Elements of Informed Consent

by Mark Hughes, MD, MA

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    00:01 So, what are the elements of informed consent? Well, first of all, there are preconditions.

    00:07 Even before you get to the consent process, you have to establish whether the patient is making decisions voluntarily.

    00:13 And also that they have the capacity or the ability to make decisions.

    00:18 There's another lecture we're going to have about assessing decision making capacity.

    00:23 But for now, let's just say, we need to make sure the patient is making decisions freely.

    00:27 And that they have the ability to make those decisions.

    00:30 So we're going to start with that.

    00:33 We then have to go through information elements.

    00:37 So that's us disclosing information to the patient about the recommended treatment.

    00:41 When we'll go through, what are the requirements there.

    00:44 But also checking that they've understood that information.

    00:48 And then lastly, there are going to be consent elements.

    00:51 So, when we've given the information, we have to then see if they make a decision.

    00:57 Are they going to say, Yes, consent to it, or say No, refuse that decisions.

    01:03 All of those things are going to be the elements of the informed consent process.

    01:10 Alright, so let's look at these elements individually.

    01:13 In another lecture, we're going to talk about the threshold elements, the voluntariness, and the decision making capacity.

    01:19 Let's focus in now on the information elements.

    01:23 So there's a need to disclose information obligation to disclose this information to the patient, so that they can render a judgment for themselves of whether or not to just accept our treatment recommendation.

    01:37 There have been various standards that have been applied over the years in terms of how much information needed to give, and the quality of that information.

    01:46 In the old days, there might have been the professional standards. Which would say, well, in the community of physicians that say.

    01:54 That professional standard would say, this is what's commonly done in terms of the information elements that should be shared with the patient.

    02:01 That's evolved into the reasonable person standard.

    02:05 So what would the average person on the street if you were going to propose a treatment to them? What do you think are the things that they would need to know that would be material to them making a decision? and that's generally the standard that we try to apply today, the reasonable person standard.

    02:20 There's also this subjective standard, which is, you're taking the reasonable person standard, but now you're also knowing the elements about the patient and their life and what's important to them.

    02:30 And so you can be much more subjective in terms of how you share that information with the patient.

    02:36 And we really enhanced the reasonable person standard to make it applicable to this particular person.

    02:42 All right, so what are the things you need to disclose? They're going to be a list of things, and we'll go through each of these.

    02:49 First of all, you've made a diagnosis.

    02:51 So you have to tell the patient what their condition is, and what the nature of their condition is. What to expect? What happened with the natural history of that condition? So, why you're proposing that it needs to be treated? That's going to then lead you into the indications for treatment.

    03:08 So if you don't treat your hypertension, your blood pressure could be very high, you could be at risk of strokes or heart attacks in the future, the consequences of having high blood pressure.

    03:19 So trying to get your blood pressure under control, that's the indication for the treatment.

    03:24 What is the nature of the proposed treatment? So in that case, for hypertension, it's perhaps taking medications, there also could be behavioral things that the person could do.

    03:33 And that might be part of your treatment, regimen proposal to the patient.

    03:38 But you have to describe the nature of the treatment.

    03:41 When it's a surgeon, and they're suggesting an operation, they need to describe what the operation entails.

    03:48 And you know, what the patient would go through in terms of post op recovery and so on.

    03:52 So what you're suggesting as the remedy for their condition through an operation.

    04:00 You also have to say, well, what are the chances of success that the proposed treatment will work or help to treat the condition? And you're perhaps recommending, because you think it is going to have some chance of success? So you want to try to describe that probability? And again, that goes along with the anticipated benefits of the proposed treatment.

    04:21 So why are you doing it? And what do you hope to achieve through the treatment? You also need to describe what are going to be the risks.

    04:30 You know, those risks that are material that could be of negative consequence to the patient, if they actually undertook the proposed treatment.

    04:40 So what are the risks of surgery? What are the risks of medication? Things that might have side effects or adverse effects or chances of a complication.

    04:51 We can't get away from complications in clinical medicine that just comes with the territory.

    04:57 So you have to describe, based on the experience of, other patients that have had this treatment or surgery or procedure, what do you anticipate those risks to be? There may be things that are uncertain, that's also part of the reality of clinical medicine.

    05:13 The uncertainties of things can happen, and the patient needs to be aware that, we can't predict everything, but we need to be aware that there are certain uncertainties, and we have to share that.

    05:28 We also have to say, Well, are there alternatives to what we are recommending.

    05:32 there may be let's not do any treatment, and just follow the natural history of the disease.

    05:37 We've already talked about with the patient needs to know what the potential downsides of that are.

    05:44 There may be other treatments that might not be as highly recommended as what you're suggesting.

    05:52 But they might be alternatives, and the patient might wish just to hear about those, and what the benefits and risks of those alternatives might be.

    06:01 And I do think it's important, when it's the clinician doing the informed consent process, that they should give a recommendation.

    06:09 So a layperson may not know enough, and some lay people will, do their own research and read up on things and try to help in figuring out how to treat a condition.

    06:21 But in most cases, people are going to be relying on the physician to give them a recommendation, and why they think the recommendation is the best option for them.

    06:31 So I think that's part of the elements of disclosure, that you give the recommendation, you give the alternatives, but why you think the recommendation is the best way to go.

    06:43 Alright, so then you have to think about the patient perspective of these things.

    06:46 So what are their what's their role in this process? So first of all, you have to invite them to participate in the decision.

    06:56 Now, that may mean that there are some patients that don't want to get a lot of information.

    07:01 And we have to respect their choices in terms of the degree of information they wish to receive.

    07:09 When we've given them information, when we disclosed it to them, we then have to assess their understanding or their comprehension of the information.

    07:16 So there may be strategies of what's called Teach Back.

    07:19 So asking them questions to see if they've understood the information retained it and then can figure out for themselves if they're going to make a decision? As I mentioned, this is for a particular patient.

    07:32 So what are the implications for them, if we've learned something about themselves and their life, and how treating the condition is going to impact their life? We have to also share the implications for that particular patient, and learn from them, why it's important.

    07:54 And then lastly, exploring their preferences.

    07:58 So, after they received the information or processing it, they may have certain preferences of.

    08:03 Well, I'm not a pill taker, I'd rather try to work on lifestyle instead to treat my hypertension.

    08:09 Whatever the case may be, you want to try to understand their preferences, and help to get to a decision.

    About the Lecture

    The lecture Elements of Informed Consent by Mark Hughes, MD, MA is from the course Informed Consent and Capacity.

    Included Quiz Questions

    1. 1. Voluntariness 2. Capacity to make a decision
    2. 1. Reading and writing in English 2. Capacity to make a decision
    3. 1. Reading at an eighth-grade level 2. Competence
    4. 1. Competence 2. Reading and writing in English
    1. Historical treatment paradigm for the condition
    2. Nature of the condition
    3. Indications for treatment
    4. Nature of the proposed treatment
    5. Probability of success
    1. Anticipated benefits
    2. Immaterial risks of negative consequence
    3. Risk factors for the condition
    4. Guarantee of success
    1. Assessment of their comprehension
    2. Invitation to decline consent
    3. Invitation to call a loved one for advice
    4. Denying the preference of a close friend
    5. Inviting the preference of a close friend

    Author of lecture Elements of Informed Consent

     Mark Hughes, MD, MA

    Mark Hughes, MD, MA

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