The Facilitation of Clinical and Therapeutic Discoveries in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Related Diseases: Protocol for the You + ME Registry Research Platform

Abstract

Background Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic, complex, heterogeneous disease that affects millions and lacks both diagnostics and treatments. Big data, or the collection of vast quantities of data that can be mined for information, have transformed the understanding of many complex illnesses, such as cancer and multiple sclerosis, by dissecting heterogeneity, identifying subtypes, and enabling the development of personalized treatments. It is possible that big data can reveal the same for ME/CFS. Objective This study aims to describe the protocol for the You + ME Registry, present preliminary results related to participant enrollment and satisfaction, and discuss the limitations of the registry as well as next steps. Methods We developed and launched the You + ME Registry to collect longitudinal health data from people with ME/CFS, people with long COVID (LC), and control volunteers using rigorous protocols designed to harmonize with other groups collecting data from similar groups of people. Results As of September 30, 2021, the You + ME Registry had over 4200 geographically diverse participants (3033/4339, 69.9%, people with ME/CFS; 833/4339, 19.2%, post–COVID-19 people; and 473/4339, 10.9%, control volunteers), with an average of 72 new people registered every week. It has qualified as “great” using a net promotor score, indicating registrants are likely to recommend the registry to a friend. Analyses of collected data are currently underway, and preliminary findings are expected in the near future. Conclusions The You + ME Registry is an invaluable resource because it integrates with a symptom-tracking app, as well as a biorepository, to provide a robust and rich data set that is available to qualified researchers. Accordingly, it facilitates collaboration that may ultimately uncover causes and help accelerate the development of therapies. Trial Registration ClinicalTrials.gov NCT04806620; https://clinicaltrials.gov/ct2/show/NCT04806620 International Registered Report Identifier (IRRID) DERR1-10.2196/36798

Do people with ME/CFS and joint hypermobility represent a disease subgroup? An analysis using registry data

“…Participants are from the You + ME Registry overseen by Solve M.E., a non-profit organization that works with international scientific, medical, pharmaceutical, and patient communities to lay the foundation for critical research into diagnostics, treatments, and cures for ME/CFS, Long COVID and other post-infection diseases. The protocol for You + ME Registry is described elsewhere ( 11 ). Briefly, participants are recruited through Solve M.E.…”

“…The You + ME Registry is a secure, online real-world clinical data repository where people with ME/CFS, people with related diseases, and control volunteers enter information on their health that is then used for biomedical discovery ( 11 ). Compared to traditional, in-person studies, the Registry enables participation from people with diverse geography, backgrounds, and disease experiences (e.g., participation of severely ill patients who are house or bed-bound).…”