Patient care and access to clinical trials in gynaecological oncology: global implications of the early phase of the COVID-19 pandemic.

PURPOSE: Our prospective international survey evaluated the impact of the early phase of the COVID-19 pandemic on the management gynaecological malignancies from the multidisciplinary physicians' perspective with particular focus on clinical infrastructures and trial participation. METHODS: Our survey consisted of 53 COVID-related questions. It was sent to healthcare professionals in gynaecological oncology centres across Europe and Pan-Arabian region via the study groups and gynaecological societies from April 2020 to October 2020. All healthcare professionals treating gynaecological cancers were able to participate in our survey. RESULTS: A total of 255 answers were collected from 30 countries. The majority (73%) of participants were gynaecological oncologists from university hospitals (71%) with at least an Intensive Care Unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years (range 0-12 weeks). Most cases that were prioritised for surgical intervention across all gynaecological tumours were early-stage disease (74%), primary situation (61%) and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumour types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. Almost half of the participants stated the pandemic negatively impacted the financial structure and support for clinical trials. Approximately 20% of clinicians did not feel well-informed regarding clinical algorithm for COVID-19 patients throughout the pandemic. Thirty percent stated that they are currently having trouble in providing adequate medical care due to staff shortage. CONCLUSION: Despite well-established guidelines, pandemic clearly affected clinical research and patientcare. Our survey underlines the necessity for building robust emergency algorithms tailored to gynaecological oncology to minimise negative impact in crises and to preserve access to clinical trials.

Surgical training of gynecologic oncology fellows: Long-term trends and implications for future education.

OBJECTIVES: The surgical training of gynecologic oncology (GO) fellows is critical to providing excellent care to women with gynecologic cancers. We sought to evaluate changes in techniques and surgical volumes over an 18-year period among established GO fellowships across the US. METHODS: We emailed surveys to 30 GO programs that had trained fellows for at least 18 years. Surveys requested the number of surgical cases performed by a fellow for seventeen surgical procedures over each of five-time intervals. A One-Way Analysis of Variance was conducted for each procedure, averaged across institutions, to examine whether each procedure significantly changed over the 18-year span. RESULTS: 14 GO programs responded and were included in the analysis using SPSS. We observed a significant increase in the use of minimally invasive (MIS) procedures (robotic hysterectomy (p < .001), MIS pelvic (p = .001) and MIS paraaortic lymphadenectomy (p = .008). There was a concurrent significant decrease in corresponding "open" procedures. There was a significant decrease in all paraaortic lymphadenectomies. Complex procedures (such as bowel resection) remained stable. However, there was a wide variation in the number of cases reported with extremely small numbers for some critical procedures. CONCLUSIONS: The experience of GO fellows has shifted toward increased use of MIS. While these trends in care are appropriate, they do not diminish the need in many patients for complex open procedures. These findings should help spur the development of innovative training to maintain the ability to provide these core, specialty-defining procedures safely.

Assessment of socioeconomic and racial differences in patients undergoing concurrent gynecologic oncology and urogynecology surgeries: a National Inpatient Sample (NIS) database study.

OBJECTIVE: To assess social determinants of health impacting patients undergoing gynecologic oncology versus combined gynecologic oncology and urogynecology surgeries. METHODS: We identified patients who underwent gynecologic oncology surgeries from 2016 to 2019 in the National Inpatient Sample using the International Classification of Diseases-10 codes. Demographics, including race and insurance status, were compared for patients who underwent gynecologic oncology procedures only (Oncologic) and those who underwent concurrent incontinence or pelvic organ prolapse procedures (Urogynecologic-Oncologic). A logistic regression model assessed variables of interest after adjustment for other relevant variables. RESULTS: From 2016 to 2019 the National Inpatient Sample database contained 389 (1.14%) Urogynecologic-Oncologic cases and 33 796 (98.9%) Oncologic cases. Urogynecologic-Oncologic patients were less likely to be white (62.1% vs 68.8%, p=0.02) and were older (median 67 vs 62 years, p<0.001) than Oncologic patients. The Urogynecologic-Oncologic cohort was less likely to have private insurance as their primary insurance (31.9% vs 38.9%, p=0.01) and was more likely to have Medicare (52.2% vs 42.8%, p=0.01). After multivariable analysis, black (adjusted odds ratio (aOR) 1.41, 95% CI 1.05 to 1.89, p=0.02) and Hispanic patients (aOR 1.53, 95% CI 1.11 to 2.10, p=0.02) remained more likely to undergo Urogynecologic-Oncologic surgeries but the primary expected payer no longer differed significantly between the two groups (p=0.95). Age at admission, patient residence, and teaching location remained significantly different between the groups. CONCLUSIONS: In this analysis of a large inpatient database we identified notable racial and geographical differences between the cohorts of patients who underwent Urogynecologic-Oncologic and Oncologic procedures.

