Making it Personal: Understanding symptom exacerbations in myalgic encephalomyelitis / chronic fatigue syndrome

Study Background

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is characterised by the cardinal symptom of post-exertional malaise (PEM). PEM is experienced as marked, rapid physical and/or cognitive fatigue (or exacerbation of another symptom) in response to minimal exertion. ME/CFS is most commonly associated with symptoms of chronic and disabling fatigue but patients with the condition also experience a wide range of other symptoms such as musculoskeletal pain, headaches, sleep problems, impaired cognitive function and more. It is well-recognised that individuals with ME/CFS can vary widely in regards to the severity and particular cluster of symptoms they experience. ME/CFS can have a significant impact on an individual’s function and quality of life. ME/CFS affects 0.2-0.7% of the Australian population, predominantly women (>85%), and has a substantial economic burden on the individual and wider society, including higher health care utilisation and loss of productivity.

There is no known cure for ME/CFS but there are a number of pharmacological and non-pharmacological approaches for managing the symptoms of ME/CFS. There is no consensus about which approach is most effective. The gold standard research design for testing treatments is the ‘randomised controlled trial’ (RCT). However, RCTs focus on whether a treatment is effective for a group of patients on average rather than whether a treatment is effective for an individual. N-of-1 trials and other single-case designs can be used to evaluate treatment response symptoms fluctuations over time at the individual level.

Study Aim

This study aims to assess the feasibility and acceptability of using N-of-1 methods to explore symptom exacerbations in ME/CFS at the individual-patient level.

Study Design

This study involves a series of single-case observational studies (also referred to as N-of-1 observational designs). Participants provide daily data via a wrist-worn electronic diary for 6-12 weeks. Each single-case observational study has a patient-centred design. At the end of the study participants receive personalised feedback about symptoms patterns and the factors that are associated with symptom exacerbations.

Ethical Approval

This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research. Ethics ID: 2018/HE000741.