Evidence map›Paper›PMID 23848435›Full record

Trial reportRespiratory research2013

Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials.

Harold R Collard, Eric Yow, Luca Richeldi, Kevin J Anstrom, Craig Glazer, IPFnet investigators

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2013. 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 94 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 2 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.

NCT02460588 phase3completednot on this mapstarted 2015, after this paper: background citation

Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2015 to 2019Enrolled120ConditionsIdiopathic Pulmonary FibrosisArmsCyclophosphamide, Placebo, Corticosteroid (prednisolone)
NCT05674994 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial

TypeinterventionalSponsorFondation Hôpital Saint-JosephRan2023 to 2026Enrolled110ConditionsAcute Exacerbation of Idiopathic Pulmonary FibrosisArmsMethylprednisone/Prednisone, Placebo
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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

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

6 authors.

Harold R CollardUniversity of California San Francisco, San Francisco, CA, USA. hal.collard@ucsf.edu
Eric Yow
Luca Richeldi
Kevin J Anstrom
Craig Glazer
IPFnet investigators

Funding

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 K24 HL111316
6 · The paper itself

Abstract

backgroundAcute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.

methodsThree investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.

resultsThirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.

conclusionsIn this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.

Indexed as

Disease ProgressionAcute DiseaseAdultAgedClinical Trials as TopicFemaleHumansIdiopathic Pulmonary FibrosisMaleMiddle AgedOutcome Assessment, Health CarePhosphodiesterase 5 InhibitorsPiperazinesPurinesReproducibility of ResultsSensitivity and SpecificityPhosphodiesterase 5 InhibitorsPiperazinesPurinesSildenafil CitrateSulfones

Identifiers

PMID23848435
PMCPMC3729659

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.