Background: Prospectively collected, standardized, patient-centered outcome data sets for men with prostate cancer are lacking. We report an international collaboration which has defined such a set for localized prostate cancer, and which will allow inter-institutional, national and international outcomes comparisons, and aid patient education, self-assessment and dissemination of best practices.
Methods: Through the International Consortium for Health Outcomes Measurement (ICHOM), a working group of urologists, radiation oncologists, registry representatives and patient advocates was convened to develop a recommended minimum set of measures which institutions would collect on all patients with localized prostate cancer. Using a modified Delphi method over a series of in-person meetings and conference calls, a final set of recommendations was developed.
Results: Approximately 30 experts in prostate cancer care from North America, Europe, Australia, and the Middle East participated in the process, representing academic centers, registries and patients. The group recommended cross-disciplinary measures applicable to a variety of treatment approaches from surveillance to radiation and prostatectomy. Standards were identified for disease control definitions as well as baseline patient and disease-specific risk stratification factors. Domains of patient reported outcomes to be tracked in follow up included urinary incontinence, urinary irritation, bowel irritation, sexual function, and symptoms related to hormonal therapy. Finally, specific tools to assess these domains and gaps in our current tools were identified and recommended. The final recommended set will be presented.
Conclusions: Standardized outcome reporting is a necessary component in the movement towards high-value health care. Patient-centered outcomes related to toxicity and disease control have be identified and systemized by a multidisciplinary group of experts. The result of this project is an initial step in what will be an iterative process with the goal of improving the care of all men with prostate cancer. An pilot global comparisons project has been proposed based on implementing the final set of recommendations.