The Solve ME/CFS Initiative (SMCI) is in the final stages of constructing a new state-of-the art patient registry platform. Last year, we took the initiative in addressing a knowledge gap barrier to defining the natural history of ME/CFS, while simultaneously modernizing electronic health record platforms for ME/CFS. This new patient registry platform will incorporate the latest in cutting-edge registry design while enhancing our ability to collaborate and exchange data with various organizations and groups. This contributes to the overarching goal of harnessing robust, patient-driven data in a national registry. The development of this tool is vital to furthering the scientific understanding of ME/CFS and producing tangible benefits for the ME/CFS community.
The registry will elevate our data collection efforts to the next level. This platform features the benefits of modern registry design, a collaborative network, and patient-centered functionality, giving individuals power over their own health information. The registry will enable a range of functionality to include:
- Performing longitudinal and cross-sectional studies.
- Informing clinical trial design.
- Sharing information with organizations and researchers for educational and research purposes.
- Collecting demographic, genetic, social sciences, health disparity, comorbidity and treatment outcome data.
- Conducting relevant and targeted surveys.
- Creating an information hub that will benefit the ME/CFS community as a whole.
It is important to note that the establishment of a national registry dedicated to the ME/CFS community is occurring in conjunction with other vital research improvement developments. The Platform for Engaging Everyone Responsibly (aka P.E.E.R. platform) is equipped to incorporate Electronic Health Records and creates more comprehensive patient history over time. Additionally, the Common Data Elements (CDE) project, a collaboration between NIH and CDC, is a national effort to standardize and define relevant health information. This allows research to be comparable between studies and precise patient information to be analyzed to draw conclusions about the disease.
This registry is also immensely important in light of the NIH ME/CFS collaborative Data Management Coordinating Centers (DMCCs) initiative, expected to launch in early 2018. SMCI’s registry will work in conjunction with the NIH Collaborative Research Centers (CRCs) to knit together a comprehensive and integrated approach to data collection, management, and its use in research.
Above: A summary of the various interfaces including a map of the key registry components.
- It is helpful to define the basic principles of patient registries in order to unpack the power they have for understanding and solving ME/CFS. A patient registry is a system that utilizes observational study methods to catalogue uniform data from a population defined by a disease, condition, or exposure.
- Registries can advance basic scientific discovery goals, translational research, and inform policymaking.
- They have the power to capture real-world health data that might be obscured from clinical studies.
- Those that are designed in a patient-centered way better home in on comparisons and outcomes that matter to people and allow for individual autonomy and preferences. PEER accomplishes this particular piece through “PrivacyLayer” technology from Private Access. This allows for granular privacy settings and the ability for users to participate in multiple research projects of their choice over time.
Above: A graphic illustrating Public Views of Privacy and Health Research. Courtesy of Genetic Alliance, based on data from a 2009 study commissioned by Institute of Medicine. This is the approach used by the SMCI PEER Registry.
Registries can exist within a research network to provide a shared infrastructure and standardized data collection. This can potentially extend intersectional benefits across disease populations based on generalizability of the data. Given the many factors of the ME/CFS illness, (for example, symptom overlap, such as pain and fatigue that are evident across many diseases like diabetes and cancer), and comorbidities (e.g. POTS, fibromyalgia), participation in a broad and collaborative research network will be very valuable.
We believe that the research network will allow us reciprocal benefit with participating research groups and position SMCI as a key source of information to other disease organizations, government agencies, and the public. Dr. Zaher Nahle, Chief Scientific Officer and Vice President for Research, asserted “creating a modern platform with collaborative features supported by an initial award from the Robert Wood Johnson Foundation is a key development that will assist patients, researchers, organizations, and policy makers.” He emphasized that SMCI views this as a community project and is approaching and collaborating with all stakeholders available. The SMCI team is also fortunate to now have talented public health specialist Allison Ramiller on board as our scientific administrator working on this project and collaborating with all stakeholders.
Originally made possible by a grant from the Robert Wood Johnson Foundation White Label Partnership for Engaging Everyone Responsibly (PEER) project, an innovative, patient-centered research network. This competitive grant program is managed by Genetic Alliance, a leading advocacy organization committed to transforming health through genetics and promoting novel partnerships and access to information to enable translational research. This support further establishes our commitment to connecting patients with researchers and expediting the discovery process.