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 Thuermann; 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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate 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 elab-orated 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. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Original language	English
Pages (from-to)	87-95
Number of pages	9
Journal	Journal of Clinical Epidemiology
Volume	127
DOIs	https://doi.org/10.1016/j.jclinepi.2020.07.011
Publication status	Published - Nov 2020

Keywords

Deprescribing
Reporting guidelines
CONSORT statement
Study design
Primary care
Randomized controlled trial
ADVERSE DRUG-REACTIONS
OLDER-ADULTS
MEDICATION-USE
WITHDRAWAL
HEALTH
CRITERIA

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Cite this

Blom, J. W., Muth, C., Glasziou, P., McCormack, J. P., Perera, R., Poortvliet, R. K. E., Numans, M. E., Thuermann, P., Thiem, U., Thio, S. L., Van Driel, M., Beyer, M., Van den Akker, M., & Knottnerus, J. A. (2020). Describing deprescribing trials better: an elaboration of the CONSORT statement. Journal of Clinical Epidemiology, 127, 87-95. https://doi.org/10.1016/j.jclinepi.2020.07.011

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title = "Describing deprescribing trials better: an elaboration of the CONSORT statement",

abstract = "Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate 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 elab-orated 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. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).",

keywords = "Deprescribing, Reporting guidelines, CONSORT statement, Study design, Primary care, Randomized controlled trial, ADVERSE DRUG-REACTIONS, OLDER-ADULTS, MEDICATION-USE, WITHDRAWAL, HEALTH, CRITERIA",

author = "Blom, {Jeanet W.} and Christiane Muth and Paul Glasziou and McCormack, {James P.} and Rafael Perera and Poortvliet, {Rosalinde. K. E.} and Numans, {Mattijs E.} and Petra Thuermann and Ulrich Thiem and Thio, {Sioe Lie} and {Van Driel}, Mieke and Martin Beyer and {Van den Akker}, Marjan and Knottnerus, {J. Andre}",

note = "Publisher Copyright: {\textcopyright} 2020 The Authors",

year = "2020",

month = nov,

doi = "10.1016/j.jclinepi.2020.07.011",

language = "English",

volume = "127",

pages = "87--95",

journal = "Journal of Clinical Epidemiology",

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T1 - Describing deprescribing trials better

T2 - an elaboration of the CONSORT statement

AU - Blom, Jeanet W.

AU - Muth, Christiane

AU - Glasziou, Paul

AU - McCormack, James P.

AU - Perera, Rafael

AU - Poortvliet, Rosalinde. K. E.

AU - Numans, Mattijs E.

AU - Thuermann, Petra

AU - Thiem, Ulrich

AU - Thio, Sioe Lie

AU - Van Driel, Mieke

AU - Beyer, Martin

AU - Van den Akker, Marjan

AU - Knottnerus, J. Andre

PY - 2020/11

Y1 - 2020/11

N2 - Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate 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 elab-orated 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. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

AB - Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate 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 elab-orated 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. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

KW - Deprescribing

KW - Reporting guidelines

KW - CONSORT statement

KW - Study design

KW - Primary care

KW - Randomized controlled trial

KW - ADVERSE DRUG-REACTIONS

KW - OLDER-ADULTS

KW - MEDICATION-USE

KW - WITHDRAWAL

KW - HEALTH

KW - CRITERIA

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DO - 10.1016/j.jclinepi.2020.07.011

M3 - Article

C2 - 32707072

SN - 0895-4356

VL - 127

SP - 87

EP - 95

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -