Page 47 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

We took particular care to identify changes in the observational protocols used by research teams
that had published more than one paper providing information relevant to Key Question 2.

Key Question 3 (Factors Affecting the Offer, Acceptance and
Adherence to Observational Management Strategies)
For studies using multivariable models to identify factors associated with the offer,
acceptance or adherence of WW or AS, we extracted information on the definition of the
observational strategy evaluated in each study, the statistical analysis methods used to identify
factors of interest, and the main findings as related to Key Question 3.
For studies using qualitative methods to identify factors associated with the offer, acceptance
or adherence of WW or AS, we extracted information on the research methods used, the
definition of the observational strategy addressed in each study, and a qualitative summary of
key study findings.

Key Question 4 (comparative effectiveness of observational
management strategies and active treatment)
From each eligible comparative treatment study we extracted the following information:
detailed descriptions of the interventions being compared, the source populations of each study,
details of the eligibility criteria used, sample size information, study start and end dates,
followup duration, baseline characteristics of the enrolled patient populations, measurement
instruments, the definitions of specific outcomes, and estimates of the treatment effect.

Systematic Reviews

For systematic reviews, we extracted information on the data sources used, the dates covered
by the literature searches, the inclusion and exclusion criteria used, the number of eligible studies
identified, whether quantitative synthesis (meta-analysis) was performed, and a description of
key study findings.

Quality Assessment

Primary Research Studies

We assessed the methodological quality of only observational and randomized studies
included for Key Question 4. The EPC, in consultation with the TOO, decided that formal
quality assessment was unlikely to be informative for Key Questions 1-3 because it was not
deemed well applicable to the descriptive literature summarized for these Key Questions. For
Key Question 4, quality assessment was performed by the team member doing the primary data
extraction. The quality grade was confirmed by at least one other team member.
We assessed the methodological quality of studies based on predefined criteria. We used a
three-category grading system (A, B, or C) to denote the methodological quality of each study as
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described in the AHRQ methods guide. This grading system has been used in most of the
previous evidence reports generated by our EPC. This system defines a generic grading scheme
that is applicable to varying study designs including RCTs, nonrandomized comparative trials,
cohort, and case-control studies. For RCTs, we primarily considered the methods used for
randomization, allocation concealment, and blinding as well as the use of intention-to-treat
analysis, the report of dropout rate, and the extent to which valid primary outcomes were

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