Evidence map›Paper›PMID 19776222›Full record

Trial reportRheumatology (Oxford, England)2009

Minimally important differences in the Mahler's Transition Dyspnoea Index in a large randomized controlled trial--results from the Scleroderma Lung Study.

Dinesh Khanna, Chi-Hong Tseng, Daniel E Furst, Philip J Clements, Robert Elashoff, Michael Roth, David Elashoff, Donald P Tashkin, for Scleroderma Lung Study Investigators

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00883129 (Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease), which is not on this map. Cited by 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
1.8field-weighted citation impact, top 16% 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.

NCT00883129 phase2completednot on this map

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)

TypeinterventionalSponsorMichael RothRan2009 to 2015Enrolled142ConditionsScleroderma, Interstitial Lung DiseaseArmsMycophenolate mofetil, Cyclophosphamide, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 6 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Guideline
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  4. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018
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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

9 authors at 1 institution in 1 country.

Dinesh KhannaDepartment of Medicine, Division of Rheumatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA 90095, USA. dkhanna@mednet.ucla.edu
Chi-Hong Tseng
Daniel E Furst
Philip J Clements
Robert Elashoff
Michael Roth
David Elashoff
Donald P Tashkin
for Scleroderma Lung Study Investigators
University of California, Los Angeles · US

Funding

SCLERODERMA LUNG STUDYU01HL060587 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 1999 to 2003
$2.3M
Health Values and Minimally Important Differences in Systemic SclerosisK23AR053858 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2007 to 2011
$617k
NHLBI NIH HHS U01 HL060587NHLBI NIH HHS UO1 HL605NIAMS NIH HHS K23 AR053858NIAMS NIH HHS K23 AR053 858-02
6 · The paper itself

Abstract

objectiveScleroderma Lung Study (SLS) showed that cyclophosphamide (CYC) was better than placebo (PLA) in preventing progression of forced vital capacity percentage (FVC%) predicted and dyspnoea at 12 months. Our objective was to assess minimally important difference (MID) for Mahler's Transition Dyspnoea Index (TDI) in SLS.

methodsA total of 158 subjects participated in the SLS. Data from the two treatment groups were combined for this analysis. We used five patient-reported anchors from the short form (SF)-36 instrument to assess MID for TDI-SF-36 transition question and four questions from SF-36 pertaining to walking on a flat surface or climbing stairs. On the SF-36 transition question, patients who rated as a little better or a little worse were defined as the MID subgroup. For other questions, patients who reported improvement from 'Limited a lot' to 'Limited a little' and 'Limited a little' to 'No limit' and vice versa were defined as the MID subgroup.

resultsThe MID estimates for the TDI improvement and worsening ranged from 1.05 to 2.16 (mean score = 1.5) U and from -0.61 to -2.55 (mean score = -1.5) U, respectively. Change in this group was larger than that of the no-change group (mean score = 0.38 U). Patients who achieved the MID for improvement at 12 months had a greater improvement in their FVC% predicted (3.6%) compared with those who did not (-3.3%; P < 0.001).

conclusionA change (improvement/worsening) of 1.5 U in the TDI is the MID for SSc-related interstitial lung disease (SSc-ILD). This can aid in interpreting clinically important changes in breathlessness in SSc-ILD.

Indexed as

Severity of Illness IndexAdultCyclophosphamideDouble-Blind MethodDyspneaFemaleHumansImmunosuppressive AgentsLung Diseases, InterstitialMaleMiddle AgedQuality of LifeScleroderma, SystemicTreatment OutcomeVital CapacityCyclophosphamideImmunosuppressive Agents

Identifiers

PMID19776222
PMCPMC2777487
OpenAlexW2125049108

What OpenQuestion holds

Textmetadata
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.