1. Will SEID Diagnostic Criteria Improve Diagnosis and Treatment? 2015 Webinar Series | Friday, April 17, 2015 | 1:00 PM Eastern Lucinda Bateman, MD The Fatigue Consultation Clinic Founder Leading ME/CFS Expert www.SolveCFS.org

2. ABOUT OUR WEBINARS Welcome to the 2015 webinar series! The audience is muted, use the question box to send me questions Webinars are recorded and the recording is made available on our YouTube channel and website SMCI is a research organization and does not provide medical advice

3. Will SEID Diagnostic Criteria Improve Diagnosis and Treatment? 2015 Webinar Series | Friday, April 17, 2015 | 1:00 PM Eastern Lucinda Bateman, MD The Fatigue Consultation Clinic Founder Leading ME/CFS Expert www.SolveCFS.org

4. Lucinda Bateman MD April 2015 Will *SEID Diagnostic Criteria Improve Diagnosis and Treatment? *Systemic Exertion Intolerance Disease

5. www.iom.edu/reports/2015/me-cfs.aspx The INSTITUTE OF MEDICINE report ”BEYOND ME/CFS: REDEFINING AN ILLNESS” outlines new diagnostic criteria

6. From SUMMARY: (PAGES 1-13) 836,000 to 2.5 million people have ME/CFS An estimated 84-91% not yet diagnosed (2004-2006) Patients struggle for years before getting a diagnosis 75% take > 1 year to get diagnosed (only 25% in first yr) 30% took >5 years to get a diagnosis HCPs are often skeptical about the serious nature of the illness, and have the misconception that it is a psychogenic illness or even a "figment of the patient's imagination" < 1/3 of medical schools include ME/CFS-specific information on the curriculum Only 40% of medical textbooks include information on ME/CFS (Introduction, page 16)

7. WHY IS ME/CFS NOT DIAGNOSED? CFS is often seen as a diagnosis of exclusion or a “garbage can” diagnosis Definition: A diagnosis of exclusion is a diagnosis reached by a process of elimination, which may be necessary if the illness cannot be established with complete confidence from history, examination and/or testing. This often causes delays or leads to misdiagnosis of a psychological problem. LBMD: It can also lead to the habit of passing/dumping patients from doctor to doctor. Sometimes no one takes responsibility for diagnosis or treatment of the ME/CFS

8. WHY IS ME/CFS NOT DIAGNOSED? Multiple overlapping subjectively defined case definitions -- In my opinion, often ignored or misused by the majority of physicians Fukuda CFS criteria. --- I would not be surprised if few physicians are able to correctly list these diagnostic criteria. Canadian Consensus Criteria for ME/CFS. --- I find few physicians who are familiar with these diagnostic criteria. For ICC ME, even fewer U.S. physicians are aware these criteria exist Fibromyalgia. —The term FM is more used and integrated due to FDA drug approval. But in my experience, many HCPs call everything in their fatigue/pain spectrum “garbage can” either FM or CFS, whichever is the more familiar term.

9. TREATMENT OF ME/CFS? Once diagnosed, patients frequently complain that HCPs do not know how to deliver appropriate care for their condition, and often subject them to treatment strategies that exacerbate their symptoms. Many patients report being subject to hostile attitudes from their HCP (IOM Report Introduction, page 16) LBMD--- many cannot find a doctor who will accept a patient with the diagnosis and/or provide care, or they are told “I don’t see people with that diagnosis.” Patients are sometimes told there is no treatment for CFS

10. THE PURPOSE OF THE IOM REPORT IS TO IMPROVE CLINICAL DIAGNOSIS The charge to the IOM committee was to recommend clinical diagnostic criteria that would address the needs of health care providers, patients, and their caregivers: Identify the evidence for the clinical diagnostic criteria described in the existing case definitions. Develop evidence-based clinical diagnostic criteria Recommend whether new terminology for ME/CFS should be adopted (i.e. the new name---SEID) Develop an outreach strategy for disseminating the new criteria nationwide to health professionals The committee was not asked to investigate the etiology, pathophysiology, pathogenesis, or treatment of ME/CFS

11. THE PURPOSE OF IOM REPORT IS TO IMPROVE CLINICAL DIAGNOSIS The committee decided that new diagnostic criteria which are more focused on the common core symptoms of ME/CFS are warranted for this disorder The goal is that these more focused diagnostic criteria will make it easier for clinicians to recognize and accurately diagnose patients in a timely manner.

