Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001799
Adrian P J Rabe, Wei J Loke, Danuta Kielar, Tamsin Morris, Vivian H Shih, Lynda Olinger, Mihaela G Musat, Zhiyi Lan, Sharada Harricharan, Olivia Fulton, Azeem Majeed, Liam G Heaney
Introduction Effective treatment of severe asthma requires patient adherence to inhaled and biological medications. Previous work has shown that patient support programmes (PSP) can improve adherence in patients with chronic diseases, but the impact of PSPs in patients with severe asthma treated with biologics has not been thoroughly investigated. Methods We conducted a systematic literature review to understand the impact of PSPs on treatment adherence, asthma control and health-related quality of life (HRQoL) in patients with severe asthma. Embase, MEDLINE and EconLit databases were searched for studies published from 2003 (the year of the first biological approval for severe asthma) to June 2023 that described PSP participation among patients with severe asthma on biological treatment. Direct pooling of outcomes was not possible due to the heterogeneity across studies, so an indirect treatment comparison (ITC) was performed to determine the effect of PSP participation on treatment discontinuation. The ITC used patient-level data from patients treated with benralizumab either enrolled in a PSP (VOICE study, Connect 360 PSP) or not enrolled in a PSP (Benralizumab Patient Access Programme study) in the UK. Findings 25 records of 21 studies were selected. Six studies investigated the impact of PSPs on treatment adherence, asthma control or HRQoL. All six studies reported positive outcomes for patients enrolled in PSPs; the benefits of each PSP were closely linked to the services provided. The ITC showed that patients in the Connect 360 PSP group were less likely to discontinue treatment compared with the non-PSP group (OR 0.26, 95% CI 0.11 to 0.57, p<0.001). Conclusions PSPs contribute to positive clinical outcomes in patients with severe asthma on biological treatment. Future analyses will benefit from thorough descriptions of PSP services, and study designs that allow direct comparisons of patient outcomes with and without a PSP. Data may be obtained from a third party and are not publicly available.
{"title":"Impact of patient support programmes among patients with severe asthma treated with biological therapies: a systematic literature review and indirect treatment comparison","authors":"Adrian P J Rabe, Wei J Loke, Danuta Kielar, Tamsin Morris, Vivian H Shih, Lynda Olinger, Mihaela G Musat, Zhiyi Lan, Sharada Harricharan, Olivia Fulton, Azeem Majeed, Liam G Heaney","doi":"10.1136/bmjresp-2023-001799","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001799","url":null,"abstract":"Introduction Effective treatment of severe asthma requires patient adherence to inhaled and biological medications. Previous work has shown that patient support programmes (PSP) can improve adherence in patients with chronic diseases, but the impact of PSPs in patients with severe asthma treated with biologics has not been thoroughly investigated. Methods We conducted a systematic literature review to understand the impact of PSPs on treatment adherence, asthma control and health-related quality of life (HRQoL) in patients with severe asthma. Embase, MEDLINE and EconLit databases were searched for studies published from 2003 (the year of the first biological approval for severe asthma) to June 2023 that described PSP participation among patients with severe asthma on biological treatment. Direct pooling of outcomes was not possible due to the heterogeneity across studies, so an indirect treatment comparison (ITC) was performed to determine the effect of PSP participation on treatment discontinuation. The ITC used patient-level data from patients treated with benralizumab either enrolled in a PSP (VOICE study, Connect 360 PSP) or not enrolled in a PSP (Benralizumab Patient Access Programme study) in the UK. Findings 25 records of 21 studies were selected. Six studies investigated the impact of PSPs on treatment adherence, asthma control or HRQoL. All six studies reported positive outcomes for patients enrolled in PSPs; the benefits of each PSP were closely linked to the services provided. The ITC showed that patients in the Connect 360 PSP group were less likely to discontinue treatment compared with the non-PSP group (OR 0.26, 95% CI 0.11 to 0.57, p<0.001). Conclusions PSPs contribute to positive clinical outcomes in patients with severe asthma on biological treatment. Future analyses will benefit from thorough descriptions of PSP services, and study designs that allow direct comparisons of patient outcomes with and without a PSP. Data may be obtained from a third party and are not publicly available.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"11 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840166","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001976
Musaad A Alshammari, Ahmad Alamer, Lina Al Lehaibi, Mashael Alghamdi, Haneen Alotaibi, Mukhtar Alomar, Fawaz Alasmari, Faleh Alqahtani, Abdualziz Alhossan, Tahani K Alshammari
Introduction The COVID-19 pandemic continues to be a global threat to public health, with over 766 million confirmed cases and more than 6 million reported deaths. Patients with a smoking history are at a greater risk of severe respiratory complications and death due to COVID-19. This study investigated the association between smoking history and adverse clinical outcomes among COVID-19 patients admitted to a designated medical centre in Saudi Arabia. Methods A retrospective observational cohort study was conducted using patient chart review data from a large tertiary medical centre in the eastern region of the country. Patients admitted between January and December 2020 were screened. The inclusion criteria were ≥18 years of age and confirmed COVID-19 infection via reverse-transcription-PCR. The exclusion criteria were unconfirmed COVID-19 infection, non-COVID-19 admissions, unconfirmed smoking status, vaccinated individuals, essential chart information missing or refusal to consent. Statistical analyses comprised crude estimates, matching weights (as the main analysis) and directed acyclic graphs (DAGs) causal pathway analysis using an ordinal regression model. Results The sample comprised 447 patients (never-smoker=321; ever-smoker=126). The median age (IQR) was 50 years (39–58), and 73.4% of the sample were males. A matching weights procedure was employed to ensure covariate balance. The analysis revealed that the odds of developing severe COVID-19 were higher in the ever-smoker group with an OR of 1.44 (95% CI 0.90 to 2.32, p=0.130). This was primarily due to an increase in non-invasive oxygen therapy with an OR of 1.05 (95% CI 0.99 to 1.10, p=0.101). The findings were consistent across the different analytical methods employed, including crude estimates and DAGs causal pathway analysis. Conclusion Our findings suggest that smoking may increase the risk of adverse COVID-19 outcomes. However, the study was limited by its retrospective design and small sample size. Further research is therefore needed to confirm the findings. Data available upon request.
