A critical evaluation for validation of composite and unidimensional postoperative pain scales in horses

Paula Barreto da Rocha; Bernd Driessen; Sue M. McDonnell; Klaus Hopster; Laura Zarucco; Miguel Gozalo-Marcilla; Charlotte Hopster-Iversen; Pedro Henrique Esteves Trindade; Thamiris Kristine Gonzaga da Rocha; Marilda Onghero Taffarel; Bruna Bodini Alonso; Stijn Schauvliege; Stelio Pacca Loureiro Luna

doi:10.1371/journal.pone.0255618

Peer Review History

Original SubmissionFebruary 5, 2021
5 May 2021 Decision Letter - Antonio Humberto Hamad Minervino, Editor PONE-D-21-04051 A critical evaluation for validation of composite and unidimensional postoperative pain scales in horses: a multicenter study PLOS ONE Dear Dr. Luna, 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. ============================== ACADEMIC EDITOR: The manuscript was revised by experts and it requires major revision before it can be accepted for publication. Please take into consideration the important points raised by reviewer #2 when revising this manuscript. ============================== Please submit your revised manuscript by Jun 19 2021 11:59PM. 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Kind regards, Antonio Humberto Hamad Minervino, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (if provided): The manuscript was revised by experts and it requires a major revision before it can be accepted for publication. Please carefully check the comments made by reviewer #2 and revise the manuscript. 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) Thank you for stating the following in the Competing Interests section: [The authors have declared that no competing interests exist.]. We note that you received funding from a commercial source: Narkovet Consulting®, LLC, Please provide an amended Competing Interests Statement that explicitly states this commercial funder, along with any other relevant declarations relating to employment, consultancy, patents, products in development, marketed products, etc. Within this Competing Interests Statement, please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your amended Competing Interests Statement within your cover letter. We will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests 3) Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 4) Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. [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: Partly ******** 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: 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: The manuscript presents excellent results from the assessment of different pain scales (composite and unidimensional) in the postoperative period of horses. The study presents a robust statistical evaluation and analyzes criteria that are important to understand the advantages and limitations of the different types of scale. I suggest adding the p values for the Spearman correlation analysis in tables 3 and 6. Reviewer #2: The authors are applauded for their efforts to analyze and report this complicated analysis of a large data set. The topic is important to equine medicine/surgery, the experimental design is well-explained, and the information is likely important in our continued search for the best possible way to assess/measure pain in equine patients. It is always challenging to conduct this type of pain assessment in a non-standardized population of clinical patients. I think the authors do a good job in trying to manage the extraneous variables and diminish bias. The manuscript suffers, however, from a lack of focus and clarity. The manuscript is difficult to interpret because of the wide variety of analyses, acronyms, and competing/conflicting statements. A table of acronyms should be included for reference. A similar table with concise definitions of terminology such as reliability, repeatability, sensitivity, specificity, consistency, validity, etc would be helpful. I realize that descriptors for most terms are included in Table 1 in conjunction with a description of the statistical tests which were utilized, but the definitions are not easily interpreted by scientists who may not be experts in this type of experimental design. I strongly recommend that the manuscript be written with language that makes the information more broadly accessible without sacrificing the precision that is important for interpretation of results. The stated objective for the study is to compare results obtained with select unidimensional or composite pain scales by evaluators with variable backgrounds. I don't think that the authors can draw any meaningful conclusions about the experience of evaluators based on only 1 of each type of individual. A much larger number of individuals (e.g. many students, many technicians, many surgeons, many internists) would be required to make conclusions regarding whether the experience of the individual performing the assessment has a significant impact on the assessment. It was interesting that the need for rescue analgesia appeared to have the most intra-observer variability. This type of assessment may depend on many factors other than the perceived level of pain. Some individuals believe that it is reasonable for post-operative patients to experience moderate pain while other individuals believe all pain should be minimized or treated. For example, some individuals may believe that pain should be treated with a VAS of 2 and others may believe that pain should not be treated unless there was a VAS of 8. These are philosophical differences that were not addressed in the discussion. I'm not sure that the need for rescue analgesia is appropriate to be included in the analysis in the same way as the presumably more objective scoring systems. (This doesn't mean that it shouldn't be included in the manuscript but perhaps it should be handled in a different way or at least discussed.) ****** 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: 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.] 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.0255618.r001
Revision 1
25 Jun 2021 Author Response Additional Editor Comments (if provided): The manuscript was revised by experts and it requires a major revision before it can be accepted for publication. Please carefully check the comments made by reviewer #2 and revise the manuscript. Answer: The authors appreciate the editor and the reviewers for taking the time and effort to review this manuscript. All corrections were performed according to the editor´s and reviewers' suggestions, as described below 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 Answer: adjustments have been performed to meet PLOS ONE´s style requirements 2) Thank you for stating the following in the Competing Interests section: [The authors have declared that no competing interests exist.]. We note that you received funding from a commercial source: Narkovet Consulting®, LLC, Please provide an amended Competing Interests Statement that explicitly states this commercial funder, along with any other relevant declarations relating to employment, consultancy, patents, products in development, marketed products, etc. Within this Competing Interests Statement, please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your amended Competing Interests Statement within your cover letter. We will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests Answer: The Competing Interests Statement has been included in the cover letter and manuscript. 3) Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Answer: supporting Information file captions were included, and citations were updated in-text 4) Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. Answer: the ethics statement appears only in Methods section now. [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: Partly ________________________________________ 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: 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: The manuscript presents excellent results from the assessment of different pain scales (composite and unidimensional) in the postoperative period of horses. The study presents a robust statistical evaluation and analyzes criteria that are important to understand the advantages and limitations of the different types of scale. I suggest adding the p values for the Spearman correlation analysis in tables 3 and 6. Answer: the authors appreciate your time and effort in reviewing this manuscript and your positive comments. The p values for the Spearman correlation analysis were included in tables 3 and 6 as required. Reviewer #2: The authors are applauded for their efforts to analyze and report this complicated analysis of a large data set. The topic is important to equine medicine/surgery, the experimental design is well-explained, and the information is likely important in our continued search for the best possible way to assess/measure pain in equine patients. It is always challenging to conduct this type of pain assessment in a non-standardized population of clinical patients. I think the authors do a good job in trying to manage the extraneous variables and diminish bias. The manuscript suffers, however, from a lack of focus and clarity. The manuscript is difficult to interpret because of the wide variety of analyses, acronyms, and competing/conflicting statements. Answer: the authors appreciate your time and effort in reviewing this manuscript and your constructive comments. We did our best to improve clarity. Although an abbreviation list was already available in the previous version, we excluded the acronyms in the text to provide an easier reading. A table of acronyms should be included for reference. A similar table with concise definitions of terminology such as reliability, repeatability, sensitivity, specificity, consistency, validity, etc would be helpful. I realize that descriptors for most terms are included in Table 1 in conjunction with a description of the statistical tests which were utilized, but the definitions are not easily interpreted by scientists who may not be experts in this type of experimental design. I strongly recommend that the manuscript be written with language that makes the information more broadly accessible without sacrificing the precision that is important for interpretation of results. Answer: concise definitions of terminology and the rationale behind the methods used for statistical analysis has been included as a new column in Table 1. Results are better explained in lines 301-303, 339-348, 351-354 and, 392-395. Some comments have also been included in Discussion (lines 499-511,514-515, and 530-532). We hope the manuscript is more comprehensible and easier to follow. The stated objective for the study is to compare results obtained with select unidimensional or composite pain scales by evaluators with variable backgrounds. I don't think that the authors can draw any meaningful conclusions about the experience of evaluators based on only 1 of each type of individual. A much larger number of individuals (e.g. many students, many technicians, many surgeons, many internists) would be required to make conclusions regarding whether the experience of the individual performing the assessment has a significant impact on the assessment. Answer: the authors agree with your comment. It would be necessary at least six individuals of each category to draw any conclusion about the results of the observers. All points regarding this topic were excluded from Discussion. It was interesting that the need for rescue analgesia appeared to have the most intra-observer variability. This type of assessment may depend on many factors other than the perceived level of pain. Some individuals believe that it is reasonable for post-operative patients to experience moderate pain while other individuals believe all pain should be minimized or treated. For example, some individuals may believe that pain should be treated with a VAS of 2 and others may believe that pain should not be treated unless there was a VAS of 8. These are philosophical differences that were not addressed in the discussion. I'm not sure that the need for rescue analgesia is appropriate to be included in the analysis in the same way as the presumably more objective scoring systems. (This doesn't mean that it shouldn't be included in the manuscript but perhaps it should be handled in a different way or at least discussed.) Answer: Thank you for your comment. This was included in Discussion (lines 465-469). According to your suggestion, rescue analgesia results were excluded from Tables 2 and 4 of the main text, as the same information is provided in Supporting Information (S3 and S4 Tables). Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0255618.r002
21 Jul 2021 Decision Letter - Antonio Humberto Hamad Minervino, Editor A critical evaluation for validation of composite and unidimensional post-operative pain scales in horses PONE-D-21-04051R1 Dear Dr. Luna, 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, Antonio Humberto Hamad Minervino, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): I am pleasure to inform that this manuscript can be publish in the journal. The authors successfully correct all the issues raised during review and the manuscript meets all the criteria for publication at PLoS One. 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 #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 #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: (No Response) ****** 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 #2: (No Response) ****** 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 #2: (No Response) ****** 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 #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 #2: No https://doi.org/10.1371/journal.pone.0255618.r003
Formally Accepted
27 Jul 2021 Acceptance Letter - Antonio Humberto Hamad Minervino, Editor PONE-D-21-04051R1 A critical evaluation for validation of composite and unidimensional postoperative pain scales in horses Dear Dr. Luna: 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. Antonio Humberto Hamad Minervino Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0255618.r004

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