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

ABSTRACT: AIMS:The 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. METHODS:Pooled 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. RESULTS:A 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 (??=?0.89) and test-retest reliability (intraclass correlation coefficient?=?0.68) were high. CSD total scores were correlated with the LCQ total (r?=?-0.62) and cough severity VAS (r?=?0.84). Participants with a PGIC score of 1 or 2 (most improved groups) had the greatest mean score improvement on the CSD Total (Day 0 to Day 28), supporting responsiveness (similar findings for subscales). A change threshold of ?1.3-point reduction on the total and subscale scores is appropriate to define clinically meaningful improvement. CONCLUSION:The 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. The reviews of this paper are available via the supplemental material section.

SUBMITTER: Martin Nguyen A

PROVIDER: S-EPMC7225816 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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

Martin Nguyen Allison A Bacci Elizabeth E Dicpinigaitis Peter P Vernon Margaret M

Therapeutic advances in respiratory disease 20200101

<h4>Aims</h4>The 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 ...[more]

PMID: 32345170

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Project description:BACKGROUND:The differential sensitivity of cough to antitussive therapies implies the existence of heterogeneity in cough hypersensitivity, but how such heterogeneity is expressed across individual patients is poorly understood. We investigated the phenotypes of cough hypersensitivity by examining transient receptor potential ankyrin 1 (TRPA1)- and transient receptor potential vanilloid 1 (TRPV1)-mediated cough sensitivity in patients with chronic refractory cough. METHODS:Using a selective TRPA1 agonist, allyl isothiocyanate (AITC), we established an AITC cough challenge as a measure of TRPA1-mediated cough sensitivity. The AITC cough challenge and the widely used capsaicin (a selective TRPV1 agonist) cough challenge were performed with 250 patients with chronic refractory cough and 56 healthy subjects. The concentration of AITC or capsaicin solution causing at least two (C2) and five coughs (C5) was recorded. Cough sensitivity was expressed as the mean (95% confidence interval) of log C5, and cough hypersensitivity was defined as a log C5 value lower than that of healthy subjects. RESULTS:A distinct concentration-response effect of inhaled AITC was identified both in patients with chronic refractory cough and in healthy subjects. Cough sensitivity to AITC and capsaicin was significantly higher in patients than in healthy subjects (AITC: 2.42 [2.37-2.48] vs 2.72 [2.66-2.78] mM, p?=?0.001; capsaicin: 1.87 [1.75-1.98] vs 2.53 [2.36-2.70] ?M, p?=?0.001) and was higher in females than in males for both healthy subjects and patients (all p?<?0.05). Among the 234 patients who completed both challenges, 25 (10.7%) exhibited hypersensitivity to both AITC and capsaicin, 44 (18.8%) showed hypersensitivity to AITC only, 28 (11.9%) showed hypersensitivity to capsaicin only, and 137 (58.6%) exhibited hypersensitivity to neither. Those with TRPA1- and/or TRPV1-mediated hypersensitivity were predominantly female, while those without TRPA1- and TRPV1-mediated hypersensitivity were mainly male. CONCLUSIONS:Four phenotypes of cough hypersensitivity were identified by the activation of TRPV1 and TRPA1 channels, which supports the existence of heterogeneity in cough pathways and provides a new direction for personalized management of chronic refractory cough. TRIAL REGISTRATION:ClinicalTrials.gov NCT02591550 .

Project description:Purpose:The sleep diary is the gold standard of self-reported sleep duration, but its comparability to sleep questionnaires is uncertain. The purpose of this study was to compare self-reported sleep duration between a sleep diary and a sleep questionnaire and to test whether sleep-related disorders were associated with diary-questionnaire differences in sleep duration. Participants and methods:We compared self-reported sleep duration from 5,432 questionnaire-sleep diary pairs in a longitudinal cohort of 1,516 adults. Participants reported sleep information in seven-day sleep diaries and in questionnaires. Research staff abstracted average sleep durations for three time periods (overall; weekday; weekend) from diaries and questionnaires. For each time period, we evaluated diary-questionnaire differences in sleep duration with Welch's two-sample t-tests. Using linear mixed effects regression, we regressed overall diary-questionnaire sleep duration difference on several participant characteristics: reporting any insomnia symptoms, having sleep apnea, sex, body mass index, smoking status, Short Form-12 Physical Health Composite Score, and Short Form-12 Mental Health Composite Score. Results:The average diary-reported overall sleep duration (7.76 hrs) was longer than that of the questionnaire (7.07 hrs) by approximately 41 mins (0.69 hrs, 95% confidence interval: 0.62, 0.76 hrs). Results were consistent across weekday- and weekend-specific differences. Demographic-adjusted linear mixed effects models tested whether insomnia symptoms or sleep apnea were associated with diary-questionnaire differences in sleep duration. Insomnia symptoms were associated with a 17 min longer duration on the diary relative to the questionnaire (?=0.28 hrs, 95% confidence interval: 0.22, 0.33 hrs), but sleep apnea was not significantly associated with diary-questionnaire difference. Female sex was associated with greater diary-questionnaire duration differences, whereas better self-reported health was associated with lesser differences. Conclusion:Diaries and questionnaires are somewhat disparate methods of assessing subjective sleep duration, although diaries report longer duration relative to questionnaires, and insomnia symptoms may contribute to greater perceived differences.

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

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

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