Embed Size (px)
Citation preview
NOTICE: This document contains correspondence generated during peer review and subsequent
revisions but before transmittal to production for composition and copyediting:
• Comments from the reviewers and editors (email to author requesting revisions)
• Response from the author (cover letter submitted with revised manuscript)*
*The corresponding author has opted to make this information publicly available.
Personal or nonessential information may be redacted at the editor’s discretion.
Questions about these materials may be directed to the Obstetrics & Gynecology editorial office:
Date: Jan 06, 2020To: "Lisa Haddad" From: "The Green Journal" [email protected]: Your Submission ONG-19-2197
RE: Manuscript Number ONG-19-2197
Trichomonas vaginalis in Pregnancy: Patterns and Predictors of Testing, Infection, and Treatment
Dear Dr. Haddad:
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 14 days from the date of this letter. If we have not heard from you by Jan 20, 2020, we will assume you wish to withdraw the manuscript from further consideration.
REVIEWER COMMENTS:
Reviewer #1: This is a retrospective study looking at the factors associated with diagnosis and treatment of Trichomonas during pregnancy. The associated pregnancy complications and high rate of asymptomatic infection make this a relevant topic for obstetricians. A total of 3174 women were included in this study, defined by delivery during the study period. 76% of these women were tested for Trichomonas at least once during the pregnancy. The article is well-written and easy to follow. The primary limitation of this study is the lack of true prevalence, as not all women were tested and criteria for testing are not clear.
1. The Introduction makes a compelling argument for the importance of this topic. 81 - testing of women in corrections is mentioned. What is the recommendation for these women? 96 - This study is not truly designed to evaluate for risk factors for testing positive because not all women were tested. It is not known what percentage of women who were not tested were positive and whether factors associated with testing positive in this group are similar or not.
2. Materials and Methods104 - Please describe methods of data abstraction. Who performed the abstraction, and was this through manual chart review or other electronic records search? How were eligible deliveries identified and multiples or second deliveries identified?
3. Results 170 - 3265 women noted as included here. The abstract refers to 3174 women included. Please explain the discrepancy 204 - 207 women were diagnosed by NAAT alone. Does this include women with a discrepant wet mount result? How many women were tested with both modalities? 229 - Only 24% of women tested complained of vaginal discharge. What were the indications for testing for other 76% of women? 55% of women who tested positive did not have abnormal discharge according to Table 1. What decision was made to test these women? If these were otherwise asymptomatic women undergoing routine screening, this seems a significant potential impact of routine screening. Would be interesting to look at factors associated with women who were asymptomatic but tested positive.
4. Discussion 251 - This study did not fully identify risk factors for infection as the number of individuals with infection who were not tested is not known. 283 - Given the greater time to treatment with NAAT and the high specificity of wet mount, do the authors recommend a reflex approach?
View Letter
6 1/21/2020, 1:33 PM
5. Table 1Could consider dividng this table into two as the second half of the table (test result) is a subset of the first (those tested). This table is also very long. Consider eliminating variables with low occurrence (h/o SAB) or with limited biologically plausible relationship (e.g. asthma, unless truly suspected to be related).
Figure 1 Numbers of eligible women again do not agree, 3174 listed here. Showing the 755 women with no testing to the right suggests they were not included in analysis. Consider a separate branch placing these women adjacent to those with documented testing.
Reviewer #2: This a retrospective cohort study of pregnant women delivering at Grady Hospital evaluating the predictors of trichomonas testing and diagnosis. The strengths of this study include a large sample size from a high risk population using a relatively new testing modality (NAAT). The manuscript is well written, and brings attention to a very common STI that is often forgotten. The study is limited by being retrospective and limited to a single institution.
1) Materials/methods, paragraph 2, last sentence: Were multiple gestations (twins, triples) excluded? Figure 1 makes it seem like they are, but this is not mentioned in the methods or results. If they are excluded, what was the rationale, as this is not a study evaluating pregnancy or neonatal outcomes?
2) Results, paragraph 3, sentence 2 (and also table 1): I am concerned regarding how "abnormal vaginal discharge" was coded in the analysis (32% vs. 0%) for trichomonas testing. Did you only collect the presence of vaginal discharge complaint on those patients that received a trichomonas test. Were there patients in the cohort that had vaginal discharge and did not get a trichomonas test? Was this not feasible? Please clarify. And if the charts with trichomonas tests were only reviewed, then please note this as a limitation in the conclusion.
3) Table 1: I recommend removing the first 3 rows of the table about the specific trichomonas tests used and place it as a sentence in the results. The formatting of this table makes it very difficult to read in current submission.
4) Results, paragraphs 3 and 5: I would recommend consistently report percentages and p-values with the clinical and demographic predictors listed for both trichomonas testing and trichomonas diagnosis.
5) Results, paragraph 4, second to last sentence: "Due to the distribution of vaginal symptoms" please clarify what this means.
6) Conclusion, final paragraph, second to last sentence: This sentence is unnecessary.
7) Conclusion, final paragraph, final sentence: I recommend noting in this sentence that the high prevalence of trichomonas found in this study of pregnant women as a reason needed for the future research priorities listed.
Reviewer #3: Review of Manuscript ONG-19-2197 "Trichomonas vaginalis in Pregnancy: Patterns and predictors of testing, infection, and treatment"
Kim and colleagues have reported on 2-year data from Atlanta that evaluated the incidence of testing, positive test results and evaluated other potential variables in a relatively large group of pregnant women that were evaluated for trichomonas. In general the authors were clear and to the point with the objective and findings of their study. A STROBE checklist for this retrospective cohort was included I have the following questions and or comments.
Title - Consider noting in the title that this is from a referral center or safety net hospital.
Précis - Since you evaluated only trichomonas I would remove the comment about it being the most common non-viral STI, which to me almost suggested that the paper evaluated multiple STIs but rather focused only on trichomonas.
Abstract - I think you can combine the 2 sentences in the objective to 1. Consider including the strongest aRR in the abstract.
Introduction - Line 81 - perhaps "…correction facilities." Line 87 - What is considered the gold standard in clinical practice (You comment later that you used NAAT as the gold standard to calculate pertinent variables and not in discussion NAAT is gold standard but please consider noting in the intro as well)? Would be important to state if either test is or neither are.
Methods - Line 113 - how would a woman that had testing from an outside facility and then moved into the catchment area be handled for this study? Line 117 - What is there were discordant results - did you consider analyzing these
View Letter .
2 of 6 1/21/2020, 1:33 PM
patients separately? What did you select a p value of < 0.20 rather than 0.10 for inclusion?
Results - Did you consider reporting means and St Dev for measure of central tendency as this is a relatively large sample size? Consider including the pertinent p values for the statistically different variables you comment upon for instance in the paragraph starting at line 180. Line 215 paragraph - 95% Cis are often reported with the OR or RR per convention and please consider adding this information so readers do not have to turn to the table to obtain. Discussion - The strengths and limitations of the study were saved for the last paragraph. If possible, it may be better to have this as the penultimate paragraph and then have a new concluding paragraph.
Tables - I found Table 1 hard to read as constructed. The data seems reasonable but again the presentation hindered my review. Table 2 much easier to read as was Table 3.
Figures - There appears to be an issue in the bottom left corner of figure 1. Not sure that figure 2 is needed. Could be supplementary.
STATISTICAL EDITOR COMMENTS:
The Statistical Editor makes the following points that need to be addressed:
General: Sensitivity and specificity are cited in Abstract and in text, but there should be CIs included with these estimates, and they are important enough to include in a separate Table.
Tables 2,3: Need to cite the variables included in the final model. Using the various factors identified in Tables 2 and 3, if one were to use some combination of them, then what proportion of women could have been (1) predicted to have been tested and (2) been predicted as having a (+) test? It seems that the latter is particularly important, since the overall prevalence among those tested was 15%, so any clinically useful parameters to increase the efficiency of testing would be useful. Or, if the variables are statistically associated, but the false positives and false negatives are unfavorable, then how can this information be applied to improve testing?
Fig 2: Need to use more informative terms for title and y-axis. Need to include "N" for number at the various time points along the x-axis for each group.
EDITOR COMMENTS:
We no longer require that authors adhere to the Green Journal format with the first submission of their papers. However, any revisions must do so. I strongly encourage you to read the instructions for authors (the general bits as well as those specific to the feature-type you are submitting). The instructions provide guidance regarding formatting, word and reference limits, authorship issues, and other things. Adherence to these requirements with your revision will avoid delays during the revision process, as well as avoid re-revisions on your part in order to comply with the formatting. Please use the STARD guidelines, as specified in the instructions for authors for reports of diagnostic testing.
Line 44: The abstract objective should be a single “To” statement; you can combine the two that you have.
Line line 49: How was it decided which test was done. This is not clear in your abstract. Also, please state in the methods something about selective testing rather than universal. Also, important to tell us if the testing with NAAT was ONLY for trich or was it a panel? Clearly, a wet mount could also test for BV and candida.
Line 61: Your abstract results need more data. I’ve suggested some—word count of course needs to be considered. Put what you think is the most important data in the abstract. Please tell us in the results section how many tested + by each test and how many of each test were done. This should come before the results of the testing…. something like ;
x/2419 were tested by wet microscopy only and there were y/x positive results. z/2419 were tested by NAAT with a/z results. b/2419 were tested both ways with a positive result on either of c/b; positive for wet mount only in xxxx and NAAT only in……Then tell us sensistivity and specificity. You can leave out treatment line (59) as that does not seem relevant to your objectives. Line 63: how do you know if this is reinfection or persistence? Line 64: How was BV diagnosed?
Line 73: One of your reviewers suggested removing “non-viral” here and elsewhere. I think it is fine and important here.
View Letter
3 of 6 1/21/2020, 1:33 PM
Line 81: Is “in corrections” the accepted terminology? It seems odd. “Incarcerated women” seems clearer.
Line 83: Please provide the full name for the CDC. Line 84—please make it clear that you mean verticle transmission of HIV—it’s implied but not stated.
Line 88-can you give some information (as you did for microscopy) about why NAAT is not ideal?
Line 102: Please describe any guidelines for testing. Is there a preference for wetmount v NAAT? Does the provider perform the wetmount herself and do providers who do this undergo CLIA certification?
Line177 Since there are clear recommendations for screening for trich and other sti’s in women with HIV can you do an analysis without the HIV positive women?
