Diagnostic study overview — Diagnostic accuracy study

Clinical use question

Define the target condition, intended population and clinical role of the index test.

Protocol

Prespecify thresholds, reference standard, sampling, blinding and analysis; obtain required ethics and consent approvals.

Recruit representative participants

Recruit the intended clinical spectrum and document consecutive, random or other sampling and exclusions.

Apply tests

Apply the index test and reference standard using recorded order, timing and blinded interpretation where feasible.

Resolve missing or indeterminate results

Retain indeterminate, failed and missing results with reasons; prespecify incomplete-verification analyses.

Estimate accuracy

Estimate sensitivity, specificity and relevant predictive values with uncertainty at the planned threshold.

Assess limitations

Assess spectrum, verification, reference-standard limitations and applicability to the proposed pathway.

Report

Report participant and test flow, threshold selection and accuracy under STARD, including excluded and incomplete results.

Diagnostic study overview

End flow

Protocol and decision register

Record the protocol, approvals and registration where applicable. Preserve planned decisions and amendments separately from results.

Protocol and rationale evidence

Attach the dated protocol, model or test specification, approvals and amendments. Identify any applicable study registration, registry and identifier explicitly. Diagnostic accuracy and prediction studies are not automatically interventional clinical trials; a disease registry is a data source, not protocol registration.