Detection of endometrial cancer using tampon-based collection and methylated DNA markers.

OBJECTIVE: Alterations in DNA methylation are early events in endometrial cancer (EC) development and may have utility in EC detection via tampon-collected vaginal fluid. METHODS: For discovery, DNA from frozen EC, benign endometrium (BE), and benign cervicovaginal (BCV) tissues underwent reduced representation bisulfite sequencing (RRBS) to identify differentially methylated regions (DMRs). Candidate DMRs were selected based on receiver operating characteristic (ROC) discrimination, methylation level fold-change between cancers and controls, and absence of background CpG methylation. Methylated DNA marker (MDM) validation was performed using qMSP on DNA from independent EC and BE FFPE tissue sets. Women ≥45 years of age with abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB) or any age with biopsy-proven EC self-collected vaginal fluid using a tampon prior to clinically indicated endometrial sampling or hysterectomy. Vaginal fluid DNA was assayed by qMSP for EC-associated MDMs. Random forest modeling analysis was performed to generate predictive probability of underlying disease; results were 500-fold in-silico cross-validated. RESULTS: Thirty-three candidate MDMs met performance criteria in tissue. For the tampon pilot, 100 EC cases were frequency matched by menopausal status and tampon collection date to 92 BE controls. A 28-MDM panel highly discriminated between EC and BE (96% (95%CI 89-99%) specificity; 76% (66-84%) sensitivity (AUC 0.88). In PBS/EDTA tampon buffer, the panel yielded 96% (95% CI 87-99%) specificity and 82% (70-91%) sensitivity (AUC 0.91). CONCLUSION: Next generation methylome sequencing, stringent filtering criteria, and independent validation yielded excellent candidate MDMs for EC. EC-associated MDMs performed with promisingly high sensitivity and specificity in tampon-collected vaginal fluid; PBS-based tampon buffer with added EDTA improved sensitivity. Larger tampon-based EC MDM testing studies are warranted.

Smoking Behaviors Among Indigenous Pregnant People Compared to a Matched Regional Cohort.

INTRODUCTION: Smoking commercial tobacco products is highly prevalent in American Indian and Alaska Native (Indigenous) pregnancies. This disparity directly contributes to maternal and fetal mortality. Our objective was to describe cigarette smoking prevalence, cessation intervention uptake, and cessation behaviors of pregnant Indigenous people compared to sex and age-matched regional cohort. AIMS AND METHODS: Pregnancies from an Indigenous cohort in Olmsted County, Minnesota, identified in the Rochester Epidemiology Project, were compared to pregnancies identified in a sex and age-matched non-Indigenous cohort from 2006 to 2019. Smoking status was defined as current, former, or never. All pregnancies were reviewed to identify cessation interventions and cessation events. The primary outcome was smoking prevalence during pregnancy, with secondary outcomes measuring uptake of smoking cessation interventions and cessation. RESULTS: The Indigenous cohort included 57 people with 81 pregnancies, compared to 226 non-Indigenous people with 358 pregnancies. Smoking was identified during 45.7% of Indigenous pregnancies versus 11.2% of non-Indigenous pregnancies (RR: 3.25, 95% CI = 1.98-5.31, p ≤ .0001). Although there was no difference in uptake of cessation interventions between cohorts, smoking cessation was significantly less likely during Indigenous pregnancies compared to non-Indigenous pregnancies (OR: 0.23, 95% CI = 0.07-0.72, p = .012). CONCLUSIONS: Indigenous pregnant people in Olmsted County, Minnesota were more than three times as likely to smoke cigarettes during pregnancy compared to the non-indigenous cohort. Despite equivalent uptake of cessation interventions, Indigenous people were less likely to quit than non-Indigenous people. Understanding why conventional smoking cessation interventions were ineffective at promoting cessation during pregnancy among Indigenous women warrants further study. IMPLICATIONS: Indigenous pregnant people in Olmsted County, Minnesota, were greater than three times more likely to smoke during pregnancy compared to a regional age matched non-Indigenous cohort. Although Indigenous and non-Indigenous pregnant people had equivalent uptake of cessation interventions offered during pregnancy, Indigenous people were significantly less likely to quit smoking before fetal delivery. This disparity in the effectiveness of standard of care interventions highlights the need for further study to understand barriers to cessation in pregnant Indigenous people.

The cost of diagnosing endometrial cancer: Quantifying the healthcare cost of an abnormal uterine bleeding workup.

OBJECTIVE: The evaluation of women with perimenopausal abnormal uterine bleeding (AUB) and postmenopausal bleeding (PMB) to detect endometrial cancer (EC) and its precursors is not standardized and can vary widely. Consequently, costs associated with the workup and management undoubtedly vary. This study aimed to quantify costs of AUB/PMB evaluation to understand the healthcare burden associated with securing a pathologic diagnosis. METHODS: Women ≥45 years of age presenting to a single institution gynecology clinic with AUB/PMB for diagnostic workup were prospectively enrolled February 2013-October 2017 for a lower genital tract biospecimen research study. Clinical workup of AUB/PMB was determined by individual provider discretion. Costs of care were collected from administrative billing systems from enrollment to 90 days post enrollment. Costs were standardized and inflation-adjusted to 2017 US Dollars (USD). RESULTS: In total, there were 1017 women enrolled with 5.6% diagnosed with atypical hyperplasia or endometrial cancer (EC). Within the full cohort, 90-day median cost for AUB/PMB workup and management was $2279 (IQR $512-4828). Among patients with a diagnostic biopsy, median 90-day costs ranged from $2203 (IQR $499-3604) for benign or disordered proliferative endometrium (DPE) diagnosis to $21,039 (IQR $19,084-24,536) for a diagnosis of EC. CONCLUSIONS: The costs for diagnostic evaluation of perimenopausal AUB and PMB vary greatly according to ultimate tissue-based diagnosis. Even reassuring benign findings that do not require further intervention-the most common in this study's cohort-yield substantial costs. The development of sensitive, specific, and more cost-effective diagnostic strategies is warranted.

Choosing and Using Patient-Reported Outcome Measures in Clinical Practice.

The increasing use of patient-reported outcome (PRO) measures is forcing clinicians and health care systems to decide which to select and how to incorporate them into their records and clinical workflows. This overview addresses 3 topics related to these concerns. First, a literature review summarizes key psychometric and practical factors (such as reliability, responsiveness, computer adaptive testing, and interpretability) in choosing PROs for clinical practice. Second, 3 clinical decision support issues are highlighted: gathering PROs, electronic health record effect on providers, and incorporating PROs into clinical decision support design and implementation. Lastly, the salience of crosscutting domains as well as 9 key pragmatic decisions are reviewed. Crosscutting domains are those that are relevant across most medical and mental health conditions, such as the SPADE symptom pentad (sleep problems, pain, anxiety, depression, low energy/fatigue) and physical functioning. The 9 pragmatic decisions include (1) generic vs disease-specific scales; (2) single- vs multidomain scales; (3) universal scales vs user-choice selection; (4) number of domains to measure; (5) prioritization of domains when multiple domains are assessed; (6) action thresholds; (7) clinical purpose (screening vs monitoring); as well as the (8) frequency and (9) logistical aspects of PRO administration.

Surgical Science-Simbionix Robotic Hysterectomy Simulator: Validating a New Tool.

STUDY OBJECTIVE: To gather validity evidence for and determine acceptability of Surgical Science-Simbionix Hysterectomy Modules for the DaVinci Xi console simulation system (software; 3D Systems by Simbionix [now Surgical Science-Simbionix], Littleton, CO, and hardware; Intuitive Surgical, Inc., Sunnyvale, CA) and evaluate performance benchmarks between novice and experienced or expert surgeons. DESIGN: Prospective education study (Messick validity framework). SETTING: Multicenter, academic medical institutions. PARTICIPANTS: Residents, fellows, and faculty in obstetrics and gynecology were invited to participate at 3 institutions. Participants were categorized by experience level: fewer than 10 hysterectomies (novice), 10 to 50 hysterectomies (experienced), and more than 50 hysterectomies (expert). A total of 10 novice, 10 experienced, and 14 expert surgeons were included. INTERVENTIONS: Participants completed 4 simulator modules (ureter identification, bladder flap development, colpotomy, complete hysterectomy) and a qualitative survey. Simulator recordings were reviewed in duplicate by educators in minimally invasive gynecologic surgery using the Modified Global Evaluative Assessment of Robotic Skills (GEARS) rating scale. MEASUREMENTS AND MAIN RESULTS: Most participants felt that the simulator realistically simulated robotic hysterectomy (64.7%) and that feedback provided by the simulator was as or more helpful than feedback from previous simulators (88.2%) but less helpful than feedback provided in the operating room (73.5%). Participants felt that this simulator would be helpful for teaching junior residents. Simulator-generated metrics correlated with GEARS performance for the bladder flap and ureter identification modules in multiple domains including total movements and total time for completion. GEARS performance for the bladder flap module correlated with experience level (novice vs experienced/expert) in the domains of interest and total score but did not consistently correlate for the other procedural modules. Performance benchmarks were evaluated for the bladder flap module for each GEARS domain and total score. CONCLUSION: The modules were well received by participants of all experience levels. Individual simulation modules appear to better discriminate between novice and experienced/expert users than overall simulator performance. Based on these data and participant feedback, the use of individual modules in early residency education may be helpful for providing feedback and may ultimately serve as 1 component of determining readiness to perform robotic hysterectomy.

Decisions and Consequences: Validation of High-Stakes Simulation-Based Assessments in Gynecologic Surgery.

STUDY OBJECTIVE: Simulation-based assessment is poised for application in educational promotion and credentialing in gynecologic surgery. With high-stakes assessment, validation necessitates evidence, not just about the trustworthiness of decisions but of beneficial consequences to education and healthcare as well. In this paper, we unpack the modern conceptualization of validity as it pertains to surgical simulation and high-stakes competency assessment. DESIGN: N/A SETTING: N/A PATIENTS: N/A INTERVENTIONS: N/A MEASUREMENTS AND MAIN RESULTS: N/A CONCLUSION: Validity in high-stakes simulation-based assessment necessitates evidence, not just about the trustworthiness of score-based decisions but of beneficial consequences to education and healthcare as well.

A Systematic Review of Validity Evidence for the Fundamentals of Laparoscopic Surgery Examination in Gynecology.

OBJECTIVE: The Fundamentals in Laparoscopic Surgery (FLS) examination is designed to test laparoscopic surgery skills. Our aim for this systematic review was to examine validity evidence supporting or refuting the FLS examination specifically as a high-stakes summative assessment tool in gynecology. DATA SOURCES: The data sources were PubMed, MEDLINE, Embase, and Scopus. METHODS OF STUDY SELECTION: The study eligibility criterion was the subject of the FLS examination as an assessment tool in gynecology. We developed a data extraction tool and assigned articles for screening and extraction to all authors, who then abstracted data independently. Conflicts that arose during the extraction process were resolved by consensus. We organized validity evidence for the cognitive and manual skills portions on the basis of the categories of current validation standards. TABULATION, INTEGRATION, AND RESULTS: From 1971 citations identified, 9 studies were included, involving 319 participants. For the cognitive portion of the test, the results were mixed in 5 studies in relationships with the other variables category. For the manual portion of the test, most of the studies focused on the relationships with other variables evidence with mixed findings. The concerning findings in the manual skills portion included the lack of transferability of skills to the operating room, limited mixed evidence for improvement in operating room performance, and worse performance by obstetrics and gynecology surgeons compared with other specialties. We did not find supportive content-based, response process, or consequential evidence in either the cognitive or manual skills portion of the test. CONCLUSION: Validity evidence for the FLS examination was either mixed, as it pertained to relationships with other variables, or lacking in other important evidence categories. Further evidence is required to justify the use of the FLS examination scores as a high-stakes summative assessment.

Correcting the Fundamentals of Laparoscopic Surgery "Illusion of Validity" in Laparoscopic Vaginal Cuff Suturing.

STUDY OBJECTIVE: The "illusion of validity" is a cognitive bias in which the ability to interpret and predict surgical performance accurately is overestimated. To address this bias, we assessed participants comparing fundamentals of laparoscopic surgery (FLS) and non-FLS tasks with cadaveric vaginal cuff suturing to determine the most representative simulation task for laparoscopic vaginal cuff suturing. DESIGN: Validity (Messick framework) study comparing FLS and non-FLS tasks with cadaveric vaginal cuff suturing. SETTING: Simulation center cadaver laboratory. PARTICIPANTS: Obstetrics and gynecology residents (n = 21), minimally invasive gynecologic surgery fellows (n = 3), gynecologic surgical subspecialists (n = 4), general obstetrician/gynecologists (n = 10). INTERVENTIONS: Tasks included a simulated vaginal cuff (ipsilateral port placement), needle passage through a metal eyelet loop (contralateral and ipsilateral), and intracorporeal knot tying (contralateral and ipsilateral). Simulation task times were compared with the placement of the first cadaveric vaginal cuff suture time, as well as the in-person and blinded Global Operative Assessment of Laparoscopic Skills (GOALS) score ("relations to other variables" validity evidence). Statistical analyses included Spearman's test of correlation (continuous and ordinal variables) or Wilcoxon rank sum test (categoric variables). MEASUREMENTS AND MAIN RESULTS: There was a stronger association with cadaver cuff suturing time for simulated vaginal cuff suturing time (r = 0.73, p <.001) compared with FLS intracorporeal contralateral suturing time (r = 0.54, p <.001). Additional measures associated with cadaveric performance included subspecialty training (median: 82 vs 185 seconds, p = .002), number of total laparoscopic hysterectomies (r = -0.53, p <.001), number of laparoscopic cuff closures (r = -0.61, p <.001), number of simulated laparoscopic suturing experiences (r = -0.51, p <.001), and eyelet contralateral time (r = 0.52, p <.001). Strong agreement between the in-person and blinded GOALS (intraclass correlation coefficient = 0.80) supports response process evidence. Correlations of cadaver cuff time with in-person (Spearman's r = -0.84, p <.001) and blinded GOALS (r = -0.76, p <.001) supports relations to other variables evidence CONCLUSION: The weaker correlation between FLS suturing and cadaver cuff suturing compared with a simulated vaginal cuff model may lead to an "illusion of validity" for assessment in gynecology. Since gynecology specific validity evidence has not been well established for FLS, we recommend prioritizing the use of a simulated vaginal cuff suturing assessment in addition to FLS.

