I would like to see a cost analysis of this to really justify the use of antibiotics in these cases. Journal style does not include the use of commas (/) except in numeric expressions. Please write or insert the page numbers where each item appears in the checklist margin.
Abbreviations and acronyms should be spelled out the first time they are used in the abstract and again in the body of the manuscript. The authors acknowledge the inherent limitations of a retrospective study and have addressed them in the limitations section of the Discussion. There were 8 SSIs within the entire cohort of patients who underwent chromopertubation; 7 of the patients received perioperative antibiotics (5 superficial SSIs and 2 organ/space SSIs).
Lines 254-255 ; The wide confidence interval around your aOR decreases the precision of your measurement
Was the use of hemostatic agents a significant predictor of infectious morbidity? The Green Journal has published that the use of gel-thrombin matrix may increase this
The discussion section is overall too long and wordy and should be cut down to focus on the specific findings and their implications
The limitations of your discussion should be further expounded upon to reference the above mentioned criticisms
Lines 348-350; This sentence should be toned down- a retrospective review is not enough to change guidelines particularly when this particular one may be skewed in ints interpretation
Reviewer #2: This is a large retrospective study examining the infectious outcomes following myomectomy by any route, with respect to administration of prophylactic antibiotics
In this study, patients who received ANY antibiotics before or during the event were included in the group of those who received antibiotics. Please refer to rules 276-278 for our definition of high risk factors which include any of the following. Patients were categorized as “high risk” if any of the aforementioned characteristics were met and a composite variable was created to control for in the regression analysis.
90-91, whether there is a distinction between "postoperative infectious outcomes" and "surgical site infection" for the purpose of this study. Yes, we collected data on all postoperative infectious outcomes, including surgical site infections; surgical site is our primary outcome of interest. Infections that were not surgical site infections were primarily urinary tract infections and fevers of unknown origin treated with antibiotics.
Analyzes performed report results for postoperative infections as a whole, in addition to a separate analysis of surgical site infection. Thanks for this interesting point, but we respectfully clarify that our study includes surgeries performed between 2009-2016 before the recent updated ACOG publication, so it may not reflect the June 2018 guidelines. , but then you would receive it during the case if the situation changed and the surgeon decided to give it.
Thanks for the clarification point; we have included patients who received ANY antibiotics before or during the case were included in the cohort of those who received antibiotics. There were no occult leiomyosarcomas found in our study and this has been added to the results section, line 356.
The study defines infections as minor or major and also uses the classification language of SSI. In this study, patients who received any antibiotics before or during the case were included in the cohort of those who received antibiotics, and data on the time of antibiotic administration were not collected. Interestingly, the rate of endometrial cavity entry was higher in the no-antibiotic group, suggesting that the decision to administer antibiotics was made early in the case before intraoperative findings such as cavity entry.
239-40 Regarding minor vs major, this appears to place deep incisional infections of SSI in the minor group. It may be that surgeons are wary of this postoperative fever which can create a clinical dilemma, therefore they may choose to administer perioperative / prophylactic antibiotics in attempts to avoid it, although it is often non-infectious in etiology as described in the original manuscript not. Yes; 100% of the patients who received antibiotics for fever of unknown origin also received perioperative antibiotics.
317-319 It is difficult to tell from looking at the tables whether there were infections in the patients who underwent hysteroscopic approach and, if so, how those infections were classified. As touched upon in the discussion, it may be that the findings of the study have the potential to be more pronounced outside of a tertiary care center with subspecialists. There was a relationship between subspecialty and the decision for antibiotics; REI surgeons operated on 72% of the antibiotic group and MIGS surgeons operated on 59% of the group that did not receive antibiotics.
The authors acknowledge the limitation of including those without a formal postoperative visit in the no-SSI group and it is possible that they may have gone outside for care. I think this article has merits, but the final picture of the data is clouded by insufficient control.
STATISTICAL EDITOR COMMENTS
It should not include those without a postoperative visit in any SSI group who may have gone to outpatient treatment. In lines 215 through 218, adjust the comparisons for the method of myomectomy—abdominal, laparoscopic, robotic, hysteroscopic. In lines 218 to 221, entry into the endometrial cavity and use of chromotubation should be adjusted for the number of fibroids and total volume and route.
