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Table 1 Threats to validity of diagnostic accuracy studies

From: Diagnostic randomized controlled trials: the final frontier

Common threats to validity Definition
Internal validity (bias)  
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