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What do our patients understand about their trial
participation? Assessing patients’ understanding of
their informed consent consultation about randomised
clinical trials
C Behrendt,
1
TGo
¨lz,
2
C Roesler,
3
H Bertz,
2
AWu
¨nsch
1
ABSTRACT
Background Ethically, informed consent regarding
randomised controlled trials (RCTs) should be
understandable to patients. The patients can then give
free consent or decline to participate in a RCT. Little is
known about what patients really understand in
consultations about RCTs.
Methods Cancer patients who were asked to participate
in a randomised trial were surveyed using a semi-
standardised interview developed by the authors. The
interview addresses understanding, satisfaction and
needs of the patients. The sample included eight patients
who participated in a trial and two who declined. The
data were analysed on the basis of Mayring’s qualitative
analysis.
Results Patients’ understanding of informed consent
was less developed than anticipated, especially
concerning key elements such as randomisation, content
and procedure of RCTs. Analysing the result about
satisfaction of the patients, most of the patients
described their consultations as hectic and without
advance notice. Health limitations due to cancer played
a decisive role. However, most of the patients perceived
their physician to be sympathetic. Analysing the needs of
patients, they ask for a clear informed consent
consultation with enough time and adequate advance
notice.
Conclusion This study fills an important empirical
research gap of what is ethically demanded in an RCT
consultation and what is really understood by patients.
The qualitative approach enabled us to obtain new
results about cancer patients’ understanding of informed
consent, to clarify patients’ needs and to develop new
ideas to optimise the informed consent.
BACKGROUND
According to WHO, the annual death rate from
cancer worldwide was 7.9 million deaths in 2007
and experts anticipate this number increasing to 12
million deaths by 2030.
1
Consequently, treatment
needs are rising and optimisation of treatment is
desirable. Randomised clinical trials (RCTs) to test
new treatment options are therefore indispensable
in oncology. However, patients who participate in
a trial might not benefit directly themselves; the
outcome will provide information about future
treatment options. Patients must therefore neces-
sarily be appropriately informed about risks and
uncertain benefits in order to make a truly auton-
omous decision as to whether or not to participate.
They also require adequate information about
crucial aspects of RCTs in order to make an
informed decision.
2
The crucial question is whether the physician’s
way of debriefing is adequate to reach a satisfactory
understanding of key elements and meet patients’
demands. To date, there have only been a few
studies about the understanding of informed
consent (IC) which take the patients’perspective
into account.
3e6
Most studies are questionnaire-
based, largely lacking why patients consent or
what they need.
37
The primary aim of this study
was to analyse patients’understanding of oral and
written IC information. Secondary aims were to
assess satisfaction and patients’needs on the basis
of direct patient statements.
IC and difficulties in communication
IC is a process to ensure that patients understand
the information relevant to the trial and then
decide whether to accept or decline participation.
8 9
Authors from different fieldsdphysicians, lawyers,
philosophers and psychologistsdsingle out the
following aspects as being essential for IC: (1)
competence, (2) disclosure, (3) understanding, (4)
voluntariness and (5) consent.
8
Without these
elements, a free decision to participate in an RCT
would not be guaranteed.
The disclosure of accurate information in RCT
consultations should be viewed as an ethical
imperative,
10
however difficult to realise. By
analysing recorded physicianepatient conversa-
tions, Brown and colleagues
11
showed that half of
the sample could not adequately recall facts (eg,
randomisation or right to withdraw participation).
Kusec and colleagues
12
assessed that, even though
patients declared their understanding of most
aspects of what the physician explained, the
discrepancies revealed in comprehension tests were
high.
What should ideal communication in IC look like?
Brown et al
9
state that the following seven aspects
should be considered in IC: (1) treatment alterna-
tives; (2) costebenefit analysis of different thera-
pies; (3) giving the patient time for the decision; (4)
offering support; (5) encouraging the patient to ask
questions; (6) letting the patient express his or her
(previous) knowledge of RCTs; and (7) confirming
the voluntariness of participating. Experts describe
the ideal consultation as honest, precise, empa-
thetic and hope-preserving. To achieve these aims,
communication should take place in stages and
1
Department of Psychosomatic
Medicine and Psychotherapy,
University Hospital Freiburg,
Freiburg, Germany
2
Department of Internal
Medicine I (Hematology and
Oncology) Hematology and
Oncology, University Hospital
Freiburg, Freiburg, Germany
3
Catholic University of Applied
Sciences, Freiburg, Germany
Correspondence to
Alexander Wu
¨nsch,
Psychooncological Service of
Department of Psychosomatic
Medicine and Psychotherapy,
University Hospital Freiburg,
Hauptstr. 8, D-79104 Freiburg,
Germany; alexander.wuensch@
uniklinik-freiburg.de
CB was the principal
investigator of the study. CB,
AW and CR developed the
interview guideline. CB held all
interviews, transcribed and
analysed them with feedback
from AW and CR. HB provided
medical background information
during the study design process.
