Impact of negative tuberculin skin test on growth among disadvantaged Bangladeshi children

S. M. Abdul Gaffar; Mohammod Jobayer Chisti; Mustafa Mahfuz; Tahmeed Ahmed

doi:10.1371/journal.pone.0224752

Peer Review History

Original SubmissionJuly 30, 2019
4 Sep 2019 Decision Letter - HASNAIN SEYED EHTESHAM, Editor PONE-D-19-21500 Impact of negative tuberculin skin test on growth among disadvantaged Bangladeshi children PLOS ONE Dear Dr. Gaffar, 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. We would appreciate receiving your revised manuscript by Oct 19 2019 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. 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Thank you for your ethics statement: 'Ethical approvals were obtained from Research Review Committee (RRC) and Ethical Review Committee (ERC) of icddr,b (protocol no: PR-16007; Version 1.03; March 1, 2016). Each participant enrolled in BEED study is treated according to what is morally right and proper. Separate consent forms are being used for children and adult participants. After complete disclosure, a signed informed consent statement is obtained from each subject. For minors, informed consent is obtained from the parents or authorised legal guardian of the subject. 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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 Reviewer #2: No ******** 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). 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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: This study has aimed to explore the determinants of TST positivity in children. TB screening as one of the secondary causes of malnutrition was performed on 243 stunted or at-risk of stunting children. Screened children underwent a chest radiograph (CXR), TST, and physical examination for TB diagnosis. The current study has examined the growth differences between TST-positive and TST-negative undernourished children aged 12 to 18 months who received nutritional intervention prospectively for 90 feeding days. This is the first study which intended to estimate an impact of TST positivity on children’s growth in response to a community-based nutritional intervention. Although the current study was designed towards understanding the tuberculosis in malnutrition children, unexpectedly, nothing significant found in the study. This study should be published in a medical journal for reporting the relationship between tuberculosis and malnutrition in children, but the study is not fit for an international peer-reviewed journal like PLOS ONE. Reviewer #2: The manuscript presented no new significant findings. Moreover, it is already known fact to use INH prophylaxis in paediatric populations. The control group lacks significant number of cases to justify and establish the hypothesis raised. The study also document several limitations, raising questions on study design and case controlling. Outcome is not justified significantly. It is encouraged to increase the study participants and include more objectives rather than only nutritional aspects in paediatric populations. ****** 6. 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Revision 1
8 Oct 2019 Author Response Reviewers’ comments to PLOS ONE questions and to the author with author responses: Question 1: Is the manuscript technically sound, and do the data support the conclusions? Reviewer #1: Yes Response: Thank you. Reviewer #2: No Response: Thank you. We have now revised the conclusion in the text for better clarity and hope revised conclusion will qualify for the publication. Question 2: Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Response: Thank you. Reviewer #2: Yes Response: Thank you. Question 3: Have the authors made all data underlying the findings in their manuscript fully available? Reviewer #1: Yes Response: Thank you. Reviewer #2: No Response: Thank you. The full dataset was uploaded during the manuscript submission process. Question 4: Is the manuscript presented in an intelligible fashion and written in standard English? Reviewer #1: Yes Response: Thank you. Reviewer #2: Yes Response: Thank you. 5. Review Comments to the Author Reviewer #1: This study has aimed to explore the determinants of TST positivity in children. TB screening as one of the secondary causes of malnutrition was performed on 243 stunted or at-risk of stunting children. Screened children underwent a chest radiograph (CXR), TST, and physical examination for TB diagnosis. The current study has examined the growth differences between TST-positive and TST-negative undernourished children aged 12 to 18 months who received nutritional intervention prospectively for 90 feeding days. This is the first study which intended to estimate an impact of TST positivity on children’s growth in response to a community-based nutritional intervention. Although the current study was designed towards understanding the tuberculosis in malnutrition children, unexpectedly, nothing significant