Ileal Pouch Registry


Frequently Asked Questions

Contents

What is the aim of the Ileal Pouch Registry and what will it offer?

The aim of the Ileal Pouch Registry is to improve standards in ileal pouch surgery through a process of continuous national audit of activity and outcome using an observational registry. The Ileal Pouch Registry is a national registry that will allow both institutions and individual surgeons to anonymously benchmark their results against their peers. By doing so, it will satisfy the requirement for all surgeons to participate in national audit.

Who is on the team running the Registry?

The Registry is run on behalf of the Association of Coloproctology of Great Britain and Ireland (ACPGBI). The Registry working group consists of the project lead and Chair Omar Faiz (Consultant Colorectal Surgeon), Professor John Nicholls (Professor of Surgery), Mr Graeme Wilson (Consultant Colorectal Surgeon), Richard Lovegrove (Specialist Registrar), Anna Wordley (Nurse Consultant), Dr Peter Walton (Managing Director, Clinical Dendrite Systems), Elaine Burns (Clinical Research Fellow), Mr Justin Davies (Consultant Colorectal Surgeon) and Mr Steve Brown (Consultant Colorectal Surgeon).

Who do the team answer to?

The team answer to the ACPGBI through the Clinical Services Committee.

Data ownership and submission

The institutions inputting data to the registry own their data. Individual units are free to publish their own outcomes using their own data. The submission of data to the Registry is strongly encouraged by the ACPGBI but submission is voluntary.

Data confidentiality and anonymisation

The patient data are anonymised at the point of data submission. Individual units hold the key to this anonymisation. By the time that the data has been amalgamated centrally it is anonymised for patient, surgeon and trust identifiers. Dendrite Clinical Systems hold the codes to the surgeon and trust anonymisation. The team managing the registry do not have access to individual surgeon and trust identifiers.

Anonymised data are held centrally by Dendrite Clinical Systems in accordance with UK data protection laws. Dendrite Clinical Systems are registered as a "Data Bureau" under the 1994 Data Protection Act and act as safe keepers of data. They cannot release any data without the express written permission of the ACPGBI.

Dendrite Clinical Systems are used by numerous other specialist medical and surgical societies to host national databases (such as the Cardiac Surgical and Bariatric Registries) that are similar to the Ileal Pouch Registry.

Clinical governance

Clinical governance for the database remains the responsibility of ACPGBI through the Multidisciplinary Clinical Committee. The sole purpose of the Registry is to allow surgeons to anonymously monitor their own activity and performance alongside that of their peers. Using national registries for clinical governance purposes is hazardous when operative caseloads are small, data submission is not mandatory and clinical outcomes take a long time to establish. The purpose of the Pouch Registry is not, therefore, to seek out and identify surgeons with poor clinical outcomes.

However, in instances where an anonymised individual surgeon's performance is clearly far worse than that of their peers, and deviates from acceptable clinical outcomes obtainable from the literature, a recourse for intervention is necessary. Under these circumstances the identity of the outlier will remain anonymous but the existence of the outlying data will be conveyed to the Clinical Services Committee of the ACGBI. The Committee can request the identity of the surgeon’s institution from Dendrite Clinical Systems and will decide on how to proceed.

Research and audit

Under information governance regulations, collection of patient consent is not mandatory when patient information is held and used for audit purposes.

Output from the database will take the form of an annual audit report. This report will contain anonymised surgeon data, trust activity data, and where possible, outcome data. The Registry is intended primarily as an audit tool to allow surgeons and institutions to monitor their activity and performance against other submitting units, thereby driving standards in pouch surgery.

The Registry is not intended as a research tool. Some surgeons may wish to use the database for clinical research, either acting alone or through collaboration with other institutions. Under such circumstances patient consent may be required for data holding and management. Further advice from the National Information Governance Board on this issue is recommended to those wishing to use the registry to undertake research.

Contact information

Queries on database: Omar Faiz (o.faiz@imperial.ac.uk)

Clinical support on database: Richard Lovegrove (r.lovegrove@me.com)

Technical Advice: support@e-dendrite.com