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Communicating with the Elderly: Decision Making and Informed Consent in
Subjects with Frailty or Dementia
Article · September 2007
DOI: 10.1177/174701610700300309
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2. Introduction
The elderly are under-represented in clinical research
and more specifically in clinical trials on medicinal
products or medical devices. Communication and the
decision making process are not impaired in the eld-
erly through normal ageing, only through the pres-
ence of an accompanying pathology. However, assess-
ment of elderly people in the context of their environ-
ment and difficulties in assessing their mental profile,
particularly in the absence of any global agreement
concerning the tools to be used, can be a very difficult
exercise. This makes it difficult to ensure that deci-
sion-making and informed consent, necessary for
their enrolment into research or a clinical trial, has
been properly given.
Those capabilities that the subject must demon-
strate to show their capacity to make a decision will be
discussed and suggestions made as to how communi-
cation with the elderly might be improved on the basis
of existing published literature and guidelines.
Definitions
Elderly people
The first question is ‘how do we define the elderly?’
Are there any guidelines or definitions from the
authorities? The only accepted international guide-
line there has been so far is the International
Conference on Harmonization (ICH) - E7 text of
1994 [1] which gives an arbitrary threshold of 65
years. Today this has to be considered obsolete, par-
ticularly as we now recognize that the pathophysio-
logical age is more accurate than the calendar age.
Indeed the European Medicines Agency Committee
for Human Medicinal Products (EMEA) in its 2006
document ‘adequacy of guidance on the elderly
regarding medicinal products for human use’ [2]
gives no definition or stratification for the elderly
population but says that the current threshold (at 65
years) needs to be reconsidered. In relation to drug
metabolism then it is suggested that the age of 75
years and above should be considered as an age with
a clinical significance, with a decrease in renal func-
tion, hepatic metabolism and modifications of cardiac
function.
The world population is ageing, especially in
industrialized countries, and people and patients over
the age of 80 years very common. In consideration of
drug metabolism we need representation from each
age group within the elderly population range. Table
1, for example, shows the stratification by age in the
French population which is not dissimilar to other
countries in the ICH regions.
Frailty
The EMEA document [2] recognizes that the frail
constitute a subgroup within the elderly. Frailty itself
Research Ethics Review (2007) Vol 3, No 3, 97–101 © The Association of Research Ethics Committees 2007
Presented at AREC/EFGCP conference ‘To serve and protect’, Edinburgh, 7-8 June 2007.
Conference presentation
Communicating with the elderly: decision
making and informed consent in subjects
with frailty or dementia
LAURENCE HUGONOT-DIENER1
and JEAN-MARC HUSSON2
1
MEDFORMA. B. 79 108 bis Bd A. Blanqui 75013 Paris and Consultation Mémoire Hôpital Rothshild 75012 Paris.
2
Hôpital Saint Joseph, Paris and Co-chair, European Forum for Good Clinical Practice, geriatric medicine working party, Brussels.
Email: medforma@pda.fr
Obtaining a valid informed consent from an elderly person, especially when frail or with possible dementia, will ini-
tially involve the practical problem of assessing the ability to communicate. Only then can the assessment of decision-
making capacities and the obtaining of informed consent for participation in research be progressed.
Normal ageing does not impair communication or decision-making, but pathological status does, this may, or may not,
be associated with the ageing process. Perceptual impairment may, in particular, interfere with the communication.
Once the subject ‘appreciates and understands that he/she has the right to make a choice then it is important to
ensure that he/she fully understands the decision he/she is being asked to make and can communicate and explain in
his/her own words why a particular decision was made.
In this paper suggestions, based upon existing guidelines or texts, will be made as to how to improve communica-
tion with the elderly and the capabilities that the subject must demonstrate to show his capacity to make a decision
will be discussed.
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3. has not been univocally defined, although chronic
conditions, co-morbidity and physical dependency,
possibly together with social and environmental con-
ditions, have a part to play in the definition. Any
future modification to the ICH-E7 text will have to be
aware of, and take into account, this sub-group.
Regulatory requirement for clinical
research and trials
There is no particular European regulatory framework
which specifically covers physiological or patho-phys-
iological research. Each Member State has its own
approach which may cover all or only a part of the
range of necessary requirements for recruitment.
Medicinal products and medical devices are, how-
ever, covered by their own directives. Directive
2001/20/EC on clinical trials on medicinal products,
and specifically article 5, ‘clinical trials in incapacitat-
ed adults not able to give informed legal consent’ [3]
includes the following:
• The person not able to give informed legal consent
has received information according to his/her
capacity of understanding regarding the trial, the
risks and the benefits.
• The explicit wish of a subject who is capable of
forming an opinion and assessing the information
to refuse participation in, or to be withdrawn from,
the clinical trial at any time is to be considered by
the investigator or where appropriate the principle
investigator.
For the elderly and the frail to participate in
research there is therefore a clear requirement to be
able to assess their understanding and capacity for
consent.
Communication assessment in the elderly
The assessment and approach to the decision-making
capacity of any individual consists of three main parts:
1. Participation should be entirely voluntary and
assessment should be able to provide evidence that
the individual can make a choice;
2. Information to the subjects should be relevant,
simple and clear enough to be understood in
his/her own language and this understanding
should be assessed;
3. The validity of the subjects’ decision depends over-
all on their ability to communicate and it is impor-
tant that this should also be evaluated.
In practice it is not usually difficult to determine
whether a person lacks all ability to make decisions.
In the elderly, during normal ageing, the ability to
communicate and understand is not impaired; how-
ever, communication may be impaired by pathologi-
cal situations which may, or may not, be associated
with the ageing process [4]. There may therefore on
the one hand be a general sensory impairment or a
frailty aggravated by social or environmental condi-
tions and on the other hand discrete disease patholo-
gy such as dementia, depression or an aphasia follow-
ing a stroke.
Sensory impairment
Sensory abilities [4] have to be assessed before provid-
ing any information to elderly subjects because ageing
is associated with impairment in sensory capabilities.
There are clear changes in the evolution of vision
with age with a decreased sensitivity to light, a
reduced ‘smoothness’ to colours and a decreasing
amplitude of accommodation, all of which have start-
ed by the age of 20 years. There is also a progressive,
bilateral symmetrical hearing loss (presbyacusia)
which occurs with age.
Dementia
When the diagnosis of dementia has been made
according to recognised procedures (eg the
Diagnostic and Statistical Manual of Mental Disorders
sourcebook [5] or the NINCSD-ADRDA [6] criteria)
it has to be recognized that the natural history of
these dementias varies from a subject to another, and
therefore the decision-making ability of individuals
will be impaired to a variable degree according to the
stage of the disease and the pathology (eg Alzheimer’s
disease, fronto-temporal dementia, Lewy body
dementia, or vascular dementia).
The most widely used tool to assess the stage of
the disease in Alzheimer’s disease is the Mini Mental
State (MMS) examination [7]. This is a short global
cognitive 30 items test, assessing several intellectual
functions:
Laurence Hugonot-Diener and Jean-Marc Husson98
Age (years) Percentage of French population Number
65 - 74
75 - 79
80 - 84
85 - 100
over 100
15.9
7
4
1.5
9.5 million
4.2 million
2.4 million
900 000
13 000 (estimate)
Table 1: Stratification of the French population (total 65 million people) over the age of 65 years.
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4. • Spatial and temporal orientation (5 + 5)
• Attention (5)
• Memory (3 + 3)
• Language (8)
• Constructional praxis (1)
Figure 1 represents the natural history of Alzheimer’s
disease based on the MMS from which it can be seen
that the average judgment impairment occurs at a
moderately severe stage of the disease, ie under an
MMS total score of 15/30.
In other types of dementia assessment of these abil-
ities requires more focussed psychometric tests than
the MMS with the inclusion of assessment on ‘logical
test or problem solving’, ‘agnosia’, and ‘language com-
prehension’ (semantic or category deficit of under-
standing) as well as specific communication abilities.
Taking into account all factors referred to above
the following comprehensive geriatric assessment
(Figure 2) using a range of different tools and param-
eters has been proposed [8].
It should be clear that researchers must be aware
of the different abilities involved in decision making
in order to ensure that elderly volunteer subjects
understand the relevant information, and appreciate
the research study and its consequences for them as
individuals, as well as be able to manipulate informa-
tion rationally.
Aphasia
Aphasia, which often follows a stroke, is a particular
condition where communication is impaired. Clinical
and psychometric assessment is made to classify the
type of aphasia with classification of the aphasic syn-
dromes being based on fluency, auditory comprehen-
sion and the ability to repeat verbal material.
Comprehension is preserved in some fluent aphasia
as well as in non-fluent aphasia.
Figure 3 shows such a classification [9].
Evaluation guidelines
There are several guidelines for assessing the ‘decision-
making capabilities’ [10-12] of potential research sub-
jects with cognitive impairment. In these the subject
must demonstrate to a doctor or a nurse that he/she has
capabilities to make a decision and this includes:
1. Ability to make a choice. This is the less stringent
component. Subjects may fail to demonstrate this
ability either because they demonstrate that they
are unable to reach a decision, or to make their
wishes known. Investigators have to ensure that
the subject ‘appreciates’ and understands that
he/she has the right to make a choice.
99Communicating with the elderly: decision making and informed consent in subjects with frailty or dementia
Figure 1: The natural history of Alzheimer’s disease.
Evolution of mean patients’ decline on MMS cognitive
function (with and without treatment).
Figure 2: A proposed comprehensive geriatric assessment for dementia using different tools and parameters.
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5. Laurence Hugonot-Diener and Jean-Marc Husson100
2. Ability to understand relevant information. That
the subject understands the decision he/she is
being asked to take and nature of the consequences
of ‘participation’ in order to give an informed con-
sent (or refusal). Information should be presented
in short, simple sentences.
After each ‘input’ of information, it is necessary
to ask the subject to tell the professional health in
his/her own words what was just said. It is neces-
sary to listen for accuracy of the recalled informa-
tion; the subject does not have to use medical ‘jar-
gon’. The investigator has to assist the subject in
considering what he/she thinks will be the benefit
and/or burden to him/her of each treatment option
(or refusal). For example what would be the likely
outcome of the tests/interventions according to the
individuals personal goals, interests, life-style,
comfort, longevity, anxiety reduction, etc.
3. Ability to appreciate the situation and its likely
consequences. That the subject can communicate
his/her decisions and explain in his/her own words
why a particular decision was made. Denial, delu-
sion, and psychotic levels of distortion can impair
appreciation, as can any condition that limits
understanding.
4. Ability to manipulate information rationally. This
component focuses on a subject’s ability to
employ rational thought processes to compare the
risks and the benefits of the options which they
are facing.
5. Ability to remember his/her decision. The subject’s
decision must be stable and consistent over a peri-
od of time.
The University of California San Diego (UCSD)
task force decisional tree (Figure 4) is a good tool to
evaluate ‘decision-making capabilities’ [12].
It is important that the process for determining
capacity to understand information and subsequently
obtaining informed consent should not be rushed. In
practice many healthcare decisions are not made with
individual patients but involve family members (or
care providers). In this situation the authentic wishes
of an elderly person with dementia should be respect-
ed and not over-ruled in the interests of what the fam-
ily or care staff feels is best for them.
Prospective studies about decision-
making and elderly
There are a small number of published studies
which consider decision-making and the elderly and
this is an area which should be subject to further
research. The following is a brief summary of the
recent studies in this area.
• A prospective study by Elena Paillaud and co-
workers [13] sought to determine the preferences
of elderly in-patients concerning the provision of
medical information, in relation to life threatening
situations, either to themselves or to a designated
surrogate.
A questionnaire and the MMS (to select subjects
without any cognitive impairment) was completed
by 426 French elderly inpatients, aged 70 years or
over, by two geriatricians within the week following
admission to one of three geriatric units. The
results showed that 32.6% wanted to receive com-
plete information, 77% wished to be informed if
there were a life-threatening situation; 28% had
designated a surrogate.
Figure 3: Classification of the aphasic syndromes,
based on fluency, auditory, comprehension, and
ability to repeat verbal material.
Figure 4: Decision tree for evaluation of ‘decision-
making capabilities’.
IRB = institutional review board (ethics committee)
TCS transcortical sensory aphasia
TCM transcortical motor aphasia
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6. The authors concluded that the MMS total score,
physical disability, a low level of confidence in med-
icine and the presence of family members, specifi-
cally children, are independent determinants of a
high level of information expectation.
• Barton W, Palmer et al. [14] conducted a prospec-
tive study to compare decisional capacity among 3
different diagnostic groups; patients with schizo-
phrenia (n=35), with Alzheimer’s disease (n=30) or
with diabetes mellitus (n=36), and had examined
the degree to which impaired understanding can be
detected using a brief set of screening questions.
Results showed that decisional capacity differed
among the THREE groups. The diabetic group
showed the best capacity, followed by the schizo-
phrenic patients, and then those with Alzheimer’s
disease. There was, however, a considerable hetero-
geneity within each group.
The authors conclusion was that level of cogni-
tive deficit, assessed by MMS, is a potential marker
of those who should receive comprehensive capac-
ity evaluations (particularly in the understanding
component) as this was the best predictor of deci-
sional capacity.
• Williams B. et al [15] have conducted a ‘follow up
study’ of people living in Tayside Scotland, who
opted out of a cross-sectional survey. 887 people,
aged 65-84 years, were invited to take part in a
home-based cross sectional survey and of these 471
(54%) refused to take part. Permission was
obtained to follow up the refusers with information
subsequently being obtained from 417.
Demographic characteristics of people who had
refused to take part in the original cross sectional
survey and the reasons they gave for not taking part
were collected. The authors concluded that an
expression of non-consent does not necessarily
mean that a fully informed evaluation of the pros
and cons of participation or non-participation of
subjects has taken place. The meaningfulness of
expressions of non-consent may therefore be a
cause for concern and should be subject to further
research.
Conclusion
Procedures to determine decisional capacity in elder-
ly people participating in research protocols needs to
be reviewed in order to achieve a European consen-
sus. The decision tree from the UCSD task force
(Figure 4, [10]) should be considered as a good start-
ing point for further discussion. As the next step a
European workshop is to be convened in order to
work towards the validation of European tools for the
assessment of decisional capacity in the elderly.
References
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support of special populations: geriatrics, 1994. Available at
www.fda.gov/cder/Guidance/iche7.pdf.
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guidance on the Elderly regarding medicinal products for human
use; 14 December 2006. Available at www.emea.europa.eu/pdfs/
human/opiniongen/49892006en.pdf.
3. Directive 2001/20/EC on clinical trials on medicinal products –
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101Communicating with the elderly: decision making and informed consent in subjects with frailty or dementia
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