Cost-effectiveness of Transcendental Meditation (TM) for treating Post-Traumatic Stress Disorder (PTSD)

Erik J. Groessl; Thomas R. Rutledge

doi:10.1371/journal.pone.0316995

Peer Review History

Original SubmissionAugust 5, 2024
5 Nov 2024 Decision Letter - Ben Green, Editor PONE-D-24-32697Cost-Effectiveness of Transcendental Meditation (TM) for Treating Post-Traumatic Stress Disorder (PTSD)PLOS ONE Dear Dr. Groessl, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Dec 20 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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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 financial disclosure: “As noted in the manuscript Acknowledgments section, Erik Groessl was financially compensated by the David Lynch Foundation for some of his work on this analysis.” Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: “Dr. Groessl’s work on this analysis was partially supported by consulting fees from the David Lynch Foundation. Dr. Groessl and Dr. Rutledge have received research support for other studies from the David Lynch Foundation.” We note that you have provided funding information that is currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: “As noted in the manuscript Acknowledgments section, Erik Groessl was financially compensated by the David Lynch Foundation for some of his work on this analysis.” Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 4. 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: Erik Groessl, PhD was financially compensated by the David Lynch Foundation for some of his work on this analysis. This non-profit foundation promotes Transcendental Meditation (TM) as a beneficial health practice and charges a fee for training in TM.” 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 updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. 5. In the online submission form you indicate that your data is not available for proprietary reasons and have provided a contact point for accessing this data. Please note that your current contact point is a co-author on this manuscript. According to our Data Policy, the contact point must not be an author on the manuscript and must be an institutional contact, ideally not an individual. Please revise your data statement to a non-author institutional point of contact, such as a data access or ethics committee, and send this to us via return email. Please also include contact information for the third party organization, and please include the full citation of where the data can be found. 6. 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. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: 1. Although the article explores the cost-effectiveness of TM, the introduction section fails to fully explain the potential impact and application value of this study in practical clinical settings. The lack of a more specific explanation of the importance of the research results in readers not having a deep understanding of the practical significance of the research. 2. Lack of treatment compliance assessment: The article did not mention how to address patients' compliance issues during treatment, especially for treatment methods such as TM and PE that require continuous patient participation. Whether patients can fully follow the treatment plan for meditation or exposure therapy may significantly affect the efficacy. The results section did not discuss how patient treatment compliance affects the cost-effectiveness analysis results. If patients are unable to continue TM or PE, the efficacy may be greatly reduced, which will directly affect the economic conclusions of the study. 3. The statistical analysis section of the article is relatively simple, and it is recommended to further refine it. For example, adding descriptions of multivariate regression analysis or other multivariate analyses to explain the combined impact of different variables on the results. 4. Improve chart and data display, add more intuitive presentation methods, so that readers can easily understand the results of cost-benefit analysis. 5. The conclusion of the article points out that TM is more cost-effective than PE and HE in PTSD treatment, but due to the limitations of the study sample (only veterans), this conclusion may be difficult to extrapolate to other populations. Especially for non veterans, PTSD patients of different age groups and genders, they may have different responses to TM. It is suggested to point out that this conclusion is mainly applicable to the veteran population and call for further verification in other PTSD patient populations. Discuss how to optimize the mental health policies for veterans through this study, and how to promote TM as an effective treatment for PTSD. 6. The discussion section on the comparison between Transcendental Meditation (TM), Exposure Therapy (PE), and Health Education (HE) is more superficial and focuses more on the cost-effectiveness results. There is no in-depth analysis of the advantages and disadvantages of these therapies in terms of clinical improvement. Reviewer #2: This study aimed to examine the costs of Transcendental Meditation and incremental cost-effectiveness of Transcendental Meditation compared with a guideline-based therapy. The strength of this study was to conduct analysis using a rigorous method. However, there were some concerns in this study. First, in the Introduction, the authors had better cite the following Cochrane review and describe the article: “Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post‐traumatic stress disorder (PTSD) in adults. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD003388. DOI: 10.1002/14651858.CD003388.pub4.” Second, in the Materials and Methods, they had better cite Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement and adhere to the statement instead of the previous version of CHEERS statement. Reference Husereau, D., Drummond, M., Augustovski, F. et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMC Med 20, 23 (2022). https://doi.org/10.1186/s12916-021-02204-0 Third, they had better add CHEERS 2022 Checklist as a supplementary file. The statements in the paper corresponding to each item in this checklist can be added to https://don-husereau.shinyapps.io/CHEERS/ and this checklist can be downloaded. I have cited the explanation to use the checklist as follows: “Those using the checklist should indicate the section of the manuscript where relevant information can be found. We recommend using a section heading with a paragraph number since referring to line or page numbers becomes confusing as repagination or line number changes occur within or after the publication process. If an item does not apply to a particular economic evaluation (e.g., items 11-13 for cost analyses, or items 16 and 22 for non-modelling studies), then checklist users are encouraged to report “Not Applicable”. If information is otherwise not reported, checklist users are encouraged to write, “Not Reported”. Users should avoid the term “Not conducted” as CHEERS is intended to guide and capture reporting.” Fourth, they had better revise the manuscript, or add new limitations in the discussion if any important items in the CHEERS 2022 Checklist were not met. ****** 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: Yes: Masahiro Banno ******** [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.0316995.r001
Revision 1
17 Dec 2024 Author Response Reviewer #1: 1. Although the article explores the cost-effectiveness of TM, the introduction section fails to fully explain the potential impact and application value of this study in practical clinical settings. The lack of a more specific explanation of the importance of the research results in readers not having a deep understanding of the practical significance of the research. Thank you for this important suggestion. We have added a solid paragraph, with references, to the introduction (lines 80-90) to address this point and better frame the research question for the audience. 2. Lack of treatment compliance assessment: The article did not mention how to address patients' compliance issues during treatment, especially for treatment methods such as TM and PE that require continuous patient participation. Whether patients can fully follow the treatment plan for meditation or exposure therapy may significantly affect the efficacy. The results section did not discuss how patient treatment compliance affects the cost-effectiveness analysis results. If patients are unable to continue TM or PE, the efficacy may be greatly reduced, which will directly affect the economic conclusions of the study. We have added a few sentences (lines 308-313) to highlight this issue, and explain that treatment dropout rates may have contributed to difference in effectiveness and therefore, cost-effectiveness. However, compliance rates were previously reported in the main results paper of the RCT, and our analysis only focuses on cost-effectiveness. Thus, since those rates were not significantly different in the prior study, we did not want to overemphasize that point. 3. The statistical analysis section of the article is relatively simple, and it is recommended to further refine it. For example, adding descriptions of multivariate regression analysis or other multivariate analyses to explain the combined impact of different variables on the results. We have clarified that probabilistic sensitivity analysis is a multivariate analysis of the impact of all input parameters simultaneously (line 206). We have also added a paragraph towards the end of the discussion to better discuss possible influences of model inputs along with the overall conclusions (lines 346-358). We also appreciate the suggestion of an econometric approach. However, because the prior study did not collect healthcare cost data or QALY data from individual subjects, we were not able to reliably calculate individual cost-effectiveness estimates. Limiting our options for explanatory analyses. 4. Improve chart and data display, add more intuitive presentation methods, so that readers can easily understand the results of cost-benefit analysis. We agree that the data presentation may not have been clear to those less familiar with cost-effectiveness analyses because there were 3 intervention groups and 2 different measures of effectiveness (QALYs and rate of clinical improvement). Thus, we have edited Table 2 (lines 563-568) to provide more information, explain abbreviations, and highlight the most important findings in light blue. We have also rewritten the text (lines 244-263) describing these results to be clearer and to focus the attention on the highlighted section and its importance. Although we attempted, we did not find a better way to present these data in a single clear figure or display. 5. The conclusion of the article points out that TM is more cost-effective than PE and HE in PTSD treatment, but due to the limitations of the study sample (only veterans), this conclusion may be difficult to extrapolate to other populations. Especially for non-veterans, PTSD patients of different age groups and genders, they may have different responses to TM. It is suggested to point out that this conclusion is mainly applicable to the veteran population and call for further verification in other PTSD patient populations. Discuss how to optimize the mental health policies for veterans through this study, and how to promote TM as an effective treatment for PTSD. We agree with this suggestion, and we have expanded our limitations section (lines 371-378) as recommended. 6. The discussion section on the comparison between Transcendental Meditation (TM), Exposure Therapy (PE), and Health Education (HE) is more superficial and focuses more on the cost-effectiveness results. There is no in-depth analysis of the advantages and disadvantages of these therapies in terms of clinical improvement. Thank you. We have added two solid paragraphs (lines 346-368) towards the end of the discussion to better discuss possible influences of model inputs, along with the overall conclusions, and implications for clinical decision-making. Because, our paper is focused on health economics, an in-depth, comprehensive discussion of PTSD clinical decision-making seems beyond the current scope. Additionally, as we now better note in the limitations section, there remains just one full-scale RCT of TM for PTSD and this is thus the first cost-effectiveness analysis. Given these limitations, we think it is better to keep conclusions somewhat tentative and not speculate or over interpret results. That is why we kept the discussion more focused. Reviewer #2: This study aimed to examine the costs of Transcendental Meditation and incremental cost-effectiveness of Transcendental Meditation compared with a guideline-based therapy. The strength of this study was to conduct analysis using a rigorous method. However, there were some concerns in this study. First, in the Introduction, the authors had better cite the following Cochrane review and describe the article: “Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post‐traumatic stress disorder (PTSD) in adults. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD003388. DOI: 10.1002/14651858.CD003388.pub4.” Thank you for this suggestion. We agree this is an important review and we now cite this in the 2nd paragraph of the introduction (lines 60-64). Second, in the Materials and Methods, they had better cite Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement and adhere to the statement instead of the previous version of CHEERS statement. Reference Husereau, D., Drummond, M., Augustovski, F. et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMC Med 20, 23 (2022). https://doi.org/10.1186/s12916-021-02204-0. We have updated the manuscript (line 105). Thank you for catching this error. We had this reference on file and intended to cite the CHEERS 2022 standards. Third, they had better add CHEERS 2022 Checklist as a supplementary file. The statements in the paper corresponding to each item in this checklist can be added to https://don-husereau.shinyapps.io/CHEERS/ and this checklist can be downloaded. We have completed the CHEERS 2022 checklist and added this as a supplementary file. (S2 CHEERS checklist) Fourth, they had better revise the manuscript, or add new limitations in the discussion if any important items in the CHEERS 2022 Checklist were not met. All items were met except for 3-4 checklist items that were not applicable. These pertained only to subgroup analyses which were not performed, and to stakeholder input which was not obtained for this study. The funder had no input for the analysis. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0316995.r002
20 Dec 2024 Decision Letter - Ben Green, Editor Cost-effectiveness of Transcendental Meditation (TM) for treating Post-traumatic stress disorder (PTSD) PONE-D-24-32697R1 Dear Dr. Groessl, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Ben Green Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0316995.r003
Formally Accepted
15 Jan 2025 Acceptance Letter - Ben Green, Editor PONE-D-24-32697R1 PLOS ONE Dear Dr. Groessl, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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 Professor Ben Green Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0316995.r004

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