Marianne Bonnert, Stephen Nash, Erik M Andersson, Sten Erik Bergström, Christer Janson, Catarina Almqvist
{"title":"Internet-delivered cognitive-behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial.","authors":"Marianne Bonnert, Stephen Nash, Erik M Andersson, Sten Erik Bergström, Christer Janson, Catarina Almqvist","doi":"10.1136/bmjresp-2023-002035","DOIUrl":"10.1136/bmjresp-2023-002035","url":null,"abstract":"<p><strong>Introduction: </strong>There is an established association between asthma and anxiety. The overlap between asthma symptoms and symptoms of anxiety may cause individuals to overestimate their asthma severity and restrict their daily activities leading to a low quality of life. There is currently weak evidence for treatments targeting anxiety related to asthma, but cognitive-behavioural therapy (CBT) has shown some promising but mixed results. The current randomised controlled trial will investigate if exposure-based internet-delivered CBT (Internet-CBT) is more effective than treatment as usual+medical education (TAU+ME) to relieve symptoms of anxiety and asthma control.</p><p><strong>Methods and analysis: </strong>90 participants will be randomised 1:1 to 8 weeks of Internet-CBT or TAU+ME. The primary outcome, the patient-reported Catastrophising Asthma Scale, will be analysed from baseline to the primary endpoint at 16 weeks using hierarchical linear mixed model of the slope over time. Secondary outcomes, such as asthma control, quality of life and forced expiratory volume in 1 s, will be analysed correspondingly.</p><p><strong>Ethics and dissemination: </strong>All participants will be informed about the study and leave their consent before study entry. All results will be analysed at group level and reported through publication in a peer-reviewed scientific journal within the field. The study received ethical approval by the Swedish Ethical Review Authority in January 2020 (ID: 2019-05985; 2022-01117-02).</p><p><strong>Trial registration number: </strong>Registered at ClinicalTrials.gov (ID: NCT04230369).</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11131118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141157208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical features and 1-year outcomes of variable obstruction in participants with preserved spirometry: results from the ECOPD study in China.","authors":"Fan Wu, Haiqing Li, Zhishan Deng, Huajing Yang, Youlan Zheng, Ningning Zhao, Cuiqiong Dai, Jieqi Peng, Lifei Lu, Zihui Wang, Xiang Wen, Shan Xiao, Kunning Zhou, Xiaohui Wu, Gaoying Tang, Qi Wan, Ruiting Sun, Jiangyu Cui, Changli Yang, Shengtang Chen, Jianhui Huang, Shuqing Yu, Yumin Zhou, Pixin Ran","doi":"10.1136/bmjresp-2023-002210","DOIUrl":"10.1136/bmjresp-2023-002210","url":null,"abstract":"<p><strong>Background: </strong>There are limited data on the clinical features and longitudinal prognosis of variable obstruction, particularly among never smokers and different variable obstruction types. Therefore, we aimed to evaluate the clinical characteristics of the participants with variable obstruction and determine the relationship between variable obstruction and the development of chronic obstructive pulmonary disease (COPD) and the decline of lung function in a community-dwelling study of Chinese, especially among never smokers and different variable obstruction subtypes.</p><p><strong>Methods: </strong>Participants with preserved spirometry (postbronchodilator forced expiratory volume in 1 s (FEV<sub>1</sub>)/forced vital capacity (FVC) ≥0.70) at baseline from the Early COPD cohort were included in our analysis. Participants with variable obstruction (prebronchodilator FEV<sub>1</sub>/FVC <0.70) were compared with those without variable obstruction (prebronchodilator FEV<sub>1</sub>/FVC ≥0.70). We performed subgroup analyses in never smokers, former and current smokers, and different variable obstruction types (postbronchodilator FVC <prebronchodilator FVC or postbronchodilator FVC ≥prebronchodilator FVC).