Line 180: Throughout the results section, please provide statistical data to support qualitative descriptions of differences in variables. As written, we can easily observe numeric differences, but statistical differences are unstated.
P Values vs Effect Size and Confidence IntervalsWhile P values are a central part of inference testing in statistics, when cited alone, often the strength of the conclusion can be misunderstood. Whenever possible, 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.This is true for the abstract as well as the manuscript, tables and figures.
Please provide absolute values for variables, in addition to assessment of statistical significance.
We ask that you provide crude OR’s followed by adjusted OR’s for all variables.
Line 202: Journal style does not include the virgule (/) except in numeric expressions. Please edit here and throughout the paper. This is a much clearer description of your data regarding positive tests. Please consider my recommendations above in the abstract section.
Line 217: increase compared to what?
Line 229: Is this 24% of allo women or just 24% of those with z+ test?
Line 256: Please consider that some of these may have been persistent and not reinfections, related to resistance to the drug, incomplete medication use, or never starting meds. You persistently call this reinfection, but in this section, you do mention the possibility of persistence, Please add this as possibility when ever you simply describe this as reinfection. ‘Line 270: is this a theory or well substantiated?
Line 303: Should the partner be offered therapy when the patient is treated?
Your reference #24 is the NEJM article reporting the MFMU trial showing increased risks of preterm birth for women screened for trich and treated with metronidazole, which has been the primary narrative against the practice of screening and treating. Your objective of this paper is not to show an improved outcome with treatment, but you really don't address the MFMU results. Is there more recent data to suggest that one should screen asymptomatic women and treat them? Have any high quality papers demonstrated an improvement in outcome? If not, it's hard to justify this approach. This needs to be addressed thoroughly in your revision.
EDITORIAL OFFICE 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. B. OPT-OUT: No, please do not publish my point-by-point response letter.
2. As of December 17, 2018, Obstetrics & Gynecology has implemented an "electronic Copyright Transfer Agreement" (eCTA) and will no longer be collecting author agreement forms. 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
View Letter
6 1/21/2020, 1:33 PM
you will be walked through the various questions that comprise the eCTA. Each of your coauthors will receive an email from the system requesting that they review and electronically sign the eCTA.
Please check with your coauthors to confirm that the disclosures listed in their eCTA forms are correctly disclosed on the manuscript's title page.
3. 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 and gynecology data definitions at https://www.acog.org/About-ACOG/ACOG-Departments/Patient-Safety-and-Quality-Improvement/reVITALize. If use of the reVITALize definitions is problematic, please discuss this in your point-by-point response to this letter.
4. 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.
5. Specific rules govern the use of acknowledgments in the journal. Please note the following guidelines:
* 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 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).
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 limits for different article types are as follows: Original Research articles, 300 words. Please provide a word count.
7. 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.
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.
9. 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%").
10. Please review the journal's Table Checklist to make sure that your tables conform to journal style. The Table Checklist is available online here: http://edmgr.ovid.com/ong/accounts/table_checklist.pdf.
11. 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
View Letter
5 of 6 1/21/2020, 1:33 PM
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 via the Clinical Guidance & Publications page at https://www.acog.org/Clinical-Guidance-and-Publications/Search-Clinical-Guidance.
12. Figures
Figure 1: Are items in the final box (NAAT only, wet prep only, etc.) not mutually exclusive?
Figure 2: Please upload as a high res figure file (eps, tiff, jpeg, etc.).
13. 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 http://edmgr.ovid.com/acd/accounts/ifauth.htm.
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.
14. If you choose to revise your manuscript, please submit your revision through Editorial Manager at http://ong.editorialmanager.com. Your manuscript should be uploaded in a word processing format such as Microsoft Word. Your revision's cover letter should include the following: * A confirmation that you have read the Instructions for Authors (http://edmgr.ovid.com/ong/accounts/authors.pdf), and * A point-by-point response to each of the received comments in this letter.
If you submit a revision, we will assume that it has been developed in consultation with your co-authors and that each author has given approval to the final form of the revision.
Again, your paper will be maintained in active status for 14 days from the date of this letter. If we have not heard from you by Jan 20, 2020, we will assume you wish to withdraw the manuscript from further consideration.
Sincerely,
Nancy C. Chescheir, MDEditor-in-Chief
2018 IMPACT FACTOR: 4.9652018 IMPACT FACTOR RANKING: 7th out of 83 ob/gyn journals
__________________________________________________In compliance with data protection regulations, you may request that we remove your personal registration details at any time. (Use the following URL: https://www.editorialmanager.com/ong/login.asp?a=r). Please contact the publication office if you have any questions.
View Letter .
6 of 6 1/21/2020, 1:33 PM
January 20th, 2020 Obstetrics & Gynecology Editorial Board Dear Dr. Chescheir and Editorial Board Members, Thank you for the feedback and suggestions to improve our manuscript entitled “Trichomonas vaginalis in Pregnancy: Patterns and Predictors of Testing, Infection, and Treatment.” We have addressed each of the editors’ and reviewers’ comments below and included line numbers for the revisions (based on the tracked changes version). We thank you for your consideration and look forward to hearing from you. Sincerely. Lisa Haddad, MD, MS, MPH Associate Professor Division of Family Planning Department of Gynecology and Obstetrics Emory University School of Medicine
Reviewer #1: This is a retrospective study looking at the factors associated with diagnosis and treatment of Trichomonas during pregnancy. The associated pregnancy complications and high rate of asymptomatic infection make this a relevant topic for obstetricians. A total of 3174 women were included in this study, defined by delivery during the study period. 76% of these women were tested for Trichomonas at least once during the pregnancy. The article is well-written and easy to follow. The primary limitation of this study is the lack of true prevalence, as not all women were tested and criteria for testing are not clear. 1. The Introduction makes a compelling argument for the importance of this topic. 81 - testing of women in corrections is mentioned. What is the recommendation for these women?
