Presentation (CTI)

OBJECTIVES: Policy-makers increasingly face decisions about replacing or updating screening tests within established screening programmes, yet little practical guidance exists to support these evaluations. Assessing screening test replacement requires identifying the downstream consequences of differences between existing and proposed tests and determining the evidence needed to evaluate these changes. We therefore developed a framework and a practical tool to support evaluation of proposed changes to screening tests within established screening programmes
METHODS: Framework development involved: (1) identifying a foundational framework from published methods literature; (2) synthesising methodological themes describing how test changes influence downstream outcomes and evidence requirements; and (3) refining the framework through application to Health Technology Assessment (HTA) reviews of screening test changes. An expert-informed tool was subsequently developed using the framework and iteratively refined through discussion and application to screening test replacement scenarios.
RESULTS: We identified 33 screening frameworks, 46 diagnostic and screening test frameworks, and 194 HTA evaluations of screening test changes. The resulting framework synthesised evidence pathways and methodological considerations relevant to evaluating replacement, triage, add-on, threshold, and risk-based screening test modifications. The accompanying tool outlines a structured process for evaluating proposed changes to screening tests, including defining the value proposition of the new test, determining proportionate evidence requirements, prioritising review questions, and interpreting downstream consequences of test changes. Three levels of evidence review (minimal, expedited, and full review) were proposed according to the likely impact of the test change and the degree of uncertainty.
CONCLUSIONS: The framework and practical tool provide a structured and practical approach for evaluating proposed changes to screening tests within established screening programmes. By supporting consideration of downstream consequences, evidence requirements, and implementation issues, they may improve consistency and transparency in screening policy decision-making.