Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure

Alexander Kogel; Pierre Hepp; Tina Stegmann; Adrienn Tünnemann-Tarr; Roberto Falz; Patrick Fischer; Felix Mahfoud; Ulrich Laufs; Sven Fikenzer

doi:10.1371/journal.pone.0269470

Peer Review History

Original SubmissionSeptember 15, 2021
21 Mar 2022 Decision Letter - Antonino Salvatore Rubino, Editor PONE-D-21-29862Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failurePLOS ONE Dear Dr. Kogel, 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. ACADEMIC EDITOR:The manuscript has undergone a deep review from one reviewer. The authors should address all the queries raised by the reviewer before full consideration for publication Please submit your revised manuscript by May 01 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. 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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: Thank you for your submitted manuscript entitled, “Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure. The area of the research is interesting, however it needs a few amendments. Overall, the paper is well-written, well-written statistics. ABSTRACT • Clarify the subjects’ level and background • Could be a relevant conclusion of the present study to find what is important to know. INTRODUCTION • The introduction is consistent and easy to follow. Hypotheses are clearly formulated. • The Authors should clarify the actual heritage of this study. I am concerned about the originality of the present study. METHOD • How was sample size determined? (Sampling technique!) • What about the inclusion and exclusion criteria? STATISTICAL ANALYSIS • Please, present methods of data analysis and criterion of results interpretation. • Please add a power analysis, which takes into account the number of variables • RESULTS • Obviously, the authors conducted a variance analysis. Please describe and explain the used test(s) in the statistical section. • Results description is a little chaotic and insufficient. Please, add some introductions to the description of the results and indicate what and why you did. Each result presented in the tables should be commented on in the text. Without that, readers do not know how to interpret the tables. • DISCUSSION • Discussion should be more based on the literature CONCLUSION • Why might one want to cite this paper? What is the true impact of the literature? ****** 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: Yes:** Souhail Hermassi [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". 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Revision 1
1 Apr 2022 Author Response Revision of PONE-D-21-29862 Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure Point-by-point response to the reviewers General comment to the editor: We thank the editors and the reviewer for their time and helpful comments which improved the manuscript. All changes were highlighted in the revised manuscript. Reviewers' comments to the author: Thank you for your submitted manuscript entitled, “Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure. The area of the research is interesting, however it needs a few amendments. Overall, the paper is well-written, well-written statistics. Response: Thank you for the positive feedback and the recommendations. ABSTRACT • Clarify the subjects’ level and background Response: We moved the information from “Aims” to “Methods” “12 patients with clinically stable chronic heart failure (HF) (age 63.8±12 years, left ventricular ejection fraction (LVEF) 43.8±11 %, NTProBNP 573±567 pg/ml)…” • Could be a relevant conclusion of the present study to find what is important to know. Response: Thank you, we have extended the Conclusion accordingly. “Both surgical and FFP masks reduce exercise capacity in heart failure patients, while FFP2 masks reduce oxygen uptake and peak ventilation. This reduction in cardiopulmonary performance should be considered in heart failure patients for which daily life activities are often just as challenging as exercise is for healthy individuals.” INTRODUCTION • The introduction is consistent and easy to follow. Hypotheses are clearly formulated. Response: Thank you. • The Authors should clarify the actual heritage of this study. I am concerned about the originality of the present study. Response: Although there are several recent publications regarding the impact of face masks and exercise, there is currently a lack of data concerning patients with heart failure. Since the topic is of very high daily relevance, we are convinced that the data can be helpful for all who are monitoring/diagnosing heart failure patients in the context of training and exercise und pandemic conditions. METHOD • How was sample size determined? (Sampling technique!) Response: The sample size was based on results of our prior study. “The study was powered to detect a difference of 10% in VO2max/kg between nm and ffpm with β=0.2 and α=0.05.” This was the underlying basis for the sample size calculation. This is mentioned in the “Statistical analysis”. • What about the inclusion and exclusion criteria? Response: Thank you very much. We added the following information in the Method section: Inclusion/Exclusion criteria Inclusion: • Clinically stable chronic heart failure • Heart Failure with reduced Ejection Fraction (HFrEF), mildly reduced Ejection Fraction (HFmrEF) and Heart Failure with preserved Ejection Fraction, HFpEF Exclusion: • Contraindications to ergometry: • Acute coronary syndrome • Symptomatic high-grade valvular ventricular disease • Decompensated heart failure • Acute pulmonary embolism • Acute inflammatory heart disease • Acute aortic dissection • Blood pressure at rest >180/100 mmHg • Acute leg vein thrombosis • Acute severe general illness • Extracardiac disease with significantly limited life expectancy (≤6 months) • Untreated severe ventricular arrhythmias • Symptomatic bradycardia, AV block II° type 2 Mobitz, or AV block III° without pacemaker care • Limited mobility with need for walkers, wheelchair, or motorized devices without ability to perform ergometry • Implanted pacemaker or CRT systems (ICD allowed) • COPD stage III STATISTICAL ANALYSIS • Please, present methods of data analysis and criterion of results interpretation. Response: As written in the Methods section (Statistical analysis): “For distribution analysis, the D'Agostino–Pearson normality test was used. For normal distribution, comparisons were made using one-way repeated measures ANOVA with Turkey's post hoc test for multiple comparisons. Otherwise, the Friedman non-parametric test and Dunn's post hoc test were used. Pearsons r was used for correlation analyses and R2 as the coefficient of determination.” The significance level was defined as p < 0.05. • Please add a power analysis, which takes into account the number of variables Response: Thank you very much. Related to the main endpoints (Watt, VO2max, oxygen pulse) we included the effect sizes (eta-squared) in the text as follows: The significant differences measured using the FFP2 masks were associated with very high effect sizes (eta-squared) for the main endpoints: Watt (�2=0.62), VO2max (�2=0.41), and oxygen pulse (�2=0.33). RESULTS • Obviously, the authors conducted a variance analysis. Please describe and explain the used test(s) in the statistical section. Response: As written in the Methods section (Statistical analysis): “… comparisons were made using one-way repeated measures ANOVA with Turkey's post hoc test for multiple comparisons.” • Results description is a little chaotic and insufficient. Please, add some introductions to the description of the results and indicate what and why you did. Each result presented in the tables should be commented on in the text. Without that, readers do not know how to interpret the tables. Response: We added short introductions to the result subsections to highlight why we did the respective test. revised the manuscript to present each result in the text as well as in the tables. DISCUSSION • Discussion should be more based on the literature Response: We added relevant and current literature to the discussion. CONCLUSION • Why might one want to cite this paper? What is the true impact of the literature? Response: The manuscript is very important for the scientific community because the data show for the first time the impact of face masks in incremental exercise tests in heart failure patients, which may result in downgrading based on Weber classification. Additionally, this information is important for all caregivers of heart failure patients. Attachments Attachment Submitted filename: Response to reviewer comments_010422.docx https://doi.org/10.1371/journal.pone.0269470.r002
23 May 2022 Decision Letter - Antonino Salvatore Rubino, Editor Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure PONE-D-21-29862R1 Dear Dr. Kogel, 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, Antonino Salvatore Rubino, M.D., Ph.D. 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: Thank you for your effort ! The manuscript is well written after the minor revision and now is suitable for publication ****** 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:** Souhail Hermassi https://doi.org/10.1371/journal.pone.0269470.r003
Formally Accepted
12 Aug 2022 Acceptance Letter - Antonino Salvatore Rubino, Editor PONE-D-21-29862R1 Effects of surgical and FFP2 masks on cardiopulmonary exercise capacity in patients with heart failure Dear Dr. Kogel: 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. Antonino Salvatore Rubino Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0269470.r004

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