Analysis of medico-legal claims related to deliveries: Caesarean section vs. vaginal delivery

Nasim Eshraghi; Marjan Ghaemi; Zahra Shabannejad; Elham Bazmi; Mehdi Foroozesh; Mohammad Haddadi; Sepideh Azizi; Zeinab Mansouri; Sedigheh Hantoushzadeh

doi:10.1371/journal.pone.0312614

Peer Review History

Original SubmissionMarch 2, 2024
26 Apr 2024 Decision Letter - Andrea Cioffi, Editor PONE-D-24-07510Analysis of Medico-Legal Claims Related to Deliveries: Cesarean Section vs. Vaginal DeliveryPLOS ONE Dear Dr. Hantoushzadeh, 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. The article needs structural, formal, and clarity improvements (as indicated by the reviewers). Moreover, is necessary an editing withe typos and grammar check (if possible, use professional editing services). Please submit your revised manuscript by Jun 10 2024 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. 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To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? 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: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No 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: Yes Reviewer #2: No ****** 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: Though the authors cover a pertinent topic on medico-legal claims, the write-up needs to be improved to ensure that the grammar is right and appropriate. The manuscript needs to make a number of corrections to make it more informative to the readership. The statistical analysis needs to be improved. A table of baseline characteristics needs to be added and preferably adding a multivariate analysis would improve the strength of the associations made by the authors. The discussion is more around Europe than even the local context or SSA. The conclusions don't seem to fully arise from the study and the recommendations drawn are not from the study findings. Reviewer #2: Dear authors, thank you for conducting an interesting topic; the findings have important implications for clinicians and public health. However, I have some comments that should be addressed before the publication - the entire manuscripts need to be revised for grammatical errors and punctuation issues and references for some sentences are missing ( e.g. Discussion part paragraph 2 the end sentences should be added. - The authors should include statistical analysis methods in the abstract part - the authors in the main manuscript, stated the conducted using medico-legal dispute documents from March 2018 to February 2020. This information is better if also available in the methods section of the abstract - also, there are some inconsistencies in your abstract and main manuscript. for example, in the abstract, we analyzed medico-legal cases that during two years, but in your result we stated .. a total of 227 women with obstetric claims, meeting the inclusion criteria, were included in this study over three years. why does difference happen? study period should be consistent - this study does not incorporate a qualitative study of the reason for claims associated with delivery from a Health care provider perspective and mothers, and other stakeholders. so, better if should be stated as the limitation of this study. - finally. based on your findings why not suggest that public intervention should be targeted at reducing the prevalence of delivery-related claims? ****** 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: Yes: Ebisa Zerihun ******** [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. 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Revision 1
7 May 2024 Author Response Dear Editor and Reviewers, I would like to express my gratitude for considering this manuscript for revision and for providing valuable comments. I have carefully addressed each comment and made the necessary changes in the main text accordingly. Thank you once again for your time and input. I look forward to your further evaluation of the revised manuscript. Sincerely Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Thank you. I ensured that manuscript meets PLOS ONE's style requirements 2. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and previous work in the [introduction, conclusion, etc.]. We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. [If the overlap is with the authors’ own works: Moreover, upon submission, authors must confirm that the manuscript, or any related manuscript, is not currently under consideration or accepted elsewhere. If related work has been submitted to PLOS ONE or elsewhere, authors must include a copy with the submitted article. Reviewers will be asked to comment on the overlap between related submissions (http://journals.plos.org/plosone/s/submission-guidelines#loc-related-manuscripts).] We will carefully review your manuscript upon resubmission and further consideration of the manuscript is dependent on the text overlap being addressed in full. Please ensure that your revision is thorough as failure to address the concerns to our satisfaction may result in your submission not being considered further. Thank you for your feedback. I have thoroughly reviewed the entire manuscript using the plagiarism detection tool, iThenticate. I have also attached the file for your reference. Based on the results, I believe that the similarity rate is within an acceptable range, considering that there may be some common words or phrases present in the manuscript. If you have any specific concerns or questions about the detected similarities, please let me know, and I'll be happy to assist you further. 3. In this instance it seems there may be acceptable restrictions in place that prevent the public sharing of your minimal data. However, in line with our goal of ensuring long-term data availability to all interested researchers, PLOS’ Data Policy states that authors cannot be the sole named individuals responsible for ensuring data access (http://journals.plos.org/plosone/s/data-availability#loc-acceptable-data-sharing-methods). Data requests to a non-author institutional point of contact, such as a data access or ethics committee, helps guarantee long term stability and availability of data. Providing interested researchers with a durable point of contact ensures data will be accessible even if an author changes email addresses, institutions, or becomes unavailable to answer requests. Before we proceed with your manuscript, please also provide non-author contact information (phone/email/hyperlink) for a data access committee, ethics committee, or other institutional body to which data requests may be sent. If no institutional body is available to respond to requests for your minimal data, please consider if there any institutional representatives who did not collaborate in the study, and are not listed as authors on the manuscript, who would be able to hold the data and respond to external requests for data access? If so, please provide their contact information (i.e., email address). Please also provide details on how you will ensure persistent or long-term data storage and availability. Thank you. I provide the information for a non-author contact person who can be reached for data access. Name: Zahra Omidi Email: z.omidii67@gmail.com Tel: +98 9123491650 4. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ Thank you. I provided the orchid id for the corresponding authors. Is the manuscript technically sound, and do the data support the conclusions? 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: Partly Reviewer #2: Yes ________________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No 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: Yes Reviewer #2: No ________________________________________ 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: Though the authors cover a pertinent topic on medico-legal claims, the write-up needs to be improved to ensure that the grammar is right and appropriate. The manuscript needs to make a number of corrections to make it more informative to the readership. Thank you for your comment. I have revised the manuscript to address the grammar issues. The statistical analysis needs to be improved. A table of baseline characteristics needs to be added and preferably adding a multivariate analysis would improve the strength of the associations made by the authors. Thank you for your comment. I have made the following revisions to the manuscript: 1. Added the baseline characteristics in Table 1. 2. Conducted a multivariable analysis to enhance the strength of the study. 3. Included the results of the regression analysis in the Results section. The discussion is more around Europe than even the local context or SSA. Thank you for your comment. I have revised the discussion part of the manuscript to include the results of relevant Iranian research. The conclusions don't seem to fully arise from the study and the recommendations drawn are not from the study findings. Thank you for your comment. I have revised the conclusion part. Regarding the recommendation, given the high number of lawsuits against OB/GYN surgeons and the importance of identifying the factors associated with these claims, our study's findings suggest that evaluating medicolegal documents could assist surgeons in being better informed and potentially reducing the risk of receiving complaints. Reviewer #2: Dear authors, thank you for conducting an interesting topic; the findings have important implications for clinicians and public health. However, I have some comments that should be addressed before the publication - the entire manuscripts need to be revised for grammatical errors and punctuation issues and references for some sentences are missing ( e.g. Discussion part paragraph 2 the end sentences should be added. Thank you for your comment. I appreciate your review of this article and your interest in the topic. I have added the end sentence to the end of the second paragraph and made revisions to the manuscript accordingly. - The authors should include statistical analysis methods in the abstract part Thank you for your comment. I have included the statistical analysis in the abstract part of the manuscript. - the authors in the main manuscript, stated the conducted using medico-legal dispute documents from March 2018 to February 2020. This information is better if also available in the methods section of the abstract Thank you for your comment. I have included this information in the abstract part of the manuscript. - also, there are some inconsistencies in your abstract and main manuscript. for example, in the abstract, we analyzed medico-legal cases that during two years, but in your result we stated .. a total of 227 women with obstetric claims, meeting the inclusion criteria, were included in this study over three years. why does difference happen? study period should be consistent Thank you for your comment. I apologize for the mistake. I have corrected it. - this study does not incorporate a qualitative study of the reason for claims associated with delivery from a Health care provider perspective and mothers, and other stakeholders. so, better if should be stated as the limitation of this study. Thank you for your comment. I have incorporated this limitation into our study. - finally. based on your findings why not suggest that public intervention should be targeted at reducing the prevalence of delivery-related claims? Thank you for your comment. I have incorporated this conclusion into our study. Attachments Attachment Submitted filename: commen cesarean.docx https://doi.org/10.1371/journal.pone.0312614.r002
5 Jun 2024 Decision Letter - Andrea Cioffi, Editor PONE-D-24-07510R1Analysis of Medico-Legal Claims Related to Deliveries: Cesarean Section vs. Vaginal DeliveryPLOS ONE Dear Dr. Hantoushzadeh, 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. Formal and structurally relevant revisions are still needed (as indicated by one of the reveiwers). Please pay particular attention to the reviewer’s comments. Please submit your revised manuscript by Jul 20 2024 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, Andrea Cioffi Academic Editor PLOS ONE [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? 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 Reviewer #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: (No Response) ****** 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: Yes Reviewer #2: (No Response) ****** 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 Reviewer #2: (No Response) ****** 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: Reviewer’s comments: Dr Herbert Kayiga General comments: I take this privilege to appreciate authors for revising the manuscript. Most of the comments were not addressed in the current submission. I wonder whether they submitted the correct version of manuscript. Otherwise, I don’t see any improvement made in the revised version. Specific comments: Abstract: Introduction: It would be ideal to mention the authority like the WHO, FIGO or Iranian Ministry of Health said …. rather than “it was said…. I still notice the authors didn’t revise this aspect. The write up on “Chi-square or t-tests were employed to compare factors between paid claims and closed claims” should be put in the methods section. Methods: The revision has been made concerning the study period but other aspects as indicated in the reviewer’s report are not made. See the comments before It would be prudent to indicate where exactly the study was conducted and the setting “was it in private or public health facility setting?” Who was responsible for making the claims? Are there charges implicated with the medico-legal claims? What kind of penalties are available for the implicated healthcare providers? Where there any instrumental deliveries as indicated in the settings? If yes, what proportion of women had instrumental delivery? Results: It’s still quite confusing as the comments raised in the first report are not addressed. Kindly see the points below. It’s not clear whether the reference cadre were surgeons or general doctors. What claims were reported against other staffs? Clarity is needed for closed vs paid claims. Previous comments; I think it would have been so handy knowing how high the claims that accrued when compared to the vaginal delivery. This is however, implied. What was the reference group? What kind of neonatal complications led to the observed high claims as seen in the vaginal route? What other cadres made up for the other staffs? Are these cadres permitted to perform the caesarean sections as the obstetricians? Elaborate more on the difference between closed and paid claims to avoid confusion. The authors mention “However, the number of instrumental deliveries and the reasons for claims, exhibited significant differences between the two groups (P=0.021)”. It’s not clear though the groups that are being compared. How many instrumental deliveries occurred in the caesarean vs. vaginal groups if I can assume that these are the comparative groups? The conclusion: I notice that comments were still not addressed. “The study concluded that caesarean section did not result in an increased risk of medicolegal claims or payment compensation compared to vaginal delivery”, doesn’t appear to be arising from the work. If caesarean section constituted high maternal complications than vaginal delivery, why is it then that it didn’t have higher claims? What complication rates were sufficient to constitute a claim? Introduction/Background: I notice the comments raised are not addressed as expected. I wonder whether authors really saw the comments in this area. The global C/s rate is not mentioned. The role of other staffs is not clear and how they get implicated is not clear. More clarity is needed on the contextual setting in the private and public facilities in Iran in regards to the delivery processes. See comments below; Is it the global perspective that all obstetricians/gynaecologists face higher medico-legal claims more other physicians or a context-based observation? In some countries, surgeons are more at risk than the obstetricians. I think to would be prudent to mention the context or setting of where the reduced mortality following c/sections is observed because in low resource settings, the cost and mortality is way higher following caesarean delivery than observed for vaginal delivery. What is the global caesarean section rate? I would be nice if wherever there’s a comparison, the reference range is mentioned. What is the setting like in Iran? Are there any other cadres allowed to do caesarean sections other than obstetricians? Who conducts vaginal deliveries? Is it still the obstetricians or even the midwives do the job? I would be ideal helping the readership to have glimpse of the delivery processes in Iran. Are the claims similar for elective vs. emergent caesareans? It would have been nice to know of the implications of these medico-legal claims in Iran. Try to introduce the concept of paid and closed claims as indicated in the abstract highlighting the difference. What authority determines the nature of claim that arises? Is it the legal fraternity or the medical council? It is so informative if you can help the readership view the impact through the lenses of the Iranian medico-legal environment. Methods: Comments not addressed. I pray the authors submitted the right version for the review! No effort was made to address the concerns raised. Comments submitted before: I think it’s best to call it methods rather than method. Please add these years in the abstract write up. It would be nice to separate the study design and the ethical approvals. Write these subsections differently and add more details in each of them. Who were the participants? Was it the patients or the affected family members? Was it a document review process or you conducted participant interviews? How did you minimize recall biases since the interviews or document review was 3-5 years after the incidences? How did you identify the potential participants? What measures were put in place to ensure that patient safety was observed? At what point were the discussions held? Was it after the hospital admissions or after discharge from the health facilities? What is the setting of the deliveries? Who takes the mandate to determine whether instrumental, vaginal or caesarean section is to be taken? How do the patients get to obtain care in the Iranian setting? Is at the jurisdiction of the Ministry of Health or the patients? Who determines whether the care accorded to the patient is optimal or not so as to determine to proceed to the next phase of making a legal claim? What was the baseline from which these documents were drawn? I see the other cadres constituted anaesthetists, and midwives. These all have different responsibilities in hospital setting. Did you expect them to have the same weight in terms of claims? It also appears like the cases were obstetric in nature, what kind of gynaecological causes attracted attention in the study period? Were there any other physicians like GPs, Surgeons who had cases in this study period because some of the patients had bowel or bladder injuries? Kindly add a write up on the study settings. It’s not clear who made the decisions on the wards, who runs the care of the patients. Are the claims more in private than the public settings? Is there any correlation between the patient volumes and the legal claims? Who determine the nature of the claims? How does a medical case become a medico-legal claim? Who files the claims? Is it the patients, their lawyers or the hospital that files a claim? How do the cases get up in court? What kind of penalties are issues in court? The inclusion and exclusion criteria are not mentioned in the write up. Clarity is needed to determine the proportion of deliveries that turned out to be claims in the study period. Results: Authors didn’t revise the manuscript as expected. There are typos that need to be revised in the submitted version. There are overlapping tables on subsequent pages like 2. The titles could be improved to have ‘claims’ rather than groups! Significant findings with p-values < 0.05 can be made bold. Comments raised in previous review I think it would nice to write more about the settings of the health facilities in the methods rather than introducing them in the result section for the first time. It’s still not clear if it’s a document review or participant interviews. Please add a table to show the baseline characteristics of the participants. It’s not so clear who the other medical staffs that were involved in the study. What participant characteristic were more likely to make a claim? Prime gravida or multiparous? Best in the introduction of the results section to mention how many deliveries occurred generally, how many SVDs, instrumental deliveries (vacuum or forceps) occurred in the study periods? Who assisted in the deliveries and the key aspects that contributed to a claim and a non-claim? How many closed or paid claims were reported? Were there any c/sections that were done with no indication? I don’t see any IUFD in the table? Did you regard perinatal mortality as IUFDs? Otherwise, how did you capture early neonatal deaths? The two groups being compared that were mentioned to be similar are quite confusing. Did you mean among those that malpractice vs. cases with no malpractice or vaginal vs. c/section? What characteristics were reported among those whose claims were paid? Are these characteristics similar among those who had vaginal vs. caesarean delivery? Adding a multivariate analysis would have improved the