Trial reportChest2014
Study design implications of death and hospitalization as end points in idiopathic pulmonary fibrosis.
Trial report in Chest, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 30 citations in OpenAlex.
- Trial
- Telomere Length and Use of Immunosuppressive Medications in Idiopathic Pulmonary Fibrosis.American journal of respiratory and critical care medicine · 2019Trial
- Design of the MIST study: a double-blind, randomised, placebo-controlled phase 2b trial of pirfenidone solution for inhalation in patients with progressive pulmonary fibrosis.BMJ open respiratory research · 2025Article
- On Target: CYFRA 21-1 as an Idiopathic Pulmonary Fibrosis Biomarker.American journal of respiratory and critical care medicine · 2022Article
- Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial.Frontiers in pharmacology · 2022Article
- The natural history of idiopathic pulmonary fibrosis in a large European population: the role of age, sex and comorbidities.Internal and emergency medicine · 2021Observational
- An updated approach to determine minimal clinically important differences in idiopathic pulmonary fibrosis.ERJ open research · 2021Article
- Minimal clinically important difference in idiopathic pulmonary fibrosis.Breathe (Sheffield, England) · 2021Review
- Toward Realizing the Full Potential of Registries in Interstitial Lung Disease.Annals of the American Thoracic Society · 2020Article
- In-hospital mortality trends among patients with idiopathic pulmonary fibrosis in the United States between 2013-2017: a comparison of academic and non-academic programs.BMC pulmonary medicine · 2020Article
- Article
- Obstacles to early treatment of idiopathic pulmonary fibrosis: current perspectives.Therapeutics and clinical risk management · 2019Review
- Pirfenidone Reduces Respiratory-related Hospitalizations in Idiopathic Pulmonary Fibrosis.American journal of respiratory and critical care medicine · 2017Article
- TOLLIP, MUC5B, and the Response to N-Acetylcysteine among Individuals with Idiopathic Pulmonary Fibrosis.American journal of respiratory and critical care medicine · 2015Article
- Models of disease behavior in idiopathic pulmonary fibrosis.BMC medicine · 2015Article
- Idiopathic pulmonary fibrosis: from clinical trials to real-life experiences.European respiratory review : an official journal of the European Respiratory Society · 2015Review
- 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.The Lancet. Respiratory medicine · 2015Article
- Idiopathic Pulmonary Fibrosis: Diagnosis and Clinical Manifestations.Clinical medicine insights. Circulatory, respiratory and pulmonary medicine · 2015Review
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundThe feasibility of an interventional clinical trial in idiopathic pulmonary fibrosis (IPF) using death and hospitalization as primary end points is an area of uncertainty. Using data from a large well-characterized clinical trial population, this article aims to illustrate the impact of cohort enrichment and study duration on sample size requirements for IPF clinical trials in which death alone or death plus hospitalization serve as the primary end point.
methodsEvent rate estimates for death and hospitalization were determined from patients enrolled in National Institutes of Health-sponsored IPF Clinical Research Network clinical trials. Standard equations were applied to estimate the total sample size required for varying gender, age, and pulmonary function (GAP) stage-based cohorts.
resultsRisk estimates for death and hospitalization in the clinical trial cohort were substantially lower than those published. An IPF trial with death as its primary end point enrolling subjects designated as GAP stage 1 and 2 over 1 year with a minimum follow-up of 1 year would require an estimated 7,986 subjects to achieve 90% power for a hazard ratio of 0.70. Alternatively, an IPF trial with death plus hospitalization as its primary end point enrolling subjects with GAP stage 2 and 3 over 2 years with a minimum follow-up of 1 year would require an estimated 794 subjects for the same power and hazard ratio.
conclusionsStudy design decisions, in particular cohort enrichment strategies, have a substantial impact on sample size requirements for IPF clinical trials using time-to-event primary end points such as death and death plus hospitalization.
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What OpenQuestion holds
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.