Metrics details. This study aimed to assess how pragmatic the design of the self-labelled pragmatic randomised controlled trials in the manual therapy field is. Two independent reviewers collected and extracted data related to the intention of the trial, the rationale for the intervention, and specific features of the trial and performed an assessment using the PRECIS-2 tool.
Self-labelled pragmatic randomised controlled trials showed a moderately pragmatic attitude. Peer Review reports. Medical research is often criticised for its low resemblance to real clinical settings [ 1 , 2 ]. Moreover, there is a large gap between the amount of medical research available and that useful for healthcare practitioners [ 3 ]. In that sense, there is an increasing interest in trials designed with a pragmatic attitude to respond to the currently poor generalisability of many studies [ 1 , 4 , 5 ].
Explanatory trials assess how a specific intervention impacts participants optimally, often using placebos or active comparators. They focus on measurable symptoms or markers and aim to minimise participant variability. In contrast, pragmatic trials evaluate interventions in real-world clinical settings to ensure broader applicability and effectiveness across diverse patient populations and treatment settings, requiring larger, more flexible designs [ 7 ]. It is essential to highlight that the pragmatic term refers to an attitude rather than a characteristic of the study and that a continuum exists from explanatory to pragmatic [ 7 ].
Pragmatic trials have been used in pharmacological research in phase IV trials [ 12 ]. However, the development of pharmacological and non-pharmacological interventions differs substantially because non-drug interventions are not as commonly regulated as drugs are e.
Arguably, this situation encourages trialists to attempt a pragmatic approach directly but using explanatory designs, concluding with recommendations of treatment pragmatic attitude regardless of the absence of high-quality efficacy trials this was also observed by Zwarestein et al. Although pragmatism is possible in both early and late-stage development trials, caution is required because, without efficacy evidence, results can be strongly biased toward a positive outcome [ 1 , 14 , 15 , 16 ].
