Safety Warning about Laparoscopic Power Morcellation in Hysterectomy: A Cost-Effectiveness Analysis of National Impact.

Background: Following a 2014 safety warning (that laparoscopic power morcellation may increase tumor dissemination if patients have occult uterine cancer), hysterectomy practice shifted from laparoscopic to abdominal approach. This avoided morcellating occult cancer, but increased perioperative complications. To inform the national impact of this practice change, we examined the cost-effectiveness of hysterectomy practice in the postwarning period, in comparison to counterfactual hysterectomy practice had there been no morcellation warning. Materials and Methods: We constructed a decision tree model to simulate relevant outcomes over the lifetime of patients in the national population undergoing hysterectomy for presumed benign indications. The model accounted for both hysterectomy- and occult cancer-related outcomes. Probability-, cost-, and utility weight-related input parameters were derived from analysis of the State Inpatient Databases, State Ambulatory Surgery and Services Databases, data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry, and published literature. Results: With an estimated national sample of 353,567 adult women, base case analysis showed that changes in hysterectomy practice after the morcellation warning led to a net gain of 867.15 quality-adjusted life years (QALYs), but an increase of $19.54 million in costs (incremental cost-effectiveness ratio = $22,537/QALY). In probabilistic sensitivity analysis, the practice changes were cost-effective in 54.0% of the simulations when evaluated at a threshold of $50,000/QALY, which increased to 70.9% when evaluated at a threshold of $200,000/QALY. Conclusion: Hysterectomy practice changes induced by the morcellation warning are expected to be cost-effective, but uncertainty in parameter values may affect the cost-effectiveness results.

Office versus Institutional Operative Hysteroscopy: An Economic Model.

STUDY OBJECTIVE: Model and compare estimated health system costs and gynecologic practice revenues when hysteroscopic surgery is performed in the office or institutional setting, either an ambulatory surgical center (ASC) or a traditional operating room (OR). DESIGN: Economic modeling exercise. INTERVENTIONS: Nonclinical. MEASUREMENTS AND MAIN RESULTS: An economic model was developed that included US reimbursement rates for the office and institutional settings and the inherent expenses required for office hysteroscopic surgery. For Current Procedural Terminology code 58558, hysteroscopic biopsy and/or polypectomy, total health system costs were estimated as follows: office, $1382.48; ASC, $1655.31; OR $2918.10. In the modeled office setting, costs for the same procedure were estimated from instrumentation and supply list prices obtained from vendors and staffing costs from national databases. Revenue and cost modeling were performed and compared both for 1 to 10 monthly procedure volumes and by hysteroscopic systems, whereas other elements of the procedure were standardized, including technique, staffing, generic supplies, and the use of local anesthesia. Four vendors provided system price information: 1 purpose built, 1 electromechanical, and 2 traditional. The projected office-based, per case net revenue with the purpose-built system was always greater than in the ASC or OR and relatively independent of monthly procedure volume (1 per month $743.59; 10 per month $876.17). For the traditional and electromechanical systems, it took from 2 to 5 monthly procedures to realize a net revenue greater than $239.39. Using 3 sets of vendor matched instruments, at 10 cases per month, the per case net revenue for the electromechanical system was $514.00, and for the 2 traditional systems $564.02 and $693.72. CONCLUSION: Performance of office-based hysteroscopic surgery is associated with reduced health system costs compared with the institutional environment. The net revenue for the practice was dependent on both the volume of procedures performed and the hysteroscopic system and technique selected.

Endometrial Sampling for Preoperative Diagnosis of Uterine Leiomyosarcoma.

STUDY OBJECTIVES: To examine the effectiveness of endometrial sampling for preoperative detection of uterine leiomyosarcoma in women undergoing hysterectomy, identify factors associated with missed diagnosis, and compare the outcomes of patients who had a preoperative diagnosis with those of patients who had a missed diagnosis. DESIGN: Retrospective cohort study using linked data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry from 2003 to 2015. SETTING: Inpatient and outpatient encounters at civilian hospitals and ambulatory surgery centers in New York State. PATIENTS: Women with uterine leiomyosarcoma who underwent a hysterectomy and a preoperative endometrial sampling within 90 days before the hysterectomy. INTERVENTIONS: Endometrial sampling. MEASUREMENTS AND MAIN RESULTS: A total of 79 patients with uterine leiomyosarcoma met the sample eligibility criteria. Of these patients, 46 (58.2%) were diagnosed preoperatively, and 33 (41.8%) were diagnosed postoperatively. Patients in the 2 groups did not differ significantly in age, race/ethnicity, bleeding symptoms, or comorbidities assessed. In multivariable regression analysis, women who had endometrial sampling performed with hysteroscopy (compared with women who had endeometrial sampling performed without hysteroscopy) had a higher likelihood of preoperative diagnosis (adjusted risk ratio [aRR] 3.03; 95% confidence interval [CI], 1.43-6.42). Patients with localized stage (vs distant stage) or tumor size >11 cm (vs <8 cm) were less likely to be diagnosed preoperatively (aRR 0.50; 95% CI, 0.28-0.89, and aRR 0.54; 95% CI, 0.30-0.99, respectively). Supracervical hysterectomy was not performed in any of the patients whose leiomyosarcoma was diagnosed preoperatively compared with 21.2% of the patients who were diagnosed postoperatively (p = .002). CONCLUSION: Endometrial sampling detected leiomyosarcoma preoperatively in 58.2% of the patients. The use of hysteroscopy with endometrial sampling improved preoperative detection of leiomyosarcoma by threefold. Patients with a missed diagnosis had a higher risk of undergoing suboptimal surgical management at the time of their index surgery.

Physician attitudes and knowledge on prophylactic salpingectomy in perimenopausal patients.

PURPOSE: Eighty percent of the approximately 500,000 hysterectomies performed annually in the US are for benign indications. There is lack of consensus regarding concurrent removal of fallopian tubes and/or ovaries. Ovarian cancer risk reduction is the principal benefit but the adverse consequences of ovarian removal can include vasomotor disturbance, vaginal dryness, cardiovascular disease, osteoporosis, and cognitive decline. Emerging evidence on the role of fallopian tubes in ovarian carcinogenesis and the consequences of oophorectomy have led the American College of Obstetricians-Gynecologists (ACOG) to recommend bilateral salpingectomy with ovarian conservation during benign hysterectomy for women at population risk for ovarian cancer. METHODS: Five hundred members of the ACOG Collaborative Ambulatory Research Network (CARN) were randomly selected to participate in this survey study. RESULTS: 165 completed the survey (35.3% response rate). Most respondents reported that a family history of breast, ovarian or colon cancer and patient age influence their decision to offer salpingectomy more than 75% of the time. Factors that a majority of respondents reported discussing during counseling included possible ovarian cancer risk reduction, surgical menopause, severity of symptoms, and the effects on bone and cardiovascular health. The respondents mean score for the knowledge-based questions was only 1.7 (±0.92) out of 4 points. CONCLUSION: Several factors may affect decision making for prophylactic salpingectomy at the time of hysterectomy however paramount among these is cancer risk reduction. Most physicians found it difficult to discuss and implement a change in care for patients with preconceived notions of ovarian preservation or removal.

Hospital variation in responses to safety warnings about power morcellation in hysterectomy.

BACKGROUND: Safety warnings about power morcellation in 2014 considerably changed hysterectomy practice, especially for laparoscopic supracervical hysterectomy that typically requires morcellation to remove the corpus uteri while preserving the cervix. Hospitals might vary in how they respond to safety warnings and altered hysterectomy procedures to avoid use of power morcellation. However, there has been little data on how hospitals differ in their practice changes. OBJECTIVE: This study aimed to examine whether hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation and compare the risk of surgical complications at hospitals that had different response trajectories in use of laparoscopic supracervical hysterectomy. STUDY DESIGN: This was a retrospective analysis of data from the New York Statewide Planning and Research Cooperative System and the State Inpatient Databases and State Ambulatory Surgery and Services Databases from 14 other states. We identified women aged ≥18 years undergoing hysterectomy for benign indications in the hospital inpatient and outpatient settings from October 1, 2013 to September 30, 2015. We calculated a risk-adjusted utilization rate of laparoscopic supracervical hysterectomy for each hospital in each calendar quarter after accounting for patient clinical risk factors. Applying a growth mixture modeling approach, we identified distinct groups of hospitals that exhibited different trajectories of using laparoscopic supracervical hysterectomy over time. Within each trajectory group, we compared patients' risk of surgical complications in the prewarning (2013Q4-2014Q1), transition (2014Q2-2014Q4), and postwarning (2015Q1-2015Q3) period using multivariable regressions. RESULTS: Among 212,146 women undergoing benign hysterectomy at 511 hospitals, the use of laparoscopic supracervical hysterectomy decreased from 15.1% in 2013Q4 to 6.2% in 2015Q3. The use of laparoscopic supracervical hysterectomy at these 511 hospitals exhibited 4 distinct trajectory patterns: persistent low use (mean risk-adjusted utilization rate of laparoscopic supracervical hysterectomy changed from 2.8% in 2013Q4 to 0.6% in 2015Q3), decreased medium use (17.0% to 6.9%), decreased high use (51.4% to 24.2%), and rapid abandonment (30.5% to 0.8%). In the meantime, use of open abdominal hysterectomy increased by 2.1, 4.1, 7.8, and 11.8 percentage points between the prewarning and postwarning periods in these 4 trajectory groups, respectively. Compared with the prewarning period, the risk of major complications in the postwarning period decreased among patients at "persistent low use" hospitals (adjusted odds ratio, 0.88; 95% confidence interval, 0.81-0.94). In contrast, the risk of major complications increased among patients at "rapid abandonment" hospitals (adjusted odds ratio, 1.48; 95% confidence interval, 1.11-1.98), and the risk of minor complications increased among patients at "decreased high use" hospitals (adjusted odds ratio, 1.31; 95% confidence interval, 1.01-1.72). CONCLUSION: Hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation. Complication risk increased at hospitals that shifted considerably toward open abdominal hysterectomy.

An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.

OBJECTIVE: To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures. DESIGN: Mixed qualitative-quantitative approach. SETTING: Convened seven meetings with stakeholders to obtain input and feedback on the tool. PARTICIPANTS: Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country. INTERVENTIONS: With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals. OUTCOMES: Abstraction tool to evaluate the quality of informed consent documents. RESULTS: We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%. CONCLUSIONS: We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

Quality of informed consent documents among US. hospitals: a cross-sectional study.

OBJECTIVE: To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. DESIGN: Retrospective observational study of informed consent documents. SETTING: 25 US hospitals, diverse in size and geographical region. COHORT: Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. PRIMARY OUTCOME: The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0-20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. RESULTS: Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. CONCLUSION: All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital's informed consent documents can serve as a first step in driving attention to gaps in quality.

Association Between Power Morcellation and Mortality in Women With Unexpected Uterine Cancer Undergoing Hysterectomy or Myomectomy.

PURPOSE: Despite concerns that power morcellation may adversely affect prognosis of patients with occult uterine cancer, empirical evidence has been limited and inconclusive. In this study, we aimed to determine whether uncontained power morcellation at the time of hysterectomy or myomectomy is associated with increased mortality risk in women with occult uterine cancer. METHODS: By linking statewide hospital discharge records with cancer registry data in New York, we identified 843 women with occult endometrial carcinoma and 334 women with occult uterine sarcoma who underwent a hysterectomy or myomectomy for presumed benign indications during the period October 1, 2003, through December 31, 2013. Within this cohort, we compared disease-specific and all-cause mortality of women who underwent laparoscopic supracervical hysterectomy/laparoscopic myomectomy (LSH/LM), a surrogate indicator for uncontained power morcellation, with women who underwent supracervical abdominal hysterectomy and total abdominal hysterectomy (TAH), which did not involve power morcellation. Multivariable Cox regressions and propensity score method were used to adjust for patient characteristics. RESULTS: Among women with occult uterine sarcoma, LSH/LM was associated with a higher risk for disease-specific mortality than TAH (adjusted hazard ratio [aHR], 2.66, 95% CI, 1.11 to 6.37; adjusted difference in 5-year disease-specific survival, -19.4%, 95% CI, -35.8% to -3.1%). In the subset of women with leiomyosarcoma, LSH/LM was associated with an increased risk for disease-specific mortality compared with supracervical abdominal hysterectomy (aHR, 3.64, 95% CI, 1.50 to 8.86; adjusted difference in 5-year disease-specific survival, -31.2%, 95% CI, -50.0% to -12.3%) and TAH (aHR, 4.66, 95% CI, 1.97 to 11.00; adjusted difference in 5-year disease-specific survival, -37.3%, 95% CI, -54.2% to -20.3%). Among women with occult endometrial carcinoma, there was no significant association between surgical approach and disease-specific mortality. CONCLUSION: Uncontained power morcellation was associated with higher mortality risk in women with occult uterine sarcoma, especially in those with occult leiomyosarcoma.

Laparoscopic Hysterectomy Route, Resource Use, and Outcomes: Change After Power Morcellation Warning.

OBJECTIVE: To examine changes in utilization of different types of laparoscopic hysterectomy, as well as their associated resource use and surgical outcomes, after the U.S. Food and Drug Administration (FDA) safety statement in April 2014 regarding power morcellation. METHODS: We retrospectively analyzed data from the 2012-2016 American College of Surgeons National Surgical Quality Improvement Program and identified 145,746 women undergoing hysterectomy for benign indications. We measured use of laparoscopic supracervical hysterectomy compared to total laparoscopic hysterectomy (including laparoscopic-assisted vaginal hysterectomy) in these patients, as well as operative time, surgical setting (inpatient vs outpatient), length of stay, and 30-day surgical outcomes (wound complication, medical complication, reoperation, and readmission). We used an interrupted time series analysis to examine the association between FDA warning and changes in utilization and outcomes of laparoscopic hysterectomy. RESULTS: After adjusting for patient characteristics and background trends in practice, use of laparoscopic supracervical hysterectomy was significantly lower in the postwarning than prewarning period (odds ratio [OR]=0.49, 95% CI 0.45-0.53), whereas use of total laparoscopic hysterectomy was not affected (OR 1.01, 95% CI 0.96-1.06). Overall, after an initial reduction, use of laparoscopic hysterectomy (laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy combined) increased over time in the postwarning period (adjusted OR of utilization for each calendar quarter elapsed=1.03, 95% CI 1.02-1.03). After the FDA warning, operative time for laparoscopic supracervical hysterectomy increased by 11.45 minutes (95% CI 6.22-16.69), whereas the decreasing trend in the likelihood of inpatient stay for total laparoscopic hysterectomy was attenuated (OR for each calendar quarter elapsed=0.92 in prewarning period, 95% CI 0.91-0.93; and 0.97 in postwarning period, 95% CI 0.97-0.98). There was no significant change in 30-day surgical outcomes after the FDA warning. CONCLUSION: Rates of laparoscopic supracervical hysterectomy fell in association with power morcellation safety warnings, whereas rates of other laparoscopic hysterectomies continued to rise. There was no change in patient outcomes among laparoscopic hysterectomies.

Prevalence, characteristics, and risk factors of occult uterine cancer in presumed benign hysterectomy.

BACKGROUND: Occult uterine cancer at the time of benign hysterectomy poses unique challenges in patient care. There is large variability and uncertainty in estimated risk of occult uterine cancer in the literature and prior research often did not differentiate/include all subtypes. OBJECTIVES: To thoroughly examine the prevalence of occult uterine cancer in a large population-based sample of women undergoing hysterectomy for presumed benign indications and to identify associated risk factors. STUDY DESIGN: Using the New York Statewide Planning and Research Cooperative System database, we identified 229,536 adult women who underwent an inpatient or outpatient hysterectomy for benign indications during the period October 1, 2003 to December 31, 2013 at civilian hospitals and ambulatory surgery centers throughout the state. Diagnosis of corpus uteri cancer within 28 days after the index hysterectomy was determined using linked state cancer registry data. We estimated the prevalence of occult uterine cancer (overall and by subtype) and developed and validated risk prediction models using a random split sample approach. RESULTS: Overall, 0.96% (95% confidence interval: 0.92-1.00%) of the women had occult uterine cancer, including 0.75% (95% confidence interval: 0.71-0.78%) with endometrial carcinoma and 0.22% (95% confidence interval: 0.20-0.23%) with uterine sarcoma. The prevalence of leiomyosarcoma was 0.15% (95% confidence interval: 0.13-0.17%). Seventy-one percent of the endometrial carcinomas and 58.0% of the uterine sarcomas were at localized stage. The risk for occult uterine cancer ranged from 0.10% in women aged 18-29 years to 4.40% in women aged ≥75 years; and varied from 0.14% in women undergoing hysterectomy for endometriosis to 0.62% for uterine fibroids and 8.43% for postmenopausal bleeding. The risk of occult uterine cancer was also significantly associated with race/ethnicity, obesity, comorbidity, and personal history of malignancy. Prediction models incorporating these risk factors had high negative predictive values (99.8% for endometrial carcinoma and 99.9% for uterine sarcoma) and good rule-out accuracy despite low positive predictive value. CONCLUSIONS: In women undergoing hysterectomy for presumed benign indications, 0.96% had unexpected uterine cancer. Patient characteristics such as age, surgical indication, and medical history may help guide risk stratification.

Decreased Surgical Site Infection Rate in Hysterectomy: Effect of a Gynecology-Specific Bundle.

OBJECTIVE: We implemented a hysterectomy-specific surgical site infection prevention bundle after a higher-than-expected surgical site infection rate was identified at our institution. We evaluate how this bundle affected the surgical site infection rate, length of hospital stay, and 30-day postoperative readmission rate. METHODS: This is a quality improvement study featuring retrospective analysis of a prospectively implemented, multidisciplinary team-designed surgical site infection prevention bundle that consisted of chlorhexidine-impregnated preoperative wipes, standardized aseptic surgical preparation, standardized antibiotic dosing, perioperative normothermia, surgical dressing maintenance, and direct feedback to clinicians when the protocol was breached. RESULTS: There were 2,099 hysterectomies completed during the 33-month study period. There were 61 surgical site infections (4.51%) in the pre-full bundle implementation period and 14 (1.87%) in the post-full bundle implementation period; we found a sustained reduction in the proportion of patients experiencing surgical site infection during the last 8 months of the study period. After adjusting for clinical characteristics, patients who underwent surgery after full implementation were less likely to develop a surgical site infection (adjusted odds ratio [OR] 0.46, P=.01) than those undergoing surgery before full implementation. Multivariable regression analysis showed no statistically significant difference in postoperative days of hospital stay (adjusted mean ratio 0.95, P=.09) or rate of readmission for surgical site infection-specific indication (adjusted OR 2.65, P=.08) between the before and after full-bundle implementation periods. CONCLUSION: The multidisciplinary implementation of a gynecologic perioperative surgical site infection prevention bundle was associated with a significant reduction in surgical site infection rate in patients undergoing hysterectomy.

Occult Gynecologic Cancer in Women Undergoing Hysterectomy or Myomectomy for Benign Indications.

OBJECTIVE: To estimate the prevalence of corpus uteri, cervix uteri, and ovarian malignancy in women undergoing hysterectomy or myomectomy for presumed benign indications. METHODS: We conducted a secondary analysis of data from the 2014-2015 American College of Surgeons National Surgical Quality Improvement Program. Adult women undergoing hysterectomies and myomectomies without evidence for known or suspected cancer at the beginning of surgery were identified from the database. Our primary outcome measure was pathology-confirmed malignancy in the corpus uteri, cervix uteri, and ovary. We performed adjusted logistic regression analysis to examine the association of patient characteristics with the risk for malignancy. RESULTS: Our sample included 24,076 women undergoing hysterectomy and 2,368 women undergoing myomectomy. Malignancy of the corpus uteri was found in 1.44% (95% CI 1.29-1.59%) of the women undergoing hysterectomy. The prevalence varied considerably across surgical routes with the rate being 0.23% (95% CI 0.06-0.58%) in laparoscopic supracervical hysterectomy and 1.89% (95% CI 1.65-2.14%) in total laparoscopic or laparoscopic-assisted vaginal hysterectomy. Older women were significantly more likely to have preoperatively undetected malignancy of the corpus uteri (adjusted odds ratio 6.46, 95% CI 4.96-8.41 for age 55 years or older vs age 40-54 years). Additionally, 0.60% (95% CI 0.50-0.70%) and 0.19% (95% CI 0.14-0.25%) of the women undergoing hysterectomy were found to have malignancy of the cervix uteri and the ovary, respectively. Among patients undergoing myomectomy, 0.21% (95% CI 0.03-0.40%) were found to have malignancy of the corpus uteri with no occult cervical or ovarian cancer identified. CONCLUSION: Prevalence of occult corpus uteri, cervical, and ovarian malignancy was 1.44%, 0.60%, and 0.19%, respectively, among women undergoing hysterectomy and it varied by patient age and surgical route.

Utilization of gynecologic services in women with breast cancer receiving hormonal therapy.

BACKGROUND: The selective estrogen receptor modulator tamoxifen is now widely used for the treatment and prevention of breast cancer. Tamoxifen use has been associated with a variety of gynecologic problems. Despite the frequency with which hormonal therapy is used for the treatment of breast cancer, limited population-level data are available to describe the occurrence of gynecologic conditions and the use of surveillance testing in women receiving tamoxifen and aromatase inhibitors. OBJECTIVE: We performed a population-based analysis among women with breast cancer receiving hormonal therapy with tamoxifen, a drug commonly used in premenopausal and sometimes postmenopausal women, to determine the frequency of gynecologic abnormalities and use of diagnostic and surveillance testing. We compared these findings to women treated with aromatase inhibitors, agents commonly used in postmenopausal women. STUDY DESIGN: The MarketScan database was used to identify women diagnosed with breast cancer from 2009 through 2013 who underwent mastectomy or lumpectomy. Women receiving tamoxifen (age <50 vs ≥50 years) were compared to women ≥50 years of age treated with aromatase inhibitors. We examined the occurrence of gynecologic symptoms and diseases (vaginal bleeding, endometrial polyps, endometrial hyperplasia, and endometrial cancer) and gynecologic procedures and interventions (transvaginal ultrasound, endometrial biopsy, hysteroscopy/dilation and curettage, and hysterectomy). Time-dependent analyses were performed to examine symptoms and testing. RESULTS: A total of 75,170 women, including 15,735 (20.9%) age <50 years treated with tamoxifen, 13,827 (18.4%) age ≥50 years treated with tamoxifen, and 45,608 (60.7%) age ≥50 years treated with aromatase inhibitors were identified. The cumulative incidence of any gynecologic symptom or pathologic diagnosis during the study period was 20.2%, 12.3%, and 3.5%, respectively (P < .001), while the cumulative incidence of any gynecologic procedure or intervention during the study period was 34.2%, 20.9%, and 9.0%, respectively (P < .0001). Among women without symptoms or pathology, interventions were performed in 20.0%, 11.0%, and 6.8%, respectively (P < .0001). CONCLUSION: Compared to women taking aromatase inhibitors, gynecologic symptoms, procedures, and pathology are higher for both premenopausal and postmenopausal women with breast cancer on tamoxifen. Increased efforts to curb use of gynecologic interventions in asymptomatic women are needed.

Utilization of sentinel lymph node biopsy for uterine cancer.

BACKGROUND: To limit the potential short and long-term morbidity of lymphadenectomy, sentinel lymph node biopsy has been proposed for endometrial cancer. The principle of sentinel lymph node biopsy relies on removal of a small number of lymph nodes that are the first drainage basins from a tumor and thus the most likely to harbor tumor cells. While the procedure may reduce morbidity, efficacy data are limited and little is known about how commonly the procedure is performed. OBJECTIVE: We examined the patterns and predictors of use of sentinel lymph node biopsy and outcomes of the procedure in women with endometrial cancer who underwent hysterectomy. STUDY DESIGN: We used the Perspective database to identify women with uterine cancer who underwent hysterectomy from 2011 through 2015. Billing and charge codes were used to classify women as having undergone lymphadenectomy, sentinel lymph node biopsy, or no nodal assessment. Multivariable models were used to examine clinical, demographic, and hospital characteristics with use of sentinel lymph node biopsy. Length of stay and cost were compared among the different methods of nodal assessment. RESULTS: Among 28,362 patients, 9327 (32.9%) did not undergo nodal assessment, 17,669 (62.3%) underwent lymphadenectomy, and 1366 (4.8%) underwent sentinel lymph node biopsy. Sentinel lymph node biopsy was performed in 1.3% (95% confidence interval, 1.0-1.6%) of abdominal hysterectomies, 3.4% (95% confidence interval, 2.7-4.1%) of laparoscopic hysterectomies, and 7.5% (95% confidence interval, 7.0-8.0%) of robotic-assisted hysterectomies. In a multivariable model, more recent year of surgery was associated with performance of sentinel lymph node biopsy. Compared to abdominal hysterectomy, those undergoing laparoscopic (adjusted risk ratio, 2.45; 95% confidence interval, 1.89-3.18) and robotic-assisted (adjusted risk ratio, 2.69; 95% confidence interval, 2.19-3.30) hysterectomy were more likely to undergo sentinel lymph node biopsy. Among women who underwent minimally invasive hysterectomy, length of stay and cost were lower for sentinel lymph node biopsy compared to lymphadenectomy. CONCLUSION: The use of sentinel lymph node biopsy for endometrial cancer increased from 2011 through 2015. The increased use was most notable in women who underwent a robotic-assisted hysterectomy.

Inpatient Laparoscopic Hysterectomy in the United States: Trends and Factors Associated With Approach Selection.

STUDY OBJECTIVE: To examine utilization patterns of different laparoscopic approaches in inpatient hysterectomy and identify patient and hospital characteristics associated with the selection of specific laparoscopic approaches. DESIGN: Using data from the 2007 to 2012 National (Nationwide) Inpatient Sample (NIS), we identified adult women undergoing inpatient laparoscopic hysterectomy for nonobstetric indications based on International Classification of Diseases, Ninth Revision, Clinical Modification codes. Benign cases were categorized based on laparoscopic approach, classified as total laparoscopic hysterectomy (TLH), laparoscopic-assisted vaginal hysterectomy (LAVH), or laparoscopic supracervical hysterectomy (LSH). We assessed changes in the use of these approaches during 2007 to 2012, and used multinomial logistic regression to examine the association of patient and hospital characteristics with the choice of laparoscopic approach in 2012. The NIS sample weights were applied to generate nationally representative estimates. DESIGN CLASSIFICATION: Retrospective study (Canadian Task Force classification III). SETTING: Hospital inpatient care nationwide. PATIENTS: Female adult patients in the NIS database who underwent an inpatient laparoscopic hysterectomy between 2007 and 2012. INTERVENTION: Inpatient laparoscopic hysterectomy. MEASUREMENTS AND MAIN RESULTS: Of the inpatient laparoscopic hysterectomies performed in 2012, 83.2% were for benign indications. The TLH approach accounted for 48.3% of all laparoscopic hysterectomies, followed by LAVH at 37.3% and LSH at 14.4%. Robotic assistance was reported in 45.0% of all cases and 72.3% of malignant hysterectomies. An examination of temporal trends during 2007 to 2012 demonstrates a shift in the laparoscopic approach from LAVH toward TLH, with a slight decrease in LSH. Patient race/ethnicity, income, indication for hysterectomy, and comorbid conditions, as well as hospital teaching status, urban/rural location, bed size, type of ownership, and geographic region, were significantly associated with the choice of laparoscopic approach. CONCLUSION: Benign laparoscopic hysterectomy is increasingly performed as TLH rather than LAVH. In addition to clinical factors, the selection of laparoscopic approach is influenced by patient socioeconomic and hospital characteristics.

Shoulder Dystocia and Neonatal Resuscitation: An Integrated Obstetrics and Neonatology Simulation Case for Medical Students.

INTRODUCTION: The new model in medical education of longitudinal clinical clerkships can be complemented by high-technology simulation, which provides a safe space for learners to consolidate clinical knowledge and practice decision-making skills, teamwork, and communication. We developed an interdisciplinary training intervention including a simulation case and structured debriefing to link clinical content between pediatrics and obstetrics at a major academic medical center. METHODS: In this case, a 38-year-old female at 38 weeks gestation presents with onset of labor complicated by shoulder dystocia. After the appropriate maneuvers, a depressed neonate is delivered and requires resuscitation. Major equipment needed includes a high- or low-technology birthing mannequin and an infant mannequin. RESULTS: Fifty-four third-year medical students participated in this simulation-based intervention at the completion of their integrated pediatrics and obstetrics clerkship. Ninety-one percent of students agreed that the shoulder dystocia simulation was designed appropriately for their learning level and enhanced their ability to handle a risky delivery. Ninety-four percent agreed that the neonatal resuscitation simulation was designed appropriately for their learning level, and 89% reported an enhanced ability to handle a similar situation in the clinic following the intervention. The average overall ratings were 4.24 (SD = 0.61) and 4.06 (SD = 0.89) on a 5-point scale (1 = poor, 5 = excellent) for the obstetrics and pediatrics simulations, respectively. DISCUSSION: The integrated obstetrics and pediatrics scenario is feasible to run and clinically accurate. Two distinct areas of medicine in the third-year curriculum are logically incorporated into one cohesive simulation-based training intervention that students found positive and realistic.

