Evidence map›Paper›PMID 29099620›Full record

ArticleAmerican journal of respiratory and critical care medicine2018

Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II).

Suzanne Kafaja, Philip J Clements, Holly Wilhalme, Chi-Hong Tseng, Daniel E Furst, Grace Hyun Kim, Jonathan Goldin, Elizabeth R Volkmann, Michael D Roth, Donald P Tashkin and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in American journal of respiratory and critical care medicine, 2018. 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 65 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 9 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.

NCT00004563 phase3completednot on this map

Cyclophosphamide Versus Placebo in Scleroderma Lung Study

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan1999 to 2013Enrolled158ConditionsLung Diseases, Pulmonary Fibrosis, Systemic Scleroderma, Scleroderma, SystemicArmsCyclophosphamide, Placebo
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

65 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
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  5. Guideline
  6. Pooled it
  7. Stem cell transplantation for systemic sclerosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  8. Pooled it
  9. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
  10. Trial
  11. Trial
  12. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial.American journal of respiratory and critical care medicine · 2024
    Trial
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  20. Article

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Suzanne KafajaUCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; skafaja@mednet.ucla.edu.
Philip J ClementsUCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; pclements@mednet.ucla.edu.
Holly WilhalmeUCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; hwilhalme@mednet.ucla.edu.
Chi-Hong TsengUCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; tseng.ch@gmail.com.
Daniel E FurstUCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; DEFurst@mednet.ucla.edu.
Grace Hyun KimUCLA, Radiological Science, Los Angeles, California, United States ; gracekim@mednet.ucla.edu.
Jonathan GoldinUCLA School Of Medicine, Los Angeles, California, United States ; jgoldin@mednet.ucla.edu.
Elizabeth R VolkmannUniversity of California Los Angeles David Geffen School of Medicine, 12222, Department of Medicine, Los Angeles, California, United States ; evolkmann@mednet.ucla.edu.
Michael D RothUCLA School of Medicine, Department of Medicine, Los Angeles, California, United States ; mroth@mednet.ucla.edu.
Donald P TashkinUCLA School Of Medicine, Los Angeles, California, United States ; dtashkin@mednet.ucla.edu.
Dinesh KhannaUniversity of Michigan, Ann Arbor, Michigan, United States ; khannad@umich.edu.

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
MOCSLID-DCCR01HL089901 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 2008 to 2012
$9.1M
SCLERODERMA LUNG STUDYU01HL060587 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 1999 to 2003
$2.3M
MOCSLID-CCCR01HL089758 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 2008 to 2012
$2.0M
Outcomes Research in Rheumatic DiseasesK24AR063120 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2012 to 2022
$1.6M
SCLERODERMA LUNG STUDYU01HL060606 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 1999 to 2006
$1.3M
Systemic Sclerosis-Associated Interstitial Lung Disease Response IndexR01AR070470 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2017 to 2019
$642k
NCATS NIH HHS UL1 TR001881NHLBI NIH HHS R01 HL089758NHLBI NIH HHS R01 HL089901NHLBI NIH HHS U01 HL060587NHLBI NIH HHS U01 HL060606NIAMS NIH HHS K24 AR063120NIAMS NIH HHS R01 AR070470
6 · The paper itself

Abstract

objectivesTo assess the reliability and the minimal clinically important differences (MCID) for FVC% predicted in the Scleroderma Lung Study I and II.

methodsUsing data from SLS I and II (N=300), we evaluated the test-retest reliability for FVC% predicted (FVC%; screening vs. baseline) using intra-class correlation (ICC). MCID estimates at 12 months were calculated in the pooled cohort (SLS-I and II) using 2 anchors: Transition Dyspnea Index (≥change of 1.5 units for improvement and worsening, respectively) and the SF-36 Health Transition question: "Compared to one year ago, how would you rate your health in general now?", where "somewhat better" or "somewhat worse" were defined as the MCID estimates. We next assessed the association of MCID estimates for improvement and worsening of FVC% with patient reported outcomes (PROs) and computer-assisted quantitation of extent of fibrosis (QLF) and of total ILD (QILD) on HRCT.

resultsReliability of FVC%, assessed at a mean of 34 days, was 0.93 for the pooled cohort. The MCID estimates for the pooled cohort at 12 months for FVC% improvement ranged from 3.0 % to 5.3% and for worsening from -3.0% to -3.3%. FVC% improvement by ≥MCID was associated with either statistically significant or numerical improvements in some PROs, QILD, and QLF, while FVC% worsening ≥MCID was associated with statistically significant or numerical worsening of PROs, QILD, and QLF.

conclusionFVC% has acceptable test-retest reliability, and we have provided the MCID estimates for FVC% in SSc-ILD based changes at 12 months from baseline in two clinical trials. Clinical trial registration available at www.clinicaltrials.gov, IDs NCT00004563 and NCT00883129.

Indexed as

Minimal Clinically Important DifferenceCohort StudiesDisease ProgressionFemaleHumansLungLung Diseases, InterstitialMaleMiddle AgedReproducibility of ResultsScleroderma, SystemicVital Capacity

Identifiers

PMID29099620
PMCPMC6008871

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.