By K. Kimberly McCleary, President & CEO
The challenge of comparing results from CFS research studies conducted in different laboratories was one of the barriers to progress identified at the April 2011 ME/CFS State of the Knowledge Workshop sponsored by the National Institutes of Health. Variability arises from a lack of standard sampling methods, patient characteristics and clinical assessments and the frequent failure for these parameters to be described in the manuscripts reporting results.
To address this problem, eight members of the federal CFS Advisory Committee (plus a colleague from Harvard) have published a consensus set of minimum data elements with the goal of improved consistency of reported methods and better comparisons among published studies.
“Minimum Data Elements for Research Reports on CFS”
Jason LA, Unger ER, Dimitrakoff J, Fagin A, Houghton M, Cook D, Marshall GD, Klimas NG, Snell C.
Brain, Behavior and Immunity
E-publication ahead of print available Jan. 26, 2012
Link to abstract*: http://bit.ly/zT5dO0
The paper includes two tables that outline the minimal and additional data elements recommended (table 1) and additional elements (table 2). Table 1 includes study design, demographics of study population, case definition, symptom inventory, medical and psychiatric exclusions and co-morbidities (including screening laboratory tests and current medications) and self-reported functional impairment/levels of activity. For the last item, they recommend six validated instruments.
Table 2 recommends collection and reporting of nine additional elements: functional assessment, cognition, allostatic load, HPA-axis activity, immune functioning and allergies, sympathetic activity (salivary amylase and heart rate variability), coping, genomic and transcription studies and proteomic studies. They note in the text, “As post-exertional malaise is a key symptom of all CFS case definitions, it would be appropriate to measure the extent of activity and how such activity might result in symptoms of fatigue and malaise.” They go on to describe different measurement tools that might be employed, acknowledging the limitations where appropriate.
As stated in the opening paragraphs of the paper, “…it would be both scientifically and clinically useful and informative to sub-categorize patients according to disease-relevant variables including clinical criteria, co-morbidities, biomarkers, etc.” The authors indicate that they at work on another paper that outlines domains of illness (e.g., fatigue, pain, sleep disturbance, etc.) and specific and reliable measures to measure them.
In the paper’s final paragraph, the authors state,
“Additional work that needs to be done involves the collection of standardized data fully characterizing CFS patients across clinical settings will make collection of biologic samples and establishment of a biorepositories a crucial resource for the next generation of molecular testing. Having standardized data and biologic samples in the hands of experienced investigators, will increase the chance of validating findings and establishing meaningful sub-groups of CFS linked to biologic alterations amenable to therapeutic interventions. At the present time, there are three groups that are attempting to do just this; one headed by the Chronic Fatigue Initiative, the other by the CFS group at the CDC, and a third by the CFIDS Association’s [SolveCFS] BioBank.
It’s encouraging to see this kind of collaborative effort to build tools that will improve comparability of studies and strengthen the design of news ones. It is essential for validation of biomarkers, identification of objective diagnostics and subtyping tools and demonstrating the efficacy of various treatments for CFS.
*We are seeking to provide access to the full text of this paper through our collaboration with patientINFORM. Please check back in a few days for updates.
K. Kimberly McCleary served as the Association’s chief staff executive from 1991-2013.February 8, 2012