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This document presents the CDC's CFS Public Health Research Program 5-year strategic plan, which takes into account the November 2008 Peer Review Panel's recommendations, comments during and following the April 2009 Stakeholders´ Meeting, and discussions with collaborators. In brief, the CFS Public Health Research Program´s primary aim is to reduce morbidity associated with CFS. Program strategy over the next 5-years will follow an interactive biosystems public health model with increasing emphasis on design, implementation, and evaluation of interventions to reduce morbidity associated with CFS. This document briefly:
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CFS is a complex illness representing alterations in multiple ecologically and biologically interrelated homeostatic systems. CFS is not the result of a single mutation or simple environmental factor but arises from a combined action of many genes, environmental factors (including infection) and risk conferring behavior; and, it is clinically heterogeneous and comprised of subtypes. Research Program strategy follows an interactive biosystems public health model as illustrated below. The next 5 years´ work will have an increasing emphasis on translational research, involving design, implementation, and evaluation of interventions to reduce the morbidity associated with CFS and to improve the quality of life of persons with the illness.
Educational intervention involves, on the most immediate level, providing current evidence-based information on diagnosis and management of CFS to health care providers, persons with CFS and their caregivers. On a broader scale it involves providing the most current evidence-based information concerning CFS to federal, state, and local public health authorities, related government agencies, and HMOs and building long-term relationships with government and non-government agencies.
Educational intervention research involves identifying barriers to health care utilization that can be targeted through providers, patients, caregivers, public health authorities, and HMOs. More importantly, it involves measuring outcomes associated with various intervention activities.
The CFS Public Health Research Program conducts public health research leading to the control and prevention of CFS (and similar medically unexplained chronically fatiguing illnesses) and to improve the quality of life of persons with these illnesses. Goals associated with our 5 year vision for the program are to:
Program strategy has successfully focused on obtaining baseline information necessary to plan clinical and educational interventions and to quantitatively/qualitatively measure outcomes associated with intervention efforts. Strategy over the next 5-years will focus on 4 translational research goals to plan, implement and evaluate clinical, educational and public health interventions, and to measure associated outcomes. Many of the Peer Review Panel´s comments and comments offered by Stakeholders reflected parallel thinking.
The aim of this workshop (to be held summer 2009) is to establish a collaborative international consortium of investigators who will present and discuss evidence- and practice-based findings related to the treatment, and management of CFS. Our aim is to produce published management guidelines that are applicable to practicing health care professionals in the treatment of CFS and to establish a network of investigators, clinicians, and others who will meet regularly to discuss clinical management issues pertinent to CFS and related illnesses.
Addresses Goal 2 (B.2)
CFS is defined by symptoms and disability, has no confirmatory physical signs or characteristic laboratory abnormalities, and the etiology and pathophysiology remain inchoate. Difficulties with accurate case ascertainment contribute to this ignorance. To help resolve this, CDC convened an International CFS Study Group, which met in 2000, 2001, and 2002 and in 2003 published recommendations to guide systematic and reproducible application of the case definition. The Study Group´s recommendations have been criticized as too cumbersome for routine use in clinical practice and there is a need for current international consensus as to status of the published 2003 Study Group recommendations and as to an appropriate CFS case definition for health care providers. In 2010 CDC will convene an international workshop to discuss research and clinical CFS diagnostic criteria for adults and children and will produce published guidelines as to diagnostic criteria.
Addresses Goal 2 (B.1)
The illness CFS is clinically heterogeneous and likely comprised of subtypes representing various behavioral, genetic, environmental, and infectious factors and different biological pathways. To begin the process of developing collaborative research and data sharing networks, we will initiate another series of International CFS Study Group workshops to critically assess current clinical and empirical knowledge concerning the pathophysiology and heterogeneity of CFS and identify research priorities and to discuss issues such as common data elements, data collection techniques, and data sharing. Planning of this meeting and selection of participants will draw heavily upon experience from the 2 workshops discussed above. We anticipate that the International CFS Study Group will meet in 2010.
