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BACKGROUND: Refractory chronic cough (RCC) and unexplained chronic cough (UCC) adversely affect patients' quality of life (QoL). This multicenter, non-interventional study evaluates the relationship between cough severity and QoL and other patient-reported outcomes (PROs) in Spanish outpatients. METHODS: RCC/UCC patients self-administered a printed survey comprising the cough-severity visual analog scale (VAS), adapted Cough Severity Diary (CSD), and Leicester Cough Questionnaire (LCQ), plus purpose-designed items regarding the physical and everyday-life impact of cough. Patients were stratified into VAS score tertiles. The impact of cough on QoL and other PROs in each tertile, and relationships between LCQ scores and the tertiles, were assessed. RESULTS: The VAS was completed by 189 patients, and VAS score tertiles were identified as 0-50, 60-70, and 80-100 mm. The only between-tertile difference in demographic or cough characteristics was cough duration. VAS score tertiles were linearly associated with mean LCQ domain and total scores, as well as the proportion of patients with the highest scores on all adapted CSD items, and almost all physical and everyday-life impact items. In multiple linear-regression models, an increase of one tertile in the VAS score was associated with a decrease of 2.23 points in the LCQ total score, indicating poorer cough-related QoL. CONCLUSION: As self-assessed in patients with RCC/UCC, cough-severity VAS scores were strongly associated with the impact of cough on QoL and everyday life. Patients with VAS scores of 60-100 mm reported the greatest impact and thus may benefit the most from targeted cough therapies.

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Background: Chronic cough is a frequent reason for seeking consultation with primary care providers. The recent widespread adoption of virtual care offers a promising alternative that can be used to optimize the assessment and management of this condition. The objective of this review was to map and identify the strategies used to assess and/or manage chronic cough virtually, and to explore their impact on cough severity and patient satisfaction with virtual care. Methods: A scoping review was conducted in MEDLINE, EMBASE, and CINAHL in May 2023. Research questions were defined based on the Population, Concept, Context mnemonic, and literature search was conducted using a three-step approach. Study selection involved the steps of identification, screening, eligibility, and inclusion. A descriptive synthesis was performed, and quantitative variables were presented as absolute and relative frequencies. Results: A total of 4953 studies were identified and seven met the inclusion criteria. The following mHealth and telehealth strategies were identified: diagnostic website, specialized online clinic, online speech language therapy, and remote follow-up to assess the effectiveness of in-person interventions. Results indicated that these virtual strategies can be useful to assess chronic cough, treat, and track chronic cough symptoms. Overall, patients were satisfied with the approaches. Conclusion: Although literature is scarce, evidence suggests that virtual strategies for the assessment and management of chronic cough may be effective and are well-received by patients. However, further research is needed to identify the type and characteristics of virtual approaches leading to optimize and facilitate the care of patients with this condition. This will also help develop a strong body of evidence to support their incorporation into guidelines and clinical practice.

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OBJECTIVE: This study aimed to determine the long-term outcomes of patients with chronic refractory cough (CRC) following treatment for cough suppression therapy (CST). Currently, there is a lack of objective data regarding the long-term outcome of behavioral treatment for CRC. METHODS: From the charts of 106 adult patients diagnosed with CRC, 24 patients were identified as having long-term data at least 3 months post-CST in the form of otolaryngologic examination, Voice Handicap Index-10 (VHI-10), and Cough Severity Index (CSI) scores. Patients underwent otolaryngologic evaluation and completed the VHI-10 and CSI assessments during pretreatment, posttreatment, and long-term follow-up visits. Patients were also divided into two groups based on their number of comorbidities. RESULTS: Twenty of the 24 patients had significant reduction in cough severity after completing CST (P < 0.001). A significant difference was also found in CSI scores from pretherapy to the long-term follow-up visits (P = 0.001). No significant difference was found in CSI scores from posttherapy to long-term follow-up visits (P = 0.93). No significant difference was found in VHI-10 scores over time (P = 0.83). No correlation was found between changes in cough and voice severity and number of comorbidities at the tested level. CONCLUSIONS: Findings of no significant change in CRC over the long term compared to posttherapy measures suggest that patients were able to maintain improvement in cough over the long term despite various comorbidities. The current results suggest that CST represents a satisfactory approach to treating CRC and provides patients with an ongoing tool to maintain reduced cough severity. No significant correlations between number of comorbidities and mean CSI or VHI-10 scores were found over the long term.

