Introduction
Hepatitis C is a disease in the liver caused by hepatitis C virus (HCV), with estimates suggesting about 150 million people being infected globally (i.e., 1.6% of the population)
[1]. Approximately 80% of the patients with hepatitis become chronic
[2], developing complications, such as liver cirrhosis, terminal liver diseases, or hepatocellular carcinoma over a few years or decades
[3]. In Korea, the prevalence of HCV representing the entire population is not yet known
[4], but approximately 10–15% of cases with liver cirrhosis or hepatocellular carcinoma are estimated to be caused by chronic hepatitis C
[5].
HCV is parenterally transmitted, and its major routes of infection are transfusion of blood or blood products contaminated by HCV; organ transplant; intravenous drug abuse including narcotic drugs, unsafe injections, or medical procedures; and sexual contact with HCV carriers
[6]. In particular, it is known that the reuse of contaminated needles, endoscopies, dental treatments and piercing, acupuncture or tattooing without appropriate sterilization are the risk factors of HCV infection in countries with the high prevalence of HCV
[6].
Because chronic diseases often result in social devaluation or stigma
[7], they negatively affect the physical and psychosocial health of patients
[8]. A previous study found that patients with chronic hepatitis C experience shame, decreased self-esteem, fear, depression, and isolation
[9]. It was also revealed that patients with hepatitis C have a sense of guilt where they hide the disease or attribute it to themselves being careless due to the view that patients with chronic hepatitis C are considered illegal drug abusers
[9].
Since 1989, when HCV was first discovered
[10], treatments for chronic hepatitis C have been rapidly developed and many direct-acting antivirals are waiting for approval, to replace the standard combination treatment of peginterferon and ribavirin, which has shown many side effects
[11]. For these direct-acting antiviral products to be approved by the Ministry of Food and Drug Safety, a clinical trial needs to be conducted on human beings to confirm the effectiveness and safety of the new drugs
[12]. Therefore, those who participate in clinical trials may feel scared and anxious due to the possible side effects or uncertainties from the unknown drugs
[13], and experience emotional disorders, decreased self-esteem, and powerlessness
[14]. For these reasons, patients with chronic hepatitis C participating in clinical trials need to be provided with the appropriate knowledge and information on the clinical trial(s), and an understanding should be made on their experience in illness treatment to support their emotions.
In other countries, studies on the stigma, treatment experience, and illness experience of patients with chronic hepatitis C are actively underway
9,
15,
16,
17. In Korea, however, only a very few studies on the illness experience of hepatitis B, among other chronic liver diseases, have been carried out
18,
19, and few studies have been conducted on patients with chronic hepatitis C
[20].
The illness experience of individual patients varies depending on individuals, families, and societies; it is attributable to the social, cultural, and environmental context of the group to which they belong. A focused ethnography can be used when a researcher focuses on a special aspect rather than a general aspect and is familiar with the study environment
[21]. This study attempted to understand the illness experience of Korean patients with chronic hepatitis C participating in clinical trials in the sociocultural context in an in-depth and comprehensive manner.
Materials and methods
2.1 Research design
This is a focused ethnography to explore the illness experience of Korean patients with chronic hepatitis C who participate in clinical trials in the sociocultural context. The first author of this study was in constant contact with patients with chronic hepatitis C in the Department of Gastroenterology. The gastroenterology outpatient clinic is a place reflecting the culture that can affect the experience of patients and is of help for exploring the culture related to the illness experience of patients with chronic hepatitis C participating in clinical trials. The gastroenterology outpatient clinic for this study is located at a tertiary hospital in a metropolitan city in Korea.
2.2 Participants
We included 11 adults who intended to participate in the study after reading the notice for recruiting with regard to the illness experience of patients with chronic hepatitis C participating in clinical trials (
Table 1).
2.3 Data collection
Data were collected through in-depth interviews and participatory observations. During the interviews, the responses and attitudes of participants and the emotion and feeling of the interviewer were recorded in detail. In-depth interviews were conducted two to three times per participant with each interview taking 1–1.5 hours in a meeting room of the gastroenterology department or a tea house, depending on the preference of participants. Participatory observations were made at the level of observation as participants. The observations as participants were performed in such a way that the author as a medical professional collected data while providing consultations and treatment processes by responding to the demands made by participants.
2.4 Ethical issue
The study was approved by the Institutional Review Board (IRB No. 1041386-20150826-HR-008-03), and was conducted in accordance with the principles of the Declaration of Helsinki. Before data collection, the participants provided signed informed consent. Their rights and privacy were protected throughout the study.
2.5 Data analysis
Data were analyzed with the domain analysis, taxonomical analysis, componential analysis, and theme analysis proposed by Spradley
[22]. In the first step, the recorded interviews by participants were transcribed. An overall picture for the treatment of patients with chronic hepatitis C was drawn through this step. In the second step, a categorization was made by planning the questions for the next steps or the focuses of observations and considering the semantic relations of the explored data based on the domain analysis. In the third step, a componential analysis was performed, in which the properties of the categories were systematically derived by classifying the data into similar meanings. In the fourth step, the process of the theme analysis was carried out, where the culture theme that reappeared both implicitly and explicitly in the treatment processes for patients with chronic hepatitis C and repeatedly appeared in the culture was discovered.
Discussion
This study employed a focused ethnography approach to derive psychological change and cultural significance experienced by patients with hepatitis C, which is not well-known in the sociocultural background of Korea, while they were participating in clinical trials.
From this study, the cultural theme of “less-known illness, less-familiar illness” was derived in the cultural domain of the illness experience of Korean patients with chronic hepatitis C. With this theme, four categories were derived: “my illness discovered by accident,” “shaken life,” “scary but inevitable treatment method,” and “precious life that can't be wasted,” along with the semantic structure of 12 properties. Each category is discussed in the following sections.
In the first category of “my illness discovered by accident,” the major experience related to the diagnosis of patients was found to include “uncertainty” and “regret.” In addition, they experienced “a sense of stigma” from people around them due to the lack of awareness of hepatitis C. Hepatitis C is more chronic than hepatitis B (5% vs. 50–80%)
[23] and has a long process of development without specific symptoms
[24]. Therefore, the diagnosis of hepatitis C often causes frustration to the patients, because they usually are diagnosed during their regular check-ups without any symptoms for a long time. In Korea, the combination treatment of peginterferon and ribavirin had been a standard treatment for hepatitis C until the revision of the treatment guideline by the Korean Association for the Study of the Liver in 2015
[25]. However, the combination treatment had many side effects and required a longer treatment period with a lower cure rate. As a result, those who were diagnosed with chronic hepatitis C felt uncertain due to the recognition that it is not easy to be treated, and regretted for their behaviors in the past. In addition, a social stigma was created because of the lack of knowledge on the transmission routes of hepatitis C by the general public. Therefore, an education program needs to be developed for patients or the general public on the causes, transmission routes, and treatment methods of hepatitis C.
In the second category of “shaken life,” patients are unhappy with the medical staff who did not properly explain how to manage the disease after the diagnosis of chronic hepatitis C, and afraid that the disease may rapidly develop into cirrhosis or liver cancer. While they are tempted to take the food that people say is beneficial for the liver, they are also cautious of the food because it can reduce the detoxicating function of the liver. The fact that the participants of this study were not satisfied with the explanation from the medical staff contrasts with the results reported by Sun and Ju
[20], who noted that participants considered physicians and nurses their information sources for chronic hepatitis C by 72.6% and 7.1%, respectively. This indicates that although physicians explain patients about chronic hepatitis C, they could not explain enough for patients to be satisfied. Frazer et al
[26] also revealed that the level of knowledge on hepatitis C of nurses is lower than that on other infectious diseases. Therefore, education for hepatitis C customized to nurses needs to be provided to the nurses who are in contact with patients with hepatitis C by developing a program based on the knowledge level of nurses on hepatitis C.
In the third category of “scary but inevitable treatment method,” patients were afraid of participating in clinical trials in many aspects and felt frustrated due to the side effect of the existing standard treatments, but they became hopeful with the encouragement by people around them and the results of clinical trials. Although the treatment guideline for chronic hepatitis C was revised in 2015 and took effect partly from 2016, patients are still concerned about the side effects because the new guideline has not been proved on a long-term basis. They, however, made their mind to participate because they did not have other options. Therefore, a program that can reduce the uneasiness of patients by understanding their psychological mechanism needs to be run before they participate in clinical trials.
In the fourth category of “precious life that can't be wasted,” they wanted to be reborn by thoroughly ensuring medication compliance and to change the recognition on the stigma in which people link the cause of hepatitis C with the abuse of narcotic injection. Considering the previous studies suggesting that medication compliance in chronic diseases is better when the level of knowledge of patients is higher
27,
28, an effort needs to be made to enhance their knowledge on chronic hepatitis C. To this end, the need of patients for the domain they want to know should be first identified and then a systematic education program should be developed to address such need.
The results of this study will be the basic data to develop an education program to improve the knowledge of the general public or patients with chronic hepatitis C on hepatitis C and prevent the transmission of the disease.
