By Jody Lyneé Madeira, author of Taking Baby Steps: How Patients and Fertility Clinics Collaborate in Conception
In the past two years, a revolutionary change has unsettled established informed consent practices in reproductive medicine: educating patients undergoing intrauterine insemination (IUI) or in vitro fertilization (IVF) about treatment risks, benefits, and side effects through multimedia e-learning applications instead of lengthy paper documents. Like other consent aids, these technologies are designed to supplement consent conversations with physicians. While a handful of e-learning applications exist in other medical fields, EngagedMD is the first-to-market—the first application designed and utilized to solve common informed consent problems in Assisted Reproductive Technology (ART), such as ensuring consistent consent presentations and that patients read or understand consent documents.
These applications are marketed as products that have ethical and commercial benefits; they not only improve patient education, but offer subscribing clinics better risk protection, and allow practices to improve efficiency and even increase patient volume. At the same time, these technologies implicate informed consent’s “dark side”—the idea that consent documents fail for reasons other than poor patient recall and comprehension, especially patients’ emotions[1] and their perceptions that these forms are bureaucratic and protect physicians at their expense.[2]
Currently, little research exists on patients’ lived experience of informed consent, despite common speculation about its ineffectiveness. There is a critical need for more systematic empirical evaluation of both patients’ consent experiences and the efficacy of diverse informed consent aids and mediums. Investigating these issues within ART is particularly interesting because patients must confront unique ethical, legal, and medical decisions, and their choices also affect their potential offspring.
What information exists, however, suggests that patients strongly prefer applications over traditional paper consent forms. In the first survey of patients undergoing IUI and IVF using EngagedMD, 6,333 individuals completed an online survey asking several questions about their perspectives on informed consent and various consent aids. Significantly, patients undergoing IVF and IUI start with a healthy attitude towards informed consent; 99% stated that it was “very important” or “important” to be educated about their care. Moreover, 83% felt that it enhanced their ability to sign informed consent documents, 85% “agreed” or “strongly agreed” that EngagedMD enhanced their ability to converse with their medical team. Patients regarded the application as more educational and efficient than other consent aids; it was second only to physician consultations, and ranked as superior to staff training, internet-based sources, and paper documents. Most patients also indicated that it made them feel more in control of medical decisions (79%).
Of course, technologies like EngagedMD also have their weaknesses. A minority of patients felt that such detailed and visually accessible portrayals of risk information increased their anxiety. Moreover, such applications lack safeguards that prevent providers from using such technologies improperly, relying upon them to satisfy all informed consent duties, in lieu of conversations. As competing products appear, issues such as customization will introduce tensions between providing a very comfortable and customizable patient consent experience and preserving quality – ensuring that all patients have consistent informed consent encounters.
These results suggest that patients’ common criticism of informed consent forms—that they’re too long, and too difficult to understand—haven’t yet tainted their faith in the process. Patients enjoy being informed, and recognize that information contributes to treatment experience, emotional and physical well-being and safety, and cycle outcome—as well as improving treatment relationships.
[1] Jody Lyneé Madeira, Taking Baby Steps: How Patients and Fertility Clinics Collaborate in Conception (forthcoming, 2017).
[2] Jody Lyneé Madeira & Barbara Andraka-Christou, Paper Trails, Trailing Behind: Improving Informed Consent to IVF Through Multimedia Applications, J. of L. & the Biosciences 3(1): 2-28 (2016).
Jody Lyneé Madeira is Professor of Law at the Maurer School of Law, Indiana University Bloomington, and the author of Killing McVeigh: The Death Penalty and the Myth of Closure.
