Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods feasibility analysis

Kristina L. Foster; Sarah Sanders; Christi A. Madden; Lacy Malloch; Amy Swango-Wilson; Barbara Jandasek; Maryam Y. Garza; Jaime Baldner; Erin Dawley; Timothy VanWagoner; Jerome Philip Saul; Ann M. Davis

doi:10.1371/journal.pone.0333229

Peer Review History

Original SubmissionMay 9, 2025
20 Jun 2025 Decision Letter - Taiwo Opeyemi Aremu, Editor PONE-D-25-24666Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods feasibility analysisPLOS ONE Dear Dr. Foster, 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 04 2025 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols . We look forward to receiving your revised manuscript. Kind regards, Taiwo Opeyemi Aremu Academic Editor PLOS ONE 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 2. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. 3. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 4. 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. [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: Partly Reviewer #2: Yes ******** 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). 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: 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 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: This article is a mixed-methods analysis of the barriers/facilitators and perspectives of study-staff performing a pediatric clinical trial in rural areas. The goal of the study was to assess the efficacy of recruitment, retention, and other study procedures unique to the rural pediatric setting. The themes that emerged from the qualitative analysis provide rich data with actionable conclusions to performing pediatric clinical trials in rural areas. One weakness is the single quantitative question in Survey 1 pertaining to the perceived "difficulty" of recruitment style. This could have been expanded to provide a nuanced response to the feasibilities of the recruitment methods. The major finding that the study staff felt "neutral" about the recruitment methods is slightly misleading due to the one question asked with the issues stated above; in addition, it appears 14 of the 27 respondents were not actually involved in the recruitment, even though they responded to the question, leading me to question the validity of the response. Lines 287-295 could be an opportunity to address this. Numerical data on retention would compliment the themes that centered on retention, such as what were recruitment and then retention rates for each site? Perhaps this will be published elsewhere but I think it would bolster the themes related to retention. Overall this is a very well written paper and an important topic! Thank you for doing this work. Reviewer #2: Foster et al have studied research staff opinions/visons on how to conduct multisite randomized clinical trials with rural populations. It is a work on a quite specific subject. It is however possible to apply the results to other trial settings as well, so it has potential to be interesting for wider research communities as well. Overall, the present paper is well-written, and I found no unclarities or errors to be revised. The study itself and the results were reported promptly and without remarkable corrections needed. However, in the discussion and conclusions section, I found only the results repeated, and the actual discussion remained somewhat short. It should be more detailed within the article limits: study conclusions to a wider audience, their meaning within research context, and suggestions for the future research, if available. Authors’ visions of the combined qualitative/quantitative research? ****** 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.0333229.r001
Revision 1
20 Aug 2025 Author Response Thank you for the review of our manuscript. We appreciate the comments of the reviewers and are pleased to resubmit to PLOS One our manuscript entitled “Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods feasibility analysis.” We have pasted each critique below along with our updates to the manuscript for each point. First addressing editor requirements: 1. We utilized PLOS ONE’s style templates and believe we are complying with all guidelines. 2. I copied the language about our central IRB and consent processes from the Methods section of the manuscript and put it in the Ethics Statement section, so they match. 3. All the grant information in the ‘Funding Information’ section is correct. With apologies for the original ‘Financial Disclosure’ mismatch. 4. Reference list was reviewed; there are no retractions and just one addition. Reviewer Feedback Reviewer #1: This article is a mixed-methods analysis of the barriers/facilitators and perspectives of study-staff performing a pediatric clinical trial in rural areas. The goal of the study was to assess the efficacy of recruitment, retention, and other study procedures unique to the rural pediatric setting. The themes that emerged from the qualitative analysis provide rich data with actionable conclusions to performing pediatric clinical trials in rural areas. One weakness is the single quantitative question in Survey 1 pertaining to the perceived "difficulty" of recruitment style. This could have been expanded to provide a nuanced response to the feasibilities of the recruitment methods. We agree with the reviewer that it could have been possible to have more than one question about recruitment. However, as the study has already been completed this is not possible at this time. The major finding that the study staff felt "neutral" about the recruitment methods is slightly misleading due to the one question asked with the issues stated above; in addition, it appears 14 of the 27 respondents were not actually involved in the recruitment, even though they responded to the question, leading me to question the validity of the response. Lines 287-295 could be an opportunity to address this. This is a fair concern. To address this, we added the following to line 209: “raising questions about the validity of responses to this question”. We additionally added further discussion in lines 303-309 with “Study staff without direct recruitment responsibilities seem to have enough knowledge of recruitment processes to form an opinion about how those efforts are going. They are involved in study meetings and likely hear how recruitment is going and work closely enough with those who are recruiting to draw their own conclusions. While their opinions may not be the most relevant, they still have value. Additionally, while these study staff answered the quantitative question about recruitment, they did not answer the qualitative portion.” Numerical data on retention would compliment the themes that centered on retention, such as what were recruitment and then retention rates for each site? Perhaps this will be published elsewhere but I think it would bolster the themes related to retention. This is a great point. We have added the following to the manuscript on lines 157-160 in the Methods section where the prior iAmHealthy trial is described: “Primary outcome data from the trial were published elsewhere [22] and indicate that the vast majority of patients were recruited using the active method of recruitment (95%); data not yet published indicate that 91% of the sample was retained through the final measurement.” Overall this is a very well written paper and an important topic! Thank you for doing this work. Thank you so much! We appreciate you taking the time to review and provide valuable feedback. Reviewer #2: Foster et al have studied research staff opinions/visons on how to conduct multisite randomized clinical trials with rural populations. It is a work on a quite specific subject. It is however possible to apply the results to other trial settings as well, so it has potential to be interesting for wider research communities as well. Overall, the present paper is well-written, and I found no unclarities or errors to be revised. The study itself and the results were reported promptly and without remarkable corrections needed. Thank you so much also! We know your time is valuable and appreciate your review. However, in the discussion and conclusions section, I found only the results repeated, and the actual discussion remained somewhat short. It should be more detailed within the article limits: study conclusions to a wider audience, their meaning within research context, and suggestions for the future research, if available. Authors’ visions of the combined qualitative/quantitative research? To address this valid concern, we added to and reworked the Discussion section, some of which was included above. Rather than include it all here, we hope it is appropriate to direct you to that section, lines 285-335. https://doi.org/10.1371/journal.pone.0333229.r002
11 Sep 2025 Decision Letter - Taiwo Opeyemi Aremu, Editor Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods feasibility analysis PONE-D-25-24666R1 Dear Dr. Foster, 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. For questions related to billing, please contact billing support . 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, Taiwo Opeyemi Aremu, MD, MPH, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewer #1: Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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: Thank you for addressing my concerns! One minor wording feedback I have is on line 159, instead of saying "data not yet published," it might be more prudent to say "preliminary data" or actually include the data of 91% retention in the results section. It is confusing to say data not yet published but then "publish" it here in this sentence, if that makes sense. Reviewer #2: Within the submission files, I did not find the article version with tracked changes. However, reading the discussion section of the article, I found it substancially improved. ****** 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: No Reviewer #2: No ******** https://doi.org/10.1371/journal.pone.0333229.r003
Formally Accepted
Acceptance Letter - Taiwo Opeyemi Aremu, Editor PONE-D-25-24666R1 PLOS ONE Dear Dr. Foster, 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 You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days 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. You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing. 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. Taiwo Opeyemi Aremu Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0333229.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .