One of the most important considerations for research institutions when conducting medical research is informed consent — the process by which participants are made aware of a study’s aims, goals, procedures and risks. Researchers at the University of Alabama at Birmingham are collaborating with a company called Mytrus to investigate a novel way to obtain informed consent.
The approach will examine an interactive “direct-to-participant” method using new technology, including an iPad app, in a study supported by the Agency for Healthcare Research and Quality.The prevailing method to acquire informed consent frequently involves a research associate explaining the particulars of a trial to individuals or small groups. There are usually a myriad of forms to be read, understood and signed. It can be a complicated, expensive process.
“These long forms are often overwhelming, and investigators are not always certain that subjects fully understand the important details and risks of the study,” said Kenneth G. Saag, M.D., professor in the UAB Department of Medicine and director of UAB’s Center for Education & Research on Therapeutics of Musculoskeletal Disorders.
UAB will use the Mytrus system to enroll 60 people in a dummy trial for osteoporosis. The goal is to see if the iPad app system will be more efficient and provide more complete understanding of the trial.
With the Mytrus system, patients use an iPad app to watch videos that emphasize the most important aspects of the study. They can also listen to a recorded summary, read a text-based form about the study onscreen or print a paper copy to review. The system includes an interactive quiz after each video and the ability for the patient to highlight words or phrases about which they have questions.
“We think that this has several advantages over the standard paper-based method,” said Steven Cummings, M.D., chief scientific officer for Mytrus. “This method of informed consent assures that patients really understand the essential features of a study before they sign up.”
Comparative-effectiveness research requires a large number of study subjects and works best in a real-world setting. It incorporates the interactions between local physicians and their patients, as opposed to having patients come to a specialized research institution. Saag said the Mytrus system might be especially beneficial when conducting comparative-effectiveness research, which employs large research networks of medical practices to find cost-effective ways of treating common conditions. UAB is a national leader in this type of research.
“The lengthy, traditional informed-consent process is difficult for a local physician to implement, creating a barrier to their participation in these studies,” Saag said. “Using technology like the Mytrus system to improve the informed-consent process may help overcome some of those barriers. We need these sorts of large, pragmatic comparative-effectiveness trials to give doctors and patients the information they need make the best choices between available treatments.”
CERTS works closely with two large physician groups on comparative-effectiveness research studies: the Alabama Practice-Based Research Network and the American Academy of Family Physicians Research Network. Saag hopes the Mytrus D2P system will facilitate increased physician participation in those networks.