found in the study. This study should be published in a medical journal for reporting the relationship between tuberculosis and malnutrition in children, but the study is not fit for an international peer-reviewed journal like PLOS ONE. Response: Thanks for your overall positive comments. Our primary objective was to examine the growth differences between TST-positive and TST-negative undernourished children aged 12 to 18 months who received nutritional intervention prospectively for 90 feeding days in the parent Bangladesh Environmental Enteric Dysfunction (BEED) study. We observed statistically significant improvement of length for age Z-score (LAZ) and weight for age Z-score (WAZ) among the TST-negative participants at the end of intervention period. Our secondary objective was to explore the determinants of TST positivity at enrollment. We observed several factors (maternal age, education, and occupation) that were significantly associated with TST positivity in our study children during univariate logistic regression analysis. However, as you mentioned, multivariable logistic regression failed to identify any association of those factors with TST positivity. As you rightly noticed this is the first study which is intended to estimate an impact of TST positivity on children’s growth in response to a community-based nutritional intervention, and importantly, the objectives of the study are aligned with the methods, results, and conclusion, we feel the revised manuscript bears merit for publication in the PLOS ONE. Reviewer #2: The manuscript presented no new significant findings. Moreover, it is already known fact to use INH prophylaxis in paediatric populations. The control group lacks significant number of cases to justify and establish the hypothesis raised. The study also documents several limitations, raising questions on study design and case controlling. Outcome is not justified significantly. It is encouraged to increase the study participants and include more objectives rather than only nutritional aspects in paediatric populations. Response: Thank you. Improved growth velocity in absence of TST positivity and/or active PTB disease below the age of two years is a novel finding which may imply immense public health implications. Moreover, we were unable to ascertain household contact of most of the TST-positive and clinical PTB cases in our study. This observation indicates that a considerable number of undiagnosed adult TB cases may be still available in the community. Contact tracing system is not well conducted in developing countries with a high burden of tuberculosis cases. Thus, our finding underscores the importance to screen the undernourished children for latent pulmonary tuberculosis with or without smear-positive adult household contact who may be benefited from INH prophylaxis, already recommeneded by the WHO. We have revised our conclusion on the basis of your recommendation. Now, we also calculated the sample size using the formula of a descriptive study: n = Z² p(1-p)/d² and found 163 participants is sufficient for this type of screening program [where, n = required sample size, Z = standard normal variant value for 95% confidence level (1.96), p = expected proportion of the condition (12.4% according to a tuberculin survey conducted in Bangladesh), and d = precision (0.05)]. However, we screened 243 children and we believe the available sample will allow us to perform a case-control analysis between TST-positive and TST-negative participants, nested in the main BEED study. We have incorporated this sample size calculation in the text on page 4. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0224752.r002
22 Oct 2019 Decision Letter - HASNAIN SEYED EHTESHAM, Editor Impact of negative tuberculin skin test on growth among disadvantaged Bangladeshi children PONE-D-19-21500R1 Dear Dr. Gaffar, 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, HASNAIN SEYED EHTESHAM Academic Editor PLOS ONE Additional Editor Comments (optional): This manuscript describes the study on the impact of the TST positivity on children’s growth in response to community based intervention. This is one of the first study of its kind and has value in terms of management of tuberculosis. The manuscript has been comprehensively revised based on the suggestions of the Reviewers. They have highlighted the positive aspects of the manuscript and also calculated the sample size which enable appropriate conclusions to be drawn. Other queries have also been addressed. Reviewers' comments: https://doi.org/10.1371/journal.pone.0224752.r003
Formally Accepted
28 Oct 2019 Acceptance Letter - HASNAIN SEYED EHTESHAM, Editor PONE-D-19-21500R1 Impact of negative tuberculin skin test on growth among disadvantaged Bangladeshi children Dear Dr. Gaffar: I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Prof HASNAIN SEYED EHTESHAM Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0224752.r004

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