Sputum Assessment Questionnaire Research Articles

Current cough and sputum assessed by the cough and sputum assessment-questionnaire (CASA-Q) is associated with quality of life impairment in cystic fibrosis

BackgroundCough and sputum are major symptoms in cystic fibrosis (CF) that contribute to the impairment of quality of life.MethodsThis prospective single centre cross-sectional pilot study aimed to evaluate the results of a self-administered questionnaire assessing cough and sputum symptoms (2 domains), and their impact (2 domains) on daily activities in the previous week, named the Cough and Sputum Assessment Questionnaire (CASA-Q) in CF adult patients at stable state, and to analyse associations with clinical, functional, microbiological, radiological data, and two quality of life scales: the Cystic Fibrosis Questionnaire Revised (CFQ-R) and the Saint George Respiratory Questionnaire (SGRQ).ResultsForty-eight patients were included in this analysis (69% men; median age of 27.8 ± 8.1 years; median body mass index of 21.8 + 3.3 kg/m²; mean FEV1 of 64 ± 30% of the predicted value). The mean values of the CASA-Q domains were 58 ± 23 for cough symptoms, 77 ± 24 for cough impact, 62 ± 25 for sputum symptoms and 84 ± 21 for sputum impact. Impairment in CASA-Q cough and sputum domains was associated with dyspnea mMRC scale (p < 0.005 for all 4 domains of CASA-Q) and exacerbations in the previous year (p < 0.05 for CASA-Q symptoms domains). We also found correlations between all domains of the CASA-Q and quality of life questionnaires including SGRQ (p < 0.001) and to a lesser extend CFQ-R. We identified a clinical phenotype (female gender, ΔF508 heterozygous mutation, dyspnea mMRC scale) associated with an impairment of CASA-Q score and quality of life using a 2-step cluster analysis.ConclusionsCASA-Q allows the assessment of cough and sputum in CF adult patients and is associated with quality of life impairment. This simple easy-to-use tool could be used in routine clinical practice and in clinical studies to assess cough and sputum in CF patients.Trial RegistrationThe study was registered on ClinicalTrials.gov (NCT02924818, first posted on 5th October 2016).

The Effects of a 'New Generation' of Heat and Moisture Exchangers in Laryngectomized Patients with Previous Heat and Moisture Exchanger Experience.

Objectives: To evaluate the effects of a new generation of heat and moisture exchangers (NG-HMEs) on pulmonary rehabilitation, quality of life, patient satisfaction, and usage patterns. Methods: A prospective observational study on 23 laryngectomized patients with prior HME experience from June 1, 2021 to November 30, 2021. Patients were interviewed at inclusion, after 6 weeks and after 12 weeks after the introduction of NG-HMEs. Two validated questionnaires were used to report pulmonary complaints and quality of life: the Cough and Sputum Assessment Questionnaire (CASA-Q), the European Quality of Life 5 Dimensions Index Score (EQ-5D Index Score), and the European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D-VAS). Usage patterns and patient satisfaction were reported using study-specific questionnaires. Results: The patients had an average age of 65.7 ± 6.8 years, with 87% being male, on average 33.7 ± 35.3 months after total laryngectomy (TLE). NG-HMEs were used for a mean of 21.87 ± 4.63 hours/day (P = .034). After 12 weeks of use, patients reported the following changes in the CASA-Q domains: cough symptoms (+5; P = .663), cough impact (0; P = .958), sputum symptoms (+8; P = .13), and sputum impact (+3; P = .489). The EQ-5D index score increased (+0.024; P = .917) as well as the EQ-5D VAS (+0.8; P = .27). All patients rated their experience with NG-HMEs with ≥3 out of 5. The patients who used NG-HMEs as instructed (n = 13) reported more profound changes in the CASA-Q domains: cough symptom (+11; P = .129), cough impact (+7; P = .209), sputum symptom (+11; P = .123), and sputum impact (+10; P = .102). Conclusions: Our results show that NG-HMEs could have a positive clinical impact on pulmonary rehabilitation after TLE, even in HME-experienced patients. The use of NG-HMEs does not affect the quality of life. The possible effects of NG-HMEs require further evaluation in long-term studies to fully assess their efficacy.

MT14 Defining Health States to Assess the Cost-Effectiveness of Interventions in Laryngectomized Patients

Current cost-effectiveness models of heat and moisture exchangers (HMEs) for laryngectomized patients, do not consider the potential changes in health-related quality of life (HRQoL) due to reduced cough and sputum symptoms and impact. The aim of this study is to investigate whether the Cough and Sputum Assessment Questionnaire (CASA-Q) can be used to identify health states that distinguish in HRQoL, or utility, for cost-effectiveness models.

