Exploring Stakeholders' Perspectives About N-of-1 Clinical Trials and Single-Case Designs in Healthcare
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Description: N-of-1 trials and single-case designs (SCD) are used to evaluate individual-patient response to interventions. This is in contrast to group-based research designs (e.g. randomised controlled trials), which tell us more about the average response to interventions for the group studied. N-of-1 trials and SCDs are being increasingly recognised as a useful method across a number of disciplines, but generally their adoption has been limited. This may be related to a number of inaccurate beliefs about these methods or perceived barriers to using them. It is important to explore stakeholder perspectives of N-of-1 trials and SCDs in order to identify strategies to increase awareness and adoption. To date, there are few high-quality studies investigating multiple stakeholder perspectives about using N-of-1 trials and SCDs studies in the healthcare context. Most studies have focused on the views of clinicians or patients, with few exploring views of other important stakeholders such as funders, statisticians, methodologists, publishers and regulators. Furthermore, the existing evidence is based on poorly reported research methodology with no theoretical basis about the potential factors that might influence awareness and adoption. A comprehensive, theory-based, in-depth investigation of perspectives across multiple stakeholders groups is needed. This can inform the development of intervention strategies to improve awareness and adoption of N-of-1 trials and SCD studies in healthcare.