October 2023 saw the conclusion of the consultation phase on the UK Department of Health and Social Care (DHSC) ‘My full reality: the interim delivery plan on ME/CFS‘ . ME Research UK commented fully on the provisions as they relate to research and the limitations the charity saw in the plans.
3,338 responses were received –
- 47 were from organisations – including the views of ME Research UK
- 3,113 were from individuals sharing their personal views
- 53 were from individuals responding on behalf of someone else
- 125 were from individuals sharing their professional views
Such were the number of responses that the DHSC has taken over a year to analyse the results but these were released online on 19 December 2024 as ‘Improving the experiences of people with ME/CFS: consultation outcome’ and covers the areas of the draft Delivery Plan namely
- research
- attitudes and education
- living with ME/CFS
- language used in relation to ME/CFS
Responses relevant to Research
According to the DHSC analysis of responses the suggestions for further improvement to the Interim Delivery Plan (IDP) in order of strength of support, related to:
- ring-fencing funding, as well as securing more funding and parity of funding with other conditions
- scope of research
- ‘quick wins’
- rebuilding trust with people with ME/CFS
Funding
While supporting the ‘Research’ chapter and the positive language in the IDP, respondents voiced that there is a need for a funding commitment, including ring-fenced funding, particularly for biomedical research, to ensure parity with other long-term conditions and to make a tangible impact.
Grant funding to projects aligned with the James Lind Alliance top 10s of priorities for research were featured.
Strategy
Responses called for development of an actionable ME/CFS research strategy. SMART (specific, measurable, achievable, relevant and time-bound) research targets and metrics, and monitoring of actions and milestones, should be put in place. Short-term, medium-term and long-term goals should be identified.
Also identified was a need for co-operation and join-up at international level.
Also, an annual report on why (un)successful applications were accepted or rejected from the Medical Research Council and the National Institute for Health and Care Research (NIHR) was mooted.
There was also calls for a centralised database of research and a centre for research excellence, as proposed in the 2022 All-Party Parliamentary Group report.
Research capacity
Government was also called upon to encourage funders to prioritise research into ME/CFS and educate those involved in the processes to ensure fair assessment of applications.
Also, to put in place actions to increase research capacity, and proactively encourage research proposals and grant applications.
Attract and keep researchers in the field, including by securing funding and putting in place actions to support researchers at different stages (such as studentships and fellowships). A more cohesive and inclusive research community is needed, and researchers should be experienced in ME/CFS.
Join up researchers to maximise benefits and reduce duplication.
Research scope
The consultation found support for a focus on biomedical research and research into repurposing medicines used to treat other conditions with overlaps in symptomatology, rather than psychosocial research. There is an urgent need to identify biomarkers for this illness, and some respondents felt that psychological research into ME/CFS should be paused until we have a better understanding of biological aspects of the disease. Other respondents, however, expressed concern about the general trajectory of research towards a purely biomedical focus and away from any consideration about the importance of biopsychosocial factors in this condition.
There were calls to compose a list of all aspects that should be researched, including impact of childhood trauma. Research should also investigate the impact of stress and socio-economic factors on recovery.
Research and understanding of other overlapping functional conditions (such as functional neurologic disorder or irritable bowel syndrome) may have a higher yield.
Research into different types of ME/CFS (such as severe) and age groups (such as children and young people), as well as more research into those who are recovering or have recovered from ME/CFS and long COVID, is needed.
Decode ME was given as a great example of a successful study.
Openness required to ‘avoid tunnel vision’, including looking beyond long COVID as a trigger.
Combine research into long COVID and ME/CFS.
Research to assess the current disease burden of ME.
Research into the harms suffered by ME/CFS patients due to relapses, disease progression and trauma caused by process deadlines, the assessment or review process, issues with duration, behaviours, environment, poor understanding and so on.
The need for research that could have quick results, including the benefits of taking supplements. More research into complementary medicine.
Focusing on a neuroplasticity (the brain’s ability to change and adapt throughout life)-based approach was described as helpful. More research is needed on acupuncture and vagus nerve damage.
Patient involvement
Include patients with ME/CFS in study cohorts rather than people experiencing fatigue, and ensure inclusion of the ME element when naming the condition.
