Pulmonary rehabilitation in Iranian outpatients with mustard gas lung disease: a randomised controlled trial.

OBJECTIVE: People with mustard gas lung disease experience cough, sputum, breathlessness and exercise limitation. We hypothesised that pulmonary rehabilitation (PR) would be beneficial in this condition. DESIGN: An assessor-blind, two-armed, parallel-design randomised controlled clinical trial. SETTING: Secondary care clinics in Iran. PARTICIPANTS: 60 men with breathlessness due to respiratory disease caused by documented mustard gas exposure, mean (SD) age 52.7 (4.36) years, MRC dyspnoea score 3.5 (0.7), St. George's Respiratory Questionnaire (SGRQ) 72.3 (15.2). INTERVENTIONS: Participants were allocated either to a 6-week course of thrice-weekly PR (n=31) or to usual care (n=29), with 6-week data for 28 and 26, respectively. OUTCOME MEASURES: Primary endpoint was change in cycle endurance time at 70% baseline exercise capacity at 6 weeks. Secondary endpoints included 6 min walk distance, quadriceps strength and bulk, body composition and health status. For logistical reasons, blood tests that had been originally planned were not performed and 12-month follow-up was available for only a small proportion. RESULTS: At 6 weeks, cycle endurance time increased from 377 (140) s to 787 (343) s with PR vs 495 (171) s to 479 (159) s for usual care, effect size +383 (231) s (p<0.001). PR also improved 6 min walk distance+103.2 m (63.6-142.9) (p<0.001), MRC dyspnoea score -0.36 (-0.65 to -0.07) (p=0.016) and quality of life; SGRQ -8.43 (-13.38 to -3.48) p<0.001, as well as quadriceps strength+9.28 Nm (1.89 to 16.66) p=0.015. CONCLUSION: These data suggest that PR can improve exercise capacity and quality of life in people with breathlessness due to mustard gas lung disease and support the wider provision of this form of care. TRIAL REGISTRATION NUMBER: IRCT2016051127848N1.

Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT).

INTRODUCTION: The most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is a multidisciplinary research team who have conducted research on the risk factors associated with CP respiratory disease, a systematic review on management and a Delphi study on the development of a consensus for the prevention and management of respiratory disease in CP. These strategies have not been investigated; therefore, it is not known if implementation is feasible, if they improve patient outcomes or if they are acceptable for families. METHODS AND ANALYSIS: Mixed-method feasibility pilot randomised controlled trial with economic analysis. Twenty children with CP aged 0-12 years who are at risk of respiratory disease will be followed up for 1 year. All children will receive baseline assessments for comparison. The control group will receive usual care from their treating teams. The intervention group will receive comprehensive assessments from physiotherapy, speech pathology and respiratory medicine. An individualised investigation and treatment plan will then be made. Participants in both groups will complete fortnightly patient-reported outcome surveys to assess symptoms and health service use. Analysis will include assessments of acceptability through qualitative interviews, implementation by ability to recruit, randomise and retain, practicality including costs of intervention and hospitalisation, and explore efficacy through quality-of-life surveys and decreased health service use for respiratory-related symptoms. ETHICS AND DISSEMINATION: Ethics and governance approvals have been obtained through Child and Adolescent Health Service Human Research Ethics Committee. At completion, this study will lead to the design of the definitive protocol to test intervention efficacy that maximises recruitment, retention and adherence to interventions. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620000114943).

Measurement properties of the incremental step test for people with chronic obstructive pulmonary disease: a cross-sectional study.

OBJECTIVES: The new incremental step test (IST) is a field test that was developed for people with chronic obstructive pulmonary disease (COPD), based on the characteristics of the incremental shuttle walk test (ISWT); however, its measurement properties still need to be determined. We aimed, first, to assess the construct validity (through the comparison with the ISWT), within-day reliability and measurement error of the IST in people with COPD; and, second, to identify whether the participants have a learning effect in the IST. DESIGN: Cross-sectional study, conducted according to COnsensus-based Standards for the selection of health status Measurement INstruments guidelines. SETTING: A family health unit in Portugal, April 2022 to June 2023. PARTICIPANTS AND ANALYSIS: 63 participants (67.5±10.5 years) attended two sessions to perform two IST and two ISWT, separately. Spearman's correlations were used to compare the best performances between the IST and the ISWT. Intraclass correlation coefficient (ICC2,1) was used for reliability, and the SE of measurement (SEM), minimal detectable change at 95% CI (MDC95) and Bland and Altman 95% limits of agreement (LoA) were used for measurement error. The learning effect was explored with the Wilcoxon signed-rank test. RESULTS: The IST was significant and strongly correlated with the ISWT (0.72<ρ<0.74, p<0.001), presented an ICC2,1 of 0.95 (95% CI 0.92 to 0.97), SEM=11.7 (18.9%), MDC95=32.4 (52.2%) and the LoA were -33.61 to 31.48 for the number of steps. No difference was observed between the number of steps of the two attempts of the IST (p>0.05). CONCLUSIONS: The IST can be suggested as a valid and reliable test to assess exercise capacity in people with COPD, with no learning effect when two IST are performed on the same day. The measurement error of the IST is considered indeterminate. TRIAL REGISTRATION NUMBER: NCT04715659.

