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Question 1 of 4
1. Question
Question 1 of 4
A clinical study is conducted to assess the role of non-specific beta-blockers in secondary prevention of variceal bleeding. Patients with liver cirrhosis surviving the first episode of variceal bleeding are treated with propranolol. The drug assignment (propranolol vs. placebo) is performed randomly. After patients have agreed to participate in the study, a computer assigns a random number to each patient which places him or her in one of the two groups. This drug assignment strategy is most helpful for controlling which of the following?
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Question 2 of 4
2. Question
Question 2 of 4
A clinical trial is designed to evaluate the effect of a beta-blocker on the survival of patients with class IV heart failure. The beta-blocker or placebo therapy is given to patients along with standard therapy for heart failure. Neither the patient nor clinicians are aware of the drug (beta-blocker or placebo) that the patient is taking. The latter study design feature is used to prevent which of the following?
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Question 3 of 4
3. Question
Question 3 of 4
A large-scale double-blind randomized clinical trial is conducted to assess the effect of a new aldosterone antagonist on the mortality and morbidity of congestive heart failure, class III-IV. 2,000 patients are enrolled: 1200 are assigned to the drug and 800 are assigned to placebo. According to the study results, patients treated with the new drug have improved survival (RR = 0.85, p = 0.02) and decreased risk of hospitalization (RR = 0.65, p < 0.01). The investigators also report that 10% of the placebo group and 14% of the treatment group discontinued therapy and that an additional 6% of patients in the placebo group were prescribed a different aldosterone antagonist. It is described in the statistical methods that the analysis was performed using the ‘intention-to-treat’ approach. Which of following is the best statement concerning the benefits of ‘intention-to-treat’?
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Question 4 of 4
4. Question
Question 4 of 4
A large-scale clinical trial is conducted to evaluate the effect of the beta-blocker therapy on the survival of patients with chronic heart failure, class IV. The patients with severe heart failure are randomly assigned to carvedilol, a beta-blocker or to placebo. In their report of the study results, the investigators include a table with baseline characteristics (age, race, prevalence of hypertension, etc) of the patients in the treatment and placebo groups. According to the table, both groups have similar distributions of these characteristics. The similar distributions of these characteristics best reflects which of the following:
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