Medicolegal, infrastructural, and financial aspects in gynecologic cancer surgery and their implications in decision making processes: Quo Vadis?

Surgical decision making is complex and involves a combination of analytic, intuitive, and cognitive processes. Medicolegal, infrastructural, and financial factors may influence these processes depending on the context and setting, but to what extent can they influence surgical decision making in gynecologic oncology? This scoping review evaluates existing literature related to medicolegal, infrastructural, and financial aspects of gynecologic cancer surgery and their implications in surgical decision making. Our objective was to summarize the findings and limitations of published research, identify gaps in the literature, and make recommendations for future research to inform policy.

Cost impact analysis of enhanced recovery after minimally invasive gynecologic oncology surgery.

OBJECTIVE: The implementation of a peri-operative care program based on enhanced recovery after surgery principles for minimally invasive gynecologic oncology surgery led to an improvement in same day discharge from 29% to 75% at our center. This study aimed to determine the program's economic impact. METHODS: Our initial enhanced recovery quality improvement program enrolled consecutive patients undergoing minimally invasive hysterectomy at a single center during a 12-month period and compared them to a pre-intervention cohort. The primary outcome was overall costs. The secondary outcomes were surgical and post-operative visit costs. The surgical visit costs included pre-operative and operating room, post-operative stay, pharmacy, and interventions costs. The 30-day post-operative visit costs included clinic and emergency room, and readmission costs. The costs for every visit were collected from the case-cost department and expressed in 2020 Canadian dollars (CAD). RESULTS: A total of 96 and 101 patients were included in the pre- and post-intervention groups, respectively. The median total cost per patient for post-intervention was $7252 compared with $8381 pre-intervention (p=0.02), resulting in a $1129 cost reduction per patient. The total cost for the program implementation was $134 per patient for a total cost of $13 106. The median post-operative stay cost was $816 post-intervention compared with $1278 pre-intervention (p<0.05). Statistically significant savings for the post-intervention group were also found for operative visit, operating room costs, and pharmacy (p<0.05). On multivariate analysis, surgical approach was the only factor associated with operating room costs, whereas both surgical approach and group (pre- vs post-intervention) impacted the total and post-operative stay costs (p<0.05). CONCLUSION: In addition to increasing the same day discharge rate after minimally invasive gynecologic oncology surgery, an enhanced recovery-based peri-operative care program led to significant reductions in cost.

An implementation science approach to the systematic study of access to gynecologic cancer care.

INTRODUCTION: Barriers to access to cancer care are profoundly threatening to patients with gynecologic malignancies. Implementation science focuses on empirical investigation of factors influencing delivery of clinical best practices, as well as interventions designed to improve delivery of evidence-based care. We outline one prominent framework for conducting implementation research and discuss its application to improving access to gynecologic cancer care. METHODS: Literature on the use of the Consolidated Framework for Implementation Research (CFIR) was reviewed. Delivery of cytoreductive surgery for advanced ovarian carcinoma was selected as an illustrative case of an evidence-based intervention (EBI) in gynecologic oncology. CFIR domains were applied to the context of cytoreductive surgical care, highlighting examples of empirically-assessable determinants of care delivery. RESULTS: CFIR domains include Innovation, Inner Setting, Outer Setting, Individuals, and Implementation Process. "Innovation" relates to characteristics of the surgical intervention itself; "Inner Setting" relates to the environment in which surgery is delivered. "Outer Setting" refers to the broader care environment influencing the Inner Setting. "Individuals" highlights attributes of persons directly involved in care delivery, and "Implementation Process" focuses on integration of the Innovation within the Inner Setting. CONCLUSIONS: Prioritization of implementation science methods in the study of access to gynecologic cancer care will help ensure that patients are able to utilize interventions with the greatest prospect of benefiting them.

Medicaid Expansion and Postoperative Mortality in Women with Gynecologic Cancer: A Difference-in-Difference Analysis.

