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

ID: 
96
Personal Details
This submission reflects the views of
Organisation Name: 
ME/CFS South Australia Inc
Specific Questions
1a. How well does the report present the difficulties faced by ME/CFS patients in receiving clinical care?: 
Ok
Comments: 
Thanks for recognition of patient experiences: stigma, isolation, delayed diagnosis, lack of supportive care, misunderstanding, being ignored/dismissed, iatrogenic harm, epistemic injustice. Report inadequately addresses: Iatrogenic harm • Clinicians access outdated, irrelevant harmful information: PACE material in RACGP-HANDI, Cochrane Review of Exercise Therapy 2017. • Clinicians don't understand: ME/CFS is severe/disabling. 50% don’t believe in ME/CFS. • Six-month delay in diagnosis is detrimental. ICC is an important diagnostic option. • p17, Clinicians rarely know/respect pacing. Harms arise when pacing overlooked: risk of worsening disability, possibly permanent. • p16, GET, “...risk of worsening symptoms..." overlooks risk of potentially permanent worsening of disability/illness severity. • PEM is misunderstood, particularly triggers other than physical or cognitive tasks. Note PEM Questionnaire (2018): https://doi.org/10.1177%2F1359105318805819 • PEM impacts on safe medical care: capacity to seek care; recovery from seeking care (including waiting room experiences); clinician misunderstanding/disbelief of PEM. • P18, "... identified needs ...to the attention of..." Centrelink and NDIS systemically disadvantage applicants: incorrect advice to assessors; medical reports from clinicians not understanding ME/CFS. Language • Fatigue/CF/CFS: conflation by clinicians/researchers undermines: patients describing their ME/CFS; relevance of research findings. • p21, "...PEM is not unique to ME/CFS..." The term PEM, created for ME/CFS (Fukuda, 1994), has been misappropriated for other 'fatiguing illnesses'. People with ME/CFS cannot describe unique symptoms/illness experience without unique, clearly defined language. Research misusing 'PEM' leads to harmful clinical misunderstandings. Diagnosis • Needed: fast, accurate diagnosis; Clinician education in consistent diagnosis for ME/CFS, not chronic fatigue. • p17 Objective measures exist for some ME/CFS diagnostic criteria, including PEM, orthostatic intolerance, disordered sleep. • p21 Fukuda (1994) reference is 2004. In 2019 Fukuda is clinically inappropriate (doesn't require PEM Accessing Medical Care • Lack of designated specialty/knowledgeable specialists. • Housebound patients cannot access medical care, except hospital admissions. • Teleservices rarely have Medicare rebates.
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: 
Thank you for including the CCC and IACFSME Primer for clinician use. Report inadequately addresses: Resources/Tools • p28, "...advises updating Australian ME/CFS clinical practice guidelines..." Need replacing not updating. • p29, "NHMRC guideline development...". NHMRC approved guidelines need level 1&2 evidence. International co-funding could enable updating the IACFSME primer in the interim. • Clinicians access outdated/irrelevant, harmful information: e.g. PACE material in RACGP-HANDI, Cochrane Review of Exercise Therapy 2017. • Clinicians need NHMRC guidance to identify the best resources. i.e. IACFSME and ICC primers. • p21 diagnostic criteria: Clinicians need ICC for early diagnosis to prevent harm. • Lack of designated specialty and knowledgeable specialists to support other clinicians. Education/Experience • p13, Key Points: Add that: complex and heterogeneous presentations do not fit the dominant medical model for diagnosing and treating illness. • Clinicians need training in multi-system illnesses. • p17, "Clinicians...diagnose...with observable objective data..." Clinicians are unaware of objective data, e.g.PEM, orthostatic intolerance, disordered sleep. • PEM is misunderstood, especially triggers other than physical or cognitive tasks. Note PEM Questionnaire (2018):https://doi.org/10.1177%2F1359105318805819 • Clinicians rarely understand harms of PEM, including worsening disability and increasing illness severity. • p17, Clinicians rarely know/respect pacing. Harms arise when pacing overlooked: risk of worsening disability, possibly permanent. • Clinicians rarely meet severely ill/disabled patients, whose needs remain misunderstood and unmet. • p6, "The dominant treatment paradigm has assumed..." is misleading. It is one discredited biopsychosocial treatment paradigm which remains in clinical use despite resultant harms and stigma. Language • p21,"...PEM is not unique to ME/CFS..." The term PEM is undermined by its use for other conditions, where post-exertional impact is very different, thus compromising clinician assessment, medical reports and patient management. PEM requires unique definition for ME/CFS to capture the unique post-exertional response. • Fatigue/CF/CFS: conflation by clinicians results in misdiagnosis and inappropriate advice.
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?: 
We support: • p18, Provide clinical guidance to NDIS. • p19, Consumer engagement requiring understanding and flexibility. • p21, Use of CCC and CDEs in research. Report inadequately addresses: Research • p6, "...have not confirmed the mechanisms of disease..." This is not confirmed for many diseases, yet undermines ME/CFS research funding. • p13, point 1. The impact of inconsistent diagnostic criteria is exacerbated by conflation of Fatigue/CF/CFS. • pp13-14 & p21, Fukuda criteria: Reference no. 13 date is 2004. Retaining Fukuda 1994 in Australian research will lead to poorly-defined cohorts. • p21 Researchers studying early stages of ME/CFS require ICC diagnosis. • PEM and pacing/'staying within the energy envelope' should be explicit research priorities. Clinical • Clinical guidance must address: o PEM as uniquely experienced in ME/CFS o PEM in both diagnostic approaches and management strategies, identifying delayed onset and extended recovery o PEM as risk factor for worsening disability/severity o pacing o demographic groups o illness/disability severity levels. Note: mild ME/CFS equals 50% reduction in functioning. o risks of harm: GET; response to drugs; waiting six months for diagnosis. • p13, point 4: Clinicians use CCC consistently without difficulty. (Used in SA since 2004 SA GP guidelines.) • p18, "For these ME/CFS patients [GET] may not be appropriate." Change 'may not' to 'is not'. • p6, point 2: This discredited treatment paradigm should be deleted or heavily qualified. • p28, 2002 guidelines need replacing, not updating. • p6, point 5: Funding to update IACFSME could be added to p23 Committee Recommendations, Strategic focus 3, to rapidly provide up-to-date clinical guidance. • p29,"NHMRC guideline development options...". Add: Interim guidelines from international co-funding of IACFSME primer update. • p29, Resources on NHMRC webpage should be culled based on current evidence. • Need to recommend removal of RACGP-HANDI PACE materials.
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?: 
We support: • p8, Pathways to Prevention provides a starting point for indicating current gaps in research. GAPS Policy • p13, Key points: Add: Historical government neglect of research funding urgently needs redressing. • p15, "...mismatch between the amount of research funded and burden of disease." Committee recommendations, p23, Strategic Focus 1, have not captured this. (Current funding levels around $110,000pa, despite ME/CFS DALY scores: mild handicap 0.137, moderate 0.449, severe/profound 0.760.) • Fatigue/CF/CFS: Report recommendations are for ME/CFS, not 'fatiguing illnesses'. • p13, section 4.1:Aetiology is unknown for many conditions, yet treatments abound. Higher priorities are: o hypothesis-generating pathophysiological research o replication of promising studies o clinical trials. • Research requires clinically meaningful, objective outcome measures. • Support new technology and statistical methods appropriate to ME/CFS complexity. • p21, Diagnostic criteria: Early ME/CFS requires ICC diagnosis. • Research design should consider: o demography (geography/ethnicity/age/etc) o illness severity o illness duration (ICC diagnosis for early stages) • Research priority: PEM/PEM management: o criteria/descriptors for PEM in ME/CFS o triggers o delayed onset o extended recovery o harm from PEM causing worsening disability/illness severity. Clinical/Translational • p17, Physical activity and pacing: Use of heart rate monitors needs research to identify protocols and effectiveness. • Evaluation: o impact of limited access to health services o best practice protocols/clinics. • Section 3.1.3 Absent: Norwegian government's research funding, including clinical trials. • No mention of clinical drug trials: Cortene, Rituximab, Cyclophosphamide, Suramin, Ampligen Pathophysiology • p13, key point 5: "...ME/CFS being ... misunderstood..." PEM in particular is misunderstood. The unique characteristics of PEM in ME/CFS and the potential for harm from PEM are not well recognised. • Need adequate funding to identify specificity for known biomarkers. • Absent from report and Attachment D: Jarred Younger's Neuroinflammation, Pain and Fatigue Laboratory at UAB.
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?: 
We strongly support: • p19, section 5.2: Four principles • p21: p23, Strategic Focus 1: Adoption of diagnostic criteria requiring PEM; using CCC and CDEs; and Paediatric Primer. • p22, Three recommendations. • p23, Strategic Focus 2, Objectives and recommendations • p24, key points: Four points. • p24, TCR includes hypothesis-generating studies. • p25, "The Committee also recommends..." inclusion of severely affected patients. • p25, consumer engagement. There are weaknesses: • No explicit reference to clinical importance of describing and understanding PEM as uniquely experienced in ME/CFS. PEM and its management, including pacing, are research priorities, including risk of short- and long-term harm from triggering PEM. • Fatigue/CF/CFS must be clearly differentiated from ME/CFS research. • p4; p13; p25, 5.3.1.1: Historically, aetiology studies in CFS have not led to insights for ME/CFS. Community priorities are for ME/CFS studies not fatiguing illnesses. • p6, $1.63 million NHMRC funding (approximately $110,000pa). How will NHMRC prevent future ME/CFS funding being spent on other conditions? • p21, Early stage ME/CFS requires ICC diagnosis. Research options must allow study of early stage ME/CFS. • p23, Strategic Focus 1: Research funding must address historical funding neglect. • p23, Strategic Focus 3 recommendation: New clinical practice guidelines needed, not updating. • p25, “The Committee also recommends inclusion..." Identify separately, 'very severe' and 'severe'. • p25, Consumer engagement (broad, not just one or two representatives.) • p27, Reliance on PHRN and NCRIS is problematic. Many people hide their ME/CFS diagnosis from electronic data bases. Additionally, clinicians who ‘do not believe in ME/CFS’ will not record the diagnosis. • p30, section 5.3.4.2: Mason's recommendations are not accurately presented. Additionally, small-scale biobanks are inappropriate for large-scale studies. Biobanks are welcome, but not urgent priority. • Level of funding needs to support Level 1&2 evidence to influence clinical guidelines.

Page reviewed: 23 September, 2019