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.