"A treatment trial is proposed to test the efficacy of vitamin E as a preventative agent for cancer. One problem with such a study is how to assess compliance among participants. A small pilot study is undertaken to establish criteria for compliance with the proposed study agents. In this study, 10 patients are given 400 IU/day of vitamin E and 10 patients are given similar-sized tablets of placebo over a 3-month period. Their serum-vitamin E levels are measured before and after the 3-month period, and the change (3-month baseline) is shown in Table 5.2" (p. 139).

Change in Serum Vitamin E (mg/dl) in Pilot Study

5.36 Suppose a change of 0.30 mg/dl in serum levels is proposed as a test criterion for compliance; that is, a patient who shows a change of greater than or equal to 30 mg/dl is considered a compliant vitamin-E taker. If normality is assumed, what percentage of the vitamin-E group would be expected to show a change of at least 0.30 mg/dl?

5.37 Is the measure in Problem 5.36 a measure of sensitivity, specificity, or predictive value? Why?

5.38 What percentage of the placebo group would be expected to show a change of not more than 0.30 mg/dl?

5.39 Is the measure in Problem 5.38 a measure of sensitivity, specificity, or predictive value? Why?

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