Does Regional Culture Matter in Patient Engagement?

Atsushi Tsukamoto
Daiichi Sankyo Co., Ltd.

Gaz Monteath
Link Global Solution Inc.

ore and more attention is being paid to patient engagement initiatives in the development of new therapies. The European Medicines Agency (EMA) now has one of the longest histories in patient engagement activities and deliverables through its diligent work with patients. Meanwhile, the US Food and Drug Administration (FDA) has spent significant time and resources on workshops with patients, and deliverables are available to the public as part of the Patient-Focused Drug Development (PFDD) initiative. Analogous activities are becoming more and more noticeable in many countries and regions as efforts to understand real medical needs from patients’ points of view, and there is increasing desire to meet those needs.

One natural question that arises is whether patient needs in some countries or regions are similar to those in other countries or regions. To answer this question, we first need to know what therapies are available in those regions, and also what the local standard of care (SOC) is. The reason is that medical needs may be directly related to the options available to the patient. Second, even if the same options are available, how they are used may be different due to ease of access, price, or standard treatment guideline differences. Last but certainly not least, in some cases cultural aspects may have an impact on patient needs, as well as on treatment selection in the context of their decision-making process in the real world.

Medical Practice and Cultural Impact

Some patients act on a perceived right to ask lots of questions to understand available treatment options, as well as the benefits and risks associated with them, while other patients may hesitate to do so. In some countries such as Japan, patients tend to follow doctors’ recommendations without asking many questions. In general, this is related to the values and behaviors ingrained in them by the Confucian style of education they experienced throughout their school years and beyond. In this style, typical communication is one-way; i.e., the person who has more knowledge gives information and guidance, and the person with less knowledge receives it, learns from it, and usually simply accepts it. In such a culture, respect for seniority and authority is important. At the other end of a putative scale is the Socratic style in which people, regardless of the amount of their respective subject matter knowledge, are encouraged to discuss and challenge one another’s opinions and then come to a (more robust) conclusion.

These are just different approaches and, at an absolute level, neither is better. However, the resulting familiarity, or lack of familiarity, with open discussion and debate must be taken into account in medical practice to more fully understand patients’ behavior and their real needs and challenges.

Socio-economic status and medical literacy are other factors, and these may impact patient views as well as their treatment option selections. Needless to say, these matter even within the same region. Previously noted government initiatives by the EMA and FDA place significant focus on patient education to systematically and collectively understand their needs. Furthermore, in real medical practice, those elements impact not only treatment selection but also the attendant needs and satisfaction.

Life-Threatening Disease

In some countries, a family may decide what a patient is allowed to know about his or her disease condition, especially whether the disease is serious or even life-threatening. For example, a family member of an elderly grandmother with multiple diseases, including one that is life-threatening, may prefer her doctor not to tell detailed information and condition to the grandmother because it may confuse and upset her. Another example is the parent of a very sick son who may not want her son to know his likely fate, even if he is legally an adult, asking the doctor and related medical practitioners not to talk about it with him. This is prohibited by law in some countries, such as in the US with HIPAA, but in other countries, there may be considerable leeway. (This was exemplified by an enlightening and passionate discussion at the DIA 2019 Global Annual Meeting Forum Session cited below.) Clearly, then, the medical needs and opinions of patients, as well as those of the patients’ families, may differ due to medical practice differences. In many cases, these differences may be rooted in various, culturally influenced expectations.

Clinical Trials

In the Forum Session, Noriko Fujiwara neatly summarized the differences between medical treatment and clinical trials by showing how those differences interact with cultural elements of patient needs and preferences. In medical treatment, the goal is to address individual patient needs, and the benefit is for the patient being treated. On the other hand, in clinical trials, in addition to individual patient benefit, the goal is to answer a specific research question, and the benefit is potentially for current and future patients not participating in clinical trials. Written informed consent is not necessarily a mandatory process in medical treatment, whereas it is in clinical trials, with participants being well aware of the benefits and risks of potential treatment. There is more uncertainty in a clinical trial setting in terms of individual patient therapy as compared to specific medical treatment for a known patient. Whether or not to participate in clinical trials may depend on individual patient desires to contribute to future patients with similar conditions. In this context, collectivist cultures may be more supportive of participation in clinical trials than are individualist cultures, but because there are multiple confounding factors (such as extrinsic incentives and access to alternative treatments), we do not yet see clear evidence of this tendency. Robert Hilke is one of many voices calling for further investigation.

CONCLUSION

There is a significant cultural element to patient needs and preferences in medical treatment based on local educational foundations and medical practices in the region. The real impact on clinical trials is still not clear, though, so further research and investigation are necessary.

ACKNOWLEDGEMENT

This article is based on preparation discussion for a DIA Annual meeting session. We thank the speakers, Noriko Fujiwara (Institute of Medical Science, University of Tokyo) and Robert Hilke (Hilke Communications Corporation).

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