• Thank you for this clarification. The recommendation for screening women with HIV or incarcerated women was added.
• “Although 80% of infections are asymptomatic, there are no national recommendations for trichomoniasis screening in HIV negative women, except for incarcerated women, where screening is recommended.” (Lines 175-177)
96 - This study is not truly designed to evaluate for risk factors for testing positive because not all women were tested. It is not known what percentage of women who were not tested were positive and whether factors associated with testing positive in this group are similar or not.
• We hope our statement to examine these risk factors helps identify these patterns rather than define the risk factors
2. Materials and Methods 104 - Please describe methods of data abstraction. Who performed the abstraction, and was this through manual chart review or other electronic records search? How were
eligible deliveries identified and multiples or second deliveries identified?
• We added who the data abstraction was completed by and that the abstraction was performed via manual chart review
• “Data were abstracted from the electronic medical record by manual chart review for all 3,723 deliveries occurring at Grady Memorial Hospital under the care of Emory Department of Gynecology and Obstetrics providers between July 1, 2016 and June 30, 2018. Study data were collected and managed using REDCap electronic data capture tools hosted at Emory University.1 Data abstraction was completed by residents, medical students, and masters in public health students.” (Lines 208-215)
3. Results 170 - 3265 women noted as included here. The abstract refers to 3174 women included. Please explain the discrepancy
• Thank you for bringing this discrepancy to our attention. We have fixed the correct numbers of women identified and included in the study
• “After excluding 375 women with no prenatal care or triage visits at Grady Memorial Hospital and 83 repeat deliveries from the same woman during the study period, 3,265 women were included in the analysis.” (Lines 272-274).
204 - 207 women were diagnosed by NAAT alone. Does this include women with a discrepant wet mount result? How many women were tested with both modalities?
• Thank you for these questions. We combined the testing mechanisms and sensitivities from throughout the results section to be more clear and concise.
• “A total of 2,489 women (76%) were tested for Trichomonas vaginalis by NAAT or wet mount microscopy (Table 2). Of the 366 women with trichomoniasis, 207 (57%) were diagnosed by NAAT alone, 101 (28%) were diagnosed by wet mount alone, and 58 (16%) were positive by both modalities. Sensitivity and specificity of wet mount was 26% and 99%, respectively, for diagnosing trichomoniasis when compared to NAAT.” (Lines 284-288)
229 - Only 24% of women tested complained of vaginal discharge. What were the indications for testing for other 76% of women? 55% of women who tested positive did not have abnormal discharge according to Table 1. What decision was made to test these women? If these were otherwise asymptomatic women undergoing routine screening, this seems a significant potential impact of routine screening. Would be interesting to look at factors associated with women who were asymptomatic but tested positive.
• The 24% of reported vaginal discharge was removed, as it did not fit where in this section of the manuscript. Given the high prevalence of trichomoniasis at our hospital and the ease of adding-on trichomoniasis to our NAAT testing, many more women have been tested under routine prenatal screening. Given our finding that the vast majority of women were asymptomatic at time of diagnosis, we tried to highlight the risk factors for all these women and did not feel strongly these women should be differentiated.
4. Discussion 251 - This study did not fully identify risk factors for infection as the number of individuals with infection who were not tested is not known.
• We hope our high rate of testing in asymptomatic women and our description of
the group not tested in our results help clarify the limitations of the risk factors we identified
283 - Given the greater time to treatment with NAAT and the high specificity of wet mount, do the authors recommend a reflex approach?
• We are unsure if a reflex approach should be used given the percentage of patients treated did not significantly differ, however the reflex approach for testing for trichomoniasis may be beneficial
• “In contrast, the specificity of microscopy was 99%, suggesting a positive wet mount may not require further testing whereas a negative result may be inaccurate.” (Lines 478-479)
5. Table 1 Could consider dividing this table into two as the second half of the table (test result) is a subset of the first (those tested). This table is also very long. Consider eliminating variables with low occurrence (h/o SAB) or with limited biologically plausible relationship (e.g. asthma, unless truly suspected to be related).
• A second table has been created specifically for testing modality and multiple rows of the table with limited biologically plausible relationships have been removed
Figure 1 Numbers of eligible women again do not agree, 3174 listed here. Showing the 755 women with no testing to the right suggests they were not included in analysis. Consider a separate branch placing these women adjacent to those with documented testing.
• Thank you for identifying this discrepancy. We have corrected our numbers and updated our Figure 1.
Reviewer #2: This a retrospective cohort study of pregnant women delivering at Grady Hospital evaluating the predictors of trichomonas testing and diagnosis. The strengths of this study include a large sample size from a high risk population using a relatively new testing modality (NAAT). The manuscript is well written, and brings attention to a very common STI that is often forgotten. The study is limited by being retrospective and limited to a single institution. 1) Materials/methods, paragraph 2, last sentence: Were multiple gestations (twins, triples) excluded? Figure 1 makes it seem like they are, but this is not mentioned in the methods or results. If they are excluded, what was the rationale, as this is not a study evaluating pregnancy or neonatal outcomes?
