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- W2024249097 abstract "In her letter, Adamiak [ [1] Adamiak Multilevel endpoints and the problem of theoretical aggregation and overlapping. J Clin Epidemiol. 2008; 61: 198-199 Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar ] references the examples presented by Borm et al. [ [2] Borm G.F. van der Wilt G.J. Kremer J.A. Zielhuis G.A. A generalized concept of power helped to choose optimal endpoints in clinical trials. J Clin Epidemiol. 2007; 60: 375-381 Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar ] and the review of our group [ [3] Ferreira-Gonzalez I. Permanyer-Miralda G. Busse J.W. Bryant D.M. Montori V.M. Alonso-Coello P. et al. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol. 2007; 60: 651-657 Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar ], claiming that they do not provide any guidance to the problem with aggregation, unit of analysis, or the theoretical foundation of composite measures. The premise of the author is that composite or multiple outcomes in clinical trials may usually involve various levels of reality (i.e., the clinical one, focused on disease process and the social one, focused on organizational context). For instance, a common composite endpoint used in cardiovascular trials is “death or nonfatal myocardial infarction or hospitalization” during follow-up. Here, the component “hospitalization” depends not only on the patient's health status but also on clinical decisions not necessarily linked to the biological process. For this reason, the author states that these composite endpoints are actually “multilevel endpoints” and, in this instance, multilevel analysis should be considered to improve the internal and external validity of the clinical trial. Furthermore, since it is plausible that patients will be affected by ecological environments, multilevel analysis could be an appropriate methodology for these “multilevel endpoints” used in pharmacological trials." @default.
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- W2024249097 title "Are composite endpoints multilevel endpoints?" @default.
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