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Date: Jan 15, 2021
To: "Stephanie Wethington"
From: "The Green Journal" [email protected] Subject: Your Submission ONG-20-3270
RE: Manuscript Number ONG-20-3270
Outcomes of Women Undergoing Excision of the Retained Cervix Following Supracervical Hysterectomy Dear Dr. Wethington:
Your manuscript has been reviewed by the Editorial Board and by special expert referees. Although it is judged not acceptable for publication in Obstetrics & Gynecology in its present form, we would be willing to give further consideration to a revised version.
If you wish to consider revising your manuscript, you will first need to study carefully the enclosed reports submitted by the referees and editors. Each point raised requires a response, by either revising your manuscript or making a clear and convincing argument as to why no revision is needed. To facilitate our review, we prefer that the cover letter include the comments made by the reviewers and the editor followed by your response. The revised manuscript should indicate the position of all changes made. We suggest that you use the "track changes" feature in your word processing software to do so (rather than strikethrough or underline formatting).
Your paper will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Feb 05, 2021, we will assume you wish to withdraw the manuscript from further consideration.
REVIEWER COMMENTS:
Reviewer #1: The authors aimed to study the outcomes of women undergoing excision of the retained cervix after TSH.
Manuscript is good, you have described your limitations in an adequate manner, but conclusions need to be more straight- forward to your data.
Abstract - You cannot conclude that retained cervix will increase the risk for malignancy - it would be interesting to calculate the percentage of subtotal hysts performed and subtract by the number of retained cervices that were operated - this would probably give you the number of asymptomatic cases. This is a limitation - you don't have detailed information of the group of women with retained cervix that did not operate. I would remove the last sentence of the conclusion.
Introduction - Reference number 6 is not updated - there is an update of this review presented in last 2020 IUGA meeting (https://www.iugameeting.org/2020-meeting/program/abstract-sessions?where_person=62) - moreover, there is a non- Cochrane review published with the same outcomes - if you are looking for replace this 2012 review by these two (https://pubmed.ncbi.nlm.nih.gov/30910330/ and https://pubmed.ncbi.nlm.nih.gov/30467762/) You say that you aim to characterize the surgical techniques - however, this is not described in the results. I would remove this. Surgical technique is not surgical route.
Methods - Not having an ICD-9 code to distinguish vaginal and abdominal approach brings limitations because vaginal and abdominal approaches present different repercussions/ complications. It is interesting to know that fibroids were the commonest reason for trachelectomy - cervical fibroids? Fibroids from the istmus? Strange because supposedly, fibroids would not be the highest reason for performing this surgery - I would assume that bleeding would be the highest reason as cervical ongoing cyclical bleeding can happen up to 15% of cases. Pelvic pain as well, especially for endometriosis' cases.
Revise the indication because this is not expected.
Discussion - Summary of main findings and strengths and limitations are well-written. I would also add the importance of physician as source of information to remove or retain the cervix. ( suggestion: - https://pubmed.ncbi.nlm.nih.gov /26479433/) . I would also add in the discussion the lack of a non-surgical group from women with retained cervix, and the lack of sample size/power calculation.
Reviewer #2:
Good overview of an important topic.
View Letter
1 of 5 2/8/2021, 3:19 PM
The complication rate seems extraordinarily high, particularly the rate of transfusion. It would be worth some exploration of why that might be, though obviously it would be speculative.
Was there any mention of mesh usage in these patients - i.e. were any of the supracervical hysterectomies done for prolapse concomitantly with sacrocolpopexies?
There are a few grammatical errors present that will likely be corrected by the authors themselves - parallelism, a couple of commas.
Reviewer #3: This is a retrospective nested cohort study from the National Inpatient Sample database (NIS) from 2010-2014 for evaluating the outcome of women undergoing trachelectomy after having supracervical hysterectomy for benign and cancer indications.
Main issues:
1- Most of patients undergoing trachelectomy for benign indications both prolapse and benign gynecology issues would have been excluded from this database because they undergo those surgeries as an outpatient procedure, leaving only those who had complications or those who had cancer and that can be the reason for the more than expected
complications and longer length of stay.
2- Another concern is the issue with coding, there is not specific code for trachelectomy for benign indications, there is codes that are confusing like 67.4 which is amputation of the cervix. This is evident by the small number of trachelectomy done in 5 years of NIS which is an evidence of difficulty to ascertain cases. Adding the lack of direct verification by the authors, I am not sure this included sample is an accurate representation of the target population.
3- Finally, the lack of precision for determining the route is a major issue, there is a huge difference between a vaginal trachelectomy done for prolapse with uterosacral suspension that takes less than 60 minutes and open abdominal or robotic trachelectomy that takes 4 hours for cervical cancer.
For example, if you do a laparoscopic trachelectomy which is the most common route of trachelectomy for benign indications (CPT code 57530); this code cannot be reported because the procedure was performed laparoscopically. CPT rules dictate that correct coding would be an unlisted laparoscopic code). Such a common case will be missed by the NIS for 2 reasons: first, it was not coded right because of the lack of proper billing code and second, it was an outpatient procedure! A better way to evaluate this research question is to use a multi-center cohort that include trachelectomy.
STATISTICAL EDITOR COMMENTS:
The Statistical Editor makes the following points that need to be addressed:
lines 31-32: Given that the sample is representative, then one can characterize the indications for, complication rates of this subset (that is, women who had excision of the retained cervix after supra cervical hysterectomy). One cannot, from these data, generalize to all women who had supra cervical hysterectomy, that was not the cohort analyzed.
line 40: This is an estimate, based on extrapolation of the size of the NIS. Should make that clear to the reader.
lines 147-149: LOS is often skewed. Were the LOS normally distributed? If not, then should cite as median (range or IQR), rather than citing as mean and assuming normality to assess the variability.
Table 1: Need to enumerate any missing data.
Table 3: For the association with Gyn cancer, the CIs are fairly wide. Was there sufficient power to generalize the conclusion of no difference in rate of complications for that group? Similarly, for excision of 2+ trachelectomies vs 0-1, was there sufficient power for the overall rate of complications and its subsets? For age, should state referent (I assume per 1 year increment).
View Letter
2 of 5 2/8/2021, 3:19 PM
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5 2/8/2021, 3:19 PM
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View Letter
5 2/8/2021, 3:19 PM
2019 IMPACT FACTOR: 5.524
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View Letter
5 2/8/2021, 3:19 PM
February 4, 2021
Please find attached our resubmission of an original manuscript entitled:
“Outcomes of Women Undergoing Excision of the Retained Cervix Following Supracervical Hysterectomy.” The comments submitted by the reviewers, statistician and editor were extremely helpful and we have addressed each of them with changes to the manuscript. Attached is a point by point response to the comments, a clean version of the updated manuscript and the original with track changes.
This updated version has been reviewed and approved by all authors.
Thank you again for considering our manuscript and we look forward to your response.
Kind regards,
Stephanie L. Wethington
REVIEWER COMMENTS:
Reviewer #1:
The authors aimed to study the outcomes of women undergoing excision of the retained cervix after TSH. Manuscript is good, you have described your limitations in an adequate manner, but
conclusions need to be more straight-forward to your data. Abstract - You cannot conclude that retained cervix will increase the risk for malignancy - it would be interesting to calculate the percentage of subtotal hysts performed and subtract by the number of retained cervices that were operated - this would probably give you the number of asymptomatic cases. This is a limitation - you don't have detailed information of the group of women with retained cervix that did not operate. I would remove the last sentence of the conclusion.
***We have edited the abstract to clarify the language around risk of malignancy and the last sentence of the conclusion. Unfortunately a limitation of the database used is that we are unable to determine the number of asymptomatic cases who did not have a retained cervix removed (noted in limitations at line 274-276).
Introduction - Reference number 6 is not updated - there is an update of this review presented in last 2020 IUGA meeting
(https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.iugameeting.org%2 F2020-meeting%2Fprogram%2Fabstract-
sessions%3Fwhere_person%3D62&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0 a4cf3c4cd0e0f408d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350 998352674%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJB TiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=2uEE%2FjLFOjl%2BfLTkwLnD1FBW bDnTMDpHu4pNJWQVBEU%3D&reserved=0) - moreover, there is a non-Cochrane review published with the same outcomes - if you are looking for replace this 2012 review by these two (https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.go v%2F30910330%2F&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f 408d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998352674%7 CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWw iLCJXVCI6Mn0%3D%7C1000&sdata=dVAJdKHeQGw9dIpfSsPAN6q6DENBOssv8ksSrvr DgDY%3D&reserved=0 and
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov
%2F30467762%2F&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f4 08d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998352674%7C Unknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiL CJXVCI6Mn0%3D%7C1000&sdata=K1gcF146mF9QFMI7aqPalr4Eb1e3INKHs%2BUPt0b TA94%3D&reserved=0)
***Thank you very much for these extremely helpful references. We have corrected #6 and added the suggested references.
You say that you aim to characterize the surgical techniques - however, this is not described in the results. I would remove this. Surgical technique is not surgical route.
