Evidence map›Paper›PMID 25185630›Full record

Trial reportFemale pelvic medicine & reconstructive surgery

Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence.

John Eric Jelovsek, Zhen Chen, Alayne D Markland, Linda Brubaker, Keisha Y Dyer, Susie Meikle, David D Rahn, Nazeema Y Siddiqui, Ashok Tuteja, Matthew D Barber

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Female pelvic medicine & reconstructive surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03543566 (Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 8% 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.

NCT03543566 completednot on this map

Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence (Darifenacin for Treatment of Women With Dual Incontinence)

TypeobservationalSponsorUniversity of Alabama at BirminghamRan2018 to 2019Enrolled32ConditionsUrinary Incontinence, Urge, Fecal Incontinence
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 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

10 authors at 7 institutions in 1 country.

John Eric JelovsekFrom the *Cleveland Clinic, Cleveland, OH; †University of Michigan; Ann Arbor, MI; ‡Department of Veteran Affairs and University of Alabama at Birmingham, Birmingham, AL; §Loyola University Chicago, Chicago, IL; ∥University of California San Diego, San Diego, CA; ¶Eunice Kennedy Shriver National Institutes of Health, Bethesda, MD; #University of Texas Southwestern, Dallas, TX; **Duke University, Durham, NC; and ††Department of Veteran Affairs and University of Utah, Salt Lake City, UT.
Zhen Chen
Alayne D Markland
Linda Brubaker
Keisha Y Dyer
Susie Meikle
David D Rahn
Nazeema Y Siddiqui
Ashok Tuteja
Matthew D Barber
Duke University · USUniversity of Michigan–Ann Arbor · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USLoyola University Chicago · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, San Diego · US

Funding

Pelvic floor Disorders Network-Data Coordinating CenterU01HD041249 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI WEI, JOHN T · 2001 to 2010
$19.8M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
UNC Pelvic Floor Disorders Research CollaborativeU10HD041267 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VISCO, ANTHONY G · 2001 to 2015
$5.0M
The Pelvic Floor Disorders NetworkU10HD041250 · NICHD · LOYOLA UNIVERSITY CHICAGO · PI BRUBAKER, LINDA · 2001 to 2015
$3.8M
Pelvic Floor Disorders NetworkU10HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LUKACZ, EMILY S. · 2006 to 2015
$3.3M
The Cleveland Clinic Clinical SiteU10HD054215 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI BARBER, MATTHEW D · 2006 to 2015
$3.2M
Pelvic Floor Disorders Network 2021UG1HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI David Dwight Rahn · 2016 to 2026
$3.0M
NICHD Pelvic Floor Disorders Network Clinical Sites (U10)U10HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI SCHAFFER, JOSEPH I · 2006 to 2015
$1.9M
Pittsburgh Pelvic Floor Research ProgramU10HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2011 to 2015
$1.6M
UTAH PELVIC FLOOR DISORDERS NETWORKU10HD054136 · NICHD · UNIVERSITY OF UTAH · PI NYGAARD, INGRID E · 2006 to 2015
$1.6M
NICHD NIH HHS U01 HD041249NICHD NIH HHS U01 HD41249NICHD NIH HHS U10 HD041250NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD054136NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD054215NICHD NIH HHS U10 HD054241NICHD NIH HHS U10 HD069006NICHD NIH HHS U10 HD41250NICHD NIH HHS U10 HD41261NICHD NIH HHS U10 HD41267NICHD NIH HHS U10 HD54136NICHD NIH HHS U10 HD54214NICHD NIH HHS U10 HD54215NICHD NIH HHS U10 HD54241NICHD NIH HHS UG1 HD054241
6 · The paper itself

Abstract

objectivesThe objective of this study was to estimate the minimum important difference (MID) for the Fecal Incontinence Severity Index (FISI), the Colorectal-Anal Distress Inventory (CRADI) scale of the Pelvic Floor Distress Inventory, the Colorectal-Anal Impact Questionnaire (CRAIQ) scale of the Pelvic Floor Impact Questionnaire, and the Modified Manchester Health Questionnaire (MMHQ).

methodsWe calculated the MIDs using anchor-based and distribution-based approaches from a multicenter prospective cohort study investigating adaptive behaviors among women receiving nonsurgical and surgical management for fecal incontinence (FI). Patient responses were primarily anchored using a Global Impression of Change scale. The MID was defined as the difference in mean change from baseline between those who indicated they were "a little better" and those who reported "no change" on the Global Impression of Change scale 3 months after treatment. The effect size and SE of measurement were the distribution methods used.

resultsThe mean changes (SD) in FISI, CRADI, CRAIQ, and MMHQ scores from baseline to 3 months after treatment were -8.8 (12.0), -52.7 (70.0), -60.6 (90.0), and -12.6 (19.2), respectively. The anchor-based MID estimates suggested by an improvement from no change to a little better were -3.6, -11.4 and -4.7, -18.1 and -8.0, and -3.2 for the FISI, CRADI (long and short version), CRAIQ (long and short version), and MMHQ, respectively. These data were supported by 2 distribution-based estimates.

conclusionsThe MID values for the FISI are -4, CRADI (full version, -11; short version, -5), CRAIQ (full version, -18; short version, -8), and MMHQ -3. Statistically significant improvements that meet these thresholds are likely to be clinically important.

Indexed as

Quality of LifeSeverity of Illness IndexAnxietyFecal IncontinenceFemaleHumansMiddle AgedPatient SatisfactionProspective StudiesSurveys and Questionnaires

Identifiers

PMID25185630
PMCPMC4213305
OpenAlexW2327324808

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.