Treatment pathways, economic burden and clinical outcomes in new users of inhaled corticosteroid/long-acting B2-agonist dual therapy with chronic obstructive pulmonary disease in a primary care setting in England: a retrospective cohort study.

OBJECTIVE: Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy. This study described treatment use, healthcare resource utilisation (HCRU), healthcare costs and outcomes following initiation of single-device ICS/LABA as initial maintenance therapy (IMT). DESIGN: Retrospective cohort study. SETTING: Primary care, England. DATA SOURCES: Linked data from the Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets. PARTICIPANTS: Patients with COPD and ≥1 single-device ICS/LABA prescription between July 2015 and December 2018 were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Treatment pathways, COPD-related HCRU and healthcare costs, COPD exacerbations, time to triple therapy, medication adherence (proportion of days covered ≥80%) and indexed treatment time to discontinuation. Data for patients without prior maintenance therapy history (IMT users) and non-triple users were assessed over a 12-month follow-up period. RESULTS: Of 13 451 new ICS/LABA users, 5162 were IMT users (budesonide/formoterol, n=1056; beclomethasone dipropionate/formoterol, n=2427; other ICS/LABA, n=1679), for whom at 3 and 12 months post-index, 45.6% and 39.4% were still receiving any ICS/LABA. At >6 to ≤12 months, the proportion of IMT users with ≥1 outpatient visit (10.1%) and proportion with ≥1 inpatient stay (12.6%) had increased from those at 3 months (9.0% and 7.4%, respectively). Inpatient stays contributed most to total COPD-related healthcare costs. For non-triple IMT users, at 3 and 12 months post-index, 4.5% and 13.7% had ≥1 moderate-to-severe COPD exacerbation. Time to triple therapy initiation and time to discontinuation of index medication ranged from 45.9 to 50.2 months and 2.3 to 2.8 months between treatments. Adherence was low across all time points (21.5-27.6%). Results were similar across indexed therapies. CONCLUSIONS: In the year following treatment initiation, ICS/LABA adherence was poor and many patients discontinued or switched therapies, suggesting that more consideration and optimisation of treatment is required in England for patients initiating single-device ICS/LABA therapy.

Screening and early warning system for chronic obstructive pulmonary disease with obstructive sleep apnoea based on the medical Internet of Things in three levels of healthcare: protocol for a prospective, multicentre, observational cohort study.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnoea (OSA) are prevalent respiratory diseases in China and impose significant burdens on the healthcare system. Moreover, the co-occurrence of COPD and OSA exacerbates clinical outcomes significantly. However, comprehensive epidemiological investigations in China remain scarce, and the defining characteristics of the population affected by COPD and OSA, alongside their intrinsic relationship, remain ambiguous. METHODS AND ANALYSIS: We present a protocol for a prospective, multicentre, observational cohort study based on a digital health management platform across three different healthcare tiers in five sites among Chinese patients with COPD. The study aims to establish predicative models to identify OSA among patients with COPD and to predict the prognosis of overlap syndrome (OS) and acute exacerbations of COPD through the Internet of Things (IoT). Moreover, it aims to evaluate the feasibility, effectiveness and cost-effectiveness of IoT in managing chronic diseases within clinical settings. Participants will undergo baseline assessment, physical examination and nocturnal oxygen saturation measuring. Specific questionnaires screening for OSA will also be administered. Diagnostic lung function tests and polysomnography will be performed to confirm COPD and OSA, respectively. All patients will undergo scheduled follow-ups for 12 months to record the changes in symptoms, lung functions and quality of life. Primary outcomes include the prevalence and characteristics of OS, while secondary outcomes encompass OS prognosis and the feasibility of the management model in clinical contexts. A total of 682 patients with COPD will be recruited over 12-24 months. ETHICS AND DISSEMINATION: The study has been approved by Peking University Third Hospital, and all study participants will provide written informed consent. Study results will be published in an appropriate journal and presented at national and international conferences, as well as relevant social media and various stakeholder engagement activities. TRIAL REGISTRATION NUMBER: NCT04833725.

