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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