PROTEUS — TRIALS
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, and users should refer to the guidance document most relevant to their objective (e.g., refer to regulator’s guidance for regulatory submissions).
ISOQOL Recommendations
The ISOQOL Measure Selection Standards recommend that a PRO measure have evidence of the following: