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Issues in the Interpretation and Design of Studies Investigating Drug‐Related Morbidity and Mortality
Author(s) -
EastonCarter Kylie L,
Chapman Colin B,
Brien Joanne E
Publication year - 2002
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr2002323235
Subject(s) - medicine , causality (physics) , interpretation (philosophy) , intensive care medicine , drug , drug reaction , pharmacology , physics , quantum mechanics , computer science , programming language
While drug‐related morbidity and mortality are currently of significant concern, considerable controversy exists regarding the frequency of these adverse events. Much of this controversy can be explained by differences in methods used to investigate drug‐related morbidity and mortality. The definitions used, patient populations studied, monitoring methods employed, and the use of causality and clinical significance classifications are the primary factors contributing to the differences encountered. This paper aims to provide an appreciation of the impact of these factors on the interpretation and design of studies investigating drug‐related morbidity and mortality.