Table 1.

STARD checklist for the reporting of studies of diagnostic accuracy (first official version, January 2003)

Section and Topic	Item #
TITLE/ASTRACT/KEWORDS	1	Is the article a study of diagnostic accuracy?
INTRODUCTION	2	State the research questions or aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups
METHODS
Participants	3	Describe the study population: the inclusion and exclusion criteria and the settings and locations where the data were collected
	4	Describe 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?
	5	Describe participant sampling: was this a consecutive series of participants defined by selection criteria in the previous 2 items? If not, specify how participants were further selected
	6	Describe data collection: was data collection planned before the index tests and reference standard were performed (prospective study) or after (retrospective study)?
Test Methods	7	Describe the reference standard and its rationale
	8	Describe 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
	9	Describe definition of and rationale for the units, cutoff points, or categories of the results of the index tests and the reference standard
	10	Describe the number, training, and expertise of the persons executing and reading the index tests and the reference standard
	11	Were 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 Methods	12	Describe methods for calculating or comparing measures of diagnostic accuracy and the statistical methods used to quantify uncertainty (eg 95% confidence intervals)
	13	Describe methods for calculating test reproducibility, if done
RESULTS
Participants	14	Report when study was done, including beginning and ending dates of recruitment
	15	Report clinical and demographic characteristics (e.g., age, sex, spectrum of presenting symptoms, comorbidity, current treatments, and recruitment center)
	16	Report 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 Results	17	Report time interval from index tests to reference standard, and any treatment administered between
	18	Report distribution of severity of disease (define criteria) in those with the target condition and other diagnoses in participants without the target condition
	19	Report 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
	20	Report any adverse events from performing the index test or the reference standard
Estimates	21	Report estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals)
	22	Report how indeterminate results, missing responses, and outliers of index tests were handled
	23	Report estimates of variability of diagnostic accuracy between readers, centers, or subgroups of participants, if done
	24	Report estimates of test reproducibility, if done
DISCUSSION	25	Discuss the clinical applicability of the study findings