CDC CFS Public Health Research Program 5-year Strategic Plan (Oct 2009)

Discussion in 'Fibromyalgia Main Forum' started by QuayMan, Oct 23, 2009.

  1. QuayMan

    QuayMan Member

    [I'm highlighting a couple of things which caught my eye. All of #4 (Workshops and International Research Networks) I think is important. The most important issue at the moment in my opinion is that the empirical definition for CFS (Reeves 2005) continues to be used. The version on the website in rich text is easier to read]


    First Follow-up Study of CFS and Chronic Unwellness in Georgia
    [..]
    "?Evaluate association between medical history, exercise patterns, tobacco use, and CFS"

    ------
    Clinical behavioral intervention studies will be conducted in collaboration with Emory University School of Medicine, Bibb County Medical Society, Mercer School of Medicine, Mayo Clinic, and UK National Health Service. Anticipated protocol development will begin in late 2010-2011, with studies continuing through 2013.

    ?Evaluate cognitive behavioral therapy and graded exercise in participants
    ?Stratify impact of intervention by various parameters including duration of illness, onset type, early life stress, psychiatric comorbidity, cortisol responsiveness, and fMRI changes



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

    http://cdc.gov/cfs/cfs_strategic_plan.html

    Centers for Disease Control and Prevention CFS Public Health Research Program 5-year Strategic Plan
    (October 2009)


    In November 2008, CDC convened an external peer review panel to examine its Chronic Fatigue Syndrome Research Program. One recommendation of this panel was to develop a strategic plan for research. CDC sought broad public input in the development of its plan, including comments during and following an April 2009 public meeting, discussions with collaborators, and input received at and following the May 2009 HHS CFS Advisory Committee meeting.

    In response to CDC´s request for input to the strategic research plan, from April 27 through July 30, 2009, we received almost 1,200 items of correspondence from scientific societies, patient advocacy organizations, researchers, physicians, and many individuals with CFS and their family members. Comments specific to the draft could be categorized into the following topic areas:

    •Pathophysiology of CFS
    •Causes of CFS
    •Diagnostics
    •In-hospital and pharmacologic studies
    •Treatment and management of illness
    •Provider and public education
    •CFS in children

    The current strategic plan addresses all of these issues.

    Many comments received also raised questions not directly related to the research plan and pointed out misconceptions about CFS and CDC´s activities. We are developing a revision to our website to address these questions and concerns and will also explore other mechanisms to improve our communications with patients and our partners regarding these important issues.

    The CFS Public Health Research Program 5-year Strategic Plan published below reflects CDC´s goals and planned activities to address this important public health issue.

    I. CFS Public Health Research Program Strategy
    CFS is a complex illness representing alterations in multiple ecologically and biologically interrelated homeostatic systems. CFS is clinically heterogeneous and comprised of subtypes. CFS is not the result of a single mutation or simple environmental factor but likely arises from a combined action of many genes, environmental factors (including infection), and risk conferring behaviors. CDC´s CFS Public Health Research Program´s 5-year strategic plan takes into account recommendations of the November 2008 Peer Review Panel, comments solicited from stakeholders, and discussions with collaborators. As noted by the Peer Review Panel´s report and in alignment with CDC´s public health mission, program strategy has successfully focused on obtaining baseline information necessary to plan interventions and to qualitatively and quantitatively measure associated outcomes. These activities complement clinical research initiatives that focus on the causes, consequences, and treatment of CFS and related diseases, such as those sponsored by the National Institutes of Health (NIH) and other research organizations. CDC has ongoing collaborations with these organizations and plans to strengthen these collaborations further, as recommended by the Peer Review Panel.

    Over the next five years, the CFS Public Health Research Program strategy will follow an interactive, biosystems model approach with increasing emphasis on translational research that involves the design, implementation, and evaluation of clinical, educational, and public health interventions. By conducting public health research that leads to control and prevention strategies, the overarching goal is to reduce the morbidity associated with CFS (and similar medically unexplained chronically fatiguing illnesses) and to improve the quality of life of persons with these illnesses.

