Consent document translation expense hinders inclusive clinical trial enrolment.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Reducing health disparities in endometrial cancer care in 2024.

PURPOSE OF REVIEW: To summarize the most recent publications explaining disparities among patients diagnosed with endometrial cancer and identify areas of improvement. RECENT FINDINGS: Racial disparities in endometrial cancer care have been identified along the cancer continuum including risk, diagnosis, access to treatment, and overall survival. The mortality gap in endometrial cancer is one of the top five widest Black-White mortality gaps among all cancer diagnoses in the United States. Many publications have demonstrated that the disparities exist, the aim of this review is to identify actionable areas of improvement. To mitigate racial disparities, we must acknowledge that Black patients are at higher risk of high-risk subtypes of endometrial cancer, and their presentation can vary from what is considered typical for the most common type of endometrial cancer. We must address that practice recommendations for diagnosis may not be generalizable to all races and ethnicities, and that racism has an impact on how providers approach a work-up for Black vs. White patients. Finally, we must improve access to appropriate treatment by steadfastly adhering to recommended practice guidelines regardless of race/ethnicity and improving efforts to enroll a diverse patient population to clinical trials. SUMMARY: In this review, we sought to identify specific and actionable areas of improvement to reduce racial disparities in endometrial cancer care.

Ovarian cancer surveillance in the clinical follow up of women with known BRCA1 or BRCA2 pathogenic variants in a large health care system.

OBJECTIVE: To assess CA 125 and transvaginal ultrasound surveillance in women with BRCA1 or BRCA2 pathogenic variants in a pragmatic clinical setting with>1 year follow up. METHODS: Retrospective cohort study in a large integrated health care system of women identified from 1/1/2003 to 12/31/2017 with a BRCA1 or BRCA2 pathogenic variant with at least one intact ovary. Demographic and clinical data were collected from date of genetic testing until oophorectomy, an ovarian cancer diagnosis, or 7/1/2019. Primary outcome was frequency and findings of CA 125 tests and ultrasounds performed; secondary outcome was epithelial ovarian cancers diagnosed. RESULTS: There were 1418 women, age ≥ 30 years with a BRCA1 or BRCA2 pathogenic variant with at least one intact ovary. Of the total of 1683 ultrasounds and 2437 CA 125 tests done, 1022 ultrasounds and 1709 CA 125 tests were performed for surveillance in 771 women followed >1 year. Of these women 241 (31%) women had no surveillance, and 530 (69%) women underwent any surveillance. Only 108 (20%) underwent regular surveillance. The number who underwent regular surveillance declined each year. Twenty-one women underwent surveillance indicated surgery with only 2 ovarian cancers found by surveillance. CONCLUSIONS: Many women with BRCA1 or BRCA2 pathogenic variants undergo ultrasound and CA 125 surveillance testing but abnormal surveillance testing led to diagnosis of ovarian cancer in only two cases. These findings question the use of CA 125 and ultrasound surveillance in the clinical setting for ovarian cancer detection in women with BRCA1 or BRCA2 pathogenic variants.

Breast cancer risk in BRCA mutation carriers after diagnosis of epithelial ovarian cancer is lower than in carriers without ovarian cancer.

OBJECTIVE: Evaluate the incidence and characteristics of breast cancers (BC) diagnosed following an epithelial ovarian cancer (EOC) diagnosis in women with pathogenic BRCA mutations. METHODS: Retrospective cohort study of all women in an integrated healthcare system with BRCA mutations diagnosed with EOC from 1/1/1997-12/31/2018. Primary outcome was rate of subsequent BC diagnosis. Secondary outcomes included risk factors associated with development of BC, median time to detection following EOC, and method of detection. RESULTS: There were 284 women with BRCA-associated EOC identified. Fifty-two women had risk-reducing mastectomy and were excluded. Of the 232 eligible women with a median follow-up of 5.6 years, 33 (14%) women were diagnosed with BC following EOC: 27 (11%) new cases and 6 (3%) recurrences. Twelve (36%) cases of BC were detected on screening mammogram, 4 (12%) on screening MRI, and 9 (27%) on work-up after presenting with a palpable lump. Twenty-nine (87%) were early stage (0-II) disease. Median interval from EOC to BC diagnosis was 80 months (IQR 32, 134) for new and 63 months (IQR 21, 94) for recurrent BCs. There was one death from breast cancer while 12 women died of ovarian cancer. CONCLUSIONS: Most BC following BRCA-associated EOC is early stage and not associated with mortality. Given BC rate similar to general population and median diagnosis at 6.6 years following ovarian cancer, increased BC screening may not be warranted in the early years after EOC diagnosis.

Beyond Men, Women, or Both: A Comprehensive, LGBTQ-Inclusive, Implicit-Bias-Aware, Standardized-Patient-Based Sexual History Taking Curriculum.

Introduction: This standardized-patient-based module prepares medical students to take inclusive, comprehensive sexual histories from patients of all sexual orientations and gender identities. Health disparities faced by lesbian, gay, bisexual, transgender, and queer (LGBTQ) people are at least partially the result of inadequate access to health care and insufficient provider training. This module incorporates implicit bias activities to emphasize the important role providers can play in mitigating these disparities through compassionate, competent care. Furthermore, two of the three included cases highlight the negative impact sexual dysfunction can have on emotional well-being. Methods: Over 3 hours, students participate in a 30-minute large-group lecture and three 40-minute small-group standardized patient encounters with debrief. Prework consists of a short video on sexual history taking, assigned readings, and an implicit bias activity. These materials are included in this resource, along with lecture slides, facilitator guide, and standardized patient cases. Though the cases are adaptable to all levels of medical education, this module is designed for second-year and early third-year medical students. Results: Qualitative student evaluations were positive, and postparticipation surveys revealed statistically significant improvement in comfort with their ability to take a sexual history in general, and take one from patients with a differing sexual orientation. Deployed in the second year of our Doctoring curriculum, this module continues to receive positive evaluations. Discussion: Introducing these skills begins to address the curricular deficiencies seen across medical education and lays the foundation for a more competent health care workforce to address the needs of LGBTQ patients.