12 March 2017 - This study determined methodological requirements for health-related quality of life measurement and data presentation in the early benefit assessment.

The authors identified a range of requirements regarding quality of life (QoL) assessment, analysis, presentation, and interpretation, which go beyond official regulations. Disease-specific questionnaires are preferred and have to be validated according to certain standards and in the respective patient group. Effects must exceed the minimal important difference, which in turn must be validated in compliance with specific requirements. Often, instruments were not accepted as QoL measures, sometimes inconsistently across EBAs. Another frequent reason for non-acceptance of QoL data was that more than 30 % of randomised patients could not be analysed due to missing data.

The authors concluded that non-compliance with methodological requirements for QoL evidence impairs chances for positive benefit evaluation

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