Review: 'Through the Shadowlands’ describes Julie Rehmeyer's ME/CFS Odyssey
I should note at the outset that this review is based on an audio version of the galleys and the epilogue from the finished work. Julie Rehmeyer sent me the final version as a PDF, but for some reason my text to voice software (Kurzweil) had issues with it. I understand that it is...
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HHS, NIH, AHRQ and CDC respond to Aug 2015CFSAC recommendations

Discussion in 'General ME/CFS News' started by Kati, Jan 20, 2016.

  1. Kati

    Kati Patient in training

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    http://www.hhs.gov/advcomcfs/recommendations/08182015-agency-responses.html

    (For those who don't want to or can't read this much text, I will post highlights below)

    Recommendations from the Chronic Fatigue Syndrome Advisory Committee (CFSAC) and Agency Responses, August 18-19, 2015 CFSAC meeting
    Part 1: Recommendation from CFSAC’s Patient Registry Working Group
    Consistent with CFSAC’s Recommendation #4 to Standardize Assessment Methods and Measures, CFSAC recommends:

    Development and on-going use of a patient registry: In order to reduce one obstacle to ME/CFS research, we request that NIH institute a plan for the development and long-term maintenance of a ME/CFS patient registry. CFSAC recommends that investigators be required to utilize common data elements and deposit data into a patient registry (either new or existing). This requirement would be incorporated into all future Requests for Applications (RFAs) developed by funding agencies for ME/CFS.

    NIH Response: The NIH Data Sharing Policyrequires that all grant applications include a data sharing plan; NIH acceptance of the grantee’s submitted or negotiated sharing plan is incorporated as a term and condition of the award. Because funds are typically directed to hypothesis-driven, investigator-initiated research, funding opportunities for patient registries are limited, but many disease organizations support valuable registries for the patients they serve. NIH agrees that going forward it will be crucial to utilize standardized assessment methods and measures, as well as common data elements so that data can be compared across studies. Additional discussions are required to determine the best platform for sharing data and allowing access to this data to the greater research community.

    Part 2: Recommendations #1-15 from CFSAC’s Working Group on the Institute of Medicine(IOM) and Pathways to Prevention (P2P) Reports:

    Research Direction, Funding, and Goals (#1-7)
    1. Prioritize Development of Biomarkers and Objective Diagnostic Tests: CFSAC recommends that targeted Requests for Applications (RFAs), which clearly prioritize the identification and validation of distinct biomarkers and objective diagnostic tests and give preference to collaborative network initiatives, be issued as soon as possible. RFAs should advance the study of fMRI, positron emission tomography (PET) and other imaging technologies; 2-day cardiopulmonary function/recovery with gas exchange; cytokine abnormalities; gene expression, protein, or metabolite signatures; natural killer (NK) cell function; and other promising markers for diagnostic or therapeutic use. CFSAC believes that time is of the essence regarding this urgent recommendation.

    NIH Response: NIH agrees that identification and validation of biomarkers and other objective diagnostic tests would likely advance the community’s ability to understand the disease progression and ultimately to develop and test new therapeutic interventions. NIH is currently funding several ME/CFS studies that focus on identification of changes in brain mast cells, miRNA in cerebral spinal fluid (CSF), gene expression during post-exertional symptom flare, genomic and proteomic approaches, as well as the microbiome and inflammatory markers. It is important that such studies be precise in their objectives; a “biomarker” is useful only in terms of what it marks, ie., a marker of disease pathogenesis, disease progression, disease risk, therapeutic target, etc. Once a biomarker is identified, it must be clinically validated and the generalizability of the measurement in multiple subgroups of the ME/CFS population and across multiple laboratories must be determined. It will be critical to evaluate the results from each of the ongoing studies. Insights gleaned from new studies will enable the identification of biomarkers that show sufficient promise to move into a validation-phase study. One challenge in the biomarker field is distinguishing those measurable differences that are closely tied to the causes of the illness from those that are consequences of the burden of illness. The other difficulty is loss of discriminatory power when studies involve multiple patient populations since it is likely that ME/CFS will prove to be heterogeneous.

    We simply do not yet know enough to solve the very complex problems of this illness. The majority of the grant awards made by NIH are investigator-initiated applications that bring new ideas and innovation to focus on a specific area of research in health and disease. This is crucial to advance the understanding of ME/CFS and most of the disorders in the NIH portfolio. Also, a greater fundamental understanding of ME/CFS is likely to generate more potential biomarkers. NIH encourages applications from investigators interested in research on ME/CFS across all of the grant mechanisms, including those specifically designed for trainees and young investigators. This can be done utilizing existing grant announcements with grants being reviewed and funded according to their scientific merit and potential impact on the field.

