Clinical relevance of patient-reported outcomes: New threshold proven feasible in practice

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Clinical relevance of patient-reported outcomes: New threshold proven feasible in practice

In order to show the clinical relevance of a difference between two treatment alternatives, in recent years, the manufacturer dossiers submitted in early benefit assessments of new drugs have increasingly contained responder analyses for patient-relevant outcomes. In such analyses, it is investigated whether the proportion of patients experiencing a noticeable change in the respective outcome differs between the two treatment groups in a study. This involves information on health-related quality of life or on individual symptoms such as pain or itching, which patients recorded with the help of scales in questionnaires.

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