Review for 10.1186/s12876-020-01332-w (2020)

Reviewer ’s report  
 
Title: Real-world clinical effectiveness and safety of vedolizumab  and anti -tumor necrosis factor 
alpha treatment in ulcerative colitis and Crohn ’s disease patient s: A German retrospective chart 
review  
 
Version: 1 Date: 27 Apr 2020  
 
Reviewer: Research Square Reviewer 1  
 
Reviewer's report:  
 
PEER REVIEWER ASSESSMENTS:  
 
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several 
testable research questions? (Brief or other artic le types: is there a clear objective?)  
Yes - there is a clear objective  
 
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for the 
objective?  
Yes - the approach is appropriate  
 
EXECUTION - Are the experiments and anal yses performed with sufficient technical rigor to 
allow confidence in the results?  
Yes - experiments and analyses were performed appropriately  
 
STATISTICS - Is the use of statistics in the manuscript appropriate?  
Yes - appropriate statistical analyses have  been used in the study  
 
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not 
overstated?  
No - there are minor issues  
 
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently 
for you to now recommend the work as a technically sound contribution? If not, can further 
revisions be made to make the work technically sound?  
Probably - with minor revisions  
 
PEER REVIEWER COMMENTS:  
 
GENERAL COMMENTS: The authors have responded adequately to most of my concerns.  
They have mainly made changes to reflect their responses in the manuscript itself?  
Overall impression of the revised manuscript: Acceptable with minor revisions  
 
 
 
 
REQUESTED REVI SIONS:  
Authors response:„ We have revised the study limitations discussion to specify that study data 
were limited to what was recorded in the patient chart". Please add that you might have 
underestimated adverse events by this procedure and that you did not distinguish between serious 
and non.serious AE.  
Please add that there were no deaths during the study period.  
P 19, line 41: Double sentence: „This real -world chart review study had several limitations."  
 
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 b y the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
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 specif y 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 complet e 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 publication 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 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 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 you r reply is yes to any, please give details below.  
 
This reviewer has been recruited by a partner organization, Research Square. Reviewers with 
declared or apparent competing interests are not utilized for t hese reviews. This reviewer has 
agreed to publication  of their comments online under a Creat ive Commons Attribution License 
attributed to Research Square and was paid a small honorarium f or completing the review within 
a specified timeframe. Honoraria for reviews such as this are paid regardless of the revie wer 
recommendation.  
 
I agree to the open peer review  policy of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named r eport 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available under an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as con fidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal