Accuracy of hepatitis B disease surveillance, Gannan prefecture, Gansu province, China; 2017

Pinggui Wang; Lijie Zhang; Jian He; Guomin Zhang; Yvan Ma; Weimin Lv; Xiaoshu Zhang; Jin An

doi:10.1371/journal.pone.0274798

Peer Review History

Original SubmissionMarch 26, 2022
21 Apr 2022 Decision Letter - Antonio De Vincentis, Editor PONE-D-22-06387Accuracy of hepatitis B disease surveillance, Gannan Prefecture, Gansu Province, China; 2017PLOS ONE Dear Dr. Zhang, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jun 05 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: In this paper, Wang et al. analyzed the accuracy of diagnosis of hepatitis B in the national diagnosis reporting system in Gannan, China. They concluded that the falsely high incidence in the reporting system was due to diagnostic and reporting inaccuracies. This paper simply shows the poor diagnostic ability of clinicians for hepatitis B in this area. There are some concerns in this paper as below. 1. The reasons why many patients without hepatitis B were overdiagnosed are not fully evaluated. Such data are required to improve the ability of diagnosis. 2. If education for clinicians improves the accuracy of diagnosis of hepatitis B even though partly, it would be important data also for other areas. 3. Page 5, “We interviewed medical staff on factors that affect the quality of hepatitis B detection, diagnosis, and reporting for each of the three categories of HBV infection…” – there is no results of this interview in the result section. 4. Pages 7-8, “When asked by the investigators why few IgM tests were performed…” – please show how many clinicians were asked and how many were answered. 5. Page 8, “Clinician knowledge” – there is little information on the clinicians. Did they work at the 7 hospitals where the diagnosis of hepatitis B was surveyed? 6. Page 8, “Clinician knowledge” – how many clinicians accurately diagnosed all the simulated cases? Additionally, please show mean (or median) score for the 6 scenarios. Reviewer #2: Zhang and co-authors performed a nice study regarding HBV misdiagnosis. Congratulations for the good idea. The results are really concerning! I have some comments for them: Can you precisely explain how HBV cases are classified in the NNDRS? Were the 427 inpatients reported admitted for an HBV related disease? Did outpatients seek medical care for an HBV related disease? On study limitations you state that “The study was conducted only among hospitalized cases…” but you included 372 outpatients, can you clarify it? Did you find any similar study in the literature? I would be nice if you can find any predictor for misclassification such as level of expertise, age, years of practice, subspeciality of clinicians making those reports and for those taking the interviews. I suggest adding in the discussion section how theses findings may impact in clinical studies performed for data obtained from databases relying only in medical reports not confirmed by serological data. Why do you think there is such a high rate of misdiagnosis in an endemic HBV region? Please add some comments in the discussion section. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0274798.r001
Revision 1
22 Jun 2022 Author Response Response to reviewer #1: 1. The reasons why many patients without hepatitis B were over diagnosed are not fully evaluated. Such data are required to improve the ability of diagnosis. In our study, we found that there were 7 inpatients whose hepatitis B surface antigen were negative. By reviewing the medical records of these 7 inpatients, they were diagnosed as chronic gastroenteritis, dermatitis, head trauma, costal neuritis, pregnant woman, hepatitis A and hepatitis C, respectively. They should not be reported to the hepatitis B surveillance system. These 7 inpatients were diagnosed correctly, but some mistakes occurred when the clinician reported to NNDRS. 2. If education for clinicians improves the accuracy of diagnosis of hepatitis B even though partly, it would be important data also for other areas. The survey showed that many clinicians in Gannan didn’t understand the diagnostic and reporting criteria of hepatitis B well which affecting the accuracy of diagnosis of hepatitis B. So providing education for clinicians on the diagnostic and report criteria of hepatitis B is needed to improve the accurate of diagnose and reporting of hepatitis B. We agree that it would be important data also for other areas. 3. Page 5, “We interviewed medical staff on factors that affect the quality of hepatitis B detection, diagnosis, and reporting for each of the three categories of HBV infection…” – there is no results of this interview in the result section. Sorry for the confusion. We redescribed this sentence to make it more clear. In fact, we evaluated clinicians’ diagnosis capacity and accuracy of reporting for hepatitis B by interviewing using a questionnaire. We interviewed all the clinicians who were working in the 7 hospitals where cases were reported when the survey was conducted. We set 6 simulated case scenarios to identify the accuracy of diagnosis of hepatitis B for clinicians. The six simulated case scenarios included three AHB case scenarios, two CHB case scenarios, and one hepatitis B virus carrier scenario. We added the results of 41 clinician diagnosis capacity and accuracy of reporting for hepatitis B in the revised manuscript on line 246 in page 10. 4. Pages 7-8, “When asked by the investigators why few IgM tests were performed…” – please show how many clinicians were asked and how many were answered. We interviewed 41 clinicians and all answered the question. 78% (32/41) of clinicians said that this test was not helpful for clinical treatment, We added this information on line 229 in page 9. 5. Page 8, “Clinician knowledge” – there is little information on the clinicians. Did they work at the 7 hospitals where the diagnosis of hepatitis B was surveyed? We interviewed 41 clinicians who worked at the 7 hospitals where the diagnosis of hepatitis B was surveyed. There were 20 males and 21 females. 36 of them were college and bachelor degree. 5 of them were high school education level. The professional title of 29 of them were residents, 8 attending physicians, and 4 associate chief physicians. 20 clinicians had less than 10 years of service, 6 had 10-19 years of service, 15 clinicians had more than 20 years of service.20 of them came from internal department, 15 from obstetrics and gynecology department, the others came from clinical laboratory, department of pediatrics. We added this information on line235 in page 9. 6. Page 8, “Clinician knowledge” – how many clinicians accurately diagnosed all the simulated cases? Additionally, please show mean (or median) score for the 6 scenarios. Among the 41 clinicians, only 3 of them accurately diagnosed all the simulated cases. The mean score was 3.83 ± 2.16 for the 6 scenarios (1 point for each scenario). The mean score was highest in clinicians from department of pediatrics（4.33±2.44）, followed by internal medicine department (4.00±1.39), obstetrics and gynecology department (3.73±2.63), the lowest mean score was 2.66±1.85 for clinicians from clinical laboratory department. The mean score of residents, attending physicians, and associate chief physicians, were 3.79 ± 2.08,3.63 ± 2.58, and 4.5 ± 0.98, respectively. The mean score in clinicians with high school degree were 3.40 ± 2.35, college and bachelor were 3.89 ± 2.11. From the length of service of surveyed clinicians, Clinicians with 20 years had the highest score (4.13 ± 1.73), followed by clinicians with less than 10 years (3.85 ± 1.78) and 10-19 years (3.00 ± 3.20). We added this information on line 246 in page 10. Response to reviewer #2: 1.Can you precisely explain how HBV cases are classified in the NNDRS? According to the National diagnosis and reporting guideline of hepatitis B, if cases with hepatitis B symptoms and/or ALT abnormalities have HBsAg positive test results within 6 months, the case should be diagnosed as acute hepatitis B. If the HBsAg positive result was tested 6 months ago, the case should be diagnosed as chronic hepatitis B. When the tested time of the HBsAg positive result was unknown, and the anti-HBc IgM was positive, the case could be diagnosed as acute hepatitis B. If a case with HBsAg positive test results had no hepatitis B symptoms and no ALT abnormalities, the case should be diagnosed as hepatitis B carrier. We added this information on line 122 in the Methods in page 5. 2.Were the 427 inpatients reported admitted for an HBV related disease? Did outpatients seek medical care for an HBV related disease? Of the 427 hospitalized cases, we surveyed 400 cases successfully. We did not find the other 27 inpatients’ medical record. Of the 400 inpatients surveyed, only 84 admitted for a HBV related disease, 159 admitted for Gynecologic diseases and in-hospital delivery, 37 were for injury and surgical diseases, 29 were for disease of respiratory system, others were for stomach, cardiovascular, the neurology system, Skin and the urinary system. In China, all inpatients should test HBV when they were admitted. Outpatients also sought medical care for an HBV related disease. If clinician diagnosed them as hepatitis B, they should also be reported to the NNDRS. In this study, we didn’t evaluate these reported HBV cases from outpatient because they didn’t have detailed medical records information as those inpatients. 3.On study limitations you state that “The study was conducted only among hospitalized cases…” but you included 372 outpatients, can you clarify it? In this study, there were total 799 cases of hepatitis B was reported from the seven hospitals. Among them, 427 (53%) were inpatients and 372 (47%) were outpatients. Among the 427 inpatients, 400 (94%) were evaluated for accuracy of diagnosis because they have detailed medical records information including laboratory test. All the related results in this manuscript were for the 400 inpatients, not including the 372 outpatients. 4.Did you find any similar study in the literature? We searched total two similar studies in Chinese Journal of Vaccines and Immunization. One is “Actuality analysis on diagnose and report for hepatitis B in Gansu province” published in 2004, another is “Analysis on Reported Hepatitis B Cases on Pilot Surveillance in 18 Counties of 8 Provinces of China” published in 2007. Our study focused on the Gannan prefecture where had the highest reported hepatitis B incidence in Gansu province. We cited these two papers as 8th and 10th reference in this manuscript. 