A cross sectional study to examine factors influencing COVID-19 vaccine acceptance, hesitancy and refusal in urban and rural settings in Tamil Nadu, India

Ashish Joshi; Krishna Mohan Surapaneni; Mahima Kaur; Ashruti Bhatt; Denis Nash; Ayman El-Mohandes

doi:10.1371/journal.pone.0269299

Peer Review History

Original SubmissionNovember 9, 2021
15 Dec 2021 Decision Letter - Sheikh Mohd Saleem, Editor PONE-D-21-35060A cross sectional study to examine factors influencing COVID-19 vaccine acceptance, hesitancy and refusal in urban and rural settings in Tamil Nadu, IndiaPLOS ONE Dear Dr. Joshi, 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. ============================== ACADEMIC EDITOR: As the study has employed a big sample size and it has been found that the tables and the sample (n) does not match. Kindly clarify on similar terms. Also, provide ethical clearance no from the institution in the revised manuscript. Such issues would be dealt seriously in the revised version. ============================== Please submit your revised manuscript by Jan 29 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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. 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Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. 5. 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. [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: Yes Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: 1. The study has been carried out in a rural area in Tamil Nadu. Shouldn't the corresponding author be from the institute where the data has been collected? 2. The study has been carried out in government PHC's across Tamil Nadu, however there has been no mention of permission being granted/ ethical clearance frim the government to carry out this study. Kindly clarify. 3. Were pregnant and lactating women included in the study? If they were, it would have contributed to more hesitancy. At this time, vaccines were still not recommended for pregnant or lactating women. 4. The sample size is 3130. However, all tables that have been included in the study do not have 'n' specified in the heading and the numbers in the cells don't add up to 3130. Kindly clarify. (Table 1-4) 5. This study is very extensive and has collected a lot of data. However, I think there is too much data for one paper. The emphasis should be on vaccine naiive individuals with few causes of hesitancy being studied. 6. Patients who were vaccinated with the COVID vaccine before and questions about cost and effectiveness are best left to another paper. Table 2, 7 and table 4 do not contribute valuable data. 7. The numbers in Table 5a do not add up to 3130. Table 5 b can be added to supplementary data or summarized into one line at the end. 8. This paper has a good concept but has too much data. Was a focus group discussion held prior to the study to determine the main causes of vaccine hesitancy? That would help guide us better on what variables to concentrate on. 9. Discussion is too long. Kindly shorten it to be shorter and clearer. Reviewer #2: 1) Fragmentation of sentence needed in line 74-75. 2) Lines 86-93 are misplaced. It would be wise to elaborate on it in the "Discussion". 3) Line 99-100- Check for grammar. 4) Lines 130-152 are misplaced and irrelevant. 5) Choose only one format to discuss the data in lines 298-304. (e.g.- either "10%" or "ten percent") 6) Repetitive use of words that convey the same message ("efficacy" and "effectiveness") in lines 299-301 should be avoided. Kindly re-phrase the sentence. ****** 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:** Aditya Anurag [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.0269299.r001
Revision 1
28 Jan 2022 Author Response Reviewer #1: 1. The study has been carried out in a rural area in Tamil Nadu. Shouldn't the corresponding author be from the institute where the data has been collected? Response: The study has been carried out in both rural and urban settings. The corresponding author is responsible for the conceptualization of the study, study design, research questions and the institute in Tamil Nadu is responsible for the implementation of the study protocol and the data collection. 2. The study has been carried out in government PHC's across Tamil Nadu, however there has been no mention of permission being granted/ ethical clearance from the government to carry out this study. Kindly clarify. Response: Yes, the study was carried out after permission was granted by the PHCs. 3. Were pregnant and lactating women included in the study? If they were, it would have contributed to more hesitancy. At this time, vaccines were still not recommended for pregnant or lactating women. Response: We thank the reviewer for identifying the missing component in the exclusion criteria. The pregnant and lactating women were excluded from the study. The exclusion criteria have been revised accordingly. 4. The sample size is 3130. However, all tables that have been included in the study do not have 'n' specified in the heading and the numbers in the cells don't add up to 3130. Kindly clarify. (Table 1-4) Response: We appreciate the feedback from the reviewer. As suggested, we have specified the ‘n’ in each heading of the table. Since, the data had missing variables the it was analysed separately for every variable. Therefore, the total sample size does not match the ‘n’ for all the variables included in the study. 