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NOTICE: This document contains correspondence generated during peer review and subsequent revisions but before transmittal to production for composition and copyediting:

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Date: Aug 12, 2022

To: "Bracha Leah Pollack"

From: "The Green Journal" [email protected] Subject: Your Submission ONG-22-1252

RE: Manuscript Number ONG-22-1252

Permanent versus Absorbable Suture in Apical Prolapse Surgery: A Systematic Review and Meta-Analysis Dear Dr. Pollack:

Thank you for sending us your work for consideration for publication in Obstetrics & Gynecology. Your manuscript has been reviewed by the Editorial Board and by special expert referees. The Editors would like to invite you to submit a revised version for further consideration.

If you wish to revise your manuscript, please read the following comments submitted by the reviewers and Editors. Each point raised requires a response, by either revising your manuscript or making a clear argument as to why no revision is needed in the cover letter.

To facilitate our review, we prefer that the cover letter you submit with your revised manuscript include each reviewer and Editor comment below, followed by your response. That is, a point-by-point response is required to each of the EDITOR COMMENTS (if applicable), REVIEWER COMMENTS, STATISTICAL EDITOR COMMENTS (if applicable), and EDITORIAL OFFICE COMMENTS below. Your manuscript will be returned to you if a point-by-point response to each of these sections is not included.

The revised manuscript should indicate the position of all changes made. Please use the "track changes" feature in your document (do not use strikethrough or underline formatting).

Your submission will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Sep 02, 2022, we will assume you wish to withdraw the manuscript from further consideration.

REVIEWER COMMENTS:

Reviewer #1: These authors have distilled a complex literature into some very clear conclusions. Specifically, for native tissue suspension and for sacrocolpopexy (separately), they found no difference in "anatomic success" between absorbable versus permanent suture.

This is an important aspect of surgical technique. I believe this will be of interest to our readers. I found the paper well written. The figures and tables were clear.

However, I am concerned that the conclusions might be an oversimplification, given the heterogeneity of the studies. Most of the studies considered were single arm and considered only one suture type. Therefore, differences among the patient populations or study methods could bias the results of this systematic review. The most important factors would include (1) the definition for treatment success, (2) preoperative prolapse severity, and (3) the duration of follow up.

Heterogeneity among those variables, if they differ substantially between the two comparators, could influence the results.

I recommend that these data be provided. For example, I would ideally like to see this information included in tables 1-2 (or figures 2 and 4). If possible, I would also recommend that the authors summarize these data for the reader, especially if there are evident differences between studies of permanent versus absorbable suture.

Also, the authors indicate that the primary outcome considered was "anatomic outcomes" (line 61) but they also

considered "subjective symptoms of a bulge, re-operations or re-treatments (line 88). This discrepancy should be clarified.

I believe some of the studies included in the figures are not in the table and not included in the references. Examples:

Kowalski 2020, Bradley 2017, Chung 2011.

They mention that "there seemed to be more suture exposure and dyspareunia reported with permanent suture" (lines 162-3) but "numbers were not reported consistently or often; therefore there was not enough data for statistical comparison" (lines 163-4). There is a similar pattern noted in the comments about sacrocolpopexy (lines 191-3 and 193-4). Given that a formal comparison was not possible and that reporting was inconsistent, it might be more appropriate

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to omit the former comment. Specifically I recommend the authors omit the comment regarding the impression that a difference existed. I also recommend omitting the comment in the discussion on lines 203-5 indicating that the use of absorbable suture "[minimizes] adverse events such as suture exposure and dyspareunia". I don't believe their study allows that conclusion.

Reviewer #2: The authors conducted a systematic review and meta-analysis of using permanent versus absorbable suture in apical prolapse surgery.

Strength: This review potentially provides useful information for surgeons to make informed decision on choosing permanent vs. absorbable suture in daily practice.

