Describing deprescribing trials better: an elaboration of the CONSORT statement

被引:13
作者
Blom, Jeanet W. [1 ]
Muth, Christiane [2 ]
Glasziou, Paul [3 ]
McCormack, James P. [4 ]
Perera, Rafael [5 ]
Poortvliet, Rosalinde. K. E. [1 ]
Numans, Mattijs E. [1 ]
Thuermann, Petra [6 ]
Thiem, Ulrich [7 ,8 ]
Thio, Sioe Lie [1 ]
Van Driel, Mieke [9 ]
Beyer, Martin [2 ]
Van den Akker, Marjan [2 ,10 ]
Knottnerus, J. Andre [10 ]
机构
[1] Leiden Univ Med Ctr, Publ Hlth & Primary Care, POB 9600, NL-2300 RC Leiden, Netherlands
[2] Goethe Univ Frankfurt Main, Inst Gen Practice, Frankfurt, Germany
[3] Bond Univ, Inst Evidence Based Healthcare, Fac Hlth Sci & Med, Gold Coast, Australia
[4] Univ British Columbia, Fac Pharmaceut Sci, Vancouver, BC, Canada
[5] Univ Oxford, Nuffield Dept Primary Care Hlth Sci, Med Stat, Oxford, England
[6] Univ Witten Herdecke, Helios Univ Hosp Wuppertal, Dept Clin Pharmacol, Witten, Germany
[7] Ctr Geriatr & Gerontol, Albertinen Haus, Hamburg, Germany
[8] Univ Med Ctr Eppendorf, Geriatr & Gerontol, Hamburg, Germany
[9] Univ Queensland, Primary Care Clin Unit, Fac Med, Brisbane, Qld, Australia
[10] Maastricht Univ, Care & Publ Hlth Res Inst, Dept Gen Practice, Maastricht, Netherlands
关键词
Deprescribing; Reporting guidelines; CONSORT statement; Study design; Primary care; Randomized controlled trial; ADVERSE DRUG-REACTIONS; OLDER-ADULTS; MEDICATION-USE; WITHDRAWAL; HEALTH; CRITERIA;
D O I
10.1016/j.jclinepi.2020.07.011
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
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/).
引用
收藏
页码:87 / 95
页数:9
相关论文
共 44 条
  • [1] Prescriber barriers and enablers to minimising potentially inappropriate medications in adults: a systematic review and thematic synthesis
    Anderson, Kristen
    Stowasser, Danielle
    Freeman, Christopher
    Scott, Ian
    [J]. BMJ OPEN, 2014, 4 (12):
  • [2] Preventability of Drug-Related Harms - Part II Proposed Criteria, Based on Frameworks that Classify Adverse Drug Reactions
    Aronson, Jeffrey K.
    Ferner, Robin E.
    [J]. DRUG SAFETY, 2010, 33 (11) : 995 - 1002
  • [3] Discontinuing medications: A novel approach for revising the prescribing stage of the medication-use process
    Bain, Kevin T.
    Holmes, Holly M.
    Beers, Mark H.
    Maio, Vittorio
    Handler, Steven M.
    Pauker, Stephen G.
    [J]. JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 2008, 56 (10) : 1946 - 1952
  • [4] The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial
    Ballard, Clive
    Hanney, Maria Luisa
    Theodoulou, Megan
    Douglas, Simon
    McShane, Rupert
    Kossakowski, Katja
    Gill, Randeep
    Juszczak, Edmund
    Yu, Ly-Mee
    Jacoby, Robin
    [J]. LANCET NEUROLOGY, 2009, 8 (02) : 151 - 157
  • [5] BEERS MH, 1991, ARCH INTERN MED, V151, P1825
  • [6] Avoiding Nocebo Effects to Optimize Treatment Outcome
    Bingel, Ulrike
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2014, 312 (07): : 693 - 694
  • [8] Potentially inappropriate prescribing and adverse health outcomes in community dwelling older patients
    Cahir, Caitriona
    Bennett, Kathleen
    Teljeur, Conor
    Fahey, Tom
    [J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2014, 77 (01) : 201 - 210
  • [9] America's Opioid Epidemic: Supply and Demand Considerations
    Clark, David J.
    Schumacher, Mark A.
    [J]. ANESTHESIA AND ANALGESIA, 2017, 125 (05) : 1667 - 1674
  • [10] THE ROLE OF MEDICATION NONCOMPLIANCE AND ADVERSE DRUG-REACTIONS IN HOSPITALIZATIONS OF THE ELDERLY
    COL, N
    FANALE, JE
    KRONHOLM, P
    [J]. ARCHIVES OF INTERNAL MEDICINE, 1990, 150 (04) : 841 - 845