Title: Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple
regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori
infection: rationale and design of an open-label, multicenter, randomized controlled trial
Version: 2 Date: 23 Nov 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
Yes - there is a clear objective
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
N/A - no experiments or analyses
STATISTICS - Is the use of statistics in the manuscript appropriate?
Yes - appropriate statistical analyses have been used in the study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
Yes - the author's interpretation is reasonable
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Yes - current version is technically sound
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: My concerns centered on 4 issues
1. Contingency plan for missing data
2. Mention limitations in the discussion section
3. Validated questionnaires on adverse events
4. Bonafide sample size calculation
Point 1 and 3 zero down on the measures needed for the study, and the authors now give a
bit better background how they will deal with missing data and with the use of an unvalidated
questionnaire. Point 4 is a core point, the authors want to perform a non-inferiority study
with 3 arms and this , usually, requires a larger sample than currently listed. On basis of
the assumptions given, the power calculation  appears to be correct. I duly note that the
assumptions are much more lax than in their previous publication https://www.tandfonline.com/
doi/full/10.1080/19490976.2020.1754118  and that the power of the study, with 85%, is
relatively low
I appreciate the willingness by the authors to adhere to the CONSORT ‘guidelines’, but the
actual statement is missing.
REQUESTED REVISIONS:
The trial is ongoing and I would like to see it completed
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors have addressed the concerns I had
Title: Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple
regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori
infection: rationale and design of an open-label, multicenter, randomized controlled trial
Version: 2 Date: 23 Nov 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
Yes - there is a clear objective
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
N/A - no experiments or analyses
STATISTICS - Is the use of statistics in the manuscript appropriate?
Yes - appropriate statistical analyses have been used in the study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
Yes - the author's interpretation is reasonable
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Yes - current version is technically sound
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: My concerns centered on 4 issues
1. Contingency plan for missing data
2. Mention limitations in the discussion section
3. Validated questionnaires on adverse events
4. Bonafide sample size calculation
Point 1 and 3 zero down on the measures needed for the study, and the authors now give a
bit better background how they will deal with missing data and with the use of an unvalidated
questionnaire. Point 4 is a core point, the authors want to perform a non-inferiority study
with 3 arms and this , usually, requires a larger sample than currently listed. On basis of
the assumptions given, the power calculation  appears to be correct. I duly note that the
assumptions are much more lax than in their previous publication https://www.tandfonline.com/
doi/full/10.1080/19490976.2020.1754118  and that the power of the study, with 85%, is
relatively low
I appreciate the willingness by the authors to adhere to the CONSORT ‘guidelines’, but the
actual statement is missing.
REQUESTED REVISIONS:
The trial is ongoing and I would like to see it completed
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors have addressed the concerns I had
Please review this paper.
user
Title: Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple
regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori
infection: rationale and design of an open-label, multicenter, randomized controlled trial
Version: 2 Date: 23 Nov 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses one or several
testable research questions? (Brief or other article types: is there a clear objective?)
Yes - there is a clear objective
DESIGN - Is the current approach (including controls and analysis protocols) appropriate for
the objective?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with sufficient technical rigor to
allow confidence in the results?
N/A - no experiments or analyses
STATISTICS - Is the use of statistics in the manuscript appropriate?
Yes - appropriate statistical analyses have been used in the study
INTERPRETATION - Is the current interpretation/discussion of the results reasonable and not
overstated?
Yes - the author's interpretation is reasonable
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your concerns sufficiently
for you to now recommend the work as a technically sound contribution? If not, can further
revisions be made to make the work technically sound?
Yes - current version is technically sound
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: My concerns centered on 4 issues
1. Contingency plan for missing data
2. Mention limitations in the discussion section
3. Validated questionnaires on adverse events
4. Bonafide sample size calculation
Point 1 and 3 zero down on the measures needed for the study, and the authors now give a
bit better background how they will deal with missing data and with the use of an unvalidated
questionnaire. Point 4 is a core point, the authors want to perform a non-inferiority study
with 3 arms and this , usually, requires a larger sample than currently listed. On basis of
the assumptions given, the power calculation  appears to be correct. I duly note that the
assumptions are much more lax than in their previous publication https://www.tandfonline.com/
doi/full/10.1080/19490976.2020.1754118  and that the power of the study, with 85%, is
relatively low
I appreciate the willingness by the authors to adhere to the CONSORT ‘guidelines’, but the
actual statement is missing.
REQUESTED REVISIONS:
The trial is ongoing and I would like to see it completed
ADDITIONAL REQUESTS/SUGGESTIONS:
The authors have addressed the concerns I had
assistant