Sputum-Rheology-Based Strategy for Guiding Azithromycin Prescription in COPD Patients with Frequent Exacerbations: A Randomized, Controlled Study (“COPD CARhE”)

(1) Background: We have previously shown that sputum rheology can discriminate between patients with COPD and other muco-obstructive lung diseases, and that it is correlated with mucin content and sputum eosinophilia. We now hypothesize that it could be a more-accurate guide than clinical evaluation for the prescription of azithromycin to prevent exacerbations of COPD and to reduce exposure to antibiotics; (2) Methods: "COPD CaRhe" is a multicentric, randomized, controlled trial comparing outcomes in two parallel arms (36 vs. 36 patients). Patients will be recruited in the university hospitals of Montpellier, Bordeaux, and Toulouse, in France, and they should have a diagnosis of COPD with frequent exacerbations (≥3/year). Enrollment will occur during a routine visit to a respiratory department, and follow-up visits will occur every 3 months for a period of 1 year. At each visit, a 3-month prescription of azithromycin will be provided to those patients who obtain a score of <70 on the Cough and Sputum Assessment Questionnaire (CASA-Q) or a critical stress score of σc > 39 on a rheological assessment of sputum, depending upon their randomization group. The primary outcome will be the number of exacerbations of COPD; (3) Discussion: By using sputum rheology, the COPD CaRhe study may provide clinicians with an objective biomarker to guide the prescription of azithromycin while reducing the cumulative exposure to macrolides.

Impaired cough-related quality of life in patients with nontuberculous mycobacteriosis.

Cough and sputum are the significant symptoms of nontuberculous mycobacteriosis (NTM) and impair quality of life (QOL). However, the relationship between these symptoms and clinical features is not fully understood. This study aimed to investigate cough-related QOL in NTM patients. The study subjects included 78 patients with NTM at our hospital from October to December 2015. They completed the Leicester Cough Questionnaire (LCQ) and the Cough and Sputum Assessment Questionnaire (CASA-Q) (both questionnaires: the higher, the better); the Frequency Scale for the Symptoms of gastroesophageal reflux disease (GERD) (FSSG), a validated Japanese questionnaire for GERD (the higher, the worse), was also assessed. The FSSG consists of 12 items, including the reflux-related symptoms and dysmotility symptoms domains, each of which is quantified on a scale of 0-4 points, and the cut-off score for GERD is set at 8 points. Associations between these scores and clinical parameters were assessed. The total LCQ score was reduced-the physical domain was dominant. The total LCQ and CASA-Q scores were reduced, with dominance in the physical and symptoms domains, respectively. The reflux-related symptoms score was higher than the dysmotility symptoms score. A multivariate linear regression analysis revealed that the mean total LCQ score was independently associated with current smoking, fibrocavitary type, bilateral cavitary lesion, and FSSG total score. Cough-related QOL was impaired in NTM patients who currently smoked, had radiological characteristics, and had GERD.

Real-life effectiveness of indacaterol/glycopyrronium/mometasone for symptomatic relief of cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy in patients with asthma: REACH study design.

Cough is a major symptom in patients with asthma and poses a significant burden compared with other asthma symptoms. However, there are no approved treatments in Japan, developed to specifically treat cough in patients with asthma. We present the design of REACH, an 8-week real-life study, which will evaluate the efficacy of a combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF) in asthmatic patients with cough refractory to medium-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). Patients with asthma (age ≥20 to <80 years) with a cough visual analogue scale (VAS) ≥40 mm will be randomised 2:1:1 to receive IND/GLY/MF medium-dose 150/50/80 μg once daily or step-up to a high-dose regimen of fluticasone furoate/vilanterol trifenatate (FF/VI) 200/25 µg once daily or budesonide/formoterol fumarate (BUD/FM) 160/4.5 µg four inhalations twice daily during the 8-week treatment period. The primary objective is to demonstrate the superiority of IND/GLY/MF medium-dose over high-dose ICS/LABA in terms of cough-specific quality of life after 8 weeks. The key secondary objective is to demonstrate the superiority of IND/GLY/MF in terms of subjective assessment of cough severity. Cough frequency (VitaloJAK cough monitor) and capsaicin cough receptor sensitivity will be evaluated in eligible patients. Cough VAS scores, fractional exhaled nitric oxide, spirometry and blood tests, and the Asthma Control Questionnaire-6, Cough and Sputum Assessment Questionnaire, and Japanese version of the Leicester Cough Questionnaire will be evaluated. REACH will provide valuable evidence on whether a switch to IND/GLY/MF medium-dose or step-up to high-dose ICS/LABA is beneficial for patients with persistent cough despite treatment with medium-dose ICS/LABA.

