The authors of Mayer-Hamblett and colleagues (1), which was published in the November 1, 2018, issue of the Journal, have alerted us to an errant data point that was included in the article.
The authors explained that the value for one of the placebo participants’ height at visit 8 (18 mo after randomization) was discovered to be too small when compared with additional data they obtained for this subject. The calculation for FEV1% predicted uses height; therefore, this participant’s FEV1% predicted was calculated incorrectly, giving a falsely high FEV1% predicted at the final study visit (18-mo visit). Therefore, the third sentence in Secondary Clinical Outcomes in the Results section (p. 1181) should be corrected to read as follows:
No significant difference between treatment groups was seen with respect to the average 18-month change in FEV1% predicted among participants who were old enough to perform spirometry (n = 69 azithromycin and n = 63 placebo; 0.47% difference; 95% CI, −5.45 to 6.40; P = 0.863; Figure E6), or any other spirometry parameters (data not shown).
In addition, corrected graphs have been included in the online supplement for this article (Figures E5 and E6).
The authors state that the corrected data and calculations bring the estimate of the treatment effect closer to the null hypothesis and do not alter their original interpretation of the result of no significant difference between treatment groups with respect to lung function. They apologize for the error.
Reference
- 1.Mayer-Hamblett N, Retsch-Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, Black P, Brown P, Cairns A, Davis SD, Graff GR, Kerby GS, Orenstein D, Buckingham R, Ramsey BW OPTIMIZE Study Group. Azithromycin for early Pseudomonas infection in cystic fibrosis. The OPTIMIZE randomized trial. Am J Respir Crit Care Med. 2018;198:1177–1187. doi: 10.1164/rccm.201802-0215OC. [DOI] [PMC free article] [PubMed] [Google Scholar]