overall impact and eliminate any confounding factors. Discussion: Authors haven’t revised the manuscript as expected. Comments from previous review: It would be ideal to recap the overall aim of the study and mention the key significant findings before comparison with the other studies. Knowing the contribution of the other specialties in regards to the claims contributed by obs/gyn would have been so handy at this point. In the write up there are no gyn cases! So how would you conclude that obs has more legal claims than gyn even in the Iranian setting? Which region are you referring to with the CS rate of 48%? Please don’t assume that the readers see through your eyes. Mentioning “Additionally, the rate of paid claims among emergency caesarean sections was similar to that of vaginal deliveries” is not the best comparison. I think I would compare it to the elective cases as the participant characteristics would be different”. I find most of the comparisons in Europe! It would have been interesting to hear how neighbouring countries to Iran or Sub-Saharan Africa would compare in regards to medico-legal claims and obstetric cases. The strength of the study is not water-tight. Having it conducted in Iran doesn’t make it a strength in my view. Is it that there are many claims following c/s in Iran or because WHO thinks the C/s rate is higher than in other settings? The limitations are not so clear as well. How would conducting a case-control study improve the study findings for your study? What did you mean by conduction the whole province evaluation would be a limitation? What challenges did you meet in executing this study? Conclusion: Authors haven’t revised the manuscript as per the expectation. Comments from previous review In my evaluation, the claim that “this study revealed that claims related to deliveries were often associated with perinatal death” can not be drawn from the study findings. Though instrumental delivery is claimed to be a cause of malpractice, the authors make no mention of how many instrumental deliveries were reported among the claims. Clarity needs to be made in this regard. Though the authors claim to have conducted the study to educate the specialists on medico-legal claims, there is no mention that there was a gap in the knowledge among the specialists. I request for recommendations that can be drawn from the study findings that can inform policy and future research. Reviewer #2: I am writing to thank you for your careful consideration of my comments. I am pleased to see that you have addressed all of my concerns. Thank you again for your hard work and dedication. ****** 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: Yes: Dr. Herbert Kayiga Reviewer #2: Yes: Ebisa Zerihun ******** [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: Reviewers comments to the Plos one manuscript_version 2.docx https://doi.org/10.1371/journal.pone.0312614.r003
Revision 2
17 Jun 2024 Author Response Dear Reviewer: Thank you so much for reviewing this article and for your comments. I want to sincerely apologize that I missed addressing your feedback in the previous version. To be honest, I was unable to see your comments in the prior decision letter, which led to this oversight on my part. I feel terrible about that, and I have made every effort to thoroughly incorporate your feedback in this latest revision. Please let me know if there are any other changes or clarifications you would like me to make. I am looking forward to hearing from you. I greatly appreciate the time and consideration you have provided throughout this process. Attachments Attachment Submitted filename: Reviewers comments to the Plos one manuscript_version 2 (1).docx https://doi.org/10.1371/journal.pone.0312614.r004
13 Aug 2024 Decision Letter - Andrea Cioffi, Editor PONE-D-24-07510R2Analysis of Medico-Legal Claims Related to Deliveries: Cesarean Section vs. Vaginal DeliveryPLOS ONE Dear Dr. Hantoushzadeh, 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. Some minor revisions are still needed as indicated by reviewers. Please submit your revised manuscript by Sep 27 2024 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, Andrea Cioffi 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.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #3: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? 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: Yes Reviewer #3: No ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #3: 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: Yes Reviewer #3: 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: Yes Reviewer #3: 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: Reviewer’s comments: Dr Herbert Kayiga General comments: I take this privilege to appreciate authors for revising the manuscript. Most of the comments have been addressed in the current submission. Minor changes are required to ensure consistence in the write up. The grammar needs to be improved and very long sentences shortened. Add more references to the discussion. It’s more of what you found and less of how your findings compare to existing literature. Specific comments: Abstract: Introduction: We can say that “The Iranian National Health Service (NHS) suggested…. Be consistent with the writing “caesarean section”. In some places you write ‘Cesarean sections,” Introduction/Background: Kindly indicate year the global caesarean