Appendix F: Methodology checklist: the QUADAS-2 tool for studies of diagnostic test accuracy

The following checklists are taken directly from the 'QUADAS-2' publication (Whiting PF Rutjes AWS, Westwood ME et al. and the QUADAS-2 group [2011] QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine 155: 529–36) and from the QUADAS website.

Phase 1: State the review question

Patients (setting, intended use of index test, presentation, prior testing):

.

Index test(s):

.

Reference standard and target condition:

.

Phase 2: Draw a flow diagram for the primary study

Phase 3: Risk of bias and applicability judgements

QUADAS-2 is structured so that four key domains are each rated in terms of the risk of bias and the concern regarding applicability to the review question (as stated in Phase 1). Each key domain has a set of signalling questions to help reach the judgements regarding bias and applicability.

Domain 1: Patient selection

A. Risk of bias

Describe methods of patient selection:

.

.

.

.

Was a consecutive or random sample of patients enrolled?

Yes / No / Unclear

Was a case-control design avoided?

Yes / No / Unclear

Did the study avoid inappropriate exclusions?

Yes / No / Unclear

Could the selection of patients have introduced bias?

Risk: Low / High / Unclear

B. Concerns regarding applicability

Describe included patients (prior testing, presentation, intended use of index test and setting):

.

.

.

Is there concern that the included patients do not match the review question?

Concern: Low / High / Unclear

Domain 2: Index test(s)

A. Risk of bias

Describe the index test and how it was conducted and interpreted:

.

.

.

.

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes / No / Unclear

If a threshold was used, was it pre-specified?

Yes / No / Unclear

Could the conduct or interpretation of the index test have introduced bias?

Risk: Low / High / Unclear

B. Concerns regarding applicability

Is there concern that the index test, its conduct, or interpretation differ from the review question?

Concern: Low / High / Unclear

Domain 3: Reference standard

A. Risk of bias

Describe the reference standard and how it was conducted and interpreted:

.

.

.

.

Is the reference standard likely to correctly classify the target condition?

Yes / No / Unclear

Were the reference standard results interpreted without knowledge of the results of the index test?

Yes / No / Unclear

Could the reference standard, its conduct, or its interpretation have introduced bias?

Risk: Low / High / Unclear

B. Concerns regarding applicability

Is there concern that the target condition as defined by the reference standard does not match the review question?

Concern: Low / High / Unclear

Domain 4: Flow and timing

A. Risk of bias

Describe any patients who did not receive the index test(s) and/or reference standard or who were excluded from the 2x2 table (refer to flow diagram):

.

.

.

Describe the time interval and any interventions between index test(s) and reference standard:

.

.

.

.

Was there an appropriate interval between index test(s) and reference standard?

Yes / No / Unclear

Did all patients receive a reference standard?

Yes / No / Unclear

Did patients receive the same reference standard?

Yes / No / Unclear

Were all patients included in the analysis?

Yes / No / Unclear

Could the patient flow have introduced bias?

Risk: Low / High / Unclear

Notes on use of Methodology checklist: the QUADAS-2 tool for studies of diagnostic test accuracy

For the accompanying notes on how to use the QUADAS-2 tool, please see:

  • Whiting PF, Rutjes AWS, Westwood ME et al. and the QUADAS-2 group (2011) QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine 155: 529–36

  • The QUADAS website


This page was last updated: 30 November 2012