Tag: Institute of Medicine

To Serve or Not to Serve: Ethical and Policy Implications

Abstract:

The Institute of Medicine (IOM) is one of the nation’s more influential health-related non-profit organizations. It plays a large role in shaping health policy by commissioning panels to develop “white papers” describing research and recommendations on a variety of health topics. These white paper publications are often used to help make policy decisions at the legislative and executive levels. Such a prominent institution might seem like a natural ally for policy-related collaborative efforts. As community psychologists, we strongly endorse efforts to positively influence public policy at the national level. However, while serving on influential panels and commissions like the IOM might seem to be very much part of the ethos of our discipline, there are occasions when such institutions are pursuing a mission that inadvertently has the potential to instigate divisive friction among community activists and organizations.

A case study is presented whereby I describe my decision not to accept an invitation to serve on a controversial IOM panel. I explore the ethical challenges regarding maintaining my independence from this institution and its attempt to redefine chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME), as well as the process of searching for alternative avenues for collaborating with community activists to influence policy related to these debilitating illnesses.

© Society for Community Research and Action 2017.

Source: Jason LA. To Serve or Not to Serve: Ethical and Policy Implications. Am J Community Psychol. 2017 Sep 18. doi: 10.1002/ajcp.12181. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28921637

Clinical criteria versus a possible research case definition in chronic fatigue syndrome/myalgic encephalomyelitis

Abstract:

Background: The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome. Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition.

Purpose: The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities.

Methods: Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by six or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the 36-item Short-Form Health Survey (SF-36). Due to unequal sample sizes and variances, Welch’s F tests and Games-Howell post-hoc tests were conducted.

Results: Using a large database of over 1000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups.

Conclusion: Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study.

 

Source: Leonard A. Jason, Stephanie McManimen, Madison Sunnquist, Julia L. Newton & Elin Bolle Strand. Clinical criteria versus a possible research case definition in chronic fatigue syndrome/myalgic encephalomyelitis. Fatigue: Biomedicine, Health & Behavior. Published online: 06 Mar 2017

 

Replacing Myalgic Encephalomyelitis and Chronic Fatigue Syndrome with Systemic Exercise Intolerance Disease Is Not the Way forward

Abstract:

Myalgic encephalomyelitis (ME), described in the medical literature since 1938, is characterized by distinctive muscular symptoms, neurological symptoms, and signs of circulatory impairment. The only mandatory feature of chronic fatigue syndrome (CFS), introduced in 1988 and redefined in 1994, is chronic fatigue, which should be accompanied by at least four or more out of eight “additional” symptoms.

The use of the abstract, polythetic criteria of CFS, which define a heterogeneous patient population, and self-report has hampered both scientific progress and accurate diagnosis. To resolve the “diagnostic impasse” the Institute of Medicine proposes that a new clinical entity, systemic exercise intolerance disease (SEID), should replace the clinical entities ME and CFS. However, adopting SEID and its defining symptoms, does not resolve methodological and diagnostic issues.

Firstly, a new diagnostic entity cannot replace two distinct, partially overlapping, clinical entities such as ME and CFS. Secondly, due to the nature of the diagnostic criteria, the employment of self-report, and the lack of criteria to exclude patients with other conditions, the SEID criteria seem to select an even more heterogeneous patient population, causing additional diagnostic confusion. This article discusses methodological and diagnostic issues related to SEID and proposes a methodological solution for the current “diagnostic impasse”.

 

Source: Twisk FN. Replacing Myalgic Encephalomyelitis and Chronic Fatigue Syndrome with Systemic Exercise Intolerance Disease Is Not the Way forward. Diagnostics (Basel). 2016 Feb 5;6(1). pii: E10. doi: 10.3390/diagnostics6010010. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4808825/ (Full article)

 

Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease

Abstract:

The Institute of Medicine recently proposed a new case definition for chronic fatigue syndrome (CFS), as well as a new name, Systemic Exertion Intolerance Disease (SEID). Contrary to the Fukuda et al.’s CFS case definition, there are few exclusionary illnesses specified for this new SEID case definition.

The current study explored this decision regarding exclusionary illnesses using the SEID criteria with four distinct data sets involving patients who had been identified as having CFS, as well as healthy controls, community controls, and other illness groups. The findings indicate that many individuals from major depressive disorder illness groups as well as other medical illnesses were categorized as having SEID. The past CFS Fukuda et al. prevalence rate in a community based sample of 0.42 increased by 2.8 times with the new SEID criteria. The consequences for this broadening of the case definition are discussed.

