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: 0 Date: 24 Feb 2020  
 
Reviewer: Research Square Reviewer 1  
 
Reviewer's report:  
 
PEER REVIEWER ASSESSMENTS:  
 
OBJECTIVE - Full research articles: i s there a clear objective that addresses a testable research 
question(s) (brief or other article 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?  
No - there are major issues  
 
EXECUTION - Are the experiments and analyses performed with technical rigor to allow 
confidence in the results?  
No - there are minor issues  
 
STATISTICS - Is the use of statistics in the manuscript appropriate?  
No - there are issues with the statistics in the study  
 
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not 
overstated?  
Yes - the author's interpre tation is reasonable  
 
OVERALL MANUSCRIPT POTENTIAL - Is the current version of this work technically 
sound? If not, can revisions be made to make the work technically sound?  
Maybe - with major revisions  
 
PEER REVIEWER COMMENTS:  
 
GENERAL COMMENTS:  
Overall  positive impression  
The patient samples are well characterized. The statistical methods to assess effectiveness are 
appropriate.  
The reports of the assessment  of adverse events did not meet current standards.  
 
 
 
 
REQUESTED REVISIONS:  
The details how advers e events were assessed, need to be better explained and the results need 
urgently reported with more details. Were subjective AE assessed by open questions or by 
structured check list ?Who assessed AE? Which lab tests were conducted to assess objective AE?  
Please make a distinction (and give criteria) for non -serious and serious AE. Please report the 
rates of hospitalisations during the study. Where there any death during the study period?  
An a priori power calculation is necessary if you make statistical c omparisons between the 
biologicals.  
 
The methods to assess abdominal pain needs to be better explained: What is the meaning of an 
AP score 0 -1; pain or no pain? This simple distinction would be inadequate.  
One important outcome is missing, namely if there w as a reduction of corticosteroids by the 
biologicals. How many patients were free of corticosteroids at the defined date of remission? In 
how many patients corticosteroids were increased during the study period?  
 
ADDITIONAL REQUESTS/SUGGESTIONS:  
No 
 
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.  
 
No 
 
Are the conclusions drawn adequately supported b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
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  
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: 0 Date: 24 Feb 2020  
 
Reviewer: Research Square Reviewer 1  
 
Reviewer's report:  
 
PEER REVIEWER ASSESSMENTS:  
 
OBJECTIVE - Full research articles: i s there a clear objective that addresses a testable research 
question(s) (brief or other article 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?  
No - there are major issues  
 
EXECUTION - Are the experiments and analyses performed with technical rigor to allow 
confidence in the results?  
No - there are minor issues  
 
STATISTICS - Is the use of statistics in the manuscript appropriate?  
No - there are issues with the statistics in the study  
 
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not 
overstated?  
Yes - the author's interpre tation is reasonable  
 
OVERALL MANUSCRIPT POTENTIAL - Is the current version of this work technically 
sound? If not, can revisions be made to make the work technically sound?  
Maybe - with major revisions  
 
PEER REVIEWER COMMENTS:  
 
GENERAL COMMENTS:  
Overall  positive impression  
The patient samples are well characterized. The statistical methods to assess effectiveness are 
appropriate.  
The reports of the assessment  of adverse events did not meet current standards.  
 
 
 
 
REQUESTED REVISIONS:  
The details how advers e events were assessed, need to be better explained and the results need 
urgently reported with more details. Were subjective AE assessed by open questions or by 
structured check list ?Who assessed AE? Which lab tests were conducted to assess objective AE?  
Please make a distinction (and give criteria) for non -serious and serious AE. Please report the 
rates of hospitalisations during the study. Where there any death during the study period?  
An a priori power calculation is necessary if you make statistical c omparisons between the 
biologicals.  
 
The methods to assess abdominal pain needs to be better explained: What is the meaning of an 
AP score 0 -1; pain or no pain? This simple distinction would be inadequate.  
One important outcome is missing, namely if there w as a reduction of corticosteroids by the 
biologicals. How many patients were free of corticosteroids at the defined date of remission? In 
how many patients corticosteroids were increased during the study period?  
 
ADDITIONAL REQUESTS/SUGGESTIONS:  
No 
 
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.  
 
No 
 
Are the conclusions drawn adequately supported b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
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  
Please review this paper.
user
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: 0 Date: 24 Feb 2020  
 
Reviewer: Research Square Reviewer 1  
 
Reviewer's report:  
 
PEER REVIEWER ASSESSMENTS:  
 
OBJECTIVE - Full research articles: i s there a clear objective that addresses a testable research 
question(s) (brief or other article 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?  
No - there are major issues  
 
EXECUTION - Are the experiments and analyses performed with technical rigor to allow 
confidence in the results?  
No - there are minor issues  
 
STATISTICS - Is the use of statistics in the manuscript appropriate?  
No - there are issues with the statistics in the study  
 
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not 
overstated?  
Yes - the author's interpre tation is reasonable  
 
OVERALL MANUSCRIPT POTENTIAL - Is the current version of this work technically 
sound? If not, can revisions be made to make the work technically sound?  
Maybe - with major revisions  
 
PEER REVIEWER COMMENTS:  
 
GENERAL COMMENTS:  
Overall  positive impression  
The patient samples are well characterized. The statistical methods to assess effectiveness are 
appropriate.  
The reports of the assessment  of adverse events did not meet current standards.  
 
 
 
 
REQUESTED REVISIONS:  
The details how advers e events were assessed, need to be better explained and the results need 
urgently reported with more details. Were subjective AE assessed by open questions or by 
structured check list ?Who assessed AE? Which lab tests were conducted to assess objective AE?  
Please make a distinction (and give criteria) for non -serious and serious AE. Please report the 
rates of hospitalisations during the study. Where there any death during the study period?  
An a priori power calculation is necessary if you make statistical c omparisons between the 
biologicals.  
 
The methods to assess abdominal pain needs to be better explained: What is the meaning of an 
AP score 0 -1; pain or no pain? This simple distinction would be inadequate.  
One important outcome is missing, namely if there w as a reduction of corticosteroids by the 
biologicals. How many patients were free of corticosteroids at the defined date of remission? In 
how many patients corticosteroids were increased during the study period?  
 
ADDITIONAL REQUESTS/SUGGESTIONS:  
No 
 
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.  
 
No 
 
Are the conclusions drawn adequately supported b y the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
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  
assistant