{"title":"Association between COVID-19 severity and tobacco smoking status: a retrospective cohort study using propensity score matching weights analysis","authors":"Musaad A Alshammari, Ahmad Alamer, Lina Al Lehaibi, Mashael Alghamdi, Haneen Alotaibi, Mukhtar Alomar, Fawaz Alasmari, Faleh Alqahtani, Abdualziz Alhossan, Tahani K Alshammari","doi":"10.1136/bmjresp-2023-001976","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001976","url":null,"abstract":"Introduction The COVID-19 pandemic continues to be a global threat to public health, with over 766 million confirmed cases and more than 6 million reported deaths. Patients with a smoking history are at a greater risk of severe respiratory complications and death due to COVID-19. This study investigated the association between smoking history and adverse clinical outcomes among COVID-19 patients admitted to a designated medical centre in Saudi Arabia. Methods A retrospective observational cohort study was conducted using patient chart review data from a large tertiary medical centre in the eastern region of the country. Patients admitted between January and December 2020 were screened. The inclusion criteria were ≥18 years of age and confirmed COVID-19 infection via reverse-transcription-PCR. The exclusion criteria were unconfirmed COVID-19 infection, non-COVID-19 admissions, unconfirmed smoking status, vaccinated individuals, essential chart information missing or refusal to consent. Statistical analyses comprised crude estimates, matching weights (as the main analysis) and directed acyclic graphs (DAGs) causal pathway analysis using an ordinal regression model. Results The sample comprised 447 patients (never-smoker=321; ever-smoker=126). The median age (IQR) was 50 years (39–58), and 73.4% of the sample were males. A matching weights procedure was employed to ensure covariate balance. The analysis revealed that the odds of developing severe COVID-19 were higher in the ever-smoker group with an OR of 1.44 (95% CI 0.90 to 2.32, p=0.130). This was primarily due to an increase in non-invasive oxygen therapy with an OR of 1.05 (95% CI 0.99 to 1.10, p=0.101). The findings were consistent across the different analytical methods employed, including crude estimates and DAGs causal pathway analysis. Conclusion Our findings suggest that smoking may increase the risk of adverse COVID-19 outcomes. However, the study was limited by its retrospective design and small sample size. Further research is therefore needed to confirm the findings. Data available upon request.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"31 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140889895","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001962
Camilla S Powierza, Margaret M Doyle, Katherine Wasden, Taylor A Intihar, Amy S Korwin, Shyoko Honiden, Melissa P Knauert
Introduction Early enteral nutrition (EN) in critically ill adult patients is thought to improve mortality and morbidity; expert guidelines recommend early initiation of EN in critically ill adults. However, the ideal schedule and dose of EN remain understudied. Study objective Our objective was to evaluate the relationship between achieving 70% of recommended EN within 2 days of intubation (‘early goal EN’) and clinical outcomes in mechanically ventilated medically critically ill adults. We hypothesised that early goal EN would be associated with reduced in-hospital death. Methods We conducted a retrospective cohort study of mechanically ventilated adult patients admitted to our medical intensive care unit during 2013–2019. We assessed the proportion of recommended total EN provided to the patient each day following intubation until extubation, death or 7 days whichever was shortest. Patients who received 70% or more of their recommended total daily EN within 2 days of intubation (ie, ‘baseline period’) were considered to have achieved ‘early goal EN’; these patients were compared with patients who did not (‘low EN’). The primary outcome was in-hospital death; secondary outcomes were successful extubation and discharge alive. Results 938 patients met eligibility criteria and survived the baseline period. During the 7-day postintubation period, 64% of all patients reached 70% of recommended daily calories; 33% of patients achieved early goal EN. In unadjusted and adjusted models, early goal EN versus low EN was associated with a lower incidence of in-hospital death (subdistribution HR (SHR) unadjusted=0.63, p=0.0003, SHR adjusted=0.73, p=0.02). Early goal EN was also associated with a higher incidence of successful extubation (SHR unadjusted=1.41, p<0.00001, SHR adjusted=1.27, p=0.002) and discharge alive (SHR unadjusted=1.54, p<0.00001, SHR adjusted=1.24, p=0.02). Conclusions Early goal EN was associated with significant improvement in clinical metrics of decreased in-hospital death, increased extubation and increased hospital discharge alive. Data are available on reasonable request.
{"title":"Early goal enteral nutrition associated with decreased in-hospital death in mechanically ventilated critically ill adults: a retrospective cohort study","authors":"Camilla S Powierza, Margaret M Doyle, Katherine Wasden, Taylor A Intihar, Amy S Korwin, Shyoko Honiden, Melissa P Knauert","doi":"10.1136/bmjresp-2023-001962","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001962","url":null,"abstract":"Introduction Early enteral nutrition (EN) in critically ill adult patients is thought to improve mortality and morbidity; expert guidelines recommend early initiation of EN in critically ill adults. However, the ideal schedule and dose of EN remain understudied. Study objective Our objective was to evaluate the relationship between achieving 70% of recommended EN within 2 days of intubation (‘early goal EN’) and clinical outcomes in mechanically ventilated medically critically ill adults. We hypothesised that early goal EN would be associated with reduced in-hospital death. Methods We conducted a retrospective cohort study of mechanically ventilated adult patients admitted to our medical intensive care unit during 2013–2019. We assessed the proportion of recommended total EN provided to the patient each day following intubation until extubation, death or 7 days whichever was shortest. Patients who received 70% or more of their recommended total daily EN within 2 days of intubation (ie, ‘baseline period’) were considered to have achieved ‘early goal EN’; these patients were compared with patients who did not (‘low EN’). The primary outcome was in-hospital death; secondary outcomes were successful extubation and discharge alive. Results 938 patients met eligibility criteria and survived the baseline period. During the 7-day postintubation period, 64% of all patients reached 70% of recommended daily calories; 33% of patients achieved early goal EN. In unadjusted and adjusted models, early goal EN versus low EN was associated with a lower incidence of in-hospital death (subdistribution HR (SHR) unadjusted=0.63, p=0.0003, SHR adjusted=0.73, p=0.02). Early goal EN was also associated with a higher incidence of successful extubation (SHR unadjusted=1.41, p<0.00001, SHR adjusted=1.27, p=0.002) and discharge alive (SHR unadjusted=1.54, p<0.00001, SHR adjusted=1.24, p=0.02). Conclusions Early goal EN was associated with significant improvement in clinical metrics of decreased in-hospital death, increased extubation and increased hospital discharge alive. Data are available on reasonable request.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"27 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140925554","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001746
Nikita Simms-Williams, Prasad Nagakumar, Rasiah Thayakaran, Nicola J Adderley, Richard Hotham, Adel H Mansur, Krishnarajah Nirantharakumar, Shamil Haroon
Background Asthma remains a common cause of hospital admissions across the life course. We estimated the contribution of key risk factors to asthma-related hospital and intensive care unit (ICU) admissions in children, adolescents and adults. Methods This was a UK-based cohort study using linked primary care (Clinical Practice Research Datalink Aurum) and secondary care (Hospital Episode Statistics Admitted Patient Care) data. Patients were eligible if they were aged 5 years and older and had been diagnosed with asthma. This included 90 989 children aged 5–11 years, 114 927 adolescents aged 12–17 years and 1 179 410 adults aged 18 years or older. The primary outcome was asthma-related hospital admissions from 1 January 2017 to 31 December 2019. The secondary outcome was asthma-related ICU admissions. Incidence rate ratios adjusted for demographic and clinical risk factors were estimated using negative binomial models. Population attributable fraction (PAF) was estimated for modifiable risk factors. Results Younger age groups, females and those from ethnic minority and lower socioeconomic backgrounds had an increased risk of asthma-related hospital admissions. Increasing medication burden, including excessive use of short-acting bronchodilators, was also strongly associated with the primary outcome. Similar risk factors were observed for asthma-related ICU admissions. The key potentially modifiable or treatable risk factors were smoking in adolescents and adults (PAF 6.8%, 95% CI 0.9% to 12.3% and 4.3%, 95% CI 3.0% to 5.7%, respectively), and obesity (PAF 23.3%, 95% CI 20.5% to 26.1%), depression (11.1%, 95% CI 9.1% to 13.1%), gastro-oesophageal reflux disease (2.3%, 95% CI 1.2% to 3.4%), anxiety (2.0%, 95% CI 0.5% to 3.6%) and chronic rhinosinusitis (0.8%, 95% CI 0.3% to 1.3%) in adults. Conclusions There are significant sociodemographic inequalities in the rates of asthma-related hospital and ICU admissions. Treating age-specific modifiable risk factors should be considered an integral part of asthma management, which could potentially reduce the rate of avoidable hospital admissions. Data are not publicly available. Access to anonymised patient data from CPRD is subject to a data sharing agreement containing detailed terms and conditions of use following protocol approval from the MHRA Independent Scientific Advisory Committee. This study-specific analysable dataset is, therefore, not publicly available but can be requested from the corresponding author subject to research data governance approvals. Details about Independent Scientific Advisory Committee applications and data costs are available on the CPRD website (cprd.com).
背景 哮喘仍然是整个生命过程中入院治疗的常见原因。我们估算了儿童、青少年和成人中与哮喘相关的入院和重症监护室（ICU）的主要风险因素。方法 这是一项基于英国的队列研究，使用的是关联的初级医疗（临床实践研究数据链 Aurum）和二级医疗（医院病历统计入院患者护理）数据。年龄在 5 岁及以上并被诊断患有哮喘的患者均符合条件。其中包括 90 989 名 5-11 岁的儿童、114 927 名 12-17 岁的青少年和 1 179 410 名 18 岁或以上的成年人。主要结果是2017年1月1日至2019年12月31日期间与哮喘相关的住院情况。次要结果是与哮喘相关的重症监护病房入院人数。采用负二项模型估算了调整人口统计学和临床风险因素后的发病率比。针对可改变的风险因素估算了人群可归因分数（PAF）。结果 年轻群体、女性、少数民族和社会经济背景较差的人群哮喘相关入院风险增加。用药负担加重，包括过度使用短效支气管扩张剂，也与主要结果密切相关。在哮喘相关的重症监护病房入院治疗中也观察到了类似的风险因素。青少年和成人吸烟（PAF 分别为 6.8%，95% CI 为 0.9% 至 12.3% 和 4.3%，95% CI 为 3.0% 至 5.7%）、肥胖（PAF 为 23.3%，95% CI 为 20.5%至26.1%）、抑郁症（11.1%，95% CI 9.1%至13.1%）、胃食管反流病（2.3%，95% CI 1.2%至3.4%）、焦虑症（2.0%，95% CI 0.5%至3.6%）和慢性鼻炎（0.8%，95% CI 0.3%至1.3%）。结论 与哮喘有关的住院率和重症监护室入院率存在明显的社会人口不平等。治疗特定年龄段的可改变风险因素应被视为哮喘管理不可分割的一部分，这有可能降低可避免的入院率。数据不公开。从 CPRD 中获取匿名患者数据需签署数据共享协议，其中包含经 MHRA 独立科学咨询委员会批准后的详细使用条款和条件。因此，该研究特定的可分析数据集不对外公开，但可向通讯作者索取，但需获得研究数据管理批准。有关独立科学顾问委员会申请和数据成本的详细信息，请访问 CPRD 网站 (cprd.com)。
{"title":"Risk factors for asthma-related hospital and intensive care admissions in children, adolescents and adults: a cohort study using primary and secondary care data","authors":"Nikita Simms-Williams, Prasad Nagakumar, Rasiah Thayakaran, Nicola J Adderley, Richard Hotham, Adel H Mansur, Krishnarajah Nirantharakumar, Shamil Haroon","doi":"10.1136/bmjresp-2023-001746","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001746","url":null,"abstract":"Background Asthma remains a common cause of hospital admissions across the life course. We estimated the contribution of key risk factors to asthma-related hospital and intensive care unit (ICU) admissions in children, adolescents and adults. Methods This was a UK-based cohort study using linked primary care (Clinical Practice Research Datalink Aurum) and secondary care (Hospital Episode Statistics Admitted Patient Care) data. Patients were eligible if they were aged 5 years and older and had been diagnosed with asthma. This included 90 989 children aged 5–11 years, 114 927 adolescents aged 12–17 years and 1 179 410 adults aged 18 years or older. The primary outcome was asthma-related hospital admissions from 1 January 2017 to 31 December 2019. The secondary outcome was asthma-related ICU admissions. Incidence rate ratios adjusted for demographic and clinical risk factors were estimated using negative binomial models. Population attributable fraction (PAF) was estimated for modifiable risk factors. Results Younger age groups, females and those from ethnic minority and lower socioeconomic backgrounds had an increased risk of asthma-related hospital admissions. Increasing medication burden, including excessive use of short-acting bronchodilators, was also strongly associated with the primary outcome. Similar risk factors were observed for asthma-related ICU admissions. The key potentially modifiable or treatable risk factors were smoking in adolescents and adults (PAF 6.8%, 95% CI 0.9% to 