The effects of knowledge, attitudes, and significant others on decisions to enroll in a clinical trial on osteoporosis: implications for recruitment of older African-American women.

This preliminary study explored the roles of knowledge, attitudes, and significant others on decisions of older African-American women to enroll in a clinical trial involving estrogen and osteoporosis. Sixteen older African-American women (average age 75 years) participated in three focus groups. Twelve of the women had enrolled in the clinical trial and four, although eligible, refused to enroll. Discussions revealed that knowledge of osteoporosis and estrogen and expectations of personal rewards and group benefits from medical research appear to differentiate the women who participated in the clinical trial from those who refused. The women who participated also perceived the research institution as accessible. In addition, assuring full disclosure of testing procedures and test results eased their apprehensions about participation. However, the women who refused to enroll saw no personal benefit and were unwilling to expose themselves, in part because of their age, to the risks of taking estrogen and the uncertain outcomes of the clinical trial. The study illustrates how focus groups can be used to develop multiple strategies to enable recruitment of older African-American women with different demographic characteristics, levels of knowledge, and attitudes toward a disease and medical research.     

A comparison of stroke risk factors in patients enrolled in stroke prevention trials

The high prevalence of stroke risk factors may explain, in part, the high incidence of stroke in African Americans. To further investigate the role of stroke risk factors, we compared stroke risk factor profiles of patients in the African-American Antiplatelet Stroke Prevention Study (AAASPS) with those in other stroke prevention studies in which the enrollees were predominately white. The baseline characteristics of the AAASPS enrollees obtained from an interim AAASPS database of 1,087 patients from 65 centers in the U.S. between December 1995 and June 1999 was compared to the baseline characteristics of 53,293 predominantly non-African American patients enrolled in 23 other stroke prevention studies (pNAA). Percentages were reported for qualitative characteristics, and means and standard deviations (SDs) for quantitative characteristics. For selected qualitative characteristics, 95% confidence intervals were given for population percentages in each study. The comparison of baseline characteristics showed that hypertension was more prevalent in AAASPS (84% [95% CI 82.2, 86.61) compared to pNAA trial patients (range of 27% to 67%). Diabetes mellitus was more common in AAASPS (39.1%) compared to pNAA trial patients (17.1%). Cardiac disease, however, was less common in AAASPS than in pNAA trials. The frequency of baseline characteristics of AAASPS patients is different from those of pNAA studies. Risk factor profiles are important as they may help to predict stroke subtype and outcome. Furthermore, the differences in baseline characteristics may portend differences in response to treatment and incidence of adverse events.     

Increasing participation of minorities in cancer clinical trials: summary of the "Moving Beyond the Barriers" Conference in North Carolina

A day-long seminar was held at Wake Forest University School of Medicine to address barriers among ethnic minorities in cancer clinical trials and explore ways that individuals who design and conduct clinical trials could increase minority representation. Speakers addressed implications of under-representation of minorities and identified barriers to minority participation. State-wide focus group results were presented and revealed suspicion of medical research among minorities and the need for bridging to minority communities to improve participation in cancer clinical trials. Working groups assembled and identified barriers specific to trial design, providers, and participants. Attendees were encouraged to devise strategies within their institutions to overcome barriers to minority participation.     

Who will enroll? Predicting participation in a phase II AIDS vaccine trial.

BACKGROUND: The problems of underenrollment and selective enrollment may undermine AIDS vaccine trials. If prospective study subjects' stated willingness to participate (WTP) in hypothetical vaccine trials predicts future enrollment, then measuring WTP before recruitment may enhance the enrollment in, and ethics of, such trials. METHODS: We prospectively studied changes over an 18-month period in the stated WTP in, and knowledge of, a hypothetical AIDS vaccine trial among 610 Philadelphia residents at high risk for HIV infection. Of these people, 499 were subsequently recruited to participate in an actual, phase II AIDS vaccine trial. We used multivariable logistic regression and the area under the receiver-operating characteristic (ROC) curve to model predictors of actual enrollment. RESULTS: Actual enrollment rates were 8.3%, 6.8%, 15.8%, and 29.0% among those who had initially said they were "definitely not," "probably not," "probably," and "definitely" willing to participate, respectively (p =.006). The area under the ROC curve was 0.65, indicating a modest ability of stated WTP to differentiate those who enroll from those who do not. Knowledge of basic vaccine trial concepts, though unrelated to enrollment, increased over an 18-month period with repeated education sessions (p <.0001), whereas stated WTP declined over this same period (p <.0001). CONCLUSION: Although other factors not captured by stated WTP may also influence future enrollment, prospectively assessing stated WTP may augment the validity of the informed consent process, help prevent underenrollment, and clarify the population from which the study sample is drawn.     