However, the authors are suggested to address following concerns to further improve their manuscript:

1. Study Selection:

a. The authors excluded braided polyester (line 84) in the permanent suture group. However, given the authors hypothesized "permanent suture results in better anatomic outcomes (line 63), I would suggest the authors to clarify whether they excluded anything in the comparator group to reduce potential reviewer selection bias.

b. Please articulate the definition and/or formula of computing "anatomic success" (e.g., > POP-Q point XX). Based on the current definition (line 87-89), it is a bit difficult to understand how the permanent and absorbable anatomic success (rates) were calculated in Table 1 and Table 2.

c. Please spell out the full name of POP-Q (Pelvic Organ Prolapse Quantification?) first.

2. Results:

a. Patient information: I would suggest the authors to provide a summary of patient information (e.g., BMI, age, history of C-section/L&D) in those reviewed articles if available. This will help readers/surgeons to choose an appropriate type of suture for a given patient group. Currently, this manuscript seems to be built on an assumption that patents' conditions have no impact on the outcome of using permanent and absorbable suture. If this assumption has been tested, the authors should add the citation.

b. Please add necessary legends/notes to Table 1, Table 2, Figure 2, 3 and 4 to help readers better understand them.

For example, in Table 1, does "N" refer to patients enrolled in the reviewed study? What does "ES" mean in Figure 2?

c. In line 162-163 and line 191-193, I would recommend the authors to specify the number rather than stating "there seemed to be more suture exposure and dyspareunia reported with permanent suture".

d. For the PRISMA checklist appendix, I would suggest the authors scan and turn it into a professional PDF document rather than a picture.

3. Discussion and Conclusion: The authors should specify permanent sutures reviewed in this study excluded braided polyester to articulate the finding. For example, the authors may point out success rate was high and similar for

absorbable suture and permanent suture (excluding braided polyester) for USLS/SSLF and ASC with medium term follow- up.

STATISTICAL EDITOR COMMENTS:

lines 29, 147-149: Since the two suture types are being compared, should contrast the 87% vs the 86%, not simply cite the 87% with its CIs.

lines 30-31 and lines 154-155: Likewise for the 91% vs the 86%.

General: Since CIs are cited with the point estimates, should omit the p-values, they are redundant.

lines 186-195: Need to expand on this part of results, even though the data are limited. Could be in supplemental material. Since it is commented on in Discussion, it needs further exposition of data and analysis.

Figs 2 and 4: Need to include weights for each study.

Fig 3: Since there were only 2 entries for this metanalysis, the counts are insufficient to evaluate heterogeneity. Also, the metanalysis does not add to the two component studies and simply recapitulates the findings of the larger study.

Fig 5: The aggregate finding essentially recapitulates the larger study of Powell 2021.

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Appendix 2: Need to include weights for the studies

For figs 2, 4 and Appendix 2, should include funnel plots, which could be in supplemental.

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***

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Again, your manuscript will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Sep 02, 2022, we will assume you wish to withdraw the manuscript from further consideration.

Sincerely,

John O. Schorge, MD Deputy Editor, Gynecology

__________________________________________________

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8/15/22 Dear Editors;

Thank for the opportunity to revise our manuscript, “ONG-22-1252, Permanent versus Absorbable Suture in Apical Prolapse Surgery: A Systematic Review and Meta-Analysis”. We have responded to each comment below as indicated in bold. We have included a clean and tracked changes document.

Sincerely,

Cara Grimes and Bracha Pollack (on behalf of the study team)

REVIEWER COMMENTS:

Reviewer #1: These authors have distilled a complex literature into some very clear

conclusions. Specifically, for native tissue suspension and for sacrocolpopexy (separately), they found no difference in "anatomic success" between absorbable versus permanent suture.

This is an important aspect of surgical technique. I believe this will be of interest to our readers. I found the paper well written. The figures and tables were clear.

