Define the following:
- Predictor variable
- Outcome variable
- Dichotomous variable
- Continuous variable
PART 2: (50 points)
Sample size calculations:
The research question is whether there is a difference in the efficacy of Study drug A and Study drug B (which is the standard of care) for the treatment of type 2 diabetes. The investigator has planned a quadruple blind randomized clinical trial to study whether the study drug A is effective in reducing glycosylated hemoglobin (HbA1c) as compared to study drug B (standard of care ) in participants with Type 2 Diabetes after 12 weeks.
A previous study has reported the mean HbA1C level in subjects treated for diabetes is 8 % (% here is a unit of measure) with a standard deviation of 2% (% here is a unit of measure). The investigator would like to be able to detect a difference of 20% or more in the mean HbA1C levels between the two groups
Please note: HbA1c is measured and expressed in percentage as units and not as a percentage of proportions.
Use a two-sided ⍺ = 0.05
And power 0.80.
Calculate the sample size (Answer points 1 – 6)
Hint: Use appropriate table (6A, 6B or 6C depending on the test you select) from the textbook.
Now, considering a 10% dropout rate what would be the increased sample size. (Answer point 7)
State in details:
- The null hypothesis (5 points)
- The alternative hypothesis (5 points)
- Type of test to be used and justification for its use (10 points)
- The information provided (5 points)
- Steps for calculating the sample size (10 points)
- Final answer (5 points)
- Calculations for sample size considering the dropout rate (10 points)
Sample Solution