• Multiple gestations were included in the study and Figure 1 has been corrected. 2) Results, paragraph 3, sentence 2 (and also table 1): I am concerned regarding how "abnormal vaginal discharge" was coded in the analysis (32% vs. 0%) for trichomonas testing. Did you only collect the presence of vaginal discharge complaint on those patients that received a trichomonas test. Were there patients in the cohort that had vaginal discharge and did not get a trichomonas test? Was this not feasible? Please clarify. And if the charts with trichomonas tests were only reviewed, then please note this as a limitation in the conclusion.
• Unfortunately we only collected data regarding the presence of vaginal discharge
in those tested. This limitation has been added to our conclusion.
• “Limitations include retrospective data collection, which limited available variables, symptomatic data only collected from those tested, and potential lack of generalizability given a single site with a high-risk population.” (Lines 530-532)
3) Table 1: I recommend removing the first 3 rows of the table about the specific trichomonas tests used and place it as a sentence in the results. The formatting of this table makes it very difficult to read in current submission.
• The first 3 rows regarding testing have been removed and made into their own separate table in table 2. The columns of the table have been simplified for improved readability.
4) Results, paragraphs 3 and 5: I would recommend consistently report percentages and p-values with the clinical and demographic predictors listed for both trichomonas testing and trichomonas diagnosis.
• Additional statistical data, including percentages and p-values, have been incorporated throughout our results section
5) Results, paragraph 4, second to last sentence: "Due to the distribution of vaginal symptoms" please clarify what this means.
• This sentence has been removed upon further evaluation of not providing added benefit to the paper
6) Conclusion, final paragraph, second to last sentence: This sentence is unnecessary.
• This sentence has been removed 7) Conclusion, final paragraph, final sentence: I recommend noting in this sentence that the high prevalence of trichomonas found in this study of pregnant women as a reason needed for the future research priorities listed.
• The statement regarding the high prevalence of trichomoniasis found in our study has been added to the last sentence of our paper
• “Given the high prevalence of trichomoniasis of pregnant women found in this study, future directions for research include investigating the effect of trichomoniasis and treatment on perinatal outcomes, the impact of partner treatment, and further elucidation of how treatment may affect the vaginal microbiome.” (Lines 534-537)
Reviewer #3: Review of Manuscript ONG-19-2197 "Trichomonas vaginalis in Pregnancy: Patterns and predictors of testing, infection, and treatment" Kim and colleagues have reported on 2-year data from Atlanta that evaluated the incidence of testing, positive test results and evaluated other potential variables in a relatively large group of pregnant women that were evaluated for trichomonas. In general the authors were clear and to the point with the objective and findings of their study. A STROBE checklist for this retrospective cohort was included I have the following questions and or comments. Title - Consider noting in the title that this is from a referral center or safety net hospital.
• Thank you for this suggestion. Given our title is already 96 characters, we
deferred adding this to our title to adhere to the Journal’s character limit. Précis - Since you evaluated only trichomonas I would remove the comment about it being the most common non-viral STI, which to me almost suggested that the paper evaluated multiple STIs but rather focused only on trichomonas.
• We hope to emphasize the importance of trichomoniasis by stating its high prevalence in an accurate manner as the most common STI after HPV.
Abstract - I think you can combine the 2 sentences in the objective to 1. Consider including the strongest aRR in the abstract.
• The two sentences for the objective have been combined.
• “To identify factors associated with being tested for and diagnosed with trichomoniasis in pregnancy and to describe patterns of treatment and tests of reinfection or persistence.” (Lines 48-49)
Introduction - Line 81 - perhaps "…correction facilities." Line 87 - What is considered the gold standard in clinical practice (You comment later that you used NAAT as the gold standard to calculate pertinent variables and not in discussion NAAT is gold standard but please consider noting in the intro as well)? Would be important to state if either test is or neither are.
• Correction facilities has been changed to “incarcerated women.” We added NAAT is the gold standard compared to wet prep.
• “Although 80% of infections are asymptomatic, there are no national recommendations for trichomoniasis screening in HIV negative women, except for incarcerated women, where screening is recommended.” (Line 175-177)
• “Nucleic Acid Amplification Testing (NAAT) is the gold standard given its higher sensitivity, however takes longer to result.” (Lines 183-185)
Methods - Line 113 - how would a woman that had testing from an outside facility and then moved into the catchment area be handled for this study? Line 117 - What is there were discordant results - did you consider analyzing these patients separately? What did you select a p value of < 0.20 rather than 0.10 for inclusion?
• Only women with a trichomoniasis result at our facility were included in our study population. There were many negative wet preps with positive NAATs, however only one NAAT that was negative with a positive wet prep. We used a p<0.20 rather than 0.10 for inclusion because given our sample size, we wanted to be more inclusive with the variables. Unfortunately, our study was not designed to evaluate discordant results. Given previous data stating the low sensitivity of wet prep, we did not feel these data would be comparable. We also found women with symptoms were more likely to receive a wet prep, therefore concerned these data would be skewed.
