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Framework for assessing the internal validity of studies of prognosisa
Study Feature Qualities Sought Patients Recruited at a common point (usually early) in the course of the disease Ideally complete (all eligible patients included) Source and selection of patients is explained Diagnostic and inclusion criteria well-described and defined Clinical and demographic characteristics fully described Follow-up Sufficiently long to be meaningful Outcome Appropriate Unbiased Assessed blinded to prognostic information Fully defined and known for all patients Candidate prognostic variables Fully defined, including method of measurement Available for all patients Analysis Continuous predictors analyzed appropriately Statistical adjustment for all important factors Treatments Randomized or at least standardized Fully described and explained a Modified from Altman.10
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