Evidence map›Paper›PMID 35241434›Full record

Trial reportBMJ open respiratory research2022

Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases.

Jeffrey J Swigris, Donald M Bushnell, Klaus Rohr, Heiko Mueller, Michael Baldwin, Yoshikazu Inoue

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMJ open respiratory research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02999178 (A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT02999178 phase3completednot on this map

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

TypeinterventionalSponsorBoehringer IngelheimRan2017 to 2019Enrolled663ConditionsLung Diseases, InterstitialArmsNintedanib, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  3. Patient-reported outcome measures for cough used in interstitial lung disease: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
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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

6 authors at 4 institutions in 3 countries.

Jeffrey J SwigrisNational Jewish Health, Denver, Colorado, USA swigrisj@njhealth.org.ORCID 0000-0002-2643-8110
Donald M BushnellEvidera (Pharmaceutical Product Development, LLC), Bethesda, Maryland, USA.
Klaus RohrBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Heiko MuellerBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Michael BaldwinBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Yoshikazu InoueNational Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.ORCID 0000-0003-3994-874X
Boehringer Ingelheim (Germany) · DENational Jewish Health · USNHO Kinki Chuo Chest Medical Center · JPPharmaceutical Product Development (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. We evaluated the ability of these domain scores to detect change and estimated their meaningful change thresholds in patients with progressive fibrosing ILDs.

methodsThe INBUILD trial enrolled subjects with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis. The L-PF questionnaire was completed at baseline and week 52. The responsiveness of the Dyspnoea and Cough scores was evaluated by comparing changes in these scores with 52-week changes in three anchors: forced vital capacity % predicted and two self-reported items, one for global physical health and one for global quality of life. We used a triangulation approach including anchor-based and distribution-based methods to estimate meaningful change thresholds.

resultsThe analyses included 542 subjects with an L-PF Dyspnoea score at baseline and week 52, and 538 subjects with an L-PF Cough score at baseline and week 52. The L-PF Dyspnoea and Cough scores were responsive to change over 52 weeks. Triangulation of anchor-based and distribution-based estimates resulted in meaningful change thresholds of 6 to 7 points for the L-PF Dyspnoea score and 4 to 5 points for the L-PF Cough score to differentiate subjects who were stable or improved from those who deteriorated.

conclusionThese analyses support the responsiveness, one aspect of validity, of the L-PF Dyspnoea and Cough domains scores as measures of symptom severity in patients with progressive fibrosing ILDs. Estimates for meaningful change thresholds in these domain scores may be of value in interpreting the effects of interventions in these patients. TRIAL REGISTRATION NUMBER: NCT02999178.

Indexed as

Idiopathic Pulmonary FibrosisLung Diseases, InterstitialCoughDyspneaHumansQuality of LifeSurveys and Questionnairesinterstitial fibrosis

Identifiers

PMID35241434
PMCPMC8896030
OpenAlexW4214809239

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.