Creation of a standardized set of patient-centered outcomes for advanced prostate cancer: An international effort.

282 Background: Clinical trials and international registries assess outcomes considered relevant to men with advanced prostate cancer (CaP). However, we lack a single standardized set of outcomes, making direct comparisons between populations and quality of care assessments challenging. We sought to create a minimum standardized set of outcomes relevant to men with advanced CaP. Methods: The International Consortium for Health Outcomes Measurement assembled a multi-disciplinary working group to create a minimum set of measures to collect for men with advanced CaP. We used a modified Delphi method to establish pertinent measures and case-mix characteristics. Results: Approximately 24 experts, including clinicians and patient advocates, from North America, Europe, and Australia participated. We defined the included population as men with metastatic prostate cancer or biochemical recurrence who failed or were ineligible for salvage therapy. Outcomes important to all men with advanced CaP, such as overall survival, and measures specific to subgroups, such as time to metastasis, were identified. Measures gathered from clinical data include risk-stratification characteristics and measures of disease control. Patient-reported outcome measures, like pain control, depression, and erectile, urinary, and bowel dysfunction, were also identified. Conclusions: Standardized outcome measures are necessary to assess quality of care across different populations, and are critical to ensure value in health care. Our international, multi-disciplinary team identified clinical data and patient-reported outcomes to provide a basis for international health outcome comparisons and future assessments of quality of care for men with advanced CaP.