XVI.Add.II.3.1. Qualitative methods

Qualitative research plays a distinctive role in evaluating healthcare interventions (15), especially on issues not yet well understood (9,10). It can study cognitive processes and experiences in their natural setting, such as knowledge, risk awareness, trust, reasoning processes and attitudes about medicines, communication needs and preferences, and experiences of using medicines in real life. Factors that may be enablers and barriers for implementing RMM in healthcare and achieving behavioural change can be identified through qualitative research. These factors include those relating to the interaction between humans and systems elements, as investigated by human factors discipline for enhancing safety and reducing adverse incidences and human error (16–18)9 .

Qualitative studies may generate concepts or hypothesis to be further investigated through quantitative research and inform protocols, sampling strategies and measurement tools for quantitative studies. Qualitative studies may also explore explanations and reasons for results from quantitative research (19) and identify reasons other than the RMM leading to the outcomes of interest. Among the various possible study designs (20), the following are well-established and particularly relevant for evaluating RMM:

• Interpretative phenomenological study: Investigates a phenomenon in the real-world context (21), e.g. the cognitive process or experience of patients and healthcare professionals with disease, medicines use and RMM, including related media behaviours, communication needs and preferences (22).
• Grounded theory study: Aims at developing concepts that are grounded in the data and subsequently formulates – through an iterative and comparative process – a well-grounded theory on a cognitive process or experience, e.g. to explore existing knowledge and beliefs in context of health communication (6,23–25).
• Mixed methods study: Combines qualitative with quantitative methods to benefit from the strengths of each, typically using multiple data sources, perspectives and data analysis methods, for example in an approach called triangulation (5–7).
• Case study: Intends to gain an in-depth understanding of a unique event in its complexity, applying qualitative, quantitative or mixed methods data and analysis, e.g. for understanding experiences of patients and healthcare professionals with RMM for a specific medicinal product, a specific RMM tool or RMM implementation in specific healthcare settings (26,27).
• Action research study: Evaluates ongoing implementation of an action in a participatory approach (6,28), e.g. the implementation of a RMM in healthcare with active research participation of patients and healthcare professionals.

Qualitative studies should be designed for rigour, and tools for assessing their quality are encouraged to be used, in order for the studies to serve as evidence for evaluation and decisionmaking on RMM (10,19,29,30).