Lack of pragmatic attitude of self-labelled pragmatic trials on manual therapy: A methodological review

Abstract

Background Pragmatic randomized controlled trials are getting more interest to improve trials external validity. This study aimed to assess how pragmatic the design of the self-labelled pragmatic randomised controlled trials in the manual therapy field is. Methods We searched MEDLINE and the Cochrane Central Register of Controlled Trials for self-labelled pragmatic randomised controlled trials in the manual therapy field until January 2022 were included. 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. Results Of 37 self-labelled pragmatic trials, the mean PRECIS-2 score was 3.5 (SD: 0.6). Choice of outcome measures, how the interventions were performed, the follow-up of the participants and how all the available data were included in the statistical analysis were the domains rated as most 'pragmatic'. Participants' eligibility, recruitment, and setting obtained lower scores. Less than 20% of the trials claimed that the aim was to investigate an intervention under real-world conditions and to make clinical decisions about its effectiveness. In the 22% of the sample the authors described neither the proof-of-concept of the intervention nor the state of previous studies addressing related research questions. Conclusions Self-labelled pragmatic randomised controlled trials showed a moderately pragmatic attitude. Beyond the label ‘pragmatic’, the description of the intention of the trial and the context of every PRECIS-2 domain is crucial to understanding the real pragmatism of a trial.