Emergency Department Visits Before Cancer Diagnosis Among Women at Mayo Clinic.

Objective: To determine associations of incident cancer diagnoses in women with recent emergency department (ED) care. Patients and Methods: A retrospective cohort study analyzing biological females aged 18 years and older, who were diagnosed with an incident primary cancer (12 cancer types studied) from January 1, 2015, to December 31, 2021, from electronic health records. The primary outcome was a cancer diagnosis within 6 months of a preceding ED visit. Secondary outcomes included patient factors associated with a preceding ED visit. Results: Of 25,736 patients (median age of 62 years, range 18-101) diagnosed with an incident primary cancer, 1938 (7.5%) had an ED visit ≤6 months before a diagnosis. The ED-associated cancer cases were highest in lung cancer (n=514, 14.7%) followed by acute lymphoblastic leukemia (n=22, 13.3%). Patient factors increasing the likelihood of ED evaluation before diagnosis included 18-50 years of age (OR=1.32; 95% CI, 1.09-1.61), Elixhauser score (measure of comorbidities) >4 (OR=17.90; 95% CI, 14.21-22.76), use of Medicaid or other government insurance (OR=2.10; 95% CI, 1.63-2.69), residence within the institutional catchment areas (OR=3.18; 95% CI, 2.78-3.66), non-Hispanic Black race/ethnicity (OR=1.41; 95% CI, 1.04-1.88), and established primary care provider at Mayo Clinic (OR=1.45; 95% CI, 1.28-1.65). The ED visits were more likely in those who died within 6 months of diagnosis (n=327, 37.8%) than those who did not die (n=1611, 6.5%). Conclusion: Patient characteristics identified in this study offer opportunities to provide cancer risk assessment and health navigation, particularly among individuals with comorbidities and limited health care access.

Modification of Fundamentals of Laparoscopic Surgery Manual Tasks Simulation Curriculum With the Addition of the Vaginal Cuff Closure Training.

OBJECTIVE: Fundamentals of Laparoscopic Surgery (FLS) is a multiple-choice test and a manual skills exam using simulation that Obstetrics and Gynecology (OBGYN) residents must pass to qualify for board certification. There is insufficient validity evidence supporting the use of FLS as a high-stakes exam. This study examines the correlation between OBGYN residents' performance on the FLS manual tasks and simulated vaginal cuff closure. METHODS: We compared residents' performance on FLS tasks with simulated vaginal cuff suturing on a model. During the first coached simulation session, after completion of training on the standard 5 FLS tasks, residents were coached on vaginal cuff closure using a simulated model placed inside the standard FLS box trainer. At a subsequent session, their performance was scored using the Global Operative Assessment of Laparoscopic Skills Scale (GOALS) and a second task-specific metric, and these scores were compared to their official FLS score. RESULTS: Twenty-nine residents completed the vaginal cuff simulation training between June 2019 and November 2021. Nineteen of the 29 were able to complete the cuff closure with the mean time to completion being 14.5 minutes. We found no correlation between official manual skills FLS scores and vaginal cuff GOALS scores (rho = -0.02, p = 0.90) or cuff closure assessment tool score (rho = -0.015, p = 0.048). There was also no correlation between time to completion for any FLS task and vaginal cuff closure OSAT scores. All residents reported that they found the cuff to be a useful addition to the FLS curriculum. CONCLUSIONS: Our study demonstrated that trainee performance on a simulated vaginal cuff closure model did not correlate with official FLS manual tasks skills. This finding adds to the body of evidence disputing the use of FLS as a high-stakes exam to assess laparoscopic skills in gynecology in the relationship with other variables category.

Disparities in Timeliness of Endometrial Cancer Care: A Scoping Review.

