Title: CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN
CHINA – A REAL-WORLD, MULTICENTER STUDY
Version: 2 Date: 18 Mar 2021
Reviewer's report:
"CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN CHINA –
A REAL-WORLD, MULTICENTER STUDY"
1) Ethical issues may be a concern for acceptance of publication: Authors described that all the
subjects involved in this study have provided a written informed consent. In big data analysis,
which generally collects data from national EMR, it is difficult to obtain the consent of all
participants. Please comment which of the following is correct, 1) obtained a written consent
form specific to this study only from all participants, 2) obtained a comprehensive consent to
provide data to the EMR (Happy life science), 3 ) Opt-out only. If possible, please indicate a
website (such as trial.gov) where we can find published clinical research disclosures and consent
forms of this study.
2) Methods: The rate of alcoholic pancreatitis is very low in this study. A diagnostic definition
of the etiology of each pancreatitis should be provided. General guidelines recommend ERCP
treatment for patients with gallstone pancreatitis with cholangitis. There is concern that post-
ERCP pancreatitis may be counted as gallstone pancreatitis.
3) This study is a clinical study that evaluates the results of drug treatment. Details of the specific
dose, duration and timing of each drug should be included in the analysis. Other important
prognostic factors for pancreatitis, initial infusion volume, enteral nutrition, meal start time, and
CT image severity (CT severity index) should be analyzed.
4) Please show the definition of outcomes: disease complication, organ failure (Line 141).
5) Statics#Authors should show the method of multi valuate analysis for each outcomes in detail.
Authors should show the result of multivariate analysis about not only enzyme inhibitor but also
others such as severity of AP, organ failure etc.
6) My major concern is about the outcome measurement for this study. To improve the quality
of the manuscript, as with most other clinical studies of pancreatitis, the author should set in-
hospital mortality as the primary outcome.
7) Results: Table1 "discharge failure, discharge complication, Death and abandonment" is not
common term in clinical research. Authors should use different words or provide definitions
of these. Also, please describe the specific definition of "Standardized medication". "Days in
hospital" and "length of hospital stay" are listed respectively, but please clarify the difference.
8) Institutional treatment strategies for the use of somatostatin and octreotide for acute
pancreatitis should be presented. Differences in treatment trends and treatment results at each
participating facility should also be shown. That can be the largest bias.
9) It is presumed that the big data used in this research is extracted from electronic medical
records. However, the authors state that " In the group of “somatostatin / octreotide”, patients
who received both somatostatin and octreotide, but either sequentially or at different time points
is unknow." Specifically, please submit a list of extracted items, which data items were extracted
from EMR.
10) Analysis of the time to normalization of amylase and lipase is not related to the outcome of
pancreatitis treatment, you know. I don't think this consideration is necessary.
11) Analysis of real-world data with significant limitations such as inadequate factor analysis
from inadequate clinical information. The statement in the conclusion that "Somatostatin was
found to be more effective than octreotide with respect to both the efficacy and discharge
complications in the patients hospitalized with AP. In consideration of the results, we believe
that somatostatin should be recommended to AP patients.” is slightly overstating.
Title: CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN
CHINA – A REAL-WORLD, MULTICENTER STUDY
Version: 2 Date: 18 Mar 2021
Reviewer's report:
"CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN CHINA –
A REAL-WORLD, MULTICENTER STUDY"
1) Ethical issues may be a concern for acceptance of publication: Authors described that all the
subjects involved in this study have provided a written informed consent. In big data analysis,
which generally collects data from national EMR, it is difficult to obtain the consent of all
participants. Please comment which of the following is correct, 1) obtained a written consent
form specific to this study only from all participants, 2) obtained a comprehensive consent to
provide data to the EMR (Happy life science), 3 ) Opt-out only. If possible, please indicate a
website (such as trial.gov) where we can find published clinical research disclosures and consent
forms of this study.
2) Methods: The rate of alcoholic pancreatitis is very low in this study. A diagnostic definition
of the etiology of each pancreatitis should be provided. General guidelines recommend ERCP
treatment for patients with gallstone pancreatitis with cholangitis. There is concern that post-
ERCP pancreatitis may be counted as gallstone pancreatitis.
3) This study is a clinical study that evaluates the results of drug treatment. Details of the specific
dose, duration and timing of each drug should be included in the analysis. Other important
prognostic factors for pancreatitis, initial infusion volume, enteral nutrition, meal start time, and
CT image severity (CT severity index) should be analyzed.
4) Please show the definition of outcomes: disease complication, organ failure (Line 141).
5) Statics#Authors should show the method of multi valuate analysis for each outcomes in detail.
Authors should show the result of multivariate analysis about not only enzyme inhibitor but also
others such as severity of AP, organ failure etc.
