Exploring Willingness to Participate in Clinical Trials by Ethnicity
01 Aug 2017-Journal of racial and ethnic health disparities (Springer International Publishing)-Vol. 4, Iss: 4, pp 763-769
TL;DR: Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participation vary.
Abstract: African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.
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TL;DR: Several themes emerged, such as how to adapt to potential participants’ language competency and literacy levels, the importance to engage in culturally appropriate verbal and non-verbal communication, and to establish a sense of homophily between recruiters and patients.
Abstract: Clinical trials and research studies often fail to recruit participants from the minorities, hampering the generalizability of results. In order to mitigate this problem, the present study investigated how race/ethnicity affects the process of recruiting people from racial and ethnic minority groups, by conducting 11 focus groups with professional recruiters. Several themes emerged, such as how to adapt to potential participants' language competency and literacy levels, the importance to engage in culturally appropriate verbal and non-verbal communication, and to establish a sense of homophily between recruiters and patients. In addition, recruiters pointed out possible solutions to accommodate socioeconomic concerns, to adapt to contextual factors-including immigration status-and ultimately to respond to potential participants' mistrust of medical research. These findings are discussed, and future recommendations are provided.
47 citations
Cites result from "Exploring Willingness to Participat..."
...Adding to findings from previous studies [6, 14, 26, 29, 39], our study demonstrates that medical mistrust among potential participants not only is due to historical forces but also can be attributed to direct experiences...
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TL;DR: An overview of reimbursement policy by public and private payers before and during the COVID-19 pandemic is provided, implications in cancer care are described, and considerations for future reimbursement policy are offered.
Abstract: The first confirmed case of coronavirus disease 2019 (COVID-19) in the United States was reported on January 20, 2020. As of September 17, 2020, there were more than 6.6 million confirmed cases and 196,277 deaths. Limited data are available on outcomes of immunocompromised patients, but early published reports from China indicate that those with cancer have a 3.5 times higher risk of ICU admission, mechanical ventilation, or death than those without cancer. Because of the uncertain behavior of COVID-19, it has become imperative for practices to limit exposure to vulnerable patients. Telemedicine has been one of the cornerstones of caring for patients with cancer during the COVID-19 pandemic. This review provides an overview of reimbursement policy by public and private payers before and during the COVID-19 pandemic, describes implications in cancer care, and offers considerations for future reimbursement policy.
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TL;DR: The challenges and strategies related to the recruitment of minority survivors of breast cancer and to the recruit of survivors of Breast cancer with lymphedema into the Women In Steady Exercise Research (WISER) Survivor Clinical Trial are reported.
Abstract: BACKGROUND
Black women are more likely to experience adverse effects from cancer treatment such as lymphedema. Thus, black women may particularly benefit from research regarding interventions to improve lymphedema. Herein, the authors report the challenges and strategies related to the recruitment of minority survivors of breast cancer and to the recruitment of survivors of breast cancer with lymphedema into the Women In Steady Exercise Research (WISER) Survivor Clinical Trial.
METHODS
Subjects for this community-based trial were recruited from the Philadelphia area through active (mailings) and passive (printed materials and Web site) recruitment strategies. In addition, education sessions coordinated through partner hospitals in communities with a predominantly minority population were conducted to increase awareness of lymphedema in survivors of breast cancer. Women who were interested in the study were screened for lymphedema via telephone questionnaire and invited to see a study-related certified lymphedema therapist to confirm the presence of lymphedema.
RESULTS
Screening was conducted among 2295 women: 628 were eligible, 450 consented, and 351 were randomized. Minority women comprised 38% of the study population. Letters to women on state and hospital registries resulted in a 0.4% randomization rate; education sessions yielded a 10% randomization rate. The authors observed that approximately 23.6% of the study sample had no previous diagnosis of lymphedema.
CONCLUSIONS
The WISER Survivor Clinical Trial faced multiple recruitment challenges and used unique strategies to successfully enroll minority survivors of breast cancer into a lifestyle intervention. Cancer 2018;124:95-104. © 2017 American Cancer Society.
17 citations
Cites background from "Exploring Willingness to Participat..."
