Recruiting for a randomized controlled trial from an ethnically diverse population: Lessons from the Maternal Infection and Preterm Labor Study
Participants and nonparticipants were similar with regard to most characteristics Table 1. Most subjects who agreed to participate in the trial were Caucasian; one-quarter were African American Table 2.
Although more Caucasian than African American participants enrolled by number, the percentage of those enrolling of the total eligible was the same, 28%. The ethnicities of patients enrolling was different from those declining to enroll (P = .042) Table 2. Specifically, the enrollment rate for African participants was half that for African American patients. Of 23 eligible patients, no Hispanic or Asian patients were enrolled in the trial. Only 12% of the enrollees were immigrants, compared to the 88% who declined to be studied (P = .014). Only 1 subject who required an interpreter was enrolled (P = .008).
Discussion
Our study was successful in recruiting African American patients. Unlike other studies, African American individuals were as likely to enroll as their Caucasian counterparts. Our success in minority recruitment is even more significant in that there was no specific strategy used to recruit minority women.
Perceptions about research participation and barriers to enrolling in clinical trials have been studied in African American populations.5,6,8,10,11,14,15 Lack of trust in and fear of medical research is still prevalent in the African American community.6,8,11,14,15 In the past, medical experimentation had been perpetrated on African American individuals without their consent, as illustrated by the Tuskegee Experiment and by medical procedures carried out on slaves without their consent.16 These acts have justifiably made some patients distrustful of the medical establishment and research.1,14 Lack of transportation, lack of childcare, and lack of time for study activities have also been cited as barriers to patient participation in other studies.6,11,15
We believe that having the patient’s own physician or nurse performing enrollment, including obtaining informed consent, improved recruitment. Our patients did not have to see any outside providers or study personnel in order to be enrolled. Recruitment was high, even though 96% of the physicians involved were not members of a minority group.
We believe that having enrollment performed and all data collected quickly at routine patient visits may have assisted recruitment. In addition, we have on-site childcare for patients and their families, and such service may have removed barriers to participation.
We found that patients who were immigrants, especially those requiring translators, were much less likely to enroll in this trial. Cultural factors were likely to play a role.17 Most of our African patients were from East Africa (Somalia and Ethiopia), and nearly all had undergone ritual circumcision. Our experience with this patient population has shown that they prefer to limit vaginal examinations.
Little research exists about the recruitment of individuals with ethnicities other than African American for research trials. Swanson and Ward15 reviewed the research on recruiting minorities for clinical trials and concluded with 20 steps needed to recruit more minorities into research trials. Only 1 trial of minority perceptions (other than African American) about research could be located. Roberson11 conducted phone surveys of inner city African American, Native American, and Hispanic individuals to see which factors about enrolling in cancer clinical trials were important to them. She found that the study subjects “knew little about cancer clinical trials and basically had no opportunity to participate.” All 3 minority groups expressed concerns about being treated like “guinea pigs” and a “mistrust of white people.” Hispanic subjects specifically expressed concerns about communication in their own language.
Several studies have described successful recruitment of minority populations (other than African American) for clinical trials. Two studies have shown successful recruitment of Hispanic and African American women for clinical trials on primary prevention using mass mailings and media announcements.10,18 Small and coworkers12 trained and then used bicultural interviewers to successfully recruit 3 non-English-speaking immigrant populations for a study of maternal satisfaction with hospital birthing in Australia. These studies, however, did not take place in a primary care clinic setting. Our study provides new information about the recruitment of minorities for a clinical trial in such a setting.
The strength of this study was in its completeness of data. The data were collected systematically from forms currently used routinely in the medical record, thereby reducing bias. This study was limited by the lack of direct information regarding reasons for refusal among women declining enrollment.
Proven methods of increasing minority participation in research of all kinds are crucially needed. Our study suggests that clinic-based research, with enrollment by a patient’s primary care physician or nurse, can have a significant positive effect on recruitment. In addition, a different approach to immigrants, especially those not conversant in English, will be needed for successful recruitment in future studies. Further research should be both quantitative and qualitative to better understand the recruitment process in underserved and ethnically diverse patient populations.
