Clinical and bioethical implications of health care interruption during the COVID-19 pandemic: A cross-sectional study in outpatients with rheumatic diseases

Guillermo A. Guaracha-Basáñez; Irazú Contreras-Yáñez; Gabriela Hernández-Molina; Anayanci González-Marín; Lexli D. Pacheco-Santiago; Salvador S. Valverde-Hernández; Ingris Peláez-Ballestas; Virginia Pascual-Ramos

doi:10.1371/journal.pone.0253718

Peer Review History

Original SubmissionJanuary 29, 2021
7 Apr 2021 Decision Letter - Luca Navarini, Editor PONE-D-21-03232 Clinical and bioethical implications of health care interruption during the Covid-19 pandemic: A cross-sectional study in outpatients with rheumatic diseases. PLOS ONE Dear Dr. Pascual-Ramos, 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 May 22 2021 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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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 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 If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references.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 If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.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: Yes Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know 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: I strongly recommend to accept this paper that focuses the tension between public health ethics and clinical ethics. I would also suggest the authors to consider the fact that also rheumatic diseases constitute a public health object, therefore there should not be any conflict between them, whereas it happens it means a poor understanding of the very concept of public health. Reviewer #2: The authors presented a very well-organized paper on the effects of the SARS-CoV2 pandemic on rheumatic patients. However, some changes are required: line 108 there is a code (NCTO45573589). What is it for? Line 241: How the Authors compared disease activity before and after the missed visit? Do they used the same score systems Could the Authors clarify the symptoms and the laboratory markers used to evaluate the “disease activity”? How did these items change for the different diseases? Do they relate to any validated score? Which diseases are listed in “other rheumatologic diseases? Could they clarify if the disease activity assessment relies only on PROs? Line 319: The Authors should better discuss their results. Line 324: Long disease duration, substantial disease activity, need for rheumatic medical care, and NP with rheumatic disease-associated treatment was associated with increased disease activity. Where are these results? How did face-to-face visits compare to telemedicine affected disease control? The discussion is too long and sometimes is unfocused English should be improved ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 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Revision 1
13 Apr 2021 Author Response RESPONSES TO EDITOR AND REVIEWERS 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. Response We have revised PLOS ONE´s manuscript style requirements. 2. 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. Response We have revised the references list. We added the DOI number to all the references and complete a published media reference. We did not identify any cited papers that have been retracted. Reviewer #1: I strongly recommend to accept this paper that focuses the tension between public health ethics and clinical ethics. I would also suggest the authors to consider the fact that also rheumatic diseases constitute a public health object, therefore there should not be any conflict between them, whereas it happens it means a poor understanding of the very concept of public health. Response We really appreciate the comment. We agree with the reviewer, chronic diseases such as rheumatic diseases are object of public health. Our specialty cares for people with rheumatic and inflammatory diseases that affect the joints and connective tissues; nonetheless, as clinicians, rheumatologists work at the bed-side, and take care of individuals who are affected by a rheumatic disease; we adopt a patient-centered approach, that considers unique patients and their unique circumstances, priorities and needs; we build patient-doctor relationships with patients, at the individual level, and hardly consider the population level, which is the matter of public health. The tension between public health ethic and bed-side clinical ethics certainly needs a more comprehensive approach, but we have been required to shorten and focus the discussion. Reviewer #2: The authors presented a very well-organized paper on the effects of the SARS-CoV2 pandemic on rheumatic patients. However, some changes are required: Response Thank you for the comment. Line 108 there is a code (NCT04557358). What is it for? Response We apologize for the information missed. We have added that the study was registered at clinicaltrials.gov (largest clinical trials database, which is run by United States Library of Medicine at the National Institutes of health). NCT04557358 is the identifier assigned when the current clinical trial was registered. Line 241: How the Authors compared disease activity before and after the missed visit? Do they used the same score systems Response We have added the following paragraph to be more precise, in the- Assessment of the clinical status of rheumatic disease section: “In addition, an independent observer who was a certified rheumatologist, reviewed all the charts from the patients included, and scored the categories related to the clinical status of the underlying rheumatic disease, according to the pre-specified criteria summarized in table 2, twice, at the last consultation before HCI and at the first face-to face consultation after the OCDIR was reinstalled. Pre-specified criteria included symptoms, clinical findings and serological markers, available in the medical charts; these were identified, analyzed and integrate by the independent observer, who additionally considered the specific diagnosis of the underlying rheumatic disease.” Table 2 summarizes the pre-specified criteria used to define the subcategories, within each of the 3 categories related to the clinical status of the rheumatic disease. Could the Authors clarify the symptoms and the laboratory markers used to evaluate the “disease activity”? How did these items change for the different diseases? Do they relate to any validated score? Response: No validated scores were used, as they usually relied on serological markers that were not consistently available on the medical charts. Instead, disease activity status was defined based on the independent observer judgment (a certified rheumatologist) who integrated (available) symptoms, clinical findings and serological marker and considered the underlying rheumatic diagnosis; this approach reflects current daily practice, where the use of validated tools is exceptional and limited to research purposes. We propose the paragraph described in the previous query. Which diseases are listed in “other rheumatologic diseases? Response We have added a supplementary table (Supplementary table 1. N° (%) of patients with a face-to-face consultation at the OCDIR, with the ten most frequent rheumatic diagnoses specified) that depicts the patients’ distribution of the most frequent underlying rheumatic diagnoses. Could they clarify if the disease activity assessment relies only on PROs? Response Unfortunately PROs were not included as part of the assessment of the patients disease activity status. PROs regularly require time from the patients and formats to record the PROs, and both were limited when the outpatient clinic was reinstalled for face-to-face consultations. A better description of how disease activity was assessed, is provided in the corresponding section and table 2. Line 319: The Authors should better discuss their results. Response We propose the following paragraph: “Meanwhile, Ciurea et al. [3] demonstrated that a transient reduction in the rheumatology services during the COVID-19 pandemic had no detrimental impact on the disease course in 666 Swiss patients with axial spondyloarthritis, RA and psoriatic arthritis; however, the authors reported a 129% increase in the number of remote assessments, in an effort to compensate for the drop of the face-to face consultations, that might have influenced patients’ outcomes”. Line 324: Long disease duration, substantial disease activity, need for rheumatic medical care, and NP with rheumatic disease-associated treatment was associated with increased disease activity. Where are these results? Response We apologize for the misunderstanding due to the lack a consistency when describing the sub-categories related to the current course of disease activity. We have been more precise and consistent with the terms used all along the text. In particular “increased disease activity” has been changed to “clinical deterioration” in the manuscript. How did face-to-face visits compare to telemedicine affected disease control? Response The study was not designed to answer the question; in addition, remote consultations do not consistently assess and record the level of the underlying rheumatic disease activity. The discussion is too long and sometimes is unfocused Response We have shortened the discussion (20%) and tried to focus on the relevant clinical and ethical aspects. English should be improved Response Before submitting the manuscript, it was sent to a professional editing service for English language style review and a certificate was issued by the Wiley editing Service Company. We have additionally revised the updated version. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0253718.r002
11 Jun 2021 Decision Letter - Luca Navarini, Editor Clinical and bioethical implications of health care interruption during the COVID-19 pandemic: A cross-sectional study in outpatients with rheumatic diseases PONE-D-21-03232R1 Dear Dr. Pascual-Ramos, 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, Luca Navarini Academic Editor PLOS ONE Additional Editor Comments (optional): 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 ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 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 ****** 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 ****** 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: I've not the necessary knowledge to assess the statistical analysis. The authors have successfully addressed the questions I asked. ****** 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: Yes:** Giampaolo Ghilardi https://doi.org/10.1371/journal.pone.0253718.r003
Formally Accepted
28 Jun 2021 Acceptance Letter - Luca Navarini, Editor PONE-D-21-03232R1 Clinical and bioethical implications of health care interruption during the COVID-19 pandemic: A cross-sectional study in outpatients with rheumatic diseases Dear Dr. Pascual-Ramos: 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. Luca Navarini Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0253718.r004

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