5. This study is very extensive and has collected a lot of data. However, I think there is too much data for one paper. The emphasis should be on vaccine naiive individuals with few causes of hesitancy being studied. Response: As suggested in the following comment, we have deleted table 7 and 8 to shorten the paper so that it contains valuable data. Table 2 has been added as a supplementary material. 6. Patients who were vaccinated with the COVID vaccine before and questions about cost and effectiveness are best left to another paper. Table 2, 7 and table 4 do not contribute valuable data. Response: As suggested in the following comment, we have deleted table 7 and 8 to shorten the paper so that it contains valuable data. Table 2 has been added as a supplementary material. Table 4 talks about the vaccine acceptance and hesitancy hence we have not deleted the table. 7. The numbers in Table 5a do not add up to 3130. Table 5 b can be added to supplementary data or summarized into one line at the end. Response: Since, the data had missing variables the it was analysed separately for every variable. As suggested, we have added the Table5b to the supplementary data. 8. This paper has a good concept but has too much data. Was a focus group discussion held prior to the study to determine the main causes of vaccine hesitancy? That would help guide us better on what variables to concentrate on. Response: We thank the reviewer for the feedback. But we did not hold a focus group discussion prior to the study. Only open-ended questions were asked to determine the main causes of vaccine hesitancy among the population. 9. Discussion is too long. Kindly shorten it to be shorter and clearer. Response: As suggested, we have shortened the discussion. Additionally, we have divided the discussion into conclusion as well to clearly summarize the key message. Reviewer #2: 1) Fragmentation of sentence needed in line 74-75. Response: As suggested, we have fragmented the sentence as below: “Concerns about vaccine hesitancy are growing globally, especially in populous countries with low literacy. This prompted the WHO to declare it among the top ten health threats in 2019.” 2) Lines 86-93 are misplaced. It would be wise to elaborate on it in the "Discussion". Response: We appreciate the reviewer’s comment. But, the lines were added to state the prevalence of the vaccine hesitancy rates across the world so as it give an overview of the studies conducted in this domain. Besides, we have mentioned and elaborated the prevalence of the vaccine hesitancy in the “Discussion” as well. 3) Line 99-100- Check for grammar. Response: As suggested by the reviewer, we have corrected the lines to: “The emergence of contagious and/or virulent variants, lower immunity of the vulnerable individuals, and lack of participation in COVID-19 preventive measures may have contributed to a resurgence of the COVID-19 cases”. 4) Lines 130-152 are misplaced and irrelevant. Response: We thank the reviewer for the comment. The lines were added to provide a brief background of the COVID-19 infection and the vaccination rates in the state to strengthen the rationale behind conducting the cross-sectional study. 5) Choose only one format to discuss the data in lines 298-304. (e.g.- either "10%" or "ten percent") Response: As suggested we have edited the format of the data to maintain the consistency. 6) Repetitive use of words that convey the same message ("efficacy" and "effectiveness") in lines 299-301 should be avoided. Kindly re-phrase the sentence. Response: As suggested the lines have been re-phrased. Attachments Attachment Submitted filename: Response_To_Reviewers.docx https://doi.org/10.1371/journal.pone.0269299.r002
4 Mar 2022 Decision Letter - Sheikh Mohd Saleem, Editor PONE-D-21-35060R1A cross sectional study to examine factors influencing COVID-19 vaccine acceptance, hesitancy and refusal in urban and rural settings in Tamil Nadu, IndiaPLOS ONE Dear Dr. Joshi, 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. ============================== ACADEMIC EDITOR: Please insert comments here and delete this placeholder text when finished. Be sure to: Kindly address each comment from the reviewer in the next revision which you shall submit. Please ensure that your decision is justified on PLOS ONE’s publication criteria and not, for example, on novelty or perceived impact. For Lab, Study and Registered Report Protocols: These article types are not expected to include results but may include pilot data. ============================== Please submit your revised manuscript by Apr 18 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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, Sheikh Mohd Saleem, MBBS, MD Academic Editor PLOS ONE Additional Editor Comments (if provided): The article still needs some modifications and revision. Kindly address each comment of the reviews seriously. A major revision is warranted. [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: 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 #1: Yes Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 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: 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 #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thank you for the changes that have been made. I still feel the article is long and certain points are being repeated in the results section and discussion section. 1. Line 382-384 and 399-402 can be removed. This has already been explained in the comments section. 2. Line 494 comments on a 'third' pandemic wave. Consider changing it to fourth, since we are at the tail end of the third wave in India. 3. To make the article comprehensive and easier to read, I would suggest shortening the text explanation before each table. The same information is again listed out in the discussion section. 4. Ethical clearance has been obtained from the institution. However, urban and rural PHC's are not run by the institution (Panimalar) but are run by the State Government of Tamil Nadu. Would a separate ethical clearance be required from the State government to utilize data of patients attending their PHC's? Reviewer #2: The manuscript is still a bit lengthy and sometimes wavers from the topic. Lines 110-120 in Introduction and lines 144-155 in Materials and Methods may be removed/cut-short as they seem inappropriately placed and are making the manuscript unnecessarily lengthy. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes:** ADITYA ANURAG [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.0269299.r003
Revision 2
3 May 2022 Author Response Reviewer #1: Thank you for the changes that have been made. I still feel the article is long and certain points are being repeated in the results section and discussion section. 1. Line 382-384 and 399-402 can be removed. This has already been explained in the comments section. Response: We have deleted the suggested lines. 2. Line 494 comments on a 'third' pandemic wave. Consider changing it to fourth, since we are at the tail end of the third wave in India. Response: Thank you for the feedback. We can changed the third wave to fourth COVID-19 pandemic wave. 3. To make the article comprehensive and easier to read, I would suggest shortening the text explanation before each table. The same information is again listed out in the discussion section. Response: We thank the reviewer for the feedback. We have shorten the text explanation before each table and deleted the few lines listed again in the discussion. We have listed only the key findings in the text explanation before each table. 4. Ethical clearance has been obtained from the institution. However, urban and rural PHC's are not run by the institution (Panimalar) but are run by the State Government of Tamil Nadu. Would a separate ethical clearance be required from the State government to utilize data of patients attending their PHC's? Response: The Institutional Ethics Committee of Panimalar Medical College Hospital & Research Institute (PMCHRI-IHEC) has been approved and recognized by the CDSCO, NECRBHR, Department of Health Research, Government of India. The PMCHRI-IHEC is an independent authority to approve the clinical trials or any protocol involving the human subjects as study participants. Once the protocol is approved by the IHEC, the study can be carried out as per the approved protocol without any deviation across the state as mentioned in the study protocol and as approved by the IHEC. The letter stating the same has been uploaded in the supporting document. Reviewer #2: The manuscript is still a bit lengthy and sometimes wavers from the topic. Lines 110-120 in Introduction and lines 144-155 in Materials and Methods may be removed/cut-short as they seem inappropriately placed and are making the manuscript unnecessarily lengthy. Response: Thank you for the feedback. We have removed the suggested lines (110-120) to make the article comprehensive. We have cut-short the lines 144-155. We have also deleted the lines 133-137 to shorten the manuscript. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0269299.r004
19 May 2022 Decision Letter - Sheikh Mohd Saleem, Editor A cross sectional study to examine factors influencing COVID-19 vaccine acceptance, hesitancy and refusal in urban and rural settings in Tamil Nadu, India PONE-D-21-35060R2 Dear Dr. Joshi, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Sheikh Mohd Saleem, MBBS, MD 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 #1: 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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: All questions have been addressed. Introduction can be shortened if possible. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No https://doi.org/10.1371/journal.pone.0269299.r005
Formally Accepted
31 May 2022 Acceptance Letter - Sheikh Mohd Saleem, Editor PONE-D-21-35060R2 A cross sectional study to examine factors influencing COVID-19 vaccine acceptance, hesitancy and refusal in urban and rural settings in Tamil Nadu, India Dear Dr. Joshi: 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. Sheikh Mohd Saleem Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0269299.r006

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