Evidence map›Paper›PMID 32345170›Full record

ArticleTherapeutic advances in respiratory disease

Quantitative measurement properties and score interpretation of the Cough Severity Diary in patients with chronic cough.

Allison Martin Nguyen, Elizabeth Bacci, Peter Dicpinigaitis, Margaret Vernon

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 8% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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  15. Efficacy and Safety of Gefapixant for Refractory or Unexplained Chronic Cough over 52 Weeks.American journal of respiratory and critical care medicine · 2023
    Article
  16. Review
  17. Article
  18. Article
  19. Chronic cough: new insights and future prospects.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  20. Cough symptom severity in patients with refractory or unexplained chronic cough: a systematic survey and conceptual framework.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
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

4 authors at 3 institutions in 1 country.

Allison Martin NguyenMerck Sharp & Dohme Corp., 770 Sumneytown Pike, West Point, PA 19486 USA.ORCID 0000-0002-6385-5570
Elizabeth BacciEvidera Inc, Bethesda, MD, USA.
Peter DicpinigaitisAlbert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.
Margaret VernonEvidera Inc, Bethesda, MD, USA.
Ithaka Harbors · USAlbert Einstein College of Medicine · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe Cough Severity Diary (CSD) was developed in accordance with the FDA guidance for patient-reported outcome measures and is focused on capturing the patient's perception of cough in terms of frequency, intensity, and disruption due to their cough. The measure includes a series of seven items asking patients to rate the frequency (three items), intensity (two items), and disruptiveness (two items) of their cough. The instrument was designed to be completed daily before bedtime, has a recall period of 'today,' and responses to items are entered on an 11-point numeric rating scale ranging from 0 to 10 with anchors on each end. The objective of this analysis was to confirm the domain structure of the CSD and assess its reliability, validity, and responsiveness in adult patients with refractory or unexplained chronic cough (RCC/UCC). Criteria for defining meaningful changes in mean weekly CSD total and domain scores in the context of a clinical trial were also developed.

methodsPooled data from a phase II randomized controlled trial of an investigational treatment for RCC/UCC were analyzed. Participants were non-smokers, had RCC/UCC for ⩾1 year, and a baseline cough severity visual analogue scale (VAS) ⩾40 mm. CSD scores (baseline, week 4), were analyzed; the Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts were used for validation. CSD domain structure (Total, Frequency, Intensity, Disruption) was assessed for scoring.

resultsA total of 253 participants were included (mean age 60.2; 76% female). Global fit of the three-factor CSD was acceptable. For the CSD total score, internal consistency (α = 0.89) and test-retest reliability (intraclass correlation coefficient = 0.68) were high. CSD total scores were correlated with the LCQ total (

conclusionThe CSD is a reliable, valid, and responsive measure of cough symptom severity in patients with refractory or unexplained chronic cough and fit-for-purpose for assessing changes in cough severity in clinical trials.

Indexed as

Diaries as TopicPatient Reported Outcome MeasuresAgedChronic DiseaseClinical Trials, Phase II as TopicCost of IllnessCoughFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicSeverity of Illness IndexTime FactorsTreatment Outcomechronic coughclinically meaningful changeLeicester Cough Questionnairepatient reported outcomes

Identifiers

PMID32345170
PMCPMC7225816
OpenAlexW3022308046

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.