NHS Digital Data Release Register - reformatted

Cardiff University

Project 1 — DARS-NIC-184980-J5B6C

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2017/03 — 2017/05.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Objectives:

Treatment choice and outcome substantially decided by age. Patients <60 years have a significantly improved survival, Of patients >60 years treated intensively over the last 15 years there is little evidence of improvements in survival, CR rate not improved beyond 60% and relapse is 85% of patients. Large groups of patients >60 years are not considered fit for intensive treatment - median survival 4 months. Median age of disease is 65 years. As the general population lives longer, the number of patients in this age group will increase. There is an urgent need to find new treatments for patients >60 years who are not catered for in most trials. HCTU will use the data to support the analysis and long term follow up of the AML15 clinical trial with an aim of producing academic papers.


Project 2 — DARS-NIC-316558-W0T8G

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2017/03 — 2018/05.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

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

Objectives:

Treatment choice and outcome substantially decided by age. Patients <60 years have a significantly improved survival. Of patients >60 years treated intensively over the last 15 years there is little evidence of improvements in survival, CR rate not improved beyond 60% and relapse in 85% of patients. Large groups of patients >60 years are not considered fit for intensive treatment - median survival 4 months. Median age of disease is 65 years As the general population lives longer, the number of patients in this age group will increase. Urgent need to find new treatments for patients >60 years who are not catered for in most trials.


Project 3 — DARS-NIC-333498-D1K7G

Opt outs honoured: Y, N

Sensitive: Non Sensitive, and Sensitive

When: 2016/04 (or before) — 2018/05.

Repeats: One-Off

Legal basis: Section 251 approval is in place for the flow of identifiable data, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Office for National Statistics Mortality Data
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics

Benefits:

This study will provide evidence for the long-term effectiveness and costs of one of the most promising early intervention programmes in a targeted vulnerable population. It will inform policy about whether to continue implementing a programme for which there is no existing UK evidence for effectiveness. The recognised potential programme benefits – in particular for child maltreatment have largely been evidenced in the longer term. This project presents a unique opportunity to extend learning from the trial by using existing outcome data in combination with newly arising data. The original study (BB:0-2) has already been viewed by the relevant DH Policy team. Cardiff University expect the trial results will inform post-election decision-making regarding the implementation of this programme. The policy team within the Department of Health are fully aware of the follow-on study. The academic research team and DH policy team have a rolling joint dissemination meeting (to manage trial results dissemination) and Cardiff University will continue this relationship into the work of the follow on study, whilst being mindful of maintaining independence of the research team. The Department of Health hold the licence for the program in the UK. Its continued availability will depend upon evidence produced by the trial, and Cardiff University expect by the follow-on study. This project is looking at the long term effects of a home-visiting intervention commissioned by the Department of Health. The study aims to determine the long-term effectiveness of this intervention in reducing objective and associated measures of maltreatment. There was no pre-existing evidence for programme effectiveness in the UK (England). The completed trial provided definitive evidence of short-term impact. The current work will provide new evidence about longer-term impact on maltreatment. Existing evidence for programme effectiveness related to maltreatment exists in the US context only. US evidence (specifically for maltreatment) includes Olds et al JAMA 1997 278 (8); 637-643. Both the original trial (Funder: DH PRP) and the follow-on study (Funder: NIHR-Public Health Research Programme NIHR PHR) are independent evaluations of the intervention. It is important for the research team to retain this independence and aim to produce high quality evidence to inform practice and policy. The Department of Health have indicated the importance of the work by funding both studies to a combined value of £6M. The evidence base for policy should comprise all relevant research and not the results of a single trial cohort, although Cardiff University’s trial cohort will produce the most directly relevant evidence. The Department of Health funded the research team to run a large stakeholder event in January (2016) to which practitioners, policy leads and lay representatives from across the UK attended. Following discussion with the Department of Health (23 March 2015), Cardiff University can also state that the intervention under investigation is currently embedded across 135 local authorities and that the results of the trial will influence not only policy but commissioning decisions in local authorities who now have responsibility for commissioning public health services for children aged 0-5. Cardiff University expect that the results accruing from the current data request will have similar reach and engagement from commissioners.

Outputs:

Results of the final analyses (following the second data extraction) will be reported to the Department of Health (NIHR-Public Health Research, and the DH Policy Research Programme), and to the FNP National Unit (FNPNU). The FNPNU is responsible for national delivery of FNP and is commissioned by the Department of Health and Public Health England who hold the license in England and have the lead role for its strategic policy direction. All local authorities in England will be notified of the results, as (since October 2015) they have responsibility for commissioning public health services for children aged 0-5. Participants will receive a summary of the results and all reports and publications will be made available in full in the public domain on the Cardiff University website. The research team have convened and met twice with a stakeholder group, including relevant policy leads from each country in the UK delivering FNP (England, Scotland, Northern Ireland). Cardiff University will stage a similar event to present and discuss the implications for practice and policy of the results of this longer-term follow up of participants. The reports are planned for summer 2018. In addition to the policy and public outputs, there will also be academic outputs which are outlined below. The purpose of these academic outputs are to report the methods used in order to answer the research question as well as the results of the study. These will be presented both in writing and at conferences for the purpose of sharing knowledge to aid other researchers using these methods, these data, and these topic areas. Publishing in scientific journals will involve rigorous independent scientific peer review. This provides additional reassurance to the funder, the public and other researchers that the methods and results presented are of high quality, credible and scientifically robust. The study plans the following academic publications: 1. A ‘protocol’ paper to be published in BMC Paediatrics is planned for April 2016. This will describe the aims, objectives and research design of the study. This exposes our approach to the scrutiny of other academics, raises awareness of the work taking place and provides an indication about when to expect the results. 2. A paper describing the piloting process of the study and describing data quality, the success of data matching at multiple information centres and the linkage conducted at SAIL. Academics will learn from the methodology of this work and use this to inform their own research. This is planned for first half of 2017 also in BMC Paediatrics. 3. A paper on main results of the study to be published in the Lancet is planned for mid-2018. This is a high impact international journal which will reach academics across the UK and in other countries with the results of the long-term outcomes of FNP. The individuals who will be cleaning and analysing the de-identified data include an individual who is also studying for a PhD. This individual will be discussing in their PhD thesis how a variety of data sources can be combined to build a clear picture of confirmed maltreatment, markers of maltreatment, and predictors of maltreatment for women and children recruited to the original trial and this long-term follow up. This differs from the main results of the study which focuses on confirmed cases of maltreatment only. Results presented for this PhD will be the availability and validity of linking fields that allow different data sources to be linked for measuring maltreatment. All access for analysis is to de-identified data, no identifiable data will be accessed. Published results will only contain aggregated data with small numbers suppressed. The small numbers policy specified in the HSCIC terms and conditions will be followed.

Processing:

Cardiff University will provide the following fields to the HSCIC: • Study ID • NHS Number • Date of Birth • Sex • Postcode The HSCIC will link this information to the HES and ONS mortality data, strip out the identifers and return a pseudonymised output to the data processor, the Swansea University’s Secure Anonymised Information Linkage (SAIL) Databank. Cardiff University will also send SAIL a copy of the original study (BB:0-2) data and will separately send participant identifiers to the Department for Education which will supply linked pseudonymised data from its records to SAIL. The only identifier provided to SAIL from each of the 3 sources will be the Study ID. SAIL will assign an anonymous linking field (ALF) to each individual to replace the study ID. The study ID-ALF key will be encrypted and stored securely by SAIL. The individuals analysing the data will not have access to this key. The key will be same for each of the datasets so that all data can be linked up without using identifiers to do so. The key will be retained by SAIL for two reasons – firstly, any individual who expresses at a later date a wish to be removed from the study can then be removed from the dataset. Secondly, Cardiff University are following up these individuals for four years therefore a refresh/update of the data will be required when all children are aged 6 years and SAIL will need to assign the ALF to these data. This data linkage model was discussed and agreed with individuals at HSCIC during the development of the project. The research team work within the United Kingdom Clinical Research Collaboration (UKCRC) fully registered clinical trials unit - South East Wales Trials Unit at Cardiff University. All data will be maintained in the safe data haven in Swansea [SAIL] within which all analyses will be undertaken. The research database will not be made available to other researchers (this will be a project specific resource). Access to the pseudonymised dataset will be via a secure remote portal. No data will leave the secure environment at SAIL. Approved, named data users (the research team - as listed in the application) can access the portal and defined data views remotely, subject to the appropriate access level being set and secure access keys being provided to them. The contract between Cardiff University and Swansea University will confirm who will have access to the project database. Access is restricted to only those individuals listed in the application to HSCIC, who are either staff at Cardiff University or Swansea University. In addition, data cannot be downloaded from the portal, all exports of data are approved by SAIL who ensure raw data and results with small numbers (and therefore a risk of identification) are not exported. Only graphs, statistical analyses outputs and aggregated tables will be exported out of the secure portal. Baseline data and follow-up data from Building Blocks trial will be included in the main analysis, so that the total follow-up period for each participant will be just over six years. The following is a high level sSummary of the main analysis of the linked pseudonymised dataset: Participants who received FNP during the trial (intervention arm) will be compared with those who did not (Control arm). Rates of maltreatment will be compared between the two groups as well as describing differences in education, health and social care outcomes. Standard costings will be applied to episodes of healthcare and an economic analysis will compare costs between the groups. More detail of the analysis plan is outlined below: • Analyses will be conducted on an intention-to-treat basis and due emphasis placed on confidence intervals for the between-arm comparisons (FNP versus Usual Care). • Descriptive statistics of demographic and outcome measures will be used to ascertain any marked imbalance between the arms at 2 years. • The primary comparative analysis on Child in Need (CIN) status at any point between birth and 6 years will use logistic multilevel modelling to investigate differences between the groups. [Objective 1] • Multilevel modelling will allow for clustering of effect within a site and family nurse and where this indicates little impact of clustering on effect, results from the single level model will be presented. • Comparisons will be presented as adjusted risk differences and odds ratios, alongside 95% confidence intervals and p-values. • Modelling the impact of key subgroups and different intervention elements (e.g. gestational age at programme entry, dosage) on outcome will be undertaken by extending the primary models and testing for interaction effects [Objectives 2 & 4]. • Logistic multilevel modelling will also be used to analyse the associated secondary outcomes (e.g. proportion of children with injuries and ingestions) [Objective 2]. • Counts data such as the number of emergency attendances will be analysed using Poisson multilevel regression modelling [Objective 2] • Economic evaluation will consider costs and consequences of the FNP over the six years of follow up. The within trial cost consequences analysis will be extended from 0-2 to 0-6 years through collection of resource use data from medical and education records (including from the latter data related to social care usage). The nature of the data collected during the extended period will allow the long-term model to include additional predictors and hence produce more robust long-term estimates of costs and effects [Objective 5]. Following analysis, aggregated results / publishable information can be requested out of the secure environment for wider disclosure (subject to the data file being approved by data guardians at SAIL). Data guardians check for sensitive data, and small numbers that could risk disclosure before approving the file.

Objectives:

The Family Nurse Partnership (FNP) has been developed and licenced by the University of Colorado. It is a voluntary, preventive programme for vulnerable young first time mothers. It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two. Its three aims are: to improve pregnancy outcomes, improve child health and development and improve parents’ economic self-sufficiency. A strong and rigorous US evidence base, developed over 30 years, has shown FNP benefits the most needy young families in the short, medium and long term across a wide range of outcomes helping improve social mobility and break the cycle of inter-generational disadvantage and poverty. Proven benefits include: • improvements in antenatal health • reductions in children’s injuries, neglect and abuse • improved parenting practices and behaviour • fewer subsequent pregnancies and greater intervals between births • improved early language development, school readiness and academic achievement • increased maternal employment and reduced welfare use • increases in fathers’ involvement  The University of Colorado (UC) has licensed the FNP to the Department of Health (DH). The model of international replication for FNP specified by UC follows four stages: (i) adaptation to local context; (ii) pilot testing of feasibility and acceptability; (iii) randomised controlled trial, and (iv) replication and expansion. The programme was adapted for implementation and introduced in England in 2007. Due to the greatly differing nature of publicly funded health and social care service provision and socio-cultural context between England and the US, the relative benefits of the programme need to be replicated in England and costs determined before wide-spread implementation can be recommended. DH is committed to strengthening the evidence base for FNP in an English context. To that end, DH commissioned the ‘Building Blocks’ randomised controlled trial (RCT) from Cardiff University to provide independent evidence on the effectiveness of the FNP programme in improving short term outcomes for young parents and their babies. The trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015. The FNP described these as “important early findings and add to the evidence we have from the US, Netherlands and other early evaluation in England to help improve FNP in England.” The National Institute of Health Research has now funded Cardiff University to undertake a follow up study to examine child outcomes to age six. This will build on the original study examining the longer term impact of FNP intervention. The study objectives are: 1. To determine the effectiveness of the FNP programme in reducing objectively measured long-term maltreatment outcomes when compared to usually provided health and social care alone. Using a multi-method multisource approach to maltreatment research main outcomes will be: Child in need status, child protection registration, referral to social care (overall; child protection; Child in Need) 2. To determine the long-term effectiveness of the FNP programme in reducing maltreatment when assessed using associated measures of injuries and ingestions, hospital DNA rates and immunisation rates. 3. To determine the long-term impact of the FNP programme upon intermediate programme outcomes, most notably subsequent pregnancies. 4. To explore the impact of theoretical moderators of programme effect, including domestic abuse and baseline client characteristics 5. To determine the costs and consequences of the FNP programme over the full period of available follow-up. Cardiff University will follow up the mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from the HSCIC and data from Department for Education (DfE) which will be linked with the original trial data. The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study will provide evidence for the long-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Specifically, data requested from HSCIC will provide the basis for key study outcomes which are indicators of maltreatment. The study will provide evidence to inform policy about whether to continue implementing a programme. The proposal presents a unique opportunity to extend learning from the trial by using existing trial outcome data in combination with newly arising routinely recorded data. There will be two waves of data request and extraction from the HSCIC. This is the first application. The study will follow up participants until all the children reach six years of age, which will be March 2017. The second data request will request data up to and including dataset period 2016/17. The justification for this first application is firstly a proof of principle – that the data are sufficient to answer the research questions, to identify additional variables (if required) and to develop and validate a plan for cleaning and analysis for the second (and final) analysis. This will also ensure timely delivery of the results to the Department of Health and the policy makers for FNP in the UK.


