The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research
نویسندگان
چکیده
Researchers and trialists face many uncertainties when designing and conducting research. Embedded methodology studies can help to resolve these. However, despite hundreds of thousands of trials, there are probably only a few hundred studies assessing the effects of different methods for doing this research. The concept of the SWAT (Study Within A Trial) programme is to aid the development of such research by increasing awareness of, and stimulating interest in the need for this research and providing a framework and resource to inspire and generate ideas, and to store, disseminate and modify such research. The programme was established as part of the development of an All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council’s Network of Hubs in the UK and the Global Health Network. It will facilitate this research into research. Each SWAT comprises of simple, one or two page protocols and, as of April 2015, 19 different SWAT outlines have been registered. This presentation will detail the SWAT concept, and describe the core outline which consists of the following sections: background, intervention, comparator, allocation, primary outcomes, secondary outcomes, analysis, possible problems, likely costs, publications, and version information. The SWAT website will be available to view, and examples of completed SWATs will be shown. The presentation should stimulate ideas for future SWAT, and encourage researchers to see how they might maximize the impact of embedding research into research, leading to improvements in the design of future clinical trials and other studies. Authors’ details Queen’s University Belfast, Belfast, UK. University of Liverpool, Liverpool, UK.
منابع مشابه
SWAT-1: The effectiveness of a ‘site visit’ intervention on recruitment rates in a multi-centre randomised trial
BACKGROUND Recruitment rates in multi-centre randomised trials often fall below target recruitment rates, causing problems for study outcomes. The Studies Within A Trial (SWAT) Programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council Network of Hubs in the United Kingdom and others, is developing methods for evaluating aspe...
متن کاملChallenges in the Design, Conduct, Analysis, and Reporting of Randomized Clinical Trial Studies in Iran: A Qualitative Study
Background and Objectives: Randomized clinical trials are the gold standard for evaluating the effectiveness and safety of medical interventions. Some unpredictable challenges may affect the results of these studies. Therefore, the aim of this study was to identify the challenges of clinical trial studies in different stages including design, conduct, analysis, and reporting. Methods: This ...
متن کاملThe impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial
BACKGROUND Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evalua...
متن کاملTrial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiativ...
متن کاملGuidelines for reporting embedded recruitment trials
BACKGROUND Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment t...
متن کامل