Title: Efficacy of endoscopic submucosal resection with a ligation device for small rectal
neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial
(BANDIT trial)
Version: 1 Date: 18 Dec 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
Yes - there is a clear objective
STUDY DESIGN - Is the chosen study design appropriate for the research question and does
the methodology align well with the established recommendations for the chosen study design?
Yes - the design is appropriate and the methodology aligns well with the recommendations
METHODOLOGY - Does the document provide sufficient explanation of the methods such that
the planned analyses would appear to have the technical rigor needed to allow confidence in the
results being obtained?
No - there are minor issues
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
No - there are issues with the statistical approach described in the protocol
SUPPORTING RESULTS - (For reports that present preliminary results) Do the presented
results clearly relate to the study objective and support the need for the study?
No – there are minor issues
ETHICAL STATEMENTS AND APPROVALS - For protocols involving humans, animals or
both, has adherence to all relevant ethical guidelines and ethical treatment of subjects been
addressed in the description of the study design?
Yes - these items are addressed appropriately
OVERALL MANUSCRIPT POTENTIAL - Are the study design and methodological approach
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: This is a study protocol for a prospective randomized study. The
protocol has been well written, and scientifically sound.
Some areas have been written in the past tense, and will need to be revised.
REQUESTED REVISIONS:
L320 Sample size calculation - Why is the R0 rate of EMR used in the calculation? Results of
ESMR-L is already available.
L338 - Analysis - "The main analysis was conducted using" - need to be written in past tense
Title: Efficacy of endoscopic submucosal resection with a ligation device for small rectal
neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial
(BANDIT trial)
Version: 1 Date: 18 Dec 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
Yes - there is a clear objective
STUDY DESIGN - Is the chosen study design appropriate for the research question and does
the methodology align well with the established recommendations for the chosen study design?
Yes - the design is appropriate and the methodology aligns well with the recommendations
METHODOLOGY - Does the document provide sufficient explanation of the methods such that
the planned analyses would appear to have the technical rigor needed to allow confidence in the
results being obtained?
No - there are minor issues
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
No - there are issues with the statistical approach described in the protocol
SUPPORTING RESULTS - (For reports that present preliminary results) Do the presented
results clearly relate to the study objective and support the need for the study?
No – there are minor issues
ETHICAL STATEMENTS AND APPROVALS - For protocols involving humans, animals or
both, has adherence to all relevant ethical guidelines and ethical treatment of subjects been
addressed in the description of the study design?
Yes - these items are addressed appropriately
OVERALL MANUSCRIPT POTENTIAL - Are the study design and methodological approach
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: This is a study protocol for a prospective randomized study. The
protocol has been well written, and scientifically sound.
Some areas have been written in the past tense, and will need to be revised.
REQUESTED REVISIONS:
L320 Sample size calculation - Why is the R0 rate of EMR used in the calculation? Results of
ESMR-L is already available.
L338 - Analysis - "The main analysis was conducted using" - need to be written in past tense
Please review this paper.
user
Title: Efficacy of endoscopic submucosal resection with a ligation device for small rectal
neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial
(BANDIT trial)
Version: 1 Date: 18 Dec 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
Yes - there is a clear objective
STUDY DESIGN - Is the chosen study design appropriate for the research question and does
the methodology align well with the established recommendations for the chosen study design?
Yes - the design is appropriate and the methodology aligns well with the recommendations
METHODOLOGY - Does the document provide sufficient explanation of the methods such that
the planned analyses would appear to have the technical rigor needed to allow confidence in the
results being obtained?
No - there are minor issues
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
No - there are issues with the statistical approach described in the protocol
SUPPORTING RESULTS - (For reports that present preliminary results) Do the presented
results clearly relate to the study objective and support the need for the study?
No – there are minor issues
ETHICAL STATEMENTS AND APPROVALS - For protocols involving humans, animals or
both, has adherence to all relevant ethical guidelines and ethical treatment of subjects been
addressed in the description of the study design?
Yes - these items are addressed appropriately
OVERALL MANUSCRIPT POTENTIAL - Are the study design and methodological approach
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: This is a study protocol for a prospective randomized study. The
protocol has been well written, and scientifically sound.
Some areas have been written in the past tense, and will need to be revised.
REQUESTED REVISIONS:
L320 Sample size calculation - Why is the R0 rate of EMR used in the calculation? Results of
ESMR-L is already available.
L338 - Analysis - "The main analysis was conducted using" - need to be written in past tense
assistant