PONE-D-24-18282Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based studyPLOS ONE

Dear Dr. Gatti,

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:

While the manuscript exhibits intriguing potential, it requires significant revisions and further refinement.<o:p></o:p>

Although the inherent interest in the subject matter is acknowledged, the reviewers have raised crucial concerns that must be properly addressed.

Please submit your revised manuscript by Aug 30 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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We look forward to receiving your revised manuscript.

Kind regards,

Marcelo Arruda Nakazone, M.D., Ph.D.

Academic Editor

PLOS ONE

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Additional Editor Comments (if provided):

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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: No

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

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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: No

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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

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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 the opportunity to revise this manuscript. The authors evaluated the association of cardiac implantable electronic devices with health-related quality of life (HRQoL). While the article is grammatically sound, it requires a more comprehensive explanation of the research methodology.

MAJOR COMMENTS

Abstract

1. Please describe the statistical analyses performed in the methods section.

2. What is the reference group in these analyses?

3. In this sentence in lines 14-15 "the presence of defibrillator was associated with lower EQ-VAS (-3.4, 95% confidence intervals (CI) -6.7; -0.1 and -4.8, 95% CI -8.8;-0.7)", what do these coefficients represent?

4. What is the study design?

5. Please indicate that HRQoL measurements were conducted twice.

Introduction

The authors ought to incorporate a literature review detailing what is already known about the topic, identifying the knowledge gaps in existing literature, and explaining how this study addresses those gaps.

Methods:

1. Please provide a comprehensive description of the independent variables in this analysis

2. Statistical Analysis - Line 10: What type of regression was used? This question is particularly important because the outcome variables are bounded (EQ-VAS ranges from 1-100)

3. What is the study design?

MINOR COMMENTS

Line 4: Please remove the comma after "(CRT-P)" and change" [on] health-related quality of life (HRQoL)" to "[with] health-related quality of life (HRQoL) "

Line 8: Please replace "February 2022 to analyze" with "February 2022 was used to analyze"

Lines 9-10: Please consider rephrasing this sentence to make the meaning of "prevalence of females" clearer. Does it mean the proportion of females? If so, the sentence could be revised as follows: "The median age was 77 years with females constituting 38% of the PM group and 17% of the ICD group.

Reviewer #2: This study asks and addresses an important question – what are the effects of cardiac implantable electronic devices (CIED) on the well-being of patients? Importantly, this assessment of well-being is performed by the patients themselves. This paper is well written and presents a series of well-explained and sensible analyses. Understanding the impact of various variables on post-implantation well-being is clearly important, and this paper makes an important contribution to this area of inquiry.

It is interesting (and surprising to me) that the baseline HRQoL values seem so high? For example, the median baseline EQ-5D index is greater than 0.9. Isn’t this a surprisingly high number for patients about to undergo surgery? I think it would be useful for the authors to discuss this and comment on the range of values observed in other relevant groups e.g. healthy population.

Minor edits -

Typo in title! “in in”

Abstract –

Change “one year the” to “one year of the”

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Reviewer #1: No

Reviewer #2: Yes: Akshay Bareja

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PONE-D-24-18282R1Health-related quality of life in a large cohort of patients with cardiac implantable electronic devices A registry-based studyPLOS ONE

Dear Dr. Gatti,

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:

Thank you for addressing the previous comments. The manuscript presents a subject of potential interest. However, one of the reviewers has raised questions about specific aspects that need to be properly addressed. Please ensure that these points are considered in your revision to enhance the manuscript's clarity and depth.

==============================

Please submit your revised manuscript by Nov 14 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.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Marcelo Arruda Nakazone, M.D., Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

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.

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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 #2: All comments have been addressed

Reviewer #3: All comments have been addressed

Reviewer #4: All comments have been addressed

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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 #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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 #2: No

Reviewer #3: Yes

Reviewer #4: Yes

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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 #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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 #2: (No Response)

Reviewer #3: Authors are undertaking an interesting task of comparing quality of life changes associated with CIED implantation.

Needless to say, study is hindered by only analyzing answers of motivated patients and we should keep that in mind.

I have questions requiring clarification

“since its preventive nature instead of physical symptomatology treatment, may no impact patients' reported outcomes… Furthermore, the fear of inappropriate shocks, a higher

rate of complication and restrictions on driving license and specific activities may have

counteracted other beneficial effects perceived by the patients”

Very confusing statement to me since I see only grouped analysis of ICD implants without break down for primary and secondary prevention and I think these should that be analyzed separately

“Our study showed a significant improvement in HRQoL that was not replicated in the

primary prevention indication. These findings may show, as reported in the European Heart

Rhythm Association survey on long-term HRQoL and acceptance of implantable ICD (32), that

patients who experience major arrhythmias had a larger psychological benefit from the security

193 provided by the defibrillator who may overcome the fear of complication”

Again, I do not see the comparison. What worries me is that secondary prevention was an indication in nearly half of the ICD group

No worsening of symptoms of quality of life needs to be highlighted I consider that a major finding of this study. My view is that any improvement is a bonus for many patients, particularly those with heart failure.

Reviewer #4: Very interesting article and addresses a very important subject that is the quality of life of people with implantable electronic cardiac devices

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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 #2: No

Reviewer #3: No

Reviewer #4: No

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[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.

Health-related quality of life in a large cohort of patients with cardiac implantable electronic devices

A registry-based study

PONE-D-24-18282R2

Dear Dr. Gatti,

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.

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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,

Marcelo Arruda Nakazone, 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 #3: All comments have been addressed

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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 #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: 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 #3: 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 #3: 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 #3: acceptable in current format

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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 #3: No

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