When conducting clinical studies, researchers aim to control for as many variables as possible to easily examine the efficacy of new treatments. It may mean that only a limited patient population is available.
Eva Mistry of the University of Cincinnati (MBBS, MSCI) finds that as stroke researchers continue to make breakthroughs to improve care, this approach may lead to a large proportion of patients who were disabled before stroke being overlooked. said to be connected to
“We typically measure improvements associated with stroke treatment based on whether the patient’s function has improved or returned to normal,” said Dr. , UC Gardner Institute for Neuroscience. “If patients started out with functional impairment, we can imagine that certain baseline limitations prevent them from functioning well, and we end up excluding these patients.”
Mistry said the practice disproportionately excludes underrepresented minority patients, elderly patients and female patients. Because these groups are statistically more likely to live with a disability in the United States.
Because these patients were not included in studies, guidelines from organizations such as the American Heart Association and the American Stroke Association generally recommend that new effective treatments be offered only to patients with no history of pre-stroke disability. Recommended.
“So clinicians see it as gospel, hedge it, and say they can’t offer this treatment,” Mistry said. Because I’ve never studied populations.”
Mistry is the principal investigator of a new $9.6 million-funded study from the Patient-Centered Outcomes Institute (PCORI) examining the effectiveness of stroke treatments for patients with pre-stroke disabilities. about this population.
research focus
The overriding goal of the study, Mistry said, is to produce data that describe stroke outcomes in patients with pre-stroke deficits. Approximately 30% of patients with ischemic stroke due to blood clots in the brain have pre-stroke disability.
“Then we will provide future researchers and scientists with the tools and data to avoid reflexively excluding patients from studies based on baseline impairments, thereby providing evidence-based clinical care.” can do,” she said.
Specifically, the research team will focus on the efficacy of a treatment called endovascular thrombectomy (EVT). This is a minimally invasive surgery that uses a catheter to remove blood clots from blood vessels in the brain of ischemic stroke patients and is highly effective, killing her two in five ischemic stroke patients. and reduce obstacles.
Over four years, approximately 1,100 patients at 12 US centers will be enrolled in the study, and researchers will compare outcomes in subsets that received EVT and those that did not. Registration is expected to open in fall 2023.
“In addition to collecting many of the usual outcomes that measure stroke, we will also collect many new outcomes, such as detailed measures of pre- and post-stroke disability and function, pre- and post-stroke quality of life, and social support. The burden of care before and after,” Mistry said.
Input to the community
Mistry noted that even with a focus on this particular patient group, it would be possible to enroll a different cohort of patients than the overall population of people with disabilities in the United States. It emphasizes the importance of patient and community involvement and representation in the research it receives, and community partners have been involved in the research from the earliest stages.
“We have been working with these partners for over several years to ensure that the study design reflects what is important to them to measure as a result,” Mistry said. We will continue to work with them throughout the project to ensure that we are enrolling a diverse patient population that is representative of the population of conditions we wish to study.”
Yolanda Vaughn, a patient partner in this study, has worked with Vanderbilt University for the past 15 years as a community trainer, Community Engagement Studio facilitator, and patient advocate.
“This project aligns with my desire to help researchers get the information they need to get medicines, treatments and resources into communities faster,” said Vaughn. “It’s a job worth doing and I believe that if one of us gets sick, we all get sick. So if we all get better, our community gets better.” and our world will be a better place.”
While continuing to advise researchers, Vaughn sees himself as a kind of “evangelist” for the project, keeping patients and doctors informed of what’s going on, answering questions, and helping with enrollment efforts. doing.
“I think there is value in getting everyone involved in research when appropriate. I think that means we need to work on building trust in our community. We intend to respect you and our intention is not to hurt you,” she said. “The more people we can involve, regardless of race, ethnicity, or gender, the richer the data. The greater our ability to save lives.”
Vaughn said it is important for community organizations, partners and advocates to participate and act as a bridge to the patient community. This work includes translating medical terminology so that members of the community can understand it, but also respecting their experience and knowledge and putting their voices at the center of research.
“When doctors discover a drug or cure, there is a long delay in treatment, but it takes 10 or 15 years before it actually gets into the hands of patients. “At the end of this study, we will be able to change the trajectory of people in pre-stroke conditions, or those who may have had a stroke, to get the care they need.” I hope you find the information useful.”
Shani Woods, PhD, is a caregiver partner on this study and brings her research expertise and her personal experience as an assistant professor of social work at Austin Peay State University. I am taking care of my sick parents. She credits Mistry with saving her mother’s life after her stroke, and Mistry was at one point Woods’ parents’ primary neurologist.
Woods says her background as a social worker has allowed her to access and use the resources. Her parents have health insurance, but not all caregivers do. Caregivers’ needs are often ignored even when resources are ample.
“Often the focus is on the patient, which is very important in wishing the patient well. I don’t think so,” said Woods. “[Such as] You might even ask about their mental health needs, perhaps their need for a break or rest, or just how they’re doing.
Woods is trained in clinical and translational research with a focus on understanding health inequalities, health equity and psychosocial issues, bringing a unique perspective to research.
“We look at things from the angle of what’s going on in the environment,” she said. And we’re looking at how these systems work together.”
Woods said he is excited to be a part of research that will contribute to new knowledge and advancements in stroke care, especially as African-American and other communities of color are disproportionately affected by stroke. .
“This is groundbreaking because it’s inclusive first and foremost, and it also gives us an opportunity to talk more about health disparities,” she said. And I think it’s going to have a really helpful impact on shaping and informing how we do surgery, because patients will have more of a psychosocial perspective that I share.”
Fundraising for PCORI
This study was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposal. It was selected for funding through the PCORI program, which is designed to support research that is broadly applicable to a variety of patient and care settings and produces results that can be more rapidly translated into routine clinical practice.
UC’s Mistry said this was his first experience leading research funded by PCORI and that the process was “awe-inspiring.”
“PCORI’s primary focus is patient-centric results. They are paramount to making research results available and translatable to all end-users,” said Mistry. “It’s been a really great experience working with them so far.”
Many clinical studies test whether an approach to care works under carefully controlled conditions in specialized research centers, where healthcare is delivered in such optimized conditions and settings. Such practical clinical studies test the efficacy of treatments in “real-world” practice settings, such as typical hospitals and outpatient clinics, and involve a wider range of study participants. can be included and the results can be applied more generally.
“This project was selected for PCORI funding not only for its scientific merit and commitment to involving patients and other healthcare stakeholders, but also for its implementation in a real-world setting,” said Dr. said Nakela L. Cook, M.D., Executive Director of PCORI. “It may answer important questions and fill important evidence gaps in the treatment of patients with pre-stroke disability. looking forward to it.”
