ME Research UK — Energising ME Research

MRC publish their CFS/ME Research Strategy

The Medical Research Council (MRC) is a national organisation funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The CFS/ME research strategy just completed was developed by an independent Research Advisory Group set up in response to a request, in 2002, from the Chief Medical Officer for England for MRC to develop a research strategy to advance biomedical and health services research on CFS/ME. The Research Advisory Group was chaired by Professor Nancy Rothwell (School of Biological Sciences, University of Manchester) to take this task forward. The document makes long term and short term recommendations for research that will lead to greater understanding of CFS/ME and advances in patient care. The press release of the MRC says that it will, “enable researchers and funders in the UK and elsewhere to press ahead with work on all aspects of this complex and debilitating illness”.

While it is too early to gauge the report’s reception generally — and far too early to gauge its effect on real people with ME (present and future) — not all initial responses have been positive. Some have already accused the Research Advisory Group of ignoring the evidence, and some are still digesting the meaning of statements, such as “[the group] has not provided a detailed plan for the science, nor set out an agenda of the many research projects that might merit support”, and “it is not an essential prerequisite to identify triggers and causal pathways in order to undertake research on CFS/ME”.

Summary

  1. This research strategy for CFS/ME has been developed by a Medical Research Council (MRC) CFS/ME Research Advisory Group. The Research Advisory Group was convened in response to the request of the Department of Health in England for the MRC to develop a broad strategy for advancing biomedical and health services research on CFS/ME, following the publication of the Report of the Chief Medical Officer (CMO)’s Independent Working Group in January 2002. The remit of the MRC CFS/ME Research Advisory Group was not to review the existing body of knowledge, but in the light of the Report of the CMO’s Independent Working Group on CFS/ME (including its recommendations for research) and other recent reviews of current knowledge and understanding of CFS/ME, propose a research strategy.
  2. The MRC CFS/ME Research Advisory Group fully endorses the conclusions of the Report of the CMO’s Independent Working Group, namely that CFS/ME is a real, serious and debilitating condition, and that research into all aspects of CFS/ME is needed.
  3. The MRC CFS/ME Research Advisory Group has used the term ‘CFS/ME’ in this strategy. The Research Advisory Group acknowledges that the descriptive term ‘CFS/ME’ does not refer to a specific diagnosis but, as discussed below, considers that it is appropriate when a broad approach is being recommended. In the same manner, the singular term ‘condition’ is used, but this does not indicate that the MRC CFS/ME Research Advisory Group holds any particular position on whether CFS/ME is one condition with heterogeneity of cause, pathogenesis and severity, or is a number of similar conditions with different individual characteristics.
  4. The MRC CFS/ME Research Advisory Group met formally three times between September 2002 and March 2003, and held numerous other discussions. A consultation exercise was undertaken over July and August 2002 using a set of structured questions, which was independently analysed. The lay members of the MRC CFS/ME Research Advisory Group met with ME charities, CFS/ME patients and their carers, to better understand their perspectives.
  5. The MRC CFS/ME Research Advisory Group has not provided a detailed plan for the science, nor set out an agenda of the many research projects that might merit support. A research strategy is proposed which aims to provide a framework for advancing the understanding of the illness and patient care.
  6. In considering ways to advance research on CFS/ME, the Research Advisory Group has focused on a number of strategic themes: case definition, an epidemiological framework, pathophysiology, interventions, health service research, research capacity and the value of lay participation.
  7. The MRC CFS/ME Research Advisory Group recommends that research studies should aim to be as inclusive as possible in terms of the recruitment of participants, and due consideration should be given to sample size to allow for possible subgroup effects. There should be clearly stated inclusion and exclusion criteria, with detailed justification if certain types of patients are not included. This recommendation does not imply that there is no merit in studying specific, well described patient groups, but that there is an obligation for researchers to be explicit as to the selection criteria, and that these criteria are scientifically justified in the context of the research being undertaken.
  8. The MRC CFS/ME Research Advisory Group considers there should be an agreed standardised research case definition and a classification of severity and any other relevant characteristics that define subgroups. Improved definition of the phenotypes of potential subgroups that may come under a CFS/ME spectrum, and overlaps with other conditions, will underpin research on causes, mechanisms, and management. A definition of a clinically important improvement in disease status, with a classification of the degree of improvement, is essential for natural history and intervention studies.
  9. In the short term, the MRC CFS/ME Research Advisory Group considers that the research community should be encouraged to develop high quality research proposals for funding that address key issues for CFS/ME research that are amenable for study at the present time: case-definition, understanding symptomatology, and new approaches to management.
  10. In view of the probable multiplicity of potential causal factors and the widely disparate findings so far reported, the MRC CFS/ME Research Advisory Group considers that studies investigating causal pathways and mechanisms, whilst having merit, would not have the same immediate impact on increasing understanding of CFS/ME, nor reducing the suffering of patients. This is not say that such studies should be abandoned, rather that it is not an essential prerequisite to identify triggers and causal pathways in order to undertake research on CFS/ME.
  11. The MRC CFS/ME Research Advisory Group considers it is appropriate to explore potential interventions for CFS/ME in the absence of knowledge of causation or pathogenesis, as it is in other illnesses. Randomised controlled trials of adequate size, using standardised case definitions, eligibility criteria, and baseline and outcome assessments, could be used to evaluate one or more of the interventions which have been shown in one or more trials to have a benefit. Standardisation will allow results to be more widely generalised and compared between studies.
  12. Given the present difficulties in identifying priorities for health services research in CFS/ME, it is not clear whether it is appropriate to make HSR a priority at this time.
  13. It is essential that the researcher–funder–lay partnership is nurtured, to ensure that the best evidence is easily available to all, and to facilitate the growth of consumer involvement in the design, conduct and dissemination of research — as a means to enhancing its quality, relevance, and credibility. The MRC CFS/ME Research Advisory Group considers that there is a key role for patient organisations to help attract participants to research, especially the severely ill, and to help in the dissemination of research results.