6) My major concern is about the outcome measurement for this study. To improve the quality
of the manuscript, as with most other clinical studies of pancreatitis, the author should set in-
hospital mortality as the primary outcome.
7) Results: Table1 "discharge failure, discharge complication, Death and abandonment" is not
common term in clinical research. Authors should use different words or provide definitions
of these. Also, please describe the specific definition of "Standardized medication". "Days in
hospital" and "length of hospital stay" are listed respectively, but please clarify the difference.
8) Institutional treatment strategies for the use of somatostatin and octreotide for acute
pancreatitis should be presented. Differences in treatment trends and treatment results at each
participating facility should also be shown. That can be the largest bias.
9) It is presumed that the big data used in this research is extracted from electronic medical
records. However, the authors state that " In the group of “somatostatin / octreotide”, patients
who received both somatostatin and octreotide, but either sequentially or at different time points
is unknow." Specifically, please submit a list of extracted items, which data items were extracted
from EMR.
10) Analysis of the time to normalization of amylase and lipase is not related to the outcome of
pancreatitis treatment, you know. I don't think this consideration is necessary.
11) Analysis of real-world data with significant limitations such as inadequate factor analysis
from inadequate clinical information. The statement in the conclusion that "Somatostatin was
found to be more effective than octreotide with respect to both the efficacy and discharge
complications in the patients hospitalized with AP. In consideration of the results, we believe
that somatostatin should be recommended to AP patients.” is slightly overstating.
Please review this paper.
user
Title: CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN
CHINA – A REAL-WORLD, MULTICENTER STUDY
Version: 2 Date: 18 Mar 2021
Reviewer's report:
"CURRENT DIAGNOSIS AND TREATMENT OF ACUTE PANCREATITIS IN CHINA –
A REAL-WORLD, MULTICENTER STUDY"
1) Ethical issues may be a concern for acceptance of publication: Authors described that all the
subjects involved in this study have provided a written informed consent. In big data analysis,
which generally collects data from national EMR, it is difficult to obtain the consent of all
participants. Please comment which of the following is correct, 1) obtained a written consent
form specific to this study only from all participants, 2) obtained a comprehensive consent to
provide data to the EMR (Happy life science), 3 ) Opt-out only. If possible, please indicate a
website (such as trial.gov) where we can find published clinical research disclosures and consent
forms of this study.
2) Methods: The rate of alcoholic pancreatitis is very low in this study. A diagnostic definition
of the etiology of each pancreatitis should be provided. General guidelines recommend ERCP
treatment for patients with gallstone pancreatitis with cholangitis. There is concern that post-
ERCP pancreatitis may be counted as gallstone pancreatitis.
3) This study is a clinical study that evaluates the results of drug treatment. Details of the specific
dose, duration and timing of each drug should be included in the analysis. Other important
prognostic factors for pancreatitis, initial infusion volume, enteral nutrition, meal start time, and
CT image severity (CT severity index) should be analyzed.
4) Please show the definition of outcomes: disease complication, organ failure (Line 141).
5) Statics#Authors should show the method of multi valuate analysis for each outcomes in detail.
Authors should show the result of multivariate analysis about not only enzyme inhibitor but also
others such as severity of AP, organ failure etc.
6) My major concern is about the outcome measurement for this study. To improve the quality
of the manuscript, as with most other clinical studies of pancreatitis, the author should set in-
hospital mortality as the primary outcome.
7) Results: Table1 "discharge failure, discharge complication, Death and abandonment" is not
common term in clinical research. Authors should use different words or provide definitions
of these. Also, please describe the specific definition of "Standardized medication". "Days in
hospital" and "length of hospital stay" are listed respectively, but please clarify the difference.
8) Institutional treatment strategies for the use of somatostatin and octreotide for acute
pancreatitis should be presented. Differences in treatment trends and treatment results at each
participating facility should also be shown. That can be the largest bias.
9) It is presumed that the big data used in this research is extracted from electronic medical
records. However, the authors state that " In the group of “somatostatin / octreotide”, patients
who received both somatostatin and octreotide, but either sequentially or at different time points
is unknow." Specifically, please submit a list of extracted items, which data items were extracted
from EMR.
10) Analysis of the time to normalization of amylase and lipase is not related to the outcome of
pancreatitis treatment, you know. I don't think this consideration is necessary.
11) Analysis of real-world data with significant limitations such as inadequate factor analysis
from inadequate clinical information. The statement in the conclusion that "Somatostatin was
found to be more effective than octreotide with respect to both the efficacy and discharge
complications in the patients hospitalized with AP. In consideration of the results, we believe
that somatostatin should be recommended to AP patients.” is slightly overstating.
assistant