...There are multiple reasons minorities have been underrepresented in intervention studies.(12,13) For example, in the black community, there is a long documented history of a distrust of research and the health care system....
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...Minorities in general are underrepresented in medical research.(11,12) There are multiple reasons minorities have been underrepresented in intervention studies....
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TL;DR: In this paper, the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data were assessed.
Abstract: OBJECTIVE/HYPOTHESIS The aim of this study is to assess the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data. STUDY DESIGN Systematic Review and Population analysis. METHODS A systematic review was performed to identify CRS clinical trials, conducted in the U.S. and published between 2010 and 2020 in which patients were prospectively enrolled. Pooled racial and ethnicity data were compared to national and corresponding regional census data. RESULTS Eighty-three studies were included, comprising 12,027 patients. 50.4% were male and the average age was 49.2 years. 8,810 patients underwent a surgical procedure. Of the 12,027 patients, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% were classified as Other. The racial and ethnic composition of the pooled study population differs significantly from the national U.S. census data with the underrepresentation of each minority population (P ≤ .0002). Regional sub-analyses yield variable results. In the Northeast and West, there was an underrepresentation of all minority populations. In the South and Midwest, Black enrollment was similar to the U.S. census data, while all other minorities were underrepresented. CONCLUSIONS The racial and ethnic composition of patients enrolled in prospective CRS clinical trials differs significantly from the demographics of the U.S. POPULATION The generalizability and external validity of findings derived from studies comprised of demographically mismatched populations has not been established. Future efforts to enroll more representative populations should be emphasized by the research community, funding bodies, and editorial boards. LEVEL OF EVIDENCE NA Laryngoscope, 131:1722-1728, 2021.
16 citations
References
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TL;DR: Differences in cancer incidence, mortality, and survival in relation to race/ethnicity, and census data on poverty in the county or census tract of residence are highlighted.
Abstract: This article highlights disparities in cancer incidence, mortality, and survival in relation to race/ethnicity, and census data on poverty in the county or census tract of residence. The incidence and survival data derive from the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Program; mortality data are from the National Center for Health Statistics (NCHS); data on the prevalence of major cancer risk factors and cancer screening are from the National Health Interview Survey (NHIS) conducted by NCHS. For all cancer sites combined, residents of poorer counties (those with greater than or equal to 20% of the population below the poverty line) have 13% higher death rates from cancer in men and 3% higher rates in women compared with more affluent counties (less than 10% below the poverty line). Differences in cancer survival account for part of this disparity. Among both men and women, five-year survival for all cancers combined is 10 percentage points lower among persons who live in poorer than in more affluent census tracts. Even when census tract poverty rate is accounted for, however, African American, American Indian/Alaskan Native, and Asian/Pacific Islander men and African American and American Indian/Alaskan Native women have lower five-year survival than non-Hispanic Whites. More detailed analyses of selected cancers show large variations in cancer survival by race and ethnicity. Opportunities to reduce cancer disparities exist in prevention (reductions in tobacco use, physical inactivity, and obesity), early detection (mammography, colorectal screening, Pap tests), treatment, and palliative care.
1,629 citations
"Exploring Willingness to Participat..." refers background in this paper
...Increasing enrollment of African-American and HispanicAmerican participants in clinical trials is crucial not only for having proportionate representation in CTs but also because these populations are disproportionately affected by cancers [7, 8], and have lower cancer survival rates than their white counterparts [9]....
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TL;DR: In most categories, CAM use was common among outpatients and given the number of patients combining vitamins and herbs with conventional treatments, the oncology community must improve patient-provider communication, offer reliable information to patients, and initiate research to determine possible drug-herb-vitamin interactions.
Abstract: PURPOSE: Oncologists are aware that their patients use complementary/alternative medicine (CAM). As cancer incidence rates and survival time increase, use of CAM will likely increase. This study assessed the prevalence and predictors of CAM use in a comprehensive cancer center. SUBJECTS AND METHODS: Subjects were English-speaking cancer patients at least 18 years of age, attending one of eight outpatient clinics at The University of Texas M.D. Anderson Cancer Center, Houston, TX, between December 1997 and June 1998. After giving written informed consent, participants completed a self-administered questionnaire. Differences between CAM users and nonusers were assessed by χ2 and univariate logistic regression analysis. A multivariate logistic regression model identified the simultaneous impact of demographic, clinical, and treatment variables on CAM use; P values were two-sided. RESULTS: Of the 453 participants (response rate, 51.4%), 99.3% had heard of CAM. Of those, 83.3% had used at least one CAM approac...
