Randomised control trial
Stokroos R. J, Albers F. W. J, Tenvergert E. M.Antiviral Treatment of Idiopathic Sudden Sensorineural Hearing Loss: A Prospective, Randomized, Double-blind Clinical Trial
Acta Oto-Laryngologica
July 1998, Vol./is. 118/4(488-95)
- 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, it uses the hypothesis that idipathic sudden sensorineural hearing loss is caused by a viral infection and attempts to answer the question of whether the use of antivirals in this condition would improve outcomes.
2
Design
2.1
Is the study design suitable for the objectives
Yes
2.2
Who / what was studied?
Multicentre trial of 44 patients aged between 11- 71 years in the Netherlands who had cochlear hearing loss of unknown aetiology, with hearing loss at least 30dB, who presented with in 24 hours of symptoms onset and had blank otological history.
2.3
Was this the right sample to answer the objectives?
Yes but did include unknown number of patients who were under 18.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
No sample size estimate performed. The small sample size could result in a type 2 error.
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?
Yes
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
Randomization was performed by the hospital pharmacist.
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 measures both patient subjective symptoms (hearing improvement, tinnitus, pressure sensation in the ear) and objective measures of audiometric parameters looking at speech discrimination and pure-tone audiometry with an improvement of 10 dB FI being considered significant.
3.2
Are the measurements valid?
Yes
3.3
Are the measurements reliable?
Yes
3.4
Are the measurements reproducible?
Subjective measurements of hearing recovery, tinnitus, pressure sensation and dizziness may not be reproducible. The objective measures of pure-tone audiometry and speech audiometry are likely to be.
3.5
Were the patients and the investigators blinded?
Yes
4
Presentation of results
4.1
Are the basic data adequately described?
No table one
4.2
Were groups comparable at baseline?
No. The severity of initial hearing loss was different between the two groups with more cases of profound hearing loss being found in the placebo treated group than the aciclovir treated group.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
No table two. Does not show results of all statistical tests undertaken.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
Yes
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?
Yes
8.2
What aids to implementation exist?
8.3
What barriers to implementation exist?