</p><p><strong>Results: </strong>The final analysis included 1140 participants with preserved spirometry (169 in the variable obstruction group) at baseline. Participants with variable obstruction were older, had lower lung function and had greater severe emphysema and computed tomography-defined air trapping than participants without variable obstruction. Participants with variable obstruction had a significantly increased risk of incident spirometry-defined COPD (relative risk: 3.22, 95% confidence interval 2.23 to 4.64, p <0.001) than those without variable obstruction after adjustment for covariates. These findings remained consistent among both former and current smokers, never smokers, and different variable obstruction types. Additionally, participants with variable obstruction had a faster decline in postbronchodilator FEV<sub>1</sub>/FVC (2.3±0.5%/year vs 0.9±0.4%/year, mean difference: 1.4 (95% confidence interval 0.5 to 2.3), p=0.002) than participants without variable obstruction after adjustment for covariates.</p><p><strong>Conclusions: </strong>The results of our study revealed that variable obstruction can identify individuals who are at risk for the development of COPD and accelerated postbronchodilator FEV<sub>1</sub>/FVC decline in preserved spirometry.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11129023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141092539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stefanie Harding, Alan Richardson, Angela Glynn, Luke Hodgson
{"title":"Influencing factors of sedentary behaviour in people with chronic obstructive pulmonary disease: a systematic review.","authors":"Stefanie Harding, Alan Richardson, Angela Glynn, Luke Hodgson","doi":"10.1136/bmjresp-2023-002261","DOIUrl":"10.1136/bmjresp-2023-002261","url":null,"abstract":"<p><strong>Background: </strong>People with chronic obstructive pulmonary disease (COPD) are more likely to adopt a sedentary lifestyle. Increased sedentary behaviour is associated with adverse health consequences and reduced life expectancy.</p><p><strong>Aim: </strong>This mixed-methods systematic review aimed to report the factors contributing to sedentary behaviour in people with COPD.</p><p><strong>Methods: </strong>A systematic search of electronic databases (Medline, CINAHL, PsycINFO and Cochrane Library) was conducted and supported by a clinician librarian in March 2023. Papers were identified and screened by two independent researchers against the inclusion and exclusion criteria, followed by data extraction and analysis of quality. Quantitative and qualitative data synthesis was performed.</p><p><strong>Results: </strong>1037 records were identified, 29 studies were included (26 quantitative and 3 qualitative studies) and most studies were conducted in high-income countries. The most common influencers of sedentary behaviour were associated with disease severity, dyspnoea, comorbidities, exercise capacity, use of supplemental oxygen and walking aids, and environmental factors. In-depth findings from qualitative studies included a lack of knowledge, self-perception and motivation. However, sedentarism in some was also a conscious approach, enabling enjoyment when participating in hobbies or activities.</p><p><strong>Conclusions: </strong>Influencers of sedentary behaviour in people living with COPD are multifactorial. Identifying and understanding these factors should inform the design of future interventions and guidelines. A tailored, multimodal approach could have the potential to address sedentary behaviour.</p><p><strong>Prospero registration number: </strong>CRD42023387335.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11129033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141092479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amy Hai Yan Chan, Braden Te Ao, Christina Baggott, Alana Cavadino, Amber A Eikholt, Matire Harwood, Joanna Hikaka, Dianna Gibbs, Mariana Hudson, Farhaan Mirza, Muhammed Asif Naeem, Ruth Semprini, Catherina L Chang, Kevin C H Tsang, Syed Ahmar Shah, Aron Jeremiah, Binu Nisal Abeysinghe, Rajshri Roy, Clare Wall, Lisa Wood, Stuart Dalziel, Hilary Pinnock, Job F M van Boven, Partha Roop, Jeff Harrison
