Study identification  (Include author, title, reference, year of publication)

Guideline topic:

Key Question No:

Before completing this checklist, consider:

• Is the paper really a study of diagnostic accuracy? It should be comparing a specific diagnostic test against another, and not a general paper or comment on diagnosis.
• Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist..

Reason for rejection: Reason for rejection: 1. Paper not relevant to key question □   2. Other reason □  (please specify):

Checklist completed by:

SECTION 1:  INTERNAL VALIDITY

1.1

The spectrum of patients is representative of the patients who will receive the test in practice.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.2

Selection criteria are clearly described.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.3

The reference standard is likely to classify the condition correctly.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.4

The period between reference standard and index test is short enough to be reasonably sure that the target condition did not change between the two tests.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.5

The whole sample, or a random selection of the sample, received verification using a reference standard of diagnosis.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.6

Patients received the same reference standard regardless of the index test result.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.7

The reference standard was independent of the index test (i.e. the index test did not form part of the reference standard).

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.8

The execution of the index test was described in sufficient detail to permit replication of the test.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.9

The execution of the reference standard was described in sufficient detail to permit replication of the test.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.10

Index test results were interpreted without knowledge of the results of the reference standard.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.11

Reference standard results were interpreted without knowledge of the results of the index test.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.12

Uninterpretable or intermediate test results are reported.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

1.13

An explanation is provided for withdrawals from the study.

Well covered
Adequately addressed
Poorly addressed

Not addressed
Not reported
Not applicable

Section 2:   OVERALL ASSESSMENT OF THE STUDY

2.1

How reliable are the conclusions of this study?
Code ++, +, or -

2.2

Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?

2.3

Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.

The following section is provided for non-SIGN users of this checklist and is being developed to conform to the standards set by the Guidelines International Network Evidence Tables Working Group.
Members of SIGN guideline groups do not need to complete this section.

Section 3:   description OF THE STUDY
PLEASE PRINT CLEARLY

3.1

How many patients are included in this study?
Please indicate number of patients included, with inclusion/exclusion criteria used to select them.

3.2

What is the prevalence (proportion of people with the disease being tested for) in the population from which patients were selected?

3.3

What are the main characteristics of the patient population?
Include all relevant characteristics – e.g. age, sex, ethnic origin, comorbidity, disease status, community/hospital based

3.4

What test is being evaluated in this study?
Consider whether the technology being described is comparable / relevant to the test being considered in the guideline. i.e. make sure the test has not been superceded by later developments.

3.5

What is the reference standard with which the test being evaluated is compared?
Indicate whether a gold standard, or if not how this standard was validated.

3.7

What is the estimated sensitivity of the test being evaluated? (state 95% CI)

3.8

What is the estimated specificity of the test being evaluated? (state 95% CI)

3.9

What is the positive predictive value of the test being evaluated?
Positive predictive value = proportion of patients with a positive test result that actually had the disease.

3.10

What is the negative predictive value of the test being evaluated?
Negative predictive value = proportion of patients with a negative test result that actually did not have the disease.

3.11

What are the likelihood ratios for the test being evaluated?
If not quoted in the study, a number of tools are available that simplify calculation of LRs. Please indicate where results are calculated rather than taken from the study.

3.12

How was this study funded?
List all sources of funding quoted in the article, whether Government, voluntary sector, or industry.

3.13

Are there any specific issues raised by this study?