Is IQWiG's 15% threshold universally applicable in assessing the clinical relevance of patient reported outcomes changes? An ISPOR Special Interest Group report.

Value in Health

8 September 2022 - To assess the clinical relevance of patient reported outcomes, a response threshold of ≥ 15% of the patient reported outcome scale range will be universally adopted for health technology assessment in Germany. 

Authors consider the implications for patient reported outcome data analyses within the context of current psychometric practices for derivation of responder definitions and methodologies accepted by the German Federal Joint Committee and the US FDA.

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Michael Wonder

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Michael Wonder