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.

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