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Methods for developing diagnostic criteria for conditions without objective tests, biomarkers, or reference

Samuel J White1, Timothy H Barker1, Tracy Merlin2

  • 1Health Evidence Synthesis, Recommendations & Impact (HESRI), School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.

Journal of Clinical Epidemiology
|November 20, 2025
PubMed
Summary

Developing diagnostic criteria without objective tests is inconsistent. This review found common methods lack transparency, evidence, and diverse perspectives, highlighting a need for methodological guidance to improve accuracy and equity in healthcare.

Keywords:
Consensus developmentDiagnostic criteriaEvidence-based practiceGuideline developmentReference standardsScoping review

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