However, I am concerned that the conclusions might be an oversimplification, given the heterogeneity of the studies. Most of the studies considered were single arm and considered only one suture type. Therefore, differences among the patient populations or study methods could bias the results of this systematic review. The most important factors would include (1) the definition for treatment success, (2) preoperative prolapse severity, and (3) the duration of follow up. Heterogeneity among those variables, if they differ substantially between the two comparators, could influence the results. I recommend that these data be provided. For example, I would ideally like to see this information included in tables 1-2 (or figures 2 and 4). If possible, I would also recommend that the authors summarize these data for the reader, especially if there are evident differences between studies of permanent versus absorbable suture.

Thank you for your comments and we agree with the limitations you describe about our work.

To explore your concern about heterogeneity of the patient population, we added the following information to Tables 1 and 2: (1) the definition for treatment success, and (2) preoperative prolapse severity. Additionally, in response to another reviewer with a similar point, we also added age and BMI. The duration of follow-up is already present, in a separate column in Tables 1 and 2, and commented on in our manuscript (lines 27, 29, 156, 171)

We have added summary sentences on line 151-153 and 207-210 to reflect this new information.

Lines 151-153: “The average age of the study populations ranged from 53 to 59 years of age, while

average BMI was between 22 and 30. Most studies reported POPQ stage. When reported, the

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majority of patients had at least stage 3 prolapse. (Table 1).” Overall, we felt that these studies generally represented the expected population to receive vaginal suspension - post-menopausal, not obese with advanced stage prolapse past the hymen.

Lines 207-210: “The average age of the study population ranged from 43 to 70 years of age, while average BMI was between 20 and 29. Most studies reported POPQ stage. When reported, the majority of patients had at least stage 3 prolapse. Several studies reported mean POP-Q

measurements.” Overall, we felt that these studies generally represented the expected population to receive sacrocolpopexy - post-menopausal, not obese with advanced stage prolapse past the hymen.

We have previously addressed this limitation in the discussion (lines 340-345), “The studies included represent a wide age range and diverse populations. Although this heterogeneity may actually make this data more applicable to a wider scope of patients that we encounter, this may also account for differences in the outcomes”. We hope that the addition of this information to the tables and results section makes our manuscript clearer overall.

Also, the authors indicate that the primary outcome considered was "anatomic outcomes" (line 61) but they also considered "subjective symptoms of a bulge, re-operations or re-treatments (line 88). This discrepancy should be clarified.

We defined our primary outcome as “anatomic success defined by POP-Q measurements, stage or grade, subjective symptoms of a bulge, re-operations, or re-treatments” (line 105-107). In this case, we used the word “anatomic” to include ways to measure prolapse/bulge, ie anatomy, without considering function (bladder and bowel symptoms, sexual dysfunction). Thus, we included

“subjective symptoms of a bulge” as an “anatomic success measure”, since it is a symptom that is specifically related to the topography/anatomy of the vagina. This fits with studies that demonstrate

“symptoms of a bulge or something that is falling out of the vagina” have a sensitivity of

67%/specificity of 87% for clinically meaningful prolapse past at or past the hymen. (PMID 11744905)

I believe some of the studies included in the figures are not in the table and not included in the references. Examples: Kowalski 2020, Bradley 2017, Chung 2011.

This has been corrected. All studies were listed in the text, table, and figures, but the years were incorrect in the figure but correct in the manuscript and references.

They mention that "there seemed to be more suture exposure and dyspareunia reported with

permanent suture" (lines 162-3) but "numbers were not reported consistently or often; therefore there was not enough data for statistical comparison" (lines 163-4). There is a similar pattern noted in the comments about sacrocolpopexy (lines 191-3 and 193-4). Given that a formal comparison was not possible and that reporting was inconsistent, it might be more appropriate to omit the former comment. Specifically I recommend the authors omit the comment regarding the impression that a difference existed. I also recommend omitting the comment in the discussion on lines 203-5 indicating that the use of absorbable suture "[minimizes] adverse events such as suture exposure and

dyspareunia". I don't believe their study allows that conclusion.

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Per comments from the statistical editor, we performed a statistical analysis of the adverse events. We have added this to our methods on line 137: “Adverse events were compared with the two-sample test of proportions.”. We have added Appendix 4 and 6 and the following sentences to the manuscript:

Line 196-200: “There was more suture exposure in the permanent group vs absorbable group with a difference 5.6%, 95% CI: .026, .086. There were more surgeries for suture/mesh in the

permanent group vs absorbable group with a difference 4.6%, 95% CI: .012, .081. There was more granulation tissue in the permanent group vs absorbable group with a difference 10.1%, 95% CI: .064, .138. There was no difference in dyspareunia. (Appendix 4)

Line 281-307: “There were more suture exposures in the permanent group vs absorbable group with a difference 2.7%, 95% CI: .013, .041 with permanent suture 5.26 times more likely to become exposed than absorbable, RR = 5.26, 95% CI: 1.56, 17.69. (Appendix 6, 7). There were more surgeries for suture/mesh complications in the permanent vs absorbable group with a difference 1.7%, 95% CI:

.006, .028. There was no difference in mesh erosion or dyspareunia between permanent and absorbable suture.”

Reviewer #2: The authors conducted a systematic review and meta-analysis of using permanent versus absorbable suture in apical prolapse surgery.

Strength: This review potentially provides useful information for surgeons to make informed decision on choosing permanent vs. absorbable suture in daily practice.

However, the authors are suggested to address following concerns to further improve their manuscript:

1. Study Selection:

a. The authors excluded braided polyester (line 84) in the permanent suture group. However, given the authors hypothesized "permanent suture results in better anatomic outcomes (line 63), I would suggest the authors to clarify whether they excluded anything in the comparator group to reduce potential reviewer selection bias.

We have added the following sentence to clarify that we did not exclude anything in the comparator group. Line 104 “No absorbable sutures were excluded from inclusion.”

b. Please articulate the definition and/or formula of computing "anatomic success" (e.g., > POP-Q point XX). Based on the current definition (line 87-89), it is a bit difficult to understand how the permanent and absorbable anatomic success (rates) were calculated in Table 1 and Table 2.

We have moved the following sentence: “Our content experts (PP, CLG, DMP) collectively determined a single composite anatomic success proportion for each study” to an earlier location in our manuscript (moved from line 105 (original manuscript) to line 107-108 (new manuscript with tracked changes)) and we have added the following sentence to follow on line 108: “This

determination of a single composite anatomic success proportion was made taking into account POP-

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Q measurements, stage or grade, subjective symptoms of a bulge, re-operations, or re-treatments.

We were careful to make sure cases were not doubly counted and to arrive at a proportion that considered all of the above factors.” Additionally, we added a column in both Table 1 and Table 2 called “Definition of treatment of success” to indicate how the single composite anatomic success proportion was determined for each study.

c. Please spell out the full name of POP-Q (Pelvic Organ Prolapse Quantification?) first.

We have added this on line 105.

2. Results:

a. Patient information: I would suggest the authors to provide a summary of patient information (e.g., BMI, age, history of C-section/L&D) in those reviewed articles if available. This will help

readers/surgeons to choose an appropriate type of suture for a given patient group. Currently, this manuscript seems to be built on an assumption that patents' conditions have no impact on the outcome of using permanent and absorbable suture. If this assumption has been tested, the authors should add the citation.

We have added the following information to Tables 1 and 2 to help summarize the patient information in each included study: age, BMI, and prolapse severity. Very few to no studies included history of prior cesarean section vs vaginal delivery so we chose not to include this.

We have added summary sentences on line 151-153 and 207-210 to reflect this new information.

Lines 151-153: “The average age of the study populations ranged from 53 to 59 years of age, while average BMI was between 22 and 30. Most studies reported POPQ stage. When reported, the majority of patients had at least stage 3 prolapse. (Table 1).” Overall, we felt that these studies generally represented the expected population to receive vaginal suspension - post-menopausal, not obese with advanced stage prolapse past the hymen.