Project 4 — DARS-NIC-42321-K7G1C

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/12 — 2017/02.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Critical Care
  • Office for National Statistics Mortality Data (linkable to HES)
  • Mental Health and Learning Disabilities Data Set
  • Mental Health Minimum Data Set
  • Improving Access to Psychological Therapies Data Set

Benefits:

This project is being conducted to identify problems in health care quality and delivery for CYP with AMH and neurodisability against those who are not affected by these conditions. It is a follow up study to the HQIP ‘Overview of Child Deaths in Four UK Countries’ report, which found that two thirds of children who died in England and Wales had chronic conditions, of which 30-40% were affected by neurological or sensory conditions and 30-40% were affected by mental health, learning difficulties or behavioural conditions. It’s recognised that until the data has been processed and the outputs created, that there is difficulty in recognising the true benefits. However, exploration of the reasons why these CYP are admitted to hospital, the patterns of healthcare utilisation, as well as the assessment of quality of care indicators (e.g. waiting times) could highlight gaps in care and areas for improvement. The allocation of NHS funding to this timely project indicates its necessity and the findings, if disseminated appropriately (see previous section), could have a considerable impact. A secondary benefit of this work is that the assessment of the feasibility of such a large, data-linkage study using population-based healthcare data will provide recommendations for improvements in data recording and data accessibility. Furthermore, this work could be used to facilitate research questions. Since, although only AMH and CP will be addressed, the issues these populations face in terms of healthcare accessibility are similar to other conditions or diseases and the methods used in this study can be replicated and extended. Ultimately however, it is hoped that through wide dissemination of the report - a launch day, press coverage, social media, summary sheets relevant to children and lay audiences, conferences, academic publications etc. - the report will act as a communicative platform for clinicians and policy makers to improve services for patients.

Outputs:

This project is the first government funded investigation into the extent to which routinely collected data may be used to inform and improve the health and social care received by CYP in the UK. The proposed project outcomes for the CP and AMH work are as follows; CP – 1) A descriptive analysis of the number, nature and reasons for hospital admissions, specifically admissions to Paediatric intensive care units (PICU) for children with CP compared for England, Northern Ireland, Scotland and Wales. 2) A description of primary and secondary care utilization for a representative population of children with CP in England and Wales 3) A description of healthcare utilization for cohorts of children with CP in each Nation to include outpatient, Emergency department attendeances where possible and severity where possible 4) A comparison of health care utilization at transition from children to adult services AMH 1) A description of primary and secondary care utilization for a representative population of children with AMH (SH, A&D, ED) in England and Wales 2) A description of healthcare utilization for cohorts of children with AMH (SH, A&D, ED) in each Nation to include outpatient, Emergency department attendances where possible and severity where possible 3) A comparison of health care utilization at transition from children to adult services Using these outcomes it is hoped that the key questions detailed within the objectives will be answered. These outcomes will form the final national project report, that is due in December 2017. It will inform keystakeholders such as: service users, clinicians, health care commissioners, Departments of Health, Royal Colleges and policy makers, clinical standards and guideline development groups. The full report will be available on the HQIP and NCEPOD websites free of charge. The report will be clear and concise, and made readily available as a PDF for easy circulation. The professional groups will be advised on areas which they can improve quality of care for adolescents with mental health disorders and CYP with chronic neurodisability. The recommendations made will be targeted at the most relevant group(s) to implement them. Key patient group stakeholders that will be informed and worked with on launch day include the children and young people’s patient safety expert group, the children and young peoples’ outcomes forum and The Child Health Intelligence Network. In addition to the policy and public outputs, there will also be academic outputs. The purpose of these academic outputs are to report the methods used in order to answer the research question as well as the results of the study. Furthermore, reflection and feedback on the problems and barriers in obtaining and analysing UK wide data will be a valuable aid to future research. Academic outputs will be presented both in writing and at conferences for the purpose of sharing knowledge, to aid other researchers using these methods, these data, and these topic areas. Publishing in scientific journals will involve rigorous independent scientific peer review. This provides additional reassurance to the funder, the public and other researchers that the methods and results presented are of high quality, credible and scientifically robust. The project plans to publish academic papers in peer reviewed journals such as, the Journal of Affective Disorders, BMJ Open, Archives of Disease of Child hood, Child; Care Health and Development. Academic conferences will include RCPCH Annual Conference and the Faculty of Public Health Annual Conference, and invited keynote talks will report on methodological, epidemiology and key findings for public health practitioners and CYP clinicians. Its recognised that the provision for both groups of children require joined up multidisciplinary care and as such a communication and dissemination plan to deliver the findings to multidisciplinary audiences that include patient representation has been created . All stakeholder groups will be asked to put links on their websites, add items into bulletins or newsletters regularly throughout the programme about the study. Alongside this, a project ‘discussion board’ where issues and problems can be posted and discussed has been created amongst the stakeholders. This has the added advantage of maintaining lines of communication across the project team. Social media will be used following feedback from the stakeholders, and there are plans to include patient and participant leaflets, podcasts, and the use of social media such as YouTube where patients and carers will be asked to put the reports' findings in their own words. NCEPOD sends out quarterly updates to medical directors where there are questionnaire or case note requests and this process will be adopted for this programme. A newsletter with study progress updates twice per year will be sent out to these directors. Published results at a national level will only contain aggregated data with small numbers suppressed, in line with the HES analysis guide and the relevant Mental Health suppression guidelines.

Processing:

It is proposed that record level data from each participating nation (England, Wales, Scotland and Northern Ireland) will be released to the Secure Anonymised Information Linkage (SAIL) databank. SAIL have previous experience of hosting NHS Digital data and will be the safe haven for the datasets. Researchers at Cardiff University have been approved by SAIL to access the data (via data access agreement, completion of Research Data and Confidentiality e­learning course, submission of CV). The Cardiff researchers will travel to SAIL and access the data on site at Swansea via the SAIL Gateway, but no record level data will be removed from the system. The SAIL Gateway is the remote data access system, and is the sole method by which approved data users are able to access any record level SAIL data. Access is restricted to only those individuals listed in the application to NHS Digital who are substantive employees of either Cardiff University or Swansea University. NCEPOD and HQIP will not have access to the data. Only aggregated and anonymised data will small numbers suppressed, in line with the HES analysis guide and the relevant Mental Health suppression guidelines will be removed from the system. SAIL will also hold data from Wales, Scotland and Northern Ireland and comparisons at a national aggregated and anonymised level will be made where possible. No record level data from the other countries, or any other source, will be linked to NHS Digital data. Study population: The study population will include HES data linked to ONS, and MHMDS/MHLDDS data, as well as a separate extract of IAPT data, for 0-25 year olds. The MHMDS/MHLDDS and ONS data supplied be only be for those patients who appear in the HES data. All those aged 0-25 years within the HES, ONS, or MHMDS/MHLDDS are requested to be used as comparison groups. Data are requested for a 10 year time period - January 1st 2004 to 31st December 2014. The population of interest is children and young people (11-25 years) who have mental disorders (SH, A&D, ED which form the AMH) and CYP (0-25 years) with chronic neurodisability (CP) who are residents in England. For AMH, only patients 11 and older will be analysed as the number of cases below at start are low, whereas CP is often identified at a much younger age so the full age range can be used for that condition. The population of interest will be identified and flagged by analysts in SAIL using algorithms based upon relevant ICD 10 codes (e.g. G80 for CP and X60-84 (SH), F32-39 (A & D) and F50 (ED) for AMH). Furthermore, age filters will be applied (those born after 01/01/1979) to the IAPT data, as NHS Digital cannot apply filters to this data set. The extraneous IAPT data not covering 0-25 year olds will be destroyed. Cardiff staff will analyse both the AMH and the CP data, with Swansea staff analysing the AMH information. Patient and Public Participation: The service user groups for both themes form part of the study advisory groups and regularly inform project design. A further component of the NCEPOD lead project includes patient, parent and carer surveys. The findings from these are fed back into the study design. Data Cleaning and preparation: As with all analyses of routinely collected datasets there is potential for misclassification in coding diagnoses, linkage errors and missing data. Consistency checks will be made by SAIL analysts and missing data between the national datasets described. Data Analysis: This will be undertaken when datasets become available and is likely to take 12-14 months overall. The linked data will then be analysed by a team of researchers at both Cardiff and Swansea Universities who are experienced in data linkage and using large datasets. Summary of the main analysis of the linked dataset: Reasons for hospital admission, number of admissions and length of stay in CYP with AMH or CP will be described and compared to those without AMH or CP. Causes of death and patterns of healthcare utilisation prior to death will be examined. Reasons and frequency of admission will be compared, before, during and after the transition from paediatric to adult services. Patterns based on age, gender, demographics and area-based social deprivation will be investigated. Descriptive statistics, chi-squared tests, rate ratios and regression analysis will be used as appropriate. Comparison between countries will be made where possible using appropriate statistical methodologies e.g. Poisson regression.

Objectives:

The national Child Health Outcome Review continues the work of the Confidential Enquiry into Child Health (CMACE). This new programme is commissioned by the Health Quality Improvement Partnership (HQIP) on behalf of NHS England, NHS Wales, the Northern Ireland Department of Health, Social Services and Public Safety (DHSSPS), the Scottish Government, the states of Guernsey, the States of Jersey and the Isle of Man government. NHS representatives from each of the four nations (England, Wales, Scotland and Northern Island) )sit on the CMACE's Independent Advisory Group. The project is being undertaken as a partnership between the National Confidential Enquiry into Patient Outcome and Death (NCEPOD), Cardiff and Swansea Universities with Swansea's SAIL (The Secure Anonymised Information Linkage) Databank being at the core of project. This work will add to the findings of the CMACE which found that the highest proportions of child deaths were among those with chronic disabilities and mental health problems in adolescence. There are two workstreams to this programme and are being run separately - 1) This is run by NCEPOD which consists of a case note review, organisational survey and consultation with children and their parents regarding their care. NCEPOD are performing this and it does not impact the work of the second workstream, and vice versa. 2) This is being run by Swansea University and Cardiff Universities. It will link administrative health care data, which offers a source of data to provide a population based overview of adolescent mental health (AMH) and childhood neurodisability for children and young people (CYP). The data will be stored and accessed within SAIL, based at Swansea University along with the AMH team. The chronic neurodisability team are based at Cardiff University who will travel to Swansea to access the data. The project arose from the findings of the report, “Clinical Outcome Review Programme: Overview of Child Deaths in Four UK Countries” commissioned by the Healthcare Quality Improvement Partnership (HQIP), which found 30-40% of children who died in England and Wales were affected by neurological or sensory conditions and 30-40% of 13-18 year olds were affected by mental health problems, learning disabilities and behavioural conditions. The aim of this study is to explore: 1. Characteristics of hospital and primary care attendances including rates, reasons, length of stay and outcomes for the populations of interest and the general children and young people population 2. The interface between different care settings for example primary and secondary care and health and social care 3. Transition between child and adult services These aims will be investigated according to condition, age and socio-demographic characteristics. NHS Digital data is vital to this project in order to report on the rates at which children and young people with AMH and chronic neurodisabilities attend hospital in England, and the reasons why they are admitted. It will also provide information about the nature and outcomes of such attendances in comparison to children and young people without either of the conditions of interest. This data will feed into the wider project objective of exploring healthcare for children and young people with AMH and chronic disabilities across the four nations and will compliment the qualitative research carried out by NCEPOD. Cerebral palsy (CP) has been selected as the index condition for chronic neurodisability and self-harm (SH), anxiety and depression (A & D), and eating disorders (ED) as the index conditions for AMH disorders. The priority questions the study aims to answer for CP and AMH using NHS Digital data are as follows; CP – What is the annual incidence of hospital admissions per child with CP by disease severity? What are the reasons for hospital admission (disease type /procedure) by disease severity? How many inpatient, outpatient attendances/ED attendances are made annually by children with CP? What is the pattern of primary care attendances per child by severity and age (subject to data availability from CPRD)? How many children in each age group received MRI at diagnosis? How many children receive regular hip X Ray surveillance? AMH - What is the annual incidence of hospital admissions per child with SH, A&D, ED? What are the reasons for hospital admission? How many inpatient, outpatient, attendances/ED are made annual by CYP with SH, A&D, ED? What is the pattern of primary care attendances per child (subject to data availability from CPRD) What is the relationship between primary care attendance and hospital admissions and outpatient attendances? What is the relationship between GP or hospital attendance for SH, A&D or ED and overall mortality?


