FACTUAL OR EVALUATIVE? HOW THE LANGUAGE OF JOINT CLINICAL ASSESSMENT REPORTS SHAPES NATIONAL APPRAISAL
Author(s)
Mondher Toumi, MSc, PhD, MD1, Kamilia Ben Abdallah, Eng2, Laurent Boyer, MD1, Anna Kapusniak, MSc3.
1Aix-Marseille University, Marseille, France, 2Clever-Access, Tunis, Tunisia, 3Clever-Access, Cracow, Poland.
1Aix-Marseille University, Marseille, France, 2Clever-Access, Tunis, Tunisia, 3Clever-Access, Cracow, Poland.
OBJECTIVES: A JCA report is meant to state facts, not verdicts — added-benefit judgements belong to Member States. Yet the words a report chooses can decide the outcome before national appraisal begins. This study examined whether the categorical vocabulary of assessment outputs is consistent with their "factual" designation and how report language shapes national appraisal.
METHODS: A conceptual and methodological analysis used Regulation (EU) 2021/2282 (notably Recital 28), methodological guidance, and structured evidence-appraisal frameworks for certainty and risk of bias. Categorical formulations used to characterise evidence and effects were examined for the extent to which they encode evaluative judgement, and the relationship between report language and national value conclusions was assessed.
RESULTS: Certain categorical formulations — such as statements that a clinically meaningful benefit has not been demonstrated, or that clinical relevance cannot be established — function as evaluative conclusions rather than neutral descriptions, even where the report is formally designated factual. Because national bodies anchor appraisal on the joint report, such formulations can pre-shape national value conclusions, narrowing the appraisal space the framework reserves to Member States. The underlying issue is not that scientific judgement is present — interpretation of uncertainty and bias is unavoidable — but that judgement expressed through categorical language is neither transparently reasoned nor grounded in published quantitative criteria, reducing reproducibility and contestability.
CONCLUSIONS: Disciplining the words — through language standards and structured, reasoned articulation of judgement — would align reports with their factual mandate and protect the line between EU-level evidence and national value decisions.
METHODS: A conceptual and methodological analysis used Regulation (EU) 2021/2282 (notably Recital 28), methodological guidance, and structured evidence-appraisal frameworks for certainty and risk of bias. Categorical formulations used to characterise evidence and effects were examined for the extent to which they encode evaluative judgement, and the relationship between report language and national value conclusions was assessed.
RESULTS: Certain categorical formulations — such as statements that a clinically meaningful benefit has not been demonstrated, or that clinical relevance cannot be established — function as evaluative conclusions rather than neutral descriptions, even where the report is formally designated factual. Because national bodies anchor appraisal on the joint report, such formulations can pre-shape national value conclusions, narrowing the appraisal space the framework reserves to Member States. The underlying issue is not that scientific judgement is present — interpretation of uncertainty and bias is unavoidable — but that judgement expressed through categorical language is neither transparently reasoned nor grounded in published quantitative criteria, reducing reproducibility and contestability.
CONCLUSIONS: Disciplining the words — through language standards and structured, reasoned articulation of judgement — would align reports with their factual mandate and protect the line between EU-level evidence and national value decisions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA108
Topic
Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas