CFSAC IOM/P2P Working Group Background, Recommendations and Rationale
Discussion regarding "follow-up" recommendations
Background for Recommendation #1
Standing Recommendation from August 2015
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.
Discussion: While HHS agreed that updating the proposed Diagnostic Criteria is important, the reply indicated that the timeframe "will depend on the availability" of new evidence. The CFSAC IOM/P2P Working Group feels strongly that the internal federal processes required to schedule the necessary meeting should begin as soon as possible in order that reexamination occur as recommended, and in no case, beyond the 5-year timeframe indicated by the Institute of Medicine. Progress regarding this disease has been hampered by the Fukuda definition for more than two decades despite the fact that the criteria was designed to be an overly broad and temporary research definition. A serious commitment regarding the important timeline recommended in the Institute of Medicine report is warranted.
Initiate the process for review of the IOM Diagnostic Criteria so as to occur no later than May 2019:
CFSAC recommends that HHS initiate the federal processes required as soon as feasible such that a methodological and multidisciplinary workgroup can be convened in a timely fashion, and in no event later than May 2019, to reexamine and update the IOM diagnostic criteria. Further, CFSAC recommends that said workgroup be required to consider and incorporate new evidence to update and refine the criteria for sensitivity and specificity during different stages of disease and different levels of severity.
Rationale: The IOM recommended that a multidisciplinary group be convened to reexamine the proposed criteria when firm evidence supports modification, or within five years, whichever comes first. At this time, it is fully expected that updates will be appropriate sooner rather than later. Indeed, recognized disease expert and IOM Committee Member Dr. Nancy Klimas stated to this committee that a one year delay in the contract date of the IOM’s review would have had an impact on the proposed criteria based on newer evidence. Given the time-consuming federal procedures and funding requirements inherent in such an endeavor, the process should be initiated as soon as feasible. Additionally, to ensure that robust evidence is available and this timeline can be met, CFSAC urges the NIH to issue RFAs which aggressively pursue the studies needed to validate potential biomarkers that have already been identified. As the IOM cut-off date for literature review was May 2014, a review that occurs no later than May 2019 is warranted.
Background for Recommendation #2
Standing Recommendation from August 2015
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.
Discussion: There was no response provided to this recommendation. Upon discussion with the CFSAC DFO, the Working Group believes that the intent may have been unclear regarding specific action to be taken. However, what is clear is that the disease continues to be conflated with medically unexplained chronic fatigue by researchers, medical providers, media and the general public. Further, medical education resources continue to focus on "fatigue" and/or fail to emphasize the hallmark symptom of post-exertional malaise due to systemic exertion intolerance.[i] As recognized by the Institute of Medicine, the confusion about the nature of the disease ultimately results in harm to patients from inappropriate care.[ii]
A number of statements in the IOM report make it clear that the committee recognized two (or more) sets of patients – those that have the disease they studied, and those with other fatiguing conditions that still meet Fukuda or other chronic fatigue syndrome criteria.
"The committee recognizes that some patients diagnosed by other criteria, such as the Fukuda definition (Fukuda et al., 1994), will not fulfill all of the criteria proposed here, but it emphasizes that all patients should receive appropriate care."
"The committee emphasizes that although some patients previously diagnosed with ME/CFS may not meet the proposed criteria, clinicians should address their symptoms and concerns."
“The diagnostic criteria for ME have required the presence of specific or different symptoms from those required by the diagnostic criteria for CFS; thus, a diagnosis of CFS is not equivalent to a diagnosis of ME.”
Also, the repeated use of certain phrasing, e.g. "for this disease" and for the illness "described in this report," makes it clear that IOM recommendations are only to be applied to patients who meet the proposed criteria. Although the IOM panel was not charged with making recommendations about what should happen to Fukuda CFS once IOM-criteria patients are pulled out, it is clear that patients who do not meet IOM diagnostic criteria should not be considered to have the disease.
