From: Diagnostic randomized controlled trials: the final frontier
Common threats to validity | Definition |
---|---|
Internal validity (bias) | Â |
Context bias | Experimental test more likely to be reported as abnormal in populations with high disease prevalence |
Clinical review bias | Experimental test or reference standard interpreted with knowledge of participant clinical characteristics |
Test review bias | Experimental test interpreted with knowledge of the reference standard test results |
Diagnostic review bias | Reference standard test interpreted with knowledge of the experimental test results |
External validity (generalizability) | |
Spectrum bias | Disease severity, participant demographics or participant co-morbidity influence experimental test accuracy |
Limited challenge bias | Potential study participants with confounders known to influence experimental test accuracy excluded from study |