Randomised control trial
Tucci DL; Farmer JC Jr; Kitch RD; Witsell DlTreatment of sudden senorineural hearing loss with systemic steroids and valacyclovir
Otology & Neurotology
May 2002, Vol./is. 23/3 (301-8)
- Submitted by:Anna Morgan - ST6 Emergency Medicine
- Institution:Homerton Hospital
- Date submitted:2nd May 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes: to determine if the addition of an antiretroviral medication to systemic steroids improves recovery in the treatment of idiopathic sudden sensorineural hearing loss.
2
Design
2.1
Is the study design suitable for the objectives
Yes: randomized, double-blind, placebo-controlled trial.
2.2
Who / what was studied?
84 Adult patients in 45 sites in the USA who presesented with sudden onset hearing loss (either (1)loss of at least 30 dB in 3 consecuative frequencies over < 3 days or (2) marked hearing loss in patients with previously normal hearing) of less than 10 days duration.
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?
A sample size estimate was made. The sample size needed to detect a 30% improvement in the proportion of patients recovering useful hearing based on an alpha of 0.05 and a power of 90% was determined to be 58 patients (in the treatement group) and the study recruitment goal was 127 patients (in total).
In the event only 84 patients were included in statistical analysis of the study, therefore a power of 80% was achieved.
In the event only 84 patients were included in statistical analysis of the study, therefore a power of 80% was achieved.
2.5
Were all subjects accounted for?
No, there was a drop out rate of 10.5%. In addition 10 patients were deleted from final analysis either because a cause was found for their hearing loss, they did not take medication or it was decided retrospectivly that they did not meet the inclusion criteria for the study.
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?
The pharmacy at the clinical research institute distributed blinded medication to participating sites. These were kept in participating sites pharmacies. No one on site would be aware of which boxes contained placebo and which contained valacyclovir.
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?
The outcomes measured were (1) quantative: audiometric assessment looking at pure tone audiogram and speech discrimination score at week 2 and 6 and (2) subjective: results of Hearing Screening Inventory (looks at symptoms of hearing loss and dizziness and tinitus) and acute Short Form-12 questionnaires (a general quality of life survey).
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?
Yes
4
Presentation of results
4.1
Are the basic data adequately described?
Yes but does not show difference between demographic information between two groups.
4.2
Were groups comparable at baseline?
Yes in terms of audiologic data. Insufficient information is available to determine if they were similar in terms of demographic data.
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?
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. Based on the findings of this paper I would not recommend using antivirals in sudden sensorineural hearing loss.
8
Implementation
8.1
Can any necessary change be implemented in practice?
My practice at present is not to use antivirals. The findings of this paper would appear to support this practice.
8.2
What aids to implementation exist?
8.3
What barriers to implementation exist?