TG gave important support in
representing the results. All
authors participated in the
writing process of this
manuscript and approved the
final version.
Received 16 January 2010
Revised 9 September 2010
Accepted 17 September 2010
Published Online First
23 November 2010
74 J Med Ethics 2011;37:74e80. doi:10.1136/jme.2010.035485
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should convey optimism as far as possible. Furthermore, the
amount of information should be adapted to the patient.
13
Aims of the study
The aim of the study was to assess to what extent these theo-
retical ideals are found in practice. The questions were how
much patients effectively understood of their IC; how satisfied
they were during the information process; and what their needs
were in order to optimise IC.
MATERIAL AND METHODS
Sample population
Patients who had been informed about a phase III trial within
the last 6 months were eligible to take part in the study. To
avoid a bias of only assessing patients with a possible positive
attitude about RCTs, we also included patients who declined
trial participation. Patients were approached with the help of
trial physicians of the University Hospital Freiburg, mostly
from the department of hematology and oncology. The study
was approved by the local ethics committee. Sociodemographic
data of the sample are shown in table 1. The average time
delay between IC date and the interview was 2.65 months
(range 0.5e5.5). The interviews took place in rooms of the
University Hospital in Freiburg and all planned appointments
were realised.
Instrument
Different sources were used to create the half-standardised
interview guideline (see box 1) such as literature about manual
construction,
14
quality of IC,
91516
and included aspects from
a current communication workshop about clinical trials from
the authors.
16
The interview covered different aspects of the IC
and started with open questions so that patients had the
opportunity to give free answers. By active listening, a broad
range of statements should be detected. The interview guideline
was first tested among psychology students before being applied
to patients. All interviews were audiotaped, lasted 18e53 min
and were transcribed using the program f4 (http://www.
audiotranskription.de) by CB.
17
Data analysis
Mayring’s inductive content analysis was used.
18
In total, 504
text passages were analysed covering 260 min of recorded
material. The material was examined and categories were
gradually derived. After analysing 50% of the original material,
the formed categories were revised and adapted in order to
confirm their reliability (eg, to avoid overlapping categories).
18
Figure 1 shows an example using Mayring’s method.
RESULTS
Understanding of IC, satisfaction and needs were assessed. The
following sections show the main categories, derived from
subcategories which were built out of 504 text passages in total
(see figure 1). These emerged from the qualitative content
analysis
18
after peer group discussion under the supervision of an
expert in qualitative methods (CR).
Understanding of IC
Thirteen main categories concerning patients’understanding of
IC were extracted from 199 text passages.
(1) Recall of information about IC; (2) recall of content; (3) recall of
RCT process
The 10 interviews show a low recall of information about the
clinical trial by the patients. One patient stated: “I only wanted to
sleep and he basically made my ears bleed. I didn’t understand
anything”.
Some patients knew about the concept of RCTs but certain
indifference was detected as clarified in this patient’s citation:
“They might have sold me 20 washing machines and I would have
signed it. I would have signed anything at that moment”.
We identified a restricted understanding of IC by patients
with regard to aspects of disclosure, knowledge about random-
isation, experimental matter and written information: “I think
that a person without a medical background would probably not
understand what all that means”.
To summarise, recall of information, of IC content and of
RCT process were rather low.
(4) Experimental aspect
Only a few patients understood the experimental aspect of
RCTs. Some patients were not aware of the fact that the applied
medicine in the experimental arms of clinical trials is not yet on
the market. “I mean, this isn’t something that hasn’t been tested, I
still know that. Well, that it isn’t something that only serves experi-
mental purposes, but is on the market officially”.
The deficient knowledge about the experimental aspect indi-
cates that most of the patients had difficulties in understanding
this fact.
(5) Randomisation
The term ‘randomisation’was often unknown as well as the
understanding of random allocation. For instance, patients
thought that they were allocated to the trial arms depending on
age, health status or that the physician is responsible for the
allocation. After having explained the term ‘randomisation’by the
interviewer, half of the patients did not know why it is applied.
Patients were unaware of the fact that allocation is not based
on individual aspects.
(6) Consent form; (7) ideal method of treatment; (8) treatment
alternatives
The written IC was rarely read and hardly understood. Even
a patient who, coincidentally, was a physician himself found the
consent form complicated: “I had to read it three times before I
understood it. (.) I think I got an overall picture of it but I forgot the
rest”.
Table 1 Sociodemographic and clinical data of the
sample
Variable
Sex
Female 4
Male 6
Age
Minimum 18
Maximum 69
Average 39.6
Nationality
German 8
Italian 1
Albanian 1
Type of disease
T-Non-Hodgkin’s lymphoma 1
Bronchial carcinoma 2
Acute lymphatic leukaemia 6
Acute myeloid leukaemia 1
J Med Ethics 2011;37:74e80. doi:10.1136/jme.2010.035485 75
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Box 1 Half-standardised interview guideline
Objective/subjective understanding of informed consent (IC) in randomised clinical trials (RCTs)
<How long has it been since you were informed by the doctor?
<Who informed you?
<Do you know the name of your study?
<Can you remember what was discussed in your Informed Consent concerning your RCT?
<Can you, in your own words, say what your RCT is about?
– What is the procedure in RCTs?
– What are the research goals in RCTs?
– Maybe: Why are RCTs conducted?
– Maybe: What is experimental about RCTs?
<Can you name reasons why you took part in the RCT?
– How much time did you have to make your decision?
– Is your participation voluntary?
<Were you presented with alternatives to the RCT?
– If so, which ones?
– Is your current treatment proven to be the most effective?
<How far can you profit from your participation?
– What are the benefits of participating?
– What are drawbacks that occur through your participation?
– Of what use is the RCT you are participating in to future patients?
<Are there any risks in your RCT?
<In RCTs, patients are assigned different treatments.
– Were you informed about this?
– The technical term for this is randomisation. Was the term randomization explained to you by the doctor who informed you?
– If so, what does randomisation mean?
– Why is randomisation applied?
Written informed consent
<At the beginning of your participation in the RCT you signed a written informed consent. Did you read it?
– What was easy to understand, what was unclear?
– Why are written informed consents collected?
– Could you have refused to sign the written informed consent if you had not wanted to participate in this RCT?
Communication in IC
<How was the conversation for you?
– Atmosphere of the conversation?
– Enough time?
– Detailed?
<How was the doctor’s language during the informed consent? (Clear and easy to comprehend?)
<Did the doctor respond to your needs during the conversation?
– Did the doctor encourage you to ask questions?
<Did you feel pressured by the doctor?
<Was the conversation structured, that is, was the process clear to you, and were you able to follow the doctor?
<How openly was the issue of randomisation addressed and the uncertainty associated with it?
<In RCTs, tests take place to determine whether a certain treatment is effective. This means that there is a measure of uncertainty. How
did that affect you?
<Do you think that the way in which the doctor presented information to you during the informed consent had an influence on your
decision?
– What was helpful for you during the conversation?
– What was not so good?
<Did the manner in which the doctor explained the facts to you motivate you to participate in an RCT?
– Did you feel supported by your doctor?
Patient’s mental state
<How were you during the informed consent?
– What kind of thoughts went through your head?
– What were your feelings?
<What were your feelings?
– Did you have any fears?
– Were you hopeful?
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A lack of clinical equipoise could be identified. Most of the
patients had a treatment preference but decided in the way the
physician tried to convince them: “Well, it is good for me that I am
in the [experimental] trial arm. It is going to have a better outcome”.
Trial alternatives were not relevant to the majority of the
patients and some of them were even convinced that such
options do not exist: “I didn’t think about alternatives [of the trial]
at the time and I think there really aren’t any ”.
An insufficiently read consent form might have influenced the
belief of an ideal treatment arm and the lack of knowledge about
treatment alternatives.
(9) Research goals; (10) benefit for future patients
Research goals and benefits for the patients themselves or future
patients could be stated precisely by the patients: “Sure, if it helps
the research then of course it also helps the patients because it is
possible that the medication could be developed or researched further, so
that these side effects which I am experiencing now might no longer
appear for the next patients”.
Most of the patients were able to explain the trial aims and
benefits.
(11) Dis/advantages of participating; (12) risk through participation;
(13) voluntariness
The interviewed sample was convinced about having no disad-
vantages or risks in participation in a RCT. One commented:
“No, there is no risk at all!”
Our study results show that, despite the lack of under-
standing, every patient knew it was not an obligation to
participate in a RCT.
Patients’ satisfaction and perception
In the second part of the analysis, patients’perception and
satisfaction were assessed and we could derive 13 main cate-
gories selected from 213 passages.
– Was anything unsettling to you? If so, what?
– Did you feel overwhelmed?
– Did you feel pressured?
– Were you afraid? If so, of what?
<How would you describe your general feeling/your mood during the time before the informed consent?
<On the whole, are you happy with the way the informed consent took place?
<Was there anything that should have been different?
– What did you miss, and what did you not like?
– What would you need?
– What could the doctor improve?
<Is there anything that I forgot to ask?
– Is there anything that you would like to add?
Figure 1 Example of the qualitative
analysis process. Original quote (randomisation has already been explained)
Interviewer: “Do you know why patients are randomised?”
Patient: “Well, what other opportunities would I have? Physicians might do it and then personal opinions and such
would be connected to the decision. If allocation is done by randomisation (...) then I’m free from such things, then
I know, okay, it is without prejudices.”
Paraphras e
If physicians took the decision, which arm the patient is placed in, their personal opinions would play a role. When
the decision is based on chance, it is unbiased.
Generalisation (statements of 3 patients)
Randomisation is done to increase the scientific value, otherwise subjective decisions of the allocator would be
integrated and the result would not be a true one. This way, neither patient nor physician has an impact.
Grouping to a subcategory (Statements of 6 patients, the others did not know what randomisation meant)
This way, the physician cannot bias the decision
the allocation is done according to health case and state
the inner attitude towards the medication is positive if you do not know if it is a placebo or not
Randomisation takes place in order to have an equal amount of people in both groups, A and B
Revision of categories after 50% of the material
Several subcategori es are aggregated, for example before revision, statements were divided in physician’s
motivation and physician’s influence on the participation decision. When observing anew, we discovered that
patients’ statements are overlapping and two subcategories would be redundant. Consequently, we simply split it
up in high and low influence.
●
●
●
●
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(1) Relation to trial physician
Patients expressed their satisfaction with the trial physician. “I
heard him talkfor 15 min. Straight away he seemed like a really niceguy ”.
Trial physicians were described as friendly and dedicated.
(2) Physician’s language; (3) structure of consultation
The communication competency was considered adequate
according to some of the patients. Yet one stated: “I think, maybe
in his medical lingo he did a good job, I am not a physician, but at the
beginning, I didn’t understand a word he was saying”.
Relating to the structure, one patient commented: “He had
a sheet of paper and went through it point to point. It was very
structured”.
Hence, the perception of physician’s language and structure of
consultation varied according to the individual.
(4) Complexity of conversation; (5) saturation; (6) time factor
Some patients experienced the complexity of the IC as satis-
factory while some of them found it hard to bear.
Some of the patients thought that the IC was too short. They
stated that it took about 10 min.
Complexity, saturation and amount of time apparently
differed in several consultations.
(7) Dialogue atmosphere
The dialogue atmosphere was hardly criticised at all. “Well, I
never had the feeling that I was being pushed to do anything”.
Yet two patients felt pressured by the trial physicians. “It all
went so fast, it just basically happened in passing by”.
(8) Reasons for participation; (9) physician’s influence on
participation decision
This category points out the wish to support research and trust
in the physician. Moreover, hope for the ideal treatment, as well
as the desire to be part of the experimental group, were reasons
for participating. Those who declined took a sceptical view of
randomisation and preferred to let their physician decide about
their treatment. Besides, they felt pressured because the IC
consultation wasn’t announced in advance and was executed
too fast in their opinion.
Half of the patients shared the impression that their physician
was trying to convince them to participate in the trial.
(10) Emotions and thoughts; (11) hope; (12) trial-related uncertainty
Where patients’emotions and thoughts during the IC process
were assessed, uncertainty about future treatment, fears and
hope were expressed: “Yes, hope! During the conversation and
several days after, when I experienced everything here, with all the
people, I really have to say, I thought it was great [to be accepted onto
the study] and it also gave me hope, definitely”.
By asking open questions, we figured out that a lot of patients
were tired, impatient and distracted during their IC.
Concerning the trial-related uncertainty, one of the declining
patients stated: “It dealt with new medication and I did not want to
be a guinea pig in that case”.
In this category we see how much the disease influences the
perception of the consultation and at what point the physician’s
sensitivity can affect patients.
(13) Encouragement in asking questions
Most of the patients remembered that their physician encour-
aged them to ask questions. Concerning this important topic,
patients were satisfied.
Patients’ desires and needs
In the third part of the analysis on patients’desires and needs, 92
passages were taken into account and seven main categories
were found.
(1) Information needs; (2) helpful aspects; (3) suboptimal aspects
Patients stated different needs on the amount of information:
“.it doesn’t interest me. At the moment my health simply has the
highest priority and, later, I can always ask again if I want to know
something. That is the way I see it. My girlfriend is quite different, she
wants to know everything.”.
For the patients, helpful aspects in the RCT were the avail-
ability of the study physician as a stable contact who took care
in the treatment time: “The feeling that they are making an effort for
me, that I am not just a number, that really came across and I think
that is good”.
Suboptimal aspects were, for example, the use of difficult
medical terms.
(4) Desires of the patients and (5) how physicians’ replied to them
Patients’expressed their desires as follows: the conversation
should take place at another period of time, when the patient is
in a healthier condition. According to patients, the trial physi-
cian’s information should be understandable with enough time.
Moreover, the conversation should be announced in advance to
prevent confusion.
(6) Role of ‘significant others’ and (7) role of nursing staff
The presence of ‘significant others’, relatives and nurses was
perceived as very supportive and as highly important by patients.
To summarise, the main categories of the interview text
passages, composed of the subcategories about IC under-
standing, satisfaction and needs, show a high need for
optimisation in oncological IC for RCTs.
DISCUSSION
The understanding of IC was mostly unsatisfactory
Ethical demands of IC in RCTs, as mentioned in the back-
ground,
8
are insufficiently observed in reality. The disclosure
aspect was only realised in a limited way. However, the patients’
health condition also plays an important role. Most of the
patients were already receiving chemotherapy when having the
IC consultation and commented that it was hard to follow
a complicated consultation in this situation. So the ethically
demanded component of competence was not met sufficiently.
Analysing the interviews for the understanding of random-
isation, the results show an alarmingly insufficient under-
standing.
8
There was a strong requirement for explanation of
this uncommon term.
Concerning written information about the RCT, our results
confirm the findings of Corbett and colleagues
19
that the written
IC is not read by many patients and, if so, is only partially
understood.
Preference of treatment was noted, as already mentioned by
other authors.
3420
The physician’s effort to motivate patients
to attend RCTs can be contradictory to clinical equipoisedthe
balance between both treatment arms.
Analysing patients’views about their knowledge of treatment
alternatives, some of the patients were convinced that there
were no trial alternatives. This confirms the results of Brown
et al
11
and is contradictory to the ethical demand that RCTs
should be a free alternative to a standard therapy.
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Most patients thought that there was no disadvantage in
participating, which shows a misunderstanding and underlines
the necessity of further optimisation of the IC.
Our results show that the element ‘voluntariness’,
8
though,
was achieved. All patients were aware of the voluntary character
about participation.
In some cases patients expressed satisfaction and in other
cases not
The time and effort invested in the debriefing dialogue was very
diverse. One was very critical and stated. “He just quickly told me
in the corridor how this was going to work”. This patient declined
participation in the end.
The dialogue atmosphere was hardly criticised at all, which
indicates trust and security. This can influence the decision for
participation in a positive way.
21
Half of the patients shared the impression that their physician
was trying to convince them to participate, which does not
meet ethical guidelines.
11
Most of the patients remembered that
their physician encouraged them to ask questions, which is part
of the IC ideal, according to Brown et al.
9
Several desires and needs regarding the IC process were
mentioned by the patients
Patients varied in their information needs, which confirms the
findings of Vogel et al
22
who pointed out that individual infor-
mation and participation needs are hard to predict.
Patients’desires were conveyed by stating that the conversation
should take place at another time when the patient is in a healthier
condition: “I think they have to do it at a time when the patient is feeling
well and maybe also a bit more clearly so that the patient understands it
because not everyone can understand their language”.
This evokes a dilemma, given that the health condition of the
patient is the reason why he/she might be included in an
oncological RCT.
The majority of patients thought that the ward’s atmosphere
was helpful, which underlines the relevant role of nurses. This
accords with the statements by Cox.
23
Fluctuations between
fear and hope are connected with the changing desire for more
information and declining participation in a clinical trial.
24
To summarise, there is a remarkable discrepancy between the
expectations towards IC in theory
8
and the situation in reality,
at least for our sample.
There are, nevertheless, clear limits in this analytical
approach:
(1) The study focused on recollection of experience. The time
between discussion about the clinical trial and this interview
was about 2.5 months. The reported recall of information in the
discussion might not be identical to what was really mentioned
throughout the interviews. So there can be a bias.
(2) Qualitative data depend on the context and are never
identical in replication. Qualitative analyses run the risk of
misinterpreting the interviewed patients. Statements are
reduced, abstracted and aggregated.
21
That way, a part of the
conversational content gets lost and misunderstanding in the
labelling of categories can be a problem. However, it is an
attempt to understand the subtle meaning and significance of
complex behaviour, relying on a few carefully selected cases with
many, sometimes infinite, numbers of variables.
(3) Findings of qualitative studies are limited in generalisation.
We only have an assortment of impressions and cannot transfer
them to all conversations about IC in university hospitals. The
results are based on a rather small sample. It cannot be ruled out
that other patients may have reported different recollections of
their IC. Our principal aim was to consider patients who
declined participation in an RCT as well as those who partici-
pated. We had sufficient data for participants but not for
non-participants. This weakness of the study was due to a few
eligible patients who declined to participate in a trial during the
interview process. We contacted two more individuals but one
was too ill for the interview appointment and the other did not
speak German sufficiently. To confirm the reliability of our
results, further patient interviews would be required.
(4) The first author built and named the categories and the
peer group discussion under supervision of an expert tried to
restrict biases, whereas a discursive form within the research
team would have been more appropriate.
25
(5) We decided to use a semi-structured interview guideline
which enabled us to focus on crucial aspects of IC. A more
unstructured conversation with patients could have led to
further discoveries. However, we saw the danger that some
patients might not have reported any details of their IC
consultations and therefore we conceptualised our interview
guideline by open questions in the beginning to be followed by
more detailed questions. In so doing, we could assess specific
ethical and legal details of the IC.
CONCLUSION
This qualitative approach gained an insight into patients’views
about RCTs by assessing their process of reflection and
reasoning. The study also revealed weak points of current IC,
including the finding that patients’understanding of IC was less
developed than anticipated.
Our results indicate that reasonable time for the consultation
and an adequate amount of information are very important.
Duration of the IC interview and avoiding overloading the
patient are also important factors to be considered.
We conclude that patients’desires for their IC interview are as
follows:
1. clear and precise information after giving advanced notice of
the interview;
2. preferably at a point when the patient’s health is in a stable
condition;
3. taking enough time for the patient;
4. demonstrating respect by acknowledging that everyone has
different requirements concerning the information provided;
5. consideration of the pace of the conversation;
6. avoiding incomprehensible expressions and jargon;
7. giving the patient time to think about his/her decisions;
8. assuring that the patient feels secure;
9. inviting the patient to ask questions; and
10. allowing the relatives to join in the conversation.
Acknowledgements The authors thank all patients for reflecting on their
experience, and also the staff of the oncology department, University Hospital
Freiburg, who were very cooperative and without whom the study would not have
been possible.
Competing interests None.
Ethics approval This study was conducted with the approval. Ethics Committee of
the University Hospital Freiburg.
Provenance and peer review Not commissioned; externally peer reviewed.
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participation? A pilot study to assess informed consent and patient expectations.
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Clinical ethics
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doi: 10.1136/jme.2010.035485
2010 2011 37: 74-80 originally published online November 23,J Med Ethics
C Behrendt, T Gölz, C Roesler, et al.
trialsconsultation about randomised clinical
understanding of their informed consent
trial participation? Assessing patients'
What do our patients understand about their
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