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. 2019 Jul 25;14(7):e0219569. doi: 10.1371/journal.pone.0219569

Table 2. STARD 2015 checklist.

Study
Item Section STARD 2015 Checklist Criteria J. Death (1993) S.K. Inouye (1998) B.R. Nair (2007) C.J. Büla (2009) J.P. Tuijl (2012) C. Travers (2013)
1 Title or Abstract Identification as a study of diagnostic accuracy using at least one measure of accuracy (such as sensitivity, specificity, predictive values or AUC) 2 2 2 2 2 2
2 Abstract Structured summary of study design, methods, results and conclusions (for specific guidance, see STARD for Abstracts) -1 2 2 1 2 2
3 Introduction Scientific and clinical background, including the intended use and clinical role of the index test 2 2 2 2 2 2
4 Introduction Study objectives and hypotheses 2 2 2 2 2 2
5 Methods Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) 2 2 2 2 2 2
6 Methods Eligibility criteria 2 2 2 2 2 2
7 Methods On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry) 2 2 2 2 2 2
8 Methods Where and when potentially eligible participants were identified (setting, location and dates) 1 2 1 1 2 2
9 Methods Whether participants formed a consecutive, random or convenience series 2 2 0 2 2 2
10a Methods Index test, in sufficient detail to allow replication 2 2 2 2 2 2
10b Methods Reference standard, in sufficient detail to allow replication 2 2 2 2 2 2
11 Methods Rationale for choosing the reference standard (if alternatives exist) 2 1 2 1 2 2
12a Methods Definition of and rationale for test positivity cut-offs or result categories of the index test, distinguishing pre-specified from exploratory 2 2 2 2 2 2
12b Methods Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing pre-specified from exploratory 2 2 2 2 2 2
13a Methods Whether clinical information and reference standard results were available to the performers or readers of the index test 2 2 2 2 2 2
13b Methods Whether clinical information and index test results were available to the assessors of the reference standard 0 0 2 2 2 2
14 Methods Methods for estimating or comparing measures of diagnostic accuracy 2 2 2 2 2 2
15 Methods How indeterminate index test or reference standard results were handled 2 -1 -1 2 -1 2
16 Methods How missing data on the index test and reference standard were handled 0 2 -1 -1 -1 2
17 Methods Any analyses of variability in diagnostic accuracy, distinguishing prespecified from exploratory -1 2 -1 2 2 1
18 Methods Intended sample size and how it was determined -1 -1 -1 -1 -1 -1
19 Results Flow of participants, using a diagram -1 -1 -1 -1 -1 -1
20 Results Baseline demographic and clinical characteristics of participants 1 2 1 2 2 2
21a Results Distribution of severity of disease in those with the target condition 2 2 1 2 -1 2
21b Results Distribution of alternative diagnoses in those without the target condition -1 -1 -1 -1 -1 -1
22 Results Time interval and any clinical interventions between index test and reference standard 2 0 0 0 1 2
23 Results Cross tabulation of the index test results (or their distribution) by the results of the reference standard 2 2 2 -1 2 2
24 Results Estimates of diagnostic accuracy and their precision (such as 95% CIs) 1 2 2 2 2 2
25 Results Any adverse events from performing the index test or the reference standard -1 2 2 2 2 -1
26 Discussion Study limitations, including sources of potential bias, statistical uncertainty and generalizability 1 2 2 2 2 2
27 Discussion Implications for practice, including the intended use and clinical role of the index test 1 2 2 2 2 2
28 Other Information Registration number and name of registry -1 -1 -1 -1 -1 2
29 Other Information Where the full study protocol can be accessed 2 2 2 2 2 2
30 Other Information Sources of funding and other support; role of funders -1 2 -1 2 2 2
Sum of all reporting items 35 48 37 45 46 55

(A) Legend: 2 = fully reported, 1 = partially reported, 0 = unclear, -1 = not reported/missing