PONE-D-23-03001

Diagnostic accuracy of digital technologies compared with 12-lead ECG in the diagnosis of atrial fibrillation in adults: A protocol for a systematic review

PLOS ONE

Dear Dr. Vethanayagam,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we have decided that your manuscript does not meet our criteria for publication and must therefore be rejected.

I am sorry that we cannot be more positive on this occasion, but hope that you appreciate the reasons for this decision.

Kind regards,

Burak Katipoğlu

Academic Editor

PLOS ONE

Additional Editor Comments:

Dear Authors, I regret to inform you that the language and sentence structures of this manuscript are at times incomprehensible. The paper needs rewriting and thorough language editing to allow for a proper peer review.

First of all, I think there are too many subjective sentences in the introduction part of the article.

I could not find how many articles were included in this systematic review. And I couldn't find how many articles were excluded and why.

I could not find any evidence in the references that Digital Technologies are more cost-effective than diagnosis with a 12-lead ECG. Is AF recognition training more expensive in 12-lead ECG?

Mobile devices are used a lot in the world, but can these phones be less accessible in low and middle income countries? It has not been reported which of the digital technologies determined as the primary outcome can be used in these countries.

I could not conclude which device is the most diagnostic as a result of this article.

There is no forest plot in the tables section.

In this systematic review, the methodology seems to have been described but not concluded.

In its current state, I do not recommend accepting this paper.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Partly

Reviewer #4: Partly

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Partly

Reviewer #4: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

Reviewer #2: No

Reviewer #3: No

Reviewer #4: No

**********

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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I think the subject of the article is quite original and interesting. When I read the topic, it really excited me. But I think some definitions are missing. I couldn't understand how and where to use predictive values. Since I do not know the number of data in the study, I cannot comment on this issue. At the same time, the exclusion and inclusion criteria in the study were not clearly explained. Besides, I think that the English used makes it difficult to understand. I think it will be a good interesting article when these are edited.

Reviewer #2: After reviewing the current manuscript, our comment is regarding:

The inclusion and exclusion criteria should be clear. And better to add an illustration that would demonstrate the protocol and proposed flow of the systematic review.

Regards

Reviewer #3: Dear Editor, Thank you for giving us the opportunity to review this article titled

“Diagnostic accuracy of digital technologies compared with 12-lead ECG in the diagnosis of

atrial fibrillation in adults: A protocol for a systematic review”.

The subject mentioned in the article is as if it was just designed and just remained. We see that the diagnostic method compared methodologically is not standardized. smart watch, smart belts, holter etc. We could not find any data on which of these devices is more effective in the old literature in which the normal technique was compared. The prevalence of smartphone use has been mentioned, but we see that there is no need for additional devices to smartphones for this diagnostic method and data on how widely these devices are used are not mentioned. We cannot see an analysis of the cost of the additional devices to be given to each individual and the evaluation made by a trained person in the study. In addition, this situation is a situation that may be more appropriate in high-income societies, not in low and middle-income countries. Again, we cannot see the values of the results obtained from the study list included in the meta-analysis in the study text. This obscures the issue of how the study was designed and how the data was obtained and how it was interpreted. This creates the opinion that the evaluation is based on a wish, not on objective parameters. The article is not suitable for publication as it is.

Reviewer #4: Dear Authors, Thank you for giving us the opportunity to review this article titled “Diagnostic accuracy of digital technologies compared with 12-lead ECG in the diagnosis of atrial fibrillation in adults: A protocol for a systematic review”.

I regret to inform you that the language and sentence structures of this manuscript are at times incomprehensible. The paper needs rewriting and thorough language editing to allow for a proper peer review.

First of all, I think there are too many subjective sentences in the introduction part of the article.

I could not find how many articles were included in this systematic review. And I couldn't find how many articles were excluded and why.

I could not find any evidence in the references that Digital Technologies are more cost-effective than diagnosis with a 12-lead ECG. Is AF recognition training more expensive in 12-lead ECG?

Mobile devices are used a lot in the world, but can these phones be less accessible in low and middle income countries? It has not been reported which of the digital technologies determined as the primary outcome can be used in these countries.

I could not conclude which device is the most diagnostic as a result of this article.

There is no forest plot in the tables section.

In this systematic review, the methodology seems to have been described but not concluded.

In its current state, I do not recommend accepting this paper.

Kind Regards.

**********

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: Ayşe Büşra ÖZCAN

Reviewer #2: Yes: Rami Riziq Yousef Abumuaileq

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.]

- - - - -

For journal use only: PONEDEC3

PONE-D-23-03001R1Diagnostic accuracy of digital technologies compared with 12-lead ECG in the diagnosis of atrial fibrillation in adults: A protocol for a systematic reviewPLOS ONE

Dear Dr. Kumarendran,

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 carefully address all the comments and concerns raised from the reviewers.

Please submit your revised manuscript by Dec 17 2023 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,

Ernesto Iadanza

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #5: Partly

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Partly

Reviewer #5: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #5: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

Reviewer #5: 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

Reviewer #2: No

Reviewer #5: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for your revision. I think it is still not clear how and what kind of convenience the use of electronic devices can provide. However, the fact that the subject is new and interesting will guide different studies. Bets Regards..

Reviewer #2: The authors have partially addressed our comments.

A Research Protocol journal may fit better for the current manuscript.

Regards

Reviewer #5: This proposed systematic review aims to address an important health issue, atrial fibrillation, that is affecting 59.7 million people worldwide. It specifically mentions disparities in access to screening devices in low-middle-income countries (LMICs), which is an important gap in the current literature. If the authors consistently and cogently articulate this point throughout the manuscript, they would have made a strong case for their proposed review. Unfortunately, this point was not consistently carried through, as highlighted in my comments below.

1. The authors have highlighted that low-middle-income countries (LMICs) lack diagnostic equipment and are under-resourced in healthcare systems, generating further barriers. This is a good point. The costs of the screening devices could be barriers. Therefore, the authors may consider adding “device costs” as a parameter in their review. I have noted the authors' reply to Reviewer 3 that the device cost is outside the scope of the review. Paradoxically, the authors added, “As mentioned in our introduction (lines 72-82), mobile access is steadily increasing in LMICs, which makes the topic of using digital technologies an increasingly important topic to explore for such settings”. I perceive “not including device costs in the review” as a wasted opportunity to enhance the consistency and cogency of the authors’ argument that LMICs need affordable screening devices, and the review may generate useful information for LMICs. Of course, this matter is left to the decision of the authors and Editor-in-Chief.

2. The authors wrote, “No one review has reviewed the diagnostic accuracy of all existing devices, making it difficult to compare their accuracy.” This statement provokes arguments because (a) it is almost impossible to review all devices as there is a lack of standardisation and governance in publishing evaluation studies on devices, and (b) it is inappropriate to compare the accuracy of heterogeneous digital devices made of different technologies, such as comparing photoplethysmographic (PPG) devices, oscillometry, mechanocardiographic devices, modified BP meters versus ECG devices that produce rhythm traces. However, it would be more relevant and appropriate if the comparisons were stratified by type of technologies e.g., ECG, PPG, oscillometry etc. The authors can refer to the published systematic review and meta-analysis of the diagnostic accuracy of handheld ECG devices that produced rhythm traces in diagnosing AF (Wong KC, Klimis H, Lowres N, von Huben A, Marschner S, Chow CK. Diagnostic accuracy of handheld electrocardiogram devices in detecting atrial fibrillation in adults in community versus hospital settings: a systematic review and meta-analysis. Heart. 2020 Aug;106(16):1211-1217. doi: 10.1136/heartjnl-2020-316611) and “Giebel GD, Gissel C. Accuracy of mHealth Devices for Atrial Fibrillation Screening: Systematic Review; JMIR Mhealth Uhealth 2019;7(6):e13641”. In addition, the authors cited a series of systematic reviews and meta-analyses in their references 10 to 14. What are the gaps among these reviews? What else are you adding to the literature? The authors should explain how their proposed review addresses the gaps in the current literature.

3. Two reviewers commented about the lack of clarity in inclusion and exclusion criteria. The authors referred them to their existing statements in the manuscript. Perhaps the authors assume inclusion and exclusion criteria are mutually exclusive. However, the authors may think about other exclusion criteria, such as “studies that involved more than one person in interpreting the same ECG findings without reporting the consensus results among the interpreters.”

4. In the second comment, Reviewer 2 asked about the elaboration of the flow of review. The authors replied about including the PRISMA diagram, which is a conventional requirement. I think, in addition to the PRISMA diagram, the authors should elaborate on the number of reviewers in screening titles/ abstracts and how that flows into full-text review (e.g., X number of reviewers check the first N number of full text, resolve discrepancies & reach consensus, then Y number of reviewer proceed with the remaining full-text review).

5. The authors should be aware of potential spectrum effects that have been reported in the literature, i.e., variations of diagnostic accuracy due to differences in the settings in which the devices were used, such as in the community versus the hospital and characteristics of the users. A systematic review and meta-analysis of diagnostic accuracy of handheld ECG devices in diagnosing AF in community and hospital settings reported the variations in AF diagnostic accuracy (doi: 10.1136/heartjnl-2020-316611). Hence, the authors may consider adding the parameter "setting of application" in their review and explore the potential spectrum effect in their reviews.

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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: Rami Riziq Yousef Abumuaileq

Reviewer #5: Yes: Kam Cheong Wong

**********

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Attachments

Attachment

Submitted filename: Kam_Cheong_Wong_review.docx

Diagnostic accuracy of digital technologies compared with 12-lead ECG in the diagnosis of atrial fibrillation in adults: A protocol for a systematic review

PONE-D-23-03001R2

Dear Dr. Kumarendran,

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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Kind regards,

Ernesto Iadanza

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: Partly

Reviewer #5: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: Partly

Reviewer #5: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #2: Yes

Reviewer #5: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #5: 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 #2: Yes

Reviewer #5: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: 1- Discussed and highlight properly the expected limitations and challenges of the current protocol.

2- Present carefully your measures to avoid significant bias, heterogeneity.

Kindest regards

Reviewer #5: Thank you for addressing the comments. The manuscript has addressed its objectives and scope systematically and appropriately.

**********

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: Yes: Rami Riziq Yousef Abumuaileq

Reviewer #5: Yes: Kam Cheong Wong

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