12. SEID/SYSTEMIC EXERTION INTOLERANCE DISEASE DIAGNOSTIC CRITERIA 1) Substantial reduction or impairment of function with fatigue (Fatigue and its Impact on Function, pg 73) 2) Post-exertional malaise (pg 78) 3) Unrefreshing sleep (Sleep-Related Symptoms, pg 86)...are almost always present based on the existing evidence 4) Cognitive impairment (Neurocognitive Manifestations, pg 96) and/or 5) Orthostatic intolerance (Orthostatic Intolerance/Autonomic Dysfunction, pg 107)...are frequently present based on the existing evidence When viewed together these core findings distinguish SEID from other fatiguing disorders WHEN present the majority of the time and of moderate, substantial, or severe intensity Pain, immune impairment, infection symptoms support the diagnosis.

13. WHY WERE THESE CORE DIAGNOSTIC SEID CRITERIA CHOSEN? These manifestations of ME/CFS illness were: the most frequent (experienced by almost all) and most severe (most disabling) best supported by the evidence the more objectively measurable The report places emphasis on ME/CFS/SEID being "a diagnosis to be made" ---not simply what's left over after every other possible illness has been ruled out. The diagnosis of SEID can be established with confidence from history, examination and testing (i.e. it is not a diagnosis of exclusion).

14. THIS, OF COURSE, DOES NOT IMPLY THAT OTHER ILLNESSES SHOULD NOT BE EVALUATED AND TREATED. IOM Recommendation 1: “Physicians should diagnose ME/CFS [SEID] if diagnostic criteria are met following an appropriate history, physical examination, and medical workup.” LBMD--- Thus, if another diagnosis, or combination of diagnoses, in the period of workup or “differential diagnosis”, completely explains the clinical presentation, then there may be no need to make a diagnosis of SEID. This would require clinical judgment. Sometimes it takes a few months to clarify these issues.

15. HELPFUL DIAGNOSTIC TIPS ARE RECOMMENDED FOR THE HCP LISTEN to the patient (pg 213) Take a careful and detailed history Section D in the APPENDIX lists questionnaires and tools that are useful for making a diagnosis and provides links to online resources for the HCP (pg 269) Fatigue Function PEM Sleep problems Cognitive symptoms Orthostatic intolerance Pain

16. DETAILED DIAGNOSTIC DESCRIPTIONS IN EACH SECTION OF THE REPORT Chapter 4 (the core criteria): Fatigue and Its Impact on Function, pg 73 Post-Exertional Malaise (PEM), pg 78 Sleep-Related Symptoms, pg 86 Neurocognitive Manifestations, pg 96 Orthostatic Intolerance and Autonomic Dysfunction, pg 107 Chapter 5 (other manifestations) Pain, pg 141 Immune Impairment, pg 147 Neuroendocrine Manifestations, pg 152 Infection, pg 157 Chapter 6 (all of the above in pediatric population)

17. FEDS URGED TO IMPROVE DIAGNOSTIC TOOLS IOM Recommendation 2: “The Department of Health and Human Services/DHHS should develop a toolkit [a group of standardized and validated tests] appropriate for screening and diagnosing… ME/CFS [SEID] in a wide array of clinical settings … including primary care practices, emergency departments, mental/behavioral health clinics, physical/occupational therapy units, and medical subspecialty services (e.g., rheumatology, infectious diseases, neurology).” The development of clinical questionnaire or history tools that are valid across populations of patients and readily usable in the clinical environment should be an urgent priority.

18. …AND FUND AN UNBIASED REVISION OF SEID DIAGNOSTIC CRITERIA, SOON, IN ORDER TO CONSIDER EMERGING SCIENTIFIC EVIDENCE IOM Recommendation 3: “ A multidisciplinary group should reexamine the diagnostic criteria… when firm evidence supports modification to improve the identification or care of affected individuals. Such a group should consider, in no more than 5 years [i.e. within less than 5 years], whether modification of the criteria is necessary. Funding for this update effort should be provided by nonconflicted sources, such as the Agency for Healthcare Research and Quality, through its Evidence-based Practice Centers process, and foundations.”

