Trust is central to the relationship between patients and their clinicians. It’s also essential to the relationship between patients and researchers if patients are to fully engage in clinical research. As the healthcare industry becomes more patient-centered, clinical researchers will need to work closely with patients to assist them in finding answers to critical health questions.
Trust through Engagement and Transparency
(Download a copy)
One way to build trust is to include patients in the research process. PCORnet, the National Patient-Centered Clinical Research Network, aims to transform clinical research by engaging patients–and others in the healthcare community—in collaborative partnerships that produce useful clinical knowledge and improve health care. In PCORnet, patients participate in the development and governance of the network, as well as in all the stages of each project.
Patient engagement, however, is only one aspect of building the trust necessary to marshal a robust patient-centered clinical research paradigm. Researchers must also address patients’ feelings of vulnerability related to person health issues, both their own and those of family members. The clinical research community is developing approaches that will ease these feelings of vulnerability. Such approaches may include incorporating patients’ perspectives, demonstrating respect for patients’ viewpoints, ensuring the privacy of health data, and making the best effort to design the study so that it leads to improvements in health.
Trust can be nourished through transparency, which is a key element of open science. Anyone interested should be able to learn how a study is being carried out and have access to findings once the work is complete.
Being ADAPTABLE
PCORnet’s first demonstration project, the recently announced study called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness), illustrates PCORnet’s aims of patient engagement and open science. The project, which involves seven PCORnet partner networks, will compare the effect of two different aspirin doses given to prevent heart attacks and strokes in high-risk patients with a history of heart disease. ADAPTABLE is publicly requesting advice and feedback on key aspects of the study from patients, physicians, and research communities and simultaneously ushering in a new research paradigm defined by unprecedented transparency.
ADAPTABLE’s commitment to engagement and transparency began with asking patients, physicians, and researchers for input on the study protocol via a survey posted on the PCORnet website; this effort yielded more than 200 thoughtful responses and comments, which are being taken under consideration as the protocol is finalized. On a lighter note, in the spirit of soup-to-nuts stakeholder involvement, all study partners are voting on ADAPTABLE’s logo, thereby having a voice in the study’s visual identity.
Approaches to patient-centered clinical research like those being applied in ADAPTABLE enable patients to inform researchers about what matters most to them and their families. In turn, researchers can design trials that focus on the clinical outcomes most meaningful to patients. Study designs tailored to reflect patient values build trust throughout the entire research enterprise.
As ADAPTABLE moves forward, we hope the study’s commitment to engagement and openness will not only improve the design and execution of the trial but will allow other research teams to learn from our experiences, both successes and challenges. Such studies advance clinical trial methodology by encouraging researchers to extricate themselves from their usual ways and reconsider how clinical trials should be conducted.
In doing so, you will be helping to put patients first in clinical research. Stay tuned for updates and more opportunities for involvement as we travel on this new and exciting journey together.
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.
Image
Dr. Hernandez's points are very well-taken.
After many years as a professional patient advocate, health coach and navigator for medically-underserved communities, I affirm the need for involving patients and their caretaking support systems in all aspects of research.
Historically, public health care initiatives and qualitative research that studied health gaps in impoverished populations, often utilized "participatory evaluation" techniques to involve patients in evaluating their health and community-development needs. Back in the "day", we worked hard at training community leaders in processes for examining their needs.
One of the best examples, in the 1980s, came from the grassroots development organization called, " Save The Children". STC lead community-health organizations right into the heart of neighborhoods and gathered folks together to teach study participants how to evaluate not just health-care needs, but larger development issues, as well.
Save the Children staff, like Jane Vella, often trained peer-educators/leaders in a self-evaluation process that gave "voice and choice" to community leaders approached by public health researchers.
I encourage Dr. Hernandez and our fellow public-health research colleagues who are interested in effective trust-building, to look at the Participatory Evaluation literature of the 1980s and 90s.
It might strengthen your historical understanding of what has worked to establish solid patient-researcher relationships, in the past.
Keep up the good work, Dr. Hernandez and kudos to PCORI for innovative initiatives!