***The terminology was corrected throughout the manuscript.
Methods - Not having an ICD-9 code to distinguish vaginal and abdominal approach brings limitations because vaginal and abdominal approaches present different repercussions/
complications.
***We have added this issue to our discussion to clarify the significance of this element of the methods, line 272-274.
It is interesting to know that fibroids were the commonest reason for trachelectomy - cervical fibroids? Fibroids from the istmus? Strange because supposedly, fibroids would not be the highest
reason for performing this surgery - I would assume that bleeding would be the highest reason as cervical ongoing cyclical bleeding can happen up to 15% of cases. Pelvic pain as well, especially for endometriosis' cases. Revise the indication because this is not expected.
***We also were surprised that this was the most common indication for trachelectomy.
The database used does not allow us to specify the location of the fibroid. We have added discussion of this to our discussion at lines 238-244.
Discussion - Summary of main findings and strengths and limitations are well-written. I would also add the importance of physician as source of information to remove or retain the cervix. (
suggestion: -
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov
%2F26479433%2F&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f4 08d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998352674%7C Unknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiL CJXVCI6Mn0%3D%7C1000&sdata=m9%2Bw%2FV%2Ffl6K%2BfnD0I0ix260SWW7NOmi gFh10EebpD0s%3D&reserved=0) .
**This is a fabulous reference and we have incorporated it into our discussion, reference 12.
I would also add in the discussion the lack of a non-surgical group from women with retained cervix, and the lack of sample size/power calculation.
***We have added in our discussion the lack of a non-surgical group for comparison.
Because of our sample size and the lack of a non-surgical group for comparison, we do not report odds ratios or relative risks in our paper. As we did not plan a comparative analysis, we do not present power calculation for this.
Reviewer #2:
Good overview of an important topic.
The complication rate seems extraordinarily high, particularly the rate of transfusion. It would be worth some exploration of why that might be, though obviously it would be speculative.
***While on first blush the complication rate is high, the largest retrospective review demonstrates a similar complication rate. We have postulated why this might be in line 210- 212.
Was there any mention of mesh usage in these patients - i.e. were any of the supracervical hysterectomies done for prolapse concomitantly with sacrocolpopexies?
***A limitation of the dataset is that we are unable to determine whether mesh was used as a part of the supracervical hysterectomy.
There are a few grammatical errors present that will likely be corrected by the authors themselves - parallelism, a couple of commas.
*** Thank you, we have corrected throughout the paper.
Reviewer #3: This is a retrospective nested cohort study from the National Inpatient Sample database (NIS) from 2010-2014 for evaluating the outcome of women undergoing trachelectomy after having supracervical hysterectomy for benign and cancer indications.
Main issues:
1- Most of patients undergoing trachelectomy for benign indications both prolapse and benign gynecology issues would have been excluded from this database because they undergo those surgeries as an outpatient procedure, leaving only those who had complications or those who had cancer and that can be the reason for the more than expected complications and longer length of stay.
*** We have added this to the discussion more clearly. We also consider that widespread use of outpatient hysterectomy has increased significantly in the past decade, as has the rate of MIS hysterectomy (Nationwide trends in the utilization of and payments for
hysterectomy in the United States among commercially insured women, Morgan, Daniel M.
et al.).
2- Another concern is the issue with coding, there is not specific code for trachelectomy for benign indications, there is codes that are confusing like 67.4 which is amputation of the cervix. This is evident by the small number of trachelectomy done in 5 years of NIS which is an evidence of difficulty to ascertain cases. Adding the lack of direct verification by the authors, I am not sure this included sample is an accurate representation of the target population.
