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.
- Informed consent
- patient physician communication
- randomised controlled trials
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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 necessarily be appropriately informed about risks and uncertain benefits in order to make a truly autonomous 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.3–6 Most studies are questionnaire-based, largely lacking why patients consent or what they need.3 7 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 fields—physicians, lawyers, philosophers and psychologists—single 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 physician–patient conversations, Brown and colleagues11 showed that half of the sample could not adequately recall facts (eg, randomisation or right to withdraw participation). Kusec and colleagues12 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 al9 state that the following seven aspects should be considered in IC: (1) treatment alternatives; (2) cost–benefit analysis of different therapies; (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, empathetic and hope-preserving. To achieve these aims, communication should take place in stages and 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 theoretical 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
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 0.5–5.5). The interviews took place in rooms of the University Hospital in Freiburg and all planned appointments were realised.
Different sources were used to create the half-standardised interview guideline (see box 1) such as literature about manual construction,14 quality of IC,9 15 16 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 18–53 min and were transcribed using the program f4 (http://www.audiotranskription.de) by CB.17
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?
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?
– 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?
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.
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 analysis18 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 randomisation, 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 experimental purposes, but is on the market officially”.
The deficient knowledge about the experimental aspect indicates that most of the patients had difficulties in understanding this fact.
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”.
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 disadvantages 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 understanding, 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 categories selected from 213 passages.
(1) Relation to trial physician
Patients expressed their satisfaction with the trial physician. “I heard him talk for 15 min. Straight away he seemed like a really nice guy”.
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 satisfactory 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 encouraged 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 availability 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 physician'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 understanding, satisfaction and needs, show a high need for optimisation in oncological IC for RCTs.
The understanding of IC was mostly unsatisfactory
Ethical demands of IC in RCTs, as mentioned in the background,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 randomisation, the results show an alarmingly insufficient understanding.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 colleagues19 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.3 4 20 The physician's effort to motivate patients to attend RCTs can be contradictory to clinical equipoise—the 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 al11 and is contradictory to the ethical demand that RCTs should be a free alternative to a standard therapy.
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 al22 who pointed out that individual information 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 theory8 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 participated. 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.
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:
clear and precise information after giving advanced notice of the interview;
preferably at a point when the patient's health is in a stable condition;
taking enough time for the patient;
demonstrating respect by acknowledging that everyone has different requirements concerning the information provided;
consideration of the pace of the conversation;
avoiding incomprehensible expressions and jargon;
giving the patient time to think about his/her decisions;
assuring that the patient feels secure;
inviting the patient to ask questions; and
allowing the relatives to join in the conversation.
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.
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.
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.