Children's Surgery Outcome Reporting (CSOR) Research Database - Case and contact details identification

The University of Oxford requires access to NHS England data in order to support the Children’s Surgery Outcome Reporting (CSOR) research database. Data held within the CSOR research database will be used to understand where there is unwarranted variation between hospitals in the management and outcomes of children with six surgical conditions (oesophageal atresia, gastroschisis, Hirschsprung’s disease, congenital diaphragmatic hernia, necrotising enterocolitis, and posterior urethral valves), and to provide participating hospitals with information that they can use to improve the care they deliver. NHS England data covered within the scope of this agreement will be used for two purposes:

1. Identify children who are alive and eligible for inclusion in the CSOR research database, and whose parents can therefore be approached to provide quality of life data.

2. Identify living and deceased children who are eligible for inclusion in the CSOR research database, in order to ensure complete case ascertainment.

CSOR is part of a series of recruitment pilots testing new use cases and capabilities for the minimal viable product (MVP) NHS DigiTrials recruitment service. As part of the pilot, University of Oxford will provide suitable feedback regarding response rates to the invitations in order for NHS DigiTrials to undertake suitable analysis of the service. Development work will be undertaken on the MVP to assist with meeting the needs of the CSOR research database where these are not already met by the MVP and where it is feasible to do so.

The following NHS England Data will be accessed:

• Personal Demographics Service – necessary for the purposes of identifying individuals who are eligible to participate in the CSOR study

• Hospital Episode Statistics (HES) – necessary for the purposes of confirming eligibility for the CSOR study.

• Civil Registration of Deaths – necessary for the purposes of ensuring that any child who has sadly passed away, is updated on CSOR records.

The level of the Data will be Identifiable. This is necessary because University of Oxford require enough information to be able to contact the parents of surviving infants and to cross-check information about deceased individuals against data received from other sources.

The Data will be minimised as follows:

• Limited to a study cohort identified by NHS England as meeting the following criteria:

- Patients born of or after 1st June 2023.

- Patients admitted, operated on or discharged from a participating hospital (as detailed on s251 approval documentation) after 1st of June 2023

- Patients with an ICD-10 code on their health record for one of the following diagnoses:

* Atresia of oesophagus without fistula

* Atresia of oesophagus with tracheo-oesophageal distula

* gastroschisis

* Necrotizing enterocolitis of fetus and newborn

* Perinatal intestinal perforation

* Hirschsprung disease

* Congenital diaphragmatic hernia

* Other congenital malformations of diaphragm

* Congenital posterior urethral valves

Based on incidences of the six included conditions, it is anticipated that there will be approximately 40-50 eligible infants identified per hospital per year. Whilst it is not possible to state an exact number of invites to be sent out, it is the aim of the study to invite all eligible infants.

ADDITIONAL EXCLUSION CRITERIA:

Due to complexities with modifying electronic patient record systems in participating hospitals, each hospital started local data collection on a different date. Therefore, infants will be excluded if they were born and underwent operative treatment for their qualifying condition prior to the date that data collection started in that child’s treating hospital. These criteria cannot be identified by NHS England data and therefore will be applied by the CSOR team when NHS England data are cross-checked against data received from other sources.

Oxford University Hospitals (OUH) NHS Foundation Trust and the University of Oxford agree that whilst data reside with OUH, OUH will be the Data Controller. Once the data is received by the University of Oxford, they become the Data Controller. Therefore, the University of Oxford and OUH will be Joint Data Controller and are the organisations responsible for ensuring that the Data will only be processed for the purpose described above.

The University of Oxford is the Sponsor. No organisations other than NHS England, the University of Oxford and OUH NHS Foundation trust will act as controllers, sponsors or processors of the data shared under this DSA.

The lawful basis for CSOR processing personal data under the UK GDPR is: 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.

The lawful basis for CSOR processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participant. The performance uptake report will be provided under consent.

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the CSOR programme. University of Oxford will promote this information via their project webpage and NHS England will also promote this information via a dedicated opt-out webpage for the study on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to University of Oxford for invitations to be sent.

CSOR is funded by National Institute for Health and Care Research. University of Oxford are the research sponsor.

NHS England are responsible for:

1. Applying the inclusion criteria to the datasets (to generate a data list of potential participants).

2. Removing objections or opt outs (where a national Data opt-out or a study-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

3. Sending identifiers on to University of Oxford and OUH for the purposes of inviting individuals to join the CSOR study.

4. Agreeing with University of Oxford and key processing timelines

Participating hospitals - The participating hospitals are involved in CSOR as participant identification centres, but will not be accessing data covered by this DSA. Where queries exist in relation to the eligibility of infants identified in data provided by NHS England under this DSA, these queries will be resolved by communication with staff based within these participating hospitals. Communication will be undertaken through the secure CSOR portal, with data remaining on the University of Oxford and Oxford University Hospitals NHS Foundation Trust servers.

Project Management Group (PMG) - the research database is run on a day-to-day basis by this group which reports to the CSOR Co-Investigator Group and CSOR research database steering committee, who in turn are responsible to the National Institute for Health and Care Research (NIHR) Health Services and Delivery Research programme. At each participating site, local Principal investigators report to the PMG based at the National Perinatal Epidemiology Unit (NPEU) based at University of Oxford. The core PMG consists of Chief investigator (CI), Programme Manager, Postdoctoral Clinical Research Fellow, Statistician, and Programmer. The core PMG meets weekly.

Co-Investigator Group (CIG) - this extended PMG meets every 3-4 months and comprises all members of the co-applicant group, the key collaborators and the members of the core PMG to review progress, troubleshoot and plan strategically.

CSOR Research Database Steering Committee consists of representatives from CSOR team, surgeons and non-surgeons from participating data collection centres, independent members and public representatives.

The terms of reference of the Steering Committee are:

- To provide overall supervision, management, strategic direction and governance of the activities of the CSOR Research Database.

- To approve any protocol amendments and any later changes necessitated by considerations of feasibility and practicability.

- To consider, review, modify and approve the data being collected by the CSOR Research Database to ensure that it remains sufficient to meet the primary objectives of the database.

- To consider and approve applications for addition of new conditions to the CSOR Research Database.

-To consider and approve applications for addition of new sites to the CSOR Research Database.

- To monitor and supervise the progress of data collection and analysis.

- To monitor and supervise the progress of development of case-mix adjustment models and their subsequent application to the data for the purposes of generating expected outcomes data.

- To monitor and supervise the data feedback processes (providing participating hospitals with feedback to help them understand how to improve their outcomes).

- To advise the CSOR Research Database Management Group on all aspects of the programme, including publicity and presentation.

- To consider and approve applications for use of the CSOR Research Database data by third party researchers (no data will be considered for sharing with third party researchers during the time-period of this DSA).

- To consider and review the CSOR Research Database process evaluation.

Access to identifiable NHS England data is restricted to substantive employees of NHS England, OUH and University of Oxford.

The National Perinatal Epidemiology Unit (NPEU) Parent Advisory Group (PAG) consisting of over a hundred parents of children with surgical conditions, charities and support group representatives have informed development of the CSOR research database from concept through to implementation. The group was formed approximately 15 years ago, and continue to meet annually. This group have inputted into the purpose, design, participant facing materials, and data processing methodology of the CSOR research database. In particular, this group have helped to review the acceptability of using data without consent, including data obtained from NHS England, and the process through which parents are consented to provide quality of life data. These topics have been explored further in focus groups undertaken with parents of children with surgical conditions who are not part of the NPEU PAG. Groups have been supportive of the methodology used, with a common theme being surprise that data are not already used in this manner where there is such a clear, pressing need for research to improve the care of children.

Parents, and adults treated for surgical conditions as a child, continue to be integral to delivery of the CSOR research database. Quarterly meetings of the Co-investigator group are held, with parent representatives present at all. These parent representatives continue to provide vital input to the ongoing design and management of the research database, particularly in relation to challenges related to the consent of parents. Work has been undertaken over the year with charities and support groups, including Sands, the Twins Trust, CHAMPS appeal, TOFS (charity supporting Tracheo-Oesophageal Fistula), The Congenital Diaphragmatic Hernia Support Charity (CDH UK) and NEC UK (charity supporting research into Necrotising Enterocolitis) to seek input into specific elements of the programme. These include design and revision of public facing materials, utilization/oversight of data, and refining our methodology. Examples of areas where public partners are inputting greatly is in designing an approach to parents of eligible twins where one of the twins has passed away, and investigating further whether and how parents of children who have passed away should be invited to contribute to the programme.

Four parent, patient and support group representatives sit on the Steering Committee governing the CSOR research database.. These representatives provide valuable input into a wide range of aspects related to the governance of the database, including the scope of recruitment for children with necrotizing enterocolitis, development of case-mix adjustment models, and approaches for onward sharing of data.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will use the inclusion criteria provided by University of Oxford to identify potential participants for the purposes of recruiting individuals to the CSOR study. NHS England will remove any records where a National Data Opt-Out or study-specific opt-out has been registered, as well as special categories of people for whom the data should not be disseminated such as those on a witness protection programme.

NHS England will provide the relevant records of the identified potential participants from the Personal Demographics Service dataset, Civil Registration of Deaths dataset and HES APC dataset to University of Oxford on a monthly basis.

The Data will contain directly identifying data items including NHS number, Title, First Name, Surname, Address and Postcode, which are required for the purposes of contacting potential participants. Additional information will include qualifying diagnoses, treating hospital, and where relevant date of death.

The Data will also be processed by OUH Foundation Trust but will not be transferred to any other location.

On a weekly basis, the University of Oxford will send out invitations to all eligible participants who have not previously been invited to participate. Based upon incidences of the included conditions it is anticipated that approximately 4-5 new eligible infants will be identified per participating hospital per calendar month. The process for consenting parents identified through the data shared by NHS England under this DSA is detailed below.

Data collection centre staff from the child’s treating hospital (as identified by the data provided by NHS England) will be asked to confirm that the child was treated for their qualifying condition at their hospital and that according to the records held by the hospital the child meets the CSOR eligibility criteria. Data collection centre staff will also be asked to confirm if the child’s parents are likely to be receptive to hearing about CSOR at that point in time. This communication is undertaken within the secure CSOR portal, with all data remaining on the servers of OUH NHS Foundation Trust and the University of Oxford.

If parents are likely to be receptive, then they will be sent links to the CSOR Participant Information Leaflet (PIL) and Consent Form in electronic (text and email) and written format. Consent will be taken through an online form, with parents/guardians receiving information on how to contact appropriate research staff if they have questions or wish to discuss further. This approach to consent is being taken, as opposed to an active consenting by a member of the research team, as the study is low risk, involving data collection with no intervention or alteration to patient care. Parents/guardians will be able to access a copy of the completed consent form through the CSOR web-portal. Consent will be sought to:

- Contact them for the purposes of obtaining annual quality of life data relating to their child and linking this data to clinical data obtained from data collection centres’ EPR systems and from other routinely collected sources, gathered by national organisations in England and Scotland (NHS England / ISD Scotland).

- Review relevant sources (e.g. NHS DigiTrials Communications Service) for the purposes of ensuring contact details are kept up to date, and preventing contact with parents/guardians if their child has died

- Contact them about participation in future studies

Where an eligible child has been identified and it has been indicated that currently the parents/guardians are unlikely to be receptive to discussions about providing parent reported quality of life data, the identifying data collection centre will be contacted one week after identification of the infant, and monthly thereafter, to report whether the infant’s clinical condition is improving, unchanged, or deteriorating. If the infant’s condition is unchanged or improving, the parents/guardians will be sent the links to the PIL and consent form.

If parents/guardians have not submitted a consent form (either consenting, or actively opting out of the study), reminders will be sent 7 days, 28 days, 6 months and one-year after the PIL and consent form were sent. At 7 days, reminders will be sent via text and email. At the remainder of the time points, consent information will also be sent via post, and attempts to contact will be made via telephone.

If no response is received within one month of the one-year reminder, the infant’s and parent/guardian’s identifiable data will be removed entirely from the database.

This approach has been developed following focus group work with parents of children with surgical conditions, and subsequent review and discussion of the approach and consent process with a Parent Advisory Group established at the National Perinatal Epidemiology Unit, University of Oxford. The group felt that the approach of chasing consent four times was an appropriate balance between ensuring that those who wanted to participate were given sufficient opportunity to do so, whilst those who did not were not overly burdened. Their feedback also determined the time points to use for chasing up consent and the methods we will use to contact parents/guardians. The parents explained that the lives of parents/guardians of children with surgical conditions were usually busy and often chaotic, and therefore not responding to a request to participate in research such as the CSOR Research Database was usually due to having forgotten to reply rather than actively deciding not to participate.

The Data will be stored on the secure servers hosted by Nuffield Department of Population Health, (NDPH), based at the University of Oxford.

The Data will be backed-up by NDPH server backup procedures.

The Data will be accessed on servers at University of Oxford via CSOR application, in-house programming team & server administrator.

The Data will not leave England at any time.

Access is restricted to substantive employees of Oxford University Hospitals NHS Trust and University of Oxford only.

No organisations stated in this agreement, other than NHS England, Oxford University Hospitals NHS Trust, or University of Oxford will have access to identifiable data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The identifiable data (NHS number and date of birth) shared with the University of Oxford and OUH will be cross-checked against data already held by the University of Oxford in the CSOR research database to confirm whether an identified infant has already been identified through an alternative data source. This is necessary to prevent approaching infants parents who have already been approached to participate in the study. The identifiable data sent to University of Oxford and OUH, will not however be linked with any other data.

University of Oxford will destroy all data files received from NHS England.

As CSOR is a research database, there is no maximum recruitment target. Recruitment will be ongoing as long as funding for the database is maintained. Data processing will produce information on whether complete case ascertainment has been achieved for each participating site. This will provide assurance that feedback information provided to hospitals in relation to their outcomes is based upon a representative cohort of infants that have been treated in that hospital.

Recruitment progress will inform:

- Reporting to: Sponsor, Co-investigator group, Steering Committee, NIHR (funder), through milestone updates linked to the funding award letter.

- Lay friendly updates to partner charities, support groups, and the NPEU PAG through meetings, newsletters and study reports.

- Presentations at relevant national and international conferences

- Publications in relevant peer reviewed journals

- Modification and development of the CSOR research database

- Ongoing conversations with partner organisations around development of similar databases and recruitment methodology for other conditions/specialty areas.

Any outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset from which the information was derived. Identifiable data requested from NHS England will only be used to identify and invite potential participants as well as to confirm complete case ascertainment in participating sites.

The outputs will be communicated to relevant recipients through the following dissemination channels:

Social Media

- Newsletters (quarterly newsletters are sent to CSOR collaborator organisations and the NPEU PAG)

- Journals (manuscripts will be submitted to relevant peer reviewed journals describing the database development, processes, analysis of collected data, and evaluation of the working of the database)

- Workshops (an annual CSOR study day will be hosted to provide feedback of all aspects of the research database to interested parties)

- Public report (public reports to the funders will be published.)

- Leaflets (lay summary leaflets of key elements of the research database will be produced and disseminated via existing mailing lists, charities and support organisations and the CSOR website).

Recruitment will continue until 31st August 2026 under current funding agreements. At this point an evaluation of the research database will be completed and key outputs will be disseminated over the following 12 months. Interim updates through newsletters, study days, etc will be disseminated throughout the course of the funding agreement.

The ability to utilise NHS England data will help to optimise recruitment, in order to deliver the CSOR programme in a timely, effective and efficient manner. Using NHS England’s NHS DigiTrials Recruitment Service to generate potential participants’ information, in order to invite parents potentially eligible children to join the CSOR study is expected to significantly increase the recruitment reach of the study. Utilising data from NHS England also enables confirmation that complete case ascertainment has been achieved in each participating site. This is necessary to provide reassurance that feedback to hospitals relating to their outcomes is based upon a representative population of infants treated by the hospital.

Participating in the CSOR research database will not impact the treatments that individual participating children receive. However, some parents report that they find it beneficial to participate in research projects such as this as it enables them to feel like there is some benefit to come from their child’s illness/their experiences.

Recruiting individuals into the CSOR study, using the NHS DigiTrials recruitment service is ultimately expected to provide benefits to health and social care as it will allow identification of unwarranted variation between hospitals in the management and outcomes of children with surgical conditions. When coupled with the feedback provided to hospitals through the linked CSOR appreciative inquiry process this will lead to improvements in the care delivered to children with surgical conditions, and thereby improvements in their health and wellbeing. The research database will also serve as a world-leading research database, enabling important clinical questions relating to the treatment of children with surgical conditions to be answered for the first time. This will improve the quality of treatments offered to these children.

The CSOR research database team have established links with all relevant professional and patient organisations. These include:

- NHS England

- British Association of Paediatric Surgeons

- British Association of Paediatric Urologists

- Royal College of Surgeons

- Royal College of Paediatrics and Child Health

- British Association of Perinatal Medicine

- United Kingdom Paediatric Colorectal Group

- All hospitals commissioned to provide specialised surgery for children in England and Scotland

- CDH UK

- NEC UK

- TOFS

- CHAMPS Appeal

- Gastroschisis Foundation

- SANDS

- Bladder and Bowel UK

- Twins Trust

The CSOR research database team engage with these stakeholders and influencers to ask for their support with engaging members of the public who are eligible to join the CSOR research database. They will be asked to raise awareness of the CSOR research database via their own communication channels which will increase familiarity and trust to the letter invite. This is in addition to advertising within individual hospitals Neonatal Intensive Care Units (NICUs), surgical wards and outpatient departments, and through the CSOR research database website.

Yielded Benefits is not a requirement for new applications.