Factors Associated with Burnout and Frustration among Minimally Invasive Gynecologic Surgery Fellows.

STUDY OBJECTIVE: Determine the prevalence of burnout and frustration among participants currently completing a fellowship in minimally invasive gynecologic surgery (FMIGS). DESIGN: Cross-sectional survey. SETTING: An anonymous survey was distributed to fellows in November 2018. PARTICIPANTS: Current FMIGS fellows. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: A total of 57 of 83 (67.7%) FMIGS participants in American Association of Gynecologic Laparoscopists-accredited programs completed a survey regarding fellowship characteristics and experiences. Overall, 40 participants (70.2%) indicated that they were satisfied with their fellowship program experience. There were 33 participants (57.9%) who reported burnout, and 38 participants (66.7%) had experienced anxiety, depression, or extreme fatigue during the last month. Of those who reported burnout, 26 (76.5%) reported that they did not receive support from their fellowship program. Participants who experienced burnout were more likely to be in their second year (p = .003), spent less time per week doing scholarly activities (p = .048), and were less satisfied with their fellowship experience (p <.001). Participants who experienced anxiety, depression, or extreme fatigue had more cofellows in their program (p = .031), worked on average more hours per week (p = .020), and were more often required to practice obstetrics in their fellowship (p = .022). CONCLUSION: Burnout symptoms are common among physicians across multiple specialties. Our findings suggest that this issue is prevalent among FMIGS participants. In addition, there is a lack of access to emotional and psychologic support programs for fellows experiencing burnout. We hope that this study will prompt attention to this important topic by both individual programs and American Association of Gynecologic Laparoscopists as a society to increase awareness and access to resources and promote wellness for fellows.

Impact of Legislation on Opioid Prescribing following Hysterectomy and Hysteroscopy in Arizona and Florida.

OBJECTIVES: This study aimed to determine the oral morphine equivalents (OMEs) prescribed and refill rates following hysterectomy and hysteroscopy in the setting of opioid prescribing practice changes in 2 states. DESIGN: This is a retrospective cohort analysis consisting of 2,916 patients undergoing hysterectomy or hysteroscopy between July 2016 and September 2019 at 2 affiliated academic hospitals in states that underwent legislative changes in opioid prescribing in 2018. METHODS: Participants were identified using the Current Procedural Terminology procedure codes in Arizona and Florida. Hysterectomy was chosen as the most invasive gynecologic procedure, while hysteroscopy was chosen as the least invasive. Medical records were abstracted to find opioid prescriptions from 90 days before surgery to 30 days after discharge. Patients with opioid use between 90 and 7 days before surgery were excluded. Prescriptions were converted to OMEs and were calculated per quarter year. Statistical analysis included Wilcoxon rank sum t tests for OMEs and χ2 t tests for refill rates. Interrupted time-series analysis was used to determine significant change in OMEs before and after legislative change. Statistical analysis was performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). RESULTS: In Arizona, 1,067 hysterectomies were performed; 459 (43%) vaginal, 561 (52.6%) laparoscopic/robotic, and 47 (4.4%) abdominal. There were 530 hysteroscopies. Overall median OMEs decreased from 225 prior to July 2018 to 75 after July 2018 (p < 0.0001). The opioid refill rate remained unchanged at 7.4% (p = 0.966). In Florida, there were 769 hysterectomies; 241 (31.3%) vaginal, 476 (61.9%) laparoscopic/robotic, and 52 (6.8%) abdominal. There were 549 hysteroscopies. Overall median OMEs decreased from 150 prior to July 2018 to 0 after July 2018 (p < 0.0001). The opioid refill rate was similar (7.8% before July 2018 and 7.3% after July 2018; p = 0.739). LIMITATIONS: Limitations include involvement of a single hospital institution with a total of 10 fellowship-trained surgeons and biases inherent to retrospective study design. CONCLUSIONS: Legislative and provider-led changes coincided with decreases in opioid prescribing after 2018 in both states without increasing rates of refills and showed actual data reflected in the medical record. Gynecologists must actively participate in safe prescribing practices to decrease opioid dependence and misuse.

