Abstract
BackgroundPragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which considers how pragmatic a trial is across a number of domains. It is not known whether a pragmatic approach to all PRECIS-2 domains leads to results being more relevant to primary care. The aim of this study was to investigate the views of people with influence on primary care practice towards the design of randomised trials, pragmatic approaches to trial design, and the PRECIS-2 domains.MethodsWe carried out semi-structured interviews with people who influence practice in primary care in the UK. A thematic analysis was undertaken using the framework approach.ResultsWe conducted individual or small group interviews involving an elite sample of 17 individuals. We found that an exclusively pragmatic approach to randomised trials may not always make the results of trials more applicable to primary care. For example, it may be better to have less flexibility in the way interventions are delivered in randomised trials than in practice. In addition, an appropriate balance needs to be struck when thinking about levels of resourcing and the intensity of steps needed to improve adherence in a trial. Across other aspects of a trial’s design, for example the population and trial setting, a pragmatic approach was viewed as more appropriate.ConclusionsTo maximize the relevance of research directed at primary care, trials should be conducted with the same populations and settings that are found in primary care. Across other aspects of trials it is not always necessary to match the conditions found in practice.
Highlights
Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice
Pragmatic trials are often thought of as randomised trials that test interventions under the conditions found in routine care: aside from aspects of routine care modified by the intervention itself, other aspects of care should be as they usually would be [5,6,7,8,9,10]
Summary Whilst broadly supporting the principle of pragmatic trials, this study identifies a number of issues that those conducting and funding trials of interventions to be delivered in primary care should take into account to improve the relevance of the research to primary care
Summary
Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which considers how pragmatic a trial is across a number of domains It is not known whether a pragmatic approach to all PRECIS-2 domains leads to results being more relevant to primary care. Randomised trials are seen by many as being the best design for providing evidence about the effectiveness of different interventions. They do not always produce evidence that is relevant to primary care because they are frequently conducted under conditions that are different from those found in primary care [1, 2]. There is growing interest in pragmatic trials from the pharmaceutical industry with the GetReal collaboration aiming to show how real world evidence, including pragmatic trials, could be used in pharmaceutical research and development [14]
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