    2. Address Gaps in Basic, Translational, Clinical, and Epidemiological Research: CFSAC recommends that the NIH issue Requests for Applications (RFAs), and the CDC allocate targeted funding, to address the gaps in basic, translational, clinical and epidemiological research as identified in the NIH Pathways to Prevention Workshop Report, the IOM’s Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, the AHRQ Evidence Report Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, andthe 2011 NIH State of the Knowledge Workshop Report. Such RFAs should be issued as soon as feasible. As was made clear by the NIH P2P panel, “Innovative biomedical research is urgently needed."

    CDC Response: Pending the availability of funding in FY 2016, CDC will continue the Multi-site Clinical Assessment of CFS study involving seven (7) ME/CFS clinics across the United States. Data is being collected that addresses some gaps in clinical and epidemiologic research; specifically NK cell function testing, evaluating questionnaires most effective in measuring ME/CFS, and cognitive testing.

    NIH Response: NIH agrees that innovative biomedical research on ME/CFS is urgently needed and encourages investigators to submit grant applications focused on new approaches to study the disease. This can be done immediately without specific RFAs for ME/CFS and grants will be reviewed and funded according to their scientific merit and potential impact on the field. The Trans-NIH Working Group on ME/CFS will also facilitate the funding and execution of studies with project aims that span the missions of multiple Institutes and Centers.

    3. Advance Treatments and Therapeutics: CFSAC recommends that the NIH make use of resources such as the NIH Clinical Center as well as other public and private options as soon as feasible for clinical trials and fast-track testing of new or repurposed therapies. High quality multi-site clinical trials using well-characterized patients (as defined in the recommendation that follows) are considered essential to facilitate the approval of effective drugs, address both biologic and clinical outcomes, and establish outcome measures for treatment and prognosis.

    NIH Response: NIH intramural scientists are working to design a protocol to study patients with ME/CFS utilizing the unique resources of the NIH Clinical Center. The investigators believe that intensive clinical studies of a well-characterized subgroup of individuals with ME/CFS will be essential to gaining insight into the underlying mechanism(s) of ME/CFS. Greater insights into the pathophysiology of the disease are critically needed to inform development of therapies that will benefit individuals with ME/CFS. For therapeutic trials a cadre of committed, well-trained investigators will be essential to bring therapies to well-designed phase 2 trials with clear Go/NoGo endpoints. It is likely that a larger group of committed investigators will be required to carry out larger phase 3 trials. NIH will work with the scientific and patient communities to enable the development of clinical trials in the future.

    4. Standardize Assessment Methods and Measures: As both the IOM and P2P reports have emphasized the need for improved methods and standards for both research and clinical care, CFSAC recommends the following strategy to advance those goals:

    1. CFSAC recommends that federally-funded research specify use of the 2003 Canadian Consensus Criteria as a research case definition for patient selection (in addition to other requirements established for specific research purposes) using standardized and uniform assessment methods and measures for applying the definition.
    2. CFSAC recommends timely formation of a methodological workgroup comprised of disease experts and stakeholders to establish uniform assessment methods, measures and data standards for federally-funded research; define and standardize disease terminology; operationalize symptom assessment methods in clinical care; and advance clinical guidelines and validated tools for diagnosis and treatment.
    CDC Response: CDC studies use standardized and uniform assessment methods for applying research case definitions and is sharing this information with other investigators, including NIH’s intramural program. CDC is exploring the possibility of partnering with NINDS to co-sponsor development of common data elements for ME/CFSwhich would be an important step to help standardize data collection.

    NIH Response: NIH agrees that standardized and uniform assessment methods and measures would facilitate the study of ME/CFS and the ability to subtype individuals with the disease. Utilizing common data elements across all clinical studies would facilitate data sharing and comparison of results across different studies. Working together, the NIH and CDC plans to explore the feasibility of developing Common Data Elements that can be used across all federally-funded research efforts. The CDC is currently supporting studies to develop standardized and uniform assessment methods and measures.

    5. Assign the Disease to an Institute: Given the clear involvement of neurological dysfunction in ME/CFS, CFSAC recommends that the disease be assigned to the National Institute of Neurological Disorders and Stroke (NINDS). CFSAC supports a continuing role for the Trans-NIH ME/CFS Working Group but recommends that leadership of the group be held jointly by the National Institute of Neurological Disorders and Stroke (NINDS) and by the National Institute of Allergy and Infectious Diseases (NIAID).

