Turner 1988.
Methods | RCT Power analysis: not reported |
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Participants | Location: San Francisco, CA, USA 22 participants: mean age 55 years (SD 4), pMDI‐spacer group; 57 years (SD 3), nebuliser group. 53 asthma patients were also included and reported separately Baseline characteristics: comparable Setting: emergency room COPD definition: ≥10 pack‐years of smoking and onset of symptoms ≥ age 30 Exclusion criteria: younger than 18, older than 75, acute myocardial infarction, heart failure, intubation, inability to perform an FEV1, allergy towards metaproterenol or pregnant |
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Interventions | Randomly assigned to 3 x 0.65 mg metaproterenol via pMDI + spacer + placebo, or nebuliser metaproterenol 15 mg + placebo. Each treatment was given 3 times at 30 min intervals. Beta2 ‐agonist: metaproterenol pMDI: brand not reported Spacer: InspirEase, Key Pharmaceuticals, USA Nebuliser: Acorn II, Marquest Medical, USA Dosage ratio spacer/nebuliser: 1:7.7 Co‐interventions: oxygen, IV steroids; theophylline was withheld Medication adherence rates: not reported |
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Outcomes | FEV1, Borg scale, pulse, respiratory rate, blood pressure Time points: baseline, after 30 and 90 minutes |
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Notes | Source of funding not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation protocol was described in unpublished data quote: "therapy was then determined . . . by a random list of numbers" Comment: probably done |
Allocation concealment (selection bias) | Low risk | Randomisation protocol was described in unpublished data quote: "therapy was then determined . . . by a random list of numbers". Comment: based on the quality of the trial and procedures for a trial performed in this decade, we estimate the risk to be low |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quotation: "double blind" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quotation: "double blind" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: none detected |
Selective reporting (reporting bias) | Low risk | Change in FEV1 was not reported; we obtained access to the full data and calculated this ourselves |
Other bias | High risk | COPD was defined only as ≥10 pack years of smoking and onset of symptoms ≥ age 30, and therefore less than fully clearly separated from asthma. Comment: this might lead to bias, especially since asthmatics tend to have larger bronchodilator responses |
ATS: American Thoracic Society; COPD: chronic obstructive pulmonary disease; FEF: forced expiratory flow; FEV1 : forced expiratory volume in 1 second; FVC: forced vital capacity; IV: Intravenous;PaCO2 : partial pressure of carbon dioxide in arterial blood; PaO2 : partial pressure of oxygen in arterial blood; PEF(R): peak expiratory flow (rate); pH: potential of hydrogen; pMDI: pressurised metered‐dose inhaler; SaO2 : symbol for the percentage of oxygen saturation of arterial blood; SEM: standard error of the mean; SD: standard deviation;tcCO2: transcutaneous carbon dioxide.