Gordon 2007.
Methods | A prospective, randomised, non‐blinded controlled clinical trial Comparison of a single dose of IM dexamethasone versus oral prednisolone Randomization was reported but method was not described. Allocation concealment method was accomplished using sequentially numbered opaque study packets containing group assignments. |
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Participants | Patients with known history of asthma who presented to the ED with moderate asthma exacerbation who did not require admission on presentation. Asthma was defined as at least 2 prior episodes of respiratory illness treated with bronchodilators. Clinical asthma score adapted from a previous pulmonary score was used to evaluate asthma children aged from 5 to 17 years measuring: respiratory rate, retractions and wheezing. Reported enrolling patients with moderate exacerbations. Unable to assess exacerbation severity based on baseline PEF Ages: enrolled patients 18 months to 7 years. Median age of IM corticosteroid group: 38 months (IQR: 29‐59). Median age of oral corticosteroid group: 42 months (IQR: 28‐60.5) Patients who received IV therapy (not due to vomiting but to severity of asthma) were excluded from study. Set in United States Sex: 110 men, 71 women |
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Notes | Authors were not contacted No registered protocol was identified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided on how patients were randomised. Quote (p. 521): "After written informed consent was obtained, we randomised patients to 1 of 2 treatment groups in blocks of 6, 8, or 10." |
Allocation concealment (selection bias) | Low risk | Allocation concealment ensured via sequentially numbered opaque packets containing group assignments kept in ED and opened by physician immediately after enrolment. Quote (p. 522): "Allocation concealment was maintained by use of sequentially numbered opaque study packets containing group assignments, which were kept in the ED and opened by the treating physician immediately after enrolment." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Non‐blinded study. Quote (p. 522): "Treating physicians were not masked to study group." "At the time of disposition from the ED or 3 hours after enrolment for those patients still in the ED, physicians not blinded to group assignment performed a standardized repeat physical examination including the assessment of a second asthma score." Quote (p. 527): "The only people masked to group assignment in this study were the investigators who assigned follow‐up scores at the 4‐day return visit." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessment completed via physician blinded to group assignment and not involved in patient's care on the initial visit. Quote (p. 523): "At the 4‐day follow‐up visit, a physician masked to group assignment and not involved in the patient's care on the initial visit performed a standard examination, including assignment of an asthma score. Physicians and guardians were instructed not to engage in any conversation before completion of the physical examination. After completing and recording this physical examination, the physician administered a structured interview regarding interim use of bronchodilators and ICS, guardian's perception of bronchodilators and ICS, guardian's perception of clinical improvement, need for further medical care since enrolment, and compliance with oral steroid regimen." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information on study attrition provided in flow diagram provided (p. 523). Excluded patients balanced between groups. Quote (p. 523, 525‐6): "Of 194 randomised patients, 13 were subsequently excluded from the study (7 in the dexamethasone arm and 6 in the prednisolone arm) for the following reasons: 6 had initial asthma scores of only 2, 4 had previously participated, 1 had only one prior episode of wheezing, 1 had taken prednisolone within the previous month, and 1 patient was randomised to the dexamethasone group, but inappropriately given prednisolone in the ED. The guardians of 2 included patients randomised to dexamethasone withdrew their consent for further participation during the ED visit (one before drug administration, one afterward)." |
Selective reporting (reporting bias) | Unclear risk | No available protocol |
Other bias | Unclear risk | Source of funding was not stated. |