OBJECTIVE: We use the person-centered Pathway to Treatment framework to assess the scope of evidence on disparities in endometrial cancer stage at diagnosis. This report is intended to facilitate interventions, research, and advocacy that reduce disparities. DATA SOURCES: We completed a structured search of electronic databases: PubMed, EMBASE, Scopus, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials databases. Included studies were published between January 2000 and 2023 and addressed marginalized population(s) in the United States with the ability to develop endometrial cancer and addressed variable(s) outlined in the Pathway to Treatment. METHODS OF STUDY SELECTION: Our database search strategy was designed for sensitivity to identify studies on disparate prolongation of the Pathway to Treatment for endometrial cancer, tallying 2,171. Inclusion criteria were broad, yet only 24 studies addressed this issue. All articles were independently screened by two reviewers. TABULATION, INTEGRATION, AND RESULTS: Twenty-four studies were included: 10 on symptom appraisal, five on help seeking, five on diagnosis, and 10 on pretreatment intervals. Quality rankings were heterogeneous, between 3 and 9 (median 7.2) per the Newcastle-Ottawa Scale. We identified three qualitative, two participatory, and two intervention studies. Studies on help seeking predominantly investigate patient-driven delays. When disease factors were controlled for, delays of the pretreatment interval were independently associated with racism toward Black and Hispanic people, less education, lower socioeconomic status, and nonprivate insurance. CONCLUSIONS: Evidence gaps on disparities in timeliness of endometrial cancer care reveal emphasis of patient-driven help-seeking delays, reliance on health care-derived databases, underutilization of participatory methods, and a paucity of intervention studies. SYSTEMATIC REVIEW REGISTRATION: Given that PROSPERO was not accepting systematic scoping review protocols at the time this study began, this study protocol was shared a priori through Open Science Framework on January 13, 2021 (doi: 10.17605/OSF.IO/V2ZXY), and through peer review publication on April 13, 2021 (doi: https://doi.org/10.1186/s13643-021-01649-x).

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.

Indigenous Smoking Behaviors in Olmsted County, Minnesota: A Longitudinal Population-Based Study.

OBJECTIVE: To describe smoking behaviors and pharmaceutical cessation aid uptake in a population-based Indigenous cohort compared with an age- and sex-matched non-Indigenous cohort. PATIENTS AND METHODS: Using the health record-linkage system of the Rochester Epidemiology Project (January 1, 2006, to December 31, 2019), smoking data of Indigenous residents of Olmsted County in Minnesota were abstracted to define the smoking prevalence, incidence, cessation, relapse after cessation, and pharmaceutical smoking cessation aid uptake compared with a matched non-Indigenous cohort. Prevalence was analyzed with a modified Poisson regression; cessation and relapse were evaluated with generalized estimating equations. Incidence was evaluated with a Cox proportional hazards model. RESULTS: Smoking prevalence was higher in the Indigenous cohort (39.0% to 47.0%; n=898) than the matched cohort (25.6% to 30.3%; n=1780). Pharmaceutical uptake was higher among the Indigenous cohort (35.8% of n=584 ever smokers vs 16.3% of n=778 ever smokers; P<.001). Smoking cessation events occurred more frequently in the Indigenous cohort (relative risk, 1.10; 95% CI, 1.06 to 1.13; P<.001). Indigenous former smokers were more likely to resume smoking (relative risk, 3.03; 95% CI, 2.93 to 3.14; P<.001) compared with the matched cohort. These findings were independent of socioeconomic status, age, and sex. CONCLUSION: Smoking in this Indigenous cohort was more prevalent compared with a sex- and age-matched non-Indigenous cohort despite more smoking cessation events and higher use of smoking cessation aids in the Indigenous cohort. The relapse rate after achieving cessation in the Indigenous cohort was more than three times higher than the non-Indigenous cohort. This finding has not been previously described and represents a potential target for relapse prevention efforts in US Indigenous populations.

Platelet-derived exosomes induce cell proliferation and wound healing in human endometrial cells.

