Myalgic Encephalomyelitis—Chronic Fatigue Syndrome Common Data Element item content analysis, 2023, Slavin, Bateman, Systrom et al.

[SNT Gatchaman]

Myalgic Encephalomyelitis—Chronic Fatigue Syndrome Common Data Element item content analysis
Mary D. Slavin; Hannah M. Bailey; Emily J. Hickey; Ananya Vasudevan; Aileen Ledingham; Linda Tannenbaum; Lucinda Bateman; David L. Kaufman; Daniel L. Peterson; Ilene S. Ruhoy; David M. Systrom; Donna Felsenstein; Lewis E. Kazis

Introduction
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multisystem chronic disease estimated to affect 836,000–2.5 million individuals in the United States. Persons with ME/CFS have a substantial reduction in their ability to engage in pre-illness levels of activity. Multiple symptoms include profound fatigue, post-exertional malaise, unrefreshing sleep, cognitive impairment, orthostatic intolerance, pain, and other symptoms persisting for more than 6 months. Diagnosis is challenging due to fluctuating and complex symptoms. ME/CFS Common Data Elements (CDEs) were identified in the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element Repository. This study reviewed ME/CFS CDEs item content.

Methods
Inclusion criteria for CDEs (measures recommended for ME/CFS) analysis: 1) assesses symptoms; 2) developed for adults; 3) appropriate for patient reported outcome measure (PROM); 4) does not use visual or pictographic responses. Team members independently reviewed CDEs item content using the World Health Organization International Classification of Functioning, Disability and Health (ICF) framework to link meaningful concepts.

Results
119 ME/CFS CDEs (measures) were reviewed and 38 met inclusion criteria, yielding 944 items linked to 1503 ICF meaningful concepts. Most concepts linked to ICF Body Functions component (b-codes; n = 1107, 73.65%) as follows: Fatiguability (n = 220, 14.64%), Energy Level (n = 166, 11.04%), Sleep Functions (n = 137, 9.12%), Emotional Functions (n = 131, 8.72%) and Pain (n = 120, 7.98%). Activities and Participation concepts (d codes) accounted for a smaller percentage of codes (n = 385, 25.62%). Most d codes were linked to the Mobility category (n = 69, 4.59%) and few items linked to Environmental Factors (e codes; n = 11, 0.73%).

Discussion
Relatively few items assess the impact of ME/CFS symptoms on Activities and Participation. Findings support development of ME/CFS-specific PROMs, including items that assess activity limitations and participation restrictions. Development of psychometrically-sound, symptom-based item banks administered as computerized adaptive tests can provide robust assessments to assist primary care providers in the diagnosis and care of patients with ME/CFS.

Link | PDF (PLOS ONE)

 

[Ravn]

Relatively few items assess the impact of ME/CFS symptoms on Activities and Participation. Findings support development of ME/CFS-specific PROMs, including items that assess activity limitations and participation restrictions

Haven't yet read the paper properly but on a quick skim it doesn't look like they discussed if or how to include this new questionnaire in the Common Data Elements PROMs list:
https://www.s4me.info/threads/norwa...ctioning-in-pwme-cfs-open-for-feedback.24995/

 

[Ravn]

Have now read this and the short and unsurprising summary is this: the PROMs currently available for ME/CFS research aren't good enough

The slightly longer version:

The authors analysed Patient Reported Outcome Measures (PROMs) held in the ME/CFS Common Data Elements Repository (CDEs).

To do this they matched the concepts asked about in the PROMs against the concepts listed in the WHO International Classification of Functioning, Disability and Health (ICF) categories. They chose the ICF because it's an "internationally recognized framework"

Result 1: There are categories in the ICF which would be appropriate to measure in ME/CFS but which are largely ignored by the currently available PROMs

A smaller percent (25.62%) of ME/CFS CDEs meaningful concepts were linked to the ICF Activities and Participation Component. Examination of category/subcategories demonstrates a limited representation of activities that are important to persons with ME/CFS. For example, decreased social interaction is an important participation restriction experienced by persons with ME/CFS [34]; however, only 1.73% of ME/CFS CDEs meaningful concepts pertained to social activities and social interactions. Analysis of content related to Environmental Factors also revealed little representation in ME/CFS CDEs. Examples of the impact of Environmental Factors on the lives of persons with ME/CFS include support from others and accessibility issues

Result 2: There are categories in the ICF which superficially appear to measure relevant factors in ME/CFS but which are off-target on closer inspection

The definition of Fatiguability provides an accurate description of ME/CFS symptoms; however, this ICF subcategory is located under Exercise Tolerance Functions under Functions of the cardiovascular, hematological, immunological and respiratory system, which is not a precise description of fatiguability experienced by persons with ME/CFS. ICF categories Energy Level and Energy and Drive Functions, located under Mental Functions, describe ME/CFS symptoms; however, it is important to note that the ICF does not include a category for energy impairments not related to mental function

Result 3: The ICF does not have any suitable categories for PEM

Limitations of the ICF framework posed several challenges to linking, particularly for concepts related to fatigue and PEM. Previous efforts to define ME/CFS ICF Core Sets [28] identified similar limitations in applying the ICF. Specifically, ME/CFS ICF Core Set developers acknowledged a discrepancy between the clinical manifestations of PEM and available ICF categories; the authors emphasized the need for ICF categories that better describe ME/CFS symptoms [28]

So clearly there's work to be done. Or maybe there is work being done? Does anyone know what the bolded (by me) section below refers to?

Future research is needed to identify optimal structure for PROM item content and address item content gaps. Study findings suggest that focusing on developing items that assess activity limitations and participation restrictions may be an effective strategy to better understand symptom impact. This effort will require qualitative research to develop items that reflect the lived experiences of persons with ME/CFS [37]. Work is currently underway to develop ME/CFS condition-specific PROM item banks. Use of computerized adaptive tests (CATs) to administer these item banks will increase efficiency for researchers and clinicians and decrease patient burden.

Oh, and this is a nice touch:

The research team wishes to express much appreciation to Dr. Ronald Tompkins for his past leadership and vision for new innovative diagnostic assistive approaches that identify the complex symptomatology of those with ME/CFS for use in clinical practice.

Mary Dimmock provided guidance on ME/CFS CDEs and interpretation of the ICF framework.