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Clinical Questions Addressed by the CER (1 of 2)

Comparative Adverse Effects of Oral Agents: CV Effects

Applicability Resources. Clinical experts and stakeholders can provide general information important to framing applicability issues. What does the population of interest looks like? What types of care or procedures are routine or represent standard of care? Are certain subpopulations characteristically different from others?
This slide contains a table entitled Evidence Table Template for Applicability. The table consists of six columns and two rows. The first row is a header row containing the title headings for each column. Column one is titled Trial.  Column two is titled population. Column three is titled intervention. Column four is titled comparator. Column five is titled outcomes, setting. Column six is titled comments. There is one data row. In the single data row, the contents of each cell are as follows:
Column 1: citation Smith et al., followed by the number 24 as a superscript.  
Column 2: Heart failure population. Population is underlined. On the next line, below: Mean age: 65 years. 65 years is underlined. On the next line, below: NYHA class II or III: 83%. Column 3: Surgical debulking of myocardium. Column 4: Watchful waiting. (ACE inhibitor use, 34%; beta-blocker use, 40%. )  Column 5: Hospitalizations and survival.  Survival is underlined.  This is followed by: Median followup at 1 year. Year is underlined. This is followed on the next line below by the words Single, large, tertiary care hospital. Column 6: An efficacy trial (underlined;) limited standardization of intervention (underlined,) comparator did not include optimal medical therapy (underlined,) unclear how the benefits and harms would compare in a smaller community hospital.

Evidence Table Template for Applicability

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

This slide set is based on a comparative effectiveness review (CER) titled, Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) or Angiotensin II-Receptor Blockers (ARBs) Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease (IHD), that was developed by the University of Connecticut/Hartford Hospital Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) and is available online at effectivehealthcare.ahrq.gov (Contract No. 290-2007-10067-I). CERs represent comprehensive systematic reviews of the literature usually comparing two or more types of treatment, such as different drugs, for the same disease. Primary clinical trials were identified from searches of MEDLINE (1966 to February 2009), Embase (1974 to February 2009), and the Cochrane Central Register of Controlled Trials (1966 to February 2009). The methods used to develop this CER followed version 1.0 of the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews published by AHRQ (draft available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf).

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function

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