UK Acromegaly Registry
Background and purpose of the UK Acromegaly Registry
Acromegaly is a rare disease with a prevalence estimated at 40 per million.
It is apparent that the condition is associated with increased morbidity
and mortality, but the results of studies carried out by individual centres
have been limited due to the lack of sufficient patient numbers. It was
proposed that a UK national register should be established to provide sufficient
patient numbers to address key epidemiological and therapeutic issues.
The aims and objectives of this project are as follows: -
- To gather prospective and retrospective data on acromegaly in
the UK with a view to obtaining a large series so that the database
will be able to generate more significant data than has been possible
previously.
- To use this data to provide epidemiological evidence about long-term
mortality and morbidity in acromegaly.
- To provide data on results of treatment by surgery, radiotherapy
and medical therapy.
- To disseminate this data at conferences and in publications and
to provide feedback to patient support groups.
- To encourage centres to audit their own practice against the
full dataset.
The project started in 1997 as a (standalone) project with 8 centres.
In 2002 it became a Society for Endocrinology project. It is managed by
a Steering Committee of eight members, appointed by the Society Clinical
Committee. Currently some 2100 out of an estimated 3000 UK patients have
been entered, from 26 centres
Methodology
Participants
Any UK endocrine centre that is involved in the management of patients
with acromegaly can participate. Ideally, each centre should contribute
a minimum of 40 patients
Target group
Patients who have been diagnosed as suffering from acromegaly from 1970 onwards Patients may be recruited by any or all of the following methods:
- By analysis of the endocrine unit's own records
- By analysis of the hospital records
- By analysis of local health authority records
Database
A PC database was developed for the collection of data for a number of pituitary diseases, including acromegaly. The database has been completely rewritten in the widely used Access 2000 format, with a flexible specification, which will enable it to adapt to changes in treatment. The rewrite also sought to be as compatible as possible with wider developments in IT within the UK National Health Service.
Ownership of data
The central data will be owned by the Society for Endocrinology.
Use of data
Each centre may use the data on its own patients. Applications to use
national data should be submitted to the Sub-committee. All publications,
including abstracts, will have a lead author(s) for and on behalf of the
UK National Acromegaly Register. All participants, including data entry
personnel, should be acknowledged. All publications must be submitted to
the Sub-committee for prior approval.
Ethics
All data is collected, stored and used in strict accordance with current
UK legislation on data protection, ethics and written informed patient
consent. The study has MREC approval (MREC 03/5/076).
Governance
A Steering Group of eight participants will be appointed by the Clinical
Committee of the Society for Endocrinology and will function as a Sub-committee
of the Clinical Committee. Members will serve a term of three years, renewable
for a further three years at the discretion of the Clinical Committee.
The Clinical Committee will appoint a chair from amongst the Sub-committee,
whose term will also be three years, renewable.
The Sub-committee will meet twice per year. Its remit will be to set targets
for achievable research aims within set periods of time and to ensure that
these targets are met. It will also review the accounts annually and refer
them to the Clinical Committee for approval, with any comments.
There will be an annual meeting of the project to which all participants
will be invited. There will be presentations at this meeting on the status
of the database and the outcome of research and/or audit originating from
the database. The annual accounts will also be presented. The Sub-committee
will set the detail of the programme.
Finances
The database project is self-financing. The Society for Endocrinology
will not be required to provide any funding.
The accounts will be managed by the Society for Endocrinology as a separate,
restricted account. Quarterly and annual accounts will be produced. Annual
accounts will be presented first to the Sub-committee and then, after approval
by the Clinical and Finance Committees, to the participants at the annual
meeting.
Centres receive a nominal fee per new patient added, subject to supplying satisfactory data.
Project management
The staffing of the project will be managed by the Society for Endocrinology.
The Project Manager will report to the Executive Director as a line manager
and to the Project Chairman as regards the content of the project. Any
other personnel employed directly by the project will report to the Project
Manager.
The central register is hosted on a stand alone secure server at the Society for Endocrinology, who provide support and development, which is recharged to the project account.
Up to two user groups meetings are held per year. One data entry person from each centre is funded by the project to attend and centres may send more at their own cost if required.
Sponsors
The Society gratefully acknowledges substantial support from Novartis (UK) for the ongoing UK database through an unrestricted educational grant, and Novartis (Germany) for similar support for the database rewrite.
The Society is also grateful to the Clinical Endocrinology Trust for their funding of the project.
The project has also had grants from the Department of Health in the past. Any future sponsorship proposals should be submitted to the Sub-committee and the Clinical Committee for consideration.
Recent developments and links to other projects
In 2003 links were established with the German Endocrine Society, who
has started a similar project, using the same database. More details are
given on their project website German
acromegaly register (in German). The project was extended to Austria
in 2004 under licence.
The UK project is registered on the Docdat database of multi-centre databases Docdat
Database.
Publications
Bates PR, Carson MN, Trainer PJ, Wass JA; UK National Acromegaly Register Study Group (UKAR-2).Wide variation in surgical outcomes for acromegaly in the UK. Clin Endocrinol 2008;68(1):136-42.
Jenkins PJ, Bates P, Carson MN, Stewart PM, Wass JA. Conventional pituitary
irradiation is effective in lowering serum growth hormone and insulin-like
growth factor-I in patients with acromegaly. J Clin Endocrinol Metab.
2006 Apr; 91(4): 1239-45
J A H Wass, M N Carson and P Bates. The Changing Patterns of Presentation
and treatment of Acromegaly in the UK as reflected by the UK National Acromegaly
Database. BES 2004 [PDF] reprinted
from Endocrine Abstracts 7 P125
MN Carson. The UK National Acromegaly Database. BES March 2003 P47
P R Bates, M N Carson and J A Wass Surgical Outcomes for Acromegaly Vary
Widely: A Report on Behalf of the UK National Acromegaly Study Group. American
Endocrine Society Endo 2002 P2-179
PR Bates, MN Carson, PJ Trainer, JAH Wass and the UK National Acromegaly Register Study Group 2007; Wide variation in surgical outcome in the UK. Clinical Endocrinology in press
M N Carson, P Bates and J A H Wass. Somatostatin Analog Therapy for Acromegaly
in Clinical Practice: A Report on Behalf of the UK National Pituitary Database.
American Endocrine Society, 20-23 June 2001 P2-190
P J. Jenkins, E Elliot, M Carson, R N Clayton, J A H Wass. On behalf of
The UK National Acromegaly Register Study Group. Use of a National Database
to Explore the Effects of Pituitary Irradiation on Serum GH and IGF-1 in
Acromegaly. American Endocrine Society June 2000 P2-163
J A H Wass, M N Carson, P Bates, J S Bevan, M Scanlon, PM Stewart, B Walker,
GM Besser, RN Clayton, PJ Jenkins on behalf of The UK National Acromegaly
Register Study Group. UK Acromegaly Database – Results of Surgery.
BES 13-16th March 2000. P54
P J Jenkins, E L Elliott, M N Carson, P R Bates. On behalf of The UK National
Acromegaly Register Study Group The Effects of Pituitary Irradiation on
Serum GH and IGF-1 in Acromegaly –Results from the UK National Database.
Society for Endocrinology November meeting 8-9 November 1999 OC4
M N Carson'*, J Crompton2, R N Clayton3, J A Wass4. Collecting Data for
Acromegaly using the UK Pituitary Register US Endocrine Society ENDO 1999
M N Carson', J Crompton2, R N Clayton3 and J A H Wass. The UK Pituitary
register; Collecting Data for Acromegaly. BES 12-15 April 1999, P 50
M N Carson, J Crompton, B Ricketts and B R Walker. Lessons from Establishing
a Computer Database of Patients with Pituitary Disease. American Endocrine
Society Endo 1998
M N Carson, J Crompton, B Ricketts and B R Walker. Lessons from Establishing
a Computer Database for Management of Patients with Pituitary Disease.
BES 1998 P193
Support information
The following downloadable files are available which provided further
background:
Recent project newsletters
Spring
2008 Newsletter (pdf) (63kb)
Summer
2007 Newsletter (pdf) (63kb)
Winter
2007 Newsletter (pdf) (70kb)
Autumn
2006 Newsletter (pdf) (70kb)
Further information on the project is available from:
Dr Debbie Willis
Project Manager
email:Debbie.s.willis@btinternet.com
Kenneth Burns
Network and Messaging Specialist
Society for Endocrinology
22 Apex Court
Woodlands
Bradley Stoke BS32 4JT
Tel: +44 (01454) 642213
For email enquiries Contact the
Society