Fricke et al. (2026)
- Authors: Carmen Fricke, Peter Deibert, Philipp Maier, Winfried Kern, Oliver Krumnau, Friedrich Barsch
- Institutes: Institute for Exercise and Occupational Medicine, University Medical Center Freiburg, Freiburg, Germany, Faculty of Medicine, University of Freiburg, Freiburg, Germany
- Publisher: BMJ Open
- Link: DOI
Summary
This protocol addresses a critical gap in medical research by focusing on the most severely ill ME/CFS patients who are usually excluded from studies due to their inability to travel. By establishing and testing safe, home-based diagnostic procedures, the ACHTSAM study aims to provide a validated framework for including housebound individuals in future clinical trials and improving their access to specialized care. This work is a vital step toward making research more inclusive and representative of the entire patient spectrum.
What was researched?
This research presents the study protocol for a prospective, non-interventional pilot study investigating the feasibility and tolerability of home-based diagnostic assessments for patients with severe and very severe ME/CFS.
Why was it researched?
Severely affected patients are often housebound or bedbound and are typically underrepresented in clinical research because of the risks of post-exertional malaise and the logistical challenges of traveling to specialized clinics.
How was it researched?
The study employs a two-phase approach: Phase 1 involves remote screening and identification via validated questionnaires, while Phase 2 consists of carefully staged home visits by a medical team. Assessments include physiological monitoring (such as endothelial function tests), cognitive evaluations, and biological sampling to determine if these procedures can be conducted without triggering significant symptom worsening.
What has been found?
As a protocol publication, the paper details the systematic design intended to identify patient-reported and physiological barriers to standardized diagnostic procedures. The study aims to determine the specific proportion of assessments that can be successfully completed by patients with very low functional capacity (Bell score ≤30) without necessitating premature termination.
Discussion
The protocol highlights the importance of patient and caregiver involvement in study design to ensure safety and relevance. A primary challenge identified is the difficulty in attributing delayed post-exertional malaise to specific individual tests given the multisystem nature of the assessments.
Conclusion & Future Work
The ACHTSAM study intends to demonstrate that including housebound patients in high-quality research is feasible through specialized outreach. Establishing these safe diagnostic standards is a prerequisite for developing targeted therapeutic strategies and future clinical trials for the most vulnerable ME/CFS populations.