The American College of Radiology’s (ACR’s) support for increased patient involvement in medical imaging and image-guided therapies has expanded to radiological science through recent efforts by the ECOG-ACRIN Cancer Research Group to engage patient advocates and patients themselves in the design and implementation of imaging-related comparative effectiveness research (CER).
The cooperative research group was established from the merger of the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ACRIN).
The ECOG-ACRIN Medical Foundation was awarded a $250,000 grant in 2016 from the Patient-Centered Outcomes Research Institute (PCORI) giving project leader Ruth Carlos, MD, FACR, a professor of radiology at University of Michigan Health Services, and her colleagues an opportunity to increase patient engagement in imaging CER. Thirty-six patients and patient-advocates attended a CER workshop in Reston, VA, Feb. 24–25 for lectures and breakout sessions that could help make ECOG-ACRIN’s approach to CER more valuable and accessible to patients.
The engagement effort originated from the understanding that the current approach to imaging research may be meaningful to radiologists and ordering physicians, but CER trials can lack relevance to patients who have the most to gain from their findings. According to Carlos, the project endeavors to address biases, such as a research investigator’s assumption that patients can never know enough to contribute as research partners on studies about their diagnosis and treatment or the patient’s belief that investigators won’t listen to them or adjust their imaging trial protocols to meet their real needs.
Before the February 2017 workshop, selected patients attended the 2016 ECOG-ACRIN Spring Meeting where they worked with investigators to develop a patient-centered priority list for CER trials. Carlos noted that over-diagnosis and over-treatment, which are highly pertinent to imaging researchers, for example, are not as important for many patients. They tend to be more concerned about effective communications with their physicians and access to medical imaging that gives them rapid, definitive answers about their conditions.
Diversity was emphasized for patients and patient advocates invited to attend the workshop and participate in follow-up surveys and other communications to measure the program’s impact in the next year.
“We wanted patients who have experiences that are distinct from each other to allow us to get as broad a set of experiences as possible,” Carlos said.
The workshop involved lectures by research investigators and statisticians who familiarized participants with CER methodology and breakout sessions where the faculty and participants were assigned to one of four teams that addressed the design, implementation, data analysis or dissemination of results of an ECOG-ACRIN CER study that is now at that specific stage of its development.
One group examined the design of a CER study that compares the relative diagnostic accuracy of breast MRI and digital breast tomosynthesis. At first, the discussion focused on the adequacy of a survey designed to assess patient comfort during breast MRI, but it shifted to inadequacies of patient preparation for breast MRI as described in the session by two patients who had undergone the procedure. Their input could lead to changes in informed consent and the process for briefing study subjects on what they can expect during their breast MRI exams,” said Andrea Borondy Kitts, MS, MPH, a lung cancer patient advocate and planning committee member.
“Participants assigned to the session on dissemination stressed the importance of communications for successful patient recruitment, orientation, engagement and retention. They emphasized the need to update patients periodically on the progress toward the study’s publication and dissemination of results. Subjects are also more likely to comply with follow-up survey requests and other inquiries when they are thanked for their participation,” Kitts noted.
The program is now entering a year-long follow-up period to measure the sustainability of patient engagement in new CER imaging trials initiated by ECOG-ACRIN. Carlos would like to see clinical trials that are developed with the help of patients representing various communities to gain useful and comprehendible answers for themselves and other patients like them back home.
“Part of this is really winning hearts and minds,” she said. “We are changing the culture of how scientists approach clinical trials by putting value on the patient experience and their potential for contributing to trial designs and execution.”