Shared medical appointments: Translating research into practice for patients treated with ablation therapy for atrial fibrillation

Monika M. Schmidt; Joan M. Griffin; Pamela McCabe; Lynette Stuart-Mullen; Megan Branda; Thomas J. OByrne; Margaret Bowers; Kathryn Trotter; Christopher McLeod

doi:10.1371/journal.pone.0246861

Peer Review History

Original SubmissionApril 16, 2020
24 Nov 2020 Decision Letter - Elena G. Tolkacheva, Editor PONE-D-20-10458 Shared Medical Appointments: Translating Research into Practice for Patients treated with ablation therapy for Atrial Fibrillation PLOS ONE Dear Dr. Schmidt, 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 address comments indicated by the Reviewer. Please submit your revised manuscript by Jan 08 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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Please refer to our statistical reporting guidelines for assistance (https://journals.plos.org/plosone/s/submission-guidelines.#loc-statistical-reporting). 3. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files. [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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: In this retrospective study, Schmidt and colleagues determined if perceived self-management differed between patients who participated in shared medical appointments (SMA) compared to patients provided standard of care. They showed that perceived self-management was not significantly different at baseline or 6 months. Patients in SMAs reported a greater knowledge at baseline and higher goal setting at 6 months with symptom severity following a similar trend. In summary, the findings of the study show that patients who participated in SMAs had similar perceived self-management, patient satisfaction with provider communication, symptom severity, and healthcare utilization with their counterparts but experienced significant improvement in knowledge about their AF. General Comments This is an interesting study that determined if perceived self-management differed between patients who participated in SMAs as compared to patients who were provided standard of care. The rationale for the study relates to studies showing that SMAs have been effective at targeting lifestyle change in other chronic diseases and may be beneficial in patients with AF. Overall the manuscript is well-written, and the conclusions are supported by the data presented. However, clarification of the following specific comments will greatly enable the reader to interpret the results and potential implications of the study. Specific Comments 1. As so many different surveys were used in the study, it is hard to keep track of which ones used to determine differences between the SMA and control group. These should be revised to improve readability and understanding of the study. The benefits of using a comprehensive and AF-specific questionnaire such as AFEQT should be discussed. 2. The rationale for excluding patients with a history of chronic kidney disease on hemodialysis and cancer was unclear. 3. Choosing to evaluate an SMA approach in patients referred for AF ablation therapy may not be optimal. A more appropriate cohort would be a group of patients referred to an AF Clinic in whom the choice of therapy has not already been decided may provide very different results. 4. It is unclear if the primary endpoint of the study used the 3- or 6-month surveys and there appears to be some variability in the number of patients who completed one or both of these. 5. It is a little surprising that there was no difference in patient activation measure or patient assessment of chronic illness. Some explanation for this finding should be provided. 6. It is important to correlate outcomes with success rate of the AF ablation procedure in the two groups. 7. The study is limited to white patients and a tertiary referral center. It’s applicability to patients of different ancestries and non-tertiary referral centers is unclear. ****** 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 [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.0246861.r001
Revision 1
8 Jan 2021 Author Response Specific Comments 1. As so many different surveys were used in the study, it is hard to keep track of which ones used to determine differences between the SMA and control group. These should be revised to improve readability and understanding of the study. The benefits of using a comprehensive and AF-specific questionnaire such as AFEQT should be discussed. Thank you for the opportunity to clarify this important point. We have revised the manuscript to include the following language: “Consistent with Social Cognitive Theory, the theoretical basis of the intervention, we captured data on the different theoretical domains using different, psychometrically-sound scales. Other scales, such as the AF Effect on Quality of life (AFEQT), capture important aspects of quality of life, but are devoid of domains included in our framework, such as patient activation, knowledge of atrial fibrillation, patient provider communication, and severity of symptoms experienced by patients. These specific domains were important in understanding the ability of the patient and provider to exchange information bidirectionally during the medical encounter in order to evaluate potential differences between standard care and the SMA group.” Referring to the AFSS scale, “This scale has been included in other large-scale studies, including the ARREST-AF study, which was intended to allow comparability of findings across studies.” 