Evidence map›Paper›PMID 27319365›Full record

Observational studyAmerican journal of obstetrics and gynecology2016

Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse.

Vivian W Sung, Kyle J Wohlrab, Annetta Madsen, Christina Raker

Registry-linked trialOpen access · greenAbstract readComparative StudyObservational Study
In one paragraph

Observational study in American journal of obstetrics and gynecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03446950 (Candy Cane vs. Boot Stirrups in Vaginal Surgery), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03446950 nacompletednot on this mapstarted 2018, after this paper: background citation

Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial

TypeinterventionalSponsorUniversity of LouisvilleRan2018 to 2020Enrolled155ConditionsPhysical Activity, Surgery, Vaginal Hysterectomy, Vaginal SurgeryArmsVaginal Surgery
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Vivian W SungDivision of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI. Electronic address: vsung@wihri.org.
Kyle J WohlrabDivision of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI.
Annetta MadsenDivision of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI.
Christina RakerDivision of Research, Women and Infants Hospital of Rhode Island, Providence, RI.
Brown University · USWomen & Infants Hospital of Rhode Island · US

Funding

Brown/WIH Women's Reproductive Health Research Career Development ProgramK12HD050108 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI HAMPTON, BRITTANY STAR · 2005 to 2019
$4.1M
Patient-Reported Outcomes in Functioning for Female Pelvic Floor DisordersK23HD060665 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI SUNG, VIVIAN W · 2009 to 2013
$671k
NICHD NIH HHS K12 HD050108NICHD NIH HHS K23 HD060665
6 · The paper itself

Abstract

backgroundPelvic organ prolapse can have a negative impact on a woman's overall functioning. When choosing between surgery or pessary, many women have information needs about long-term expectations. Whereas it has been shown that both surgery and pessary can improve prolapse symptoms, there is less information comparing comprehensive functioning outcomes and goal attainment between the 2 treatments.

objectiveOur primary objective was to compare patient-reported goal attainment and comprehensive physical, social, and emotional functioning outcomes after surgery vs pessary for symptomatic prolapse. STUDY

designWe conducted a prospective, observational, cohort study including women choosing surgery or pessary for symptomatic stage 2 or greater prolapse. Women undergoing any modality of prolapse surgery or those anticipating using a pessary long-term to avoid surgery were eligible. Women completed questionnaires at baseline (before treatment) and up to 12 months after treatment including the following: (1) pretreatment goals and actual posttreatment goals achieved; (2) 5 functioning outcomes encompassing physical, social, and emotional function using the Patient-Reported Outcomes Measurement Information System surveys; and (3) validated symptom and quality-of-life questionnaires. Treatment goals were categorized into symptom goals (prolapse, urinary, bowel, pain) and function goals (physical, social, emotional, sexual). Goals achieved were compared using a χ

resultsA total of 160 women were enrolled and 72 surgical (90%) (mean follow-up 12 months) and 64 pessary patients (80%) (mean follow up 8 months) had posttreatment data. Fourteen discontinued pessary use and 8 ultimately crossed over to surgery. At follow-up, a higher proportion of women in the surgery arm reported successfully achieving symptom goals and function goals compared with women who chose pessary (P < .05). Women who continued pessary use had comparable goal attainment with women in the surgery group for almost all goal categories, whereas women who discontinued the pessary or crossed over to surgery had significantly lower goal attainment compared with both the surgery and pessary continuation groups. On multiple logistic regression, only college education or higher was associated with an increased odds of not achieving all pretreatment goals (odds ratio, 2.70, 95% confidence interval, 1.1-6.6, P = .03). Regarding functioning outcomes, within groups, there were statistically significant improvements between pre- and posttreatment Patient-Reported Outcomes Measurement Information System functioning scores in all 5 domains for the surgery group and 4 of 5 domains in the pessary group (P < .05). When comparing between groups, women who had surgery reported significantly greater improvements in the physical function, social roles, and depression domains compared with the pessary group (P < .05).

conclusionWomen undergoing either surgery or pessary for symptomatic prolapse experience goal attainment and improvements in physical, social, and emotional functioning, although surgery is associated with greater improvements.

Indexed as

GoalsGynecologic Surgical ProceduresPatient Outcome AssessmentPessariesRecovery of FunctionAdultAgedFemaleFollow-Up StudiesHumansLogistic ModelsMiddle AgedPatient SatisfactionPelvic Organ ProlapseProspective StudiesQuality of Lifegoalpatient-reported outcomespelvic floor disorderspelvic prolapsepessarysurgical treatment

Identifiers

PMID27319365
PMCPMC5086295
OpenAlexW2442344571

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.