abcdefghijklm
eÉ~äíÜ=aÉé~êíãÉåí=
Dear Colleague
NATIONAL ANONYMOUS TONSIL ARCHIVE (NATA):
STUDY
OF
PREVALENCE
OF
VARIANT
CREUTZFELDT-JAKOB DISEASE (vCJD) INFECTION
IN THE UK POPULATION
cêçã=íÜÉ=
aÉéìíó=`ÜáÉÑ==
jÉÇáÅ~ä=lÑÑáÅÉê=
=
aê=^áäÉÉå=hÉÉä=
______________________________
pí=^åÇêÉïÛë=eçìëÉ=
bÇáåÄìêÖÜ=beN=Pad=
qÉäÉéÜçåÉ=MNPNJOQQ=OTVV=
c~ñ=MNPN=OQQJPQTT=
This letter is to inform you of arrangements for implementation
of the national anonymous tonsil archive study, and to ask that a
specific consent form for ENT procedures is adopted across
Scotland.
______________________________
As you will know, for some years there have been concerns
regarding the spread of variant Creutzfeldt-Jakob disease (vCJD)
via healthcare procedures, concerns which were increased with
the probable transmission of infection via blood transfusion in
two instances. Our knowledge of the infectivity of abnormal
prion protein and the natural history of vCJD is limited at
present, with considerable uncertainties. Further studies are key
to determining overall levels of public health risk, and the extent
to which the UK population has been exposed and infected. This
would help to plan interventions to limit the further spread of
infection, and to plan care provision for those who may develop
the disease.
_____________________________
NT=^ìÖìëí=OMMR=
______________________________
`jlEOMMRFQ=
=
cçê=~Åíáçå=
=
Chief Executives of NHS Boards
Medical Directors of NHS Boards
______________________________
=
cçê=áåÑçêã~íáçå=
=
Directors of Nursing
Directors of Public Health
CPHMs (CD&EH)
Medical Director, Health
Protection Scotland
______________________________
It is a priority for UK Health Departments to establish a UK
archive of tonsils specimens in order to determine the prevalence
of the variant CJD infection in the population. Results from
studies of stored appendix and tonsil specimens have given
estimates of a prevalence of vCJD infection of 46-692 per
million in the population aged 10-30 years. This is much higher
than had been estimated from clinical cases alone. The National
Anonymous Tonsil Archive (NATA) aims to provide a UK
archive of 100,000 prospectively collected, unlinked
anonymised pairs of tonsils that will be used to undertake studies
of detectable abnormal prion protein. The study has been
MREC approved for the whole of the UK.
=
cìêíÜÉê=båèìáêáÉë=
Dr Peter Christie
Senior Medical Officer
Room 2N.07, St Andrew’s House,
Edinburgh EH1 3DG
Tel 0131 244 2806
Fax 0131 244 2030
Peter.Christie@scotland.gsi.gov.uk
The tonsils will be collected from people of all ages during
routine tonsillectomies: only tissues not required for patient
care, and which would normally be discarded, will be used.
abcde abc a
SE Approved
Version 1.1
Based on the annual tonsillectomy rate in Scotland, the aim is to provide 10% of the UK
samples (10,000 tonsil pairs) over a 3 year period.
The study is already underway in England and Wales. Because of the shrinking time
window for collecting useful data from these tonsils (as the BSE-exposed population
moves out of the peak age range for tonsillectomy), it is imperative that the study
commences in Scotland as soon as possible. SEHD has allocated funding to Health
Protection Scotland (HPS) over 3 years for the Scottish arm of the study, which is being coordinated on a UK basis by the Health Protection Agency (HPA) Centre for Infections on
behalf of UK Health Departments and the Medical Research Council.
It was agreed with Scottish ENT surgeons that, to be consistent with the English and Welsh
arm of the study, a common consent form for all ENT procedures (including
otorhinolaryngology, and head and neck surgery) should be developed in Scotland. This
would use the exact phrases contained within the consent form in use in England and Wales,
which was approved by an MREC specifically for use in NATA recruitment throughout the
UK, including Scotland. On this basis, common Otorhinolaryngology, Head and Neck
Surgery (ENT) consent forms for adults and for children have been developed (see attached)
in collaboration with members of the Scottish Otolaryngology Society, Medical Directors,
SEHD & HPS. The consent forms were also referred to the Central Legal Office for
clearance, specifically with regard to consent for children and adults with incapacity. A guide
to the NATA study for patients and parents is also attached.
I appreciate that this may cause you some inconvenience, but I am requesting that you
commence immediate use of these consent forms, supplies of which can be obtained by
contacting Johanna Reilly, Publication Manager, Health Protection Scotland Tel 0141 300
1187; Fax 0141 300 1170; e mail: johanna.reilly@hps.scot.nhs.uk.
The collection of tonsils in Scotland is being co-ordinated by Health Protection Scotland and
will commence in Scotland over the next few months. A Study Co-ordinator will visit each
ENT Department to explain the practical details of the process, which involves collection
of tonsils and sending them by pre-arranged courier to a central UK location. If you have any
queries relating to the NATA, please contact Ms. Joan Sneddon, Nurse Consultant Infection
Control,
Health
Protection
Scotland
Tel
0141
300
1165;
e
mail:
joan.sneddon@hps.scot.nhs.uk or Dr. Hester Ward, Consultant Epidemiologist, National
CJD Surveillance Unit Tel 0131 537 2128; e mail h.ward@ed.ac.uk.
I should be grateful if this letter and attachments could be circulated to appropriate
staff within your area, including ENT surgeons and pathology departments.
Many thanks for your co-operation in this matter, which I hope will be of benefit to public
health and to the delivery of healthcare in the future.
Yours sincerely
DR A KEEL
Deputy Chief Medical Officer
2