Reviewer’s report
Title: 
Direct oral anticoagulants increase bleeding risk after endoscopic
sphincterotomy: A retrospective study
Version: 
1 
Date: 
11 Aug 2021
Reviewer's report:
PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is 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?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with 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?
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 interpretation 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?
Yes - current version is technically sound
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: 
Overall Impression: 
This is an excellent article that supplies very strong evidence that with
appropriate use of the JGES guidelines, although the rate of hemorrhage after
EST is greater, the overall rate of complications and severe hemorrhage is not.
There is an excellent discussion of the duration of cessation of the DOAC that
should serve as a guideline for interventional endoscopists.
What have the authors done well: 
The groups are well analyzed and the important variables are evaluated well
done.
In what ways does it not meet best practice: 
Excellent study.
REQUESTED REVISIONS: 
Are there additional revisions the authors should make-consider: 
1. line 25. I would change the word "is" to " can be"
2. line 38. round off the percentages--the n is only 42.
3. line 39, if you mean statistically higher, say so but also add the p. Value. If the
p value is >0.05, you cannot use the word "significantly". Also in the following
sentence, you need the p values and the word "statistically" needs to be added to
line 44 as well.
4. Line 54. add the word "potential" after the word "a" instead of "an" 
5. Line 56. again, was the incidence "statistically higher" in ref 8? The word
"significantly" in scientific publications should be reserved for statistical
analysis; too many writers use it to emphasize potential differences when no stats
are done. 
6. Line 118, is the word " cholangitis " the correct word? What relevance is a
platelet count <100,000 for patient with cholangitis? Do you mean
thrombophylia instead?
7. Line 138 and throughout the text, when referring only to the DOAC group, all
percentages need to be rounded off (see #2 above). I will not mention this again.
8. Lines 155 -157. again? Statistically? Because in the methods section, you say
that p<0.05 is statistically significant, you do need to add the p value more. BUT,
I would suggest that in some places 
you would benefit 
by adding the p Value,
especially for the bleeding where the p value was 0.004 (not 0.00405; that p
value has far too many significant figures!). While this p Value is much less than
0.05, it is not "more" statistically significant but obviously has a lesser chance of
being 
wrong, so 
I would 
add thi. 
9. Line 165. What do you mean by "induced"?
10. Lines 196-199. limit the number of significant figures in the p Value--
P=0.000186 is just not appropriate scientifically 0.009 is much more acceptable.
11. Line 180-281. do you really believe that such a study is warranted? Maybe a
better statement would be "may be warranted" and end the sentence with
something like "although these and other data are quite convincing, questioning
the need for a true randomized study". Yes, this is my opinion, but I would bet it
is yours and most all interventional endoscopists as well- not all studies like
yours REQUIRE an RCT 
YOUR CALL--my comment is only a suggestion.
12. Table 1 as well as other tables, p values cannot be 1 unless the numbers are
exactly the same. I would change all the "1s" to 0.99. Also, look at the p Value
for "total"--please change it as well as several others in the tables.
13. Table 4. how many values did you compare with 42 patients in the DOAC
group--you are limited on the number of variables to submit to a MVA. Better be
more precise.
Publons Reviewer Recognition
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for the benefit of Publons and you as a reviewer, carefully considering the
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find the details of processing in Publons’ privacy policy
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No
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 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.
This reviewer has been recruited by a partner organization, Research Square.
Reviewers with declared or apparent competing interests are not utilized for
these reviews. This reviewer has agreed to publication of their comments online
under a Creative Commons Attribution License attributed to Research Square
and was paid a small honorarium for completing the review within a specified
timeframe. Honoraria for reviews such as this are paid regardless of the reviewer
recommendation.
Reviewer Publication Consent.
 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
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Reviewer’s report
Title: 
Direct oral anticoagulants increase bleeding risk after endoscopic
sphincterotomy: A retrospective study
Version: 
1 
Date: 
11 Aug 2021
Reviewer's report:
PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is 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?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with 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?
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 interpretation 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?
Yes - current version is technically sound
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: 
Overall Impression: 
This is an excellent article that supplies very strong evidence that with
appropriate use of the JGES guidelines, although the rate of hemorrhage after
EST is greater, the overall rate of complications and severe hemorrhage is not.
There is an excellent discussion of the duration of cessation of the DOAC that
should serve as a guideline for interventional endoscopists.
What have the authors done well: 
The groups are well analyzed and the important variables are evaluated well
done.
In what ways does it not meet best practice: 
Excellent study.
REQUESTED REVISIONS: 
Are there additional revisions the authors should make-consider: 
1. line 25. I would change the word "is" to " can be"
2. line 38. round off the percentages--the n is only 42.
3. line 39, if you mean statistically higher, say so but also add the p. Value. If the
p value is >0.05, you cannot use the word "significantly". Also in the following
sentence, you need the p values and the word "statistically" needs to be added to
line 44 as well.
4. Line 54. add the word "potential" after the word "a" instead of "an" 
5. Line 56. again, was the incidence "statistically higher" in ref 8? The word
"significantly" in scientific publications should be reserved for statistical
analysis; too many writers use it to emphasize potential differences when no stats
are done. 
6. Line 118, is the word " cholangitis " the correct word? What relevance is a
platelet count <100,000 for patient with cholangitis? Do you mean
thrombophylia instead?
7. Line 138 and throughout the text, when referring only to the DOAC group, all
percentages need to be rounded off (see #2 above). I will not mention this again.