 

Source: Jason LA, Sunnquist M, Kot B, Brown A. Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease. Diagnostics (Basel). 2015 Jun 23;5(2):272-86. doi: 10.3390/diagnostics5020272. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4666441/ (Full article)

 

Chronic Fatigue Syndrome versus Systemic Exertion Intolerance Disease

Abstract:

BACKGROUND: The Institute of Medicine has recommended a change in the name and criteria for Chronic Fatigue Syndrome (CFS), renaming the illness Systemic Exertion Intolerance Disease (SEID). The new SEID case definition requires substantial reductions or impairments in the ability to engage in pre-illness activities, unrefreshing sleep, post-exertional malaise, and either cognitive impairment or orthostatic intolerance.

PURPOSE: In the current study, samples were generated through several different methods and were used to compare this new case definition to previous case definitions for CFS, Myalgic Encephalomyelitis (ME-ICC), Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), as well as a case definition developed through empirical methods.

METHODS: We used a cross-sectional design with samples from tertiary care settings, a biobank sample, and other forums. 796 patients from the US, Great Britain, and Norway completed the DePaul Symptom Questionnaire.

RESULTS: Findings indicated that the SEID criteria identified 88% of participants in the samples analyzed, which is comparable to the 92% that met the Fukuda criteria. The SEID case definition was compared to a four item empiric criteria, and findings indicated that the four item empiric criteria identified a smaller, more functionally limited and symptomatic group of patients.

CONCLUSION: The recently developed SEID criteria appears to identify a group comparable in size to the Fukuda et al. criteria, but a larger group of patients than the Canadian ME/CFS and ME criteria, and selects more patients who have less impairment and fewer symptoms than a four item empiric criteria.

 

Source: Jason LA, Sunnquist M, Brown A, Newton JL, Strand EB, Vernon SD. Chronic Fatigue Syndrome versus Systemic Exertion Intolerance Disease. Fatigue. 2015 Jul;3(3):127-141. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4556426/ (Full article)

 

Reflections on the Institute of Medicine’s systemic exertion intolerance disease

Abstract:

The Institute of Medicine (IOM) in the United States has recently proposed that the term systemic exertion intolerance disease (SEID) replace chronic fatigue syndrome. In addition, the IOM proposed a new case definition for SEID, which includes substantial reductions or impairments in the ability to engage in pre illness activities, unrefreshing sleep, postexertional malaise, and either cognitive impairment or orthostatic intolerance.

Unfortunately, these recommendations for a name change were not vetted with patient and professional audiences, and the new criteria were not evaluated with data sets of patients and controls. A recent poll suggests that the majority of patients reject this new name. In addition, studies have found that prevalence rates will dramatically increase with the new criteria, particularly due to the ambiguity revolving around exclusionary illnesses. Findings suggest that the new criteria select more patients who have less impairment and fewer symptoms than several other criteria. The implications of these findings are discussed in the current review.

 

Source: Jason LA, Sunnquist M, Brown A, McManimen S, Furst J. Reflections on the Institute of Medicine’s systemic exertion intolerance disease. Pol Arch Med Wewn. 2015;125(7-8):576-81. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4826027/ (Full article)

 

A critical analysis of the proposal of the Institute of Medicine to replace myalgic encephalomyelitis and chronic fatigue syndrome by a new diagnostic entity called systemic exertion intolerance disease

Abstract:

The Institute of Medicine (IOM) recently published their report in response to an assignment “to define diagnostic criteria for Myalgic Encephalomyelitis (ME)/chronic fatigue syndrome (CFS), to propose a process for reevaluation of these criteria in the future, and to consider whether a new name for this disease is warranted”.

The basic pre-assumption of the IOM committee for the development of evidence-based diagnostic criteria for ME/CFS was that ME and CFS denote conditions with similar symptoms, hence ME/CFS. The IOM committee recommends: (1) that ME/CFS will be renamed ‘systemic exertion intolerance disease’ (SEID); and that a new code should be assigned to SEID in the International Classification of Diseases (ICD), replacing the existing codes for ME (a neurological disease: G93.3) and CFS (‘signs, symptoms, and abnormal clinical and laboratory findings, not elsewhere classified’: R53.82); (2) that a diagnosis of SEID should be made if the new diagnostic criteria are met; (3) that the Department of Health and Human Services develops a toolkit appropriate for screening and diagnosing patients; and (4) that a multidisciplinary group re-examines the new diagnostic criteria when necessary.