19. APPENDIX C: DISABILITY IN ME/CFS/SEID The disability discussion highlights the *SSA evaluation for disability recommendations (pg 258-59) that describe how HCPs can document diagnostic findings in the medical record: physical exam findings (tender nodes, red throat, tender muscles or tender points, poor balance, pallor/pale, dramatic weight changes) certain supportive labs such as abnormal EBV antibody titers (very high EBV VCA IgG or early antigen), positive ANA, etc. abnormal brain MRI scan objective documentation of orthostatic intolerance abnormal exercise stress testing [including cardiopulmonary exercise testing] abnormal sleep studies *SSR 14-1p: Titles II and XVI: Evaluating Cases Involving Chronic Fatigue Syndrome (CFS) Effective Date: April 3, 2014. Federal Register Vol. 79, No. 64, page 18752

20. WIDE DISSEMINATION WILL IMPROVE USE OF THE DIAGNOSTIC CRITERIA AND IMPROVE DIAGNOSIS The IOM Report was broadly publicized Top media outlets covered the report: (>500 articles 10/2/15) JAMA Annals of Internal Medicine New York Times Washington Post.com NBC Nightly News Time Dr. Oz The New Yorker Magazine The total unique visitors for more than 720 online articles : 910,516,045

21. WIDE DISSEMINATION WILL IMPROVE USE OF THE DIAGNOSTIC CRITERIA AND IMPROVE DIAGNOSIS Dissemination strategy (Chapter 8, pg 231-246): DHHS agencies should coordinate and all use the new diagnostic criteria HCP: Target not only all Primary Care Providers, but also OB/GYN, ER, psychologists, psychiatrists, neurologists, rheumatologists, gastroenterologists, sports medicine, sleep medicine, cardiologists, physical therapists, occupational therapists, chiropractors, osteopathic practitioners and fitness instructors. In addition to Health Care Providers (HCP) information should go to: School-based professionals Professional Societies (AMA, general and specialty societies) Medical Education events Online (web) education outreach-- WebMD, Medscape, etc Training (Medical Students, Residents, Fellows) and Examination Organizations (Medical Board Exams, etc) Licensing and Certification organizations Large Health Care Systems, Medical Groups, Managed Care organizations, Insurance providers, etc Media and Social Media

22. WILL THE SEID DIAGNOSTIC CRITERIA IMPROVE DIAGNOSIS? The major purpose of the IOM report is to improve clinical diagnosis. It will succeed if supported. A new name can help overcome old stereotypes (or just “save face” and make a fresh start) The name describes the practical consequences of the illness. The fact that SEID impacts the entire body across many systems (Systemic) and has the somewhat unique feature of PEM (Exertion Intolerance), and results in reduced functional capacity (the first listed criterion) can no longer be ignored when the Disease is described each time the name is spoken or written.

23. HOW WILL THE SEID DIAGNOSTIC CRITERIA IMPROVE TREATMENT? In my opinion treatment will improve because of-- Increased diagnosis (and awareness) Calling attention to the major disabling symptoms Validating the major symptoms as real and debilitating

24. Many treatable aspects of the illness have been overlooked, or treatments have been avoided, by healthcare providers. PCPs don’t know they already know more than they think. We have tools we can use until research advances. PEM: Support for pacing and PEM-reduction or prevention strategies. Pacing or preventing PEM improves/reduces many SEID symptoms. Sleep disturbances: Many ways to help, though not often the unrefreshing aspect of sleep Orthostatic intolerance: POTS. Orthostatic hypotension. Fainting Cognitive impairment: Even recognition and patience would be helpful, along with treatment support. Pain: growing FM literature, clinical awareness and tools for management HOW WILL THE SEID DIAGNOSTIC CRITERIA IMPROVE TREATMENT?

25. May help put mental health support in the proper perspective. Validation of illness will/may improve how patients are treated by: Workplace or employers Schools Health Insurance and medication coverage Disability determination FDA and pharmaceutical companies will move forward with drug development and drug approval.

26. HOW WILL THE SEID DIAGNOSTIC CRITERIA IMPROVE TREATMENT? More diagnosed patients will create many more potential research participants. This will improve future diagnostic criteria, identification of biomarkers and subgroups, and development of treatments. Difficulty defining the illness, measuring outcomes, and recruiting patients has hampered interest in and funding of research, especially research regarding treatment. This should improve!

27. WILL SEID DIAGNOSTIC CRITERIA IMPROVE DIAGNOSIS AND TREATMENT? Yes!

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29. Thank You! Our Mission: Make ME/CFS understood, diagnosable and treatable. Our Strategy: Stimulate participatory research aimed at the early detection, objective diagnosis and effective treatment of ME/CFS through expanded public, private and commercial investment