Title: 1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right
colon: a post hoc analysis of two randomised clinical trials
Version: 0 Date: 09 Oct 2021
Reviewer's report:
To the Editor
Thank you for giving me the opportunity to review the manuscript by Manning et al. entitled:
“1L NER1006 reproducibly exceeded the strict minimum standard of 90% adequate cleansing
success in the right colon and all other segments across two randomised clinical trials”. Authors
are to be commended for putting together a concise and well-written manuscript on a very
interesting, yet underrated topic. Despite the inherent study limitations associated to the fact
that this is a post-hoc analysis, all results are extremely useful since they replicate real world
situation. Below you may find my comments:
1. The “Background” section is too long and contains many redundant information; thus, I would
suggest to remove them mainly focusing on the objectives of this study
2. Page 7, Assessments section. Please pay attention that the 90% ESGE minimum target for
adequate bowel preparation refers to the entire large bowel and not in one segment i.e. right
colon. Therefore, comparing the absolute right colon adequate-level cleansing success rate
(segmental) versus the ESGE 90% minimum target (whole) can be rather confusing. I would
like the comments of authors on this issue and would suggest to amend appropriately, especially
since this is the primary endpoint.
3. Page 7, Assessments section, lines 145-147: I query whether this post-hoc analysis was
indeed powered enough to address all these distinct issues. Moreover, providing results for
several secondary endpoints that may be also lacking significance for everyday clinical practice
(i.e. absolute adequate-level cleansing success rate in every colon segment versus the ESGE
90% minimum target for each NER1006 regimen per trial) can be extremely confusing for the
clinician reader. I would suggest to narrow down by omitting some of these and mainly focusing
on more clinically-orientated objectives.
4. Why did authors do not present the respective results regarding the Boston Bowel Preparation
Scale (BBPS) assessment since this was included in both MORA and NOCT trials?
5. Page 8, lines 154: “normal patients”. This is not appropriate nomenclature. There are
only patients with or without established risk factors to fail bowel preparation. Please revise
throughout the entire manuscript accordingly.
6. Page 8, lines 154-155: “and patients with characteristics that may contribute to both inadequate
cleansing”. Please define
7. Page 8, lines 156: “hard-to-cleanse”. Why only obese patients and no other categories were
identified among those patients?
8. Page 8, lines 161-167: These information are already available in the literature as well as
within the individual studies. I would suggest to omit them
Title: 1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right
colon: a post hoc analysis of two randomised clinical trials
Version: 0 Date: 09 Oct 2021
Reviewer's report:
To the Editor
Thank you for giving me the opportunity to review the manuscript by Manning et al. entitled:
“1L NER1006 reproducibly exceeded the strict minimum standard of 90% adequate cleansing
success in the right colon and all other segments across two randomised clinical trials”. Authors
are to be commended for putting together a concise and well-written manuscript on a very
interesting, yet underrated topic. Despite the inherent study limitations associated to the fact
that this is a post-hoc analysis, all results are extremely useful since they replicate real world
situation. Below you may find my comments:
1. The “Background” section is too long and contains many redundant information; thus, I would
suggest to remove them mainly focusing on the objectives of this study
2. Page 7, Assessments section. Please pay attention that the 90% ESGE minimum target for
adequate bowel preparation refers to the entire large bowel and not in one segment i.e. right
colon. Therefore, comparing the absolute right colon adequate-level cleansing success rate
(segmental) versus the ESGE 90% minimum target (whole) can be rather confusing. I would
like the comments of authors on this issue and would suggest to amend appropriately, especially
since this is the primary endpoint.
3. Page 7, Assessments section, lines 145-147: I query whether this post-hoc analysis was
indeed powered enough to address all these distinct issues. Moreover, providing results for
several secondary endpoints that may be also lacking significance for everyday clinical practice
(i.e. absolute adequate-level cleansing success rate in every colon segment versus the ESGE
90% minimum target for each NER1006 regimen per trial) can be extremely confusing for the
clinician reader. I would suggest to narrow down by omitting some of these and mainly focusing
on more clinically-orientated objectives.
4. Why did authors do not present the respective results regarding the Boston Bowel Preparation
Scale (BBPS) assessment since this was included in both MORA and NOCT trials?
5. Page 8, lines 154: “normal patients”. This is not appropriate nomenclature. There are
only patients with or without established risk factors to fail bowel preparation. Please revise
throughout the entire manuscript accordingly.
6. Page 8, lines 154-155: “and patients with characteristics that may contribute to both inadequate
cleansing”. Please define
7. Page 8, lines 156: “hard-to-cleanse”. Why only obese patients and no other categories were
identified among those patients?
8. Page 8, lines 161-167: These information are already available in the literature as well as
within the individual studies. I would suggest to omit them
Please review this paper.
user
Title: 1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right
colon: a post hoc analysis of two randomised clinical trials
Version: 0 Date: 09 Oct 2021
Reviewer's report:
To the Editor
Thank you for giving me the opportunity to review the manuscript by Manning et al. entitled:
“1L NER1006 reproducibly exceeded the strict minimum standard of 90% adequate cleansing
success in the right colon and all other segments across two randomised clinical trials”. Authors
are to be commended for putting together a concise and well-written manuscript on a very
interesting, yet underrated topic. Despite the inherent study limitations associated to the fact
that this is a post-hoc analysis, all results are extremely useful since they replicate real world
situation. Below you may find my comments:
1. The “Background” section is too long and contains many redundant information; thus, I would
suggest to remove them mainly focusing on the objectives of this study
2. Page 7, Assessments section. Please pay attention that the 90% ESGE minimum target for
adequate bowel preparation refers to the entire large bowel and not in one segment i.e. right
colon. Therefore, comparing the absolute right colon adequate-level cleansing success rate
(segmental) versus the ESGE 90% minimum target (whole) can be rather confusing. I would
like the comments of authors on this issue and would suggest to amend appropriately, especially
since this is the primary endpoint.
3. Page 7, Assessments section, lines 145-147: I query whether this post-hoc analysis was
indeed powered enough to address all these distinct issues. Moreover, providing results for
several secondary endpoints that may be also lacking significance for everyday clinical practice
(i.e. absolute adequate-level cleansing success rate in every colon segment versus the ESGE
90% minimum target for each NER1006 regimen per trial) can be extremely confusing for the
clinician reader. I would suggest to narrow down by omitting some of these and mainly focusing
on more clinically-orientated objectives.
4. Why did authors do not present the respective results regarding the Boston Bowel Preparation
Scale (BBPS) assessment since this was included in both MORA and NOCT trials?
5. Page 8, lines 154: “normal patients”. This is not appropriate nomenclature. There are
only patients with or without established risk factors to fail bowel preparation. Please revise
throughout the entire manuscript accordingly.
6. Page 8, lines 154-155: “and patients with characteristics that may contribute to both inadequate
cleansing”. Please define
7. Page 8, lines 156: “hard-to-cleanse”. Why only obese patients and no other categories were
identified among those patients?
8. Page 8, lines 161-167: These information are already available in the literature as well as
within the individual studies. I would suggest to omit them
assistant