https://orcid.org/0000-0002-6754-3603
Peer Review History
| Original SubmissionMay 13, 2020 |
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PONE-D-20-14175 Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot PLOS ONE Dear Dr. D'Amico, 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. Although the reviewers impressions have been quite positive, they do address some major components requiring changes. Please respond to their comments in detail. Please submit your revised manuscript by Aug 31 2020 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:
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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Kevin Mattheus Moerman, Ph.D. Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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In the figure caption of the copyrighted figure, please include the following text: “Reprinted from [ref] under a CC BY license, with permission from [name of publisher], original copyright [original copyright year].” 2. If you are unable to obtain permission from the original copyright holder to publish these figures under the CC BY 4.0 license or if the copyright holder’s requirements are incompatible with the CC BY 4.0 license, please either i) remove the figure or ii) supply a replacement figure that complies with the CC BY 4.0 license. Please check copyright information on all replacement figures and update the figure caption with source information. If applicable, please specify in the figure caption text when a figure is similar but not identical to the original image and is therefore for illustrative purposes only. [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: Partly Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: Yes ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: Yes ********** 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: Yes Reviewer #4: Yes ********** 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 Reviewer #4: 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 publication and contribution to an area that is lacking robust evidence. Overall, I am struggling to understand the quantitative statistical framework -this needs to be more explicit within your article. What is it, what was the method, make it more explicit in the results section. line 27 throughout the article you interchange use the terms insoles and orthotics and sometimes add in footwear - can you be consistent and use one term throughout (eg line 29) line 50 - neuropathy and neuropathic in same sentence line 55 add in 'the' before foot line 55 very long sentence - split into 2 line 60 add a full stop line 61 footwear is also an important aspect of reducing foot pressures and usually works in conjunction with the insole....especially as you refer to outer sole in line 74 ln 85 add 'an' at start of sentence ln 85/86 - this sentence does not make sense ln 87 remove also ln 88 clarify 'periodic systematic control' ln 90 remove 'still' ln 91 remove nevertheless ln 95 remove up ln 99 write info in full ln 109 - was acute vascular problems an exclusion? ln 121 - peripheral neuropathy consists of motor, sensory and autonomic - do you mean sensory in this sentence? ln 133 - who was double blinded? ln 133 clarify subsequent ln 134 special sandals requires better description and company ln 135 neutral flat insole - why do you need to use neutral? - flat insole would suffice but requires more description eg materials, pictures ln 136 - how much time between 1st and 2nd sessions? were the sandals worn just for the testing or also between sessions by participants? ln 137-141 - rewrite to make more readable ln 143 - clarify all foot othoses are TCCI and cad cam (flat insole is also a device) ln 143 and ln 151 contradict as you say eva used only and then you add a top cover ln 169 - clarify if TCCI and Cad cam orthoses; incidentally who made the flat insoles? ln 182- reword for clarification (eg each participant recieved ...) ln 186 - clarify if experimenatl session 1 or 2 ln 186 clarify if the two testing conditions are TCCI and cad cam ln 206 experimental sandals ln 225 - how did the speed of testing session 1 compare with session 2? ln 238 - clarify why not necessary to use masking to reader the parametric and non-parametric analysis - please clarify the purpose of these tests (eg we used the test to determine....) ln 331 - you say descrptive but i cannot find them ln 338 - you are not examining the distribution of roi's - reword ln 341 - define beneficial percentage reduction in pressure would be a useful addition to your absolute data as it would account for the large variations in participants barefoot pressure data that absolute values do not show ln 389 - robust? i am not clear how it is robust as you have not presented any justification for this ln 396 better performance - in terms of what? ln 399 - valuable point but not appropriate in this paragrapgh ln 411 - 'perfect' is a very strong word to use in this context ln 418 - what tests did you use to justify its reliability? i don't think you did so can't claim this ln 447-448 i am still not sure what the QSF framework is ln 452 - what about different gait strategies and changes over time? ln 455 full stop missing Reviewer #2: The paper presents a comparative study between three different types of orthotics in order to evaluate which is the best for reducing the foot plantar pressure. The evaluation is conducted considering 30 patients and different production technologies. The manuscript is well structured and clear in its contents. The analysis methodology is presented in detail. The conclusions are supported by well-analyzed clinical data. Custom made CAD-CAM insoles have been designed considering a single CAD tool. For the reviewer, this is the main limitation of the work. The effectiveness of an insole is strictly dependent on its geometry and therefore on the algorithm/software used to define its geometry. The reviewer recommends adding information regarding the offloading algorithm used to generate the 3D geometry of orthotics, as well as the CAD modelling procedure. As a future development, it would be interesting to see a comparison between orthotics developed with different modelling software Reviewer #3: This is an interesting topic of investigation, as we are in need of effective offloading insoles for the diabetic foot. The authors introduce a new framework to analyze pressure pictures and obtain results from, but I am trying to find the real benefits of this approach over regular in-shoe peak pressure analysis from the pressure distribution pictures, which is quite a straightforward analysis itself. What is the problem we have that stimulates the development of this new framework? How is it going to help us better to interpret in-shoe pressure pictures? Specific comments Abstract - Line 33: this is not a double-blind controlled trial. It is a cross-sectional study design - Line 36: very few quantitative results are reported compared to lots of text in the abstract, which is a bit odd given the QSF, a quantitative method that the authors are using Introduction - In line 63, the authors refer to poor adherence being a barrier to clinical success with insole designs. This is supported by trial data from Bus et al.1, an important reference that is missing from the reference list. - In line 76 the authors state: “Plantar pressure can be redistributed but not eradicated and reducing stress at one location may simply displace the risk of ulceration to a different area of the foot.” This is true for the average pressure obtained, but not necessarily for the peak of the plantar pressure, a parameter that is mostly reported in the diabetic foot literature. I would suggest to specify this in the paper. - In line 91 the authors state: Nevertheless, the strategies to design the optimal offloading insoles have to be fully standardised. In the absence of such standardisation, outcomes for digital quantitative data-driven approaches can be debatable in comparison of traditional foot orthoses supply chains [14].” Recently, two papers have been published, specifically addressing this topic, which stress that standardization and data-drive design protocols are needed, although not necessarily via CADCAM design principles2,3 - In line 95, the authors state their aim to: “Firstly, we wanted to build up a robust quantitative-statistical framework (QSF) to analyse in-shoe pressure measurements to propose a way to standardise the evaluation of offloading insoles' design and subsequent monitoring steps.” But in the section before the aim, the authors state that the design of insoles needs to be standardized. So, is it the evaluation of the insole design or the design itself that has to be standardized, as these are two different things? If referring to the design, this is more valuable than when referring to the evaluation. Methods - Why were mostly risk class 1 subjects recruited, as the insoles studies would normally apply more to a risk class 2 or 3 patient? - Line 171: “Plantar pressure data, which were integrated into its algorithms for the manufacture of the custom insoles, were also provided.” Which plantar pressure data is meant? More detail is required here - Line 182: why was a double-blind design considered important for this study? If not blinded, how would that have affected the results? - Line 234: Why were “The total surfaces of R-ROIs per each foot“ chosen as the primary variable for comparison between offloading insoles, and why not the peak pressure, which is the most commonly reported parameter. And what was the rationale for using a parameter like R-ROI and not analyzing the pressure values in a more straightforward fashion as done by others? - Line 241 onwards: the authors present the study, as the title shows as a “a novel quantitative-statistical framework”. It is not clear what is novel about it and what the ‘statistical framework’ is, as it seems that straightforward parametric and non-parametric tests are used, comparing the different conditions in a cross-sectional study fashion. - Line 257: why is for the power calculation of “underfoot pressure redistribution” the number of steps indicated, whereas normally, and for the primary parameters of R-ROI, the number of patients is reported? Results The results section is difficult to read and requires improvement - Line 279 The authors use a subheading, but this is the only one in the results section, so redundant - Line 293 to 306 reads as a legend of the Figure and should be moved to the legend, so that the results section only contains the results of the analyses - The same for lines 319 to 325 - Lines 358 – 380 contain a lot of explanation rather than results, that one would expect in the methods or discussion section - There are 8 figures and 3 tables, which is a lot for a study using just 2 parameters, straightforward analyses and very few quantitative results. In particular, the results on ROI-R are sometimes difficult to follow - I don’t see any reference in the results to the regions that are most important to offload in the neuropathic diabetic patient, like the hallux, 1st metatarsal head, where foot ulcers most commonly occur. How does the framework take that into account, as some regions are more important to analyze than others? And how does it do that in an efficient way, as from peak pressure distribution pictures from the in-shoe pressure measurement, this information can be directly observed. Discussion - Line 389 – 405 read as an introduction. I suggest to discuss the results of the study sooner - Line 418. The authors state that “ The quantitative-statistical framework herein introduced demonstrated its reliability and usefulness in identifying high-risk areas with ascertained statistical significance (i.e. R-ROIs), representing a marked improvement compared to the methods based on the direct 200kPa cut-off.” Where in the results can I find results on the reliability and usefulness of the framework and how robust it is, as the authors state in the conclusions? And based on which outcome do they conclude that this is a marked improvement compared to using the 200 kPa cutoff method? - Line 438: “ Long term monitoring is another reason to prefer the CAD-CAM design approach….”. This is contrary to a recent study that shows that handmade custom-made insoles provide more pressure relief than CADCAM insoles.3 References 1. Bus SA, Waaijman R, Arts M, et al. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care 2013; 36(12): 4109-16. 2. Bus SA, Zwaferink JB, Dahmen R, Busch-Westbroek T. State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy. Diabetes Metab Res Rev 2020; 36 Suppl 1: e3237. 3. Zwaferink JBJ, Custers W, Paardekooper I, Berendsen HA, Bus SA. Optimizing footwear for the diabetic foot: Data-driven custom-made footwear concepts and their effect on pressure relief to prevent diabetic foot ulceration. PLoS One 2020; 15(4): e0224010. Reviewer #4: Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative statistical framework for the evaluation of insoles offloading performance in diabetic foot. This study, in the field of the diabetic foot and neuropathic ulcer prevention, is important as it incorporates and develops the use of computer-aided design and manufacturing in the quantitative evaluation and design of custom-made orthotics for plantar pressure relief, in direct comparison to that for traditional total contact cast insoles. The unique point of this study is the enhanced use of digital technology in this field, which is highly likely to be the way forward for any future standardised design of custom-made insoles for optimal pressure off-loading. Major points: Overall, sections could be shortened. Certain paragraphs would benefit from being made less wordy. Could the authors comment on their finding that the TCCI and CAD-CAM_CMI approaches did not produce good offloading in some cases (Fig. 5). What was unique about these individuals? Was it related to their specific characteristics such as foot deformities, gait etc? Or is this a methodology problem? The methodology for obtaining the ‘blueprint’ images of the feet on a millimetric grid has not been detailed, however, I presume from Fig. 2 that the method involves manually drawing around the foot, then estimating the ‘areas of concern’ by observing an equivalent photo of the foot, then manually drawing the ROI’s onto the blueprint. This manual approach is not a standardised process and will undoubtedly introduce human error. The blueprint image and photo image in Fig. 2 are not even the same size for direct comparison. This is a study limitation and should be discussed. The authors may wish to draw comparisons to a recently published method which uses technology to standardise diabetic foot plantar images, developed to avoid such human error (eg. Yap et al, JDST, 2018). The Results section is too long. Eight figures and 3 tables is very excessive. My initial thoughts are that Figs. 4 & 5 could be combined into one figure (a & b), as could Figs. 7 and 8. Data from tables 2 and 3 could be incorporated into the text. There is no numerical data shown to back up the claims made about the statistical correlation of R-ROIs and at-risk locations (lines 383-387). Minor points: ‘In-shoe dynamic planar pressure measurement’ (or something similar) may be a better sub-heading than ‘Instrumentation’. There is repetition of methodology in lines 188-189 again at line 211-213. Some sweeping statements in the Discussion should be re-phrased, to better indicate that this study’s results merely confirm or reflect results from other studies. e.g. line 411 “This outcome is in perfect agreement with previous studies.” line 416 “This result is in full agreement with the findings of other authors.” ********** 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: Richard Collings Reviewer #2: No Reviewer #3: No Reviewer #4: No [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. |
| Revision 1 |
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PONE-D-20-14175R1 Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot PLOS ONE Dear Dr. D'Amico, 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. Although reviewers 1 and 2 are happy to accept this submission, reviewers 3 and 4 have remaining concerns which have not been adequately addressed. Please accurately deal with their comments and appropriately respond to their queries in a clear and concise manor. One reviewer expresses concerns about the length of the article. Since other reviewers have, in this review process, asked for additional content it may be natural and acceptable that the article has grown in length. However I do urge you to consider this reviewer's concerns and aim at formulating sections in a more concise fashion where possible. Please submit your revised manuscript by Dec 11 2020 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:
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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Kevin Mattheus Moerman, Ph.D. 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. 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: (No Response) Reviewer #4: (No Response) ********** 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: Partly Reviewer #4: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: I Don't Know Reviewer #4: 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 Reviewer #2: Yes Reviewer #3: Yes Reviewer #4: 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: Yes Reviewer #3: No Reviewer #4: 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 revisions. This is an excellent article that contributes to the offloading evidence for DFU. Reviewer #2: (No Response) Reviewer #3: Comments The authors have done a large effort to revise the manuscript based on the reviewer’s comments, improving clarity. However, they do not always adequately respond to questions raised by the reviewers and often merely refer to the revised manuscript, where a response to the point raised is expected. The authors introduce gait variability as argument to develop the QSF, but what is the clinical rationale for this? How does variability in pressure affect foot ulceration, suggesting that we need better methods that take into account these variabilities? Line 284 – 286: “Such intrinsic variability connected to gait, both normal and pathological one, implies the necessity to approach the study of its characteristics from a statistical point of view. That is, by defining a rigorous averaging process to extract mean behaviours and their associated variability from which to derive clinically relevant parameters with a statistical significance.” Ok, but to what extent do the authors fulfill this requirement? Line 300-303: “We underline that such statistical R-ROIs determination permits to manage for the intrinsic gait variability considering both the mean value and its related SD. In such a way, the drawback of a simple direct threshold comparison performed on a single peak frame map is overcome by making the determination of R-ROIs position and extent a more theoretically rigorous process.” The authors imply that the 200 kPa threshold method uses a single peak pressure frame map of the measurement of multiple step in-shoe pressure in the patient. This is not the case. A mean peak pressure map over a minimum 12 steps of in-shoe plantar pressure is used to identify regions with peak pressure >200 kPa and therefore also accounts for variability in pressure between steps, as reflected by the mean peak pressure over these steps. This should be corrected in the manuscript What the 200 kPa threshold method does not do is use the SD of the mean peak pressure, but from the paper it is not clear yet to me in what exact way the QSF does take the SD into account and why that is important beyond from a theoretical point of view. How does this work exactly? The design process of the CADCAM insoles is quite similar to Owing et al.(ref 9), but there is no reference to their approach in the methods section. This should be added Line 307-308. “For such a reason we did not give any a priori particular importance to specific anatomical regions.” Why not? Since specific regions are much more susceptible for ulceration than other. For example, in-shoe pressures in the heel are often among the highest found in the foot, but ulcers hardly ever occur on the plantar heel, so less important for the analysis and outcome Based on their outline of comparisons between the QSF and the >200 kPa threshold method, their statement that “From all the above considerations, the direct 200kPa threshold appears theoretically inadequate to grant the appropriate at-risk regions identification.” is too bold. See above comments. Furthermore, The 200kPa level method has been proven very useful in optimizing diabetic footwear and has also been identified as an appropriate threshold below which foot ulcers can be prevented when the footwear is worn (ref 41 in their paper). The QSF has not yet shown clinical relevance, merely a biomechanical or theoretical one, and since the aim of custom-made footwear is to reduce risk of ulceration, the authors should be careful with stating that demonstrated clinically relevant methods are inadequate. At most, the author may present the QSF as an alternative method that takes variability in peak pressure more into account in a statistical way and that it remains to be proven what the clinical relevance of this method is in reducing risk of ulceration Conclusions: Line 703: “Indeed, the method demonstrated its usefulness in identifying high-risk areas with ascertained statistical significance (R-ROIs) improving the direct 200kPa cut-off approach outlined in the literature.” Should be modified based on above argumentation Line 705: “The proposed technique presents another positive feature, as it allows the possibility to determine on a statistical base the underfoot pressure redistribution induced by the custom-made foot orthosis, thus preventing the risk of ulceration in different underfoot regions.” This reads as if the technique itself reduces the risk of ulceration, where the authors mean to say I think that with the technique better offloading insoles can be designed that may reduce risk of ulceration. This should be better reflected in the conclusions Authors should check their references: some papers seem to appear twice in the reference list Authors should also check grammar and typo's and English writing in the paper Reviewer #4: I requested that manuscript sections could be shortened. However, I find that many of the new phrases added to the various sections are over-elaborate, sometimes a little confusing to read, and have added considerably to the word count. I asked a specific question regarding why the TCCI and CAD-CAM-CMI approaches did not produce good offloading in some cases, and speculated if it was related to individuals’ specific characteristics such as foot deformities, gait etc? Or a methodology problem? The authors referred me to a new, 40-line paragraph in the Discussion; however, this does not appear to answer my specific question. My other queries have been answered satisfactorily. ********** 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: Richard Collings Reviewer #2: No Reviewer #3: No Reviewer #4: No [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. |
| Revision 2 |
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PONE-D-20-14175R2 Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot PLOS ONE Dear Dr. D'Amico, 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. My verdict at the moment is "minor revision". Please carefully address the remaining issues raised by the reviewer and resubmit. Please submit your revised manuscript by Mar 21 2021 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:
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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Kevin Mattheus Moerman, Ph.D. 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. 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 ********** 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 ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: Yes Reviewer #4: 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 Reviewer #4: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? 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(Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #3: The authors have made a signifiant effort to address additional comments to the manuscript The only aspects that needs modifications is the comparison between the QSF and the 200 kPa method in the conclusions of the abstract, that should read in a similar way as amended in the discussion and conclusion sections of the manuscript "The introduced QSF improves the direct 200kPa cut-off approach outlined in the literature." is not correct as there is no clinical validation of the QSF in the paper, and there is for the 200 kPa method The sentence should read as: "The introduced QSF provides a more rigorous method to the direct 200kPa cut-off approach outlined in the literature." Reviewer #4: (No Response) ********** 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 [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. 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| Revision 3 |
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Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot PONE-D-20-14175R3 Dear Dr. D'Amico, 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, Kevin Mattheus Moerman, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: |
| Formally Accepted |
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PONE-D-20-14175R3 Data-driven CAD-CAM vs traditional total contact custom insoles: a novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot Dear Dr. D’Amico: 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. Kevin Mattheus Moerman Academic Editor PLOS ONE |
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