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"comparator"

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Components. Population of interest. Intervention. Linkages that demonstrate key questions. Intermediate outcomes. Ultimate health outcomes (including harms).

Components

Learning Objectives

Three Steps To Assess Applicability. Stepwise approach to applicability: 1. Identify beforehand a limited number of factors that are most likely to influence applicability of evidence for the specific issue being reviewed and report the relevant elements from individual studies. 2. Judge limitations to the applicability of individual studies based on those factors. 3. Summarize the applicability of the body of evidence from multiple studies with respect to specific populations, interventions, comparisons, and outcomes.

Three Steps To Assess Applicability

Step 1. Determine and Report the Most Important Factors in PICOS Format. Identify most important applicability issues. Understand the real-world context. Understand how studies differ from the real-world context. Use PICOS format to organize factors. Report features from individual studies that impact applicability in evidence tables. PICOS = population, intervention, comparators, outcomes, and setting.

Step 1. Determine and Report the Most Important Factors in PICOS Format

Comparator and Applicability: Examples. A fixed-dose study that compared high-dose duloxetine to low-dose paroxetine. Many trials evaluating magnesium as a treatment for acute myocardial infarction that were conducted before thrombolytic drugs, antiplatelet drugs, beta-blockers, and primary percutaneous coronary intervention (PCI) were used. Only 1 of 23 trials that compared bypass surgery to PCI used drug-eluting stents.

Comparator and Applicability: Examples

This slide presents a table describing how the comparator or outcomes assessed can affect applicability of the study.  The table consists of two columns of six rows.  Column one is titled ,“Conditions that limit applicability” and column two is titled, “Features that should be extracted into evidence tables.” The data rows are organized under subheader rows. The first row below the column header is a subheader row is designated Comparator.  This is followed by two data rows. Each data row contains conditions described in column one and associated features to be extracted in column two. In the first row, conditions that limit applicability: regimen not reflective of current practice.  In the second column, features that should be extracted into evidence tables: medication dose, schedule and duration, followed in parentheses by the words if applicable. In the second row, conditions that limit applicability: use of substandard alternative therapy. In the second column, features that should be extracted into evidence tables: comparator chosen vs. others available, followed in parentheses by the words if applicable. The next row is the subheader row entitled, “Outcomes.” This is followed by one data row. In the column, conditions that limit applicability: surrogate endpoints, brief follow-up periods, improper definitions for outcomes, composite endpoints . In the second column, features that should be extracted into evidence tables: outcomes (benefits and harms) and  how they were defined.

Comparator, Outcomes, and Applicability

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

Step 3. Consider and Summarize the Applicability of a Body of Evidence From Individual Studies. Describe the limitations of aggregate evidence in the conclusions. Generate a summary applicability table with a PICOS structure. Aggregate applicability is not the sum of applicability of individual studies. Each individual study can have relatively low applicability in at least one PICOS domain, but the body of evidence can have high applicability. PICOS = population, intervention, comparators, outcomes, and setting.

Step 3. Consider and Summarize the Applicability of a Body of Evidence From Individual Studies

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