Addresses Goal 3 (C.1) and Goal 1 (A.5)
Field work on the First Follow-up Study of CFS and Chronic Unwellness in Georgia will be completed by July or August, 2009. Approximately 80% of those who participated in the Baseline Survey of CFS and Chronic Unwellness in Georgia have participated in the follow-up. Analysis, interpretation, and presentation of findings will occur through early 2011. Initial analyses (currently approved by IRB review) will focus on:
Addresses Goal 1 (A.1, A.2, A.3, A.4). A.5 Goal 2 (B.1, B.4) Goal 3 (C.1, C.2, C.3) Goal 4 (C.1, C.2, C.3)
The CDC cohort study in metropolitan, urban, and rural Georgia is unique in terms of resources and data and has been highly productive in terms of measurable output and outcomes, as was noted by the Peer Review Panel. Field work on the Second Follow-up Study of CFS and Chronic Unwellness in Georgia will begin in early 2010; will continue into 2011; and, analysis, interpretation and presentation of results will continue through 2012. The Second Follow-up Study will explore associations over a 5-year period between clinical parameters, laboratory biomarkers, psychosocial, and environmental factors and risk of incident CFS, persistent or progressing CFS, and recovery from CFS; this will also help to identify defined subsets of persons with CFS. The Second Follow-up Study will also measure the contribution of electrophysiologically identified sleep disorders to CFS and to the clinical course of the illness. Information from the Second Follow-up Study will be used to modify provider education activities, to evaluate effects of education activities, and to plan intervention trials. The Second Follow-up Study will also measure effects of the current economic crisis on the occurrence and clinical course of CFS.
Addresses Goal 1 (A.1, A.2, A.3, A.4). A.5 Goal 2 (B.1, B.4) Goal 3 (C.1, C.2, C.3) Goal 4 (C.1, C.2, C.3)
The goal of the collaboration with the Mayo Clinic is to utilize medical records from the Rochester Epidemiology Project to study risk factors associated with the incidence of CFS and clinical course of the illness in the population of Olmstead County. This retrospective study will allow us to categorize risk factors associated with CFS. Work will begin in 2009 with analysis, interpretation and publication/dissemination of the data occurring through 2011.
Addresses Goal 1 (A.1, A.2, A3) Goal 3 (C.1, C.2) Goal 4 (D.2).
The initial round of patient recruitment will be completed by December, 2009. Analysis, interpretation, and presentation of findings will occur through late 2010. Focus of initial analyses (approved by IRB review) will concern:
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.2, B.3, B.4) Goal 3 (C.1, C.2) Goal 4 (D.1, D.2, D.3)
A major goal of the pilot patient registry is to evaluate the efficacy and efficiency of 2 study designs for identifying, screening, and enrolling a large number of well characterized patients into a longitudinal registry and then following them longitudinally to evaluate clinical course, outcomes of intervention protocols, and to provide well characterized participants for clinical studies. We anticipate that early in the analysis of data from the pilot registry we will modify enrollment and longitudinal follow-up procedures to be compatible with larger scale regional registry efforts. First follow-up and modification of patient registry activities will occur though FY 2012. In 2013 we will consider a provider registry in another region of the country (based on outcomes of this registry and international workshops). The Registry will form the nidus of educational and clinical trial intervention studies in 2011/2012. These educational intervention studies will serve as proof of concept for extension to other areas of the country
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.2, B.3, B.4) Goal 3 (C.1, C.2) Goal 4 (D.1, D.2, D.3).
This 3-day in-hospital study with Emory University was discussed in detail during the peer review and was highly praised. Field work will be completed in June, 2009; analysis, interpretation, and presentation of findings will occur through early 2011. Focus of initial analyses (approved by IRB review) will concern:
Information obtained from this study will also be discussed during the international workshops (detailed above) and will be integrated into protocols for population cohort studies, into provider education activities, and will be utilized for planning clinical intervention trials.
Addresses Goal 1 (A.2, A.3, A.4, A.5) Goal 2 (B.1, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
All CFS research activities include a laboratory component. Laboratory studies help to clarify associations of behavioral and environmental risk factors with clinical and psychosocial attributes of CFS, to identify subsets of the illness CFS, and to identify potential therapeutic targets. Current laboratory studies measure neuroendocrine function, immune function, genetics, epigenetics, and gene expression. Laboratory studies will remain tightly integrated with all program activities through the next 5-years, and will be modified as appropriate. In addition to integration with specific protocols, aliquots of biological specimens (saliva, serum, plasma, peripheral blood mononuclear cells, DNA and RNA) collected during population and clinical studies are maintained in an anonymous biorepository linked to epidemiologic, survey, and clinical data. Exploration of the contribution of specific pathogens including potential infectious agents and/or reactivation of latent infections (e.g. HHV-6) will also be pursued through relevant collaborative relationships. Finally, metabolic derangements including alterations in glucose metabolism and oxidative stress will be investigated.
