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:
The manuscript titled, "Multimodal intervention to improve the transition of
patients with inflammatory bowel disease from pediatric to adult care: Protocol
for a randomized controlled trial" is aimed describing a randomized clinical trial
to assess the clinical and implementation effectiveness of a multimodal
intervention focused on improving patient function, transition readiness, and
outcomes among AYA patients with IBD being cared for at pediatric centers in
Canada. The proposed intervention addresses a clinical need to prepare young
adults as their make the transition from pediatric to adult care, yet enthusiasm for
the paper is significantly dampened by the purely descriptive nature and the
absence of outcome data, feasibility, and replicability concerns. In addition, the
level of details contained within the manuscript is very dense, thus making
readability quite cumbersome. 
INTRODUCTION:
1. Page 4, Line 62-63: The authors refer to typical developmental milestones that
are important to support transition skills, without offering any additional details.
Which developmental milestones are being referred to?
2. Page 5, Line 86-88: Although a hybrid type 1 design seems to be an
appropriate framework for the study, the lower quality evidence to support
intervention in transition-aged patients needs to be summarized and described
since it provides the study rationale. 
METHODS/DESIGN:
1. Page 7, Line 118: Please briefly state the rationale for limiting enrollment to
adolescents aged 16-17.5 years. Also, when does transfer of care occur at the 4
participating sites?
2. Please specify that anticipated sample size needed to obtain sufficient power
to detect significant differences. 
3. Figure 2 is broad and generic, and should either be removed or adapted to fit
this specific study. 
4. Psychometric properties of the study measures are lacking and should be
included, including sample items. 
5. Table 1 refers to the Transition Success Scores (TSS); however, this is not
mentioned or described in the manuscript. Please do so. 
6. Consider revising Table 1 to include the timing of administration, since not all
measures will be assessed at enrollment, time of transfer, and at the end of the
study period. 
7. Page 8, Line 163: Please describe how patient activation/engagement is being
assessed. 
8. Table 2 denotes that the IBD-SES and the IBDQ-32 will be administered at
month 3…why?
9. Page 9, Line 171: The authors state that the psychosocial needs identified will
be addressed by the care team and/or in the skill-building component, but it is
unclear who such psychosocial needs will be identified. Please clarify. 
10. Page 9, Line 185: Examples of "red flags" should be provided. 
11. Page 9, Line 186: A brief description of the HEEADSSS psychosocial
interviewer technique should be included. 
12. Page 9, Lines 189-190: It is unclear how the personalized skills-building
exercises differ from the skills-building virtual activities. 
a. Relatedly, please specify what criteria is being used to determine if virtual
activities are necessary. 
13. Page 10, Line 217-219: Two of the co-authors have already developed a
standardized curriculum pertaining to behavioral skills targeted in the
multimodal intervention; however, it is unclear what this pertains to. Does this
refer to the contents of Table 4? 
a. Relatedly, this curriculum should be described further or, if published, cited. 
14. Study feasibility comes into question, given the number of visits (twice
yearly for follow-up period, 3-4 meetings in year around transfer) and the
quantity of content that is proposed. Please note if an assessment of preliminary
feasibility has been conducted and if not, address such feasibility concerns. 
15. Replicability of the study is also a great concern, for the same reasons
described above. The multimodal intervention proposed herein requires a level
of support, manpower, oversight, and resources that pediatric IBD centers are
likely not to have. This must be addressed. 
16. Page 11, Line 235-236: The authors state that year 3 will focus on active
skills reassessment and repetition of skills building activities as necessary,
without specifying how skills mastery will be determined. Please address.
17. Page 12, Lines 249-253: The description of the eLearning modules is
insufficient and should include a description of the electronic and/or web
platform that will be used. 
a. In addition, additional details regarding the iterative process of improving the
eLearning modules are necessary. For example, what criteria will be used to
determine whether feedback received should result in modifications to the
modules or not. 
18. Pages 13-15: The section titled "Evaluation of the implementation approach"
is very cumbersome as there is far too much detail. Major revision is strongly
encouraged. 
19. Page 18, Sample size calculation: The description included here is not
sufficient to establish a necessary sample size. This needs to be revised to
account for the multiple study time points and multiple outcome measures being
obtained. 
20. Supplemental Table 1 is far too dense and difficult to read. Please revise to
focus on pertinent data only. 
OTHER:
1. There is far too much detail and information contained in the manuscript,
including tables, figures, and supplementary information. This makes it a very
difficult manuscript to read, and the most pertinent aspects of the multimodal
intervention are almost impossible to parse out. Major revisions are strongly
encouraged, just in the methods alone. 
2. The paper's focus on what will happen rather than what has already occurred
and the impact on patient outcomes is one of the biggest shortcomings of this
paper and raises the question of why authors are choosing to publish a qualitative
descriptive paper, rather than, at a minimum, presenting preliminary data on
feasibility and patient outcomes. 
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,
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find the details of processing in Publons’ privacy policy
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Yes
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 declare 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?
No
Are the methods sufficiently described to allow the study to be repeated?
No
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: 
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:
The manuscript titled, "Multimodal intervention to improve the transition of
patients with inflammatory bowel disease from pediatric to adult care: Protocol
for a randomized controlled trial" is aimed describing a randomized clinical trial
to assess the clinical and implementation effectiveness of a multimodal
intervention focused on improving patient function, transition readiness, and
outcomes among AYA patients with IBD being cared for at pediatric centers in
Canada. The proposed intervention addresses a clinical need to prepare young
adults as their make the transition from pediatric to adult care, yet enthusiasm for
the paper is significantly dampened by the purely descriptive nature and the
absence of outcome data, feasibility, and replicability concerns. In addition, the
level of details contained within the manuscript is very dense, thus making
readability quite cumbersome. 
INTRODUCTION:
1. Page 4, Line 62-63: The authors refer to typical developmental milestones that
are important to support transition skills, without offering any additional details.
Which developmental milestones are being referred to?
2. Page 5, Line 86-88: Although a hybrid type 1 design seems to be an
appropriate framework for the study, the lower quality evidence to support
intervention in transition-aged patients needs to be summarized and described
since it provides the study rationale. 
METHODS/DESIGN:
1. Page 7, Line 118: Please briefly state the rationale for limiting enrollment to
adolescents aged 16-17.5 years. Also, when does transfer of care occur at the 4
participating sites?
2. Please specify that anticipated sample size needed to obtain sufficient power
to detect significant differences. 
3. Figure 2 is broad and generic, and should either be removed or adapted to fit
this specific study. 
4. Psychometric properties of the study measures are lacking and should be
included, including sample items. 
5. Table 1 refers to the Transition Success Scores (TSS); however, this is not
mentioned or described in the manuscript. Please do so. 
6. Consider revising Table 1 to include the timing of administration, since not all
measures will be assessed at enrollment, time of transfer, and at the end of the
study period. 
7. Page 8, Line 163: Please describe how patient activation/engagement is being
assessed. 
8. Table 2 denotes that the IBD-SES and the IBDQ-32 will be administered at
month 3…why?
9. Page 9, Line 171: The authors state that the psychosocial needs identified will
be addressed by the care team and/or in the skill-building component, but it is
unclear who such psychosocial needs will be identified. Please clarify. 
10. Page 9, Line 185: Examples of "red flags" should be provided. 
11. Page 9, Line 186: A brief description of the HEEADSSS psychosocial
interviewer technique should be included. 
12. Page 9, Lines 189-190: It is unclear how the personalized skills-building
exercises differ from the skills-building virtual activities. 
a. Relatedly, please specify what criteria is being used to determine if virtual
activities are necessary. 
13. Page 10, Line 217-219: Two of the co-authors have already developed a
standardized curriculum pertaining to behavioral skills targeted in the
multimodal intervention; however, it is unclear what this pertains to. Does this
refer to the contents of Table 4? 
a. Relatedly, this curriculum should be described further or, if published, cited. 
14. Study feasibility comes into question, given the number of visits (twice
yearly for follow-up period, 3-4 meetings in year around transfer) and the
quantity of content that is proposed. Please note if an assessment of preliminary
feasibility has been conducted and if not, address such feasibility concerns. 
15. Replicability of the study is also a great concern, for the same reasons
described above. The multimodal intervention proposed herein requires a level
of support, manpower, oversight, and resources that pediatric IBD centers are
likely not to have. This must be addressed. 
16. Page 11, Line 235-236: The authors state that year 3 will focus on active
skills reassessment and repetition of skills building activities as necessary,
without specifying how skills mastery will be determined. Please address.
17. Page 12, Lines 249-253: The description of the eLearning modules is
insufficient and should include a description of the electronic and/or web
platform that will be used. 
a. In addition, additional details regarding the iterative process of improving the
eLearning modules are necessary. For example, what criteria will be used to
determine whether feedback received should result in modifications to the
modules or not. 
18. Pages 13-15: The section titled "Evaluation of the implementation approach"
is very cumbersome as there is far too much detail. Major revision is strongly
encouraged. 
19. Page 18, Sample size calculation: The description included here is not
sufficient to establish a necessary sample size. This needs to be revised to
account for the multiple study time points and multiple outcome measures being
obtained. 
20. Supplemental Table 1 is far too dense and difficult to read. Please revise to
focus on pertinent data only. 
OTHER:
1. There is far too much detail and information contained in the manuscript,
including tables, figures, and supplementary information. This makes it a very
difficult manuscript to read, and the most pertinent aspects of the multimodal
intervention are almost impossible to parse out. Major revisions are strongly
encouraged, just in the methods alone. 
2. The paper's focus on what will happen rather than what has already occurred
and the impact on patient outcomes is one of the biggest shortcomings of this
paper and raises the question of why authors are choosing to publish a qualitative
descriptive paper, rather than, at a minimum, presenting preliminary data on
feasibility and patient outcomes. 
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
Yes
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 declare 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?
No
Are the methods sufficiently described to allow the study to be repeated?
No
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: 
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:
The manuscript titled, "Multimodal intervention to improve the transition of
patients with inflammatory bowel disease from pediatric to adult care: Protocol
for a randomized controlled trial" is aimed describing a randomized clinical trial
to assess the clinical and implementation effectiveness of a multimodal
intervention focused on improving patient function, transition readiness, and
outcomes among AYA patients with IBD being cared for at pediatric centers in
Canada. The proposed intervention addresses a clinical need to prepare young
adults as their make the transition from pediatric to adult care, yet enthusiasm for
the paper is significantly dampened by the purely descriptive nature and the
absence of outcome data, feasibility, and replicability concerns. In addition, the
level of details contained within the manuscript is very dense, thus making
readability quite cumbersome. 
INTRODUCTION:
1. Page 4, Line 62-63: The authors refer to typical developmental milestones that
are important to support transition skills, without offering any additional details.
Which developmental milestones are being referred to?
2. Page 5, Line 86-88: Although a hybrid type 1 design seems to be an
appropriate framework for the study, the lower quality evidence to support
intervention in transition-aged patients needs to be summarized and described
since it provides the study rationale. 
METHODS/DESIGN:
1. Page 7, Line 118: Please briefly state the rationale for limiting enrollment to
adolescents aged 16-17.5 years. Also, when does transfer of care occur at the 4
participating sites?
2. Please specify that anticipated sample size needed to obtain sufficient power
to detect significant differences. 
3. Figure 2 is broad and generic, and should either be removed or adapted to fit
this specific study. 
4. Psychometric properties of the study measures are lacking and should be
included, including sample items. 
5. Table 1 refers to the Transition Success Scores (TSS); however, this is not
mentioned or described in the manuscript. Please do so. 
6. Consider revising Table 1 to include the timing of administration, since not all
measures will be assessed at enrollment, time of transfer, and at the end of the
study period. 
7. Page 8, Line 163: Please describe how patient activation/engagement is being
assessed. 
8. Table 2 denotes that the IBD-SES and the IBDQ-32 will be administered at
month 3…why?
9. Page 9, Line 171: The authors state that the psychosocial needs identified will
be addressed by the care team and/or in the skill-building component, but it is
unclear who such psychosocial needs will be identified. Please clarify. 
10. Page 9, Line 185: Examples of "red flags" should be provided. 
11. Page 9, Line 186: A brief description of the HEEADSSS psychosocial
interviewer technique should be included. 
12. Page 9, Lines 189-190: It is unclear how the personalized skills-building
exercises differ from the skills-building virtual activities. 
a. Relatedly, please specify what criteria is being used to determine if virtual
activities are necessary. 
13. Page 10, Line 217-219: Two of the co-authors have already developed a
standardized curriculum pertaining to behavioral skills targeted in the
multimodal intervention; however, it is unclear what this pertains to. Does this
refer to the contents of Table 4? 
a. Relatedly, this curriculum should be described further or, if published, cited. 
14. Study feasibility comes into question, given the number of visits (twice
yearly for follow-up period, 3-4 meetings in year around transfer) and the
quantity of content that is proposed. Please note if an assessment of preliminary
feasibility has been conducted and if not, address such feasibility concerns. 
15. Replicability of the study is also a great concern, for the same reasons
described above. The multimodal intervention proposed herein requires a level
of support, manpower, oversight, and resources that pediatric IBD centers are
likely not to have. This must be addressed. 
16. Page 11, Line 235-236: The authors state that year 3 will focus on active
skills reassessment and repetition of skills building activities as necessary,
without specifying how skills mastery will be determined. Please address.
17. Page 12, Lines 249-253: The description of the eLearning modules is
insufficient and should include a description of the electronic and/or web
platform that will be used. 
a. In addition, additional details regarding the iterative process of improving the
eLearning modules are necessary. For example, what criteria will be used to
determine whether feedback received should result in modifications to the
modules or not. 
18. Pages 13-15: The section titled "Evaluation of the implementation approach"
is very cumbersome as there is far too much detail. Major revision is strongly
encouraged. 
19. Page 18, Sample size calculation: The description included here is not
sufficient to establish a necessary sample size. This needs to be revised to
account for the multiple study time points and multiple outcome measures being
obtained. 
20. Supplemental Table 1 is far too dense and difficult to read. Please revise to
focus on pertinent data only. 
OTHER:
1. There is far too much detail and information contained in the manuscript,
including tables, figures, and supplementary information. This makes it a very
difficult manuscript to read, and the most pertinent aspects of the multimodal
intervention are almost impossible to parse out. Major revisions are strongly
encouraged, just in the methods alone. 
2. The paper's focus on what will happen rather than what has already occurred
and the impact on patient outcomes is one of the biggest shortcomings of this
paper and raises the question of why authors are choosing to publish a qualitative
descriptive paper, rather than, at a minimum, presenting preliminary data on
feasibility and patient outcomes. 
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
Yes
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 declare 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?
No
Are the methods sufficiently described to allow the study to be repeated?
No
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