5.I would be nice if you can find any predictor for misclassification such as level of expertise, age, years of practice, subspeciality of clinicians making those reports and for those taking the interviews. We calculated the inaccurately reporting rates in different departments. The highest inaccurately report rate were 100% in pediatrics, followed by obstetrics and gynecology (91%), traditional Chinese medicine (81%), surgery(74%) and internal medicine(74%). Among 59 duplicated reports, 93%(55/59) were reported from internal medicine department. Among 261 hepatitis B carriers, 47%(146/261) were reported by gynaecology and obstetrics department. We added this information and the following table on line 216 in page8. Tabble1. The inaccurately reporting rates in different departments Departments Cases should not be reported Should be reported The rate of inaccurately report（%） HepatitisB carriers Duplicate reports Without hepatitis B Total Internal medicine 68 55 3 44 170 74 Surgery 32 2 1 12 47 74 Traditional Chinese medicine 13 0 0 3 16 81 Gynaecology and obstetrics 146 1 2 14 163 91 Paediatrics 2 1 1 0 4 100 Total 261 59 7 73 400 82 The mean score was highest in clinicians from department of pediatrics（4.33±2.44）, followed by internal medicine department (4.00±1.39), obstetrics and gynecology department (3.73±2.63), the lowest mean score was 2.66±1.85 for clinicians from clinical laboratory department. The mean score of residents, attending physicians, and associate chief physicians, were 3.79 ± 2.08,3.63 ± 2.58, and 4.5 ± 0.98, respectively. The mean score in clinicians with high school degree were 3.40 ± 2.35, college and bachelor were 3.89 ± 2.11. From the length of service of surveyed clinicians, Clinicians with 20 years had the highest score (4.13 ± 1.73), followed by clinicians with less than 10 years (3.85 ± 1.78) and 10-19 years (3.00 ± 3.20). We added this information on line 248 in page10. 6.I suggest adding in the discussion section how these findings may impact in clinical studies performed for data obtained from databases relying only in medical reports not confirmed by serological data. In this study, we evaluated the accuracy of clinicians' diagnosis and reporting of hepatitis B by reviewing medical records of inpatients. We made the decision based on the previous disease history, clinical symptoms, imaging examination, laboratory serological test results recorded in medical records. All these data were accurate and true. So our findings could show the real status of clinicians' diagnosis and reporting of hepatitis B. We added this information on line 270 in page 11. 7.Why do you think there is such a high rate of misdiagnosis in an endemic HBV region? Please add some comments in the discussion section. There were some reasons for such a high rate of misdiagnosis in the endemic HBV region. First, some clinicians did not understand the diagnosis criteria correctly. The hospital does not organize the training on hepatitis B diagnosis; Second, some testing items conducive to the classified diagnosis of hepatitis B are not carried out in local hospitals, such as Anti-HBc IgM, HBV DNA and liver needle biopsy, perhaps because the classified diagnosis has little significance to the treatment of patients. We added this information on line274 in discussion part in page 11. Attachments Attachment Submitted filename: Rsponse to reviewers(0621).docx https://doi.org/10.1371/journal.pone.0274798.r002
11 Jul 2022 Decision Letter - Antonio De Vincentis, Editor PONE-D-22-06387R1Accuracy of hepatitis B disease surveillance, Gannan Prefecture, Gansu Province, China; 2017PLOS ONE Dear Dr. Zhang, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please check and address the last issue raised by Rev#1. Please submit your revised manuscript by Aug 25 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Antonio De Vincentis Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. 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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: (No Response) Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: (No Response) Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: (No Response) Reviewer #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The authors addressed the comments from reviewers and the manuscript has been modified almost properly. The revised manuscript includes supporting information, but it is completely same as the tables in the main manuscript. Therefore, the supporting information part should be deleted. Reviewer #2: Thanks to the authors for addressing all comments. Interesting results. I hope you establish an educating campaign in these hospitals about HBV diagnosis. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0274798.r003
Revision 2
1 Sep 2022 Author Response Dear editor, Thanks for your and the reviewers’ valuable comments and recommendations. We had re-checked all the references in the article and replaced reference number 1 with the latest one. We corrected some authors’ name spelling and the journal spelling according to PLOS journal demand. The URL for some references were updated, and some missing literature DOI addresses were added. We deleted the supporting information part because it was the same as the tables in the main manuscript. For the second reviewer‘s comments, we recommended the hospitals to conduct education campaign about HBV diagnosis and reporting criteria in the discussion part in the main manuscript. Thanks again for all your comments. Best regards, Lijie Zhang, China CDC Correspondent author Attachments Attachment Submitted filename: 2022-8-1 Rsponse to editor and reviewers(1).docx https://doi.org/10.1371/journal.pone.0274798.r004
4 Sep 2022 Decision Letter - Antonio De Vincentis, Editor Accuracy of hepatitis B disease surveillance, Gannan Prefecture, Gansu Province, China; 2017 PONE-D-22-06387R2 Dear Dr. Zhang, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Antonio De Vincentis Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0274798.r005
Formally Accepted
11 Sep 2022 Acceptance Letter - Antonio De Vincentis, Editor PONE-D-22-06387R2 Accuracy of hepatitis B disease surveillance, Gannan prefecture, Gansu province, China; 2017 Dear Dr. Zhang: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Antonio De Vincentis Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0274798.r006

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