An analysis of published trials found that current use of pragmatic trial labels is uninformative.

Autor: Taljaard M; Ottawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mtaljaard@ohri.ca., Nicholls SG; Ottawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada., Howie AH; Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada., Nix HP; Schulich School of Medicine & Dentistry, Western University, London, Ontario N6G 2M1, Canada., Carroll K; Ottawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada., Moon PM; Department of Family Medicine, Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada., Nightingale NM; Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada., Giraudeau B; Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France; INSERM CIC1415, CHRU de Tours, Tours, France., Hey SP; Center for Bioethics, Harvard Medical School, Boston, MA, USA., Eldridge SM; Wolfson Institute of Population Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK., Weijer C; Departments of Medicine, Epidemiology & Biostatistics, and Philosophy, Western University, London, Ontario N6A 5W9, Canada., Zwarenstein M; Department of Family Medicine, Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada.
Jazyk: angličtina
Zdroj: Journal of clinical epidemiology [J Clin Epidemiol] 2022 Nov; Vol. 151, pp. 113-121. Date of Electronic Publication: 2022 Aug 18.
DOI: 10.1016/j.jclinepi.2022.08.007
Abstrakt: Objectives: Randomized trials labelled as "pragmatic" are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains).
Study Design and Setting: We reviewed primary trial reports published 2014-2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Results: Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Conclusion: Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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