Early full-day leg movement kinematics and swaddling patterns in infants in rural Guatemala: A pilot study

Jinseok Oh; Eva Leticia Tuiz Ordoñez; Elisa Velasquez; Marines Mejía; Maria del Pilar Grazioso; Peter Rohloff; Beth A. Smith

doi:10.1371/journal.pone.0298652

Peer Review History

Original SubmissionJuly 18, 2023
16 Oct 2023 Decision Letter - Tadashi Ito, Editor PONE-D-23-20339Early full-day leg movement kinematics and swaddling patterns in infants in rural GuatemalaPLOS ONE Dear Dr. Smith, 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 Nov 30 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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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 ****** 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: an interesting topic and the manuscript get some significant finding. However, we have several concerns about this manuscript. Title needs to be modified. “Pilot Study” should appear in the title. Abstract: Trial design is not mentioned. Methods: How was sample size determined? Discussion: 1. The discussion section needs to be described scientifically. Kindly frame it along the following lines: i. Main findings of the present study ii. Comparison with other studies iii. Implication and explanation of findings iv. Strengths Reviewer #2: From my point of view, this paper addresses a type of new technology in assessing leg movement kinematics in infants, which may be so important especially for infants at risk of impaired growth and development. This paper demonstrated that age is associated with leg movement rates and movement acceleration. This paper may open the door for new research about using wearable sensors to detect growth and development impairments. I would like to thank the authors for their work. Reviewer #3: The reviewer thank the authors for their effort. Please add a paragraph in the introduction section to indicate the term "swaddling" you should write about the validity and reliability of the used sensors. Please, write more details about precautions while wearing the sensors and how they are stabilized. Why you depend upon evaluating the movement of lower limb and neglected the movement of upper limbs. If you didn't have an explanation , please write that in limitation of the study. Also, The nature of nutrition and its variance between infants should be mentioned in the limitation of the study. You mentioned that "infants with medical illness were excluded from the study, please give examples. ****** 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: No Reviewer #2: No Reviewer #3: Yes:** Asmaa* M. Elbandrawy ********** [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. https://doi.org/10.1371/journal.pone.0298652.r001
Revision 1
21 Dec 2023 Author Response [This is also attached as 'Rebuttal_Letter.docx'] The authors would like to thank the reviewers for their fair reviews and detailed list of constructive suggestions. We greatly appreciate the opportunity to submit a minor revision of our paper for your renewed consideration. Below we specify how we met journal requirements and respond to reviewers’ comments and point to the corresponding changes we made in the paper. Journal requirements 1. Please ensure that your manuscript meets PLOS ONE’s style requirements, including those for file naming. >> We have reviewed the style requirements and updated the manuscript. We have also regenerated figures and saved them as ‘Fig1.tiff’, ‘Fig2.tiff’ and etc. 2. In the ethics statement in the Methods, you have specified that verbal consent was obtained. Please provide additional details regarding how this consent was documented and witnessed, and state whether this was approved by the IRB. >> Verbal consent was approved by the IRB. Further details are now provided in the methods of the paper. 3. Please include a complete copy of PLOS’ questionnaire on inclusivity in global research in your revised manuscript. >> Please see attached questionnaire. 4. Note on depositing data. >> De-identified data will be deposited in the NIH DASH repository once all analyses are completed. 5. Request for the relevant accession numbers or DOIs necessary to access your data. >> As noted above, deidentified data will be deposited in a public repository once all analyses are completed, but these are still ongoing. Therefore, we have changed these details for the time being to: “data is available from the corresponding authors upon reasonable request.” 6. Figure 1 contains copyrighted images. >> A new Fig 1 is prepared. As for the image of the sensor used in the study, we took picture of the sensor we purchased. We inquired the manufacturer (APDM WEARABLE TECHNOLOGIES INC.) about using an image of the sensor and received a response from its legal department that any publicly available image does not need its permission including images on the website. I attach the email communication that confirms the use of the image (APDM_Opal_sensor_image_use_permission.pdf) 7. Please review your reference list to ensure that it is complete and correct. >> Reference 1 has erratum but was not retracted. The reference is most up to date with the correction made (on 9/17/2018). The correction below was already reflected in the reference we included: The following sentence should have been included in the Acknowledgments section of this Article: “We acknowledge the contribution of Charles R J Newton (University of Oxford, Oxford, UK) to an earlier version of this article.” Reviewer 1’s concerns: 1. Title needs to be modified. “Pilot Study” should appear in the title. >> The revised title now indicates that this is a pilot study. 2. Abstract: trial design is not mentioned >> The revised abstract (Methods) now clarifies that we conducted a longitudinal observational study. 3. Method: How was sample size determined? >> As stated in the manuscript, “we decided a priori that a sample of 40 infants would be sufficient for testing for associations and determining effect sizes for future studies based on a recently completed clinical trial assessing infants across 6 months at Maya Health Alliance [16] .” In previous work, we found large effect sizes (Cohen’s d = 0.8 – 1.3) for differences in leg movement quantity and acceleration between infants with typical development and infants broadly at risk for developmental delay. Here, we used GPower to determine that with a sample size of 30 infants we would be able to detect a difference across 6 months between children of one-third to one-half of SD with 80% power, alpha = 0.05 and intra-individual correlations of 0.5-0.8. 4. Discussion: The discussion section needs to be described scientifically. Kindly frame it along the following lines: >> a. The Discussion section now does not have sub-headings. Originally the first two subheadings were the main findings of the study. Instead, it is now more explicitly stated as below: “The first main finding of the present study is that …” (3rd sentence of the first paragraph) “The second main finding of this study is that …” (1st sentence of the second paragraph) >> b. In the first paragraph, a new citation [17] was inserted to further illustrate one interpretation of the result. In the second paragraph, comparisons were already made (citations 20, 21 and 22). >> c. Implication and explanation of finding were also provided in the original manuscript at the following positions: - 4th sentence of the first paragraph - last half of the second paragraph >> d. Strengths and limitations are now summarized after the Discussion section. Reviewer 2’s concerns: NA Reviewer 3’s concerns: 1. Please add a paragraph in the introduction section to indicate the term “swaddling”. >> The last paragraph of the Introduction lists swaddling as one covariate. We added an additional sentence in the last paragraph better defining swaddling: Swaddling is the common practice in rural Guatemala and many other settings of keeping the infant tightly wrapped in fabric while sleeping and also, frequently, when carried on the caregiver’s back when performing chores or when out of the house. 2. You should write about the validity and reliability of the used sensors. >> We have added this sentence (with the relevant citations) at the end of the Apparatus paragraph in Methods: “The validity of measuring the quantity, duration, and acceleration of infant leg movements has been reported previously.” 3. Please, write more details about precautions while wearing the sensors and how they are stabilized. >> We have inserted this sentence to the Apparatus paragraph in Methods: “The size of the pocket was designed specifically to hold the sensors in place, and a variety of sizes of legwarmers to choose from provided a close but not too tight fit for each infant.” 4. Why you depend upon evaluating the movement of lower limb and neglected the movement of upper limbs. If you didn’t have an explanation, please write that in limitation of the study. >> There is no reason to expect significant differences in overall movement quantity or characteristics of lower limbs compared to upper limbs in these infants. As wearing 4 sensors would be unnecessarily burdensome for the participants and require many more resources, we opted to focus on quantifying the movement of lower limbs as a representation of neuromotor control. Lower limb movement in early life has been reported to be associated with later walking onset of infants, making it one reasonable measure for the neurodevelopmental status of the infants. 5. Also, the nature of nutrition and its variance between infants should be mentioned in the limitation of the study. >> We have added the following sentence to the Limitations paragraph: Individual level variability among infants in key covariables, such as nutritional status, may have obscured the magnitude of some findings in this small sample size; we mitigated this by using linear mixed models includes random effects for individuals and fixed effects for key covariables. 6. You mentioned that “infants with medical illness were excluded from the study, please give examples. >> We have added a phrase (Participants and Recruitment Procedures paragraph in Methods) to elaborate: “including heart disease, kidney disease, congenital abnormality, genomic syndromes and severe neurological deficits.” Attachments Attachment Submitted filename: Rebuttal_Letter.docx* https://doi.org/10.1371/journal.pone.0298652.r002
30 Jan 2024 Decision Letter - Tadashi Ito, Editor Early full-day leg movement kinematics and swaddling patterns in infants in rural Guatemala: a pilot study PONE-D-23-20339R1 Dear Dr. Beth A. Smith, 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, Tadashi Ito Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: 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 #1: Yes Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 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 ****** 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 ****** 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: All the addresses modifications have been done as required from the authors , so I see it’s technically good Reviewer #2: I would like to thank the authors for their work.This paper may open the door for new research about using wearable sensors to detect growth and development impairments. ****** 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 ******** https://doi.org/10.1371/journal.pone.0298652.r003
Formally Accepted
21 Feb 2024 Acceptance Letter - Tadashi Ito, Editor PONE-D-23-20339R1 PLOS ONE Dear Dr. Smith, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Tadashi Ito Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0298652.r004

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