Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020.

OBJECTIVE: To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication. METHODS: We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed. RESULTS: Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30-0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24-2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59-2.71; family planning: aHR 1.55 95% CI 1.06-2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38-0.88). No significant differences were seen between subspecialties with respect to publication. CONCLUSION: Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials.

Air versus Saline: The Effect of Tissue Expander Fill on Outcomes of Prepectoral Breast Reconstruction.

BACKGROUND: Traditionally, saline is used for intraoperative/postoperative expansion in two-stage alloplastic breast reconstruction. Recently, intraoperative expansion with air has been proposed, to reduce pressure on the mastectomy skin flap in the immediate postoperative setting. The authors examined whether the intraoperative tissue expansion medium (i.e., air versus saline) affected postmastectomy complications in two-stage prepectoral reconstruction. METHODS: This was a retrospective cohort study of 87 patients (144 breasts) undergoing prepectoral breast reconstruction at the authors' institution. Patient data were abstracted from medical records. Stepwise, multivariable-adjusted logistic regression using robust variances was used to identify predictors of postmastectomy complications. Statistical and power analyses were completed. RESULTS: Of the 87 study patients, 29 (33.3 percent) received intraoperative saline fill and 58 (66.7 percent) received air fill. Demographic/clinical data were well-matched between cohorts. Median follow-up was 165 days, and average patient age was 46.7 years. Initial tissue expander fill volumes were similar between study cohorts ( p = 0.2). The crude association between air versus saline fill on overall complication rates suggested that air-filled tissue expanders may be protective (OR = 0.4; p = 0.03), and the suggested protective effect was maintained with borderline significance even after potential confounders (i.e., American Society of Anesthesiologists class III or higher, body mass index, diabetes, mastectomy specimen weight, smoking status) were added to the model (OR = 0.4; p = 0.05). In addition, fewer complications requiring salvage reoperation were observed with air-filled tissue expanders (adjusted OR = 0.3; p = 0.02). CONCLUSIONS: The medium used for immediate intraoperative tissue expansion impacted postmastectomy outcomes in patients undergoing two-stage prepectoral breast reconstruction. The results demonstrated that air-filled tissue expanders were associated with fewer postoperative complications/salvage reoperations relative to saline-filled tissue expanders. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Assessing Gender-Affirming Chest Surgery Outcomes: Does Gender Identity Alter Gaze?

BACKGROUND: Outcomes of gender-affirming chest surgery can be variable. Placement of nipple-areolar complexes and orientation of scars can drastically affect the aesthetic outcomes of these procedures, as may observer gender identity. Here, we compared attention and perception of outcomes following gender-affirming chest surgery between laypersons, based on gender identity. METHODS: Transgender and cisgender participants were enrolled and shown images of surgery naïve chests and postoperative masculinized and feminized chests, blinded to the gender identity of the photographed subject. Gaze data were captured using the Tobii X2 60 eye-tracking device. Participants scored the perceived gender and aesthetic appearance of each image. RESULTS: Eighteen cisgender and 14 transgender participants were enrolled. When viewing male chests, transgender participants spent significantly longer fixated on the nipples (naïve: 802 vs. 395 ms; p = 0.02, masculinized: 940 vs. 692 ms, p = 0.002). For masculinized chests, cisgender participants spent significantly longer fixated on the inframammary scar (483 vs. 391 ms; p = 0.04). On images of feminized chests, transgender participants spent longer viewing the nipples when compared to cisgender participants (1017 vs. 847 ms; p = 0.04). Cisgender viewers spent longer fixating on the postoperative scar on feminized chests (113 vs. 59 ms; p = 0.02) and also viewed feminized chests as significantly more masculine and masculinized chests as more feminine, when compared to transgender participants (p < 0.05). CONCLUSIONS: This is the first study to use eye-tracking to assess how laypersons assess chests for gender determination. The findings suggest that observer gender identity has an effect on areas of focus and gender perception of chests that underwent gender-affirmation surgery. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine Ratings, please refer to Table of Contents or online Instructions to Authors www.springer.com/00266 .

Revision Rates in Prepectoral Versus Subpectoral Delayed-Immediate Autologous Breast Reconstruction.

INTRODUCTION: Breast reconstruction in the prepectoral plane has recently fallen into favor. Minimizing the number of revisionary procedures after reconstruction is an important factor in improving patient care, but long-term studies on the effects of prepectoral reconstruction are limited. In this study, we compare the revision rates after delayed-immediate, autologous reconstruction between prepectoral and subpectoral reconstructions. METHODS: Postoperative charts for all patients undergoing subpectoral or prepectoral delayed-immediate autologous breast reconstruction were retrospectively reviewed at our single tertiary-care institution between 2009 and 2018. Patient demographics, comorbidities, and oncologic history were recorded. Charts after second stage reconstruction were reviewed for up to eighteen months to determine if revisions were necessary. Data collected included the total number of surgeries performed, the average number of procedures performed during each surgery, and the type of revision that was performed. Statistical tests included the chi squared test, unpaired t-test, and logistic regressions. RESULTS: Data from 89 patients with 125 breast reconstructions were collected. There was a 41.6% of these that were prepectoral reconstructions (P), and 58.4% were subpectoral reconstructions (S). For both groups, nipple sparing, followed by skin sparing mastectomies were most common. Mastectomy rates were not statistically different. Fewer breasts in the prepectoral cohort required any revisions (P, 21.2% vs S, 47.9%; P = 0.002). The subpectoral cohort had higher rates of soft tissue rearrangement (P, 7.7% vs S, 21.9%, P = 0.032), fat grafting (P, 9.6% vs S, 27.4%; P = 0.014), and nipple reconstruction (P: 5.8% vs 20.5%, P = 0.020). Mean follow-up time was not significantly different between patient groups (P, 290.5 days vs S, 375.0 days, P = 0.142). Subpectoral expander placement was found to be the only variable independently predictive of requiring 1 or more revision (P = 0.034). CONCLUSIONS: Breast reconstruction performed in the prepectoral plane is associated with lower overall rates of revisionary surgery. Rates of soft tissue rearrangement, fat grafting, and nipple reconstruction after autologous reconstruction trended higher in subpectoral reconstructions.

Social Perception of Facial Feminization Surgery Outcomes: Does Gender Identity Alter Gaze?

BACKGROUND: The evaluation of gender-affirming facial feminization surgery (FFS) outcomes can be highly subjective, which has resulted in a limited understanding of the social perception of favorable gender and aesthetic facial appearance following FFS. Eye-tracking technology has introduced an objective measure of viewer subconscious gaze. OBJECTIVES: The aim of this study was to use eye-tracking technology to measure attention and perception of surgery-naive cisgender female and feminized transgender faces, based on viewer gender identity. METHODS: Thirty-two participants (18 cisgender and 14 transgender) were enrolled and shown 5 photographs each of surgery-naive cisgender female and feminized transgender faces. Gaze was captured with a Tobii Pro X2-60 eye-tracking device (Tobii, Stockholm, Sweden) and participants rated the gender and aesthetic appearance of each face on Likert-type scales. RESULTS: Total image gaze fixation time did not differ by participant gender identity (6.00 vs 6.04 seconds, P = 0.889); however, transgender participants spent more time evaluating the forehead/brow, buccal/mandibular regions, and chin (P < 0.001). Multivariate regression analysis showed significant associations between viewer gender identity, age, race, and education, and the time spent evaluating gender salient facial features. Feminized faces were rated as more masculine with poorer aesthetic appearance than surgery-naive cisgender female faces; however, there was no significant difference in the distribution of gender appearance ratings assigned to each photograph by cisgender and transgender participants. CONCLUSIONS: These results demonstrate that gender identity influences subconscious attention and gaze on female faces. Nevertheless, differences in gaze distribution did not correspond to subjective rated gender appearance for either surgery-naive cisgender female or feminized transgender faces, further illustrating the complexity of evaluating social perception of favorable FFS outcomes.

Single-Unit technique for the use of acellular dermal matrix in immediate expander-based breast reconstruction.

BACKGROUND: The use of acellular dermal matrices (ADMs) in immediate two-stage prosthetic breast reconstruction following mastectomy is now a common practice. The procedure confers several compelling benefits, including coverage of the inferior pole, enhanced definition of the inframammary fold, and reduction of capsular contracture. However, operative techniques used to create the ADM inferolateral sling can be unwieldy in practice, typically involving the placement of the ADM followed by positioning and anchoring of the prosthetic expander. At best, this may be a relatively minor nuisance, but may potentially influence outcomes, including discrepancies in symmetry. METHODS: We present a novel modification that aims to streamline this procedure. Perforations are made through the allograft, through which the tissue expander tabs are brought through and sutured together ex vivo to allow the ADM and expander to be placed into the inframammary fold position as a single unit. A retrospective chart review was then performed of patients who underwent breast reconstruction utilizing this technique between July 2015 and December 2018. Outcomes including postsurgical complications such as infection, malposition, and reoperation were analyzed. RESULTS: Sixty-two patients met the inclusion criteria, corresponding to 108 breasts. The average follow-up was 18 months. The overall complication rate was 29.6% of breasts. The most commonly observed complications were mastectomy skin necrosis (9.3%) and major infection (8.3%). There was a 7.4% rate of malposition. CONCLUSIONS: This simple but effective modification in ADM technique is associated with a comparable complication rate and allows for greater ease and consistency in tissue expander placement.

The safety and efficacy of autologous fat grafting during second stage breast reconstruction.

BACKGROUND: Patients often pursue revisions following implant-based breast reconstruction (IBR) to achieve their desired result. Fat grafting is a popular choice for patients and can be performed at second stage reconstruction or at a future date as a revisionary surgery. We investigate the best time to fat graft in IBR by comparing the outcomes of patients who received fat grafting during implant placement with those who pursued fat grafting during a tertiary procedure. METHODS: We retrospectively reviewed the charts of 157 patients (270 breasts) who underwent immediate two-stage IBR and fat grafting over a five-year period (2012-2016) at our institution. Two cohorts were created based on timing of first fat grafting procedure: immediate (IFG) and delayed (DFG). Charts were reviewed for postoperative complications or revisions. RESULTS: Complication rates were lower when fat grafting was performed during the second stage (p = 0.0331). Patients in the DFG cohort required more than one additional revision (p < 0.001) until the completion of reconstruction. Patients in the IFG cohort completed their reconstruction and revisions more than one year earlier than the DFG cohort (p < 0.001). Multivariable regressions showed IFG to be associated with decreased revisions (p < 0.001) and total fat grafting procedures (p = 0.008). CONCLUSIONS: These results indicate that fat grafting at the second stage does not increase overall complication rates, require fewer additional surgeries, and enables patients to reach their desired aesthetic appearance in a shorter time frame. Fewer total surgeries translate not only to a more economical option but also obviate the risk of complications that come with additional surgeries.

Erratum: Abstract 199: Gender Identity Alters Gaze: The Use of Eye Tracking to Assess Outcomes in Gender-affirming Chest Surgery - Erratum.

[This corrects the article DOI: 10.1097/01.GOX.0000667852.45222.46.].