Lines 207-210: “The average age of the study population ranged from 43 to 70 years of age, while average BMI was between 20 and 29. Most studies reported POPQ stage. When reported, the majority of patients had at least stage 3 prolapse. Several studies reported mean POP-Q

measurements.” Overall, we felt that these studies generally represented the expected population to receive sacrocolpopexy - post-menopausal, not obese with advanced stage prolapse past the hymen.

We have previously addressed this limitation in the discussion (lines 340-345), “The studies included represent a wide age range and diverse populations. Although this heterogeneity may actually make this data more applicable to a wider scope of patients that we encounter, this may also account for differences in the outcomes”. We hope that the addition of this information to the tables and results section makes our manuscript clearer overall.

b. Please add necessary legends/notes to Table 1, Table 2, Figure 2, 3 and 4 to help readers better understand them. For example, in Table 1, does "N" refer to patients enrolled in the reviewed study?

What does "ES" mean in Figure 2?

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Our figure legend is on lines 616-684 in the manuscript. We have expanded this legend and added necessary footnotes to our Tables.

”ES” means Effect Size” and we have added this to our figure legend on line 639 and 657 c. In line 162-163 and line 191-193, I would recommend the authors to specify the number rather than stating "there seemed to be more suture exposure and dyspareunia reported with permanent suture".

Per comments from the statistical editor, we performed a statistical analysis of the adverse events. We have added this to our methods on line 137: “Adverse events were compared with the two-sample test of proportions.”. We have added Appendix 4 and 6 and the following sentences to the manuscript:

permanent group vs absorbable group with a difference 4.6%, 95% CI: .012, .081. There was more granulation tissue in the permanent group vs absorbable group with a difference 10.1%, 95% CI: .064, .138. There was no difference in dyspareunia. (Appendix 4)

d. For the PRISMA checklist appendix, I would suggest the authors scan and turn it into a professional PDF document rather than a picture.

Completed.

3. Discussion and Conclusion: The authors should specify permanent sutures reviewed in this study excluded braided polyester to articulate the finding. For example, the authors may point out success rate was high and similar for absorbable suture and permanent suture (excluding braided polyester) for USLS/SSLF and ASC with medium term follow-up.

We have added this information to line 347-348: “Absorbable and permanent suture

(excluding braided polyester) has similar success rates when used for apical prolapse repair”.

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STATISTICAL EDITOR COMMENTS:

lines 29, 147-149: Since the two suture types are being compared, should contrast the 87% vs the 86%, not simply cite the 87% with its CIs.

lines 30-31 and lines 154-155: Likewise for the 91% vs the 86%.

We have corrected both of these on lines 27-30 “At 23 month follow-up, there was no difference in permanent versus absorbable suture in USLS/SSLF (proportional anatomic success 88%

(CI: 0.81, 0.93) vs 88% (CI: 0.82, 0.92). Similarly, at 18 month follow-up, there was no difference in permanent versus absorbable suture in ASC (proportional anatomic success 92% (CI: 0.88, 0.95) vs 96% (CI: 0.92, 0.99).”

General: Since CIs are cited with the point estimates, should omit the p-values, they are redundant.

Agree. We have removed p-values throughout the document

lines 186-195: Need to expand on this part of results, even though the data are limited. Could be in supplemental material. Since it is commented on in Discussion, it needs further exposition of data and analysis.

We performed a statistical analysis of the adverse events. We have added this to our methods on line 137: “Adverse events were compared with the two-sample test of proportions.”. We have added Appendix 4 and 6 and the following sentences to the manuscript:

permanent group vs absorbable group with a difference 4.6%, 95% CI: .012, .081. There was more granulation tissue in the permanent group vs absorbable group with a difference 10.1%, 95% CI: .064, .138. There was no difference in dyspareunia. (Appendix 4)

Figs 2 and 4: Need to include weights for each study.

We have updated Figure 2, Figure 4 (now Figure 3) and Appendix 2 (now Appendix 3) with weights and have added funnel plots for Figures 2 and Figures 4 (now Figure 3) as Appendix 2 and 4.

