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1.
JAMA Oncol ; 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38935372

ABSTRACT

Importance: Poor performance of the transvaginal ultrasonography triage strategy has been suggested as a contributor to racial disparity between Black individuals and White individuals in endometrial cancer (EC) stage at diagnosis in population-level simulation analyses. Objectives: To examine the false-negative probability using ultrasonography-measured endometrial thickness (ET) thresholds as triage for EC diagnosis among Black individuals and assess whether known risk factors of EC modify ET triage performance. Design, Setting, and Participants: This retrospective diagnostic study of merged abstracted electronic health record data and secondary administrative data (January 1, 2014, to December 31, 2020) from the Guidelines for Transvaginal Ultrasound in the Detection of Early Endometrial Cancer sample assessed Black individuals who underwent hysterectomy in a 10-hospital academic-affiliated health care system and affiliated outpatient practices. Data analysis was performed from January 31, 2023, to November 30, 2023. Exposure: Pelvic ultrasonography within 24 months before hysterectomy. Main Outcome and Measures: Ultrasonography performed before hysterectomy as well as demographic and clinical data on symptom presentation, endometrial characterization, and final EC diagnosis were abstracted. Endometrial thickness thresholds were examined for accuracy in ruling out EC diagnosis by using sensitivity, specificity, and negative predictive value. False-negative probability was defined as 1 - sensitivity. Accuracy measures were stratified by risk factors for EC and by factors hypothesized to influence ET measurement quality. Results: A total of 1494 individuals with a uterus (median [IQR] age, 46.1 [41.1-54.0] years) comprised the sample, and 210 had EC. Fibroids (1167 [78.1%]), vaginal bleeding (1067 [71.4%]), and pelvic pain (857 [57.4%]) were the most common presenting diagnoses within 30 days of ultrasonography. Applying the less than 5-mm ET threshold, there was an 11.4% probability that someone with EC would be classified as not having EC (n = 24). At the 4-mm (cumulative) threshold, the probability was 9.5%, and at 3 mm, it was 3.8%. False-negative probability at the 5-mm threshold was similar among EC risk factor groups: postmenopausal bleeding (12.4%; 95% CI, 7.8%-18.5%), body mass index greater than 40 (9.3%; 95% CI, 3.1%-20.3%); and age 50 years or older (12.8%; 95% CI, 8.4%-18.5%). False-negative probability was also similar among those with fibroids on ultrasonography (11.8%; 95% CI, 6.9%-18.4%) but higher in the setting of reported partial ET visibility (26.1%; 95% CI, 10.2%-48.4%) and pelvic pain (14.5%; 95% CI, 7.7%-23.9%). Conclusion and Relevance: These findings suggest that the transvaginal ultrasonography triage strategy is not reliable among Black adults at risk for EC. In the presence of postmenopausal bleeding, tissue sampling is strongly recommended.

2.
Article in English | MEDLINE | ID: mdl-38864118

ABSTRACT

Objective: To assess the appropriateness of hysterectomies performed at a large tertiary health system using the 1997 RAND appropriateness classification system and an updated algorithm. Design: We abstracted structured and unstructured data from electronic medical records on patient demographics, primary indication(s) for hysterectomy, diagnosis codes associated with the hysterectomy, previous treatments, and laboratory results. Subjects: Patients aged 18-44 years. Exposure: Receipt of hysterectomy for benign and nonobstetric conditions from October 2014 to December 2017. Main Outcome Measures: Using these data, we provided a RAND-based (dichotomous: inappropriate/appropriate) and Wright-based (3-level: inappropriate/ambiguous/appropriate) appropriateness rating and characterized missing information patterns associated with inappropriate ratings. Results: We analyzed 1,829 hysterectomies across 30 nonmutually exclusive primary indications for surgery. Nearly a third (32.8%) of surgeries had only one primary indication for surgery. Using the RAND-based classifier, 31.3% of hysterectomies were rated as appropriate and 68.7% as inappropriate. Using the Wright-based algorithm, 58.1% of hysterectomies were rated as appropriate, 15.7% as ambiguous, and 26.2% as inappropriate. Missing information on diagnostic procedures was the most common characteristic related to both RAND-based (46.1%) and Wright-based (51.2%) inappropriate ratings. Conclusions: The 1997 RAND classification lacked guidance for several contemporary indications, including gender-affirming care. RAND also has an outdated requirement for diagnostic surgeries such as laparoscopies, which have decreased in practice as diagnostic imaging has improved. Sensitivity analyses suggest that inappropriate surgeries cannot all be attributed to bias from missing electronic medical record data. Accurately documenting care delivery for benign gynecological conditions is key to ensuring quality and equity in gynecological care.