***There is only one ICD-9 code for amputation of the cervix, which can be used for either fertility-sparing trachelectomy or excision of retained cervical stump. We only included women with a history of hysterectomy to insure our study population is women undergoing excision of retained cervical stump. Given the limitations of ICD-9 codes, we believe this is as true a population as we can gather from available national data. And as excision of a retained cervix is a relative rare procedure (~X performed at our institution last year), obtaining national estimates as we do in our study is essential to understanding
complication rates and counseling patients. This coding has been used in prior studies, including: https://pubmed.ncbi.nlm.nih.gov/31982179/
3- Finally, the lack of precision for determining the route is a major issue, there is a huge
difference between a vaginal trachelectomy done for prolapse with uterosacral suspension that takes less than 60 minutes and open abdominal or robotic trachelectomy that takes 4 hours for cervical cancer. For example, if you do a laparoscopic trachelectomy which is the most common route of trachelectomy for benign indications (CPT code 57530); this code cannot be reported because the procedure was performed laparoscopically. CPT rules dictate that correct coding would be an unlisted laparoscopic code). Such a common case will be missed by the NIS for 2 reasons: first, it was not coded right because of the lack of proper billing code and second, it was an outpatient procedure! A better way to evaluate this research question is to use a multi-center cohort that include trachelectomy.
***We agree with the reviewer that the CPT code for trachelectomy (57530) cannot be used for laparoscopic procedures and thus laparoscopic procedures would be unlisted
laparoscopic procedure for billing. Therefore we used the ICD-9 code to identify
trachelectomies, not only the CPT code. This significantly limits the risk for missed MIS procedures.
STATISTICAL EDITOR COMMENTS:
The Statistical Editor makes the following points that need to be addressed:
lines 31-32: Given that the sample is representative, then one can characterize the indications for, complication rates of this subset (that is, women who had excision of the retained cervix after supra cervical hysterectomy). One cannot, from these data, generalize to all women who had supra cervical hysterectomy, that was not the cohort analyzed.
***The language has been clarified.
line 40: This is an estimate, based on extrapolation of the size of the NIS. Should make that clear to the reader.
***The language has been clarified.
lines 147-149: LOS is often skewed. Were the LOS normally distributed? If not, then should cite as median (range or IQR), rather than citing as mean and assuming normality to assess the variability.
***The language has been clarified.
Table 1: Need to enumerate any missing data.
***This has been added to table 1
Table 3: For the association with Gyn cancer, the CIs are fairly wide. Was there sufficient power to generalize the conclusion of no difference in rate of complications for that group? Similarly, for
excision of 2+ trachelectomies vs 0-1, was there sufficient power for the overall rate of complications and its subsets? For age, should state referent (I assume per 1 year increment).
***In terms of power, 15% of the sample (~170 women) underwent excision of the retained cervix for cancer of whom around 71 had complications (41%). We had 80% power to detect a 12% difference in overall complication rates between these groups at a two-sided p-value of 0.05. For hospital volume, 28% of the sample underwent surgery at a high-volume
hospital (n~320) of whom around 89 had complications (27%). We had 80% power to detect a 10% difference in overall complication rates between these groups at a two-sided p-value of 0.05.
For power, we have added a statement to the methods at line 154-155.
For age, we have added the following to the bottom of table 3: “The youngest patient was 24 years old for reference (i.e., each one-year increase in age translates to a 0.01 decrease in odds of overall complications).”
EDITOR COMMENTS:
1. The Editors of Obstetrics & Gynecology are seeking to increase transparency around its peer- review process, in line with efforts to do so in international biomedical peer review publishing. If your article is accepted, we will be posting this revision letter as supplemental digital content to the published article online. Additionally, unless you choose to opt out, we will also be including your point-by-point response to the revision letter. If you opt out of including your response, only the revision letter will be posted. Please reply to this letter with one of two responses:
A. OPT-IN: Yes, please publish my point-by-point response letter.
2. Obstetrics & Gynecology uses an "electronic Copyright Transfer Agreement" (eCTA). When you are ready to revise your manuscript, you will be prompted in Editorial Manager (EM) to click on
"Revise Submission." Doing so will launch the resubmission process, and you will be walked
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Please check with your coauthors to confirm that the disclosures listed in their eCTA forms are correctly disclosed on the manuscript's title page.
***We have added a statement on the title page that the authors have no disclosures.
3. For studies that report on the topic of race or include it as a variable, authors must provide an explanation in the manuscript of who classified individuals' race, ethnicity, or both, the
classifications used, and whether the options were defined by the investigator or the participant. In addition, the reasons that race/ethnicity were assessed in the study also should be described (eg, in the Methods section and/or in table footnotes). Race/ethnicity must have been collected in a formal or validated way. If it was not, it should be omitted. Authors must enumerate all missing data
regarding race and ethnicity as in some cases, missing data may comprise a high enough proportion that it compromises statistical precision and bias of analyses by race.
