Prevalence of erectile dysfunction in Thai scleroderma patients and associated factors

Wichien Sirithanaphol; Ajanee Mahakkanukrauh; Ratanavadee Nanagara; Chingching Foocharoen

doi:10.1371/journal.pone.0279087

Peer Review History

Original SubmissionNovember 13, 2021
8 Aug 2022 Decision Letter - Luca Navarini, Editor PONE-D-21-36106Prevalence of erectile dysfunction in Thai scleroderma patients and associated factorsPLOS ONE Dear Dr. Foocharoen, 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 Sep 22 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. 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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 Acknowledgments Section of your manuscript: "The authors thank (a) the Research and Graduate Studies, the Scleroderma Research Group and the Faculty of Medicine, Khon Kaen University, for their support, and (b) Mr. Bryan Roderick Hamman for assistance with the English-language presentation under the aegis of the Publication Clinic Khon Kaen University, Thailand." 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If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.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: Partly ******** 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: This is an interesting and well written study on “Prevalence of erectile dysfunction in Thai scleroderma patients and associated factors”. The authors suggest for the first time to study abnormal urological disease like phimosis, etc. My minor points are: Line 196, “A previous study 196 revealed the association between ED and disease severity in terms of extensive skin tightness 197 evaluated by mRSS, having restrictive lung function, high pulmonary arterial pressure, and renal or muscle involvement.” What is the renal involmente? Was renal scleroderma crisis relate to ED? Loine 214: “The findings represent the role of vasculopathy for ED development in SSc” Please add tehe reference Rosato et al and discuss the role of endothelium dysfunction with microvascular damage in SSc patients with ED. (Rosato E, Barbano B, Gigante A, Aversa A, Cianci R, Molinaro I, Quarta S, Pisarri S, Afeltra A, Salsano F. Erectile dysfunction, endothelium dysfunction, and microvascular damage in patients with systemic sclerosis. J Sex Med. 2013 May;10(5):1380-8. doi: 10.1111/jsm.12110. Epub 2013 Feb 27. PMID: 23444914.) Reviewer #2: The authors presented a well detailed and thorough assessment of sexual disfunction in male patients affected by Systemic Sclerosis, the quality of the study and the combined urological assessment make it very good sound. However, there are some points that may be implemented to make the paper even better in my opinion: I'm following the line orders of the downloaded reviewer version 101. evaluated should be changed into "were evaluated for" (maybe just a typo) 120. I would suggest a more scientific term for "tip of the penis" 126. "Univariable analysis": I would suggest to name one by one the statistical tests that were used 126. "Odds ratio": odds ratios for continuous predictors were extimated with a one-predictor logistic regression, exponentiating the coefficient on the predictor and its confidence bounds, and then reporting this as the odds ratio and its 95% confidence interval? I feel this part overall could be more detailed 162-164: I think that this particular data is redundant and suffers from multicollinearity, I would note it down straight afterwards or in the limitations of the study 223-224: the concept about phimosis: How was the skin thightness score in patients with phimosis? Since you said in the results that the skin score for the genitalia in all patients was zero, this assumption might be too arbitrary. Lastly I would cite: J Scleroderma Relat Disord. 2019 Feb;4(1):71-76. doi: 10.1177/2397198318776593. ****** 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. https://doi.org/10.1371/journal.pone.0279087.r001
Revision 1
11 Aug 2022 Author Response Dear Dr.Luca Navarini, Academic Editor PLOS ONE RE: PONE-D-21-36106 Title: Prevalence of erectile dysfunction in Thai scleroderma patients and associated factors Thank you very much for your letter dated June 15, 2022, including the reviewers’ comments. We are grateful for the opportunity to improve our original manuscript, and for your consideration of this revised version. We have made changes to the original manuscript, addressing the reviewers’ concerns. The changes are listed below. We believe that the changes suggested by the reviewers strengthen the study, making for a greater impact on the field of scleroderma. Thank you very much for your consideration of this updated version. Sincerely, Chingching Foocharoen, MD (on behalf of all the authors) 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: This is an interesting and well written study on “Prevalence of erectile dysfunction in Thai scleroderma patients and associated factors”. The authors suggest for the first time to study abnormal urological disease like phimosis, etc. My minor points are: Line 196, “A previous study 196 revealed the association between ED and disease severity in terms of extensive skin tightness 197 evaluated by mRSS, having restrictive lung function, high pulmonary arterial pressure, and renal or muscle involvement.” What is the renal involvement? Was renal scleroderma crisis related to ED? Response: Yes, renal involvement was renal crisis. We revised the sentence to make it clearer. The severity of SSc disease is associated with the risk of developing ED. A previous study revealed the association between ED and disease severity in terms of extensive skin tightness evaluated by mRSS, and having restrictive lung function, high pulmonary arterial pressure, and renal crisis or muscle involvement.4 Line 214: “The findings represent the role of vasculopathy for ED development in SSc” Please add the reference Rosato et al and discuss the role of endothelium dysfunction with microvascular damage in SSc patients with ED. (Rosato E, Barbano B, Gigante A, Aversa A, Cianci R, Molinaro I, Quarta S, Pisarri S, Afeltra A, Salsano F. Erectile dysfunction, endothelium dysfunction, and microvascular damage in patients with systemic sclerosis. J Sex Med. 2013 May;10(5):1380-8. doi: 10.1111/jsm.12110. Epub 2013 Feb 27. PMID: 23444914.) Response: Thank you for the suggestion. We reviewed the article and cited the article in the text as below. Rosato et al. found a positive correlation between the IIEF-5 score and digital sphygmic waves and skin perfusion evaluated using digital photoplethysmography. The authors also found an association between the IIEF-5 score and laser Doppler perfusion imaging of the skin and the digits.22 In addition, female sexual dysfunction was reported, and there was a negative correlation between the Doppler indices of the clitoral artery and the Female Sexual Function Index score.23 The findings exemplify the role of vasculopathy for ED development in male and female sexual dysfunction in SSc. ________________________________________ Reviewer #2: The authors presented a well detailed and thorough assessment of sexual disfunction in male patients affected by Systemic Sclerosis, the quality of the study and the combined urological assessment make it very good sound. However, there are some points that may be implemented to make the paper even better in my opinion: I'm following the line orders of the downloaded reviewer version 101. evaluated should be changed into "were evaluated for" (maybe just a typo) Response: The term has been changed according to the suggestion. 120. I would suggest a more scientific term for "tip of the penis" Response: Thank you for the suggestion. The term has been changed to “glans of penis” 126. "Univariable analysis": I would suggest to name one by one the statistical tests that were used Response: Thank you for the suggestion. The term has been changed to one used in statistical tests. 126. "Odds ratio": odds ratios for continuous predictors were estimated with a one-predictor logistic regression, exponentiating the coefficient on the predictor and its confidence bounds, and then reporting this as the odds ratio and its 95% confidence interval? Response: Yes, the odds ratio, used for continuous data, was calculated by exponentiation of the coefficient from logistic regression. I feel this part overall could be more detailed 162-164: I think that this particular data is redundant and suffers from multicollinearity, I would note it down straight afterwards or in the limitations of the study Response: We appreciate the comment. The multicollinearity was not investigated, so we added the statement in limitations of the study as below. Our study has some limitations: a) we had no control to make a comparison of the prevalence between the general population and SSc patients; b) the study was conducted at a single centre, so the results might not be generalizable; c) there were some missing data such as the WHO functional class; d) there was a small number of patients with no ED that might have resulted in a low power of analysis; and, e) multicollinearity of the data was not investigated. 223-224: the concept about phimosis: How was the skin thightness score in patients with phimosis? Since you said in the results that the skin score for the genitalia in all patients was zero, this assumption might be too arbitrary. Response: Thank you for the comments. Phimosis is tightness of the foreskin of the penis, making the skin unable to be pulled back or retracted. The foreskin in phimosis is not thickness like the skin thickness as in SSc. In addition, skin in the other areas of genitalia (penis and scrotum) were normal, so the skin score of the genitalia were all evaluated with a score of zero, according to the method of mRSS assessment. Lastly I would cite: J Scleroderma Relat Disord. 2019 Feb;4(1):71-76. doi: 10.1177/2397198318776593. Response: Thank you for the suggestion. We reviewed the article and cited the article in the text as below. The cause and pathogenesis of ED in SSc remain unclear. Several etiologies contribute to the development of ED, including age, medications, neurogenic, psychogenic, and vasculogenic causes.2,15–17 The hypothesis of the combination of fibrosis and vasculopathy in SSc have been thoroughly studied.18–20 One study of SSc revealed diminishing systolic and diastolic blood flow velocities (evaluated by duplex ultrasound) in the penile arteries,19 and another study compared to normal controls found reduced temperature (as assessed by thermal imaging) of the penis with ED.20 Rosato et al. found a positive correlation between the IIEF-5 score and digital sphygmic waves and skin perfusion evaluated using digital photoplethysmography. The authors also found an association between the IIEF-5 score and laser Doppler perfusion imaging of the skin and the digits.22 In addition, female sexual dysfunction was reported, and there was a negative correlation between the Doppler indices of the clitoral artery and the Female Sexual Function Index score.23 The findings exemplify the role of vasculopathy for ED development in male and female sexual dysfunction in SSc. Tissue fibrosis was a possible pathogenesis of ED in SSc. Nehra et al. found corporal fibrosis in penile tissues obtained during penile prosthesis insertion.18 Sex hormone and neurological were thought to be possible roles of ED in SSc, but current data do not support the hypothesis.19,23 To date, the cause of ED in SSc has yet to be defined. Attachments Attachment Submitted filename: response letter to reviewers_11-8-22.docx https://doi.org/10.1371/journal.pone.0279087.r002
1 Dec 2022 Decision Letter - Yuan-Ti Lee, Editor PONE-D-21-36106R1 Prevalence of Erectile Dysfunction in Thai Scleroderma Patients and Associated Factors PLOS ONE Dear Dr. Foocharoen, 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 Sep 22 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, Luca Navarini 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.0279087.r003
Formally Accepted
9 Jan 2023 Acceptance Letter - Yuan-Ti Lee, Editor PONE-D-21-36106R1 Prevalence of Erectile Dysfunction in Thai Scleroderma Patients and Associated Factors Dear Dr. Foocharoen: 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. Yuan-Ti Lee Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0279087.r004

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