Typology of drug discontinuation trials - Methodological recommendations

TY - JOUR

T1 - Typology of drug discontinuation trials - Methodological recommendations

AU - Viniol, Annika

AU - Haasenritter, Jörg

AU - Grede, Nina

AU - Wegscheider, Karl

AU - Becker, Annette

AU - Sitter, Helmut

AU - Gágyor, Ildikó

AU - Sönnichsen, Andreas

AU - Mortsiefer, Achim

AU - Junius-Walker, Ulrike

AU - Donner-Banzhoff, Norbert

N1 - Copyright © 2021. Published by Elsevier Inc.

PY - 2021/9

Y1 - 2021/9

N2 - OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation.STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels.RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type.CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

AB - OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation.STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels.RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type.CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

U2 - 10.1016/j.jclinepi.2021.03.017

DO - 10.1016/j.jclinepi.2021.03.017

M3 - SCORING: Journal article

C2 - 33775810

VL - 137

SP - 23

EP - 30

JO - J CLIN EPIDEMIOL

JF - J CLIN EPIDEMIOL

SN - 0895-4356

ER -