Community Advisory Committee Introduces Guidelines to Accelerate Meaningful ME/CFS Research

by Therese Russo and Kathi Kuehnel, lead authors on behalf of the Community Advisory Committee

Researchers from across the NIH’s ME/CFS Collaborative Research Center (CRC) consortium held a two-day network meeting in October to share findings from their past four years of NIH-funded research.  This year, the Community Advisory Committee (CAC) was invited to participate and also present its work. With support from the NIH, Columbia launched the CAC with the goals of increasing stakeholder communication and research participation, and accelerating the pace of ME/CFS research.

Centering the community perspective by including the CAC in the consortium’s meetings represents a shift from the norm: to the ME/CFS community, research has often seemed like a mysterious “black box,” with few mechanisms to ensure transparency and engagement.  Patients often wait years for even interim updates on studies. People with ME/CFS have advocated for greater involvement at all stages of the research process for years, and patient advocacy was crucial to the establishment of the CAC.

Partnering with people who have lived experience with a disease leads to research that has a deeper impact and better outcomes in patient care ¹. Meaningful patient inclusion also improves grant writing, recruitment strategy, dissemination strategy, patient interviews, data collection and both tool development and refinement. Despite these benefits, there are few efforts to include patient perspectives in ME/CFS research. The CAC was created to more effectively engage patients throughout the research cycle. 

“Most of us live with this awful illness every single day. We never get to turn it off, leave it at the office or forget about it. We never escape its harsh reality. Every day, we know that many people are waking up and asking themselves, can I live like this any longer?… We have everything riding on your research. Every hope. Every dream. We are fully invested in your success….partner with us and together let’s create impact with and for a community that desperately needs us to get this right.”

-Sabrina Poirier, CAC Member at 2020 NIH CRC Annual Meeting 

The CAC is composed of 15 people with ME/CFS and/or family members of people with ME/CFS. Members come from diverse personal and professional backgrounds, including research, health care, advocacy, education, law, politics, health policy, social work, and community building.  Members also include representatives from ME/CFS nonprofits and research organizations, including #MEAction, the Solve ME/CFS Initiative (Solve M.E.), the Bateman Horne Center, Doctors with M.E., U.S. ME/CFS Clinician Coalition and ICanCME. 

Taken together, this committee’s decades of lived experience with the disease, and the members’ deep connections in the ME/CFS community, position the group to provide insight and guidance on what research will most benefit the patient community and how researchers can design studies that are feasible and practical from the perspective of people with ME/CFS. 

At the October network meeting, the Director of Scientific & Medical Outreach at #MEAction and CAC member Jaime Seltzer presented a draft of the CAC’s Study Feasibility Working Group’s² paper ME/CFS Study Design and Recruitment: A Toolkit for Researchers and Research Coordinators. The Toolkit guides researchers in best practices for recruiting, selecting, and retaining research subjects; accommodating their related medical, sensory, and energy issues; and engaging people with lived disease experience in research design, implementation, and dissemination.

“There is abundant evidence that patient involvement improves research quality,” says Seltzer. “Studies in which patients shape or direct research have the most successful recruitment, and using in-group language can elicit more honest answers and ‘buy-in’ in epidemiological surveys. Patient-oriented research has also been shown to affect healthcare outcomes like diagnostic rates and earlier interventions.”

Dr. Rochelle Joslyn, PhD (Immunology), who has more than a decade of experience in human biomedical research, provided the CAC’s Research Priorities Working Group’s assessment on key barriers and urgent needs in ME/CFS research, as outlined in a comprehensive research priorities document that will be published soon. 

The presentation included a “Gordian Knot” image representing the interplay of biological, medical, social, legal and political constraints that have inhibited research and kept ME/CFS patients sick and without treatment for decades. The CAC urged members of the CRCs and NIH to bring about real change and deliver meaningful outcomes for people living with ME/CFS by working together to address these long-standing issues.

“Patients’ lived experience, diverse and complementary skills, and deep connection to the broader ME community are critical assets that must be leveraged to successfully move the field,” says Dr. Joslyn.

There is important overlap in the recommendations from both presentations. Both underscored the need for:

1. A standardized, high-quality ME/CFS case definition, and patient selection methods³; 
2. Consistent, objective measurement of the hallmark symptom – post exertional malaise (PEM); and 
3. Intentional, robust inclusion of Black, Indigenous, and People of Color (BIPOC) and severely ill people as research subjects. 

These presentations were starting points for an ongoing conversation between researchers and the CAC members. Collaboration and consensus-building amongst people with different positions and perspectives in research and medicine necessarily takes time and steady communication. But ultimately, it yields more robust, patient-centered outcomes. 

We will provide detailed reports on both the CAC’s Study Design Toolkit and Research Priorities in future blog posts. 

In months to come, we will begin posting the new ME/CFS Research Network Webinar series, which will feature presentations from across the network, along with panel discussions to delve deeper and answer the community’s questions. Research topics will include immune dysregulation, disordered energy metabolism, gastrointestinal dysbiosis, and other biological abnormalities in ME/CFS patients. 

The NIH CRCs have begun to develop biomarker and clinical trial hypotheses, which we hope to see funded in the upcoming NIH competitive renewal applications.  And not insignificantly, the field is beginning to see consistent findings across the Centers. This reproducibility is essential for building confidence in the validity and reliability of key results. 

The CAC’s goal is to continue making this information more accessible to the community of people living with ME/CFS and related conditions, for a more informed, empowered global community. Stay tuned. 

¹For several papers on these topics see the following:

• Forsythe LP, Carman KL, Szydlowski V, Fayish L, Davidson L, Hickam DH, Hall C, Bhat G, Neu D, Stewart L, Jalowsky M, Aronson N, Anyanwu CU. Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute. Health Aff (Millwood). 2019 Mar;38(3):359-367. doi: 10.1377/hlthaff.2018.05067. PMID: 30830822;
• Esmail L, Moore E, Rein A. Evaluating patient and stakeholder engagement in research: moving from theory to practice. J Comp Eff Res. 2015 Mar;4(2):133-45. doi: 10.2217/cer.14.79. PMID: 25825842;
• Ennis L, Wykes T. Impact of patient involvement in mental health research: longitudinal study. Br J Psychiatry. 2013 Nov;203(5):381-6. doi: 10.1192/bjp.bp.112.119818. Epub 2013 Sep 12. PMID: 24029538

²For more information about the working group structure of this Community Advisory Committee, see this October 2020 blog entry. 

³The 2011 NIH State of Knowledge report reads: “According to presenters, working toward a single, more usable and accurate case definition for this illness would create a more solid foundation for research and ultimately benefit people living with this illness.” For more details, see the full report.