Aim: To investigate the regenerative effects of a platelet-derived purified exosome product (PEP) on human endometrial cells. Materials & methods: Endometrial adenocarcinoma cells (HEC-1A), endometrial stromal cells (T HESC) and menstrual blood-derived stem cells (MenSC) were assessed for exosome absorption and subsequent changes in cell proliferation and wound healing properties over 48 h. Results: Cell proliferation increased in PEP treated T HESC (p < 0.0001) and MenSC (p < 0.001) after 6 h and in HEC-1A (p < 0.01) after 12 h. PEP improved wound healing after 6 h in HEC-1A (p < 0.01) and MenSC (p < 0.0001) and in T HESC between 24 and 36 h (p < 0.05). Conclusion: PEP was absorbed by three different endometrial cell types. PEP treatment increased cell proliferation and wound healing capacity.

The uterus has a remarkable ability to heal itself. Every month the inside lining of the uterus grows in preparation for pregnancy and sheds if no pregnancy occurs. Unfortunately, this cycle of growth, shedding and repair can be injured and lead to menstrual changes, pain or even infertility. In this study, we looked how special cell messengers ­ called exosomes ­ could help uterine cells. Exosomes are special messengers that contain substances to help the body heal and regenerate injured cells and tissues. We obtained exosomes created from human transfusion-grade platelets. We studied the exosomes' effects in three different cell types that all are important inside the uterine lining. Specifically, we studied the ability of the exosomes to help cells proliferate and migrate into a wound. In this study, exosomes were recognized by the human endometrial cells and were absorbed. Once they were inside the cells, they increased cell proliferation as well as the ability of the cells to heal a scratch wound. Furthermore, the more exosomes we presented to the cells, the more the cells were able to proliferate and move into a wound for healing. These findings lay the groundwork for future studies in animal models of uterine injury.

Distinctions in PCOS Induced by Letrozole Vs Dehydroepiandrosterone With High-fat Diet in Mouse Model.

Polycystic ovarian syndrome (PCOS) is a complex health condition associated with metabolic disturbances and infertility. Recent data suggest that the prevalence of PCOS is increasing among women globally, although the etiology of these trends is undefined. Consequently, preclinical models that better reflect the biology of PCOS are urgently needed to facilitate research that can lead to the discovery of prevention strategies or improved management. The existing animal models have several limitations as they do not reflect all the PCOS features metabolically and/or phenotypically. Therefore, there is no clear consensus on the use of appropriate animal model and selection of the most appropriate PCOS-inducing agent. To that end, we have established a Swiss albino mouse model of PCOS based on 3 weeks of daily treatment with letrozole (50 µg/day; intraperitoneal) and dehydroepiandrosterone (DHEA, 6 mg/100 g body weight; subcutaneous) in 5-week-old female mice fed on normal or high-fat diet (HFD). Mice were regularly assessed for body weight, blood glucose, and estrous cycle. Three weeks after drug administration, mice were sacrificed and assessed for blood-based metabolic parameters as well as ovarian function. Our results indicate that DHEA combined with HFD produces changes mimicking those of clinical PCOS, including elevated serum testosterone and luteinizing hormone, dyslipidemia, poor ovarian microenvironment, and development of multiple ovarian cysts, recapitulating cardinal features of PCOS. In comparison, normal diet and/or letrozole produced fewer features of PCOS. The data from the experimental models presented here can improve our understanding of PCOS, a growing concern in women's health.

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.

Impact of robotic single and dual console systems in the training of minimally invasive gynecology surgery (MIGS) fellows.