Lessons learned from community-based minority health care serving system participation in an NIH clinical trial

To address the historically low rate of minority participation in clinical trials, the NIH and others have provided incentives to increase the diversity of patients and study sites involved in NIH-funded research. An example of the efforts to achieve this aim was the creation of the Partnerships Program to Reduce Cardiovascular Health Disparities," whereby a health care system that serves a predominantly minority patient population partners with a research-intensive medical center that has a track record of NIH-supported research. In the city of Baltimore, Maryland, the Bon Secours Baltimore Health System partnered with the University of Maryland and was awarded 1 of 7 U01 partnerships within cardiovascular health. This commentary describes the qualitative experiences of the participating physicians and not a quantitative analysis of the study data or findings. It describes the lessons learned by Bon Secours that can address patient and physician barriers to clinical trial participation. Based upon the views of participating physicians, it is easiest to engage physicians when there is a supportive principal investigator and appropriate infrastructure to do research. Patient recruitment requires cultural competence and sensitivity, and using minority physicians, nurses, and staff may greatly assist in building the trust that is necessary for patients to be willing to participate in research. Clarity of the study's purpose and aims at the outset is critical, and reinforcement with educational sessions helped with physician and patient retention throughout the study.     

Progress and pitfalls in underrepresented minority recruitment: perspectives from the medical schools

PURPOSE: To assess current initiatives at U.S. medical schools to recruit underrepresented minorities (URM) and to identify perceived barriers to enrollment of URM students. METHODS: We developed a survey that was mailed to the dean of Student Affairs of all U.S. allopathic and osteopathic medical schools in 2002. Respondents were asked to list their schools' URM recruitment programs and rate the effectiveness of these programs. They were also asked to indicate barriers to URM recruitment from a list of 37 potential barriers and rate their overall success with URM recruitment. RESULTS: The study had a 59% response rate. All schools reported a wide variety of initiatives for URM recruitment with > or =50% of all schools using each of the 11 strategies. The three most commonly listed barriers to URM recruitment were MCAT scores of applicants (90%), lack of minority faculty (71%) and lack of minority role models (71%). Most schools rated their recruitment efforts highly; on a scale of 1 to 10 (10 being very successful), the average score was an 8. CONCLUSION: While schools continue to invest tremendous efforts in recruiting minority applicants, admissions criteria, lack of URM faculty and the need for external evaluation remain important barriers to achieving a diverse physician workforce.     

Non-respondents in a post-myocardial infarction trial: characteristics and reasons for refusal

We surveyed the 270 survivors of acute myocardial infarction who refused to participate in the Warfarin Re-Infarction Study (WARIS). Information on medical variables were derived from registration forms completed by hospital staff upon discharge, whereas data on a variety of health conditions and reasons for refusal were gathered by mailed questionnaires, 178 (66%) of which were returned. Some disparities were found when comparing non-respondents and participants, the former showing more potential bad risk factors. The diversities between participants and non-respondents are of yet unknown prognostic importance. However, the presence of such differences imply that information on characteristics of non-respondents in clinical trials is desirable in terms of generalizability of the trial results. Reasons stated for non-participation reflect poor motivation, low mobility and saturation with focusing on disease. A slight co-variation between social status and reasons for refusal was noted.     

An investigation of patients' attitudes to ECT by means of Q-analysis

This paper is a preliminary investigation into the application of Q-analysis in clinical psychiatry. Q-analysis is used to describe the interrelationships of attitudes that two groups of patients were observed to hold towards ECT. The data were collected as part of the Leicestershire ECT trial. One group comprised 96 patients who consented to enter the trial. The other group was formed by 23 patients who refused to participate in the trial, but who agreed to be interviewed so that their attitudes could be assessed. The method of applying Q-analysis is described, and the resultant outputs for the two groups are discussed. The presence of insight, a subjective need for treatment and trust in ECT were significant features in the 96 patients who agreed to enter the trial. However, among this group there was a subset of patients who were very anxious and who had little desire to receive ECT or trust in it. Among the 23 patients who refused to participate in the trial two main viewpoints could be discerned. First, there was a subgroup who seemed accurately to assess their need for treatment, had insight and trust in ECT as well as specifically wanting to receive it. The second was composed of patients who were very apprehensive, did not want ECT and generally were unhappy about being in hospital. In both groups it was considered that level of knowledge was relatively unimportant in the formation of attitudes.     

