Diagnostic Accuracy Study Report Template (STARD 2015)

Diagnostic Accuracy Study Report: [Index test] for [target condition]

Report template for a study that estimates how well a test (the index test) identifies a target condition against a reference standard. The sections follow the topics and order of STARD 2015 (30 essential items, BMJ 2015;351:h5527), with the participant flow diagram and the 2x2 cross-tabulation. STARD item numbers appear in brackets, for example [12a]. Topics are written in original words; use the template with the official STARD 2015 checklist and flow diagram from the EQUATOR Network. For tests that use artificial intelligence, also use STARD-AI (2025). This is a reporting format, not clinical, statistical or regulatory advice. Replace every [bracketed] value and every row marked Example.

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Contents

1. Title and abstract
2. Introduction
3. Methods
4. Analysis
5. Results
6. Discussion
7. Other information
8. STARD cross-reference, glossary and references

1. Title and abstract

The title and abstract let readers recognise the study design and its main result.

1.1 Title [1]

Diagnostic accuracy of [index test] for [target condition] in [population and setting]: a [prospective, cross-sectional] study

Example: "Sensitivity and specificity of a point-of-care rapid antigen test for group A streptococcal pharyngitis in children: a prospective diagnostic accuracy study."

1.2 Structured abstract [2]

2. Introduction

The introduction sets out why the test matters and what the study tries to estimate.

2.1 Scientific and clinical background [3]

[Describe the target condition, the current pathway and the intended use and clinical role of the index test. Say what decision a positive or negative result should change.]

Example: Sore throat is common in children and most cases are viral. Culture takes 24 to 48 hours. A rapid test at the first visit could act as a replacement for culture in deciding on antibiotics, so a high sensitivity is needed to avoid missed infections.

2.2 Objectives and hypotheses [4]

3. Methods

The methods describe the design, participants and tests as they were used.

3.1 Study design [5]

[State whether data collection was planned before the index test and reference standard were done (prospective) or after (retrospective).]

3.2 Participants [6, 7, 8, 9]

3.3 Test methods [10a, 10b, 11, 12a, 12b, 13a, 13b]

4. Analysis

This section describes the statistical methods.

4.1 Estimating accuracy [14]

Accuracy is derived from the 2x2 table of index test result against reference standard result:

[Name the method for confidence intervals, for example Wilson score intervals for proportions and the log method for likelihood ratios, and the software and version.] Predictive values depend on prevalence; report them only for the setting studied, or recalculate them for other prevalences with the likelihood ratios.

4.2 Indeterminate and missing results [15, 16]

4.3 Variability analyses [17]

4.4 Sample size [18]

The number of participants with the target condition needed for a given precision of sensitivity is:

Example: expected sensitivity $\text{Se} = 0.85$, half-width $d = 0.06$ and $z = 1.96$ give $n_{\text{cases}} = 3.8416 \times 0.1275 / 0.0036 = 136.05$, rounded up to 137 children with a positive culture. With an expected prevalence of 25%, $137 / 0.25 = 548$ children; allowing 10% for missing or invalid results, $548 / 0.9 = 608.9$, rounded up to 609. Recruitment continued to the end of the planned season and enrolled 640.

5. Results

This section reports who took part and how accurate the test was.

5.1 Participant flow [19]

The diagram follows participants from eligibility to the final analysis.

Example: reasons for exclusion before enrolment: did not meet the criteria 118, declined 41, other 13 (total 172). Children in the main analysis: $640 - 5 - 5 - 1 - 9 = 620$.

5.2 Baseline characteristics [20, 21a, 21b]

5.3 Time interval and interventions [22]

[Time between index test and reference standard, and any treatment started in between.] Example: both swabs were taken at the same visit (interval 0 days); no antibiotic was given before swabbing.

5.4 Cross-tabulation [23]

5.5 Estimates of accuracy [24]

Confidence intervals: Wilson score for proportions, log method for likelihood ratios. The ratios in the calculation column are rounded for display; the estimates use unrounded values.

5.6 Adverse events [25]

[Any adverse events from performing the index test or the reference standard.] Example: no adverse events beyond brief gagging during swabbing were recorded.

6. Discussion

The discussion interprets the estimates for the intended use of the test.

6.1 Limitations [26]

• [Sources of bias, for example imperfect reference standard or partial verification]
• [Statistical uncertainty, for example a wide interval for sensitivity in a subgroup]
• [Generalisability: setting, prevalence, operators and test version]

6.2 Implications for practice [27]

[State what the results mean for the intended use and clinical role.] Example: with a negative likelihood ratio of 0.14, a negative result lowers the probability of a positive culture from 27.4% to about 5.0% in this setting. Whether that is low enough to withhold culture is a clinical and guideline decision, not something this study settles.

7. Other information

8. STARD cross-reference, glossary and references

This section maps the STARD 2015 items to this report and lists terms and sources.

8.1 STARD 2015 cross-reference

8.2 Glossary

8.3 References and related templates

Standard and licence note

Structure aligned with STARD 2015: Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al., STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies, BMJ 2015;351:h5527 (https://doi.org/10.1136/bmj.h5527), listed as the current guideline by the EQUATOR Network on 2026-10-30. This template follows the order of its 30 items, paraphrased in original text, and reproduces no checklist wording; use the official checklist and flow diagram for submission and check the EQUATOR page for updates and extensions. This is a reporting format, not clinical, statistical or regulatory advice. Template licence: MIT.