Bias and applicability assessment

Assess verification and spectrum effects

Review selection, test interpretation, reference classification and participant timing together. An apparently precise estimate can remain biased or inapplicable to the intended setting. Record the version and scope of any appraisal tool used.

Flow diagram

Bias and applicability assessmentF1.S1Assess participant spectrumF1.S2Assess index-test biasF1.S3Assess reference and verificationbiasF1.S4Assess timing and participant flowF1.S5Plan sensitivity and applicabilityjudgmentsF1.N1Bias and applicability registerDomainConcernPlannedmitigationSensitivityEvidenceJudgmentF1.S0 Start flowBias and applicability assessmentF1.S999 End flowEnd flow

Steps

Assess participant spectrum

Compare selection with the intended clinical setting.

Assess index-test bias

Evaluate thresholds, blinding and interpretation.

Assess reference and verification bias

Examine partial or differential verification and imperfect standards.

Assess timing and participant flow

Consider exclusions, missing tests and intervening treatment.

Plan sensitivity and applicability judgments

Document evidence supporting conclusions and limits.

Bias and applicability assessment

End flow

Tables and supporting information

Bias and applicability register

Bias and applicability registerDomainConcernPlannedmitigationSensitivityEvidenceJudgment

Leave study-specific judgments blank.

Sources