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