Protocol ACHTSAM study protocol: outreach diagnostics and assessment of tolerability in severe ME/CFS—a pilot study 2026 Fricke et al

Andy

Andy

Senior Member (Voting rights)

Abstract​

Introduction Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, multisystem condition that often emerges after viral infections and affects physical and cognitive function. Severely affected patients are underrepresented in research due to immobility and exertional intolerance.

Methods This is a prospective, non-interventional observational study investigating the feasibility and tolerability of home-based diagnostics in patients with severe and very severe ME/CFS. Phase 1 includes remote identification using validated questionnaires. Phase 2 involves home visits for physiological, cognitive and biological assessments. The primary outcome is feasibility; secondary outcomes include tolerability and methodological barriers.

Ethics/dissemination The study protocol was approved by the Ethics Committee of the University of Freiburg (No. 25-1031-S1). Written informed consent is obtained from all participants. Results will be disseminated via peer-reviewed publications and patient support groups.

Trial registration number DRKS00035231; FRKS005506.

Open access
 
They list a lot of tests they are going to do. I have no idea why they’d do most of them for the process of determining the right diagnosis.

There are two phases, which presumably means two separate home visits.

Phase 2a and 2b include activities with an expected total duration of 85 and 75 minutes, respectively. Both phases include a 30 minute long cognitive assessment with numerous tests.

I really don’t understand what they are trying to achieve.
 
"Questionnaires phase 1

All questionnaires should be completed and returned to the institute within two weeks. Non-responders will receive one reminder; delays >4 weeks will lead to exclusion. The aim of the survey is to comprehensively and accurately assess the individual burden of illness based on self-reported information. "

Patients who manage to enrol in the trial are highly likely to be excluded at the very first stage... It’s a rather odd way of trying to determine the extent to which patients with severe or very severe disease can participate in clinical trials.
 
Surely it's already obvious that fixed half-hour cognitive assessments with "numerous tests", presumably also on fixed dates, are very unlikely to be tolerable? And the same goes for a list of biological tests done all at once?

It's inaccessible, inflexible, will almost inevitably result in significantly worsened symptoms ("non-interventional" to the researchers maybe, but the poor buggers on the receiving end might have a different opinion), and it's unnecessary anyway. Diagnosis can be done much more sympathetically, and set protocols like this aren't used in real life.

If it's not already obvious, they could just ask severely and very severely ill people whether it would be tolerable. They don't need to expose them to risk by actually doing it.
 
I participate in the study, I am living in Switzerland. The questionnaires werte quite eas and fast for me (severe but cognitive quite well). In 2.5 weeks will be the first home visit.
They made it very clear that the visit can be paused or cancelled any time abd aound very encouraging and sensitive about that
 
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