Evidence map›Paper›PMID 34697975›Full record

Trial reportTherapeutic advances in respiratory disease

Validation of a visual analog scale for assessing cough severity in patients with chronic cough.

Allison Martin Nguyen, Elizabeth D Bacci, Margaret Vernon, Surinder S Birring, Carmen La Rosa, David Muccino, Jonathan Schelfhout

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02612610 (A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough), which is not on this map. Cited by 85 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 4 pooled it
10.1field-weighted citation impact, top 1% 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.

NCT02612610 phase2completednot on this map

A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough

TypeinterventionalSponsorAfferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2015 to 2016Enrolled253ConditionsRefractory Chronic CoughArmsGefapixant, Placebo (for gefapixant)
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 4 syntheses or guidelines pooled it, 106 citations in OpenAlex.

  1. Pooled it
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  3. Cough monitoring systems in adults with chronic respiratory diseases: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
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  7. Dual αAmerican journal of respiratory and critical care medicine · 2025
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  9. Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE).American journal of respiratory and critical care medicine · 2025
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25 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

7 authors at 3 institutions in 2 countries.

Allison Martin NguyenMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0002-6385-5570
Elizabeth D BacciEvidera Inc., Bethesda, MD, USA.
Margaret VernonEvidera Inc., Bethesda, MD, USA.
Surinder S BirringCentre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Carmen La RosaMerck & Co., Inc., Kenilworth, NJ, USA.
David MuccinoMerck & Co., Inc., Kenilworth, NJ, USA.
Jonathan SchelfhoutMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USIthaka Harbors · USKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with chronic cough experience considerable burden. The cough severity visual analog scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm). Although cough severity scales are widely used in clinical practice and research, their use in patients with refractory or unexplained chronic cough has not been formally validated.

methodsThis analysis includes data from a phase 2b randomized controlled trial of the P2X3-receptor antagonist gefapixant for treatment of refractory or unexplained chronic cough (NCT02612610). Cough severity VAS scores were assessed at baseline and Weeks 4, 8, and 12. The cough severity VAS was validated using several outcomes, including the Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), patient global impression of change (PGIC) scale, and objective cough frequency. Validation metrics included test-retest reliability, convergent and known-groups validity, responsiveness, and score interpretation (i.e., clinically meaningful change threshold).

resultsThe analysis included 253 patients (median age, 61.0 years; females, 76%). Test-retest reliability of the cough severity VAS was moderate (intraclass correlation coefficient, 0.51). The cough severity VAS had acceptable convergent validity with other related measures (Pearson

conclusionsThe cough severity VAS is a valid and responsive measure. A cough severity VAS reduction of ⩾ 30 mm can discriminate clinically meaningful changes in chronic cough severity in clinical studies.

Indexed as

CoughQuality of LifeChronic DiseaseFemaleHumansMiddle AgedReproducibility of ResultsSurveys and QuestionnairesVisual Analog Scaleclinically meaningful changecough monitoringCough Severity Diaryidiopathic coughLeicester Cough Questionnaireminimal important differenceobjective cough frequencypatient-reported outcomesresponder threshold

Identifiers

PMID34697975
PMCPMC8552382
OpenAlexW3211195696

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.