Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse

The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the...

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Veröffentlicht in:American journal of obstetrics and gynecology 2021-04, Vol.224 (4), p.362.e1-362.e11
Hauptverfasser: Jelovsek, J. Eric, Gantz, Marie G., Lukacz, Emily, Sridhar, Amaanti, Zyczynski, Halina, Harvie, Heidi S., Dunivan, Gena, Schaffer, Joseph, Sung, Vivian, Varner, R. Edward, Mazloomdoost, Donna, Barber, Matthew D.
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container_end_page 362.e11
container_issue 4
container_start_page 362.e1
container_title American journal of obstetrics and gynecology
container_volume 224
creator Jelovsek, J. Eric
Gantz, Marie G.
Lukacz, Emily
Sridhar, Amaanti
Zyczynski, Halina
Harvie, Heidi S.
Dunivan, Gena
Schaffer, Joseph
Sung, Vivian
Varner, R. Edward
Mazloomdoost, Donna
Barber, Matthew D.
description The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel “intermittent” success and failure over time. Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure cl
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Eric ; Gantz, Marie G. ; Lukacz, Emily ; Sridhar, Amaanti ; Zyczynski, Halina ; Harvie, Heidi S. ; Dunivan, Gena ; Schaffer, Joseph ; Sung, Vivian ; Varner, R. Edward ; Mazloomdoost, Donna ; Barber, Matthew D.</creator><creatorcontrib>Jelovsek, J. Eric ; Gantz, Marie G. ; Lukacz, Emily ; Sridhar, Amaanti ; Zyczynski, Halina ; Harvie, Heidi S. ; Dunivan, Gena ; Schaffer, Joseph ; Sung, Vivian ; Varner, R. Edward ; Mazloomdoost, Donna ; Barber, Matthew D. ; National Institute of Child Health and Human Development Pelvic Floor Disorders Network ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network</creatorcontrib><description>The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of &gt;0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel “intermittent” success and failure over time. Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores. True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of “surgical success” at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2020.10.009</identifier><identifier>PMID: 33039390</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; anatomic definition ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Multicenter Studies as Topic ; Patient Outcome Assessment ; pelvic organ prolapse ; Pelvic Organ Prolapse - surgery ; quality of life ; Quality-Adjusted Life Years ; Randomized Controlled Trials as Topic ; recurrent event ; reoperation ; Retreatment - statistics &amp; numerical data ; Retrospective Studies ; subjective definition ; surgical outcomes ; time to event ; Treatment Failure</subject><ispartof>American journal of obstetrics and gynecology, 2021-04, Vol.224 (4), p.362.e1-362.e11</ispartof><rights>2020 Elsevier Inc.</rights><rights>Copyright © 2020 Elsevier Inc. 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Eric</creatorcontrib><creatorcontrib>Gantz, Marie G.</creatorcontrib><creatorcontrib>Lukacz, Emily</creatorcontrib><creatorcontrib>Sridhar, Amaanti</creatorcontrib><creatorcontrib>Zyczynski, Halina</creatorcontrib><creatorcontrib>Harvie, Heidi S.</creatorcontrib><creatorcontrib>Dunivan, Gena</creatorcontrib><creatorcontrib>Schaffer, Joseph</creatorcontrib><creatorcontrib>Sung, Vivian</creatorcontrib><creatorcontrib>Varner, R. Edward</creatorcontrib><creatorcontrib>Mazloomdoost, Donna</creatorcontrib><creatorcontrib>Barber, Matthew D.</creatorcontrib><creatorcontrib>National Institute of Child Health and Human Development Pelvic Floor Disorders Network</creatorcontrib><creatorcontrib>Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network</creatorcontrib><title>Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of &gt;0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel “intermittent” success and failure over time. Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores. True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of “surgical success” at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.</description><subject>Aged</subject><subject>anatomic definition</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Patient Outcome Assessment</subject><subject>pelvic organ prolapse</subject><subject>Pelvic Organ Prolapse - surgery</subject><subject>quality of life</subject><subject>Quality-Adjusted Life Years</subject><subject>Randomized Controlled Trials as Topic</subject><subject>recurrent event</subject><subject>reoperation</subject><subject>Retreatment - statistics &amp; numerical data</subject><subject>Retrospective Studies</subject><subject>subjective definition</subject><subject>surgical outcomes</subject><subject>time to event</subject><subject>Treatment Failure</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UU1r3DAQFaWl2aT9AzkUHXuot_rw2haUQgj5KAR6aHIWY3m0lbEtV5IX8u8rs0loLj1IYmbeezOaR8g5Z1vOePW130Lv91vBxJrYMqbekA1nqi6qpmrekg1jTBRK1s0JOY2xX0OhxHtyIiWTSiq2If2vxRiMkcLUUQtuWAJSyKd7nGB05gsNaJYQcEoUD-sdEyTMeJsw0LiEvTMw0BQQ0rjWrQ90xuHgDPVhDxOdgx9gjviBvLMwRPz49J6Rh-ur-8vb4u7nzY_Li7vClLtdKuqyVGBVjV0NqGqwbNdZYaCSyLuWt9bm3wllm5Yb20rB2nJnJWttW2aabeQZ-X7UnZd2xM7koQIMeg5uhPCoPTj9ujK533rvD7rJG6yrOgt8fhII_s-CMenRRYPDABP6JWqRJ1Qqb5JnqDhCTfAxBrQvbTjTq0m616tJejVpzeUWmfTp3wFfKM-uZMC3IwDzmg4Og47G4WSwc9mNpDvv_qf_F1Wcp3Y</recordid><startdate>20210401</startdate><enddate>20210401</enddate><creator>Jelovsek, J. 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source MEDLINE; Elsevier ScienceDirect Journals
subjects Aged
anatomic definition
Female
Follow-Up Studies
Humans
Middle Aged
Multicenter Studies as Topic
Patient Outcome Assessment
pelvic organ prolapse
Pelvic Organ Prolapse - surgery
quality of life
Quality-Adjusted Life Years
Randomized Controlled Trials as Topic
recurrent event
reoperation
Retreatment - statistics & numerical data
Retrospective Studies
subjective definition
surgical outcomes
time to event
Treatment Failure
title Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse
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