Describing deprescribing trials better: an elaboration of the CONSORT statement

Jeanet W Blom; Christiane Muth; Paul Glasziou; James P McCormack; Rafael Perera; Rosalinde K E Poortvliet; Mattijs E Numans; Petra Thürmann; Ulrich Thiem; Sioe Lie Thio; Mieke Van Driel; Martin Beyer; Marjan Van den Akker; J Andre Knottnerus

doi:10.1016/j.jclinepi.2020.07.011

Describing deprescribing trials better: an elaboration of the CONSORT statement

J Clin Epidemiol. 2020 Nov:127:87-95. doi: 10.1016/j.jclinepi.2020.07.011. Epub 2020 Jul 22.

Authors

Affiliations

¹ Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.w.blom@lumc.nl.
² Institute of General Practice, Goethe University Frankfurt/Main, Frankfurt am Main, Germany.
³ Institute for Evidence-Based Healthcare, Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Australia.
⁴ Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.
⁵ Nuffield Department of Primary Care Health Sciences, Medical Statistics, University of Oxford, Oxford, UK.
⁶ Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.
⁷ Department of Clinical Pharmacology, University of Witten/Herdecke, Helios University Hospital Wuppertal, Witten, Germany.
⁸ Centre of Geriatrics and Gerontology, Albertinen-Haus, Hamburg, Germany; Geriatrics and Gerontology, University Medical Centre Eppendorf, Hamburg, Germany.
⁹ Faculty of Medicine, Primary Care Clinical Unit, The University of Queensland, Brisbane, Australia.
¹⁰ Institute of General Practice, Goethe University Frankfurt/Main, Frankfurt am Main, Germany; Department of General Practice, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
¹¹ Department of General Practice, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.

PMID: 32707072
DOI: 10.1016/j.jclinepi.2020.07.011

Abstract

Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elaborate and explain CONSORT items in this regard.

Study design and setting: As a first step in a multistage process and based on a systematic review of deprescribing trials, we elaborated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials.

Results: We identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants.

Conclusion: This article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices.

Keywords: CONSORT statement; Deprescribing; Primary care; Randomized controlled trial; Reporting guidelines; Study design.

Publication types

Systematic Review

MeSH terms

Checklist
Delphi Technique
Deprescriptions*
Drug-Related Side Effects and Adverse Reactions
Equivalence Trials as Topic
Guidelines as Topic*
Humans
Placebos / therapeutic use
Randomized Controlled Trials as Topic*
Research Design
Research Report / standards*

Substances

Placebos