Randomised control trial
Uri N; Doweck I; Cohen-Kerem R; Greenberg EAcyclovir in the treatment of idiopathic sudden sensorineural hearing loss
Otolaryngology - Head & Neck Surgery
April 2003, vol./is. 128/4 (544-9)
- Submitted by:Anna Morgan - ST6 Emergency Medicine
- Institution:Homerton Hospital
- Date submitted:1st May 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes its objective is to see if using acyclovir improves outcomes in patients with idiopathic sudden sensorineural hearing loss.
2
Design
2.1
Is the study design suitable for the objectives
Yes it is a RCT that compares a group treated with acyclovir and hydrocortisone with one treated with hydrocortisone alone.
2.2
Who / what was studied?
Patients aged 18-60 in Israel who presented within 7 days of having developed idiopathic hearing loss of at least 20 dB. Recruited between 1991-96.
2.3
Was this the right sample to answer the objectives?
Yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
The sample size is only 60 and no sample size estimates have been performed, it is possible that a type 2 error could occur.
2.5
Were all subjects accounted for?
Yes
2.6
Were all appropriate outcomes considered?
Yes
2.7
Has ethical approval been obtained if appropriate?
Not stated
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
Does not state how randomisation was carried out.
2.10
Are the outcomes clinically relevant?
Yes
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes it looked for an improvement of 15 dB in audiometry of pure tone or speech reception threshold.
3.2
Are the measurements valid?
Yes
3.3
Are the measurements reliable?
Yes
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
No
4
Presentation of results
4.1
Are the basic data adequately described?
No table one was included
4.2
Were groups comparable at baseline?
Yes
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
No
5
Analysis
5.1
Are the data suitable for analysis?
Yes
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
Yes
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes
6.2
Is the discussion biased?
No
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b
7.3
Does this paper help me answer my problem?
Yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
8.2
What aids to implementation exist?
8.3
What barriers to implementation exist?