Core Outcome Measures in Effectiveness Trials

Defining a Standard Set of Patient-centered Outcomes for Men with Localized Prostate Cancer

General Information

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. Patientreported
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.
2014 Published by Elsevier B.V. on behalf of European Association of Urology.

Neil E. Martin a,b,1, Laura Massey a,1
Caleb Stowell a
Chris Bangma c
Alberto Briganti d
Anna Bill-Axelson e
Michael Blute f
James Catto g
Ronald C. Chen h
Anthony V. D’Amico b
Gu¨nter Feick i
John M. Fitzpatrick j
Steven J. Frank k
Michael Froehner l
Mark Frydenberg m,
Adam Glaser n
Markus Graefen o
Daniel Hamstra p
Adam Kibel q
Nancy Mendenhall r
Kim Moretti s
Jacob Ramon t
Ian Roos u
Howard Sandler v
Francis J. Sullivan w,
David Swanson x
Ashutosh Tewari y
Andrew Vickers z
Thomas Wiegel aa, Hartwig Huland o


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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