STARD checklist for the reporting of studies of diagnostic accuracy
Manuscript number and/or corresponding author name:
Section and Topic Item # On page #
TITLE/ABSTRACT/ 1 Identify the article as a study of diagnostic accuracy (recommend MeSH heading
KEYWORDS 'sensitivity and specificity').
INTRODUCTION 2 State the research questions or study aims, such as estimating diagnostic accuracy or
comparing accuracy between tests or across participant groups.
METHODS Describe
Participants 3 The study population: The inclusion and exclusion criteria, setting and locations where
the data were collected.
4 Participant recruitment: Was recruitment based on presenting symptoms, results from
previous tests, or the fact that the participants had received the index tests or the
reference standard?
5 Participant sampling: Was the study population a consecutive series of participants
defined by the selection criteria in item 3 and 4? If not, specify how participants were
further selected.
6 Data collection: Was data collection planned before the index test and reference
standard were performed (prospective study) or after (retrospective study)?
Test methods 7 The reference standard and its rationale.
8 Technical specifications of material and methods involved including how and when
measurements were taken, and/or cite references for index tests and reference standard.
9 Definition of and rationale for the units, cutoffs and/or categories of the results of the
index tests and the reference standard.
10 The number, training and expertise of the persons executing and reading the index tests
and the reference standard.
11 Whether or not the readers of the index tests and reference standard were blind
(masked) to the results of the other test and describe any other clinical information
available to the readers.
Statistical methods 12 Methods for calculating or comparing measures of diagnostic accuracy, and the statistical
methods used to quantify uncertainty (e.g. 95% confidence intervals).
13 Methods for calculating test reproducibility, if done.
RESULTS Report
Participants 14 When study was done, including beginning and ending dates of recruitment.
15 Clinical and demographic characteristics of the study population (e.g. age, sex, spectrum
of presenting symptoms, comorbidity, current treatments, recruitment centers).
16 The number of participants satisfying the criteria for inclusion that did or did not undergo
the index tests and/or the reference standard; describe why participants failed to receive
either test (a flow diagram is strongly recommended).
Test results 17 Time interval from the index tests to the reference standard, and any treatment
administered between.
18 Distribution of severity of disease (define criteria) in those with the target condition; other
diagnoses in participants without the target condition.
19 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, the distribution of
the test results by the results of the reference standard.
20 Any adverse events from performing the index tests or the reference standard.
Estimates 21 Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95%
confidence intervals).
22 How indeterminate results, missing responses and outliers of the index tests were
handled.
23 Estimates of variability of diagnostic accuracy between subgroups of participants,
readers or centers, if done.
24 Estimates of test reproducibility, typically imprecision (as CV) at 2 or 3 concentrations.
DISCUSSION 25 Discuss the clinical applicability of the study findings.