    NIH Response: While neurological dysfunction is evident in ME/CFS as it is in many other systemic diseases, there are clearly many other systems involved in most individuals with ME/CFS. The fact that the root cause and the driving pathobiology behind ME/CFS are unknown argues persuasively for a trans-NIH approach to research on this disease. Notably, orthostatic tachycardia and hypotension (NHLBI), depression (NIMH), pain (NIH pain consortium of 25 institutes, centers, and program offices), sleep abnormalities (NHLBI, NINDS), immune system impairment (NIAID), and neuroendocrine abnormalities (NIDDK) are variably expressed in individuals with ME/CFS. A new trans-NIH working group, with involvement of multiple Institute Directors, is being established. NINDS will assume the initial period of leadership of the working group and provide continuous staffing. This group will provide a forum for coordination of ME/CFS research across all NIH institutes, centers and offices, as well as for discussion of scientific opportunities and gaps in the research that can be addressed by working together to further research on ME/CFS. Given the decade-long decrease in the funding capabilities of NIH, major new projects would most likely require co-funding from multiple institutes.

    6. Appoint a Cross-Agency Leader: To address the breadth and magnitude of needs raised by the IOM and P2P reports, CFSAC recommends that the HHS appoint a senior-level cross-agency leader ("czar") with the authority, position and fiscal responsibility required to coordinate, develop, implement, and monitor a broad strategic cross-agency response to this disease through open and collaborative engagement of both internal and external stakeholders. At minimum, the strategic cross-agency plan should address the critical need for research, drug development, epidemiology, medical education, medical care and public awareness. It is recommended that this cross-agency leader serve as Designated Federal Official (DFO) to the CFSAC and be required to provide a comprehensive biannual report regarding progress and goals.

    HHS responds: Given the additional NIH focus on ME/CFS that has recently been announced, a cross-agency leader with fiscal responsibility would not be appropriate at this time. Management and leadership of CFSAC will remain within the Office of the Assistant Secretary for Health.

    7. Provide Research Funding Commensurate with the Burden of Disease: To facilitate the above goals, CFSAC recommends that the Secretary work with HHS agencies to ensure that total research funding is commensurate with the epidemiologic prevalence and economic burden imposed by this disease. Based on disease prevalence, equitable funding is estimated to be $250,000,000 per year.

    CDC Response: CDC has established cooperative agreements to collaborate with external researchers as well as supported an intramural program using appropriated funds. Currently nearly half of CFS funds coming to CDC are used to support extramural programs. One such example is the ongoing Multi-site Clinical Assessment of CFS study that involves 7 ME/CFS clinics across the United States.

    AHRQ response: Consistent with its mission, AHRQ will welcome grant proposals as they relate to the dissemination and implementation of patient centered outcomes research related to ME/CFS.

    NIH Response: The NIH recognizes that ME/CFS is a chronic condition that imposes significant limitations and health concerns for the individuals with the disease. Public health needs are a critical factor in NIH’s funding decisions, but scientific merit, portfolio balance, and budgetary impact are also important considerations. Often, the funding level is driven by the number of high quality applications that are received. NIH encourages the ME/CFS research community to submit grant applications utilizing new and innovative approaches to study the disease.

    Diagnostic Criteria: A Path for Moving Forward (#8-9)
    8. Use Information from the IOM Report to Detail and Clarify the Criteria:

    1. CFSAC recommends that a brief disease overview be provided with the Diagnostic Criteria in order to advance understanding of the complex, multi-systemic nature of the disease; emphasize the IOM findings of systemic exertion intolerance, immune and neurological impairment and other physiological dysfunction; reflect the range of debilitating symptoms that are commonly experienced by patients; and begin to "change the narrative" regarding the disease.
    2. CFSAC recommends that each category of Core Criteria be described, using language provided in the IOM report, in order to facilitate understanding of the distinct presentation of symptoms required for diagnosis. CFSAC recommends that objective testing identified by the IOM (for cases of diagnostic uncertainty or other reasons) be included as well.
    3. CFSAC recommends that the phrase "Unrefreshing Sleep” be changed to “Sleep Abnormalities” to more accurately reflect the myriad sleep-related problems associated with the disease.
    4. CFSAC recommends that "Important and Frequently-reported Symptoms that Support Diagnosis" (as identified by the IOM) be consistently reflected in conjunction with Core Criteria in all materials developed, specifically immune and neurological impairment, pain, and other common symptoms/ manifestations.
    5. CFSAC recommends sole use of an expanded version of the Criteria as reflected herein (Box 1) rather than the simplified version (IOM Box S) and algorithm (IOM Fig S-1) which do not convey the full nature of the disease or the important symptoms that support diagnosis.
    HHS responds: CDC is creating a partnership with stakeholders, including disease experts, patient advocates and professional associations, to get advice on the kind of educational materials and toolkits that need to be developed. In addition, the IOM has developed a brief document for clinicians: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Key Facts as well as a 14-page Report Guide for Clinicians.

