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Clinical Questions Addressed by the CER (1 of 2)

Factors Affecting Outcomes: Demographic Subgroups

Make Judgments About the Applicability of Individual Studies. For efficacy trials, clearly report characteristics that may limit applicability. Describe those characteristics in the text or in evidence tables under the heading “comments” or “limitations.” Describe how important factors would affect applicability and the expected direction and magnitude of bias.

Make Judgments About the Applicability of Individual Studies

This slide presents a table of two columns, with one header row and five data rows.  The header row contains titles describing the contents of each column. Column one is labeled Domain.  Column two is labeled Description of Applicability Evidence for a Key Question.  In row one, column one, Domain: Population. Description of Applicability Evidence for a Key Question: The population and disease stage are representative of the United States population with heart failure. In row two, Domain: Intervention. Description of Applicability Evidence for a Key Question: The intervention is plausible. In row three, Domain: Comparators. Description of Applicability Evidence for a Key Question: Watchful waiting is reasonable if the baseline treatment in both groups was standard medical therapy. Standard medical therapy is not being used in most patients. Subgroup analyses suggest that benefits are predominantly in those patients not receiving standard therapy.  In row four, Domain: Outcomes. Description of Applicability Evidence for a Key Question: Although hospitalizations and survival are being evaluated, other outcomes, including harms, are not. In row five, Domain: Setting. Description of Applicability Evidence for a Key Question: The settings for the studies are large tertiary medical centers, which may overestimate the benefits of therapy in actual practice and accentuate the harms.

Step 3. Completed Applicability Summary Table

This slide presents a table consisting of three columns, with one header row and one data row. Column one is labeled Comparison, Column two is labeled Strength of Evidence and Column three is labeled Conclusions With Description of Applicability. In the single data row the contents of each cell is as follows. Column One: Myocardial debulking versus watchful waiting. Column Two: Low. Column Three:  When compared with watchful waiting, the use of myocardial debulking reduced hospitalizations without affecting survival. These results are predominantly limited to patients 65 years of age and older with NYHA class II and III disease. This is similar to the population with heart failure in the United States. In a subgroup analysis, benefits were accentuated in patients not receiving standard medical therapy with ACE inhibitors and ß-blockers, thus limiting applicability. No harms were being evaluated. These trials were conducted in select, large, tertiary medical centers and may not be applicable to other settings.

Summary Table for Body of Evidence Applicability

Key Question 1: Clinical Bottom Line — Behavioral Interventions

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