Some Followup Thoughts from Dr. Hochhauser

 

summing up

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!

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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.

https://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_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.

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2 replies
  1. Hanish
    Hanish says:

    Thank you Dr. Hochhauser for bringing this important issue.
    I have few advice, which I have seen few physicians and surgeons follow in India, maybe they can be of some use. Now a days, informed consent has become more of a paper formality. I believe that when I opt for any procedure or medication for a patient or if I am convincing any individual to participate in research, it becomes my duty to see to it that s/he should be aware of all the scenarios s/he may face. My experience says that the most effective method is verbal way. I have worked with few physicians and surgeons who take out time and sit with patients and their family members. They discuss the possible side effect or harms as well as the benefit of the procedure or medications. Sometime when the surgeon directly talks to the patient, the patient feels more comfortable which helps him to take proper decision.
    To make medical stuff more clear, few doctors compare day-to-day activity to explain the complex pathophysiology of diseases. Like for example, once we explained the pathophysiology of varicose vein by comparing it with sewage system and how a shunt can help such blockage. It helped us to explain an anxious patient to understand the procedure and many possible adverse effect it may or may not cause in future. It worked since many patients don’t understand medical stuff but when you present it in common language it becomes easy for them to digest and think ahead.
    The physicians prefer to talk to family member too, so that they are also in loop. Usually maximum of patients are so terrified by knowing that they are suffering from a diseases or disorder that they loss their power of comprehension. When you explain them something in that stressed out moments, most of the time they don’t remember what they hear or understand what you are talking and sometime they even lose the power to take right decision. But if you have someone they trust with them in the room, like their family member, it help them to stay confident and take decision. If they forget some instruction, any important details afterwards, these family members may help them understand.
    Since India is multi linguistic country, our consent forms are usually in at least two language- English and a regional language. But still it becomes hard when you have illiterate, in that situation, we explain everything verbally.
    One last thing I think may be more helpful, is Health literacy advocacy. When you attain herd immunity for Health Illiteracy, things can become more easy.

  2. nicole.margarella37
    nicole.margarella37 says:

    After reading your follow-up points, it almost makes it completely discouraging to find some sort of effective way to convey everything necessary in an informed consent document. As you said, compliance would always win and it makes sense. Doctors need to cover all of their bases in the age of law suits, but what is interesting is that I don’t think people would “sue” if they didn’t understand what was written, because in order to participate, the document must be signed, waiving any right they may have had to do that. Conversation to me seems optimal if all parties are using ethical practices. The first thing I thought of was having a simplified statement next to a legal one side by side, however depending on how that is written, that could be a source of trouble as well, where a patient could potentially say in those areas the risk wasn’t explained fully. And as you stated in your first point, this could also make the form even more lengthy contributing to information overload. Perceived understanding and cultural differences are something I hadn’t originally considered. I understand the patient’s embarrassment at not fully understanding, but these are their rights, and if they are willing to get by without saying anything, how is the health professional supposed to address that? They are there to answer and explain any questions and concerns and the people at the front desk should be willing to as well. I work at a front desk in a medical office, and many times I sit with patients and explain and help them fill out forms when needed. I understand it may not work that way everywhere but I think it should. I honestly think conversation is key here because there is no way to get around the legal aspect. Could you really blame a doctor for that? Some people look for loopholes and ways to make money that may not necessarily be the doctor’s fault, but if it wasn’t plain and clear as a risk in a signed form, they would find themselves more often in legal battles. To address some of the other points, it’s interesting that a sick patient would be considered impaired. Maybe in this case another person should be necessary to be accountable for them. The app idea clearly needs a lot of work, but I think that having access to an informed consent document before seeing the doctor is good so that there is adequate time to read it and look up anything the patient was unsure about. While the art of conversation tends to drift in the digital age, I think it is important that it is encouraged in a medical setting. Something a simple as “do you have any questions?” can go a long way, and maybe particular dialogue questions like that should be required before the patient is seen.

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