Reviewer ’s report  
 
Title: RESEARCH PROTOCOL: CISPLATIN -ASSOCIATED OTOTOXICITY AMONGST  
PATIENTS RECEIVING CANCER CHEMOTHERAPY AND THE FEASIBILITY OF AN  
AUDIOLOGICAL MONITORING PROGRAM  
 
Version: 1 Date: 21 Jul 2017  
 
Reviewer: Samson Jamesdaniel  
 
Reviewer's report:  
 
The manuscript entitled "Research Protocol: Cisplatin -Associated Ototoxicity Amongst Patients 
Receiving Cancer Chemotherapy And The Feasibility Of An A udiological Monitoring Program" 
aims to determine the incidence of cisplatin -induced ototoxicity in cervical cancer patients in the 
province of KwaZulu -Natal, South Africa and explores the feasibility of a monitoring program.  
 
 
This is an important topic of  high clinical significance as the ototoxic side effect of cisplatin 
could compromise the quality of life of those treated with this widely -used highly effective anti -
cancer drug. Though the proposed study is well designed there are certain concerns that n eed to 
be addressed.    
 
 
First, the inclusion criteria suggests that adults i.e. ≥18 years of age will be included in this 
study. However, no upper age limit is set for recruiting participants. Because age is an important 
risk factor for hearing loss it wo uld be difficult to disentangle the contribution of age to hearing 
loss in older patients treated with cisplatin. The authors need to discuss how they intend to 
resolve this issue or if they would specify an upper age limit, which will exclude patients wit h 
risk of age -related hearing loss.  
 
 
Second, the authors plan to do follow -up audiometric testing at 1, 3, and 6 months after the 
completion of cisplatin treatment cycle. If continued progression of hearing loss is suspected 
even after the 3 month period, the testing could be done at 6 months instead of 3 months. If not, 
the testing at 6 months could be excluded. Because the cost of audiometric testing would be an 
important factor in determining the feasibility of the monitoring program the authors need to 
clarify the reasons for proposing audiometric testing at both 3 months and 6 months.  
 
 
Third, the interview questionnaire for patients needs to be modified to gather information about 
concurrent use of antioxidants or dietary supplements, recent use of amin oglycoside antibiotics, 
and occupational or recreational exposure to other risk factors such as heavy metals and solvents 
because these exposures can interfere with the hearing loss induced by cisplatin.  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in t he manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied fo r patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
If you can answer no to all of the above, write 'I declare that I h ave no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I h ave no competing interests  
 
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