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Use of Quality Standards in FDA Approval Decisions

A total of 50 health status patient-reported outcome measures (PROMs) are validated in cardiovascular diseases (CVDs), but their use in the psychometric properties recommended by FDA is limited, a study shows. Nearly all the identified PROMs were disease-specific, with only 5 generic PROMs.

“Eleven (22%) of the 50 PROMs validated in CVDs had minimally important differences (MIDs) established, and 8 (16%) reported on the validation of all psychometric properties recommended by the FDA,” the authors write. “By [COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)] standards, only 2 PROMs (4%) had all of their psychometric properties rated as sufficient in quality, and 32 PROMs (64%) had less than 50% of psychometric properties rated as sufficient.”

“We found that few PROMs comprehensively report the process for developing and validating PROMs or fulfill criteria for good measurement properties,” the authors add while discussing these results. “That is, no generic PROM and only 1 in 6 disease-specific PROMs fulfilled all of the FDA requirements for product approval. No generic PROMs and only 2 disease-specific PROMs had all 9 COSMIN-defined properties classified as sufficient. Our work highlights the need for careful adherence to standardized methodological criteria for PROM development and validation and clear reporting of the psychometric properties of existing instruments.”

Source: Annals of Internal Medicine