    II. CFS Public Health Research Program Goals - What CDC desires to accomplish
    1.Refine understanding of the etiologic pathways involved in CFS in order to improve diagnosis and to identify therapeutic targets
    ?Identify risk factors related to constellations of 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
    ?Measure neuroendocrinologic, metabolic, immunologic, 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
    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
    3.Improve diagnosis and management of CFS through basic research
    ?Collaborate to establish an international CFS research network
    ?Collaborate to conduct clinical intervention trials
    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
    III. CFS Public Health Research Program Activities - How CDC plans to meet its Goals
    1.Population-based surveillance
    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 was completed in August 2009. Approximately 80% of those who participated in the baseline survey also participated in the follow-up study. Analysis, interpretation, and presentation of findings will occur through early 2011. Focus of initial analyses will be on information that can be used to modify provider education activities.

    ?Determine knowledge, attitudes, and beliefs concerning CFS and the effect on clinical course of the illness
    ?Evaluate direct and indirect economic impact of CFS
    ?Evaluate association of barriers to healthcare utilization with illness course
    ?Evaluate association between medical history, exercise patterns, tobacco use, and CFS
    ?Refine analysis of allostatic load, cortisol, alpha amylase, inflammation index, and genetics of CFS
    ?Evaluate incidence of metabolic syndrome and diabetes
    Second Follow-up Study of CFS and Chronic Unwellness in Georgia
    Field work on the second follow-up study of CFS and chronic unwellness in Georgia will begin in mid-2010 and continue into 2011, with analysis of results occurring through 2012.

    ?Identify defined subsets of persons with CFS
    ?Modify provider education activities, evaluate effects of education activities, and plan intervention trials
    ?Explore associations between clinical parameters, laboratory biomarkers, psychosocial, and environmental factors and the risk of incident CFS, persistent or progressing CFS, and recovery from CFS
    ?Measure the contribution of electrophysiologically identified sleep disorders to CFS and to the clinical course of the illness
    Mayo Clinic Rochester Epidemiology Project
    Retrospective collaborative study will 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. Work will begin in late 2009 with analysis, interpretation, and publication of data occurring through 2011.

    ?Categorization of risk factors associated with CFS
    CFS Among Adolescents in Foster Care
    The Georgia Department of Human Services has requested CDC, in collaboration with Emory University, to determine the relevance of unwellness among adolescent wards of the Georgia foster care program as these children manifest an excess of CFS risk factors. Planning will begin in late 2009, field work on the initial survey will begin in 2010, initial analyses will be complete by late 2010, and intervention studies will occur through 2013.

    ?Identify risk and resilience factors for CFS
    Bibb County CFS 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 mid-2010.

    ?Identify the most efficacious and efficient manner of identifying, screening, and enrolling patients in longitudinal registry
    ?Identify clinical differences between patients enrolled through the registry and persons with CFS identified in the population-based studies
    ?Identify provider education issues
    Bibb County CFS Patient Registry - first follow-up study
    First follow-up and modification of patient registry activities will occur though FY 2012. In 2013, a provider registry may be considered in another region of the country.

    ?Evaluate clinical course and outcomes of intervention protocols
    ?Identify well-characterized participants for clinical studies
    2.Clinical and Laboratory Studies
    In-Hospital Clinical Studies
    Field work from a three-day, in-hospital study, in collaboration with Emory University, was completed in July 2009 and analyses will occur through early 2011. Study findings will be integrated into protocols for population cohort studies, provider education activities, and clinical intervention trials.

    ?Identify brain regions associated with cognitive deficits in CFS
    ?Identify neural circuits involved in CFS-associated interoception
    ?Evaluate HPA axis, autonomic nervous system, immune system, and neuroendocrine system function during stress
    ?Identify genetic and epigenetic covariables
    ?Identify pathophysiologic and clinical subsets presenting as the illness CFS
    Laboratory Studies
    The integration of laboratory studies with specific CFS research protocols helps to clarify associations of behavioral and environmental risk factors (including infection) with clinical and psychosocial attributes of CFS, to identify subsets of the illness CFS, and to identify potential therapeutic targets.