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PURPOSE: Objective 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. METHODS: Data 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. RESULTS: Correlations 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. CONCLUSION: Objective 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.

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Background: Chronic cough (CC) is a common condition, but the burden of CC in general populations remains largely unknown. This study aims to investigate the disease prevalence and burden among community-based CC patients in South Korea and Taiwan, using structured tools. Methods: A population-based cross-sectional study uses data from the 2020 South Korea and Taiwan National Health and Wellness Survey (NHWS) as well as a CC survey conducted between January-February 2020 and March-April 2020, respectively. Health outcome measures included health-related quality of life (HRQoL), health state utilities, work productivity and activity impairment (WPAI), and measurement of depression, anxiety, and insomnia among CC patients. Results: The weighted lifetime and 12-month prevalence of CC was 6.20% and 4.34% in South Korea, and 8.27% and 5.55% in Taiwan. Compared to matched non-CC controls, CC patients reported poorer HRQoL (SF-12v2) in terms of physical component summary (PCS) score (South Korea: 47.69 ± 7.68 vs. 50.08 ± 7.29; Taiwan: 48.58 ± 7.15 vs. 50.50 ± 7.30) and mental component summary (MCS) score (44.15 ± 8.85 vs. 46.28 ± 8.50; 42.44 ± 7.78 vs. 44.60 ± 8.08), health state utilities EQ-5D index (0.73 ± 0.23 vs. 0.82 ± 0.16; 0.82 ± 0.13 vs. 0.86 ± 0.14), and more visits to healthcare professionals (7.80 vs. 4.61; 6.09 vs. 4.20) (p < 0.05). In terms of WPAI, CC patients reported higher impairments in presenteeism (32.8% vs. 21.0%; 25.9% vs. 19.4%), total work productivity (36.2% vs. 22.3%; 27.7% vs. 20.6%), and total activity (34.2% vs. 23.2%; 27.7% vs. 20.3%) than non-CC controls (p < 0.001). CC patients in South Korea and Taiwan experienced anxiety, depression, and insomnia more than non-CC controls. Poorer health outcomes were associated with the severity of CC. Patients with severe CC (visual analogue scale [VAS]>4) in both nations reported lower PCS score (45.80 vs. 49.48; 47.41 vs. 49.22) and higher absenteeism (8.5% vs. 3.6%; 5.5% vs. 1.8%) than patients with mild CC (VAS≤4) (p < 0.05). Conclusions: The findings revealed that the disease burden of CC in general populations of South Korea and Taiwan is considerable with a negative impact on the overall quality of life, social and work life, and psychological comorbidities and is significantly associated with increased severity of the CC. There is an unmet need for further treatment interventions for CC patients to relieve the burden of CC in both nations.

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INTRODUCTION: Patients 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. METHODS: This 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). RESULTS: The 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 r of 0.53 and -0.41 for CSD and LCQ total scores, respectively; p < 0.0001 for each). Known-groups validity was supported by significant differences in mean cough severity VAS scores across severity groups defined using CSD, LCQ, and cough frequency tertiles. A large effect size was observed in patients with the greatest improvements in PGIC (Cohen d = -1.8). A ⩾ 30-mm reduction in the cough severity VAS was estimated as a clinically meaningful change threshold for clinical trials in chronic cough. CONCLUSIONS: The 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.

