PONE-D-19-17102

The SiESTa (SEaav SedaTion) Scale project: development of a multifactorial composite sedation inventory for dogs

PLOS ONE

Dear Dr Fernando Martinez-Taboada,

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.

Dear Authors, both reviewers expressed some concerns regarding your manuscript. In particular the second reviewer had the major concerns and some of them are very critical. I invite you to try to respond accordingly to all the concerns of the reviewer and amend the manuscript accordingly

We would appreciate receiving your revised manuscript by Nov 11 2019 11:59PM. When you are 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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Kind regards,

Francesco Staffieri

Academic Editor

PLOS ONE

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2.  Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information."

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Additional Editor Comments (if provided):

Dear Authors, both reviewers expressed some concerns regarding your manuscript. In particular the second reviewer had the major concerns and some of them are very critical. I invite you to try to respond accordingly to all the concerns of the reviewer and amend the manuscript accordingly

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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: No

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: I Don't Know

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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: No

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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: No

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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: the acronym used is not consistent with the words: I suggest to find a single word for each letter for example SIESTA dog:Seaav Integrated Evaluation Sedation Tool for Anaesthesia in dogs

Abstract

Line 45: please specify how many anaesthetists sent the questionnaires back. It is not clear how the clinicians involved used the questionnaires.

Line 56: there are not enough information in the abstract to asses that the questionnaire used was successful in evaluating the real sedation status of the animals.

M&M

Line 113: please specify if the answer to this first phase was anonymous or not.

Results

Line 184: please correct the capital letter of “State” in “state”.

Line 191: please specify why on 205 case there were 94 male and 101 female: 10 dogs are missing.

Table 1: I suggest to put the total number for each class of drugs in order to see what is explained in the legend: more than 1 drug was used on the same animal. Anyway is not clear why the authors want to give this information because is not possible from the table understand which kind of sedative protocol/combination was done; I suggest to divide the cases in only opioid, or only sedative agents and combinationS (opioids+ sedatives or sedative + tranquillisers, etc.). It would be interesting to associate the drugs used to the level of sedation, to see if the evaluation of sedation was consistent with the protocol.

Unfortunately the annexes are in spanish and not in english.

In M&M is missing the description of comparison between the level so sedation given by the descriptive scale and the one resulted from the questionnaire.

Reviewer #2: Reviewer report

This manuscript describes the attempted development of a sedation scale in dogs, based on a Delphi method.

I have limited my comments to the study design and underlying assumptions as the analytical techniques (classification tree and random forest) employed are beyond my expertise.

I have concerns regarding the study methods, some of which may profoundly limit interpretation of the results.

1. Study participants - participants are repeatedly described as “experts” but there is no evidence, based on information provided in the manuscript, how many of them meet widely accepted definitions of expert status (American or European College Diplomate holders). Holding a research degree (MSc or PhD) is not a reflection of clinical experience or training, or even relevance to the subject of this study. This poses several problems, some of which are likely to have interfered with the collected data and consequently biased the results and interpretation.

a. participants may have provided limited descriptors, reflecting limited training experience. To some extent this is reflected in the Discussion, where the authors identify that some criteria, such as jaw tone, were not mentioned.

b. participants reflect a single mother tongue, Spanish. It is well established that health assessment scale development should consider differences in the interpretation and meaning of terms between languages. It is concerning that a scale developed in Spanish has been translated in to English for publication, with no apparent assessment of whether scale performance has been affected as a result of translation.

c. Participant assessments using the developed scale were compared to a simple descriptive scale. This problematic because feedback from the same participants was used to develop the scale. Ideally, animals would have been video-recorded (with appropriate consent) and the the videos scored by a separate, independent group of observers.

d. the authors suggest that similarities in terminology and jargon used by participants during the Delphi process were beneficial. Given the lack of apparent minimal consistent training level, how could authors be certain that terminology and jargon were applied consistently by participants?

2. Scale development process

a. the argument in favour of dichotomous outcomes as being more objective is misguided. Though forcing a participant to select a dichotomous outcome appears objective, the underlying assessments are in large part subjective. There is no indication that objective measures were employed in many of the final predictors described. This could explain why the scale performed less well when animals had levels of sedation that were not at the extremes (“no” or “profound” sedation).

b. from the methods (phase 1 and 2) it appears there was considerable author input in selecting and classifying the final descriptors - this may be a necessary step, but it would be helpful to have assurance that any author bias was limited - perhaps the authors would consider making their data available on-line?

c. some descriptors are clearly highly subjective and uncontrolled e.g. responses to noise and name.

d. for some descriptors, participants had the option of selecting which would be tested. This suggests the possibility that the testing method was not standardised, with the risk that the outcome of a test would be influenced by what occurred previously. For example, if attempts were made to place a dog in lateral recumbency, this could change the level of sedation, affecting the test that followed (e.g. response to noise).

e. There appears to be an underlying assumption that the method used by the authors to collect descriptors is somehow superior to methods used in previously published studies (e.g. Young et al.). Just because the described method has been named “Delphi” does not confer legitimacy over older studies conducted before the Delphi concept existed or was widely applied. It is highly likely that descriptors generated in previous studies were achieved through consensus discussion.

f. I could not find Fig 2.

g. As identified by the authors, participants were not blinded to the status of the dogs. This would appear a critical limitation, especially when no further testing has been done to evaluate scale performance with observers blinded to treatment.

3. The language used throughout needs editing to raise the standard of scientific english. There is a tendency to use slang (“in fact”) and poorly defined terms (“awareness” - how can we know if an animal is aware? Similarly, “state of mind”).

4. As the authors describe, other sedation scales have been published for use in dogs, including one that was validated according to psychometric principles (validity and reliability testing). With the study goal of developing this novel scale, it would have been invaluable to perform some comparisons with pre-existing scale. In general terms, it is extremely difficult to interpret the performance of a novel scale when it is compared against a non-validated scale (as was the case here). Therefore, it is probably unsurprising that the results show the extremes of sedation (no sedation and profound sedation) to be in close agreement. Surely it is accurately classifying the full continuum (including crossing the threshold in to general anaesthesia) that is of greatest interest?

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Reviewer #1: No

Reviewer #2: No

[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 to be viewed.]

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 us at figures@plos.org. Please note that Supporting Information files do not need this step.

PONE-D-19-17102R1

The SIESTA (SEAAV Integrated Evaluation Sedation Tool for Anaesthesia) project: initial development of a multifactorial sedation assessment tool for dogs.

PLOS ONE

Dear Dr Martinez-Taboada

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.

==============================

Many thanks for your re-submission to PLOS One

Your manuscript was re-assigned to me as Academic editor.

Two reviewers were split on the manuscript, with one suggesting accept and one suggesting rejection

Therefore it went to a review by a third reviewer, and they have recommended that some changes be made.

I apologise for the delay in getting the comments back to you but hopefully you can understand why this was required.

I therefore invite you to further modify the manuscript, and resubmit it along with a response to reviewers comments

I wish you the best of luck with your revisions

Many thanks

Simon

==============================

We would appreciate receiving your revised manuscript by Mar 30 2020 11:59PM. When you are 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.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter.

To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'.

Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out.

We look forward to receiving your revised manuscript.

Kind regards,

Simon Russell Clegg, PhD

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

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: (No Response)

Reviewer #3: (No Response)

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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: No

Reviewer #3: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: I Don't Know

Reviewer #3: 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

Reviewer #3: 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

Reviewer #3: No

**********

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: Dear authors, thank you for revising the manuscript in a critical manner.

This paper is very interesting and it will be helpful for the clinical activity

Reviewer #2: Thank you to the authors for providing responses to my previous comments and suggestions. While I appreciate their efforts in justifying some of the decisions made during study design, I remain unconvinced that various assumptions underlying the design of this study are valid. Specifically, I do not feel that the justifications provided for the following are sufficient: wide variability in experience and training of participants, claims that performing the study in one language can generate a usable tool in another language, dependence on dichotomous outcomes, varying consistency in how assessments were applied by users.

Reviewer #3: This is an important and thorough investigation and it will be interesting to read further about the validation phase. However, I do have some doubts about the accuracy and clarity of English, which is a pity after the exhaustive research involved. To give some specific examples: frequent use of 'etc' when it's not clear about what the implied 'and others' actually are (e.g. a fundamental tool in the development of new sedative drugs, drug combinations, routes of administration, etc.); inconsistency in use of 'anaesthetists' and 'anaesthesiologists'; 'central nerve system'. I realise these are minor points, but I think they are vitally important because if we write descriptions of studies that might confuse readers assumed to be of equal knowledge and understanding, they might justifiably wonder whether the conduct of the study had been similarly confused. Maybe a good copy editor would be able to help, because this important work really needs to be published!

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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

Reviewer #3: No

[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 to be viewed.]

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 us at figures@plos.org. Please note that Supporting Information files do not need this step.

The SIESTA (SEAAV Integrated Evaluation Sedation Tool for Anaesthesia) project: initial development of a multifactorial sedation assessment tool for dogs.

PONE-D-19-17102R2

Dear Dr. Martinez-Taboada

We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements.

Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication.

Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

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With kind regards,

Simon Russell Clegg, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Many thanks for resubmitting your manuscript to PLOS One

It was reviewed by the same reviewer as last time, and I am pleased to say that they have recommended publication

I have therefore recommended that your manuscript be accepted, and you should hear from the editorial office soon

I wish you all the best with your future research and it was a pleasure working with you

Many thanks

Simon

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 #3: 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 #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: 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 #3: 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 #3: 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 #3: Thank you for making the amendments suggested in my last review. I think the manuscript reads much more clearly now.