rate was taken. Discussion: The write up has greatly improved but more references need to be added to beef up arguments. For example “In a previous study conducted by Azimi et al. in Iran, they conducted an observational study on 1,116 medical claims in the field of obstetrics and gynecology over a two-year period”. “Another study conducted in Italy revealed that approximately 30% of complaints related to childbirth resulted in payment compensation. In consistent with our results, the majority of these claims were associated with caesarean section complications, extending beyond the surgical procedure itself”. No references added. Reviewer #3: Researchers have conducted a suitable study for legal issues and complaints about cesarean section and vaginal delivery. Such a conclusion cannot be drawn from the results of this study, and the findings do not match the conclusions. The limitations of the study are not mentioned in detail. Researchers should note that significant statistical difference and significant statistical significance always mean clinically significant difference and may not be clinically significant. It seems that this happened in this study. ****** 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: Yes: Dr Herbert Kayiga Reviewer #3: 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: Reviewers comments to the Plos one manuscript_version 3.docx https://doi.org/10.1371/journal.pone.0312614.r005
Revision 3
6 Sep 2024 Author Response Reviewer #1: Reviewer’s comments: Dr Herbert Kayiga General comments: I take this privilege to appreciate authors for revising the manuscript. Most of the comments have been addressed in the current submission. Minor changes are required to ensure consistence in the write up. The grammar needs to be improved and very long sentences shortened. Add more references to the discussion. It’s more of what you found and less of how your findings compare to existing literature. Thank you so much for your Comments. I sincerely appreciate your valuable comments, which I believe have greatly helped to improve our study. I want to express my deep gratitude for your time and consideration. I have revised the text and included additional relevant references. Specific comments: Abstract: Introduction: We can say that “The Iranian National Health Service (NHS) suggested…. Thank you for your comment. I revised it. Be consistent with the writing “caesarean section”. In some places you write ‘Cesarean sections,” Thank you for your comment. I revised it. Introduction/Background: Kindly indicate year the global caesarean rate was taken. Thank you for your comment. I added the year. Discussion: The write up has greatly improved but more references need to be added to beef up arguments. For example “In a previous study conducted by Azimi et al. in Iran, they conducted an observational study on 1,116 medical claims in the field of obstetrics and gynecology over a two-year period”. “Another study conducted in Italy revealed that approximately 30% of complaints related to childbirth resulted in payment compensation. In consistent with our results, the majority of these claims were associated with caesarean section complications, extending beyond the surgical procedure itself”. No references added. Thank you for your comment. I added the references. Reviewer #3: Researchers have conducted a suitable study for legal issues and complaints about cesarean section and vaginal delivery. Such a conclusion cannot be drawn from the results of this study, and the findings do not match the conclusions. Thank you for your comment. I revised the conclusion. The limitations of the study are not mentioned in detail. Thank you for your comment. I mentioned more detail for limitation. Researchers should note that significant statistical difference and significant statistical significance always mean clinically significant difference and may not be clinically significant. It seems that this happened in this study. Thank you for your comment. Our findings indicate that instrumental delivery is associated with an increased risk of paid claims, a trend also observed in previous studies. While this may evolve in future research, it could be clinically relevant. Attachments Attachment Submitted filename: minor revision.docx https://doi.org/10.1371/journal.pone.0312614.r006
10 Oct 2024 Decision Letter - Andrea Cioffi, Editor Analysis of Medico-Legal Claims Related to Deliveries: Cesarean Section vs. Vaginal Delivery PONE-D-24-07510R3 Dear Dr. Hantoushzadeh, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Andrea Cioffi Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #3: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? 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 #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: 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 #3: 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 #3: 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 #3: (No Response) ****** 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 #3: No ******** https://doi.org/10.1371/journal.pone.0312614.r007
Formally Accepted
8 Nov 2024 Acceptance Letter - Andrea Cioffi, Editor PONE-D-24-07510R3 PLOS ONE Dear Dr. Hantoushzadeh, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Andrea Cioffi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0312614.r008

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