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OBJECTIVES//HYPOTHESIS: To determine changes in voice severity when treating chronic cough refractory to medical treatment with cough suppression therapy (CST) in patients with chronic cough and voice complaints. Chronic cough has been reported to be refractory to medical treatment and frequently co-occurs with voice disorders. The possible effects of CST on self-assessed changes in chronic cough and voice disorders have not been demonstrated. STUDY DESIGN: Retrospective analysis of the effects of cough suppression therapy (CST) on self-assessed changes in chronic cough and voice disorder severity in patients with both chronic cough and voice disorders. METHODS: Forty-three adult patients with the primary complaint of chronic refractory cough underwent pre- and post-treatment diagnostic examinations, completed pre- and post-treatment Voice Handicap Index-10 (VHI-10) and Cough Severity Index assessments, and were treated by a licensed speech-language pathologist using CST. Twenty-seven subjects were assigned to the cough (C) group and 16 to the cough-voice (CV) group based on the severity of their VHI-10 scores. RESULTS: Post-test analysis showed significant improvement in cough severity for both groups and significant improvement in voice severity for the CV group. The VHI-10 scores for the C group did not change significantly. The median number of treatment sessions was 3, with a range of 1-13 sessions. Correlation between changes in severity and number of treatment sessions was not found to be significant at the tested level. CONCLUSIONS: CST represents a unifying approach for treatment of patients with CRC and comorbid voice disorders. CST offered cross-over effects to the voice when subjects were treated for their primary complaint of chronic cough. This treatment of the primary complaint improves function in systems that share a common pathway. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2747-2751, 2021.

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BACKGROUND: Despite close link exists between cough severity and quality of life (QoL), whether gender difference is implied in the effect of cough on QoL has not been studied yet. This study primarily aims to investigate whether the association between cough severity and QoL is modified by gender in patients with postinfectious cough. METHODS: Secondary analyses were performed in 180 participants with postinfectious cough in a multisite randomized controlled trial. Baseline demographics, clinical characteristics and score of cough specific quality of life questionnaire (CQLQ) were collected. Linear regression analyses were conducted to examine gender difference in CQLQ score and the association between cough severity and CQLQ score. RESULTS: Difference between women and men was not significant in CQLQ total score in the unadjusted analysis (P = 0.077). Women had a 2.20-point higher CQLQ total score than men (95% confidence interval (CI) 0.11-4.30; P = 0.039), after adjusting for age, cough duration, cough severity, and clinical center. Gender significantly modified the association between cough severity and CQLQ total score (coefficient 1.80, 95% CI 0.29-3.30; P = 0.020), after adjusting for age, cough duration, and study center. An increase of 1-point in cough severity was associated with a 2.55-point (95% CI 1.16-3.95) increase in CQLQ total score in women versus a 1.26-point (95% CI 0.20-2.31) increase in men (P = 0.020). CONCLUSIONS: Female sex may be associated with worse QoL than men, and women's QoL may be more significantly impaired as cough symptom deteriorates. Gender difference should be taken into account in the clinical settings and research of cough and cough related QoL. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTRTRC12002297. Registered 19 June 2012, http://www.chictr.org.cn/abouten.aspx .

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Introduction: Small airway dysfunction (SAD) commonly presents in patients with classic asthma, which is associated with airway inflammation, disease severity, and asthma control. However, the prevalence of SAD, its relationship with cough severity and airway inflammation, and its development after antiasthmatic treatment in patients with cough variant asthma (CVA) need to be clarified. This study aimed to investigate the prevalence of SAD and its relationship with clinical and pathophysiological characteristics in patients with CVA and the change in small airway function after antiasthmatic treatment. Methods: We retrospectively analyzed 120 corticosteroid-naïve patients with CVA who had finished a standard questionnaire and relevant tests in a specialist cough clinic, such as cough visual analog scale (VAS), differential cells in induced sputum, fractional exhaled nitric oxide (FeNO) measurement, spirometry, and airway hyper-responsiveness. Information of 1-year follow-up was recorded in a part of patients who received complete cough relief after 2 months of treatment. SAD was defined as any two parameters of maximal mid-expiratory flow (MMEF)% pred, forced expiratory flow at 50% of forced vital capacity (FEF50%) pred, and forced expiratory flow at 75% of forced vital capacity (FEF75%) pred measuring <65%. Results: SAD occurred in 73 (60.8%) patients with CVA before treatment. The patients with SAD showed a significantly longer cough duration (24.0 vs. 6.0, p = 0.031), a higher proportion of women (78.1 vs. 59.6%, p = 0.029), older mean age (41.9 vs. 35.4, p = 0.005), and significantly lower forced expiratory volume in 1 s (FEV1%) pred, FEV1/FVC, MMEF% pred, FEF50% pred, FEF75% pred, PEF% pred, and PD20 (all p < 0.01) as compared with patients without SAD. There were no significant differences in cough VAS, sputum eosinophils count, FeNO, and TIgE level between patients with SAD and those without SAD. Among 105 patients who completed 2 months of antiasthmatic treatment and repeatedly experienced spirometry measurement, 57 (54.3%) patients still had SAD, despite a significant improvement in cough VAS, sputum eosinophils, FeNO, FEF50% pred, and PEF% pred (all p < 0.01). As compared with patients without SAD, patients with SAD showed no significant differences in the relapse rate (50.0 vs. 41.9%, p = 0.483) and wheeze development rate (10.4 vs. 0%, p = 0.063) during the follow-up. Conclusions: Small airway dysfunction occurred in over half of patients with CVA and persisted after short-term antiasthmatic treatment, which showed distinctive clinical and pathophysiological features.

