It is generally agreed that decision-making within the medicines development process should aim to incorporate patients’ perspectives, preferences and views. If patients are fully involved from the beginning of this process, more acceptable, better-grounded decisions, which are fully reflective of patients’ needs, are likely to be made. Valuing and incorporating patients’ views represents an important step towards a more democratic and fair decision-making process. However, it can also pose a number of challenges and obstacles.
What are the challenges?
Patients are sometimes misleadingly referred to as if they are a single, indistinct category with shared preferences and views. However, such a high degree of homogeneity is not always reflected in the real world. As stated in the International Alliance of Patients’ Organizations’ (IAPO’s) Declaration on patient-centred healthcare, every patient has unique values, needs, and preferences.
Furthermore, patients’ levels of acceptability of treatment options is not determined by a fixed combination of standardised and unchangeable criteria. The way in which patients apply their own acceptability criteria to weigh up and evaluate treatment options depends on individual (personal) factors as well as on contextual and external variables.
An additional obstacle that can prevent successful patient involvement in decision-making is a lack of trust between patients and researchers. Research conducted by IAPO within the GetReal project showed that trust in those who conduct or develop research is one of the factors that patients tend to value most when deciding whether to take part in research activities.
These issues raise the following questions:
- Which methods can be used to adequately capture patients’ preferences and perspectives?
- How can patients be involved in decision-making processes in a way that respects each patient’s uniqueness?
- How can patients be involved in decision-making processes in a way that enhances patients’ trust both in who conducts research and the process itself?
How to explore and incorporate patient perspectives
Researchers still tend to rely heavily on mainstream quantitative methodologies to explore patients’ preferences and perspectives. However, these methods are not always adequate to fully capture the vast array of patient views about topics that can have an impact on their quality of life. Some practical steps can be undertaken to encourage patient involvement, generate data that better reflects what patients want and help to establish a sense of trust:
- Patients’ experiences and stories should be looked at as a complementary and unique source of data, which can be used to gain a deeper understanding of what matters to patients. This process can result in the selection of outcomes that are better aligned with patient perspectives.
- Appropriate research methodologies should be used to explore these sources of information and translate them in data that can be relied on to inform decisions. Traditional quantitative methodologies should be complemented by semi-structured interviews and focus groups. These methods are flexible enough to value each participant’s unique perspective and allow patients to speak freely, which helps to increase patient trust in the process.
- Patients need to be adequately informed about the purpose of their involvement. They should have sufficient knowledge of the research objectives and, most importantly, be shown clearly how their input has contributed to the process and their views have been used.
Image. Ways to involving patients in medicines development
Key contributor
Antonio Ciaglia, International Alliance of Patients’ Organizations (IAPO)