Evidence map›Paper›PMID 25890798›Full record

ArticleThe Lancet. Respiratory medicine2015

Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials.

Michael T Durheim, Harold R Collard, Rhonda S Roberts, Kevin K Brown, Kevin R Flaherty, Talmadge E King, Scott M Palmer, Ganesh Raghu, Laurie D Snyder, Kevin J Anstrom and 2 more

3 registry-linked trialsOpen access · greenAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Respiratory medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 3% 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.

NCT00517933 phase3completednot on this map

Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorDuke UniversityRan2007 to 2009Enrolled180ConditionsPulmonary Fibrosis, Hypertension, PulmonaryArmsSildenafil Citrate, Placebo
NCT00650091 phase3completednot on this map

Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF

TypeinterventionalSponsorDuke UniversityRan2009 to 2014Enrolled264ConditionsPulmonary FibrosisArmsN-acetylcysteine (NAC), Placebo
NCT00957242 phase3terminatednot on this map

AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)

TypeinterventionalSponsorDuke UniversityRan2009 to 2011Enrolled145ConditionsIdiopathic Pulmonary FibrosisArmswarfarin, placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Telomere Length and Use of Immunosuppressive Medications in Idiopathic Pulmonary Fibrosis.American journal of respiratory and critical care medicine · 2019
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Exploring the 175-year history of spirometry and the vital lessons it can teach us today.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  19. Article
  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Michael T DurheimDuke Clinical Research Institute, Durham, NC, USA; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University, Durham, NC, USA.
Harold R CollardDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, CA, USA.
Rhonda S RobertsDuke Clinical Research Institute, Durham, NC, USA.
Kevin K BrownDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, CO, USA; Department of Medicine, University of Colorado, Denver, CO, USA.
Kevin R FlahertyDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
Talmadge E KingDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, CA, USA.
Scott M PalmerDuke Clinical Research Institute, Durham, NC, USA; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University, Durham, NC, USA.
Ganesh RaghuDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington, Seattle, WA, USA.
Laurie D SnyderDuke Clinical Research Institute, Durham, NC, USA; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University, Durham, NC, USA.
Kevin J AnstromDuke Clinical Research Institute, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Fernando J MartinezDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, Ann Arbor, MI, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: fjm2003@med.cornell.edu.
IPFnet investigators
University of California, San Francisco · USClinical Research Institute · USUniversity of Michigan–Ann Arbor · USUniversity of Washington · US

