N-of-1 Trials in Healthcare

Abstract

Interest in N-of-1 trials and single-case designs is increasing worldwide, particularly due to the movement towards personalised medicine and patient-centred healthcare. For decades, group-based designs such as the randomised controlled trial have been understood as the “gold standard” for testing treatments, however these designs have provided us with little information about the individual-level improvements in health and well-being outcomes that are of vital importance to healthcare. There is growing recognition of the wide applicability of N-of-1 trials and single-case designs to a number of diverse health disciplines and the value they can bring to clinical research and practice through the focus on understanding individuals. This Special Issue aimed to showcase novel applications of N-of-1 trials and single-case designs in any health-related discipline, with a specific focus on applications in new health conditions, interventions and contexts, as well as developments in data analysis. This Special Issue presents a collection of thirteen articles that highlight the importance of these methods in both clinical research and practice. Together, the articles report findings from research studies, describe protocols for future studies, and outline key discussion points and opinions for advancing the field. The articles represent a variety of single-case designs, including experimental and observational designs, and demonstrate the substantial flexibility and versatility of N-of-1 trials and single-case studies and their value in healthcare.