    ?Measure neuroendocrinologic, metabolic, immunologic, and infectious characteristics of CFS
    ?Evaluate genetics, epigenetics, and gene expression
    ?Identify potential diagnostic and therapeutic agents
    ?Evaluate the potential association of human herpes virus 6 (HHV-6) and xenotropic murine leukemia virus-related virus (XMRV) with CFS using specimens from well-characterized patients and matched controls
    ?Maintain a biorepository of clinical specimens collected during population and clinical studies for in-house and collaborative molecular analyses
    ?Develop a funding opportunity announcement to explore the application of novel pathogen discovery approaches to existing, well-characterized clinical specimens
    Clinical Intervention Studies
    Clinical behavioral intervention studies will be conducted in collaboration with Emory University School of Medicine, Bibb County Medical Society, Mercer School of Medicine, Mayo Clinic, and UK National Health Service. Anticipated protocol development will begin in late 2010-2011, with studies continuing through 2013.

    ?Evaluate cognitive behavioral therapy and graded exercise in participants
    ?Stratify impact of intervention by various parameters including duration of illness, onset type, early life stress, psychiatric comorbidity, cortisol responsiveness, and fMRI changes


    Results from the CFS adolescent foster care study will be used to plan a large-scale longitudinal intervention study that will occur through 2013.

    ?Identify and target specific risk factors for CFS


    Pharmacologic intervention trials will be conducted in collaboration with partners that may include pharmaceutical companies and academia. Anticipated protocol development will begin in 2010-2011 and studies could occur through 2013.

    ?Target pathophysiologic pathways involved in CFS
    Data Sharing
    The CFS Public Health Research Program embraces the philosophy of transparency in the preparation, dissemination, and use of scientific information, including large datasets. A recent example of this approach resulted in the publication of a collection of findings and advances that could not have been made by any one research organization alone. The CFS Public Health Research Program is committed to working with the Office of Science and Technology Policy, the Department of Health and Human Services, CFS research colleagues, and others, to develop working policies and procedures to implement these data-sharing goals while maintaining appropriate protection for all research study participants.

    3.Educational Intervention and Research
    DocStyles
    DocStyles is a CDC sponsored national survey to aid in understanding healthcare providers´ knowledge, attitudes, and beliefs concerning CFS. CDC anticipates receiving an analysis database in October 2009, based on questions in the current DocStyles survey, and publishing the results in early 2010.

    ?Design educational interventions and evaluate their efficacy
    ?Develop questions for next DocStyles survey
    CDC CFS Website
    Based on statistical and data mining analysis of website utilization patterns, a new CDC CFS website is under design and should be operational in late 2009, with two additional major revisions anticipated by 2013. Beginning in late 2009, CDC will also explore links with other websites including those of state and city health departments, Medscape, and WebMD.

    ?Detailed analyses of public and professional user needs
    CFS Provider CME
    CDC anticipates continuing the CME component of provider education for primary care physicians, nurse practitioners, physician assistants, and allied health professionals. In 2010-2011, the current courses will be revised.

    ?Design and implementation of a more focused set of CFS continuing education courses
    Pilot Health Care Provider Education
    Partnerships formed with healthcare providers participating in the patient registry in Bibb County will provide an opportunity to conduct a focused community health care provider education and intervention study.

    ?Engage CSTE and state and local health departments in the development of a CFS toolkit and orchestrate its dissemination to public health agencies
    ?Engage national public health practice organizations, state and local health departments, and HMOs
    4.Workshops and International Research Networks
    International Workshop - Clinical Management of CFS
    The aim of this workshop, anticipated to be held in 2010, 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.