Performance of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD: Evidence from Clinical and Online Patient Interaction Studies.

Patient perception of the burden of chronic bronchitis symptoms in chronic obstructive pulmonary disease (COPD) can be assessed using patient-reported outcome measures (PROMs). The Cough and Sputum Assessment Questionnaire (CASA-Q) was developed and tested for this purpose. This study reviewed the performance of the CASA-Q in published online studies and tested a novel approach to complement traditional methods of qualitative content validation. A targeted literature search was performed to identify published clinical studies of COPD using the CASA-Q as an endpoint. The performance of the questionnaire was examined in relation to other study endpoints, including clinical and functional measurements and other PROMs. Assessment of the content validity of the CASA-Q was carried out by comparing the content and structure of the questionnaire with published qualitative patient data from previously conducted online social media listening (SML) and online bulletin board (OBB) studies. In the interventional clinical trials, CASA-Q change scores were consistent with study objectives and other endpoints, including FEV1 and other PROMs. Two observational studies showed cross-sectional correlations with other PROMs like the St.-George's Respiratory Questionnaire (SGRQ) and COPD assessment test (CAT) scores. Qualitative data from the SML and OBB patient studies were consistent with the content and structure of the CASA-Q, supporting the content validity of the measure. Results suggest that the CASA-Q is appropriately responsive to changes in cough and sputum symptoms and clinical impact in trials of COPD. The mapping of qualitative findings from online SML and OBB studies to CASA-Q domains and items confirm the content validity of the instrument. These results suggest the CASA-Q can be a valuable tool for evaluating treatment effect in COPD trials.

Effect of a Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum Expectoration in Chronic Obstructive Pulmonary Disease

Background. Chronic obstructive pulmonary disease (COPD) is a multifactorial, progressive chronic lung disease. COPD was rated as the third largest cause of death by the World Health Organization (WHO) in 2016. Cough and sputum are present in about 60% of COPD patients. For persons with COPD who are unable to attend the standard centre-based program, home-based pulmonary rehabilitation offers a cost-effective option. The aim. To compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients with chronic obstructive pulmonary disease. Methods. Forty COPD-diagnosed subjects with ages between 40 to 60 years were recruited for this randomized clinical trial. The participants were randomly distributed into self-managed (n=18) and supervised (n=19) groups. Data was collected using a 6-minute walk test, the Leicester Cough Questionnaire and a cough and sputum assessment questionnaire at baseline after 6 weeks post treatment. Results. There was a significant difference found between self-managed and supervised groups for six-minute walk test with P value to be P &gt; 0.005. While analysing LCQ, overall no significant difference was observed demonstrating between two groups with P &gt; 0.05; besides, physical factors showed a significant difference during the pre-session which showed P = 0.004. No significant difference was found while analysing values from Cough and sputum assessment questionnaire with P &gt; 0.05 Conclusion. Supervised exercise program and self-managed group show equal improvement in COPD patients. Self-management exercise should be encouraged for active involvement of patient during the treatment and to promote self-preventive behavior. Keywords: sputum, cough, self-management, pulmonary rehabilitation.

Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures.

BackgroundAn understanding of the experience of patients with progressive fibrosing interstitial lung disease (PF-ILD) is needed to select appropriate patient-reported outcome measures (PROMs) to evaluate treatment effect in clinical trials.MethodsA systematic literature review was conducted to develop a preliminary conceptual model of the symptoms experienced by patients with PF-ILD and the impacts the disease has on them. An online survey and consensus meetings were then conducted with 12–14 stakeholders (patients, clinicians, regulatory and payer advisors) to refine the conceptual model and critically appraise how key concepts should be measured by PROMs. PROMs assessed included Living with Idiopathic Pulmonary Fibrosis, Living with Pulmonary Fibrosis, the King's Brief Interstitial Lung Disease questionnaire, Cough and Sputum Assessment Questionnaire, Evaluating Respiratory Symptoms, Leicester Cough Questionnaire, Functional Assessment of Chronic Illness Therapy (Dyspnoea/Fatigue) and St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis.ResultsThe literature review identified 36 signs/symptoms and 43 impacts directly or indirectly related to pulmonary aspects of PF-ILD. The most relevant symptoms identified by participants included shortness of breath on exertion, fatigue and cough; relevant impacts included effects on physical functioning, activities of daily living and emotional wellbeing. These are presented in a conceptual model. Consensus opinion was that existing PROMs need further modification and validation before use in clinical trials.ConclusionsThe conceptual model improves understanding of the symptoms and impacts that living with PF-ILD has on patients’ wellbeing. It can help to inform the choice of PROMs in clinical trials and highlight aspects to assess in the clinical care of patients with PF-ILD.

Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers.

To evaluate the effects of new devices-heat and moisture exchangers (HMEs) and adhesives-on pulmonary symptoms, subject adherence, quality of life, dermatologic symptoms, and patient satisfaction after laryngectomy. Prospective crossover study. Between December 2020 and April 2021, 40 patients were enrolled who had undergone laryngectomy, routinely used HMEs and adhesive, and were followed in our Department of Otolaryngology-Head and Neck Surgery. Patients were allocated into group A (new products) or group B (usual care) for 6 weeks. Then the 2 groups reversed, and each patient acted as his or her own control. Patients kept a diary and cough tally sheet. At baseline and after each 6-week period, 2 questionnaires were administered: EQ-5D (European Quality of Life-5 Dimensions) and CASA-Q (Cough and Sputum Assessment Questionnaire). Six weeks of using new products resulted in the following effects for both groups: (1) a significant reduction in daily forced expectoration and dry coughs, (2) a significant improvement in all domains of the CASA-Q, (3) an increase in adherence to HME use, (4) a significant reduction in shortness of breath and skin irritation, and (5) significantly better scores in the anxiety/depression domain of the EQ-5D. Achieving this reduction in patients who were already highly adherent to HME use is clinically relevant and underscores the importance of using better-performing HMEs that can compensate for the humidification deficit. Improving pulmonary symptomatology could reduce patient restrictions in daily life and avoidance of social activity, with a consequent positive effect on quality of life.

Effect of Particulate Matter 2.5 on Airway Inflammation and Mucus Hyper secretion of Chronic Obstructive Pulmonary Disease

To study the effect of Particulate Matter 2.5 on airway inflammation and mucus hyper secretion in Chronic obstructive pulmonary disease patients. Particulate Matter 2.5 was collected by particulate samplers and prepared into 30, 300, 3000 μg/ml Particulate Matter 2.5 solution. Normal human lung epithelial cells were treated with Phosphate-buffered saline solution for 12h, 48h and 96h. The cells viability was measured by Cell Counting Kit-8. Quantitative Polymerase Chain Reaction was used to measure the Micro Ribonucleic acid contents of Interleukin 1 beta, Interleukin 8, tumor necrosis factor-beta in BEAS2B cells after Particulate Matter 2.5 treatment. Chronic Obstructive Pulmonary Disease patients (N=200) from the Affiliated Hospital of Hangzhou Normal University from January 2019 to December 2019 were enrolled and randomly grouped into low exposure group and high exposure group. Before treatment and 6 mo after treatment, forced expiratory volume at 1s/forced vital capacity and forced expiratory volume 1 % prediction were detected. Cough and Sputum Assessment Questionnaire scale was conduct to assess the mucus hyper secretion of patients. Particulate Matter 2.5 could significantly inhibit the activity of bronchial epithelial cells Normal human lung epithelial cells cells in a time-dependent and concentrationdependent manner (p<0.05). Moreover, Particulate Matter 2.5 could significantly increase the expression of Interleukin 1 beta, Interleukin 8 and tumor necrosis factor-beta in bronchial epithelial cells Normal human lung epithelial cells cells (p<0.05), and the higher the concentration of Particulate Matter 2.5 and the longer the action time, the more significant the proinflammatory effect was. The forced expiratory volume 1/forced vital capacity and forced expiratory volume 1 % prediction of Chronic Obstructive Pulmonary Disease patients with high Particulate Matter 2.5 exposure were significantly lower than that of patients with low Particulate Matter 2.5 exposure (p<0.05), and the Cough and Sputum Assessment Questionnaire scores were significantly increased (p<0.05). High and long-term exposure to Particulate Matter 2.5 can reduce the activity of pulmonary epithelial cells in a time and concentration dependent manner, and significantly increase the expression levels of inflammatory factors such as Interleukin 1 beta, Interleukin 8, tumor necrosis factor-beta. The proinflammatory effects showed a time-dependent and concentration-dependent manner. High exposure to Particulate Matter 2.5 can damage the lung function of Chronic Obstructive Pulmonary Disease patients and increase the secretion of airway mucus.

Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Cough and Sputum in Patients with COPD.