Use "Black" and "White" (capitalized) when used to refer to racial categories. The nonspecific category of "Other" is a convenience grouping/label that should be avoided, unless it was a
prespecified formal category in a database or research instrument. If you use "Other" in your study, please add detail to the manuscript to describe which patients were included in that category.
***The capitalization has been addressed. We have added a statement in the methods to address the use of race and data collection.
4. Standard obstetric and gynecology data definitions have been developed through the reVITALize initiative, which was convened by the American College of Obstetricians and Gynecologists and the members of the Women's Health Registry Alliance. Obstetrics & Gynecology has adopted the use of the reVITALize definitions. Please access the obstetric data definitions at
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acog.org%2Fpractic
e-management%2Fhealth-it-and-clinical-informatics%2Frevitalize-obstetrics-data-
definitions&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f408d8b98 a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998352674%7CUnknow n%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI 6Mn0%3D%7C1000&sdata=axSbM9IENntORHV%2FwiNxLopHr24JSf2l3yE%2B3HivloY
%3D&reserved=0 and the gynecology data definitions at
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acog.org%2Fpractic e-management%2Fhealth-it-and-clinical-informatics%2Frevitalize-gynecology-data-
definitions&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f408d8b98 a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998352674%7CUnknow n%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI 6Mn0%3D%7C1000&sdata=bJYz0Imhm4N6usUKnas54RHeQEnk%2BQETx9%2F0U9czW hY%3D&reserved=0. If use of the reVITALize definitions is problematic, please discuss this in your point-by-point response to this letter.
***We have applied these definitions where appropriate
5. Because of space limitations, it is important that your revised manuscript adhere to the following length restrictions by manuscript type: Original Research reports should not exceed 22 typed, double-spaced pages (5,500 words). Stated page limits include all numbered pages in a manuscript (i.e., title page, précis, abstract, text, references, tables, boxes, figure legends, and print appendixes) but exclude references.
***We adhere to this limitation
6. The most common deficiency in revised manuscripts involves the abstract. Be sure there are no inconsistencies between the Abstract and the manuscript, and that the Abstract has a clear
conclusion statement based on the results found in the paper. Make sure that the abstract does not contain information that does not appear in the body text. If you submit a revision, please check the abstract carefully.
In addition, the abstract length should follow journal guidelines. The word limit for Original Research articles is 300 words. Please provide a word count.
*** Our abstract has a conclusion that is supported by the text of the manuscript. Our abstract is 299 words.
7. Only standard abbreviations and acronyms are allowed. A selected list is available online at https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fedmgr.ovid.com%2Fong
%2Faccounts%2Fabbreviations.pdf&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb 0a4cf3c4cd0e0f408d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C63746335 0998362628%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJ BTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=99titaJx4Qw85ZmHaM4O9vPmHXJd AhBON09wLQfR8pE%3D&reserved=0. Abbreviations and acronyms cannot be used in the title or précis. Abbreviations and acronyms must be spelled out the first time they are used in the abstract and again in the body of the manuscript.
*** The two non-standard abbreviations previously used in our manuscript have been removed.
8. The journal does not use the virgule symbol (/) in sentences with words. Please rephrase your text to avoid using "and/or," or similar constructions throughout the text. You may retain this symbol if you are using it to express data or a measurement.
***The symbol has been removed.
9. ACOG is moving toward discontinuing the use of "provider." Please replace "provider"
throughout your paper with either a specific term that defines the group to which are referring (for
example, "physicians," "nurses," etc.), or use "health care professional" if a specific term is not applicable.
***The word provider does not appear in the text.
10. In your Abstract, manuscript Results sections, and tables, the preferred citation should be in terms of an effect size, such as odds ratio or relative risk or the mean difference of a variable
between two groups, expressed with appropriate confidence intervals. When such syntax is used, the P value has only secondary importance and often can be omitted or noted as footnotes in a Table format. Putting the results in the form of an effect size makes the result of the statistical test more clinically relevant and gives better context than citing P values alone.
If appropriate, please include number needed to treat for benefits (NNTb) or harm (NNTh). When comparing two procedures, please express the outcome of the comparison in U.S. dollar amounts.
Please standardize the presentation of your data throughout the manuscript submission. For P values, do not exceed three decimal places (for example, "P = .001"). For percentages, do not exceed one decimal place (for example, 11.1%").
***This has been reviewed and corrected.
11. Line 179: Your manuscript contains a priority claim. We discourage claims of first reports since they are often difficult to prove. How do you know this is the first report? If this is based on a systematic search of the literature, that search should be described in the text (search engine, search terms, date range of search, and languages encompassed by the search). If it is not based on a systematic search but only on your level of awareness, it is not a claim we permit.
***We do not have enough space to add the reports of a systematic search of the literature so we have deleted this comment. In preparation for the project we had completed a literature search that served as the basis for this statement.
12. Please review the journal's Table Checklist to make sure that your tables conform to journal style. The Table Checklist is available online here:
https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fedmgr.ovid.com%2Fong
%2Faccounts%2Ftable_checklist.pdf&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bc b0a4cf3c4cd0e0f408d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C6374633 50998362628%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLC JBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=8UJZWPhcIPb8UzigAMirRAZZg9%
2BUTtIj3OxNkWRSYpw%3D&reserved=0.
***This has been reviewed and our tables conform to these guidelines.
13. Please review examples of our current reference style at
https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fong.editorialmanager.com
%2F&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f408d8b98a30c8
%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998362628%7CUnknown%7C TWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0
%3D%7C1000&sdata=u94%2F7v5DL6Vk9oAl5DIf0cBSDmzkMYDp%2BdcjfaRW8Io%3D
&reserved=0 (click on the Home button in the Menu bar and then "Reference Formatting Instructions" document under "Files and Resources). Include the digital object identifier (DOI) with any journal article references and an accessed date with website references. Unpublished data, in- press items, personal communications, letters to the editor, theses, package inserts, submissions, meeting presentations, and abstracts may be included in the text but not in the reference list.
In addition, the American College of Obstetricians and Gynecologists' (ACOG) documents are frequently updated. These documents may be withdrawn and replaced with newer, revised versions.
If you cite ACOG documents in your manuscript, be sure the reference you are citing is still current and available. If the reference you are citing has been updated (ie, replaced by a newer version), please ensure that the new version supports whatever statement you are making in your manuscript
and then update your reference list accordingly (exceptions could include manuscripts that address items of historical interest). If the reference you are citing has been withdrawn with no clear replacement, please contact the editorial office for assistance ([email protected]). In most cases, if an ACOG document has been withdrawn, it should not be referenced in your manuscript (exceptions could include manuscripts that address items of historical interest). All ACOG
documents (eg, Committee Opinions and Practice Bulletins) may be found at the Clinical Guidance page at
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acog.org%2Fclinical
&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f408d8b98a30c8%7C 9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998362628%7CUnknown%7CTW FpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3 D%7C1000&sdata=zjcxqihYVnRGvmW%2BjKNAofLFJHxRBLLD7hxJK8TnPoU%3D&am p;reserved=0 (click on "Clinical Guidance" at the top).
*** Reference style has been reviewed and our references have been updated.
14. Each supplemental file in your manuscript should be named an "Appendix," numbered, and ordered in the way they are first cited in the text. Do not order and number supplemental tables, figures, and text separately. References cited in appendixes should be added to a separate References list in the appendixes file.
*** Supplemental tables have been moved to a separate document, which has been attached.
15. Authors whose manuscripts have been accepted for publication have the option to pay an article processing charge and publish open access. With this choice, articles are made freely available online immediately upon publication. An information sheet is available at
https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Flinks.lww.com%2FLWW- ES%2FA48&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e0f408d8b9 8a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998362628%7CUnkno wn%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXV CI6Mn0%3D%7C1000&sdata=t%2BxPRiXzCkmXmUCbaMemvShXf82lqRo3qir2DdTDzzw
%3D&reserved=0. The cost for publishing an article as open access can be found at
https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwkauthorservices.editage.
com%2Fopen-
access%2Fhybrid.html&data=04%7C01%7Cswethington%40jhmi.edu%7Cd4bcb0a4cf3c4cd0e 0f408d8b98a30c8%7C9fa4f438b1e6473b803f86f8aedf0dec%7C0%7C0%7C637463350998362628%
7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haW wiLCJXVCI6Mn0%3D%7C1000&sdata=EzwceFA9xYMGg83KktjHZcqO1ivvN4Ny%2Bca OWlQ4jnA%3D&reserved=0.
Please note that if your article is accepted, you will receive an email from the editorial office asking you to choose a publication route (traditional or open access). Please keep an eye out for that future email and be sure to respond to it promptly.
*** We will respond to this request as needed.
