Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia

Mebrihit Arefaine Tesfu; Tilahun Teklehaymanot Habtemariam; Nega Berhe Belay

doi:10.1371/journal.pone.0284646

Peer Review History

Original SubmissionAugust 14, 2022
7 Dec 2022 Decision Letter - Yury E Khudyakov, Editor PONE-D-22-22777RISK factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia: A Case-control studyPLOS ONE Dear Dr. Tesfu, 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. ============================== Your manuscript was reviewed by 2 experts in the field. Both identified several important problems in your submission. Please review the attached comments and provide point-by-point responses. ============================== Please submit your revised manuscript by Jan 21 2023 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. 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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: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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: Yes 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: No 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: The authors aimed to study the magnitude of HBV infection and its risk factors among pregnant women who attended public hospitals in Addis Ababa (Ethiopia). Although the issue is not new, they have included a large population in a place where infection is a heavy burden of disease, even when diagnosis is easy and infection can be prevented. However, the study lacks several major aspects that severely impair the scientific significance and needs some changes: - After reading the manuscript, it appears that the authors propose a multicentre prospective cohort study with a nested case-control study, although it is not clearly reflected in the Methods section. - The tables are unclear, mainly table 2. I would consider simplifying it to allow a more comprehensible reading. - Formatting of references does not follow the "Vancouver” style. - The authors should revise the language to improve readability. Reviewer #2: The research done by Tesfu et al. on risk factors associated with Hepatitis B virus infection among pregnant women has public health importance and screened large sample size about 12,138 pregnant women. So it good and in the range of PLOS One journal. However there are points must be corrected before publication. 1. RISk factor is written in capital letters, please correct it Risk factor. 2. Why do you exclude HIV infected patents, because sexual transmitted infection as one of risk factor in your study? 3. In line 125-126, correct in this way. Variables significant at p <0.25 with the dependent variable in bivariate analysis were selected for multivariable analysis. 4. In result part, in table one marital status and religion, it says others, you should have to specify below in the table as foot note. 5. I have seen your recommendation but you have not specified the stake, please try to make that. Major comment 1. In the method part, sample size part, there is no sample size calculation. How do you reach 300 case and 300 control , it is not clear? 2. What is your sampling technique; it is not indicated in the method part? Is it quota sampling or random what? 3. You have used predesigned and pre-tested, where do you pre-test your questionnaire, it is not mentioned well? 4. The test used for the diagnosis of HBsAg is rapid test for the selection of cases and controls which is weak for this purpose , it would have been good to use ELISA or PCR? ****** 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. Attachments Attachment Submitted filename: Comments and sugestion for review.docx https://doi.org/10.1371/journal.pone.0284646.r001
Revision 1
28 Feb 2023 Author Response Thank you for giving us the opportunity to submit a revised manuscript of<< Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia >>for publication in the journal of PLOS ONE. We appreciate the time and effort that you and the reviewers dedicated to provide feedback on our manuscript and are grateful for the insightful comments on and valuable improvements to our paper .We have incorporated almost all of the suggestions made by the reviewers. Those changes are marked within the manuscript. Please see below, in blue, for a point-by-point response to the reviewers’ comments. Academic editors and Reviewer’s comment to the authors 1. RISk factor is written in capital letters, please correct it Risk factor. Author response: We agree and corrected it. 2. Why do you exclude HIV infected patents, because sexual transmitted infection as one of risk factor in your study? Author response: Since HIV and HBV have similar route of transmission the risk factors may be over lapped that is why we exclude HIV seropositive pregnant woman. 3. In line 125-126, correct in this way. Variables significant at p <0.25 with the dependent variable in bivariate analysis were selected for multivariable analysis. Author response: we accepted the reviewers comment and corrected it. 4. In result part, in table one marital status and religion, it says others, you should have to specify below in the table as foot note. Author response: we agree and corrected it. 5. I have seen your recommendation but you have not specified the stake, please try to make that. Author response: we agree and revised it. Major comment 1. In the method part, samplesize part, there is no sample size calculation. How do you reach 300 case and 300 control, it is not clear? Author response: we accept the comment and corrected it as follow To determine the MTCT of HBV and the protective effect of the immune-prophylaxis vaccine in Ethiopia, a sample size of 369 HBV-positive pregnant women was calculated using, 40% of MTCT of HBV in the absence of post-exposure prophylaxis in Nigeria, and giving any particular outcome to be with 5% marginal error, 95% confidence interval, and using the following single population determination formula. n = (z ∂/2) 2 p (1-p) d2 To get 369 HBsAg positive, 12,318 pregnant women were screened for HBsAg as routine antenatal care (ANC) service in the selected public hospitals during the study period, and 300 of them were included in this study. The women whose screening results were positive for HBsAg were considered as cases. The purposive sampling technique was used to get the cases, and, for each HBsAg positive woman, the next HBsAg negative woman was interviewed and acted as a control. Thus 300 cases and 300 controls were involved in the study. 