Page 44 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

considered eligible. We evaluated only the descriptions of the observational management
strategies.
When a center or research group had published multiple studies reporting on potentially
overlapping patient populations, the publication that provided the most complete information on
eligibility criteria and followup protocols (i.e., the study that was most informative regarding the
components relevant to Key Question 2) was used as the primary source of information for this
report. We also considered additional publications from the same cohort when they reported
important changes (e.g., in cases where papers explicitly reported changes in the study protocol
that affected the definition of the observational strategy). When all articles from the same center
or research team used the same observational strategy (i.e., when the same definition was
consistently used in all publications), we generally referenced the article with the earliest
publication date. We included studies from any country.

Key Question 3 (Factors Affecting the Offer of, Acceptance of, and
Adherence to Observational Management Strategies)
We considered three types of studies relevant to Key Question 3: (1) studies of any design
that used multivariable methods to predict the offer, acceptance, or adherence of observational
management; (2) studies that used qualitative research methods to identify such factors; and
(3) experimental studies that examined a factor of interest addressing the same issues, when
applicable (e.g., decision aids). We included studies from any country. For each type of study we
employed different criteria:

Studies Using Quantitative Methods to Predict Offer, Acceptance or
Adherence
For this category, we considered studies reporting on factors predicting the offer of,
acceptance of, or adherence to observational management strategies (including AS and WW).
We excluded studies explicitly reporting that patients receiving androgen deprivation therapy
(ADT) were considered together with patients receiving no treatment (WW or AS). We also
excluded studies defining observational management strategies as the lack of surgical treatment
or radiotherapy, without providing information on how other treatments (such as ADT) were
handled in the analyses. However, studies that provided no definition of the observational
strategy employed (e.g., “expectant management” with no other information on how treatment
groups were defined) were included.
Both prospective and retrospective studies of any design were eligible, so long as one
treatment group was managed using observational management strategies. We required that
studies used multivariable methods (e.g., multivariable regression or analysis of covariance) to
adjust for potential confounders. At a minimum we required adjustment for age and tumor stage
(if the analysis was not limited to patients with localized cancer).

Studies Using Qualitative Methods

For this category, we considered studies using qualitative research methods (e.g., focus
groups or surveys) to obtain information on factors that affect the offer of, acceptance of, or
adherence to AS or WW. Eligible studies had to use a predefined approach to collect information
(e.g., a structured or semi-structured interview, a questionnaire).

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