This editorial reviews the working procedure of the IOM and two of the outcomes: the recommendation to introduce a new clinical entity (SEID) and new diagnostic criteria. Based upon the contents of the report, and the arguments of the IOM, a search of PubMed and the archive of the Journal of Chronic Fatigue Syndrome using the search terms ME (and old synonyms) and CFS, and a search of PubMed related to the five core symptoms of SEID was conducted.

Reviewing the working method and the recommendations, it is concluded that the new diagnostic criteria for SEID are based upon important methodological shortcomings and that the introduction of SEID to replace both ME and CFS has several profound negative consequences outweighing the advantages.

 

Source: Twisk FN. A critical analysis of the proposal of the Institute of Medicine to replace myalgic encephalomyelitis and chronic fatigue syndrome by a new diagnostic entity called systemic exertion intolerance disease. Curr Med Res Opin. 2015;31(7):1333-47. doi: 10.1185/03007995.2015.1045472. Epub 2015 May 29. https://www.ncbi.nlm.nih.gov/pubmed/25912615 (Full article)

 

Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness

Excerpt:

Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) are serious, debilitating conditions that affect millions of people in the United States and around the world. ME/CFS can cause significant impairment and disability. Despite substantial efforts by researchers to better understand ME/CFS, there is no known cause or effective treatment. Diagnosing the disease remains a challenge, and patients often struggle with their illness for years before an identification is made. Some health care providers have been skeptical about the serious physiological — rather than psychological — nature of the illness. Once diagnosed, patients often complain of receiving hostility from their health care provider as well as being subjected to treatment strategies that exacerbate their symptoms.

Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome proposes new diagnostic clinical criteria for ME/CFS and a new term for the illness — systemic exertion intolerance disease(SEID). According to this report, the term myalgic encephalomyelitis does not accurately describe this illness, and the term chronic fatigue syndrome can result in trivialization and stigmatization for patients afflicted with this illness. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome stresses that SEID is a medical — not a psychiatric or psychological — illness.

This report lists the major symptoms of SEID and recommends a diagnostic process.One of the report’s most important conclusions is that a thorough history, physical examination, and targeted work-up are necessary and often sufficient for diagnosis. The new criteria will allow a large percentage of undiagnosed patients to receive an accurate diagnosis and appropriate care. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will be a valuable resource to promote the prompt diagnosis of patients with this complex, multisystem, and often devastating disorder; enhance public understanding; and provide a firm foundation for future improvements in diagnosis and treatment.

Copyright 2015 by the National Academy of Sciences. All rights reserved.

 

Source: Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 2015 Feb.  The National Academies Collection: Reports funded by National Institutes of Health. https://www.ncbi.nlm.nih.gov/books/NBK274235/ (Full article)

 

Examining the Institute of Medicine’s Recommendations Regarding Chronic Fatigue Syndrome: Clinical Versus Research Criteria

Abstract:

The Institute of Medicine (2015) has proposed a new clinical case definition for what had been known as chronic fatigue syndrome (CFS). This new criteria involved the following domains: substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities; post-exertional malaise; unrefreshing sleep; and at least one of the two following symptoms: cognitive impairment or orthostatic intolerance.

In addition, in August of 2015, the CFS Advisory Committee, which makes recommendations to the Secretary of US Department of Health and Human Services, proposed that the Canadian 2003 criteria should serve as the research case for CFS. Up to now, there have not been any published investigations comparing these clinical and research criteria.

Using patient samples collected in the United States, Great Britain, and Norway, the current study compared and contrasted patients who met the clinical and research criteria. Overall findings indicated that those meeting the research criteria in comparison to those meeting the clinical criteria were significantly more impaired on a wide variety of symptoms and functional areas. The implications of these findings are discussed.

 

Source: Jason LA, McManimen S, Sunnquist M, Brown A, Newton JL, Strand EB. Examining the Institute of Medicine’s Recommendations Regarding Chronic Fatigue Syndrome: Clinical Versus Research Criteria. J Neurol Psychol. 2015;2015(Suppl 2). pii: http://www.avensonline.org/wp-content/uploads/JNP-2332-3469-S2-0002.pdf. Epub 2015 Nov 25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008852/ (Full article)