3.
J Comp Eff Res ; 13(3): e230159, 2024 03.
Article in English | MEDLINE | ID: mdl-38348827

ABSTRACT

Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. Patients & methods: This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. Data analysis: Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. Discussion/conclusion: Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC. Clinical Trial Registration: NCT04930159 (ClinicalTrials.gov).


Subject(s)
Endometrial Neoplasms , Female , Humans , Endometrial Neoplasms/therapy , Intention to Treat Analysis , Prospective Studies , Randomized Controlled Trials as Topic , Research , Social Work
4.
J Pain Symptom Manage ; 67(4): 317-326.e3, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38218413

ABSTRACT

CONTEXT: Though discrimination in healthcare settings is increasingly recognized, the discriminatory experiences of patients with serious illness has not been well studied. OBJECTIVES: Describe racial differences in patient-reported experiences with discrimination in the healthcare setting and examine its association with mistrust. METHODS: We used surveys containing patient-reported frequency of discrimination using the Discrimination in Medical Setting (DMS) and Microaggressions in Health Care Settings (MHCS) scales, mistrust using the Group Based Medical Mistrust (GBMM) scale, and patient characteristics including patient-reported race, income, wealth, insurance status, and educational attainment. Univariable and multivariable linear regression models as well as risk ratios were used to examine associations between patient characteristics including self-reported race, and DMS, MHCS, and GBMM scores. RESULTS: In 174 participants with serious illness, racially minoritized patients were more likely to report experiencing discrimination and microaggressions. In adjusted analyses, DMS scores were associated with elements of class and not with race. Black, Native American/Alaskan Native (NA/AN), and multiracial participants had higher MHCS scores compared to White participants with similar levels of income and education. Higher income was associated with lower GBMM scores in participants with similar DMS or MHCS scores, but Black and NA/AN participants still reported higher levels of mistrust. CONCLUSION: In this cross-sectional study of patients with serious illness, discriminatory experiences were associated with worse mistrust in the medical system, particularly for Black and NA/AN participants. These findings suggest that race-conscious approaches are needed to address discrimination and mistrust in marginalized patients with serious illness and their families.


Subject(s)
Black or African American , Trust , Humans , Cross-Sectional Studies , Delivery of Health Care , Racial Groups , United States , White , American Indian or Alaska Native
5.
BMC Womens Health ; 23(1): 674, 2023 12 19.
Article in English | MEDLINE | ID: mdl-38114962

ABSTRACT

BACKGROUND: Hysterectomy is a common surgery among reproductive-aged U.S. patients, with rates highest among Black patients in the South. There is limited insight on causes of these racial differences. In the U.S., electronic medical records (EMR) data can offer richer detail on factors driving surgical decision-making among reproductive-aged populations than insurance claims-based data. Our objective in this cohort profile paper is to describe the Carolina Hysterectomy Cohort (CHC), a large EMR-based case-series of premenopausal hysterectomy patients in the U.S. South, supplemented with census and surgeon licensing data. To demonstrate one strength of the data, we evaluate whether patient and surgeon characteristics differ by insurance payor type. METHODS: We used structured and abstracted EMR data to identify and characterize patients aged 18-44 years who received hysterectomies for non-cancerous conditions between 10/02/2014-12/31/2017 in a large health care system comprised of 10 hospitals in North Carolina. We used Chi-squared and Kruskal Wallis tests to compare whether patients' socio-demographic and relevant clinical characteristics, and surgeon characteristics differed by patient insurance payor (public, private, uninsured). RESULTS: Of 1857 patients (including 55% non-Hispanic White, 30% non-Hispanic Black, 9% Hispanic), 75% were privately-insured, 17% were publicly-insured, and 7% were uninsured. Menorrhagia was more prevalent among the publicly-insured (74% vs 68% overall). Fibroids were more prevalent among the privately-insured (62%) and the uninsured (68%). Most privately insured patients were treated at non-academic hospitals (65%) whereas most publicly insured and uninsured patients were treated at academic centers (66 and 86%, respectively). Publicly insured and uninsured patients had higher median bleeding (public: 7.0, uninsured: 9.0, private: 5.0) and pain (public: 6.0, uninsured: 6.0, private: 3.0) symptom scores than the privately insured. There were no statistical differences in surgeon characteristics by payor groups. CONCLUSION: This novel study design, a large EMR-based case series of hysterectomies linked to physician licensing data and manually abstracted data from unstructured clinical notes, enabled identification and characterization of a diverse reproductive-aged patient population more comprehensively than claims data would allow. In subsequent phases of this research, the CHC will leverage these rich clinical data to investigate multilevel drivers of hysterectomy in an ethnoracially, economically, and clinically diverse series of hysterectomy patients.


Subject(s)
Insurance Coverage , Surgeons , Female , Humans , United States , Adult , Medically Uninsured , Hospitals , Hysterectomy , Insurance, Health
6.
Womens Health Issues ; 33(6): 652-660, 2023.
Article in English | MEDLINE | ID: mdl-37689493

ABSTRACT

INTRODUCTION: Black women with uterine fibroids experience greater symptom severity and worse treatment outcomes compared with their White counterparts. Black veterans who use Veterans Health Administration (VA) health care experience similar disparities. This study investigated the experiences of Black veterans receiving care for uterine fibroids at VA. METHODS: We identified Black veterans aged 18 to 54 years with newly diagnosed symptomatic uterine fibroids between the fiscal years 2010 and 2012 using VA medical record data, and we recruited participants for interviews in 2021. We used purposive sampling by the last recorded fibroid treatment in the data (categorized as hysterectomy, other uterine-sparing treatments, and medication only/no treatment) to ensure diversity of treatment experiences. In-depth semistructured interviews were conducted to gather rich narratives of veterans' uterine fibroid care experiences. Transcribed interviews were analyzed using content analysis. RESULTS: Twenty Black veterans completed interviews. Key themes that emerged included the amplified impact of severe fibroid symptoms in male-dominated military culture; the presence of multilevel barriers, from individual to health care system factors, that delayed access to high-quality treatment; insufficient treatments offered; experiences of interpersonal racism and provider bias; and the impact of fertility loss related to fibroids on mental health and intimate relationships. Veterans with positive experiences stressed the importance of finding a trustworthy provider and self-advocacy. CONCLUSIONS: System-level interventions, such as race-conscious and person-centered care training, are needed to improve care experiences and outcomes of Black veterans with fibroids.


Subject(s)
Leiomyoma , Uterine Neoplasms , Veterans , Female , Male , Humans , Uterine Neoplasms/drug therapy , Uterine Neoplasms/surgery , Veterans Health , Leiomyoma/surgery , Hysterectomy
8.
J Gen Intern Med ; 2023 Aug 24.
Article in English | MEDLINE | ID: mdl-37620725

ABSTRACT

BACKGROUND: Racism negatively affects clinical outcomes in Black patients, but uncertainty remains among physicians regarding how to address interpersonal anti-Black racism incidences involving them to facilitate racial healing and promote accountability. OBJECTIVE: Elicit physician perspectives on addressing concerns from Black patients about interpersonal racism involving them or their team. PARTICIPANTS: Twenty-one physician subspecialists at an urban academic medical center. APPROACH: We conducted one-on-one semi-structured interviews to help inform the development of a clinician-facing component of a program to address the distress of racism experienced by Black patients with serious illness. We asked clinicians to describe experiences discussing racism with patients and identify additional resources to support these conversations. MAIN MEASURES: Physician perspectives, including barriers and facilitators, to promote racial healing and clinician accountability when discussing clinician-perpetuated interpersonal racism with Black patients. KEY RESULTS: Of the 21 participating physicians, 67% were women with a mean age of 44.2 years and mean of 10.8 years of experience as an attending physician. Four identified as Asian, three identified as Black, and 14 identified as White. Participants largely felt unprepared to discuss racism with their patients, especially if the harm was caused by them or their team. Participants felt patients should be given tools to discuss concerns about racism with their clinicians, but worried about adding additional burdens to Black patients to call out racism. Participants believed programs and processes with both patient- and clinicians-facing components had the potential to empower patients while providing resources and tools for clinicians to engage in these highly sensitive discussions without perpetuating more harm. CONCLUSIONS: Addressing and improving communication about interpersonal racism in clinical settings are challenging. Dual-facing programs involving patients and clinicians may help provide additional resources to address experiences of interpersonal racism and hold clinicians accountable.

9.
J Womens Health (Larchmt) ; 32(10): 1104-1110, 2023 10.
Article in English | MEDLINE | ID: mdl-37527205

ABSTRACT

Background: Provider uncertainty about the appropriate guideline-concordant evaluation of endometrial cancer (EC) symptoms may be a factor in racial inequities in EC. To evaluate the relationship between EC knowledge and reported practice patterns in a nationally representative survey of first-line providers for initial EC symptoms. Materials and Methods: This was a mailed cross-sectional survey of physicians and nurse practitioners from professional organization roster of providers from Obstetrics and Gynecology (OBGYN), Family Medicine, Internal Medicine, and Emergency Medicine. It queried demographics, practice characteristics, EC knowledge, and guideline-concordant practice patterns via three case vignettes. Regions of low response were retargeted to ensure strong representation among providers caring for Black women patients. EC knowledge was analyzed via a composite score (range: -3 to 10, with higher scores representing more EC knowledge), and adjusted prevalence ratios (PRs) used to test the association between knowledge and reported practice patterns. Results: Among 531 returned surveys (response rate = 38%), OBGYN had highest (53%) frequency of >6 (median) EC knowledge score, and Emergency Medicine had the lowest (15%) (p < 0.001). Nonguideline-concordant practice patterns were reported in 14%, 41%, and 35% of the three EC cases presented. Providers with knowledge >6, (n = 205) were significantly more likely to report guideline-concordant care on case vignettes (PR 1.28-1.36). Conclusions: In a national survey of multi-specialty backgrounds, there were basic knowledge gaps about EC and EC risk factors among providers, and a sizeable proportion reported nonguideline concordant practices. These findings indicate the importance of targeted education and training for first-line providers, as EC incidence rises.


Subject(s)
Endometrial Neoplasms , Gynecology , Obstetrics , Pregnancy , Humans , Female , Cross-Sectional Studies , Endometrial Neoplasms/diagnosis , Endometrial Neoplasms/epidemiology , Family Practice , Surveys and Questionnaires , Practice Patterns, Physicians'
10.
Obstet Gynecol ; 142(3): 477-480, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37590979

ABSTRACT

Endometrial cancer (EC) is the most common gynecologic cancer in the United States. Black individuals with EC have had a more than 90% higher 5-year mortality risk than White people while being subject to lower quality care across the entire disease process. In this commentary, I offer the perspective that EC is part of the reproductive justice movement, as a representation of threat to reproductive health independent of childbearing. With this work, I want to place EC squarely among the discursive arguments that reproductive justice makes in the interconnectedness of fertility, reproductive health, parenthood, and, ultimately, life.


Subject(s)
Endometrial Neoplasms , Health Inequities , Healthcare Disparities , Reproduction , Social Justice , Female , Humans , Black People , Endometrial Neoplasms/ethnology , Fertility , United States
11.
Obstet Gynecol ; 142(2): 350-359, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37473411

ABSTRACT

OBJECTIVE: To evaluate whether greater symptom severity can explain higher hysterectomy rates among premenopausal non-Hispanic Black compared with White patients in the U.S. South rather than potential overtreatment of Black patients. METHODS: Using electronic health record data from 1,703 patients who underwent hysterectomy in a large health care system in the U.S. South between 2014 and 2017, we assessed symptom severity to account for differences in hysterectomy rates for noncancerous conditions among premenopausal non-Hispanic Black, non-Hispanic White, and Hispanic patients. We used Poisson generalized linear mixed modeling to estimate symptom severity (greater than the 75th percentile on composite symptom severity scores of bleeding, bulk, or pelvic pain) as a function of race-ethnicity. We calculated prevalence ratios (PRs). We controlled for factors both contra-indicating and contributing to hysterectomy. RESULTS: The overall median age of non-Hispanic White (n=1,050), non-Hispanic Black (n=565), and Hispanic (n=158) patients was 40 years. The White and Black patients were mostly insured (insured greater than 95%), whereas the Hispanic patients were often uninsured (insured 58.9%). White and Black patients were mostly treated outside academic medical centers (nonmedical center: 63.7% and 58.4%, respectively); the opposite was true for Hispanic patients (nonmedical center: 34.2%). Black patients had higher bleeding severity scores compared with Hispanic and White patients (median 8, 7, and 4 respectively) and higher bulk scores (median 3, 1, and 0, respectively), but pain scores differed (median 3, 5, and 4, respectively). Black and Hispanic patients were disproportionately likely to have severe symptoms documented on two or more symptoms (referent: not severe on any symptoms) (adjusted PR [Black vs White] 3.02, 95% CI 2.29-3.99; adjusted PR [Hispanic vs White] 2.61, 95% CI 1.78-3.83). Although Black and Hispanic patients were more likely to experience severe symptoms, we found no racial and ethnic differences in the number of alternative treatments attempted before hysterectomy. CONCLUSION: We did not find evidence of overtreatment of Black patients. Our findings suggest potential undertreatment of Black and Hispanic patients with uterine-sparing alternatives earlier in their disease progression.


Subject(s)
Genital Diseases, Female , Hysterectomy , Patient Acuity , Female , Humans , Black People/statistics & numerical data , Ethnicity , Hispanic or Latino/statistics & numerical data , Hysterectomy/adverse effects , United States/epidemiology , White/statistics & numerical data , Premenopause/ethnology , Adult , Overtreatment , Genital Diseases, Female/epidemiology , Genital Diseases, Female/ethnology , Genital Diseases, Female/surgery
12.
JAMA Netw Open ; 6(7): e2321746, 2023 07 03.
Article in English | MEDLINE | ID: mdl-37405773

ABSTRACT

Importance: Black patients with serious illness experience higher-intensity care at the end of life. Little research has used critical, race-conscious approaches to examine factors associated with these outcomes. Objective: To investigate the lived experiences of Black patients with serious illness and how various factors may be associated with patient-clinician communication and medical decision-making. Design, Setting, and Participants: In this qualitative study, one-on-one, semistructured interviews were conducted with 25 Black patients with serious illness hospitalized at an urban academic medical center in Washington State between January 2021 and February 2023. Patients were asked to discuss experiences with racism, how those experiences affected the way they communicated with clinicians, and how racism impacted medical decision-making. Public Health Critical Race Praxis was used as framework and process. Main Outcomes and Measures: The experience and of racism and its association, as described by Black patients who had serious illness, with patient-clinician communication and medical decision-making within a racialized health care setting. Results: A total of 25 Black patients (mean [SD] age, 62.0 [10.3] years; 20 males [80.0%]) with serious illness were interviewed. Participants had substantial socioeconomic disadvantage, with low levels of wealth (10 patients with 0 assets [40.0%]), income (annual income <$25 000 among 19 of 24 patients with income data [79.2%]), educational attainment (mean [SD] 13.4 [2.7] years of schooling), and health literacy (mean [SD] score in the Rapid Estimate of Adult Literacy in Medicine-Short Form, 5.8 [2.0]). Participants reported high levels of medical mistrust and high frequency of discrimination and microaggressions experienced in health care settings. Participants reported epistemic injustice as the most common manifestation of racism: silencing of their own knowledge and lived experiences about their bodies and illness by health care workers. Participants reported that these experiences made them feel isolated and devalued, especially if they had intersecting, marginalized identities, such as being underinsured or unhoused. These experiences were associated with exacerbation of existing medical mistrust and poor patient-clinician communication. Participants described various mechanisms of self-advocacy and medical decision-making based on prior experiences with mistreatment from health care workers and medical trauma. Conclusions and Relevance: This study found that Black patients' experiences with racism, specifically epistemic injustice, were associated with their perspectives on medical care and decision-making during serious illness and end of life. These findings suggest that race-conscious, intersectional approaches may be needed to improve patient-clinician communication and support Black patients with serious illness to alleviate the distress and trauma of racism as these patients near the end of life.


Subject(s)
Health Literacy , Physician-Patient Relations , Racism , Humans , Male , Middle Aged , Death , Trust , Black or African American , Female , Aged
13.
Womens Health Issues ; 33(4): 405-413, 2023.
Article in English | MEDLINE | ID: mdl-37105835

