Evidence map›Paper›PMID 21724699›Full record

Trial reportThe Journal of rheumatology2011

Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument.

Dinesh Khanna, Daniel E Furst, Paul Maranian, James R Seibold, Ann Impens, Maureen D Mayes, Philip J Clements, Terri Getzug, Ron D Hays

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of rheumatology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT04300426 phase2completednot on this mapstarted 2020, after this paper: background citation

Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week Study

TypeinterventionalSponsorOslo University HospitalRan2020 to 2022Enrolled75ConditionsSystemic SclerosisArms"ACHIM" as solute (10^9 intestinal microbes/ml)
NCT04630782 unknown statusnot on this mapstarted 2020, after this paper: background citation

Precision Medicine in Systemic Sclerosis Gastrointestinal Disease: Evaluating Imaging and Stool Biomarkers for Differentiating Disease Stages and Treatment Responses

TypeobservationalSponsorSingapore General HospitalRan2020 to 2023Enrolled70ConditionsSystemic Sclerosis, SclerodermaArmsPET-MRI scan
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  7. Review
  8. Article
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  16. Determinants of Six-Minute Walk Test Performance in Women with Systemic Sclerosis.Journal of musculoskeletal & neuronal interactions · 2023
    Article
  17. Article
  18. Article
  19. Article
  20. Management of scleroderma gastrointestinal disease: Lights and shadows.Journal of scleroderma and related disorders · 2022
    Review
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

9 authors.

Dinesh KhannaDivision of Rheumatology, Department of Medicine, University of Michigan, 24 Frank Lloyd Wright Drive, Lobby M, Suite 2500, SPC 5753, Ann Arbor, MI 48106, USA. khannad@med.umich.edu
Daniel E Furst
Paul Maranian
James R Seibold
Ann Impens
Maureen D Mayes
Philip J Clements
Terri Getzug
Ron D Hays

Funding

The Center for Health Improvement of Minority ElderlyP30AG021684 · NIA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Homero Erwin del Pino · 2002 to 2026
$19.7M
TRAINING COREP20MD000182 · NIMHD · CHARLES R. DREW UNIVERSITY OF MED &SCI · PI RODRIGUEZ, MICHAEL A., SHAPIRO, MARTIN F. · 2002 to 2016
$16.5M
UCLA OLDER AMERICANS INDEPENDENCE CENTERP30AG028748 · NIA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI IRWIN, MICHAEL R · 2006 to 2017
$9.8M
Role of TGF-beta and CTGF Signaling Transgenic Mouse Models of SclerodermaP50AR054144 · NIAMS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI TAN, FILEMON K. · 2006 to 2010
$7.7M
Health Values and Minimally Important Differences in Systemic SclerosisK23AR053858 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2007 to 2011
$617k
NIAMS NIH HHS K23 AR053858NIAMS NIH HHS P50 AR054144NIA NIH HHS P30 AG021684NIA NIH HHS P30AG021684NIA NIH HHS P30 AG028748NIA NIH HHS P30-AG028748NIMHD NIH HHS 2P20MD000182NIMHD NIH HHS P20 MD000182
6 · The paper itself

Abstract

objectiveTo provide minimally important difference (MID) estimates for the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) in a longitudinal observational cohort.

methodsWe administered the UCLA SCTC GIT 2.0 to 115 patients with systemic sclerosis (SSc) at 2 timepoints 6 months apart. The UCLA SCTC GIT 2.0 has 7 multi-item scales: Reflux, Distension/Bloating, Diarrhea, Fecal Soilage, Constipation, Emotional Well-being, and Social Functioning and a total GIT score. All scales are scored from 0 [better health-related quality of life (HRQOL)] to 3 (worse HRQOL) except the diarrhea and constipation scales (ranges 0-2 and 0-2.5, respectively). Patients also rated their overall and upper and lower GIT involvement during the second visit using a response scale with options "much better; somewhat better; almost the same; somewhat worse; or much worse." The minimally changed group was defined by those reporting they were somewhat better or somewhat worse compared to first visit.

resultsStudy participants were 84% female and 81% white with a mean disease duration of 6.9 years. The MID estimates for improvement ranged from 0.07 for the Social Functioning scale to 0.36 for the Emotional Well-being scale. For worsening, the MID estimates ranged from 0.06 for the Fecal Soilage scale to 0.21 for the Social Functioning scale.

conclusionWe provide MID estimates for the UCLA SCTC GIT 2.0 scales. This information can aid in interpreting scale scores in future randomized controlled trials and observational studies.

Indexed as

Gastrointestinal DiseasesCohort StudiesDifferential ThresholdFemaleFollow-Up StudiesGastrointestinal AgentsHealth StatusHumansLongitudinal StudiesMaleMiddle AgedProspective StudiesQuality of LifeResearch DesignScleroderma, SystemicGastrointestinal Agents

Identifiers

PMID21724699
PMCPMC3368014

What OpenQuestion holds

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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.