Can loratadine help in treating granulocyte-colony stimulating factor-induced bone pain?

ABSTRACT: Febrile neutropenia is an oncologic emergency with serious consequences. Granulocyte colony stimulating factors (G-CSFs), used to stimulate neutrophil production to prevent febrile neutropenia, can cause bone pain in more than 25% of patients. Severe bone pain may not respond to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or dose reduction of the G-CSF agent. A study found that patients taking loratadine had fewer treatment-associated adverse reactions and discontinuations than those on naproxen. Although more research is needed, loratadine's tolerability, ease of administration, and potential benefit mean that it should be considered for management of pegfilgrastim-associated bone pain. This article describes a patient whose G-CSF-induced bone pain was completely alleviated by loratadine.

Outcomes and patient perspectives following implementation of tiered opioid prescription guidelines in gynecologic surgery.

OBJECTIVES: To report the impact of implementing standardized guidelines for opioid prescriptions after gynecologic surgery and describe patient perspectives before and after implementation for those undergoing laparotomy for ovarian cancer. METHODS: Patients undergoing gynecologic surgery between October 2017 and May 2018 were prescribed opioids at discharge using tiered guidelines; prescriptions were compared to consecutive historical controls (March 2017-October 2017). A subset of ovarian cancer laparotomy patients were surveyed regarding postoperative opioid consumption and patient experience. RESULTS: A total of 620 women in the tiered guideline cohort were compared with 599 historical controls. Following implementation, 95.8% of prescriptions met guidelines. Median milligram morphine equivalents (MME) prescribed decreased from 150 to 75 (p ≤ 0.001) with no change in opioid refills (7.7 vs 6.9%, p = 0.62). In surveyed ovarian cancer patients, 100% of tiered guideline patients and 92% of historical controls felt satisfied with pain control (p = 0.24), despite a 50% reduction in prescribed MME and 14.6% receiving no opioids at discharge (p = 0.002). The median (IQR) MME consumed after discharge was 15 (0, 75) in tiered guideline patients vs. 24 (0, 135) in historical controls, and 38.2% and 42.4% consumed no opioids, respectively. Mean time between surgery and opioid use cessation was <1 week in both groups; patients' perceptions of opioid prescription appropriateness did not change (p = 0.49). More than 75% of patients kept their remaining opioids rather than dispose of them. CONCLUSIONS: Reducing prescribed opioids after gynecologic surgery using tiered guidelines did not increase opioid refills or worsen patients' perceptions of postoperative pain. Even after laparotomy, very little opioids were required over a short duration after dismissal. Infrequent disposal of leftover opioids highlights the need to avoid over-prescribing.

Discharge Readiness after Robotic and Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To evaluate which factors may be predictive of patient readiness of discharge after robotic and laparoscopic hysterectomy. DESIGN: A prospective cohort study (Canadian Task Force classification II-2). SETTING: A single tertiary care center in the United States. PATIENTS: All 230 patients undergoing robotic and laparoscopic hysterectomy between November 2015 and April 2017. INTERVENTIONS: The primary outcome measure was whether or not the patient felt ready for discharge when she was sent home, and this was assessed using a survey 4 to 6 weeks after surgery. Secondary outcomes included the number of postoperative phone calls, 30-day readmission, and also whether the patient felt knowledgeable about postoperative symptoms and restrictions (both assessed via a 4- to 6-week survey). Associations of baseline, operative, and postoperative characteristics with outcomes were evaluated using regression models appropriate for the nature of the given outcome measure. MEASUREMENTS AND MAIN RESULTS: Of the 230 patients, 207 (90%) reported they felt ready for discharge on the postoperative survey. The majority of patients strongly agreed that they felt knowledgeable about what symptoms to expect postoperatively (60%) and about postoperative restrictions (71%). The median number of postoperative phone calls was 1 (range, 0-11), with 104 patients (45%) having more than 1 postoperative call. The only factor that was significantly associated with a lack of readiness for discharge was a longer total operating room time (p = .011). Factors associated with more postoperative phone calls were a urogynecologic indication (p = .005), a cancer indication (p = .024), a longer total operative room time (p = .014), a postoperative complication (p <.001), and not seeing a patient education video (p = .018). Knowledge of postoperative restrictions was significantly worse for older patients (p = .004) and varied significantly according to surgeon (p = .038). No significant predictors of knowledge of postoperative symptoms were identified. CONCLUSIONS: Discharge readiness and knowledge of postoperative restrictions and symptoms were high in patients who underwent laparoscopic and robotic hysterectomies. The risk factors for outcomes that were identified highlight groups of patients who can be targeted for preemptive interventions both preoperatively and postoperatively.

Surgical Care for Women with Endometrial Cancer in Florida.

Objective: The goal of this research was to analyze if disparities in route of hysterectomy for endometrial cancer exist in Florida. Materials and Methods: In this retrospective cohort study, Florida inpatient and ambulatory surgery databases (2014-2016) were examined to find cases of patients with endometrial cancer who underwent hysterectomy in the state. Logistic regression models were used to compare patient- and hospital-level factors associated with having minimally invasive surgery (MIS) versus open surgery, and complications in patients having open hysterectomy versus MIS. Results: Overall, 6513 patients met the inclusion criteria. MIS was performed in 81.4% of cases. The odds of using a minimally invasive approach to hysterectomy (vaginal, robotic, or laparoscopic) were significantly lower for black women (odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.34-0.50) as well as for other non-white patients (OR: 0.64; 95% CI: 0.49-0.84). Patients with Medicaid (OR: 0.42; 95% CI: 0.30-0.59) or Medicare managed care (OR: 0.73; 95% CI: 0.59-0.91), or who received care at a teaching hospital (OR: 0.82; 95% CI: 0.68-0.98) or government hospital (OR: 0.50; 95% CI: 0.38-0.65) were also less likely to receive MIS. Patients receiving care at a high-volume (OR: 1.69; 95% CI: 1.30-2.20) or medium-volume (OR: 3.11; 95% CI: 2.37-4.08) hospital, or patients who were located in the Central (OR: 1.71; 95% CI: 1.17-2.48) or Peninsula (OR: 1.73; 95% CI: 1.17-2.56) regions, compared to the Florida Panhandle, had greater odds of receiving MIS. Conclusions: Although Florida has a high adoption of MIS for treating endometrial cancer, disparities persist. Efforts of state-level entities should focus on improving access to minimally invasive hysterectomy for racial minorities with endometrial cancer.

Robotic Placement of the FENIX Continence Restoration System in a Patient with Previous Radiation to the Pelvis: A Case Report.

Fecal incontinence (FI) is a disabling problem affecting women. Conservative treatment includes dietary modification, antimotility agents, and pelvic floor physical therapy. If conservative medical management is unsuccessful, surgical intervention may be required. Surgical options include rectal sphincteroplasty, bulking agent injection, radiofrequency anal sphincter remodeling, and sacral nerve stimulation therapy. Recently, a new therapy for FI, the FENIX Continence Restoration System (Torax Medical, Inc., Shoreview, MN), has become available. The FENIX device is placed through a perineal incision; however, pelvic radiation and previous anal carcinoma are both contraindications. We report the case of a 62-year-old woman with FI after anal carcinoma. Treatment included surgery, chemotherapy, and pelvic radiation. Initially, she was treated with conservative therapy and sacral nerve stimulation, which were only partially effective. A physical examination showed perineal skin changes consistent with previous radiation, which increased the patient's risk of infection and a nonhealing wound. Therefore, a robotic approach was used to place the FENIX device and improve the patient's quality of life. Our case sets a precedent for expanding the treatment options of FI in patients with previous pelvic radiation and using a robotic approach for the placement of the FENIX device.

Use of the Limbs and Things Hysterectomy Model to Describe the Process for Establishing Validity.

