Database Updates and Resulting Changes in Data in Study of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy

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To the Editor My coauthors and I report some database updates and resulting changes in our Original Investigation titled “Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial,” published in the September 17, 2019, issue of JAMA.1 During the final database cleaning for the final 5-year study database lock, a biannual study-wide audit review of the Pelvic Organ Prolapse Quantification (POPQ) examination data identified some updates that influenced the value of the primary outcome (treatment failure). There were 3 failure events for which a POPQ data correction either increased the time to initial failure (1 patient randomized to undergo hysteropexy) or changed the value of the event from a failure to a nonfailure (1 patient randomized to undergo hysteropexy and 1 randomized to undergo hysterectomy). In addition, there were a few minor database updates that did not affect the primary outcome but altered some of the at-visit failure and failure-type rates. The adjusted hazard ratio of failure for hysteropexy vs hysterectomy changed from 0.62 to 0.61.