Multi-site Clinical Assessment of CFS

Scientific studies, such as this one, follow strict rules for selecting participants. Unless you are a patient at one of the seven participating clinical sites, and meet the eligibility assessment, you cannot join the study.

Full and open competition was used in soliciting offers for this requirement. The request for proposals (RFP 2011-N-13483) was posted in FedBizOpps in July 2011. This proposed procurement action was not set-aside for small business. All the valid contract proposals submitted within 30 days of the posting of the solicitation were reviewed and three contracts were awarded with a total of seven clinic sites.

No specific case definition was used. Any patient (aged 18 – 70 years) that is managed or diagnosed with CFS, post-infective fatigue (PIF) or myalgic encephalomyelitis (ME) at any of the seven participating clinical sites is eligible for participation in this study. Clinicians from each participating clinical site will determine whether a patient has CFS based on their clinical experience and expertise in CFS.

The goal of the study was to collect standardized data to characterize the illness as managed by clinical experts. This data can then be used to evaluate the strengths and weaknesses of current case definitions and determine refinements or additions of sub-groups for both clinical and research work.