Results - Did you consider reporting means and St Dev for measure of central tendency as this is a relatively large sample size? Consider including the pertinent p values for the statistically different variables you comment upon for instance in the paragraph starting at line 180. Line 215 paragraph - 95% Cis are often reported with the OR or RR per convention and please consider adding this information so readers do not have to turn to the table to obtain.
• P-values and additional statistical data have been added throughout the results section. CIs have been added to reported aRRs.
Discussion - The strengths and limitations of the study were saved for the last paragraph. If possible, it may be better to have this as the penultimate paragraph and then have a new concluding paragraph.
• We hope the addition of the start of our last sentence restating the high prevalence of trichomoniasis found in our study helps better summarize our paper.
• “Given the high prevalence of trichomoniasis of pregnant women found in this study, future directions for research include investigating the effect of trichomoniasis and treatment on perinatal outcomes, the impact of partner treatment, and further elucidation of how treatment may affect the vaginal microbiome.” (Lines 534-537)
Tables - I found Table 1 hard to read as constructed. The data seems reasonable but again the presentation hindered my review. Table 2 much easier to read as was Table 3.
• Table 1 has been separated into two tables and multiple rows removed. We hope this improves the clarity and readability of the table.
Figures - There appears to be an issue in the bottom left corner of figure 1. Not sure that figure 2 is needed. Could be supplementary.
• Figure 1 has been reconstructed to avoid formatting errors. Figure 2 will be included in the supplementary section of our submission.
STATISTICAL EDITOR COMMENTS: The Statistical Editor makes the following points that need to be addressed: General: Sensitivity and specificity are cited in Abstract and in text, but there should be CIs included with these estimates, and they are important enough to include in a separate Table.
• A separate table has been made regarding testing modality and the sensitivity and specificity (Table 2). The confidence intervals for these numbers have been added to the results section.
• “Sensitivity and specificity of wet mount was 26% (CI 18-34%) and 99% (CI 98-99%), respectively, for diagnosing trichomoniasis when compared to NAAT.” (Lines 292-293)
Tables 2,3: Need to cite the variables included in the final model. Using the various factors identified in Tables 2 and 3, if one were to use some combination of them, then what proportion of women could have been (1) predicted to have been tested and (2) been predicted as having a (+) test? It seems that the latter is particularly important, since the overall prevalence among those tested was 15%, so any clinically useful parameters to increase the efficiency of testing would be useful. Or, if the variables are statistically associated, but the false positives and false negatives are unfavorable, then how can this information be applied to improve testing?
• Thank you for this comment. From our study, we found we are not great at predicting who will be trichomoniasis positivity, therefore enhanced screening may be valuable. We hope that we will be able to narrow our screening and optimize the use of NAAT for testing.
Fig 2: Need to use more informative terms for title and y-axis. Need to include "N" for number at the various time points along the x-axis for each group.
• Thank you for this feedback. Figure 2 has been updated to include “N” numbers along the x-axis.
EDITOR COMMENTS: We no longer require that authors adhere to the Green Journal format with the first submission of their papers. However, any revisions must do so. I strongly encourage you to read the instructions for authors (the general bits as well as those specific to the feature-type you are submitting). The instructions provide guidance regarding formatting, word and reference limits, authorship issues, and other things. Adherence to these requirements with your revision will avoid delays during the revision process, as well as avoid re-revisions on your part in order to comply with the formatting. Please use the STARD guidelines, as specified in the instructions for authors for reports of diagnostic testing.
• The Instructions for Authors, specifically for original research cohort studies, has been reviewed and formatting incorporated into our manuscript.
• STARD guidelines have been reviewed and incorporated into sections discussing the sensitivity and specificity of wet prep compared to NAAT. In addition, figure 1 has been reformatted according to the prototypical STARD flowchart.
Line 44: The abstract objective should be a single “To” statement; you can combine the two that you have.
• The two sentences have been combined to be a single objective statement
• “To identify factors associated with testing for and diagnosis of trichomoniasis in pregnancy and to describe patterns of treatment and tests of reinfection or persistence.” (Lines 48-49)
Line line 49: How was it decided which test was done. This is not clear in your abstract. Also, please state in the methods something about selective testing rather than universal. Also, important to tell us if the testing with NAAT was ONLY for trich or was it a panel? Clearly, a wet mount could also test for BV and candida.
• A sentence clarifying when testing was performed (routine prenatal or for symptomatic visits) was added. We also specified testing with NAAT was performed via panel. NAAT testing only for trichomoniasis was performed for test of reinfections.
• “Testing for Trichomonas vaginalis was by wet mount microscopy or nucleic acid amplification testing (NAAT) for routine prenatal testing or symptomatic visits.” (Lines 52-53)
Line 61: Your abstract results need more data. I’ve suggested some—word count of course needs to be considered. Put what you think is the most important data in the abstract. Please tell us in the results section how many tested + by each test and how many of each test were done. This should come before the results of the testing…. something like;
x/2419 were tested by wet microscopy only and there were y/x positive results. z/2419 were tested by NAAT with a/z results. b/2419 were tested both ways with a positive result on either of c/b; positive for wet mount only in xxxx and NAAT only in……Then tell us sensistivity and specificity. You can leave out treatment line (59) as that does not seem relevant to your objectives.
