A qualitative study on the facilitators and barriers to adopting the N-of-1 trial methodology as part of clinical practice: potential versus implementation challenges

Abstract

Purpose To investigate opinions among healthcare stakeholders whether implementation of the N-of-1 trial approach in clinical practice is a feasible way to optimize evidence-based treatment results for unique patients. Methods We interviewed clinicians, researchers, and a patient advocate (n = 13) with an interest in or experience with N-of-1 trials on the following topics: experience with N-of-1, measurement, validity and reliability, informally gathered data usability, and influence on physician-patient relationship. Interviews were analysed using qualitative, thematic analysis. Results The N-of-1 approach has the potential to shift the current healthcare system towards embracing personalized medicine. However, its application in clinical practice carries significant challenges in terms of logistics, time investment and acceptability. New skills will be required from patients and healthcare providers, which may alter the patient-physician relationship. The rise of consumer technology enabling self-measurement may leverage the uptake of N-of-1 approaches in clinical practice. Conclusions There is a strong belief that the N-of-1 approach has the potential to play a prominent role in transitioning the current healthcare system towards embracing personalized medicine. However, there are many barriers deeply ingrained in our healthcare system that hamper the uptake of the N-of-1 approach, making it momentarily only interesting for research purposes.

Keywords

• n-of-1 trials
• individual point of care studies
• single case designs
• single subject research
• personalized healthcare
• personal science