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.1, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
Early appropriate clinical intervention effectively reduces the morbidity associated with CFS and similar illnesses. Clinical intervention studies will initially involve currently accepted modalities (e.g., cognitive behavioral and graded exercise therapy); we also anticipate developing pharmacologic intervention studies. Intervention studies will address changes in morbidity of persons with various CFS endophenotypes (identified through field, in-hospital, and laboratory studies discussed above). In addition to direct clinical intervention protocols, intervention studies will involve a substantial provider education effort (discussed below). Intervention studies will occur through the next 5-years and will assume increasing attention through that time.
Addresses Goal 1 (A.3, A.4) Goal 2 (B.2, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
Clinical behavioral intervention studies (conducted in collaboration with Emory University School of Medicine, the Bibb County Medical Society, Mercer School of Medicine, Mayo Clinic, and UK National Health Service) will evaluate cognitive behavioral therapy and graded exercise, and will utilize participants from the provider registry. We will develop protocols and select participants based on outcome of the international workshop on CFS treatment and management (discussed above) and information from ongoing studies of CFS. We plan to stratify impact of intervention by various parameters (e.g., duration of illness, onset type, early life stress, psychiatric comorbidity, cortisol responsiveness, fMRI changes). Selection of stable parameters for outcome measures comprises one of the largest challenges to evaluating the impact of intervention and this is a workshop topic. We anticipate that protocol development for these initial behavioral intervention studies will occur through 2010 and that conduct of these studies will likely occur through 2011/2012.
Pharmacologic trials, as appropriate, will be based on outcomes of the Emory GCRC study, and the evolving CFS evidence-base. We have initiated discussions with several pharmaceutical companies and collaborators at Emory, Case Western Reserve, and Harvard concerning pharmacological intervention trials targeting pathophysiologic pathways involved in CFS.
A major CFS Research Program activity involves providing evidence-based information to the public and to providers; to assuring that the information addresses their current concerns; and, to providing the information in a readily accessible format. We do this through the CDC CFS website. Based on statistical and data mining analysis of website utilization patterns, we are designing a new website, which will be operational in 2009. We will continue detailed analysis of public and professional needs and web utilization and anticipate two additional major revisions of the website through FY 2013. Between major revisions, iterations of the website will be updated as needed, considering evolution of the CFS evidence-base. As part of the 5-year plan, CDC will explore links with state/city health department websites and other websites such as Medscape and WebMD.
Addresses Goal 2 (B.3) Goal 4 (D.1, D.2, D.3).
We anticipate continuing the CME component of provider education for primary care physicians, nurse practitioners, physician assistants, and allied health professionals through the next 5-years. In 2009 we plan on revising the current courses based on:
In 2011 (based on ongoing analyses) we anticipate designing and implementing a more focused set of CFS continuing education courses.
Addresses Goal 2 (B.3) Goal 4 (D.2, D.3).
Partnerships formed with healthcare providers participating in the patient registry provide an opportunity to conduct a focused community health care provider education/intervention study and data collected as part of cohort surveillance and the longitudinal registry will allow us to evaluate outcomes. Based on recommendations from the international workshop on CFS treatment and management (to be held summer 2009), we will design and implement a health care provider education/intervention study in Bibb county, which will occur through FY 2010. Analysis and interpretation of findings and their dissemination will occur through 2011 and we anticipate will be extended through 2013.
Addresses Goal 2 (B.3, B.4) Goal 4 (D.2, D.3).
We are engaging CSTE and state and local health departments in the development of a CFS toolkit and orchestrate its dissemination to public health agencies. Health departments use such toolkits for a variety of public health problems. Over the next 5-years a major component of our translational public health medicine effort will involve engagement with national public health practice organizations, state and local health departments, and HMOs.
Addresses Goal 4 (D.1, D.2, D.3).
Educational intervention research involves identifying barriers to health care utilization that can be targeted through providers, patients, caregivers, public health authorities, and HMOs. More importantly, it involves measuring changes associated with various intervention activities, which have little utility as mere exercises without associated outcome measures. Educational intervention research activities (discussed in all the preceding sections) form an integral part of population cohort surveillance, patient registries, and specific educational interventions.
Addresses Goal 2 (B.3, B.4) Goal 4 (D.2, D.3).
Page last modified on May 29, 2009