Our guest blogger, Mark Hochhauser, has been reading and digesting all of your contributions, personal experiences, and thoughts about what’s needed to improve informed consent. He couldn’t respond to each of you but asked me to post his summary thoughts below. He thanks you as I do. A GREAT discussion!
Mark Hockhauser November 4, 2015
1) Even consent forms in plain language may be too long. Information overload is a major cognitive problem, but consent forms are so inclusive that even if they’re written at more readable levels, the amount of information is still overwhelming. In some clinical trial consent forms in oncology, I’ve seen as many as 247 possible risk factors; how can anyone make sense of that?
2) Perceived understanding is typically much lower than actual understanding. People often think they understand more than they really do–especially those who have low levels of understanding. It takes a lot of knowledge to know what you don’t know. Patients are reluctant to admit they don’t understand, or they’re ashamed, or they don’t want the doctor to think less of them, etc. See: Dunning-Kruger effect.
3) Consent forms may be considered as documents that protect the organization and the providers. So they’re often written in legal and medical jargon (which protects the organization) instead of plain language (which helps patients make more informed decisions.) No one seems to be able to over-rule the lawyers, so that in the conflict between compliance vs communication, compliance always wins.
4) Often information is given to patients verbally. How many times has a procedure been explained verbally to you with no easy-to-understand written materials? Patients often come out of a doctor’s office remembering very little of what was said, which is why they may need a companion to take notes.
5) Patients are often sick, scared, stressed, hungry, thirsty and on prescription drugs, any or all of which can make it hard for them to understand complicated informed consent information. That means that sick patients can be cognitively impaired.
6) Informed consent is becoming a mobile app for smartphones and tablets. That can create usability problems, such as: how many screens compared to how many pages; eye-hand coordination needed to navigate the app (especially for elderly patients); font size legibility; app familiarity among older vs younger patients; text density on the screen; familiarity with Apple vs Android vs Windows devices, etc.
7) Health care providers and researchers don’t always develop consent forms with different cultures in mind. One of my standard recommendations is for consent form writers to collaborate with cultural organizations in their communities, so that consent forms are developed with their expert insights. Unfortunately, that doesn’t happen as often as it should, partly because it means sharing power and control.