{"title":"DIGIPREDICT: physiological, behavioural and environmental predictors of asthma attacks-a prospective observational study using digital markers and artificial intelligence-study protocol.","authors":"Amy Hai Yan Chan, Braden Te Ao, Christina Baggott, Alana Cavadino, Amber A Eikholt, Matire Harwood, Joanna Hikaka, Dianna Gibbs, Mariana Hudson, Farhaan Mirza, Muhammed Asif Naeem, Ruth Semprini, Catherina L Chang, Kevin C H Tsang, Syed Ahmar Shah, Aron Jeremiah, Binu Nisal Abeysinghe, Rajshri Roy, Clare Wall, Lisa Wood, Stuart Dalziel, Hilary Pinnock, Job F M van Boven, Partha Roop, Jeff Harrison","doi":"10.1136/bmjresp-2023-002275","DOIUrl":"10.1136/bmjresp-2023-002275","url":null,"abstract":"<p><strong>Introduction: </strong>Asthma attacks are a leading cause of morbidity and mortality but are preventable in most if detected and treated promptly. However, the changes that occur physiologically and behaviourally in the days and weeks preceding an attack are not always recognised, highlighting a potential role for technology. The aim of this study 'DIGIPREDICT' is to identify early digital markers of asthma attacks using sensors embedded in smart devices including watches and inhalers, and leverage health and environmental datasets and artificial intelligence, to develop a risk prediction model to provide an early, personalised warning of asthma attacks.</p><p><strong>Methods and analysis: </strong>A prospective sample of 300 people, 12 years or older, with a history of a moderate or severe asthma attack in the last 12 months will be recruited in New Zealand. Each participant will be given a smart watch (to assess physiological measures such as heart and respiratory rate), peak flow meter, smart inhaler (to assess adherence and inhalation) and a cough monitoring application to use regularly over 6 months with fortnightly questionnaires on asthma control and well-being. Data on sociodemographics, asthma control, lung function, dietary intake, medical history and technology acceptance will be collected at baseline and at 6 months. Asthma attacks will be measured by self-report and confirmed with clinical records. The collected data, along with environmental data on weather and air quality, will be analysed using machine learning to develop a risk prediction model for asthma attacks.</p><p><strong>Ethics and dissemination: </strong>Ethical approval has been obtained from the New Zealand Health and Disability Ethics Committee (2023 FULL 13541). Enrolment began in August 2023. Results will be presented at local, national and international meetings, including dissemination via community groups, and submission for publication to peer-reviewed journals.</p><p><strong>Trial registration number: </strong>Australian New Zealand Clinical Trials Registry ACTRN12623000764639; Australian New Zealand Clinical Trials Registry.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11116853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kieran J Rothnie, Robert P Wood, Alexandrosz Czira, Victoria L Banks, Lucinda J Camidge, Olivia K I Massey, Monica Seif, Chris Compton, Raj Sharma, David M G Halpin, Afisi S Ismaila, Claus F Vogelmeier
{"title":"Outcomes of patients with COPD switching from multiple-inhaler to once-daily single-inhaler triple therapy in a real-world primary care setting in England: a retrospective pre-post cohort study.","authors":"Kieran J Rothnie, Robert P Wood, Alexandrosz Czira, Victoria L Banks, Lucinda J Camidge, Olivia K I Massey, Monica Seif, Chris Compton, Raj Sharma, David M G Halpin, Afisi S Ismaila, Claus F Vogelmeier","doi":"10.1136/bmjresp-2023-001890","DOIUrl":"10.1136/bmjresp-2023-001890","url":null,"abstract":"<p><strong>Background: </strong>Compared with multiple-inhaler triple therapy (MITT), single-inhaler triple therapy (SITT) with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) demonstrated improved lung function and meaningful improvements in chronic obstructive pulmonary disease (COPD) Assessment Test score. This real-world study compared the effectiveness of switching patients with COPD in England from MITT to once-daily SITT with FF/UMEC/VI by evaluating rates of COPD exacerbation, healthcare resource use (HCRU) and associated direct medical costs.