Page 40 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Methods

The present review evaluates trends in the epidemiology and natural history of prostate
cancer in the United States. It also reports on aspects relevant to active surveillance (AS),
watchful waiting (WW), and other “no treatment” approaches for managing localized disease.
The evidence presented was obtained through a systematic review of the published scientific
literature using established methodologies as outlined in the Agency for Healthcare Research and
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Quality’s (AHRQ) Methods Guide for Comparative Effectiveness Reviews.

AHRQ Task Order Officer
The Task Order Officer (TOO) was responsible for overseeing all aspects of this project. The
TOO facilitated a common understanding among all parties involved in the project, resolved
ambiguities, and fielded all EPC queries regarding the scope and processes of the project. The
TOO and other staff at AHRQ reviewed the report for consistency, clarity, and to ensure that it
conforms to AHRQ standards.

External Expert Input

The EPC convened a group of experts in the epidemiology and treatment of prostate cancer
to form the Technical Expert Panel (TEP). Members of the TEP provided clinical and
methodological expertise and input to help interpret the Key Questions guiding this review,
identify important issues, and define parameters for the review of evidence. Discussions between
the EPC, TOO, and the TEP occurred during a series of teleconferences and via email. In
addition, input from the TEP was sought during compilation of the report when questions arose
about the scope of the review. See Acknowledgement for the list of TEP members, and title page
for our local domain experts.

Key Questions
The Key Questions listed in the Introduction were provided by the NIH Consensus
Development Program (CDP). The Key Questions have not been altered for the review.

Analytic Framework

To guide this systematic review and facilitate the interpretation of the Key Questions, we
developed an analytic framework (Figure 1) that depicts the logical progression and
interconnection of all five Key Questions of interest. The relevant population is patients with
localized prostate cancer. Key Question 1 addresses changes in the last 30 years with respect to
patient, tumor, and system-level characteristics at diagnosis, as well as trends in the diagnostic
strategies employed. Key Question 2 examines the definitions of active surveillance (AS) and
other observational strategies in terms of common metrics and followup protocols, as they have
been implemented in clinical research. Patients diagnosed with localized prostate cancer are
faced with a decision to either enter an AS monitoring protocol or receive immediate treatment
with curative intent. Key Question 3 addresses the patient-, physician-, and system-level factors
that influence this decision, in term of the offer and acceptance of, or adherence to AS. Key
Question 4 addresses the short- and long-term outcomes and costs associated with AS versus
immediate treatment with curative intent. Outcomes of interest include prostate specific- and all-
cause mortality, morbidity of primary treatment, incidence of metastatic disease, quality of life,

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