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Consultation on draft report to the NHMRC CEO for ‘Myalgic Encephalomyelitis / Chronic Fatigue Syndrome’ submission

ID: 
15
Personal Details
First Name: 
Margaret
Last Name: 
Fleuren
Specific Questions
1a. How well does the report present the difficulties faced by ME/CFS patients in receiving clinical care?: 
Ok
Comments: 
While the report recognises that fatigue is a difficult issue in language between clinicians and patients (Box 1, p20), the problem of Post-Exertional Malaise (PEM) being misunderstood has been glossed over (pp15-17). Report reference 31 regarding language, definitions and descriptions of PEM: • Fukuda (1994) created the term 'Post-Exertional Malaise' and thus had no prior medical meaning attached to it. By not defining PEM for twenty years, the CDC inadvertently exposed the term to "inaccurate and inconsistent interpretations by clinicians, researchers, and patients." • Often PEM is conflated with post-exertional fatigue. • The CDC, in describing PEM, use the ambiguous and broad words 'malaise' and 'sickness'. • Patients struggle to be understood by clinicians because there is no clearly defined vocabulary to adequately describe their unique symptoms and experience of illness Additional aspects of PEM in ME/CFS not mentioned: • The disabling effects of PEM when post-exertional symptoms other than fatigue or pain can be equally or more disabling; even daily activities such as cooking or reading can provoke PEM • PEM triggers that are not physical or cognitive tasks, ie mould, Multiple Chemical Sensitivity, emotional stress, temperature, light, sound, movement. • When seeking medical care, PEM becomes an issue: the capacity to seek care; recovery from seeking care (including waiting-room exacerbation of PEM) and clinician misunderstanding or disbelief of PEM. The importance of PEM as a factor in GET (p16, in section 4.5.1, Graded Exercise Therapy) has not been clearly acknowledged. Patient experience is that GET will cause PEM and the worsening of symptoms, thus increasing disability, which may become permanent. Objective measures in PEM are misrepresented (p17 section 4.5.2, Paragraph 3). Such measures include: the 24-hour repeat exercise test (Hodges et al 2017,); repeat grip test; differences in metabolite-detecting, adrenergic, and immune gene expression (White et al, 2012).
1b. How well does the report present the challenges facing clinicians in providing care, when there is lack of clarity on diagnostic and management tools, and minimal professional education about the condition?: 
Ok
Comments: 
The report misrepresents the uniqueness of PEM in ME/CFS (p21 section 5.2.2). While this claim remains undisputed, clinical management will be compromised. The definition of PEM is being undermined by its use for other conditions where the post-exertional impact is very different. This complicates clinician assessment, medical reports and management of ME/CFS sufferers. PEM was defined originally for ME/CFS exclusively (Fukuda, 1994) and it needs to be defined in a unique way; one that differentiates the post exertional response in ME/CFS from post exertional responses in other conditions. (Exercise intolerance is not fatigue; see report reference 17 - IOM and SEID.) PEM in ME/CFS is unique in that it is precipitated by triggers additional to physical and cognitive exertion, and results in extra illness-related symptoms. It is widely accepted that PEM as it occurs in ME/CFS differentiates ME/CFS from other illnesses. In Draft Report reference 73 (Bennet et al 2007) • Cancer-Related Fatigue - PEM only lasts for several hours • Chronic Fatigue Syndrome - PEM needs to last more than 24 hours • Analysis shows the differences in PEM symptoms between the two illness groups In Draft Report reference 74 (Cotler et al 2018) • Step one enables identification of PEM; step two enables differentiation between ME/CFS and Multiple Sclerosis and Post-Polio Syndrome. Draft Report reference 31 (Chu 2018): • There are characteristics that distinguish PEM from the post-exertional or emotionally distressing experiences of healthy people and people with other illnesses. People who do not have ME/CFS are unlikely to experience: • symptoms beyond an exacerbation of normal responses to emotional distress or physical exertion; • delayed onset of and extended recovery from exertion-exacerbated symptoms; • worsened sleep, pain, and mood with physical activity. In White et al's 2012 study, PEM is what differentiates ME/CFS from Multiple Sclerosis.
