Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method

Takaaki Tanaka; Masashi Hirooka; Yohei Koizumi; Takao Watanabe; Osamu Yoshida; Yoshio Tokumoto; Yoshiko Nakamura; Koutarou Sunago; Atsushi Yukimoto; Masanori Abe; Yoichi Hiasa

doi:10.1371/journal.pone.0246315

Peer Review History

Original SubmissionOctober 20, 2020
16 Nov 2020 Decision Letter - Wenyu Lin, Editor PONE-D-20-32923 Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method PLOS ONE Dear Dr. Hiasa, 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 by one reviewer during the review process. Please submit your revised manuscript by Dec 24 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: 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Wenyu Lin, PhD 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. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. In your Methods section, please provide additional information about the participant recruitment method and the demographic details of your participants. Please ensure you have provided sufficient details to replicate the analyses such as: a) a description of how participants were recruited, and b) descriptions of where participants were recruited and where the research took place. 3. Please provide a sample size and power calculation in the Methods, or discuss the reasons for not performing one before study initiation. 4.Thank you for including your ethics statement: "The study was approved by the Ethics Committee (IRB No. jRCTs062190005). The nature of the study was explained to the patients, and written informed consent was obtained from each patient according to the principles of the Declaration of Helsinki.". Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. 5.Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works. https://doi.org/10.1002/hep.31579 (lines 32-57) https://doi.org/10.1111/j.1440-1746.2010.06325.x (lines 61-62) http://docplayer.net/35808840-Mr-imaging-of-the-spleen-spectrum-of-abnormalities-1.html (lines 285-289) https://doi.org/10.1053/j.gastro.2012.09.049 (lines 279-304) We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough. [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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: I had the opportunity to review your paper “Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method” which I found very interesting. This paper is written clearly but there is a point that deserve attention: Major point 1. Endoscopic findings of esophagogastric varices should be defined according to "General Rules for Recording Endoscopic Findings of Esophagogastric Varices”. ****** 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:** Hiroshi Yoshida [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.0246315.r001
Revision 1
8 Jan 2021 Author Response January 8, 2021 Dr. Wenyu Lin, PhD Academic Editor Dear Dr. Wenyu Lin and Zsanett Szabo Thank you very much for providing us with the opportunity to resubmit our manuscript. We have revised the paper based on the comments of the reviewers. We appreciate the reviewers’ input, which we believe strengthened our manuscript considerably. Similarly, we have provided a point-by-point response to each of the comments in the pages that follow. In the revised version of the manuscript, the revised sections are indicated in green font. We reaffirm that the findings of our study have not been submitted for publication before, nor are they under consideration elsewhere. Thank you very much for considering our revised manuscript. We look forward to your response. Sincerely, Yoichi Hiasa Department of Gastroenterology and Metabology Ehime University Graduate School of Medicine Shitsukawa, Toon, Ehime 791-0295, Japan Tel: +81-89-960-5308; Fax: +81-89-960-5310 E-mail: hiasa@m.ehime-u.ac.jp 1. Thank you for including your ethics statement on the online submission form: "The study was approved by the Accredited Clinical Research Review Committee National University Corporation Ehime University Clinical Research Review Committee (IRB No. jRCTs062190005). The nature of the study was explained to the patients, and written informed consent was obtained from each patient according to the principles of the Declaration of Helsinki". To help ensure that the wording of your manuscript is suitable for publication, would you please also add this statement at the beginning of the Methods section of your manuscript file. We appreciate the reviewers for these comments. In previous manuscripts, the following text was at the end of Study design: "The study was approved by the Accredited Clinical Research Review Committee National University Corporation Ehime University Clinical Research Review Committee (IRB No. jRCTs062190005). The nature of the study was explained to the patients, and written informed consent was obtained from each patient according to the principles of the Declaration of Helsinki ". In the revised manuscript, this statement has been changed to appear at the beginning of study design in the Methods section. (From page 9, line 89 to page 10, line 93). 2. Thank you for addressing text overlap in your submission. One sentence of overlap still remains in the second paragraph of the Discussion section:"The spleen is an intraperitoneal organ with a smooth serosal surface and is attached to the retroperitoneum by fatty ligaments that also contain its vascular supply. The splenic surfaces are described relative to their locations and are termed the diaphragmatic (phrenic) and visceral surfaces. The visceral surface is divided into an anterior or gastric ridge and a posterior or renal portion."http://docplayer.net/35808840-Mr-imaging-of-the-spleen-spectrum-of-abnormalities-1.htmlPlease ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text. Further consideration is dependent on this concern being addressed. We appreciate the reviewers for these comments. When I checked the text of the part you pointed out, I have already corrected it with the revised manuscript I submitted the other day. This time, we are changing the font color. Please confirm. (From page 36, line 304 to page 36, line 309). December 23, 2020 Dr. Wenyu Lin, PhD Academic Editor Dear Dr. Wenyu Lin, Thank you very much for providing us with the opportunity to resubmit our manuscript. We have revised the paper based on the comments of the reviewers. We appreciate the reviewers’ input, which we believe strengthened our manuscript considerably. Similarly, we have provided a point-by-point response to each of the comments in the pages that follow. In the revised version of the manuscript, the revised sections are indicated in red font. We reaffirm that the findings of our study have not been submitted for publication before, nor are they under consideration elsewhere. Thank you very much for considering our revised manuscript. We look forward to your response. Sincerely, Yoichi Hiasa Department of Gastroenterology and Metabology Ehime University Graduate School of Medicine Shitsukawa, Toon, Ehime 791-0295, Japan Tel: +81-89-960-5308; Fax: +81-89-960-5310 E-mail: hiasa@m.ehime-u.ac.jp 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf We appreciate the reviewers for these comments. Accordingly, we have checked the style requirements of PLOS ONE and modified the file names and contribution. Similarly, we have revised the font of the manuscript title to 18pt. (Page 1, lines 1-3, page 1, lines 5-7, page 2, line 12, page 2, line20). 2. In your Methods section, please provide additional information about the participant recruitment method and the demographic details of your participants. Please ensure you have provided sufficient details to replicate the analyses such as: a) a description of how participants were recruited, and b) descriptions of where participants were recruited and where the research took place. We appreciate the reviewers for these comments. Accordingly, we have added information regarding the recruitment of participants and participant demographics. a) Patients were admitted to the Department of Gastroenterology and Metabology, Ehime University Hospital from June 2019 to September 2019. Patients who underwent abdominal ultrasonography and liver and spleen stiffness measured using transient elastography were recruited. b) The selection criteria were: 1) 20 to 90 years of age and 2) Performance Status (ECOG) of 0 to 2. Notably, the patient’s sex was not considered in the course of selection. Abdominal ultrasonography was performed in the laboratory of the inpatient ward; on the same day, the patients underwent B-mode examination, SWE, and Fibroscan on an empty stomach more than 2 hours after eating. All participants were provided with a written explanation of the purpose, method, and details regarding handling of personal information of the research (From page 9, line 89 to page 10, line 100). 3. Please provide a sample size and power calculation in the Methods, or discuss the reasons for not performing one before study initiation. We would like to thank the reviewer for this comment. Accordingly, calculation of the sample size and detection power has been described in the Methods section of the revised manuscript (From line 101 on page 10 to line 115 on page 12). 4. Thank you for including your ethics statement: "The study was approved by the Ethics Committee (IRB No. jRCTs062190005). The nature of the study was explained to the patients, and written informed consent was obtained from each patient according to the principles of the Declaration of Helsinki.". Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. We would like to thank the reviewer for this comment. Accordingly, we have amended the Ethics Statement to include the full name of the Ethics Committee / Institutional Review Board that approved our study (From line 130 on page 13 to line 132 on page 14). 5. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works. https://doi.org/10.1002/hep.31579 (lines 32-57) https://doi.org/10.1111/j.1440-1746.2010.06325.x (lines 61-62) http://docplayer.net/35808840-Mr-imaging-of-the-spleen-spectrum-of-abnormalities-1.html (lines 285-289) https://doi.org/10.1053/j.gastro.2012.09.049 (lines 279-304) We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough. We would like to thank the reviewer for indicating this. Accordingly, we have revised the manuscript by rephrasing the duplicated texts (to different expressions) and quoting the sources in relevant instances. The part of https://doi.org/10.1002/hep.31579 (lines 32-57) has been corrected (From page 3, line 24 to page 6, line 51). The part of https://doi.org/10.1111/j.1440-1746.2010.06325.x (lines 61-62) has been corrected (Page 6, line 54 to line 55). The part of http://docplayer.net/35808840-Mr-imaging-of-the-spleen-spectrum-of-abnormalities-1.html (lines 285-289) has been corrected Page 36, line 305 to line 310). The part of https://doi.org/10.1053/j.gastro.2012.09.049 (lines 279-304) has been corrected (From page 35, line 300 to page 38, line 327). 6. Reviewer #1: I had the opportunity to review your paper “Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method” which I found very interesting. This paper is written clearly but there is a point that deserve attention: Major point 1. Endoscopic findings of esophagogastric varices should be defined according to "General Rules for Recording Endoscopic Findings of Esophagogastric Varices”. We appreciate the reviewer for indicating this. The endoscopic findings of the esophagogastric varices have been modified according to the "General Rules for Recording Endoscopic Findings of Esophagogastric Varices ". Although some changes have been made to the description of varices in the manuscript before this round, the endoscopists evaluated the endoscopic findings according to the " General Rules for Recording Endoscopic Findings of Esophagogastric Varices" in this study. No change was observed in the result obtained (From page 19, line 187 to page 20, line 192). https://doi.org/10.1371/journal.pone.0246315.r002
18 Jan 2021 Decision Letter - Wenyu Lin, Editor Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method PONE-D-20-32923R1 Dear Dr. Hiasa, 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, Wenyu Lin, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Dear Yoichi, Congratulations on your nice work! Best wishes, Wenyu 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 ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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: I had the opportunity to review your paper “Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method”. There is no problem to publish the manuscript. ****** 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 https://doi.org/10.1371/journal.pone.0246315.r003
Formally Accepted
22 Jan 2021 Acceptance Letter - Wenyu Lin, Editor PONE-D-20-32923R1 Development of a method for measuring spleen stiffness by transient elastography using a new device and ultrasound-fusion method Dear Dr. Hiasa: 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. Wenyu Lin Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0246315.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .