Linda and Leon Bryant and family were just the kind of people Daniel Mullins, PhD, and his coalition were looking for to fill the pages of their new report "Integrating Patients' Voices in Study Design Elements."
The report is aimed at encouraging medical researchers to include 'hard-to-reach' patients in future studies and clinical trials.
Mrs. Bryant said researchers need to understand the "family dynamics" of caring for an Alzheimer's patient, such as Mr. Bryant, who was diagnosed in 2010. "It's good to clarify ways research can help the caregiver and how it can be beneficial to the caregiver. Others know exactly what I'm going through," she said. Mr. and Mrs. Bryant, along with their son and his wife, (pictured) participated in one of dozens of focus groups of caregivers and patients of different medical conditions, which were conducted by the coalition in the six-month study led by the University of Maryland School of Pharmacy.
The resulting report continues precedents set in recent years to expand the consciousness of scientific research, says study leader Mullins, a professor in the Department of Pharmaceutical Health Services Research at the School.
In 1993, for example, women's health advocates persuaded Congress to pass legislation requiring women and minorities to be part of National Institutes of Health-funded trials. Until the mid-1980s clinical trials were conducted primarily on a pool of white males because some leaders believed that women, with their cycling hormones, would complicate results.
Similarly, says Mullins, "Researchers usually don't outreach to some groups of patients perhaps because it takes more time and effort to include them. But these overlooked people typically have greater health needs."
Opportunity for change arrived on Mullins' desk with a unique contract from the Patient-Centered Outcomes Research Institute (PCORI). His consortium of leaders from community and research groups in Baltimore, including faculty from the pharmacy, medical, and nursing schools at the University, went right to work finding and gathering feedback from hard-to-reach patients and their caregivers. PCORI is an independent agency established by the federal Affordable Care Act of 2010 as a non-governmental, nonprofit organization.
The coalition conducted focus groups and interviews with patients and their caregivers who are:
African-Americans, predominantly of low socio-economic status (SES); bilingual Spanish-speaking patients, predominantly of SES; patients found through faith-based organizations; mobility limited; visually impaired; hearing impaired; physicians who treat hard-to-reach patients; nurses who treat hard-to-reach patients; parents of children who are hard-to-reach patients; and caregivers of patients with cognitive impairments.
The new report provides detailed comments and opinions from each group. For example, Eileen Rivera Ley, who attended a focus group of visually impaired patients, said, "On this study, it is even refreshing to be consulted." Ley, who is legally blind and runs a health and disability advocacy group, added, "I am all for being a patient-centered health care system. It is going to turn everything on its head. It is not as much about research, but about dialogue. Get the eye doctors to really understand the issues. Educate the clinicians," said Ley. She attended the group with her husband, who is also visually impaired.
Another visually impaired participant, who identified himself simply as Jesse, said, "For young males who don't go to the doctor, it is hard to get them involved. But even for senior citizens, you need to go out and find them. Same for us."
Jesse, like dozens of other participants in many groups, suggested that the researchers use nonprofit organizations that represent hard-to-reach patient populations, in his case, "use the National Federation for the Blind. Find the chapter presidents online. It is a simple matter to reach out to them." Ley added, "Yes, it is a very huge and powerful network."
The report summarizes its findings into "10 Solid Suggestions How to Elicit Hard-to-Reach Patients' Perspectives and Partner with Patient Communities":
* Use a period of "pre-engagement" when recruiting research participants and partners.
* Involve the full spectrum of people who will be affected by the research, including hard-to-reach patients.
* Provide a lay summary of study findings at an end-of-study celebration.
* Build bridges for active patient engagement by creating and maintaining trust.
* Realize that people may not be willing to openly disclose medical information.
* Bring PCORI to communities where people live.
* Keep people up-to-date on what is going on with the research.
" Recognize that people make health care choices and participate in research based upon
who they are as individual persons, not just as patients.
* Provide education on exactly what is meant by the term "research."
* Make a sincere effort to "give back" to the community.
"Bringing it back to the community is a piece that for many years the research community has left out, yet the method, called participatory research, has been around for years," says Beth Barnet, MD, professor of family and community medicine at the University's School of Medicine. "It is quite forward thinking and now part of the PCORI perspective." Barnet's principal role in the study was interviewing family primary care physicians. "They said the same things as patients did, 'You have to work with patients to earn their trust'," she says.
A copy of the PCORI report can be found here.
According to its website, the institute's goal is to help patients, their caregivers, and clinicians make better-informed health care decisions by supporting the development of trusted, high-quality, useful information on options for prevention, diagnosis, and treatment of diseases and conditions. PCORI provides "evidence on the effectiveness, benefits, and harms of different treatment options for different patients from studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care," Joe Selby, MD, MPH, executive director of PCORI, said in a statement.