Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results

Sheila Veronese; Marco Cambiaghi; Nicola Tommasi; Andrea Sbarbati; John J. Galvin III

doi:10.1371/journal.pone.0282261

Peer Review History

Original SubmissionAugust 26, 2022
27 Dec 2022 Decision Letter - Paul Hinckley Delano, Editor PONE-D-22-23874Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual resultsPLOS ONE Dear Dr. Veronese, 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 Feb 09 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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[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: No 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: 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 is a retrospective cohort study aimed at assessing whether intraoperative electrophysiological data from 24 ABI patients correlated with postoperative perceptual outcomes. The abstract is adequate, and has listed rationale and setting details, alongside the most important findings. The introduction section is too long, and several paragraphs discussing details regarding hearing outcomes should be transferred to the discussion section. The objectives of the study are presented clearly and the introduction section communicates the need for investigating the electrophysiological variables impacting perceptual outcomes of ABI surgery. I would also recommend using a STROBE flowchart and checklist. Inclusion and exclusion criteria need to be clearly stated. I would consider including children with mental delay a significant confounding factor, but due to the small number of patients, exclusion is not neccessary, but rather an ancillary statistical analysis with mental delay as a separate binary variable to control sampling bias. However, since the methodology included a small number of patients, evaluated through tests assesing correlation, but not causality. I would suggest using an ancillary multivariate multinomial logistic regression model if a causal connection is to be evaluated between the three groups of perceptual outcomes (level 0-3) and number of electrodes. The tables and figures are adequate and support data interpretation. I have no concerns regarding internal or external manuscript validity. The discussion is fine, addressing all of the objectives of the manuscript, alongside other published relevant studies. A honest limitations and shortcomings paragraph is needed. Reviewer #2: I enjoyed reading this article. It presents innovative and new data to the research community regarding ABI. As this is a rare surgery, performed in a few centers worldwide, it is of great interest to publish long term results for ABI patients. The retrospective study is well designed; very well written article and interesting findings. Good figures and tables. Only two little minor details and can be published: page 7: The evoked potentials were selected because more adequate than other potentials in terms of... missing a word page 10: eliminate the period before Level 3 (line 189) ****** 6. 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Revision 1
25 Jan 2023 Author Response To the editor: We thank the editor and the reviewers for their helpful comments. We have incorporated nearly all suggestions into the revised MS. Below we respond to specific comments. Please let us know if you need further information. Sincerely, Sheila Veronese 1. Is the manuscript technically sound, and do the data support the conclusions? Reviewer #1: Yes Reviewer #2: Yes ________________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ________________________________________ 3. Have the authors made all data underlying the findings in their manuscript fully available? Reviewer #1: Yes Reviewer #2: Yes ________________________________________ 4. Is the manuscript presented in an intelligible fashion and written in standard English? Reviewer #1: Yes Reviewer #2: Yes ________________________________________ 5. Review Comments to the Author Reviewer #1: This is a retrospective cohort study aimed at assessing whether intraoperative electrophysiological data from 24 ABI patients correlated with postoperative perceptual outcomes. The abstract is adequate, and has listed rationale and setting details, alongside the most important findings. >>Thank you. The introduction section is too long, and several paragraphs discussing details regarding hearing outcomes should be transferred to the discussion section. >>We have moved some of the Introduction to the Discussion. For the inclusion criteria, we now state: “Inclusion criteria were 10 years of follow-up, the ability to communicate orally in Italian for adults, and the ability of family members to report on communication for children unable to speak. Exclusion criteria were the presence of motor deficits or body malformations that prevented perceptual testing. Note that children with mental delay were not excluded from the study because their diagnosis was made later in years based on other learning delays.” The objectives of the study are presented clearly and the introduction section communicates the need for investigating the electrophysiological variables impacting perceptual outcomes of ABI surgery. I would also recommend using a STROBE flowchart and checklist. >> We have added a new figure (Figure 1) which presents a STROBE flow diagram of the patient selection process. Inclusion and exclusion criteria need to be clearly stated. >>In the original MS (and unchanged here), we explicitly stated the inclusion and exclusion criteria. I would consider including children with mental delay a significant confounding factor, but due to the small number of patients, exclusion is not necessary, but rather an ancillary statistical analysis with mental delay as a separate binary variable to control sampling bias. However, since the methodology included a small number of patients, evaluated through tests assessing correlation, but not causality. I would suggest using an ancillary multivariate multinomial logistic regression model if a causal connection is to be evaluated between the three groups of perceptual outcomes (level 0-3) and number of electrodes. >> Two multivariate logistic regression models were evaluated, one with 15 subjects (excluding the single subject with score 0) and one with 13 subjects (also excluding the 2 mentally delayed children) - file attached as Supplemental Informations. Although neither model detected a significant relationship between the number of active electrodes and 10 yr outcome data, there was a positive trend, consistent with the results previously reported in the MS. Accordingly, we prefer to retain the previous analysis. If the reviewer and editor think it’s worthwhile, we could present the multivariate logistic regression models as supplementary data. The tables and figures are adequate and support data interpretation. I have no concerns regarding internal or external manuscript validity. The discussion is fine, addressing all of the objectives of the manuscript, alongside other published relevant studies. >>Thank you. An honest limitations and shortcomings paragraph is needed. >>We have added to the end of the Discussion: “One limitation to the present study is that the perceptual outcome categories were somewhat broad, enough so that they could be used to characterize both pediatric and adult perception. The categories represented increasing levels of difficulty, similar to the principles of the speech recognition hierarchy introduced by Geers (1994) and developed for the pediatric population [45]. As deafness in the adult ABI patients was due to tumors, neuropathy, head trauma, etc. (but not presbycusis), we felt that the present categories could be applicable to adults and children. While developmental differences between adults and children were not considered, children generally outperformed adults, possibly due to a better neural substrate [33], or greater neural plasticity [34]. Greater standardization of perceptual outcomes appropriate for adults and children would allow for better characterization of ABI outcomes.” Reviewer #2: I enjoyed reading this article. It presents innovative and new data to the research community regarding ABI. As this is a rare surgery, performed in a few centers worldwide, it is of great interest to publish long term results for ABI patients. The retrospective study is well designed; very well written article and interesting findings. Good figures and tables. >>Thank you. Only two little minor details and can be published: page 7: The evoked potentials were selected because more adequate than other potentials in terms of... missing a word >>Revised as: “The evoked potentials were selected because they were more appropriate than other cortical potentials in terms of the presence and stability of responses [21], and because they were indifferent to anesthesia [22,23]. page 10: eliminate the period before Level 3 (line 189) >>Corrected. Attachments Attachment Submitted filename: Veronese - Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0282261.r002
13 Feb 2023 Decision Letter - Paul Hinckley Delano, Editor Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results PONE-D-22-23874R1 Dear Dr. Veronese, 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, Paul Hinckley Delano, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0282261.r003
Formally Accepted
22 Feb 2023 Acceptance Letter - Paul Hinckley Delano, Editor PONE-D-22-23874R1 Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results Dear Dr. Veronese: 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. Paul Hinckley Delano Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0282261.r004

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