Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: Impact on estimates and treatment needs

Patrícia de Carvalho; Marcelo Bönecker; Gustavo Tello; Jenny Abanto; Luciana Butini Oliveira; Mariana Minatel Braga

doi:10.1371/journal.pone.0234122

Peer Review History

Original SubmissionNovember 20, 2019
21 Jan 2020 Decision Letter - Richard Johannes Wierichs, Editor PONE-D-19-32314 Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: impact on estimates and treatment needs PLOS ONE Dear Mrs Carvalho, 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. Dear Dr. Carvalho, the comments of the reviewer can be found in the attached document. If you have problems to access this document, do not hessitate to contact me. Thank you fo chosing PLOS ONE Best wishes Richard Wierichs We would appreciate receiving your revised manuscript by Mar 06 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. 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The PLOS ONE style templates can be found at http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. 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. [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: 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 ****** 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 manuscript is scientifically sound and the methodology well spelt out with minor correction. however, there is need for the author to send to professional english editor for editing. I have also raised few queries in the manuscript and the authors must address these. ****** 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: Yes: Oyedele Titus Ayodeji [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: PONE-D-19-32314_reviewer plos one.pdf https://doi.org/10.1371/journal.pone.0234122.r001
Revision 1
6 Mar 2020 Author Response Dear Editor in chief, We are very pleased with the possibility of publishing our research on Plos one. All reviewers' comments were analyzed and accepted, as in fact they would improve the quality of the article. In one of the suggestions, the reviewer recommended a review in English by a professional. Therefore, we attached the professional certificate for this review. We are at your disposal for further clarification. Sincerely, The authors Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0234122.r002
2 Apr 2020 Decision Letter - Richard Johannes Wierichs, Editor PONE-D-19-32314R1 Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: impact on estimates and treatment needs PLOS ONE Dear Mrs Carvalho, 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. ============================== Dear Dr. Carvalho, Thank you for adressing the raised question. Attached you'll find new reviewer's comments. Although inviting an additional reviewer I think that your manuscript will benefit by addressing the new questions. Thank you in advance ============================== We would appreciate receiving your revised manuscript by May 17 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. We look forward to receiving your revised manuscript. Kind regards, Richard Johannes Wierichs, DDS 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 #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 #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #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: 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 #2: I read the paper and I found it very interesting. Overall the manuscript is of interest, however I may rise some comments: - Materials and methods Sample size. Taking into account what is written in the introduction and the aim of the paper, there is the possibility that the sample selected is insufficient. The authors should perhaps better explain how they reached the number of 642 children. Please add dat about no responders, children affected by systemic diseases etc. The calibration was carried out not clinically, why? How many examiners? Kappa values have several weak points as described by Feinstein. A.R, Cicchetti. D.V. High agreement but low kappa: I. The Problems of Two Paradoxes. Journal of Clinical Epidemiology 1990; 43: 543-548. Please discuss this issue The methods are not clear. All the health centers had a dental clinic, too? How was the examination organized? Which statistical package was used? -Results The absolute agreement recorded was quite low 0.65, please discuss if a possible bias due to this might be present and how to overcome it. No data regarding the actual disease (dt/ds) of the dmft/s index or about the filling are presented. Moreover, when the authors wrote caries prevalence is caries experience. Please clarify. ****** 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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0234122.r003
Revision 2
16 May 2020 Author Response Dear Reviewers, We respectfully thank the reviewers for their valuable contributions. Their respective suggestions request for correction that certainly qualify and give greater consistency to our text. We describe below the treatment given to each of the amendments proposed by the reviewers for re-submission of manuscript PONE-D-19-32314-R1: "Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: impact on estimates and treatment needs. Changes in the revised manuscript were highlighted. Reviewer #2: I read the paper and I found it very interesting. Overall the manuscript is of interest, however I may rise some comments: Answer: We are very thankful for the reviewer's feedback on our manuscript. We are going to address each specific comment below. - Materials and methods - Sample size. Taking into account what is written in the introduction and the aim of the paper, there is the possibility that the sample selected is insufficient. The authors should perhaps better explain how they reached the number of 642 children. Answer: To sample calculation, we assumed an expected prevalence of 53%. This figure was based on data from 5-year-old children in the last National Survey (SB Brasil 2010) since the municipality had not conducted any epidemiologic surveys on caries before. We also assumed precision of 5% to obtain a confidence interval of 95%. Then, a sample size of 383 children was estimated. Finally, this figure was correct by the design effect of 1.4 and, besides, increased by 20% to compensate possible non-responders. Based on these calculations, the minimum sample size required would be 642 children. As children were selected simultaneously in different centers in the National Vaccination Day, a margin of error for each center was considered. In the end, a total of 664 children were selected. Considering the prevalence assumed as expected is close to 50%, we calculated some figure very close to the largest sample size we could achieve (n=385). We used the webpage Sampsize for the calculations. We understood the reviewer's concern about sample size since we used different cut-off points for estimating the prevalence rates. However, during study planning, we considered that and intentionally opted to make the most conservative calculation, based on the previous prevalence of cavitated lesions in Brazilian children, since it can provide the largest sample size possible. Based on the expose, we consider our sample size is adequate to the study purpose. On the other hand, we decided to clarify some aspects about calculations in the manuscript to clarify this methodological step (Page 5) and also included a more informative reference about the national data (reference 14 – Page 20). (SB Brasil 2010 – 46.6% caries-free – then, caries prevalence considered as 53.6%.) Brasil. Ministério da Saúde. Projeto SB Brasil 2010. Pesquisa Nacional de Saúde Bucal. Resultados Principais. Brasília, 2012. Please add dat about no responders, children affected by systemic diseases etc. Answer: Actually, we had the response rate on page 10. It was 99.85%. Only one child was excluded due to incompleteness in the filled forms. The reason for non-inclusion was on the same page. No children affected by systemic diseases needed to be excluded, although this was one of our selection criteria at the protocol. The calibration was carried out not clinically, why? We used the same methodology from previous surveys in which we obtained good results (1, 2). This methodology showed to be a feasible alternative to shorten or eliminate the need of examinating children several times in the calibration exercises and permits to create a wider variety of clinical examples to calibrate the examiners to use the ICDAS. It seems to provide quite similar reproducibility figures to those observers, further, in vivo (3). Besides, This is specially important considering multiple scores this system requires to be trained, compared with the WHO criteria, for instance. Those are some of the reasons why we chose the laboratory methodology to calibrate the examiners. More detailed advantages may be found in the cited paper (3). A brief justification for the use of this methodology was included in the Methods section (page 5). How many examiners? Kappa values have several weak points as described by Feinstein. A.R, Cicchetti. D.V. High agreement but low kappa: I. The Problems of Two Paradoxes. Journal of Clinical Epidemiology 1990; 43: 543-548. Please discuss this issue Answer: Twenty examiners volunteered to participate as examiners in this survey. We apologize for this missing information. It is now included in this version (page 6). We are thankful for the comment about Kappa values interpretation and agree with him. In this version, we described the prevalence of caries in the sample used to calibration exercises and a more detailed description of the calibration process (Page 7). We also calculated (Page 9) and reported the maximum possible Kappa values in the Results section (Page 10), considering possible imbalance of marginal totals or not perfect symmetric among them. Finally, we included a brief discussion about the impact of these occurrences on Kappa magnitude and, possibly, in our calibration results (Pages 18-19) (4, 5). The methods are not clear. All the health centers had a dental clinic, too? How was the examination organized? Answer: The examination is described in the item "Children's oral examination", in the Methods section. In the revised version, we clarified that each health center had a dental unit in which the examination was performed (1st paragraph, page 8). Which statistical package was