often unable to provide a definitive or conclusive
answer.
Contact
Dr Chris Bridle
c.bridle@warwick.ac.uk
(024) 761-50222
POSTER TEMPL ATE BY:
www.PosterPresentations.com
Selected Publications
Warwick Clinical Trials Unit is an academic unit undertaking clinical
trials addressing real issues of local, national and international
importance.
Michie S, Jochelson K, Markham WA, Bridle C. (In Press). Review of
the content and effectiveness of behaviour change interventions
targeting low-income groups. Jr Epidemiology & Community Health.
We lead or support the development of high quality randomised
controlled trials in selective, focused areas that are consistent with the
research strategy of Warwick Medical School, and in which the
University of Warwick has a key stake in the intellectual property.
Riemsma RP, Pattenden J, Bridle C, Sowden AJ, Mather L, Watt IS,
Walker A, (2003) 'Systematic review of the effectiveness of stagebased interventions to promote smoking cessation' British Medical
Journal, 326, 1175-1177.
Our main research themes include Emergency and Critical Care,
Rehabilitation, Cancer, and Methodology. This poster provides an
overview of our Methodology research.
Williamson E, Williams M, Gates S, Lamb SE (2008) A systematic
literature review of psychological factors and the development of Late
Whiplash Syndrome. Pain, 135(2):20-30.
Process Evaluation
Recruitment of Ethnic Minorities to RCTs
Response
Process evaluation is now seen as good practice in large
randomised controlled trials (RCT). Older peoples
exercise in residential accommodation. (OPERA) is a
large RCT that is looking to reduce depression in older
people living in care homes. The trial includes an
extensive Process evaluation that will determine the
extent to which the trial is implemented by measuring its
activities and quality, as well as whether or not it is
reaching its intended audience. Using qualitative (e.g.
interviews) and quantitative methods the 7 key
components of process evaluation will be explored in the
OPERA process evaluation these are: Context, Reach,
Dose Delivered, Dose Received, Fidelity, Recruitment and
implementation. d.r.ellard@warwick.ac.uk
Ethnic minorities are reported to be under-represented in
cancer randomised controlled trials (RCTs)
Monetary incentives are a potential method of improving
the response rate to postal questionnaires. 2,144
participants (MINT) were randomised to receive a £5 gift
voucher with their follow-up questionnaire, or no gift
voucher.
Delphi Survey
Thirty-five international experts participated in a 3-round
Delphi survey. This formal consensus approach involved a
series of mailed questionnaires interspersed by controlled
feedback; the opinions of ‘the experts were then
statistically aggregated. The study established consensus
on the operational definition/ criteria of a commonly used
physical examination sign and identified issues for future
research. These findings may contribute to the
standardisation of the test and provide common directions
for researchers in the field.
A.chorti@warwick.ac.uk
Under-representation of any patient group within a
clinical trial, can seriously bias trial results, and
subsequent extrapolation of results into the general
population
Research has been conducted to determine barriers to
participation in RCTs but not by ethnicity
It is important to determine the magnitude of the
problem and put strategies in place in order to increase
Black Minority and Ethnic (BME) patient participation
The aims of this research are to:
 Quantify and evaluate the under-representation of
BME patients in cancer RCTs
 Prospectively collect and evaluate reasons given by
patients not wishing to participate in RCTs by ethnic
group
 Conduct a systematic literature review of
interventions to improve the recruitment and
retention of BME patients into RCTs
g.iqbal@warwick.ac.uk
Provision of the gift voucher resulted in a small
improvement in the questionnaire return rate (75.7%
versus 68.7%; risk ratio 1.10, 95% confidence interval
1.05, 1.16).
Providing a £5 gift voucher is an effective strategy for
improving questionnaire response rate and reducing the
quantity of missing data in this trial population.
s.gates@warwick.ac.uk
In a large randomised clinical trial of back pain, (BeST
trial), follow-up data was collected by postal
questionnaires. If no questionnaire was returned, then the
patient was chased up by telephone, and a limited amount
of information on response was collected, to increase the
response rate.
Our observational study showed that the two data
methods could be combined for all outcomes
r.lall@warwick.ac.uk