12.3% and 4.3%, 95% CI 3.0% to 5.7%, respectively), and obesity (PAF 23.3%, 95% CI 20.5% to 26.1%), depression (11.1%, 95% CI 9.1% to 13.1%), gastro-oesophageal reflux disease (2.3%, 95% CI 1.2% to 3.4%), anxiety (2.0%, 95% CI 0.5% to 3.6%) and chronic rhinosinusitis (0.8%, 95% CI 0.3% to 1.3%) in adults. Conclusions There are significant sociodemographic inequalities in the rates of asthma-related hospital and ICU admissions. Treating age-specific modifiable risk factors should be considered an integral part of asthma management, which could potentially reduce the rate of avoidable hospital admissions. Data are not publicly available. Access to anonymised patient data from CPRD is subject to a data sharing agreement containing detailed terms and conditions of use following protocol approval from the MHRA Independent Scientific Advisory Committee. This study-specific analysable dataset is, therefore, not publicly available but can be requested from the corresponding author subject to research data governance approvals. Details about Independent Scientific Advisory Committee applications and data costs are available on the CPRD website (cprd.com).","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"35 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840189","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2024-002310
Panagis Galiatsatos, Brian Garibaldi, Dapeng Yao, Yanxun Xu, Jamie Perin, Andi Shahu, John W Jackson, Damani Piggott, Oluwaseun Falade-Nwulia, Jocelyn Shubella, Henry Michtalik, Harolyn M E Belcher, Nadia N Hansel, Sherita Golden
Introduction In the USA, minoritised communities (racial and ethnic) have suffered disproportionately from COVID-19 compared with non-Hispanic white communities. In a large cohort of patients hospitalised for COVID-19 in a healthcare system spanning five adult hospitals, we analysed outcomes of patients based on race and ethnicity. Methods This was a retrospective cohort analysis of patients 18 years or older admitted to five hospitals in the mid-Atlantic area between 4 March 2020 and 27 May 2022 with confirmed COVID-19. Participants were divided into four groups based on their race/ethnicity: non-Hispanic black, non-Hispanic white, Latinx and other. Propensity score weighted generalised linear models were used to assess the association between race/ethnicity and the primary outcome of in-hospital mortality. Results Of the 9651 participants in the cohort, more than half were aged 18–64 years old (56%) and 51% of the cohort were females. Non-Hispanic white patients had higher mortality (p<0.001) and longer hospital length-of-stay (p<0.001) than Latinx and non-Hispanic black patients. Discussion In this large multihospital cohort of patients admitted with COVID-19, non-Hispanic black and Hispanic patients did not have worse outcomes than white patients. Such findings likely reflect how the complex range of factors that resulted in a life-threatening and disproportionate impact of incidence on certain vulnerable populations by COVID-19 in the community was offset through admission at well-resourced hospitals and healthcare systems. However, there continues to remain a need for efforts to address the significant pre-existing race and ethnicity inequities highlighted by the COVID-19 pandemic to be better prepared for future public health emergencies. Data are available on reasonable request.
{"title":"Lack of racial and ethnic disparities in mortality in minority patients hospitalised with COVID-19 in a mid-Atlantic healthcare system","authors":"Panagis Galiatsatos, Brian Garibaldi, Dapeng Yao, Yanxun Xu, Jamie Perin, Andi Shahu, John W Jackson, Damani Piggott, Oluwaseun Falade-Nwulia, Jocelyn Shubella, Henry Michtalik, Harolyn M E Belcher, Nadia N Hansel, Sherita Golden","doi":"10.1136/bmjresp-2024-002310","DOIUrl":"https://doi.org/10.1136/bmjresp-2024-002310","url":null,"abstract":"Introduction In the USA, minoritised communities (racial and ethnic) have suffered disproportionately from COVID-19 compared with non-Hispanic white communities. In a large cohort of patients hospitalised for COVID-19 in a healthcare system spanning five adult hospitals, we analysed outcomes of patients based on race and ethnicity. Methods This was a retrospective cohort analysis of patients 18 years or older admitted to five hospitals in the mid-Atlantic area between 4 March 2020 and 27 May 2022 with confirmed COVID-19. Participants were divided into four groups based on their race/ethnicity: non-Hispanic black, non-Hispanic white, Latinx and other. Propensity score weighted generalised linear models were used to assess the association between race/ethnicity and the primary outcome of in-hospital mortality. Results Of the 9651 participants in the cohort, more than half were aged 18–64 years old (56%) and 51% of the cohort were females. Non-Hispanic white patients had higher mortality (p<0.001) and longer hospital length-of-stay (p<0.001) than Latinx and non-Hispanic black patients. Discussion In this large multihospital cohort of patients admitted with COVID-19, non-Hispanic black and Hispanic patients did not have worse outcomes than white patients. Such findings likely reflect how the complex range of factors that resulted in a life-threatening and disproportionate impact of incidence on certain vulnerable populations by COVID-19 in the community was offset through admission at well-resourced hospitals and healthcare systems. However, there continues to remain a need for efforts to address the significant pre-existing race and ethnicity inequities highlighted by the COVID-19 pandemic to be better prepared for future public health emergencies. Data are available on reasonable request.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"56 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840134","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001881
Ye Wang, Ruoxi He, Xiaoxia Ren, Ke Huang, Jieping Lei, Hongtao Niu, Wei Li, Fen Dong, Baicun Li, Ting Yang, Chen Wang