used? Answer: For the analyses, we used the statistical software Stata 13.1 (StataCorp LP, College Station, USA) and MedCalc version 18.9 (MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2018). The maximum Kappa values possible (κmax) were calculated given the observed marginal frequencies using the application available in http://vassarstats.net/kappa.html . We apologize for not having included this information in the 1st version, but we did it in the revised one (Page 10). -Results The absolute agreement recorded was quite low 0.65, please discuss if a possible bias due to this might be present and how to overcome it. Answer: Actually, the absolute agreement among examiners in calibration with extracted teeth may be classified as substantial. This level of examiners' agreement might not be perfect, but acceptable considering the index nature (more than one score to classify caries lesions) and the sample created (to permit examiners to be in contact with a diverse possibility of cases). We consider the prevalence we create in the sample, and the variety of scores included influenced these figures. Even being similar to sample prevalence in the survey, the more difficult classifications are usually added to permit examiner's awareness of them. Based on previous observations, we believe similar, or even higher, figures to those observed in laboratory training might be found in clinical assessment following such type of training. Clinical and laboratory assessments offered different challenges(3), and one may compensate the other in terms of final results. Therefore, even costing appropriate training for that, the careful interpretation of reproducibility values under these constraints permits to corroborate the inclusion of initial caries lesions on epidemiological surveys may be a feasible possibility to be used, when necessary. We included these aspects in the Discussion section, Pages 17-18. No data regarding the actual disease (dt/ds) of the dmft/s index or about the filling are presented. Moreover, when the authors wrote caries prevalence is caries experience. Please clarify. Answer: Data about filling may be found on Pages 11-12 when describing the sample according to the presence of fillings, urgent needs and pain episodes. 4.1% of children presented the component f in dmft. In the revised version, we also reported the mean of dmft and its components, using the WHO classification (Page 12). In the present study, we intended to evaluate how using a scoring system to classify lesions with different severities could impact on estimates as caries prevalence and caries experience. As caries prevalence, we considered the number of cases (classified in each threshold) by the number of children evaluated. Then, if one child had at least one caries lesions at that threshold, she/he would be considered as a case. On the other hand, for caries experience, we used the dmft. For the study purpose, according to thresholds, only the component d varied. Then, at each threshold, we counted how many teeth had caries to compose the component d. Other components (mf) were fixed for calculations. We detailed these aspects on Page 9-10 in the revised manuscript. We are at your disposal for any necessary clarifications. Sincerely, The Authors References mentioned in this letter. 1. Braga MM, Oliveira LB, Bonini GA, Bonecker M, Mendes FM. Feasibility of the International Caries Detection and Assessment System (ICDAS-II) in epidemiological surveys and comparability with standard World Health Organization criteria. Caries research. 2009;43(4):245-9. 2. Braga MM, Mendes FM, Martignon S, Ricketts DN, Ekstrand KR. In vitro Comparison of Nyvad's System and ICDAS-II with Lesion Activity Assessment for Evaluation of Severity and Activity of Occlusal Caries Lesions in Primary Teeth. Caries research. 2009;43(5):405-12. 3. Piovesan C, Moro BL, Lara JS, Ardenghi TM, Guedes RS, Haddad AE, et al. Laboratorial training of examiners for using a visual caries detection system in epidemiological surveys. BMC oral health. 2013;13:49. 4. Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Physical therapy. 2005;85(3):257-68. 5. Feinstein AR, Cicchetti DV. High agreement but low kappa: I. The problems of two paradoxes. Journal of clinical epidemiology. 1990;43(6):543-9. Attachments Attachment Submitted filename: Response to Reviewers 2nd revision.docx https://doi.org/10.1371/journal.pone.0234122.r004
20 May 2020 Decision Letter - Richard Johannes Wierichs, Editor Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: impact on estimates and treatment needs PONE-D-19-32314R2 Dear Dr. Carvalho, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Richard Johannes Wierichs, DDS Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0234122.r005
Formally Accepted
10 Jun 2020 Acceptance Letter - Richard Johannes Wierichs, Editor PONE-D-19-32314R2 Inclusion of initial caries lesions in a population-based sample of Brazilian preschool children: impact on estimates and treatment needs Dear Dr. Carvalho: 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. Richard Johannes Wierichs Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0234122.r006

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