We did not complete a funnel plot for Appendix 2 as fewer than 10 studies were included.

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Fig 3: Since there were only 2 entries for this metanalysis, the counts are insufficient to evaluate heterogeneity. Also, the metanalysis does not add to the two component studies and simply recapitulates the findings of the larger study.

Agree. We have removed this figure. We have adjusted the numbering of the remaining figures.

Fig 5: The aggregate finding essentially recapitulates the larger study of Powell 2021.

The benefit to performing a meta-analysis here is that more subjects are factored in to the analysis but we agree that the Powell study (weight 68.73) contributes the most to this result. We have added the following on line 309 “Finally, a benefit of meta-analysis is that more subjects are factored into the analysis but our findings for sacrocolpopexy (Figure 4, Appendix 7) are primarily driven by the Powell study (weight 68.73).

⁹

“

Appendix 2: Need to include weights for the studies

For figs 2, 4 and Appendix 2, should include funnel plots, which could be in supplemental.

We have updated Figure 2, Figure 4 (now Figure 3) and Appendix 2 (Now Appendix 3) with weights and have added funnel plots for Figures 2 and Figures 4 (now Figure 3) as Appendix 2 and 4.

We did not complete a funnel plot for Appendix 2 as less then 10 studies were included.

EDITORIAL OFFICE COMMENTS:

1. If your article is accepted, the journal will publish a copy of this revision letter and your point-by-point responses as supplemental digital content to the published article online. You may opt out by writing separately to the Editorial Office at [email protected], and only the revision letter will be posted.

2. When you submit your revised manuscript, please make the following edits to ensure your submission contains the required information that was previously omitted for the initial double-blind peer review:

* Funding information (ie, grant numbers or industry support statements) should be disclosed on the title page and at the end of the abstract. For industry-sponsored studies, describe on the title page how the funder was or was not involved in the study.

* Include clinical trial registration numbers, PROSPERO registration numbers, or URLs at the end of the abstract (if applicable).

* Name the IRB or Ethics Committee institution in the Methods section (if applicable).

* Add any information about the specific location of the study (ie, city, state, or country), if necessary for context.

3. Obstetrics & Gynecology's Copyright Transfer Agreement (CTA) must be completed by all authors.

When you uploaded your manuscript, each coauthor received an email with the subject, "Please verify

your authorship for a submission to Obstetrics & Gynecology." Please ask your coauthor(s) to complete

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this form, and confirm the disclosures listed in their CTA are included on the manuscript's title page. If they did not receive the email, they should check their spam/junk folder. Requests to resend the CTA may be sent to [email protected].

4. ACOG uses person-first language. Please review your submission to make sure to center the person before anything else. Examples include: "People with disabilities" or "women with disabilities" instead of

"disabled people" or "disabled women"; "patients with HIV" or "women with HIV" instead of "HIV- positive patients" or "HIV-positive women"; and "people who are blind" or "women who are blind"

instead of "blind people" or "blind women."

5. The journal follows ACOG's Statement of Policy on Inclusive Language (https://www.acog.org/clinical- information/policy-and-position-statements/statements-of-policy/2022/inclusive-language). When possible, please avoid using gendered descriptors in your manuscript. Instead of "women" and

"females," consider using the following: "individuals;" "patients;" "participants;" "people" (not

"persons"); "women and transgender men;" "women and gender-expansive patients;" or "women and all those seeking gynecologic care."

6. 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://www.acog.org/practice- management/health-it-and-clinical-informatics/revitalize-obstetrics-data-definitions and the gynecology data definitions at https://www.acog.org/practice-management/health-it-and-clinical-

informatics/revitalize-gynecology-data-definitions. If use of the reVITALize definitions is problematic, please discuss this in your point-by-point response to this letter.

7. Make sure your manuscript meets the following word limit. The word limit includes the manuscript body text only (for example, the Introduction through the Discussion in Original Research manuscripts), and excludes the title page, précis, abstract, tables, boxes, and figure legends, reference list, and supplemental digital content. Figures are not included in the word count.

