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Cited by 2Health Policy Implementation ScienceMeta-analysis and systematic reviewsStatistical Methods in Clinical Trials

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

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Roura, S., Alvarez, G., Hohenschurz-Schmidt, D., Solà, I., Núñez-Cortés, R., Bracchiglione, J., C. Fernández-Jané, Phalip, J., Gich, I., Sitjà-Rabert, M., Urrútia, G.·2024·BMC Medical Research Methodology
DOI 10.1186/s12874-024-02393-1PMC PMC11552307

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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 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. RESULTS: 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. 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.

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Metadata

Authors
Roura, S., Alvarez, G., Hohenschurz-Schmidt, D., Solà, I., Núñez-Cortés, R., Bracchiglione, J., Fernández-Jané, C., Phalip, J., Gich, I., Sitjà-Rabert, M., & Urrútia, G.
Affiliations
  • Universitat Autònoma de Barcelona (ES)
  • Iberoamerican Cochrane Centre (ES)
  • Universitat Pompeu Fabra (ES)
  • Inserm (FR)
  • Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (ES)
ORCID
Venue
BMC Medical Research Methodology
Publisher
Springer Science and Business Media LLC
Published
2024-11-11
Volume
24
Issue
1
Pages
273-273
ISSN
1471-2288 (ISSN-L)
DOI
10.1186/s12874-024-02393-1
PMC
PMC11552307
OpenAlex
W4404224032
Cited by
2
References
97
Citations by year
2025: 2
FWCI
1.17
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by-nc-nd)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by-nc-nd)
  • HAL (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • Universidad de Chile (submittedVersion, cc-by-nc-nd)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
pragmatic randomized controlled trial, manual therapy, PRECIS-2, trial design, generalizability, outcome measures
MeSH terms
Humans, Research Design, Randomized Controlled Trials as Topic, Musculoskeletal Manipulations, Pragmatic Clinical Trials as Topic

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