HIV vaccine trial participation among ethnic minority communities: barriers, motivators, and implications for recruitment

BACKGROUND: Underrepresentation of ethnic minority communities limits the generalizability of HIV vaccine trial results. We explored perceived barriers and motivators regarding HIV vaccine trial participation among low-socioeconomic ethnic minority respondents at risk for HIV. METHODS: Six focus group interviews were conducted using a semistructured interview guide. Participants (N = 58, mean age = 36 years, 37% female, and 56% Latino/a and 35% African American) were recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. RESULTS: Perceived barriers to HIV vaccine trial participation, in rank order, were (1) vaccine-induced HIV infection, (2) physical side effects, (3) uncertainty about vaccine efficacy, (4) uncertainty about other vaccine characteristics, (5) mistrust, (6) low perceived HIV risk, (7) study demands, (8) stigma, and (9) vaccine-induced HIV seropositivity. Motivators were (1) protection against HIV infection, (2) free insurance and/or medical care, (3) altruism, and (4) monetary incentives. CONCLUSIONS: Population-specific HIV vaccine trial recruitment and implementation strategies should address trial risks from a family perspective, cultural gender norms, mistrust, low perceived HIV risk, the importance of African-American and Latino/a community participation in HIV vaccine trials, and misconceptions about gaining protection against HIV infection. Increasing the cultural relevance of trial recruitment and implementation should facilitate the participation of Latinos/as and African Americans in HIV vaccine trials.     

Maximising recruitment and retention of general practices in clinical trials: a case study

Background

There is limited evidence regarding the factors that facilitate recruitment and retention of general practices in clinical trials. It is therefore pertinent to consider the factors that facilitate research in primary care.

Aim

To formulate hypotheses about effective ways of recruiting and retaining practices to clinical trials, based on a case study.

Design of study

Case study of practice recruitment and retention to a trial of delivering antenatal sickle cell and thalassaemia screening.

Setting

Two UK primary care trusts with 123 practices, with a high incidence of sickle cell and thalassaemia, and high levels of social deprivation.

Method

Practices were invited to take part in the trial using a research information sheet for practices. Invitations were sent to all practice managers, GPs, practice nurses, and nurse practitioners. Expenses of approximately £3000 per practice were available. Practices and the research team signed research activity agreements, detailing a payment schedule based on deliverables. Semi-structured interviews were completed with 20 GPs who participated in the trial. Outcome measures were the number of practices recruited to, and completing, the trial.

Results

Four practices did not agree to randomisation and were excluded. Of 119 eligible practices, 29 expressed an interest in participation. Two practices withdrew from the trial and 27 participated (two hosted pilot studies and 25 completed the trial), giving a retention rate of 93% (27/29). The 27 participating practices did not differ from non-participating practices in list size, number of GPs, social deprivation, or minority ethnic group composition of the practice population.

Conclusion

Three factors appeared important in recruiting practices: research topic, invitation method, and interest in research. Three factors appeared important in retaining practices: good communication, easy data-collection methods, and payment upon meeting pre-agreed targets. The effectiveness of these factors at facilitating recruitment and retention requires assessment in experimental studies.     

A Response to History: A Review of One Medical School's Efforts to Graduate Minority Physicians

The number of minority physician graduates depends upon both the recruitment and retention of physician manpower. Numbers cannot be increased until the problems of recruiting and retaining minority students are minimized. This paper describes the process by which one medical school initiated changes to overcome barriers to recruiting, admitting, and graduating more minority students for medical practice.     

Attitude towards clinical trials: Results of a survey of persons interested in research

Objective and design:Patient recruitment is a major problem in clinical trials. In a survey, the attitude of a public sample towards clinical trials was assessed. Subjects:In a survey 225 visitors to the Heinrich-Heine University were interviewed with respect to their attitude towards clinical trials. Methods:Visitors were interviewed with regard to sociodemographic variables, disease status, knowledge about and experience of trials and attitude towards clinical trials. Three scenarios for clinical trials were presented (dental trial, surgical trial, pharmaceutical trial). Results:In general, a positive attitude was found. Clinical trials were judged important by 89.5% of the survey participants; however, only 25% would take part in clinical trials. The likelihood of potential participation was lower in the surgical trial than in the dental or pharmaceutical trial scenarios. The willingness to participate was significantly higher in persons, who considered trials to be important, with general knowledge about clinical trials and with previous trial participation. Conclusions:The willingness to participate in a clinical trial is still low in the public. More information and involvement in clinical trials may improve the general attitude.     

