The recruitment of minority patients is hard under any circumstances. But finding research subjects for conditions with a social stigma is especially difficult.
Barbara Gladson is director of the biopharma educational initiative at the University of Medicine and Dentistry of New Jersey (UMDNJ). She gave a fascinating presentation on her work at the 2010 annual Drug Information Association (DIA) meeting in Washington, D.C. Gladson is assisting on hepatitis and liver-related trials in the Newark, New Jersey facility. Through the UMDNJ foundation, she's also seeking grants from federal and industry sources for other conditions, including diabetes and hypertension.
In cancer trials at UMDNJ during 2007, Gladson related, twenty African-American patients out of 396 with the disease were enrolled, a 5.1 percent rate. Among Latinos, 12 patients enrolled out of 260 with cancer, a rate of 4.6 percent. That was a wake up call. “It should have been much more ethnically diverse,” Gladson said. “I am hoping this is a way to recruit patients not just to our liver trials but to all of our trials.”
In a perfect world, she said, she’d like to see the numbers of minorities in her trials rise above the low single digits. One helpful factor is to have a principal investigator with the same ethnic background as the target patient population for the study. That helps overcome reluctance and suspicion of the medical profession and research in particular.
Another technique: using a computer kiosk of the sort you might find in any shopping mall. Each one is programmed with a short script that includes educational and survey elements. A single kiosk at one clinical location was able to screen 1,000 patients a year. The team at UMDNJ now has three more kiosks and is trying to obtain funding and projects for additional units.
The first kiosk was programmed by a physician colleague of Gladson's, UMDNJ surgeon Andrew De La Torre, who was unable to present his research at the DIA event. Gladson built on his work and added clinical trial recruitment aspects to the kiosk effort—not to mention filling in for him at the DIA session.
Gladson readily acknowledges that she and De La Torre didn't invent the kiosks; they've been used in domestic violence and HIV screening at other universities. But she feels the kiosks could be helpful in urban environments where older patients, perhaps more skeptical about medical ethics, might not participate in research on their own.
The reason is simple. With some conditions and patients, more personal medical information is disclosed to an inanimate object. “There is a seventeen percent increase in disclosure of information when you have them speak to a computer,” Gladson said, citing other research.
Tell Me Everything
The kiosks ask about transfusions, prostitution, homosexuality, syringe usage, and other topics. Sensitive stuff. Reached after the DIA conference, Gladson said the higher level of disclosure to a paper survey or a computer may be related to fairly basic emotions. "It's about the fear of being judged," she said.
In the satellite clinic or hospital, a clinical research associate (CRA) approaches patients in the waiting area. Patients who agree to participate in a survey accompany the CRA to a private room. Some informal assistance with the kiosk is helpful, Gladson says, due to the age and computer skills of some of the patients.
When the kiosks are just running unattended during regular office hours, without a CRA on hand, the recruiting process doesn't seem as successful. "Patients do need a little guidance," says Gladson. A printer gives the patient information (their body-mass index, for example) to take home or be given to a physician.
The kiosks will soon provide a variety of information about other conditions that can be triggered by answers to questions about ethnicity, gender or age. Older African-American men will get a notice about prostate cancer; younger women will get information about the human papilloma virus.
So far, the computers have been programmed in Creole, Spanish and English. “We provide them with a headset so there is privacy,” Gladson notes, adding that the ear pieces are disposable. The kiosk drives part of the screening process. If a patient says he may have a risk factor, the computer prompts him to schedule a blood test.
To be as clear as possible, the material is calibrated to a second grade reading level. The local institutional review board approved all the language in the survey, as well as a single-page consent form.
The only potential harm to participation in the kiosk project, apparently, was anxiety from the questionnaire's discussion of disease risk factors. But that can presumably be mitigated by having nurses and physicians close at hand. In her presentation, Gladson noted that some of the language referring to certain demonized industries or government agencies could be unnecessarily alarming; she subsequently tweaked the text to be as neutral and nonthreatening as possible.
Where do the kiosks come from? The university's IT wizards? A high-end marketing firm on Madison Avenue? No. Ebay, it seems, has an abundance of suitable computers perfectly able to handle the task and collect a bit of data. “It is pretty cheap and easy to put out there,” Gladson says. In the future, she's hoping to be able to place the kiosks in community pharmacies, where they would help with basic medical education and, incidentally, with patient recruitment for clinical trials.
Editor's note: More information about Gladson's work can be found at her project's website.