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: 20 Mar 2017  
 
Reviewer: Bruce Carleton  
 
Reviewer's report:  
 
General Comments  
 
This is a well -intentioned study that aims to address multiple issues related to ototoxicity in a 
target population of women treated for cervical cancer on a chemotherapeutic regimen including 
cisplatin. It is proposed for a part of the world where there i s a paucity of previous work on 
cisplatin -induced ototoxicity.  The study design of collecting audiological data at multiple time 
points ( pre -treatment baseline, mid -treatment and post -treatment) is commendable.  We have 
left the statistical analysis issu es to the other reviewer who apparently previously requested such 
information.   
 
 
 
Specific Comments regarding audiological data collection and analysis:  
 
1. The data collection on the "audiological evaluation recording form"  (additional file #7) 
does not match the narrative in additional file #8 with respect to the pure tone audiometry 
frequencies to be tested.  
 
 
 
2. Utility of testing frequencies above 16,000 Hz is questionable.  Please justify.  
 
 
 
3. Intra -octave frequencies were omitted, pa rticularly  3000 and 6000 Hz which are highly 
contributory to speech understanding. Why?  
 
 
 
4. Classification of degree of hearing loss based on standard pure tone average (500, 1000 
and 2000 Hz) (additional file #8) may fail to capture significant oto toxic change to 
hearing status.  This is a significant limitation and should be added to the discussion 
under limitations.  A justification of why this classification was done is needed as well.  
 
5. Page 17 of the manuscript  section 2.8.3 is confusi ng. For example, what does line 41 
"severity of hearing loss on an ordinal scale" actually mean?  
 
 
 
6. There is a substantial amount of basic audiological test methods for some procedures, e.g. 
classification of tympanometry tracings are described in d etail in additional file #8 where 
reference to Jerger classification is sufficient. This is combined with a lack of detail 
regarding other procedures or  important elements such as instrumentation and 
calibration.  These details should be added to ensure g eneralizability and reproducibility 
of findings is maximized.  
 
 
 
7. If the purpose of testing is for ototoxic monitoring, contralateral acoustic reflexes are not 
indicated. They may be included as part of a diagnostic test battery if specified by the 
institution. Ipsilateral reflexes are useful for establishing middle ear status beyond middle 
ear pressure and eardrum mobility.  
 
 
 
8. The "P.I. Function" on the "audiological evaluation recording form" (additional file #7) is 
not referenced in the narr ative "measurements for audiological evaluation" (additional 
file #8).  
 
 
 
9. It is not clear how the data collected from the "participants who are non -responsive" 
(page 13 of the manuscript) would be used in the analysis.  
 
 
 
10. 10.  There are two refer ences to "lung cancer" that should be "cervical cancer" (additional 
files #4 and # 9).  
 
 
 
11. 11.  On page 16 of the manuscript document,  line 51 is missing the range specification 
("51%" instead of "51 -75%").  
 
 
 
12. Study Design, Section 2.3 on page 8 of the manuscript has a very brief description of how 
the quantitative and qualitative methodologies will be used but they are not clearly tied to 
the specific aspects of data collection. There is reference to "field notes" (line 29) but no 
subsequent indicat ion of exactly what "field notes" are to be documented or analyzed.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
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.  
 
I am able to assess the statistics  
 
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 I have no competing interests  
 
No longer hold ANY patents or patent pending applications despite previous disclosures in other 
publications.  All pate nts or applications have been abandoned globally.  
 
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