Myalgic Encephalomyelitis-Chronic Fatigue Syndrome Common Data Element item content analysis

Area of Science:

• Neurology
• Chronic Illness Research
• Patient-Reported Outcomes

Background:

• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex multisystem disease affecting millions, characterized by profound fatigue, post-exertional malaise, and cognitive impairment.
• Diagnosis is challenging due to fluctuating symptoms, highlighting the need for standardized assessment tools.
• Common Data Elements (CDEs) are crucial for consistent data collection in ME/CFS research and clinical practice.

Purpose of the Study:

• To review and analyze the item content of ME/CFS Common Data Elements (CDEs) available in the NIH NINDS CDE Repository.
• To evaluate how well existing CDEs align with the International Classification of Functioning, Disability and Health (ICF) framework.
• To identify gaps in current CDEs, particularly concerning the impact of ME/CFS on daily activities and participation.

Main Methods:

• A systematic review of ME/CFS CDEs was conducted, applying specific inclusion criteria (symptom assessment, adult focus, PROM suitability, no visual responses).
• Independent review of CDE item content by team members.
• Utilized the World Health Organization ICF framework to categorize and link meaningful concepts within the CDEs.

Main Results:

• Out of 119 reviewed ME/CFS CDEs, 38 met the inclusion criteria, yielding 944 items linked to 1503 ICF concepts.
• The majority of concepts (73.65%) mapped to ICF Body Functions (b-codes), with 'Fatiguability,' 'Energy Level,' 'Sleep Functions,' 'Emotional Functions,' and 'Pain' being most frequent.
• Concepts related to Activities and Participation (d-codes) constituted a smaller proportion (25.62%), with limited assessment of environmental factors (e-codes).

Conclusions:

• Existing ME/CFS CDEs primarily focus on symptom manifestation (body functions) rather than the impact on daily life (activities and participation).
• There is a clear need for the development of ME/CFS-specific, psychometrically sound patient-reported outcome measures (PROMs).
• These PROMs should include items assessing activity limitations and participation restrictions to aid in diagnosis and patient care by primary care providers.