From the Chief Medical Officer, Sir Liam Donaldson
Richmond House
79 Whitehall
London
SW1A 2NS
Tel: +44 (0)20 7210 5150-4
Fax: +44 (0)20 7210 5407
www.doh.gov.uk/cmo
June 2004
An
integrated approach to human transmissible spongiform encephalopathies (prion
diseases): surveillance, health care, public health controls, clinical trials
and other clinical research.
The first UK
clinical trial of potential therapy for Creutzfeldt-Jakob Disease (CJD) is
expected to begin shortly. We
need to ensure a high level of patient referral to the trial whilst maintaining
the public health surveillance function, and delivery of the care package for
patients with this disease.
The
responsibility for care and investigation of individual patients remains with
the consultant responsible for that patient in consultation with the general
practitioner. Nevertheless, the Department of Health is asking the local
consultant neurologist, or consultant in other speciality with responsibility
for the patient’s care, to report to both the National CJD Surveillance Unit
and the National Prion Clinic all suspect cases of CJD and other prion diseases.
Both the National CJD Surveillance Unit and the National Prion Clinic are able
to provide clinical advice about individual patients.
It
is essential that local consultants continue to report patient details, with
consent, to the National CJD Surveillance Unit for public health and
surveillance purposes. In
addition, consultants will also wish to ensure that the patient and his or her
family, carer or independent representative are put in touch with the national
care package co-ordinator, based at the National CJD Surveillance Unit, who can
facilitate access to local support services.
Simultaneously,
local consultants are asked to report patient details, with consent, to the
National Prion Clinic, so that patients can be offered the chance to participate
in the PRION 1 trial, should the diagnosis be confirmed as probable or definite
CJD or another prion disease, and also to participate in related research
programmes. Completed forms should
be faxed to the units, contact details are provided in Annex D.
Referring consultants may also wish to utilise the specialist clinical
and diagnostic expertise at the National Prion Clinic.
The
report to the National CJD Surveillance Unit and the National Prion Clinic
should take place on a single form (attached at Annex A) and must be authorised
by the patient or their representative. Patients/families
should be provided with a single information leaflet explaining the work of both
the National CJD Surveillance Unit and the National Prion Clinic.
A copy, produced jointly by the two units, is at Annex
B.
Annex
C aims to clarify roles and responsibilities for the reporting, surveillance,
diagnosis and care of patients with CJD and other transmissible spongiform
encephalopathies, as well as arrangements for public health control measures and
research. Contact details are at
Annex D.
On encountering patients whom they suspect to be suffering
from CJD, or a related prion disease, consultant neurologists (or other
clinicians) will:
q
complete the national reporting form and obtain consent from
the patient, lead relative or carer/patient representatives;
q
fax or post the completed form, with consent, to the
National CJD Surveillance Unit and the National Prion Clinic;
q
advise the patient, carer, or independent representative
that staff from the National CJD Surveillance Unit will visit the patient for
national surveillance purposes (with their consent). They will also be given the opportunity to participate in
research programmes operated by the Unit should they so wish;
q
consider utilising the expertise in diagnosis and management
of patients offered by staff at the National Prion Clinic;
q
advise the patient, carer or independent representative
that staff from the National Prion Clinic will visit and offer the
opportunity to participate in therapeutic trials and/or other clinical research
programmes, should they so wish.
q
make
available samples of blood and Cerebrospinal Fluid (CSF), and the results of
Magnetic Resonance Imaging (MRI) scans to the two units.
Maintaining
high levels of public health protection from the risks of vCJD and other prion
diseases, ensuring high quality care for patients with the disease, their
families and carers, as well as furthering understanding of prion disease
This
letter and its annexes are intended to clarify and strengthen arrangements to
make sure that this happens.
Yours
sincerely