8. Lines 155 -157. again? Statistically? Because in the methods section, you say
that p<0.05 is statistically significant, you do need to add the p value more. BUT,
I would suggest that in some places 
you would benefit 
by adding the p Value,
especially for the bleeding where the p value was 0.004 (not 0.00405; that p
value has far too many significant figures!). While this p Value is much less than
0.05, it is not "more" statistically significant but obviously has a lesser chance of
being 
wrong, so 
I would 
add thi. 
9. Line 165. What do you mean by "induced"?
10. Lines 196-199. limit the number of significant figures in the p Value--
P=0.000186 is just not appropriate scientifically 0.009 is much more acceptable.
11. Line 180-281. do you really believe that such a study is warranted? Maybe a
better statement would be "may be warranted" and end the sentence with
something like "although these and other data are quite convincing, questioning
the need for a true randomized study". Yes, this is my opinion, but I would bet it
is yours and most all interventional endoscopists as well- not all studies like
yours REQUIRE an RCT 
YOUR CALL--my comment is only a suggestion.
12. Table 1 as well as other tables, p values cannot be 1 unless the numbers are
exactly the same. I would change all the "1s" to 0.99. Also, look at the p Value
for "total"--please change it as well as several others in the tables.
13. Table 4. how many values did you compare with 42 patients in the DOAC
group--you are limited on the number of variables to submit to a MVA. Better be
more precise.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
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 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.
This reviewer has been recruited by a partner organization, Research Square.
Reviewers with declared or apparent competing interests are not utilized for
these reviews. This reviewer has agreed to publication of their comments online
under a Creative Commons Attribution License attributed to Research Square
and was paid a small honorarium for completing the review within a specified
timeframe. Honoraria for reviews such as this are paid regardless of the reviewer
recommendation.
Reviewer Publication Consent.
 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
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Please review this paper.
user
Reviewer’s report
Title: 
Direct oral anticoagulants increase bleeding risk after endoscopic
sphincterotomy: A retrospective study
Version: 
1 
Date: 
11 Aug 2021
Reviewer's report:
PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is 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?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with 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?
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 interpretation 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?
Yes - current version is technically sound
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: 
Overall Impression: 
This is an excellent article that supplies very strong evidence that with
appropriate use of the JGES guidelines, although the rate of hemorrhage after
EST is greater, the overall rate of complications and severe hemorrhage is not.
There is an excellent discussion of the duration of cessation of the DOAC that
should serve as a guideline for interventional endoscopists.
What have the authors done well: 
The groups are well analyzed and the important variables are evaluated well
done.
In what ways does it not meet best practice: 
Excellent study.
REQUESTED REVISIONS: 
Are there additional revisions the authors should make-consider: 
1. line 25. I would change the word "is" to " can be"
2. line 38. round off the percentages--the n is only 42.
3. line 39, if you mean statistically higher, say so but also add the p. Value. If the
p value is >0.05, you cannot use the word "significantly". Also in the following
sentence, you need the p values and the word "statistically" needs to be added to
line 44 as well.
4. Line 54. add the word "potential" after the word "a" instead of "an" 
5. Line 56. again, was the incidence "statistically higher" in ref 8? The word
"significantly" in scientific publications should be reserved for statistical
analysis; too many writers use it to emphasize potential differences when no stats
are done. 
6. Line 118, is the word " cholangitis " the correct word? What relevance is a
platelet count <100,000 for patient with cholangitis? Do you mean
thrombophylia instead?
7. Line 138 and throughout the text, when referring only to the DOAC group, all
percentages need to be rounded off (see #2 above). I will not mention this again.
8. Lines 155 -157. again? Statistically? Because in the methods section, you say
that p<0.05 is statistically significant, you do need to add the p value more. BUT,
I would suggest that in some places 
you would benefit 
by adding the p Value,
especially for the bleeding where the p value was 0.004 (not 0.00405; that p
value has far too many significant figures!). While this p Value is much less than
0.05, it is not "more" statistically significant but obviously has a lesser chance of
being 
wrong, so 
I would 
add thi. 
9. Line 165. What do you mean by "induced"?
10. Lines 196-199. limit the number of significant figures in the p Value--
P=0.000186 is just not appropriate scientifically 0.009 is much more acceptable.
11. Line 180-281. do you really believe that such a study is warranted? Maybe a
better statement would be "may be warranted" and end the sentence with
something like "although these and other data are quite convincing, questioning
the need for a true randomized study". Yes, this is my opinion, but I would bet it
is yours and most all interventional endoscopists as well- not all studies like
yours REQUIRE an RCT 
YOUR CALL--my comment is only a suggestion.
12. Table 1 as well as other tables, p values cannot be 1 unless the numbers are
exactly the same. I would change all the "1s" to 0.99. Also, look at the p Value
for "total"--please change it as well as several others in the tables.
13. Table 4. how many values did you compare with 42 patients in the DOAC
group--you are limited on the number of variables to submit to a MVA. Better be
more precise.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
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 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.
This reviewer has been recruited by a partner organization, Research Square.
Reviewers with declared or apparent competing interests are not utilized for
these reviews. This reviewer has agreed to publication of their comments online
under a Creative Commons Attribution License attributed to Research Square
and was paid a small honorarium for completing the review within a specified
timeframe. Honoraria for reviews such as this are paid regardless of the reviewer
recommendation.
Reviewer Publication Consent.
 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
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
assistant