</p><p><strong>Methods: </strong>Retrospective cohort pre-post study using linked primary care electronic health record and secondary care administrative datasets. Patients diagnosed with COPD at age ≥35 years, with smoking history, linkage to secondary care data and continuous GP registration for 12 months pre-switch and 6 months post-switch to FF/UMEC/VI were included. Index date was the first initiation of an FF/UMEC/VI prescription immediately following MITT use from 15 November 2017 to 30 September 2019. Baseline was 12 months prior to index, with outcomes assessed 6/12 months pre-switch and post-switch, and stratified by prior COPD exacerbation status.</p><p><strong>Results: </strong>We included 2533 patients (mean [SD] age: 71.1 [9.9] years; 52.1% male). In the 6 months post-switch, there were significant decreases in the proportion of patients experiencing ≥1 moderate-to-severe (36.2%-28.9%), moderate only (24.4%-19.8%) and severe only (15.4%-11.8%) COPD exacerbation (each, p<0.0001) compared with the 6 months pre-switch. As demonstrated by rate ratios, there were significant reductions in exacerbation rates of each severity overall (p<0.01) and among patients with prior exacerbations (p<0.0001). In the same period, there were significant decreases in the rate of each COPD-related HCRU and total COPD-related costs (-24.9%; p<0.0001).</p><p><strong>Conclusion: </strong>Patients with COPD switching from MITT to once-daily SITT with FF/UMEC/VI in a primary care setting had significantly fewer moderate and severe exacerbations, and lower COPD-related HCRU and costs, in the 6 months post-switch compared with the 6 months pre-switch.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141074504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hayley Barnes, Seham Elmrayed, Christopher Michael Barber, Johanna Feary, Cathryn T Lee, Sheiphali Gandhi, Cheryl E Peters, Margaret L Salisbury, Kerri A Johannson
{"title":"Scoping review of exposure questionnaires and surveys in interstitial lung disease.","authors":"Hayley Barnes, Seham Elmrayed, Christopher Michael Barber, Johanna Feary, Cathryn T Lee, Sheiphali Gandhi, Cheryl E Peters, Margaret L Salisbury, Kerri A Johannson","doi":"10.1136/bmjresp-2023-002155","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-002155","url":null,"abstract":"<p><strong>Background: </strong>Many interstitial lung diseases (ILDs) have clear causal relationships with environmental and occupational exposures. Exposure identification can assist with diagnosis, understanding disease pathogenesis, prognostication and prevention of disease progression and occurrence in others at risk. Despite the importance of exposure identification in ILD, there is no standardised assessment approach. Many questionnaires are in clinical and research use, yet their utility, applicability, relevance and performance characteristics are unknown.</p><p><strong>Objectives: </strong>This scoping review aimed to summarise the available evidence relating to ILD exposure assessment questionnaires, identify research gaps and inform the content for a future single evidence-based ILD questionnaire.</p><p><strong>Methods: </strong>A scoping review based on Arksey and O'Malley's methodological framework was conducted.</p><p><strong>Eligibility criteria: </strong>Any questionnaire that elicited exposures specific to ILD was included. A modified COSMIN Risk of Bias Framework was used to assess quality.</p><p><strong>Sources of evidence: </strong>Relevant articles were identified from MEDLINE and EMBASE up to 23 July 2023.</p><p><strong>Results: </strong>22 exposure questionnaires were identified, including 15 generally pertaining to ILD, along with several disease-specific questionnaires for hypersensitivity pneumonitis (n=4), chronic beryllium disease, sarcoidosis and silicosis (1 questionnaire each). For most questionnaires, quality was low, whereby the methods used to determine exposure inclusion and questionnaire validation were not reported or not performed. Collectively the questionnaires covered 158 unique exposures and at-risk occupations, most commonly birds, mould/water damage, wood dust, asbestos, farming, automotive mechanic and miners. Only five questionnaires also provided free-text fields, and 13 queried qualifiers such as temporality or respiratory protection.</p><p><strong>Conclusions: </strong>Designing a robust ILD-specific questionnaire should include an evidence-based and relevance-based approach to exposure derivation, with clinicians and patients involved in its development and tested to ensure relevance and feasibility.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patrick Goodley, Philip A J Crosbie, Matthew Sperrin, Zoe Merchant, Richard Booton, Haval Balata
{"title":"When to reinvite initially ineligible populations for targeted lung cancer screening?","authors":"Patrick Goodley, Philip A J Crosbie, Matthew Sperrin, Zoe Merchant, Richard Booton, Haval Balata","doi":"10.1136/bmjresp-2023-002193","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-002193","url":null,"abstract":"<p><strong>Introduction: </strong>Targeted low-dose CT lung cancer screening reduces lung cancer mortality. England's Targeted Lung Health Check programme uses risk prediction tools to determine eligibility for biennial screening among people with a smoking history aged 55-74. Some participants initially ineligible for lung cancer screening will later become eligible with increasing age and ongoing tobacco exposure. It is, therefore, important to understand how many people could qualify for reinvitation, and after how long, to inform implementation of services.</p><p><strong>Methods: </strong>We prospectively predicted future risk (using Prostate, Lung, Colorectal and Ovarian trial's risk model (PLCO<sub>m2012</sub>) and Liverpool Lung Project version 2 (LLP<sub>v2</sub>) risk models) and time-to-eligibility of 5345 participants to estimate how many would become eligible through the course of a Lung Health Check screening programme for 55-74 years.</p><p><strong>Results: </strong>Approximately a quarter eventually become eligible, with those with the lowest baseline risks unlikely to ever become eligible. Time-to-eligibility is shorter for participants with higher baseline risk, increasing age and ongoing smoking status. At a PLCO<sub>m2012</sub> threshold ≥1.51%, 68% of those who continue to smoke become eligible compared with 18% of those who have quit.</p><p><strong>Discussion: </strong>Predicting which participants may become eligible, and when, during a screening programme can help inform reinvitation strategies and service planning. Those with risk scores closer to the eligibility threshold, particularly people who continue to smoke, will reach eligibility in subsequent rounds while those at the lowest risk may be discharged from the programme from the outset.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097831/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew J Fisher, Michael White, Nicola Goudie, Anneka Kershaw, Julia Phillipson, Michelle Bardgett, Joanne Lally, Alex Bevin-Nicholls, Thomas Chadwick, Andrew Bryant, Sian Russell, Hesther Smith, Laura Frisby, Rebecca Errington, Martin Carby, Richard Thompson, Karthik Santhanakrishnan, Jasvir Parmar, James L Lordan, Luke Vale, Helen Hancock, Catherine Exley, Andrew R Gennery, James Ms Wason
{"title":"Extracorporeal photopheresis (ECP) in the treatment of chronic lung allograft dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK).","authors":"Andrew J Fisher, Michael White, Nicola Goudie, Anneka Kershaw, Julia Phillipson, Michelle Bardgett, Joanne Lally, Alex Bevin-Nicholls, Thomas Chadwick, Andrew Bryant, Sian Russell, Hesther Smith, Laura Frisby, Rebecca Errington, Martin Carby, Richard Thompson, Karthik Santhanakrishnan, Jasvir Parmar, James L Lordan, Luke Vale, Helen Hancock, Catherine Exley, Andrew R Gennery, James Ms Wason","doi":"10.1136/bmjresp-2023-001995","DOIUrl":"10.1136/bmjresp-2023-001995","url":null,"abstract":"<p><strong>Background: </strong>Long-term survival after lung transplantation is limited compared with other organ transplants. The main cause is development of progressive immune-mediated damage to the lung allograft. This damage, which can develop via multiple immune pathways, is captured under the umbrella term chronic lung allograft dysfunction (CLAD). Despite the availability of powerful immunosuppressive drugs, there are presently no treatments proven to reverse or reliably halt the loss of lung function caused by CLAD. The aim of the E-CLAD UK trial is to determine whether the addition of immunomodulatory therapy, in the form of extracorporeal photopheresis (ECP), to standard care is more efficacious at stabilising lung function in CLAD compared with standard care alone.