Racial and ethnic enrollment disparities in clinical trials of poly(ADP-ribose) polymerase inhibitors for gynecologic cancers.

OBJECTIVES: Disparities persist in the enrollment of racial/ethnic groups in clinical trials for ovarian cancers. We sought to analyze the enrollment rates of patients by race/ethnicity in phase II/III clinical trials involving poly(ADP-ribose) polymerase (PARP) inhibitors for ovarian cancers and compare these to the racial/ethnic prevalence of ovarian cancers in the United States. METHODS: This study was a retrospective review of clinical trials registered with ClinicalTrials.gov. Studies included evaluated PARP inhibitors for the treatment of ovarian, fallopian tube, and primary peritoneal cancers. Enrollment rates for clinical trials were stratified by race/ethnicity and type of cancer. Enrollment fractions (EFs) were calculated using prevalence data from the Surveillance, Epidemiology, and End Results Program. Odds ratios (OR) and 95% confidence intervals (CI) were calculated to compare racial/ethnic group enrollment rates to Non-Hispanic (NH) White enrollment rates. RESULTS: Forty-eight trials were identified, 15 of which met inclusion criteria. The EFs for included trials, were 1.5% for NH-White, 0.47% for NH-Black, 0.33% for Hispanic, and 2.38% for Asian/Pacific Islander. Patients who identified as NH-Black and Hispanic were significantly underrepresented compared to those who identified as NH-White (OR 0.23, 95% CI [0.18-0.29] and OR 0.3, 95% CI [0.25-0.38] respectively, p < 0.001). CONCLUSIONS: NH-Black and Hispanic patients are significantly underrepresented in clinical trials evaluating PARP inhibitors for ovarian cancers compared to NH-White cohorts. Phase II/III trials assessing PARP inhibitors for ovarian cancers do not accurately represent the populations diagnosed with these malignancies. Enrollment strategies are needed to increase diversity in PARP inhibitor clinical trials for women's cancers.

Discrepancies Created by Surgeon Self-Reported Operative Time and the Effects on Procedural Relative Value Units and Reimbursement.

OBJECTIVE: To demonstrate discrepancies between operative times in the ACS NSQIP (American College of Surgeons National Surgical Quality Improvement Project) and self-reported operative time from the American Medical Association's Relative Value Scale Update Committee (RUC) and their effect on relative value units (RVU) determination. METHODS: This is a cross-sectional review of registry data using the ACS NSQIP 2016 Participant User File and the Centers for Medicare & Medicaid Services physician procedure time file for 2018. We analyzed total RVUs for surgeries by operative time to calculate RVU per hour and stratified by specialty. Multivariate regression analysis adjusted for patient comorbidities, age, length of stay, and ACS NSQIP mortality and morbidity probabilities. The surgeon self-reported operative times from the Centers for Medicare & Medicaid Services physician were compared with operative times recorded in the ACS NSQIP, with excess time from RUC estimates termed "overreported time." RESULTS: Analysis of 901,917 surgeries revealed a wide variation in median RVU per hour between specialties. Orthopedics (14.3), neurosurgery (12.9), and general surgery (12.1) had the highest RVU per hour, whereas gynecology (10.2), plastic surgery (9.5), and otolaryngology (9) had the lowest (P<.001 for all comparisons). These results remained unchanged on multivariate regression analysis. General surgery had the highest median overreported operative time (+26 minutes) followed by neurosurgery (+23.5 minutes) and urology (+20 minutes). Overreporting of the operative time strongly correlated to higher RVU per hour (r=0.87, P=.002). CONCLUSION: Despite reliable electronic records, the AMA-RUC continues to use inaccurate self-reported RUC surveys for operative times. This results in discrepancies in RVU per hour (and subsequent reimbursement) across specialties and a persistent disparity for women-specific procedures in gynecology. Relative value unit levels should be based on the available objective data to eliminate these disparities.

