Are ethnic and racial minority women less likely to participate in clinical trials?

Patel, Siddharth; Staples, Jeanine N.; Garcia, Christine; Chatfield, Lindsay; Ferriss, J. Stuart; Duska, Linda R.

doi:10.1016/j.ygyno.2020.01.040

Cited by 31 publications

(26 citation statements)

References 26 publications

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“…AA women compared with EA women were more likely to respond to direct, in-person recruitment methods by concordant outreach staff, rather than general, public advertisements. However, although identification of potential participants depended on the recruitment method used, once women expressed interest, we observed similar rates of consent by AA and EA women, which is consistent with the experience of others ( 9 , 10 , 13 ) supporting the willingness of AA women to participate in clinical trials.…”

Section: Discussionsupporting

confidence: 77%

Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections

McCann

Rodriguez

Erwin

et al. 2022

Current Developments in Nutrition

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Recruitment of minority participants to clinical trials, especially studies without therapeutic intent, has been historically challenging. This study describes barriers to and successes of recruitment and retention strategies to dietary studies. A flaxseed study was conducted in healthy, postmenopausal women of African ancestry (AA) and European ancestry (EA) to assess associations between gut microbial community composition and host metabolism (NCT01698294). To ensure equitable participation by AA and EA, multiple forms of recruitment were utilized, including advertisements, posters, email, word of mouth, and community outreach. Successful recruitment and retention of AA women to the intervention depended upon the specific methods used. AA women vs. EA women were more likely to respond to direct recruitment and community-based methods, rather than general advertisements. However, once women expressed interest, similar rates of consent were observed for AA and EA (51.6% vs. 55.7%, AA and EA, respectively, P > 0.05) supporting the willingness of minority populations to participate in clinical research. Retention, however, was lower among AA vs EA women (57.6% vs. 80.9%, AA and EA, respectively; P < 0.01) which may be related to multiple factors including health reasons, intolerance to flaxseed, non-compliance with study requirements, time constraints, and non-specified personal reasons. This study confirms the utility of direct community-based strategies for recruitment of diverse populations into non-therapeutic dietary intervention studies. The methods used successfully identified eligible women who expressed willingness to consent to the trial and were able to achieve > 70% of recruitment goals for AA women. Future efforts are warranted to improve retention to complex studies. Registration: clinicaltrials.gov registration NCT01698294. SUMMARY This report describes the experience and success at recruitment of a diverse study sample for a dietary intervention and shows community engagement methods are effective for African American women.

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Section: Discussionsupporting

confidence: 77%

Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections

McCann

Rodriguez

Erwin

et al. 2022

Current Developments in Nutrition

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“…Other studies have demonstrated the disparities of care which occur in ethnic minorities and the access and management given in gynecological pathology in the USA ( 7 , 8 , 9 ). Descriptive studies of AUB subtype distribution in a population in the USA have never been performed.…”

Section: Introductionmentioning

confidence: 99%

Abnormal uterine bleeding types according to the PALM-COEIN FIGO classification in a medically underserved American community

Sabre¹,

Serventi²,

Nuritdinova³

et al. 2021

J Turkish German Gynecol Assoc

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Objective: To describe the distribution of abnormal uterine bleeding (AUB) type according to the polyp (AUB-P); adenomyosis (AUB-A); leiomyoma (AUB-L); malignancy and hyperplasia (AUB-M); coagulopathy (AUB-C); ovulatory dysfunction (AUB-O); endometrial (AUB-E); iatrogenic (AUB-I); and not yet classified International Federation of Gynecology and Obstetrics classification system in a medically underserved American inner-city population. Our secondary objective was to find an association between risk factors and type of AUB. Material and Methods: We conducted a descriptive cross-sectional analysis at our outpatient women’s health clinic located in the Bronx, New York City, from November 2016 to December 2019. Results: Among 390 patients, the most common AUB type was AUB-L (n=185, 47.4%), followed AUB-P (n=100, 25.6%), AUB-A (n=55, 14.1%), AUB-O (n=19, 4.9%), AUB-M (n=15, 3.8%), AUB-E (n=14, 3.6%) and AUB-I (n=2, 0.5%). Race was distributed as follows: Hispanic (68.2%), Black (25.9%), Caucasian (3.3%), and Asian (2.1%). Comorbidities included hypertension (36.4%), diabetes (15.6%), and thyroid disease (6.9%). The median age at diagnosis was significantly higher in AUB-M (59 years old, p<0.001), AUB-P (52.5 years old, p<0.001), AUB-E (51.5 years old, p=0.001) compared to AUB-L (46 years old). The median body mass index (BMI) was significantly higher in AUB-E (34.2 kg/m 2 , p=0.048) and AUB-O (32.6 kg/m 2 , p=0.038) compared to AUB-L (30 kg/m 2 ). Race was equally distributed among the AUB types. AUB-M (66.6%, p=0.002), AUB-E (57.1%, p=0.022), AUB-P (47%, p<0.001), and AUB-A (30.8%, p<0.001), had statistically significantly more cases of hypertension compared to AUB-L (28.1%). AUB-P (27%, p<0.001), AUB-M (26.6%, p=0.025), AUB-E (35.7%, p=0.001) and AUB-A (9%, p<0.001) had more patients with diabetes mellitus (DM) than AUB-L (3.3%). Conclusion: In an American population of medically underserved patients, the most common cause of AUB was leiomyoma and the most common race was Hispanic. Women with AUB-L were younger, with lower BMI, and with fewer cases of hypertension and DM when compared to other types of AUB.

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“…This should be coupled by provision of appropriate tools in plain language that clearly explain potential benefits to patients and their families, while also highlighting race/ethnicity‐driven measures of cancer risk and outcomes 36 . Educational interventions were, in fact, shown to increase willingness to participate in clinical trials, although different tools may be needed for specific racial/ethnic minority groups 37 . Considerations of community perspectives and cultural appropriateness would surely increase the success of such educational tools and initiatives 38,39 .…”

Section: What Can We Do About It?mentioning

confidence: 99%

“…36 Educational interventions were, in fact, shown to increase willingness to participate in clinical trials, although different tools may be needed for specific racial/ ethnic minority groups. 37 Considerations of community perspectives and cultural appropriateness would surely increase the success of such educational tools and initiatives. 38,39 Science is often presented in a format that lacks cultural acknowledgment or evidence of beneficial relevance to the communities (eg, testimonials by ethnically diverse cancer survivors) or may fail to address barriers to trust.…”

Section: Addressing Patients' Awareness Trust and Understanding Of Clinical Trialsmentioning

confidence: 99%

Addressing racial/ethnic disparities in cancer clinical trials: Everyone has a role to play

Habr

Ferdinand

2021

Cancer

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Are ethnic and racial minority women less likely to participate in clinical trials?

Cited by 31 publications

References 26 publications

Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections

Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections

Abnormal uterine bleeding types according to the PALM-COEIN FIGO classification in a medically underserved American community

Addressing racial/ethnic disparities in cancer clinical trials: Everyone has a role to play

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