Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia

Yuka Kojima; Norihiko Misawa; Tatsunori Yamamoto; Shigeru Honda

doi:10.1371/journal.pone.0265135

Peer Review History

Original SubmissionJuly 8, 2021
31 Jan 2022 Decision Letter - Suho Lim, Editor PONE-D-21-22264 Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia. PLOS ONE Dear Dr. Honda, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 14 2022 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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We will update your Data Availability statement to reflect the information you provide in your cover letter Additional Editor Comments (if provided): Dear Shigeru Honda Manuscript entitled PONE-D-21-22264 "Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia." which you submitted to PLOS ONE, has been reviewed. It has been considered by our two reviewers who found it to be interest, however extensive revisions are required for it to be suitable for publication. Please refer to the review comments listed carefully. Especially, the reviewers raised significant concerns and would like to address these issues. Please pay careful attention to each of the points raised by reviewers. Thank you for your contribution. Sincerely yours. [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 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: No 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: Yes 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: This study evaluated the intraoperative vital signs and associated factors under local anesthesia. I propose several points to be clarified. 1. The authors described the operation was performed within 30 mins. Please provide the mean operation time in table 1. 2. Were there any patients who needed additional medications due to high blood pressure before the surgery? If so, please describe that point in method section, and provide that information in result section such as the proportion of patients who were administered additional medication to control the high BP. 3. Please provide the ocular information affecting the cataract surgery. Were all cases senile cataract? And if it is possible, axial length, presence of uveitis, or previous surgical history should be provided. 4. The pulse rate and systolic BP can be affected by the pain sensation due to surgical procedure such as iris touching. The pupil of DM patients usually dilated poorly. If it is possible, please state the information about the pupil size or posterior synechia. 5. In the same context as point 4, young patients usually feel pain better than older patients. Although, the mean age of two groups is not different significantly, DM patients were younger in table 1. I think presenting the factors which is not significant (including age) in table 2 and 3 would be helpful for better understanding of readers. Reviewer #2: The authors evaluated the intraoperative alteration of the vital signs in diabetic patients during cataract surgery with local anesthesia and emphasized the need for careful monitoring by the physicians to avoid possible systemic complications However, there are several concerns to be clarified before publication. 1. In figure 3, I think it is necessary to correct the figure legend as "Time course of pulse rate" 2. In figure 1, the mean SBP in DM group was more than 150 mmHg at 5-10 minutes from the beginning of surgery. Did you take any treatment for that? 3. In general, cataract surgery does not cause much pain, but blood pressure and pulse rate could be different depending on the severity of pain. It is better to describe whether you have considered this. 4. There were several reports that bradycardia, hypotension associated lidocaine toxicity. Therefore, the possibility that lidocaine administration used for sub-tenon’s block may affect purse rate or blood pressure should be considered. ****** 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:** Areum Jeong [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.0265135.r001
Revision 1
2 Feb 2022 Author Response Author response to the reviewers We greatly appreciate the reviewers for many valuable comments given to our manuscript. We would provide the point-by-point answers for each comment. In addition, we would announce that the number of DM group has been changed from 104 to 103 after recounting the subjects and values of associated parameters have been slightly changed after recalculation, which does not affect the conclusion. Reviewer #1: This study evaluated the intraoperative vital signs and associated factors under local anesthesia. I propose several points to be clarified. 1. The authors described the operation was performed within 30 mins. Please provide the mean operation time in table 1. Response: Thank you very much for this comment. Firstly, we apologize for a mistyping of operation time. Actually, all surgeries were performed within 50 minutes (not 30 minutes) which has been corrected in the text (page 6, line 9). The mean operation times have been added in Table 1. In addition, vales of BMI and eGFR have also been presented in Table 1. 2. Were there any patients who needed additional medications due to high blood pressure before the surgery? If so, please describe that point in method section, and provide that information in result section such as the proportion of patients who were administered additional medication to control the high BP. Response: We do not use additional hypotensive drugs before cataract surgery and rarely use such drugs during the surgery. If systolic BP of a patient is over 200 mmHg we firstly advise the patient to relax and repeat BP measurements several times (usually every 5 minutes). If BP is not decreased after repeated BP measurements, an injection of hypotensive drug might be used depends on surgeon’s discretion. Hence, it is quite rare to use additional hypotensive drugs within 15 minutes from the beginning of surgeries. However, we have mentioned about the possible use of hypotensive drugs as a limitation of this study in discussion part. (page 15, line 4-6) 3. Please provide the ocular information affecting the cataract surgery. Were all cases senile cataract? And if it is possible, axial length, presence of uveitis, or previous surgical history should be provided. Response: Thank you for this comment. We agree that ocular status may affect cataract surgery and difficult procedures might cause intraoperative pain which could influence vital signs. However, in the present study, we obtained the data after anonymization of personal information (patient’s name, ID of clinical record etc.) and no correspondence table was made. Hence, we cannot obtain additional data about ocular status or past history. 4. The pulse rate and systolic BP can be affected by the pain sensation due to surgical procedure such as iris touching. The pupil of DM patients usually dilated poorly. If it is possible, please state the information about the pupil size or posterior synechia. Response: We really appreciate the reviewer for this advice since we did not include intraoperative pain as a possible association factor with vital signs. Unfortunately, we cannot search additional information from anonymized data. Therefore, we have mentioned the possible influence of intraoperative pain as a limitation of this study in discussion part. (page 15, line 2-4) 5. In the same context as point 4, young patients usually feel pain better than older patients. Although, the mean age of two groups is not different significantly, DM patients were younger in table 1. I think presenting the factors which is not significant (including age) in table 2 and 3 would be helpful for better understanding of readers. Response: We have presented all explanatory variables in Table 2 and 3 which should help the readers to understand non-significant factors. Reviewer #2: The authors evaluated the intraoperative alteration of the vital signs in diabetic patients during cataract surgery with local anesthesia and emphasized the need for careful monitoring by the physicians to avoid possible systemic complications However, there are several concerns to be clarified before publication. 1. In figure 3, I think it is necessary to correct the figure legend as "Time course of pulse rate" Response: Thank you very much for this comment. We have corrected the mistyping. 2. In figure 1, the mean SBP in DM group was more than 150 mmHg at 5-10 minutes from the beginning of surgery. Did you take any treatment for that? Response: We rarely use additional hypotensive drugs during cataract surgery. If systolic BP of a patient is over 200 mmHg we firstly advise the patient to relax and repeat BP measurements several times (usually every 5 minutes). If BP is not decreased after repeated BP measurements, an injection of hypotensive drug might be used depends on surgeon’s discretion. Hence, it is quite rare to use additional hypotensive drugs within 15 minutes from the beginning of surgeries. However, we have mentioned about the possible use of hypotensive drugs as a limitation of this study in discussion part. (page 15, line 4-6) 3. In general, cataract surgery does not cause much pain, but blood pressure and pulse rate could be different depending on the severity of pain. It is better to describe whether you have considered this. Response: We appreciate the reviewer for this advice. Actually, we did not evaluate intraoperative pain in this study. However, unfortunately, we cannot perform further evaluation for additional factors since the original data of present study were obtained after anonymization of personal information (patient’s name, ID of clinical record etc.) without correspondence table. Therefore, we have mentioned the possible influence of intraoperative pain as a limitation of this study in discussion part. (page 15, line 2-4) 4. There were several reports that bradycardia, hypotension associated lidocaine toxicity. Therefore, the possibility that lidocaine administration used for sub-tenon’s block may affect purse rate or blood pressure should be considered. Response: Thank you for this comment. We agree that lidocaine may affect vital signs. In the present study, sub-Tenon’s lidocaine was administrated for both of DM patients and non-DM patients, so we consider that the difference between these two groups would remain under the possible influence of lidocaine. Revised parts are indicated in red. We hope that all reviewers’ comments have been adequately addressed. Again, thank you so much for reviewing our manuscript. Attachments Attachment Submitted filename: Author response.docx https://doi.org/10.1371/journal.pone.0265135.r002
24 Feb 2022 Decision Letter - Suho Lim, Editor Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia. PONE-D-21-22264R1 Dear Dr. Honda, 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, Suho Lim Guest 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: (No Response) Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) 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: (No Response) 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: (No Response) 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: The manuscript has been well improved. I think most of the comments have been addressed. In my opinion this paper is worth to be published in Plos one. 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 https://doi.org/10.1371/journal.pone.0265135.r003
Formally Accepted
14 Mar 2022 Acceptance Letter - Suho Lim, Editor PONE-D-21-22264R1 Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia. Dear Dr. Honda: 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. Suho Lim Guest Editor PLOS ONE https://doi.org/10.1371/journal.pone.0265135.r004

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