Review of the Task Force Report on PRO Data Collection in Clinical Trials Using Mixed Modes

摘要

Congratulations to the ISPOR PRO Mixed Modes Good Research Practices Task Force [1] for tackling a challenging question that many patient-reported outcome (PRO) researchers have pondered either publicly or privately as they review PRO results tables based on data collected through a combination of data collection methods: "Would these results and the study conclusions be different if the same mode had been employed?" The report's general recommendation to "Just say no!" to mixing modes within a single study (or set of studies that may be pooled) is good advice and, if followed, will save many headaches and resources. If ignored and data are combined without consideration of the guidance offered in this report, post hoc evaluations may be necessary to backfill evidence to support the fact that the PRO data and conclusions are not compromised, especially to support medical product labeling.