Background There is a lack of individualised prediction models for patients hospitalised with chronic obstructive pulmonary disease (COPD) for clinical practice. We developed and validated prediction models of severe exacerbations and readmissions in patients hospitalised for COPD exacerbation (SERCO). Methods Data were obtained from the Acute Exacerbations of Chronic Obstructive Pulmonary Disease Inpatient Registry study ([NCT02657525][1]) in China. Cause-specific hazard models were used to estimate coefficients. C-statistic was used to evaluate the discrimination. Slope and intercept were used to evaluate the calibration and used for model adjustment. Models were validated internally by 10-fold cross-validation and externally using data from different regions. Risk-stratified scoring scales and nomograms were provided. The discrimination ability of the SERCO model was compared with the exacerbation history in the previous year. Results Two sets with 2196 and 1869 patients from different geographical regions were used for model development and external validation. The 12-month severe exacerbations cumulative incidence rates were 11.55% (95% CI 10.06% to 13.16%) in development cohorts and 12.30% (95% CI 10.67% to 14.05%) in validation cohorts. The COPD-specific readmission incidence rates were 11.31% (95% CI 9.83% to 12.91%) and 12.26% (95% CI 10.63% to 14.02%), respectively. Demographic characteristics, medical history, comorbidities, drug usage, Global Initiative for Chronic Obstructive Lung Disease stage and interactions were included as predictors. C-indexes for severe exacerbations were 77.3 (95% CI 70.7 to 83.9), 76.5 (95% CI 72.6 to 80.4) and 74.7 (95% CI 71.2 to 78.2) at 1, 6 and 12 months. The corresponding values for readmissions were 77.1 (95% CI 70.1 to 84.0), 76.3 (95% CI 72.3 to 80.4) and 74.5 (95% CI 71.0 to 78.0). The SERCO model was consistently discriminative and accurate with C-indexes in the derivation and internal validation groups. In external validation, the C-indexes were relatively lower at 60–70 levels. The SERCO model discriminated outcomes better than prior severe exacerbation history. The slope and intercept after adjustment showed close agreement between predicted and observed risks. However, in external validation, the models may overestimate the risk in higher-risk groups. The model-driven risk groups showed significant disparities in prognosis. Conclusion The SERCO model provides individual predictions for severe exacerbation and COPD-specific readmission risk, which enables identifying high-risk patients and implementing personalised preventive intervention for patients with COPD. Data are available on reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02657525&atom=%2Fbmjresp%2F11%2F1%2Fe001881.atom
背景 目前缺乏针对慢性阻塞性肺病（COPD）住院患者的个性化预测模型供临床实践使用。我们开发并验证了慢性阻塞性肺疾病（COPD）恶化住院患者严重恶化和再入院预测模型（SERCO）。方法 数据来自中国慢性阻塞性肺疾病急性加重住院患者登记研究（[NCT02657525][1]）。采用病因特异性危险模型估算系数。C统计量用于评估区分度。斜率和截距用于评估校准和模型调整。通过 10 倍交叉验证对模型进行内部验证，并使用不同地区的数据对模型进行外部验证。提供了风险分级评分表和提名图。将 SERCO 模型的判别能力与前一年的病情加重史进行了比较。结果 两组分别来自不同地区的 2196 名和 1869 名患者的数据被用于模型开发和外部验证。在开发队列中，12 个月严重恶化累积发生率为 11.55%（95% CI 10.06% 至 13.16%），在验证队列中为 12.30%（95% CI 10.67% 至 14.05%）。COPD特异性再入院发生率分别为11.31%（95% CI 9.83%至12.91%）和12.26%（95% CI 10.63%至14.02%）。人口统计学特征、病史、合并症、药物使用、慢性阻塞性肺病全球倡议分期和相互作用均被列为预测因素。严重恶化的 C 指数在 1、6 和 12 个月分别为 77.3（95% CI 70.7 至 83.9）、76.5（95% CI 72.6 至 80.4）和 74.7（95% CI 71.2 至 78.2）。再住院率的相应值分别为 77.1（95% CI 70.1 至 84.0）、76.3（95% CI 72.3 至 80.4）和 74.5（95% CI 71.0 至 78.0）。在推导组和内部验证组中，SERCO 模型的 C 指数一直具有很高的区分度和准确性。在外部验证中，60-70 级的 C 指数相对较低。SERCO 模型对结果的判别优于既往严重恶化病史。调整后的斜率和截距显示，预测风险和观察风险之间非常接近。然而，在外部验证中，模型可能会高估高风险组的风险。模型驱动的风险组在预后方面存在显著差异。结论 SERCO 模型可对严重恶化和慢性阻塞性肺病特异性再入院风险进行个体预测，从而识别高风险患者并对慢性阻塞性肺病患者实施个性化预防干预。如有合理要求，可提供相关数据。本研究中使用和/或分析的数据集可向通讯作者索取。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02657525&atom=%2Fbmjresp%2F11%2F1%2Fe001881.atom
{"title":"Developing and validating prediction models for severe exacerbations and readmissions in patients hospitalised for COPD exacerbation (SERCO) in China: a prospective observational study","authors":"Ye Wang, Ruoxi He, Xiaoxia Ren, Ke Huang, Jieping Lei, Hongtao Niu, Wei Li, Fen Dong, Baicun Li, Ting Yang, Chen Wang","doi":"10.1136/bmjresp-2023-001881","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001881","url":null,"abstract":"Background There is a lack of individualised prediction models for patients hospitalised with chronic obstructive pulmonary disease (COPD) for clinical practice. We developed and validated prediction models of severe exacerbations and readmissions in patients hospitalised for COPD exacerbation (SERCO). Methods Data were obtained from the Acute Exacerbations of Chronic Obstructive Pulmonary Disease Inpatient Registry study ([NCT02657525][1]) in China. Cause-specific hazard models were used to estimate coefficients. C-statistic was used to evaluate the discrimination. Slope and intercept were used to evaluate the calibration and used for model adjustment. Models were validated internally by 10-fold cross-validation and externally using data from different regions. Risk-stratified scoring scales and nomograms were provided. The discrimination ability of the SERCO model was compared with the exacerbation history in the previous year. Results Two sets with 2196 and 1869 patients from different geographical regions were used for model development and external validation. The 12-month severe exacerbations cumulative incidence rates were 11.55% (95% CI 10.06% to 13.16%) in development cohorts and 12.30% (95% CI 10.67% to 14.05%) in validation cohorts. The COPD-specific readmission incidence rates were 11.31% (95% CI 9.83% to 12.91%) and 12.26% (95% CI 10.63% to 14.02%), respectively. Demographic characteristics, medical history, comorbidities, drug usage, Global Initiative for Chronic Obstructive Lung Disease stage and interactions were included as predictors. C-indexes for severe exacerbations were 77.3 (95% CI 70.7 to 83.9), 76.5 (95% CI 72.6 to 80.4) and 74.7 (95% CI 71.2 to 78.2) at 1, 6 and 12 months. The corresponding values for readmissions were 77.1 (95% CI 70.1 to 84.0), 76.3 (95% CI 72.3 to 80.4) and 74.5 (95% CI 71.0 to 78.0). The SERCO model was consistently discriminative and accurate with C-indexes in the derivation and internal validation groups. In external validation, the C-indexes were relatively lower at 60–70 levels. The SERCO model discriminated outcomes better than prior severe exacerbation history. The slope and intercept after adjustment showed close agreement between predicted and observed risks. However, in external validation, the models may overestimate the risk in higher-risk groups. The model-driven risk groups showed significant disparities in prognosis. Conclusion The SERCO model provides individual predictions for severe exacerbation and COPD-specific readmission risk, which enables identifying high-risk patients and implementing personalised preventive intervention for patients with COPD. Data are available on reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02657525&atom=%2Fbmjresp%2F11%2F1%2Fe001881.atom","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140883985","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}
