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Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery

Jelovsek, J. Eric, MD, MMEd; Chagin, Kevin, MS; Lukacz, Emily S., MD, MAS; Nolen, Tracy L., DrPh; Shepherd, Jonathan P., MD, MSc; Barber, Matthew D., MD, MHS; Sung, Vivian, MD, MPH; Brubaker, Linda, MD, MS; Norton, Peggy A., MD; Rahn, David D., MD; Smith, Ariana L., MD; Ballard, Alicia, MD; Jeppson, Peter, MD; Meikle, Susan F., MD, MSPH; Kattan, Michael W., PhD for the NICHD Pelvic Floor Disorders Network

doi: 10.1097/AOG.0000000000002750
Female Pelvic Reconstruction: Original Research: PDF Only

OBJECTIVE: To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery.

METHODS: Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery. Complications were defined as any serious adverse event or Dindo grade III complication within 12 months of surgery. Significant change in health status was defined as a minimum important change of SF-6D utility score (±0.035 points) from baseline. Thirty-two candidate risk factors were considered for each model and model accuracy was measured using concordance indices. All indices were internally validated using 1,000 bootstrap resamples to correct for bias.

RESULTS: The models accurately predicted composite recurrent prolapse (concordance index=0.72, 95% CI 0.69–0.76), bothersome vaginal bulge (concordance index=0.73, 95% CI 0.68–0.77), prolapse beyond the hymen (concordance index=0.74, 95% CI 0.70–0.77), serious adverse event (concordance index=0.60, 95% CI 0.56–0.64), Dindo grade III or greater complication (concordance index=0.62, 95% CI 0.58–0.66), and health status improvement (concordance index=0.64, 95% CI 0.62–0.67) or worsening (concordance index=0.63, 95% CI 0.60–0.67). Calibration curves demonstrated all models were accurate through clinically useful predicted probabilities.

CONCLUSION: These prediction models are able to provide accurate and discriminating estimates of prolapse recurrence, complications, and health status 12 months after prolapse surgery.

Prediction models for pelvic organ prolapse recurrence, complications, and health status 12 months postoperatively provide accurate risk–benefit estimates to aide in surgical patient counseling.

Obstetrics, Gynecology & Women’s Health Institute and Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; the Department of Obstetrics & Gynecology, Duke University, Durham, North Carolina; the Department of Reproductive Medicine, UC San Diego Health System, San Diego, California; RTI International, Research Triangle Park, North Carolina; the Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; the Department of Obstetrics and Gynecology Women and Infants Hospital, Providence, Rhode Island; the Department of Obstetrics & Gynecology and Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, Illinois; the Department of Obstetrics and Gynecology University of Utah, Salt Lake City, Utah; the Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas; the Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania; the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; Northwest Physician Group, Amarillo, Texas; and the Department of Medicine, University of Texas Health Science Center at Houston, Houston, Texas.

Corresponding author: J. Eric Jelovsek, MD, MMEd, 209 Baker House, DUMC 3084, Durham, NC 27710; email: eric.jelovsek@duke.edu.

Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (2U01HD41249, 2U10 HD41250, 2U10 HD41261, 2U10 HD41267, 1U10 HD54136, 1U10 HD54214, 1U10 HD54215, 1U10 HD54241, U10 HD069013, U10 HD069025, U10 HD069010, U10 HD069010, and U01 HD069031) and the National Institutes of Health Office of Research on Women’s Health.

Financial Disclosure Dr. Brubaker has received honorarium from UpToDate. Emily S. Lukacz has received research grants or support from Boston Scientific (research funding), Uroplasty (research funding), and Pfizer (study drug donation). She has been a consultant to AMS, Axonics, and Renew Medical and has received royalties from UpToDate. The other authors did not report any potential conflicts of interest.

Presented at the Joint American Urogynecologic Society–International Urogynecologic Society Annual Meeting, July 21–26, 2014, Washington, DC.

Each author has indicated that he or she has met the journal's requirements for authorship.

Received February 27, 2018

Received in revised form April 25, 2018

Accepted May 22, 2018

© 2018 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.