A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia

Bilal Chughtai; Sirikan Rojanasarot; Kurt Neeser; Dmitry Gultyaev; Shuai Fu; Samir K. Bhattacharyya; Ahmad M. El-Arabi; Ben J. Cutone; Kevin T. McVary

doi:10.1371/journal.pone.0266824

Peer Review History

Original SubmissionSeptember 24, 2021
11 Nov 2021 Decision Letter - Peter F.W.M. Rosier, Editor PONE-D-21-30773A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasiaPLOS ONE Dear Dr. Rojanasarot, 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. ============================== In your M&M you explain that you use the Rezum patient of ref 10 and the ‘model patient’. These patients had prostates 30-80gm and flowrates <15mL/s. I have two questions about that: can you describe this model patient including the objective parameters that I have mentioned to provide the reader with more clarity, but more important: I think that many of the studies that you referred to have also included persons with (much) smaller prostates. The minimum of 30g has a good reason (with TURP as the comparator) because we do know that (TURP)resection/‘desobstruction’ in patients with small volumes hardly improves flowrates. Can you speculate/or conclude or comment on how this has affected costs. Is lowering the threshold to surgery which may be a consequence related to this cost-effective? (and are interventions not relatively more prone to re-intervention when done for patients without BPH and or with (only) other dysfunctions than bladder outflow obstruction? Did you include (costs of) continued (LUT) medication in long term AE (not explicitly mentioned with ‘retreatment’ and or in the tables (these) mention a.e. symptoms but not treatment. This also brings me to your first sentence ‘Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)…’ the word ‘attributed to’ is not particularly cost saving (for all types of management including medication), or am I wrong? I ask you to consider commenting on this. Last: You extrapolated follow up in your model. Can you better explain in the main text P5L94-96 what you did? Please submit your revised manuscript by Dec 26 2021 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. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 3. Thank you for stating the following in the Competing Interests section: [B Chughtai is a paid clinical consultant for Boston Scientific, MedeonBio, Olympus, and Allergan as well as an investigator for Teleflex. S Rojanasarot, B Cutone, and S Bhattacharyya are employees at Boston Scientific. K Neeser, D Gultyaev, and S Fu are employees of Certara Evidence & Access, a consulting company that is paid by Boston Scientific for the services render. 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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. [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: 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: Minimal Invasive Techniques in benign prostatic hyperplasia increase the interest in these new procedures. Congratulation to the authors to focus on the expenses of these new techniques and the quality of life of the patients. Reviewer #2: Well conducted comprehensive analysis. Highlights key differences between various mist procedures in accurate and technically sound fashion. Accounts for upfront and retreatment costs. It would be interesting to make note if claims data varies significantly from pivots trial data ****** 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". 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Revision 1
23 Nov 2021 Author Response Reviewers’ Comments In your M&M you explain that you use the Rezum patient of ref 10 and the ‘model patient’. These patients had prostates 30-80gm and flowrates <15mL/s. I have two questions about that: • Can you describe this model patient including the objective parameters that I have mentioned to provide the reader with more clarity, but more important: I think that many of the studies that you referred to have also included persons with (much) smaller prostates. The minimum of 30g has a good reason (with TURP as the comparator) because we do know that (TURP)resection/‘desobstruction’ in patients with small volumes hardly improves flowrates. Response: Thank you very much for the great clinical insight. In our systematic review and meta-analysis, we used the inclusion criteria of men with prostate volumes ≤80 cm3. The criteria are documented on page 7 of the manuscript. From the systematic review, we found that the baseline mean prostate volumes ranged from 33.1 cm3 to 80.0 cm3 while baseline peak flow rates ranged from 4.5 mL/s to 9.9 mL/s. To clarify this point, we included the following statement in the result section of the manuscript on page 14 “The baseline prostate volumes of patients in the 20 included publications ranged from 33.1 cm3 to 80.0 cm3 while their baseline peak flow rates ranged from 4.5 mL/s to 9.9 mL/s.” • Can you speculate/or conclude or comment on how this has affected costs. Is lowering the threshold to surgery which may be a consequence related to this cost-effective? (and are interventions not relatively more prone to re-intervention when done for patients without BPH and or with (only) other dysfunctions than bladder outflow obstruction? Response: This is a really good observation. The retreatment rates are one of the key components that drive the total treatment costs. If lowering the threshold to surgery reduces the retreatment rates, changing the criteria for surgery would have an impact on the cost-effectiveness results. For BPH management, clinical guidelines including the 2021 American Urological Association (AUA) Guideline for BPH1 and the indication for use of treatment options include specific prostate volume details. The prostate volume details determine available treatment options for men with BPH. Therefore, lowering the threshold to surgery may not adhere to recommended clinical guidelines. • Did you include (costs of) continued (LUT) medication in long term AE (not explicitly mentioned with ‘retreatment’ and or in the tables (these) mention a.e. symptoms but not treatment. Response: For men who had recurring LUTS due to BPH symptoms post-MIST or surgical procedures, they could receive BPH medical therapy of generic tamsulosin 40 mg once daily long term. We have previously included the information in Table 1 on page 10. To better clarify this point in the manuscript, we have updated the following statement in the clinical input section of the manuscript on page 8 “Patients who experienced failed MIST or surgical procedures could either receive medical therapy of generic tamsulosin 40 mg once daily to manage their recurring symptoms, undergo the same treatment again, or undergo more invasive surgical procedures.” This also brings me to your first sentence ‘Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)…’ the word ‘attributed to’ is not particularly cost saving (for all types of management including medication), or am I wrong? I ask you to consider commenting on this. Response: “Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia” is a common term used in the Urology field to describe the bothersome symptoms from an enlarged prostate gland. The same term is used in the AUA Guideline for the management of benign prostatic hyperplasia/ lower urinary tract symptoms.1 In this cost-effectiveness analysis context, only men with moderate-to-severe LUTS were considered given that if the conditions are not treated, the quality of life of these men would be negatively impacted. Men with anatomic enlargement of the prostate but without LUTS are not included as their first disease management is not a treatment but watchful waiting. Last: You extrapolated follow up in your model. Can you better explain in the main text P5L94-96 what you did? Response: Thank you for this comment. To clarify this point in the manuscript, we included the following statement in the clinical inputs section of the manuscript on page 8 “Since some AE rates were not available in the literature (S2 Table), we extrapolated the rates from 2 years to 5 years by applying the change of the AE rates between the second-last and last available quarter to subsequent cycles until the AE rates became 0%.” Reference: 1. Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline part II, surgical evaluation and treatment. J Urol 2021; 206: 818. Attachments Attachment Submitted filename: Rezum US CEA manuscript - Response to reviewers Final.docx https://doi.org/10.1371/journal.pone.0266824.r002
18 Jan 2022 Decision Letter - Peter F.W.M. Rosier, Editor PONE-D-21-30773R1A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasiaPLOS ONE Dear Dr. Rojanasarot, 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: Few small comments to answer and or include in the manuscript. ============================== Please submit your revised manuscript by Mar 04 2022 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Peter F.W.M. Rosier, M.D. PhD Academic Editor PLOS ONE 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. Additional Editor Comments (if provided): Thank you for your revision and answers to the question. You have however not explained why ref 39 contradict your statement regarding prostate sizes. You have added 'tamulosin 40mg (which should be tamsilosin 40μg) but in fact patients receive 'CT' again (that should also include antimuscarinics). This should be included (likely with more than just one 'office visit' in 5y) unless you have good arguments not to include this in the calculations. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: 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 #1: Yes Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 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: (No Response) Reviewer #2: Well performed analysis of key metrics to consider in BPH therapy. Further comments on the applicability of this research to other parts of the world would be good to see. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [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.0266824.r003
Revision 2
15 Feb 2022 Author Response Dear Dr Rosier, Many thanks again for your consideration of this manuscript. I have prepared a response to reviewers document that include my answers to all questions and comments. Please let me know if you have additional questions. Best regards, Sirikan Rojanasarot Attachments Attachment Submitted filename: US CEA manuscript - Response to reviewers_Revision2_Final.docx https://doi.org/10.1371/journal.pone.0266824.r004
3 Mar 2022 Decision Letter - Peter F.W.M. Rosier, Editor PONE-D-21-30773R2A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasiaPLOS ONE Dear Dr. Rojanasarot, 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: I am very sorry but you still have not corrected the dosage of tamsilosin. Please connect with your co-authors! Please submit your revised manuscript by Apr 17 2022 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Peter F.W.M. Rosier, M.D. PhD Academic Editor PLOS ONE 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. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: [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.0266824.r005
Revision 3
11 Mar 2022 Author Response Dear Dr. Rosier: Many thanks again for your suggestions and expertise. I have corrected the dosage of tamsulosin from 40 mg to 400 μg once daily. The co-authors and I cross-checked the dose and confirmed that 400 μg is the dose used in the US. We are really grateful for the opportunity to submit our research to PLOS ONE and thank you for your consideration. Sincerely, Siri Attachments Attachment Submitted filename: US CEA manuscript - Response to reviewers_Revision4.docx https://doi.org/10.1371/journal.pone.0266824.r006
29 Mar 2022 Decision Letter - Peter F.W.M. Rosier, Editor A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia PONE-D-21-30773R3 Dear Dr. Rojanasarot, 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, Peter F.W.M. Rosier, M.D. PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0266824.r007
Formally Accepted
8 Apr 2022 Acceptance Letter - Peter F.W.M. Rosier, Editor PONE-D-21-30773R3 A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia Dear Dr. Rojanasarot: 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. Peter F.W.M. Rosier Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0266824.r008

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