Reviewer ’s report  
 
Title: The effect of written information and counselling by an advanced practice nurse on  
resilience in women with vulvar neoplasia during six months after surgical treatment and the  
influence o f social support, recurrence, and age: A secondary analysis of a multicenter 
randomized  controlled trial, WOMAN -PRO -II 
 
Version: 0 Date: 04 Feb 2020  
 
Reviewer: BEATRIZ AYALA  
 
Reviewer's report:  
 
Main weaknesses of the study were the small sample size and lost to follow up of 26.5%.  
Below are some other comments:  
* It would be important to add the final number of participants per group and those lost to 
follow up in the abstract.  
* The number of pa rticipants included was less than 50% of the estimated sample size (if 
the attrition rate were 15%). Could the authors assure that that small sample size (49 instead of 
106) plus those lost to follow up allow drawing adequate conclusions for this study? It  is well 
known that reporting more than 20% loss is a serious threat to validity.  
* Why the enrollment period was not extended?  
* In limitation of the study, the authors should also explain what sample size should be 
required for this study considering th e objectives of this study and lost to follow of 26.5%; and 
how these small sample size and lost to follow up would impact the results (validity) of this 
study (which means that the sample size required for this study would be larger than 106 
participants) .  
* The conclusion in the abstract and in the study should be more cautious taking into 
account the small sample size and the lost to follow up of 26.5%.  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the a uthors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your commen ts to the authors.  
 
No 
 
Are you able to assess any statistics in the 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 comme nts 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 fo llowing 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 a ny 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 for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial c ompeting interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
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on my report to the authors and, if the manuscript is accepted for publication, my named report  
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I agree to the open peer review policy of the journal