BackgroundCough and sputum are highly prevalent in patients with chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) has shown to be effective in managing these symptoms. However, the interpretation of the magnitude of PR effects is hindered by the lack of minimal clinically important differences (MCIDs).PurposeThis study established MCIDs for the Leicester cough questionnaire (LCQ) and the cough and sputum assessment questionnaire (CASA-Q), in patients with COPD after PR.Patients and MethodsAn observational prospective study was conducted in patients with COPD who participated in a 12-weeks community-based PR program. Anchor- (mean change, receiver operating characteristic curves and linear regression analysis) and distribution-based methods [0.5*standard deviation; standard error of measurement (SEM); 1.96*SEM; minimal detectable change and effect size] were used to compute the MCIDs. The anchors used were: i) patients and physiotherapists global rating of change scale, ii) COPD assessment test, iii) St. George’s respiratory questionnaire and iv) occurrence of an exacerbation during PR. Pooled MCIDs were computed using the arithmetic weighted mean (2/3 for anchor- and 1/3 for distribution-based methods).ResultsForty-nine patients with COPD (81.6% male, 69.8±7.4years, FEV150.4±19.4%predicted) were used in the analysis. The pooled MCIDs were 1.3 for LCQ and for CASA-Q domains were: 10.6 - cough symptoms; 10.1 - cough impact; 9.5 - sputum symptoms and 7.8 - sputum impact.ConclusionThe MCIDs found in this study are potential estimates to interpret PR effects on cough and sputum, and may contribute to guide interventions.

Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial

ObjectiveTo evaluate the impact of combining nebulised hyaluronic acid plus hypertonic saline (HA+HS) with oscillatory positive expiratory pressure (oscillatory-PEP) on sputum expectoration and related symptoms in adults with cystic fibrosis (CF). DesignRandomised crossover trial. SettingSeven centres. ParticipantsTwenty-two outpatients with CF. InterventionsUsual care (HA+HS followed by autogenic drainage) and combined therapy (HA+HS with oscillatory-PEP followed by autogenic drainage]. Each treatment was performed for 5 days. Main outcome measuresSputum expectoration was measured during the nebulisation period (primary outcome), during autogenic drainage and for 24hours post intervention. The Cough and Sputum Assessment Questionnaire (CASA-Q) and its domains (cough symptoms, cough impact, sputum symptoms and sputum impact), the Leicester Cough Questionnaire (LCQ) and lung function tests were used. Tolerance and patient preference were registered. ResultsTwenty-two participants [mean age 25 (standard deviation 8) years, percentage predicted forced expiratory volume in 1second 67 (22)] were recruited. Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period {median difference 1.8ml [95% confidence interval (CI) 0.2–6.2]}. Both treatments led to similar expectoration during autogenic drainage and for 24hours post intervention. Combined therapy led to a greater improvement in the sputum symptoms domain [6.7 points (95% CI 3.3–13.3] and total CASA-Q score [2.4 points (95% CI 0.1–9.3)] compared with usual care. No differences in LCQ score or lung function were observed. Fewer adverse events were reported using combined therapy, which was selected as the preferred intervention. ConclusionsCombined nebulisation increased immediate sputum expectoration, improved sputum symptoms and reduced adverse events compared with usual care in patients with CF. Clinical trial numberNCT02303808.

Gathering Structured Patient Insight to Drive the PRO Strategy in COPD: Patient-Centric Drug Development from Theory to Practice.

We illustrate our experience of gathering patient insights on the most patient-relevant symptoms in chronic obstructive pulmonary disease (COPD) via a structured and systematic approach towards ‘patient-centric’ drug development, leveraging recent advances in digital technologies using online platforms. The four-step approach comprised the following: literature search, social media listening (SML) study, online bulletin board (OBB) exercise, and design of an online patient preference study (PPS). The initial online studies (SML and OBB) revealed that, besides dyspnoea and exacerbations, patients perceive cough and mucus production as equally important aspects of disease management for COPD. To further build and quantify patients’ understanding of the importance of these symptoms, an online patient preference survey is underway. Based on these findings, we have elected to include the Cough and Sputum Assessment Questionnaire or CASA-Q, a validated instrument to collect patient-reported outcomes (PRO), besides the use of the COPD assessment test or CAT to assess the severity and impact of COPD in drug development studies for COPD. Additionally, to capture movement and sleep disturbance, we consider the inclusion of actigraphy as a digital evidence-capture end point. Lastly, in a phase II trial, a survey questionnaire on incontinence will be administered to evaluate the importance of this issue among patients. We believe that integrating insights derived from “online” studies (SML, OBB, and PPS) into drug development offers an opportunity to truly listen to patients’ voices in early product design ensuring relevance of end points selected for the clinical trial program. This approach also has the potential to complement conventional qualitative and quantitative data collection requirements for PRO instrument development. While awaiting final guidance from the US Food and Drug Administration, or FDA, the recently released draft documents on collecting representative patients’ input reference social media as a tool to collect qualitative patient preference data and these developments suggest that patient preference data can influence future clinical trial design, end point selection, and regulatory reviews.Funding: Novartis Pharma AG, Basel.

