Maternal counseling for preterm deliveries, assessing an effective method of counseling: A randomized trial

Shaaista Budhani; Mopelola Akintorin; Kenneth Soyemi; Louis Fogg; Mary Arlandson; Rajeev Kumar

doi:10.1371/journal.pone.0294168

Peer Review History

Original SubmissionFebruary 2, 2023
2 Feb 2023 Author Response https://doi.org/10.1371/journal.pone.0294168.r001
2 May 2023 Decision Letter - Dumbani Kayira, Editor PONE-D-22-35479MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL.PLOS ONE Dear Dr. Kumar, 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 16 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, Dumbani Lyspin Kayira, MBBS, MSc, FCPaed(SA) Guest Editor PLOS ONE 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 . 2. In the ethics statement in the Methods, you have specified that verbal consent was obtained. Please provide additional details regarding how this consent was documented and witnessed, and state whether this was approved by the IRB 3. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: - https://doi.org/10.1016/j.jpeds.2016.08.006 - https://doi.org/10.1542/peds.2015-2336 - http://weirdthings.com/t8oxgd0/interpretation-of-wilcoxon-signed-rank-test In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. 4. Please include your ethics statement in the Methods section of your manuscript. In the Methods section of your revised manuscript, please include the full name of the institutional review board or ethics committee that approved the protocol, the approval or permit number that was issued, and the date that approval was granted. 5. Please upload the trial protocol and the ethics documents you submitted as separate files. 6. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. 7. Please include a separate caption for each figure in your manuscript. 8. Please upload a copy of Figure 2, to which you refer in your text on page 7. If the figure is no longer to be included as part of the submission please remove all reference to it within the text. 9. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments (if provided): Abstract Major comment: The results section within the abstract seems to focus on the secondary outcome. It does not present actual results for the primary outcome. Only a conclusion is presented saying there was no significant difference in recall rates between the two groups (which means the two counseling methods had similar effectiveness). Please present in a very concise manner the actual rates or measures of effect and/or p-values on which this conclusion is based. The results section should share the actual results on which the conclusion is based, as the abstract is stand-alone. Introduction Minor comment: As you present the purpose of the study at the end of the introduction, please very briefly touch on specifically assessing “recall rates” for your primary outcome. That is the main element you evaluated. Minor comment: You have presented the purpose as a question. Please end with a question mark for punctuation. Methods Minor comment: Please provide a reference for the validated knowledge questionnaire which you mention was used in a previously published study (reference to that previous study) Minor comment: Please provide a reference for the Spanish translation of the same knowledge questionnaire which you mention you validated in a pilot study at your institution (reference to this validation pilot study for the Spanish version) Results Major comment: You present secondary outcome (anxiety score) before the primary outcome, and in more detail. The primary outcome (recall rates) is only found as one sentence (more of a conclusion) in the last paragraph of the results section; there is no table or any number provided on the primary outcome. Yet as the primary outcome even your sample size calculation was based on detecting a knowledge difference between the two groups. Please swap around. Start with the primary outcome (recall rates) and provide adequate results on recall rates across the two groups for short term problems, long term problems, intervention, and incidence rates (provide numbers or even a table, and not just one concluding sentence in the last paragraph) Minor comment: I am not sure what Figure 2 refers to. Please double check if there should be a reference to figure 2. [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: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 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 ****** 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 ****** 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 paper reports on a small study which compares the effectiveness of verbal counselling versus verbal plus supplemental material for women threatened with preterm delivery. They found no significant differences. The study was reasonably well carried out but is not of much general interest to the broader medical/scientific community. Other points. There was no assessment of the literacy abilities of the individual in the two groups, and whether that affected their understanding of the written materials. The STAI inventory (p6). is the short version of the STAI used based on the State rather than the Trait scale? ****** 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 ******** [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.0294168.r002
Revision 1
13 Oct 2023 Author Response MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL. Dear Editors and Reviewers, Thank you for your time and consideration in reviewing our manuscript. We appreciate your feedback. All comments have been addressed. Please see below for our responses. Comments: 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. Response: Manuscript has been updated to meet PLOS ONE’s style as required. 2. In the ethics statement in the Methods, you have specified that verbal consent was obtained. Please provide additional details regarding how this consent was documented and witnessed, and state whether this was approved by the IRB Response: Verbal consent explanation has been updated in the manuscript. 3. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: - https://doi.org/10.1016/j.jpeds.2016.08.006 - https://doi.org/10.1542/peds.2015-2336 - http://weirdthings.com/t8oxgd0/interpretation-of-wilcoxon-signed-rank-test Response: Plagiarism has been addressed. In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. Response: Duplicated text has been edited all the work has been cited (9,10). 4. Please include your ethics statement in the Methods section of your manuscript. In the Methods section of your revised manuscript, please include the full name of the institutional review board or ethics committee that approved the protocol, the approval or permit number that was issued, and the date that approval was granted. Response: Ethics statement has been added. IRB name has been added. 5. Please upload the trial protocol and the ethics documents you submitted as separate files. Response: Protocol and Ethics documents have been submitted as separate files. 6. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. Response: Data has been uploaded to Mendley. Soyemi, Kenneth (2023), “MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL.”, Mendeley Data, V1, doi: 10.17632/ry4v5b3f2h.1 7. Please include a separate caption for each figure in your manuscript. Response: Each figure has its own caption now. Figure has been moved to supplemental information. 8. Please upload a copy of Figure 2, to which you refer in your text on page 7. If the figure is no longer to be included as part of the submission please remove all reference to it within the text. Response: Figure 2 reference has been removed. 9. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Response: Captions for supporting documents have been added at the end of manuscript. S1 Protocol: Study Protocol. S1 Appendix: Sample counseling material S1_Fig.pdf: Sample picture booklet S2 Appendix: Sample questionnaire Additional Editor Comments (if provided): Abstract Major comment: The results section within the abstract seems to focus on the secondary outcome. It does not present actual results for the primary outcome. Only a conclusion is presented saying there was no significant difference in recall rates between the two groups (which means the two counseling methods had similar effectiveness). Please present in a very concise manner the actual rates or measures of effect and/or p-values on which this conclusion is based. The results section should share the actual results on which the conclusion is based, as the abstract is stand-alone. Response: Result section has been modified to reflect primary outcome. Introduction Minor comment: As you present the purpose of the study at the end of the introduction, please very briefly touch on specifically assessing “recall rates” for your primary outcome. That is the main element you evaluated. Response: Introduction was modified to reflect “Recall rates” as primary outcome. Minor comment: You have presented the purpose as a question. Please end with a question mark for punctuation. Response: Punctuation has been added. Methods Minor comment: Please provide a reference for the validated knowledge questionnaire which you mention was used in a previously published study (reference to that previous study) Minor comment: Please provide a reference for the Spanish translation of the same knowledge questionnaire which you mention you validated in a pilot study at your institution (reference to this validation pilot study for the Spanish version) Response: Reference citation has been added for knowledge questionnaire on page. (6) Response: Reference and citation added for Spanish questionnaire. (10) Results Major comment: You present secondary outcome (anxiety score) before the primary outcome, and in more detail. The primary outcome (recall rates) is only found as one sentence (more of a conclusion) in the last paragraph of the results section; there is no table or any number provided on the primary outcome. Yet as the primary outcome even your sample size calculation was based on detecting a knowledge difference between the two groups. Please swap around. Start with the primary outcome (recall rates) and provide adequate results on recall rates across the two groups for short term problems, long term problems, intervention, and incidence rates (provide numbers or even a table, and not just one concluding sentence in the last paragraph) Response: Result section modified to reflect primary outcome and table (table 2) was added to reflect the results of primary with p values. Minor comment: I am not sure what Figure 2 refers to. Please double check if there should be a reference to figure 2. Response: Figure 2 refence was removed. [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: Yes 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know 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 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 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 paper reports on a small study which compares the effectiveness of verbal counselling versus verbal plus supplemental material for women threatened with preterm delivery. They found no significant differences. The study was reasonably well carried out but is not of much general interest to the broader medical/scientific community. Response: Counseling of parents facing a threatened preterm delivery is a big challenge for neonatologists, as anxiety levels are very high. Parents are very emotional at this time, as there life is about to change and they could be numb to information provided. This study explored the methods of delivering vast information in concise and easily understandable way to a innercity population. This study adds to pool of existing studies and raises a point of exploring methods that deliver information in more effective way. Other points. There was no assessment of the literacy abilities of the individual in the two groups, and whether that affected their understanding of the written materials. Response: Parents education level taken as proxy of their literacy abilities. The STAI inventory (p6). is the short version of the STAI used based on the State rather than the Trait scale? Response: STAI inventory (p6) has a correlation coefficient of 0.9 with full version and is used in situations where full form is inappropriate similar to our study population Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum in: Br J Clin Psychol. 2020 Jun;59(2):276. PMID: 1393159. 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 6. Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012;129(5):e1269-74. Epub 20120409. doi: 10.1542/peds.2011-1702. PubMed PMID: 22492766. 9. Akintorin M. Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling Bethesda, MD: National Library of Medicine; 2016 [cited 2016]. Available from: https://clinicaltrials.gov/study/NCT02707237. 10. Rajeev Kumar MA, Christian Castillo, Medha Kamat, LouFogg,. Randomized control study comparing different methods of counseling in mothers at risk of imminent preterm delivery Pediatric Academic Societies (PAS); May 3rd-May 6th 2014; Vancouver , Canada2014. Attachments Attachment Submitted filename: Rebuttal letter.docx https://doi.org/10.1371/journal.pone.0294168.r003
18 Dec 2023 Decision Letter - Dumbani Kayira, Editor PONE-D-22-35479R1MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL.PLOS ONE Dear Dr. Kumar, 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. ============================== Note that this round of feedback follows from a rigorous statistical review. Please address the statistical recommendations provided. We hope that this will strengthen the science in this work that you have done. ============================== Please submit your revised manuscript by Feb 01 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. We look forward to receiving your revised manuscript. Kind regards, Dr. Dumbani Kayira, MBBS, MSc, FCPaed(SA) Guest 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 #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 #2: No ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: No ****** 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 #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 #2: No ****** 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 #2: A two-arm randomized clinical trial was conducted which aimed to compare the effectiveness of verbal counseling to verbal counseling plus written and pictorial information on preterm deliveries. The conclusions are unclear. Major revision: Test the interaction of group by time rather than repeatedly testing differences in time and by group. If the interaction effect is significant, provide an interpretation of the results, but do not test main effects because the tests for main effects are uninteresting in light of significant interactions. If interaction effects are non-significant, drop the interaction effects from the model and test the main effects. Determining which results to present when testing interactions is often a multi-step process. Minor revisions: 1- Study Design section: Indicate if block randomization was used. If so, state the block size. 2- Data Analysis section: - State the alpha level and statistical testing method used in sample size calculation. - Qualitative variables are typically expressed as frequencies and percentages. - The independent t-test is written as “t-test”. - The complete name of the Mann-Whitney test is the Mann-Whitney U test and it is used to compare differences in central tendencies rather than means. 3- The following sentence is unclear: “The p tests for the Shapiro-Wilk test for the continuous variables were p = 0.07 for Age; p = 0.00 for hours, gravida, and gestational age; p = 0.01 and 0.03 for pre and Post STAI scores meaning that these variables were not normally distributed.” 4- P-values never equal zero; express small p-values as < 0.001. 5- The Wilcoxon Signed Rank test is a nonparametric test which compares central tendencies between two groups. 6- Add numeric p-values to Table 1. 7- Cite the statistical software used for the analysis. 8- Thoroughly proofread the manuscript. Provide as much clarity as possible. A few noted grammatical mistakes follow. - Study Design section: Be consistent with formats for the months of January and September. - A few sentences are missing a period at the end. 9- To assist in the review process, add line numbering to the document. ****** 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 #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.0294168.r004
Revision 2
1 Mar 2024 Author Response Dear Editor, I have edited the manuscript as requested for grammatical errors, as well as statistical changes as requested. I hope I have answered all the questions to your satisfaction. Kind Regards Rajeev Kumar Attachments Attachment Submitted filename: Rebuttal letter 2-28-2024.docx https://doi.org/10.1371/journal.pone.0294168.r005
11 Mar 2024 Decision Letter - Dumbani Kayira, Editor PONE-D-22-35479R2MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL.PLOS ONE Dear Dr. Kumar, 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 Apr 25 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. The manuscript has been considerably strengthened through the various revisions to date. The last area we are working on is the statistical rigour. This is a clinical trial. PLOS ONE pays appropriate attention to the rigor of clinical trials and routinely assigns a Statistical Reviewer to assess the trial reporting and statistics. The main comment that has not been addressed was also put forward on the last review and it is about testing for interaction of group by time as you will see in the reviewer's feedback below. I strongly recommend if you may work with a statistician to look at this comment about testing for interaction. We hope that this makes the best use of the good data that you are sharing. 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, Dr. Dumbani Kayira. MBBS, MSc, FCPaed(SA) Guest 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 #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 #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? 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 #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 #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 #2: Minor revisions: 1- Line 156: Wilcoxon is misspelled. 2- Line 156: Consider a test of the interaction effect of group by time instead of repeatedly using paired t-tests. "The paired t- test or the Wilcoxson rank signed test was used to determine if there was a statistical difference in the mean pre and post STAI tests for both intervention groups." 3- Line 180: The Wilcoxon signed rank test is not used to compare differences in means. It compares differences in central tendencies. ****** 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 #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.0294168.r006
Revision 3
27 Mar 2024 Author Response Dear Editor, We have revised the statistics with the help of professional statistician and all the minor changes have been addressed. Kind Regards Rajeev Kumar Attachments Attachment Submitted filename: Rebuttal letter 3-27-2024.docx https://doi.org/10.1371/journal.pone.0294168.r007
11 Apr 2024 Decision Letter - Dumbani Kayira, Editor MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL. PONE-D-22-35479R3 Dear Dr. Kumar, 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, Dr. Dumbani Kayira, MBBS, MSc, FC Paed(SA) Guest Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0294168.r008
Formally Accepted
Acceptance Letter - Dumbani Kayira, Editor PONE-D-22-35479R1 MATERNAL COUNSELING FOR PRETERM DELIVERIES, ASSESSING AN EFFECTIVE METHOD OF COUNSELING: A RANDOMIZED TRIAL. Dear Dr. Kumar: 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. Dumbani Lyspin Kayira Guest Editor PLOS ONE https://doi.org/10.1371/journal.pone.0294168.r009

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .