Factors influencing TB treatment interruption and treatment outcomes among patients in Kiambu County, 2016-2019

Evelyn Kimani; Samuel Muhula; Titus Kiptai; James Orwa; Theresa Odero; Onesmus Gachuno

doi:10.1371/journal.pone.0248820

Peer Review History

Original SubmissionOctober 25, 2020
7 Jan 2021 Decision Letter - Eleanor Ochodo, Editor PONE-D-20-33540 Factors influencing TB Treatment interruption and treatment outcomes among patients in Kiambu County, 2016-2019 PLOS ONE Dear Dr. Evelyn Kimani, 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. This is generally a well written paper but we ask that you respond to the editor and peer-reviewer's comments and revise your manuscript accordingly. Please ensure that a spell check is done as a number of grammatical errors have been noted. PLOS ONE does not copy edit accepted manuscripts. We therefore urge that a thorough spell check is done. Do also ensure that you go through the STROBE reporting checklist for observational studies to ensure that all relevant items are reported. Reporting according to STROBE guidelines could be added as a strength of your study in your manuscript. If done we ask that you attach this checklist when resubmitting your manuscript. The manuscript strongly concludes that men are prone to treatment interruption compared to women yet the sample population included 68% men. Wouldn't including more men bias your study findings? We would appreciate this discussion in the limitation section of your manuscript. In addition the peer reviewer has highlighted some changes that warrant your attention. These include a mismatch between statistical figures in the abstract and manuscript, encouragement to reference the latest WHO TB reports and Kenyan National Leprosy and TB program reports, misreporting of acronyms, consistency in the use of HR or aHR among other minor comments. 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If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. 9.) Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files 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: I have appended minor comments onto the manuscript for your action. In summary, the numbers in the results section and abstracts should match. I realize you used HR instead of aHR in the abstract section. Addition of latest reports such as WHO TB Report 2020 and Annual TB Program Report 2020 would greatly suffice in the manuscript. Use of acronyms without declaration is not best writing etiquette. I asked whether CHVs and CHEWs are synonymous or exclusive in the field work that was conducted as part of the study. ****** 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:** Dr. Steve Wandiga [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.0248820.r001
Revision 1
15 Feb 2021 Author Response Dear Editor, Thank you for your review. We have addressed the comments as highlighted in blue. Thank you. 1.) Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Thank you. Yes, this was checked; the manuscript conforms to the PLOS One authors submission guidelines 2.) You indicated that a waiver of consent was granted for your study,; however, you have not indicated whether the institutional review board waived the need for ethical approval. We understand that the framework for ethical oversight requirements for studies of this type may differ depending on the setting and we would appreciate some further clarification regarding your research. Could you please provide further details confirming from your institutional review board or research ethics committee (e.g., in the form of a letter or email correspondence) that ethics review was not necessary for this study? Please include a copy of the correspondence as an "Other" file." Yes there was a waiver; we have included a section on ethical consideration on page 7 and attached the ethical approval letter as an additional file (S2). 3.) We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. If you do not know anyone who can help you do this, you may wish to consider employing a professional scientific editing service. Whilst you may use any professional scientific editing service of your choice, PLOS has partnered with both American Journal Experts (AJE) and Editage to provide discounted services to PLOS authors. Both organizations have experience helping authors meet PLOS guidelines and can provide language editing, translation, manuscript formatting, and figure formatting to ensure your manuscript meets our submission guidelines. To take advantage of our partnership with AJE, visit the AJE website (http://learn.aje.com/plos/) for a 15% discount off AJE services. To take advantage of our partnership with Editage, visit the Editage website (www.editage.com) and enter referral code PLOSEDIT for a 15% discount off Editage services. If the PLOS editorial team finds any language issues in text that either AJE or Editage has edited, the service provider will re-edit the text for free. Upon resubmission, please provide the following: • The name of the colleague or the details of the professional service that edited your manuscript • A copy of your manuscript showing your changes by either highlighting them or using track changes (uploaded as a supporting information file) • A clean copy of the edited manuscript (uploaded as the new manuscript file) Thank you this has been checked, the grammar and the spelling has been checked. 4.) Please provide further details on sample size and power calculations. There was no formal sample size calculation as this was a retrospective study, however the final sample included in the study was assumed to have enough power to detect a difference between the outcome and explanatory variables. This is explained in page 6. 5.) In the statistical analysis section, please clarify which confounders or variables were accounted for in your statistical models. There is a section added on study variables on page 7. All variables were considered important in explaining the outcome of interest and were therefore adjusted for in the cox proportion model. 6.) Please include additional information regarding the data extraction tool used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed the data extraction tool as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information, or include a citation if it has been published previously. We used a treatment interrupters tracer form which is a Ministry of Health approved tool to capture the participant’s details and reasons for treatment interruption; this has been indicated in page 5. This tool has been attached as an additional file (S1) 7.) We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. The data set has been uploaded as an additional file, S3. 8.) Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. Thank you. The Ethics section has been added to the methods section page 7. 9.) Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files The tables have now been included as part of the main manuscript. The STROBE guidelines for cohort studies informed the design and reporting for this study. This has been added as additional file, S3. The manuscript strongly concludes that men are prone to treatment interruption compared to women yet the sample population included 68% men. Wouldn't including more men bias your study findings? We would appreciate this discussion in the limitation section of your manuscript. Majority of treatment interrupters in our study were men, this might have introduced a selection bias in the population included in our study. This statement has been added in page 14. In addition the peer reviewer has highlighted some changes that warrant your attention. These include a mismatch between statistical figures in the abstract and manuscript, encouragement to reference the latest WHO TB reports and Kenyan National Leprosy and TB program reports, misreporting of acronyms, consistency in the use of HR or aHR among other minor comments. Thank you, this has been corrected. We used the current reports as at the time of developing this study. Yours sincerely, Evelyn Kimani Attachments Attachment Submitted filename: Letter to the editor.docx https://doi.org/10.1371/journal.pone.0248820.r002
8 Mar 2021 Decision Letter - Eleanor Ochodo, Editor Factors influencing TB Treatment interruption and treatment outcomes among patients in Kiambu County, 2016-2019 PONE-D-20-33540R1 Dear Dr. Evelyn Kimani, 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, Eleanor Ochodo, M.D., PhD 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: The paper meets the review comments and there are no additional comments for the author and there are no concerns about dual publication, research ethics, or publication ethics from my end. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Dr. Steve Wandiga https://doi.org/10.1371/journal.pone.0248820.r003
Formally Accepted
22 Mar 2021 Acceptance Letter - Eleanor Ochodo, Editor PONE-D-20-33540R1 Factors influencing TB Treatment interruption and treatment outcomes among patients in Kiambu County, 2016-2019 Dear Dr. Kimani: 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. Eleanor Ochodo Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0248820.r004

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