Risk assessment and real-world outcomes in chronic thromboembolic pulmonary hypertension: insights from a UK pulmonary hypertension referral service.

OBJECTIVES: This study was conducted to evaluate the ability of risk assessment to predict healthcare resource utilisation (HCRU), costs, treatments, health-related quality of life (HRQoL) and survival in patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH). DESIGN: Retrospective observational study. SETTING: Pulmonary hypertension referral centre in the UK. PARTICIPANTS: Adults diagnosed with CTEPH between 1 January 2012 and 30 June 2019 were included. Cohorts were retrospectively defined for operated patients (received pulmonary endarterectomy (PEA)) and not operated; further subgroups were defined based on risk score (low, intermediate or high risk for 1-year mortality) at diagnosis. PRIMARY AND SECONDARY OUTCOME MEASURES: Demographics, clinical characteristics, comorbidities, treatment patterns, HRQoL, HCRU, costs and survival outcomes were analysed. RESULTS: Overall, 683 patients were analysed (268 (39%) operated; 415 (61%) not operated). Most patients in the operated and not-operated cohorts were intermediate risk (63%; 53%) or high risk (23%; 31%) at diagnosis. Intermediate-risk and high-risk patients had higher HCRU and costs than low-risk patients. Outpatient and accident and emergency visits were lower postdiagnosis for both cohorts and all risk groups versus prediagnosis. HRQoL scores noticeably improved in the operated cohort post-PEA, and less so in the not-operated cohort at 6-18 months postdiagnosis. Survival at 5 years was 83% (operated) and 49% (not operated) and was lower for intermediate-risk and high-risk patients compared with low-risk patients. CONCLUSIONS: Findings from this study support that risk assessment at diagnosis is prognostic for mortality in patients with CTEPH. Low-risk patients have better survival and HRQoL and lower HCRU and costs compared with intermediate-risk and high-risk patients.

Intranasal antihistamines and corticosteroids in the treatment of allergic rhinitis: a systematic review and meta-analysis protocol.

INTRODUCTION: Intranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist among different intranasal specific medications. This systematic review aims to analyse and synthesise all evidence from randomised controlled trials (RCTs) on the effectiveness of intranasal antihistamines and corticosteroids in rhinitis nasal and ocular symptoms and in rhinoconjunctivitis-related quality-of-life. METHODS AND ANALYSIS: We will search four electronic bibliographic databases and three clinical trials databases for RCTs (1) assessing patients ≥12 years old with seasonal or perennial allergic rhinitis and (2) comparing the use of intranasal antihistamines or corticosteroids versus placebo. Assessed outcomes will include the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We will assess the methodological quality of included primary studies by using the Cochrane risk-of-bias tool. Certainty in the body of evidence for the analysed outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We will perform a random-effects meta-analysis for each assessed medication and outcome, presenting results as pooled mean differences and standardised mean differences. Heterogeneity will be explored by sensitivity and subgroup analyses, considering (1) the risk of bias, (2) the follow-up period and (3) the drug dose. ETHICS AND DISSEMINATION: Ethical considerations will not be required. Results will be disseminated in a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42023416573.

Nebulised furosemide for the treatment of patients with obstructive lung disease: a systematic review protocol.

INTRODUCTION: Obstructive lung diseases (OLDs) such as asthma and chronic obstructive pulmonary disease are major global sources of morbidity and mortality. Current treatments broadly include bronchodilators such as beta agonists/antimuscarinics and anti-inflammatory agents such as steroids. Despite therapy patients still experience exacerbations of their diseases and overall decline over time. Nebulised furosemide may have a novel use in the treatment of OLD. Multiple small studies have shown improvement in pulmonary function as well as dyspnoea. This systematic review will aim to summarise and analyse the existing literature on nebulised furosemide use in OLD to guide treatment and future studies. METHODS AND ANALYSIS: We will identify all experimental studies using nebulised/inhaled furosemide in patients with asthma or chronic obstructive pulmonary disease that report any outcome. Databases will include EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Clinical Answers, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, Health Technology Assessment and the NHS Economic Evaluation Database (1995-2015). We will also search ClinicalTrials.gov and the WHO-International Clinical Trials Registry Platform. Two reviewers will independently determine trial eligibility. For each included trial, we will perform duplicate independent data extraction, risk of bias assessment and evaluation of the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: Ethical approval will not be applicable to this systematic review. The results of the study will be communicated through publication in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021284680.

Perception and clinical practice regarding mucus clearance devices with chronic obstructive pulmonary disease: a cross-sectional study of healthcare providers in Saudi Arabia.

OBJECTIVES: Clearing secretions from the airway can be difficult for people with chronic obstructive pulmonary disease (COPD). Mucus clearance devices (MCDs) are an option in disease management to help with this, but healthcare provider awareness and knowledge about them as well as current clinical practice in Saudi Arabia are not known. DESIGN: A cross-sectional online survey consisting of four themes; demographics, awareness, recommendations and clinical practice, for MCDs with COPD patients. SETTING: Saudi Arabia. PARTICIPANTS: 1188 healthcare providers including general practitioners, family physicians, pulmonologists, nursing staff, respiratory therapists and physiotherapists. PRIMARY OUTCOME MEASURES: Healthcare providers' level of awareness about MCDs, and the identification of current clinical practices of COPD care in Saudi Arabia. RESULTS: 1188 healthcare providers (44.4% female) completed the survey. Regarding devices, 54.2% were aware of the Flutter, 23.8% the Acapella and 5.4% the positive expiratory pressure mask. 40.7% of the respondents identified the Acapella, and 22.3% the Flutter as first choice for COPD management. 75% would usually or always consider their use in COPD patients reporting daily difficulty clearing mucus, whereas 55.9% would sometimes or usually consider the use of MCDs with COPD patients who produced and were able to clear mucus with cough. In clinical practice, 380 (32%) of the respondents would prescribe MCDs, 378 (31.8%) would give MCDs without prescriptions, 314 (26.4%) would not provide them at all and 116 (9.8%) would only advise patients about them. CONCLUSION: Healthcare providers are aware of the existence of MCDs and their benefits for sputum clearance and believe that MCDs are beneficial for sputum clearance in some COPD patients. TRIAL REGISTRATION NUMBER: ISRCTN44651852.

Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) represents one of the leading causes of death worldwide. Published clinical trials suggest that the Chinese patent herbal medicine Shufeng Jiedu capsule (SFJD) is safe and may be effective for treating acute exacerbations of COPD (AECOPD). However, these effects have been reported with low or very low certainty evidence. This trial aims to evaluate the effectiveness and safety of SFJD for AECOPD. METHODS AND ANALYSIS: This study is designed as a multicentre, randomised, double-blind, placebo-controlled trial. Three hundred patients with moderate or severe hospitalised AECOPD will be recruited in Beijing, Shanghai and Hefei. Participants will be randomly assigned to SFJD and usual care or placebo and usual care at a ratio of 1:1. SFJD and placebo will be administered orally four capsules three times daily for 7 consecutive days followed by an 8-week follow-up period. The primary outcome will be COPD symptom severity as measured by the EXAcerbation of Chronic Pulmonary Disease Tool score. Secondary outcomes include clinical symptoms, quality of life, length of hospital stay, a total dose of antibiotics, the frequency of recurrence of AECOPD, haematological biomarkers, death and adverse events. This study will answer the question of whether SFJD was safe to use and will improve symptoms in people with AECOPD, and will therefore reduce the necessity for antibiotics, the risk and duration of admission to hospital, and the risk of recurrence. ETHICS AND DISSEMINATION: The ethics committee of the first affiliated hospital of Anhui Medical University, Beijing University of Chinese Medicine affiliated Dongzhimen hospital and fifth people's hospital of Shanghai Fudan University approved the study protocol. Informed written consent will be obtained from all the participants. The results of this trial will be disseminated at academic conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN99049821.

Readiness of health facilities to provide services related to non-communicable diseases in Nepal: evidence from nationally representative Nepal Health Facility Survey 2021.

