Title: Incidence and predictors of elevated postpartum alanine aminotransferase in chronic
hepatitis B mothers: A prospective study protocol
Version: 4 Date: 28 May 2023
Reviewer's report:
The recent protocol aims to explore the incidence and also predictors of ALT flare during
postpartum period of CHB mothers who received proper management of CHB by antiviral
therapy as  indicated  by international recommendation  which. I totally agree  with the study
concept. However, some issues according to study design should be clarified.
According to unapproved  using  transient elastography  in many countries,  there  are 2 points
of concerns about  this  procedure.
1.  Please confirm whether it is justified to use this equipment during pregnancy in China
mainland.
2. According to alteration of volume distribution to late pregnancy and early postpartum period,
it would be some interference with the normal cut off level of LSM . Please list the reference
for those cut off for exclude significant fibrosis in pregnancy.
For the secondary endpoint  aiming to define the normal ULN of ALT in postpartum period,
I may not quite clear why  we have to explore this question. It might need some scientific
background to describe more hypotheses why the recent  recommendation of normal  ALT cut
off might not accurate during postpartum period. This hypothesis is very crucial to link in the
design of study  why researchers what to compare ALT change in  CHB mother to normal
physiological change . Otherwise, the simple  report  from only CHB pregnant population itself
might be justified as well.
The planned statistical analysis is appropriate for initial design.
The protocol is well written.
Title: Incidence and predictors of elevated postpartum alanine aminotransferase in chronic
hepatitis B mothers: A prospective study protocol
Version: 4 Date: 28 May 2023
Reviewer's report:
The recent protocol aims to explore the incidence and also predictors of ALT flare during
postpartum period of CHB mothers who received proper management of CHB by antiviral
therapy as  indicated  by international recommendation  which. I totally agree  with the study
concept. However, some issues according to study design should be clarified.
According to unapproved  using  transient elastography  in many countries,  there  are 2 points
of concerns about  this  procedure.
1.  Please confirm whether it is justified to use this equipment during pregnancy in China
mainland.
2. According to alteration of volume distribution to late pregnancy and early postpartum period,
it would be some interference with the normal cut off level of LSM . Please list the reference
for those cut off for exclude significant fibrosis in pregnancy.
For the secondary endpoint  aiming to define the normal ULN of ALT in postpartum period,
I may not quite clear why  we have to explore this question. It might need some scientific
background to describe more hypotheses why the recent  recommendation of normal  ALT cut
off might not accurate during postpartum period. This hypothesis is very crucial to link in the
design of study  why researchers what to compare ALT change in  CHB mother to normal
physiological change . Otherwise, the simple  report  from only CHB pregnant population itself
might be justified as well.
The planned statistical analysis is appropriate for initial design.
The protocol is well written.
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: 28 May 2023
Reviewer's report:
The recent protocol aims to explore the incidence and also predictors of ALT flare during
postpartum period of CHB mothers who received proper management of CHB by antiviral
therapy as  indicated  by international recommendation  which. I totally agree  with the study
concept. However, some issues according to study design should be clarified.
According to unapproved  using  transient elastography  in many countries,  there  are 2 points
of concerns about  this  procedure.
1.  Please confirm whether it is justified to use this equipment during pregnancy in China
mainland.
2. According to alteration of volume distribution to late pregnancy and early postpartum period,
it would be some interference with the normal cut off level of LSM . Please list the reference
for those cut off for exclude significant fibrosis in pregnancy.
For the secondary endpoint  aiming to define the normal ULN of ALT in postpartum period,
I may not quite clear why  we have to explore this question. It might need some scientific
background to describe more hypotheses why the recent  recommendation of normal  ALT cut
off might not accurate during postpartum period. This hypothesis is very crucial to link in the
design of study  why researchers what to compare ALT change in  CHB mother to normal
physiological change . Otherwise, the simple  report  from only CHB pregnant population itself
might be justified as well.
The planned statistical analysis is appropriate for initial design.
The protocol is well written.
assistant