Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 months

Roland von Känel; Rebecca E. Meister-Langraf; Claudia Zuccarella-Hackl; Sarah L. F. Schiebler; Hansjörg Znoj; Aju P. Pazhenkottil; Jean-Paul Schmid; Jürgen Barth; Ulrich Schnyder; Mary Princip

doi:10.1371/journal.pone.0269545

Peer Review History

Original SubmissionFebruary 14, 2022
22 Apr 2022 Decision Letter - Carmine Pizzi, Editor PONE-D-22-04546Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 monthsPLOS ONE Dear Dr. von Känel, 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 Jun 02 2022 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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[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? 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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: Based on cross-sectional studies and this ancillary data analysis, it appears that patients with ACS, sleep disturbance is common and most severe in the days after ACS with a decrease in the following three months. Female sex, history of depression, and increased fear of dying and helplessness during ACS are independently associated with greater sleep disturbance. Potentially modifiable factors were examined as well. Supplemental models and effect modifier analyses were done reasonably well. Table 2 appears to summarize the results. As a minor note, the presentation lacks design considerations given the 190 were enrolled with 180 having complete data. There should be some statistical justification for the sufficiency of 180 subjects in this analysis. Reviewer #2: The purpose of this study was to describe the course of sleep disturbance and associated factors in patients with ACS who were followed for one year. The manuscript is interesting. This topic subject is original and the long follow-up add important knowledge on this field Sleep disorders have emerged as a major cardiovascular risk factor in recent years and the pandemic has revealed how these disorders have increased as a response to stress. The manuscript offers a very interesting follow-up Methods are well described. Results are good and I like tables Sleep disturbances are a modifiable risk factor through non-drug therapy (increased physical activity, relaxation techniques, adequate nutrition) or drug therapy. A comment on this in the discussion would improve the manuscript ****** 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:** Anna Vittoria Mattioli [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.0269545.r001
Revision 1
22 Apr 2022 Author Response Response to Reviewers PONE-D-22-04546: Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 months Review Comments to the Author Reviewer #1: Based on cross-sectional studies and this ancillary data analysis, it appears that patients with ACS, sleep disturbance is common and most severe in the days after ACS with a decrease in the following three months. Female sex, history of depression, and increased fear of dying and helplessness during ACS are independently associated with greater sleep disturbance. Potentially modifiable factors were examined as well. Supplemental models and effect modifier analyses were done reasonably well. Table 2 appears to summarize the results. We thank the Reviewer for the favorable appraisal of our manuscript. Comment 1 As a minor note, the presentation lacks design considerations given the 190 were enrolled with 180 having complete data. Response We now clarified that the MI-SPRINT trial had originally enrolled a total of 190 patients and that 180 had complete data that could be analyzed for this sleep study. P 5, lines 106-109: The MI-SPRINT trial had originally enrolled a total of 190 patients. Of these, 180 had complete data for sleep disturbance and covariates at admission that could be analyzed for this ancillary sleep study. Comment 2 There should be some statistical justification for the sufficiency of 180 subjects in this analysis. Response We believe that the reviewer is asking for a power analysis to justify the sample size of our study. However, because this was a secondary analysis of data collected for a randomized controlled trial with clinically relevant ACS-induced posttraumatic stress as the primary outcome, we had not preregistered a power analysis with sleep disturbance as the outcome. Moreover, a post-hoc power analyses as an attempt to determine whether the sample size of a secondary data analysis is adequate for a proposed analysis are commonly discouraged as they may produce misleading results and are logically invalid (see, for instance, Dziak et al, 2020): Dziak JJ, Dierker LC, Abar B. The Interpretation of Statistical Power after the Data have been Gathered. Curr Psychol. 2020 Jun;39(3):870-877. doi: 10.1007/s12144-018-0018-1. However, we now mention as a limitation of our study that we had not performed a power analysis that might have justified the sample size of our ancillary sleep study. P 17, lines 362-366: Moreover, as this was a secondary analysis of data collected for a randomized controlled trial to prevent the development of ACS-induces posttraumatic stress, there was no a priori power analysis for sleep disturbances as the outcome variable. Therefore, we are unable to justify the sample size of 180 patients for this ancillary sleep study on formal statistical grounds. Reviewer #2: The purpose of this study was to describe the course of sleep disturbance and associated factors in patients with ACS who were followed for one year. The manuscript is interesting. This topic subject is original and the long follow-up add important knowledge on this field. Sleep disorders have emerged as a major cardiovascular risk factor in recent years and the pandemic has revealed how these disorders have increased as a response to stress. The manuscript offers a very interesting follow-up. Methods are well described. Results are good and I like tables. We thank the Reviewer for the favorable appraisal of our manuscript. Comment 1 Sleep disturbances are a modifiable risk factor through non-drug therapy (increased physical activity, relaxation techniques, adequate nutrition) or drug therapy. A comment on this in the discussion would improve the manuscript. Response We thank the Reviewer for this valuable point. We added the following information to the discussion, P 16, lines 320-327: The European Sleep Research Society guidelines recommend CBT as a first-line treatment for chronic insomnia (i.e., duration of at least 3 months) in adults of all ages [25]. Pharmacologic interventions (i.e., benzodiazepines, benzodiazepine receptor agonists, and some sedating antidepressants) may be considered for short-term treatment of insomnia (≤4 weeks) if CBT is not sufficiently effective or not available [25]. However, it should be noted that potential side effects of these pharmacologic interventions must be considered, which may limit (e.g., mirtazapine) or even prevent (e.g., amitriptyline) their use in patients with coronary heart disease [26]. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0269545.r002
24 May 2022 Decision Letter - Carmine Pizzi, Editor Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 months PONE-D-22-04546R1 Dear Dr. von Känel, 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, Carmine Pizzi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0269545.r003
Formally Accepted
26 May 2022 Acceptance Letter - Carmine Pizzi, Editor PONE-D-22-04546R1 Sleep disturbance after acute coronary syndrome: A longitudinal study over 12 months Dear Dr. von Känel: 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 Prof Carmine Pizzi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0269545.r004

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