ABSTRACT

INTRODUCTION: Uterine fibroids are common, nonmalignant tumors that disproportionately impact Black patients. We aimed to examine Black and White differences in receipt of any treatment and type of first treatment in the Department of Veterans Affairs, including effect modification by severity as approximated by anemia. METHODS: We used Department of Veterans Affairs administrative data to identify 5,041 Black and 3,206 White veterans with symptomatic uterine fibroids, identified by International Classification of Diseases, 9th edition, Clinical Modification, codes, between fiscal year 2010 and fiscal year 2012 and followed in the administrative data through fiscal year 2018 for outcomes. Outcomes included receipt of any treatment, hysterectomy as first treatment, and fertility-sparing treatment as first treatment. We stratified all analyses by age (<45, ≥45 years old), used generalized linear models with a log link and Poisson error distribution, included an interaction term between race and anemia, and used recycled predictions to estimate adjusted percentages for outcomes. RESULTS: There was evidence of effect modification by anemia for receipt of any treatment but not for any other outcomes. Across age and anemia sub-groups, Black veterans were less likely to receive any treatment than White veterans. Adjusted racial differences were most pronounced among veterans with anemia (<45 years, Black-White difference = -10.3 percentage points; 95% confidence interval, -15.9 to -4.7; ≥45 years, Black-White difference = -20.3 percentage points; 95% confidence interval, -27.8 to -12.7). Across age groups, Black veterans were less likely than White veterans to have hysterectomy and more likely to have a fertility-sparing treatment as their first treatment. CONCLUSIONS: We identified significant Black-White disparities in receipt of treatment for symptomatic uterine fibroids. Additional research that centers the experiences of Black veterans with uterine fibroids is needed to inform strategies to eliminate racial disparities in uterine fibroid care.


Subject(s)
Healthcare Disparities , Leiomyoma , Uterine Neoplasms , Veterans , Female , Humans , Middle Aged , Black or African American/statistics & numerical data , Delivery of Health Care/ethnology , Delivery of Health Care/standards , Delivery of Health Care/statistics & numerical data , Hysterectomy , Leiomyoma/epidemiology , Leiomyoma/ethnology , Leiomyoma/therapy , United States/epidemiology , United States Department of Veterans Affairs/statistics & numerical data , Veterans/statistics & numerical data , Uterine Neoplasms/epidemiology , Uterine Neoplasms/ethnology , Uterine Neoplasms/therapy , Adult , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data
14.
Gynecol Oncol ; 172: 29-35, 2023 05.
Article in English | MEDLINE | ID: mdl-36931101

ABSTRACT

OBJECTIVE: Underrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals. METHODS: ClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations. RESULTS: 279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001-2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration. CONCLUSIONS: Gynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.


Subject(s)
Genital Neoplasms, Female , Ovarian Neoplasms , Patient Selection , Female , Humans , Genital Neoplasms, Female/diagnosis , Genital Neoplasms, Female/therapy , Ovarian Neoplasms/diagnosis , Ovarian Neoplasms/therapy , Clinical Trials as Topic , Black or African American
15.
J Natl Compr Canc Netw ; 21(1): 27-32.e2, 2023 01.
Article in English | MEDLINE | ID: mdl-36634612

ABSTRACT

BACKGROUND: Significant disparities exist in recruitment of minorities to clinical trials, with much of the prior literature focused on race/ethnicity only. Limited English proficiency (LEP) is a known barrier in healthcare that may also drive disparities in trial enrollment. We sought to determine participation rates in gynecologic oncology trials among patients with LEP and to explore barriers to their participation. METHODS: In a retrospective cohort study, electronic health record data from >2,700 patients treated over 2 years at one academic gynecologic oncology practice were abstracted and the primary exposure of having LEP was identified. The primary outcome was enrollment in a clinical trial. Demographic, financial, clinical, and healthcare access-related covariates were also abstracted and considered as potential confounders in a multivariable logistic regression model. Age, race, ethnicity, and insurance status were further examined for evidence of effect modification. In addition, a survey was administered to all gynecologic oncology research staff and gynecologic oncology providers (n=25) to assess barriers to research participation among patients with LEP. RESULTS: Clinical trial enrollment was 7.5% among fluent English speakers and 2.2% among patients with LEP (risk ratio, 0.29; 95% CI, 0.11-0.78; P=.007), and remained significantly lower in patients with LEP after adjusting for the identified confounders of Hispanic ethnicity and insurance payer (odds ratio, 0.34; 95% CI, 0.12-0.97; P=.043). There was a trend toward race and LEP interaction: Asian patients were equally likely to participate in research regardless of language fluency, whereas White and Black patients with LEP were less likely to participate than non-LEP patients in both groups (P=.07). Providers reported that the most significant barriers to enrollment of patients with LEP in research were unavailability of translated consent forms and increased time needed to enroll patients. CONCLUSIONS: Patients with LEP were 3.4 times less likely to participate in gynecologic oncology trials than fluent English speakers. De-aggregation of race, ethnicity, and language proficiency yielded important information about enrollment disparities. These findings offer avenues for future interventions to correct disparities.


