Abstract
BackgroundThe need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations. There is a continuum between explanatory and pragmatic trials. Most trials have aspects of both, making it challenging to label and categorize a trial and to evaluate its potential for translation into practice.MethodsWe summarize our experience applying the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) combined with external validity items based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to three studies to provide a more robust and comprehensive assessment of trial characteristics related to translation of research. We summarize lessons learned using domains from the combined frameworks for use in study planning, evaluating specific studies, and reviewing the literature and make recommendations for future use.ResultsA variety of coders can be trained to use the PRECIS and RE-AIM domains. These domains can also be used for diverse purposes, content areas, and study types, but are not without challenges. Both PRECIS and RE-AIM domains required modification in two of the three studies to evaluate and rate domains specific to study type. Lessons learned involved: dedicating enough time for training activities related to the domains; use of reviewers with a range of familiarity with specific study protocols; how to best adapt ratings that reflect complex study designs; and differences of opinion regarding the value of creating a composite score for these criteria.ConclusionsCombining both frameworks can specifically help identify where and how a study is and is not pragmatic. Using both PRECIS and RE-AIM allows for standard reporting of key study characteristics related to pragmatism and translation. Such measures should be used more consistently to help plan more pragmatic studies, evaluate progress, increase transparency of reporting, and integrate literature to facilitate translation of research into practice and policy.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0096-x) contains supplementary material, which is available to authorized users.
Highlights
The need for high-quality evidence that is applicable in real-world, routine settings continues to increase
The differentiation of pragmatic from explanatory research can be traced to a seminal paper by Schwartz and Lellouch [12] wherein they define explanatory research as conducted under optimal circumstances to determine the ‘efficacy’ of an intervention while pragmatic research tests an intervention under usual conditions
The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) article examples and the presentation were useful background, there were several issues that were unclear to some reviewers, and we found it necessary to add explicit anchors for the ratings and to rate and discuss example studies not part of the formal evaluation
Summary
The need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations. The differentiation of pragmatic from explanatory research can be traced to a seminal paper by Schwartz and Lellouch [12] wherein they define explanatory research as conducted under optimal circumstances to determine the ‘efficacy’ of an intervention while pragmatic research tests an intervention under usual conditions. This distinction is important because trials are frequently designed as explanatory investigations, when the researchers’ intent is to answer the pragmatic question of effectiveness under usual or differing conditions. The importance of pragmatic research has been given a major boost by the development of criteria and evaluation tools intended to increase transparency of research and results reporting and provide a means for practitioners and policy makers to assess local applicability of trial findings [13,14,15]
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