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June 9, 2015

Incorrect Outcomes Data

JAMA. 2015;313(22):2287. doi:10.1001/jama.2015.4817

In the Original Investigation entitled “Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial,” published in the March 12, 2014, issue of JAMA (2014;311[10]:1023-1034. doi:10.1001/jama.2014.1719), surgical success rates and the significance of a group interaction were reported inaccurately because of errors in the data. After the article was published, 1 of the 9 clinical sites discovered via internal quality check that values from several participants’ pelvic organ prolapse quantification (POPQ) examinations were entered as positive when they should have been negative. These data entry errors meant that some cases were reported as surgical failures in the article when in fact they were successes. The discovery prompted the authors to perform a network-wide audit of the POPQ values at all of the clinical sites and a subsequent reanalysis. In all, the primary outcome of surgical failure changed for 16 of 307 participants. None of the study conclusions or major inferences was affected. However, several numerical changes were necessary in the text, the figure, and the tables of the anatomic (POPQ) data. This article was corrected online.