Elements of the CofEforME
The charity's' proposal for a Centre of Excellence for ME
will require key elements to be put in place or developed to enable the aetiology of the disease to be understood
and advances to be made in finding the cause of this disease by developing treatments for patients.
These would consist of – full examinations, clinical diagnosis, translational biomedical research, a research database (including biobank(s))to allow for more research opportunities and support) and improved education and training of healthcare staff with standard and up-to-date protocols being used.
Figure 1 shows the elements of the model with patient care and treatment at the centre of the model.
This proposal is located around the Norwich Research Park in Norfolk. This area contains world-class facilities with a leading university (the University of East Anglia (UEA)), leading research institutes such as The Quadram Institute (formerly Institute of Food Research), the Earlham Institute (formerly TGAC) and a modern flagship hospital (the Norfolk and Norwich University Hospital) - all of which complement the necessary biomedical research which would take place.
This proposal would make use of the existing infrastructure where patients are initially seen by GPs and referred to a consultant.
It is assumed that the local primary care would initially filter ME patients via GPs using
appropriate guidelines and having performed necessary tests, as normally happens to exclude other conditions.
GPs in the area with a special interest in ME would be used to assist and be trained in diagnosis and treatment of ME.
Once having ensured that a patient is a likely candidate for referral to an ME consultant then that referral would be made. The service would require early and correct examination and referral to the consultant
examinations of people with ME would be performed by the ME consultant at the Centre - in the hospital.
to the university hospital would be via existing methods from GPs. An important
issue is for early and correct diagnosis to be determined.
The consultant would perform a full clinical examination of the patient using a standard clinical protocols.
For home-bound patients who are unable to visit the hospital then home visits would be built into the model.
Diagnosis and Treatment
The diagnosis would be confirmed by the ME consultant (using the international standard Canadian Consensus Guidelines or its evolutionary replacement), and, once patients have been formally diagnosed as having ME, administer possible treatments. If consent is obtained the patient may then also be entered for inclusion and participation in biomedical research into the disease at the centre.
Using a standard diagnostic and clinical protocol the service would allow a model of care and appropriate care packages for people with severe presentations and to establish and co-ordinate a clinical network and disseminate best practice across that network.
Follow-up examinations would be scheduled so that patients are provided with a service and possible treatments and results from any treatments are fed back into a database which is administered between the university hospital and the university research faculty.
It is important that the consultant(s) be linked with the research taking place in the Research Park.
A parallel but complementary element will be for translational biomedical research to be started by the university in association with other complementary research organisations.
The university would undertake biomedical research into ME using cohorts of patients from those being referred to, and examined at the university hospital and provide possible recommendations for treatment.
The university research would be used for more rapid provision of possible treatments for patients whilst at the same time building up the research database for ME and allowing fostering of new areas of cooperation with other biomedical research facilities.
The research being proposed by the university would be of the most advanced possible – using virology and immunology as the key areas to build up foundations. An important aspect of the biomedical research is that properly defined and distinct patient cohorts are defined and maintained.
The research would be oriented toward translational biomedical research, which allows results from research to be applied toward treatments for ME patients.
Allied to this would be biomedical research projects – the first of which is examination of the possible link between ME and gut inflammation.
The Centre of Excellence is intended to determine the cause(s) of ME and develop treatments. Research would also be focused on international collaboration in biomedical research.
Research Database Repository
These initial and ongoing projects would enable a research repository to be established for use in further research. This research repository will assist epidemiological studies, enhance research potential and provide patients with proper records of treatment. Similarly a bio/tissuebank would be established/augmented using a registry and standard up-to-date protocols for collection.
A research protocol will be established to outline all the study procedures, including data collection and planned data analysis.
The need for training in ME is one of the main areas of interest for the charity. The proposed model would allow the GP network to have access to up to date information about ME including data on treatments and prognosis.
Specialist advice for more complex cases across the country could be provided based on referrals from other clinical commissioning groups. This in turn would complement the research database thus increasing knowledge and awareness of treatments.
Models of care and appropriate care could be developed with packages for people with severe presentations.
Medical students would be encouraged to intercalate in the later years of their training and participate in t he research - thus gaining more knowledge about the disease and passing back and sharing this experience to their peers.
Opportunities for holding working groups or seminars would facilitate the spread of knowledge amongst the community as well as
This model would be developed in the future with an ambulatory service and/or tele-medical services being employed for those who are too ill to attend the hospital for examination. Phlebotomy services would be provided for home visits to be made to allow the severely affected to participate in the research and allow treatments for these disenfranchised patients.
We would seek to establish additional biomedical research projects to be undertaken by the university and its partners in Europe which would increase the knowledge about the disease and facilitate development of treatments for patients.
In partnership with the charity more training courses would be arranged with visiting experts (researchers and clinicians) being able to share experiences and data and facilitate more education about the disease.
For an initial five year period a strategy of building a team would be implemented
which would supervise the work of at least three PhDs each year in the
Centre performing biomedical research.
This would provide the solid foundation of research at the hub.
Our 5 year Plan for Research
Potentially other partners would interact and collaborate with the research being undertaken at the hub.
We would aim to maintain this momentum of research by continuing at least this level as the Centre continues.
Future developments would see the potential of referrals from other areas (and other countries) to be created thus generating income and helping to establish the translational research and treatment facility as the foremost facility in Europe for treating myalgic encephalomyelitis.
It is hoped that an epidemiological study can be performed alongside the research. More details will be added later.
Since 2007 Invest in ME Research has been facilitating and supporting a strategy of international collaboration in research into ME which the charity believes is the most effective and quickest route to finding solutions to this disease. The charity are funding research and joined with the Alison Hunter Memorial Foundation of Australia and, with Bond University and University of East Anglia, in convening the Clinical Autoimmunity Working Group in London in May 2012 to raise awareness of ME, and promote collaboration, innovation and the foundations for a clearer strategy of biomedical research into ME.
The foundations are therefore already IiMER has organised annual CPD-accredited international ME conferences since 2006 and international researcher colloquiums since 2011 and is a founding member of European ME Alliance.
The foundations are therefore already
in place to advance science and provide the promise of better treatment and
possible restoration of function and lives back to a section of the community
who have received very little help in the past.