TY - JOUR
T1 - Models for predicting recurrence, complications, and health status in women after pelvic organ prolapse surgery
AU - NICHD Pelvic Floor Disorders Network
AU - Jelovsek, J. Eric
AU - Chagin, Kevin
AU - Lukacz, Emily S.
AU - Nolen, Tracy L.
AU - Shepherd, Jonathan P.
AU - Barber, Matthew D.
AU - Sung, Vivian
AU - Brubaker, Linda
AU - Norton, Peggy A.
AU - Rahn, David D
AU - Smith, Ariana L.
AU - Ballard, Alicia
AU - Jeppson, Peter
AU - Meikle, Susan F.
AU - Kattan, Michael W.
N1 - Funding Information:
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.
Funding Information:
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.
Funding Information:
comes Following Vaginal Prolapse Repair and Mid-urethral Sling, and Operations and Pelvic Muscle Training in the Management of Apical Support Loss trials. The two cohort studies included women from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial who chose not to undergo randomization but participated in a patient-preference cohort and a prospective cohort of women undergoing colpocleisis for advanced prolapse (Colpoclei-sis).2–5 Each model used all four data sets and was designed to separately predict patient-specific probabilities of developing recurrent prolapse, periopera-tive and postoperative complications, and change in overall health status 12 months after prolapse surgery. The Colpopexy and Urinary Reduction Efforts (n5322), Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (n5460), Operations and Pelvic Muscle Training in the Management of Apical Support Loss (n5372), and Colpocleisis (n5147) studies conducted by the Pelvic Floor Disorders Network included multiple geographically diverse clinical sites sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Each study received institutional review board approval at all sites and all participants signed informed research consent.
Funding Information:
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,
Publisher Copyright:
© 2018 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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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U2 - 10.1097/AOG.0000000000002750
DO - 10.1097/AOG.0000000000002750
M3 - Article
C2 - 29995735
AN - SCOPUS:85056542717
SN - 0029-7844
VL - 132
SP - 298
EP - 309
JO - Obstetrics and gynecology
JF - Obstetrics and gynecology
IS - 2
ER -