Standard 03 / Clinical truth

Clinical labels and annotation quality

Clinical ground truth must identify its source and reviewer standard. Report-derived labels, diagnosis codes, measurements and expert segmentations are different evidence types and should not be represented as interchangeable.

SourcesReports · diagnoses · labs · outcomes
TasksClassification · detection · segmentation
ReviewQualified clinical experts
EvidenceAgreement and adjudication
01

Code cannot create clinical truth by itself

Software can organize reports, propose labels and manage annotation files. It cannot independently determine that a tumour, stroke or fibrosis stage is correct. Clinical claims require a defined reference source and, where necessary, qualified clinician review.

02

Choose the evidence for the task

A model intended to segment anatomy needs spatial annotations. A study-level classifier may need only adjudicated labels. A quantitative biomarker may require measurements, laboratory evidence, pathology or outcomes. The annotation plan follows the intended use rather than adding masks to every case.

  • Label definition and inclusion/exclusion rules
  • Annotator qualification and blinding
  • Single-reader, double-reader or adjudicated workflow
  • Inter-reader agreement and difficult-case review
  • Versioned annotation format and source-image mapping
03

Missing and uncertain labels

Absence of a diagnosis in a report does not automatically mean a normal negative. Unknown, unassessed and technically limited cases are represented explicitly so they are not mislabeled as controls.

04

Questions, answered directly.

Can labels be generated automatically?

Automated extraction can support triage, but clinically meaningful labels still need a validation standard appropriate to the task.

Are reports equivalent to segmentations?

No. Reports provide narrative or study-level evidence; segmentations provide spatial boundaries.

Do all cases need two readers?

Not always. Reader count and adjudication should reflect task risk, label ambiguity and buyer acceptance criteria.

Institutional engagement

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