1,001 citations
TL;DR: Race remained strongly associated with a higher distrust score and even after controlling for markers of social class, African Americans were less trusting than white Americans.
Abstract: Background: Investigators have voiced concerns that distrust of research and the medical community inpedes successful recruitment of African Americans into clinical research. Objective: To examine possible differences in distrust by race and to determine to what extent other sociodemographic factors explain any racial differences in distrust. Methods: We analyzed data from 527 African American and 382 white respondents of a national telephone survey on participation in clinical research. Our main outcome was a 7-item index of distrust. Results: African American respondents were more likely that white respondents not to trust that their physicians would fully explain research participation (41.7% vs 23.4%,P<.01)and to state that they believed their physicians exposed them to unnecessary risks (45.5% vs 34.8%,P<.01). African American respondents had a significantly higher mean distrust index score than white respondents(3.1 vs 1.8,P<.01). After controlling for other sociodemographic variables in a logistic regression model, race remained strongly associated with a highter distrust score (prevalence odds ratio, 4.7;95% confidence interval,2.9-7.7). Conclusions: Even after controlling for markers of social class, African Americans were less trusting than white Americans. Racial differences in disturst have important implications for investigation as they engage African Americans in research.
935 citations
"Exploring Willingness to Participat..." refers methods in this paper
...Distrust in doctors was measured using the distrust index scale [24]....
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TL;DR: The overall prevalence of CAM use found was lower than often claimed, however, there was some evidence that the use has increased considerably over the past years and the health care systems ought to implement clear strategies of how to deal with this.
Abstract: Background. No comprehensive systematic review has been published since 1998 about the frequency with which cancer patients use complementary and alternative medicine (CAM). Methods. MEDLINE, AMED, and Embase databases were searched for surveys published until January 2009. Surveys conducted in Australia, Canada, Europe, New Zealand, and the United States with at least 100 adult cancer patients were included. Detailed information on methods and results was independently extracted by 2 reviewers. Methodological quality was assessed using a criteria list developed according to the STROBE guideline. Exploratory random effects metaanalysis and metaregression were applied. Results. Studies from 18 countries (152; >65 000 cancer patients) were included. Heterogeneity of CAM use was high and to some extent explained by differences in survey methods. The combined prevalence for “current use” of CAM across all studies was 40%. The highest was in the United States and the lowest in Italy and the Netherlands. Metaanalysis suggested an increase in CAM use from an estimated 25% in the 1970s and 1980s to more than 32% in the 1990s and to 49% after 2000. Conclusions. The overall prevalence of CAM use found was lower than often claimed. However, there was some evidence that the use has increased considerably over the past years. Therefore, the health care systems ought to implement clear strategies of how to deal with this. To improve the validity and reporting of future surveys, the authors suggest criteria for methodological quality that should be fulfilled and reporting standards that should be required.
593 citations
TL;DR: The identification of barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.
Abstract: Summary Background Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials. Methods We did a systematic review to assess studies of barriers to participation in experimental trials and randomised trials for validity and content. We estimated the frequency with which patients identified particular issues by pooling across studies that presented data for barriers to participation in clinical trials as proportions. Findings We analysed 12 qualitative studies (n=722) and 21 quantitative studies (n=5452). Two qualitative studies inquired of patients who were currently enrolled onto clinical trials, and ten inquired of patients who were eligible for enrolment onto various clinical trials. Barriers to participation in clinical trials were protocol-related, patient-related, or physician-related. The most common reasons cited as barriers included: concerns with the trial setting; a dislike of randomisation; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Meta-analysis confirmed the findings of our systematic review. Interpretation The identification of such barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.
456 citations
"Exploring Willingness to Participat..." refers background in this paper
...About 5 % of eligible patients actually enroll in clinical trials, and only 10% of that group are ethnic minorities [1, 2]....
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