</p><p><strong>Methods and analysis: </strong>E-CLAD UK is a Phase II clinical trial of an investigational medicinal product (Methoxsalen) delivered to a buffy coat prepared via an enclosed ECP circuit. Target recruitment is 90 bilateral lung transplant patients identified as having CLAD and being treated at one of the five UK adult lung transplant centres. Participants will be randomised 1:1 to intervention plus standard of care, or standard of care alone. Intervention will comprise nine ECP cycles spread over 20 weeks, each course involving two treatments of ECP on consecutive days. All participants will be followed up for a period of 24 weeks.The primary outcome is lung function stabilisation derived from change in forced expiratory volume in one second and forced vital capacity at 12 and 24 weeks compared with baseline at study entry. Other parameters include change in exercise capacity, health-related quality of life and safety. A mechanistic study will seek to identify molecular or cellular markers linked to treatment response and qualitative interviews will explore patient experiences of CLAD and the ECP treatment.A patient and public advisory group is integral to the trial from design to implementation, developing material to support the consent process and interview materials.</p><p><strong>Ethics and dissemination: </strong>The East Midlands-Derby Research Ethics Committee has provided ethical approval (REC 22/EM/0218). Dissemination will be via publications, patient-friendly summaries and presentation at scientific meetings.</p><p><strong>Trial registration number: </strong>EudraCT number 2022-002659-20; ISRCTN 10615985.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140896864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adam Smith, Darren Greenwood, Mike Horton, Thomas Osborne, Madeline Goodwin, Román Rocha Lawrence, Darren Winch, Paul Williams, Ruairidh Milne, Manoj Sivan
{"title":"Psychometric analysis of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) in a prospective multicentre study.","authors":"Adam Smith, Darren Greenwood, Mike Horton, Thomas Osborne, Madeline Goodwin, Román Rocha Lawrence, Darren Winch, Paul Williams, Ruairidh Milne, Manoj Sivan","doi":"10.1136/bmjresp-2023-002271","DOIUrl":"10.1136/bmjresp-2023-002271","url":null,"abstract":"<p><strong>Background: </strong>Long COVID (LC) is a novel multisystem clinical syndrome affecting millions of individuals worldwide. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is a condition-specific patient-reported outcome measure designed for assessment and monitoring of people with LC.</p><p><strong>Objectives: </strong>To evaluate the psychometric properties of the C19-YRSm in a prospective sample of people with LC.</p><p><strong>Methods: </strong>1314 patients attending 10 UK specialist LC clinics completed C19-YRSm and EuroQol 5D-5L (EQ-5D-5L) longitudinally. Scale characteristics were derived for C19-YRSm subscales (Symptom Severity (SS), Functional Disability (FD) and Overall Health (OH)) and internal consistency (Cronbach's alpha). Convergent validity was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale. Known groups validity was assessed for the Other Symptoms subscale as tertiles, as well as by hospitalisation and intensive care admission. Responsiveness and test-retest reliability was evaluated for C19-YRSm subscales and EQ-5D-5L. The minimal important difference (MID) and minimal clinically important difference (MCID) were estimated. Confirmatory factor analysis was applied to determine the instrument's two-factor structure.</p><p><strong>Results: </strong>C19-YRSm demonstrated good scale characteristic properties. Item-total correlations were between 0.37 and 0.65 (for SS and FD), with good internal reliability (Cronbach's alphas>0.8). Item correlations between subscales ranged between 0.46 and 0.72. Convergent validity with FACIT was good (-0.46 to -0.62). The three subscales discriminated between different levels of symptom burden (p<0.001) and between patients admitted to hospital and intensive care. There was moderate responsiveness for the three subscales ranging from 0.22 (OH) to 0.50 (SS) which was greater than for the EQ-5D-5L. Test-retest reliability was good for both SS 0.86 and FD 0.78. MID was 2 for SS, 2 for FD and 1 for OH; MCID was 4 for both the SS and FD. The factor analysis supported the two-factor SS and FD structure.