Meaningful differences and changes for five Patient-Reported Outcomes Measurement Information System domains in a large cohort of patients with cancer.

BACKGROUND: Patient-reported outcomes are valuable sources of information in research and clinical care, particularly in populations experiencing long-term effects on health-related quality of life such as patients with cancer. Identifying meaningful differences and changes in patient-reported outcomes can prove useful in research and clinical settings. METHODS: Data from a system-wide symptom-management intervention trial were analyzed. Patients with cancer completed Patient-Reported Outcomes Measurement Information System (PROMIS) computer-adaptive tests in pain, fatigue, depression, anxiety, and physical function at baseline and 6 months. The authors used a combination of distribution-based and anchor-based approaches to estimate meaningful differences in PROMIS scores at baseline. Meaningful change estimates were calculated using mean changes in PROMIS scores in response to selected anchors. RESULTS: The sample (n = 3907) was predominantly female (66.1%) and non-Hispanic (84.2%). Overall, the sample reported PROMIS scores close to the general population standard (mean ± standard deviation score, 50 ± 10). Longitudinal anchor-based estimates ranged from 2.4 to 8.0 points for pain interference, 2.0-4.4 points for depression, 2.2-4.5 points for anxiety, 2.0-6.3 points for fatigue, and 1.9-4.4 points for physical functioning. Longitudinal, anchor-based findings revealed smaller changes than cross-sectional differences indicating the responsiveness of PROMIS measures to patient-reported meaningful changes over time. Supporting distribution-based information using SEM criteria produced generally smaller values, ranging from 1.14 for depression to 2.14 for fatigue. CONCLUSIONS: PROMIS computer-adaptive test measures of pain, fatigue, anxiety, depression, and physical function are sensitive to group differences and changes over time. Regular symptom monitoring in conjunction with the recommended thresholds could be useful in research and clinical settings.