BACKGROUND: The association between Medicaid expansion and postoperative mortality after surgery for gynecologic cancer is unknown. Our objective was to compare 30- and 90-day postoperative mortality after gynecologic cancer surgery before and after 2014 in states that did and did not expand Medicaid. METHODS: We searched the National Cancer Database for women aged 40-64 years old between 2010 and 2016 who underwent surgery for a primary gynecologic malignancy. We used pre/post and quasi-experimental difference-in-difference (DID) multivariable logistic regressions to evaluate mortality pre-2014 (2010-2013) and post-2014 (2014-2016) for states that did and did not expand Medicaid in January 2014. We completed univariable logistic regressions for covariates of interest. RESULTS: Among 169,731 women, 30-day postoperative mortality in expansion states after 2014 significantly decreased for endometrial cancer (odds ratio [OR] 0.42, 95% confidence interval [CI] 0.26-0.67) and ovarian cancer (OR 0.67, 95% CI 0.46-0.99) and increased for cervical cancer (OR 3.82, 95% CI 1.12-13.01). Compared with non-expansion states, expansion states had improved 30-day postoperative mortality for endometrial cancer after 2014 (DID OR 0.54, 95% CI 0.31-0.96). Univariable analysis demonstrated improved 30-day postoperative mortality for Black women with endometrial cancer in expansion states (DID OR 0.22, 95% CI 0.05-0.95). There was improved 90-day postoperative mortality for endometrial cancer in expansion states (OR 0.66, 95% CI 0.50-0.85), and improved 90-day postoperative mortality for Midwestern women with ovarian cancer in expansion states on univariable analysis (DID OR 0.48, 95% CI 0.26-0.91). CONCLUSIONS: State Medicaid legislation was associated with improved postoperative survival in women with endometrial cancer and subgroups of women with endometrial and ovarian cancer.

Healthcare associated infections in gynecologic oncology: clinical and economic impact.

OBJECTIVE: The purpose of this study was to assess the rate and type of infections in gynecological cancer patients. We also performed an economic analysis to provide an overview of costs related to healthcare associated infections. METHODS: We retrospectively collected data from culture samples at the site of infection from patients undergoing surgery or chemotherapy, admitted to the Gynecologic Oncology Unit, Fondazione Policlinico Agostino Gemelli IRCCS, from January 2017 to December 2018. We performed univariate and multivariate analyses to calculate potential risk factors for prolonged length of hospitalization. The average cost per patient was calculated, including the cost of hospital stay, operating room, medications, and diagnostic and invasive procedures. RESULTS: Among 5682 patients, 322 (5.6%) gynecological cancer patients with healthcare associated infections were identified. A total of 249 patients (77.3%) had undergone surgery in the previous 30 days and 73 (22.7%) patients were receiving chemotherapy. In the whole population, the most common healthcare associated infections were urinary infections (58%) and surgical wound infections (42.1%). In addition, 14.5% of patients had central venous catheter infections and 21.7% had blood stream infections. Median length of stay was 20 days (range 1-100). Among surgical patients, advanced age (odds ratio (OR) 1.233, 95% confidence interval (CI) 1.001 to 1.519, p=0.049), bowel resection (OR 2.659, 95% CI 1.493 to 4.735, p=0.001), surgical site infection (OR 10.447, 95% CI 1.143 to 95.5, p=0.038), and central venous catheter infection (OR 9.856, 95% CI 1.139 to 85.319, p=0.038) were independently associated with an increased risk of prolonged hospital stay (>20 days). The overall direct cost of healthcare associated infections was $6 273 852 per year. CONCLUSIONS: The infection rate in our population was 5.6%. The most common healthcare associated infections were urinary and surgical wound infections. Among surgical patients, advanced age, bowel resection, surgical site, and central venous catheter infection were associated with an increased length of hospitalization. Healthcare associated infections cause an increase in the length of stay after surgery and hospital costs.

Preoperative assessment using the five-factor modified frailty index: A call for standardized preoperative assessment and prehabilitation services in gynecologic oncology.

