Evidence map›Paper›PMID 36348054›Full record

Trial reportLung2022

Validation and Meaningful Change Thresholds for an Objective Cough Frequency Measurement in Chronic Cough.

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

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Lung, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

8 authors at 4 institutions in 2 countries.

Jonathan SchelfhoutMerck & Co., Inc., Rahway, NJ, USA.
Allison Martin NguyenMerck & Co., Inc., Rahway, NJ, USA.
Surinder S BirringCentre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Elizabeth D BacciEvidera, Seattle, WA, USA.
Margaret VernonEvidera, Bethesda, MD, USA.
David R MuccinoMerck & Co., Inc., Rahway, NJ, USA.
Carmen La RosaMerck & Co., Inc., Rahway, NJ, USA.
Jaclyn A SmithDivision of Infection, Immunity and Respiratory Medicine, 2nd Floor Education and Research Centre, University of Manchester and Manchester University NHS Foundation Trust, Southmoor Rd, Wythenshawe, Manchester, M23 9LT, UK. Jacky.Smith@manchester.ac.uk.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USIthaka Harbors · USKing's College London · GBManchester University NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeObjective cough frequency is used to assess efficacy of chronic cough (CC) treatments. The objective of this study was to explore the relationship between objective cough frequency and cough-specific patient-reported outcomes (PROs) and estimate a clinically meaningful change threshold (MCT) for objective cough frequency.

methodsData collected in a phase 2b study in participants with refractory or unexplained CC were used to investigate the relationship between 24-h cough frequency (measured using an ambulatory cough monitor) and cough-specific PROs (i.e., cough severity visual analog scale, cough severity diary, Leicester Cough Questionnaire). Convergent validity was assessed using Spearman ρ. An MCT for 24-h cough frequency was estimated using the patient global impression of change (PGIC) scale as an anchor.

resultsCorrelations between 24-h cough frequency and cough-specific PROs at baseline, Week 4, and Week 12 were significant (P < 0.0001) but low to moderate in strength (ρ = 0.30-0.58). Participants categorized as very much improved/much improved (i.e., PGIC of 1 or 2) or minimally improved (i.e., PGIC of 3) had mean 24-h cough frequency reductions of 55% and 30%, respectively. Receiver operating characteristic curve analysis suggested that a 24-h cough frequency reduction of 38% optimizes sensitivity and specificity for predicting a PGIC score of 1-3.

conclusionObjective 24-h cough frequency is significantly associated with cough-specific PROs, but cough frequency and PROs most likely capture distinct aspects of CC. A ≥ 30% reduction in 24-h cough frequency is a reasonable MCT to define treatment response in CC clinical trials.

Indexed as

CoughHumansPain MeasurementPatient Reported Outcome MeasuresROC CurveChronic coughClinically meaningful changeCough monitoringCough severityObjective cough frequencyPatient-reported outcomes

Identifiers

PMID36348054
PMCPMC9675653
OpenAlexW4308532051

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.