    9. Validate and Refine the Proposed Criteria within Two Years: CFSAC recommends that the proposed Diagnostic Criteria be validated, and refined if needed, within two years by disease experts and/or by the methodological workgroup recommended herein for sensitivity and specificity during different stages of disease and different levels of severity.

    HHS responds: Updating these clinical guidelines with the latest available evidence will be an important future step in assuring that those affected by this disease receive timely and accurate evaluation and diagnosis. When to begin the process of updating the guidelines will depend on the availability of such evidence.

    Medical Education and Guidelines (#10-13)
    10. Provide Disease Guidance with the Criteria: In order to improve diagnostic accuracy while appropriate tools are developed and validated, CFSAC recommends development of clinical guidelines for the assessment of post-exertional malaise (PEM) along with a brief guidance document designed to accompany and supplement the Criteria in all dissemination efforts. Disease guidance should include the following key information:

    1. Disease Overview: Identification of ME/CFS as an acquired, chronic multi-systemic disease characterized by "systemic exertion intolerance" resulting in significant relapse after exertion of any sort; A statement that the disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction resulting in significant functional impairment accompanied by a pathological level of fatigue; Clear indication that the disease is not a psychiatric or somatoform disorder and that it is not synonymous with "chronic fatigue," "idiopathic fatigue" or "fatigue syndrome."
    2. Diagnostic Techniques and Procedures: Appropriate guidance on "Operationalizing the Diagnosis" (pp 11-12 of the IOM Guide for Clinicians) along with the recommended clinical guideline for assessing PEM; Information about early onset signs; A list of interim diagnostic tools (from pp 13-14 of the IOM Guide for Clinicians) with instructions and scoring criteria for assessment of PEM, impaired function, and other symptoms if/when diagnosis is in question.
    3. Differential Diagnosis: A list of conditions that share common symptoms and might be missed, including but not limited to Addison’s disease; B12 deficiency; chronic hepatitis; celiac disease; Cushing’s Syndrome; diabetes mellitus; heart disease; HIV related illness; iron deficiency or overload syndrome; lupus; Lyme disease; malignancy; myasthenia gravis; multiple sclerosis; rheumatoid arthritis; sleep disorders; thyroid imbalance or disease; tuberculosis. Additionally, guidance should be included regarding differentiation of primary psychiatric disorders (particularly depression, somatoform disorder, somatic symptom disorder, neurasthenia and similar conditions), substance abuse, and "school phobia" in pediatric patients.
    4. Comorbidities: Indication that diagnosis and treatment of co-morbid conditions are necessary when caring for patients and that clinicians may wish to consider (among others): allergies, central or obstructive sleep apnea, depression, fibromyalgia, interstitial cystitis, irritable bladder syndrome, irritable bowel syndrome, migraine, multiple chemical sensitivities, myofascial pain syndrome, prolapsed mitral valve, Raynaud’s phenomenon, reactive depression or anxiety, Sicca syndrome, and temporomandibular joint syndrome.
    5. Treatment and Care: Basic information regarding symptom-based treatment using pharmaceuticals and other clinical treatments when appropriate to address underlying pathologies and manage symptoms to the extent possible; Information regarding management of PEM; Clarification that counseling therapies are not treatments but may be helpful coping mechanisms; Declaration that the disease is not the result of fear-based avoidance of activity and that cognitive behavioral therapy (CBT) and graded exercise therapy (GET) for this purpose are inappropriate; Clear warning about the potential harms of graded exercise therapy and a statement that exercise therapy of any kind should only be considered if and when appropriately trained professionals are involved and measures are taken to ensure that the exercise does not induce post-exertional malaise or cause other physical harm. Further, treatment recommendations and clinical findings based on Oxford or Reeves definitions should no longer be applied to these patients.
    6. Resources: Links to the IOM report, the IACFS/ME primer on guidelines.gov, and other appropriate resources.
    HHS response: The IOM has developed a brief document for clinicians: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Key Facts as well as a 14-page Report Guide for Clinicians.

