CDC seeks input to shape a CFS strategic research plan

Discussion in 'Fibromyalgia Main Forum' started by QuayMan, Jun 1, 2009.

  1. QuayMan

    QuayMan Member

    http://www.cdc.gov/cfs/meetings/2009_04.htm

    Updated May 29, 2009

    CDC seeks input to shape a CFS strategic research plan

    Acting on a recommendation from an external peer review of CDC’s CFS research program conducted in November 2008, CDC presented its draft 5-year strategic research plan to the CFS Advisory Committee on May 27, 2009. CDC is seeking input from interested parties on issues that CDC will consider as it begins to finalize this research plan.

    The objective of the five-year strategic plan is to conduct public health research leading to the control and prevention of medically unexplained chronically fatiguing illnesses, in particular CFS. CDC is seeking input on the goals and objectives of its CFS research program in five major categories:

    Studies of Defined Populations
    Provider-based Patient Registries
    In-hospital Clinical Studies
    Laboratory Studies
    Provider and Public Educational Intervention Research

    UPDATE: Draft CFS Strategic Research Plan now online

    Public input can be submitted in multiple ways
    Written comments may be sent by mail or email:


    CFS Research Plan
    MS A-30
    1600 Clifton Road, NE
    Atlanta, GA 30333

    CFSResearchPlan@cdc.gov


    General comments regarding the five-year CFS Research Plan must be received at CDC by June 30, 2009.
    For Further Information Contact:
    CFSResearchPlan@cdc.gov

    ================


    One can read more easily at the CDC site

    http://www.cdc.gov/cfs/draft_5yr_research_plan.htm

    Chronic Fatigue Syndrome > CFS Draft 5-year Strategic Plan >

    CFS Public Health Research Program Draft 5-year Strategic Plan

    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:

    Discusses current research program strategy, the interactive biosystems model upon which strategy is based, and current tactical components of the research program.

    Outlines program´s 4 major goals and the logic model that serves as their framework.

    Presents projected activities (milestones) associated with the program´s 4 goals.

    On This Page:

    CFS Public Health Research Program Strategy
    Research Program Strategy Involved 3 Coordinated Complementary Tactical Components

    CFS Public Health Research Program Goals
    Research Program Strategy Involved 4 Coordinated Complementary Goals

    CFS Public Health Research Program 5-year Activities & Milestones Associated with Goals

    I. CFS Public Health Research Program Strategy
    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.

    II. Research Program Strategy Involves 3 Coordinated Complementary Tactical Components

    A. Population-based surveillance
    Cross-sectional and prospective case-control studies of defined populations to:

    Identify risk factors as related to clinical attributes (i.e., subsets) of CFS.
    Identify psychosocial, clinical, and laboratory biomarkers associated with the clinical course of CFS and subsets of the illness (i.e., identify different triggering/perpetuating factors and associated subsets of the illness).
    Evaluate effects of access to and utilization of health care and quality of health care on clinical course of the illness.
    Determine knowledge/attitudes/beliefs concerning CFS, elucidate their effects on clinical course of the illness, and measure changes associated with educational interventions.
    Evaluate direct and indirect economic impact of CFS.
    Provide a source of well characterized participants for in-hospital clinical studies.
    Health care provider based patient registries to:

    Evaluate clinical attributes/clinical course of patients with CFS (and illness subsets) who are in different health care settings.
    Provide data concerning efficacy of education efforts.
    Provide a source of well characterized participants for clinical studies and treatment trials.
    Data repository to further characterize CFS in relation to risk markers. This will involve collaboration with other investigators (i.e., data sharing).

    B. Clinical and laboratory studies
    Hypothesis testing in-hospital clinical studies to:

    More precisely identify risk factors as related to clinical attributes (i.e., identify subsets).
    Measure psychoneuroendocrinologic and immune system characteristics of CFS (i.e., identify subsets).
    Elucidate pathophysiologic mechanisms (i.e., identify subsets).
    Suggest therapeutic targets for various subsets of CFS.
    Laboratory studies to:

    Measure neuroendocrinologic, metabolic, immune and infectious characteristics of CFS (i.e., identify subsets).
    Identify potential diagnostic and therapeutic targets for various subsets of the illness.
    Identify pathophysiologic mechanisms associated with subsets of CFS.
    Identify therapeutic targets.
    Maintain a biorepository for in-house and collaborative molecular analyses.
    C. Educational Intervention & Research
    Educational Intervention
    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
    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.

    III. CFS Public Health Research Program Goals
    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:

    Refine our understanding of etiologic pathways involved in various CFS subgroups in order to improve diagnosis and to identify therapeutic targets.
    Improve clinical management of CFS patients by developing and providing evidence-based educational materials that address evaluation, diagnosis and clinical management of CFS.
    Improve diagnosis and management of CFS through basic research.
    Move CFS into the mainstream of public health concerns.
    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.