Project 5 — DARS-NIC-74625-S1Q8X

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2017/09 — 2017/11.

Repeats: One-Off

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

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Accident and Emergency

Benefits:

This study will clarify the association between childhood UTI, renal scarring and long-term complications and determine the best approach for managing ill children and UTI. Urinary tract infection (UTI) is the cause of 6% of all acute illness episodes in children presenting in primary care [Refs 8-9]. It is the most common cause of serious bacterial illness in children, and an important cause of hospital admission. [Refs 1-2] The results from this study will improve the diagnosis and management of UTI in primary care which in turn will reduce morbidity and hospital admissions. Childhood UTIs have also been associated with serious long-term complications including renal scarring, hypertension and renal failure. [Refs 3-7]. Current guidelines recommend the prompt diagnosis of childhood UTI in order to try to prevent these complications. [Ref 3] However, urine sampling from children is difficult, particularly in primary care settings. This study aims to determine whether increased urine sampling strategies benefit children with UTI and reduce complications. Although the association between childhood UTI and long-term complications are generally accepted and drive much of the current advice concerning UTI in children, the evidence for the strength of the association is weak. The National Institute for Health and Care Excellence (NICE) guideline concludes that ‘there are no appropriate studies that accurately estimate the risks of long-term complications as a result of childhood UTI’, highlighting the importance of cohort studies, such as this one.[ Ref 3]. Our study will clarify the association between childhood UTI, renal scarring and long-term complications and help to determine the best approach for managing ill children and UTI. If childhood UTI is confirmed as a significant contributor to chronic conditions such as hypertension, chronic kidney disease and renal failure, there will be an opportunity to reduce some of the burden of these conditions by the early diagnosis and treatment of childhood UTI, improving health outcomes for both children and adults, reducing hospital admissions and reducing NHS costs. This study will also determine whether a broader urine sampling strategy is warranted for acutely ill children presenting in primary care. Despite current guidelines [ref 3] which recommend urine sampling in many acutely ill children, the Cardiff and Bristol co-led DUTY study found that urine is sampled in less than 2% of all consultations with acutely ill children [ref 8]. In the EURICA study, Cardiff University found that as many as 80% of UTI in children is missed using current (non- systematic) urine sampling strategies [ref 9] It is not known whether UTI case finding with systematic urine sampling in acutely ill children is necessary to reduce the risk of serious long-term complications. If GPs continue with current practice, we know the majority of childhood UTIs in primary care will be missed but the consequences of this are not known as it unclear whether or not these missed UTIs represent increased risk of serious complications. UTI diagnosed through systematic urine sampling (obtaining urine samples from all presenting ill children) is likely to be different to UTI diagnosed using standard urine sampling on which much of the current evidence is based. The study will be able to compare outcomes for children with UTI identified through systematic sampling as part of the DUTY or EURICA study and children with UTI identified through routine sampling. It is essential to clarify the evidence base in order to be able to weigh up the cost of systematic urine sampling (which would be significant due to the large numbers involved) against the cost of morbidity associated with missed UTIs and long term complications which could also be extremely costly to the NHS. This study will determine whether there is a need for systematic urine sampling in primary care and in turn change guidelines such as NICE to reflect the evidence. Results will be communicated via peer-reviewed publications, conference presentations, and through Cardiff University websites. The National Society for Academic Care (SAPC) and the International General Practice Research on Infections (GRIN) Conferences will be targeted. These conferences are attended by practicing clinicians as well as academics from the UK and Europe. Peer-reviewed publications concerning the primary care management of common conditions are reviewed by GP update course organisers, for example the findings from the EURICA study were presented in the NB Medical Update Course in 2016; enabling dissemination of findings to clinicians directly involved in the management of ill children and UTI in primary care. Findings from this study will inform clinical guidelines. The NICE childhood UTI guideline is currently being updated and findings from the Cardiff and Bristol co-led DUTY study are being included in this review. Further information was requested from the DUTY study team by the NICE guidelines Update Team. The NICE guidelines are regularly updated and we will inform them of the results from this study when they are available. Cardiff University will also be able to describe variation in urine sampling and UTI diagnosis across Wales which will inform interventions to increase urine sampling if the findings from this study suggest that is warranted. Health and Care Research Wales are funding this study. This study was awarded the grant on the strength of the application in terms of the clinical need and impact of the research, fit with Welsh Government priority areas and on the scientific merit of the study. The early diagnosis and treatment of childhood UTI is key to preventing future health problems and is consistent with the Welsh Government's commitment of giving every child a healthy start. The Early Years and Childcare plan (Building a Brighter Future), highlights the importance of improving the quality of care, outcomes and health for every child in Wales. The project concerns both the reduction of acute morbidity in children and the prevention of chronic conditions. The importance of prevention is a strong theme throughout Welsh Government policy. The Chief Medical Officer's 2008 and 2013/14 reports emphasize 'preventing the preventable', and prevention was highlighted as one of six key areas for action in 'Our Healthy Future' and further strengthened in 'Together for Health'. In Together for Health a commitment was made to improve the health of everyone in Wales, particularly children. Improving the diagnosis of childhood UTI and determining appropriate urine sampling strategies in primary will help to reduce acute morbidity and suffering in young children and may reduce hospital admissions. Chronic conditions are highlighted as one of the most serious challenges for the NHS. Prevention is also a key priority in NHS England’s ‘Five Year Forward View (2014). Determining the most appropriate urine sampling strategy is in line with the policy of developing 'systems for assuring high quality care', identified in Together for Health and consistent with 'Prudent healthcare'. An investment in better determining causative factors and developing strategies which may be able to prevent the development of these chronic conditions will result in better health, better quality of life and ultimately better value for money. This study also maximises the benefits of the previously funded DUTY & EURICA cohorts which together represent the largest cohort of acutely ill children recruited from UK primary care (n=8166). Significant resources were invested by funders, patients and staff to develop these cohorts. There is rich clinical and economic data and uniquely, UTI status from systematically sampled urine. Long-term follow-up studies of children with UTI are urgently needed to determine risk of complications and to inform clinicians on appropriate sampling and management strategies. This study provides this opportunity without the need to recruit a new cohort of children.

