Partnerships between patients and researchers hold the promise to improve clinical research and health outcomes. But what does patient engagement mean and what does it involve? To gain a better understanding of the patient and researcher relationship, we talked with a patient representative, Bill Larsen, who partners with researchers in the ADAPTABLE Study.
The ADAPTABLE Study is researching two different doses of aspirin to determine what the best dose is for people living with heart disease to prevent a future heart attack or stroke. In ADAPTABLE, there is a team of patient representatives known as the Adaptors. Adaptors have been involved in ADAPTABLE from the beginning, working alongside the study team, participating in team meetings, and providing review and input to the protocol, consent form, study portal, and study materials.
PCORnet: How can patients inform researchers in clinical trials?
Larsen: I view my role to be that of a communicator, asking questions that are of interest to those represented in the research study, and providing relevant information and feedback to the concerned parties. Active dialogue among all concerned is what enriches the conversation and leverages the contributions of each individual to best achieve the research goals of the team.
Here are a few of the questions that I have raised in ADAPTABLE, and continually review, as the project proceeds:
- Is the proposed research really important to those most affected by the disease being studied?
- Does the recruitment approach present any obstacles to the study participants?
- Are the written recruitment materials clear and appealing?
- Do follow-up calls to initial inquiries cover the points I believe are most important?
- Are expectations for patient participation realistic?
- Are safety and security issues satisfactorily addressed?
- How will the participant be kept informed during the research process?
- In reporting the final results, are there at least some that will be written in lay language?
- Will results be distributed for maximum coverage to the affected population?
Patient representatives can help ensure that the answers to these, and other questions, fully reflect the interests, concerns, and welfare of the entire patient population.
PCORnet: Why is patient-centered research important?
Larsen: Until recent years, the focus of medical research has been heavily weighted toward basic science. This is understandable and undeniably important. It is essential for the development of new medications and procedures designed to benefit the patient.
But before the findings of basic science can be implemented, they must be tested in a real-world setting. The branch of medical research devoted to this stage is called “translational.” In order to translate the findings of basic scientific discoveries into actual solutions, they need to be tested in a controlled environment, typically in a clinical setting where the doctor and patient interact. How to achieve this is more complex than meets the eye. The concerns of both the doctor and patient must be addressed by the translational research team before success can be achieved.
From the outset of the ADAPTABLE study, we Adaptors have provided the patient perspective in all aspects. We represent all areas of the country and bring great diversity of gender, race, ethnicity, and age. We work side by side with the research team and the other parties at every stage and throughout the endeavor. We raise key questions and will continue to do so throughout the duration of the project.
PCORnet: What activity do you appreciate most from your work on the ADAPTABLE Study?
Larsen: It is the complete immersion in the whole research process, the opportunity to view it from the inside out and feel empowered to have an impact on a study with results that may potentially benefit many people. From this, I have gained a greater appreciation of the complex environment of medical research, and the underappreciated importance of the expanded role the patient must play for the benefit of all.
Want to read more? Check out the complete interview with Bill Larsen. To learn more about ADAPTABLE, join the March PCORnet Best Practice Sharing Session where study leaders will be discussing lessons learned so far.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.