Introduction Self-management, as the most common method of chronic obstructive pulmonary disease (COPD) management, is not an isolated behaviour, but a set of physical, social, cultural, psychological and existential factors affecting it. Aim This study aimed to explore the facilitators and barriers to self-management in men with COPD in the unique social, cultural, political and economic context of Iran. Methods This paper reports part of the findings of a qualitative grounded theory study aimed at exploring the process of self-management in Iranian men with COPD, which was conducted in Iran from January 2019 to July 2023. Participants included men with COPD, their family members and pulmonologists. The selection of participants in this research began with the purposeful sampling method. Data was collected using semistructured interviews. Data collection continued until the data saturation was achieved. A total of 15 interviews were conducted with nine patients, three family members of patients and three pulmonologists. The data was analysed using the constant comparative analysis method. Results The findings of this study showed that knowledge, education, experience, family involvement and financial support are the factors that facilitate self-management. Factors related to deficits include lack of education, lack of treatment support, family cooperation deficit, financial problems, medication obtaining problems and factors related to disease impacts include specific nature of the disease, residual effect, comorbidity and factors related to negative patients characteristics include false beliefs, poor self-efficacy, feeling shame and non-adherence are barriers to self-management in men with COPD. Conclusion Based on results of this study, healthcare providers and health planners can strengthen the factors that facilitate self-management and weaken or remove the barriers to self-management, so that these patients use self-management strategies with maximum capacity to control the disease. Data are available upon reasonable request. The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.
{"title":"Facilitators and barriers to self-management in Iranian men with chronic obstructive pulmonary disease: a qualitative study","authors":"Forough Rafii, Mona Alinejad-Naeini, Akbar Soleymani Babadi, Elahe Shahriari, Farshad Heidari Beni","doi":"10.1136/bmjresp-2023-002245","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-002245","url":null,"abstract":"Introduction Self-management, as the most common method of chronic obstructive pulmonary disease (COPD) management, is not an isolated behaviour, but a set of physical, social, cultural, psychological and existential factors affecting it. Aim This study aimed to explore the facilitators and barriers to self-management in men with COPD in the unique social, cultural, political and economic context of Iran. Methods This paper reports part of the findings of a qualitative grounded theory study aimed at exploring the process of self-management in Iranian men with COPD, which was conducted in Iran from January 2019 to July 2023. Participants included men with COPD, their family members and pulmonologists. The selection of participants in this research began with the purposeful sampling method. Data was collected using semistructured interviews. Data collection continued until the data saturation was achieved. A total of 15 interviews were conducted with nine patients, three family members of patients and three pulmonologists. The data was analysed using the constant comparative analysis method. Results The findings of this study showed that knowledge, education, experience, family involvement and financial support are the factors that facilitate self-management. Factors related to deficits include lack of education, lack of treatment support, family cooperation deficit, financial problems, medication obtaining problems and factors related to disease impacts include specific nature of the disease, residual effect, comorbidity and factors related to negative patients characteristics include false beliefs, poor self-efficacy, feeling shame and non-adherence are barriers to self-management in men with COPD. Conclusion Based on results of this study, healthcare providers and health planners can strengthen the factors that facilitate self-management and weaken or remove the barriers to self-management, so that these patients use self-management strategies with maximum capacity to control the disease. Data are available upon reasonable request. The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"20 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140939917","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001919
Aline Stalder Siebeneichler, Desiree M Schumann, Meropi Karakioulaki, Nora Brachsler, Andrei M Darie, Leticia Grize, Thiago G Heck, Michael Tamm, Philipp Latzin, Daiana Stolz
Background Methods used to assess ventilation heterogeneity through inert gas washout have been standardised and showed high sensitivity in diagnosing many respiratory diseases. We hypothesised that nitrogen single or multiple breath washout tests, respectively nitrogen single breath washout (N2SBW) and nitrogen multiple breath washout (N2MBW), may be pathological in patients with clinical suspicion of asthma but normal spirometry. Our aim was to assess whether N2SBW and N2MBW are associated with methacholine challenge test (MCT) results in this population. We also postulated that an alteration in SIII at N2SBW could be detected before the 20% fall of forced expiratory volume in the first second (FEV1) in MCT. Study design and methods This prospective, observational, single-centre study included patients with suspicion of asthma with normal spirometry. Patients completed questionnaires on symptoms and health-related quality-of-life and underwent the following lung function tests: N2SBW (SIII), N2MBW (Lung clearance index (LCI), Scond, Sacin), MCT (FEV1 and sGeff) as well as N2SBW between each methacholine dose. Results 182 patients were screened and 106 were included in the study, with mean age of 41.8±14 years. The majority were never-smokers (58%) and women (61%). MCT was abnormal in 48% of participants, N2SBW was pathological in 10.6% at baseline and N2MBW abnormality ranged widely (LCI 81%, Scond 18%, Sacin 43%). The dose response rate of the MCT showed weak to moderate correlation with the subsequent N2SBW measurements during the provocation phases (ρ 0.34–0.50) but no correlation with N2MBW. Conclusions Both MCT and N2 washout tests are frequently pathological in patients with suspicion of asthma with normal spirometry. The weak association and lack of concordance across the tests highlight that they reflect different but not interchangeable pathological pathways of the disease. Data are available upon reasonable request.