Outputs:

This study aims to clarify the association between childhood UTI, renal scarring and long-term complications and to determine whether systematic urine sampling improves outcomes for children with UTI. In addition to the funders of the study, Health and Care Research Wales, which is part of the Welsh Government, the findings from this study will be of interest to clinicians, parents of children and groups reviewing and developing clinical guidelines (such as NICE) across the UK and Europe with similar patient populations and clinical practices. This study was awarded the grant on the strength of the application in terms of the clinical need and impact of the research, fit with Welsh Government priority areas and on the scientific merit of the study. The results from this study will be reported to the funder – Health and Care Research Wales at the end of the study (September 2018) who will review the report with a view to making recommendations on the management of UTI infections in childhood, based on the findings in the report, prior to making it publicly available. The funders will not suppress the findings from the report before it is published - the requirement for review is to ensure their own Public Relations (PR) team is prepared for the publication of the report to the public domain. The early diagnosis and treatment of childhood UTI is key to preventing future health problems and is consistent with the Welsh Government's commitment of giving every child a healthy start. A lay summary of the results will be made available on the University project website, the participant website they are sent via opt-out and both will link to any publications and news items. All DUTY and EURICA participants were contacted to inform them of the study and given them the option of opting out of the study. They were given the link to the participant website and informed that the website will be updated throughout the course of the study. Results will therefore be made available in lay terms on the website. In addition to the policy (via report for funder) and public outputs (via website), there will also be academic outputs which are outlined below. The purpose of these academic outputs is to report the methods used in order to answer the research questions and the results and implications of the study findings. These will be presented both in writing and at conferences for the purpose of sharing knowledge, to aid other researchers using these methods, these data and these topic areas. Publishing in scientific journals will involve rigorous independent scientific peer review. This provides additional reassurance to the funder, the public and other researchers that the methods and results presented are of high quality. The study plans the following academic publications: A ‘protocol paper’ to be submitted for publication to BMJ open or BMC Family Practice. This is planned for Summer 2018. Proposed Title - The long-term follow-up of urinary tract infection (UTI) in childhood: A Protocol Paper. This will describe the aims, objectives and research design of the study. This exposes the Universities approach to the scrutiny of other academics, raises awareness of the work taking place and provides an indication about when to expect the results. A paper on the main results of the study will be submitted for publication to a UK clinical journal such as the BMJ or BJGP. This is planned for early 2019. Proposed Title - The long-term follow-up of urinary tract infection (UTI) in childhood. Cardiff University will target a high impact journal which will reach academics and clinicians across the UK and in other countries with the results of the long-term outcomes of childhood UTI. All access for analysis is to de-identified data; no identifiable data will be accessed. Published results will only contain aggregated data with small numbers suppressed in line with the HES analysis guide, indeed all outputs from the SAIL data safe haven will abide by the small number policy. Cardiff University plan to present results at conferences in 2018-2019. This is likely to include the Society for Academic Primary Care National Conference (July 2019) and the General Practice Research on Infections International Meeting (October 2018). A paper on the main results of the study will be submitted for publication to a UK clinical journal such as the BMJ or BJGP. This is planned for 2019.

Processing:

Cardiff University are the Data Controllers. A contract between Cardiff University and Swansea University has been set up to allow SAIL staff (Swansea University) to process the data from NHS Digital on the study team's behalf. SAIL databank will also act as a data provider of Welsh Health data. All data that the study team in Cardiff University will access is pseudonymised. SAIL are responsible for converting the study ID to an anonymised linking field. SAIL staff are all substantive employees of Swansea University. The team in Cardiff are all substantive employees of Cardiff University. Additional detail about SAIL - lifted from the SAIL Databank Website (https://saildatabank.com/faq/): “SAIL stands for Secure Cardiff University will provide the following fields to NHS Digital: Study ID NHS Number Date of Birth Sex Postcode NHS Digital will link this information to HES Accident and Emergency, Admitted Patient Care and Outpatient data, strip out identifiers and return a pseudonymised output to the data processor, the Swansea University's Secure Anonymised Information Linkage (SAIL) Databank. Cardiff University will also send SAIL a copy of the DUTY and EURICA data (their answers from questionnaires conducted during the original study) and will separately send participant identifiers to NWIS which will supply pseudonymised Welsh health data on its records to SAIL. The only identifier provided to SAIL will be the Study ID. SAIL will assign an anonymous linking field (ALF) to each individual to replace the study ID. The study ID-ALF key will be encrypted and stored securely in SAIL. The individuals analysing the data will not have access to this key. The key will be the same for each of the datasets so that all data can be linked up without using identifiers to do so. The key will be retained by SAIL so that any individual who expresses at a later date a wish to be removed from the study can then be removed from the dataset. This data linkage model is the same as the one used, and approved, in the Building Blocks: 2-6 study (NIC-333498). In the event that a participant wishes to opt-out after data has been sent to SAIL, the Cardiff Research team will notify SAIL to request that a participant be removed from the study database. SAIL will be notified of the original study ID and will remove the corresponding ALF and data relating to that individual. The research team work at South East Wales Trials Unit, part of the Centre for Trials research at Cardiff University. The unit is fully registered with the United Kingdom Clinical Research Collaboration (UKCRC) fully registered clinical trials unit - South East Wales Trials Unit at Cardiff University. Definition of UKCRC - A Registration Process has been established for Clinical Trials Units responsible for coordinating multi-centre clinical studies. This is intended to help improve the quality and quantity of available expertise to carry out UK clinical trials. To gain UKCRC Registration, trials units must demonstrate a track record of experience in coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long term viability of capacity for trials coordination. All data will be maintained in the safe data haven in SAIL within which all analyses will be undertaken. The research database will not be made available to other researchers (this will be a project specific resource). Access to the pseudonymised dataset will be via a secure remote portal. No data will leave the secure environment at SAIL. Approved, named data users (the research team - as listed in the application) can access the portal and defined data views remotely, subject to the appropriate access level being set and secure access keys being provided to them. The contract between Cardiff University and Swansea University will confirm who will have access to the project database. Access is restricted to only those individuals listed in the application to NHS Digital, who are either staff at Cardiff University or Swansea University. In addition, data cannot be downloaded from the portal, all exports of data are approved by SAIL who ensure raw data and results with small numbers (and therefore a risk of identification) are not exported. Only graphs, statistical analyses outputs and aggregated tables of data with small numbers suppressed in line with the HES analyses guide will be exported out of the secure portal. Systematically sampled (DUTY and EURICA children): HES data (for participants living in England) and SAIL data (for participants living in Wales) will be used. The only data linked with HES data are the EURICA, DUTY questionnaire data and the SAIL equivalent of HES (i.e. inpatient, outpatient, accident and emergency). No other data will be linked to the HES data. Routinely sampled (NOT a participant in DUTY or EURICA): Data from SAIL ONLY will be used. [SAIL data sources are: inpatient, outpatient, accident and emergency, GP, microbiology results of urine samples, congenital anomaly data and radiology data]. These data will not be linked to HES data (as these are a different cohort of individuals and therefore it would not be possible to link) Summary of the main analysis of the linked pseudonymised dataset: Children aged <5 years of age with an acute illness who had at least one microbiologically confirmed UTI identified through routine sampling will be compared with children who had at least one UTI confirmed through systematic sampling through participation in the EURICA/DUTY studies. Outcomes will include serious short-term (less than 1 year) and medium-term (1-5 years) outcomes, including hospital admission, renal imaging, renal scarring (primary outcome), vesicoureteric reflux (VUR) and renal failure outcomes for all children in these groups using the Inpatient and outpatient data from SAIL databank in Wales and HES hospital data in England. Cardiff University will also describe the two populations by children with and without confirmed UTI in each of these populations (routine and systematic sampling). More detail of the analysis plan is outlined below: • Describe the presenting features for children with and without microbiologically confirmed UTI in terms of age at consultation, gender and presenting symptom or working diagnosis from general practice records by group (routine and systematic sampling). • Describe the initial management for children with and without microbiologically confirmed UTI in terms of antibiotic treatment, hospital admission and repeat urine sampling from general practice records by group (routine sampling). • Describe the short term (up to 12 months) and medium term (one to five years) clinical outcomes (listed above) using general practice and hospital records for children with and without UTI (routine and systematic sampling). • Routine versus Selective sampling analysis: o Presentation factors, acute management, microbiology results will be examined to ascertain any marked imbalance between the two groups and identify any potential confounders of outcome. o The primary comparative analysis of renal scarring will be examined using a multilevel logistic regression model to investigate differences between the groups (routine v systematic sampling) and where numbers allowed, variation in outcome will be accounted for at the level of the general practice. o Associations between potential confounders of outcome will be examined at the univariate level and significant predictors adjusted for in the multivariable model. o Multilevel modelling will allow for clustering of effect within a general practice and where this indicates little impact of clustering on effect, results from the single level model will be presented. o Comparisons will be presented as unadjusted and adjusted risk differences and odds ratios, alongside 95% confidence intervals and p-values. o Logistic multilevel modelling will also be used to analyse the associated secondary outcomes (e.g. proportion of children with a hospital admission). o Counts data such as the number of GP consultations, urine samples sent will be analysed using Poisson or Negative Binomial multilevel regression modelling. Following analysis, aggregated results / publishable information can be requested out of the secure environment for wider disclosure (subject to the data file being approved by data guardians at SAIL). Data guardians check for sensitive data, and small numbers that could risk disclosure before approving the file. All results will be aggregated with small numbers suppressed in line with the HES analyses guide.

Objectives:

The LUCI Study (The long-term follow-up of urinary tract infection (UTI) in childhood) is funded by Welsh Government through Health and Care Research Wales. It aims to determine the short, medium and longer-term outcomes of urine infections (UTI) in childhood and to determine whether there is a difference between UTI that is identified through routine practice and UTI identified through systematic urine sampling (where all ill children have their urine sampled). Current guidelines advise the prompt diagnosis of treatment of UTI in children because childhood UTI can lead to scarring of the kidneys which is believed to lead to long term complications such as high blood pressure, chronic kidney disease and kidney failure in some cases. However, UTI is difficult to diagnose in children as the symptoms are non-specific and similar to those found in many common childhood illnesses. Cardiff University have shown that as many as 80% of UTIs are missed in primary care. A urine sample is required to diagnose UTI but urine is infrequently sampled from ill children in primary care (in less than 2% of consultations). If urine is not sampled, a UTI cannot be diagnosed. The evidence linking childhood UTI with long-term complications is weak and has been questioned. There is an urgent need to clarify the association between childhood UTI, renal scarring and long term complications as the correct approach to urine sampling and diagnosis of UTI in children hinges on this association. The studies, on which much of the current practice is based, are generally conducted in secondary care, and children have usually only had urine sampled when the clinician suspects a UTI rather than urine systematically sampled in all ill children. Therefore, the findings from these studies are not necessarily applicable to the population of acutely ill children in primary care. Not all children with UTI will have had their urine tested and therefore not all will have been diagnosed. In addition, not all of the children diagnosed will have been seen in secondary care and not all will have had a scan to look for renal scarring. Cardiff University have previously conducted two large studies of acutely ill children less than five years old in primary care (EURICA study n=1003 Wales only [Funder: Welsh Office for Research and Development (WORD), now known as Health & Care Research Wales]; DUTY study n=7163 England and Wales[Co-led by Cardiff and Bristol Universities; Funder: National Institute for Health Research Health Technology Assessment – NIHR HTA) and collected urine samples systematically from all ill children. The DUTY & EURICA studies found UTI was present in 5.9% and 5.6% respectively in NHS laboratories in the two studies. Cardiff University followed up EURICA children for six months and a sample of DUTY children for three months. Systematically sampled (DUTY and EURICA children): Cardiff University will use HES/NHS Digital data (for participants living in England) and Secure Anonymised Information Linkage (SAIL) data (for participants living in Wales). Routinely sampled (NOT a participant in DUTY or EURICA): Cardiff University will use data from SAIL ONLY. In the current study, it is proposed to use routinely collected health data (GP, hospital, microbiology) to follow DUTY and EURICA children up for 5 years to determine short (up to 1 year) and medium (1-5 years) term outcomes for UTI identified through systematic urine sampling. The outcomes of interest will include further UTI episodes, difficulties with passing urine (dysfunctional voiding syndromes), hospital admissions, any scans on the kidneys or bladder, kidney scarring, high blood pressure and kidney failure. Cardiff University want to compare the presenting features, initial management and short and medium-term outcomes of UTI identified through systematic urine sampling (using DUTY and EURICA children) with UTI identified through standard (clinician-led) urine sampling. Cardiff University will use routinely collected data to identify a group of children who had a UTI identified in childhood (before the age of five) who were not part of the DUTY or EURICA studies and therefore identified through standard sampling rather than systematic sampling. Cardiff University will compare this cohort of children with the DUTY and EURICA cohorts. Cardiff University will also determine longer term outcomes (more than five years) for those with a UTI identified through standard practice aged less than five years old where the data is available. This study maximises the benefits of the previously funded DUTY and EURICA cohorts, representing over 8000 acutely ill children recruited from UK primary care. Significant resources were invested by funders, patients and staff to develop these cohorts. Access to HES data will allow the University to determine longer-term outcomes for these children and to determine risks of adverse outcomes. It will also pave the way for even longer-term follow-up of cohorts of children with UTI (diagnosed both systematically and non-systematically) which has been identified as a high research priority by NICE. A group of 4 lay members have contributed to the development of the participant letter and the content and design of the website. Prior to the letters being sent out, one of the lay members talked through with the study team possible questions they might get from participants. The LUCI Study continue to involve this group in the research by updating them on progress. The University of Bristol and the University of Oxford will not act as data processors or data controllers in respect of this application.


