Peer Review History
| Original SubmissionMay 26, 2020 |
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PONE-D-20-15592 Repeatability, reproducibility, agreement, and safety of Tono-Pen tip cover for intraocular measurement using latex and polyethylene wrap. PLOS ONE Dear Dr. Pongpirul, 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. Both reviewers have raised a number of constructive criticisms that need to be carefully addressed in revising the manuscript. Please submit your revised manuscript by Aug 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:
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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 2. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. [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 ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 ********** 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: No Reviewer #2: 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: GENERAL: This manuscript describes a study in which the repeatability, reproducibility, and agreement of intraocular pressure (IOP) measurement with the Tono-Pen AVIA, a portable McKay-Marg tonometer, using Ocufilm and polyethylene wrap tip covers in human eyes was evaluated. A gas-sterilized, polyethylene wrap was used as an alternative to the Tono-Pen tip cover as supplied by the manufacturer. To assess intra-observer repeatability and inter-observer reproducibility, in the right eyes of human subjects, 4 IOP measurements using a polyethylene wrap tip cover were performed by two examiners, A and B, in a randomized manner. In order to assess intra-observer repeatability and agreement, in the left eyes of human subjects, 4 IOP measurements were performed by two examiners, A and B, using both a polyethylene wrap tip cover and the Ocufilm tip cover in a randomized manner. Bland-Altman plot and intra-class correlation coefficients (ICC) were used in all analyses. Cost minimization analysis was also performed. For examiner A, the repeatability of polyethylene wrap tip cover = -0.34, 95% limits of agreement (LOA) = -3.04 to 2.36, and ICC = 0.93 in the right eyes, and -0.33, 95% LOA = -3.01 to 2.36, and ICC = 0.93 in the left eyes. For examiner B, the repeatability of polyethylene wrap tip cover = - 0.02, 95% LOA = -2.88 to 2.83, and ICC = 0.92. The inter-observer reproducibility of polyethylene wrap tip cover = 0.36, 95% LOA = -3.34 to 4.07, and ICC = 0.95. The repeatability of Ocufilm = - 0.42, 95% LOA =-2.75 to 1.91, and ICC = 0.95. The authors conclude that for intraocular pressure measurement with the Tono-Pen AVIA, the polyethylene wrap tip cover demonstrates acceptable repeatability, reproducibility, and agreement with the Ocufilm tip cover, and exhibits a good safety profile, at about 1/8 × the cost. SPECIFIC COMMENTS: Study Design seems reasonably sound. However a major weakness was, as the authors acknowledge, only ocular normotensive eyes were studied. The essential conclusion of the study, that the Ocufilm versus the polyethylene cover make no significant difference to IOP measurements, may be altered if ocular hypertensive eyes were to be studied. This needs to be addressed, as expounded below. English is quite good but still needs to be redone by a native speaker or professional English writing service. There are too many grammatical errors. How was the Tono-Pen AVIA calibrated? Please explain in detail. In the IOP measurement section, it is stated that ten IOP measurements were taken, and then a mean value was calculated. Was this mean value considered to be a single IOP reading, such that, if 4 IOP values are stated as having been made, does this then imply 4 x 10 = 40 readings, i.e. 40 individual tonometer-corneal contacts? The authors make mention of pseudofacility (i.e. reduction in IOP with repeated tonometric measurement, likely if a large number of individual readings were obtained using this type of device), but make no attempt to indicate by how much IOP may have diminished as a consequence of this. Can they give some indication of this? Units (mmHg) should be included on axes of graphs. Where is the Legend for Figure 6? If I am reading it correctly, Figure 6 implies that there was a difference of as much as 4 mmHg between measurements made by Examiner A versus Examiner B. Isn’t this a rather high degree of variation? Or is this simply variation due to pulse amplitude? Again, if I am reading it correctly, Figure 9 implies that there was a difference of as much as 6 mmHg between measurements made with the OF versus the PW tip covers. Isn’t this also a rather a high degree of variation? Or again, is this simply variation due to pulse amplitude? As mentioned above, one weakness of the study, as the authors state, is that only ocular normotensive eyes were studied. The Tono-Pen tends to underestimate IOP in ocular hypertensive eyes. It very well might be the case that the different covers (Ocufilm versus polyethylene) could lead to a bigger difference in IOP measurements (depending on how high the true IOP actually is), perhaps too big to be clinically useful. The authors do state this but this needs to be made very clear. Is there any animal data, for example, in their dog study, that might show that the two different covers do not make a significant difference in the tonometric readings at high IOPs? Or any other published data. It is really necessary to show this, prior to using the tonometer with a polyethylene cover in a clinical setting. Perhaps a similar study could be performed in ocular hypertensive patients, after comparing Tono-Pen data with corresponding GAT data. When the authors mention their measurements of IOP in dogs in their previous study, did they use the Tono-Pen AVIA? Or the Tono-Pen AVIA Vet (a similar but differently calibrated device, intended for use not with humans but with dogs and cats). Or a different version of the Tono-Pen? Reviewer #2: Will there be any consideration to adjust stay design to mitigate the risk of Punctate Epithelial Erosions? Line 4: "It demonstrated" changed to "It Demonstrates" Line 6: Change to "Can be used on patient in any position" Remove "sometimes happens" from the end of "In addition to shortage at supply" ********** 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: Yes: Mike Zein, MD [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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Repeatability, reproducibility, agreement, and safety of Tono-Pen tip cover for intraocular measurement using latex and polyethylene wrap. PONE-D-20-15592R1 Dear Dr. Pongpirul, 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, Sanjoy Bhattacharya 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: 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 ********** 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: (No Response) Reviewer #2: (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 #1: No Reviewer #2: No |
| Formally Accepted |
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PONE-D-20-15592R1 Repeatability, reproducibility, agreement, and safety of Tono-Pen tip cover for intraocular measurement using latex and polyethylene wrap. Dear Dr. Pongpirul: 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. Sanjoy Bhattacharya Academic Editor PLOS ONE |
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