Title: Good performance of monoclonal antibody-based stool H. pylori antigen tests in acute
nonvariceal upper gastrointestinal bleeding patients
Version: 4 Date: 06 Mar 2025
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses a testable research
question(s) (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?
Not sure - key details are missing from the manuscript
EXECUTION - Are the experiments and analyses performed with technical rigor to allow
confidence in the results?
No - there are minor issues
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 - Is the current version of this work technically
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: In this study, Song et al. evaluated the diagnostic performance of
monoclonal antibody-based SAT for HP infection among patients presenting with acute non-
variceal upper GI bleeding using fecal nested PCR combined with Sanger sequencing as the
gold standard. They observed that monoclonal antibody-based SAT had good sensitivity (83%)
and specificity (86%) for detecting HP infection. Overall, the manuscript is well-written and
the study is well-conducted. However, my main question is regarding the study's sampling
methodology: how did the authors arrive at the sample of 82 patients included in the study?
This needs to be clarified before a definite evaluation can be made regarding the validity of the
study's sampling methodology. I also have some additional questions regarding other aspects
of the study methodology as well as some suggestions for further improvement (which I have
detailed later).
REQUESTED REVISIONS:
MAJOR COMMENTS:
1) The authors included only 82 patients from a single hospital over a period of 20 months in
this study. How was this sample of 82 patients collected? Was this a consecutive sample? If yes,
please clarify how many patients were excluded based on the various exclusion criteria (recent
treatment with antibiotics or PPI, inability to provide stool sample, etc). Also, please clarify if
the sample selection was based on the availability of test results for HP -- this is an important
consideration to assess the risk of selection bias.
2) The authors mention under section 2.1 of Methods that "patients who did not produce
sufficient stools samples for PCR testing were excluded". Please clarify how many patients were
excluded for this reason? Also mention how long of a time period was allowed for the patients
to give stool sample before they were deemed to be excluded.
3) I did not see any mention of clinical outcomes (in-hospital mortality). Were any patients
excluded from this analysis because they died prior to providing a stool sample?
4) Did the authors only include patients presenting to the emergency department with acute non-
variceal upper GI bleeding? If patients were hospitalized for other reasons and developed upper
GI bleeding while in the hospital, were they eligible for inclusion in the study?
5) Did the authors consider performing a priori sample size calculation? If yes, please mention
the details. If not, what was the reason for not calculating sample size beforehand?
6) There is no mention of the time interval between patient's presentation to the hospital and stool
& serum testing for HP. Please mention how soon the serum and stool samples were collected?
7) While the results of multivariate logistic regression analysis were not statistically significant,
it is important to report some measures of model stability. In this regard, I would encourage the
authors to perform bootstrapping and report bootstrap confidence intervals to better assess the
stability of the regression model. Please refer to doi.org/10.1002/bimj.201700067 for details.
MINOR COMMENTS:
1) In the multivariate logistic regression, only 75 patients were included. What is the reason for
this? If this is due to missing data, kindly clarify which data were missing.
2) Did any of the included patients have end-colostomy or end-ileostomy? For such patients,
were "stool" samples collected from the stoma bag?
3) In the study, 35.4% of included patients received antibiotic therapy, which is a fairly high
proportion for patients with acute non-variceal upper GI bleeding. What were the indications
for antibiotic therapy in these cases? Please clarify.
4) The term "Dieulafoy ulcer" is somewhat inaccurate and should be replaced with "Dieulafoy
lesion" throughout the manuscript. Dieulafoy lesion is a pinpoint vascular ectasia that can lead
to brisk GI bleeding.
5) In the heading for Table 4, replace "fetal" with "fecal".
ADDITIONAL REQUESTS/SUGGESTIONS:
N/A
Title: Good performance of monoclonal antibody-based stool H. pylori antigen tests in acute
nonvariceal upper gastrointestinal bleeding patients
Version: 4 Date: 06 Mar 2025
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses a testable research
question(s) (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?
Not sure - key details are missing from the manuscript
EXECUTION - Are the experiments and analyses performed with technical rigor to allow
confidence in the results?
No - there are minor issues
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 - Is the current version of this work technically
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: In this study, Song et al. evaluated the diagnostic performance of
monoclonal antibody-based SAT for HP infection among patients presenting with acute non-
variceal upper GI bleeding using fecal nested PCR combined with Sanger sequencing as the
gold standard. They observed that monoclonal antibody-based SAT had good sensitivity (83%)
and specificity (86%) for detecting HP infection. Overall, the manuscript is well-written and
the study is well-conducted. However, my main question is regarding the study's sampling
methodology: how did the authors arrive at the sample of 82 patients included in the study?
This needs to be clarified before a definite evaluation can be made regarding the validity of the
study's sampling methodology. I also have some additional questions regarding other aspects
of the study methodology as well as some suggestions for further improvement (which I have
detailed later).
REQUESTED REVISIONS:
MAJOR COMMENTS:
1) The authors included only 82 patients from a single hospital over a period of 20 months in
this study. How was this sample of 82 patients collected? Was this a consecutive sample? If yes,
please clarify how many patients were excluded based on the various exclusion criteria (recent
treatment with antibiotics or PPI, inability to provide stool sample, etc). Also, please clarify if
the sample selection was based on the availability of test results for HP -- this is an important
consideration to assess the risk of selection bias.
2) The authors mention under section 2.1 of Methods that "patients who did not produce
sufficient stools samples for PCR testing were excluded". Please clarify how many patients were
excluded for this reason? Also mention how long of a time period was allowed for the patients
to give stool sample before they were deemed to be excluded.
3) I did not see any mention of clinical outcomes (in-hospital mortality). Were any patients
excluded from this analysis because they died prior to providing a stool sample?
4) Did the authors only include patients presenting to the emergency department with acute non-
variceal upper GI bleeding? If patients were hospitalized for other reasons and developed upper
GI bleeding while in the hospital, were they eligible for inclusion in the study?
5) Did the authors consider performing a priori sample size calculation? If yes, please mention
the details. If not, what was the reason for not calculating sample size beforehand?
6) There is no mention of the time interval between patient's presentation to the hospital and stool
& serum testing for HP. Please mention how soon the serum and stool samples were collected?
7) While the results of multivariate logistic regression analysis were not statistically significant,
it is important to report some measures of model stability. In this regard, I would encourage the
authors to perform bootstrapping and report bootstrap confidence intervals to better assess the
stability of the regression model. Please refer to doi.org/10.1002/bimj.201700067 for details.
MINOR COMMENTS:
1) In the multivariate logistic regression, only 75 patients were included. What is the reason for
this? If this is due to missing data, kindly clarify which data were missing.
2) Did any of the included patients have end-colostomy or end-ileostomy? For such patients,
were "stool" samples collected from the stoma bag?
3) In the study, 35.4% of included patients received antibiotic therapy, which is a fairly high
proportion for patients with acute non-variceal upper GI bleeding. What were the indications
for antibiotic therapy in these cases? Please clarify.
4) The term "Dieulafoy ulcer" is somewhat inaccurate and should be replaced with "Dieulafoy
lesion" throughout the manuscript. Dieulafoy lesion is a pinpoint vascular ectasia that can lead
to brisk GI bleeding.
5) In the heading for Table 4, replace "fetal" with "fecal".
ADDITIONAL REQUESTS/SUGGESTIONS:
N/A
Please review this paper.
user
Title: Good performance of monoclonal antibody-based stool H. pylori antigen tests in acute
nonvariceal upper gastrointestinal bleeding patients
Version: 4 Date: 06 Mar 2025
Reviewer's report:
PEER REVIEWER ASSESSMENTS:
OBJECTIVE - Full research articles: is there a clear objective that addresses a testable research
question(s) (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?
Not sure - key details are missing from the manuscript
EXECUTION - Are the experiments and analyses performed with technical rigor to allow
confidence in the results?
No - there are minor issues
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 - Is the current version of this work technically
sound? If not, can revisions be made to make the work technically sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS:
GENERAL COMMENTS: In this study, Song et al. evaluated the diagnostic performance of
monoclonal antibody-based SAT for HP infection among patients presenting with acute non-
variceal upper GI bleeding using fecal nested PCR combined with Sanger sequencing as the
gold standard. They observed that monoclonal antibody-based SAT had good sensitivity (83%)
and specificity (86%) for detecting HP infection. Overall, the manuscript is well-written and
the study is well-conducted. However, my main question is regarding the study's sampling
methodology: how did the authors arrive at the sample of 82 patients included in the study?
This needs to be clarified before a definite evaluation can be made regarding the validity of the
study's sampling methodology. I also have some additional questions regarding other aspects
of the study methodology as well as some suggestions for further improvement (which I have
detailed later).
REQUESTED REVISIONS:
MAJOR COMMENTS:
1) The authors included only 82 patients from a single hospital over a period of 20 months in
this study. How was this sample of 82 patients collected? Was this a consecutive sample? If yes,
please clarify how many patients were excluded based on the various exclusion criteria (recent
treatment with antibiotics or PPI, inability to provide stool sample, etc). Also, please clarify if
the sample selection was based on the availability of test results for HP -- this is an important
consideration to assess the risk of selection bias.
2) The authors mention under section 2.1 of Methods that "patients who did not produce
sufficient stools samples for PCR testing were excluded". Please clarify how many patients were
excluded for this reason? Also mention how long of a time period was allowed for the patients
to give stool sample before they were deemed to be excluded.
3) I did not see any mention of clinical outcomes (in-hospital mortality). Were any patients
excluded from this analysis because they died prior to providing a stool sample?
4) Did the authors only include patients presenting to the emergency department with acute non-
variceal upper GI bleeding? If patients were hospitalized for other reasons and developed upper
GI bleeding while in the hospital, were they eligible for inclusion in the study?
5) Did the authors consider performing a priori sample size calculation? If yes, please mention
the details. If not, what was the reason for not calculating sample size beforehand?
6) There is no mention of the time interval between patient's presentation to the hospital and stool
& serum testing for HP. Please mention how soon the serum and stool samples were collected?
7) While the results of multivariate logistic regression analysis were not statistically significant,
it is important to report some measures of model stability. In this regard, I would encourage the
authors to perform bootstrapping and report bootstrap confidence intervals to better assess the
stability of the regression model. Please refer to doi.org/10.1002/bimj.201700067 for details.
MINOR COMMENTS:
1) In the multivariate logistic regression, only 75 patients were included. What is the reason for
this? If this is due to missing data, kindly clarify which data were missing.
2) Did any of the included patients have end-colostomy or end-ileostomy? For such patients,
were "stool" samples collected from the stoma bag?
3) In the study, 35.4% of included patients received antibiotic therapy, which is a fairly high
proportion for patients with acute non-variceal upper GI bleeding. What were the indications
for antibiotic therapy in these cases? Please clarify.
4) The term "Dieulafoy ulcer" is somewhat inaccurate and should be replaced with "Dieulafoy
lesion" throughout the manuscript. Dieulafoy lesion is a pinpoint vascular ectasia that can lead
to brisk GI bleeding.
5) In the heading for Table 4, replace "fetal" with "fecal".
ADDITIONAL REQUESTS/SUGGESTIONS:
N/A
assistant