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