Department of General Practice, University of Marburg, Karl-von-Frisch Str. 4, 35043, Marburg, Germany.
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg, Hamburg, Germany.
J Clin Epidemiol. 2021 Sep;137:23-30. doi: 10.1016/j.jclinepi.2021.03.017. Epub 2021 Mar 26.
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.
Multi-stage development process, including literature search and expert panels.
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.
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.
由于人们对多种药物治疗的担忧日益增加，因此迫切需要针对药物停药的临床建议。这需要在多个层面上进行研究。本文针对药物停药试验（DDT）的方法学问题进行了探讨。为此，我们提出了一种新的研究目标分类，并为评估药物停药的试验提供了相应的方法学建议。
多阶段开发过程，包括文献检索和专家小组。
只有在存在科学不确定性的情况下才需要进行临床试验。我们确定了与药物停药相关的三种不确定性情况，并从中推导出三种研究类型：1）药物有效性和/或安全性的不确定性；2）停止先前服用药物的程序的不确定性；3）用于停止一种或多种药物的复杂策略的有效性的不确定性。我们为每种研究类型制定了具体的方法学建议。
我们针对 DDT 提供了全面的研究目标、研究设计和方法学建议的定义。我们提出的分类法可以帮助研究人员阐明其研究目标和研究设计。针对特定类型的方法学建议应能提高未来药物停药试验的质量。
