Background Chronic obstructive pulmonary disease (COPD) affects > 3 million people in the UK. Acute exacerbations of COPD (AECOPD) are the second most common reason for emergency hospital admission in the UK. Pulmonary rehabilitation is usual care for stable COPD but there is little evidence for early pulmonary rehabilitation (EPR) following AECOPD, either in hospital or immediately post discharge. Objective To assess the feasibility of recruiting patients, collecting data and delivering EPR to patients with AECOPD to evaluate EPR compared with usual care. Design Parallel-group, pilot 2 × 2 factorial randomised trial with nested qualitative research and an economic analysis. Setting Two acute hospital NHS trusts. Recruitment was carried out from September 2015 to April 2016 and follow-up was completed in July 2016. Participants Eligible patients were those aged ≥ 35 years who were admitted with AECOPD, who were non-acidotic and who maintained their blood oxygen saturation level ( S pO 2 ) within a prescribed range. Exclusions included the presence of comorbidities that affected the ability to undertake the interventions. Interventions (1) Hospital EPR: muscle training delivered at the patient’s hospital bed using a cycle ergometer and (2) home EPR: a pulmonary rehabilitation programme delivered in the patient’s home. Both interventions were delivered by trained physiotherapists. Participants were allocated on a 1 : 1 : 1 : 1 ratio to (1) hospital EPR ( n = 14), (2) home EPR ( n = 15), (3) hospital EPR and home EPR ( n = 14) and (4) control ( n = 15). Outcome assessors were blind to treatment allocation; it was not possible to blind patients. Main outcome measures Feasibility of recruiting 76 participants in 7 months at two centres; intervention delivery; views on intervention/research acceptability; clinical outcomes including the 6-minute walk distance (6WMD); and costs. Semistructured interviews with participants ( n = 27) and research health professionals ( n = 11), optimisation assessments and an economic analysis were also undertaken. Results Over 7 months 449 patients were screened, of whom most were not eligible for the trial or felt too ill/declined entry. In total, 58 participants (76%) of the target 76 participants were recruited to the trial. The primary clinical outcome (6MWD) was difficult to collect (hospital EPR, n = 5; home EPR, n = 6; hospital EPR and home EPR, n = 5; control, n = 5). Hospital EPR was difficult to deliver over 5 days because of patient discharge/staff availability, with 34.1% of the scheduled sessions delivered compared with 78.3% of the home EPR sessions. Serious adverse events were experienced by 26 participants (45%), none of which was related to the interventions. Interviewed participants generally found both interventions to be acceptable. Home EPR had a higher rate of acceptability, mainly because patients felt too unwell when in hospital to undergo hospital EPR. Physiotherapists generally found the interventions to be acceptable and valued them but found delivery difficult because of staffing issues. The health economic analysis results suggest that there would be value in conducting a larger trial to assess the cost-effectiveness of the hospital EPR and hospital EPR plus home EPR trial arms and collect more information to inform the hospital cost and quality-adjusted life-year parameters, which were shown to be key drivers of the model. Conclusions A full-scale randomised controlled trial using this protocol would not be feasible. Recruitment and delivery of the hospital EPR intervention was difficult. The data obtained can be used to design a full-scale trial of home EPR. Because of the small sample and large confidence intervals, this study should not be used to inform clinical practice. Trial registration Current Controlled Trials ISRCTN18634494. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 11. See the NIHR Journals Library website for further project information.
Asthma exacerbations can be frequent and range in severity from relatively mild to status asthmaticus. The use of magnesium sulfate (MgSO4) is one of numerous treatment options available during acute exacerbations. While the efficacy of intravenous MgSO4 has been demonstrated, little is known about inhaled MgSO4.To examine the efficacy of inhaled MgSO4 in the treatment asthma exacerbations.Randomised controlled trials were identified from the Cochrane Airways Group "Asthma and Wheez*" register. These trials were supplemented with trials found in the reference list of published studies, studies found using extensive electronic search techniques, as well as a review of the gray literature and conference proceedings.Randomised (or pseudo-randomised) controlled trials were eligible for inclusion. Studies were included if patients were treated with nebulised MgSO4 alone or in combination with beta(2)-agonist and where compared to beta2-agonist alone or inactive control.Trial selection, data extraction and methodological quality were assessed by two independent reviewers. Efforts were made to collect missing data from authors. Results from fixed effects models are presented as standardized mean differences (SMD) for pulmonary functions and relative risks (RR) for hospital admission; both are displayed with their 95% confidence intervals (95% CI).Six trials involving 296 patients were included. Four studies compared nebulised MgSO4 with beta2-agonist to beta2-agonist and two studies compared MgSO4 to beta2-agonist alone. Three studies enrolled only adults and 2 enrolled exclusively pediatric patients; three of the studies enrolled severe asthmatics. Overall, there was a significant difference in pulmonary function between patients whose treatments included nebulised MgSO4 in addition to beta2-agonist (SMD: 0.30; 95% CI: 0.03 to 0.56; 4 studies); however, hospitalizations were similar between the groups (RR: 0.69; 95% CI: 0.42 to 1.12; 3 studies). Subgroup analyses did not demonstrate significant differences in lung function improvement between adults and children, but were significantly different between severe and mild to moderate asthmatics (SMD: 0.69; 95% CI 0.13 to 1.25). Conclusions regarding treatment with nebulised MgSO4 alone are difficult to draw due to lack of studies in this area.Nebulised inhaled magnesium sulfate in addition to beta2-agonist in the treatment of an acute asthma exacerbation, appears to have benefits with respect to improved pulmonary function and there is a trend towards benefit in hospital admission. The benefit is significantly greater in more severe asthma exacerbations. Heterogeneity between trials included in this review precludes a more definitive conclusion.
Physicians treating acute pulmonary embolism (PE) are faced with difficult management decisions while specific guidance from recent guidelines may be absent.
Methods
Fourteen clinical dilemmas were identified by physicians and haematologists with specific interests in acute and chronic PE. Current evidence was reviewed and a practical approach suggested.
Results
Management dilemmas discussed include: sub-massive PE, PE following recent stroke or surgery, thrombolysis dosing and use in cardiac arrest, surgical or catheter-based therapy, failure to respond to initial thrombolysis, PE in pregnancy, right atrial thrombus, role of caval filter insertion, incidental and sub-segmental PE, differentiating acute from chronic PE, early discharge and novel oral anticoagulants.
Conclusion
The suggested approaches are based on a review of the available evidence and guidelines and on our clinical experience. Management in an individual patient requires clinical assessment of risks and benefits and also depends on local availability of therapeutic interventions.
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