STUDY OBJECTIVE: To demonstrate the process for establishing or refuting validity for the Limbs and Things hysterectomy model. DESIGN: Prospective study using Kane's framework for establishing validity (Canadian Task Force classification: II-2). SETTING: Total laparoscopic hysterectomy (TLH) assessments completed in the operating room (OR) and simulation at 3 academic medical centers. PARTICIPANTS: Obstetrics and gynecology residents (n = 26 postgraduate years 3-4), a gynecologic oncology fellow (postgraduate year 5), and a gynecology oncology attending. INTERVENTIONS: Participants were rated with the myTIPreport feedback application by nonblinded faculty in the OR after TLH. In-person, simulation-based assessments were provided by 2 faculty members blinded to experience level using myTIPreport and Global Operative Assessment of Laparoscopic Skills (GOALS). Videos of simulated TLHs were rated by 2 minimally invasive gynecology fellows. MEASUREMENTS AND MAIN RESULTS: OR scores for TLH steps were significantly higher than simulation assessments (p < .001) with "competent" marked more frequently in the OR. Number of robotic + conventional TLHs performed as primary surgeon was not significantly correlated with OR myTIPreport rating (Spearman r = .30, p = .14) but was significantly correlated with myTIPreport and GOALS in-person simulation ratings (Spearman r = .39-.58, p = .001-.04). Agreement between in-person simulation rater 1 and 2 myTIPreport assessments was 71.4% (weighted κ, .68; 95% confidence interval, .45-.90), and intraclass correlation for the GOALS overall assessment was .71 (95% confidence interval, .46-.85), indicating substantial agreement. Blinded video reviews showed similar agreement (73.1%) between raters but less correlation with experience (Spearman r = .32-.42, p = .11-.03) than in-person reviews. Using area under the receiver operating characteristic curve, mean score for the individual components of GOALS that best differentiated myTIPreport noncompetent and competent levels of performance was 4.3. Feedback acceptability and model realism were rated highly. CONCLUSION: The scoring and generalization validity inferences for Limbs and Things and myTIPreport are supported when global assessments of performance are evaluated but not for individual components of the assessment instruments.

Visuospatial Aptitude Testing Differentially Predicts Simulated Surgical Skill.

OBJECTIVE: To determine whether visuospatial perception (VSP) testing is correlated to simulated or intraoperative surgical performance as rated by the American College of Graduate Medical Education (ACGME) milestones. DESIGN: (Canadian Task Force classification II-2). SETTING: Two academic training institutions. PARTICIPANTS: Forty-one residents, including 19 from Brigham and Women's Hospital and 22 from the Mayo Clinic, from 3 different specialties: obstetrics and gynecology, general surgery, and urology. INTERVENTION: Participants underwent 3 different tests: visuospatial perception testing (VSP), Fundamentals of Laparoscopic Surgery (FLS) peg transfer, and da Vinci robotic simulation peg transfer. Surgical grading from the ACGME milestones tool was obtained for each participant. Demographic and background information was also collected, including specialty, year of training, previous experience with simulated skills, and surgical interest. Standard statistical analyses were performed using Student's t test, and correlations were determined using adjusted linear regression models. MEASUREMENTS AND MAIN RESULTS: In univariate analysis, Brigham and Women's Hospital and Mayo Clinic training programs differed in times and overall scores for both the FLS peg transfer and da Vinci robotic simulation peg transfer tests (p < .05 for all). In addition, type of residency training affected time and overall score on the robotic peg transfer test. Familiarity with tasks correlated with higher score and faster task completion (p = .05 for all except VSP score). There were no differences in VSP scores by program, specialty, or year of training. In adjusted linear regression modeling, VSP testing was correlated only to robotic peg transfer skills (average time, p = .006; overall score, p = .001). Milestones did not correlate to either VSP or surgical simulation testing. CONCLUSION: VSP score was correlated with robotic simulation skills, but not with FLS skills or ACGME milestones. This suggests that the ability of VSP score to predict competence differs between tasks. Therefore, further investigation of aptitude testing is needed, especially before its integration as an entry examination into a surgical subspecialty.

Surgical Findings and Outcomes in Premenopausal Breast Cancer Patients Undergoing Oophorectomy: A Multicenter Review From the Society of Gynecologic Surgeons Fellows Pelvic Research Network.

STUDY OBJECTIVE: To describe the procedures performed, intra-abdominal findings, and surgical pathology in a cohort of women with premenopausal breast cancer who underwent oopherectomy. DESIGN: Multicenter retrospective chart review (Canadian Task Force classification II-3). SETTING: Nine US academic medical centers participating in the Fellows' Pelvic Research Network (FPRN). PATIENTS: One hundred twenty-seven women with premenopausal breast cancer undergoing oophorectomy between January 2013 and March 2016. INTERVENTION: Surgical castration. MEASUREMENTS AND MAIN RESULTS: The mean patient age was 45.8 years. Fourteen patients (11%) carried a BRCA mutations, and 22 (17%) carried another germline or acquired mutation, including multiple variants of uncertain significance. There was wide variation in surgical approach. Sixty-five patients (51%) underwent pelvic washings, and 43 (35%) underwent concurrent hysterectomy. Other concomitant procedures included midurethral sling placement, appendectomy, and hysteroscopy. Three patients experienced complications (transfusion, wound cellulitis, and vaginal cuff dehiscence). Thirteen patients (10%) had ovarian pathology detected on analysis of the surgical specimen, including metastatic tumor, serous cystadenomas, endometriomas, and Brenner tumor. Eight patients (6%) had Fallopian tube pathology, including 3 serous tubal intraepithelial cancers. Among the 44 uterine specimens, 1 endometrial adenocarcinoma and 1 multifocal endometrial intraepithelial neoplasia were noted. Regarding the entire study population, the number of patients meeting our study criteria and seen by gynecologic surgeons in the FPRN for oophorectomy increased by nearly 400% from 2013 to 2015. CONCLUSION: Since publication of the Suppression of Ovarian Function Trial data, bilateral oophorectomy has been recommended for some women with premenopausal breast cancer to facilitate breast cancer treatment with aromatase inhibitors. These women may be at elevated risk for occult abdominal pathology compared with the general population. Gynecologic surgeons often perform castration oophorectomy in patients with breast cancer as an increasing number of oncologists are using aromatase inhibitors to treat premenopausal breast cancer. Our data suggest that other abdominal/pelvic cancers, precancerous conditions, and previously unrecognized metastatic disease are not uncommon findings in this patient population. Gynecologists serving this patient population may consider a careful abdominal survey, pelvic washings, endometrial sampling, and serial sectioning of fallopian tube specimens for a thorough evaluation.