Research best practice for severe ME/CFS, adapt studies to enable participation of people with severe and very severe ME/CFS symptoms, and encourage their participation.
Ensure patients feel included and plan research with those with lived experience, taking their needs into consideration.
Include people with ME/CFS in other research as a control group – for example, immunological and gastrointestinal research.
Explore personal stories of people with ME/CFS and long COVID where gradual increase in exercise led to improvement in symptoms.
Actions
96.6% of individual respondents strongly agreed or agreed with the actions outlined for improving research in ME/CFS.
Six actions proposed in the IDP include:
- support for workshops with funders, academics and people with ME/CFS on how to develop research questions
- commissioning a landscaping review of national and international work underway in ME/CFS
- support for funders to raise awareness of opportunities for research funding
- support for funders to raise awareness of mechanisms for effective patient and public involvement and engagement in research
- support for development of case studies of research that show good practice
- support for engagement with initiatives to educate clinicians and practitioners about ME/CFS
Key actions proposed by respondents were:
- a research funding commitment
- production of a targeted research plan
- an urgent need for more research, particularly biomedical research, to understand causes and treatments
Next Steps
The government has indicated that the results of the consultation will be considered and that the ME/CFS Task and Finish Group, including senior DHSC and cross-government officials, ME/CFS specialists and representatives from NHS England, NICE, devolved governments, and ME/CFS charities and organisations will be re-convened to allow the ME/CFS Task and Finish Group to consider and agree actions in the final delivery plan on ME/CFS, which is slated to be published by the end of March 2025.
We are committed to creating a society where every person, including those with ME/CFS, receives high-quality, compassionate continuity of care that they need and deserve, with their families and carers supported.
Our Conclusions
ME Research UK is pleased to see that so many of the threads of our response have been echoed by other respondees and feature in the list of those most commented and most supported. The stronger the calls for focused and well-funded biomedical research into the causes, consequences and treatment of ME/CFS the more likely it is that government will be forced to re-think, re-focus and to ACT.
That being said, although the Key Actions are to be welcomed the Six actions proposed in the IDP appear weak and unlikely to produce the transformational change needed to achieve the research goals. These actions must be strengthened to align with the clear demands of the repsonees and to give the outcomes outlined in the Key Actions a chance to be realised.
That ring-fenced funding, prioritisation of biomedical research, and the need to encourage and retain researchers in the field have been endorsed by so many chimes with this charity’s step-by-step approach.
Biomedical ME research demands ring-fenced funding to allow meaningful, long-term multi-centered, multi-disciplinary, groudbreaking studies to be made a reality. With a secure base learnings in research can be taken from long COVID, from other diseases both nationally and internationally. Strands of co-ordinated research could include dedicated projects on the severely affected, on drugs repurposing, and other areas highlighted in the Top Ten plus results. All studies ought to be designed from the outset to be patient-focussed with full patient involvement in the design and operation of studies. Only with certainty of funding will universities and the NHS plan for research and allocate their own resources – both financial and human – and only with certainty as to funding and acceptance will researchers be attracted to and remain in the field. What is certain is that the current model of MRC Highlight Notices and the odd biomedical funded study being funded has failed. It has failed researchers, and it has most certainly failed the many hundreds of thousands of people with ME/CFS in the UK and their families and friends.
Those charged with decision-making and formulating the final Delivery Plan need only look to the Netherlands and Germany to see how dedicated funding can transform the research landscape – research consortia formed to drive research forward, existing research infrastructure created or drawn-upon and patients involved in key stages. Where in the Interim Delivery Plan is this level of ambition? By implementing the demands of respondents to the consultation there is the opportunity to forge a better future for ME/CFS research – will this opportunity be grasped?
Research into ME/CFS cannot be left to patients to fund. Attitudes within central funders must change. Only the government can dictate and demand that this happens. If the results of the consultation are translated into a strengthened and improved Delivery Plan then real change may occur but we must all await publication of the final Delivery Plan due in March 2025. However, as the government web page says “this document summarises the consultation responses only and is not intended to announce new government actions on ME/CFS.’
