Shortall 2002.
Methods | RCT Power analysis: not reported |
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Participants | Location: Eastern Maine Medical Center and St Joseph Hospital, Bangor, ME, USA 50 participants were randomised; however, only 34 were analysed. Dropouts were imbalanced (4 in pMDI group and 12 in the nebuliser group) Baseline characteristics: comparable Setting: hospital COPD definition: FEV1 < 60% predicted, FEV1/FVC < 60% after bronchodilators. Postbronchodilator < 15 % increase in FEV1. Exacerbations were defined as an increase of dyspnoea, cough or mucus production plus one or more of the following: inadequate response to outpatient treatment, marked decrease in exercise capacity, inability to eat or sleep due to dyspnoea, worsening hypoxaemia and a new or worsening hypercapnia Exclusion criteria: acute pneumonia, status asthmaticus, bronchiectasis, cystic fibrosis, upper airway obstruction, left ventricular dysfunction, positive blood culture, (non)invasive ventilation, inability to cooperate with pMDI or mask inhalation. |
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Interventions | Participants were randomised to either an oral/pMDI regimen or an IV/nebuliser regime. The oral/pMDI regimen was: methylprednisolone; 40 mg per os every 6 h until wheeze‐free, then 40 mg per os per day. Albuterol; 1 puff per 30 s the first 2 min, then 1 puff every min up to 20 puffs per 4 h and 1 puff every h as needed until alleviation of dyspnoea. Ipratropium; 1 puff per 30 s the first 2 min, 1 puff every min, up to 8 puffs per 4 h, and 1 puff every h as needed. Cefuroxim 500 mg per os twice a day. The IV/nebuliser regime was methylprednisolone; 40 mg intravenously each 6 h until wheeze‐free, then 40 mg per os per day. Nebulised 2.5 mg albuterol and 0.5 mg ipratropium every 4 h while awake and every h as needed. Cefuroxim 1.5 intravenously every 8 h Beta2 ‐agonist: albuterol Anticholinergic: ipratropium pMDI: not reported Spacer: AeroChamber, Monaghan Medical Plattsburgh, NY, USA Nebuliser: Airlife mistyneb nebulizer (Allegiance Healthcare, McGraw, IL, USA) Dosage ratio spacer/nebuliser: not reported Co‐interventions: theophylline and supplementary oxygen Medication adherence rates: not reported |
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Outcomes | FEV1 (L), change in FEV1 (L), mean length of stay, treatment failure, change in Borg scale Time points: not reported |
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Notes | Investigators did not report SDs or confidence intervals, and we could not reach them to obtain these. With help from our statistician, we calculated the SDs (assuming they were equal in both groups) The raw data provided us with a mean change in FEV1 in litres of 0.12 (oral/pMDI group, N = 19) and 0.13 in the (IV/NEB group, N = 15). Based on the formula t = (y1 − y2)/ (SD * √(1/N1+1/N2)) t = 0.15 based on the P value provided by the article, y = change. Thiswould make y1 = 0.12, y2 = 0.13, N1 = 19 and N2 = 15; we calculated the SD to be 0.193. We used a similar calculation to calculate the SD for the Borg score. Here t was 0.41 based on the provided P value. SD was calculated to be 1.55. For length of stay t = 0.85 SD was calculated to be 2.73. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quotation: "randomized" Randomisation protocol not described |
Allocation concealment (selection bias) | High risk | Randomisation protocol not described Comment: Given lack of blinding, probably not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quotation: 4 participants of the oral/pMDI group and 12 of the IV/nebuliser group did not complete the trial. It is unclear why the patients in each group dropped out. |
Selective reporting (reporting bias) | Low risk | Comment: none detected |
Other bias | High risk | The treatment groups differed not only by nebulised vs pMDI device for inhalation, but also by IV vs oral administration of systemic steroids and antibiotics, rendering all comparisons difficult to interpret. Comment: the timing of the performed lung function measurements was not reported 58% of the potential study participants were not studied for several reasons |