A review of racial differences in geriatric depression: implications for care and clinical research.

How racial differences influence depressed elders'' seeking and obtaining treatment for depression is poorly understood. Studies in other medical illnesses show older African Americans use fewer health-care services for heart disease, stroke, and renal dialysis. This article reviews the racial composition of Duke University''s Clinical Research Center (CRC) for the Study of Depression in the Elderly. Possible explanations for low participation of African Americans in such programs also are discussed. During most of the first year of the CRC project, minority enrollment varied from 5% to 10%, at least one third the African-American population of the area. Active efforts to improve minority recruitment increased this percentage to 15% by the end of the project''s second year. Likely explanations for low minority participation rates include 1) elders may recognize depressive symptoms, but do not seek or cannot obtain medical treatment, and 2) depressive symptoms may be attributed to a crisis of the spirit (so help is sought through prayer and the church), the "slowing down" process of aging, or part of life''s burden to be endured. Future attempts at both treatment and clinical research recruitment efforts are needed to address these possibilities.     

Identifying, recruiting, and enrolling adolescent survivors of childhood cancer into a randomized controlled trial of health promotion: preliminary experiences in the Survivor Health and Resilience Education (SHARE) Program

OBJECTIVE: To report on the identification, recruitment, and enrollment of adolescent survivors of childhood cancer into an ongoing randomized controlled trial (RCT) of health promotion. METHODS: A total of 244 adolescents were contacted by mail and telephone to assess their trial eligibility. Data were collected with respect to each adolescent's demographics and trial recruitment efforts (frequency and intensity of telephone call contact); exclusion and randomization status were tracked throughout. RESULTS: Thirty-one percent of adolescents were ultimately randomized in the trial and 69% were excluded from randomization (13% were ineligible, 33% refused to participate, 22% were unreachable or nonresponsive, that is, did not respond to trial mailings or telephone calls, and less than 1% were withdrawn prior to randomization). Among all eligible adolescents, the trial's consent rate was 49%. Adolescents excluded owing to refusal resided the farthest away from the intervention site and experienced the least amount of telephone call contact time. The primary reasons for trial refusal were lack of interest in health promotion (28%) and lack of time to participate (23%). CONCLUSIONS: Health promotion RCTs among adolescent survivors of childhood cancer may help prevent and control the onset and severity cancer-treatment-related late effects. However, trial success may be contingent upon tracing nonresponsive adolescents and reducing and eliminating barriers to participation.     

Improving knowledge and decision readiness to participate in cancer clinical trials: Effects of a plain language decision aid for minority cancer survivors

ObjectiveTo evaluate the impact of a web-based, plain language decision aid (CHOICES DA) on minority cancer survivors’ knowledge of cancer clinical trials (CCTs), readiness for making decisions about clinical trial participation, and willingness to participate in a clinical trial.MethodsParticipants were 64 Black and Hispanic cancer survivors from Miami, Florida. In a single arm intervention study, participants completed self-report assessments of CCT knowledge, decision readiness regarding clinical trial participation, and willingness to participate at three time points.ResultsBlack and Hispanic participants did not differ on demographic characteristics. Post-test and follow-up measures of CCT knowledge and decision readiness were significantly greater than pre-test measures for the sample overall, and for Black and Hispanic participants separately. Few significant differences were observed between Black and Hispanic participant outcomes at each survey time point, and willingness to participate did not change overall and for either group independently.ConclusionsReviewing the CHOICES DA was associated with significantly improved knowledge and decision readiness to participate in a CCT immediately and at 2-week follow-up.Practical ImplicationsThese findings suggest that CHOICES DA may support informed decision making about CCT participation within an acute, yet clinically relevant window of time for minority cancer patients who are substantially under-represented in cancer research.     

