The Children’s Surgery Outcome Reporting research database (CSOR) - DigiTrials Comms Service - Patient List Update Service

This Data Sharing Agreement (DSA) is for the University of Oxford and Oxford University Hospitals NHS Foundation Trust to utilise the NHS DigiTrials' Patient List Update Service (previously known as "Vital Status") to undertake a status check of their cohort of very young children to ensure they have not passed away before sending out communications to their parents or guardians related to the project, The Children’s Surgery Outcome Reporting research database (CSOR). This check is felt necessary by the study team, as the conditions included within the CSOR research database have a high mortality rate, and therefore, without the status check, there is a risk of contacting a recently bereaved parent or guardian which may cause significant further distress. As a result, the CSOR team wish to use NHS England’s DigiTrials Communications' Patient List Update Service to obtain the fact of death for those infants in the CSOR study cohort, and the current contactable address held in the Patient Demographics Service to enable the study to confirm which children have passed away, and therefore to prevent contact with the parents or guardians of these children.

The overall purpose of the CSOR study is to investigate whether it is possible to collect paediatric surgical outcomes data using a system that links routinely collected health data and parent reported outcomes data and provides a platform for centre specific feedback of outcomes in order to reduce unwarranted outcome variation.

At present, significant variation exists in the way children with surgical conditions are managed. Some of this variation is expected and unimportant, but some is unwarranted and associated with variation in outcome. Due to multiple limitations in the paediatric surgical data that are available for analysis (both in terms of research data, and real-time centre specific outcomes data), it is not possible to differentiate the two. There are therefore children being treated for surgical conditions whose outcomes are worse than they would be if better data were available for analysis. The CSOR research database will make it possible to identify unwarranted variation in management and outcome, and will therefore provide the data that are required to improve the care of children with surgical conditions.

There are six main workstreams to this programme of work:

1) Developing a summary metric for determining successful treatment of multiple paediatric surgical conditions

2) Identifying the additional information needed to provide feedback on outcomes

3) Collecting parent reported aspects of the minimum dataset

4) Developing the CSOR research database to collect the minimum dataset from multiple sources

5) Development of the feedback model

6) Implementation study

The data subjects in the CSOR study will be all children treated in any of the participating sites during the Data Sharing Agreement period who have a new diagnosis of one of six conditions: necrotising enterocolitis (NEC), Hirschsprung’s disease (HD), gastroschisis, posterior urethral valves (PUV), congenital diaphragmatic hernia (CDH) and oesophageal atresia (OA). There are no control subjects.

The CSOR research database will be established to collect and link the data that are required to identify unwarranted variation between hospitals in management and outcomes of children with surgical conditions. The collected data will primarily be used to determine whether hospitals observed outcomes differ to the outcomes expected based upon the case-mix of the children they have treated. This analysis will inform a facilitated feedback process through which participating sites are helped to understand why the outcomes they have achieved for children are better or worse than would be expected. This closed loop of data collection, analysis and feedback will help hospitals understand how they can improve their practice and will facilitate rapid identification and sharing of good practice. A secondary use of the collected data will be to conduct studies falling within the remit of improving the health and wellbeing of children with surgical conditions.

The CSOR study has a separate Data Sharing Agreement (DARS-NIC-608743-H5X9Z) for outcomes data relating to the study.

The University of Oxford is the sponsor for this study. The University of Oxford and Oxford University Hospitals NHS Foundation Trust are Joint Data Controllers. Only the University of Oxford will also process the data requested in this Data Sharing Agreement.

The CSOR study is funded by the National Institute for Health Research. They are involved in monitoring the progress of the study and reviewing study protocols, but do not decide the purpose and means of processing the data in the CSOR study, and are therefore not considered to be a Data Controller in this Data Sharing Agreement. NIHR have no ability to control or suppress the outcomes published under this study.

The CSOR study team have sought consent from participants to communicate with them during the course of the CSOR study at key target points. The majority of the infants in the cohort submitted under this Data Sharing Agreement to be processed through the Patient List Update Service check will be fully consented. However, there will be some invitees for whom the study team are in the process of trying to obtain consent and want to ensure that the child hasn’t died, or the parent’s contact details changed, between the time of identification of eligibility and approach to obtain consent. As a result, the study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. National Data Opt-Outs will be upheld only for those individuals in the cohort for whom Section 251 applies - in other words, those who have not provided consent.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

The need for the CSOR programme was first identified and developed through work with the Parental Advisory Group (PAG) set up by the study team at the University of Oxford. The PAG, consisting of over 100 parents/families of children with surgical conditions, charities and support group representatives from across the UK, remain actively involved throughout the course of the programme. As a minimum, annual meetings have been held to update, discuss and gather feedback on the aims and methods of establishing the research database. Feedback from the PAG has been key to the development of the proposed parent consent and data collection process. There will be two parent or patient representatives on the CSOR Research Database Steering Committee to ensure that the parent/patient voice is maintained in the functioning of the CSOR Research Database. The CSOR Research Database will continue to be reviewed at the annual PAG meeting. The members of the CSOR Research Database Steering Committee will have no access to the NHS England data described in this Data Sharing Agreement.

UK GDPR LEGAL BASIS FOR THE PROCESSING OF DATA

The University of Oxford, as a joint Data Controller who is also processing the Data will process Personal Data under UK GDPR Article 6 (1) (e) - Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. As a higher education establishment, the University of Oxford conducts research to improve health care and services, and the data requested is necessary for the performance of a task carried out in the public interest.

Oxford University Hospitals NHS Foundations Trust, as a joint Data Controller will process Personal Data under UK GDPR Article 6 (1) (e) - Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. Oxford University Hospital NHS Foundation Trust is a public authority. The Data Protection Act 2018 s7(1)(a) defines ‘public bodies’ for the purpose of the UK GDPR as “a public authority as defined by the Freedom of Information Act 2000”. The FOI Act 2000 Part 1, section 3 (1)(a)(i) specifies that a public authority means any body which is listed in Schedule 1. Schedule 1 Part 3 (40A) of the FOI Act 2000 stipulates “An NHS foundation trust” is a public authority.

The NHS Act 2006 section 43(5), which describes the functions of authorised NHS Foundation Trusts, states that ‘The authorisation must authorise and may require the NHS foundation trust— (a) to carry out research in connection with the provision of health care, (b) to make facilities and staff available for the purposes of education, training or research carried on by others'.

Additionally, under GDPR Article 9(2)(j) processing of Special Category Personal Data (of which Health data is one) is necessary for archiving for research purposes. Data minimisation processes are being followed and only Data that is specifically required for the purposes of this study have been requested, to protect the rights of the data subjects. The Controllers have satisfied themselves that this request is appropriate, necessary and proportionate for the performance of the task described in the Purpose statement and that there is no other reasonable and less intrusive means to achieve their purpose.

The University of Oxford will send in on a regular basis (to a maximum of 100 uploads over a 24 month period) a cohort of child participants via NHS England's Secure Electronic File Transfer service (SEFT). The cohort will consist of the following identifiers:

- Study ID

- NHS Number

- Date of Birth

- Column to indicate if individual has provided consent or not.

NHS England will first apply National Data Opt-Outs to individuals in the cohort who have not provided consent, and then cross-reference the Patient Demographics Service to ascertain if a date of death has been registered for the individual, and create a report on the cohort of individuals containing – where applicable - fact of death, and latest contact address held in the Patient Demographics Service. The report will then be sent back to University of Oxford via SEFT.

Processing will only be carried out by substantive employees of University of Oxford. All computers and virtual machines used by the research database team to NHS England record-level Data will be password protected at turn on. All computers and virtual machines used by the research database team to access CSOR Research Database data will be password protected at turn on. All CSOR staff handling data will be trained in the principles of Information Governance, the DPA and the UK General Data Protection Regulation (UK GDPR).

Data processing will be carried out either directly in person or remotely, using an appropriate statistical package using University of Oxford or Oxford University Hospitals NHS Foundation Trust owned devices with appropriate security protection. A software firewall on the host and hardware firewalls at the perimeter will provide network security. Access is limited to the IP range of University of Oxford clients. Log on security will use industry standard authentication methods, with passwords stored and validated by University of Oxford IT infrastructure. Access to the database itself will be restricted using role-based active directory controls. All computers and virtual machines used by the research database team to access CSOR Research Database data will be password protected at turn on. Physical access to servers is limited. The XNAT server has nightly security patches. Unneeded services are disabled. Logs are monitored and daily summaries are emailed to system admin. Remote desktop access to the CSOR Research Database is granted via virtual machine. All data analysis will be conducted within the confines of the University’s secure server, and cannot be downloaded to remote devices for storage or processing or otherwise copied. All remote access is within the specified territory of use (i.e. England and Wales).

The received Data will not be linked with any other datasets. They will be cross-checked against existing study data stored in the CSOR research database.

Where consent is not received from parents, all identifiable data will be removed within 13 months of being received.

The key immediate output will be to ensure that no communications related to the CSOR study goes to the parents or care-givers of participating individuals who have died. This will mean that all efforts are made to ensure communications do not cause undue distress to grieving parents or care-givers.

The CSOR study has a separate Data Sharing Agreement (DARS-NIC-608743-H5X9Z) for outcomes data relating to the study, which should generate outputs such as results, presentations or reports.

To enable ongoing contact with parents for the purposes of maximising data collection in relation to children’s quality of life, whilst minimising the potential for causing distress by contacting parents of children who have died between recruitment and follow-up.

The CSOR research database contains clinical and long-term outcome data from 1095 infants collected from 7 specialist NHS England sites, with 4 further sites onboarding currently, and 10 more in the pipeline. Data are collected across 6 complex surgical conditions; Hirschsprung’s, Oesophageal atresia, Gastroschisis, Necrotising enterocolitis (NEC), Posterior urethral valves (PUV) and Congenital diaphragmatic hernia (CDH). Parent reported quality of life data are also available for 273 participating infants, providing a link between clinical and patient-centred outcome. The patient list service enabled mortality check that is performed prior to communication with all parents has been critical in enabling communication.

Appreciative inquiry (AI) is in progress for 7 NHS England sites with a high-level of engagement and positive feedback. The AI framework allows hospitals to identify key strengths, areas of variation and overall outcome and implement mechanisms for improving outcomes of children treated.

Alder Hey and GOSH have completed AI#1 Introduction and review of available data. The CSOR team are supporting local technical teams to improve data flow before AI#2 briefing meetings are scheduled.

AI#2 Briefing meetings at Chelsea and Westminster and at The Evelina highlighted a strong culture of open multidisciplinary collaboration and reflective practices. The most substantive theme identified at Chelsea and Westminster for further exploration was NEC, with a focus on early referral and transfer, surgical and neonatal decision-making, and internal escalation processes. AI#2 Briefing at The Evelina highlighted the complexity of case mix, with a high proportion of significant cardiac comorbidities identified. Key themes identified for further exploration in AI#3 Themes meeting at the Evelina were supported decision-making frameworks, timing of surgery and overcoming estates and resourcing challenges for infants with NEC; and stabilisation, intervention timing and decision to operate in infants with CDH.

Oxford’s AI#3 reviewed 6 NEC cases with the key outcome of creating a formalised framework for discussion and decision making to be built around the strength of their Tripartite model of review, and availability of neonatal ultrasound, with a focus on delivering these strengths across five further areas.

Oxford’s AI#4 change planning meeting, to be led by the individual hospital with support from CSOR will review the developed framework and support implementation. Manchester have also completed AI#3, reviewing four CDH cases. Key strengths included strong MDT culture with open collaboration and trainee support. An updated care pathway implementing echocardiography guided management of pulmonary hypertension for infants with CDH is being developed and will be reviewed for implementation in AI#4 meeting.

Southampton have completed AI#4 Change Planning having developed, with their neonatal referral network, a framework for decision making and transfer in systemically unstable infants with NEC. This is now being implemented, and routine review will be led by Southampton with key learnings shared with other trusts across the country.

Key Information identified

The CSOR research data base and the appreciative inquiry process have met the CSOR objectives to i) build a system that could identify unwarranted variation between hospitals and ii) support hospitals to improve outcomes for children who have complex surgical needs.

The CSOR database demonstrates that national, multi-centre data collection is feasible at a large scale. The cohort comprises a large, clinically complex group, with differences in caseload, clinical complexity and the degree of significant co-morbidities across hospitals. Hospitals also showed differences in ethnic and socio-economic demographics. The inclusion of parent-reported quality of life data in the CSOR databased highlights the importance of non-clinical factors in assessing overall outcomes for children and their families.

The appreciative inquiry process provides a robust, data-driven framework for open, reflective and strength-based learning; allowing hospitals to identify areas for improvement in a non-judgemental format. In many cases the AI process highlighted strong multi-disciplinary decision-making frameworks in place for some conditions, which could be leveraged to inform areas where variation does occur. The AI process identified variability in the approach to surgical management of some conditions across centres, highlighting areas where national level learnings may be shared. The NEC example demonstrates a clear proof-of-concept that CSOR can translate large-scale data into actionable improvements by defining the variability, providing a clear framework for constructive discussion and implementing change management planning at a local level. The data clearly demonstrate that care-pathways should continue to be reviewed, owned and managed at the site level, with broader learnings shared to inform at the trust and national levels.