Health-state utility of patients with HER2-positive breast cancer in Vietnam: A multicenter cross-sectional study

Tram Nguyen Nguyet Luu; Dai Xuan Dinh; Thinh Xuan Tran; Thang Binh Tran; Huong Thanh Tran; Kiet Huy Tuan Pham; Huong Thi Thanh Nguyen

doi:10.1371/journal.pone.0303011

Peer Review History

Original SubmissionDecember 15, 2023
13 Mar 2024 Decision Letter - Ravishankar Jayadevappa, Editor PONE-D-23-42055Health-state utility of patients with HER2-positive breast cancer in Vietnam: a multicenter cross-sectional studyPLOS ONE Dear Dr. Dinh, 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 Apr 27 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. 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, Ravishankar Jayadevappa Academic Editor PLOS ONE Journal Requirements: 1. When submitting your revision, we need you to address these additional requirements. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. In the online submission form, you indicated that The dataset underpinning findings in this manuscript contain potentially identifying and sensitive patient information. However, the datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. All PLOS journals now require all data underlying the findings described in their manuscript to be freely available to other researchers, either a. In a public repository, b. Within the manuscript itself, or c. Uploaded as supplementary information. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If your data cannot be made publicly available for ethical or legal reasons (e.g., public availability would compromise patient privacy), please explain your reasons on resubmission and your exemption request will be escalated for approval. Additional Editor Comments: Authors are embarked on an important study in the area of utility and cost-effectiveness of breast cancer treatment. The articles require careful revision in terms of editing and proof reading. Also, some statements are unsupported, appropriate references should be used. [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: No ****** 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: No Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The findings of this study based on breast cancer patients in Viet Nam can add value as the literature suggests that there are differences in health-related quality of life of the patients across countries. However, some revisions and clarifications would benefit the paper. Some of suggestions are listed as follows. Abstract-Objective Please add a little background for conducting this study. Introduction Lines 72-73, “ The number of studies … is negligible.” This statement seems to indicate there are existing studies. If that is the case, please cite some references and explain why there is a need for this current study based on the shortcomings of the previous studies. Methods Lines 95-96, do standard hospital beds differ from inpatient beds? Please explain the difference as succinctly as possible. Also the authors may want to leave out the detail. Lines 109-111, please rewrite the sentence, which has grammatical and punctuation errors. Acronyms come after, not before, their full terms. However, the authors switched the order. For example, it should be the Depression Anxiety Stress Scale (DASS-10), not the other way around. In lines 121-122, do the authors mean to include both personal and household income? This seems unnecessary and problematic. However, the results section seems to indicate that only the personal income was entered into the regression model. Please clarify. Line 135, in “… use in national health technology guidelines,” please be more specific which nation recommends using EQ-5D-5L. This statement can be misinterpreted as Vietnamese government’s guidelines. The top line of Table 2 is mislabeled. It should not be “demographic characteristics.” In Table 3 and in line 250, there should be mobility instead of morbidity. In general, this manuscript would benefit from thorough spell and grammatical checks. Discussion Lines 245-253, please try to explain potential reasons for similarities between Viet Nam and Brazil/China and for differences between Viet Nam and the U.K/U.S. Lines 270-272 seems to hint a rationale for conducting this present study which relied on patients on pharmacological treatment only whereas the 2019 study derived utility scores from Vietnamese patients who underwent surgery as well. This point could have been used to reinforce the need for the current study in the introduction section. Reviewer #2: This is a sound piece of scientific research highlighting population characteristics of HER2 positive breast cancer patients in Vietnam. The authors do not make their data available due to potentially identifiable information, which is reasonable in the context of this manuscript. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: PONE-D-23-42055.pdf https://doi.org/10.1371/journal.pone.0303011.r001
Revision 1
22 Mar 2024 Author Response First and foremost, we want to express our deep gratitude to the editors and reviewers who gave us valuable and practical advice. We carefully read your comments and revised our manuscript. Our responses are written in blue color. Thank you so much for your assistance. .......................................................................................................................... REVIEWER REPORTS Reviewer #1: The findings of this study based on breast cancer patients in Viet Nam can add value as the literature suggests that there are differences in health-related quality of life of the patients across countries. However, some revisions and clarifications would benefit the paper. Some of suggestions are listed as follows. Abstract-Objective Please add a little background for conducting this study. We added some information about reasons for conducting our study in the Abstract. Introduction Lines 72-73, “ The number of studies … is negligible.” This statement seems to indicate there are existing studies. If that is the case, please cite some references and explain why there is a need for this current study based on the shortcomings of the previous studies. We cited two previous studies about HER2-positive breast cancer patients in the UK and Brazil. Methods Lines 95-96, do standard hospital beds differ from inpatient beds? Please explain the difference as succinctly as possible. Also the authors may want to leave out the detail. We revised this issue. They are similar. We used a general term (hospital bed) for these data. Lines 109-111, please rewrite the sentence, which has grammatical and punctuation errors. We revised this sentence. Acronyms come after, not before, their full terms. However, the authors switched the order. For example, it should be the Depression Anxiety Stress Scale (DASS-10), not the other way around. We revised this issue. In lines 121-122, do the authors mean to include both personal and household income? This seems unnecessary and problematic. However, the results section seems to indicate that only the personal income was entered into the regression model. Please clarify. We removed the variable “household monthly income” in the whole manuscript. We collected data on both patient and household monthly income. Sadly, there were many missing values about household monthly income (51 out of 301 participants). Numerous missing values can lower the quality of regression models. As a consequence, we removed this variable. Line 135, in “… use in national health technology guidelines,” please be more specific which nation recommends using EQ-5D-5L. This statement can be misinterpreted as Vietnamese government’s guidelines. We revised this issue. In the article cited, “Thirty-four pharmacoeconomic guidelines were included for review. Multi-attribute utility instruments named for use in cost-utility analysis: EQ-5D (n = 29 guidelines), the SF-6D (n = 11), HUI (n = 10), QWB (n = 3), AQoL (n = 2), CHU9D (n = 1). EQ-5D was a preferred multi-attribute utility instrument in 15 guidelines.” Kennedy-Martin M, Slaap B, Herdman M, van Reenen M, Kennedy-Martin T, Greiner W, et al. Which multi-attribute utility instruments are recommended for use in cost-utility analysis? A review of national health technology assessment (HTA) guidelines. Eur J Health Econ. 2020;21(8):1245-1257. doi: 10.1007/s10198-020-01195-8. The top line of Table 2 is mislabeled. It should not be “demographic characteristics.” In Table 3 and in line 250, there should be mobility instead of morbidity. In general, this manuscript would benefit from thorough spell and grammatical checks. We corrected these mistakes. We endeavoured to check linguistic issues. Thank you for this helpful comment. Discussion Lines 245-253, please try to explain potential reasons for similarities between Viet Nam and Brazil/China and for differences between Viet Nam and the U.K/U.S. We added some reasons for these points. Lines 270-272 seems to hint a rationale for conducting this present study which relied on patients on pharmacological treatment only whereas the 2019 study derived utility scores from Vietnamese patients who underwent surgery as well. This point could have been used to reinforce the need for the current study in the introduction section. Thank you for this helpful comment. If there is anything inappropriate or inadequate, please let us know. Thank you so much for your valuable comments. Best regards. Reviewer #2: This is a sound piece of scientific research highlighting population characteristics of HER2 positive breast cancer patients in Vietnam. The authors do not make their data available due to potentially identifiable information, which is reasonable in the context of this manuscript. The data file is included in the Supporting Information files. We removed the names of patients and shared de-identified or anonymized data to make a small contribution to the scientific integrity. Abstract: Conclusions are too broad, please revise this to directly reflect the study results We revised the Conclusion in the Abstract. Lines 47 – 49: Insert reference We revised this issue. Lines 47 – 53: newer data? Data in 2022 were added. Line 111 – 114: time during which of data collection occurred for individual patient should be reported, (pre-treatment or post-treatment). We added some information about the time during which of data collection occurred. If there is anything inappropriate or inadequate, please let us know. Thank you so much for your valuable comments. Best regards. Attachments Attachment Submitted filename: Response to Reviewers.pdf https://doi.org/10.1371/journal.pone.0303011.r002
10 Apr 2024 Decision Letter - Ravishankar Jayadevappa, Editor PONE-D-23-42055R1Health-state utility of patients with HER2-positive breast cancer in Vietnam: a multicenter cross-sectional studyPLOS ONE Dear Dr. Dinh, 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. Also, please use professional editing services. Please submit your revised manuscript by May 25 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. 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, Ravishankar Jayadevappa 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: 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 #3: 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 #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #3: 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 #3: 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 #3: No ****** 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: Congrats on successful revisions. P in p values should be italicized Check the spelling -> immunohistochemistry Reviewer #3: The authors have done a reasonable job of responding to the earlier comments. However, this reviewer has one important comment i.e, lack of adjustment for time since diagnosis. The physical and mental health can vary substantially based on how long ago the patients were diagnosed with breast cancer (prior to their study enrollment and interview). It is recommended that the authors obtain this information and incorporate it into all their analysis. ****** 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 #3: 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.0303011.r003
Revision 2
15 Apr 2024 Author Response First and foremost, we want to express our deep gratitude to the editors and reviewers who gave us valuable and practical advice. We carefully read your comments and revised our manuscript. Our responses are written in blue color. Thank you so much for your assistance. .......................................................................................................................... REVIEWER REPORTS Reviewer #1: Congrats on successful revisions. P in p values should be italicized Check the spelling -> immunohistochemistry We revised these issues. Reviewer #3: The authors have done a reasonable job of responding to the earlier comments. However, this reviewer has one important comment i.e, lack of adjustment for time since diagnosis. The physical and mental health can vary substantially based on how long ago the patients were diagnosed with breast cancer (prior to their study enrollment and interview). It is recommended that the authors obtain this information and incorporate it into all their analysis. Regarding the time since the first diagnosis, we did collect data on this variable last year. However, when we analyzed the data, the association between patients’ utility and their time since the first diagnosis was insignificant (p-value>0.05). Therefore, when we drafted the initial manuscript, we did not report this variable. As per the comment of Reviewer 3, we added several results involving this variable to the revised manuscript. It is noted that although in Table 4, there was a significant difference among the utility scores of patient groups (this variable was divided into four groups – a categorical variable). However, in the univariate linear regression model, when it is a numeric variable, the p-value is higher than 0.05 (coef=-0.001, p=0.059). As we can see from the results in Table 5, other variables, such as the stage of cancer/metastatic status, may have a stronger association with patients’ utility than the time since the first diagnosis of breast cancer. It is perfectly understandable. For example, the time since the first diagnosis of breast cancer of a patient is three months. However, this diagnosis is late and this person is a metastatic patient. If there is anything inappropriate or inadequate, please let us know. Thank you so much for your valuable comments. Best regards. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0303011.r004
18 Apr 2024 Decision Letter - Ravishankar Jayadevappa, Editor Health-state utility of patients with HER2-positive breast cancer in Vietnam: a multicenter cross-sectional study PONE-D-23-42055R2 Dear Mr. Dai Xuan Dinh, 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, Ravishankar Jayadevappa, PhD, MS Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0303011.r005

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