title: Defining a standard set of patient-centered outcomes for men with localized prostate cancer.
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.
  
  
  METHODS
  We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  RESULTS
  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.
authors.affiliation: 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.
authors.forename: Neil E
authors.initials: NE
authors.lastname: Martin
authors.affiliation: International Consortium for Health Outcomes Measurement, Cambridge, MA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Massey
authors.affiliation: International Consortium for Health Outcomes Measurement, Cambridge, MA, USA.
authors.forename: Caleb
authors.initials: C
authors.lastname: Stowell
authors.affiliation: Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Chris
authors.initials: C
authors.lastname: Bangma
authors.affiliation: Prostate Cancer Research Programme at the Urological Research Institute, Department of Urology, Vita-Salute San Raffaele University Hospital, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Briganti
authors.affiliation: Department of Surgical Sciences, Department of Urology, Uppsala University Hospital and National Prostate Cancer Register of Sweden, Uppsala, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Bill-Axelson
authors.affiliation: Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Blute
authors.affiliation: 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.
authors.forename: James
authors.initials: J
authors.lastname: Catto
authors.affiliation: Department of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Anthony V
authors.initials: AV
authors.lastname: D'Amico
authors.affiliation: Bundesverband Prostatakrebs Selbsthilfe, Pohlheim, Germany.
authors.forename: Günter
authors.initials: G
authors.lastname: Feick
authors.affiliation: Irish Cancer Society, Dublin, Ireland.
authors.forename: John M
authors.initials: JM
authors.lastname: Fitzpatrick
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Frank
authors.affiliation: Department of Urology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Froehner
authors.affiliation: Department of Surgery, Monash University, Victoria, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Frydenberg
authors.affiliation: Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Glaser
authors.affiliation: Martini-Klinik at University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Graefen
authors.affiliation: Department of Radiation Oncology, University of Michigan Health System, Ann Arbor, MI, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hamstra
authors.affiliation: Urologic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Kibel
authors.affiliation: University of Florida Proton Therapy Institute, Jacksonville, FL, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Mendenhall
authors.affiliation: South Australian Prostate Cancer Clinical Outcomes Collaborative, Repatriation General Hospital, Daw Park, South Australia, Australia.
authors.forename: Kim
authors.initials: K
authors.lastname: Moretti
authors.affiliation: Department of Urology and Uro-Oncology, Chaim Sheba Medical Center at Tel Hashomer, Tel Hashomer, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Ramon
authors.affiliation: Cancer Voices Australia, Melbourne, Victoria, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Roos
authors.affiliation: Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Sandler
authors.affiliation: Prostate Cancer Institute, NUI Galway, Galway, Ireland.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Sullivan
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: David
authors.initials: D
authors.lastname: Swanson
authors.affiliation: Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.
authors.forename: Ashutosh
authors.initials: A
authors.lastname: Tewari
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Vickers
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wiegel
authors.affiliation: Martini-Klinik at University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Hartwig
authors.initials: H
authors.lastname: Huland
mesh_terms: D032921:Consensus; D003697:Delphi Technique; D018450:Disease Progression; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008495:Medical Oncology / Q000592:standards*; D018802:Patient-Centered Care / Q000592:standards*; D011183:Postoperative Complications / Q000209:etiology; D010818:Practice Patterns, Physicians' / Q000592:standards; D011237:Predictive Value of Tests; D017064:Process Assessment, Health Care / Q000592:standards*; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D058996:Quality Improvement / Q000592:standards; D019984:Quality Indicators, Health Care / Q000592:standards*; D011788:Quality of Life; D011832:Radiation Injuries / Q000209:etiology; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Outcome measurement; Patient-reported; Prostate cancer; Value