Reference no: EM132848151

A randomized clinical trial was designed to test the efficacy of a new serotonin re-uptake inhibitor (anxiety reducing drug - ARD) to treat the symptoms of anxiety compared to a more traditional approach of behavioral therapy. The trial randomized 1,200 men and women with untreated anxiety symptoms in a 1:1 ratio to either 1) treatment with ARD, and 2) weekly behavioral therapy sessions. The primary endpoint was resolution of anxiety based on results from a validated anxiety assessment instrument. At six months of follow-up it was found that 200 persons in the ARD group and 50 in the behavioral therapy group met the primary endpoint.

1. Calculate the relative risk of anxiety symptoms for persons in the behavioral therapy group compared to those taking ARD. State your results in a sentence.

2. Calculate the efficacy (as risk reduction) of ARD compared to behavioral therapy. State your results in a sentence.

3. How many patients with untreated anxiety would you need to treated with ARD (instead of behavioral therapy) to resolve the symptoms of anxiety over 6 months?

4. In performing the analysis, it was discovered that men responded better to ARD than women, but they had similar responses to behavioral therapy. Also, the majority of subjects in the study were women. How might this affect your results? Can you suggest a study design that might improve the validity of your