Reviewer’s report
Title: 
Multimodal Intervention to Improve the Transition of Patients with
Inflammatory Bowel Disease from Pediatric to Adult Care: Protocol for a
randomized controlled trial
Version: 
0 
Date: 
22 Feb 2022
Reviewer's report:
A well written manuscript on a much-needed topic and plans for a RCT on
pediatric to adult transition in patients with IBD.
I have a few queries:
1. In one of the supplemental materials you have the Spirit checklist, yet you
don't refer to this in the manuscript. 
Is there a reason why you don't include this?
2. Inclusion criteria: you choose to enroll adolescents ages 16-17.5. 
This seems
quite a narrow range. 
For example, why not to age 18? It seems the transition to
adult care would be more than 6 months after enrollment, correct? 
And why not
age 15-17.5? Seems like a sentence of justification would support your choice.
3. 
Are all the assessments and questionnaires delivered through Red Cap? Please
clarify.
4. Is the structured transition to an adult provider presumed to occur at a certain
time in the study or time related to age? Please clarify.
5. The control group, you have 5 processes to implement. 
Are these all standard
of care? Please clarify.
6. In stage 1, implementation planning, is the worksheet generated by the
implementation game, reviewed by the research team? Please clarify
7. Under primary outcome- if the primary outcome is the score on the IBD-DI, is
the goal to see a decrease in the score? Any specific decrease, like 10%? Please
clarify.
8. under secondary clinical outcomes, you are looking at remission rates. 
How
are you assessing remission rates? And are you comparing them to controls? You
mention Table 1, but that table does not have remission rates, rather it has
disease activity measures. 
Can you clarify this?
9. Under secondary clinical outcomes, for health services utilization and costs,
again you mention "maintaining good health" but your measures seem to be
hospitalization rates, etc. 
Can you clarify this?
10. In the discussion section, I would have liked to see some reference back to
the literature, of which there is none. 
Please comment on how your results will fit
with or enhance, existing literature on the topic.
11. 
In the discussion section, page 20, line 462, consider deleting the "thus" in
the sentence.
12. 
Under l/imitations, you correctly identify that attrition may be an issue.
However, it is not clear what you mean by "the transition navigators will be
aware of the concern and use more provider-initiated interactions to sustain
adherence and engagement" What might these be? Please clarify/explain.
13. 
Since this is a protocol for an upcoming intervention, what is it that you want
the reader to take home from reading this manuscript, if published? 
Publons Reviewer Recognition
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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.
I have no competing interests
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?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Reviewer’s report
Title: 
Multimodal Intervention to Improve the Transition of Patients with
Inflammatory Bowel Disease from Pediatric to Adult Care: Protocol for a
randomized controlled trial
Version: 
0 
Date: 
22 Feb 2022
Reviewer's report:
A well written manuscript on a much-needed topic and plans for a RCT on
pediatric to adult transition in patients with IBD.
I have a few queries:
1. In one of the supplemental materials you have the Spirit checklist, yet you
don't refer to this in the manuscript. 
Is there a reason why you don't include this?
2. Inclusion criteria: you choose to enroll adolescents ages 16-17.5. 
This seems
quite a narrow range. 
For example, why not to age 18? It seems the transition to
adult care would be more than 6 months after enrollment, correct? 
And why not
age 15-17.5? Seems like a sentence of justification would support your choice.
3. 
Are all the assessments and questionnaires delivered through Red Cap? Please
clarify.
4. Is the structured transition to an adult provider presumed to occur at a certain
time in the study or time related to age? Please clarify.
5. The control group, you have 5 processes to implement. 
Are these all standard
of care? Please clarify.
6. In stage 1, implementation planning, is the worksheet generated by the
implementation game, reviewed by the research team? Please clarify
7. Under primary outcome- if the primary outcome is the score on the IBD-DI, is
the goal to see a decrease in the score? Any specific decrease, like 10%? Please
clarify.
8. under secondary clinical outcomes, you are looking at remission rates. 
How
are you assessing remission rates? And are you comparing them to controls? You
mention Table 1, but that table does not have remission rates, rather it has
disease activity measures. 
Can you clarify this?
9. Under secondary clinical outcomes, for health services utilization and costs,
again you mention "maintaining good health" but your measures seem to be
hospitalization rates, etc. 
Can you clarify this?
10. In the discussion section, I would have liked to see some reference back to
the literature, of which there is none. 
Please comment on how your results will fit
with or enhance, existing literature on the topic.
11. 
In the discussion section, page 20, line 462, consider deleting the "thus" in
the sentence.
12. 
Under l/imitations, you correctly identify that attrition may be an issue.
However, it is not clear what you mean by "the transition navigators will be
aware of the concern and use more provider-initiated interactions to sustain
adherence and engagement" What might these be? Please clarify/explain.
13. 
Since this is a protocol for an upcoming intervention, what is it that you want
the reader to take home from reading this manuscript, if published? 
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.
I have no competing interests
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?
Yes
Is the presentation of the work clear?
Yes
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: 
Multimodal Intervention to Improve the Transition of Patients with
Inflammatory Bowel Disease from Pediatric to Adult Care: Protocol for a
randomized controlled trial
Version: 
0 
Date: 
22 Feb 2022
Reviewer's report:
A well written manuscript on a much-needed topic and plans for a RCT on
pediatric to adult transition in patients with IBD.
I have a few queries:
1. In one of the supplemental materials you have the Spirit checklist, yet you
don't refer to this in the manuscript. 
Is there a reason why you don't include this?
2. Inclusion criteria: you choose to enroll adolescents ages 16-17.5. 
This seems
quite a narrow range. 
For example, why not to age 18? It seems the transition to
adult care would be more than 6 months after enrollment, correct? 
And why not
age 15-17.5? Seems like a sentence of justification would support your choice.
3. 
Are all the assessments and questionnaires delivered through Red Cap? Please
clarify.
4. Is the structured transition to an adult provider presumed to occur at a certain
time in the study or time related to age? Please clarify.
5. The control group, you have 5 processes to implement. 
Are these all standard
of care? Please clarify.
6. In stage 1, implementation planning, is the worksheet generated by the
implementation game, reviewed by the research team? Please clarify
7. Under primary outcome- if the primary outcome is the score on the IBD-DI, is
the goal to see a decrease in the score? Any specific decrease, like 10%? Please
clarify.
8. under secondary clinical outcomes, you are looking at remission rates. 
How
are you assessing remission rates? And are you comparing them to controls? You
mention Table 1, but that table does not have remission rates, rather it has
disease activity measures. 
Can you clarify this?
9. Under secondary clinical outcomes, for health services utilization and costs,
again you mention "maintaining good health" but your measures seem to be
hospitalization rates, etc. 
Can you clarify this?
10. In the discussion section, I would have liked to see some reference back to
the literature, of which there is none. 
Please comment on how your results will fit
with or enhance, existing literature on the topic.
11. 
In the discussion section, page 20, line 462, consider deleting the "thus" in
the sentence.
12. 
Under l/imitations, you correctly identify that attrition may be an issue.
However, it is not clear what you mean by "the transition navigators will be
aware of the concern and use more provider-initiated interactions to sustain
adherence and engagement" What might these be? Please clarify/explain.
13. 
Since this is a protocol for an upcoming intervention, what is it that you want
the reader to take home from reading this manuscript, if published? 
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.
I have no competing interests
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?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
assistant