![[object Object],[object Object],[object Object],[object Object],Effects of Run-in Periods and Prerandomization Exclusion Criteria](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Assessing Applicability Quiz
Similar to Assessing Applicability Quiz (20)
More from Effective Health Care Program
More from Effective Health Care Program (18)
Recently uploaded
Recently uploaded (20)
Assessing Applicability Quiz
- 1. Assessing Applicability Interactive Quiz Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov
- 6. Evidence Table Review the evidence table above. Which columns are completed in step 1 in an applicability assessment? A. Columns 1 through 5 B. Columns 1 through 6 C. Column 1 only ACE = angiotensin-converting enzyme inhibitor; NYHA = New York Heart Association; PICOS = population, intervention, comparators, outcomes, and setting Trial P I C O & S Comments Smith 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 year Setting: 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
Editor's Notes
- Assessing Applicability Interactive Quiz
- Effects of Run-in Periods and Prerandomization Exclusion Criteria Why might trials with run-in periods and high prerandomization exclusion rates negatively affect applicability? Correct. Run-in periods can be constructed so that subjects who are tolerating therapy, are adherent to therapy, and/or are experiencing therapeutic benefits can progress to be randomized. Thus, the occurrence of adverse events can be suppressed while adherence and benefits are accentuated. Incorrect. In general, run-in periods eliminate subjects who will not tolerate or are not adherent to therapy. Some trials use run-in periods to eliminate subjects who do not experience some intermediate health-outcome benefit of therapy. Therefore, run-in periods would either accentuate or not affect benefits. Incorrect. Run-in periods may suppress the occurrence of adverse events or accentuate the benefits, or both of these may occur within a trial.
- Effects of Composite End Points 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? Incorrect. Stroke is a final health outcome that can negatively affect survival, self-sufficiency, and quality of life. Correct. Composite end points make it difficult to determine which constituent outcomes are affected by an intervention. It is possible that the benefits may be concentrated in only one or two end points, rather than being evenly distributed across all of the constituent end points. This negatively affects applicability. Incorrect. Composite end points make it difficult to determine which constituent outcomes are affected by an intervention. It is possible that the benefits may be concentrated in only one or two end points, rather than being evenly distributed across all of the constituent end points. This negatively affects applicability.
- Study Population 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? Correct, but there is a better answer. The impact of a drug on bone mineral density in young, male, well-trained astronauts in outer space may not be representative of the impact on older, mostly female, patients residing on Earth. In addition, bone mineral density is a surrogate end point for the risk of bone fracture, which limits applicability. Correct, but there is a better answer. The impact of a drug on bone mineral density in young, male, well-trained astronauts in outer space may not be representative of the impact on older, mostly female, patients residing on Earth. In addition, bone mineral density is a surrogate end point for the risk of bone fracture, which limits applicability. Correct, but there is a better answer. The impact of a drug on bone mineral density in young, male, well-trained astronauts in outer space may not be representative of the impact on older, mostly female, patients residing on Earth. In addition, bone mineral density is a surrogate end point for the risk of bone fracture, which limits applicability. Correct. The impact of a drug on bone mineral density in young, male, well-trained astronauts in outer space may not be representative of the impact on older, mostly female, patients residing on Earth. In addition, bone mineral density is a surrogate end point for the risk of bone fracture, which limits applicability.
- Strength of Evidence Why should grading of the strength of evidence and assessment of applicability be carried out separately? Incorrect. Strength of evidence grading is primarily concerned with the confidence that the intervention of interest is working under study conditions. It is highly influenced by the internal validity of the study. In essence, it is asking, “Does the intervention work?” Correct. 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. Incorrect. Strength of evidence grading is primarily concerned with internal validity items, such as identifying biases.
- Evidence Table Review the evidence table above. Which columns are completed in step 1 in an applicability assessment? Correct. In step 1 of the process, data on factors identified a priori as most likely to impact applicability are extracted for each study and entered in the table by using the PICOS (population, intervention, comparators, outcomes, and setting) format. In step 2, judgments about whether a trial is an effectiveness or efficacy trial are made, and components that may negatively impact applicability are summarized in the “comments” column. B. Incorrect. In step 1 of the process, data on factors identified a priori as most likely to impact applicability are extracted for each study and entered in the table by using the PICOS format. In step 2, judgments about whether a trial is an effectiveness or efficacy trial are made, and components that may negatively impact applicability are summarized in the “comments” column. Incorrect. In step 1 of the process, data on factors identified a priori as most likely to impact applicability are extracted for each study and entered in the table by using the PICOS format. In step 2, judgments about whether a trial is an effectiveness or efficacy trial are made, and components that may negatively impact applicability are summarized in the “comments” column.
- Summary
- Author This interactive quiz augments the module on assessing applicability. It was prepared by C. Michael White, Pharm.D., FCP, FCCP, a member of the University of Connecticut/Hartford Hospital Evidence-based Practice Center. The 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_10DraftMethodsGuide.pdf).