Additionally, given that the P2P Workshop Report called for the Oxford criteria to be retired (because it could cause harm) and the AHRQ report acknowledged that Oxford criteria "is at high risk of including patients who may have an alternate fatiguing illness, or whose illness resolves spontaneously with time," it's important to ensure that study findings from such broad chronic fatigue cohorts are no longer assumed to be applicable to this disease.[iii] This issue is especially concerning now, as the PACE trial (an Oxford-criteria study used extensively as the basis of treatment recommendations for CBT and GET) has recently received considerable international criticism due to study design, conduct, and patient selection.[iv] As highlighted in an editorial on Stats.org (Sense About Statistics) in March 2016, "its conclusions not only had the power to affect the way the condition was treated, they had the power to set the agenda for further research, potentially foreclosing other approaches. As a result of PACE, the UK’s National Health Service, the Centers for Disease Control, the Mayo Clinic, and Kaiser all ended up recommending cognitive behavioral therapy and exercise for ME/CFS." Yet, as quoted in a March 2016 Stats.org article (PACE: The research that sparked a patient rebellion and challenged medicine), Peter D. White, Professor of Psychological Medicine at Queen Mary, University of London, has stated that PACE “does not purport to be studying CFS/ME but CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria).”[v]
Finally, the CDC's response to our ICD coding recommendation provided no clarification of the CDC's position regarding the disease studied by the IOM. In the US, the code being used for ME/CFS and/or SEID patients is the same code used for "chronic fatigue, unspecified." In fact, the term "chronic fatigue, unspecified" is the leading term in some systems, and often the only term that shows up when you type in code R53.82 as can be seen on the ICD lookup webpage of the Centers for Medicare & Medicaid Services.[vi] Continued use of the code for "chronic fatigue, unspecified" by medical providers and insurance companies will perpetuate the confusion about the disease that we see today. Just as importantly, systems that track disease will count patients with unspecified chronic fatigue, Fukuda CFS and IOM criteria as all having the same condition. We strongly believe that medical providers and insurers should use an ICD code that is different from the R53.82 code being used in the US today.
We expect that an urgent push for biomarker research will make all the difference in clearly identifying patients with the disease studied by the IOM. In the meantime, it's important that HHS do everything possible to clearly distinguish the disease from broader CFS criteria, like Fukuda, that do not require PEM or other core symptoms.
Separate the distinct disease acknowledged by the IOM (currently referred to as “ME,” “ME/CFS” or “SEID”) from the broader set of conditions defined by Fukuda and Oxford:
CFSAC recommends that new clinical guidelines, new CDC webpages, a new name, and a new ICD code be established for the distinct disease identified and acknowledged by the Institute of Medicine, and that they be separate and clearly distinguished from the clinical guidelines, CDC webpages, name, and ICD code used for the remaining patients diagnosed with Chronic Fatigue Syndrome (CFS) as defined by Fukuda. Statements and treatment recommendations based on the Oxford definition should not be included in clinical guidelines for this disease.
Rationale: The Institute of Medicine has made it clear that ME/CFS (SEID) is a diagnosis to be made and that the hallmark of the disease is a systemic intolerance to exertion of any kind, resulting in body-wide exacerbation of symptoms and energy production impairment. This hallmark impairment has profound implications for diagnostic and treatment/management clinical care practices.[vii] However, in the U.S. today, the same clinical guidelines, medical education, disease name, and ICD code are being used for patients who meet the IOM criteria, and for those who do not.[viii] Continuing to mix these two patient groups together perpetuates the confusion about the disease and causes harm to both groups of patients. Additionally, as indicated in CFSAC's comment to the P2P Workshop panel, we recommend that "studies using the Oxford definition not be used to inform treatment recommendations" for this disease.
As stated by the IOM, "… the Fukuda definition identifies a larger, more heterogeneous group of patients compared with the other criteria." "The committee recognizes that some patients diagnosed by other criteria, such as the Fukuda definition (Fukuda et al., 1994), will not fulfill all of the criteria proposed here, but it emphasizes that all patients should receive appropriate care."
Standing Recommendations from August 2015:
"Use information from the IOM Report to detail and clarify the criteria” (original recommendation below) Summary: Add detail from the IOM report to the proposed IOM Diagnostic Criteria, including a brief description of the disease, descriptive information regarding each symptom, and a section on other symptoms that are often present (as illustrated in the document entitled “Box 1” submitted by the CFSAC with the Recommendation).
"Provide disease guidance with the criteria” (original recommendation below) Summary: Provide certain additional information to medical providers in order to improve diagnostic accuracy.
