A treatment trial is proposed to test the efficacy of vitamin E as a preventive 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 placebo capsules 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.
A treatment trial is proposed to test the efficacy of vitamin E as a preventive 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 placebo capsules 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.
TABLE 5.2 Change in serum vitamin E (mg/dL) in pilot study
Suppose a new threshold of change, Δ mg/dL, is proposed for establishing compliance. We wish to use a level of Δ such that the compliance measures in Problems 5.36 and 5.38 for the patients in the vitamin E and placebo groups are the same. What should Δ be? What would be the compliance in the vitamin E and placebo groups using this threshold level?
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