When using patient-reported outcomes in clinical practice, the measure matters: A randomized controlled trial

Abstract

Background: Patient-reported outcome (PRO) measures are increasingly being used in clinical practice to inform individual patient management, but evidence is needed on which PROs are best suited for clinical use. Methods: This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Supportive Care Needs Survey-Short Form (SCNS-SF34), or six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS). Patients completed the PRO measures before clinic visits, and the results were provided to both the patient and clinician. At treatment completion, patients and clinicians completed brief feedback forms on the intervention's usefulness and value. Exit interviews were conducted with patients (at end of treatment) and clinicians (at end of study). The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items. Results: Of 294 eligible patients invited to participate, 224 (76%) enrolled (median age 66 years, 78% white, 72% prostate). Of the 181 patients (81%) who completed at least one feedback form item, participants in the QLQ-C30 study arm were most likely to strongly agree/agree to all items (74%) followed by PROMIS (61%) and SCNS-SF34 (52%; P = .03). Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05). Clinicians did not prefer one questionnaire over the others. Conclusion: These results suggest that, when using PROs in clinical practice for patient management, the measure matters in terms of usefulness to patients.