    AHRQ response: The IACFS/ME primer met the criteria for inclusion in guidelines.gov. Similarly, the recommendations from the IOM report that meet the current inclusion criteria could be added to the Guidelines Clearinghouse in guidelines.gov. A link to the IOM report and the diagnostic criteria outlined therein will be included in the translation products (produced by the Eisenberg Center) based on the AHRQ report aimed at clinicians and patients.

    NIH Response: The NIH does not issue clinical guidelines for any disease area but its mission is to advance the science that then informs patients, caregivers and healthcare professionals.

    11. Develop Diagnostic Tools and Clinical Practice Guidelines: CFSAC recommends that disease-specific diagnostic tools be developed and validated in collaboration with disease experts and also that comprehensive Clinical Practice Guidelines be developed in accordance with the IOM's Standards for Developing Trustworthy Clinical Practice Guidelines.

    CDC Response: CDC recognizes the importance of developing Clinical Practice Guidelines for use by primary care physicians. These need to fulfill evidence-based standards, such as GRADE and IOM’s Standards for Developing Trustworthy Clinical Practice Guidelines, and need to be developed in a collaborative and transparent manner. CDC is creating a partnership with stakeholders, including disease experts, patient advocates and professional associations, to get advice on the kind of educational materials and toolkits that need to be developed.

    12. Promote Medical Education and Awareness: CFSAC recommends that HHS promote inclusion of the disease on the United States Medical Licensing Examination (USMLE). CFSAC endorses recommendations provided in the IOM and P2P reports regarding engagement of health professional licensing and accreditation agencies, involvement of HRSA to promote training, and formation of public-private partnerships to further education and awareness regarding the disease. Additionally, CFSAC endorses the recommendation of the IOM to update all websites and materials of HHS and its agencies using consistent messaging and standard terminology based on the recommendations in this report, and to communicate with third party health information provider websites and federally supported provider networks as well.

    HHS Response: The USMLE is a nongovernmental entity. HHS is not involved with the process that the USMLE uses to determine content on medical licensing examinations, nor with health professional licensing and accreditation.

    HRSA Response: HRSA can support curricula development through grantee proposals such as the American College of Preventive Medicine which established the National Coordinating Center for Integrative Medicine (IMPriME). The purpose of IMPriME is to create sustainable, preventive medicine specific infrastructure to provide technical support for Preventive Medicine residency and other health professions training programs interested in incorporating evidence based integrative medicine content into their programs. HRSA's funding of IMPriME has allowed additional funding for the Arizona Center for Integrative Medicine in Primary Care (CIMPC). The CIMPC has agreed to include a ME/CFS case including diagnostics and treatment of the disease in their curricula. This is a positive development in ME/CFS training for clinicians. HRSA will work closely with this grantee to monitor progress on this development.

    13. Identify ICD Coding: CFSAC recommends G93.3 as the recommended ICD-10-CM code for this disease unless and until such time that robust research justifies reclassification and a new code is created.

    CDC Response: ICD-10-CM has been implemented. Due to the ICD-10 code set freeze, which has been in place since October 1, 2011, no changes were implemented to ICD-10-CM. Depending on the provider’s documentation CFS not otherwise specified is an inclusion term under code R53.82, chronic fatigue, unspecified. If the provider documents post-viral fatigue syndrome or Benign Myalgic Encephalomyelitis then code G93.3, post-viral fatigue syndrome, would be assigned.

    Acknowledgement/ Identification of the Disease (#14-15)
    14. Acknowledge the Distinct Disease Identified by the IOM: The IOM has acknowledged and identified a distinct medical condition involving systemic exertion intolerance with PEM and universal core criteria. CFSAC recommends that the disease identified by the IOM be clearly distinguished from other causes of chronic fatigue, such as conditions described by Fukuda et al, 2005 Reeves, Oxford and other forms of chronic fatigue which include patients that do not meet the IOM core criteria.

    15. Change the Narrative: CFSAC recommends a coordinated cross-agency effort to change the narrative – from "unexplained fatigue" to an understanding of the multi-systemic nature of this disease – through the use of consistent messaging provided by the IOM and P2P reports as highlighted below.

