Selecting Measures

The International Society for Quality of Life Research (ISOQOL) led an initiative in 2013 to identify minimum standards for PRO measures in patient-centered outcomes and comparative effectiveness research. These critical attributes are detailed in the paper ISOQOL Recommends Minimum Standards for Patient-Reported Outcome Measures Used in Patient-Centered Outcomes and Comparative Effectiveness Research.

A review article has demonstrated that the ISOQOL recommendations are generally consistent with other international guidance documents. Guidance documents from the U.S. Food & Drug Administration (here) and European Medicines Agency (here and here) provide their perspectives on the use of PROMs for regulatory submissions. The FDA also has draft guidance regarding core PROs in cancer clinical trials (here).

ISOQOL Recommendations

The ISOQOL Measure Selection Standards recommend that a PRO measure have evidence of the following: