Lack of pragmatic attitude of self-labelled pragmatic trials on manual therapy : a methodological review
Roura, Santiago (Universitat Autònoma de Barcelona. Departament de Medicina)
Alvarez, G. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Hohenschurz-Schmidt, D. (UCO School of Osteopathy, Health Sciences University)
Solà Arnau, Ivan (Institut de Recerca Sant Pau)
Núñez-Cortés, R. (Universidad de Chile)
Pérez Bracchiglione, Javier Andrés (Institut de Recerca Sant Pau)
Fernández-Jané, Carles (Universitat Pompeu Fabra)
Phalip, J. (Université Clermont Auvergne)
Gich, Ignasi (Institut de Recerca Sant Pau)
Sitjà-Rabert, Mercè (Universitat Ramon Llull)
Urrútia, Gerard (Institut de Recerca Sant Pau)

Date:	2024
Abstract:	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. 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 2024 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. Of 39 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 25% 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 21% of the sample the authors described neither the proof-of-concept of the intervention nor the state of previous studies addressing related research questions. 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. The online version contains supplementary material available at 10. 1186/s12874-024-02393-1.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Pragmatic clinical trials ; Musculoskeletal manipulations ; Randomized controlled trials ; Manual therapy ; Generalizability ; PRECIS-2
Published in:	BMC Medical Research Methodology, Vol. 24 (november 2024) , ISSN 1471-2288

DOI: 10.1186/s12874-024-02393-1
PMID: 39528934

12 p, 1.7 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles