The Effect of Surgeon Volume on the Outcome of Laser Vaporization: A Single-Center Retrospective Study
, Misooja Lee 2, Seiji Mabuchi 1 and Shoji Kamiura 1,*Round 1
Reviewer 1 Report
In their manuscript, the authors analyze the effect of surgeon volume on laser treatment for cervical intraepithelial neoplasia (CIN). Primary outcome measures included persistence or recurrence of CIN2 lesions (histologically confirmed) or more severe disease after laser vaporization. In the univariate and multivariate analyses of possible predictive factors surgeon volume was not significantly correlated to unsuccess.
The manuscript is written smoothly and it is interesting.
Some improvement is needed.
High- and low-volume has been chosen not on the literature review but from the median treatment of the surgeons included in the study. Moreover, the authors analyze all patients treated in a high-volume center so it could be a bias.
How do you explain the better result of 14% of relapse vs 30% of the literature?
Author Response
Reviewer #1 comments
In their manuscript, the authors analyze the effect of surgeon volume on laser treatment for cervical intraepithelial neoplasia (CIN). Primary outcome measures included persistence or recurrence of CIN2 lesions (histologically confirmed) or more severe disease after laser vaporization. In the univariate and multivariate analyses of possible predictive factors surgeon volume was not significantly correlated to unsuccess.
The manuscript is written smoothly and it is interesting.
Some improvement is needed.
Reply:
We appreciate the kind evaluation of our manuscript by the Reviewer. We have revised the manuscript carefully according to the Reviewer’s comments. We believe the revised manuscript now addresses the Reviewer’s concerns.
Reviewer #1, Comment 1
High- and low-volume has been chosen not on the literature review but from the median treatment of the surgeons included in the study. Moreover, the authors analyze all patients treated in a high-volume center so it could be a bias.
Reply:
We thank the reviewer for the insightful comments. We have incorporated the information on line 113 of the revised manuscript. In the previous studies which examined the association between surgeon’s volume and surgical outcomes, the definition of high-volume surgeon varied among each study [1]. According to the reviewer’s suggestion, we have cited the previous studies that divided high- and low-surgeon volume according to the median number of treatments that were performed [2]. As the reviewer pointed out, in our study, all surgeons belong to high-volume centers, which is a severe limitation of this study; thus, we have emphasized this point in the limitation section (Lines 290–296 of the revised manuscript).
Reviewer #1, Comment 2
How do you explain the better result of 14% of relapse vs 30% of the literature?
Reply: We thank the reviewer for the helpful comment. We have incorporated this information on line 46 and lines 283-285 of the revised manuscript. We have reviewed the previous studies again and found that the treatment failure rate was approximately 10–20% in the previous studies. We have revised the rate of treatment failure and have added the fact that the treatment failure rate in this study was consistent with previous studies.
There has been substantial modification to the paper in line with the reviewers’ suggestions, and I hope that the paper will benefit from these revisions. Once again, we thank you for the time you put in reviewing our paper and look forward to meeting your expectations.
References
- Mowat A, Maher C, Ballard E. Surgical outcomes for low-volume vs high-volume surgeons in gynecology surgery: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016;215:21-33.
- Drukker L, Hants Y, Farkash R, Grisaru-Granovsky S, Shen O, Samueloff A, Sela HY. Impact of surgeon annual volume on short-term maternal outcome in cesarean delivery. Am J Obstet Gynecol. 2016;215:85 e1-8.
Author Response File: 
Author Response.pdf
Reviewer 2 Report
Dear author’s
I was pleased to review your manuscript “The effect of surgeon volume on the outcome of laser vaporization: a single-center retrospective study“ The topic is interesting but does not brings new information.
However, the manuscript should be further improved. In order to improve the manuscript a have the following comments.
The aim of this study is not very clear. Please indicate this in the introduction section.
Methodology: Please clearly define your study groups. The study contains a control group?
I don't know if I understand. There are patients with CIN III treated using vaporisation? If yes please explain if this procedure is sufficient in lesion CIN II+.
Discussion - in this section is mandatory to compare your case with the literature.
What new information brings your article in the literature?
Please avoid self citation.
Please specify the limitations of your study.
Author Response
Reviewer #2 comments
Dear author’s
I was pleased to review your manuscript “The effect of surgeon volume on the outcome of laser vaporization: a single-center retrospective study“ The topic is interesting but does not brings new information.
However, the manuscript should be further improved. In order to improve the manuscript a have the following comments.
Reply:
We appreciate these useful comments from the Reviewer. We have revised the manuscript carefully according to the Reviewer’s comments. We believe the revised manuscript now addresses the Reviewer’s concerns.
Reviewer #2, Comment 1
The aim of this study is not very clear. Please indicate this in the introduction section.
Reply: We appreciate the reviewer’s helpful comments. To revise the manuscript per the reviewer’s suggestion following sentences have been added to specify our research hypothesis and aims for this study (lines 53–61 of the revised manuscript).
“As laser vaporization is not widely performed owing to the cost of its equipment, we believe that the examination of the effect of surgeon volume on the treatment outcome of laser vaporization may be useful. We believe that the clinical outcomes of patients undergoing laser vaporization may be favorable if they are operated by high-volume surgeons in comparison to low-volume surgeons. We hypothesized that if surgeon volume is associated with the success rate of laser vaporization, some surgical techniques such as ablation depth may affect the success rate [1]. On the contrary, if no significant relationship exists, laser vaporization for CIN may be feasible to be performed by most surgeons.”
Reviewer #2, Comment 2
Methodology: Please clearly define your study groups. The study contains a control group?
Reply: We have included the study groups on lines 121–128 of the revised manuscript,
The reviewer’s comments are helpful to improve the manuscript. In this study, there was no control group. To clearly define the study groups, we have added the description regarding the study groups. The following were the groupings performed for the purpose of this study:
(i) women with recurrence versus without recurrence; and
(ii) women treated by high-volume surgeons versus women treated by low-volume surgeons
Reviewer #2, Comment 3
I don't know if I understand. There are patients with CIN III treated using vaporisation? If yes please explain if this procedure is sufficient in lesion CIN II+.
Reply:
We thank the reviewer for this valid query. We have clarified that women with CIN3 were excluded from this study (Line 78 of the revised manuscript).
Reviewer #2, Comment 4
Discussion - in this section is mandatory to compare your case with the literature.
Reply: We appreciate the insightful comment. As no studies have examined the relationship between surgeon’s volume and the outcome of laser vaporization for CIN, we were unable to offer comparisons to our present study. However, we have added the description regarding the comparison of treatment failure rates with those of previous studies (lines 283-285 of the revised manuscript).
Reviewer #2, Comment 5
What new information brings your article in the literature?
Reply: Please also refer the comment for reply to Reviewer #3, comment 5.
We have incorporated some information in the Discussion to cite previous studies existing on the topic and to discuss future study perspectives as follows (Lines 256–261 of the revised manuscript).
“Given the limited number of laser vaporizations performed due to the high cost of equipment, a negative relationship between surgeon’s volume and the treatment outcome may be helpful to perform laser vaporization for CIN in general hospital [2]. On the contrary, minimum volume requirement of laser vaporization for CIN is still unclear; thus, further studies are warranted to identify the minimum volume standards for performing laser vaporization in cases of CIN [3,4].”
Reviewer #2, Comment 6
Please avoid self citation.
Reply: Line 244
We thank the reviewer for the suggestion. Per the reviewer’s suggestion, we have deleted the self-citations.
Reviewer #2, Comment 7
Please specify the limitations of your study.
Reply:
According to the reviewer’s comments, we have now incorporated six major limitations of this study on lines 267–312 of the revised manuscript.
There has been substantial modification to the paper in line with the reviewers’ suggestions, and I hope that the paper will benefit from these revisions. Once again, we thank you for the time you put in reviewing our paper and look forward to meeting your expectations.
References
- Yoon BS, Seong SJ, Song T, Kim ML, Kim MK. Risk factors for treatment failure of CO2 laser vaporization in cervical intraepithelial neoplasia 2. Arch Gynecol Obstet. 2014;290:115-9.
- DeMott RK. Laser vs cryotherapy for CIN and a LEEP of faith. JAMA. 1993;269:46.
- Ruiz MP, Chen L, Hou JY, Tergas AI, St Clair CM, Ananth CV, Neugut AI, Hershman DL, Wright JD. Effect of Minimum-Volume Standards on Patient Outcomes and Surgical Practice Patterns for Hysterectomy. Obstet Gynecol. 2018;132:1229-37.
- Wright JD. The Volume-Outcome Paradigm for Gynecologic Surgery: Clinical and Policy Implications. Clin Obstet Gynecol. 2020;63:252-65.
Author Response File: Author Response.pdf
Reviewer 3 Report
I read with great interest the Manuscript titled “The effect of surgeon volume on the outcome of laser 2 vaporization: a single-center retrospective study”, which falls within the aim of the Journal.
In my honest opinion, the topic is interesting enough to attract the readers’ attention. Methodology is accurate and conclusions are supported by the data analysis. Nevertheless, authors should clarify some point and improve the discussion citing relevant and novel key articles about the topic.
- OVERALL COMMENTS: - Manuscript should be further revised by a native English speaker to improve clarity and readability.
- METHODS: - Although it is a retrospective analysis, Inclusion/exclusion criteria should be better clarified by extending their description. Is the diagnose of CIN 2 confirmed by 2 independent Pathologist? Nowadays Cin2 is commonly associated with CIN 3. Its differential diagnose is really thin, and should be better clarified how did you selected your patient. This could be a bias of the study
- DISCUSSION:
- The authors have not adequately highlighted the strengths and limitations of their study. I suggest better specifying these points. For example, authors should clarify that cervical biopsy could not be representative of all the affected tissue and Laser vaporization doesn't provided any spiecment to be checked. As well, authors should mark the lost of crucial information if a cancer will be misdiagnosed, such us grading, hystottype and LVS status (see PMID: 30771718; 34116834; 34741816; 29177590)
- What are the actual clinical implications of this study? it is important to report the results obtained by the authors in the context of clinical practice and to adequately highlight what contribution this study adds to the literature already existing on the topic and to future study perspectives
Author Response
Reviewer #3 comments
read with great interest the Manuscript titled “The effect of surgeon volume on the outcome of laser 2 vaporization: a single-center retrospective study”, which falls within the aim of the Journal.
In my honest opinion, the topic is interesting enough to attract the readers’ attention. Methodology is accurate and conclusions are supported by the data analysis. Nevertheless, authors should clarify some point and improve the discussion citing relevant and novel key articles about the topic.
Reply:
We appreciate these useful comments from the Reviewer. We have revised the manuscript carefully according to the Reviewer’s comments. We believe the revised manuscript now addresses the Reviewer’s concerns.
Reviewer #3, Comment 1
- OVERALL COMMENTS: - Manuscript should be further revised by a native English speaker to improve clarity and readability.
Reply: Lines 333–334
We thank the reviewer for the helpful suggestion. Accordingly, we have submitted the manuscript to a professional English editing service. All language and grammar-related errors have been taken care of. The manuscript now has a native tone. I hope that the revised manuscript meets your expectations.
Reviewer #3, Comment 2
- METHODS: - Although it is a retrospective analysis, Inclusion/exclusion criteria should be better clarified by extending their description.
Reply:
We thank the reviewer for this beneficial suggestion. We have clarified the inclusion and exclusion criteria as follows (lines 76–82 of the revised manuscript).
“Inclusion criteria of this study were as follows 1) women with CIN2 treated with laser vaporization between the ages of 18 and 60 years; and 2) those whose follow-up period was at least 6 or more months. Exclusion criteria were as follows: women with 1) CIN3 or higher grade of the disease; 2) age >60 years; 3) first follow-up more than 12 months after laser vaporization; 4) follow-up period of less than 6 months; 5) suspected invasive cancer; 6) incomplete patient data; 7) positive pregnancy test; and 8) use of immunosuppressants.”
Reviewer #3, Comment 3
Is the diagnose of CIN 2 confirmed by 2 independent Pathologist? Nowadays Cin2 is commonly associated with CIN 3. Its differential diagnose is really thin, and should be better clarified how did you selected your patient. This could be a bias of the study
Reply: We thank the reviewer for the insightful comment. We have added the limitation of this study regarding the difficulty in identifying patients with CIN2 as follows (lines 298–304 of the revised manuscript):
“Fifth, the difficulty in the diagnosis of CIN2 may have introduced a bias in this study. Notably, the diagnosis of CIN2 in some cases of this study was not confirmed by two independent pathologists. Moreover, centrally recorded pathological findings were not available in this study. Since most of the features of CIN2 and CIN3 are overlapping, the differentiation between these two is difficult; consequently, in present study, there may have been cases that could possibly have a different grade of HIN than that originally diagnosed.”
Reviewer #3, Comment 4
- DISCUSSION:
- The authors have not adequately highlighted the strengths and limitations of their study. I suggest better specifying these points. For example, authors should clarify that cervical biopsy could not be representative of all the affected tissue and Laser vaporization doesn't provided any spiecment to be checked. As well, authors should mark the lost of crucial information if a cancer will be misdiagnosed, such us grading, hystottype and LVS status (see PMID: 30771718; 34116834; 34741816; 29177590)
Reply: We thank the reviewer for these helpful suggestions. We have added the points the reviewer raised as a limitation of this study. Following sentence has been added in the revised manuscript (lines 306–312 of the revised manuscript).
“Lastly, the cervical biopsy was not representative of all the affected tissue, and diagnosis in women treated with laser vaporization was not determined by a particular specimen. Therefore, the actual diagnosis of CIN2 is unclear in this study, resulting in a selection bias. Notably, if a malignant disease was misdiagnosed for its histological type or its lymphovascular space invasion, the prognosis of patients may be worse than that actually predicted [1-4]. Both low- and high-volume surgeons should bear this in mind while performing laser vaporization treatments for CIN.”
Reviewer #3, Comment 5
- What are the actual clinical implications of this study? it is important to report the results obtained by the authors in the context of clinical practice and to adequately highlight what contribution this study adds to the literature already existing on the topic and to future study perspectives
Reply: Please also refer the comment for reply to Reviewer #3, comment 5. According to the reviewer’s suggestion, we have added the discussion regarding the new findings of this study as follows (Lines 256–261 of the revised manuscript).
“Given the limited number of laser vaporizations performed due to the high cost of equipment, a negative relationship between surgeon’s volume and the treatment outcome may be helpful to perform laser vaporization for CIN in general hospital [5]. On the contrary, minimum volume requirement of laser vaporization for CIN is still unclear; thus, further studies are warranted to identify the minimum volume standards for performing laser vaporization in cases of CIN [6,7].”
There has been substantial modification to the paper in line with the reviewers’ suggestions, and I hope that the paper will benefit from these revisions. Once again, we thank you for the time you put in reviewing our paper and look forward to meeting your expectations.
References
- Queiroz ACM, Fabri V, Mantoan H, Sanches SM, Guimaraes APG, Ribeiro ARG, da Nogueira Silveira Lima JP, Chen MJ, Baiocchi G, da Costa A. Risk factors for pelvic and distant recurrence in locally advanced cervical cancer. Eur J Obstet Gynecol Reprod Biol. 2019;235:6-12.
- Ronsini C, Anchora LP, Restaino S, Fedele C, Arciuolo D, Teodorico E, Bizzarri N, Zannoni GF, Ferrandina G, Scambia G, et al. The role of semiquantitative evaluation of lympho-vascular space invasion in early stage cervical cancer patients. Gynecol Oncol. 2021;162:299-307.
- Falcaro M, Castanon A, Ndlela B, Checchi M, Soldan K, Lopez-Bernal J, Elliss-Brookes L, Sasieni P. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. Lancet. 2021;398:2084-92.
- Ma C, Zhang Y, Li R, Mao H, Liu P. Risk of parametrial invasion in women with early stage cervical cancer: a meta-analysis. Arch Gynecol Obstet. 2018;297:573-80.
- DeMott RK. Laser vs cryotherapy for CIN and a LEEP of faith. JAMA. 1993;269:46.
- Ruiz MP, Chen L, Hou JY, Tergas AI, St Clair CM, Ananth CV, Neugut AI, Hershman DL, Wright JD. Effect of Minimum-Volume Standards on Patient Outcomes and Surgical Practice Patterns for Hysterectomy. Obstet Gynecol. 2018;132:1229-37.
- Wright JD. The Volume-Outcome Paradigm for Gynecologic Surgery: Clinical and Policy Implications. Clin Obstet Gynecol. 2020;63:252-65.
Author Response File: Author Response.pdf
Round 2
Reviewer 3 Report
The only remaining bias is correlated to the diagnosis of CIN2, which is not confirmed by a second pathologist. This is a methodological bias. I invite you to recheck every enrolled patient by a second pathologist
Author Response
Response to Editor and the Reviewers’ comments
Thank you for reviewing our paper and considering it for publication in Current Oncology. We have reviewed our manuscript carefully and have made revision to meet the reviewers’ suggestion and requirement. We believe that our revised manuscript now satisfies the concerns raised by the editor and the reviewers.
Reviewer #3, Comment 1
The only remaining bias is correlated to the diagnosis of CIN2, which is not confirmed by a second pathologist. This is a methodological bias. I invite you to recheck every enrolled patient by a second pathologist.
Reply: lines 300-301
We appreciate the reviewer’s insightful comments. Please also refer to the comment for the reply to Editor, comment #1. Due to the limited time to revise the manuscript, it is difficult to recheck every enrolled patient by a second pathologist. We have added this issue as a limitation of this study.
Author Response File: 
Author Response.docx
Round 3
Reviewer 3 Report
The integrations made by the Authors raised the quality of the writing. They adeguatelly underlined the conceptualization bias and overcome it