2. What is your sampling technique; it is not indicated in the method part? Is it quota sampling or random what? Author response: The purposive sampling technique was used to get the cases, and, for each HBsAg positive woman, the next HBsAg negative woman was interviewed and acted as a control. 3. You have used predesigned and pre-tested, where do you pre-test your questionnaire, it is not mentioned well? Author response: we accept the comment and revised it as follow Questionnaires were carefully designed and pre-tested with individuals equivalent to 5% of the calculated sample size in Ras Desta Damtew Hospital and were slightly amended after pre-tested results revealed a lack of clarity for some responses. 4. The test used for the diagnosis of HBsAg is rapid test for the selection of cases and controls which is weak for this purpose; it would have been good to use ELISA or PCR? Author response: we agree also with this comment .But we could not do those tests because they were not easily accessible and we describe this as a limitation of the study. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0284646.r002
6 Mar 2023 Decision Letter - Yury E Khudyakov, Editor PONE-D-22-22777R1Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, EthiopiaPLOS ONE Dear Dr. Tesfu, 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. Thank you for submitting the revised version of your manuscript. You have responded to all comments by reviewers. However, the manuscript still needs revision. Risk factor associated with HBV status among pregnant women are common for acquisition of HBV infections. The discussion section would be improved by comparing to risk factors in general population. This is a research paper rather than policy and cannot contain recommendations. The observations made in the study, however, may be used to indicate importance of the identified factors for enhancing screening for HBV infections among pregnant women. Since the study did not involve application of vaccines and immunoglobulins, it is not proper to conclude on their administration. It is not sufficient to mention the use of low sensitivity assays in Limitations. Potential effects of these assays on the presented findings should be spelled out. Please submit your revised manuscript by Apr 20 2023 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. 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, Yury E Khudyakov, PhD 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. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] [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.0284646.r003
Revision 2
3 Apr 2023 Author Response Manuscript Number: PONE-D-22-22777R1 Manuscript title: Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia Response to reviewers Dear Dr. Yury E Khudyakov ( Acadamic editor of PLOS ONE journal) Thank you for giving us the opportunity to submit a revised manuscript of<< Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia >>for publication in the journal of PLOS ONE. We appreciate the time and effort that you and the reviewers dedicated to provide feedback on our manuscript and are grateful for the insightful comments on and valuable improvements to our paper .We have incorporated all of the suggestions made by the reviewers. Those changes are marked within the manuscript. Please see below, in blue, for a point-by-point response to the reviewers’ comments. Academic editors and Reviewer’s comment to the authors 1. Risk factors associated with HBV status among pregnant women are common for acquisition of HBV infections. The discussion section would be improved by comparing to risk factors in general population. Author's response: We agree and we included and comparing the risk factors of HBV infection of the pregnant women with the general population. 2. This is a research paper rather than policy and cannot contain recommendations. The observations made in the study, however, may be used to indicate the importance of the identified factors for enhancing screening for HBV infections among pregnant women. Since the study did not involve the application of vaccines and immunoglobulins, it is not proper to conclude on their administration. Author's response: we agree and corrected it. 3. It is not sufficient to mention the use of low sensitivity assays in Limitations. Potential effects of these essays on the presented findings should be spelled out. Author's response: we agree and corrected as << Due to a lack of laboratory setups, the HBsAg status of the pregnant women was not confirmed using an enzyme-linked immunosorbent assay, and there might be false positive or false negative results. In addition, since the polymerase chain reaction test was not carried out in this study, pregnant women with occult HBV infections were not identified.>. Once more we thank you for the comments. We believe our manuscript is now ready for publishing. Sincerely, Mebrihit Arefaine On behalf of all authors. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0284646.r004
5 Apr 2023 Decision Letter - Yury E Khudyakov, Editor Risk factors associated with Hepatitis B virus infection among pregnant women attending public hospitals in Addis Ababa, Ethiopia PONE-D-22-22777R2 Dear Dr. Tesfu, 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, Yury E Khudyakov, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0284646.r005

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