|
KMID : 1011320080010010035
|
|
Journal of Pharmacoepidemiology and Risk Management
2008 Volume.1 No. 1 p.35 ~ p.43
|
|
|
Causality Assessment
|
|
Lee Moo-Song
|
|
|
Abstract
|
|
|
|
Applications of a structured causality method can standardize and help to reduce biases in assessing the possible cause-effect relationship of an event to a particular drug exposure. The use of a clinical non-structured approach (global introspection) to assist adverse events believed to be associated with a drug has been shown to yield inconsistent results between raters, and its lack of structure does not further the development of the hypothesis raised in the report of the event. The choice of a method is based upon the use of the judgment; if pivotal to continued development of a drug, the most rigorous methods such as the Bayesian approach may help; if used to sort out well-documented cases that may probably be associated with a drug, then simple algorithms or scoring algorithms will usually suffice. The components of causality assessment method can help to structure data collection on individual and groups of cases; ultimately, these aggregate data can improve the description of the event of interest, and possibly its relationship to a drug, or the disease of indication. The detailed probabilistic and explicit approach in the Bayesian method can, if data are available, provide a basis for development more precise statements of the hypothesis that is posed in a spontaneous report of a suspected adverse drug reaction.
|
|
|
KEYWORD
|
|
|
Causality assessment, Adverse drug reaction, Bayesian statistics, Bias
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|