Funding

Idiopathic Pulmonary Fibrosis Clinical Research NetworkU10HL080413 · NHLBI · DUKE UNIVERSITY · PI ANSTROM, KEVIN J · 2005 to 2013
$22.6M
INTERDISCIPLINARY TRAINING PROGRAM IN LUNG DISEASET32HL007538 · NHLBI · DUKE UNIVERSITY · PI LEE, PATTY J, PALMER, SCOTT M · 1985 to 2019
$7.2M
Novel Therapeutic Approaches in IPFU10HL080371 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARTINEZ, FERNANDO J · 2005 to 2009
$1.4M
Idiopathic Pulmonary Fibrosis Clinical Research NetworkU10HL080383 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI KANER, ROBERT J · 2005 to 2009
$1.1M
IPF Clinical Trial Center at VanderbiltU10HL080370 · NHLBI · VANDERBILT UNIVERSITY · PI LOYD, JAMES E · 2005 to 2009
$974k
Combination Therapy in IPFU10HL080513 · NHLBI · UNIVERSITY OF CHICAGO · PI NOTH, IMRE · 2005 to 2009
$970k
Emory Clinical Research Center in IPFU10HL080543 · NHLBI · UNIVERSITY OF LOUISVILLE · PI ROMAN, JESSE · 2005 to 2009
$968k
UCLA IPF Clinical Research NetworkU10HL080411 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI BELPERIO, JOHN A · 2005 to 2009
$965k
Clinical Center for an Idiopathic Pulmonary Fibrosis Cl*U10HL080509 · NHLBI · UNIVERSITY OF WASHINGTON · PI RAGHU, GANESH · 2005 to 2009
$964k
Idiopathic Pulmonary Fibrosis Clinical Research NetworkU10HL080685 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KING, TALMADGE E · 2005 to 2009
$936k
Novel Therapies in Idiopathic Pulmonary FibrosisU10HL080571 · NHLBI · NATIONAL JEWISH HEALTH · PI BROWN, KEVIN K · 2005 to 2009
$927k
Forging a road to personalized medicine in interstitial lung diseasesK24HL111316 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI FLAHERTY, KEVIN R · 2012 to 2017
$909k
NHLBI NIH HHS 5T32HL007538NHLBI NIH HHS K24 HL111316NHLBI NIH HHS T32 HL007538NHLBI NIH HHS U10 HL080274NHLBI NIH HHS U10 HL080370NHLBI NIH HHS U10 HL080371NHLBI NIH HHS U10 HL080383NHLBI NIH HHS U10 HL080411NHLBI NIH HHS U10 HL080413NHLBI NIH HHS U10 HL080509NHLBI NIH HHS U10HL080509NHLBI NIH HHS U10 HL080510NHLBI NIH HHS U10 HL080513NHLBI NIH HHS U10 HL080543NHLBI NIH HHS U10 HL080571NHLBI NIH HHS U10 HL080685NHLBI NIH HHS U10HL80274NHLBI NIH HHS U10HL80370NHLBI NIH HHS U10HL80371NHLBI NIH HHS U10HL80383NHLBI NIH HHS U10HL80411NHLBI NIH HHS U10HL80413NHLBI NIH HHS U10HL80509NHLBI NIH HHS U10HL80510NHLBI NIH HHS U10HL80513NHLBI NIH HHS U10HL80543NHLBI NIH HHS U10HL80571NHLBI NIH HHS U10HL80685
6 · The paper itself

Abstract

backgroundMortality is an impractical primary endpoint for clinical trials in patients with idiopathic pulmonary fibrosis who have mild-to-moderate physiological impairment because event rates are low. Change in forced vital capacity (FVC) is widely accepted as a surrogate for mortality and is the most common primary endpoint in clinical trials for this disorder. Use of hospital admission as a predictor for mortality, independent of FVC decline, has not been well defined. We aimed to ascertain the independent and combined association of hospital admission and at least a 10% decrease in FVC with all-cause mortality.

methodsWe did a pooled cohort study of 517 patients with idiopathic pulmonary fibrosis from three IPFnet multicentre randomised controlled trials. We compared the incidence of non-elective hospital admission and a 10% or greater reduction in FVC across strata of baseline physiological impairment. We used Cox proportional-hazards models to assess the risk of all-cause mortality associated with these surrogate events, occurring up to a predefined landmark timepoint. The three studies are registered at ClinicalTrials.gov, numbers NCT00650091, NCT00517933, and NCT00957242.

findingsSeven patients died before the landmark timepoint. Of the 510 patients remaining, 38 (7%) were admitted to hospital up to the predefined timepoint and 58 (11%) had a categorical decrease in FVC of at least 10%. Most patients admitted to hospital did not have a 10% or greater decrease in FVC (30 vs eight). Both surrogate events were associated with subsequent time to death from any cause (hazard ratio [HR] for admission 4·05, 95% CI 1·36-12·11 vs HR for 10% or greater decline in FVC 4·68, 1·83-11·99). When causes of hospital admission were considered, only respiratory events were associated with mortality (5·97, 1·81-19·74).

interpretationHospital admission might be an appropriate component of a clinically meaningful composite endpoint that improves the feasibility of clinical trials in idiopathic pulmonary fibrosis. Further studies are needed to refine the most appropriate definition of hospital admission for future trials.

fundingUS National Heart, Lung, and Blood Institute (NHLBI), and The Cowlin Family Fund at the Chicago Community Trust.

Indexed as

AgedCohort StudiesFemaleHospitalizationHumansIdiopathic Pulmonary FibrosisMaleMiddle AgedProportional Hazards ModelsRiskSurvival AnalysisUnited StatesVital Capacity

Identifiers

PMID25890798
PMCPMC4760351
OpenAlexW2171738220

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.