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This week's homework is based on the following article. Please answer the questions using the information given in this abstract and in the table. Assume
This week's homework is based on the following article. Please answer the questions using the information given in this abstract and in the table. Assume that =0.05. BACKGROUND. It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes. METHODS. Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma. RESULTS. A total of 958 women were randomly assigned to a study group 485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively). However, there were significant reductions with treatment as compared with usual care in mean birth weight. The mean birth weight (SD) in the treatment group was 3302 g (502.4) and the mean birth weight (SD) in the control group was 3408 g (589.4) Table 1. Characteristics of the Study Samples at Randomization Variable Treatment Group Control Group (N=485) (N=473) Age - yr 29.25.7 28.95.6 Primigravida - no. (%) 104 (21.4) 123 (26.0) Smoking - no. (%) 38 (7.8) 31 (6.6) Body Mass Index 30.15.0 30.25.1 kg/m2 Duration of gestation - 28.81.6 28.91.5 wk *Plus-minus values are means SD. p-value 0.35 0.09 0.47 0.67 0.08 1. What is the study design? 2. What is the primary outcome in this study? 3. What are the sample sizes for the treatment and control group? 4. Based on Table 1, did randomization work in this study? Justify. 5. Generate a 95% confidence interval around the difference in the mean birth weights between treatment and control groups. 6. In the abstract, authors state the following: \"We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups).\" Provide evidence for this statement using 95% confidence intervals. Note: do not perform hypothesis testing
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