    ?Publish management guidelines applicable to practicing health care professionals in the treatment of CFS
    ?Establish a network of investigators, clinicians, and others who will meet regularly to discuss clinical management issues pertinent to CFS and related illnesses
    International Workshop - CFS Case Definition
    CDC convened an International CFS Study Group that met in 2000, 2001, and 2002, and in 2003, published recommendations to guide systematic and reproducible application of the case definition. In 2010, CDC anticipates convening an international workshop to discuss research and clinical CFS diagnostic criteria for adults and children.

    ?Develop consensus as to status of the published 2003 Study Group recommendations
    ?Develop consensus as to an appropriate CFS case definition for health care providers
    Page last modified on October 23, 2009
  2. denis321

    denis321 New Member

    stakeholder meeting in May.

    That summer workshop didn't materialize. I think it's just the CDC using buzzwords and slogans to try to calm an angry CFS community and possibly questioning from NIH and other government officials/ entities. As you might know, no CDC staff went to Reno or Banbury international conferences this year sponsored by the CFIDS.org/ WPI/ IACFS/ME AND NIH despite being invited.

    RE: the education of healthcare providers. CFIDS.org did a better job than CDC did on Medscape. They had many times (like more than 10x) the MDs participating and it was well-written by Dr. Lucinda Bateman (whose sis died of lymphoma after 15 yrs. of CFS) - not the usual CDC exercise and you'll be OK junk.

    RE: Bibb County registry - you only need one month of "unwellness" to qualify
    http://www.fatigueregistry.org/sites/fatigueregistry/default.aspx

    Lest it sound like I am bitter about the CDC, this is an agency I use to respect a lot.
  3. AuntTammie

    AuntTammie New Member

    thanks for the link to the registry info....it's even worse than I thought....it doesn't only used the horrible empirical definition, it allows anyone with unexplained fatiguing illnesses lasting a month or longer - they are watering down the definition of who can be in the study so badly, it is ridiculous ( I know they say they are trying to catch early cases of CFS, but they are going to catch everything and anything, and maybe a few true CFS cases may fall into the grp being studied, but as a whole this will be so far from being a representative sample, they would do just as well getting a completely random sampling of the general population)

    and the Drs who refer patients get the wonderful benefit (not) of further education and consultation with the CDC on CFS.....so in other words, they can just keep furthering the spread of misinformation to the Dr who are supposed to be treating CFS patients

    lovely

    it has become so bad that I would be almost as happy hearing that the CDC were disbanded and discredited as I would be hearing that there is a good and safe cure for CFS (not quite as happy, bc of course I really, really want a cure, but almost)
  4. QuayMan

    QuayMan Member

    This is new - it went up on the CDC website Oct 2009. The ones you saw after the stakeholder meetings, etc were the draft plans.
  5. QuayMan

    QuayMan Member

    denis321, I agree that I don't think there education program will be that good.
  6. Spinetti

    Spinetti New Member

    Note that it mentions XMRV, carefully giving it the same weight as HHV-6.
    These guys are such clever rascals! It's really hard to deal with them in good faith.

    Thanks for your typically insightful comments, AuntTammie!

    [This Message was Edited on 10/24/2009]
  7. denis321

    denis321 New Member

    I stand corrected.

    Too bad it wasn't up when I sent in my written testimony to CFSAC - had to be in by 10/14. I hope those who are giving verbal testimony can adapt what they say to this.
  8. AuntTammie

    AuntTammie New Member

    thanks for the compliment : )
  9. QuayMan

    QuayMan Member

    denis321, my cynical side would suggest that part of the reason it came out so late (23rd Oct) might have been so that people making written testimony wouldn't have been able to comment on it.
  10. Spinetti

    Spinetti New Member

    I don't know how you do it all, but I'm glad you do.

    Thanks, again!
    [This Message was Edited on 10/25/2009]
  11. QuayMan

    QuayMan Member

    I live at home with my parents (who are still healthy-ish) and have no dependents. So that frees me up. We all have to do what we can. Well done for everyone doing their bit.
  12. QuayMan

    QuayMan Member