Although the patient in lines 227 to 234 has had a hysterectomy, the patient should be included because of the indication - increasing infection, which would not be an indication for hysterectomy at the time of surgery. The regression analyzes did indeed control for surgical route, with the exception of hysteroscopy, which was excluded from further analyzes per the above response to Reviewer #2. If not normally distributed, quote as median (range or IQR) and test non-parametrically.
If not, it should be quoted as median (IQR or range) or as a category and test with appropriate statistics. These non-normally distributed variables are now quoted as median (IQR) and tested nonparametrically. The convergence criterion (GCONV=IE-8) is satisfied in the logistic regression model, but the wide confidence interval reflects this limitation.
Since the fitting model has limited data, try to corroborate the analysis using a matching algorithm to find suitable matches for the N=90 who did not receive antibiotics. In addition, we performed a matched cohort analysis to compare with the 90 patients who did not receive antibiotics in attempts to correct for the baseline differences and confirm our findings.
ASSOCIATE EDITOR COMMENTS
Please include absolute numbers for the infection rates in the Abstract-Results and Results sections. Please make sure these numbers match
EDITOR COMMENTS
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34;Surgical site infections (SSI) are infections of an incision or organ or space that occur after surgery.". This may not be correct. Material included in your submission that is not original or that you are unable to to transfer copyright must be listed under I.B on the first page of the copyright agreement form.
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Written permission should be obtained from all individuals named in the acknowledgements, as readers may infer that they endorse the data and conclusions. 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 another organizational meeting, that presentation should be noted. include the exact dates and location of the meeting). In both the Abstract and Results sections of the manuscript, please provide much more useful for clinicians.
In both the Abstract section and the results section of the manuscript, please provide actual numbers and percentages in addition to odds ratios (OR) or relative risk (RR). If you submit a revision, we will assume that it has been developed in consultation with your co-authors, that each author has given approval for the final form of the revision, and that the agreement form has been signed by each author and submitted with the original version remains valid.
Sent: Wednesday, January 9, 2019 4:24 PM
Subject: Re: Your Revised Manuscript 18‐1834R1 Dear Randi,
Subject: Re: Your Revised Manuscript 18-1834R1
Cc: Annie Kim
Would you consider changing the sentence to include the broader definition of SSI that the CDC uses and that you use in your paper. This allows the reader to get a sense of range, and therefore relative strength, beyond what a p-value might indicate.
Cc: Sarah Cohen
Best,
Cohen's email for comments regarding the tables and attachments containing the final and supplemental tables. We greatly appreciate your help throughout this process, and please don't hesitate to let us know if you or the Editors have any questions. Please find a final version of the manuscript attached along with updated tables with 95% CIs for applicable variables where we can calculate effect sizes.
We would defer to the editors, but we think the tables are more reader-friendly in the original version, simply listing the p-values. Thanks, I'll have my statistician update the tables and we'll be in touch once it's finalized.
- Dr. Einarsson: Please use no more than two academic degrees per person
- Line 151: Will MIGS and REI be used frequently in the rest of the paper? If not, please exclude the abbreviations
- Results: For data presented in the text, please provide the raw numbers as well as data such as percentages, effect size (OR, RR, etc)
- Line 252: What grading scale is used here?
- Line 258: Washout is not a technical term. Please substitute one
- Line 267: I think I mentioned it before, but please limit CI’s and P values to 2 or no more than 3 decimal points
- Line 311: Is this correct as edited?
Ensure that data is consistently rounded throughout your text and tables as appropriate. Results: For data presented in the text, please provide the raw numbers as well as data such as percentages, effect size (OR, RR, etc.) and data such as percentages, effect size (OR, RR, etc.) as appropriate and 95% CIs. Do you think that 95.9% of cases performed minimally invasively were by MIGS or REI cases performed minimally invasively were by MIGS or REI subspecialists or that 95.9% of ALL cases were performed by people with this education.
Line 250: We do not allow authors to suggest that there is a difference in groups when there is no statistical difference. Line 267: I think I mentioned it before, but please limit the CI and P values to 2 or no more than 3 decimal points.
Randi Zung (Ms.)
