Question
A clinical trial is run to assess the efficacy of a new pacemaker device in patients with atrial fibrillation (AF).Two hundred participants are randomized to
A clinical trial is run to assess the efficacy of a new pacemaker device in patients with atrial fibrillation (AF).Two hundred participants are randomized to receive the new pacemaker or a currently available pacemaker.There are two primary outcomes of interest - the number of days in a three-month period with an atrial fibrillation event and hospitalization for atrial fibrillation over the three month follow-up period.Data on baseline characteristics and the outcomes are shown below.
Baseline Characteristics
New Pacemaker (n=100)
Available Pacemaker (n=100)
Mean (SD) Age, years
67.3 (5.9)
66.9 (5.6)
% Male
48%
52%
Outcomes
Mean (SD) Number of days with AF event
8.4 (3.2)
14.9 (3.9)
% Hospitalized for AF
4%
9%
- Compute a 95% confidence interval for the difference in mean number of days with an AF event between participants receiving the new pacemaker as compared to the available pacemaker.
- Compute a 95% confidence interval for the mean number of days with an AF event among participants receiving the new pacemaker.
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