Table 1

 STARD checklist4,5

Section and topicItemDescription
Title, abstract, and keywords1Identify the article as a study of diagnostic accuracy (recommend MeSH heading “sensitivity and specificity”)
Introduction2State the research questions or aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups
Methods
Participants3Describe the study population: the inclusion and exclusion criteria and the settings and locations where the data were collected
4Describe participant recruitment: was this based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard?
5Describe participant sampling: was this a consecutive series of participants defined by selection criteria in items 3 and 4? If not, specify how participants were further selected
6Describe data collection: was data collection planned before the index tests and reference standard were performed (prospective study) or after (retrospective study)?
Test methods7Describe the reference standard and its rationale
8Describe technical specifications of material and methods involved, including how and when measurements were taken, or cite references for index tests or reference standard, or both
9Describe definition of and rationale for the units, cut-off points, or categories of the results of the index tests and the reference standard
10Describe the number, training, and expertise of the persons executing and reading the index tests and the reference standard
11Were the readers of the index tests and the reference standard blind (masked) to the results of the other test? Describe any other clinical information available to the readers.
Statistical methods12Describe methods for calculating or comparing measures of diagnostic accuracy and the statistical methods used to quantify uncertainty (eg, 95% confidence intervals)
13Describe methods for calculating test reproducibility, if done
Results
Participants14Report when study was done, including beginning and ending dates of recruitment
15Report clinical and demographic characteristics (eg, age, sex, spectrum of presenting symptoms, co-morbidity, current treatments, and recruitment centre)
16Report how many participants satisfying the criteria for inclusion did or did not undergo the index tests or the reference standard, or both; describe why participants failed to receive either test (a flow diagram is strongly recommended)
Test results17Report time interval from index tests to reference standard, and any treatment administered between
18Report distribution of severity of disease (define criteria) in those with the target condition and other diagnoses in participants without the target condition
19Report a cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, report the distribution of the test results by the results of the reference standard
20Report any adverse events from performing the index test or the reference standard
Estimates21Report estimates of diagnostic accuracy and measures of statistical uncertainty (eg, 95% confidence intervals)
22Report how indeterminate results, missing responses, and outliers of index tests were handled
23Report estimates of variability of diagnostic accuracy between readers, centres, or subgroups of participants, if done
24Report estimates of test reproducibility, if done
Discussion25Discuss the clinical applicability of the study findings