Physician attitudes about abortion and their willingness to consult in abortion care at a Midwestern academic medical center.

OBJECTIVE: To assess abortion-related attitudes, practices, and perceptions among physicians of all specialties at a Wisconsin academic medical center. STUDY DESIGN: We developed and disseminated a cross-sectional web and mail survey to physicians at our academic center using a list generated by Human Resources. We performed descriptive analyses and assessed bivariate relationships between measures of support for abortion, perceived climate of opinion, willingness to consult in abortion-related cases, and sociodemographic and professional characteristics. We used binary logistic regression to model willingness to consult. RESULTS: We sent the survey to 1357 physicians and received 913 (67%) responses. Participants reported strong support for unrestricted access to abortion and the efforts of abortion providers but estimated relatively lower support among peers. Compared to 556 (62%) who reported "a lot" of support for abortion access, only 183 (21%) estimated the same level of support among peers. Similarly, 615 (69%) participants reported "a lot" of support for abortion providers, compared to only 227 (25%) who estimated the same level of support among peers. Participants most commonly estimated that peers "somewhat" support abortion access (381; 43%) and abortion providers (344; 39%). Across specialties, 799 (90%) physicians said they were at least "somewhat" willing to consult in abortion-related cases. Compared to obstetrician-gynecologists and family physicians, other specialists were less likely to be willing to consult (aOR = 0.43, 95% CI 0.29-0.65), though majorities of both groups were willing. Physicians who perceived equal or higher support for abortion among peers were more likely to be willing to consult (aOR = 2.17, 95% CI 1.60-2.95). CONCLUSION: Most physicians at our center reported support for abortion; however, those who perceived less support among peers reported less willingness to consult in abortion-related care, regardless of specialty. IMPLICATIONS: Even among physicians who supported abortion, the perception that peers were less supportive deterred participation in abortion-related care at our institution. Where abortion care is isolated or stigmatized, physicians may be unaware of colleagues' true attitudes about abortion. Efforts to normalize communication about abortion care could improve access and quality.

Bone health and osteoporosis screening in gynecologic cancer survivors.

Cancer treatment-induced bone loss is a known side effect of cancer therapy that increases the risk of osteoporosis and bone fracture. Women with gynecologic cancer are at increased risk of bone loss secondary to the combined effect of oophorectomy and adjuvant therapies. Data regarding bone loss in women with gynecologic cancers are overall lacking compared to other cancer populations. Consequently, guidelines for osteoporosis screening in women with cancer are largely based on data generated among non-gynecologic cancer survivors. This article reviews current available data of bone health in women with gynecologic cancer, summarizes best-available guidelines for screening for osteoporosis in women with cancer, and provides guidance for osteoporosis screening in women with gynecologic cancers based on best available evidence.

Increasing NIH funding for academic departments of obstetrics and gynecology: a call to action.

The National Institutes of Health funding for reproductive sciences research, specifically in academic departments of obstetrics and gynecology, is disproportionately low. Research is one of the most important pillars in advancing healthcare. Despite US Congress' vision in providing increased funding to the National Institutes of Health as a whole, underfunding for research in the departments of obstetrics and gynecology remains one of the several critical drivers in the decline in reproductive health and healthcare for women in the United States.

Universal access to contraception: women, families, and communities benefit.

Universal access to contraception benefits society: unintended pregnancies, maternal mortality, preterm birth, abortions, and obesity would be reduced by increasing access to affordable contraception. Women should be able to choose when and whether to use contraception, choose which method to use, and have ready access to their chosen method. State and national government should support unrestricted access to all contraceptives. As obstetrician-gynecologists, we have a critical mandate, based on principle and mission, to step up with leadership on this vital medical and public health issue, to improve the lives of women, their families, and society. The field of Obstetrics and Gynecology must provide the leadership for moving forward. The American Gynecological and Obstetrical Society (AGOS), representing academic and public policy leaders from across all disciplines of Obstetrics and Gynecology, is well positioned to serve as a unifying organization, focused on developing a strong unified advocacy voice to fight for accessible contraception for all in the United States.

The American Gynecological and Obstetrical Society-reinvigorating for the 21st century.

The American Gynecological and Obstetrical Society (AGOS) has the potential to serve as a unifying organization to advocate for women's reproductive health care, education, and research. This report reviews a strategic plan designed to reinvigorate AGOS to address, together with our partner organizations, the ever more pressing issues and challenges in women's reproductive health.

Disparities in the allocation of research funding to gynecologic cancers by Funding to Lethality scores.

PURPOSE: To analyze National Cancer Institute (NCI) funding distributions to gynecologic cancers compared to other cancers from 2007 to 2014. METHODS: The NCI's Surveillance, Epidemiology and End Results (SEER), Cancer Trends Progress Report, and Funding Statistics were used to analyze 18 cancer sites. Site-specific mortality to incidence ratios (MIR) were normalized per 100 cases and multiplied by person-years of life lost to derive cancer-specific lethality. NCI funding was divided by its lethality to calculate Funding to Lethality scores for gynecologic malignancies and compared to 15 other cancer sites. RESULTS: Ovarian, cervical, and uterine cancers ranked 10th (score 0.097, SD 0.008), 12th (0.087, SD 0.009), and 14th (0.057, SD 0.006) for average Funding to Lethality scores. The highest average score was for prostate cancer (score 1.182, SD 0.364). In U.S. dollars per 100 incident cases, prostate cancer received an average of $1,821,000 per person-years of life lost, while ovarian cancer received $97,000, cervical cancer $87,000, and uterine cancer $57,000. Ovarian and cervical cancers had lower average Funding to Lethality scores compared to nine other cancers, while uterine cancer was lower than 13 other cancers (p < 0.01 for all comparisons). Analyses of eight-, five-, and three-year trends for gynecologic cancers showed nearly universal decreasing Funding to Lethality scores. CONCLUSION: Funding to Lethality scores for gynecologic cancers are significantly lower than other cancer sites, indicating a disparity in funding allocation that persists over the most recent eight years of available data. Prompt correction is required to ensure critical discoveries for women with gynecologic cancers.

Trends and comparative effectiveness of inpatient radical hysterectomy for cervical cancer in the United States (2012-2015).

OBJECTIVE: Report the up-to-date trends in surgical approach for cervical cancer and compare outcomes between open and minimally invasive routes. METHODS: Radical Hysterectomy (RH) cases from the National Inpatient Sample (NIS) dataset between 2012 and 2015 were grouped into abdominal (ARH) and Minimally Invasive Surgery (MIS). The MIS group was subdivided as "Laparoscopic", "Robotic", and "Converted". Univariate and multivariable logistic regression were used to analyze differences in complication rates. The National Surgical Quality Improvement Dataset 2015 was used for validation. RESULTS: A total of 7180 cases from NIS were identified. Overall, there was 44% decline in RH cases from 2012 (n = 2220) to 2015 (n = 1255). A proportionate increase in robotic cases from 31.5% in 2012 to 41.4% in 2015 was noted. By intention to treat analysis, the rate of at least one complication for abdominal cases was 24.8% compared to 10% for MIS (p < 0.001). On multivariate analysis, abdominal cases had higher odd of any one complication (aOR 2.9,95% CI 2.12-4.00), medical complication (aOR 3.25,95% CI 2.15-4.19), infectious complication (aOR 3.76,95% CI 2.1-6.1) but not for surgical complications (aOR 1.7,95% CI 0.5-5.6). AH resulted in longer hospital stay compared to MIS (4.3 vs 1.9 days, p < 0.001). Median cost of AH was $12,624, laparoscopic $12,873, robotic $14,029 and converted cases $17,036. NSQIP analysis supplemented the outcomes to 30-days and showed similar findings. CONCLUSIONS: Perioperative complications are significantly lower for MIS procedures. These data should be used for contemporary cost-effective analysis and comprehensive counseling regarding risks and benefits of the surgical approach for cervical cancer.