{"title":"Single and multiple breath nitrogen washout compared with the methacholine test in patients with suspected asthma and normal spirometry","authors":"Aline Stalder Siebeneichler, Desiree M Schumann, Meropi Karakioulaki, Nora Brachsler, Andrei M Darie, Leticia Grize, Thiago G Heck, Michael Tamm, Philipp Latzin, Daiana Stolz","doi":"10.1136/bmjresp-2023-001919","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001919","url":null,"abstract":"Background Methods used to assess ventilation heterogeneity through inert gas washout have been standardised and showed high sensitivity in diagnosing many respiratory diseases. We hypothesised that nitrogen single or multiple breath washout tests, respectively nitrogen single breath washout (N2SBW) and nitrogen multiple breath washout (N2MBW), may be pathological in patients with clinical suspicion of asthma but normal spirometry. Our aim was to assess whether N2SBW and N2MBW are associated with methacholine challenge test (MCT) results in this population. We also postulated that an alteration in SIII at N2SBW could be detected before the 20% fall of forced expiratory volume in the first second (FEV1) in MCT. Study design and methods This prospective, observational, single-centre study included patients with suspicion of asthma with normal spirometry. Patients completed questionnaires on symptoms and health-related quality-of-life and underwent the following lung function tests: N2SBW (SIII), N2MBW (Lung clearance index (LCI), Scond, Sacin), MCT (FEV1 and sGeff) as well as N2SBW between each methacholine dose. Results 182 patients were screened and 106 were included in the study, with mean age of 41.8±14 years. The majority were never-smokers (58%) and women (61%). MCT was abnormal in 48% of participants, N2SBW was pathological in 10.6% at baseline and N2MBW abnormality ranged widely (LCI 81%, Scond 18%, Sacin 43%). The dose response rate of the MCT showed weak to moderate correlation with the subsequent N2SBW measurements during the provocation phases (ρ 0.34–0.50) but no correlation with N2MBW. Conclusions Both MCT and N2 washout tests are frequently pathological in patients with suspicion of asthma with normal spirometry. The weak association and lack of concordance across the tests highlight that they reflect different but not interchangeable pathological pathways of the disease. Data are available upon reasonable request.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"51 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840205","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-002216
Anne B Chang, Stephanie T Yerkovich, Katherine J Baines, Lucy Burr, Anita Champion, Mark D Chatfield, Kah P Eg, Vikas Goyal, Robyn L Marsh, Gabrielle B McCallum, Margaret McElrea, Steven McPhail, Lucy C Morgan, Peter S Morris, Anne M Nathan, Hannah O’Farrell, Marion O Sanchez, Marianne Parsons, André Schultz, Paul J Torzillo, Nicholas P West, Lesley Versteegh, Julie M Marchant, Keith Grimwood
Introduction Bronchiectasis is a worldwide chronic lung disorder where exacerbations are common. It affects people of all ages, but especially Indigenous populations in high-income nations. Despite being a major contributor to chronic lung disease, there are no licensed therapies for bronchiectasis and there remain relatively few randomised controlled trials (RCTs) conducted in children and adults. Our RCT will address some of these unmet needs by evaluating whether the novel mucoactive agent, erdosteine, has a therapeutic role in children and adults with bronchiectasis. Our primary aim is to determine in children and adults aged 2–49 years with bronchiectasis whether regular erdosteine over a 12-month period reduces acute respiratory exacerbations compared with placebo. Our primary hypothesis is that people with bronchiectasis who regularly use erdosteine will have fewer exacerbations than those receiving placebo. Our secondary aims are to determine the effect of the trial medications on quality of life (QoL) and other clinical outcomes (exacerbation duration, time-to-next exacerbation, hospitalisations, lung function, adverse events). We will also assess the cost-effectiveness of the intervention. Methods and analysis We are undertaking an international multicentre, double-blind, placebo-RCT to evaluate whether 12 months of erdosteine is beneficial for children and adults with bronchiectasis. We will recruit 194 children and adults with bronchiectasis to a parallel, superiority RCT at eight sites across Australia, Malaysia and Philippines. Our primary endpoint is the rate of exacerbations over 12 months. Our main secondary outcomes are QoL, exacerbation duration, time-to-next exacerbation, hospitalisations and lung function. Ethics and dissemination The Human Research Ethics Committees (HREC) of Children’s Health Queensland (for all Australian sites), University of Malaya Medical Centre (Malaysia) and St. Luke’s Medical Centre (Philippines) approved the study. We will publish the results and share the outcomes with the academic and medical community, funding and relevant patient organisations. Trial registration number ACTRN12621000315819.