• Thank you for this very helpful phrasing. The test results for each modality has been included in the abstract followed by the sensitivity and specificity. The treatment line has been removed.
• “Of those, 1,808 (55%) were tested by wet mount microscopy and 1,661 (52%) by NAAT with 6% and 13% positive results, respectively. __ were tested with both methods with only _ of the wet preps being positive with a positive NAAT. The sensitivity for microscopy versus NAAT was 26% with a specificity of 99%.” (Lines 57-61)
Line 63: how do you know if this is reinfection or persistence?
• We are unsure if this is due to reinfection or persistence, however further explain these results in the discussion section.
Line 64: How was BV diagnosed?
• Bacterial vaginosis diagnosis by wet prep or culture was added to the methods section
• “Bacterial vaginosis was diagnosed by wet prep or culture.” (Lines 230-231) Line 73: One of your reviewers suggested removing “non-viral” here and elsewhere. I think it is fine and important here.
• “non-viral” was kept in the introduction
• “Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) in the United States and is more prevalent than chlamydia and gonorrhea combined.” (Lines 169-170)
Line 81: Is “in corrections” the accepted terminology? It seems odd. “Incarcerated women” seems clearer.
• “In corrections” was changed to “incarcerated women.”
• “Although 80% of infections are asymptomatic, there are no national recommendations for trichomoniasis screening in HIV negative women, except for incarcerated women.” (Lines 175-177)
Line 83: Please provide the full name for the CDC.
• The full name of the CDC has been included
• “Routine screening for trichomoniasis is recommended by the Centers for Disease Control and Prevention (CDC) for all women living with HIV as treatment of pregnant women reduces the risk of vertical transmission of HIV and decreases viral shedding in the genital tract.” (Lines 177-178)
Line 84—please make it clear that you mean vertical transmission of HIV—it’s implied but not stated.
• “vertical transmission of HIV” was clarified
• “Routine screening for trichomoniasis is recommended by the Centers for Disease Control and Prevention (CDC) for all women living with HIV as treatment
of pregnant women reduces the risk of vertical transmission of HIV and decreases viral shedding in the genital tract.” (Lines 177-180)
Line 88-can you give some information (as you did for microscopy) about why NAAT is not ideal?
• A sentence regarding the increased length of time to result was added to the cons of NAAT
• “Nucleic Acid Amplification Testing (NAAT) is the gold standard given its higher sensitivity, however takes longer to result. The risk of reinfection or persistence has been previously reported to be up to 44% in pregnant populations.” (Lines 183-185)
Line 102: Please describe any guidelines for testing. Is there a preference for wetmount v NAAT? Does the provider perform the wetmount herself and do providers who do this undergo CLIA certification?
• There are no specific guidelines regarding which type of testing a provider should start with and providers perform their own wet mounts. These statements have been added to the methods section. Providers do not undergo CLIA certification
• “Of note, there were no specific guidelines regarding the modality or order of testing performed for trichomoniasis. Wet mounts were performed by the provider during the patient’s visit and results documented in the patient’s record. NAAT cervical or vaginal swab, collected by providers for the diagnosis of trichomoniasis, chlamydia, and gonorrhea, became available at Grady Memorial Hospital on April 1, 2016 (just prior to the start of the study period).” (Lines 224-226)
Line177 Since there are clear recommendations for screening for trich and other sti’s in women with HIV can you do an analysis without the HIV positive women?
• Thank you for this comment. Given the low number of women with HIV included in our analysis, an analysis excluding them did not
• A comment to include this analysis has been added to our methods.
• “Sensitivity analysis was performed excluding HIV positive women and results did not differ substantively from those presented (data not shown).” (Lines 230-233)
Line 180: Throughout the results section, please provide statistical data to support qualitative descriptions of differences in variables. As written, we can easily observe numeric differences, but statistical differences are unstated. P Values vs Effect Size and Confidence Intervals While P values are a central part of inference testing in statistics, when cited alone, often the strength of the conclusion can be misunderstood. Whenever possible, 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. This is true for the abstract as well as the manuscript, tables and figures.
Please provide absolute values for variables, in addition to assessment of statistical significance. We ask that you provide crude OR’s followed by adjusted OR’s for all variables.
• Confidence intervals, risk rations, and p-values have been added to the abstract and throughout the results section. P-values are no longer presented alone, however with a risk ratio
Line 202: Journal style does not include the virgule (/) except in numeric expressions. Please edit here and throughout the paper. This is a much clearer description of your data regarding positive tests. Please consider my recommendations above in the abstract section.
• All “/” have been removed from the manuscript. The recommendations for the abstract section have been incorporated.
Line 217: increase compared to what?
• One-month increase from the start of the study period has been clarified
• “In multivariable Poisson regression, the following variables were associated with positive Trichomonas vaginalis infection: abnormal vaginal discharge (aRR 1.45, p<0.01), black race (aRR 2.62, p<0.01), date of delivery (aRR one-month increase from July 2016 1.02, p<0.01),” (Lines 340-342)
Line 229: Is this 24% of all women or just 24% of those with z+ test?
• This sentence was removed from this section of the manuscript given it was discussed in a prior section.
Line 256: Please consider that some of these may have been persistent and not reinfections, related to resistance to the drug, incomplete medication use, or never starting meds. You persistently call this reinfection, but in this section, you do mention the possibility of persistence, Please add this as possibility when ever you simply describe this as reinfection.