HEALTH-RELATED QUALITY OF LIFE MEASURES IN IDIOPATHIC PULMONARY FIBROSIS: DATA FROM THE IPF-PRO REGISTRY

SESSION TITLE: Diagnosis and Treatment of IPF SESSION TYPE: Original Investigations PRESENTED ON: 10/20/2019 2:15 PM - 3:15 PM PURPOSE: Idiopathic pulmonary fibrosis (IPF) is a devastating and progressive lung disease that impacts different quality of life domains. While various general and symptom-specific quality of life instruments have been applied in IPF, the extent to which each adds value beyond respiratory-specific tools is unknown. The objective of this analysis was to describe the distribution of patient-reported outcomes (PROs) in a national US cohort of patients with IPF, as well as to explore the associations between respiratory-specific and general health PROs. METHODS: We used data from the IPF-PRO Registry, a multicenter, observational registry of patients with IPF that was diagnosed or confirmed at the enrolling center in the past 6 months, to evaluate PROs at the time of enrollment (June 2014 – July 2018). PRO measurements included SGRQ total score as well as domain scores (activity, impact and symptom), cough and sputum assessment questionnaire (CASA-Q) domain scores (cough impact and cough symptoms), EuroQol index score, EuroQol visual analogue score, short form 12 (SF-12) physical component score and SF-12 mental component score. We used Pearson correlation coefficients to explore associations between each of the four SGRQ scores (total and domain-specific) and the six other PROs. As the scale for SGRQ is opposite those of the other measures, values for the six other PROs were reversed before calculating the correlation coefficient. RESULTS: Among 859 patients with available PRO data, the mean SGRQ total score was 40.5 (SD 19.5), in contrast to the previously validated mean score in healthy subjects of 6. In comparing mean domain scores, patients experienced worse quality of life in the SGRQ activity domain compared to the impact domain (55.6 vs. 29.9) as well as the CASA-Q symptom domain compared to the impact domain (59.5 vs. 73.2). Patients also reported worse quality of life in the SF-12 physical domain compared to SF-12 mental domain (38.9 vs. 52.0). Moderate to strong correlations were observed between SGRQ (total as well as all domain scores) and all six other PROs (r range = 0.28 – 0.73). Notably, of all the PROs, the SF-12 mental component score had the weakest correlations with the SGRQ total, activity, impact, and symptom scores. CONCLUSIONS: The deficits in the SGRQ total and domain scores expose the reduced quality of life in patients with IPF. While the SGRQ generally captures data gathered in the other instruments, the SF-12 mental component score may contain additional information that is not represented in the SGRQ. CLINICAL IMPLICATIONS: Patients with IPF experience substantial reductions in quality of life, particularly in activity and symptom domains. Future studies may focus on targeting quality of life interventions in domains most affected in IPF patients. DISCLOSURES: Employee relationship with Boehringer Ingelheim Please note: >$100000 Added 03/11/2019 by Shaun Bender, source=Web Response, value=Salary Employee relationship with Boehringer Ingelheim Pharmaceuticals Please note: >$100000 Added 03/12/2019 by Craig Conoscenti, source=Web Response, value=Salary Advisory Committee Member relationship with Boehringer-Ingelheim Please note: $5001 - $20000 Added 03/12/2019 by Daniel Culver, source=Web Response, value=travel Speaker/Speaker's Bureau relationship with Genentech Please note: $1001 - $5000 Added 03/12/2019 by Daniel Culver, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Mallinkrodt Please note: $1001 - $5000 Added 03/12/2019 by Daniel Culver, source=Web Response, value=Honoraria Consultant relationship with aTyr Please note: $1001 - $5000 Added 03/12/2019 by Daniel Culver, source=Web Response, value=Consulting fee No relevant relationships by Anne Hellkamp, source=Web Response Employee relationship with Boehringer Ingelheim Pharmaceuticals, Inc. Please note: >$100000 Added 03/14/2019 by Thomas Leonard, source=Web Response, value=Salary No relevant relationships by Megan Neely, source=Web Response Investigator relationship with Novartis Please note: >$100000 Added 02/14/2019 by Emily O'Brien, source=Web Response, value=Grant/Research Investigator relationship with BMS Please note: >$100000 Added 02/14/2019 by Emily O'Brien, source=Web Response, value=Grant/Research Support My spouse/partner as a Employee relationship with Biocryst Please note: >$100000 Added 03/12/2019 by Scott Palmer, source=Web Response, value=Salary PI relationship with BI Please note: >$100000 Added 03/12/2019 by Scott Palmer, source=Web Response, value=Grant/Research Support Funding to coordinate IPF-PRO Registry relationship with Faculty member in DCRI, which receives support from BI Please note: $5001 - $20000 Added 03/14/2019 by Laurie Snyder, source=Web Response, value=Grant/Research Support No relevant relationships by Aparna Swaminathan, source=Web Response Grants received to the institution relationship with Boehringer Ingelheim Please note: >$100000 Added 03/11/2019 by Jamie Todd, source=Web Response, value=Grant/Research Support

