In the following paragraphs, we first discuss the term “fragmented understanding” showing the nuances of understanding reflected by trial participants following the consent process. Then, we unpack the reasons and context surrounding fragmented understanding, including issues related to participants’ characteristics, the motivations of both study participants and study physicians, and the external factors going beyond individuals within this setting.
What is fragmented understanding?
The term “fragmented understanding” describes trial participants’ different perceptions of research and clinical trial information. In the interviews, we explored which information about the studies was difficult to understand, with an expectation that the participants might have some knowledge of the trials in which they participated. As the interviews happened several weeks after their informed consent process, it was hard for trial participants to recall information provided during the consent process. In addition, many of the trial participants could not differentiate which consultation session with study physicians included the consent processes. We found that all interviewed participants understood that they were participating in research; however, apart from that, their understanding of the nature of research and of the information about the clinical trials varied. In the following paragraphs, we provide examples of these nuanced understandings.
We found that most participants hardly recalled any information when we asked them to reflect on the clinical trials in general, so we broke down the questions and prompted the participants about specific elements of the clinical trials. Although most of them could not explain the study in detail, they showed good understanding of several specific elements. Our data from observations demonstrated that those elements were either emphasized by the physicians or frequently asked about by the potential participants during the informed consent process. For example in the consent process with one participant, the physician repeated the information about the study procedure to make sure the participant understood her responsibility when she joined the study. The physician also repeated information about the side effects because the participant kept asking about that.
When we asked the participants in the out-patient trial about what they knew about the study, many of them started with the physicians’ emphasis on their study responsibilities.
“The physician told me to follow the treatment schedule. If I agreed to join the study, I would have to follow it. If I could not do it, I should have given this chance to another patient. I could not stop the treatment in the middle because it may worsen the disease. If I agreed to join the study, I would have to follow the physician’s procedure. I thought about that carefully and I agreed to join.” (Participant 11)
This example illustrates that participants’ understanding of study requirements was influenced by study physicians’ perceptions of critical aspects of the clinical trial. We also observed that the trial participants often recalled information about risks, benefits and interventions in case of injury in our conversations about their consent process. Study benefits were the best understood aspect of the study; most participants could point out the benefits that they received from their participation, even when they had limited understanding of other elements. While many participants in the out-patient trial showed good understanding about the study risks and side effects following the consent process and their experiences in the study; some participants did not have exact memories of those elements but they could recall that the study side effects were mild and uncommon and they accepted them as unavoidable risks of any type of medication they may take. The participants’ knowledge and experiences of the study benefits and the mild risks enhanced their confidence in continuing their participation in the study.
“I felt okay, although I had some sleep deprivation. But I do not have the side effects such as vomiting or dizziness like the physician said. I didn’t have those symptoms, so I determined to join [stay in] the study.” (Participant 07)
In the in-patient trial, one participant had difficulty recalling this information and misunderstood what side effects might occur, although information about side effects was of importance in the consent process, based on our observation of the session.
“I remembered that one of the two medicines used for this [disease] – I am not sure which one – will cause diabetes. I am not sure if I remembered well.” (Participant 15)
In contrast, study procedures and the study purpose were the most challenging for participants to recall and explain. Although many participants in the out-patient clinical trial insisted that they had understood the information provided during the consent process, they failed to recall it when interviewed.
“The physician told me all information [about the study]. She explained very carefully but I do not remember anything. I only understood it at that time.” (Participant 10)
We received similar responses from participants from the in-patient trial. When asked specifically about randomization and placebo use, which are important elements of a randomized controlled trial, the participants seemed to be skeptical about those terms.
“The physician probably talked about that, but I do not remember them.” (Participant 22)
“I have never heard about that [randomization and double-blindness].” (Participant 15)
Participants’ limited understandings of these aspects of research were also recognized by the study physicians who obtained their informed consent.
“I don’t think the patients understood what we were doing [study procedure]. They might want to know when we started to use the study drug or so.” (Study physician 05)
Lastly, misunderstandings about the nature of the research was often evident amongst research participants. The participants often talked about the research in terms of a guaranteed cure and free treatment. In the out-patient trial, although the study physician explained about the nature of research at the beginning of every consent session, many patients thought they were receiving specialised treatment and were confident about being cured after participating in the research; therefore, they felt grateful for being chosen in the study.
“The physician checked me very carefully so that they could treat me. […] I am so happy. I am happy to participate in this group [study], so that I can be cured.” (Participant 12)
Additionally, this patient misunderstood not just the reality of research, but also the role of confidentiality. She thought that it was her responsibility to keep the study information confidential but not the research team’s responsibility. In the interview, she asked the researcher if she could talk about the trial with her friends and relatives. Interestingly, other participants had similar misunderstandings about this term.
