Working with the Ontario SPOR SUPPORT Unit (OSSU) to implement CIHR’s Strategy for Patient-Oriented Research (SPOR) represents an unprecedented opportunity to change the Ontario landscape for conducting large pragmatic trials, according to Dr. Dean Fergusson, head of the Ottawa Methods Centre (OMC).
The OMC is one of 12 Ontario research centres collaborating with OSSU to provide specialized expertise and support for investigators engaged in patient-oriented research (POR). Created in 2006, the OMC is part of the Ottawa Hospital Research Institute (OHRI). Its purpose is to promote and facilitate methodological excellence in clinical research.
Research is a team sport, according to Dr. Fergusson, a Senior Scientist and Director of the Clinical Epidemiology Program at OHRI. “Our philosophy at the Centre has always been to gather all of the relevant expertise and experience around the table to inform the research agenda from concept to dissemination. Adding patients and family members to the discussion is a logical next step,” he says.
While patient-oriented research is still relatively new to Canada, there are lots of great resources out there to help researchers conduct patient-oriented research. “Our job, as the methods service provider to OSSU, is to identify current resources and adapt them to the Ontario environment to create methods and tools researchers can use to bring patients and family members into the health research process.
“Our goals are to foster collaboration at the local, regional and provincial levels to optimize the quality and applicability of Ontario health research,” he says. The OMC team also aims to promote efficient and transparent research methods to minimize waste and support best practices while encouraging and supporting the development and implementation of novel methods and approaches to enhance the uptake of new knowledge at the frontlines to yield better patient outcomes.
With funding from OSSU, the OMC team has been expanded to help train and equip the next generation of patient-oriented researchers. OMC now has a roster of 30 people with a wide range of experience to help build patient-oriented research capacity in Ontario. In fact, many of OMC’s experts have already been tapped to advise research teams preparing proposals for OSSU’s IMPACT Award funding.
Last fall, the Centre initiated a global review of existing tools and frameworks for patient-oriented research, and tried to get a sense of how many published clinical trials and observational studies have actually engaged patients. The plan is to use the results of the review and scoping exercise as a platform upon which to develop patient-oriented research standards, methods and tools that Ontario investigators can use to design and conduct their own patient-oriented studies.
Dr. Fergusson is optimistic that the adoption of a patient-oriented approach to health research will help to address one of the biggest challenges Ontario investigators face when conducting clinical trials—enrolling enough patients in a study to ensure that the results are generalizable to the healthcare setting.
“The current regulatory climate,” he says, “amongst other things, stifles our ability to recruit a sufficient number of patients required in a reasonable period of time to conduct potentially practice-changing, defining trials.”
The solution, he says, lies in a shared approach with patients and society. “We would have answers to big everyday questions much more quickly if we adopted the “learning health system” model currently used in places such as the Duke Health System in North Carolina.” In a learning health system like Duke, where health services are continuously evaluated, it is understood—by the people who work there and by those being treated there—that they are going to learn from each other. “When a person seeks care or enters into a health plan at Duke, it is with the understanding that they will be involved in health research for the betterment of the entire population.
“In some cases,” Fergusson continues, “informed consent should still be required, for example, for studies involving novel therapies and innovative devices. But, for comparative effectiveness trials of three different, routinely used interventions, there is an argument to be made that patients who have consented to treatment in a learning health system have, in fact, agreed to take part in research to determine which of the three current treatment options is most effective for a particular condition.
“One could argue,” Fergusson says, “that what is not ethical is to continue using all three interventions without the evidence to indicate which one is best or safest. We really shouldn’t have these variations in care.”
The concept of assumed consent for certain types of research is inherent to the learning health system model, Fergusson says. “Adopting this model would make a huge difference in our ability to engage more patients to continuously and rigorously evaluate many of the standard procedures and interventions used in health care today.”
This change, when combined with engaging patients as partners in health research—right from the beginning—is what Fergusson sees as the greatest opportunity for OSSU. “Having patients at the table where we can learn directly from them about what outcomes and treatments are important to them (rather than relying, as we do now, on what research scientists think is important) has the potential to make care much more patient-centred and focused on important quality of life issues,” he says.
“It’s hard to believe that patients haven’t been involved in health research before now.” Some people worry that patients may not be able to understand some of the subtleties or complexities of research, or may come to the table with certain biases. But, Fergusson maintains, “Engaging patients in research will only enhance what we do. Education is key,” he says. “And, the education has to flow both ways. In health care, we translate complex issues to patients all the time and if we’re not doing that, we’re not doing our job. We need to change that.
“Embracing patient-oriented research will improve health research by leaps and bounds,” Fergusson says. “Because we’re starting fresh, if we set it up right and put the right metrics in place, we’ll be able to know what truly makes a difference in the lives of patients, and that’s just such a great idea.”