Typology of drug discontinuation trials - Methodological recommendations.
J Clin Epidemiol
; 137: 23-30, 2021 09.
Article
em En
| MEDLINE
| ID: mdl-33775810
ABSTRACT
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 ANDSETTING:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tratamento Farmacológico
/
Término Precoce de Ensaios Clínicos
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
J Clin Epidemiol
Ano de publicação:
2021
Tipo de documento:
Article