OBJECTIVE: To evaluate if the 5-factor modified frailty index (mFI) is associated with postoperative complications, readmissions or non-home discharge in gynecologic cancer patients undergoing surgery. METHODS: Patients with a diagnosis of gynecologic cancer (cervical, uterine, or ovarian cancer) who underwent surgery between 2014 and 2018 were identified through the National Surgical Quality Improvement Program (NSQIP) database. The 5-factor mFI was applied and patients classified into 6 categories (mFI groups 0,1,2, 3, 4 and 5). The incidence of 30-day complications, readmissions and non-home discharge was evaluated. Multivariable logistic regression models were used to determine the association between mFI category and readmissions/ complications. Adjusted probabilities of events were calculated based on patient characteristics. RESULTS: At total of 31,181 gynecologic cancer cases were included in the analysis: N = 2968 (9.4%) cervical, N = 20,862 (66.4%) uterine, and N = 7351 (23.4%) ovarian cancers. Of all patients, 46.1% were in category 0, 36.5% category 1, and 1% category 3-5. Factors associated with increased mFI included older age, African American race, laparoscopic surgery and obesity. A significant dose-response relationship between higher mFI and readmission and 30-day complications was noted on adjusted multivariable analysis (adjusted OR 2.37 (1.65-3.45) and 2.10 (1.59-2.75) for readmissions and complications, respectively, in mFI category 3-5). These associations were consistent within each cancer type. CONCLUSIONS: The 5-factor mFI universally predicts postoperative readmissions, 30-day complications and non-home discharge in patients with gynecologic cancer. Incorporation of mFI into routine preoperative assessment can identify patients for non-surgical treatments, prehabiliatation and short term home assessments.

Insurance-based disparities and risk of financial toxicity among patients undergoing gynecologic cancer operations.

OBJECTIVE: To evaluate the risk of financial toxicity (FT) among inpatients undergoing gynecologic cancer resections and the association of insurance status with clinical and financial outcomes. METHODS: Using the 2008-2019 National Inpatient Sample, we identified adult hospitalizations for hysterectomy or oophorectomy with a diagnosis of cancer. Hospitalization costs, length of stay (LOS), mortality, and complications were assessed by insurance status. Risk of FT was defined as health expenditure exceeding 40% of post-subsistence income. Multivariable regressions were used to analyze costs and factors associated with FT risk. RESULTS: Of 462,529 patients, 49.4% had government-funded insurance, 44.3% private, and 3.2% were uninsured. Compared to insured, uninsured patients were more commonly Black and Hispanic, admitted emergently, and underwent open operations. Uninsured patients experienced similar mortality but greater rates of complications, LOS, and costs. Overall, ovarian cancer resections had the highest median costs of $17,258 (interquartile range: 12,187-25,491) compared to cervical and uterine. Approximately 52.8% of uninsured and 15.4% of insured patients were at risk of FT. As costs increased across both cohorts over the 12-year study period, the disparity in FT risk by payer status broadened. After risk adjustment, perioperative complications were associated with nearly 2-fold increased risk of FT among uninsured (adjusted odds ratio 1.75, 95% confidence interval 1.46-2.09, p < 0.001). Among the insured, Black and Hispanic race, public insurance, and open operative approach exhibited greater odds of FT. CONCLUSION: Patients undergoing gynecologic cancer operations are at substantial risk of FT, particularly those uninsured. Targeted cost-mitigation strategies are warranted to minimize financial burden.

Use of direct oral anticoagulants for postoperative venous thromboembolism prophylaxis after surgery for gynecologic malignancies.

Venous thromboembolism is a preventable cause of postoperative mortality in patients undergoing surgery for malignancy. Current standard of care based on international guideline recommends 28 days of extended thromboprophylaxis after major abdominal and pelvic surgery for malignancies with unfractionated heparin or low molecular weight heparin. Direct oral anticoagulants have been approved for the treatment of venous thromboembolism in the general population. This regimen has a significant advantage over other types of anticoagulation regimens, particularly being administered by non-parenteral routes and without the need for laboratory monitoring. In this review, we evaluate the role of direct anticoagulation and provide an update on completed and ongoing clinical trials.

Mandate to evaluate robotic surgery implementation: a 12-year retrospective analysis of impact and future implications.

The introduction of robotic surgery in hospitals has raised much debate given the various effects on care, costs, education and medical advancement. Purchasing discussions are often approached with more questions than answers and there is a need for reports that provide a case for whether or not such technologies are advantageous from multiple perspectives, and offer insights into ways such devices can be introduced into a hospital setting. This report provides an evidence-based review of a university-affiliated tertiary care hospital's 12-year experience with robotic surgery in gynecologic oncology and delves into the various takeaways and challenges of implementing robotic surgery. Key findings were that robotic surgery significantly reduced complication rates, lengths of hospital stays for patients and overall hospital costs. Key obstacles were large upfront costs and the need for significant leadership and collaboration. Ongoing challenges to evaluating robotics include assessing long-term survival data, making comparisons with concurrently changing hospital conditions and determining how data can be generalized to other departments and institutions.

Gynecologic oncology treatment modifications or delays in response to the COVID-19 pandemic in a publicly funded versus privately funded North American tertiary cancer center.

