Marketing therapeutic precision: Potential facilitators and barriers to adoption of n-of-1 trials

Background: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. Methods: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. Results: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients. (C) 2009 Elsevier Inc. All rights reserved.