“I want to ask you a question. Now I am in the study; if someone asks me, should I tell them the truth? […] Should I let them know about this [trial participation]? Does the physician want it to be revealed?” (Participant 12)
Fragmented understanding is the term we use to describe the situation in which the trial participants showed varying degrees of understanding or misunderstanding of trial information. While partial understanding often reflects information perceived to be most important by the researchers and the participants, areas of no understanding and misunderstanding demonstrate that some core information of the study was unclear. In the next section, we will unpack the causes of fragmented understanding in our context.
What is behind fragmented understanding?
Fragmented understanding stems from a complex network of individual and structural factors. In this section, we will discuss the factors contributing to fragmented understanding, including those relating to characteristics of the trial participants, motivations of both the participants and the physicians and broader systems in which the clinical trials took place.
Characteristics of the participants
Trial participants’ characteristics, including older age, literacy level and health status during the informed consent process, had a significant impact on their understanding and recall of the study information. During the interviews, many older participants admitted that it was difficult for them to remember the study information due to their age.
“I don’t remember [the study information]. I am old now. I forget things. I don’t remember.” (Participant 10)
The physicians revealed that older people absorbed the information more slowly, which often caused great challenges for them during the consent process. Therefore, flexibility and creativity in the consent process were critical for physicians.
“It normally takes some effort to explain something to senior people. You must repeat the information over and over or explain it in different ways. When I obtained informed consent from senior patients, I often invited a family member to join the session. The patient signed the informed consent form; the family member listened to us. This person could explain the information in the way the patient might understand, while we couldn’t.” (Study physician 05)
The involvement of family members in the consent process, including having the family member help with interpreting the information into more familiar language, was a strategy that the physicians used to overcome some of the challenges arising when explaining the research to participants with low literacy and/or older age. The anxiety and shock that the participants and their family members had when they heard about the diagnosis of disease for the first time also impacted their capacity to understand the study.
“They were not in their best mental state, so it would be hard for them to acknowledge the ideas.” (Study physician 03)
While study physicians struggled to explain the study to some of their senior and low-literacy participants, additional participants found that the study information was too complicated for them to understand because of the specific knowledge it conveyed. In some cases participants decided to join the study without understanding some aspects.
“[…] If you tell me more about the study, I will still not understand it. Whatever you do, I will not understand it. We just know medicines can cure us. We don’t care about what [is] inside it. I can only understand it [the study] at my limit, I cannot understand it at your level, because this is your expertise.” (Participant 06)
In some cases, challenges with comprehending the study information were demotivating and participants found it difficult to maintain their attention throughout the consent process, despite the study team’s effort to explain the research. Researchers and participants acknowledged that trial participants’ characteristics including age, literacy level and health conditions affected the participants’ capacity to take in and understand the trial information.
Motivations of the participants and study physicians
Different motivations of both study physicians and participants during the consent process contributed greatly to fragmented understanding. Some physicians participating in the study emphasized the recruitment purpose of the process. A physician from the in-patient clinical trial viewed his informed consent process was successful when the participants agreed to participate into the study, regardless of their level of understanding.
“My informed consent process was what I wanted it to be because I wanted to enroll patients into the study and most of them agreed to do so. […]. The patients understood and agreed to join the study; but their level of understanding did not seem to be in line with the definition of informed consent.” (Study physician 03)
When the physicians stressed recruitment as the focus of informed consent, they overlooked their responsibility to make the study understandable to all participants. Additionally, fragmented understanding happened not only when the physicians focused on recruitment rates, but also when the participants were very motivated to take part in research. There were many motivations for participants to join the studies, including existing financial constraints leading to hopes that research participation would enable better access to effective treatment; trust in the healthcare workers and the research based-hospital; and altruism for helping other patients in the future.
Some participants from the out-patient clinical trial had suffered from the chronic liver disease for a decade or more. Many had lost hope of being cured because they could not afford effective treatment. A treatment course of three to six months could be around ten to thirty times higher than the national average monthly income (in addition to the high cost of monitoring viral loads before, during and after treatment). In some cases participants faced lengthy and burdensome trips to the hospital for liver function maintenance medicines every few months. Hence, the clinical trial appeared to be a life saver and joining the trial was seen to be their only option to access treatment and be cured.
“I thought as long as I received the treatment, I would be cured without paying any fee. I don’t have money to treat the disease. I simply thought so, I did not think much.” (Participant 06)
The in-patient trial participants expressed the same thoughts when they were asked about their motivations for participation. Although the physicians were open about the nature of research, the hope for a cure was so great that the participants tended to cast away their doubts about the trial or become overconfident with hope of being disease-free.
“I am afraid [of joining the trial], but the viruses are already in my body. Therefore, I wanted to try this time. Maybe the medicine will work and I will be cured. I concerned about it a lot, but I decided to join the study.” (Participant 17)
Although most of the participants we interviewed viewed it as important to thoroughly understand the study before making decisions, some found information about the clinical trial was not important for their decision making as long as they received the treatment.
“It [the understanding level of trial information] did not affect me when I made the decision to participate the study, as we had to consider our situation. I told my wife: “I would accept everything”.” (Participant 06)
Additionally, trust in the healthcare workers and the hospital where the clinical trials took place established a rationale for participation.
“I signed [the informed consent form] because I trusted them [the physicians]. I told my husband that the physicians have never been wrong; we should have not doubted if we followed them.” (Participant 22)
The genuine trust that some participants had in the study physicians led to their research participation with little consideration or understanding of the study information. This trust also created a dilemma for the physicians. On the one hand, a study physician found it challenging when her patients entrusted her to make decisions about their research participation. On the other hand, trust was recognized by the physicians as a critical element of the informed consent process so that they could better engage with the patients and improve the quality of informed consent.
“You have to build trust with the patients and then, explain the study clearly to them. Give them clear responses for their questions.” (Study physician 07)
In addition to trust in physicians, trust in the hospital and its collaboration with a foreign institution was often mentioned as a motivation for participation by the trial participants. Some of them emphasized the international involvement in the study made it more reliable.
“I felt reassured that I would receive good medicines. The fact that this study is conducted by an American university gives me a lot of assurance.” (Participant 15)
Although this participant mistook the origin of OUCRU, the foreign collaboration added another level of reassurance for her to join the study. With concerns of the medicine quality in the national market, she believed that a study conducted by an institution from a high income country would supply trusted medicines.
Furthermore, the participants often mentioned their empathy for other patients and a hope to contribute to a common good when they talked about motivation for joining the studies.
“I wish I would be cured, and the others too. The study may help more people with the disease to be treated because I saw so many patients out there.” (Participant 11)
We found different systemic issues beyond individual characteristics and practice also caused fragmented understanding. Those included incomprehensible informed consent forms, the perceptions of informed consent as a legal process, and the culture of hierachical physician–patient relationships.
The informed consent forms were criticised as being too long and too complex for people with low literacy, by both physicians and trial participants. From the review of the information sheets and consent forms of clinical trials conducted in OUCRU from 2009 to 2018, we found that the information sheets included over twenty-five items and both forms were created in English language by the research team and translated into Vietnamese language for recruitment. The physicians who obtained informed consent from the potential participants were not involved in developing the consent documents. We identified that the biggest challenge in translation was to convey the meaning of complex concepts in English in simple Vietnamese. A strict translation might lead to confusion and even incomprehension. Although ethical guidelines highlight the importance of language in informed consent forms being non-technical and understandable for participants, their representatives and potential witnesses, there was no guideline for translating jargon into lay language. One example that arose from our interviews showed that many participants did not understand the term “confidentiality” (bảo mật) in Vietnamese; which led to some confusion about whose responsibility it was to keep the participants’ information confidential, as discussed above. The complex informed consent form was also a result of the perception of informed consent as a legal process. Most physicians in the study mentioned that informed consent had its legal function to protect both sides in conflicts; therefore, it should contain all possible details. In the context where most study participants did not finish elementrary level education, thorough understanding of the long and complicated informed consent form seems unrealistic.
Data from the study demonstrated that the cultural background shaping the hierarchical relationship between physician/study physician and patient/research participant was one of many contributors to fragmented understanding. Some physicians found it a challenge when their participants were too shy to admit that they did not remember or did not understand the study information. At the same time, many participants were afraid to disturb or to annoy the physicians with further questions, but still wanted the “treatment” so they agreed to join the study without thorough understanding. In many cases, the information sheet and consent form were kept and reviewed by participants as they sought to understand more about the study during their trial journey, even though verbal consent was provided and the study physicans were available to address their concern.
“Gradually, I understood [the study information]. For some information I could not understand, I just kept reading it, word by word. Slowly, I understood it in the end. But after that, I did not remember it.” (Participant 10)
The complex language in the consent form along with a hesitation to ask for more explanation about the study prevented participants accessing and understanding some information about the study.