Illustration with the NPC Trial Data Sample Clauses

Illustration with the NPC Trial Data. The NPC trial is a randomized double-blind, placebo-controlled clinical trial to eval- uate the long term safety and efficacy of a daily 200-µg supplement of selenium (Se) in preventing two types of skin cancers, BCC and SCC. Patients with previous his- tories of BCC or SCC were recruited and randomized into the treatment group in which patients were supposed to take daily 200-µg supplement of selenium (Se), or the control group in which placebo pills were given. One of the primary end points of this trial was newly diagnosed SCC lesions. In this analysis, we are interested in the effect of baseline plasma Se on new SCC lesions. In the NPC trial, measurements of plasma Se were taken from routine clinic visits at approximately six months intervals. For those in the control group, repeated measurements for each patient might represent replicated measurements of baseline plasma Se under the assumption of stationarity (Jiang et al., 1999; Hu & Lin, 2004). This, however, would not be true for patients in the Se group since the plasma Se level was likely to change due to the treatment. As an illustration of the proposed estimation procedure, we will restrict our attention to the patients in the control group. We considered selenium measurements within 24 months of randomization and included 589 patients in the control group with at least 2 such measurements in the analysis. The average number of replicates was 4.4 with a maximum of 12 replicates. One hundred sixty seven (28.4%) patients had at least one occurrence of SCC after randomization. More specifically, 83 (14.1%), 32 (5.4%), 19 (3.2%) and 33 (5.6%) patients had 1, 2, 3 and 4 or more occurrences. The average duration of follow-up was 67.7 months and the average number of occurrences was 0.67 per patient. Table 2.4: NPC Trial SCC Data Method Estimate SE Naive II 1.280 0.634 Proposed 1.743 1.292 Note: Baseline Se measurement (Naive I), Average of all Se measurements (Naive II), Regression Calibration (RC), and Proposed Estimator (Proposed) The covariate of interest is the logarithm of the true baseline selenium. Table
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