scholarly journals Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dirk-Jan Slebos ◽  
◽  
Bruno Degano ◽  
Arschang Valipour ◽  
Pallav L. Shah ◽  
...  
BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043377
Author(s):  
Kai Zhu ◽  
Jagdeep Gill ◽  
Ashley Kirkham ◽  
Joel Chen ◽  
Amy Ellis ◽  
...  

IntroductionPulmonary rehabilitation (PR) following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) reduces the risk of hospital admissions, and improves physical function and health-related quality of life. However, the safety and efficacy of in-hospital PR during the most acute phase of an AECOPD is not well established. This paper describes the protocol for a systematic review with meta-analysis to determine the safety and efficacy of inpatient acute care PR during the hospitalisation phase.Methods and analysisMedical literature databases and registries MEDLINE, EMBASE, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Canadian Agency for Drugs and Technologies in Health, CENTRAL, Allied and Complementary Medicine Database, WHO trials portal and ClinicalTrials.gov will be searched for articles from inception to June 2021 using a prespecified search strategy. We will identify randomised controlled trials that have a comparison of in-hospital PR with usual care. PR programmes had to commence during the hospitalisation and include a minimum of two sessions. Title and abstract followed by full-text screening will be conducted independently by two reviewers. A meta-analysis will be performed if there is sufficient homogeneity across selected studies or groups of studies. The Population, Intervention, Comparator, Outcomes and Study characteristics framework will be used to standardise the data collection process. The quality of the cumulative evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations framework.Ethics and disseminationAECOPD results in physical limitations which are amenable to PR. This review will assess the safety and efficacy of in-hospital PR for AECOPD. The results will be presented in a peer-reviewed publication and at research conferences. Ethical review is not required for this study.


BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e032931
Author(s):  
Pooja Saini ◽  
Tanith Rose ◽  
Jennifer Downing ◽  
Bashir Matata ◽  
Samantha Pilsworth ◽  
...  

ObjectiveTo examine the effects of a consultant-led, community-based chronic obstructive pulmonary disease (COPD) service, based in a highly deprived area on emergency hospital admissions.DesignA longitudinal matched controlled study using difference-in-differences analysis to compare the change in outcomes in the intervention population to a matched comparison population, 5 years before and after implementation.SettingA deprived district in the North West of England between 2005 and 2016.InterventionA community-based, consultant-led COPD service providing diagnostics, treatment and rehabilitation from 2011 to 2016.Main outcome measuresEmergency hospital admissions, length of stay per emergency admission and emergency readmissions for COPD.ResultsThe intervention was associated with 24 fewer emergency COPD admissions per 100 000 population per year (95% CI −10.6 to 58.8, p=0.17) in the postintervention period, relative to the control group. There were significantly fewer emergency admissions in populations with medium levels of deprivation (64 per 100 000 per year; 95% CI 1.8 to 126.9) and among men (60 per 100 000 per year; 95% CI 12.3 to 107.3).ConclusionWe found limited evidence that the service reduced emergency hospital admissions, after an initial decline the effect was not sustained. The service, however, may have been more effective in some subgroups.


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