Discrepancies between author- and industry-reported disclosures of financial relationships at an annual gynecologic oncology research meeting.

OBJECTIVE: Trillions of dollars pass to physicians from industry-related businesses annually, leading to many opportunities for financial conflicts of interest. The Open Payments Database (OPD) was created to ensure transparency. We describe the industry relationships as reported in the OPD for presenters at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting and evaluate concordance between author disclosures of their financial interests and information provided by the OPD. METHODS: This is an observational, cross-sectional study. Disclosure data were collected from authors with oral and featured abstract presentations in the 2019 SGO annual conference. These disclosures were compared to data available for each author in the 2018 OPD, which included the amount and nature of industry payments. RESULTS: We examined the disclosures of 301 authors who met inclusion criteria. Of 161 authors who had disclosure statements on their presentations,147 reported "no disclosures," and 14 disclosed industry relationships. The remaining 140 did not list any disclosure information. Sixty percent (184/301) of authors had industry relationships in the 2018 OPD, including 173 of 287 (60.3%) of authors who either reported no disclosures or did not have disclosure data available in their presentations. These transactions totaled over 43 million USD from 122 different companies, with most payments (46%) categorized as "Research or Associated Research." Accurate disclosure reporting was associated with receiving higher payments or research payments, and being a presenting author. CONCLUSIONS: Most authors at the SGO annual conference did not correctly disclose their industry relationships when compared with their entries in the OPD.

Gynecologic Care in Women With Down Syndrome: Findings From a National Registry.

OBJECTIVE: To estimate receipt of recommended gynecologic care, including cancer screening and menstrual care, among women with Down syndrome in the United States. METHODS: We conducted a retrospective cohort study of women participating in DS-Connect, the National Institute of Health's registry of women with Down syndrome. Using 2013-2019 survey data, we estimated the proportion of women receiving recommended age-appropriate well-woman care (Pap tests, mammogram, breast examination, pelvic examination) and compared receipt of gynecologic care to receipt of other preventive health care. We also estimated proportion receiving care for menstrual regulation. RESULTS: Of 70 participants with Down syndrome, 23% (95% CI 13-33) of women received all recommended gynecologic components of a well-woman examination. Forty-four percent (95% CI 32-56) of women aged 18 years and older reported ever having a gynecologic examination, and 26% (95% CI 15-37) reported ever having a Pap test. Of women aged 40 years or older, 50% (95% CI 22-78) had had a mammogram. Fifty-two percent (95% CI 41-65) had tried medication for menstrual regulation, and 89% (95% CI 81-96) received all recommended components of nongynecologic routine health care. CONCLUSION: Women with Down syndrome received gynecologic care, including cancer screening, at lower-than-recommended rates and at substantially lower rates than other forms of health care. Efforts to improve gynecologic care in this vulnerable population are needed.

Comparing Single-Site and Multiport Robotic Hysterectomy with Sentinel Lymph Node Mapping for Endometrial Cancer: Surgical Outcomes and Cost Analysis.

STUDY OBJECTIVE: To compare operative times, surgical outcomes, and costs of robotic laparoendoscopic single-site (R-LESS) vs multiport robotic (MPR) total laparoscopic hysterectomy (TLH) with sentinel lymph node (SLN) mapping for low-risk endometrial cancer. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Academic university hospital. PATIENTS: Patients with a biopsy-proven diagnosis of complex atypical hyperplasia (CAH) or low-grade (1 or 2) endometrial cancer with body mass index <30 kg/m2 and undergoing robotic TLH and SLN mapping between 2012 and 2016 were included. INTERVENTIONS: Surgical outcomes and cost data were collected retrospectively and analyzed based on the surgical approach with R-LESS vs MPR assistance. MEASUREMENTS AND MAIN RESULTS: Twenty-seven patients who met the inclusion criteria were identified, including 14 patients who underwent R-LESS TLH with SLN mapping and 13 patients who underwent MPR TLH with SLN mapping. Median uterine weight was comparable in the 2 cohorts (111.3 g vs 83.8 g; p = .33). Operative and console times were equivalent with the R-LESS and MPR approaches (median, 175 minutes vs 184 minutes, p = .61 and 136 vs 140 minutes, p = .12, respectively). Median estimated blood loss was 50 mL in both cohorts. Successful bilateral SLN mapping occurred in 85.7% of the R-LESS procedures and 76.9% of MPR procedures. No intraoperative or 30-day complications were encountered, and all patients were discharged within 23 hours of surgery. MPR was associated with additional disposable instrument and drape costs of $460 to $660 compared with R-LESS, depending on the surgeon's instrument selection. Average total hospital charges were lower for R-LESS procedures ($13,410 vs $15,952; p < .05). CONCLUSION: In highly selected patients with CAH or low-grade endometrial cancer undergoing TLH and SLN mapping, R-LESS appears to result in equivalent perioperative outcomes as a MPR approach while offering a more cost-effective option. Further research is needed to determine the benefits of R-LESS procedures in the gynecologic oncology setting.

Patient, surgeon, and hospital disparities associated with benign hysterectomy approach and perioperative complications.

BACKGROUND: Hysterectomy is among the most common major surgical procedures performed in women. Approximately 450,000 hysterectomy procedures are performed each year in the United States for benign indications. However, little is known regarding contemporary US hysterectomy trends for women with benign disease with respect to operative technique and perioperative complications, and the association between these 2 factors with patient, surgeon, and hospital characteristics. OBJECTIVE: We sought to describe contemporary hysterectomy trends and explore associations between patient, surgeon, and hospital characteristics with surgical approach and perioperative complications. STUDY DESIGN: Hysterectomies performed for benign indications by general gynecologists from July 2012 through September 2014 were analyzed in the all-payer Maryland Health Services Cost Review Commission database. We excluded hysterectomies performed by gynecologic oncologists, reproductive endocrinologists, and female pelvic medicine and reconstructive surgeons. We included both open hysterectomies and those performed by minimally invasive surgery, which included vaginal hysterectomies. Perioperative complications were defined using the Agency for Healthcare Research and Quality patient safety indicators. Surgeon hysterectomy volume during the 2-year study period was analyzed (0-5 cases annually = very low, 6-10 = low, 11-20 = medium, and ≥21 = high). We utilized logistic regression and negative binomial regression to identify patient, surgeon, and hospital characteristics associated with minimally invasive surgery utilization and perioperative complications, respectively. RESULTS: A total of 5660 hospitalizations were identified during the study period. Most patients (61.5%) had an open hysterectomy; 38.5% underwent a minimally invasive surgery procedure (25.1% robotic, 46.6% laparoscopic, 28.3% vaginal). Most surgeons (68.2%) were very low- or low-volume surgeons. Factors associated with a lower likelihood of undergoing minimally invasive surgery included older patient age (reference 45-64 years; 20-44 years: adjusted odds ratio, 1.16; 95% confidence interval, 1.05-1.28), black race (reference white; adjusted odds ratio, 0.70; 95% confidence interval, 0.63-0.78), Hispanic ethnicity (adjusted odds ratio, 0.62; 95% confidence interval, 0.48-0.80), smaller hospital (reference large; small: adjusted odds ratio, 0.26; 95% confidence interval, 0.15-0.45; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.79-0.96), medium hospital hysterectomy volume (reference ≥200 hysterectomies; 100-200: adjusted odds ratio, 0.78; 95% confidence interval, 0.71-0.87), and medium vs high surgeon volume (reference high; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97). Complications occurred in 25.8% of open and 8.2% of minimally invasive hysterectomies (P < .0001). Minimally invasive hysterectomy (adjusted odds ratio, 0.22; 95% confidence interval, 0.17-0.27) and large hysterectomy volume hospitals (reference ≥200 hysterectomies; 1-100: adjusted odds ratio, 2.26; 95% confidence interval, 1.60-3.20; 101-200: adjusted odds ratio, 1.63; 95% confidence interval, 1.23-2.16) were associated with fewer complications, while patient payer, including Medicare (reference private; adjusted odds ratio, 1.86; 95% confidence interval, 1.33-2.61), Medicaid (adjusted odds ratio, 1.63; 95% confidence interval, 1.30-2.04), and self-pay status (adjusted odds ratio, 2.41; 95% confidence interval, 1.40-4.12), and very-low and low surgeon hysterectomy volume (reference ≥21 cases; 1-5 cases: adjusted odds ratio, 1.73; 95% confidence interval, 1.22-2.47; 6-10 cases: adjusted odds ratio, 1.60; 95% confidence interval, 1.11-2.23) were associated with perioperative complications. CONCLUSION: Use of minimally invasive hysterectomy for benign indications remains variable, with most patients undergoing open, more morbid procedures. Older and black patients and smaller hospitals are associated with open hysterectomy. Patient race and payer status, hysterectomy approach, and surgeon volume were associated with perioperative complications. Hysterectomies performed for benign indications by high-volume surgeons or by minimally invasive techniques may represent an opportunity to reduce preventable harm.

Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis.

BACKGROUND: In the staging of endometrial cancer, controversy remains regarding the role of sentinel lymph node mapping compared with other nodal assessment strategies. OBJECTIVE: We conducted a systematic review to evaluate the diagnostic accuracy and clinical impact of sentinel lymph node mapping in the management of endometrial cancer. DATA SOURCES: We searched Medline, Embase, and the Cochrane Central Registry of Controlled trials for studies published in English before March 25, 2016 (PROSPERO CRD42016036503). STUDY ELIGIBILITY CRITERIA: Studies were included if they contained 10 or more women with endometrial cancer and reported on the detection rate, sensitivity, and/or impact on treatment or survival of sentinel lymph node mapping. STUDY APPRAISAL AND SYNTHESIS METHODS: Two authors independently reviewed abstracts and full-text articles for inclusion and assessed study quality. The detection rate, sensitivity, and factors associated with successful mapping (study size, body mass index, tumor histology and grade, injection site, dye type) were synthesized through random-effects meta-analyses and meta-regression. RESULTS: We identified 55 eligible studies, which included 4915 women. The overall detection rate of sentinel lymph node mapping was 81% (95% confidence interval, 77-84) with a 50% (95% confidence interval, 44-56) bilateral pelvic node detection rate and 17% (95% confidence interval, 11-23) paraaortic detection rate. There was no difference in detection rates by patient body mass index or tumor histology and grade. Use of indocyanine green increased the bilateral detection rate compared with blue dye. Additionally, cervical injection increased the bilateral sentinel lymph node detection rate but decreased the paraaortic detection rate compared with alternative injection techniques. Intraoperative sentinel lymph node frozen section increased the overall and bilateral detection rates. The sensitivity of sentinel node mapping to detect metastases was 96% (95% confidence interval, 91-98); ultrastaging did not improve sensitivity. Compared with women staged with complete lymphadenectomy, women staged with sentinel lymph node mapping were more likely to receive adjuvant treatment. CONCLUSION: Sentinel lymph node mapping is feasible and accurately predicts nodal status in women with endometrial cancer. The current data favors the use of cervical injection techniques with indocyanine green. Sentinel lymph mapping may be considered an alternative standard of care in the staging of women with endometrial cancer.

Unplanned 30-day hospital readmission as a quality measure in gynecologic oncology.