    • ME/CFS is an acquired, chronic multi-systemic disease characterized by "systemic exertion intolerance" resulting in significant relapse after exertion of any sort. The disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction, resulting in significant functional impairment accompanied by a pathological level of fatigue. The cause of the disease remains unknown, although in many cases symptoms may have been triggered by an infection or other prodromal event.
    • The disease is not psychiatric in nature and should not be equated with neurasthenia, somatic symptom disorder, or functional somatic syndrome.
    • ME/CFS has been reported in patients younger than age 10 and older than age 70.
    • There is strong scientific evidence of immunologic and inflammatory pathologies, neurotransmitter signaling disruption, microbiome perturbation, and metabolic or mitochondrial abnormalities in the disease.
    • PEM is a primary feature that helps distinguish ME/CFS from other conditions and manifests as muscular or cognitive fatigability and exacerbation of some or all of an individual’s symptoms after seemingly minor physical or cognitive exertion or activity. PEM may be delayed and is unpredictable in duration.
    • At least one-quarter of ME/CFS patients are bedbound or housebound at some point in the illness and most patients never regain their pre-disease level of functioning.
    • ME/CFS patients have been found to be more functionally impaired than those with other disabling illnesses including type 2 diabetes mellitus, congestive heart failure, hypertension, depression, multiple sclerosis, and end-stage renal disease.
    • Pediatric ME/CFS can follow acute infectious mononucleosis and EBV. Orthostatic intolerance and autonomic dysfunction are common in pediatric patients; neurocognitive abnormalities emerge when pediatric patients are tested under conditions of orthostatic stress or distraction; there is a high prevalence of profound fatigue, unrefreshing sleep, and post-exertional exacerbation of symptoms.
    • The disease is not synonymous with "chronic fatigue, "idiopathic fatigue" or "fatigue syndrome."
    Part 3: CFSAC’s responses to 4 questions asked by HHS during the August 2015 meeting
    1. The IOM committee made the following recommendation to HHS: “The Department of Health and Human Services should develop a toolkit appropriate for screening and diagnosing patients with myalgic encephalomyelitis/chronic fatigue syndrome in a wide array of clinical settings that commonly encounter these patients, including primary care practices, emergency departments, mental/behavioral health clinics, physical/occupational therapy units, and medical subspecialty services (e.g., rheumatology, infectious diseases, neurology).” (See IOM Report, table 7-1, page 214-)
    What toolkits are most needed to aid primary care practitioners (PCPs) in making a diagnosis of ME/CFS? These toolkits might include best practices or standardized, validated instruments and would help clarify whether key components such as PEM, orthostatic hypotension, and unrefreshing sleep, are present in a particular patient.

    CFSAC recommends:

    • A validated instrument/questionnaire for post-exertional malaise (PEM)
    • Cognitive assessment
    • Assessment for orthostatic intolerance
    • Work with American College of Physicians to develop toolkits
    • Sleep dysfunction questionnaire
    • Assessment tool to characterize ME/CFS course over time (longitudinal assessment)
    • Developing surveys/questionnaire for pediatric and adult ME/CFS patients separately
    • Anaerobic assessment tool
    CDC Response:Validated instruments for all the domains of illness are needed for ME/CFS. CDC’s Multi-site Clinical Assessment of CFS study (7 sites across the U.S.) was designed to address many of these areas. The study is using standardized questionnaires to evaluate all aspects of the illness and is collecting information on ME/CFS patients and ill comparison groups longitudinally. The data will help identify measures that best correlate with illness and that differentiate ME/CFS from other conditions. The study is also evaluating simplified cognitive tests and orthostatic intolerance to determine which would be helpful to clinicians. The study questionnaires were modified when pediatric/adolescent patients were enrolled, and the effectiveness of these questionnaires will be evaluated. In addition, CDC is creating a partnership with all stakeholders, including disease experts, patient advocates and professional associations, to get advice on the kind of educational materials and toolkits that need to be developed. NIH will soon commence a complementary research agenda to gain a greater understanding of the disease.

    1. Page 237, the IOM report notes that “Studies have found that professional societies rank among the health care providers’ top sources for new information. As such, they are an important audience for HHS’s efforts to reach out to and educate and influence health care providers.” The report lists a number of professional societies on pp 236-237.
    What are CFSAC’s suggestions for engaging these societies so that they will disseminate the ME/CFS diagnostic criteria to their members and constituents?

