Key needs, quality performance indicators and outcomes for patients with atrial fibrillation and multimorbidity: The AFFIRMO study

Donato Giuseppe Leo; Caterina Trevisan; Adele Ravelli; Trudie C. A. Lobban; Deirdre A. Lane; on behalf of the AFFIRMO Study investigators

doi:10.1371/journal.pone.0310106

Peer Review History

Original SubmissionMarch 30, 2024
28 Jun 2024 Decision Letter - Aviral Vij, Editor PONE-D-24-12600Key Needs, Quality Performance Indicators and Outcomes for patients with Atrial Fibrillation and Multimorbidity: The AFFIRMO Study.PLOS ONE Dear Dr. Lane, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that your paper has merit however needs minor revisions and some editions/response to reviewers comments. 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 12 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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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. Thank you for stating the following financial disclosure: [The AFFIRMO project has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant agreement No 899871.]. 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. 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: a) 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. b) 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. 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. Additional Editor Comments (if provided): [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: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes Reviewer #3: 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: No Reviewer #2: Yes Reviewer #3: 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 Reviewer #3: 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 would like to start by appreciating all the work done by authors in presenting this research article. This appears to be a multinational survey study and lot of work has been put in collecting data and its presentation among patients, providers of different countries. Since it is ongoing, the data has not been fully presented yet. However, the objective of this data collection is not very clearly explained. it is not very clear from abstract how the data collection and analysis will improve the clinical and self management of patients of AF in the context of multimorbidity. While selecting subjects for survey, there was no specific inclusion criteria used, subjects appear to be included from patients, providers and caregivers of AF with multimorbidity. Also, I did not find any exclusion criteria in supplemental material. Rest of the work looks great! Reviewer #2: The work put forth by the authors in compiling the results of their study in "Key Needs, Quality Performance Indicators and Outcomes for Patients with Atrial Fibrillation and Multimorbidity: The AFFIRMO study" is highly commendable and much appreciated. The study's primary objective is to identify the needs, quality performance indicators (QPIs), and outcomes relevant to patients, caregivers, and healthcare professionals to improve the care of patients with Atrial Fibrillation. This study is relevant to Cardiovascular medicine literature as it focuses primarily on providing holistic care of Atrial Fibrillation which represents a significant number of our patients. The major takeaways from the article were 1. The study identifies key needs and key outcomes of elderly atrial fibrillation patients. Overall, the manuscript is highly insightful and well-written; however, I would like the authors to throw some light on some of the points mentioned below. 1 . Healthcare providers who participated in the survey were mostly above age 70 about 73%. Is this accurate? This does not correlate with years of practice distribution 2 . Can the authors expand on how the difference in healthcare systems across countries might have affected the key needs and outcomes list? Reviewer #3: The authors a very important study where they analyze the healthcare goals of atrial fibrillation patients, their care givers and health care providers. Withstanding the main limitation of the the final list being based on UK patients, The study is overall very well done. I have the following questions/suggestions to the authors: -How was living with assistance defined? -Is there any data regarding the locations of these patients- whether they are urban or rural? It would be interesting to know this since healthcare views tend to vary in these locations. -Given the patient population is predominantly white, the applicability of the current study on a global scale is somewhat limited. I would recommend authors address this in their limitation section. ****** 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: Yes: Aniesh Bobba Reviewer #3: Yes: Mukunthan Murthi ******** [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.0310106.r001
Revision 1
22 Jul 2024 Author Response Dear Professor Vij We thank the Reviewers for their constructive comments and for the opportunity to revise our manuscript entitled “Key Needs, Quality Performance Indicators and Outcomes for patients with Atrial Fibrillation and Multimorbidity: The AFFIRMO Study". We have addressed the comments made by the Editor and by the Reviewers and provided a point-by-point-response below. We have also uploaded a revised copy of the manuscript with tracked changes, together with a clean copy. We hope that the revised manuscript is now suitable for publication in PLoS ONE. We look forward to hearing from you. Yours sincerely, Professor Deirdre Lane and Dr Donato G. Leo on behalf of the co-authors EDITOR’S COMMENTS: 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 Authors’ reply: Many thanks for your comment. We have now revised our manuscript as the template suggests. Tracked changes are active in the revised manuscript. 2. Thank you for stating the following financial disclosure: [The AFFIRMO project has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant agreement No 899871.]. 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. Authors’ reply: Yes, the above-mentioned statement is correct: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." 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: a) 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. b) 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. Authors’ reply: “data cannot be publicly shared for ethical reasons, as data contain potentially identifying or sensitive patient information, but data sets can be made available upon request to the research team”. 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. Authors’ reply. We have checked the reference list and made some minor edits (e.g., added page numbers for some references which were missing). We have not changed the current references nor added additional references, and we have not cited any paper that has been retracted REVIEW COMMENTS TO THE AUTHOR REVIEWER #1: Reviewer #1: I would like to start by appreciating all the work done by authors in presenting this research article. This appears to be a multinational survey study and lot of work has been put in collecting data and its presentation among patients, providers of different countries. Since it is ongoing, the data has not been fully presented yet. Authors’ reply: We thank you for your appreciation of our work. The survey and Delphi study presented in this manuscript were completed prior to our submission and the overall Work Package (of which this is a part) is also complete. However, the objective of this data collection is not very clearly explained. Authors’ reply: We have now edited and provided more details at the end of the Introduction section (page 5), which now reads as follows: “The AFFIRMO sub-study reported here aimed to identify the key needs, QPIs, and outcomes relevant to patients with AF and multimorbidity, their caregivers, and healthcare professionals (HCP) involved in their clinical management. This aim was to understand the key aspects of care that need to be improved in the management of these patients and to inform the clinical trial of the AFFIRMO study, where an empowerment toolbox will be provided to patients and caregivers, enabling them to receive information about their health conditions.” it is not very clear from abstract how the data collection and analysis will improve the clinical and self management of patients of AF in the context of multimorbidity. Authors’ reply: We have now edited the Abstract (Page 2) to make it clearer how this study will improve the clinical and self-management of patients with AF in the context of multimorbidity. It now reads: “The final key needs, QPIs and outcomes obtained from the Delphi process will inform the AFFIRMO clinical trial, which aims to test the iABC app which incorporates an empowerment toolbox for patients and their caregivers, providing information to improve patient engagement and empowerment to help improve the clinical and self-management of patients with AF in the context of multimorbidity.” While selecting subjects for survey, there was no specific inclusion criteria used, subjects appear to be included from patients, providers and caregivers of AF with multimorbidity. Authors’ reply: Eligible criteria were defined in the manuscript in the Methods section (Page 6), under the details of the online survey, as follows: “The survey was open to patients with AF and one or more concomitant chronic health conditions (multimorbidity), and their caregivers (dyads and non-dyads), and to HCPs managing patients with AF and one or more concomitant chronic health conditions.” Also, I did not find any exclusion criteria in supplemental material. Rest of the work looks great! Authors’ reply: We have now added the exclusion criteria in the Methods section, page 6: “Exclusion criteria were as follows: (i) inability to consent, (ii) moderate or severe cognitive impairment (e.g. dementia), (iii) presence of moderate or severe conditions that may prevent completion of the survey, (iv) inability to complete the survey online, and (v) unwilling to participate in the study.” REVIEWER #2: Reviewer #2: The work put forth by the authors in compiling the results of their study in "Key Needs, Quality Performance Indicators and Outcomes for Patients with Atrial Fibrillation and Multimorbidity: The AFFIRMO study" is highly commendable and much appreciated. The study's primary objective is to identify the needs, quality performance indicators (QPIs), and outcomes relevant to patients, caregivers, and healthcare professionals to improve the care of patients with Atrial Fibrillation. This study is relevant to Cardiovascular medicine literature as it focuses primarily on providing holistic care of Atrial Fibrillation which represents a significant number of our patients. The major takeaways from the article were 1. The study identifies key needs and key outcomes of elderly atrial fibrillation patients. Overall, the manuscript is highly insightful and well-written; however, I would like the authors to throw some light on some of the points mentioned below. 1. Healthcare providers who participated in the survey were mostly above age 70 about 73%. Is this accurate? This does not correlate with years of practice distribution Authors’ reply: We think there may have been a misunderstanding with the data presented in our manuscript. The mean age you have highlighted relates to the patients that have participated in the online survey (Table 1, page 19), not to the healthcare provider (HCP) group. The mean age for the HCP group is 47.4 (SD±10.6) years, as reported in Table 3 (page 23) of the manuscript. This is also reported in the results of the online survey (page 8): “A total of 1,305 participants completed the online survey. Of these, 659 (50.5%) were patients with a mean (SD) age of 70.9 (10.2) years and 348 (52.8%) female; 201 (%) were caregivers, mean (SD) age 58.3 (15.2) years and 147 (73.1%) female; and 445 (%) were HCPs, mean (SD) age 47.4 (10.6) and 257 (57.2%) female.” 2 . Can the authors expand on how the difference in healthcare systems across countries might have affected the key needs and outcomes list? Authors’ reply: We have now expanded on this in the limitations (page 12), and it now reads as follows: “The presence of only UK patient and caregiver participants in the Delphi process (due to the need of a common language for the discussion) is a limitation, which may have presented viewpoints related to one specific healthcare system, and may have influenced the key needs, QPIs, and outcomes selected. However, HCPs from five countries contributed to the Delphi process which ensured diversity in healthcare system perspectives. Further, the Delphi workshops discussed the needs, QPIs and outcomes identified by patients, caregivers and HCPs from five European healthcare systems via the on-line surveys, which minimises the possible UK-biased perspective of healthcare.” REVIEWER #3: Reviewer #3: The authors a very important study where they analyze the healthcare goals of atrial fibrillation patients, their care givers and health care providers. Withstanding the main limitation of the final list being based on UK patients, The study is overall very well done. I have the following questions/suggestions to the authors: -How was living with assistance defined? Authors’ reply: We did not provide any specific definition of ‘living with assistance’. This data was part of the self-reported information collected by the online survey. Therefore, patients identified themselves as living with assistance or not (as reported in Table 1, page 19). -Is there any data regarding the locations of these patients- whether they are urban or rural? It would be interesting to know this since healthcare views tend to vary in these locations. Authors’ reply: No, unfortunately we did not collect further information on geographical location other than country. -Given the patient population is predominantly white, the applicability of the current study on a global scale is somewhat limited. I would recommend authors address this in their limitation section. Authors’ reply: We have now added this detail in the limitation section of our manuscript (page 12) which now reads as follows: “Moreover, patients and caregivers who participated in the survey were mainly of White ethnicity which may reduce the generalisability of our findings.” Attachments Attachment Submitted filename: Response to Reviewers letter.docx https://doi.org/10.1371/journal.pone.0310106.r002
26 Aug 2024 Decision Letter - Aviral Vij, Editor Key Needs, Quality Performance Indicators and Outcomes for patients with Atrial Fibrillation and Multimorbidity: The AFFIRMO Study. PONE-D-24-12600R1 Dear Dr. Lane, 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, Aviral Vij Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0310106.r003
Formally Accepted
30 Aug 2024 Acceptance Letter - Aviral Vij, Editor PONE-D-24-12600R1 PLOS ONE Dear Dr. Lane, 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. Aviral Vij Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0310106.r004

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