OBJECTIVE: To compare gynecologic oncology surgical treatment modifications and delays during the first wave of the COVID-19 pandemic between a publicly funded Canadian versus a privately funded American cancer center. METHODS: This is a retrospective cohort study of all planned gynecologic oncology surgeries at University Health Network (UHN) in Toronto, Canada and Brigham and Women's Hospital (BWH) in Boston, USA, between March 22,020 and July 302,020. Surgical treatment delays and modifications at both centers were compared to standard recommendations. Multivariable logistic regression was performed to adjust for confounders. RESULTS: A total of 450 surgical gynecologic oncology patients were included; 215 at UHN and 235 at BWH. There was a significant difference in median time from decision-to-treat to treatment (23 vs 15 days, p < 0.01) between UHN and BWH and a significant difference in treatment delays (32.56% vs 18.29%; p < 0.01) and modifications (8.37% vs 0.85%; p < 0.01), respectively. On multivariable analysis adjusting for age, race, treatment site and surgical priority status, treatment at UHN was an independent predictor of treatment modification (OR = 9.43,95% CI 1.81-49.05, p < 0.01). Treatment delays were higher at UHN (OR = 1.96,95% CI 1.14-3.36 p = 0.03) and for uterine disease (OR = 2.43, 95% CI 1.11-5.33, p = 0.03). CONCLUSION: During the first wave of COVID-19 pandemic, gynecologic oncology patients treated at a publicly funded Canadian center were 9.43 times more likely to have a surgical treatment modification and 1.96 times more likely to have a surgical delay compared to an equal volume privately funded center in the United States.

Anxio-depressive symptoms in Moroccan women with gynecological cancer: Relief factors.

INTRODUCTION: Psychosocial determinants can affect the mental health of women who have been diagnosed with gynecological cancer. The aim of this study was to examine how social support and self-esteem are associated with anxiety and depression symptoms in women with gynecological cancer, and who are treated by radical surgery. METHODS: A cross-sectional study was performed, within the oncology department of Ibn Rochd University Hospital, Casablanca, on 100 Moroccan women. They all had undergone radical surgery for gynecological cancer, hysterectomy and/or oophorectomy. RESULTS: Our results showed that patients with gynecological cancer treated by radical surgery exhibited high prevalence rates of anxiety (66%) and depression symptoms (59%). Associations showed that age, having children, medical coverage system, area of residence, working status and socioeconomic status were significantly related to the prevalence of anxiety and depression symptoms (P<0.05). The general social support, family support and significant other support besides high self-esteem reduce significantly the risk of getting anxiety and depression symptoms (P-values<0.05). DISCUSSION: Among patients with gynecological cancer treated by radical surgery, high prevalence of anxiety and depression symptoms was found. Social support and high self-esteem could help improve mental health issues related to this type of cancer.

Assessment of physical function by subjective and objective methods in patients undergoing open gynecologic surgery.

OBJECTIVE: To evaluate the utility of patient-reported outcomes (PROs) to measure physical functioning in perioperative care for patients with gynecological (GYN) tumors. METHODS: 180 patients with GYN tumors undergoing open surgery participated in this longitudinal study. The physical functioning was measured by a subjective PRO tool, the Interference subscales of the MD Anderson Symptom Inventory (MDASI-I); as well as by an objective tool, the Timed Up & Go test (TUGT), perioperatively. Longer time (>20 s) needed to complete the TUGT was defined as "Prolonged". Patients completed EuroQoL-5D as well. The association between the scores of MDASI-I items and TUGT was assessed via the Spearman correlation coefficient. The known-group validity was assessed using the t-test and Cohen's D effect size. RESULTS: Compliance rates at preoperative, discharge and postoperative time points of MDASI-I were 98%, 95%, 96%; while TUGT completion rates were 92%, 75%, and 80%, respectively. Patients who had refused TUGT at discharge reported a significantly worse "MDASI-general activity" score compared to patients who completed TUGT (mean score of 7.00 vs. 5.38, P = 0.020). Patient-reported "Walking" on MDASI-I significantly differentiated patients with prolonged vs. those with frail/normal TUGT at discharge (mean score of 4.89 vs. 2.79, Cohen's d effect size = 0.82, P < 0.001). MDASI-I demonstrated excellent known-group validity per performance status and for the EuroQoL-5D subscales. CONCLUSION: Patient-reported physical functioning impairment after GYN surgery correspond with observed worse scores of the objective functioning measure test (TUGT). MDASI-I assessment represents a feasible and valid tool to evaluate functional status and warrants further implementation in the perioperative setting.