• Persistence has been added to sections discussing reinfection. When “test of reinfection” has been used, we maintained this name while also including “test of cure.” In parts regarding the reasoning for persistent infection, persistence has been added as a reason for a positive result.
• High rates of reinfection or persistence may reflect either re-exposure (untreated current partner or new partners), barriers to antibiotic adherence, or poor efficacy of current treatment regimens.” (Lines 394-396)
Line 270: is this a theory or well substantiated?
• The theory of treating trichomoniasis precipitating PTL has been clarified as a theory.
• “Mechanistically, treatment of trichomoniasis has been thought to precipitate preterm labor via toxin release or alterations to the vaginal microbiome.” (Lines 416-418)
Line 303: Should the partner be offered therapy when the patient is treated?
• We added the use of partner treatment is not recommended in the US and requires further evidence. We also mention that partner therapy has not been
studied in pregnant women.
• “A positive test three months after treatment could be due to inadequate treatment, nitroimidazole resistance, or lack of partner treatment.2 The use of partner treatment with trichomoniasis requires further evidence as it is not recommended in the U.S.” (Lines 490-492)
• “Partner therapy for trichomoniasis has not been studied in pregnant women,3 representing another avenue for future research.” (Lines 526-528)
Your reference #24 is the NEJM article reporting the MFMU trial showing increased risks of preterm birth for women screened for trich and treated with metronidazole, which has been the primary narrative against the practice of screening and treating. Your objective of this paper is not to show an improved outcome with treatment, but you really don't address the MFMU results. Is there more recent data to suggest that one should screen asymptomatic women and treat them? Have any high quality papers demonstrated an improvement in outcome? If not, it's hard to justify this approach. This needs to be addressed thoroughly in your revision.
• Thank you for this comment. Unfortunately, we failed to find high quality papers demonstrating improved outcomes with treating trichomoniasis. We further described our critiques of the NEJM article compared to current recommendations and recommended further studies be performed to evaluate this interesting relationship.
• “One randomized trial investigating the treatment of asymptomatic trichomoniasis found an increased risk of preterm labor in treated women.24 However, this study diagnosed trichomoniasis with culture and used a treatment regimen of eight grams of metronidazole over more than two weeks.7 Culture has a sensitivity of 75-96% compared to NAAT,25 and the dose of metronidazole in this study was four times greater than the current recommended dose of two grams once. Mechanistically, trichomoniasis treatment has been thought to precipitate preterm labor via toxin release or alterations to the vaginal microbiome.24 However, randomized controlled trials have not evaluated the effect of current testing and treatment regimens on preterm birth. Further studies are needed to clarify the mechanism between trichomoniasis and perinatal outcomes.” (Lines 411-420)
EDITORIAL OFFICE 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. B. OPT-OUT: No, please do not publish my point-by-point response letter.
• A OPT-IN: Yes, please publish my point-by-point response letter. 2. As of December 17, 2018, Obstetrics & Gynecology has implemented an "electronic Copyright Transfer Agreement" (eCTA) and will no longer be collecting author
agreement forms. 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 through the various questions that comprise the eCTA. Each of your coauthors will receive an email from the system requesting that they review and electronically sign the eCTA. Please check with your coauthors to confirm that the disclosures listed in their eCTA forms are correctly disclosed on the manuscript's title page. 3. 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 and gynecology data definitions at https://www.acog.org/About-ACOG/ACOG-Departments/Patient-Safety-and-Quality-Improvement/reVITALize. If use of the reVITALize definitions is problematic, please discuss this in your point-by-point response to this letter. 4. 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. 5. Specific rules govern the use of acknowledgments in the journal. Please note the following guidelines: * 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 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). 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 limits for different article types are as follows: Original Research articles, 300 words. Please provide a word count.
7. 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. 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. 9. 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%"). 10. Please review the journal's Table Checklist to make sure that your tables conform to journal style. The Table Checklist is available online here: http://edmgr.ovid.com/ong/accounts/table_checklist.pdf. 11. 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 via the Clinical Guidance & Publications page at https://www.acog.org/Clinical-Guidance-and-Publications/Search-Clinical-Guidance. 12. Figures Figure 1: Are items in the final box (NAAT only, wet prep only, etc.) not mutually exclusive?
• Figure 1 has been updated according to the STARD guidelines. Table 2 now has
the breakdown of type of testing and their results Figure 2: Please upload as a high res figure file (eps, tiff, jpeg, etc.). 13. 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 http://edmgr.ovid.com/acd/accounts/ifauth.htm. 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. 14. If you choose to revise your manuscript, please submit your revision through Editorial Manager at http://ong.editorialmanager.com. Your manuscript should be uploaded in a word processing format such as Microsoft Word. Your revision's cover letter should include the following: * A confirmation that you have read the Instructions for Authors (http://edmgr.ovid.com/ong/accounts/authors.pdf), and * A point-by-point response to each of the received comments in this letter. If you submit a revision, we will assume that it has been developed in consultation with your co-authors and that each author has given approval to the final form of the revision. Again, your paper will be maintained in active status for 14 days from the date of this letter. If we have not heard from you by Jan 20, 2020, we will assume you wish to withdraw the manuscript from further consideration.
