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.

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. Highlights: Key findings The potential merits of adopting N-of-1 trials into clinical practice (in terms of efficacy and participation) was acknowledged by all participants. The trade-off between methodological rigidity and practical application for the patient was mentioned by clinicians as an important barrier for the use of N-of-1 trials in clinical practice. There appears to be substantial dissensus on the usefulness of "informal/pragmatic" N-of-1 trials in clinical practice; clinicians appear the strongest advocates for strict methodological rigour. What this adds to what is known Previous research suggests that lack of knowledge by researchers, clinicians, and patients on the topic of N-of-1, operational complexity, and costs are primary barriers for adoption of N-of-1 trials in clinical practice. Our work confirms the abovementioned barriers and adds to this list: the current design of the healthcare system and the lack of consensus on methodological requirements. The Quantified Self movement as well as the advances in the wearable technology were mentioned by (patient)researchers as facilitators for the adoption of N-of-1 methodologies in clinical practice. What is the implication, what should change now Education on N-of-1 trials need to be included in the medical (and thus not only the biomedical sciences) curriculum. The N-of-1 approach might help promote shared decision making in which patient can lead using their own data. Best practices of N-of-1 adoption in clinical practice need to be identified and used as examples to further inform communication between medical stakeholders and policymakers. [ABSTRACT FROM AUTHOR]