Consultant Letter p1
Invitation to Consultant Clinicians.
We are writing to invite you to participate in an important, prospective national study of childhood immune thrombocytopenic purpura (ITP). A national Registry has been established for children aged between two months and sixteen years diagnosed with acute and chronic ITP and will share data with an international registry for ITP (PARC, Paediatric and Adult intercontinental Registry on Chronic ITP). Previous UK Audits have established the frequency of acute ITP and bleeding complications in acute ITP but there has been no studies collecting longer term data on those patients who develop chronic ITP.
The primary objective of the National Registry will be to establish the consequences of acute and chronic ITP on the frequency and severity of bleeding symptoms and on the requirement for treatment in these conditions. Secondary objectives include the collection of data on the long term outcomes of ITP, on the frequency and outcome of intracranial and other significant haemorrhage, and on the various treatment strategies used to increase patients’ platelet counts. We anticipate that information collected through the Registry will subsequently be used to identify children at high or low risk of significant haemorrhage so that interventional treatment could be offered appropriately.
What work is involved for data collection?
MREC has agreed that all sites participating in this study are exempt from site-specific assessment. There is no need to inform Local Research Ethics Committees (LRECs) about the research. For notification of your local R&D department copies of the NHS R&D form, REC application and approval letter can be downloaded from the website: www.uk-itp.org
Children with ITP can be registered within 12 months of initial diagnosis. Registration details can be entered directly onto the secure server using any NHS computer or alternatively over the phone with our data manager. Data requested will consist of standard information stored in the medical notes such as bleeding episodes, therapy required and blood counts.
Follow up information will be requested six months after registration: no further information will then be collected on those children whose ITP has resolved whereas data will continue to be collected annually on children with ongoing chronic ITP. All Data can then be returned electronically and will be stored in an anonymised form on the secure national database. Telephone support is available from members of the research co-ordinators to deal with any further questions and technical support for supply information onto the registry is available from out IT team.
We hope that you will agree to participate in this study which has Corec approval and is supported by the ITP Support Group. You will be aware of the lack of consensus which exists about the management of acute and chronic ITP, and of the incomplete information which exists on the outcome of these disorders in childhood. The establishment of this Registry will provide much needed data which will be used to inform clinicians and families on prognosis, risk and optimal treatment strategies for paediatric ITP.
Further information about this study can be obtained from any of the study co-ordinators listed on the following page.
Thank you for your interest.
Yours sincerely
Dr John Grainger
Chairman
UK Paediatric ITP Working Party
The following organisations have written in support of this registry:
The Paediatric subcommittee of British Society for Haematology
The ITP Support association
Consultant Paediatric Haematologist
Royal Manchester Children’s Hospital,
Pendlebury,
Manchester M27 4HA
Tel. 0161 922 2245
Fax 0161 922 2545
Email / Dr Paula Bolton-Maggs
Consultant Haematologist
Manchester Royal Infirmary
Oxford Rd
Manchester M13 9WL
Tel 0161 276 4811
Fax 0161 276 8085
Dr Sarah Ball
Reader/Hon Consultant in Paediatric Haematology
St George's University of London
Cranmer Terrace
London SW17 0RE
Tel 0208 725 3921
Fax 0208 725 0636
Email / Dr Mike Richards
Consultant Paediatric Haematologist,
Children's Day Hospital,
St James's University Hospital,
Leeds LS9 7TF
Tel 0113 2066295
Fax 0113 2470248
Dr Mike Williams
Consultant Paediatric Haematologist
Birmingham Children's Hospital
Steelhouse Lane
Birmingham B4 6NH
Tel. 0121 333 9843
Fax0121 333 9841
www.uk-itp.org UK Paediatric chronic ITP Registry (version 2) dated 16.08.06