In Reply We would like to thank Dr Albrich and colleagues and Dr Mori and colleagues for their valuable comments. Several issues of our Original Investigation1 should be clarified for a better understanding.
The choice of noninferiority margin of 3 points on the community-acquired pneumonia (CAP) symptom score is based on a previous study2 that measures this score in 4 different time points.2 From the “pretherapy” to “during therapy” time points, the mean of the score decreased 14 points; and from the “during therapy” to “test of cure” time points the score decreased 7 points, and at this point, approximately 93% of patients achieved clinical success. From this time until 1-month follow-up, changes were minor and results stabilized while the clinical success rate remained similar, and symptom score decreased about 3 points. In response to the question raised by Dr Mori and colleagues, taking the noninferiority design, we have added the 1-sided 95% CI for the between-group difference (Table). Noninferiority was confirmed in the CAP symptom score at day 10 because the upper limit of the 1-sided 95% CI was not higher than the margin of 3 points. Noninferiority was not confirmed in the CAP symptom score at day 5, but it should be highlighted that the primary outcome was measured at day 10 while no intervention was already made at day 5.
Uranga A, Bilbao A, Quintana JM. Validation of IDSA/ATS Algorithm for Duration of Pneumonia Therapy—Reply. JAMA Intern Med. 2017;177(2):284–285. doi:https://doi.org/10.1001/jamainternmed.2016.8586
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: