NHS Digital Data Release Register - reformatted

University Hospital Southampton NHS Foundation Trust

Project 1 — DARS-NIC-10497-N0K9V

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care

Objectives:

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.

Expected 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.

Outputs:

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.

Processing:

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.


Project 2 — DARS-NIC-148284-T2GPT

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

The Hertfordshire Birth Cohort explores the relationship between intrauterine experience (as summarised by birthweight) and eventual cause of death. It also includes data on weight at one year, allowing the effect of growth in infancy to be studied. In addition, a subst of individulas have attended clinics to characterise their health and are still being followed-up with their consent.


Project 3 — DARS-NIC-60714-M4T1M

Opt outs honoured: N (Reasonable Expectation)

Sensitive: Non Sensitive, and Sensitive

When: 2018/06 — 2018/09.

Repeats: One-Off, Ongoing

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report

Objectives:

Emergency bowel surgery (laparotomy) is a common major emergency surgical procedure, performed to treat life threatening conditions caused by cancer, infections or previous surgery. Over 30,000 people in England & Wales undergo this surgery annually at a cost of over £650m. Outcomes from emergency bowel surgery are poor; 14% of patients aged over 50 die within a month of surgery, rising to 20% within three months. The National Emergency Laparotomy Audit (NELA) is hosted by the Royal College of Anaesthetists (RCoA) and is part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP), overseen by the Healthcare Quality Improvement Partnership (HQIP). NELA was commissioned following evidence of a high incidence of death, and a wide variation in the provision of care and mortality, for patients undergoing emergency laparotomy in hospitals across England, Wales and Scotland. NELA is an audit which looks at the improvement of the quality of care for patients undergoing emergency laparotomy (~30,000/yr within the audit) through the provision of high quality comparative data from all providers of emergency laparotomy surgery. FLO-ELA are using NELA to identify the 100 hospitals which have been invited to participate in FLO-ELA (~50% of the total NELA group). Patients who are undergoing the procedures at those hospitals will then be invited to consent to the FLO-ELA trial. Through this consent, patients agree that NELA will share pseudonymised data on aspects of their care while in hospital with the FLO-ELA trial, to allow the trial to describe the clinical characteristics and trial-related care of its participants. This is clearly described in the FLO-ELA consent materials and FLO-ELA data flow diagram and is based on an established data sharing agreement between HQIP/RCoA and FLO-ELA. The audit and the trial are two separate pieces of research which have a clear link. FLO-ELA (FLuid Optimisation in Emergency LAparotomy) is a large randomised clinical trial proposal funded by the National Institute for Health Research Health Technology Assessment (HTA) stream. It aims to determine whether a discrete medical intervention (perioperative cardiac output-guided haemodynamic therapy) reduces deaths after emergency laparotomy when compared with usual care. Although this intervention may be beneficial for patients undergoing planned major surgery, it has not yet been tested in patients undergoing emergency laparotomy. The FLO-ELA trial is being funded by the NIHR HTA Efficient Study Design stream, for trials able to give robust research output at greater pace and scale and/or lower cost than conventional trial designs. By linking this trial to NELA - recruiting a subset of patients eligible for inclusion in NELA, utilising the existing NELA network of hospitals and the NELA webtool and dataset for trial participant data (with ONS/HES follow up) - The study have a trial proposal which will be large enough (~8000 patients) to give a definitive answer on whether this treatment is effective, in a timely and cost-effective fashion. This represents a unique opportunity to generate practice-changing research in a challenging patient group, with the potential to save hundreds of lives every year. Trial objectives: 1. To establish whether the use of minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid (goal-directed haemodynamic therapy, GDHT), for patients aged 50 and over undergoing emergency laparotomy will reduce mortality within 90 days of randomisation, when compared with usual care. 2. To determine whether GDHT reduces mortality one year after randomisation, and is cost-effective. Primary outcome measure • Mortality within 90 days of randomisation Secondary outcome and process measures • Mortality within one year of randomisation • Duration of hospital stay (number of days from randomisation until hospital discharge) • Duration of stay in a level 2 or level 3 critical care bed within the primary hospital admission • Hospital readmission as an inpatient (overnight stay) within 90 days from randomisation

Expected Benefits:

The FLO-ELA trial will provide the highest level of evidence for this intervention, informing the decision to widely implement on a national level by confirming the extent of any clinical benefit or harm, healthcare costs and cost effectiveness. A positive outcome from this trial could change practice across the developed world. NELA would expect rapid translation of this intervention into routine clinical practice within 12-24 months of trial report. This is supported in the UK by the ongoing National Emergency Laparotomy Audit and its parent organisation the Healthcare Quality Improvement Partnership. This quality improvement vehicle will maintain long term engagement and sustained interest in this area with the large number of clinicians involved in the FLO-ELA trial and the wider clinical community after trial completion. Further, the study will provide specific reports on the findings of the FLO-ELA trial for healthcare policy makers. Through the support of the advisory group, findings will be disseminated appropriately to NHS England and devolved nations, NHS trusts and other stakeholder groups. The research study will advise on the implications of findings and optimal implementation. As a definitive pragmatic effectiveness trial, with an intervention delivered by clinicians in a large number of NHS sites and in a patient group highly representative of the ultimate target population, rapid and widespread uptake of the trial findings into routine practice is expected. This has the potential to rapidly change care for over 30,000 patients across the UK each year. If shown to be beneficial, this could equate to several hundred lives being saved each year. Conversely, if no benefit is found, this treatment can be discarded, allowing clinicians to focus on other areas of care for this challenging patient group.

Outputs:

Outputs from the FLO-ELA trial analysis will only include aggregated data, no individual level data received from NHS Digital will ever leave the safe haven where the analysis is taking place. The following outputs are planned: Final Report to Funder - March 2022 Final FLO-ELA Investigators Meeting - summer 2022 Peer Reviewed Publications - summer 2022 Conferences and meetings - 2022 - ongoing In accordance with current practice, appropriately pseudonymised record-level data may be shared with researchers in the future to support further studies in this area such as meta-analysis. This will be subject to the strict data sharing policy in place at the Pragmatic Clinical Trials Unit. Patient consent will be requested for such future data sharing at the time of recruitment into the trial. Appropriate approvals from NHS Digital will also be sought prior to any data sharing. Details of expected outputs: The main scientific report (aggregated / summary data only) will be sent to a high level journal such as the Lancet for their consideration first. Second choices would include the British Medical Journal, the New England Journal of Medicine, and the Journal of the American Medical Association. These are all general interest journals read by a wide range of healthcare workers worldwide. The study plan to invite all the co-investigators (from 100 hospitals) to a final FLO-ELA meeting where they will disseminate and discuss the findings. The study will also present the work at scientific meetings and congresses. For example the ‘Annual Congress of Enhanced Recovery and Perioperative Medicine’ and the ‘Evidence-Based Peri-Operative Medicine’ conferences. They will also disseminate the aggregated findings through the mainstream media and also through social media (e.g. Twitter) with the support of their patient representatives. The main target audience will be surgeons, anaesthetists and intensive care doctors but also patients and their carers. A plain English summary of the trial results and any important trial information will be presented here http://www.floela.org/ More broadly, work will be carried out with patient partners and the PCPIE group at the Royal College of Anaesthetists to plan lay-orientated dissemination of the trial results to a non-medical audience.

Processing:

The Royal College of Anesthetists (RCoA) are the principal data processors for NELA and manage the extraction of the records from the NELA IT system. The FLO-ELA team at the Pragmatic Clinical Trials Unit (PCTU), Queen Mary University London will act as data processors to integrate NELA data with HES and ONS outcomes data for patients recruited into FLO-ELA. They will perform this role under contract by the study sponsor, University Hospital Southampton NHS Foundation Trust, the trust are involved in making decisions about the outputs and what the data will be used for. The Royal College of Anaesthetists (RCoA) cannot access and is not permitted to access FLO-ELA data, including any of the data disseminated under this Agreement by NHS Digital. The Royal College of Anaesthetists role is to act as a data processor for NELA on behalf of HQIP. The request for HES data was made following consultation with the study health economist. All selected data fields are required for an accurate appraisal of resource-use and cost during the study period. Necessary data minimisation steps were undertaken in order to exclude those fields which are not necessary to answer the research questions: this included fields related to maternal, neonatal (etc.) care. Patient identifiers for participants in the FLO-ELA trial will be collected within the PCTU trial randomisation system. The FLO-ELA team will send the file of patient identifiers and the FLO-ELA ID to NHS Digital for linkage to HES and ONS fields. After linking, NHS Digital will remove all supplied identifiers, leaving only the FLO-ELA ID, Date and Cause of Death. The FLO-ELA team at Queen Mary University London will receive files from NHS Digital that contain the HES and ONS fields, as well as the FLO-ELA ID. The identifiable fields received by the FLO-ELA team are ONS Date of Death and cause of death. The full Date of Death is required to be able to calculate survival at two time points (90 day, one year). The FLO-ELA team will not use ONS Date of Death to identify any individual patients. The data received from NHS Digital will not be linked back to the identifiable NELA database. An extract of pseudonymised NELA data will be linked to the HES-ONS data via the NELA ID. The health economic analysis in the study will combine resource-use data (to estimate the cost of care) and outcomes in terms of quality-of-life to carry out a cost-effectiveness analysis. Initial resource-use during the intervention period will be obtained from routine data recorded in the NELA database. Subsequent resource-use during the follow-up period will be estimated by observing the number of hospital admissions, critical care days, accident & emergency visits and outpatient visits recorded in HES. The quality-of-life outcomes will be estimated by mapping participant characteristics to a different but similar population in a previous study called EPOCH. No quality-of-life data will be collected from patients in the FLO-ELA study, and the EPOCH dataset represents a different group of patients from another study. Therefore this mapping does not involve onward linkage of individuals’ record-level data to other datasets containing their data. The NELA data and the HES-ONS data will also be linked to a Health Economics (HE) dataset via the FLO-ELA ID. The HES dataset does not contain any identifiers. The FLO-ELA team Statisticians and Health Economists who will work on the linked dataset do not have access to the identifiable data set held by the RCoA or any identifiers held locally at hospitals. All processing of ONS data will be in line with standard ONS terms and conditions. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). No record level data will be shared with any organisation not noted in this application only the sharing of aggregated data with small numbers suppressed in line with the HES analysis guide is permitted. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. Data will only be processed at QMUL no access will be provided at Southampton FT.