Review for 10.1186/s12876-022-02307-9 (2022)

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. 
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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