Time to major adverse drug reactions and its predictors among children on antiretroviral treatment at northwest Amhara selected public hospitals northwest; Ethiopia, 2023

Bantegizie Senay Tsega; Abebe Habtamu; Moges Wubie; Animut Takele Telayneh; Bekalu Endalew; Samuel Derbie Habtegiorgis; Molla Yigzaw Birhanu; Worku Misganaw Kebede; Keralem Anteneh Bishaw

doi:10.1371/journal.pone.0309796

Peer Review History

Original SubmissionJuly 7, 2023
17 Jul 2024 Decision Letter - Edmund Tetteh Nartey, Editor PONE-D-23-20912TIME TO MAJOR ADVERSE DRUG REACTIONS AND ITS PREDICTORS AMONG CHILDREN ON ANTIRETROVIRAL TREATMENT AT NORTHWEST AMHARA SELECTED PUBLIC HOSPITALS NORTHWEST; ETHIOPIA, 2023.PLOS ONE Dear Dr. Bishaw, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Aug 31 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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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: My Review Comments The researchers retrospectively studied time to major adverse drug reactions and its predictors among children on antiretroviral treatment in selected public hospitals in Ethiopia. This study is quite interesting because adverse drug reactions (ADRs) are common in HIV treatment and as the authors rightly put it, determining the incidence rate and predictors of ADRs among children on ART may be useful in improving treatment outcomes and minimizing harm. The authors indicated limited evidence regarding the time to ADRs and its predictors among children on ART in Ethiopia, and this further justified the study. The researchers employed a structured data extraction checklist to collect data for the study. They further indicated how data was analyzed and how parameters of interest were determined. The authors determined the incident rate of major ADRs per person/month, while they used the Cox proportional hazards regression model to identify predictors of major adverse drug responses. They declare statistical significance when p-values of less than 0.05 at 95% CI were attained. The researchers followed the participants up for between 6 and 59 months for a total of 9916 person-months and observed an incidence rate of major ADRs of 3.5 / 1000 person-months. From the results of the study, the researchers reported congruence of their observed incidence rate of major ADRs among children on ART with previous studies in Ethiopia. They further reported advanced clinical stages of HIV / AIDS, poor treatment adherence, taking ART medications twice or more, and not taking opportunistic infection prophylaxis as predictors of major ADRs. Introduction The introduction was quite well-written. The authors gave some statistics on the global and Sub-Saharan Africa prevalence of HIV/AIDS with some useful information on ensuing ADRs during treatment of affected patients. The authors then narrowed down on similar studies carried out in Namibia, Nigeria, and in Ethiopia. Method The study area, setting, and population were well defined, as well as the duration of the recruitment of study participants retrospectively. The data extraction period was also specified to be from February 15 to March 30/2023. The researchers stated how the sample test for the study was determined. The authors also explained the sampling technique and sampling procedure used to enroll the study participants and this was quite appropriate. Variables and operational definitions were provided by the authors. The authors stated a data collection checklist and procedure that is quite sound. They also included how data quality control was achieved. The researchers gave details on how data was analyzed. The authors secured ethical clearance for the study and included the approval number. They also secured permissions from the study sites. Results A table and description of social demographic characteristics were provided. Under baseline clinical, immunological, ART drug and prophylaxis related characteristics, the researchers stated that more than half of the study participants (60.16%) used DTG-based ART regimens but failed to show what ART drug regimen the remaining 39.84% of the study participants used. Minor Revision Abstract 1. Authors should write ART, and AHR in full at first use. Introduction 2. Paragraph 3 line 5: Authors should write AVR in full at first use. 3. Paragraph 5 line 4: Authors should write AZT in full at first use. 4. Paragraph 6 line 4: Authors should write BMI, and TDF-3TC-EFV in full at first use. 5. Paragraph 7 line 3: Authors should write TDF-NVP in full at first use. 6. Paragraph 8 line 2: Authors should write MADRs, and DTG in full at first use. Methods 7. Authors should write all abbreviations in full at first use in all sections of the manuscript. Results 8. Under baseline clinical, immunological, ART drug and prophylaxis related characteristics, the researchers stated that "more than half of the study participants (60.16%) used DTG-based ART regimens" but failed to show what ART drug regimen the remaining 39.84% of the study participants used. The authors should include this data and discuss any observed effect the different ART regimen may have on time to major ADRs in study participants. Discussion The discussion was well written. 9. However, the authors compared their findings with previous findings but gave no brief description of such findings. The authors should include very brief description of the previous findings to make their comparison more meaningful. Reviewer #2: Opening Comments: This is an important by Bantegizie Senay and colleagues. It sought to retrospectively examine adherence of children infected with HIV to ARTs’ in Amhara in Ethiopia. The manuscript is well written... Title: Time to Major Adverse Drug Reactions and Its Predictors Among Children on Antiretroviral Treatment at Northwest Amhara Selected Public Hospitals Northwest; Ethiopia, 2023. Abstract - The abstract is ok, and well structured. Introduction - Paragraph 5, line 5: Revise ‘4.18–2.3 gm/dl’ to read 4.2 -2.3 g/dl - Paragraph 6, line 2: Revise ….’majority of (90.74%)’….to read ….’majority (90.7%) of’ …., and delete the last 2 words (i.e. of ART ) at the end of that sentence. - Last Paragraph, second line: Write the acronym ‘MADRs’ in full, and put the MADRs in parentheses or bracket here Methods Study area, setting, and population - Revise the first sentence into 2 sentences - Line 6 and 7, add the respective hospitals to complete that sentence Data Quality Control - Last sentence, from Line 4: Should read 5% with the number obtained in parentheses - Write DMCSH and FHCSH in full Data Analysis - Line 2: Correct the error in the acronym MADR’s from MDAR’s Results Incidence of major adverse drug reaction - Line 1, Paragraph 2: Kindly take a second look at the sentence ‘The incidence rate of MADR among females and males was 4.2/4278 and 3/5638 person months’ in comparison with the female: male population in Table 1, Review and confirm that its collaborative and correct Discussion - Line 5: Should read…. The study reports that …. - Second Paragraph, Line 2: Revise to read: ‘in Debre Markos (in Ethiopia) and Mali’. Conclusions - Revise the first sentence, especially the quotation of the value ‘3.5/1000’. Summary 1. Manuscript requires minor revisions indicated. Thanks ****** 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: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: R_enyn PONE -D-23-20912 R1.docx https://doi.org/10.1371/journal.pone.0309796.r001
Revision 1
15 Aug 2024 Author Response Date: August 13, 2024 Manuscript ID: PONE-D-23-20912 Title: Time to Major Adverse Drug Reactions and Its Predictors among Children on Antiretroviral Treatment at Northwest Amhara Selected Public Hospitals Northwest; Ethiopia, 2023. Response to editors Dear Editors: Thank you for sending us your valuable comments, which immensely improved our manuscript. We included all the editorial comments raised and we also enclosed the point by point response of six (6) pages attached here with. It is my pleasure to inform you that the manuscript was edited meticulously by the English Language expert from Debre Markos University - Ethiopia. Respectfully, Bishaw, KA Corresponding author Reviewer #1: My Review Comments The researchers retrospectively studied time to major adverse drug reactions and its predictors among children on antiretroviral treatment in selected public hospitals in Ethiopia. This study is quite interesting because adverse drug reactions (ADRs) are common in HIV treatment and as the authors rightly put it, determining the incidence rate and predictors of ADRs among children on ART may be useful in improving treatment outcomes and minimizing harm. The authors indicated limited evidence regarding the time to ADRs and its predictors among children on ART in Ethiopia, and this further justified the study. The researchers employed a structured data extraction checklist to collect data for the study. They further indicated how data was analyzed and how parameters of interest were determined. The authors determined the incident rate of major ADRs per person/month, while they used the Cox proportional hazards regression model to identify predictors of major adverse drug responses. They declare statistical significance when p-values of less than 0.05 at 95% CI were attained. The researchers followed the participants up for between 6 and 59 months for a total of 9916 person-months and observed an incidence rate of major ADRs of 3.5 / 1000 person-months. From the results of the study, the researchers reported congruence of their observed incidence rate of major ADRs among children on ART with previous studies in Ethiopia. They further reported advanced clinical stages of HIV / AIDS, poor treatment adherence, taking ART medications twice or more, and not taking opportunistic infection prophylaxis as predictors of major ADRs. Introduction The introduction was quite well-written. The authors gave some statistics on the global and Sub-Saharan Africa prevalence of HIV/AIDS with some useful information on ensuing ADRs during treatment of affected patients. The authors then narrowed down on similar studies carried out in Namibia, Nigeria, and in Ethiopia. Method The study area, setting, and population were well defined, as well as the duration of the recruitment of study participants retrospectively. The data extraction period was also specified to be from February 15 to March 30/2023. The researchers stated how the sample test for the study was determined. The authors also explained the sampling technique and sampling procedure used to enroll the study participants and this was quite appropriate. Variables and operational definitions were provided by the authors. The authors stated a data collection checklist and procedure that is quite sound. They also included how data quality control was achieved. The researchers gave details on how data was analyzed. The authors secured ethical clearance for the study and included the approval number. They also secured permissions from the study sites. Results A table and description of social demographic characteristics were provided. Under baseline clinical, immunological, ART drug and prophylaxis related characteristics, the researchers stated that more than half of the study participants (60.16%) used DTG-based ART regimens but failed to show what ART drug regimen the remaining 39.84% of the study participants used. Minor Revision Response: Dear reviewer, thank you the constructive comment. Abstract Comment 1: Authors should write ART, and AHR in full at first use. Response: Dear reviewer, correction was made accordingly and highlighted in the main document Introduction Comment 2. Paragraph 3 line 5: Authors should write AVR in full at first use. Response: Dear, correction was made accordingly and highlighted in the main document Comment 3. Paragraph 5 line 4: Authors should write AZT in full at first use. Response: Dear, correction was made accordingly and highlighted in the main document Comment 4. Paragraph 6 line 4: Authors should write BMI, and TDF-3TC-EFV in full at first use. Response: Dear, correction was made accordingly and highlighted in the main document Comment 5. Paragraph 7 line 3: Authors should write TDF-NVP in full at first use. Response: Dear, correction was made accordingly and highlighted in the main document Comment 6. Paragraph 8 line 2: Authors should write MADRs, and DTG in full at first use. Response: Dear, correction was made accordingly and highlighted in the main document Methods Comment 7. Authors should write all abbreviations in full at first use in all sections of the manuscript. Response: Dear, correction was made accordingly and highlighted in the main document Results Comment 8. Under baseline clinical, immunological, ART drug and prophylaxis related characteristics, the researchers stated that "more than half of the study participants (60.16%) used DTG-based ART regimens" but failed to show what ART drug regimen the remaining 39.84% of the study participants used. The authors should include this data and discuss any observed effect the different ART regimen may have on time to major ADRs in study participants. Response: Dear, thank for the constructive comment. Discussion based on this idea was considered and included in the main document. Discussion The discussion was well written. Comment 9. However, the authors compared their findings with previous findings but gave no brief description of such findings. The authors should include very brief description of the previous findings to make their comparison more meaningful. Response: Dear, thank for the