Validation of postnatal growth and retinopathy of prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from low-middle income country

Haroon Tayyab; Adnan Mirza; Roha Ahmad Choudhary; Hassan Jabbar; Mohammed Abbas Motiwala; Sehrish Nizar Ali Momin; Shiraz Hashmi; Khadijah Abid

doi:10.1371/journal.pone.0302534

Peer Review History

Original SubmissionSeptember 15, 2023
14 Feb 2024 Decision Letter - Stefan Grosek, Editor PONE-D-23-26742Validation of Postnatal growth and Retinopathy of Prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from developing worldPLOS ONE Dear Dr. Tayyab, 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 Authors While you manuscript is very intersting the reviewers raised many concerns which need to be addressed by the authors. I hope that you will be able to address all recommended issues. ============================== Please submit your revised manuscript by Mar 30 2024 11:59PM. 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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ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. Additional Editor Comments: Dear Authors This is interesting study however many issued were raised by both reviewrs which need to be addressed by the authors. I hope that you will be able to answer to all recommended comments. Kind regards [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: No Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: No ****** 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 Reviewer #2: No ****** 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: No ****** 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 article titled "Validation of Postnatal Growth and Retinopathy of Prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from developing world" reports on a study conducted to validate the Postnatal Growth and Retinopathy of Prematurity (G-ROP) screening criteria in a cohort of premature infants in Pakistan. This research addresses an important topic in the field of neonatal care and ophthalmology, contributing valuable insights to the literature on retinopathy of prematurity (ROP) screening in low- and middle-income countries. This retrospective analysis included 134 case files of premature infants in a tertiary care hospital from January 2018 to February 2022. The G-ROP criteria were applied to assess sensitivity for identifying type 1 ROP, type 2 ROP, and any ROP. The study reported a high sensitivity of 100% for type 1 ROP and 98.7% for any type of ROP, with only 19 babies requiring treatment. The authors highlighted the potential of the G-ROP model in identifying ROP but noted limitations, such as a small sample size and a higher ROP incidence than in other studies, and recommended further research and validation with larger sample sizes. While the article is interesting and relevant, there are major limitations that prevent me from an acceptance recommendation. Please see my comments below: Strengths: • Relevance: The study addresses an important topic in the field of neonatal care and ophthalmology, focusing on the validation of a widely recognized screening tool in a developing country context. • Novelty: The study claims to be the first of its kind in Pakistan, adding novelty to the literature on retinopathy of prematurity (ROP) screening in developing countries. • Clear Objective: The article clearly states its primary objective, which is to explore the effectiveness of the G-ROP model in identifying ROP successfully. • Data Collection and Analysis: The article describes the data collection process, including the time frame and criteria for inclusion, which adds transparency to the study. Additionally, the use of sensitivity and specificity in data analysis is standard and appropriate. Weaknesses: • Minor: o Use of Developing Country Terminology: the article refers to Pakistan as a "developing South Asian country." This terminology is somewhat outdated and not preferred in the academic literature. The term "low or middle-income country" is considered more appropriate as it doesn't carry the same negative connotations. o Use of Pie Diagrams: Pie charts are often criticized for their limited ability to convey complex data effectively. Authors should consider using more suitable data visualization methods such as bar charts or histograms. o Missing Patient Numbers in Discussion: the article lacks the number of patients included in studies from the UK and Italy in the discussion section, this is an oversight that should be addressed for completeness and to provide context for the reader. • Major: • Sample Size: While the sample size of 166 is relatively large for a single-center study, it may still be considered small for validating a screening tool, and this limitation is acknowledged by the authors. A larger sample would enhance the study's robustness and generalizability. How was the sample size calculated or what would be an appropriate sample for this type of study. • Retrospective Design: The study is retrospective in nature, which can introduce potential bias and limitations regarding the accuracy and completeness of the data. Ways to address bias in the methods as well as how bias can affect the results must be discussed. See STROBE checklist: https://www.strobe-statement.org/checklists/ • High Incidence of ROP: The reported incidence of ROP (56.7%) in this study appears to be higher than what is typically reported in the literature, which raises questions about the study's population selection or diagnostic criteria. Please discuss • Exclusion of Cases: The exclusion of cases with incomplete records might introduce a selection bias, as those cases might have different characteristics from those included. • Lack of Follow-Up Information: The study does not provide information on the long-term follow-up and outcomes of the infants who were screened and diagnosed with ROP, which is crucial for evaluating the effectiveness of the screening criteria. • No Discussion on Specific Challenges: Although the introduction mentions several challenges faced in low- and middle-income countries regarding ROP screening, the study does not elaborate on how these challenges influenced the results or the implications for implementing G-ROP screening criteria in such contexts. • Concluding Statement: The conclusion is somewhat vague, and it is suggested that larger studies with multiple centers should be conducted. It would be beneficial to provide more concrete recommendations or implications based on the study's findings. In summary, while the article has strengths in terms of relevance and clear objectives, it also suffers from significant limitations related to sample size, data completeness, and design. Additionally, addressing concerns about the terminology used for developing countries, data visualization, and missing information in the discussion would enhance the overall quality and readability of the article. Nevertheless, my recommendation is to decline the submission. Reviewer #2: Major revision of this manuscript is needed to be considered for publication in PLOS One. Please start with type 1, type 2 and any ROP and show all the babies included in a diagram with G-ROP criteria marked. An important issue would also be how many exams were spared when using these criteria etc.... ****** 6. 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Revision 1
30 Mar 2024 Author Response RESPONSE LETTER Journal Requirements: When submitting your revision, we need you to address these additional requirements. 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 The title page and main body is revised according to PLOS one guidelines. 2. Note from Emily Chenette, Editor in Chief of PLOS ONE, and Iain Hrynaszkiewicz, Director of Open Research Solutions at PLOS: Did you know that depositing data in a repository is associated with up to a 25% citation advantage (https://doi.org/10.1371/journal.pone.0230416)? If you’ve not already done so, consider depositing your raw data in a repository to ensure your work is read, appreciated and cited by the largest possible audience. You’ll also earn an Accessible Data icon on your published paper if you deposit your data in any participating repository (https://plos.org/open-science/open-data/#accessible-data). Thank you, we are submitting our data sheet for repository. 3. In this instance it seems there may be acceptable restrictions in place that prevent the public sharing of your minimal data. However, in line with our goal of ensuring long-term data availability to all interested researchers, PLOS’ Data Policy states that authors cannot be the sole named individuals responsible for ensuring data access (http://journals.plos.org/plosone/s/data-availability#loc-acceptable-data-sharing-methods). Agreed 4. Data requests to a non-author institutional point of contact, such as a data access or ethics committee, helps guarantee long term stability and availability of data. Providing interested researchers with a durable point of contact ensures data will be accessible even if an author changes email addresses, institutions, or becomes unavailable to answer requests. Data requests can be made to Assistant Manager: Asif Hukma, Departmentpt of Ophthalmology and visual sciences email: asif.hukma@aku.edu Before we proceed with your manuscript, please also provide non-author contact information (phone/email/hyperlink) for a data access committee, ethics committee, or other institutional body to which data requests may be sent. If no institutional body is available to respond to requests for your minimal data, please consider if there any institutional representatives who did not collaborate in the study, and are not listed as authors on the manuscript, who would be able to hold the data and respond to external requests for data access? If so, please provide their contact information (i.e., email address). Please also provide details on how you will ensure persistent or long-term data storage and availability. It can be accessed by contacting Asif Hukma (email: asif.hukma@aku.edu) 5. 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. Ethic statement has been moved to methods section Reviewer #1: The article titled "Validation of Postnatal Growth and Retinopathy of Prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from developing world" reports on a study conducted to validate the Postnatal Growth and Retinopathy of Prematurity (G-ROP) screening criteria in a cohort of premature infants in Pakistan. This research addresses an important topic in the field of neonatal care and ophthalmology, contributing valuable insights to the literature on retinopathy of prematurity (ROP) screening in low- and middle-income countries. This retrospective analysis included 134 case files of premature infants in a tertiary care hospital from January 2018 to February 2022. The G-ROP criteria were applied to assess sensitivity for identifying type 1 ROP, type 2 ROP, and any ROP. The study reported a high sensitivity of 100% for type 1 ROP and 98.7% for any type of ROP, with only 19 babies requiring treatment. The authors highlighted the potential of the G-ROP model in identifying ROP but noted limitations, such as a small sample size and a higher ROP incidence than in other studies, and recommended further research and validation with larger sample sizes. While the article is interesting and relevant, there are major limitations that prevent me from an acceptance recommendation. Please see my comments below: Strengths: • Relevance: The study addresses an important topic in the field of neonatal care and ophthalmology, focusing on the validation of a widely recognized screening tool in a developing country context. • Novelty: The study claims to be the first of its kind in Pakistan, adding novelty to the literature on retinopathy of prematurity (ROP) screening in developing countries. • Clear Objective: The article clearly states its primary objective, which is to explore the effectiveness of the G-ROP model in identifying ROP successfully. • Data Collection and Analysis: The article