Rodrigo 1995.
| Methods | ‐ Prospective, randomised, double‐blind study. ‐ Comparison of ipratropium bromide and salbutamol vs. salbutamol alone. ‐ Method of randomisation unclear. ‐ No information on allocation concealment provided. |
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| Participants | ‐ Patients presenting to the ED with an exacerbation of asthma with an FEV and PEF ≤ 50% of predicted value. ‐ Set in Uruguay. ‐ Ages: 18 to 50 years. ‐ Asthma exacerbation severity of presenting patients was unclear. Insufficient information presented. |
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| Interventions | ‐ Multiple doses of combination inhaled therapy. Study interventions provided via MDI spacer. ‐ Group one received four puffs of ipratropium bromide (20 μg/puff) and salbutamol (100 μg/puff) every 10 minutes for 3 hours. ‐ Group two received four puffs of salbutamol (100 μg/puff) along with placebo (propellant) every 10 minutes for 3 hours. ‐ Additional co‐interventions provided in the ED included IV hydrocortisone (500 mg) after upon completion of initial treatment for all patients. |
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| Outcomes | ‐ Outcomes included pulmonary function and adverse events. ‐ Outcome measurements were performed at baseline, as well as 30, 60, 90, 120, 150, and 180 minutes after the start of treatment. |
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| Notes | ‐ Contacted authors for additional information but no response received. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised but no information provided. Quote (p. 177): "Los sujetos fueron asignados aleatoriamente a uno de dos grupos de tratamiento." (T ranslation: "Subjects were randomly assigned to one of two treatment groups"). |
| Allocation concealment (selection bias) | Unclear risk | No information provided on allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double blinded but no information was provided. Quote (p. 177): "Se utilizaron procedimiento de tipo doble ciego." (Translation: "We used double‐blind procedures.") |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided on whether outcome assessors were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how many patients were screened, refused or excluded. |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | Unclear risk | No source of funding provided. |