Randomised control trial
Paul Walsh, MB, BCh, BAOComparison of Nebulized Epinephrine to Albuterol in Bronchiolitis
Academic Emergency Medicine
2008; 15:305-313
- Submitted by:Tammy Provatas - Emergency Physician- Resident
- Institution:Grand Rapids Medical Education and Research/Michgan State University
- Date submitted:18th February 2010
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to compare the effects of albuterol versus racemic rpinephrine on hospital admission rates and length of stay in children with bronchiolitis.
2
Design
2.1
Is the study design suitable for the objectives
Yes; it is a double blinded randomized control trial
2.2
Who / what was studied?
703 children less than 18 months of age presenting to two different emergency department that were clinically given the diagnosis of bronchiolitis.
2.3
Was this the right sample to answer the objectives?
Yes, the study group is representative of the population. They also made appropriate exclusions: children that required no treatment, children that required intubation and those that received bronchodilators prior to enrollment.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
They calculated a sample size of 374 to provide 90% power to the study.
2.5
Were all subjects accounted for?
Yes, they explained that the children that were excluded were done so based on exclusion eligibility or multiple enrollments.
2.6
Were all appropriate outcomes considered?
Yes; they considered discharge home vs. extended emergency department stay vs. hospital admission. They also took into consideration repeat emergency department visits and death.
2.7
Has ethical approval been obtained if appropriate?
Yes; both hospital sites had institutional review board approval.
2.8
Were the patients randomised between treatments?
Yes, they were placed into blocks of 50 to reduce the risk of allocation bias and physicians being able to guess the identity of the drug.
2.9
How was randomisation carried out?
It was performed using a computer generated random number series. The pharmacist had sole access to the list and the codes were secured until the study was completed.
2.10
Are the outcomes clinically relevant?
Yes; in 2002, bronchiolitis resulted in 149,000 hospital admissions and annual costs of $543 million.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes; they looked at successful discharge from the hospital. This included no admission within 72 hours of discharge.
3.2
Are the measurements valid?
Yes, they are valid.
3.3
Are the measurements reliable?
There was a clearly defined admission criteria with the exception of allowing for clinician judgment.
3.4
Are the measurements reproducible?
Yes; under the same circumstances and similiar patient population, the results could be reproduced.
3.5
Were the patients and the investigators blinded?
Yes; all members of the health care team and the patients and patients family were blinded with the exception of the pharmacist.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes, see Table 2
4.2
Were groups comparable at baseline?
Yes, see Table 1. The two groups were comparable in all aspects.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes, the results are well layed out in a table that is easy to interpret.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes, all patients were accounted for.
4.5
Were side effects reported?
Yes; they discussed tachycardia, perioral cold-induced urticaria. They even accounted for one death.
5
Analysis
5.1
Are the data suitable for analysis?
Yes except for 62 patients that had incomplete severity of illness data collected.
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
Yes, they used Stata 9.2 for statistical analysis.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes, they reported that their findings contrasted with other existing studies.
6.2
Is the discussion biased?
No, they discussed all limitations of the study and how their findings contrasted with other existing studies.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes, the authors adjusted for severity of illness.
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b
7.3
Does this paper help me answer my problem?
This paper offers support for the use of albuterol over racemic epinephrine but there was no comparison of nebulized medication to purely supportive care.
8
Implementation
8.1
Can any necessary change be implemented in practice?
If a patient with bronchiolitis is in extremis then albuterol can be considered an adjunct to supportive care.
8.2
What aids to implementation exist?
Albuterol is more readily available for use than racemic epinephrine.
8.3
What barriers to implementation exist?
Lack of additional studies to support this study.