• General practice
  • Health services
  • Internal medicine
  • Neuroscience
  • Paediatrics
  • Pharmacology
  • Primary care

Location: UQ Centre for Clinical Research (Herston)

Type of student:

  • Both HDR and Extra-curricular
  • Honours students
  • 4 Unit Masters of Public Health (MPH) Student
  • PGY1: Post-graduate year 1
  • PGY2: Post-graduate year 2

Type of work:

  • Literature review
  • Qualitative methods

Brief synopsis:

Background: N‐of‐1 clinical trials are a type of single-case design and are randomised controlled trials of treatment versus a placebo (or another treatment) within an individual patient to determine individual response to treatment (please click here for further information and examples). N-of-1 trials provide the highest level of evidence for making treatment decisions for individual patients. There are several other types of single-case designs. Despite the value of using these methods in a healthcare context, previous research has identified potential barriers to the uptake of N-of-1 clinical trials and single-case designs.

Aim: This study aims to explore different stakeholder perspectives about the use of N-of-1 clinical trials and single-case designs in healthcare. Stakeholders include health care professionals (e.g. general practitioners, psychologists, physiotherapists), patients, trialists/methodologists, biostatisticians, health care funders, Institutional Ethics Review Board members, regulators and journal editors.

Methods: In depth, one-to-one semi-structured interviews will be conducted with people from each stakeholder group. The interview schedule will be based on the Theoretical Domains Framework (TDF; Michie et al., 2005). The TDF provides a broad and inclusive approach to understanding theory-based predictors of clinical and health-related behaviour. The TDF was developed by an expert consensus group, which reviewed 33 behavioural theories and their associated 128 theoretical constructs, identifying 12 theoretical domains based on commonalities between constructs. The TDF broadly covers all scientific explanations of behaviour based on current theorising and has been used widely to understand the perceptions and behaviours of clinicians and patients. Prior to the interview, participants will complete a pre-interview questionnaire collecting demographic data and will view a short informational video on N-of-1 clinical trials and single-case designs. Quantitative data will be analysed descriptively. Qualitative interview data will be analysed using framework analysis.

Implications: This study will produce in-depth data about different stakeholders’ perspectives which will be used to develop theory-based strategies to increase awareness and uptake of N-of-1 clinical trials and single-case designs in healthcare.

Learning objectives for students: Students will learn about a novel research method. N-of-1 trials and single-case designs play a key role in the movement towards personalised medicine, patient-centred healthcare, and shared decision-making. The student will also gain experience and skills in relation to conducting research with various population groups.


Dr Suzanne McDonald

Dr Suzanne McDonald

Senior Research Technician
UQ Centre for Clinical Research