Neil E Martin1, Laura Massey2, Caleb Stowell2, Chris Bangma3, Alberto Briganti4, Anna Bill-Axelson5, Michael Blute6, James Catto7, Ronald C Chen8, Anthony V D'Amico9, Günter Feick10, John M Fitzpatrick11, Steven J Frank12, Michael Froehner13, Mark Frydenberg14, Adam Glaser15, Markus Graefen16, Daniel Hamstra17, Adam Kibel18, Nancy Mendenhall19, Kim Moretti20, Jacob Ramon21, Ian Roos22, Howard Sandler23, Francis J Sullivan24, David Swanson25, Ashutosh Tewari26, Andrew Vickers27, Thomas Wiegel28, Hartwig Huland16. 1. International Consortium for Health Outcomes Measurement, Cambridge, MA, USA; Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, USA. Electronic address: nmartin@lroc.harvard.edu. 2. International Consortium for Health Outcomes Measurement, Cambridge, MA, USA. 3. Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands. 4. Prostate Cancer Research Programme at the Urological Research Institute, Department of Urology, Vita-Salute San Raffaele University Hospital, Milan, Italy. 5. Department of Surgical Sciences, Department of Urology, Uppsala University Hospital and National Prostate Cancer Register of Sweden, Uppsala, Sweden. 6. Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 7. University of Sheffield Academic Urology Unit and Academic Unit of Molecular Oncology, CR-UK/YCR, Sheffield Cancer Research Centre, University of Sheffield Medical School, Sheffield, UK. 8. Department of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA. 9. Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, USA. 10. Bundesverband Prostatakrebs Selbsthilfe, Pohlheim, Germany. 11. Irish Cancer Society, Dublin, Ireland. 12. Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. 13. Department of Urology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. 14. Department of Surgery, Monash University, Victoria, Australia. 15. Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK. 16. Martini-Klinik at University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 17. Department of Radiation Oncology, University of Michigan Health System, Ann Arbor, MI, USA. 18. Urologic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 19. University of Florida Proton Therapy Institute, Jacksonville, FL, USA. 20. South Australian Prostate Cancer Clinical Outcomes Collaborative, Repatriation General Hospital, Daw Park, South Australia, Australia. 21. Department of Urology and Uro-Oncology, Chaim Sheba Medical Center at Tel Hashomer, Tel Hashomer, Israel. 22. Cancer Voices Australia, Melbourne, Victoria, Australia. 23. Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 24. Prostate Cancer Institute, NUI Galway, Galway, Ireland. 25. Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. 26. Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA. 27. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. 28. Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
Abstract
BACKGROUND: Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. OBJECTIVE: To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. DESIGN, SETTING, AND PARTICIPANTS: We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. RESULTS AND LIMITATIONS: We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. CONCLUSIONS: We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. PATIENT SUMMARY: Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.
BACKGROUND: Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. OBJECTIVE: To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. DESIGN, SETTING, AND PARTICIPANTS: We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. RESULTS AND LIMITATIONS: We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. CONCLUSIONS: We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. PATIENT SUMMARY: Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.
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