Ensuring the Voice of Very Severely Affected ME/CFS Patients in Research

Purpose: To provide a research model enabling very severely affected Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients to participate in studies, addressing their unique challenges and ensuring their voices are heard.

Key Points:

1. Challenges in Research Participation:
   • Historically, very severely affected ME/CFS patients have been excluded from studies due to their condition being described as “hard to reach.”
   • Common barriers include cognitive impairments, physical limitations, and misrepresentation of their illness.
2. Research Model Development:
   • A questionnaire was created with reasonable adjustments to maximize participation, such as simple design, flexibility, and direct outreach methods.
   • Patients were given the option to complete the questionnaire via phone, text, or with the help of family and caregivers.
3. Participation Outcomes:
   • Five very severely affected patients completed the study, providing invaluable qualitative data.
   • Adjustments, like allowing extended timeframes and flexible appointments, minimized health risks and improved participation rates.
4. Key Recommendations for Researchers:
   • Utilize support from charities and advocacy organizations for outreach.
   • Design surveys with simple language and user-friendly completion options.
   • Offer telephone or text support and ensure flexibility in deadlines.
   • Engage researchers with expert knowledge of ME/CFS to ensure patient-friendly methodologies.

Target Audience: Researchers, healthcare providers, ME/CFS advocates, and policymakers seeking to include very severely affected patients in research.

Overall Outcome: The study demonstrates that with adequate support and adjustments, very severely affected ME/CFS patients can meaningfully contribute to research. The document provides a replicable model for future studies aiming to include this marginalized group.