Videos explain concepts of clinical research

When a doctor asks a patient if he or she would like to be randomized into an arm of a standard-of-care treatment study, does the patient really understand the question? Can a jargon-filled consent form, written by lawyers and medical researchers, really help?

These are the communications challenges that bioethicists faced when they began exploring the ethical implications of the new world of comparative-effectiveness research, in which patients are randomly prescribed treatment options in a doctor’s office. This study, led by David Magnus, PhD, director of the Stanford Center for Biomedical Ethics, and bioethicists from the Seattle Children’s Research Institute and University of Washington, will result in policy guidelines for conducting ethical research within medical practices. While their final recommendations won’t be out until later this fall, the group has just released three short videos that can be used by investigators to help explain key research concepts to patient volunteers.

Evaluating treatment effectiveness

“This project was launched in the aftermath of a controversial research consent form used in a study that compared two oxygen-delivery levels for extremely premature babies,” Magnus said. “While many of us argued that the research was done in an appropriate fashion, there were critics who disagreed. Even though these at-risk infants were randomly assigned to one of two standard treatment options, some felt that the clinical risks of standard practices should be seen as research risks. Researchers, the public and the bioethics community were deeply divided on whether the consent form adequately warned parents about participation risks. To avoid these ambiguities in the future, we decided to launch a study to explore better ways to explain these risks.”

Comparative-effectiveness research is a key component of the Affordable Care Act’s health-care reform mandate. The law provides incentives for medical practices to continually evaluate the relative effectiveness of competing medical interventions as a way of delivering better, less costly care to more people. The widespread adoption of electronic medical records is enabling researchers to conduct these head-to-head comparisons in more automated ways, reducing the time and expense associated with the tightly controlled clinical trials used to evaluate new drugs and devices.

But with these new research methods, which involve unseen researchers  analyzing anonymized medical records, there comes a host of unaddressed ethical questions. Can patients grant institutions a blanket approval for all randomized, standard-of-care studies, or must permissions be granted for each individual study? How should physicians explain to patients the risks associated with being randomly assigned one of several drug options? When should study participants be given the choice to move over to a more effective treatment option?

Educating patients

The search for answers began in October 2013, starting with focus groups consisting of patients, parents and research safety review board members from the University of Washington, Seattle Children’s Hospital and Stanford University. Stanford collaborators were Mildred Cho, PhD, professor of pediatrics and associate director of the Stanford Center for Biomedical Ethics; senior scholar Sandra Soo-Jin Lee, PhD; Philip Lavori, PhD, professor and chair of health research and policy; Steven Alexander, MD, professor of pediatrics; David Rosenthal, MD, professor of pediatrics; and Glenn Chertow, MD, professor of medicine.

Before they could really get started, they realized that they had a medical jargon problem. No meaningful discussions could take place until they had educated patients on some fundamental concepts of medical research, such as randomization and informed consent. Their solution was to produce three short, animated videos that would rapidly get everyone up to the same level of understanding.

“One of our first challenges was to dispel the ‘doctors know best’ myth. Doctors don’t always know which treatments are best for individual patients,” said Magnus. “In the absence of good evidence, these choices are often influenced by advertising, insurance coverage and local preferences. Busting this myth was essential in explaining why comparative-effectiveness research is so important.”

Producing these videos was harder than the team ever imagined — it took about 50 revisions over nine months — but during the process, the bioethicists learned a great deal about the best way to educate patients on medical research. The videos were produced with the help of Booster Shot Media.

“We’re pleased that the videos we thought were simply a means to an end have taken on a life of their own,” said Magnus. “We hear they are considering using them at Duke, Johns Hopkins and the NIH for educational purposes.”

Need for evidence

Over 85 percent of our major professional guideline recommendations are not based on high-quality evidence,” said Robert Califf, MD, director of the Duke Translational Medicine Institute. “Only if we increase participation of informed research participants will we make major improvements in clinical care by basing medical and health decisions on evidence. These videos give us a means of informing people about what participation means in common-sense terms.”

In the coming month, the bioethicists will finish up recommendations for acceptable levels of risk in running comparative studies within a clinical setting and the best ways to get patient consent for research participation. Collaborating with the Providence Health System in Spokane, Wash., they will get feedback on these issues from individuals who have complex health-care problems, safety board reviewers and the public. They plan on publishing their final policy recommendations and communicating them to the National Institutes of Health and U.S. Office for Human Research Protections later this year.

The videos, which are now available online, cover the following topics:

• “Which Medication is Best?” explores the influences and uncertainty associated with physicians’ prescribing preferences.
• “Research on Medical Practices” explains medical record reviews, study randomization and randomization of clinics and hospitals.
• “Informing or Asking” describes ways to explain study participation to patients.

This project is supported by the NIH National Center for Advancing Translational Sciences’ Clinical and Translational Sciences Award to the Institute of Translational Health Sciences at the University of Washington, and to Spectrum, the Stanford Center for Clinical and Translational Research and Education.

The videos and information about the study are available at https://www.youtube.com/watch?v=vbLHl2zeJYA