</p><p><strong>Conclusions: </strong>The C19-YRSm is a condition-specific, reliable, valid and responsive patient-reported outcome measure for LC.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140896866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Keir E J Philip, Sara C Buttery, Sarah Bowen, Adam Lewis, Edmund Jeffery, Saeed M Alghamdi, Parris Williams, Ali M Alasmari, Abdullah S Alsulayyim, Christopher M Orton, Francesca Conway, Ley Chan, Bavithra Vijayakumar, Anand Tana, James Tonkin, Alexis Perkins, Justin L Garner, Karthikan Srikanthan, Ahmed Sadaka, Matthew J Pavitt, Winston Banya, Adam Lound, Sarah Elkin, Michael I Polkey, William D-C Man, Keir Lewis, Phoene Cave, Daisy Fancourt, Nicholas S Hopkinson
{"title":"Singing for lung health in COPD: a multicentre randomised controlled trial of online delivery","authors":"Keir E J Philip, Sara C Buttery, Sarah Bowen, Adam Lewis, Edmund Jeffery, Saeed M Alghamdi, Parris Williams, Ali M Alasmari, Abdullah S Alsulayyim, Christopher M Orton, Francesca Conway, Ley Chan, Bavithra Vijayakumar, Anand Tana, James Tonkin, Alexis Perkins, Justin L Garner, Karthikan Srikanthan, Ahmed Sadaka, Matthew J Pavitt, Winston Banya, Adam Lound, Sarah Elkin, Michael I Polkey, William D-C Man, Keir Lewis, Phoene Cave, Daisy Fancourt, Nicholas S Hopkinson","doi":"10.1136/bmjresp-2024-002365","DOIUrl":"https://doi.org/10.1136/bmjresp-2024-002365","url":null,"abstract":"Background Singing for lung health (SLH) is an arts-based breathing control and movement intervention for people with long-term respiratory conditions, intended to improve symptoms and quality of life. Online, remotely delivered programmes might improve accessibility; however, no previous studies have assessed the effectiveness of this approach. Methods We conducted an assessor-blind randomised controlled trial comparing the impact of 12 weeks of once-weekly online SLH sessions against usual care on health-related quality of life, assessed using the RAND 36-Item Short Form Health Survey (SF-36) Mental Health Composite (MHC) and Physical Health Composite (PHC) scores. Results We enrolled 115 people with stable chronic obstructive pulmonary disease (COPD), median (IQR) age 69 (62–74), 56.5% females, 80% prior pulmonary rehabilitation, Medical Research Council dyspnoea scale 4 (3–4), forced expiratory volume in 1 s % predicted 49 (35–63). 50 participants in each arm completed the study. The intervention arm experienced improvements in physical but not mental health components of RAND SF-36; PHC (regression coefficient (95% CI): 1.77 (95% CI 0.11 to 3.44); p=0.037), but not MHC (0.86 (95% CI −1.68 to 3.40); p=0.504). A prespecified responder analysis based on achieving a 10% improvement from baseline demonstrated a response rate for PHC of 32% in the SLH arm and 12.7% for usual care (p=0.024). A between-group difference in responder rate was not found in relation to the MHC (19.3% vs 25.9%; p=0.403). Discussion and conclusion A 12-week online SLH programme can improve the physical component of quality of life for people with COPD, but the overall effect is relatively modest compared with the impact seen in research using face-to-face group sessions. Further work on the content, duration and dose of online interventions may be useful. Trial registration number [NCT04034212][1]. Data are available upon reasonable request. Individual participant data that underlie the results in the article, after de-identification (text, tables, figures and appendices) will be available on reasonable application to the corresponding author. Data will be made immediately available following publication, no end date. Data will be available to anyone who wishes to access the data, for any purpose. Data will be available indefinitely. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04034212&atom=%2Fbmjresp%2F11%2F1%2Fe002365.atom","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"1 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}