Table 1 The STARD 2015 list
From: Updating standards for reporting diagnostic accuracy: the development of STARD 2015
Section and topic | No. | Item |
|---|---|---|
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) | |
Abstract | ||
2 | Structured summary of study design, methods, results, and conclusions (for specific guidance, see STARD for Abstracts) | |
Introduction | ||
3 | Scientific and clinical background, including the intended use and clinical role of the index test | |
4 | Study objectives and hypotheses | |
Methods | ||
Study design | 5 | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) |
Participants | 6 | Eligibility criteria |
7 | On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry) | |
8 | Where and when potentially eligible participants were identified (setting, location, and dates) | |
9 | Whether participants formed a consecutive, random, or convenience series | |
Test methods | 10a | Index test, in sufficient detail to allow replication |
10b | Reference standard, in sufficient detail to allow replication | |
11 | Rationale for choosing the reference standard (if alternatives exist) | |
12a | Definition of and rationale for test positivity cutoffs or result categories of the index test, distinguishing pre-specified from exploratory | |
12b | Definition of and rationale for test positivity cutoffs or result categories of the reference standard, distinguishing pre-specified from exploratory | |
13a | Whether clinical information and reference standard results were available to the performers or readers of the index test | |
13b | Whether clinical information and index test results were available to the assessors of the reference standard | |
Analysis | 14 | Methods for estimating or comparing measures of diagnostic accuracy |
15 | How indeterminate index test or reference standard results were handled | |
16 | How missing data on the index test and reference standard were handled | |
17 | Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory | |
18 | Intended sample size and how it was determined | |
Results | ||
Participants | 19 | Flow of participants, using a diagram |
20 | Baseline demographic and clinical characteristics of participants | |
21a | Distribution of severity of disease in those with the target condition | |
21b | Distribution of alternative diagnoses in those without the target condition | |
22 | Time interval and any clinical interventions between index test and reference standard | |
Test results | 23 | Cross tabulation of the index test results (or their distribution) by the results of the reference standard |
24 | Estimates of diagnostic accuracy and their precision (such as 95 % confidence intervals) | |
25 | Any adverse events from performing the index test or the reference standard | |
Discussion | ||
26 | Study limitations, including sources of potential bias, statistical uncertainty, and generalizability | |
27 | Implications for practice, including the intended use and clinical role of the index test | |
Other information | ||
28 | Registration number and name of registry | |
29 | Where the full study protocol can be accessed | |
30 | Sources of funding and other support; role of funders | |