Warm acupuncture on chronic obstructive pulmonary disease with phlegm-turbid obstructing of the lung: a randomized controlled trial

To verify the effect of warm acupuncture combined with western medicine in patients with acute exacerbation chronic obstructive pulmonary disease (AECOPD) with phlegm-turbid obstructing of the lung. Ninety patients with AECOPD were randomly divided into a western medicine group, a warm acupuncture group and a sham acupuncture group, 30 cases in each group. Routine treatment according to the Global initiative for chronic obstructive lung disease (GOLD) guidelines was used in the western medicine group. On the basis of the routine treatment, the warm acupuncture was applied at Fenglong (ST 40), Feishu (BL 13), Zusanli (ST 36) and other acupoints in the warm acupuncture group. In the sham acupuncture group, non-acupoints were taken on the basis of conventional treatment, and superficial acupuncture was performed for 1-3 mm, once a day for 2 weeks. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), FEV1/FVC, cough and sputum assessment questionnaire (CASA), COPD assessment test (CAT), and the change of TCM syndrome score were observed before and after treatment in all groups. After treatment, the FEV1, FVC and FEV1/FVC in each group were higher than those before treatment (P<0.05), there was no significant difference among groups after treatment (P>0.05). The CASA score, CAT score and TCM syndrome score in each group were lower than those before treatment (P<0.05). The change of the scores before and after treatment in the warm acupuncture group was higher than that in the sham acupuncture group and the western medicine group (P<0.05). There was no significant difference between the sham acupuncture group and the western medicine group (P>0.05). Warm acupuncture has a significant effect on the improvement of symptoms in patients with AECOPD with phlegm-turbid obstructing of the lung.

Improving access to community-based pulmonary rehabilitation: 3R protocol for real-world settings with cost-benefit analysis

BackgroundPulmonary rehabilitation (PR) has demonstrated patients’ physiological and psychosocial improvements, symptoms reduction and health-economic benefits whilst enhances the ability of the whole family to adjust to illness. However, PR remains highly inaccessible due to lack of awareness of its benefits, poor referral and availability mostly in hospitals. Novel models of PR delivery are needed to enhance its implementation while maintaining cost-efficiency. We aim to implement an innovative community-based PR programme and assess its cost-benefit.MethodsA 12-week community-based PR will be implemented in primary healthcare centres where programmes are not available. Healthcare professionals will be trained. 73 patients with CRD and their caregivers (dyads patient-caregivers) will compose the experimental group. The control group will include dyads age- and disease-matched willing to collaborate in data collection but not in PR. Patients/family-centred outcomes will be dyspnoea (modified Medical Research Council Questionnaire), fatigue (Checklist of individual strength and Functional assessment of chronic illness therapy – fatigue), cough and sputum (Leicester cough questionnaire and Cough and sputum assessment questionnaire), impact of the disease (COPD Assessment Test), emotional state (The Hospital Anxiety and Depression Scale), number of exacerbations, healthcare utilisation, health-related quality of life and family adaptability/cohesion (Family Adaptation and Cohesion Scale). Other clinical outcomes will be peripheral (biceps and quadriceps-hand held dynamometer, 1 or 10 repetition-maximum) and respiratory (maximal inspiratory and expiratory pressures) muscle strength, muscle thickness and cross sectional area (biceps brachialis, rectus femoris and diaphragm-ultrasound imaging), exercise capacity (six-minute walk test and one-minute sit to stand test), balance (brief-balance evaluation systems test) and physical activity (accelerometer). Data will be collected at baseline, at 12 weeks, at 3- and 6-months post-PR.Changes in the outcome measures will be compared between groups, after multivariate adjustment for possible confounders, and effect sizes will be calculated. A cost-benefit analysis will be conducted.DiscussionThis study will enhance patients access to PR, by training healthcare professionals in the local primary healthcare centres to conduct such programmes and actively involving caregivers. The cost-benefit analysis of this intervention will provide an evidence-based insight into the economic benefit of community-based PR in chronic respiratory diseases.Trial registrationThe trial was registered in the ClinicalTrials.gov U.S. National Library of Medicine, on 10th January, 2019 (registration number: NCT03799666).

