Assessing Applicability Interactive Quiz

Prepared for:

The Agency for Healthcare Research and Quality (AHRQ)

Training Modules for Systematic Reviews Methods Guide

www.ahrq.gov

Why might trials with run-in periods and high prerandomization exclusion rates negatively affect applicability?B.The adverse events seen in the intervention groups would likely be lower than in the clinical setting.C.The benefits seen in the intervention groups would likely be lower than in the clinical setting.D.Run-in periods should not negatively affect applicability.

Effects of Run-in Periods andPrerandomization Exclusion Criteria

Why might the use of a composite end point (e.g., death, nonfatal myocardial infarction, ventricular fibrillation, stroke, or stable anginal pain) negatively affect applicability?

<Stroke is a surrogate end point.

<It is often difficult to determine the effect of an intervention on each component of the composite end point.

<Composite end points do not affect applicability.

Effects of Composite End Points

A study shows that the use of a new medication in male astronauts, 25 to 35 years of age, prevents bone mineral density loss during prolonged stays in outer space when compared with no therapy. Which factors would limit the applicability of this trial to patients with osteoporosis?

B.Differences in gender and age between the study population and the general population

C.Use of a surrogate end point

D.Differences in setting between the study population and the general population

E.All of the above

Study Population

Why should grading of the strength of evidence and assessment of applicability be carried out separately?

B.Strength of evidence grading and applicability assessment are essentially the same.

C.Studies using strong methods can show that an intervention is superior to a control therapy in a study population, but it may or may not work in actual practice.

D.Strength of evidence grading is primarily associated with assessing the external validity, whereas applicability assessment is concerned with internal validity.

Strength of Evidence

Trial P I C O & S CommentsSmith et al..

Heart failure population

Mean age: 65 years

NYHA class II or III: 83%

Surgical debulking of myocardium

Watchful waiting(ACE inhibitor use, 34%; ß-blocker use, 40%)

Outcomes: hospitalizations and survival Median followup: 1 yearSetting: single, large, tertiary care hospital

An efficacy trial; limited standardization of intervention; comparator did not include optimal medical therapy; unclear how the benefits and harms would compare in a smaller community hospital

Evidence Table

Review the evidence table above. Which columns are completed in step 1 in an applicability assessment?

A. Columns 1 through 5B. Columns 1 through 6C. Column 1 only

ACE = angiotensin-converting enzyme inhibitor; NYHA = New York Heart Association; PICOS = population, intervention, comparators, outcomes, and setting

The process used to assess applicability and to distinguish efficacy trials from effectiveness trials can have many pitfalls.

Using a three-step process to assess applicability can make the process easier.

Transparent reporting of results is an important component of comparative effectiveness reviews.

Summary

This quiz was prepared by C. Michael White, Pharm.D., FCP, FCCP, a member of the University of Connecticut/Hartford Hospital Evidence-based Practice Center.

This module is based on chapter 6 in version 1.0 of the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews (available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10Draft MethodsGuide.pdf).

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