Diagnostic accuracy reporting (lite) — v1.0.0

Released: 2026-02-02 · Hash: sha256:b2482115f21c907888a0fbaee0a9a0bb49806cf43d39c56a20e236bdf990f8ea

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Title & Abstract
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must DTA-01Identify the report as a diagnostic accuracy study and name the index test and reference standard (or best available reference).
should DTA-02Abstract summarizes design, participants, clinical setting, index test, reference standard, target condition, and key accuracy estimates.
Methods
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must DTA-10State eligibility criteria and how participants were identified and recruited (e.g., consecutive series vs convenience sample).
must DTA-11Describe the study setting, locations, and relevant dates (recruitment period and data collection).
must DTA-12Define the target condition and the rationale for choosing the index test and reference standard.
must DTA-13Describe how the index test and reference standard were performed and interpreted, with enough detail to replicate.
must DTA-14Specify positivity thresholds/cutoffs for the index test (and reference standard if applicable) and whether they were pre-specified.
should DTA-15State whether index test interpreters were blinded to reference standard results (and vice versa), and what clinical information they had access to.
must DTA-16Describe statistical methods used to estimate diagnostic accuracy (e.g., sensitivity/specificity/AUC) with confidence intervals, including any comparisons.
should DTA-17
Explain how indeterminate results, missing data, and outliers were handled.
Results
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must DTA-20Report participant flow, including numbers who received the index test and reference standard, and the time interval between them (if relevant).
must DTA-21Provide participant characteristics and disease severity distribution (and alternative diagnoses where relevant).
must DTA-22Provide the cross-tabulation of index test results by reference standard results and report primary accuracy estimates with confidence intervals.
may DTA-23Report any adverse events from performing the index test or reference standard.
Discussion
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must DTA-30Discuss study limitations and potential sources of bias and variability, and comment on applicability to the intended clinical context.
Other
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should DTA-31Provide protocol/registration information (if available) and disclose funding and competing interests.