Coeliac Disease Research Database
Research type
Research Database
IRAS ID
160004
Contact name
David S Sanders
Contact email
Research summary
Coeliac Disease Research Database
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1216
Date of REC Opinion
6 Nov 2014
REC opinion
Favourable Opinion
Data collection arrangements
The Coeliac clinic at the Royal Hallamshire Hospital (RHH) currently operates an electronic clinical database, hosted by the Medical Physics department and managed to maximise patient confidentiality within the secure confines of STH NHS Foundation Trust.
The database is used to enter data including demographics, blood and pathology results, and diagnosis following clinical assessment.
We intend to develop the database to collect information from patients who prospectively provide written consent to some of their data being held, with a view to those patients being asked whether they would like to be contacted about future studies. Consent forms will be stored in the RHH coeliac clinic. Data will be
handled and stored according to local and national governance procedures.
Data collected will include:
1. Basic Demographics
2. Standard haematology, immunology and biochemistry results
3. DEXA bone density scan results
4. Histology results applicable to coeliac disease
5. Presenting symptoms and relevant past medical problems
The database will be used to identify efficiently and comprehensively patients eligible for a specific healthcare intervention in order to help recruitment into trials, and for using routine clinical data to study the course of disease and
effectiveness of healthcare used in daily Coeliac clinical practice.Research programme
The gastroenterology directorate at RHH is a large, research and clinically active directorate with a very significant outpatient and inpatient activity. RHH is one of only a handful of tertiry centres for coeliac disease in the country and as such offers a unique insight into the natural history of coeliac disease. The department is also heavily involved in a wide range of clinical research activities from small bowel and nutrition to GI bleeding and IBS. This work will allow STH to better understand the natural progression of coeliac disease and help identify which patients need long term support in a hospital setting and which patients can be safely discharged to their GP for follow up. Finally, good access to consenting patients with coeliac disease is one of the important steps identified to aid recruitment to clinical and other trials, and consequently access to the database is deemed important to allow further development of appropriate research trials, and for recruitment of patients into these trials.
Research database title
Coeliac Disease Research Database
Establishment organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Establishment organisation address
CRO, D Floor, Royal Hallamshire Hospital, Glossop Road
Sheffield
S10 2JF