The STARD 2015 list10
| 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 cut-offs or result categories of the index test, distinguishing prespecified from exploratory | |
| 12b | Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing prespecified 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 prespecified 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% CIs) | |
| 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 generalisability | |
| 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 | |