Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach

BACKGROUND: There are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations.

OBJECTIVE: We sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care.

DESIGN, SETTING, AND PARTICIPANTS: The International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set of measures.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included.

RESULTS AND LIMITATIONS:  The 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control.

CONCLUSIONS: The international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually.

PATIENT SUMMARY: Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer.

Eur Urol. 2015 Jun 27. pii: S0302-2838(15)00510-2. doi: 10.1016/j.eururo.2015.06.007. [Epub ahead of print]
Eur Urol. (PDF) 

Morgans AK1, van Bommel AC2, Stowell C3, Abrahm JL4, Basch E5, Bekelman JE6, Berry DL4, Bossi A7, Davis ID8, de Reijke TM9, Denis LJ10, Evans SM11, Fleshner NE12, George DJ13, Kiefert J14, Lin DW15, Matthew AG12, McDermott R16, Payne H17, Roos IA18, Schrag D4, Steuber T19, Tombal B20, van Basten JP21, van der Hoeven JJ22, Penson DF23; Advanced Prostate Cancer Working Group of the International Consortium for Health Outcomes Measurement.

1Vanderbilt University Medical Center, Nashville, TN, USA. 
2International Consortium for Health Outcomes Measurement, Cambridge, MA, USA; Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
3International Consortium for Health Outcomes Measurement, Cambridge, MA, USA.
4Dana-Farber Cancer Institute, Boston, MA, USA.
5University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
6University of Pennsylvania, PA, USA.
7Gustave Roussy Cancer Institute, Villejuif, France.
8Monash University Eastern Health Clinical School, Melbourne, Australia.
9Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
10Oncology Centre Antwerp, Antwerp, Belgium; US TOO Belgium, Antwerp, Belgium.
11Monash University, Melbourne, Australia.
12University of Toronto, Toronto, Canada.
13Duke University Medical Center, Durham, NC, USA.
14US TOO International, Des Plaines, IL, USA.
15University of Washington, Seattle, WA, USA.
16St. Vincent's University Hospital, Dublin, Ireland.
17University College Hospitals London, London, UK.
18Cancer Action Victoria, Melbourne, Australia.
19University Hospital Hamburg-Eppendorf, Hamburg, Germany.
20Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.
21Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
22Leiden University Medical Center, Leiden, The Netherlands.
23Vanderbilt University Medical Center, Nashville, TN, USA; VA Tennessee Valley Geriatric Research, Education, and Clinical Center (GRECC), Nashville, TN, USA.

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