    CFSAC recommends:

    • Get clinical diagnostic criteria on agenda of annual meetings of professional societies,
    • Include in publications and e-publications from these societies
    • Fund or sponsor workshops/exhibits at annual meetings for providers
    • Coordinate with and generate support with organization leaders
    • HHS agencies work with professional society contacts to disseminate information
    • These efforts should be coordinated by cross-agency leader (per CFSAC recommendation 6)
    • Work with and disseminate information to HMOs and other major payors
    AHRQ response: AHRQ funds conference grants and would welcome proposals related to ME/CFS. AHRQ will also work in tandem with other HHS agencies to use contacts AHRQ has with professional societies to help ensure that the IOM report and its recommendations are as widely available as possible.

    HRSA Response: HRSA is enthusiastic about working with professional societies and audiences to educate students, clinicians, healthcare sites, and workforce grantees on ME/CFS. Through existing mechanisms such as webinars, social media, and robust list serves, the Bureau of Health Workforce has the capability and expertise to conduct outreach and develop engagement strategies for various audiences on various topics including ME/CFS education. HRSA has and will continue to disseminate information developed by agencies within HHS about ME/CF to HRSA grantees and partners reaching thousands of health practitioners, educational institutions, and health professional organizations.

    1. Page 238, the IOM report lists a number of independent ME/CFS organizations.
    What role could these organizations play in disseminating the ME/CFS diagnostic criteria to PCPs and other health care providers?

    CFSAC recommends:

    • Media outreach, social media outreach, educational materials
    • Patient outreach/education support groups
    • Outreach to state and local chapters of professional organizations
    • Outreach and education to occupational health centers; large employer health centers
    1. In 2010, CFSAC made a formal recommendation to the HHS Secretary to: “Adopt the term ME/CFS across HHS programs.” This year, the IOM recommended that the name ME/CFS be changed to Systemic Exertion Intolerance Disease (SEID).
    Should the term SEID be adopted across HHS programs? If not, what term should HHS programs use for ME/CFS?

    CFSAC recommends:

    • The term SEID should not be adopted across HHS programs.
    • CFSAC decided not to respond to the second question at this time.
    HHS Response: The 2010 CFSAC recommendation on the disease name will remain in place.
     
    Roseblossom, jimells, mango and 4 others like this.
  2. Kati

    Kati Patient in training

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    From reading the responses from the different agencies, my comments are this pretty much looks like the status quo. NIH doesn't want to assign the disease to an institute, doesn't want to issue a RFA, says there needs to be more grant applications, that they will be reviewed by the Special Emphasis pannel (the same one which rejected Lipkin's project, twice)

    The CDC says they seem to have sufficient funding now that their budget is reinstated and that their multi-site study will be helpful. That they are working on a new toolkit.

    Requests for new language surrounding the disease is producing no answer.

    ICD coding request were not granted because the coding system is not using the new system. So it is status quo.

    CFSAC rejects renaming the disease SEID, and when asked whether MECFS should continued to be use, CFSAC chooses not to answer. So HHS says MECFS it is.
     
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  3. SOC

    SOC

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    Dear CFSAC,
    Thank you for your comments. We are going to do whatever we please without regard to your suggestions.
    Love,
    HHS, NIH, AHRQ, CDC
     
  4. SOC

    SOC

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    PS Please feel free next year to once again waste your time and ours preparing another carefully thought though list of recommendations for us to read and ignore. We sincerely want the ME/CFS community to feel like they have a voice in this process. Keep up the good work.
    Most sincerely,
    HHS, NIH, AHRQ, CDC
     
  5. *GG*

    *GG* Senior Member

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    Concord, NH
    Yes, this is why we need to leave more money in peoples pocket so they can do the right thing with it! Besides, it's there anyways.

    GO OMF etc...

    GG
     
  6. Valentijn

    Valentijn WE ARE KINA

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    Depression. Is. Not. A. Symptom. Of. ME/CFS.

    Unless they want to argue that every other damned chronic disease shouldn't be in a biological institute because patients might get depressed. Which clearly they don't, so they are full of shit. Same with pain, endrocrine stuff, etc, etc. Most of those other symptoms are peripheral or secondary to the disease itself, and obviously are not a central aspect. Flip a coin, pick immunology or neurology, and if you find out you're wrong 10 years down the line, move us to the other one.

    Generally I'm very happy with a lot of progress we've seen recently from the NIH, but they need to stop dicking around with regards to getting us completely out of the sociologically-oriented Office of Research on Women's Health and into a real institute. ORWH have proven themselves to be incapable of handling diseases, and creating a revolving door system of changing institute leadership just begs for a continued lack of accountability.