Variation in resource utilization associated with the surgical management of ovarian cancer.

OBJECTIVE: Identify the major factors that drive standardized cost in providing surgical care for women with ovarian cancer, characterize the magnitude of variation in resource utilization between centers, and to investigate the relationship between resource utilization and quality of care provided. METHODS: Retrospective cohort study of hospitals across the United States reporting to the Premier Database who cared for patients with ovarian cancer diagnosed between 2007 and 2014. The primary outcome was standardized total cost of the index hospitalization. To assess the relationship between hospital standardized costs and patient outcomes, we identified four measures of quality: 1) complications, 2) re-operation, 3) length of stay > 15 days, and 4) unplanned readmission. RESULTS: The study population included 15,857 patients treated at 226 hospitals. The median standardized cost for hospitalizations was $13,267 (IQR = $3342). Reoperation was associated with 49% increase (95% CI = 43%-56%), and having minor complication was associated with 10% (95% CI = 8%-12%) increase in standardized cost, a moderate complication was associated with 36% (95% CI = 33%-38%) increase, and a major complication was associated with 83% (95% CI = 76%-89%) increase. The average risk-adjusted hospital standardized costs for hospitals in the highest resource use quartiles was 56% higher than the average hospital costs for hospitals in the lowest quartile ($10,826 vs. $16,933). The largest variation was in operating room standardized cost (45.5% of the total variation in operating room cost is explained by differences in hospital practices) and supplies (41.7%). CONCLUSIONS: We identified significant variation in standardized costs among women who underwent surgery for ovarian cancer, operating room and supply costs are the largest drivers of variation.

Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer.

BACKGROUND: Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer. METHODS: We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database. RESULTS: In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend). CONCLUSIONS: In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).

Isolated para-aortic lymph node metastasis in FIGO stage IA2-IB2 carcinoma of the cervix: Revisiting the role of surgical assessment.

OBJECTIVES: To investigate the utility of para-aortic lymph node dissection among women undergoing radical hysterectomy and pelvic lymph adenectomy for FIGO Stage IA2-IB2 cervical cancer using the National Cancer Database (NCDB). METHODS: We identified patients with stage IA2-IB2 squamous cell, adenosquamous, or adenocarcinoma of the cervix diagnosed 2011-2014 in the NCDB. The primary outcome was the negative predictive value of histologically assessed pelvic lymph node status for para-aortic lymph node status among women undergoing pelvic and para-aortic lymph node dissection. We calculated probability of para-aortic lymph node metastasis conditional on pelvic lymph node status. Finally, we compared overall survival between patients undergoing para-aortic lymph node dissection and those in whom this procedure was omitted. RESULTS: A total of 3212 patients met study inclusion criteria, of whom 994 (30.9%) underwent para-aortic lymph node dissection. In this group, the risk of isolated para-aortic metastasis was 0.11%. The negative predictive value of surgically assessed pelvic lymph nodes to predict para-aortic lymph node status was 99.9% (95% CI 99.9-99.9). Among 93 patients with pelvic lymph node metastasis, 18 (19.4%) had concurrent para-aortic lymph node metastasis. There was no difference in overall survival between women undergoing pelvic and para-aortic lymph node dissection compared with those undergoing pelvic lymphadenectomy only (p = 0.69). CONCLUSIONS: In patients undergoing radical hysterectomy and pelvic lymphadenectomy for stage IA2-IB2 cervical cancer, para-aortic lymph node dissection is not warranted based on the low risk of isolated metastatic disease, and lack of survival benefit associated with the procedure.

Hospital Readmission as a Poor Measure of Quality in Ovarian Cancer Surgery.