Review: 4,000 words

8. Specific rules govern the use of acknowledgments in the journal. Please review the following guidelines and edit your title page as needed:

* All financial support of the study must be acknowledged.

* Any and all manuscript preparation assistance, including but not limited to topic development, data collection, analysis, writing, or editorial assistance, must be disclosed in the acknowledgments.

Such acknowledgments must identify the entities that provided and paid for this assistance, whether directly or indirectly.

* All persons who contributed to the work reported in the manuscript, but not sufficiently to be

authors, must be acknowledged. Written permission must be obtained from all individuals named in the

acknowledgments, as readers may infer their endorsement of the data and conclusions. Please note that

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your response in the journal's electronic author form verifies that permission has been obtained from all named persons.

* If all or part of the paper was presented at the Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists or at any other organizational meeting, that presentation should be noted (include the exact dates and location of the meeting or indicate whether the meeting was held virtually).

* If your manuscript was uploaded to a preprint server prior to submitting your manuscript to Obstetrics & Gynecology, add the following statement to your title page: "Before submission to Obstetrics & Gynecology, this article was posted to a preprint server at: [URL]."

* Do not use only authors' initials in the acknowledgement or Financial Disclosure; spell out their names the way they appear in the byline.

9. Be sure that each statement and any data in the abstract are also stated in the body of your

manuscript, tables, or figures. Statements and data that appear in the abstract must also appear in the body text for consistency. Make 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 manuscript.

In addition, the abstract length should follow journal guidelines. Please provide a word count.

Reviews: 300 words

10. Only standard abbreviations and acronyms are allowed. A selected list is available online at

http://edmgr.ovid.com/ong/accounts/abbreviations.pdf. 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.

11. The journal does not use the virgule symbol (/) in sentences with words, except with ratios. 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.

12. 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.

Please standardize the presentation of your data throughout the manuscript submission. For P values, do not exceed three decimal places (for example, "P = .001").

Express all percentages to one decimal place (for example, 11.1%"). Do not use whole numbers for

percentages.

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13. Please review the journal's Table Checklist to make sure that your tables conform to journal style.

The Table Checklist is available at http://edmgr.ovid.com/ong/accounts/table_checklist.pdf.

14. Please review examples of our current reference style at

https://edmgr.ovid.com/ong/accounts/ifa_suppl_refstyle.pdf. 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 formal reference list. Please cite them on the line in parentheses.

If you cite ACOG documents in your manuscript, be sure the references you are citing are still current and available. Check the Clinical Guidance page at https://www.acog.org/clinical (click on "Clinical Guidance" at the top). If the reference is still available on the site and isn't listed as "Withdrawn," it's still a current document. In most cases, if an ACOG document has been withdrawn, it should not be

referenced in your manuscript.

Please make sure your references are numbered in order of appearance in the text.

15. Figures

Figure 1: Please check or explain n values (total in first box is 4, 668; total in first exclusion box is 308).

Figures 2-5 may be resubmitted as-is, unless changes have been requested by the Statistical Editor.

16. 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.

17. 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 http://links.lww.com/LWW-ES/A48.

The cost for publishing an article as open access can be found at https://wkauthorservices.editage.com/open-access/hybrid.html.

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.

***

If you choose to revise your manuscript, please submit your revision through Editorial Manager at

http://ong.editorialmanager.com. Your manuscript should be uploaded as a Microsoft Word document.

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Your revision's cover letter should include a point-by-point response to each of the received comments in this letter. Do not omit your responses to the EDITOR COMMENTS (if applicable), the REVIEWER COMMENTS, the STATISTICAL EDITOR COMMENTS (if applicable), or the EDITORIAL OFFICE COMMENTS.

If you submit a revision, we will assume that it has been developed in consultation with your coauthors and that each author has given approval to the final form of the revision.

Again, your manuscript will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Sep 02, 2022, we will assume you wish to withdraw the manuscript from further consideration.

Sincerely,

John O. Schorge, MD