Session B Moderator Christine Grady, R.N., Ph.D., F.A.A.N.National Institutes of Health Clinical CenterRead Bio Presenting Information for Effective Communication Lisa Schwartz, M.D., M.S.The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth Medical SchoolRead Bio Steven Woloshin, M.D, M.S.The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth Medical SchoolRead Bio In this talk, Drs. Schwartz and Woloshin consider strategies—as well as available evidence—for more effective communication about informed consent. Strategies include the key fact summary, presentation, and quantification of side effects: language that explains randomization and acknowledges the inherent uncertainty of drugs that are new or being used in new ways. They will also explore how our current cultural environment challenges communication by creating unrealistic expectations about treatments under study, such as cancer center advertising touting the benefits—and masking the harms—of clinical trials, or regulatory language such as when FDA assigns the "breakthrough" designation to a drug during its research phase. Patient Decision Aids to Support Patient Decision-Making Angie Fagerlin, Ph.D.University of UtahRead Bio Patients want to be involved in their health care decisions, or, at minimum, want to understand their health conditions and the risks and benefits of treatment options. While health care providers play an important role in helping patients understand their condition and treatment options, their support may not be sufficient; patients may not remember what their provider tells them, or providers may speak in convoluted jargon. In this presentation, Dr. Fagerlin explores patient decision aids as ways to support patient understanding and provide informed consent for any treatment. Decision aids aim to present balanced information in understandable ways, to help communicate key information in medical decisions and help patients clarify their values to their providers regarding treatment choices. The International Patient Decision Aids Standards (IPDAS) Collaboration used a Delphi process to develop a set of standards for the design and evaluation of decision aids to encourage quality decision aids. These standards address the content of information (e.g., balance, accuracy, and completeness), literacy, risk communication, conflict of interest, use of testimonials, and values clarification exercises. A Cochrane review of 115 decision aid trials found that, compared to standard care, decision aids increase patients’ participation in decision-making, increase satisfaction, improve patient-provider communication, and reduce decisional conflict. Evidence, however, is variable about the impact of decision aids on treatment choice. Finally, Dr. Fagerlin observes that while few studies have compared the effectiveness of decision aids in patients’ varying levels of literacy and numeracy skills, some work has suggested that decision aids are effective among lower-literacy populations. Participant-Centered Design for Informed Consent John WilbanksSage BionetworksRead Bio Megan Doerr, M.S., C.G.C.Sage BionetworksRead Bio Mobile technologies have the potential to revolutionize both the ways in which individuals monitor their health, as well as the ways researchers collect frequent, yet sparse data on participants in clinical studies. For data from these devices to have maximal impact in a research setting, however, the development of systems to collect, manage, and broadly analyze these data is essential. But informed consent on a mobile device is complex, requiring both careful ethical analysis and attention to user experience design. In this presentation, Mr. Wilbanks and Ms. Doerr will present cases and empirical research drawn from their mobile-informed consent experiences to date, including Apple’s ResearchKit and the All of Us Research Program.