The UK charity Action for ME has announced that they are funding two new research studies, totalling £42,000. One of the funded projects is a feasibility study which will determine the suitability of using a standardized intervention to manage autonomic dysfunction, which will be led by Julia Newton of Newcastle University. The second is to be led by Dr Esther Crawley of the University of Bristol, and aims to look at the incidence, demographic and clinical features of severe paediatric M.E in the UK.
The severe paediatric M.E. British national surveillance study will measure the incidence, demographic and clinical features of severe paediatric M.E. in the UK. This study was prioritised by Action for ME’s supporters in 2013, when they were asked for vote for three projects in which they would most like to invest. (In first and second place were studies into immune responses in M.E. and patterns of mitochondrial DNA variation, both of which are already funded.)
Crawley has stated that the results should ‘help inform future research and service provision.’ While patient-groups welcome research into severe M.E, given that this population is not often studied, members of Action for ME and the wider M.E community have responded to the announcement with some questions and concerns.
The first is in reference to the fact that the study will be led by Dr Esther Crawley. She has an excellent track record in working to understand general paediatric fatigue. However, with the controversy regarding the PACE trial[i] over the last year and the extent to which it has been discredited, as well as the growing body of research supporting the fact that M.E is associated with marked physical changes, it seems unusual for an ME charity to fund the work of someone who is known for holding the biopsychosocial view. Dr Crawley, despite having stated publicly that she considers M.E to be a biological, genetically heritable illness, which has a severe impact on sufferers,[ii] has, in fact, produced research exploring whether fatigue has biopsychosocial causative factors. She studied the association between disabling fatigue and maternal anxiety and depression[iii], for example, and also disabling fatigue and family adversity[iv].
The second concern relates to the fact that M.E. will be compared with anxiety, depression and eating disorders in paediatric M.E. It is more pertinent to look at whether diagnoses such as Ehler-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome or Glandular Fever have occurred in the same patient population, rather than illnesses that are psychological in origin. Mental illnesses, while serious conditions worthy of study in their own right, are not M.E.
Finally, it is important to ask what criteria will be used in this study. Given that Dr Esther Crawley has previously studied ‘fatigue,’ in much of her research, rather than M.E as defined by the Canadian Consensus Criteria, what, if any, objective measurements will be called into play when looking at how the participants have been diagnosed? With the PACE trial being criticised, in part, because it relied on subjective self-report, how is the study going to accurately assess from just what illness each child is suffering? There is the potential for such a flaw to threaten the whole study, in rendering any data collected meaningless.
On 16th May, 2016, Action for M.E released a statement on its Facebook page in response to some of the questions asked of them. They have stated that paediatricians involved in the study will ‘report new cases of severe paediatric M.E. who fulfill the case definition using protocols developed by the BPSU.’ They say too that ‘children and young people who have fatigue that can be explained by other conditions, or for whom routine blood tests and investigations (as set out on p 140 of the NICE guideline for M.E.) have not been completed to exclude other causes of fatigue, will not be included in the study.
Action for M.E have also deleted all comments which raised concerns about the study on their Facebook post and have stated that they will delete all further comments made.
[ii] Case notes BBC Radio 4 6th November, 2007
[iii] Maternal and childhood psychological factors predict chronic disabling fatigue at age 13 years, Crawley E et al 2015 Journal of Adolescent Health, vol 56, pp 181-187
[iv] Chronic disabling fatigue at age 13 and association with family adversity, Crawley et al, Pediatrics, July 2012, volume 130, issue 1
In August, we shared with you that we and six other ME/CFS organizations had submitted a proposal to the National Center of Health Statistics (NCHS) to fix the coding of ME/CFS in the US International Classification of Diseases (ICD-10-CM). Today, we are writing with an update on that proposal and asking that you sign the