Schuckman 1998.
Methods | A prospective, randomised, double‐blinded, placebo‐controlled clinical trial Comparison of IM triamcinolone versus oral prednisone Randomization was accomplished using computer‐generated random numbers. Allocation concealment was reported and discussed as pharmacy controlled by using computerized generated set of numbers to package medications and placebo into sequentially numbered kits. |
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Participants | Patients presented to the ED with an asthma exacerbation that had an initial PEF < 350 L/min and did not require admission to hospital on ED presentation The diagnosis of asthma was according to the American Thoracic Society criteria (1987) Patients were excluded from study if had received corticosteroids within 2 weeks prior to ED presentation or were unable or unwilling to attend follow‐up evaluation. Ages: Enrolled patients 18 to 50 years. Mean age of IM corticosteroid group: 31 years (SD: 9). Mean age of oral corticosteroid group: 32 years (SD: 9) Exacerbation severity not reported. Exacerbation severity estimated as mild/moderate based on baseline PEF Set in United States Sex: 47 mean, 107 women |
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Interventions |
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Outcomes | Patients were followed up 7 to 10 days after ED enrolment.
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Notes | Author was contacted and provided clarification on the methodology of blinding and outcome data. Was unable to provide copy of the study protocol. No registered protocol was identified. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation completed via computer generated set of random numbers. Quote (p. 334): "A computer‐generated set of random numbers was used by the hospital pharmacy to package the active medications and placebos into sequentially numbered kits." |
Allocation concealment (selection bias) | Low risk | Pharmacy controlled allocation concealment. Medications and placebos packaged in sequentially numbered kits. Quote (p. 334): "A computer‐generated set of random numbers was used by the hospital pharmacy to package the active medications and placebos into sequentially numbered kits." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded study. Study authors confirmed via personnel communication that the study medications were indistinguishable from each other. Personal communication: "Syringes were prefilled and tablets looked similar for placebo and prednisone. Each patient received injection and pill bottle. They brought their bottle to follow‐up." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors (physicians) were blinded to the patient's group assignment. Quote (p. 335): "Physicians evaluating patients at follow‐up remained blinded to drug group assignment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information on study attrition provided in flow diagram provided (p. 337). Excluded patients balanced between groups. Quote (p. 335‐6): "We approached 186 patients who were potentially eligible; 15 (9%) refused to participate, and 3 (2%) resided out of town and could not return for follow‐up. A total of 168 patients were enrolled, 82 in the triamcinolone group and 86 in the prednisone group. Fourteen patients were withdrawn from analysis: 6 (3 in each group) for protocol violations because the patient was older than 50 years of age, and 8 (1 in the triamcinolone group and 7 in the prednisone group) because they were lost to follow‐up. The final study population was 154 patients, 78 in the triamcinolone group and 76 in the prednisone group." |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Low risk | No other potential source of bias found. Source of funding provided. Quote (p. 333): "Research supported by the Summa Health System Foundation." |
Abbreviations
ED: emergency department
FEV1: forced expiratory volume
FVC: forced vital capacity
ICS: inhaled corticosteroids
IM: intramuscular
MDI: metered dose inhaler
PEF: peak expiratory flow
IV: intravenous
SD: standard deviation
SEM: standard error of mean
IQR: interquartile range