Page 49 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

generated bar graphs showing the number of AS cohorts employing each specific criterion for
patient selection or as part of their followup protocol, to demonstrate items for which
heterogeneity was most prominent across cohorts.

Summary Tables
Summary tables succinctly report measures of the main outcomes evaluated. We included
information regarding population selection, country (when relevant), study design, interventions,
age data, study setting, prostate cancer stage and grade, sample size, study duration, years of
intervention, dropout rate, and study quality (for Key Question 4). For continuous outcomes, we
included the mean outcome values, their 95 percent confidence intervals (CI), standard
deviations (SD) or other measures of variability and when available, the mean difference
(between groups) and its corresponding P value, or CI, as appropriate. For categorical
(dichotomous) outcomes, we reported the number of events and total number of patients for each
intervention and relative risk metrics (odds ratios, risk ratios or hazard ratios) with their
corresponding 95 percent CI and associated P value.

Grading the Body of Evidence for Key Question 4

We graded the strength of the body of evidence for each analysis within Key Question 4 as
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per the AHRQ methods guide and an updated methods paper, with modifications as described
below. Risk of bias was assessed using a three-category grading system (A, B, or C) which
corresponds to low, medium or high risk of bias (see Quality Assessment). We assessed the
consistency of the data as either “no inconsistency” or “inconsistency present” (or “not
applicable” if only one study). The direction, magnitude, and statistical significance of all studies
were evaluated in assessing consistency, and logical explanations were provided in the presence
of equivocal results. Studies with limited relevance either included populations which related
poorly to the general population of men in the United States with localized prostate cancer or
contained substantial problems with the measurement of the outcome(s) of interest. We also
assessed the precision and sparseness of the evidence. We considered evidence to be sparse if
only one study addressed the analysis.
We rated the strength of evidence with one of the following four strengths (as per the AHRQ
methods guide): High, Moderate, Low, and Insufficient. Ratings were assigned based on our
level of confidence that the evidence reflected the true effect for the major comparisons of
interest. Ratings were defined as follows:

High. There is high confidence that the evidence reflects the true effect. Further research is very
unlikely to change our confidence in the estimate of effect. No important scientific disagreement
exists across studies. At least two quality A studies are required for this rating. In addition, there
must be evidence regarding objective clinical outcomes.

Moderate. There is moderate confidence that the evidence reflects the true effect. Further
research may change our confidence in the estimate of effect and may change the estimate. Little
disagreement exists across studies. Moderately rated bodies of evidence contain fewer than two
quality A studies or such studies are inconsistent or lack long-term outcomes of relevant
populations.

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