We spend a great deal on medical research that often does not reflect the interests of people who have the condition.
In 2016, $171.8 billion was spent on medical and health research and development in the United States, the majority (67.4%) financed by industry, which includes biopharmaceutical developers, medical technology developers and healthcare service companies. Federal spending on medical and health research is subject to statutory budget caps. The American Journal for Managed Care estimates that the US spends less than 5 cents of each health dollar on research and development. The result is industry-driven research that doesn’t reflect the needs and priorities of those who stand the most to gain from it – real people with the actual condition being studied.
The idea of involving patients is not new. Developing in tandem in the 1970s, the push for evidence-based medicine and empowering patients as partners to improve outcomes to curb wasteful healthcare spending. The Patient-Centered Outcomes Research Institute was established as part of the Affordable Care Act to engage people with lived experience in comparative effectiveness research – study of what works, from the patient’s perspective.
The projects that PCORI funds that draw on the experience and insights of all stakeholders – patients, caregivers, clinicians, employers, insurers and policy makers – to frame the research agenda/design and help the stakeholders make informed decisions. Patients, in other words, should not only to have a say in their own care as an individual, but have a voice in the direction of that care, and the research that informs it, as a group.
In 2016, Smart Policy Works (then Health & Disability Advocates) received funding to engage people with trauma induced spinal cord injury in the design, implementation and dissemination of research. The concept for our PCORI project partly arose out of the experience of one of our own team members. Ever since he suffered a wrestling accident as a teenager, he has had to act as his own case manager, telling care providers what they should be asking him, and educating physicians about how his spinal cord injury affects his health and impacts his care. We thought this must be a more common occurrence than people realize – that it must happen all the time to people with chronic conditions. Bringing together a cohort of patients with this condition, we reasoned, would allow them – working with a group of experts – to distill and synthesize their shared experience. This would better prepare them to effectively use their knowledge in future research projects, as well as providing a reference point for others on the research goals and interests of this population.
PCORI agreed, and funded a two-year project. The aim of the project was to prepare patients with trauma-induced spinal cord injuries to become “research ready” and play active roles in research to improve their health and quality of life. During 2016, we recruited the cohort of patient stakeholders, and in over the course of 2017 we worked with them on how to use their own experiences to improve future studies. Patients are often not prepared to convey to researchers what it is they care about; research is a fairly abstract concept that needs to be made “concrete.” Our work included monthly training and enhanced skill-building, such as how to identify research priorities by examining personal life experiences.
This was a remarkably rewarding experience for our entire team.
First, we all learned a great deal about the condition itself. A traumatic spinal cord injury is a disability caused by an accident, injury or violence. Like most other chronic conditions, it has implications for many other aspects of a person’s health, including increased risks for as cardiovascular disease, mental health issues and diabetes. Nearly a quarter of a million Americans live with “SCI,” and each year almost 12,000 more experience an injuries each year.
As longtime advocates for people with disabilities, we had often repeat the fact that they are a diverse population with different needs, abilities, and circumstances; but we were struck by the range of abilities even within this small group representing what seemed like one condition – injury-acquired SCI. Far from the stereotype of para- or quadriplegic wheelchair users, several participants with significant SCI were still able to walk – and one had run 19 marathons, and another was an accomplished scuba diver. Their backgrounds and personal stories were just as varied.
A number of our group come to their condition as a result of acts of violence, but in other cases it was via vehicle crashes, the consequence of surgery, and in case literally due to a bump on the head that at the time had not seemed serious.
One thing that become clear early on was that it was essential to adapt the training to the different degrees of familiarity with research, their technological fluency and their style of learning. Some of our stakeholders had been participants in research or advocacy around SCI – one had been the “star” of a medical video – while others were having their first encounters with investigative medicine.
What really made this project unique was its deep roots in lived experience among the cohort, the panel and the team. We made a point of convening an expert panel who were themselves living with a traumatic spinal cord injury or had had one-on-one experience with a person living with a traumatic spinal cord injury. This proved invaluable in forging a true understanding of the dimensions of the condition and the concerns of those living with it.
Finally, but perhaps most crucially, we made a strong effort to foreground the cohort’s own research interests. Their range of concerns really underscored the whole idea of research that is important to the patient, from the clinical “methods to make the rehabilitation process more effective and less dangerous/damaging”; to the personal “the ability to explore sexuality after injury”; to the systems level “how to improve health & well-being of justice involved” to the prosaic – and often overlooked – “life is better catheter-free.”
We were deeply committed to documentation in the form of creating profiles for each of the participants. This helped the stakeholders translate their lived experience and acquired knowledge into meaningful input for research, and to become more proficient at it. But it also embodies as a concrete vehicle for the dissemination of the insights and findings.
Because we believe work like this is so crucial to a patient-focused healthcare system, we have preserved key elements of the recently completed project as a mini-website. We are excited to make this work available to others, to serve as a model and inform future projects.
It is our sincere hope that others will be able to use, adapt and build on the curriculum we developed in this path breaking project. We invite you to contact us to connect with our stakeholders or learn more about this initiative.