PONE-D-23-28982Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyondPLOS ONE

Dear Dr. Ducharme,

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.

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it a nice work .. but you need to check the English language and submit the row data 

The device exists, is in use, and has been tested. However, I did not understand the desired benefit from the research

first the sample size are really too small to drew a conclusion 

the pain issue can't be measure just by asking ... also it is not the main issue when you collecting blood

I really like the idea of using the device ... mainly maybe for cancer patients 

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Academic Editor

PLOS ONE

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Additional Editor Comments:

it is a nice paper

but you need to check the English language and submit the row data

[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

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

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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: Yes

Reviewer #2: Yes

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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: Paper Review: "Feasibility, Acceptability, and Safety of a New Device for Self-Collection of Capillary Blood Samples in Clinical Research in Pandemic and Post-Pandemic Situations" Abstract: This paper shows that gender, acceptability, and safety of new self-collection capillary blood devices, particularly the Tasso SST device.

The study consists of two phases: a research phase with on-site visits and an implementation phase with remote visits.

Results will focus on blood volume, pain perception, device failure, adverse events, and participant satisfaction.

Advantages:

1.Comprehensive approach: Comprehensive design of the study covering both on-site and remote scenarios provides a comprehensive understanding of the device's applicability.

2.Different participant demographics: The inclusion of adults and children in the study phase with different puncture sites and analgesic options increases the relevance of the study and increases the potential for broader application .

3.Clear display of results: Clear display of results such as mean blood volume, change in pain perception, device failure rate, and adverse events. This transparency helps interpret the meaning of the research.

4.Practical Implementation: The inclusion of a remote implementation phase is in line with the evolving trend of decentralized healthcare and increases the practical value of the research.

Areas for improvement:

1. Long-term follow-up: Although this article refers to safety and satisfaction, longer-term follow-up may improve continued adoption and safety of self-collection devices over time. It may give you some insight about sexuality.

2. Comparative analysis: Comparative analysis using traditional venipuncture or other self-sampling devices strengthens the paper's contribution by providing context and benchmarks.

3.Variation in pain perception: Examining variation in pain perception across different individuals and age groups can lead to a more nuanced understanding of subjective experience.

4.Discussion of Limitations: Although the results are promising, a discussion of the study's limitations, such as potential biases or specific challenges encountered during the study, would add additional depth to the paper.

Conclusion: This article provides valuable insight into the feasibility, acceptability, and safety of the Tasso SST device for self-collection of capillary blood.

This study contributes to the evolution of the landscape of remote monitoring in clinical trials with its integrative design and clear presentation of results.

Implementation of the suggested improvements will further increase the impact and relevance of the article in the broader medical field.

Reviewer #2: The article explores the feasibility of capillary blood self-collection using the Tasso-SST device for remote monitoring. I appreciate the authors' attention to this important topic and their thorough exploration of the impact of sampling sites and topical analgesia on capillary blood volume and pain perception. The study's findings have significant implications for remote monitoring and the use of self-collection devices in healthcare, and the high satisfaction and safety levels reported are promising for the future implementation of such methods. While the article is well-written, it is important to ensure that the reference number comes after the punctuation for consistency and clarity in scientific writing.

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Reviewer #1: No

Reviewer #2: No

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Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond

PONE-D-23-28982R1

Dear Dr. Ducharme,

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,

Ramada Rateb Khasawneh

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

sorry for the delay

the paper met the plos one criteria

it is looks better now ... good luck

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

Reviewer #4: All comments have been addressed

Reviewer #5: 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

Reviewer #4: Yes

Reviewer #5: Yes

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

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: 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 #3: Yes

Reviewer #4: Yes

Reviewer #5: (No Response)

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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 #3: Yes

Reviewer #4: Yes

Reviewer #5: 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 #3: it is nice that you address all the assign issue, the paper sound better now

Good Luck in your future work

Reviewer #4: In all the manuscripts I have reviewed thus far, this is one of the best written, well thought out and answered all my questions.

Reviewer #5: (No Response)

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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

Reviewer #4: No

Reviewer #5: No

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