Review for 10.1186/s12876-020-01246-7 (2020)

Reviewer ’s report  
 
Title: Protocol of a multicentric prospective cohort study for  the VALIDation of the IBD -Disk 
instrument for assessing disability in Inflammatory Bowel Diseases: the VALIDate study.  
 
Version: 1 Date: 31 May 2019  
 
Reviewer: Radhakrishna Rao  
 
Reviewer's report:  
Authors in this study have designed a validation study named VALIDate, a prospective multi 
center cohort study with an objective to reach a sample of 400 IBD patients.  The goal of the 
study is to assess  the disability index in IBD patients.  The new design is based on existing IBD -
DI method by modified into shortened and self -administered method.  The trial is registered in 
ClinicalTrials.Gov.  
 
It is a well written manuscript. Plan for analyses of fecal  calprotectin is a useful tool, which can 
be extended to microbiome analysis.  It is also helpful to collect buccal swabs that can be used 
for surrogate marker detection such as gene polymorphism, dysbiosis and inflammatory 
markers/fecal microbiome) in ord er to evaluate the prognosis of IBD.  Overall, this is likely to be 
successful in clinical practce.  However, manuscript would have been strengthened by providing 
some results to support the advantage of this study.  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your c omments 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 yo ur comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please speci fy what aspects require further 
assessment in y our comments to the editors.  
 
Not releva nt 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, f ees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publi cation of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation t hat 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 curr ently 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 competing 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 have no conflict of interests.  
 
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to the editors, which will not be published.  
 
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