Subject(s)
Genital Neoplasms, Female , Limited English Proficiency , Female , Humans , Communication Barriers , Ethnicity , Genital Neoplasms, Female/therapy , Retrospective Studies , Clinical Trials as Topic
16.
Cancer Res Commun ; 2(10): 1282-1292, 2022 10.
Article in English | MEDLINE | ID: mdl-36311816

ABSTRACT

Current screening methods for ovarian cancer (OC) have failed to demonstrate a significant reduction in mortality. Uterine lavage combined with TP53 ultra-deep sequencing for the detection of disseminated OC cells has emerged as a promising tool, but this approach has not been tested for early-stage disease or non-serous histologies. In addition, lavages carry multiple background mutations, the significance of which is poorly understood. Uterine lavage was collected preoperatively in 34 patients undergoing surgery for suspected ovarian malignancy including 14 patients with benign disease and 20 patients with OC (6 non-serous and 14 high grade serous-like (serous)). Ultra-deep duplex sequencing (~3000x) with a panel of common OC genes identified the tumor mutation in 33% of non-serous (all early stage) and in 79% of serous cancers (including four early stage). In addition, all lavages carried multiple somatic mutations (average of 25 mutations per lavage), more than half of which corresponded to common cancer driver mutations. Driver mutations in KRAS, PIK3CA, PTEN, PPP2R1A and ARID1A presented as larger clones than non-driver mutations and with similar frequency in lavages from patients with and without OC, indicating prevalent somatic evolution in all patients. Driver TP53 mutations, however, presented as significantly larger clones and with higher frequency in lavages from individuals with OC, suggesting that TP53-specific clonal expansions are linked to ovarian cancer development. Our results demonstrate that lavages capture cancer cells, even from early-stage cancers, as well as other clonal expansions and support further exploration of TP53 mutation burden as a potential OC risk factor.


Subject(s)
Ovarian Neoplasms , Therapeutic Irrigation , Humans , Female , Ovarian Neoplasms/genetics , Mutation/genetics , Clonal Evolution , Tumor Suppressor Protein p53/genetics
17.
Am J Obstet Gynecol ; 227(2): 244.e1-244.e17, 2022 08.
Article in English | MEDLINE | ID: mdl-35283091

ABSTRACT

BACKGROUND: Disparities in adjuvant treatment between Black and White women with endometrial cancer exist and contribute to worse outcomes among Black women. However, factors leading to disparate treatment receipt are understudied. OBJECTIVE: We examined whether patient refusal of adjuvant treatment (chemotherapy or radiation) differed between Black and White women and whether treatment refusal mediated racial disparities in survival among women with endometrial cancer. STUDY DESIGN: We used the National Cancer Database, a hospital-based cancer registry, to identify non-Hispanic Black and non-Hispanic White women diagnosed with endometrial cancer from 2004 to 2016 who either received or refused recommended radiation or chemotherapy. We used logistic regression to estimate multivariable-adjusted odds ratios and 95% confidence intervals for associations between race and treatment refusal. We also examined predictors of treatment refusal in race-specific models. Accelerated failure time models were used to estimate absolute differences in overall survival by race. We used causal mediation analysis to estimate the proportion of racial differences in overall survival attributable to racial differences in adjuvant treatment refusal. We considered the overall study population and strata defined by histology, and adjusted for sociodemographic, tumor, and facility characteristics. RESULTS: Our analysis included 75,447 endometrial cancer patients recommended to receive radiation and 60,187 endometrial cancer patients recommended to receive chemotherapy, among which 6.4% and 11.4% refused treatment, respectively. Among Black women recommended for radiation or chemotherapy, 6.4% and 9.6% refused, respectively. Among White women recommended for radiation or chemotherapy, 6.4% and 11.8% refused, respectively. After adjusting for sociodemographic variables, facility characteristics, and tumor characteristics, Black women were more likely to refuse chemotherapy than White women (adjusted odds ratio, 1.26; 95% confidence interval, 1.15-1.37), but no difference in radiation refusal was observed (adjusted odds ratio, 1.00; 95% confidence interval, 0.91-1.11). Some predictors of radiation refusal varied by race, namely income, education, histology, stage, and chemotherapy receipt (P interactions<.05), whereas predictors of chemotherapy refusal were generally similar between Black and White women. Among women recommended for radiation, Black women survived an average of 4.3 years shorter than White women, which did not seem attributable to differences in radiation refusal. Among women recommended for chemotherapy, Black women survived an average of 3.2 years shorter than White women of which 1.9 months (4.9%) could potentially be attributed to differences in chemotherapy refusal. CONCLUSION: We observed differences in chemotherapy refusal by race, and those differences may be responsible for up to about 2 months of the overall 3.2-year survival disparity between White and Black women. Radiation refusal did not explain any of the 4.3-year disparity among women recommended for radiation. Treatment refusal accounts for, at most, a small fraction of the total racial disparity in endometrial cancer survival. Although a better understanding of the reasons for patient treatment refusal and subsequent intervention may help improve outcomes for some women, other causes of disparate outcomes, particularly those reflecting the social determinants of health, must be investigated.