"Change the narrative" (original recommendation below) Summary: Incorporate important statements and messages about the disease in medical education, awareness, and other disease resource materials.
Discussion: The CDC has created a Technical Development Workgroup (TDW) comprised of disease experts, professional associations, patient advocates, and organizations in order to get advice and "buy-in" regarding new educational materials. Some of the members of the CFSAC and the IOM/P2P Working Group are involved. TDW members have already been given the IOM report and the August 2015 CFSAC recommendations on education for review and consideration, and teleconferences have begun.
The IOM/P2P Workgroup recognizes that the TDW format is a tremendous opportunity which gives stakeholders a chance to interact directly and exchange ideas with representatives from a number of important medical associations in the United States. It is sincerely hoped that the process will result in exceptional educational materials that further understanding regarding this disease and the challenges that patients face.
At the same time, the members of this Workgroup feel strongly that the recommendations submitted last year are essential if the goal is to get buy-in from the majority of the patient community regarding the proposed Diagnostic Criteria. Therefore, the group has asked that the key recommendations related to the proposed Criteria be restated, along with the recommendation to "Change the Narrative" for which there was no HHS response.
Another issue of concern is that new information on UpToDate, Healthwise, and the American College of Physicians' websites combines the IOM criteria for diagnosis with treatment recommendations for PACE-style CBT and GET, in some cases attributing poor prognosis to belief that the illness is physical. As highlighted in the Stats.org article referenced earlier, the PACE results, now in question, and not even designed for ME/CFS according to Dr. Peter White, "were covered in the news media, for the most part, uncritically:"
“Psychotherapy Eases Chronic Fatigue Syndrome, Study Finds”—New York Times
“Pushing limits can help chronic fatigue patients”—Reuters
“Brain and body training treats ME, UK study says”—BBC
“Therapy, Exercise Help Chronic Fatigue Syndrome”—WebMD
“Helping chronic fatigue patients over fears eases symptoms”—Fox News
“Chronic fatigue syndrome patients’ fear of exercise can hinder treatment – study”— The Guardian
“Study supports use of 2 controversial treatments for chronic fatigue”—CNN
“Chronic Fatigue Treatments Lead To Recovery In Trial”—Medical News"[ix]
It is clear that the name, definitional, and treatment issues continue to cause confusion in the medical community. This Working Group believes that solid educational materials that best describe the disease and truly reflect the patient experience can only be created with substantial involvement of disease experts and the patient advocate community. Therefore, we submit the following recommendation for CFSAC review.
Collaborate with disease experts and stakeholders regarding all educational materials prior to release:
CFSAC recommends systematic collaboration with recognized disease experts and stakeholders for review of all items of medical education produced by HHS agencies, Institutes and Centers prior to release. Additionally, CFSAC again recommends that the best way to move forward regarding the proposed Diagnostic Criteria was reflected in recommendations that were submitted to the Secretary in August 2015 (as attached), specifically: 8.) Use information from the IOM Report to detail and clarify the criteria; 10.) Provide disease guidance with the criteria; and 15.) Change the narrative.
Rationale: Recognized disease experts have a wealth of knowledge and expertise regarding disease history, clinical presentation, diagnostic testing, treatment options and clinical trials, and as such, are valuable resources regarding this disease. When new educational materials are being developed, advance review by a workgroup(s) comprised of knowledgeable disease experts and stakeholders can provide an opportunity to increase effectiveness and positive impact regarding the goal of reeducating medical providers regarding this disease. Such a workgroup could suggest wording or other changes to clarify messaging, anticipate questions and confusion, identify potential areas of stakeholder concern or controversy, and identify resources that may be of value.
Regarding CDC website content, brochures, video clips, infographics, and other new materials to be developed, information that accurately reflects the disease and the patient experience is vital. For a patient community that has been stigmatized and underserved for decades, the availability of federally-produced educational materials that can be accessed by the medical community and/or be provided (by patients) to uninformed medical providers, caregivers, employers, schools and others would be an invaluable resource in helping to improve the quality of patients’ lives.
Use information from the IOM Report to detail and clarify the criteria:
- 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.
- 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.
- 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.
- 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.
- 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.
Proposed Diagnostic Criteria
ME/CFS is an acquired, chronic multi-systemic disease characterized by significant relapse after physical, cognitive, or emotional 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.
