Psychometric evaluation of the Informed Consent Process Scale in Chinese

Research objectives

Our purpose was to develop and test the psychometric properties of an informed consent measure scale for the clinical participants and to understand their levels of perception and various experiences involved.

Translation process of the Chinese version of Informed Consent Process Scale

Back-translation was conducted to develop the Chinese version of the informed consent questionnaire. This was a cross-sectional survey study. Dr Bob Anderson, professor emeritus of the University of Michigan Medical School, granted permission. To convey the conceptual meaning of the target language, the original consent questionnaire was translated into Mandarin using a stringent four-step back-translation that included the following: (a) translating the questionnaire into the target language, (b) back-translation, (c) pretesting the items and (d) validating the items. ⁸ The questionnaire was first translated by the third author (C-C.L.), who is fluent in both English and Chinese, and then back-translated blindly by another research team member, who is also fluent in these two languages. Afterwards, the back-translated questionnaire was sent via email to a monolingual English-speaking team member to check whether the first translation accurately contained the original meaning of each item. The background of the research members involved in the translation process is in nursing field. In order to resolve problems that arose from the first translation or the back-translation, inaccurate expression or unclear English terms or verb tenses were discussed via email. Some modifications were made based on the attempt to improve the expression of the questionnaire and to adapt some of the items for contextual differences in Taiwan and Hong Kong. Any change made for the English content then went through the full first- and back-translation process until consensus on the concept and wording was reached, and the versions of both languages were confirmed. Back-translation was conducted to develop 23 items from the Mandarin version of the questionnaire.

Research design

The cross-sectional survey was administered to the participants, and exploratory factor analysis (EFA) was conducted. More specifically, in the medical field, white lab coat represents the professional image of health providers. In Chinese culture, the majority of doctors are males and the majority of nurses are females. We would like to see whether there is any potential influence of gender and attire representing professional images on how participants respond to the ICFs. Although the existing literature showed that there is no gender preference for the more ‘instrumental’ health professions (e.g. surgeons, anaesthetists), gender preferences are more related to the health professions who engage in intimate and psychosocial health problems (e.g. gynaecologists and general practitioners (GPs)). ⁹ Since our intervention is related to psychometric evaluation, the participants may also have their gender preference while giving the responses on the consent forms depending on which gender of the researcher (health professions) they were with. How health professions’ gender influences patients’ responses on consent forms seems to be scant in the literature; hence, it is worth exploring on the perspective of gender influence in this study.

In addition, the attire of doctors and nurses may influence how participants respond to their consent forms. According to previous study conducted by Caldow et al.,10 patients mainly perceived differences between doctors and nurses based on academic ability and qualifications. Most respondents thought nurses could deal with relatively minor problems compared with doctors who are mainly in charge of diagnosis and treatment. As the attire represents different professional images and authority, participants may differ in their responses while interacting with these two different health providers.

Participants

The criteria included in the study were the following: (a) the participants had experience of having signed a research ICF within the previous 3 years, (b) their age was over 20 years and (c) they were able to communicate in Chinese. Exclusion criteria were as follows: (a) inability to independently consent and (b) inability to read or sign the study’s ICF. In order to keep the heterogeneity high, we tried to reach institutions in three different regions (north, middle and south) of Taiwan. Finally, we recruited 375 participants who had previous experience of signing an ICF within the past 3 years. While filling in the questionnaires of informed consent, the participants were free to ask the researchers if they had any inquiry regarding the study.

Data collection and ethical considerations

The institutional review boards of two selected hospitals approved this research (KMUHIRB-E-20150016; CCHIRB:150416) and the autonomy of the participants was respected as they voluntarily agreed to fill in the questionnaire anonymously. The process of data collection was first through communicating with principal investigator, co-investigators and research staffs who had conducted clinical trials within the previous 3 years and seeking the potential participants from their studies. After their verbal explanation to the potential participants, some agreed to participate in and were referred to the researchers of this study for further explanation. After receiving the explanation of the study, these participants completed the informed consent questionnaires. If the participants were not able to complete the questionnaires themselves, the researchers would assist them in interviewing them in order to collect the data. The interview took about 10 min at a quiet area such as a meeting room. The participants would be reimbursed with a gift worth of US$3 approximately.

The researcher kept personal privacy information as confidential and replaced an individual information with a code and the above data would not be available to other researchers. The completed questionnaires would be locked and kept cautiously. The contents of the questionnaires were only for academic research purposes. In addition to the relevant agencies to investigate according to law, the research team would carefully keep the confidentiality and privacy of the respondents.

Chinese version instrument

The informed consent process is culturally different and culturally sensitive. ¹⁴ In the previous literature, there is no published Chinese version. The main goal of the study, after creating a Chinese version of the scale, was to evaluate the psychometrics of the Chinese version of Informed Consent Process Scale (ICPS-CV) in an effort to help managers address the informed consent process in clinical research and properly apply interventions to facilitate the process. We included participants who had the experience in signing a research ICF within the previous 3 years, were 20–80 years old and could communicate with Chinese. To help broaden the future application of the scale, we tried to keep the heterogeneity high with regard to sample size, age, gender, total family monthly income, language, education and research participant experience. The psychometric evaluation evidence had acceptable results, with an adequate factorial analysis, a high internal consistency. The ICPS-CV is composed of three factors and 23 items in total. This includes Factor 1 – ‘Understanding of the research’, Factor 2 – ‘Trust and confidence’ and Factor 3 – ‘Doubt and uncertainty’. The specific 23 items are shown in Tables 3 and 4.

Understanding of the research

According to previous studies, patients’ understanding of clinical informed consent seemed to be an important factor that might affect their decision-making while signing an ICF. Schenker et al. ¹⁵ indicated that patient understanding in clinical informed consent is often poor. Sanchini et al.3 found that only 62% of patients understood the purpose and the nature of their trial survey and only 44% understood the study procedures. Wade et al. ¹⁶ indicated that evaluation of recruiter–patient interaction should focus on evidence of (a) patient views of the trial, randomisation and treatments; (b) improved patient understanding; and (c) patients’ understanding of clinical equipoise. Farrell et al. ¹⁷ noted in 2014 that for patients, poor information delivery can impair their understanding of recommended treatment, reduce their satisfaction with care delivery and have a detrimental impact on their treatment adherence. Our results also showed that only 47.2% of the participants completely understood the research study when they joined it. But ‘Understanding of the research’ is not the only factor; ‘Trust and confidence’ and ‘Doubt and uncertainty’ are also factors that affect their decision. Among 375 respondents in this study, majority of the respondents had ‘the ability to understand the content of the consent form of the subject’, but had scant responses in ‘I have enough time to read the subject’s consent’, the ‘risk of research’ and the ‘benefit of research’. This corresponds to the research on the West African malaria vaccine trial, of which 93% ‘did not understand the test risk’. ¹⁸ In addition, a systematic review conducted by Tam et al.2 found that only 74.0% did not understand potential benefits, and 67.0% did not understand potential risks and side effects. Therefore, the above two results correspond to each other. It is clear that the risks and benefits of research should be the focus while interpreting the research process and it is necessary to give the participants sufficient time to read the consent forms for their readiness to participate in the study.

Trust and confidence

Our results also showed that 40.8% of the participants when making decisions regarding their medical care would prefer to make those decisions equally with the doctor, and 20.8% of the participants would let the doctor make most of the decisions. In the previous research, culture has been addressed in varied issues related to healthcare ad hoc the communication or educational intervention between patients and health providers. Informed consent is different by culture. Beach et al. ¹⁹ addressed the importance of cultural competency as it could be considered a strategy for improving the knowledge, attitudes and skills of health professionals. Maybe, in the Taiwanese culture, our participants hesitate to express their doubts and discuss their uncertainties. However, evidence on this perspective on health outcomes is still lacking in the existing literature. Thus, future research should focus on cultural significance and, more specifically, investigate on the cultural differences among different regions with the same informed consent tool. As Somnath ²⁰ suggested that culture is considered multifaceted and dynamic. Individuals are more likely employ different perspectives for different issues or even for the same issue at different points in time. Cultural contexts are essential in the field of healthcare as certain cultural competence creates trust between the health professions and patients. ²¹

In our Taiwanese culture, the doctor–patient relationship and trust can affect the participant’s decision, and the review of Halkoaho et al. ¹⁴ noted that taking cultural aspects into account during the whole research process improves the quality of the research. But, in our study, 52.5% of those who provided the information to the participants were research nurses (Table 2) and, similar to the two studies of Susilo and colleagues, ^22,23 inter-professional education is needed to promote inter-professional collaboration, and informed consent practice should be tailored and improved. ²³

Doubt and uncertainty

In the 2014 study of Sherlock and Brownie, ²⁴ patients’ recollection and understanding of the medical procedure, its risks and complications, was often low, particularly among older individuals. For discretionary tests and procedures, complete information about expected benefits and risks may lead many individuals to choose alternative strategies or to be more confident in the recommended choice. ²⁵

Limitations

The main goal of our study was to conduct an EFA, not to verify correlations. And our results may be specific to the Taiwanese population; further testing may be needed in other areas where people speak the same language, although their cultures are different. The study also did not discuss how the role of participants’ memory was over the 3 years and how many might not have remembered certain specific information on the ICFs they signed. The above points could be considered the limitations of the study.