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

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