Question
1.A randomized controlled trial (RCT) was undertaken involving 481 type I (insulin-dependent) patients with diabetes who had little or no evidence of retinopathy at baseline.
1.A randomized controlled trial (RCT) was undertaken involving 481 type I (insulin-dependent) patients with diabetes who had little or no evidence of retinopathy at baseline. Retinopathies are abnormalities of the retina that sometimes occur among patients with diabetes and can result in advanced stages in substantial losses of vision. Patients were randomized to either Sorbinil, an aldose-reductase inhibitor, or placebo and were seen in 1 year and every month up to 48 months after randomization. The primary endpoint of the RCT was based on change in retinopathy severity level from baseline to the final visit at 48 months (i.e., severity level at 48 months less severity level at baseline). An ordinal grading scale was used to evaluate change: 2+ levels better, 1 level better, no change, 1 level worse., 5+ levels worse. The outcome data (number of people for each change in retinopathy severity level) for the treatment group2 are given in the table below. Use these data to answer the questions below the data table.
GROUP
Better
Worse
TOTAL
2+ Levels
1 Level
No Change
1 Level
2 Levels
3 Levels
4 Levels
5+ Levels
Placebo
5
17
84
59
37
18
9
14
243
Sorbinil
4
21
97
50
22
16
14
14
238
TOTAL
9
38
181
109
59
34
23
28
481
You conduct the appropriate statistical test at a 95% confidence level to determine if there is an association between treatment group and change in retinopathy severity level. What do you conclude from this test?Show all calculations.
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