Diagnosis requires that the patient have the following symptoms:
A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest.
Post-exertional malaise* due to systemic exertion intolerance, manifested as an exacerbation of some or all of an individual’s symptoms after seemingly minor physical or cognitive exertion or activity. PEM may result in flu-like symptoms; pain; cognitive dysfunction; nausea/gastrointestinal discomfort; weakness/instability; lightheadedness/vertigo; sensory changes; depression/anxiety; sleep disturbances; and difficulty recovering capacity. PEM may be delayed and is unpredictable in duration, potentially lasting hours, days, weeks, and even months. Subjective reports of PEM can be supported by failure to normally reproduce exercise test results (2-day CPET) and impaired cognitive function. However, this test may induce severe exacerbation of symptoms and is not required for diagnosis.
Sleep Abnormalities* which may include insomnia, sleep disturbances, daytime sleepiness, unrefreshing sleep, and nonrestorative sleep. Unrefreshing sleep is among the most common symptoms reported by patients.
At least one of the two following manifestations:
Cognitive Impairment* which may include short-term memory problems, inability to concentrate, difficulty expressing thoughts, confusion, disorientation, and difficulty performing simple activities such as watching television. Slowed information processing is common and may play a role in overall neurocognitive impairment. Neuropsychological testing is not necessary for diagnosis, however, it can be used to observe slowed information processing, memory impairments, reduced attention, and impaired psychomotor function.
Orthostatic Intolerance measured by objective heart rate and blood pressure abnormalities and physical findings during standing, bedside orthostatic vital signs, head-up tilt testing, or by patient-reported exacerbation of orthostatic symptoms with standing in day-to-day life.
* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.
Important and Frequently-reported Symptoms that Support Diagnosis:
Immune impairment: Acute, infection-like onset; Susceptibility to infection; perpetual flu-like symptoms; sore throat; tender lymph nodes; fever; new or worsened sensitivities to certain substances (e.g. foods, odors, medications, chemicals). Poor NK cell cytotoxicity (NK cell function, not number) correlates with illness severity in patients and could serve as a biomarker for the severity of the disease.
Neurological impairment: Impaired psychomotor function; muscle weakness; twitching; instability; spatial disorientation; ataxia; sensory changes (e.g. sensitivity or intolerance to light, noise and touch).
Pain: Headaches; arthralgia; myalgia; other pain symptoms (all highly variable in presence, nature and severity).
Other: Gastrointestinal impairments; genitourinary impairment; neuroendocrine manifestations (e.g. cold extremities, weight change, excessive sweating, high/low temperature, chills/shivers, loss of appetite, alcohol intolerance).
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:
- 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."
- 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.
- 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.
- 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.
- 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.
- Resources: Links to the IOM report, the IACFS/ME primer on guidelines.gov, and other appropriate resources.
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."
Endnotes with additional background information
[i] Numerous clinical guidelines continue to mix and match IOM criteria patients with evidence from studies done using Oxford criteria. For example, the 2015 UpToDate clinical guidelines recommend the IOM criteria for diagnosis but states that patients who think they have an organic disease have a poor prognosis and continues to recommend treatments based on Oxford studies. PEM is described by stating that “Excessive physical activity characteristically exacerbates the symptoms” with no discussion of lowered aerobic threshold or pacing.
- Gluckman, Stephen. “Clinical features and diagnosis of chronic fatigue syndrome (systemic exertion intolerance disease)” UpToDate. Deputy Editor Park, L. Last updated July 30, 2015. Literature review current through August 2015. Last September 18, 2015. http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-chronic-fatigue-syndrome-systemic-exertion-intolerance-disease#H15
- nbsp; Gluckman, Stephen. “Treatment of chronic fatigue syndrome (systemic exertion intolerance disease)” UpToDate. Deputy Editor Lee, P. Last updated July 30, 2015. Literature Review current through August 2015. Last accessed September 19, 2015. http://www.uptodate.com/contents/treatment-of-chronic-fatigue-syndrome-systemic-exertion-intolerance-disease?source=see_link
[ii] The IOM report noted that patients reported that health care providers “subject them to treatment strategies that exacerbate their symptoms.” Although CBT and GET are the most commonly recommended treatments for patients (largely a result of Oxford studies), numerous patient surveys have demonstrated harm from these treatments.
