Title: Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate
with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel
preparation before outpatient colonoscopy: A study protocol for the multicentre, randomised,
controlled E-PLUS trial
Version: 1 Date: 27 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?
Yes - the experiments and analyses are appropriate
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
Yes - the planned statistical methods are appropriate
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?
N/A - no results are presented
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: I read with interest the study protocol. Please see my following
comments:
Comments:
1. Please give more details on how randomization is performed, computer generated? Block
sequencing, etc.?
2. What is the blood sample being collected for? Please specify the labs.
3. What mode of anesthesia will be used? Benzo/opioids, propofol or something else? (Aziz,
M., Weissman, S., Fatima, R., Khan, Z., Mohan, B. P., Mehta, T. I., Lee-Smith, W., Hassan,
A., Sciarra, M., Nawras, A., & Adler, D. G. (2020). Impact of propofol sedation versus opioid/
benzodiazepine sedation on colonoscopy outcomes: a systematic review with meta-analysis.
Endoscopy international open, 8(6), E701–E707. https://doi.org/10.1055/a-1135-8681)
REQUESTED REVISIONS:
Please see above.
Title: Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate
with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel
preparation before outpatient colonoscopy: A study protocol for the multicentre, randomised,
controlled E-PLUS trial
Version: 1 Date: 27 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?
Yes - the experiments and analyses are appropriate
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
Yes - the planned statistical methods are appropriate
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?
N/A - no results are presented
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: I read with interest the study protocol. Please see my following
comments:
Comments:
1. Please give more details on how randomization is performed, computer generated? Block
sequencing, etc.?
2. What is the blood sample being collected for? Please specify the labs.
3. What mode of anesthesia will be used? Benzo/opioids, propofol or something else? (Aziz,
M., Weissman, S., Fatima, R., Khan, Z., Mohan, B. P., Mehta, T. I., Lee-Smith, W., Hassan,
A., Sciarra, M., Nawras, A., & Adler, D. G. (2020). Impact of propofol sedation versus opioid/
benzodiazepine sedation on colonoscopy outcomes: a systematic review with meta-analysis.
Endoscopy international open, 8(6), E701–E707. https://doi.org/10.1055/a-1135-8681)
REQUESTED REVISIONS:
Please see above.
Please review this paper.
user
Title: Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate
with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel
preparation before outpatient colonoscopy: A study protocol for the multicentre, randomised,
controlled E-PLUS trial
Version: 1 Date: 27 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?
Yes - the experiments and analyses are appropriate
STATISTICS - (For protocols with a statistical analysis plan) Are the statistical methods
appropriate?
Yes - the planned statistical methods are appropriate
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?
N/A - no results are presented
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: I read with interest the study protocol. Please see my following
comments:
Comments:
1. Please give more details on how randomization is performed, computer generated? Block
sequencing, etc.?
2. What is the blood sample being collected for? Please specify the labs.
3. What mode of anesthesia will be used? Benzo/opioids, propofol or something else? (Aziz,
M., Weissman, S., Fatima, R., Khan, Z., Mohan, B. P., Mehta, T. I., Lee-Smith, W., Hassan,
A., Sciarra, M., Nawras, A., & Adler, D. G. (2020). Impact of propofol sedation versus opioid/
benzodiazepine sedation on colonoscopy outcomes: a systematic review with meta-analysis.
Endoscopy international open, 8(6), E701–E707. https://doi.org/10.1055/a-1135-8681)
REQUESTED REVISIONS:
Please see above.
assistant