2. The rationale for excluding patients with a history of chronic kidney disease on hemodialysis and cancer was unclear. We have revised the manuscript to reflect rationale for excluding specific patient groups as follows, “Patients receiving active cancer treatment, hemodialysis, or who had an implanted left ventricular assist devices were not included as study participants because: 1.) these patients are not generally suitable for the catheter ablation procedure, and 2.) the additional care required to treat and manage these diseases while also managing care for an ablative procedure would deviate considerably from the standard of care and potentially confound results.” 3. Choosing to evaluate an SMA approach in patients referred for AF ablation therapy may not be optimal. A more appropriate cohort would be a group of patients referred to an AF Clinic in whom the choice of therapy has not already been decided may provide very different results. Thank you for bringing this important point to our attention. We have attempted to clarify our decision to include patients seeking ablative therapy as follows: “Catheter ablation is an effective strategy for rhythm control in patients with drug refractory AF and has been shown to improve disease specific quality of life compared to conventional medical therapy … More recently, a number of trials that included structured fitness and weight loss programs have demonstrated a beneficial impact, with decreases in symptom burden associated with AF and improvements in quality of life.7,8 These same benefits have been shown for patients who have undergone catheter ablation with aggressive lifestyle modification interventions” 4. It is unclear if the primary endpoint of the study used the 3- or 6-month surveys and there appears to be some variability in the number of patients who completed one or both of these. Our primary objectives were to determine if perceived self-management and satisfaction with provider communication about AF management differed between patients being treated with ablation who were exposed to a SMA approach and those who received standard care from baseline to 6 months. Secondary objectives were to explore differences between groups for knowledge about atrial fibrillation, symptom severity, and healthcare utilization... Attrition was noted in both groups.” This has been clarified in the manuscript. 5. It is a little surprising that there was no difference in patient activation measure or patient assessment of chronic illness. Some explanation for this finding should be provided. We have added the following text for clarity: In a separate analysis of patient activation of our data published elsewhere we found that patient activation for self-management in our patient population was associated with positive health status and educational attainment. Patients referred to quaternary care centers for consideration of catheter ablation (or who self-refer) often have been exposed to multiple prior encounters with clinicians and are well informed about their care. This may explain the high levels of patient activation noted at baseline. This relatively activated patient group may also explain the lack of variability for PACIC scores, with the exception of the PACIC subscale for goalsetting which is unique to the specific SMA clinical encounter. 6. It is important to correlate outcomes with success rate of the AF ablation procedure in the two groups. We have added the following text for clarity: “…we are limited by our data sources to test associations with longer term outcomes associated with AF ablation procedure success. This, in part, is due to the nature of the cardiac ablation procedure. The presence of atrial arrhythmias in the early post-ablation period is common because of ablation-related inflammation and healing and atrial arrhythmias during this period are not seen as a true recurrence33. In fact, atrial arrhythmias during this early post-ablation period are not associated with worse long-term outcomes or arrhythmia recurrence32. Ablation procedure success is best measured up to at least 1 year, but because our data is limited to the first 6 months post-ablation, we are constrained at linking intervention results with longer-term AF ablation procedure success.” 7. The study is limited to white patients and a tertiary referral center. It’s applicability to patients of different ancestries and non-tertiary referral centers is unclear. The following has been added for clarity: “Because of the unique setting and quality improvement design for our study, our findings may not be generalizable in other settings, either because of the lack of diversity in our study sample, the amount of time spent with patients or because patients who seek evaluation for a procedure at a major academic health center may be more motivated to change than patients at community health centers or those with less pronounced or disruptive symptoms. However, our results do demonstrate the feasibility of implementing an SMA approach in a busy and complex clinical setting.” Attachments Attachment Submitted filename: Response to Reviewers .docx https://doi.org/10.1371/journal.pone.0246861.r002
28 Jan 2021 Decision Letter - Elena G. Tolkacheva, Editor Shared Medical Appointments: Translating Research into Practice for Patients Treated with Ablation Therapy for Atrial Fibrillation PONE-D-20-10458R1 Dear Dr. Schmidt, 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, Elena G. Tolkacheva, PhD 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: 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 ****** 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: (No Response) ****** 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:** Dawood DARBAR https://doi.org/10.1371/journal.pone.0246861.r003
Formally Accepted
2 Feb 2021 Acceptance Letter - Elena G. Tolkacheva, Editor PONE-D-20-10458R1 Shared Medical Appointments: Translating Research into Practice for Patients Treated with Ablation Therapy for Atrial Fibrillation Dear Dr. Schmidt: 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. Elena G. Tolkacheva Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0246861.r004

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