STARD 2015 Checklist

Scope: Standards for Reporting of Diagnostic Accuracy Studies.

Reference: See source/archetypes/stard-2015.yml for canonical link and provenance.

Instructions

• Use the boxes to confirm each reporting item.
• Add reviewer notes under each section as needed.

Title or Abstract

• 1. Identification: 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: Structured summary of study design, methods, results, and conclusions (for specific guidance, see STARD for Abstracts).

Introduction

• 3. Scientific and clinical background: Scientific and clinical background, including the intended use and clinical role of the index test.
• 4. Study objectives and hypotheses: Study objectives and hypotheses.

Methods

• 5. Study design: Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study).
• 6. Participants: Eligibility criteria.
• 7. Participants: On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry).
• 8. Participants: Where and when potentially eligible participants were identified (setting, location and dates).
• 9. Participants: Whether participants formed a consecutive, random or convenience series.
• 10a. Test methods: Index test, in sufficient detail to allow replication.
• 10b. Test methods: Reference standard, in sufficient detail to allow replication.
• 11. Test methods: Rationale for choosing the reference standard (if alternatives exist).
• 12a. Test methods: Definition of and rationale for test positivity cut-offs or result categories of the index test, distinguishing prespecified from exploratory.
• 12b. Test methods: Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing prespecified from exploratory.
• 13a. Test methods: Whether clinical information and reference standard results were available to the performers/readers of the index test.
• 13b. Test methods: Whether clinical information and index test results were available to the assessors of the reference standard.
• 14. Analysis: Methods for estimating or comparing measures of diagnostic accuracy.
• 15. Analysis: How indeterminate index test or reference standard results were handled.
• 16. Analysis: How missing data on the index test and reference standard were handled.
• 17. Analysis: Any analyses of variability in diagnostic accuracy, distinguishing prespecified from exploratory.
• 18. Analysis: Sample size calculation.

Results

• 19. Participants: Flow of participants, using a diagram.
• 20. Participants: Baseline demographic and clinical characteristics of participants.
• 21. Participants: Distribution of severity of disease in those with the target condition; other diagnoses in participants without the target condition.
• 22. Test results: Time interval from index test to reference standard, and any treatment administered between them.
• 23. Test results: Cross tabulation of the index test results (or their distribution) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard.
• 24. Test results: Any adverse events from performing the index test or the reference standard.
• 25. Estimates: Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals).
• 26. Estimates: Any analyses of variability, including subgroup analyses.
• 27. Estimates: The number of indeterminate test results or missing data and where they occurred.

Discussion

• 28. Study limitations: Study limitations, including sources of potential bias, statistical uncertainty, and generalisability.
• 29. Implications for practice: Implications for practice, including the intended use and clinical role of the index test.

Other Information

• 30. Registration number and name of registry: Registration number and name of registry.
• 31. Where the full study protocol can be accessed: Where the full study protocol can be accessed.
• 32. Funding: Sources of funding and other support; role of funders.

Notes

Provenance

• Source: See sidecar metadata in source/archetypes/stard-2015.yml
• Version: 2015
• License: CC-BY-4.0