Hospital Variation in the Practice of Bilateral Salpingectomy With Ovarian Conservation in 2012.

OBJECTIVE: To examine hospital variation in the practice of bilateral salpingectomy with ovarian conservation at the time of benign hysterectomy. METHODS: We conducted a cross-sectional study using data from the 2012 National Inpatient Sample. We identified hospitalizations for benign, nonobstetric hysterectomy in adult women and excluded women who had elevated risk for ovarian cancer or a subsequent operation of the ovary. Of the remaining sample, we calculated the rate of bilateral salpingectomy with ovarian conservation for each hospital and conducted multivariable regression analysis to identify factors associated with a hospital's practice of this procedure. RESULTS: There were 63,306 hospitalizations for hysterectomy, and 20,635 were for adult women at low risk for ovarian cancer or subsequent ovarian surgery. Among these low-risk women, only 5.9% (95% confidence interval 5.4-6.5%) received bilateral salpingectomy with ovarian conservation. The rate varied markedly across 744 hospitals in the United States ranging from 0% to 72.2%. At 376 of the hospitals (50.5%), no low-risk women received bilateral salpingectomy with ovarian conservation. When categorizing hospitals into tertiles based on the proportion of their hysterectomies performed laparoscopically, hospitals in the highest tertile were more likely to have low-risk patients undergoing bilateral salpingectomy with ovarian conservation than those in the lowest tertile (adjusted odds ratio 2.343, P=.02). Geographic region, hysterectomy volume, and proportion of white patients were also significantly associated with a hospital's likelihood of having low-risk patients undergoing this procedure. CONCLUSION: The rate of bilateral salpingectomy with ovarian conservation was low in low-risk women undergoing benign hysterectomies. Hospitals varied widely in their practice.

Robotic Versus Laparoscopic Hysterectomy for Benign Disease: A Systematic Review and Meta-Analysis of Randomized Trials.

We conducted a systematic review and meta-analysis to assess the safety and effectiveness of robotic vs laparoscopic hysterectomy in women with benign uterine disease, as determined by randomized studies. We searched MEDLINE, EMBASE, the Cochrane Library, ClinicalTrials.gov, and Controlled-Trials.com from study inception to October 9, 2014, using the intersection of the themes "robotic" and "hysterectomy." We included only randomized and quasi-randomized controlled trials of robotic vs laparoscopic hysterectomy in women for benign disease. Four trials met our inclusion criteria and were included in the analyses. We extracted data, and assessed the studies for methodological quality in duplicate. For meta-analysis, we used random effects to calculate pooled risk ratios (RRs) and weighted mean differences. For our primary outcome, we used a modified version of the Expanded Accordion Severity Grading System to classify perioperative complications. We identified 41 complications among 326 patients. Comparing robotic and laparoscopic hysterectomy, revealed no statistically significant differences in the rate of class 1 and 2 complications (RR, 0.66; 95% confidence interval [CI], 0.23-1.89) or in the rate of class 3 and 4 complications (RR, 0.99; 95% CI, 0.22-4.40). Analyses of secondary outcomes were limited owing to heterogeneity, but showed no significant benefit of the robotic technique over the laparoscopic technique in terms of length of hospital stay (weighted mean difference, -0.39 day; 95% CI, -0.92 to 0.14 day), total operating time (weighted mean difference, 9.0 minutes; 95% CI, -31.27 to 47.26 minutes), conversions to laparotomy, or blood loss. Outcomes of cost, pain, and quality of life were reported inconsistently and were not amenable to pooling. Current evidence demonstrates neither statistically significant nor clinically meaningful differences in surgical outcomes between robotic and laparoscopic hysterectomy for benign disease. The role of robotic surgery in benign gynecology remains unclear.