Dear Dr Lawford,

Thank you for submitting your manuscript entitled "Association between change in willingness for joint replacement surgery after an education and exercise program for hip/knee osteoarthritis and probability of receiving actual surgery: A longitudinal cohort study of 55,059 people" for consideration by PLOS Medicine.

Your manuscript has now been evaluated by the PLOS Medicine editorial staff and I am writing to let you know that we would like to send your submission out for external peer review.

However, before we can send your manuscript to reviewers, we need you to complete your submission by providing the metadata that is required for full assessment. To this end, please login to Editorial Manager where you will find the paper in the 'Submissions Needing Revisions' folder on your homepage. Please click 'Revise Submission' from the Action Links and complete all additional questions in the submission questionnaire.

Please re-submit your manuscript within two working days, i.e. by Sep 25 2024.

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Once your full submission is complete, your paper will undergo a series of checks in preparation for peer review. Once your manuscript has passed all checks it will be sent out for review.

Feel free to email me at atosun@plos.org or us at plosmedicine@plos.org if you have any queries relating to your submission.

Kind regards,

Alexandra Tosun, PhD

Associate Editor

PLOS Medicine

Dear Dr Lawford,

Many thanks for submitting your manuscript "Association between change in willingness for joint replacement surgery after an education and exercise program for hip/knee osteoarthritis and probability of receiving actual surgery: A longitudinal cohort study of 55,059 people" (PMEDICINE-D-24-03148R1) to PLOS Medicine. The paper has been reviewed by subject experts and a statistician; their comments are included below and can also be accessed here: [LINK]

As you will see, the reviewers are supportive of the manuscript and have provided valuable comments and questions, as well as suggestions to improve the exploration of the data. After discussing the paper with the editorial team and an academic editor with relevant expertise, I'm pleased to invite you to revise the paper in response to the reviewers' comments. We plan to send the revised paper to some or all of the original reviewers, and we cannot provide any guarantees at this stage regarding publication.

When you upload your revision, please include a point-by-point response that addresses all of the reviewer and editorial points, indicating the changes made in the manuscript and either an excerpt of the revised text or the location (eg: page and line number) where each change can be found. Please also be sure to check the general editorial comments at the end of this letter and include these in your point-by-point response. When you resubmit your paper, please include a clean version of the paper as the main article file and a version with changes tracked as a marked-up manuscript. It may also be helpful to check the guidelines for revised papers at http://journals.plos.org/plosmedicine/s/revising-your-manuscript for any that apply to your paper.

We ask that you submit your revision by Dec 12 2024. However, if this deadline is not feasible, please contact me by email, and we can discuss a suitable alternative.

Don't hesitate to contact me directly with any questions (atosun@plos.org).

Best regards,

Alexandra

Alexandra Tosun, PhD

Associate Editor

PLOS Medicine

atosun@plos.org

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Comments from the reviewers:

Reviewer #1: A very interesting manuscript! This paper examines associations between self-reported surgery willingness before and after an exercise program and receipt of surgery after participation in this program (as a related note, the title was a bit weird. You're not looking at an association between a change in surgery willingness and the /probability/ of receiving surgery, but /whether/ the patient actually receives the surgery). One major strength of the study is the registry-based design that captures a population-level patient experience; choices for patient inclusion/exclusion made sense. Another strength is empirical confirmation of "surgery unwillingness" being associated with being less likely to go through with a surgery and more importantly, the authors' attempt at quantifying the extent to which this occurs. However, I do have some comments regarding the statistical analysis in the manuscript, which as is, was not entirely satisfactory.

Given that the intent wasn't to make the most accurate predictions, but rather to understand any association between receipt of this intervention/status of the intervention and the outcome, why not simply use all identified confounders in the modeling? I didn't understand what the variable selection process was trying to achieve. Even if certain variables such as sex might not have a statistically significant association with receipt of surgery, why not include them in the model so you can say that it was adjusted for? (along those lines, it actually looks like there's an association between sex and patient segmentation in terms of willingness before/after the intervention). As an aside, in the figures, you mentioned that survival curves were estimated based on the adjusted models. Does this specifically mean that for the four curves, these are for the four patient segments, marginalizing over the distribution of all confounders of all patients in each category?

Regarding the causal inference, the use of counterfactuals was certainly interesting from a real world perspective, but causal assumptions did not appear to be mentioned at all beyond assuming that all possible confounders have been accounted for (which is unrealistic here). Is a causal model being asserted, and if so, what is the causal estimand of interest? Does it accurately reflect some yes/no pairs canceling with no/yes pairs? The phrasing regarding "causal framework using counterfactual scenarios" appears in the discussion section, without sufficient justification for use of causal methods or formal evaluation of assumptions in the methodoloy. If you are going to use a causal analysis, it would have been helpful to actually do this formally. As for the actual assumptions themselves, I find it hard to believe that comparing the real-life yes/yes vs. yes/no is truly causal where everything has been accounted for. With that said, despite use of causal methodology and estimation of causal effects, results are phrased in terms of associations/as if you aren't trying to exploit causal inference methodology - this is fine, but just kind of discordant given what the methodology might imply.

An interesting aspect of your data is that there were more no/yes discordant pairs than yes/no discordant pairs, which makes sense. However, it might be of scientific interest to examine what might be associated with each of these types of patients (i.e., what is associated with a patient going from willing to unwilling to undergo surgery?), as well as examine patients who go "the wrong way" in terms of the intervention. Given that the intervention was designed to reduce patient willingness to undergo surgery, why did many of them go from unwilling to willing after the intervention? This might be of potential interest. I found it surprising that the actual results from your regression modeling was not presented at all - I strongly recommend you provide adjusted hazard ratios for your model, as you would be able to answer these types of questions. For instance, a clinician may be interested in whether there might be any potential associations based on age - are older or younger adults more/less likely to undergo surgery, especially considering that the recovery period after the operation may represent a larger burden for older adults? In general, displaying results from regression models would allow readers to understand whether certain other variables might also be associated with differential time to surgery (I'm particularly interested in a model account for all potential confounders assessed, not one based on some likelihood-based variable selection criteria).

As some final minor issues, there is some weirdness in the way results are reported. For instance, it is not clear what "hazard rate" means in line 246 (i.e., do you simply mean the hazard of surgery?).

Reviewer #2: This is a very interesting and relevant research that should be accepted if the authors addressed the following important comments:

-This paper seems to have been written by methodologists for methodologists. It is not so much accessible for the average reader with little quantitative skills, especially in survival analysis and parametric modelling. The reporting is pretty indigestible, even for an applied medical statistician. The grouping should be described in an easier way, with of course a formal description in the methods section and then the use of a reader-friendly wording. For example (but feel free to use any other relevant wording): Never considered surgery vs NO-NO, always planned surgery vs YES-YES, ultimately refused surgery vs YES-NO, or ultimately accepted surgery vs NO-YES . Moreover, the numbers presented in tables should never be repeated in the text, which should only report a digest of the main messages. The figure titles are too technical: Use footnotes to describe the technical elements, including what adjustments have been made, but don't use such hard-core titles that will put off reviewers and readers. In the text wording such as "The hazard rate (i.e., instantaneous risk of surgery for anyone who had not already had surgery at that time point) at 1-year post-intervention among those who responded YES-NO was half of that of 245 those responding YES-YES (hazard ratio 0.5 [95% CI 0.4-0.5]; Table 3; Figure 1)." is really not reader-friendly. Why not writing " the risk of surgery for anyone initially accepting but then refusing surgery at 1-y post-inter was half the risk estimated among patients still willing to undergo surgery…" or something like that?

-One key ignored methodological aspect is the clustering of data by hospital facilities: it is possible that patients attending a surgical place could be influenced by the local clinical/surgical team for or against surgery. So we cannot rule out a cluster effect. The analyses are not accounting for the multilevel nature of the used data. However, this is my experience that conducting multilevel flexible survival analysis is incredibly computer-intensive, and too often with big data, the statistical software (R or Stata) tends to crash. The authors should therefore either consider to model the clustering (Multilevel mixed-effects parametric survival analysis: Estimation, simulation, and application - Michael J. Crowther, 2019 (sagepub.com)) or discuss the potential implications of ignoring this clustering in the limitations section.

-It is unclear whether the willingness to undergo surgery is related to the severity of the symptoms experienced, and therefore the length-of-time with a high level of OA limitations. It could be that patients suffering from severe pain and functional limitations would want surgery to alleviate their symptoms; and vis-versa for those with lower or more recent OA symptoms. The authors are already adjusting for pain levels at baseline and post-intervention, but table 1 is clearly showing that the level of post-intervention pain is the highest in the YES-YES and NO-YES groups. Does it deserve further discussions? It would be dangerous for any care provider to wrongly use this article to reduce arthroplasty provision and related funding based on the overall message of this research and ignoring the specificities of the YES-YES and NO-YES groups. This requires more discussion.

-Minor comments:

*The term "incident joint replacement". What does it mean? This is non-reader friendly. Does it refer to the concept of incidence ratio, but then the concept of person-year is very briefly mentioned. Clarify, but make sure to use some wordings that are simple and accessible for all readers.

*Consider reporting a flow diagram graph rather than appendix 1.

*The number of comorbidities categories is ridiculously large, simplify to 0,1,2 3+

*In the figures, the concept "end of intervention" is difficult to grasp. Consider a more reader-friendly labelling.

Reviewer #3: This is an interesting paper that reports on secondary analyses of population based registry data for people seeking care for OA and people receiving total joint arthroplasty (TJA) in Sweden. The primary question is whether participation in a 3-month education and exercise intervention results in a change in patient willingness to undergo TJA and the relationship of pre-post willingness to subsequent receipt of TJA at 5 and 9 years follow-up. The statistical approaches used to link and analyse the data are sound, addressing potential confounders. The authors acknowledge the limitations of a single yes/no measure of willingness before and after a brief 3-month intervention as causally related to subsequent rates of TJA, yet the simplicity of the approach is compelling. Importantly, the authors found that those who converted from yes i want surgery to no i do not want surgery were less likely to receive a TJA during follow-up... in the short term specifically...compared to the yes-yes group.

My main concerns regarding the study relate to the time lag from the education/exercise intervention and receipt of surgery, and thus the causal relationship, if any. The results are hypothesis generating at best. But, the results are provocative with respect to the potential role of improved OA symptom management to reduce symptoms/improve function in helping stem growing demand for TJA for OA. That said, I have some suggestions to improve the interpretability of the findings to readers and also clarify the extent to which potential confounders have been accounted for.

Abstract: it would be helpful to clarify that all patients presenting for OA care in Sweden are provided the 3-month education and exercise intervention.

Introduction: Lines 74-76- I am not sure what the sentence that begins with "Further, joint replacement..." The sentence appears redundant - please revisit/clarify.

Methods:

Please clarify what changes, if any, were introduced to the education/exercise OA intervention over the 10-year time period of this study. Please also explain why the willingness question was introduced, and justify why a simple yes/no versus Likert scale was used as the measure of willingness.

Confounders:

To what extent was the selection of confounders informed by prior literature on the factors that influence willingness to consider TJA? Prior work has identified social network factors and other social health determinants as key to determining people with OA's perceived candidacy for surgery, perceptions of the risks and benefits of surgery, and perceived OA severity, all of which relate to willingness - please comment more explicity on how these factors were incorporated into analyses.

Was the overall burden of OA considered - i.e., the total number of joints affected?

Results:

Table 1 is very informative - there are expected differences across the groups with respect to confounders controlled for (sex, education attainment, measures of OA symptom severity), yet the results do not help the reader to understand the role of controlling for these differences on the outcomes of interest. For example, what was the effect of controlling for a prior surgeon visit? I think that greater clarity regarding a) which variables were controlled for in which analysis - e.g., footnotes in figures and tables - and mention of the effect of controlling for key confounders on the results, would help readers interpret the results and also plan for future studies to confirm or refute the findings.

Discussion:

Overall, the discussion is well-written and addresses methodological limiations inherent in secondary cohort analyses. However, as noted above, I think the discussion regarding the potential mechanisms by which the intervention resulted in changes in willingness to consider TJA, or not, could be strengthened considerably, building on prior work regardiing factors that influence the willingness construct. From the paper, it appears the primary mechanism considered was change in OA symptoms and improvement in arthritis coping / self-efficacy, which I agree may have played a role. But what about speaking with peers who had undergone TJA previously? What about interactions with surgeons, recommendations for surgery received during the intervention? Greater description of what the intervention entails, and whether surgery is explicitly discussed, and the opportunity for group discussion among patients, would be helpful in this respect.

Page 20, line 322 states that "...symptom progression as well as poor adherence to self-management strategies may have contributed to reconsideration about willingness for surgery." Could you please explain what is meant by "poor adherence" to therapy? how might this be related to change in willingness if not due to progression of symptoms?

Figures and Tables:

Please clarify variables controlled for in the various models in footnotes.

Was the overall burden of OA considered - i.e., the total number of joints affected?

Reviewer #4: Dear Author,

It was a pleasure to review your manuscript.

Well done on pursuing this research topic and using such meticulous methodology and statistical analyses. Congratulations on the amazing results and please consider my comments in the attachments and amend the manuscript accordingly.

Kind regards,

Candice

Any attachments provided with reviews can be seen via the following link: [LINK]

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Attachments

Attachment

Submitted filename: PMEDICINE-D-24-03148_R1_15Nov.pdf

Attachment

Submitted filename: PLOS_PMEDICINE-D-24-03148R1_Reviewer Response.docx

Dear Dr. Dell'Isola,

Thank you very much for re-submitting your manuscript "Association between change in willingness for joint replacement surgery after an education and exercise program for hip/knee osteoarthritis and future joint replacement surgery: A longitudinal cohort study of 55,059 people" (PMEDICINE-D-24-03148R2) for review by PLOS Medicine.

Thank you for your detailed response to the editors' and reviewers' comments. I have discussed the paper with my colleagues, and it has also been seen again by three of the original reviewers. The changes made to the paper were mostly satisfactory to the reviewer. As such, we intend to accept the paper for publication, pending your attention to the reviewers' and editors' comments below in a further revision. When submitting your revised paper, please once again include a detailed point-by-point response to the editorial comments.

The remaining issues that need to be addressed are listed at the end of this email. Any accompanying reviewer attachments can be seen via the link below. Please take these into account before resubmitting your manuscript:

[LINK]

In revising the manuscript for further consideration here, please ensure you address the specific points made by each reviewer and the editors. In your rebuttal letter you should indicate your response to the reviewers' and editors' comments and the changes you have made in the manuscript. Please submit a clean version of the paper as the main article file. A version with changes marked must also be uploaded as a marked up manuscript file. Please also check the guidelines for revised papers at http://journals.plos.org/plosmedicine/s/revising-your-manuscript for any that apply to your paper.

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We ask that you submit your revision within 1 week (Feb 20 2025). However, if this deadline is not feasible, please contact me by email, and we can discuss a suitable alternative.

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We look forward to receiving the revised manuscript. 

Sincerely,

Alexandra Tosun, PhD

Associate Editor 

PLOS Medicine

plosmedicine.org

***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.***

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Comments from Reviewers:

Reviewer #1: The authors have satisfactorily addressed all of my comments. With that said, I now have a minor quibble with respect to a change made due to a comment from the second reviewer. Specifically, hazards are not risks - I would simply call a hazard a hazard - it is the instantaneous rate of failure given that a patient had not yet failed at that time. Neither are hazards unconditional rates, which was my original comment.

The manuscript is sound and interesting, but I would strongly recommend simply using the term "hazard."

Reviewer #3: Thank you for the extensive rewriting and attention to addressing prior questions and concerns. I have no additional issues to consider.

Reviewer #4: Dear Authors,

Thank you very much for considering my comments and recommendations!

I am happy with the way that you had addressed my comments/recommendations and know that this revised manuscript will be a meaningful contribution to our wider research and health professional community.

Kind regards,

Candice

Any attachments provided with reviews can be seen via the following link:

[LINK]

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1) Please confirm that your abstract complies with our requirements, including providing all the information relevant to this study type https://journals.plos.org/plosmedicine/s/submission-guidelines#loc-abstract

2) Please ensure that all abbreviations are defined at first use throughout the text.

3) Please review your text for claims of novelty or primacy (e.g. 'for the first time') and remove this language (e.g. line 401). In addition, please check that any use of statistical terms (such as trend or significant) are supported by the data, and if not please remove them.

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Please include the ethics statement from lines 522-526 in the Methods section of your manuscript.

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1) Please clarify in the Methods and Results section how joint paint, quality of life, pain self-efficacy and number of comorbidities were measured (i.e. what scale/tool was used, as done below Table 1).

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Dear Dr Dell'Isola, 

On behalf of my colleagues and the Academic Editor, Christelle Nguyen, I am pleased to inform you that we have agreed to publish your manuscript "Association between change in willingness for joint replacement surgery after an education and exercise program for hip/knee osteoarthritis and future joint replacement surgery: A longitudinal cohort study of 55,059 people" (PMEDICINE-D-24-03148R3) in PLOS Medicine.

I appreciate your thorough responses to the reviewers' and editors' comments throughout the editorial process. We look forward to publishing your manuscript, and editorially there are only a few remaining points that should be addressed prior to publication. We will carefully check whether the changes have been made. If you have any questions or concerns regarding these final requests, please feel free to contact me at atosun@plos.org.

Please see below the minor points that we request you respond to (line numbers according to Marked Up Manuscript):

* Title: If you agree, we suggest shortening the title to: Change in willingness for joint replacement surgery after an education and exercise program for hip/knee osteoarthritis: A longitudinal cohort study of 55,059 individuals

* Abstract, l.80, please change to: ‘was then higher at 5-years (HR 1.4 [95% CI: 1.2, 1.7])’. Please ensure that you include the abbreviation for Hazard Ratio in the preceding brackets.

* Table 1: Please define ‘SD’ below the table.

* Data availability: In addition to the two website links, please include email addresses where available. We feel that the links to the general website do not provide a direct link that would allow other researchers to find out who to contact.

Before your manuscript can be formally accepted you will need to complete some formatting changes, which you will receive in a follow up email (including the editorial points above). Please be aware that it may take several days for you to receive this email; during this time no action is required by you. Once you have received these formatting requests, please note that your manuscript will not be scheduled for publication until you have made the required changes.

In the meantime, please log into Editorial Manager at http://www.editorialmanager.com/pmedicine/, click the "Update My Information" link at the top of the page, and update your user information to ensure an efficient production process. 

PRESS

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Thank you again for submitting to PLOS Medicine. We look forward to publishing your paper. 

Sincerely, 

Alexandra Tosun, PhD 

Associate Editor 

PLOS Medicine