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Laparoscopic Non-Mesh Cerclage Pectopexy for Pelvic Organ Prolapse
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Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery
J Eric Jelovsek1, Kevin Chagin, Emily S Lukacz
1Obstetrics, 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.
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.
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