Telehealth at scale can improve chronic disease management in the community during a pandemic: An experience at the time of COVID-19

Stefano Omboni; Tommaso Ballatore; Franco Rizzi; Fernanda Tomassini; Edoardo Panzeri; Luca Campolo

doi:10.1371/journal.pone.0258015

Peer Review History

Original SubmissionAugust 6, 2021
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Kind regards, Luigi Lavorgna 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 [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: N/A 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: “Home data were collected with patients' own devices and were manually inputted in the mobile app.” In my opinion, automatic data transmission would have eliminated reporting bias of manual entry. It would have been a very useful feature for the elderly due to the likelihood of physical and/or intellectual limitation. It is not clear who inputted data in the mobile app, the patients? In this case, there could be a reporting bias of manual entry? Further, elderly patients could have more difficulties. In my opinion, this could have influenced the results. Therefore, this issue should be mentioned and discussed in the limits section of the manuscript. In table 1: “Age (years)” correct as “Age (years, SD)” In the results section: “During the lockdown, a significant increase in the number of SpO2 values and a significant reduction in the entries for body temperature, body weight, blood lipids, or glucose values was observed.” The authors discussed as: “During the lockdown, a significant increase in the number of SpO2 values recorded was observed, likely because people in isolation sought a way to check their COVID-19 risk.” Why did the authors observe a significant reduction in the entries for body temperature, considering that it is the first step to check the risk of COVID-19 infection? It should be discussed. In general, the authors should discuss more deeply all their results. “In Italy, in the course of the first wave of the COVID-19 pandemic, available telehealth solutions have been used to track and promptly detect potentially infected individuals and monitor patients with any critical chronic condition restrained at home. However, preliminary reports suggest that the Country was mostly unprepared to implement existing telehealth solutions for this purpose.” However, telemedicine for the management of chronic disease (behind cardiovascular diseases) was proposed and applied in several fields of medicine. For example, there are several chronic neurological diseases for which different telemedicine tools were proposed and tested (PMID: 34142263; PMID: 33802029; PMID: 33025327; PMID: 34173087; PMID: 34436726). I would add a sentence to mention this. Reviewer #2: Interesting extensive observation. ables and figures well presented. Lack of follow-up is the major limitation. in Conclusions authors say: "the study suggests that it is urgent to implement a more significant number of telehealth solutions on the territory", could the authors give some suggestions or comment this point in Discussion? Considering recent implement in the approach with in-house therapy, could the author imagine a future project to support patients in this sense using their protocolo ? ****** 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.0258015.r001
Revision 1
13 Sep 2021 Author Response Reviewer #1: “Home data were collected with patients' own devices and were manually inputted in the mobile app.” In my opinion, automatic data transmission would have eliminated reporting bias of manual entry. It would have been a very useful feature for the elderly due to the likelihood of physical and/or intellectual limitation. It is not clear who inputted data in the mobile app, the patients? In this case, there could be a reporting bias of manual entry? Further, elderly patients could have more difficulties. In my opinion, this could have influenced the results. Therefore, this issue should be mentioned and discussed in the limits section of the manuscript. We thank the Reviewer for her/his positive evaluation of our work. We agree with the Reviewer. Indeed, the app can connect via Bluetooth to some devices that, however, need to be purchased. Unfortunately, no subject made use of these devices. Rather, they used their own devices. We added a sentence in the methods to clarify this point (page 6, lines 136-139). The patient inputted the data, and, as correctly highlighted by the Reviewer, the risk of a reporting bias was potentially high. However, we made a check of potential outliers and corrected them. We have now discussed this aspect in the limitation section of the discussion (page 16, lines 350-355). In table 1: “Age (years)” correct as “Age (years, SD)” We thank the Reviewer for noticing this omission. As per her/his request, we have now amended Table 1 (but also Table S1 and S2) by adding “mean±SD” to age. In the results section: “During the lockdown, a significant increase in the number of SpO2 values and a significant reduction in the entries for body temperature, body weight, blood lipids, or glucose values was observed.” The authors discussed as: “During the lockdown, a significant increase in the number of SpO2 values recorded was observed, likely because people in isolation sought a way to check their COVID-19 risk.” Why did the authors observe a significant reduction in the entries for body temperature, considering that it is the first step to check the risk of COVID-19 infection? It should be discussed. In general, the authors should discuss more deeply all their results. The Reviewer is correct. However, the finding is not surprising. The app returns immediate feedback on the normality of the value (see page 6, lines 124-125 “In the case of data collected at home, the mobile app provides immediate feedback to the user about the parameter's critical level”). Since subjects are familiar with the interpretation of body temperature but not with that of SpO2 the preferential use in the case of SpO2 may be linked to this app’s function, which was found particularly useful by the users. We acknowledge that this point was not adequately described and discussed. The discussion has been expanded in order to clarify this aspect (page 14, lines 309-314). Furthermore, the entire discussion has been revised and improved following both Reviewers’ suggestions. “In Italy, in the course of the first wave of the COVID-19 pandemic, available telehealth solutions have been used to track and promptly detect potentially infected individuals and monitor patients with any critical chronic condition restrained at home. However, preliminary reports suggest that the Country was mostly unprepared to implement existing telehealth solutions for this purpose.” However, telemedicine for the management of chronic disease (behind cardiovascular diseases) was proposed and applied in several fields of medicine. For example, there are several chronic neurological diseases for which different telemedicine tools were proposed and tested (PMID: 34142263; PMID: 33802029; PMID: 33025327; PMID: 34173087; PMID: 34436726). I would add a sentence to mention this. The introduction has been revised and the original sentence has been modified in order to comply with Reviewer’s suggestion (page 3, lines 71-75). Wee have also added relevant references (from 14 to 22). Reviewer #2: Interesting extensive observation. Tables and figures well presented. Lack of follow-up is the major limitation. in Conclusions authors say: "the study suggests that it is urgent to implement a more significant number of telehealth solutions on the territory", could the authors give some suggestions or comment this point in Discussion? Considering recent implement in the approach with in-house therapy, could the author imagine a future project to support patients in this sense using their protocol? We thank the Reviewer for her/his positive evaluation of our work for her/his important suggestion. We have now added a section Perspectives and provided some consideration about the future of telehealth in this field. The section regarding conclusions has also been modified. Attachments Attachment Submitted filename: Replies to Reviewers PLOS ONE.docx https://doi.org/10.1371/journal.pone.0258015.r002
16 Sep 2021 Decision Letter - Luigi Lavorgna, Editor Telehealth at scale can improve chronic disease management in the community during a pandemic: an experience at the time of COVID-19 PONE-D-21-21512R1 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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to 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, Luigi Lavorgna Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0258015.r003
Formally Accepted
17 Sep 2021 Acceptance Letter - Luigi Lavorgna, Editor PONE-D-21-21512R1 Telehealth at scale can improve chronic disease management in the community during a pandemic: an experience at the time of COVID-19 Dear Dr. Omboni: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please 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 plosone@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. Luigi Lavorgna Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0258015.r004

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