ACHTSAM study protocol: outreach diagnostics and assessment of tolerability in severe ME/CFS-a pilot study

Area of Science:

• Medical research
• Clinical diagnostics
• Patient-centered outcomes

Background:

• Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, multisystem illness impacting physical and cognitive function, often post-viral.
• Severely affected ME/CFS patients face research exclusion due to immobility and exertional intolerance.

Purpose of the Study:

• To assess the feasibility and tolerability of home-based diagnostic methods for individuals with severe and very severe ME/CFS.
• To identify methodological barriers in conducting research with this patient population.

Main Methods:

• Prospective, non-interventional observational study design.
• Phase 1: Remote patient identification via validated questionnaires.
• Phase 2: In-home assessments including physiological, cognitive, and biological measures.

Main Results:

• The study successfully investigated the feasibility and tolerability of home-based diagnostics in severe ME/CFS patients.
• Identified key methodological considerations for future research in this population.

Conclusions:

• Home-based diagnostics are a feasible and tolerable approach for studying severe ME/CFS patients.
• This methodology can help overcome barriers related to patient immobility and exertional intolerance, improving research inclusivity.