Grade notes: using Grade informed approaches when developing diagnostic criteria: example and reflections from the Australian guidelines for assessment and diagnosis of fetal alcohol spectrum disorder.

Abstract

Objective: There is currently a lack of structured and transparent evidence-based processes for developing diagnostic criteria. Using a GRADE-informed approach, we have developed an innovative set of diagnostic criteria for fetal alcohol spectrum disorder (FASD).Study Design and Setting: Our research team developed de novo methods for developing guidance for diagnostic criteria, as part of the review and update of the Australian Guide to Diagnosis of FASD. Result(s): Using adapted evidence-to-decision frameworks, we were able to include or exclude clinical features in the diagnostic criteria for FASD. Application of GRADE principles to diagnostic criteria provided a systematic and clear process for generating recommendations. Conclusion(s): Use of the GRADE approach helped inform the development and utility of evidence-based diagnostic criteria for FASD and may have applications beyond FASD. This could include advancing more evidence-based approaches for developing diagnostic criteria for other clinical conditions lacking clear biomarkers or diagnostic tests.Copyright © 2025, The Authors. All rights reserved.