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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


6.3. Decision criteria

If decisions are to be made based on the results of the study, a section of the statistical analysis plan should explain the different outcomes that might be selected for each decision, which statistics influence the decision making process and which values of the statistics will be considered to support each outcome. Often the statistical analysis will employ standard routines incorporated in statistical packages that have outputs seen as implicit decision criteria – for instance p values or confidence intervals. However, different applications of the study may require lower or higher strength of evidence – for instance policy recommendations regarding drug licensing may require a lower chance of false positive decisions than the classical one when deciding whether further investigation is needed for a product safety issue. Hence consideration of decision-making criteria with explicit reference to the type of decision to be made is beneficial.



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