OBJECTIVE: To evaluate the role of 30-day readmission rate as a quality of care metric in patients undergoing ovarian cancer surgery. METHODS: We performed a retrospective cohort study of women diagnosed between 2004 and 2013 with advanced-stage, high-grade, serous carcinoma who underwent primary treatment. Using the National Cancer Database, we compared the performance of hospital risk-adjusted 30-day readmission rate to other quality of care metrics (risk-adjusted 30- and 90-day mortality, rates of adherence to guideline-based care, and overall survival) within hospitals categorized by yearly case volume (10 or less, 11-20, 21-30, and 31 cases per year or more). RESULTS: A total of 42,931 patients met the inclusion criteria. The overall unplanned 30-day readmission rate was 6.36% (95% CI 6.13-6.59). After adjusting for comorbidity, stage, histology, and sociodemographic and treatment factors, hospitals performing 31 cases per year or more had a 24% higher likelihood of readmission (adjusted odds ratio [OR] 1.25, 95% CI 1.06-1.46) when compared with those performing 10 cases per year or less. However, hospitals performing 31 cases per year or more had a significantly lower risk-adjusted 90-day mortality (adjusted OR 0.74, 95% CI 0.60-0.91) despite higher rates of complex surgical procedures and higher rates of guideline-concordant care delivery (86% vs 77%, P<.001). In the Cox proportional hazards regression model, care at a high-volume hospital was independently predictive of lower hazard of death (adjusted hazard ratio 0.86, 95% CI 0.82-0.90). CONCLUSION: Hospitals with 31 cases per year or more have a lower 30- and 90-day mortality despite performing more complex surgeries, are more likely to be adherent to guideline-based care, and achieved higher overall survival.

Thirty-day unplanned hospital readmission in ovarian cancer patients undergoing primary or interval cytoreductive surgery: systematic literature review.

OBJECTIVES: Thirty-day readmission rate has been proposed as metric of quality and remains an ongoing clinical concern in the primary treatment of patients with advanced-stage ovarian epithelial ovarian cancer. We conducted a review of the literature to identify rates, risk factors, and predictors for 30-day readmission in this population. METHODS: A 10-year period MEDLINE (PubMed) search of English literature studies published between January 01, 2008-January 01, 2018 was performed to identify appropriate studies for review. RESULTS: Thirty -day readmission rates for ovarian cancer patients undergoing primary treatment ranged from 2.5-19.3%. Neoadjuvant chemotherapy and interval cytoreductive surgery (NACT-ICS) surgery was associated with lower readmission rates, when compared to primary debulking surgery (PDS). The most frequently reported adverse events resulting in readmission include inpatient management of ileus/small bowel obstruction, wound-related complications, and thromboembolic events. Readmission predictors included the presence of other medical comorbidities, re-operation, and major complications occurring after initial hospital discharge. Some studies reported lower rates of readmission and survival in patients treated by NACT-ICS. CONCLUSIONS: Policies and programs should be designed to measure short- and long-term outcomes in this patient population to avoid bias in assigning patients to NACT-ICS to maintain low 30-day readmission rates.

Factors associated with outcomes and inpatient 90-day cost of care in endometrial cancer patients undergoing hysterectomy - implications for bundled care payments.

OBJECTIVE: To investigate the association of obesity and other comorbidities as well as route of surgery with postoperative outcomes, as well as 30- and 90-day inpatient cost of care after hysterectomy for endometrial cancer. METHODS: From the 2013 National Readmission Database release, patients who underwent hysterectomy for endometrial cancer were included. Obesity was classified as non-obese (body mass index [BMI] < 35 kg/m2); class I/II obesity (BMI ≥ 35 but <40 kg/m2 and without obesity related medical condition qualifying it as morbid obesity), class III obesity (BMI ≥ 40 kg/m2 OR BMI ≥ 35 kg/m2 with an obesity-related medical condition). Incremental cost at 30 and 90 days was calculated using cost-to-charge ratio. RESULTS: A total of 27,658 patients were identified. Compared to non-obese patients those with class III obesity had higher rate of any medical (non-surgical) complication (22.3% vs 17.2%, p = 0.004), and higher rate of 30-day readmission (6% vs 4.4%, p = 0.003), but similar rates of surgical complications. There were no significant differences in perioperative outcomes between non-obese patients and those with class I/II obesity. Non-obese patients had higher rates of traditional laparoscopy (8.4% vs 13.6%, p < 0.001) and lower conversion rates from a minimally invasive to abdominal (5.5% vs. 8.2%, p < 0.001) than those with class III obesity. Based on multivariate regression model compared to non-obese patients, class I/II obesity (OR 1.05, 95% CI 1.02-1.09) and class III obesity (OR 1.1, 95% CI 1.1-1.18) were associated with higher cost of care. Other factors increasing cost of care included: comorbidity score per unit increase (OR 1.08, 95% 1.07-1.08), insurance status and route of surgery. CONCLUSIONS: Class III obesity was associated with higher medical (but not surgical) complication rates as well as increased overall inpatient care cost when compared to the non-obese population. Number of comorbidities significantly impacted the cost and outcomes after hysterectomy. As more healthcare initiatives focus on bundled payments, our results suggest that payment packages should adjust for obesity rates and medical comorbidities stratified by region and hospital type in order to fairly compensate for increased costs of care.

Preoperative obstructive sleep apnea screening in gynecologic oncology patients.

BACKGROUND: Women with a gynecologic cancer tend to be older, obese, and postmenopausal, characteristics that are associated with an increased risk for obstructive sleep apnea. However, there is limited investigation regarding the condition's prevalence in this population or its impact on postoperative outcomes. In other surgical populations, patients with obstructive sleep apnea have been observed to be at increased risk for adverse postoperative events. OBJECTIVE: We sought to estimate the prevalence of obstructive sleep apnea among gynecologic oncology patients undergoing elective surgery and to investigate for a relationship between obstructive sleep apnea and postoperative outcomes. STUDY DESIGN: Patients referred to an academic gynecologic oncology practice were approached for enrollment in this prospective, observational study. Patients were considered eligible for study enrollment if they were scheduled for a nonemergent inpatient surgery and could provide informed consent. Enrolled patients were evaluated for a preexisting diagnosis of obstructive sleep apnea. Those without a prior diagnosis were screened using the validated, 4-item STOP questionnaire (ie, Snore loudly, daytime Tiredness, Observed apnea, elevated blood Pressure). All patients who screened positive for obstructive sleep apnea were referred for polysomnography. The primary outcome was the prevalence of women with obstructive sleep apnea or those who screened at high risk for the condition. Secondary outcomes examined the correlation between body mass index (kg/m2) with obstructive sleep apnea and assessed for a relationship between obstructive sleep apnea and postoperative outcomes. RESULTS: Over a 22-month accrual period, 383 eligible patients were consecutively approached to participate in the study. A cohort of 260 patients were enrolled. A total of 33/260 patients (13%) were identified as having a previous diagnosis of obstructive sleep apnea. An additional 66/260 (25%) screened at risk for the condition using the STOP questionnaire. Of the patients who screened positive, 8/66 (12%) completed polysomnography, all of whom (8/8 [100%]) were found to have obstructive sleep apnea. The prevalence of previously diagnosed obstructive sleep apnea or screening at risk for the condition increased as body mass index increased (P < .001). Women with untreated obstructive sleep apnea and those who screened at risk for the condition were found to have an increased risk for postoperative hypoxemia (odds ratio, 3.5; 95% confidence interval, 1.8-4.7; P = .011) and delayed return of bowel function (odds ratio, 2.1; 95% confidence interval, 1.3-4.5; P = .009). CONCLUSION: The prevalence of obstructive sleep apnea or screening at risk for the condition is high among women presenting for surgery with a gynecologic oncologist. Providers should consider evaluating a patient's risk for obstructive sleep apnea in the preoperative setting, especially when risk factors for the condition are present.