OBJECTIVE: To assess the readiness of public and private health facilities (HFs) in delivering services related to non-communicable diseases (NCDs) in Nepal. METHODS: We analysed data from nationally representative Nepal Health Facility Survey 2021 to determine the readiness of HFs for cardiovascular diseases (CVDs), diabetes mellitus (DM), chronic respiratory diseases (CRDs) and mental health (MH)-related services using Service Availability and Readiness Assessment Manual of the WHO. Readiness score was measured as the average availability of tracer items in per cent, and HFs were considered 'ready' for NCDs management if they scored ≥70 (out of 100). We performed weighted univariate and multivariable logistic regression to determine the association of HFs readiness with province, type of HFs, ecological region, quality assurance activities, external supervision, client's opinion review and frequency of meetings in HFs. RESULTS: The overall mean readiness score of HFs offering CRDs, CVDs, DM and MH-related services was 32.6, 38.0, 38.4 and 24.0, respectively. Guidelines and staff training domain had the lowest readiness score, whereas essential equipment and supplies domain had the highest readiness score for each of the NCD-related services. A total of 2.3%, 3.8%, 3.6% and 3.3% HFs were ready to deliver CRDs, CVDs, DM and MH-related services, respectively. HFs managed by local level were less likely to be ready to provide all NCD-related services compared with federal/provincial hospitals. HFs with external supervision were more likely to be ready to provide CRDs and DM-related services and HFs reviewing client's opinions were more likely to be ready to provide CRDs, CVDs and DM-related services. CONCLUSION: Readiness of the HFs managed by local level to provide CVDs, DM, CRDs and MH-related services was relatively poor compared with federal/provincial hospitals. Prioritisation of policies to reduce the gaps in readiness and capacity strengthening of the local HFs is essential for improving their overall readiness to provide NCD-related services.

Protocol for a systematic review of the associations between inflammatory markers and lung function, muscle force and exercise capacity in people with COPD.

INTRODUCTION: The prevalence of chronic obstructive pulmonary disease (COPD) has been on the rise, with acute exacerbation of COPD associated with the highest burden and multiple pulmonary and systemic consequences. People with COPD have been found to have an abnormal response of systemic inflammation. To date, although limited, there are studies that suggest negative associations between inflammatory markers and important clinical outcomes such as exercise capacity and muscle force. This protocol aims to systematically review the evidence for (i) the associations between inflammatory markers and lung function, muscle force and exercise capacity and (ii) the influence of other factors (eg, hospitalisation, exercise programme) on the level of inflammatory markers in people with COPD. METHODS AND ANALYSIS: Scopus, PubMed, Cochrane, Web of Science and ProQuest will be searched from database inception to February 2023 using PEO search strategy (Population: adults with COPD; Exposure: inflammatory markers; Outcomes: lung function, muscle force and exercise capacity). Four reviewers working in pairs will independently screen articles for eligibility and extract data that fulfilled the inclusion criteria. Depending on the design of the included studies, either Cochrane risk-of-bias version 2 or the Newcastle-Ottawa Scale tools will be used to rate the methodological quality of the included studies. Effect sizes reported in each individual study will be standardised to Cohen's d and a random effects model will be used to calculate the pooled effect size for the association. ETHICS AND DISSEMINATION: Ethical approval is unnecessary as this study will only use publicly available data. The findings will be disseminated through publication in peer-reviewed journals and conferences. PROSPERO REGISTRATION NUMBER: CRD42022284446.

Enteral supplementation with high-dose docosahexaenoic acid on the risk of bronchopulmonary dysplasia in very preterm infants: a collaborative study protocol for an individual participant data meta-analysis.

