STARD item No. | Item description | All Articles (n = 66), % | Articles published in 2015 (n = 39), % | Articles published in 2019 (n = 27), % |
---|---|---|---|---|
Title or abstract | ||||
1 | Identification as a study of diagnostic accuracy using at least one measure of accuracy (such as sensitivity, specificity, predictive values or AUC) | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |
2* | Structured summary of study design, methods, results and conclusions (for specific guidance, see STARD for Abstracts) | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |
Introduction | ||||
3* | Scientific and clinical background, including the intended use and clinical role of the index test | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |
4* | Study objectives and hypotheses | 42 (n = 28) | 31 (n = 12) | 59 (n = 16) |
Methods | ||||
5 | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) | 92 (n = 61) | 87 (n = 34) | 100 (n = 27) |
6 | Eligibility criteria | 83 (n = 55) | 82 (n = 32) | 85 (n = 23) |
7 | On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, and inclusion in registry) | 97 (n = 64) | 97 (n = 38) | 96 (n = 26) |
8 | Where and when potentially eligible participants were identified (setting, location and dates) | 59 (n = 39) | 56 (n = 22) | 63 (n = 17) |
9 | Whether participants formed a consecutive, random or convenience series | 71 (n = 47) | 56 (n = 22) | 93 (n = 25) |
10a | Index test, in sufficient detail to allow replication | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |
10b | Reference standard, in sufficient detail to allow replication | 62 (n = 41) | 62 (n = 24) | 63 (n = 17) |
12a | Definition of and rationale for test positivity cutoffs or result categories of the index test, distinguishing prespecified from exploratory | 64 (n = 42) | 59 (n = 23) | 70 (n = 19) |
12b | Definition of and rationale for test positivity cutoffs or result categories of the reference standard, distinguishing prespecified from exploratory | 35 (n = 23) | 38 (n = 15) | 30 (n = 8) |
13a | Whether clinical information and reference standard results were available to the performers or readers of the index test | 74 (n = 49) | 72 (n = 28) | 78 (n = 21) |
13b | Whether clinical information and index test results were available to the assessors of the reference standard | 30 (n = 20) | 26 (n = 10) | 37 (n = 10) |
14 | Methods for estimating or comparing measures of diagnostic accuracy | 64 (n = 42) | 67 (n = 26) | 59 (n = 16) |
15 | How indeterminate index test or reference standard results were handled | 26 (n = 17) | 28 (n = 11) | 22 (n = 6) |
16 | How missing data on the index test and reference standard were handled | 27 (n = 18) | 31 (n = 12) | 22 (n = 6) |
17 | Any analyses of variability in diagnostic accuracy, distinguishing prespecified from exploratory | 73 (n = 48) | 69 (n = 27) | 78 (n = 21) |
18* | Intended sample size and how it was determined | 8 (n = 5) | 5 (n = 2) | 11 (n = 3) |
Results | ||||
19 | Flow of participants, using a diagram | 62 (n = 41) | 38 (n = 15) | 96 (n = 26) |
20 | Baseline demographic and clinical characteristics of participants | 74 (n = 49) | 62 (n = 24) | 93 (n = 25) |
21a | Distribution of severity of disease in those with the target condition | 88 (n = 58) | 90 (n = 35) | 85 (n = 23) |
21b | Distribution of alternative diagnoses in those without the target condition | 65 (n = 43) | 59 (n = 23) | 74 (n = 20) |
22 | Time interval and any clinical interventions between index test and reference standard | 52 (n = 34) | 56 (n = 22) | 44 (n = 12) |
23 | Cross-tabulation of the index test results (or their distribution) by the results of the reference standard | 8 (n = 5) | 5 (n = 2) | 11 (n = 3) |
24 | Estimates of diagnostic accuracy and their precision (such as 95% CIs) | 97 (n = 64) | 95 (n = 37) | 100 (n = 27) |
25 | Any adverse events from performing the index test or the reference standard | 5 (n = 3) | 3 (n = 1) | 7 (n = 2) |
Discussion | ||||
26* | Study limitations, including sources of potential bias, statistical uncertainty and generalizability | 88 (n = 58) | 82 (n = 32) | 96 (n = 26) |
27* | Implications for practice, including the intended use and clinical role of the index test | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |
Other information | ||||
28* | Registration number and name of registry | 9 (n = 6) | 3 (n = 1) | 19 (n = 5) |
29* | Where the full study protocol can be accessed | 62 (n = 41) | 59 (n = 23) | 67 (n = 18) |
30* | Sources of funding and other support; role of funders | 100 (n = 66) | 100 (n = 39) | 100 (n = 27) |