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BACKGROUND: Asthmatic cough is often refractory to standard treatments such as inhaled corticosteroids (ICS) and long-acting ß2 agonists (LABA). Tiotropium may modulate cough reflex sensitivity of acute viral cough, but its efficacy in asthmatic cough remains unknown. OBJECTIVE: To evaluate whether tiotropium improves cough and cough reflex sensitivity in patients with asthma refractory to ICS/LABA. METHODS: Seventeen consecutive patients with asthma with chronic cough despite the use of ICS/LABA (13 women; 43.4 ± 19.0 years; average ICS dose, 651 ± 189 µg/d; fluticasone equivalent) were additionally treated with tiotropium (5 µg/d) for 4 to 8 weeks to examine its effects on pulmonary function and capsaicin cough reflex sensitivity (cough thresholds C2 and C5). Cough severity, cough-specific quality of life, and asthma control were also evaluated using cough visual analog scales (VASs), the Japanese version of Leicester Cough Questionnaire (J-LCQ), and Asthma Control Test (ACT), respectively. Patients with an improved cough VAS score of 15 mm or more were considered responders to tiotropium. RESULTS: Tiotropium significantly improved cough VAS, J-LCQ, and ACT scores, but not FEV1. Changes in cough VAS score correlated with those in C2 (r = -0.58; P = .03), C5 (r = -0.58; P = .03), and ACT scores (r = -0.62; P = .02), but not in FEV1 in the overall patients. When analyses were confined to the 11 responders, tiotropium significantly improved capsaicin cough reflex sensitivity within the subgroup (C2: P = .01 and C5: P = .02) and versus the nonresponders (C2: P = .004 and C5: P = .02). CONCLUSION: Tiotropium may alleviate asthmatic cough refractory to ICS/LABA by modulating cough reflex sensitivity but not through bronchodilation.

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BACKGROUND: We hypothesized that addressing anxiety and depressive mood disorders will improve chronic cough severity and cough quality of life (CQOL). METHODS: Major tenets of the theory of unpleasant symptoms were examined in a longitudinal observational study of consecutive adults with cough of > 8 weeks' duration treated in our cough clinic. At baseline and 3 and 6 months, subjects completed 3 Punum Ladders rating cough severity, the CQOL Questionnaire, the Depression, Anxiety, and Stress Scales-21, and the Duke Functional Social Support Questionnaire. Cross-sectional baseline and longitudinal regression analyses were conducted. RESULTS: Eighty subjects (55 women) with a mean age of 58.5 ± 11.1 years and a cough duration of 86.0 ± 123.7 months were enrolled. At baseline, worse cough severity was significantly associated with less education and worse ability to speak bothered by cough and the urge to cough. Worse CQOL was significantly associated with worse depression symptoms, urinary incontinence, and ability to speak; use of self-prescribed remedies; and younger age. Significant improvements in depression and stress symptoms occurred at 3 and 6 months. Anxiety symptoms improved, particularly in the first 3 months. Improvement in cough severity was significantly associated with less education, male sex, and improvement in ability to speak and urge to cough. Improvement in CQOL was significantly associated with improvement in urinary incontinence, urge to cough, anxiety symptoms, and use of self-prescribed remedies. CONCLUSIONS: Using the theory of unpleasant symptoms, we have come to appreciate that managing psychological, physiological, and situational factors in addition to focusing on identifying the cause of cough is important to maximize improvement in CQOL.

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