The Autumn issue of the RaDaR Newsletter contains important updates about our latest amendment and the recruitment of our 15,000th patient.
After over five highly successful years in the role, Dr Graham Lipkin is stepping down as lead for the Cystinosis Rare Disease Group and a replacement is now being sought.
This is a real opportunity to lead an enthusiastic group of clinicians, in partnership with patients and Industry, to support improvement in patient service, clinical care and research of an ultra-rare disease at an exciting time of drug development and change in service model.
Following a review of our revised consent documents by NHS Digital, we have just submitted the latest RaDaR amendment to the South West – Central Bristol Research Ethics Committee.
The main changes concern clarification that RaDaR consent covers Patient View Sign-up, subject to local availability, and that patients consent to being contacted directly by a member of the central RaDaR team and/or their Rare Disease Group Lead regarding information events or further research studies.
The amendment will also allow for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will allow for a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future.
No action is required on behalf of the sites at present. We will everyone informed as to the progress of this amendment and let you know when it is approved.
If you have any queries about the amendment please contact Melanie.Dillon@RenalRegistry.nhs.uk
RaDaR consent covers Patient View sign-up – subject to availability at each renal unit.
Research staff – please add your patients to Patient View once they have consented to RaDaR. This allows for an automatic transfer of blood and urine results from your renal IT system, to Patient View and on into RaDaR.
Patients – if your hospital have signed up to Patient View, you should receive your login details shortly after consenting to RaDaR.
Any problems please contact Melanie.Dillon@RenalRegistry.nhs.uk
The Summer issue of the RaDaR Newsletter features updates from the IgA Nephropathy and aHUS groups, details of a Cystinosis patient information event in Birmingham and important information about the forthcoming Ethics amendment.
The IgA Nephropathy Rare Disease Group have had an article published in this month’s issue of the Journal of Kidney Care. The article discusses how having access to an international rare disease registry with data on this disease can help improve kidney care around the world.
The RaDaR Operational Management Board and Rare Disease Group Leads have agreed to apply for an Ethics amendment to clarify the fact that RaDaR consent covers Patient View sign-up, subject to availability at individual renal units.
The proposed amendment will also allow for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will allow for a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future.
In addition, it is proposed to ask patients to consent to being contacted directly by a member of the central RaDaR team, regarding information events or further research studies. Such communication would always be approved by the patient’s Consultant before being sent out and will largely be circulated via Patient View.
Approval will be sought from NHS Digital’s data Access Request Service (DARS).
It is aimed to submit the Ethics amendment by the of September. Please continue to recruit patients to RaDaR in the meantime, using the current consent documents.
Further details will follow in the coming weeks but we would welcome suggestions over the proposed amendment to Melanie.Dillon@RenalRegistry.nhs.uk.
RaDaR features as a Case Study on the new Understanding Patient Information website, with the focus on supporting research into rare kidney disease.
Prof Detlef Bockenhauer, chair of the Rare Disease Committee of the Renal Association, is hosting a forum to help clinicians and researchers to better understand RaDaR and Fabry Disease in particular. The event will be held during UK Kidney Week on Monday 19th June 2017 at the Pullman Hotel, Kings Dock, Liverpool, L3 4FP
The meeting has been organised by Sanofi Genzyme and will include a buffet dinner.
Places are limited and attendees are asked to RSVP to John Applegate at firstname.lastname@example.org