OBJECTIVES: Thirty-day readmission is used as a quality measure for patient care and Medicare-based hospital reimbursement. The primary study objective was to describe the 30-day readmission rate to an academic gynecologic oncology service. Secondary objectives were to identify risk factors and costs related to readmission. METHODS: This was a retrospective, concurrent cohort study of all surgical admissions to an academic, high volume gynecologic oncology service during a two-year period (2013-2014). Data were collected on patient demographics, medical comorbidities, psychosocial risk factors, and results from a hospital discharge screening survey. Mixed logistic regression was used to identify factors associated with 30-day readmission and costs of readmission were assessed. RESULTS: During the two-year study period, 1605 women underwent an index surgical admission. Among this population, a total of 177 readmissions (11.0%) in 135 unique patients occurred. In a surgical subpopulation with >1 night stay, a readmission rate of 20.9% was observed. The mean interval to readmission was 11.8days (SD 10.7) and mean length of readmission stay was 5.1days (SD 5.0). Factors associated with readmission included radical surgery for ovarian cancer (OR 2.87) or cervical cancer (OR 4.33), creation of an ostomy (OR 11.44), a Charlson score of ≥5 (OR 2.15), a language barrier (OR 3.36), a median household income in the lowest quartile (OR 6.49), and a positive discharge screen (OR 2.85). The mean cost per readmission was $25,416 (SD $26,736), with the highest costs associated with gastrointestinal complications at $32,432 (SD $32,148). The total readmission-related costs during the study period were $4,523,959. CONCLUSIONS: Readmissions to a high volume gynecologic oncology service were costly and related to radical surgery for ovarian and cervical cancer as well as to medical, socioeconomic and psychosocial patient variables. These data may inform interventional studies aimed at decreasing unplanned readmissions in gynecologic oncology surgical populations.

Disparities in Surgical Care Among Women With Endometrial Cancer.

OBJECTIVE: To analyze contemporary U.S. use of minimally invasive surgery for the treatment of endometrial cancer and associated inpatient complications and costs. METHODS: In this retrospective cohort study, the National Inpatient Sample database was analyzed in patients with nonmetastatic endometrial cancer who underwent hysterectomy during 2012-2013. Hierarchical multiple logistic regression and propensity score matching were used to compare complications among patients treated with open compared with minimally invasive hysterectomy surgery. Cost of care was also compared using generalized linear modeling. RESULTS: We identified 9,799 patients; 52.4% underwent open and 47.6% minimally invasive hysterectomy. Many patients (43.4%) were treated at low-volume hospitals (less than 10 endometrial cancer cases annually). Patients were less likely to undergo open surgery in high-volume compared with low-volume hospitals (51.8% compared with 58.1%, respectively; adjusted odds ratio [OR] 0.35, 95% confidence interval [CI] 0.13-0.94) and more likely to undergo open surgery in rural compared with urban teaching hospitals (75.6% compared with 51.1%, respectively; adjusted OR 14.34, 95% CI 9.66-21.27), government compared with nonprofit hospitals (61.3% compared with 51.1%, respectively; adjusted OR 1.66, 95% CI 1.15-2.39), and in patients of black (67.9%; OR 1.46, 95% CI 1.30-1.65) and "other" race (60.5%; adjusted OR 2.39, 95% CI 1.99-2.87) compared with white race (49.2%, referent). Open surgery was associated with increased perioperative complications (adjusted OR 2.80, 95% CI 2.48-3.17) and a $1,243 increase in cost per case compared with minimally invasive approaches (P<.001). Using minimally invasive surgery for 80% of study patients may have averted 2,733 complications and saved approximately $19 million. CONCLUSION: Most U.S. women with endometrial cancer continue to be treated with open hysterectomy surgery despite increased complication rates and financial costs associated with this approach. A disparity in endometrial cancer surgical care exists that is affected by patient race and hospital geography and cancer volumes.

Reducing overtreatment: A comparison of lymph node assessment strategies for endometrial cancer.

OBJECTIVES: To compare the utility of three lymph node (LN) assessment strategies to identify lymphatic metastases while minimizing complete lymphadenectomy rates in women with low-grade endometrial cancer (EC). METHODS: Using our institutional standard protocol (SP), patients with complex atypical hyperplasia (CAH) or grade 1/2 EC underwent sentinel lymph node (SLN) mapping, hysterectomy, and intraoperative frozen section (FS). Lymphadenectomy was performed if high-risk uterine features were identified on FS. Utilizing SP data, two alternative strategies were applied: a Universal FS Strategy (UFS), omitting SLN mapping and performing lymphadenectomy based on FS results, and a SLN-Restrictive FS Strategy (SLN-RFS) in which FS and lymphadenectomy are performed only if bilateral SLN mapping fails. RESULTS: Of 114 patients managed on the SP, SLNs were identified in 86%, with lymphatic metastases detected in eight patients. Six patients recurred after a median follow up of 15months. Most (83%) developed in those who had a negative systematic lymphadenectomy (n=4; mean LNs: 18) or no lymphadenectomy indication. When applying the alternative lymphatic assessment strategies, the SLN-RFS approach would theoretically result in lower lymphadenectomy rates compared to both the SP and the alternative UFS strategies (9.2% versus 36.8% and 36.8%, respectively; p=0.004), without a reduction in detection of LN metastases (8/8 versus 8/8 and 5/8, respectively). CONCLUSION: In this modeling analysis, an operative strategy omitting universal frozen section and restricting its use to cases with failed SLN mapping may result in lower lymphadenectomy rates and reduce the risk of overtreatment without compromising oncologic outcome for patients with EC.

Utilization of Minimally Invasive Surgery in Endometrial Cancer Care: A Quality and Cost Disparity.

OBJECTIVE: To describe case mix-adjusted hospital level utilization of minimally invasive surgery for hysterectomy in the treatment of early-stage endometrial cancer. METHODS: In this retrospective cohort study, we analyzed the proportion of patients who had a minimally invasive compared with open hysterectomy for nonmetastatic endometrial cancer using the U.S. Nationwide Inpatient Sample database, 2007-2011. Hospitals were stratified by endometrial cancer case volumes (low=less than 10; medium=11-30; high=greater than 30 cases). Hierarchical logistic regression models were used to evaluate hospital and patient variables associated with minimally invasive utilization, complications, and costs. RESULTS: Overall, 32,560 patients were identified; 33.6% underwent a minimally invasive hysterectomy with an increase of 22.0-50.8% from 2007 to 2011. Low-volume cancer centers demonstrated the lowest minimally invasive utilization rate (23.6%; P<.001). After multivariable adjustment, minimally invasive surgery was less likely to be performed in patients with Medicaid compared with private insurance (adjusted odds ratio [OR] 0.67, 95% confidence interval [CI] 0.62-0.72), black and Hispanic compared with white patients (adjusted OR 0.43, 95% CI 0.41-0.46 for black and 0.77, 95% CI 0.72-0.82 for white patients), and more likely to be performed in high- compared with low-volume hospitals (adjusted OR 4.22, 95% CI 2.15-8.27). Open hysterectomy was associated with a higher risk of surgical site infection (adjusted OR 6.21, 95% CI 5.11-7.54) and venous thromboembolism (adjusted OR 3.65, 95% CI 3.12-4.27). Surgical cases with complications had higher mean hospitalization costs for all hysterectomy procedure types (P<.001). CONCLUSION: Hospital utilization of minimally invasive surgery for the treatment of endometrial cancer varies considerably in the United States, representing a disparity in the quality and cost of surgical care delivered nationwide.

Surgical care of young women diagnosed with ovarian cancer: a population-based perspective.

OBJECTIVE: To characterize primary surgical care for women with ovarian cancer aged 50 years. METHODS: A statewide hospital discharge database was used to identify women undergoing primary surgery for ovarian cancer from 1990 to 2000. Logistic regression models were used to evaluate differences in demographic characteristics and short-term outcomes comparing women 50 years. RESULTS: Women 50 years (47.1% vs. 59.5%, P<0.0001). Younger women managed by high-volume surgeons had longer lengths of stay (5.7 days vs. 7.7 days, P<0.0001), longer ICU stays (0.2 days vs. 0.5 days, P=0.0020), more billed procedures (4.2 vs. 5.5, P<0.0001), higher adjusted cost of hospital-related care ($46,590 vs. $97,538, P<0.0001) and more comorbidities (1.0 vs. 1.6, P<0.0001) than those treated by lower-volume surgeons. Women