Title: Incidence and predictors of elevated postpartum alanine aminotransferase in chronic
hepatitis B mothers: A prospective study protocol
Version: 4 Date: 26 Jun 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
No - there are minor issues
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?
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?
No - manuscript has some fundamental flaws
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: - This article is a proposal for prospective study to investigate the
incidence and predictors of elevated postpartum alanine aminotransferase in chronic hepatitis
B mothers.
While the study proposal seems of clinical interest, I don't generally find study proposal suitable
for publications except for certain large randomized clinical trials.
The authors have clearly outlined the need for this study by reviewing the literature and finding
the gaps that need to be answered
- The authors did well by providing the necessary
info for the prospective study with great details and calculated the sample size.
- the presentation of the protocol could be more effective by clearly stating the study
OBJECTIVE in the abstract section and stating the predictors of elevated ALT the authors will
be looking for.
REQUESTED REVISIONS:
- First, as I mentioned earlier I don't recommend publications of study proposal for this type
of studies
- The authors need to mention in the title that this article is a study proposal
- There its no clear objectives mentioned in the abstract background section
- Avoid using abbreviations in the abstract without appropriate definition (MTCT)
- In the abstract methods, consider replacing primary and secondary assessments into objectives
- Abstract discussion is just repetition for what was mentioned in the methods
- Consider using the future tense for the methods section (This study is a single-center cohort
study that enrolled mothers with chronic hepatitis), in previous statement, past tense "enrolled"
was used
Title: Incidence and predictors of elevated postpartum alanine aminotransferase in chronic
hepatitis B mothers: A prospective study protocol
Version: 4 Date: 26 Jun 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
No - there are minor issues
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?
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?
No - manuscript has some fundamental flaws
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: - This article is a proposal for prospective study to investigate the
incidence and predictors of elevated postpartum alanine aminotransferase in chronic hepatitis
B mothers.
While the study proposal seems of clinical interest, I don't generally find study proposal suitable
for publications except for certain large randomized clinical trials.
The authors have clearly outlined the need for this study by reviewing the literature and finding
the gaps that need to be answered
- The authors did well by providing the necessary
info for the prospective study with great details and calculated the sample size.
- the presentation of the protocol could be more effective by clearly stating the study
OBJECTIVE in the abstract section and stating the predictors of elevated ALT the authors will
be looking for.
REQUESTED REVISIONS:
- First, as I mentioned earlier I don't recommend publications of study proposal for this type
of studies
- The authors need to mention in the title that this article is a study proposal
- There its no clear objectives mentioned in the abstract background section
- Avoid using abbreviations in the abstract without appropriate definition (MTCT)
- In the abstract methods, consider replacing primary and secondary assessments into objectives
- Abstract discussion is just repetition for what was mentioned in the methods
- Consider using the future tense for the methods section (This study is a single-center cohort
study that enrolled mothers with chronic hepatitis), in previous statement, past tense "enrolled"
was used
Please review this paper.
user
Title: Incidence and predictors of elevated postpartum alanine aminotransferase in chronic
hepatitis B mothers: A prospective study protocol
Version: 4 Date: 26 Jun 2023
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Is there a clear objective that addresses a testable research question(s)?
No - there are minor issues
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?
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?
No - manuscript has some fundamental flaws
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: - This article is a proposal for prospective study to investigate the
incidence and predictors of elevated postpartum alanine aminotransferase in chronic hepatitis
B mothers.
While the study proposal seems of clinical interest, I don't generally find study proposal suitable
for publications except for certain large randomized clinical trials.
The authors have clearly outlined the need for this study by reviewing the literature and finding
the gaps that need to be answered
- The authors did well by providing the necessary
info for the prospective study with great details and calculated the sample size.
- the presentation of the protocol could be more effective by clearly stating the study
OBJECTIVE in the abstract section and stating the predictors of elevated ALT the authors will
be looking for.
REQUESTED REVISIONS:
- First, as I mentioned earlier I don't recommend publications of study proposal for this type
of studies
- The authors need to mention in the title that this article is a study proposal
- There its no clear objectives mentioned in the abstract background section
- Avoid using abbreviations in the abstract without appropriate definition (MTCT)
- In the abstract methods, consider replacing primary and secondary assessments into objectives
- Abstract discussion is just repetition for what was mentioned in the methods
- Consider using the future tense for the methods section (This study is a single-center cohort
study that enrolled mothers with chronic hepatitis), in previous statement, past tense "enrolled"
was used
assistant