Disparities in refusal of surgery for gynecologic cancer.

OBJECTIVE: To identify sociodemographic and clinical factors associated with refusal of gynecologic cancer surgery and to estimate its effect on overall survival. METHODS: The National Cancer Database was surveyed for patients with uterine, cervical or ovarian/fallopian tube/primary peritoneal cancer treated between 2004 and 2017. Univariate and multivariate logistic regression were used to assess associations between clinico-demographic variables and refusal of surgery. Overall survival was estimated using the Kaplan-Meier method. Trends in refusal over time were evaluated using joinpoint regression. RESULTS: Of 788,164 women included in our analysis, 5875 (0.75%) patients refused surgery recommended by their treating oncologist. Patients who refused surgery were older at diagnosis (72.4 vs 60.3 years, p < 0.001) and more likely Black (OR 1.77 95% CI 1.62-1.92). Refusal of surgery was associated with uninsured status (OR 2.94 95% CI 2.49-3.46), Medicaid coverage (OR 2.79 95% CI 2.46-3.18), low regional high school graduation (OR 1.18 95% CI 1.05-1.33) and treatment at a community hospital (OR 1.59 95% CI 1.42-1.78). Patients who refused surgery had lower median overall survival (1.0 vs 14.0 years, p < 0.01) and this difference persisted across disease sites. Between 2008 and 2017, there was a significant increase in refusal of surgery annually (annual percent change +1.41%, p < 0.05). CONCLUSIONS: Multiple social determinants of health are independently associated with refusal of surgery for gynecologic cancer. Given that patients who refuse surgery are more likely from vulnerable, underserved populations and have inferior survival, refusal of surgery should be considered a surgical healthcare disparity and tackled as such.

Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns.

INTRODUCTION: The European Risk Management Plan (EU-RMP) is a proactive planning tool for identification, characterisation and management of important risks and missing information throughout the lifecycle of a medicinal product. Over the past 15 years the EU-RMP has been a part of the pharmacovigilance practice in Europe, but there are no published studies assessing impact of the growing experience and evolving regulatory framework on the content and focus of the EU-RMP. OBJECTIVES: The objectives were to study the real-world impact of evolving pharmacovigilance guidelines on the proactive lifecycle management of important risks and missing information through EU-RMPs, and to further explore the impact of different resources on the management of the benefit-risk profile. METHODS: A retrospective study based on the review of 64 EU-RMPs dated between 01 January 2006 and 01 October 2020 for seven human medicinal products for which Boehringer Ingelheim holds the Marketing Authorisation in the European Union. Data on the timing and rational behind changes (i.e., inclusion, reclassification, removal) to the safety concerns (Important Identified Risks, Important Potential Risks, Missing Information) and associated additional Pharmacovigilance activities and/or Risk Minimisation measures were collected and assessed. RESULTS: The analysed EU-RMPs included a total of 197 safety concerns, 129 of which were removed and 19 were reclassified during the observation period. The implementation of the Guidelines on Good Pharmacovigilance Practices Module V in 2012 and Revision 2 in 2017 resulted in a noticeable decrease in the number of safety concerns. Clinical trial, non-clinical and routine post-marketing data were common sources that influenced the safety concern dynamics, and results from dedicated post-authorisation studies lead to the removal of 21 important risks and missing information. Many safety concerns were related to pharmacological class effect (n = 55) and target population characteristics (n = 37). CONCLUSIONS: This study demonstrated that the growing knowledge regarding benefit-risk of approved products and the introduction of new or revised regulatory guidelines influenced the EU-RMP lifecycle of safety concerns, and moreover, the results emphasise that exchange of knowledge about the pharmacological class and target population between stakeholders are important for keeping an up-to-date understanding of a medicinal product's safety profile. The aim of improving the efficiency of risk management has leveraged the accumulation of knowledge leading to revision of regulatory guidelines and increasingly, proactive Risk Management Plans focused on safety concerns that are important for patients and public health.

Opioid prescription by gynecologic oncologists: An analysis of Medicare Part D claims.

The use of opioids across all specialties has increased greatly over the last 2 decades and along with it, opioid misuse, overdose and death. The contribution of opioids prescribed for gynecologic cancers to this problem is unknown. Data from other surgical specialties show prescriber factors including gender, geographic location, board certification, experience, and fellowship training influence opioid prescribing. To characterize national-level opioid prescription patterns among gynecologic oncologists treating Medicare beneficiaries. The Centers for Medicare and Medicaid Services database was used to access Medicare Part D opioid claims prescribed by gynecologic oncologists in 2016. Prescription and prescriber characteristics were recorded including medication type, prescription length, number of claims, and total day supply. Region of practice was determined according to the US Census Bureau Regions. Board certification data were obtained from American Board of Obstetrics and Gynecology website. Bivariate statistical analysis and linear regression modeling were performed using Stata version 14.2. In 2016, 494 board-certified US gynecologic oncologists wrote 24,716 opioid prescriptions for a total 267,824 days of treatment (median 8 [interquartile range {IQR} 6, 11] prescribed days per claim). Gynecologic oncologists had a median of 33 opioid claims (IQR 18, 64). Male physicians had significantly more opioid prescription claims than females (P < 0.01) including after adjustment for differences in years of experience. There was no difference in prescribed days per claim between male and female physicians. Physicians in the South had the greatest number of opioid prescription claims and significantly more than physicians in all other regions (P < 0.01). Gynecologic oncologists who were board certified for >15 years had a greater number of median opioid claims (28 IQR 16, 50) than those with <5 years since board certification (22 IQR 15, 38) (P= 0.04). Physicians who were board certified in palliative care (n = 19) had significantly more opioids claims (median 40; IQR 18, 91) than those without (median 32; IQR 18, 64) (P< 0.01). In 2016, there were gender-based, regional, and experience-related variations in opioid prescribing by providers caring for Medicare-insured patients.

Readability assessment of online gynecologic oncology patient education materials from major governmental, non-profit and pharmaceutical organizations.

OBJECTIVE: Patients are increasingly using online materials to learn about gynecologic cancer. Providers can refer patients to online educational materials produced by a number of different major medical organizations and pharmacology companies. The National Institutes of Health (NIH) and the American Medical Association (AMA) recommend that patient educational materials (PEMs) are written between a sixth and eighth grade reading level. In this study, we assess the readability of online PEMs published by major medical organizations and industry partners. METHODS: Websites from twelve websites providing educational materials for gynecologic oncology patients were surveyed. Online PEMs were identified and analyzed using seven validated readability indices. One-way ANOVA and Tukey's Honestly Significant Difference (HSD) post-hoc analysis were performed to detect differences in readability between publishers. RESULTS: Two-hundred and sixty PEMs were included in this analysis. Overall, PEMs were written at a mean 11th±0.6 grade reading level. Only 6.5% of articles were written at the AMA/NIH recommended reading grade level of 6th to 8th grade or below. ANOVA demonstrated a significant difference in readability between publishing associations (p<0.01). PEMs from the Centers for Disease Control had a mean 9th±1.2 grade reading level and were significantly lower than all other organizations. PEMs from The Foundation for Women's Cancer had a mean 13th±1.8 grade reading level and were significantly higher than most other organizations. PEMs from pharmaceutical companies (mean readability=10.1±1.1, N=30) required the lowest reading grade level and were significantly more readable than those from governmental organizations (11.1±1.7, p<0.05) and nonprofit medical associations (12.4±1.7, p<0.01) in ANOVA and Tukey-Kramer post hoc analysis. CONCLUSIONS: Gynecologic oncology PEMs available from twelve major organization websites are written well above the recommended sixth to eighth grade reading difficulty level.

Comparison of cost and operative outcomes of robotic hysterectomy compared to laparoscopic hysterectomy across different uterine weights.

Operative cost and outcomes between robotic and laparoscopic hysterectomy across different uterine weights. Retrospective cohort study including patients undergoing robotic and laparoscopic hysterectomy for benign disease at an Academic university hospital. One hundred and ninety six hysterectomies were identified (101 robotic versus 95 laparoscopic). Demographic and surgical characteristics were statistically equivalent. Robotic group had a higher body mass index (±SD) (32.9 ± 6.5 versus 30.4 ± 7.1, p 0.012) and more frequent history of adnexal surgery (12.9 versus 4.2%, p 0.031). Laparoscopic group had a higher number of concurrent salpingectomy (81 versus 66.3%, p 0.02). Estimated blood loss did not differ between procedures. Compared to robotic hysterectomies, laparoscopic procedures added 47 min (CI: 31-63 min; p < 0.001) of operative time, costed $1648 more (CI: 500-2797; p = 0. 005) and had triple the odds of having an overnight admission (OR = 2.94 CI: 1.34-6.44; p = 0.007). After stratification of cases by uterine weight, the mean operative time difference between the two groups in uteri between 750 and 1000 g and in uteri >1000 g was 81.3 min (CI: 51.3-111.3, p < 0.0001) and 70 min (CI: 26-114, p < 0.005), respectively, in favor of the robotic group. Mean direct cost difference in uteri between 750 and 1000 g and uteri >1000 g was 1859$ (CI: 629-3090, p < 0.006) and 4509$ (CI: 377-8641, p < 0.004), respectively, also in favor of the robotic group. In expert hands, robotic hysterectomy for uteri weighing more than 750 g may be associated with shorter operative time and improved cost profile.