constructive comment. Correction was considered and included in the main document to describe the finding of the study briefly. Reviewer #2: Opening Comments: This is an important by Bantegizie Senay and colleagues. It sought to retrospectively examine adherence of children infected with HIV to ARTs’ in Amhara in Ethiopia. The manuscript is well written... Title: Time to Major Adverse Drug Reactions and Its Predictors among Children on Antiretroviral Treatment at Northwest Amhara Selected Public Hospitals Northwest; Ethiopia, 2023. Abstract: The abstract is ok, and well structured. Introduction Comment1: Paragraph 5, line 5: Revise ‘4.18–2.3 gm/dl’ to read 4.2 -2.3 g/dl. Response: Dear, thank for the constructive comment. Correction was considered and highlighted in the main document as 4.2 -2.3 g/dl. Comment2: Paragraph 6, line 2: Revise ….’majority of (90.74%)’….to read ….’Majority (90.7%) of’ …., and delete the last 2 words (i.e. of ART) at the end of that sentence. Response: Dear correction was considered and the term “of ART” was deleted and included in the main document as “A study in Ethiopia reported that more than ninety percent (90.74%) of participants developed ADRs within one (1) year” Comment3: Last Paragraph, second line: Write the acronym ‘MADRs’ in full, and put the MADRs in parentheses or bracket here. Response: Dear, correction was made and included as major adverse drug reactions “‘MADRs” in the main document. Methods Study area, setting, and population Comment 4: Revise the first sentence into 2 sentences Response: Thank you for the comment. Correction was considered and included in the main document. Comment 5: - Line 6 and 7, add the respective hospitals to complete that sentence Response: Correction was considered and respective hospitals (Felege Hiwot Comprehensive Specialized Hospital (FHCSH), Adet Primary Hospital, Finote Selam General Hospital, and Debre Markos Comprehensive Specialized Hospital (DMCSH)) were included in the main document. Data Quality Control Comment 6: - Last sentence, from Line 4: Should read 5% with the number obtained in parentheses Response: Correction was considered and included in the main document. Comment 7: Write DMCSH and FHCSH in full. Response: Correction was considered and included in the main document Data Analysis Comment 8: Line 2: Correct the error in the acronym MADR’s from MDAR’s Response: Correction was considered and included as “MADR’s” in the main document. Results Incidence of major adverse drug reaction Comment 9: Line 1, Paragraph 2: Kindly take a second look at the sentence ‘the incidence rate of MADR among females and males was 4.2/4278 and 3/5638 person months’ in comparison with the female: male population in Table 1, Review and confirm that it’s collaborative and correct. Response: Thank you dear for the comment. I checked this sentence “The incidence rate of MADRs among females and males was 4.2/4278 and 3/5638 person months’ in comparison with the female: male population in Table 1”. Theses sentence is correct and considered as it is in the main document. It reported the incidence rate MADRs in since it is the difference in the incidence rate between male and female individuals. Discussion Comment 10: Line 5: Should read…. The study reports that …. Response: Dear, correction was considered. Comment11: - Second Paragraph, Line 2: Revise to read: ‘in Debre Markos (in Ethiopia) and Mali’. Response: Dear, correction was considered and included in the main document. Conclusions Comment 12:- Revise the first sentence, especially the quotation of the value ‘3.5/1000’. Response: Correction was considered and included in the main document Summary 1. Manuscript requires minor revisions indicated. Thanks Respectfully, Bishaw, KA Corresponding author https://doi.org/10.1371/journal.pone.0309796.r002
20 Aug 2024 Decision Letter - Edmund Tetteh Nartey, Editor TIME TO MAJOR ADVERSE DRUG REACTIONS AND ITS PREDICTORS AMONG CHILDREN ON ANTIRETROVIRAL TREATMENT AT NORTHWEST AMHARA SELECTED PUBLIC HOSPITALS NORTHWEST; ETHIOPIA, 2023. PONE-D-23-20912R1 Dear Dr. Bishaw, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Edmund Tetteh Nartey Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0309796.r003
Formally Accepted
24 Sep 2024 Acceptance Letter - Edmund Tetteh Nartey, Editor PONE-D-23-20912R1 PLOS ONE Dear Dr. Bishaw, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Edmund Tetteh Nartey Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0309796.r004

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