RE: REVISION: Perceptions of barriers and facilitators to opioid reduction after total joint arthroplasty among orthopedic surgeons practicing in Canada, Japan, and the Netherlands: A qualitative description study

Dear Dr. Chenette,

Please accept our revisions for the manuscript submission entitled, “Perceptions of barriers and facilitators to opioid reduction after total joint arthroplasty among orthopedic surgeons practicing in Canada, Japan, and the Netherlands: A qualitative description study” for consideration for publication in PLOS One.

We would like to thank the reviewers and editors for their time and effort in reviewing our manuscript and providing comments. We appreciate the quality of the feedback and have edited our manuscript to align with your comments as much as possible, providing justifications where required.

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Thank you, we have re-checked the formatting to ensure it aligns with the requirements.

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Thank you for this information. We have completed this questionnaire and have submitted it as a supplementary information file (S4 File). We referred to this file on lines 174-176.

a. In the Methods ethics statement, you specified that verbal consent was obtained. Please provide additional details regarding how this consent was documented and witnessed, and state whether this was approved by the IRB.

Thank you. We have added further details in the Methods section, lines 131-137, “Prior to data collection, participants were provided with a research ethics board (REB)-approved information letter that described the study in accessible language and provided sufficient information for participants to make an informed decision about their participation. They were given ample time to review and ask questions. Thereupon, verbal informed consent was obtained during the interview and documented on a REB-approved verbal informed consent log for audio and/or video recording and the use of quotes.”

For further clarity, all participants included in this study reviewed a REB-approved information letter before data collection that described this study in accessible language and provided sufficient information for participants to make an informed decision about their participation. The information letter described the study purpose, detailed background information, the nature of participation, and associated risks and benefits in lay language. Participants were also provided with the contact information of the study investigators, the principal investigator(s), and individual(s) outside the research team who can be contacted regarding questions or possible ethical issues. Then, verbal informed consent was obtained during the interview and documented on a verbal informed consent log, approved by the local IRB.

3. Thank you for stating the following in the Competing Interests section: [I have read the journal's policy and the authors of this manuscript have the following competing interests:

One of the authors (MP) has received funding from the Mitacs Globalink Research Award

One of the authors (VK) is a consultant for Stryker Canada and Zimmer Biomet Canada, and has a spouse who works for Stryker Canada.

One of the authors (YK) received a grant from Pioneers in Healthcare, received honoraria from Agnovos, received support for meeting attendance from RGS, and payment from NOV for participation in a Data Safety Monitoring Board or Advisory Board.

One of the authors (KM) received a grant from CIHR (BioTalent), is a participant in a Data Safety Monitoring Board or Advisory Board at the University of Calgary, and has a leadership or fiduciary role at the Clinical Orthopaedics and Related Research and Canadian Orthopaedic Association.

All other authors (PP, SS, AA, NS, EL, HS, JWB) certify that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members.].

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Thank you for letting us know. We have included the Competing Interests statement along with the aforementioned statement in our revised cover letter.

“Please note the following competing interests: One of the authors (MP) has received funding from the Mitacs Globalink Research Award. One of the authors (VK) is a consultant for Stryker Canada and Zimmer Biomet Canada, and has a spouse who works for Stryker Canada. One of the authors (YK) received a grant from Pioneers in Healthcare, received honoraria from Agnovos, received support for meeting attendance from RGS, and payment from NOV for participation in a Data Safety Monitoring Board or Advisory Board. One of the authors (KM) received a grant from CIHR (BioTalent), is a participant in a Data Safety Monitoring Board or Advisory Board at the University of Calgary, and has a leadership or fiduciary role at the Clinical Orthopaedics and Related Research and Canadian Orthopaedic Association. All other authors (PP, SS, AA, NS, EL, HS, JWB) certify that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”

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Thank you. We have submitted all data to MacSphere, McMaster University's open-access institutional repository. Upon approval, this will ensure long-term storage and accessibility of the data. For any data requests, please contact the McMaster University Office of Scholarly Communication at scom@mcmaster.ca.

5. Please upload a copy of Figures 1 and 2, to which you refer in your text on page 10. If the figure is no longer to be included as part of the submission please remove all reference to it within the text.

Thank you for letting us know. We have uploaded S3 Fig 1 and S3 Fig 2 (included in S3 File) separately as well.

6. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

We have reviewed the reference list and ensure that it is complete and correct.

Reviewers' Comments:

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.

a. Reviewer #1: Yes

b. Reviewer #2: Yes

Thank you.

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

a. Reviewer #1: Yes

b. Reviewer #2: I Don't Know

Thank you. Due to the qualitative nature of this study, data analysis involved conventional (inductive) content analysis. We summarized demographic data using ranges and proportions.

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.

a. Reviewer #1: Yes

b. Reviewer #2: No

To protect the privacy or confidentiality of human research participants, not all data can be made available publicly (i.e. direct quotations of participants that may reveal their identity). Interested researchers can contact the corresponding author or McMaster University Office of Scholarly Communication at scom@mcmaster.ca to access the minimal data that we have. They can also access this data at https://macsphere.mcmaster.ca.

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.

a. Reviewer #1: Yes

b. Reviewer #2: Yes

Thank you.

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)

5. Reviewer #1: This article addresses a critical and timely issue of reducing opioid use following joint arthroplasty, providing valuable insights through a cross-cultural comparison of prescribing practices in different countries.

Thank you for your thorough feedback and taking the time to review our manuscript.

The article could be improved with the following suggestions:

a. The results compare countries but lack sufficient emphasis on the unique cultural and systemic factors influencing opioid prescribing behaviors. The suggestion of providing more detailed comparisons between countries focuses on how cultural and systemic differences shape prescribing practices. Including a table or figure summarizing these differences would improve clarity.

The results summarize the perceptions of orthopaedic surgeons that we identified through the interview sessions. Considering the qualitative description methodology used in the study, we provided an analytical and data-driven perspective, by using conventional (inductive) content analysis, rather than interpreting the findings. We highlighted differences and similarities in the perceptions of orthopaedic surgeons identified during interviews from each of the 3 countries in S3 Tables 2 to 7 and S3 Fig 1 and S3 Fig 2.

b. The discussion could benefit from stronger connections to existing literature, particularly around the role of national policies and patient education in opioid prescribing.

Thank you for your feedback. We have discussed the role of national policies in opioid prescribing in Japan (Lines 374-387). We have also added the following to the discussion:

- “Notably, a retrospective cohort study, evaluating postoperative opioid prescription quantities, variability, and 30-day refill rates before and after implementation of orthopedic procedure-specific guidelines reported decreased opioid prescription amounts and variability” (Lines 406-409).

- “Moreover, this underscores the continued importance of educating patients on the risks associated with opioids, expectations of pain management, exploring alternative treatment options, and providing guidance on safe handling and proper disposal methods. A systematic review of 11 studies, evaluating the effectiveness of pre-operative patient education on post-operative opioid use and pain management in the orthopaedic setting, found that education related to opioid use and pain can be effective in reducing opioid prescription requests and filling[36]. Similarly, a cluster-randomized controlled trial including 539 patients reported that patient education on safe opioid disposal approximately triples opioid disposal rates compared with no education [33].” (Lines 349-358).

- “Similarly, many European countries enforce regulatory restrictions on the prescribing of opioids including dose limits, duplicate or triplicate prescriptions using special forms, and strict monitoring by pharmacies [39]” (Lines 387-389).

c. While the study identifies barriers, it lacks concrete recommendations for overcoming them. Suggestions for specific, actionable strategies tailored to each country, such as surgeon training programs, standardized protocols, or policy initiatives.

The scope of this qualitative study is limited as it serves as a preliminary exploration with a small sample size, and our findings may not gen

Attachments

Attachment

Submitted filename: OreosQual_RevisionLetter 23Jan25.docx

Dear Dr. Chenette,

Please accept our revisions for the manuscript submission entitled, “Perceptions of barriers and facilitators to opioid reduction after total joint arthroplasty among orthopedic surgeons practicing in Canada, Japan, and the Netherlands: A qualitative description study” for consideration for publication in PLOS One.

We would like to thank the reviewers and editors for their time and effort in reviewing our manuscript and providing comments. We appreciate the quality of the feedback and have edited our manuscript to align with your comments as much as possible, providing justifications where required.

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

We have checked the reference list and ensure that it is up-to-date and complete.

Reviewers' comments:

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

Thank you.

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

Thank you.

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

Reviewer #1: Yes

Thank you.

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

Thank you.

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

Thank you.

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 thoroughly addressing the previous review comments. Your revisions have significantly improved the manuscript, particularly in the areas of cultural context, policy implications, and study limitations. I appreciate your efforts in providing additional data and strengthening the discussion section.

Thank you for your feedback.

Final Recommendations:

Practical Application:

While you have acknowledged the preliminary nature of this study, including a brief section on how these findings could inform clinical guidelines or surgeon training would enhance the manuscript’s real-world impact.

Thank you for your feedback. We have added the following section in the Discussion:

“Cross-national insights can be integrated into the development of surgery-specific opioid prescribing guidelines. The variability observed across Canada, the Netherlands, and Japan highlights the need for evidence-based protocols that account for both cultural contexts and patient preferences. Our findings suggest that surgeon training programs can integrate updated guidance on multimodal pain management strategies, safe opioid prescribing, and the importance of educating patients on proper storage and disposal of unused opioid medications. Emphasizing existing national and international guidelines within training can further support consistent, informed decision-making. Addressing the identified barriers will require a multifaceted approach, including system-level changes and targeted educational interventions. Future research can evaluate the effectiveness of such strategies in supporting surgeons to adopt patient-centered, evidence-based practices that minimize opioid use while ensuring adequate pain control. Multi-center, quantitative studies are also needed to improve generalizability and explore cultural influences on prescribing behavior. Additionally, qualitative and quantitative studies exploring patient perspectives may offer a more holistic understanding of pain management preferences and inform more tailored interventions.” (Lines 404-418).

Future Research Directions:

Your inclusion of future research needs is appreciated. However, a more explicit mention of potential multi-center studies or patient perspectives could further guide subsequent investigations in this field.

Thank you for your feedback. We have added the following section in the Discussion:

“Cross-national insights can be integrated into the development of surgery-specific opioid prescribing guidelines. The variability observed across Canada, the Netherlands, and Japan highlights the need for evidence-based protocols that account for both cultural contexts and patient preferences. Our findings suggest that surgeon training programs can integrate updated guidance on multimodal pain management strategies, safe opioid prescribing, and the importance of educating patients on proper storage and disposal of unused opioid medications. Emphasizing existing national and international guidelines within training can further support consistent, informed decision-making. Addressing the identified barriers will require a multifaceted approach, including system-level changes and targeted educational interventions. Future research can evaluate the effectiveness of such strategies in supporting surgeons to adopt patient-centered, evidence-based practices that minimize opioid use while ensuring adequate pain control. Multi-center, quantitative studies are also needed to improve generalizability and explore cultural influences on prescribing behavior. Additionally, qualitative and quantitative studies exploring patient perspectives may offer a more holistic understanding of pain management preferences and inform more tailored interventions.” (Lines 404-418).

Overall, the manuscript now meets the scientific and editorial standards for publication, and I recommend acceptance.

Thank you for your dedication to advancing this important area of research.

Thank you for your feedback.

Thank you.

Attachments

Attachment

Submitted filename: OreosQual_RevisionLetter 18Jun25.docx