INTRODUCTION: Severe bronchopulmonary dysplasia (BPD) is a well-known factor consistently associated with impaired cognitive outcomes. Regarding reported benefits on long-term neurodevelopmental outcomes, the potential adverse effects of high-dose docosahexaenoic acid (DHA) supplementation on this short-term neonatal morbidity need further investigations in infants born very preterm. This study will determine whether high-dose DHA enteral supplementation during the neonatal period is associated with the risk of severe BPD at 36 weeks' postmenstrual age (PMA) compared with control, in contemporary cohorts of preterm infants born at less than 29 weeks of gestation. METHODS AND ANALYSIS: As part of an Australian-Canadian collaboration, we will conduct an individual participant data (IPD) meta-analysis of randomised controlled trials targeting infants born at less than 29 weeks of gestation and evaluating the effect of high-dose DHA enteral supplementation in the neonatal period compared with a control. Primary outcome will be severe grades of BPD (yes/no) at 36 weeks' PMA harmonised according to a recent definition that predicts early childhood morbidities. Other outcomes will be survival without severe BPD, death, BPD severity grades, serious brain injury, severe retinopathy of prematurity, patent ductus arteriosus and necrotising enterocolitis requiring surgery, sepsis, combined neonatal morbidities and growth. Severe BPD will be compared between groups using a multivariate generalised estimating equations log-binomial regression model. Subgroup analyses are planned for gestational age, sex, small-for-gestational age, presence of maternal chorioamnionitis and mode of delivery. ETHICS AND DISSEMINATION: The conduct of each trial was approved by institutional research ethics boards and written informed consent was obtained from participating parents. A collaboration and data sharing agreement will be signed between participating authors and institutions. This IPD meta-analysis will document the role of DHA in nutritional management of BPD. Findings will be disseminated through conferences, media interviews and publications to peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42023431063. TRIAL REGISTRATION NUMBER: NCT05915806.

Impact of poor air quality while deployed on respiratory health: a systematic review.

INTRODUCTION: British military personnel deploy internationally to areas with high levels of ambient air pollution. Air pollution can cause acute respiratory symptoms which lead to concern about potential long-lasting health effects. There is a requirement for evidence-based policy on chronic respiratory disease associated with military deployments to areas with poor air quality (AQ). This literature review examines the published evidence relating to the development of chronic respiratory disease in military personnel after exposure to poor AQ while deployed. METHODS: A literature search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Embase, MEDLINE and Global health databases were searched for English language studies published since 2014 examining the respiratory health of military personnel deployed to Southwest Asia since 2001. A quality appraisal of selected articles was conducted using the Critical Appraisals Skills Programme checklist and a descriptive review completed. RESULTS: Eleven studies were found, eight of which had objective outcome measures. Two prospective cohort studies were included; the remainder of the data were retrospective. CONCLUSION: High rates of respiratory symptoms are reported by personnel who deploy to areas of poor AQ, giving rise to high levels of concern. Spirometry testing has found mild deficits, mostly of an obstructive nature, in a third of those with ongoing symptoms post deployment. These have not been consistently linked with deployment length. An increased risk of asthma appears to be multi-factorial in aetiology and there is no evidence for an increased risk of chronic obstructive pulmonary disease or histological pathology post deployment. At present, there is no definitive evidence of chronic respiratory disease due to exposure to poor AQ while deployed. Further objective longitudinal studies are required to continue to investigate the association, diagnosis and management of those with ongoing symptoms.

Association between chronic obstructive pulmonary disease and periodontal disease: a systematic review and meta-analysis.

OBJECTIVES: Studies have suggested contradictory results on the relationship between chronic obstructive pulmonary disease (COPD) and periodontal disease (PD). The aim of this study was to determine whether PD increased the risk of COPD and COPD-related clinical events. DESIGN: A systematic review and meta-analysis. DATA SOURCES: PubMed, Ovid EMBASE and Ovid CENTRAL were searched from inception to 22 February 2023. ELIGIBILITY CRITERIA FOR STUDIES: We included trials and observational studies evaluating association of PD with the risk of COPD or COPD-related events (exacerbation and mortality), with statistical adjustment for smoking. DATA EXTRACTION AND SYNTHESIS: Two investigators independently extracted data from selected studies using a standardised Excel file. Quality of studies was evaluated using the Newcastle-Ottawa Scale. OR with 95% CI was pooled in a random-effect model with inverse variance method. RESULTS: 22 observational studies with 51 704 participants were included. Pooled analysis of 18 studies suggested that PD was weakly associated with the risk of COPD (OR: 1.20, 95% CI 1.09 to 1.32). However, in stratified and subgroup analyses, with strict adjustment for smoking, PD no longer related to the risk of COPD (adjusting for smoking intensity: OR: 1.14, 95% CI 0.86 to 1.51; smokers only: OR: 1.46, 95% CI 0.92 to 2.31; never smokers only: OR: 0.93, 95% CI 0.72 to 1.21). Moreover, PD did not increase the risk of COPD-related exacerbation or mortality (OR: 1.18, 95% CI 0.71 to 1.97) in the pooled result of four studies. CONCLUSIONS: This study demonstrates PD confers no risk for COPD and COPD-related events when strictly adjusted by smoking. Large-scale prospective cohort studies with control of potential confounding factors are warranted to validate the present findings.

Mortality and readmission risk for hospitalised patients with acute exacerbation of COPD with and without spirometric obstruction: a longitudinal observational study in China.

OBJECTIVE: To compare the clinical features and outcomes in patients with pre-chronic obstructive pulmonary disease (COPD) and COPD hospitalised for confirmed or suspected acute exacerbation of COPD (AECOPD). DESIGN: A multicentre, longitudinal observational cohort study. SETTING: Data were obtained from the AECOPD Inpatient Registry Study in China. PARTICIPANTS: 5896 patients hospitalised for AECOPD between 2017 and 2021. OUTCOMES: Patients were divided into the COPD (n=5201) and pre-COPD (n=695) groups according to the lung function test results. The outcomes of interest included all-cause, respiratory disease-related and cardiovascular disease-related deaths as well as readmissions within 30 days and 12 months after discharge. Cumulative incidence functions were used to estimate the risk of cause-specific mortality and readmission. Multivariate hazard function models were used to determine the association between lung function and outcomes. RESULTS: There were significant between-group differences in the symptoms at admission and medication use during hospitalisation. However, there was no significant between-group difference in the 30-day all-cause mortality (0.00 vs 2.23/1000 person-month (pm), p=0.6110) and readmission (33.52 vs 30.64/1000 pm, p=0.7175). Likewise, the 30-day and 12-month cause-specific outcomes were not significantly different between groups (30-day readmission with acute exacerbation (AE): 26.07 vs 25.11/1000 pm; 12-month all-cause mortality: 0.20 vs 0.93/1000 pm; all-cause readmission: 11.49 vs 13.75/1000 pm; readmission with AE: 9.15 vs 11.64/1000 pm, p>0.05 for all comparisons). Cumulative incidence curves revealed no significant between-group differences in the 30-day and 12-month prognosis (p>0.05). Multivariate analysis revealed no significant association of lung function categories with 30-day and 12-month mortality or readmission (p>0.05 for all effect estimations). CONCLUSIONS: Patients with pre-COPD have mild symptoms and similar risks for mortality and readmission during follow-up as patients with COPD. Patients with pre-COPD should receive optimal therapies before the occurrence of irreversible damage.

Study protocol: pneumonia and inhaled corticosteroid treatment patterns in chronic obstructive pulmonary disease - a cohort study using sequence analysis (PICCS).

INTRODUCTION: Treatment with inhaled corticosteroids (ICS) is a widely used treatment in chronic obstructive pulmonary disease. The main effects include a reduction in the number of exacerbations and, for some patients, an increase in expected mortality. Unfortunately, the treatment is also linked to an increased risk of pneumonia, and very little is known about which patients experience this increased risk. There is a need for identification of patient characteristics associated with increased risk of pneumonia and treatment with ICS. METHODS AND ANALYSIS: This is a register-based cohort study that uses the nationwide Danish registers. Data from several registers in the years 2008-2018 will be merged on an individual level using the personal identification numbers that are unique to every citizen in Denmark. Clusters based on pneumonia incidence and ICS treatment patterns will be explored with a sequence analysis in a 3-year follow-up period. ETHICS AND DISSEMINATION: This is a register-based study and research ethics approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be submitted to peer-reviewed journals and reported at appropriate national and international meetings.

Microalbuminuria on admission for acute exacerbation of COPD as a predictor of all-cause mortality and future exacerbations.

OBJECTIVES: Microalbuminuria (MAB) is a sensitive biomarker of cardiovascular risk that is directly associated with cardiovascular events and mortality. Recent studies have evaluated the presence of MAB in patients with stable chronic obstructive pulmonary disease (COPD) or hospitalised for acute exacerbation of COPD (AECOPD). METHODS: We evaluated 320 patients admitted for AECOPD in respiratory medicine departments of two tertiary hospitals. On admission, demographic, clinical and laboratory values and COPD severity were assessed. Patients were evaluated monthly for 1 year, recording new AECOPD and death from any cause. RESULTS: Patients with documented MAB (urinary albumin excretion of 30-300 mg/24 hours) on admission had worse lung function (forced expiratory volume in 1 s, %) (mean (SD) 34.2 (13.6)% vs 61.5 (16.7)%), higher modified Medical Research Council (3.6 (1.2) vs 2.1 (0.8)), lower 6 min walk test (171 (63) vs 366 (104)) and more hospitalisation days (9 (2.8) vs 4.7 (1.9)) (p < 0.001 for all comparisons). MAB was also correlated with Global Initiative for Chronic Obstructive Lung Disease 2020 COPD stages (p < 0.001). In multivariate regression analysis, MAB was a significant predictor of longer hospitalisation duration (OR 6.847, 95% CI 3.050 to 15.370, p < 0.0001). Twelve-month follow-up revealed that patients with MAB experienced more AECOPDs (4.6 (3.6) vs 2.2 (3.5), p < 0.0001) and deaths, n (%) (52 (36.6) vs 14 (7.8), p < 0.001). Kaplan-Meier survival curves demonstrated that patients with MAB presented with increased mortality, AECOPD and hospitalisation for AECOPD risk at 1 year (p < 0.001 for all comparisons). CONCLUSIONS: The presence of MAB on admission for AECOPD was associated with more severe COPD and prolonged hospitalisation, as well as with higher rates of AECOPD and mortality risk at 1-year follow-up.

PANDORA dyadic project: hope, spiritual well-being and quality of life of dyads of patients with chronic obstructive pulmonary disease in Switzerland - a multicentre longitudinal mixed-methods protocol study.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is responsible for 2.9 million deaths annually in Europe. Symptom burden and functional decline rise as patients reach advanced stages of the disease enhancing risk of vulnerability and dependency on informal caregivers (ICs).Evidence shows that hope is an important psycho-social-spiritual construct that humans use to cope with symptom burden and adversity. Hope is associated with increased quality of life (QoL) comfort and well-being for patients and ICs. A better understanding of the meaning and experience of hope over time as patients transition through chronic illness may help healthcare professionals to plan and deliver care more appropriately. METHODS AND ANALYSIS: This is a longitudinal multicentre mixed-methods study with a convergent design. Quantitative and qualitative data will be collected from dyads of advanced COPD patients and their ICs in two university hospitals at two points in time. The Herth Hope Index, WHO Quality of Life BREF, Functional Assessment of Chronic Illness Therapy-Spiritual Well-being and the French version of the Edmonton Symptom Assessment Scale will be used to collect data. Dyadic interviews will be conducted using a semi-structured interview guide with five questions about hope and their relationship with QoL.Statistical analysis of data will be carried out using R V.4.1.0. To test whether our theoretical model as a whole is supported by the data, structural equation modelling will be used. The comparison between T1 and T2 for level of hope, symptom burden, QoL and spiritual well-being, will be carried out using paired t-tests. The association between symptom burden, QoL, spiritual well-being and hope will be tested using Pearson correlation. ETHICS AND DISSEMINATION: This study protocol received ethical approval on 24 May 2022 from the Commission cantonale d'éthique de la recherche sur l'être humain-Canton of Vaud. The identification number is 2021-02477.

EXAcerbations of COPD and their OutcomeS on CardioVascular diseases (EXACOS-CV) Programme: protocol of multicountry observational cohort studies.

INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), the risk of certain cardiovascular (CV) events is increased by threefold to fivefold in the year following acute exacerbation of COPD (AECOPD), compared with a non-exacerbation period. While the effect of severe AECOPD is well established, the relationship of moderate exacerbation or prior exacerbation to elevated risk of CV events is less clear. We will conduct cohort studies in multiple countries to further characterise the association between AECOPD and CV events. METHODS AND ANALYSIS: Retrospective longitudinal cohort studies will be conducted within routinely collected electronic healthcare records or claims databases. The study cohorts will include patients meeting inclusion criteria for COPD between 1 January 2014 and 31 December 2018. Moderate exacerbation is defined as an outpatient visit and/or medication dispensation/prescription for exacerbation; severe exacerbation is defined as hospitalisation for COPD. The primary outcomes of interest are the time to (1) first hospitalisation for a CV event (including acute coronary syndrome, heart failure, arrhythmias or cerebral ischaemia) since cohort entry or (2) death. Time-dependent Cox proportional hazards models will compare the hazard of a CV event between exposed periods following exacerbation (split into these periods: 1-7, 8-14, 15-30, 31-180 and 181-365 days) and the unexposed reference time period, adjusted on time-fixed and time-varying confounders. ETHICS AND DISSEMINATION: Studies have been approved in Canada, Japan, the Netherlands, Spain and the UK, where an institutional review board is mandated. For each study, the results will be published in peer-reviewed journals.