Who joins a preventive intervention? How risk status predicts enrollment

The objective of this study was to identify social, psychological, and health‐related variables that predict mothers' refusals to join a prevention program for families of children with chronic illnesses. A two‐step recruitment process was used with 193 families of children with chronic illnesses. First, families were recruited for a longitudinal research survey. Then, mothers were given the opportunity to randomly receive one of two programs. Mothers who refused the opportunity to participate in either program continued in the research project. Data were collected through structured interviews at baseline and 12 months later. Compared to mothers who agreed to participate in one of the programs, those who refused reported more confidence, more support, and less depression and higher functional status and better adjustment in their child. Mothers who agree to participate in a longitudinal research effort but refuse to participate in an intervention program are likely to be functioning well, and may perceive no need for a program designed to prevent mental health problems. © 2001 John Wiley & Sons, Inc.     

Recruitment of underrepresented minority students to medical school: minority medical student organizations, an untapped resource

Recruitment of more underrepresented minority students (black, Hispanic and native American) to increase racial diversity in the physician workforce is on the agenda for medical schools around the nation. The benefits of having a racially diverse class are indisputable. Minority physicians are more likely to provide care to minority, underserved, disadvantaged and low-income populations. Therefore, medical schools would benefit from diversity through utilizing strategies for recruitment of underrepresented minority (URM) students. Numerous recruitment strategies have been employed to increase the number of underrepresented minority students. However, formal collaboration with minority medical student organizations is an underutilized tool in the recruitment process. Many medical schools have informally used minority medical students and members of various minority organizations on campus in the recruitment process, but a formal collaboration which entails a strategic approach on using minority medical student organizations has yet to be included in the literature. This paper discusses the innovative collaboration between the University of Toledo College of Medicine (UTCOM) chapter of the Student National Medical Association (SNMA) and the college of medicine's admissions office to strategize a recruitment plan to increase the number of underrepresented minority students at the UTCOM. This paper suggests that minority medical student organizations, particularly the SNMA, can be used as a recruiting tool; hence, admissions offices cannot negate the usefulness of having formal involvement of minority medical student organizations as a recruiting tool. This approach may also be applicable to residency programs and other graduate professional fields with a severe shortage of URM students.     

Predictors of refusal during a multi-step recruitment process for a randomized controlled trial of arthritis education

Objective

Randomized controlled trials in patient education often have difficulty enrolling vulnerable populations—specifically, older, poorer, and less educated individuals. We undertook a randomized controlled trial (RCT) of an educational intervention for arthritis management, which included strategies to remove literacy-related barriers to participation. This paper reports on the multi-stage recruitment process and assesses whether refusal to participate was related to education, age, gender, working status, or insurance status.

Methods

The recruitment protocol was designed to eliminate literacy-related barriers to participation. Patients were never asked to read or fill out forms. Interactions were oral, using everyday terms and short, clear sentences. Patients who declined during a screening call were considered Stage 1 Refusers. Patients who initially expressed interest but neither completed a baseline questionnaire nor provided consent were considered Stage 2 Refusers. Patients who consented were considered Enrollees. Age, gender, and insurance status were compared between Stage 1 Refusers and Enrollees. A second analysis compared these variables, plus educational attainment and working status, between Stage 2 Refusers, and Enrollees.

Results

Of 408 eligible patients, there were 193 (47.3%) Stage 1 Refusers, 81 (19.9%) Stage 2 Refusers and 134 (32.8%) Enrollees. A higher proportion of Stage 1 Refusers than Enrollees were ≥65 years old (58% vs. 37%, p = .0003). Multivariate analysis, adjusting for gender and insurance status, confirmed the effect of older age on refusal (OR = 2.3 (1.4, 3.6)). There were no significant differences between Stage 2 Refusers and Enrollees.

Conclusion

We found no evidence of refusal to participate due to educational attainment, working status, insurance status, or gender. Older patients were more likely to refuse participation at the first stage of recruitment.

Practice implications

Researchers should continue efforts to increase participation among older patients, particularly when studies are designed to be generalized to an elderly population as is the case with arthritis research. Strategies used in this recruitment protocol designed to remove literacy-related barriers to recruitment may be responsible for the observation that subjects with lower education did not have a higher rate of refusal. Such strategies deserve further study.     

Implicit Bias in Pediatric Academic Medicine

Objective

Despite known benefits of diversity, certain racial/ethnic groups remain underrepresented in academic pediatrics. Little research exists regarding unconscious racial attitudes among pediatric faculty responsible for decisions on workforce recruitment and retention in academia. This study sought to describe levels of unconscious racial bias and perceived barriers to minority recruitment and retention among academic pediatric faculty leaders.