![]() ![]() Objective, validated risk stratification models such as those published by Caprini 13 and Davison 14 for venous thromboembolism, or standardized outcomes measures such as the Breast-Q 15 should have lower inter-rater variability and are more appropriate for use. This can inflate the observed variance seen with statistical analysis, making a statistically significant result less likely. Subjective measures, such as the Baker grade of capsular contracture, can have high inter-rater variability and the arbitrary cutoffs may make distinguishing between groups difficult 12. The definition of risk and outcome should be clearly defined prior to study implementation. Unknown confounders can only be controlled (case control design or randomization) or during data analysis Known confounders can be controlled with study design.Registries for similar unpublished or in-progress trials prior to Register trial with an accepted clinical trials registry.Consider cluster stratification to minimize variability in. ![]()
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