Core Outcome Measures in Effectiveness Trials

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

General Information

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. Outcome measurements and statistical analysis: We used a modi?ed 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. Recog-nizing the heterogeneity of men with advanced prostate cancer, the group de?ned the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We de?ned outcomes important to all men, such as overall survival, and measures speci?c to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identi?ed patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control. Conclusions: The international multidisciplinary group identi?ed clinical data and PROMs that serve as a basis for international health outcome comparisons and quali-ty-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.

Alicia K. Morgans a,y,*, Annelotte C.M. van Bommel b,c,y, Caleb Stowell b, Janet L. Abrahm d, Ethan Basch e, Justin E. Bekelman f, Donna L. Berry d, Alberto Bossi g, Ian D. Davis h, Theo M. de Reijke i, Louis J. Denis j,k, Sue M. Evans l, Neil E. Fleshner m, Daniel J. George n, Jim Kiefert o, Daniel W. Lin p, Andrew G. Matthew m, Ray McDermott q, Heather Payne r, Ian A.G. Roos s, Deborah Schrag d, Thomas Steuber t, Bertrand Tombal u, Jean-Paul van Basten v, Jacobus J.M. van der Hoeven w, David F. Penson a,x,
on behalf of the Advanced Prostate Cancer Working Group of the International Consortium for Health Outcomes Measurement


European Journal of Urology
Further Study Information

Funding source(s):

Health Area

Disease Category

Disease Name
Prostate cancer

Target Population

Age Range


Nature / type of Intervention



Stakeholders Involved


Study Type

COS for practice

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