Goblet cell hyperplasia as a feature of neutrophilic asthma

Goblet cell hyperplasia (GCH) is a pathological finding classically reported across asthma severity levels and usually associated with smoking. Multiple biological mechanisms may contribute to excessive mucus production. We aimed to decipher the clinical meanings and biological pathways related to GCH in non-smokers with asthma. Cough and sputum assessment questionnaire (CASA-Q) responses at entry and 1year later were compared to clinical and functional outcomes in 59 asthmatic patients. GCH was assessed through periodic-acid shift (PAS) staining on endobronchial biopsies obtained at entry in a subset of 32 patients. Periodic-acid shift-staining analysis revealed a double wave distribution discriminating patients with (>10% of the epithelial area) or without GCH. CASA-Q scores were mostly driven by overall asthma severity (P<0.0001). CASA-Q scores remained stable at 1year and were independently associated with BAL eosinophil content irrespective of the presence of GCH. GCH was unrelated to the presence of bronchiectasis at CT, GERD or chronic rhinosinusitis, but correlated well with neutrophilic inflammatory patterns observed upon BAL cellular analysis (P=0.002 at multivariate analysis). BALF bacterial loads were unrelated to GCH or to CASA-Q. Goblet cell hyperplasia is disconnected from chronic cough and sputum when assessed by a specific questionnaire. GCH is related to neutrophilic asthma whereas symptoms are related to airway eosinophilia. The clinical counterpart of GCH is unlikely assessed by the CASA-Q.

Improved cough- and sputum-related quality of life after initiation of treatment in pulmonary tuberculosis

Cough and sputum are the major symptoms of pulmonary tuberculosis (TB). However, the relationship between these symptoms and treatment for TB is not fully understood. The aim of this prospective study was to clarify the cough- and sputum-related quality of life (QOL) in patients with pulmonary TB before and after initiation of treatment. The study included 85 patients with active pulmonary TB who were hospitalized from July 2014 to August 2015. They completed the Leicester Cough Questionnaire (LCQ: range 3-21, the higher the better) and the Cough and Sputum Assessment Questionnaire (CASA-Q: range 0-100, the higher the better) on admission and at discharge after 2 months of treatment. The LCQ and CASA-Q scores were reduced on admission. A multivariate linear regression analysis revealed that younger age, more than two cavitary lesions, and the presence of bronchial TB were associated with reduced LCQ total score. However, each score significantly improved at discharge, regardless of the initial grade of the sputum smear, site of the lesion, number of cavitary lesions, and presence of bronchial TB. The change in the mean LCQ total score was 2.28 (95% confidence interval, 1.56-3.00). The changes in the mean CASA-Q cough symptoms, cough impact, sputum symptoms, and sputum impact scores were 22.84 (18.44-27.25), 10.96 (7.20-14.71), 17.25 (13.33-21.18), and 5.25 (2.49-8.00), respectively. Cough- and sputum-related QOL was impaired in patients with pulmonary TB before treatment but improved after initiation of treatment regardless of the clinical characteristics.

Gastroesophageal reflux symptoms and nasal symptoms affect the severity of bronchitis symptoms in patients with chronic obstructive pulmonary disease.

Cough and sputum production (symptoms of bronchitis) are common in chronic obstructive pulmonary disease (COPD). Extrapulmonary comorbidities, such as gastroesophageal reflux disease (GERD) and post-nasal drip, also cause bronchitis symptoms. The impact of extrapulmonary comorbidities on the severity of bronchitis symptoms in COPD is unknown. The aim of this study was to quantify bronchitis symptoms and assess the impact of GERD and nasal symptoms on the severity of bronchitis symptoms in COPD. In this cross-sectional study, stable COPD patients were recruited and completed the COPD assessment test (CAT) and Cough and Sputum Assessment Questionnaire (CASA-Q) to quantify bronchitis symptoms. To evaluate extrapulmonary comorbidities, the Frequency Scale for Symptoms of GERD (FSSG) questionnaire and nasal symptom questionnaire were completed. The impact of these comorbidities on the severity of bronchitis symptoms was analyzed. Ninety-nine COPD patients were recruited. The presence of GERD symptoms (24.2% in the study population) was associated with more sputum symptoms. The presence of nasal discharge (43.4%) was associated with more cough and sputum symptoms, whereas post-nasal drip (13.1%) was associated with more sputum symptoms. On multivariate analyses, nasal discharge was associated with more cough symptoms. GERD and post-nasal drip were associated with more sputum symptoms. This study showed that the presence of GERD and/or nasal symptoms is associated with an increase in bronchitis symptoms. Careful assessment of extrapulmonary comorbidities is necessary in the evaluation of bronchitis symptoms in COPD patients.