Mapping the methodological diversity of published drug discontinuation studies—a scoping review of study topics, objectives, and designs

Autor: Nina Grede, Katrin Kuss, Ina Staudt, Norbert Donner-Banzhoff, Annika Viniol
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Trials, Vol 24, Iss 1, Pp 1-9 (2023)
Druh dokumentu: article
ISSN: 1745-6215
02362708
DOI: 10.1186/s13063-023-07105-6
Popis: Abstract Background Trials evaluating drug discontinuation (drug discontinuation trials, DDTs) show a broad methodological spectrum. There are several specific methodological aspects in drug discontinuation trials (e.g., determination of research question; configuration of intervention; definition of outcomes). To verify this specifies, we did a scoping review about the study designs of drug discontinuation trials. Methods A systematic literature search in Medline (PubMed), The Cochrane Library, EMBASE, CINAHL, Web of Science, and PsycINFO was performed. In a two-step selection process, we identified DDTs, which evaluate the discontinuation of one or more long-term medication as the investigated intervention, by two independent reviewers. Besides bibliographic data, we extracted several parameters to describe the used study design of the included DDTs: motivation for DDT, initially treatment aim of the discontinued medication, study design, methods of discontinuation, follow-up times, number of study participants, and outcome parameter. Results Out of 12,132 records, we included 581 DDTs. The most common motivation for doing a DDT were expected side effects (48.8%), the motivation of proving the efficacy of medication (21.6%), or doubts on the expected benefit of the used medication (13.8%). The majority of the discontinued medication was initially prescribed to improve the prognosis of a chronic disease (60.4%) or to relieve symptoms (31%). The study designs of the trials showed a broad methodological spectrum. The minority of the drug discontinuation trials were randomized controlled trials (34%). Conclusion The results of this scoping review illustrates the need for an evidence-based methodological standard for planning and conducting drug discontinuation trials.
Databáze: Directory of Open Access Journals
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