describes the data collection process, including the time frame and criteria for inclusion, which adds transparency to the study. Additionally, the use of sensitivity and specificity in data analysis is standard and appropriate. Weaknesses: • Minor: o Use of Developing Country Terminology: the article refers to Pakistan as a "developing South Asian country." This terminology is somewhat outdated and not preferred in the academic literature. The term "low or middle-income country" is considered more appropriate as it doesn't carry the same negative connotations. The term developing country/countries has been replaced with LMIC/s. o Use of Pie Diagrams: Pie charts are often criticized for their limited ability to convey complex data effectively. Authors should consider using more suitable data visualization methods such as bar charts or histograms. Results has been revised and comprehensive table has been added for ROP types. o Missing Patient Numbers in Discussion: the article lacks the number of patients included in studies from the UK and Italy in the discussion section, this is an oversight that should be addressed for completeness and to provide context for the reader. Number has been added. • Major: • Sample Size: While the sample size of 166 is relatively large for a single-center study, it may still be considered small for validating a screening tool, and this limitation is acknowledged by the authors. A larger sample would enhance the study's robustness and generalizability. How was the sample size calculated or what would be an appropriate sample for this type of study. Sample size calculation has been added. • Retrospective Design: The study is retrospective in nature, which can introduce potential bias and limitations regarding the accuracy and completeness of the data. Ways to address bias in the methods as well as how bias can affect the results must be discussed. See STROBE checklist: https://www.strobe-statement.org/checklists/ We acknowledged it. The retrospective design of this study inherently introduces potential biases, particularly regarding data accuracy and completeness, which could skew the results. To address these challenges, methodologies such as standardized data collection protocols, employing multiple independent reviewers, statistical adjustments for known confounders, and sensitivity analyses were implemented. These strategies aim to mitigate the impact of selection bias, information bias, and confounding factors, enhancing the reliability of the findings. However, despite these precautions, biases inherent to retrospective designs, such as the potential for misclassification of conditions or misattribution of outcomes due to incomplete or inaccurately recorded data, remain a concern. The results, therefore, must be interpreted with an understanding of these limitations, recognizing that methodological safeguards can only reduce, not eliminate, the potential for bias. This justification is added in discussion. • High Incidence of ROP: The reported incidence of ROP (56.7%) in this study appears to be higher than what is typically reported in the literature, which raises questions about the study's population selection or diagnostic criteria. Please discuss. The high incidence of ROP reported in this study at 66.4% significantly exceeds typical rates documented in the literature, suggesting unique aspects of the study's population. The study's setting in a tertiary care hospital in Pakistan, LMIC, likely plays a crucial role. LMICs often face challenges such as variability in neonatal care quality, limited access to ROP screening and treatment services, and differences in neonatal care practices.1-3 These factors can contribute to higher ROP rates compared to high-income settings. Justification has been added in discussion. Additionally there is not much significant literature available that explains the epidemiology of ROP in Pakistan. • Exclusion of Cases: The exclusion of cases with incomplete records might introduce a selection bias, as those cases might have different characteristics from those included.Recognizing this limitation, the research methodology was designed to mitigate its impact through comprehensive data collection and a large sample size from a tertiary care setting. This approach aimed to ensure a broad representation of neonates admitted to the NICU, thereby reducing the risk that excluded cases would significantly skew the results. Additionally, the application of the G-ROP criteria for case selection provided a standardized, objective basis for including infants in the study, further minimizing the potential for bias. While the exclusion of cases with incomplete records is a recognized limitation, the study's design and analytical strategies, including sensitivity analyses, were intended to address and lessen its impact, allowing for cautious interpretation of the high incidence of ROP observed in this specific setting. Justification has been added in discussion. • Lack of Follow-Up Information: The study does not provide information on the long-term follow-up and outcomes of the infants who were screened and diagnosed with ROP, which is crucial for evaluating the effectiveness of the screening criteria. We have not evaluated the long-term follow-up and outcomes for infants diagnosed with ROP in this study. Most of the similar validation studies have also not evaluated the long-term outcomes. This study was based on retrospective data with reported outcome, we have not intervened in this research therefore effect cannot be assessed also may not influence the results of this study. We acknowledged this shortcoming and future research should include prospective tracking to evaluate treatment success and disease progression over time. • No Discussion on Specific Challenges: Although the introduction mentions several challenges faced in low- and middle-income countries regarding ROP screening, the study does not elaborate on how these challenges influenced the results or the implications for implementing G-ROP screening criteria in such contexts. The discussion has been revised and challenges are specified. • Concluding Statement: The conclusion is somewhat vague, and it is suggested that larger studies with multiple centers should be conducted. It would be beneficial to provide more concrete recommendations or implications based on the study's findings. Conclusion has been revised. In summary, while the article has strengths in terms of relevance and clear objectives, it also suffers from significant limitations related to sample size, data completeness, and design. Additionally, addressing concerns about the terminology used for developing countries, data visualization, and missing information in the discussion would enhance the overall quality and readability of the article. Nevertheless, my recommendation is to decline the submission. Reviewer 2: Manuscript Number: PONE-D-23-26742 Title: Validation of postnatal growth and retinopathy of prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from developing world The manuscript utilizes G-ROP screening criteria in a population of preterm babies from a tertiary referral centre in Pakistan. The information obtained from this study is important for this particular NICU, especially in the light of comparison with other centres and countries from around the world. However, the manuscript has many inconsistencies, starting with the definition of ROP types, since type 2 ROP is constantly utilized in lieu of any ROP. This makes results very difficult/impossible to compare with other studies. I think the authors should address this issue first before proceeding to further improve the manuscript. • I would like to get a picture of overall ROP status in Pakistan in introduction. Are ROP screening criteria the same in all centres of the country (and are in accordance with AAO screening criteria? what is the survival rate of extremely preterm babies in Pakistan? Why is the chosen centre different?) Our introduction outlines the variable ROP screening practices across the country, which differ significantly due to disparities in healthcare resources and access. Unlike standardized practices seen in more developed settings, Pakistani centers may adapt their screening based on local capabilities, highlighting the necessity for studies like ours to identify effective, context-specific criteria. The survival rate of extremely preterm infants in Pakistan, influenced by varying levels of neonatal care, reinforces the importance of localized screening strategies. The chosen center for our study represents a tertiary care facility with specialized neonatal care, offering a unique perspective on the applicability and effectiveness of the G-ROP criteria within the Pakistani healthcare context. This approach aims to contribute towards developing tailored ROP screening and management protocols nationwide. Additionally, In light of the of varying socioeconomic diversity and healthcare infrastructure disparities across Pakistan, the selection of an appropriate study center is crucial where NICU and ROP care is standardized considering there are only two multidiscipnary tertiary care hospitals in Pakistan that are Joint Commission International accredited. The chosen tertiary care JCI hospital serves as a representative setting, catering to a diverse patient population and offering specialized neonatal and ophthalmological care. This setting provides an opportunity to assess the effectiveness of the G-ROP model in a real-world context • In the methods the authors claim babies stay in their NICU until 1 month of age. Please specify! Thank you for pointing out, but it was NICU infants who were either received from the labour room of the same hospital or outside were included. We have omitted this sentence to avoid confusion. • I would also like to see segregation of ROP, no ROP babies are mentioned for example (a systematic demographic Table of babies included would be very illustrative) Data is being segregated for ROP and no ROP babies in table no. 1 • Risk factors for ROP are mentioned in the methods and they are not presented in results Table 1 is added and it is displaying the results risk factors. • Poor language and grammar/typing errors can be found throughout the manuscript. Revised and proofread. • As mentioned in the results 1 baby with ROP not requiring treatment would be missed in this cohort, but this is not further discussed. Discussion has been added. • Figure 2 could be more didactic: I suggest you rescale it, so that also 29+6 babies would fall within screening criteria. Figure has been revised. • Discussion should tackle the important objections for the present study and comparisons with relevant literature shou Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0302534.r002
8 Apr 2024 Decision Letter - Stefan Grosek, Editor Validation of Postnatal growth and Retinopathy of Prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from a low middle income country PONE-D-23-26742R1 Dear Dr. Tayyab, 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, Stefan Grosek, Ph.D., M.D., Academic Editor PLOS ONE Additional Editor Comments (optional): The revised version of an article "alidation of Postnatal growth and Retinopathy of Prematurity (G-ROP) screening guidelines in a tertiary care hospital of Pakistan: A report from a low middle income country"has been sent for reevaluation. I found that the authors accepted all comments from the reviewers and very much improved it. No open issues remain and therefore I recommend to accept this article. It is well designed and written and give us new informations about ROP in middle income country. Kind regards Reviewers' comments: https://doi.org/10.1371/journal.pone.0302534.r003
Formally Accepted
29 Apr 2024 Acceptance Letter - Stefan Grosek, Editor PONE-D-23-26742R1 PLOS ONE Dear Dr. Tayyab, 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 Professor Stefan Grosek Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0302534.r004

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