    IV. Research Program Strategy Involves 4 Coordinated Complementary Goals
    A. Goal 1: Refine understanding of the etiologic pathways involved in CFS in order to improve diagnosis and to identify therapeutic targets.
    Identify psychosocial, clinical, and laboratory biomarkers associated with the clinical course of CFS and subsets of the illness.
    Identify risk factors as related to clinical attributes (i.e., subsets of CFS).
    Measure neuroendocrinologic, metabolic, immune and infectious characteristics of CFS to identify potential diagnostic and therapeutic targets for various subsets of the illness.
    Elucidate pathophysiologic mechanisms associated with symptoms and subsets of the illness.
    Develop collaborative data sharing networks to extend knowledge concerning CFS.
    B. Goal 2: Improve clinical management of CFS patients by developing and providing evidence-based educational materials that address evaluation and clinical management of CFS.
    Develop international consensus regarding diagnosis of CFS in clinical and research settings (i.e., research, clinical, pediatric/adolescent case definitions).
    Develop international consensus regarding management of CFS and future research direction.
    Provide current evidence-based information on diagnosis and management of CFS to health care providers, persons with CFS and their caregivers, and evaluate associated outcomes.
    Evaluate effects of access, utilization, and quality of health care on clinical course of the illness.
    C. Goal 3: Improve diagnosis and management of CFS through basic research.
    Collaborate to establish an international CFS research network.
    Collaborate to conduct clinical intervention trials.
    D. Goal 4: Move CFS into the mainstream of public health concerns.
    Develop collaborations with national, state and local public health authorities.
    Provide current evidence-based information concerning CFS to federal, state, and local public health authorities, related government agencies, and HMOs.
    Evaluate outcomes associated with dissemination of public health information.
    V. CFS Public Health Research Program 5-Year Activities & Milestones Associated with Goals
    A. Workshops and International Research Networks
    1. International Workshop - Clinical Management of CFS
    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)

    2. International Workshop - CFS Case Definition
    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)

    3. Workshop International - CFS Study Group
    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)

    B. Population-based Surveillance
    1. First Follow-up Study of CFS and Chronic Unwellness in Georgia.
    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:

    Associations between medical history/exercise patterns/tobacco use and CFS.
    Illness perception as related to clinical management of persons with CFS and their associations with clinical course of illness.
    Sense of community/illness perception/illness management/help seeking behavior among those with CFS and their associations with clinical course of illness.
    Interaction of sense of community/depression/and health related quality of life.
    Refined analysis of allostatic load, cortisol, alpha amylase, inflammation index, and genetics of CFS.
    Association of barriers to healthcare utilization with illness course.
    Associations of self-reported sleep disorders and occurrence with clinical course of CFS.
    Incidence of metabolic syndrome and diabetes in those with CFS and various comparison groups.
    Occurrence of other adverse health events in those with CFS and various comparison groups. Focus of initial analyses will be on information that can be used to modify provider education activities.
    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)

    2. Second Follow-up Study of CFS and Chronic Unwellness in Georgia
    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)

    3. Collaboration with Mayo Clinic Rochester Epidemiology Project
    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).

    4. Bibb County CFS Pilot Patient Registry - Initial Enrollment
    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:

    Our initial aim of identifying the most efficacious and efficient manner of identifying screening and enrolling patients.
    Identifying clinical differences between patients enrolled through the registry and persons with CFS identified the population-based studies.
    Identifying issues to concentrate on in provider education.
    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)

    5. Bibb County CFS Patient Registry - First Follow-up
    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).

    C. Clinical Studies, Laboratory Studies
    1. Pathophysiologic Mechanisms of CFS: Neuroimaging, Neuroendocrinology, Genomics
    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:

    Brain regions associated with the cognitive deficits manifested by persons with CFS.
    Neural circuits involved in CFS associated interoception.
    HPA axis, autonomic nervous system, immune system, and neuroendocrine system function during stress.
    Genetic and epigenetic covariables associated with a through c above.
    Identify pathophysiologic/clinical subsets presenting as the illness CFS.
    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).

    2. Laboratory Studies
    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).

    3. Clinical Intervention Studies
    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).

    a. Clinical Behavioral Intervention Studies
    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.

    b. Pharmacologic Trials
    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.

    D. Educational Intervention & Research
    1. Educational Intervention will continue and will evolve through the next 5-years.
    a. CFS Website
    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).

    b. CFS Provider CME
    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:

    Outcomes of the international workshop on CFS treatment and management.
    Statistical and data mining analysis of CME website utilization patterns data concerning utilization of the existing courses.
    National surveys of provider knowledge, attitudes, and beliefs.
    The changing evidence-base concerning clinical, research, and treatment.
    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).

    c. Pilot Health Care Provider Education/Intervention
    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).

    d. New Relationships with Public Health Agencies
    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).

    2. Education Intervention Research
    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
  2. skeptik2

    skeptik2 Member

    I'm afraid 90% of the people on here won't read this long article, but I hope we who really really care will go to the CDC site and print it out and tear it apart word for word.

    Only ACTION NOW will work this June, 2009!

    Let's do it!

    skeptik2

  3. QuayMan

    QuayMan Member

    Yes, skeptik2, it is very long.

    But hopefully, like you say, people can take bits out of it and share their thoughts here.