The Fenix System for Fecal Incontinence: An Overview and Surgical Demonstration.

STUDY OBJECTIVE: This video shows a new technique for the surgical management of fecal incontinence using the Fenix Continence Restoration System (TORAX Medical Inc, Shoreview, MN) in 2 patients. DESIGN: A step-by-step explanation of the video using videos and pictures (educational video) for surgeons (Canadian Task Force classification III). SETTING: The use of the Fenix System received United States Food and Drug Administration approval under a humanitarian device exemption and can be used with institutional review board approval in patients who have failed previous medical and surgical management of fecal incontinence. The device is a small, flexible band of interlinked titanium, magnetic beads on a titanium string that is placed using a perineal approach around the anal canal. Increased intra-abdominal pressure opens the beads to allow for the passage of stool. INTERVENTIONS: Placement of the device was performed in 2 patients. Case 1 is a 63-year-old woman with a long-standing history of fecal incontinence who failed sphincteroplasty, sacral neuromodulation, and an artificial sphincter cuff and pump. Case 2 is a 60-year-old woman with a long-standing history of fecal incontinence secondary to radiation therapy for rectal cancer who failed physical therapy and sacral neuromodulation. CONCLUSION: Both Fenix Continence Restoration Systems were placed successfully. Long-term postoperative effectiveness is currently being evaluated.

A randomized controlled trial of birth simulation for medical students.

OBJECTIVE: The objective of the study was to evaluate the effectiveness of a high-fidelity birth simulator (Noelle; Gaumard Scientific, Coral Gables, FL) compared with a lower-cost, low-tech, birth simulator (MamaNatalie; Laerdal Medical, Stavanger, Norway) in teaching medical students how to perform a spontaneous vaginal delivery (SVD). STUDY DESIGN: Prior to the obstetrics-gynecology clerkship, students were randomly assigned to 2 groups. The MamaNatalie group (MG) completed 45 minutes of SVD simulation using an obstetrical abdominal-pelvic model worn by an obstetrics-gynecology faculty member. The Noelle group (NG) completed 45 minutes of SVD simulation using a high-fidelity, computer-controlled mannequin facilitated by an obstetrics-gynecology faculty member. The primary outcome was student performance during his or her first SVD as rated by supervising preceptors. Surveys were also completed by students on confidence in performing steps of a SVD (secondary outcome). RESULTS: One hundred ten medical students (95% of those eligible) participated in this research study. The final postclerkship survey was completed by 93 students (85% follow-up rate). There were no significant differences in performance of SVD steps between MG and NG students as rated by preceptors. The SVD step with the least involvement by students was controlling the head (20.5% in MG, 23.3% in NG performed step with hands-off supervision). Delivery of the placenta was the SVD step with the most involvement (65.9% in MG, 52.3% in NG performed step with hands-off supervision). Baseline presimulation confidence levels were similar between MG and NG. On the immediate postsimulation survey of confidence, MG students were significantly more confident in their ability to deliver the abdomen and legs and perform fundal massage with hands-off supervision (P < .05) than NG students. Following the clerkship, MG students were significantly more confident in their ability to control the head and deliver the abdomen and legs (P < .05) than NG students. CONCLUSION: MamaNatalie is as effective as Noelle in training medical students how to perform a SVD and may be a useful, lower-cost alternative in teaching labor and delivery skills to novice learners. Because birth simulation interventions involve both a simulation model and facilitator, research is required to further determine the effect of human interaction on learning outcomes.