- Kindlon T. “Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioral Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.” Bulletin of the IACFS/ME Fall 2011; 19(2):59-111. http://web.archive.org/web/20130115105558/http:/www.iacfsme.org... This paper reported that 51 percent of respondents did worse on GET in eight surveys while 20 percent did worse on CBT in five surveys.
- ME Association. “ME/CFS Illness Management Survey Results ‘No decisions about me without me’.” May 2015. Last accessed October 26, 2015. http://www.meassociation.org.uk/2015/05/23959/ . This survey of 1428 patients conducted by U.K.’s ME Association similarly reported adverse reactions to GET.
Other examples of the continuing confusion caused by the conflation of the disease with chronic fatigue:
- Wellcome Book Prize awarded in April 2016 for book describing ME as a psychogenic illness. http://www.theguardian.com/books/2016/apr/25/wellcome-book-prize-neurologist-psychosomatic-illness-suzanne-osullivan-its-all-in-your-head
- January 2016, Newsweek and other media sources reported on study of “CFS” in teens but study was actually on patients with unexplained "chronic fatigue." http://www.newsweek.com/chronic-fatigue-syndrome-affects-1-50-teens-419365 . Study and comments by Dr. Rowe: http://pediatrics.aappublications.org/content/early/2016/01/22/peds.2015-3434
- 2015 Neurology Today article on IOM criteria with physician quote “It's important to avoid making the disease a lifestyle” and statement that the physician “often recommends cognitive behavioral therapy, a form of therapy that teaches people how to counter negative or inaccurate thoughts and cope with challenging or stressful situations.” http://journals.lww.com/neurologynow/Fulltext...
[iii] AHRQ Evidence Review (2015): “The Oxford criteria are the least specific and include patients who would not otherwise meet criteria for ME/CFS,” and stated, “future research should retire the use of the Oxford (Sharpe, 1991) case definition, given that it is at high risk of including patients who may have an alternate fatiguing illness, or whose illness resolves spontaneously with time. “
Pathways to Prevention Report (2015): “The multiple case definitions for ME/ CFS have hindered progress. In particular, continuing to use the Oxford definition may impair progress and cause harm. Therefore, for progress to occur, we recommend that this definition be retired.”
[iv] Tuller, David. Reexamining Chronic Fatigue Syndrome Research And Treatment Policy. Health Affairs blog. February 4, 2016. http://healthaffairs.org/blog/2016/02/04/reexamining-chronic-fatigue-syndrome-research-and-treatment-policy/ Tuller discusses the many problems with the PACE trial and the continued use of PACE findings in U.S. clinical guidelines.
[v] Golden, Rebecca. PACE: The research that sparked a patient rebellion and challenged medicine. Stats.org (governed by Sense About Science USA, funded by American Statistical Association and others). March 21, 2106 http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/ Golden analyzes questionable study design and significant flaws in the PACE trial, concluding "The best we can glean from PACE is that study design is essential to good science, the flaws in this design were enough to doom its results from the start.”
Butterworth, T. “On PACE.” Sense About Statistics. March 21, 2016. http://www.stats.org/editorial-on-pace/
Butterworth addresses questions about the study and how the results have been used.
[vi] Centers for Medicare & Medicaid Services. On-line ICD code lookup. (https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx?KeyWord=r53.82).
[vii] The presence of PEM has serious treatment/management implications. The kind of exercise that might be appropriate for Fukuda CFS patients is not appropriate for IOM criteria patients.
- Keller, B., Pryor, J., Giloteaux, L. Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO2peak indicates functional impairment. Journal of Translational Medicine April 2014, 12:104. PMID: 24755065. http://dx.doi.org/10.1186/1479-5876-12-104 Keller et al noted that “aerobic energy-producing processes fail to respond normally to exercise stress” in these patients and that “incautiously applied GET is likely to result in exacerbation of fatigue and other symptoms.”
[viii] The current CDC CFS website is based on the Fukuda Criteria for which PEM, cognitive dysfunction, and other core IOM-criteria symptoms are optional and autonomic dysfunction is not even addressed.
[ix] Golden, Rebecca. PACE: The research that sparked a patient rebellion and challenged medicine. Stats.org (governed by Sense About Science USA, funded by American Statistical Association and others). March 21, 2106 http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/