As Part of a Study on Treatment of Uncomplicated Cellulitis

question 720

Multiple Choice

As part of a study on treatment of uncomplicated cellulitis, outpatients age >12 seeking care at the emergency department with cellulitis and no wound, purulent drainage, or abscess were randomly assigned to either cephalexin plus trimethoprim-sulfamethoxazole for 7 days (n = 85) or cephalexin plus placebo for 7 days (n = 87) .  The primary outcome was clinical cure, defined as absence of fever and more than minimal erythema, swelling, or tenderness (days 14-21) .  A total of 24 patients in the cephalexin plus trimethoprim-sulfamethoxazole group and 18 patients in the cephalexin plus placebo group did not complete treatment as prescribed or failed to complete the test-of-clinical-cure visit; they were categorized as noncompliant patients.  The principal investigator of the study wanted to conduct a per-protocol analysis of the data.  Which of the following describes how the data pertaining to noncompliance should be treated to conduct such an analysis?

• A)Conduct separate analyses for compliant and noncompliant participants
• B)Exclude the 18 noncompliant participants in the placebo group from analysis
• C)Exclude the 24 noncompliant participants in the trimethoprim-sulfamethoxazole group from analysis
• D)Exclude the 42 noncompliant participants from analysis
• E)Keep all 42 noncompliant participants in their respective groups for analysis

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