A Renal Biopsy Registry in Scotland

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					                        A Renal Biopsy Registry in Scotland


Background
Histological examination of native or transplant renal (kidney) biopsy is the most
important diagnostic tool in patients with parenchymal renal disease. It is also the
most expensive routine histological test performed in pathology laboratories. There is
sparse information in the published literature about the indication for renal biopsy and
how renal biopsy informs clinical management and prognosis. Furthermore, little is
known about trends in biopsy practice over time and about variation in biopsy
practice between different centres and different clinicians.

Purpose of the Scottish Renal Biopsy Registry
A registry of all renal biopsies performed will be used to determine current kidney
biopsy practice, regional variations, complications of kidney biopsy and risk factors
for these complications. Ultimately the information can also be used to determine the
clinical value of renal biopsy. In the future the biopsy registry will be used as a
platform for clinical and basic research in much the same way as the Scottish Renal
Registry.

Creating a multicentre renal biopsy registry in Scotland builds on the infra-structure
and expertise that has that has been achieved by the Scottish Renal Registry.

Steering Committee
The biopsy registry is managed by a steering committee consisting of individuals
from participating units. Research projects using the data are agreed in advance by
the steering committee. Authorship of presentations and manuscripts arising from
these projects is agreed in advance and will include “on behalf of the Scottish Biopsy
Registry”

How will it work?
Experience from the Scottish Renal Registry has shown that success requires a robust
strategy for retrieving data. Data will be retrieved electronically from both the
pathology departments and renal units. By using more than one source the chance of
„missing‟ a biopsy are minimised.

The individual performing the biopsy will enter data about the biopsy procedure and
indication for biopsy on the electronic patient record. The pathology report will
contain coded text that has been agreed by the participating pathologists to classify
the biopsies within the registry. Follow up data will be collected automatically from
the electronic patient record in a similar way to the data collection for the Scottish
Renal Registry.

The Scottish Renal Registry Executive and Steering Group have agreed to the use of
their hardware and software for this purpose. The biopsy registry will be linked to the
Scottish Renal Registry to allow biopsy data to be linked to future need for renal
replacement therapy

Ethics approval
REC approval was obtained in 2005 (REC reference number: 05/S0709/12) and an
ammendment to include multiple sites in Scotland was approved in May 2007. Site
specific assessment is required to add centres (this is already drafted and can be
managed by the local hospital Research and Development department).

Patient consent
Advice has been sought. Patient consent will be assumed (as is the case with the
Scottish Renal Registry). A patient information leaflet has been created that will be
given to each patient who is undergoing renal biopsy (available to download from the
SRR website). This explains the need for the registry, the way that data are stored and
how to obtain further information. This document is designed using the Patient
Information leaflet for the approved NHS Scotland cancer registry as a template.
Details of contacts for further information and instructions on how to opt out are
given.

This process complies with current legislation and guidelines as set out in the final
report of the Confidentiality and Security Advisory Group for Scotland (CSAGS)
2004 “Protecting Patient Confidentiality” with particular reference to sections 7.6 and
7.15 that deal with the acceptability of implied consent for disease registries.



Contact one of the people below for further information:

Colin Geddes, Consultant Nephrologist, Western Infirmary, Glasgow
Telephone 0141 211 2521
Email: colin.geddes.wg@northglasgow.scot.nhs.uk

Keith Simpson, Consultant Nephrologist, Glasgow Royal Infirmary
Telephone: 0141 211 4842
Email keith.simpson@nhs.net

Stewart Fleming, Professor of Pathology, University of Dundee
s.fleming@dundee.ac.uk

Graham Stewart, Consultant Nephrologist, Ninewells Hospital, Dundee
graham.a.stewart@tuht.scot.nhs.uk

Barbara Young, Consultant Pathologist, Western Infirmary, Glasgow
Telephone: 0141 211 2005
Email: Barbara.Young@northglasgow.scot.nhs.uk

				
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