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Chapter 5: Literature Evaluation II: Beyond the Basics

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For each of the following questions, please select the best answer.

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All of the following are design characteristics of a N-of-1 trial, except:

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a. Randomized and controlled

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b. Parallel groups

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c. Single patient

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d. Crossover component

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b. Parallel groups

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A patient experiences an adverse drug reaction that is not listed in the package insert. The patient's practitioner realizes this should be shared with other practitioners so she writes and publishes this observation in the medical literature. This type of study is termed:

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a. Case series

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b. Case report

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c. Postmarketing study

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d. N-of-1 design

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b. Case report

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A study design that provides information that helps a practitioner decide if various levothyroxine products made by different companies are interchangeable is a:

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a. Non-inferiority study

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b. Stability study

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c. Bioequivalence study

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d. Case series

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c. Bioequivalence study

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If the 95% CI crosses the non-inferiority margin in a non-inferiority study, this is the conclusion that can be made:

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a. Inconclusive results

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b. Non-inferiority findings

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c. Inferiority results

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d. Superiority results

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a. Inconclusive results

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Which of the following statements does not describe the basic adaptive clinical trial (ACT) design?

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a. Allows adaptation of various components of the design

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b. Assists in deciding adaptations based on interim analysis

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c. Uses adaptive-response strategies

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d. Provides rigor and minimal confounding factors

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d. Provides rigor and minimal confounding factors

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Trial #1: The investigators have identified and will observe 1,000 patients with coronary artery syndrome and another 1,000 patients similar to the first group but without coronary artery syndrome over a 5-year period. The primary objective of this study is to see what medical complications develop in those patients with coronary artery syndrome.

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