Checklist for reporting a diagnostic test accuracy study

This checklist is relevant to studies of diagnostic accuracy and is based on the STARD statement.  Read more


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Instructions

Complete this checklist by entering the page numbers from your manuscript where readers will find each of the items listed below.

Your article may not currently address all the items on the checklist. Please modify your text to include the missing information. If you are certain that an item does not apply, please write "n/a" and provide a short explanation.

Download your completed checklist and include it as an extra file when you submit to a journal.

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). Read more

Abstract

2.

Structured summary of study design, methods, results, and conclusions (for specific guidance, see STARD for Abstracts https://www.equator-network.org/reporting-guidelines/stard-abstracts/). Read more

Introduction

3.

Scientific and clinical background, including the intended use and clinical role of the index test. Read more

4.

Study objectives and hypotheses. Read more

Methods

5.

Study design*

Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study). Read more

6.

Participants*

Eligibility criteria. Read more

7.

Participants*

On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry). Read more

8.

Participants*

Where and when potentially eligible participants were identified (setting, location and dates). Read more

9.

Participants*

Whether participants formed a consecutive, random or convenience series. Read more

10.

Test methods*

Index and reference tests in sufficient detail to allow replication. Read more

11.

Test methods*

Rationale for choosing the reference standard (if alternatives exist). Read more

12.

Test methods*

Definition of and rationale for test positivity cut-offs or result categories of the index and reference tests, distinguishing pre-specified from exploratory. Read more

13.

Test methods*

Whether clinical information and reference standard results were available to the performers / readers of the index test; Whether clinical information and index test results were available to the assessors of the reference standard. Read more

14.

Analysis*

Methods for estimating or comparing measures of diagnostic accuracy. Read more

15.

Analysis*

How indeterminate index test or reference standard results were handled. Read more

16.

Analysis*

How missing data on the index test and reference standard were handled. Read more

17.

Analysis*

Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory. Read more

18.

Analysis*

Intended sample size and how it was determined. Read more

Results

19.

Participants*

Flow of participants, using a diagram. Read more

20.

Participants*

Baseline demographic and clinical characteristics of participants. Read more

21.

Participants*

Distribution of severity of disease in those with the target condition, and distribution of alternative diagnoses in those without the target condition. Read more

22.

Participants*

Time interval and any clinical interventions between index test and reference standard. Read more

23.

Test results*

Cross tabulation of the index test results (or their distribution) by the results of the reference standard. Read more

24.

Test results*

Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals). Read more

25.

Test results*

Any adverse events from performing the index test or the reference standard. Read more

Discussion

26.

Study limitations, including sources of potential bias, statistical uncertainty, and generalisability. Read more

27.

Implications for practice, including the intended use and clinical role of the index test. Read more

Other information

28.

Registration number and name of registry. Read more

29.

Where the full study protocol can be accessed. Read more

30.

Sources of funding and other support; role of funders. Read more


To acknowledge this checklist in your methods, please state "We used the STARD checklist when writing our report [citation]". Then cite this checklist as Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, LijmerJG Moher D, Rennie D, de Vet HCW, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF, For the STARD Group. STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies..


The STARD checklist is distributed under the terms of the Creative Commons Attribution License CC-BY