    I'm also less than impressed with the NIH's continued ass-covering in not acknowledging their own role in the lack of funding biological ME research in the past, every damned time the subject comes up. They allowed reviewers to repeatedly deny funding based on gross and baseless biases. The NIH need to be specifically working to rectify those past failures, not trying to gloss them over by emphasizing the need for supposed "quality" proposals, with the implication that those rejected proposals were of low quality.
     
  7. snowathlete

    snowathlete

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    UK
    This reads to me like the person who has been replying to these over the last couple years is still in place and doing things the same way as before. there is a chance that things are changing at NIH but not filtering down enough yet or it's possible not much has really changed. If the NIH is serious then there has to be changes in the way these things are handled.

    Perhaps someone in contact can check if the NIH director is satisfied with these responses. I thought the answer to q7 was particularly poor. We know the small shitty things they already fund and it's clear we don't think they are anywhere close to good enough. Hence the recommendation. It's not professional to mess us about. This stuff about grant applications is just passing the blame. We want commensurate funding and we want it now.

    Some of the later questions didn't seem to get answered?
     
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  8. jimells

    jimells Senior Member

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    The more things change the more they stay the same: pretty words in public while stabbing us in the back. Again. Just like Charlie Brown, Lucy, and the football.

    They will never develop a real program until patients and advocates get in their faces like the Act Up people who forced NIH and CDC to take AIDS seriously. Policies change when the social cost of them becomes too high. We have to raise the cost. It's damn difficult work to do from a bed.
     
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  9. mango

    mango Senior Member

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  10. ScottTriGuy

    ScottTriGuy Stop the harm. Start the research and treatment.

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    Sad but true on both counts.
     
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  11. mfairma

    mfairma Senior Member

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    I agree. Promises will be kept when we have the power to enforce them. Part of the reason we see such glacial change is because we are too easily mollified and too quickly forget that this situation is held in place by broader systemic factors that do not work in our favor, factors that we need to change to have a hope of demanding accountability, such as our lack of an effective national advocacy organization and our collective lack of capacity to advocate, the lack of public understanding of our disease and the abysmal sociopolitics of it, the abysmal understanding and limitations of media in reporting on the disease, etc.
     
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  12. Kati

    Kati Patient in training

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  13. *GG*

    *GG* Senior Member

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  14. jimells

    jimells Senior Member

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    Vineyard1, halcyon and Kati like this.
  15. Mark

    Mark Former CEO

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    beaker and Kati like this.
  16. duncan

    duncan Senior Member

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    I don't know why ME/CFS clinicians and researchers don't create a clinician-based organization similar to the concept and goals of ILADS.

    If this were done, potentially - someday - such an organization could bring meaningful pressure to bear on the inertia that today characterizes the ME government landscape. I think at the very least it would garner more attention from media.

    If leverage on govt institutions failed, it might even unilaterally generate actionable diagnostic and treatment guidelines - like the ICC, but with the strength of an institution, not just a consensus letter.
     
  17. *GG*

    *GG* Senior Member

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    We all drop dead at the same time?

    GG
     
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  18. Snow Leopard

    Snow Leopard Hibernating

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    What will it take to convince them that ME/CFS is the exception and not the norm? We need the NIH to implement a program explicitly focused on building research capacity for ME/CFS in the USA with explicit targets (in terms of number of grants awarded / scale / funding allocated). Otherwise we'll continue to be trapped in the catch-22: no progress due to lack of research and no research due to lack of progress due to low probability of obtaining funding.

    Perhaps this should be the singular recommendation of the next CFSAC - program to substantially research capacity with explicit targets.
     
  19. Kati

    Kati Patient in training

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    What do you mean by this @Snow Leopard ? i am not sure I understand.
     
  20. Snow Leopard

    Snow Leopard Hibernating

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    They say "we would award more funding, but don't receive enough high quality applications". They fail to ask why that may be? The fact is that ME/CFS receives an order of magnitude less funding than if it was any other condition, when considering national or international disease burden.

    The fact is that due to stigma, lack of some sort of biomarker foothold, lack of momentum and leadership. The only way this cycle is going to change is either extremely good luck, or strong leadership. Leadership which builds capacity and pulls in funding. The NIH has that opportunity, but they continue to pretend that they don't need to do anything different, that things will magically change on their own. That hasn't worked over the last three decades, so it is folly to continue believe business as usual is a good policy.
     
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