- Although health research is key to driving medical advancements, it’s not always accessible or relevant to patients who need this information to make better care decisions. At the Patient-Centered Outcomes Research Institute, a call for patient-centered health research design is trying to eliminate that issue.
“We all appreciate that oftentimes when we hear about study findings, it may not necessarily reflect information on what’s important to us as patients or caregivers,” PCORI Chief Engagement and Dissemination Officer Jean Slutsky, PA, MSPH, told PatientEngagementHIT.com in a recent interview.
To get at the heart of what is important to patients and caregivers, researchers need to use patient engagement strategies when designing their research. Patient-centered research development doesn’t just mean selecting the right research topic, said Slutsky.
“It’s about the actual research question,” she explained. “It must be a question that folks would have. The outcomes that are measured in the study must be ones that are important to patients. Oftentimes, that happens when the principle investigator sits down with their patient partners and talks about the outcomes and the questions that they’re going to be researching.”
Open conversations with patient partners – who are not study participants, but rather consultants who help guide the research process – are key to creating effective and relevant research for patients and stakeholders.
“We really encourage our investigators to work with patients directly, both during the establishment of the study and during the content of the study,” Slutsky noted.
There are two primary benefits to engaging patient and caregiver partners, Slutsky explained.
First, patient partners are crucial during the participant recruitment process. While institutional review boards oversee the ethical and procedural components of research recruitment, patients can offer guidance on this process.
“Patient partners can actually provide information about how useable informed consent documents are, how readable they are,” Slutsky pointed out. “They can’t replace institutional review boards, but they can help the investigator think about ways to reach patients in more comprehensive ways and ways in which it is easier for patients to participate.”
Additionally, patients can help researchers understand how and when to best contact participants.
“Patients can be incredibly helpful when you talk about how to recruit patients into a study and how to retain them,” Slutsky noted. “They can give good advice by saying, ‘well if I were a patient you tried to approach for a study, if you approached me during this time I might be too overwhelmed to even consider contributing to the study.’”
Second, patients are helpful during the research design process. Patients often suggest research questions that are meaningful to patient and caregiver stakeholders.
“We had one study that was looking at records of patients that had strokes to see whether or not being prescribed blood thinners had them fare better than those who did not receive a prescription,” Slutsky offered as an example. “The patient members of the study suggested that a primary outcome that meant a lot to them that hadn’t even been considered by the researchers is how much more time they get to spend at home rather than in an institution.”
The research team indeed tested that outcome, and even found that the blood thinner did have a positive effect on patient care.
“At the end of the day, that piece of information would not have been available had the researchers not heard from their patient partners that they wanted to know that answer,” Slutsky asserted.
Despite the benefits to patient engagement during research design, Slutsky said efforts in this area are falling short.
“Researchers are not generally taught how to engage stakeholders and patients in the conduct of research. That’s not something that’s a part of their training curriculum, although that’s changing somewhat,” Slutsky explained.
Experts at PCORI are working to change that. The organization has developed several educational resources helping researchers identify and understand strategies for engaging patient partners in research design.
For example, PCORI has developed a Patient Engagement Rubric, which serves as a guideline for researchers working to create patient-centered research or apply for PCORI funding.
The rubric is not supposed to be comprehensive or prescriptive, according to PCORI. Instead, researchers should select which patient engagement strategies work best for their specific goals, and implement other strategies not included in the rubric where necessary.
The Patient Engagement Rubric outlines key engagement principles based on mutual respect and learning between researchers and stakeholder partners, Slutsky stated.
Patient and caregiver partners must be ready to learn more about the research process, the rubric contends. Conversely, researchers must value and respect patient partners’ time and potential medical needs.
Overall, the rubric breaks down patient-centered research development into three steps: planning the study, conducting the study, and disseminating the study results.
During the planning stage, researchers must work with patient partners to design a research question and outcomes measures that will be valuable to patients and caregivers. Researchers must also determine what kinds of patients they want to recruit and create a convenient recruitment process. Patient partners can likewise guide these efforts.
While conducting the study, researchers should consult with patients to ensure the recruitment process is effective and feasible. Patient partners can also be helpful during data analysis by pointing out valuable findings the researchers may have missed.
During the final dissemination leg of the research process, investigators should work with patients to identify useful avenues for study publication. Patients can also participate during the authoring or presentation process to offer a patient perspective on the findings.
Taking these patient-centered steps and ensuring medical research is relevant to patients is crucial to the industry’s overall mission to drive patient engagement, Slutsky said. Creating research that is useful to patients will drive patient education, resulting in better healthcare decision-making.
“Patients are faced with making medical decisions about their care all the time. If they don’t have the information to help them make those decisions, it’s a disadvantage for them,” Slutsky concluded. “The more research is funded around questions that they would want answers to and outcomes that are important to them, the more likely that it will be that the research is useful to them when they are faced with healthcare decisions.”