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

Allison Ramiller, Kathleen Mudie, Elle Seibert, Sadie Whittaker, Allison Ramiller, Kathleen Mudie, Elle Seibert, Sadie Whittaker

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://ichgcp.net/clinical-trials-registry/NCT04806620.

International registered report identifier (irrid): DERR1-10.2196/36798.

Keywords: COVID-19; chronic fatigue syndrome; data acquisition source; digital health; health application; long COVID; longitudinal cohort study; longitudinal health data; mobile health; myalgic encephalomyelitis/chronic fatigue syndrome; patient powered; postinfectious; symptom-tracking app.

Conflict of interest statement

Conflicts of Interest: None declared.

©Allison Ramiller, Kathleen Mudie, Elle Seibert, Sadie Whittaker. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.08.2022.

Figures

Figure 1
Figure 1
Overview of the first 6 months of longitudinal Registry data collection, which includes electronic surveys administered at enrollment (baseline) and follow-up time intervals in adults with ME/CFS. Individuals with ME/CFS can opt to track their symptoms using a numerical scale from 0 (symptom absent) to 4 (very severe) in a mobile app. Severity scores are defined as follows, according to the DePaul Symptom Questionnaire: 0=symptom not present, 1=mild, 2=moderate, 3=severe, 4=very severe. ME/CFS: myalgic encephalomyelitis/chronic fatigue syndrome; Registry: You + ME Registry and Biobank.
Figure 2
Figure 2
Overview of the first 6 months of longitudinal Registry data collection, which includes electronic surveys administered at enrollment (baseline) and follow-up time intervals in adult control volunteers. ME: myalgic encephalomyelitis; Registry: You + ME Registry and Biobank. SF-12: 12-item Short Form Survey; SF-36: 36-item Short Form Survey.
Figure 3
Figure 3
Overview of the first 6 months of longitudinal Registry data collection, which includes electronic surveys administered at enrollment (baseline) and follow-up time intervals in adults post–COVID-19. Individuals can opt to track their symptoms using a numerical scale from 0 (symptom absent) to 4 (very severe) in a mobile app. Severity scores are defined as follows, according to the DePaul Symptom Questionnaire: 0=symptom not present, 1=mild, 2=moderate, 3=severe, 4=very severe. ME: myalgic encephalomyelitis; Registry: You + ME Registry and Biobank. SF-12: 12-item Short Form Survey; SF-36: 36-item Short Form Survey.
Figure 4
Figure 4
Using the mobile app tracking screen, users can report the presence and severity of symptoms felt.
Figure 5
Figure 5
Using the mobile app tracking screen, users can log which treatments were taken that day. ME/CFS: myalgic encephalomyelitis/ chronic fatigue syndrome.
Figure 6
Figure 6
Using the mobile app tracking screen, users can provide a rating of general wellness.
Figure 7
Figure 7
Registry enrollment of adults with ME/CFS in the United States by state (as of September 30, 2021). Map based on longitude (generated) and latitude (generated). Each state with ME/CFS and control volunteers enrolled shows a color corresponding to enrollment count aggregated from zip code data provided by participants (N=2085). ME/CFS: myalgic encephalomyelitis/ chronic fatigue syndrome; Registry: You + ME Registry and Biobank.
Figure 8
Figure 8
Registry enrollment of adult control volunteers in the United States by state (as of September 30, 2021). Map based on longitude (generated) and latitude (generated). Each state with participants enrolled shows a color corresponding to post–COVID-19 enrollment count aggregated from zip code data provided by the participants (N=387). ME: myalgic encephalomyelitis; Registry: You + ME Registry and Biobank.
Figure 9
Figure 9
Registry enrollment of adults post–COVID-19 by country (as of September 30, 2021). Map based on longitude (generated) and latitude (generated). Each country with participants enrolled shows a color corresponding to post–COVID-19 enrollment count from country of residence data provided by the participants (N=836). ME: myalgic encephalomyelitis; Registry: You + ME Registry and Biobank.
Figure 10
Figure 10
Percentage of days tracked per week (on average) by each symptom-tracking mobile app user since date of app download. The percentage of days tracked were bucketed into three categories and color-coded in the graph: high engagement (3-7 days per week) moderate engagement (1-2 days per week) and low engagement (less than 1 day per week).
Figure 11
Figure 11
You + ME user satisfaction index measured by the net promoter score (as of September 30, 2021). ME: myalgic encephalomyelitis.

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