SIGN
Methodology Checklist 5: Studies of Diagnostic Accuracy
This checklist is based on the work of the QUADAS2 team at
Bristol Univeristy (http://www.bris.ac.uk/quadas/).
Study identification (Include author, title, reference, year of publication)
Guideline topic:
Key Question No:
Before completing this checklist, consider:
1.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.
2.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:
All the questions in the following sections have associated footnotes providing short
explanations behind each of the questions. Users who want more detailed
explanations should consult the QUADAS-2: Background Document.
DOMAIN 1 PATIENT SELECTION
Risk of bias
In a well conducted diagnostic study
Is that true in this study?
1.1
A consecutive sequence or random
selection of patients is enrolled.
Yes
Case control methods are not used.
Yes
1.2
Cant say
No
Cant say
No
1.3
Inappropriate exclusions are avoided.
Yes
Cant say
No
Applicability
1.4
The included patients and settings match
the key question.
Yes
No
Cant say
DOMAIN 2 INDEX TEST
Risk of bias
In a well conducted diagnostic Is that true in this study?
study
2.1 The index test results interpreted Yes
Cant say
without knowledge of the results of
No
the reference standard.
2.2 If a threshold is used, it is prespecified.
Yes
Cant say
No
Applicability
2.3 The index test, its conduct, and its Yes
interpretation is similar to that
No
used in practice with the target
population of the guideline.
Cant say
DOMAIN
3
STANDARD
REFERENCE
Risk of bias
In a well conducted diagnostic Is that true in this study?
study
3.1 The reference standard is likely Yes
Cant say
to correctly identify the target
No
condition.
3.2 Reference standard results are Yes
interpreted without knowledge of
No
the results of the index test.
Applicability
3.3 The target condition as defined Yes
by the reference standard
No
matches that found in the target
population of the guideline.
Cant say
Cant say
DOMAIN 4 FLOW AND TIMING
Risk of bias
In a well conducted diagnostic Is that true in this study?
study
4.1 There is an appropriate interval Yes
Cant say
between the index test and
No
reference standard.
4.2 All patients receive the same
reference standard.
Yes
4.3 All patients recruited into the
study are included in the
analysis.
Yes
Cant say
No
No
Cant say
SECTION 5: OVERALL ASSESSMENT OF THE STUDY
5.1
How well was the study done to High quality (++)
minimise bias?
Acceptable (+)
Code as follows:
Unacceptable reject 0
5.2
What is your assessment of the Directly applicable
applicability of this study to our
Some indirectness
(Please
target population?
explain in the following section for
Notes)
5.2
Notes. Summarise the authors conclusions. Add any comments on your
own assessment of the study, and the extent to which it answers your
question.