Subject(s)
Endometrial Neoplasms , White People , Black or African American , Endometrial Neoplasms/pathology , Female , Healthcare Disparities , Humans , Neoplasm Staging , Treatment Refusal
18.
J Pain Symptom Manage ; 63(5): e465-e471, 2022 05.
Article in English | MEDLINE | ID: mdl-34856335

ABSTRACT

Racial inequities in palliative and end-of-life care have been well-documented for many years. This inequity is long-standing and resistant to many intervention efforts. One reason for this may be that research in racial inequity in palliative care, and the interventions developed, do not account for the effects of race and the everyday racism that patients of color experience while navigating the healthcare system. Public Health Critical Race Praxis (PHCRP) offers researchers new routes of inquiry to broaden the scope of research priorities in palliative care and improving racial outcomes through a novel conceptual framework and methodology. PHCRP, based off critical race theory (CRT), contains 10 principles within four foci to guide researchers toward a more race conscious approach for the generation of research questions, research processes, and development of interventions targeting racial inequities.


Subject(s)
Hospice and Palliative Care Nursing , Racism , Humans , Palliative Care , Public Health
20.
Am J Obstet Gynecol ; 226(3): 388.e1-388.e11, 2022 03.
Article in English | MEDLINE | ID: mdl-34752734

ABSTRACT

BACKGROUND: Healthcare disparities research is often limited by incomplete accounting for differences in health status by populations. In the United States, hysterectomy shows marked variation by race and geography, but it is difficult to understand what factors cause these variations without accounting for differences in the severity of gynecologic symptoms that drive the decision-making for hysterectomy. OBJECTIVE: This study aimed to demonstrate a method for using electronic health record-derived data to create composite symptom severity indices to more fully capture relevant markers that influence the decision for hysterectomy. STUDY DESIGN: This was a retrospective cohort study of 1993 women who underwent hysterectomy between April 4, 2014, and December 31, 2017, from 10 hospitals and >100 outpatient clinics in North Carolina. Electronic health record data, including billing, pharmacy, laboratory data, and free-text notes, were used to identify markers of 3 common indications for hysterectomy: bulk symptoms (pressure from uterine enlargement), vaginal bleeding, and pelvic pain. To develop weighted symptom indices, we finalized a scoring algorithm based on the relationship of each marker to an objective measure, in combination with clinical expertise, with the goal of composite symptom severity indices that had sufficient variation to be useful in comparing different patient groups and allow discrimination among severe symptoms of bulk, bleeding, or pain. RESULTS: The ranges of symptom severity scores varied across the 3 indices, including composite bulk score (0-14), vaginal bleeding score (0-44), and pain score (0-30). The mean values of each composite symptom severity index were greater for those who had diagnostic codes for vaginal bleeding, bulk symptoms, or pelvic pain, respectively. However, each index demonstrated a variation across the entire group of hysterectomy cases and identified symptoms that ranged in severity among those with and without the target diagnostic codes. CONCLUSION: Leveraging multisource data to create composite symptom severity indices provided greater discriminatory power to assess common gynecologic indications for hysterectomy. These methods can improve the understanding in healthcare use in the setting of long-standing inequities and be applied across populations to account for previously unexplained variations across race, geography, and other social indicators.


Subject(s)
Hysterectomy , Uterine Hemorrhage , Algorithms , Female , Humans , Male , Pelvic Pain , Retrospective Studies , United States , Uterine Hemorrhage/diagnosis
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