NHS Digital Data Release Register - reformatted

University Hospital Southampton NHS Foundation Trust

Opt outs honoured: Y

Basis: Section 251 approval is in place for the flow of identifiable data

Format: Identifiable Sensitive

How often: Ongoing

When: unknown — 11/2016

HSCIC Id: DARS-NIC-148284-T2GPT-v0.0

Data: MRIS - Cause of Death Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Data: Hospital Episode Statistics Admitted Patient Care

Output: Analysed aggregated results will be shared in a peer reviewed healthcare journal in 2016/17 (specifically the Journal of Pediatric Surgery, The Archives of Disease in Childhood). The Trust expect that the results of this retrospective linkage analysis will provide the best available evidence to guide management of children with inflammatory bowel disease or a strong family history of the same. Small numbers will be supressed in line with the HES analysis guide.

Activities: It will be investigated by looking at;
Objective One
• How many children undergo appendectomy per year (1997-2015)?

Objective Two
• How many new diagnoses of Crohns’ disease or Ulcerative Colitis (UC) or Indeterminate Colitis (IC) are made per year in children?
• How many children require a surgical procedure for Crohn's, UC or IC (other than endoscopy) per year?
• What is the admission rate per year for children with a diagnosis of UC.

To answer these aims, the Trust will supply a list of operative codes of interest (including endoscopy which is to be excluded).

Objective Three
• Do children who have undergone appendectomy (for any reason) go on to have a higher or lower rate of a later diagnosis of UC. The Trust wishes to investigate whether children who undergo appendectomy, then are later diagnosed with UC are more/less likely to later require surgery (colectomy) for UC

The Trust wishes to investigate patients with multiple diagnoses or operative procedure codes:
1. UC diagnosis + subsequent colectomy
2. Appendectomy code, subsequent UC diagnosis (ever)
3. Appendectomy code, subsequent UC diagnosis, and subsequent colectomy code
4. Appendectomy diagnosis, subsequent UC diagnosis, no subsequent colectomy code.
5. Appendectomy code, subsequent UC diagnosis, and subsequent hospital admission rate
6. UC diagnosis, subsequent hospital admission rate
7. UC diagnosis, later appendectomy diagnosis, and then later colectomy code
8. UC diagnosis, later appendectomy code, subsequent hospital admission rate

Objective Four
• How many patients present each year with IBD and how many of them attend for Infliximab/Adalimumab each year - the 2 subgroups should then be analysed for further operative codes relating to IBD surgery. Specifically the Trust will be looking at the rate of colectomy operations (removal of part or whole of large bowel to treat inflammatory bowel disease). This is usually undertaken either after failure of medicines to control the disease satisfactorily, to treat narrowing of the bowel caused by disease or rarely to treat very serious inflammatory bowel disease in an emergency.

The Trust are interested in using this data to assess the rate and timing of such surgery relative to disease onset and treatment with these medicines. The Trust are able to assess the use of these medicines here as they have been allocated a high cost drug code which is recorded by HES. This data will be particularly interesting as it spans a period where it is expected that the use of these medicines has increased substantially.

Objective: The project is regarding children (<18yrs) with inflammatory bowel disease and surgery (IBD) (for IBD or an initial appendectomy) and the influence of biological agents on rates of surgery.

The data will be used to test 3 null hypotheses, i.e.
1. The introduction of biological agents has not affected the rate of Gastro Intestinal (GI) surgery in children with non-infective colitis (i.e. Inflammatory Bowel Disease)
2. Appendectomy does not change the risk of subsequently developing Inflammatory Bowel disease
3. Appendectomy performed after a diagnosis of Inflammatory Bowel disease does not change the risk of requiring a bowel resection.

The period of data (1997/98-2014/15) covers the time when use of Infliximab/Adalimumab use has increased, as well as allowing investigation of longitudinal trends to analyse the root causes of any systemic change in patient outcomes.

Benefits: At the present time there is minimal available evidence regarding the utility of appendicectomy in the management of inflammatory bowel disease in children (either as a preventative or treatment option). This study will provide an important step in the scientific basis for clinical management of these patients. This knowledge will be used by Paediatric surgeons and Gastroenterologists to guide the clinical management of children with Inflammatory Bowel Disease or a family history there-of.

There is also great potential for a randomised controlled clinical trial on this topic (such as the ACCURE trial which is the adult equivalent trial), however the baseline population data in this area is required to ensure that this is the correct path. The data under this agreement will not be used as part of a future clinical trial without an application to the HSCIC for approval.

Source: NHS Digital.