{"title":"Erdosteine in children and adults with bronchiectasis (BETTER trial): study protocol for a multicentre, double-blind, randomised controlled trial","authors":"Anne B Chang, Stephanie T Yerkovich, Katherine J Baines, Lucy Burr, Anita Champion, Mark D Chatfield, Kah P Eg, Vikas Goyal, Robyn L Marsh, Gabrielle B McCallum, Margaret McElrea, Steven McPhail, Lucy C Morgan, Peter S Morris, Anne M Nathan, Hannah O’Farrell, Marion O Sanchez, Marianne Parsons, André Schultz, Paul J Torzillo, Nicholas P West, Lesley Versteegh, Julie M Marchant, Keith Grimwood","doi":"10.1136/bmjresp-2023-002216","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-002216","url":null,"abstract":"Introduction Bronchiectasis is a worldwide chronic lung disorder where exacerbations are common. It affects people of all ages, but especially Indigenous populations in high-income nations. Despite being a major contributor to chronic lung disease, there are no licensed therapies for bronchiectasis and there remain relatively few randomised controlled trials (RCTs) conducted in children and adults. Our RCT will address some of these unmet needs by evaluating whether the novel mucoactive agent, erdosteine, has a therapeutic role in children and adults with bronchiectasis. Our primary aim is to determine in children and adults aged 2–49 years with bronchiectasis whether regular erdosteine over a 12-month period reduces acute respiratory exacerbations compared with placebo. Our primary hypothesis is that people with bronchiectasis who regularly use erdosteine will have fewer exacerbations than those receiving placebo. Our secondary aims are to determine the effect of the trial medications on quality of life (QoL) and other clinical outcomes (exacerbation duration, time-to-next exacerbation, hospitalisations, lung function, adverse events). We will also assess the cost-effectiveness of the intervention. Methods and analysis We are undertaking an international multicentre, double-blind, placebo-RCT to evaluate whether 12 months of erdosteine is beneficial for children and adults with bronchiectasis. We will recruit 194 children and adults with bronchiectasis to a parallel, superiority RCT at eight sites across Australia, Malaysia and Philippines. Our primary endpoint is the rate of exacerbations over 12 months. Our main secondary outcomes are QoL, exacerbation duration, time-to-next exacerbation, hospitalisations and lung function. Ethics and dissemination The Human Research Ethics Committees (HREC) of Children’s Health Queensland (for all Australian sites), University of Malaya Medical Centre (Malaysia) and St. Luke’s Medical Centre (Philippines) approved the study. We will publish the results and share the outcomes with the academic and medical community, funding and relevant patient organisations. Trial registration number ACTRN12621000315819.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"19 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140884128","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}
Pub Date : 2024-05-01DOI: 10.1136/bmjresp-2023-001936
Thu Win Kyaw, Min-Kuang Tsai, Chi Pang Wen, Chin-Chung Shu, Ta-Chen Su, Xifeng Wu, Wayne Gao
Background It has been known that smoking and various lung diseases including lung cancer can cause lung function impairment. However, the impact of different types of lung function impairments, such as preserved ratio impaired spirometry (PRISm) and airflow obstruction (AO), on the incidence and mortality of lung cancer in both general and never-smoker populations remains unclear. We wished to examine the effect of lung function impairments on lung cancer risks. Methods This was a retrospective cohort study (1 January 1994 to 31 December 2017) of individuals from a health surveillance programme in Taiwan who underwent baseline spirometry tests at the entry point. PRISm was defined as an FEV1/FVC (forced expiratory volume in 1 s/forced vital capacity) ratio >0.7 and FEV1 <0.8, while AO was defined as an FEV1/FVC ratio <0.7. Cox proportional hazards models and cubic spline curves were used to examine the associations between lung function impairments and lung cancer risks. Results The study included 461,183 individuals, of whom 14.3% had PRISm and 7.9% had AO. A total of 4038 cases of lung cancer and 3314 lung cancer-related deaths were identified during the 23 years of follow-up. Individuals with PRISm and AO exhibited a higher risk of lung cancer incidence and mortality compared with those with normal lung function. The adjusted HRs and 95% CIs were 1.14 (1.03 to 1.26) and 1.23 (1.10 to 1.37) in the overall cohort, and 1.08 (0.93 to 1.24), and 1.23 (1.05 to 1.45) in the never-smoker cohort. The risks of both developing and dying of lung cancer increased with the severity levels of lung function impairments and lower FEV1 values. Conclusion Impaired lung function is associated with increased risks of developing lung cancer and subsequent mortality. The study highlights the importance of considering lung function in lung cancer screening for better candidate selection. Data are available upon reasonable request. The data used in this study was authorised by MJ Health Research Foundation (Authorisation Code: MJHRFB2014001C). The MJ Health Research Foundation administered MJ Health Survey Database and MJ BioData, and the data were available at the website: . The study design, data collection, data analysis, data interpretation, writing of the report and submission for publication were independently decided by the authors and had no relation to the funding source. We are grateful to the Health and Welfare Data Science Center and National Health Research Institutes for providing administrative and technical support.
{"title":"Impaired lung function and lung cancer risk in 461 183 healthy individuals: a cohort study","authors":"Thu Win Kyaw, Min-Kuang Tsai, Chi Pang Wen, Chin-Chung Shu, Ta-Chen Su, Xifeng Wu, Wayne Gao","doi":"10.1136/bmjresp-2023-001936","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-001936","url":null,"abstract":"Background It has been known that smoking and various lung diseases including lung cancer can cause lung function impairment. However, the impact of different types of lung function impairments, such as preserved ratio impaired spirometry (PRISm) and airflow obstruction (AO), on the incidence and mortality of lung cancer in both general and never-smoker populations remains unclear. We wished to examine the effect of lung function impairments on lung cancer risks. Methods This was a retrospective cohort study (1 January 1994 to 31 December 2017) of individuals from a health surveillance programme in Taiwan who underwent baseline spirometry tests at the entry point. PRISm was defined as an FEV1/FVC (forced expiratory volume in 1 s/forced vital capacity) ratio >0.7 and FEV1 <0.8, while AO was defined as an FEV1/FVC ratio <0.7. Cox proportional hazards models and cubic spline curves were used to examine the associations between lung function impairments and lung cancer risks. Results The study included 461,183 individuals, of whom 14.3% had PRISm and 7.9% had AO. A total of 4038 cases of lung cancer and 3314 lung cancer-related deaths were identified during the 23 years of follow-up. Individuals with PRISm and AO exhibited a higher risk of lung cancer incidence and mortality compared with those with normal lung function. The adjusted HRs and 95% CIs were 1.14 (1.03 to 1.26) and 1.23 (1.10 to 1.37) in the overall cohort, and 1.08 (0.93 to 1.24), and 1.23 (1.05 to 1.45) in the never-smoker cohort. The risks of both developing and dying of lung cancer increased with the severity levels of lung function impairments and lower FEV1 values. Conclusion Impaired lung function is associated with increased risks of developing lung cancer and subsequent mortality. The study highlights the importance of considering lung function in lung cancer screening for better candidate selection. Data are available upon reasonable request. The data used in this study was authorised by MJ Health Research Foundation (Authorisation Code: MJHRFB2014001C). The MJ Health Research Foundation administered MJ Health Survey Database and MJ BioData, and the data were available at the website: <http://www.mjhrf.org>. The study design, data collection, data analysis, data interpretation, writing of the report and submission for publication were independently decided by the authors and had no relation to the funding source. We are grateful to the Health and Welfare Data Science Center and National Health Research Institutes for providing administrative and technical support.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"22 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140884122","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}
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