28. STARD⇒QUADASの対応
Section and Topic Item On page #
#
TITLE/ABSTRACT/ 1 Identify the article as a study of diagnostic accuracy (recommend MeSH
KEYWORDS heading '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
Participants 3 The study population: The inclusion and exclusion criteria, setting and Q1, Q2
locations where 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 Q1
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 Q2
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. Q3
8 Technical specifications of material and methods involved including how and
when measurements were taken, and/or cite references for index tests and Q8, 9
reference standard.
9 Definition of and rationale for the units, cut-offs and/or categories of the results
of the index tests and the reference standard. Q7
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
Q10, 11,
information available to the readers. 12
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.
29. STARD⇒QUADASの対応
RESULTS
Participants 14 When study was performed, including beginning and end dates of recruitment.
15 Clinical and demographic characteristics of the study population (at least
information on age, gender, spectrum of presenting symptoms). Q1
16 The number of participants satisfying the criteria for inclusion who did or did not
undergo the index tests and/or the reference standard; describe why participants
Q13,14
failed to undergo either test (a flow diagram is strongly recommended).
Q5, Q6
Test results 17 Time-interval between the index tests and the reference standard, and any treatment
administered in between. Q4
18 Distribution of severity of disease (define criteria) in those with the target condition;
other diagnoses in participants without the target condition. Q1
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. Q13
Estimates 21 Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95%
confidence intervals).
22 How indeterminate results, missing data and outliers of the index tests were handled.
Q13
23 Estimates of variability of diagnostic accuracy between subgroups of participants,
readers or centers, if done.
24 Estimates of test reproducibility, if done.
DISCUSSION 25 Discuss the clinical applicability of the study findings.
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