Evidence map›Paper›PMID 32217922›Full record

ArticleFemale pelvic medicine & reconstructive surgery2021

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

Elisabeth Erekson, Shawn Menefee, Ryan E Whitworth, Cindy L Amundsen, Lily A Arya, Yuko M Komesu, Cecile A Ferrando, Halina M Zyczynski, Vivian W Sung, David D Rahn and 5 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Female pelvic medicine & reconstructive surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
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

15 authors at 13 institutions in 1 country.

Elisabeth EreksonFrom the Department of Obstetrics and Gynecology, The Geisel School of Medicine at Dartmouth, Hanover, NH.
Shawn MenefeeUniversity of California, San Diego, and Kaiser Permanente, San Diego, CA.
Ryan E WhitworthRTI International, Research Triangle Park.
Cindy L AmundsenDuke University Medical Center, Durham, NC.
Lily A AryaUniversity of Pennsylvania, Philadelphia, PA.
Yuko M KomesuUniversity of New Mexico Health Sciences Center, Albuquerque, NM.
Cecile A FerrandoDepartment of Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.
Halina M ZyczynskiThe Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA.
Vivian W SungAlpert Medical School of Brown University, Providence, RI.
David D RahnUniversity of Texas Southwestern Medical Center, Dallas, TX.
Jasmine Tan-KimUniversity of California, San Diego, and Kaiser Permanente, San Diego, CA.
Donna MazloomdoostThe Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Marie G GantzRTI International, Research Triangle Park.
Holly E RichterUniversity of Alabama at Birmingham, Birmingham, AL.
Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN)
RTI International · USBrown University · USCleveland Clinic · USDartmouth College · USDuke Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USKaiser Permanente San Diego Medical Center · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, San Diego · USUniversity of New Mexico · USUniversity of Pennsylvania · USUniversity of Pittsburgh · US

Funding

Pelvic Floor Disorders Network Data Coordinating Center Administrative Supplement: ODSS CDE FundingU24HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MARIE G GANTZ · 2016 to 2026
$35.8M
SYNERGY: The Dartmouth Center for clinical and Translational ScienceKL2TR001088 · NCATS · DARTMOUTH COLLEGE · PI GREEN, ALAN I · 2013 to 2017
$3.3M
Brown/WIH Pelvic Floor Disorders Network Site (UG1)UG1HD069013 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI Vivian W Sung · 2016 to 2026
$3.1M
Pelvic Floor Disorders Network 2021UG1HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI David Dwight Rahn · 2016 to 2026
$3.0M
Pelvic Floor Disorders Network Clinical Sites (UG1)UG1HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Heidi S Harvie · 2016 to 2026
$3.0M
Pelvic Floor Disorders Network Clinical Site Application: The San Diego PelvicFloor ConsortiumUG1HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EMILY S. LUKACZ, Shawn A Menefee · 2016 to 2026
$2.9M
Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical SiteUG1HD041267 · NICHD · DUKE UNIVERSITY · PI NAZEMA Y SIDDIQUI · 2016 to 2026
$2.8M
Brain-Centered Therapy versus Medication for Urgency Urinary Incontinence_An RCTR01AT007171 · NCCIH · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI KETAI, LOREN HOWARD, KOMESU, YUKO MARGARET · 2012 to 2016
$2.7M
Investigation to Minimize Prolapse Recurrence Of the Vagina using Estrogen (IMPROVE)R01AG047290 · NIA · UT SOUTHWESTERN MEDICAL CENTER · PI RAHN, DAVID DWIGHT · 2015 to 2019
$2.5M
Pittsburgh Pelvic Floor Research ProgramU10HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2011 to 2015
$1.6M
Pittsburgh Pelvic Floor Research ProgramUG1HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2016 to 2021
$1.5M
University of Alabama at Birmingham: Pelvic Floor Disorders NetworkUG1HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2016 to 2021
$1.4M
NCATS NIH HHS KL2 TR001088NCCIH NIH HHS R01 AT007171NIA NIH HHS R01 AG047290NICHD NIH HHS U10 HD069006NICHD NIH HHS U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD041267NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD054241NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010NICHD NIH HHS UG1 HD069013
6 · The paper itself

Abstract

objectiveWe present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP.

methodsThe selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification.

conclusionsThis trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Indexed as

Preoperative PeriodAgedFemaleFrailtyGeriatric AssessmentHumansOutcome Assessment, Health CarePelvic Organ ProlapsePostoperative ComplicationsRandomized Controlled Trials as Topic

Identifiers

PMID32217922
PMCPMC7381379
OpenAlexW3013315764

What OpenQuestion holds

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Registered trials

None linked

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.