PONE-D-23-22780A High Precision Laser Scanning System for Measuring Shape and Volume of Transtibial Amputee Residual Limbs: Design and ValidationPLOS ONE

Dear Dr. Philen,

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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We look forward to receiving your revised manuscript.

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Mohammad Azadi

Academic Editor

PLOS ONE

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Additional Editor Comments:

The manuscript must be revised based on the reviewers’ comments plus the following issues,

1) A separated file must be provided for the authors’ answers to the comments, one by one. Moreover, all changes must be yellow-colored highlighted sentences in the revised article. The track changes condition is not suggested.

2) Using references suggested by the reviewers is not mandatory. If they are related, they could be used by the authors. If not, they could be ignored by the authors.

3) All keywords must be found in the abstract or the title.

4) The novelty of the manuscript must be highlighted in the introduction, compared to the literature review.

5) All formulations need references, unless they were extracted or introduced by the authors.

6) The background color of Figures 15, 19, and 20 must be white. The scale bar must be also added.

7) The digit numbers must be similar in Tables 2 and 4.

8) The conclusion section should be rewritten one by one, in bullets, to show the novelty.

9) The discussion is poor and it must be improved. They must be compared to other results of other similar articles.

10) References should be updated based on recent articles, published in 2015-2023. Moreover, it should be extended to at least 35 articles for a proper discussion.

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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: Yes

Reviewer #2: Yes

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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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

Reviewer #3: 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

Reviewer #3: 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: The paper focuses on developing and validating a 3D laser scanner for measuring the volume and shape of residual limbs among amputees.

The introduction needs to discuss previous studies on using laser scanning for measuring residual limb shape and volume, along with their limitations.

Make the figure captions more concise while ensuring clarity, for example in Figure 5. Please also check for typos.

Explain the parameters used in Figures within the main text (for example, in Figure 7). Clarify the differences between the flat calibration object and the flat plate.

Explain the reasoning behind choosing a 2Hz excitation frequency for evaluating the motion correction system. Also, clarify why excitation was done in the y-direction.

It is suggested to explore alternative methods to verify result accuracy beyond inter-data variability analysis.

Reviewer #2: This paper presents a nice novel method for automated 3D scanning of a residual limb towards prosthetic socket design, which claims improvements over handheld scanners and shows some novelty over prior rotating/armature-mounted scanners (i.e. not just rotating around limb axis but also covering tip, and spiral path). The authors should be complemented on a very detailed disclosure of method enabling reproducibility.

My main concern is around the many gaps in the literature review meaning that the scientific background is not adequately acknowledged and the clinical need is unclear.

The most recent cited paper was published in 2019 and there has been a lot of work since, in validating hand-held scanners. While hand-held scanners will likely never be as controlled and user-independent as an automated device like the one presented, we do need to consider what is ‘good enough’ and what is practical, low cost, reliable and unintimidating for patients in clinics.

The claimed shortcomings of scanning are based on the paper’s reference [17], around user variability; is this really still the case though? [17] is from 2010 and newest reference is from 2019, which misses much more recent work e.g. DOI:10.1109/TBME.2019.2895283 from 2019 and DOI: 10.1097/PXR.0000000000000105, https://doi.org/10.3390/s22186863 and DOI: 10.1097/JPO.0000000000000350 all from 2022 and tested with living participants, and the latter providing a comparison with hands-on casting for clinically-successful context. These scanners are now showing clinically valid results which are near or better than limit of detectible volume change and better than plaster casting. There are also several missing studies from earlier in the development of CAD/CAM (see e.g. McGarry and colleagues from Strathclyde – not this reviewer ) who did a lot of foundational work on assessment vs. cylindrical phantoms in the 2000s.

Also, a more fundamental question - if showing a new system and method, why not compare its capabilities to a clinically-standard hand-held scanner?

The study is also very light on acknowledged limitations and requirements for future work, especially with a view to clinical application. For example, the present study covers calibration and validation with residual limb analogue objects nicely, and shows a real-life case study, but the above mentioned papers often considered multiple test participants, enabling characterization of the effect of e.g. measurement size upon error or variability. Factors like packaging and development engineering to take this from a research prototype to a clinically usable device, should be noted.

Reviewer #3: Hi,

Evidence for the innovation of the article has not been provided, so it is suggested that a comparison be made with similar researches and the advantages of this method be expressed with them. For example, compare the amount of errors with reference (25. Seminati E, Canepa Talamas D, Young M, Twiste M, Dhokia V, Bilzon JL. Validity and

reliability of a novel 3D scanner for assessment of the shape and volume of amputees’ residual

limb models. PloS one. 2017;12(9):e0184498.).

Statistical analysis is incomplete and the data should be provided to the reader in the form of tables or graphs.

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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.

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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: No

Reviewer #3: No

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PONE-D-23-22780R1A High Precision Laser Scanning System for Measuring Shape and Volume of Transtibial Amputee Residual Limbs: Design and ValidationPLOS ONE

Dear Dr. Philen,

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 Mar 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,

Mohammad Azadi

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.

Additional Editor Comments:

Some minor revisions must be done, as follows,

1) The additions at L112-3 are better suited to the Discussion.

2) Instead of 'human subject' suggest 'human participant' (more inclusive).

3) Again, please check all formulations. They need references, unless they were extracted by the authors.

4) The structure is confusing. The text must have an introduction, research method, results and discussion, conclusions, and references. Others must be subparts of these sections.

5) In conclusions, a general sentence must be added about the topic.

6) Two keywords of "residual limb volume" and "laser scanner" could not be found in the abstract or the title.

7) The discussion was added in the last part. For the first parts of results, no discussion was added. It is better to add the discussion with new references to extend them up to at least 35 articles, published in 2023-2024. No references could be found for 2023.

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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 #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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 #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: (No Response)

Reviewer #2: Yes

Reviewer #3: 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 #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: The manuscript titled 'A High Precision Laser Scanning System for Measuring Shape and Volume

of Transtibial Amputee Residual Limbs: Design and Validation' can be accepted for the publication.

Reviewer #2: Thanks for careful consideration of my previous comments. I think the paper looks useful to the community and should be shared.

Very minor points that do not require another view from me:

* additions at L112-3 are better suited to the Discussion.

* instead of 'human subject' suggest 'human participant' (more inclusive)

Reviewer #3: (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 #1: No

Reviewer #2: No

Reviewer #3: Yes: Seyed Morteza Hosseini

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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.

A High Precision Laser Scanning System for Measuring Shape and Volume of Transtibial Amputee Residual Limbs: Design and Validation

PONE-D-23-22780R2

Dear Dr. Philen,

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,

Mohammad Azadi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Almost done!

Reviewers' comments: