Healthcare utilization during acute medically attended episodes of respiratory syncytial virus-related lower respiratory tract infection among infants in the United States

Jason R. Gantenberg; Robertus van Aalst; David R. Diakun; Angela M. Bengtson; Brendan L. Limone; Christopher B. Nelson; David A. Savitz; Andrew R. Zullo

doi:10.1371/journal.pone.0313573

Peer Review History

Original SubmissionJanuary 24, 2024
7 Jul 2024 Decision Letter - Farhana Haque, Editor PONE-D-24-01606Healthcare Utilization During Acute Medically Attended Episodes of Respiratory Syncytial Virus-related Lower Respiratory Tract Infection Among Infants in the United StatesPLOS ONE Dear Dr. Gantenberg, 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 21 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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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 finds a new information that not only high risk babies but healthy term infants and infants with less severe comorbidities account for the majority of healthcare visits during acute MA RSV LRTI episodes. Hence I have few observation Abstract Conclusion could include difference between payers Methods: Sample size calculation need to mention. Statistical tools used in this study is missing Reviewer #2: The study is an important addition to the RSV literature, documenting the healthcare burden among infants' first RSV LRTI episode across commercial and Medicaid data sources. I appreciate the authors' discussion of the study limitations, which are extensive and common in studies of claims data, but not often described so thoroughly. This study makes use of proprietary data sources from Merativ and Optum, and therefore, the data cannot be made publicly available. ****** 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. https://doi.org/10.1371/journal.pone.0313573.r001
Revision 1
25 Sep 2024 Author Response We appreciate the reviewers' favorable disposition toward our original submission, as well as their suggestions for improvement. We hope our responses and revisions address the comments we received. In addition, we have made a minor correction to the table in the supplement to remove an ICD code that was double-listed (see tracked version). RESPONSES TO REVIEWERS Journal 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 AUTHOR REPLY: We have reviewed the PLOS ONE style guides again and updated formatting and file-naming as needed. 2. Thank you for stating the following financial disclosure: “This work was supported by Sanofi and AstraZeneca.” Please state what role the funders took in the study. If the funders had no role, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. AUTHOR REPLY: We have updated our funding statement to include the additional information requested. The statement now reads as follows: This work was supported by Sanofi and AstraZeneca. Employees of Sanofi (RvA, CBN) contributed to the study design, interpretation of results, and manuscript review. Sanofi also provided Brown researchers access to the Optum Clinformatics Data Mart. Both Sanofi and AstraZeneca conducted intellectual property compliance review prior to submission. The decision to submit for publication rested solely with the Brown research team. 3. We note that you have indicated that there are restrictions to data sharing for this study. For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared for ethical reasons, we allow authors to make their data sets available upon request. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Before we proceed with your manuscript, please address the following prompts: 1. 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, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. 2. If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings 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 recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible. Please update your Data Availability statement in the submission form accordingly. AUTHOR REPLY: We have updated our Data Availability Statement in to provide additional information on accessing the MarketScan and Optum databases. Our updated statement reads as follows: Our funding agreements with Sanofi and AstraZeneca did not impose any restrictions on data sharing. However, we are unable to share insurance claims data because these data are owned by third parties and governed by the data owners’ usage restrictions. Researchers should contact Merative or Optum to purchase access to the claims data sets used in this paper. The surveillance data on respiratory syncytial virus we used to determine RSV season start and end dates by geographic region can be requested from the Centers for Disease Control and Prevention. We have described the method to calculate these dates in a prior publication referenced in the Methods. S5 Code contains code and select (public) data used to generate the CDM analytic dataset and results (code for the Merative analyses cannot be shared due to their licensing agreements with SAS), as well as the scripts and summary data files that produce the manuscript, including tables and figures. 4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. AUTHOR REPLY: We have added the Supporting Information captions to the end of the main manuscript, as requested. 5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. AUTHOR REPLY: Thank you. We have reviewed our reference list as requested and did not identify any necessary changes. # Reviewers’ Comments ## Reviewer 1 This study finds a new information that not only high risk babies but healthy term infants and infants with less severe comorbidities account for the majority of healthcare visits during acute MA RSV LRTI episodes. Hence I have few observations 1. Abstract: Conclusion could include difference between payers AUTHOR REPLY We appreciate the suggestion and have added the following passage to our abstract’s conclusion: The percentage of MA RSV LRTI episodes involving at least 2 visits to a healthcare setting may vary by insurance claims database, even between commercial payers. 1. Methods 1. Sample size calculation need to mention. AUTHOR REPLY We appreciate the suggestion. Sample size calculations are typically used in hypothesis testing to determine the sample size necessary to achieve a prespecified statistical power to detect a given effect size (/i.e., a difference in outcomes between two groups). Our goals in this descriptive study involved neither hypothesis testing nor causal inference, and therefore, we believe sample size calculations do not apply. 1. Statistical tools used in this study is missing AUTHOR REPLY Given our descriptive aims, we limited our statistical analysis to calculating 95% confidence intervals around estimates of proportions, in order to quantify variability due to random error. The section entitled Descriptive Analysis already provides a reference for the approximate intervals we used, and we are unsure what to add, as these were the only statistical tools (besides tabulation) used in the study. We did not conduct statistical tests because these did not apply given the aims of the study. ## Reviewer 2 The study is an important addition to the RSV literature, documenting the healthcare burden among infants’ first RSV LRTI episode across commercial and Medicaid data sources. I appreciate the authors’ discussion of the study limitations, which are extensive and common in studies of claims data, but not often described so thoroughly. This study makes use of proprietary data sources from Merativ and Optum, and therefore, the data cannot be made publicly available. AUTHOR REPLY We appreciate the reviewer’s positive assessment of our study and are happy that they found our discussion of the limitations of claims data to be helpful. https://doi.org/10.1371/journal.pone.0313573.r002
28 Oct 2024 Decision Letter - Farhana Haque, Editor Healthcare Utilization During Acute Medically Attended Episodes of Respiratory Syncytial Virus-related Lower Respiratory Tract Infection Among Infants in the United States PONE-D-24-01606R1 Dear Dr. Gantenberg, 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, Farhana Haque, MBBS MPH MSc PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0313573.r003
Formally Accepted
23 Jan 2025 Acceptance Letter - Farhana Haque, Editor PONE-D-24-01606R1 PLOS ONE Dear Dr. Gantenberg, 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 Farhana Haque Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0313573.r004

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