The advantages of dual console use in robotic surgical education have not been described. The aims of this study are to compare fellow console time, surgical steps performed, and surgical takeovers between attending and fellow surgeons using dual versus single console robotic systems. Participants included minimally invasive gynecologic surgery (MIGS) fellows (N = 3) and subspecialty trained gynecologic surgeons (N = 5). Prospective data were obtained on 126 patients (N = 77 single console, N = 49 dual console) undergoing robotic hysterectomy. Variables included demographics, surgical characteristics (fellow, month of fellowship, attending surgeon, concomitant oophorectomy, additional surgical procedures, estimated blood loss, specimen weight), and outcomes (console time, docking time, console time/docking time ratio, total case time, number of surgical steps performed by the fellow, number of surgical takeovers, complications). After controlling for potential confounders, fellows spent a mean of 25.8 min longer (P < 0.001) at the console in dual console operations compared to single. Dual console surgeries had a greater number of steps performed by the fellow (OR[> 5 steps]: 3.37, P = 0.009), a higher console time/docking time ratio (P < 0.001), and more surgical takeovers between fellow and attending (OR [> 1 takeover]: 3.53, P < 0.001). There were no significant differences between the two groups regarding docking time (P = 0.15), case time (P = 0.79), or complications (P = 0.30). Our findings suggest dual console robotic training provide fellows the opportunity for more "hands-on" experience with longer console time, higher number of surgical steps performed, and added interaction with the attending surgeon when compared with single console training. These surgical metrics provide objectivity in competency-based robotic training without increasing the complications or surgical time.

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.

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.

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.

Development of novel home-based tampon sampling for endometrial cancer: findings from community-based focus groups with Black and White women.

Novel endometrial cancer (EC) early-detection approaches may reduce racial disparities in mortality. We conducted six community-based focus groups with White and Black women (N = 57 participants) in February-March 2020 to explore acceptability of a home-based tampon sampling approach for EC. Participants also completed a survey. Data were analyzed using qualitative content analysis. Awareness of EC and risk factors was low. Acceptability regarding home sampling was high, but participants expressed concerns about instruction complexity and potential risks. Black women reported lower comfort with tampons. Increasing EC awareness, self-efficacy, and familiarization with tampons would advance prospects for at-home sample collection for EC testing.

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.

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.

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.

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.

Disparities and interventions in the timeliness of endometrial cancer diagnosis and treatment in the United States: a scoping review protocol.

BACKGROUND: Disparities in the stage at diagnosis of endometrial cancer (EC) account for a significant proportion of the disparities in morbidity and mortality experienced by vulnerable groups in the USA. Evidence suggests that disparities in timeliness of care and treatment play a significant role in stage at diagnosis. Despite an increase in literature on EC disparities, the issue remains largely unchanged. The objectives of this review will be to synthesize the evidence to identify important remaining research questions and inform future interventions to reduce the disparity in stage at diagnosis of EC in the USA. METHODS: This scoping review protocol will use the five-step framework developed by Arksey and O'Malley. A literature search will be conducted from January 2000 onwards in PubMed, EMBASE, Scopus, and Cochrane CENTRAL databases. Studies on delays in care of EC will be included if they were published in English and reported findings for the US population. Two reviewers will independently screen all citations, full-text articles, and abstract data. The study methodological quality and bias will be appraised using appropriate tools. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g., frequencies) and qualitative (e.g., content and thematic analysis) methods. The literature search, data extraction, and evidence synthesis will be informed by the Pathway to Treatment Model, which divides time to cancer care initiation into appraisal, help-seeking, diagnostic, and pre-treatment intervals. Results will be reported in accordance with the PRISMA statement. DISCUSSION: EC disparities research is currently benefitting form a growing expectation that studies have a real impact on disparities. Patient, healthcare, and disease factors impact the amount of time patients spend in different intervals of the Pathway to Treatment Model, so research and interventions aimed at reducing disparities in EC survival should be designed with cognizance to how these factors impact their target population. Reviews on disparities in stage at diagnosis of EC exist but do not provide a comprehensive picture of the pathway to treatment. This review will seek to provide an expanded bedrock of evidence for future studies to build on as they aim to more actively reduce EC disparities. TRIAL REGISTRATION: Open Science Framework ( osf.io/v2zxy ).

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.