2a. The research and clinical guidance recommendations accurately address the specific needs of the ME/CFS community.: 
Neutral
Comments: How could the recommendations be improved?: 
The report omits: • Clinical guidance must define PEM as it is uniquely experienced in ME/CFS; and must include PEM in both diagnostic approaches and management strategies. • Pacing, or staying within the energy envelope, are optimal management tools as they maintain "an optimal level of activity over time", report reference 59. As a management option it needs to be included in clinical guidance and to be researched. • Pacing (E Goudsmit) - report reference 54. Research needs to include this issue: "the absence of a standardized definition has resulted in different protocols, creating confusion and complicating the evaluation of research." • The report fails to recommend removal of the RACGP HANDI resource references to PACE. • PEM and 'pacing' or 'staying within the energy envelope' have not been explicitly identified as research priorities, despite their central importance in the management of ME/CFS. • p13, section 4, key point 1: This inconsistency in diagnostic criteria, including those that do not require PEM, has been exacerbated by conflation of Fatigue, Chronic Fatigue and Chronic Fatigue Syndrome. • The report lacks adequate reference to risks of harm that result from PEM, including risks associated with GET. Pacing as a management tool has not been adequately addressed (p17, in section 4.5.1, Physical activity and Pacing), including omission of the following three issues. • The harms of not pacing; • Even good clinicians often do not know about or respect pacing as a management tool; • Pacing reduces exertion-related symptom severity and thus improves functioning and quality of life. (Report references 54, 58, 59, 61).
2b. The research and clinical guidance recommendations provide an accurate representation of the current gaps in research.: 
Neutral
Comments: How could the recommendations be improved?: 
The report omits or does not adequately address: PEM differentiates ME/CFS from other illnesses. PEM in ME/CFS is unique as it is precipitated by a range of triggers additional to activity; and the PEM response incorporates illness-related symptoms or exacerbation of symptoms, delayed onset and extended recovery. • There is a lack of clear diagnostic criteria or descriptors for PEM in ME/CFS, with a corresponding need for congruent research and clinical case definitions. • p13, section 4, key point 5: PEM in particular is misunderstood. Its unique characteristics and the potential for harm from PEM in ME/CFS are not well recognised. There is no explicit reference to the clinical importance of describing and understanding PEM in ME/CFS. • PEM and its management are research priorities. • p17, paragraph within section 4.5.1: Physical activity and pacing, “Some patients have adopted the use of heart rate monitors to find their safe level of activity…” This needs research to identify protocols and effectiveness. • Harms from overlooking the impact of PEM, such as the risk of increasing disability or long term worsening of illness severity, have not been identified as a research gap or research priority. The report omits the studies conducted by a group of researchers at DePaul University. They have produced the DePaul Symptom Questionnaire (DSQ) which has PEM factors, with good internal and test-retest reliabilities, usable as a solid basis for the above-mentioned tasks. Refer to Leonard A Jason et al, Attachment D 5th entry, Centre for Community Research, whose papers include: Test-retest reliability of the DSQ, 2015 Deconstructing post-exertional malaise: An exploratory factor analysis, 2016 The development of an instrument to assess post-exertional malaise in patients with myalgic encephalomyelitis and chronic fatigue syndrome, 2018 Patient perceptions of post-exertional malaise, 2018 A Brief Questionnaire to Assess Post-Exertional Malaise, 2018
2c. The research recommendations inform the CEO of the most effective and strategic research options currently available.: 
Neutral
Comments: How could the recommendations be improved?: 
Post-Exertional Malaise (PEM) is an integral component of ME/CFS, and is what differentiates ME/CFS from other competing diagnoses (such as Multiple Sclerosis, Post-Polio Syndrome and Cancer Related Fatigue, references 73,74). • p21, within section 5.2.2 There is a lack of clear criteria to define the PEM that is unique to ME/CFS. The problems of language and terminology must be addressed. • There is a corresponding need for research and clinical case definitions that incorporate PEM as the unique experience of ME/CFS. • p 21, section 5.2.2, last paragraph: Adoption of diagnostic criteria that require PEM, use of the CCC and CDEs, and the Paediatric Primer are a welcome recognition of the centrality of PEM. Refer to the work of Leonard A Jason et al (DePaul Symptom Questionnaire (DSQ; https://doi.org/10.1177%2F1359105318805819). • There is no explicit reference to the clinical importance of describing and understanding PEM in ME/CFS. PEM and its management are research priorities. Clinical guidance recognition is also needed for: o the disabling effects of PEM o the harms of GET due to triggering PEM o the benefits of pacing or staying within the energy envelope and thus avoiding triggering of PEM

Page reviewed: 23 September, 2019