Preprint The German Multicenter Registry for ME/CFS MECFS-R, 2024, Hieber, Scheibenbogen, Behrends et al.

SNT Gatchaman

SNT Gatchaman

Senior Member (Voting Rights)
Staff member
The German Multicenter Registry for ME/CFS MECFS-R
Hannah Hieber; Rafael Pricoco; Katrin Gerrer; Cornelia Heindrich; Katharina Wiehler; Lorenz L Mihatsch; Matthias Haegele; Daniela Schindler; Quirin Donath; Catharina Christa; Annika Grabbe; Alissa Kircher; Ariane Leone; Yvonne Mueller; Hannah Zietemann; Helma Freitag; Franzisky Sotzny; Cordula Warlitz; Silvia Stojanov; Anna Hausruckinger; Kirstin Mittelstrass; Daniel Hattesohl; Carmen Scheibenbogen; Uta Behrends

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating multi-systemic disease characterized by a complex, incompletely understood etiology. To facilitate future clinical and translational research, a multicenter German ME/CFS registry was established to collect comprehensive, longitudinal, clinical, epidemiological, and laboratory data from adults, adolescents, and children in a web-based multilayer-secured database.

Here, we present the research protocol and first results of a pilot cohort of 174 ME/CFS patients diagnosed at two specialized tertiary fatigue centers, including 130 (74.7%) adults (mean age 38.4; SD 12.6) and 43 (25.3%) pediatric patients (mean age 15.5; SD 4.2). A viral trigger was identified in 160/174 (92.0%) cases, with SARS-CoV-2 in almost half of them.

Patients exhibited severe functional and social impairment, as reflected by a median Bell Score of 30.0 (IQR 30.0 to 40.0) and a poor health-related quality of life assessed with the Short form-36 health survey, resulting in a mean score of 40.4 (SD 20.6) for physical function and 59.1 (SD 18.8) for mental health.

The MECFS-R provides important clinical information on ME/CFS to research and healthcare institutions and, together with a multicenter ME/CFS biobank, will pave the way for research projects addressing the pathogenesis, diagnostic markers, and treatment options.

TRIAL REGISTRATION
ClinicalTrials.gov NCT05778006.


Link | PDF (Preprint: MedRxiv) [Open Access]
 
I thought the introduction of this paper was very well written. Of course I have quibbles - I guess that goes without saying - (e.g. the description of PEM) but it seemed like a nice summary of the disease and a justification for a patient registry in 8 or so paragraphs.
 
Interesting finding on the utility of the DSQ-PEM:
Most adults fulfilled the CCC (98.1%) and IOM criteria (100%), because until March 2023 only patients fulfilling CCC were included at the CFC. Remarkably, using the DSQ-PEM as a PROM prior to medical assessment at the CFC or MCFC only 139/153 (90.8%) patients scored positive for PEM (21/25 (84.0%) children and adolescents vs. 118/128 (92.2%) adults, P=0.348) while all patients clearly indicated PEM when interviewed by an ME/CFS-experienced physician. Using the DSQ-PEM as a PROM, PEM duration was reported to be 2-3 h by 1/138 (0.7%), 4- 10 h by 2/138 (1.4%), 14-24 h by 23/138 (16.6%) (18/117 (15.3%) adults vs. 5/21 (23.8%) children and adolescents), and >24 h by 112/138 (81.1%) (97/117 (82.9%) adults vs. 15/2 (71.4%) children and adolescents) of patients, indicating the majority of patients had long lasting PEM.
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acute disease at onset - 82/174 had a confirmed trigger of SARS-CoV-2
useful data
160/174 (92.0%) patients (36/43 (83.7%) children and adolescents vs. 125/131 (95.4%) adults, P=0.011) reported an acute viral infection before the onset of ME/CFS. The most frequent confirmed triggers were SARS-CoV-2 in 82/174 (47.1%) patients (78/131 (59.5%) adults vs. 5/43 (11.6%) children and adolescents, P <0.001) and EBV in 19/174 (10.9%) patients (11/43 (26%) children and adolescents vs. 10/131 (7.6%) adults, P=0.012). An influenza virus infection was documented in 2/174 (1.1%) patients (2/43 (4.7%) children and adolescents vs. 0/131 (0.0%) adults, P=0.061). In 5/174 (2.9%) patients (2/43 (4.7%) children and adolescents vs. 3/131 (2.3%) adults, P=0.421) multiple infectious triggers were recalled at the time of disease onset (Figures 2A and 2B). Other confirmed or probable infectious triggers were coxsackieviruses, mycoplasma, Borrelia burgdorferi, respiratory syncytial virus, and Group A streptococcae.
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Children and adolescents had significantly lower scores on the gastrointestinal, bladder, pupillomotor subdomains, and total scores but significantly higher scores for orthostatic intolerance.
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Justification for the registry. Of note is the relationship with clinics, so that there probably is reduced bias (or at least a different bias) in the people who are included in the registry, compared to situations where registry participation is more the result of participants hearing about the registry on social media or from patient charities. Participants have clinically confirmed disease.

Despite the considerable impact on health, participation, and HRQoL of people with ME/CFS as well as significant socioeconomic costs due to this disabling disorder, limited knowledge is available regarding the etiology, risk factors, diagnostic markers, treatment approaches, prognosis, and prevention [57-59]. Research on ME/CFS has been hindered using unsuitable case definitions, relatively small study cohorts, the lack of reliable diagnostic and prognostic biomarkers, and limited funding for research and care [60, 61]. However, generating comprehensive and large-scale routine clinical data in registries can help gain deeper insight into clinical features, pathophysiology, and care options.

To address these issues and facilitate future research on ME/CFS, we developed and implemented the German ME/CFS registry and biobank at two German tertiary care centers specialized in diagnosing and treating ME/CFS in adults, adolescents, and children. This registry aims to harmonize the diagnostic approach to ME/CFS and generate a large, well- characterized study cohort via standardized deep clinical and biological phenotyping.

Instruction manuals and individual training will be provided to future participating centers to support a valid comprehensive standard dataset. We expect to generate knowledge about potential ME/CFS subgroups, natural disease trajectories, and current medical care across all age groups and will provide baseline data for other clinical and translational research.
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