Project 6 — DARS-NIC-79434-P1T7D

Opt outs honoured: Y

Sensitive: Non Sensitive

When: 2017/12 — 2018/02.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - List Cleaning Report

Benefits:

The main benefits will be to ensure the wider study succeeds be ensuring that the only eligible participants are included. The benefit will also be that any participant who is no longer eligible will not be included in any future communication thus preventing any distress or harm being caused to family members. The outputs for the wider study as recommended for approval under NIC-333498 are detailed below. This study will provide evidence for the long-term effectiveness and costs of one of the most promising early intervention programmes in a targeted vulnerable population. It will inform policy about whether to continue implementing a programme for which there is no existing UK evidence for effectiveness. The recognised potential programme benefits – in particular for child maltreatment have largely been evidenced in the longer term. This project presents a unique opportunity to extend learning from the trial by using existing outcome data in combination with newly arising data. The original study (BB:0-2) has already been viewed by the relevant DH Policy team. Cardiff University expect the trial results will inform post-election decision-making regarding the implementation of this programme. The policy team within the Department of Health are fully aware of the follow-on study. The academic research team and DH policy team have a rolling joint dissemination meeting (to manage trial results dissemination) and Cardiff University will continue this relationship into the work of the follow on study, whilst being mindful of maintaining independence of the research team. The Department of Health hold the licence for the program in the UK. Its continued availability will depend upon evidence produced by the trial, and Cardiff University expect by the follow-on study. This project is looking at the long term effects of a home-visiting intervention commissioned by the Department of Health. The study aims to determine the long-term effectiveness of this intervention in reducing objective and associated measures of maltreatment. There was no pre-existing evidence for programme effectiveness in the UK (England). The completed trial provided definitive evidence of short-term impact. The current work will provide new evidence about longer-term impact on maltreatment. Existing evidence for programme effectiveness related to maltreatment exists in the US context only. US evidence (specifically for maltreatment) includes Olds et al JAMA 1997 278 (8); 637-643. Both the original trial (Funder: DH PRP) and the follow-on study (Funder: NIHR-Public Health Research Programme NIHR PHR) are independent evaluations of the intervention. It is important for the research team to retain this independence and aim to produce high quality evidence to inform practice and policy. The Department of Health have indicated the importance of the work by funding both studies to a combined value of £6M. The evidence base for policy should comprise all relevant research and not the results of a single trial cohort, although Cardiff University’s trial cohort will produce the most directly relevant evidence. The Department of Health funded the research team to run a large stakeholder event in January (2016) to which practitioners, policy leads and lay representatives from across the UK attended. Following discussion with the Department of Health (23 March 2015), Cardiff University can also state that the intervention under investigation is currently embedded across 135 local authorities and that the results of the trial will influence not only policy but commissioning decisions in local authorities who now have responsibility for commissioning public health services for children aged 0-5. Cardiff University expect that the results accruing from the current data request will have similar reach and engagement from commissioners.

Outputs:

The output for this application will be an updated cohort list. The outputs for the wider study as recommended for approval under NIC-333498 are detailed below. Results of the final analyses (following the second data extraction) will be reported to the Department of Health (NIHR-Public Health Research, and the DH Policy Research Programme), and to the FNP National Unit (FNPNU). The FNPNU is responsible for national delivery of FNP and is commissioned by the Department of Health and Public Health England who hold the license in England and have the lead role for its strategic policy direction. All local authorities in England will be notified of the results, as (since October 2015) they have responsibility for commissioning public health services for children aged 0-5. Participants will receive a summary of the results and all reports and publications will be made available in full in the public domain on the Cardiff University website. The research team have convened and met twice with a stakeholder group, including relevant policy leads from each country in the UK delivering FNP (England, Scotland, Northern Ireland). Cardiff University will stage a similar event to present and discuss the implications for practice and policy of the results of this longer-term follow up of participants. The reports are planned for summer 2018. In addition to the policy and public outputs, there will also be academic outputs which are outlined below. The purpose of these academic outputs are to report the methods used in order to answer the research question as well as the results of the study. These will be presented both in writing and at conferences for the purpose of sharing knowledge to aid other researchers using these methods, these data, and these topic areas. Publishing in scientific journals will involve rigorous independent scientific peer review. This provides additional reassurance to the funder, the public and other researchers that the methods and results presented are of high quality, credible and scientifically robust. The study plans the following academic publications: 1. A ‘protocol’ paper has been submitted for publication subject to acceptance by BMJ Open. This describes the aims, objectives and research design of the study. This exposes our approach to the scrutiny of other academics, raises awareness of the work taking place and provides an indication about when to expect the results. 2. A paper describing the piloting process of the study and describing data quality, the success of data matching at multiple information centres and the linkage conducted at SAIL. Academics will learn from the methodology of this work and use this to inform their own research. This is planned for second half of 2017 and the aim is to publish in BMC Paediatrics. 3. A paper on main results of the study to be published in the Lancet is planned for mid-2018. This is a high impact international journal which will reach academics across the UK and in other countries with the results of the long-term outcomes of FNP. The individuals who will be cleaning and analysing the de-identified data include an individual who is also studying for a PhD. This individual will be discussing in their PhD thesis how a variety of data sources can be combined to build a clear picture of confirmed maltreatment, markers of maltreatment, and predictors of maltreatment for women and children recruited to the original trial and this long-term follow up. This differs from the main results of the study which focuses on confirmed cases of maltreatment only. Results presented for this PhD will be the availability and validity of linking fields that allow different data sources to be linked for measuring maltreatment.

Processing:

Cardiff will send in the name, date of birth (or estimated delivery date), NHS Number, contact address and gender. for approx 110 participants. NHS Digital will trace the individuals and provide an updated list to include the following data items: name, date of birth, NHS Number, most recent contact address and gender. The list will be flagged with any individuals who have died in the interim. The list of updated identifiers will be returned to the applicants at Cardiff University. The applicants will remove those patients who no longer meet the eligibility criteria from the list i.e. those who have died. Remaining patients will be followed up as per the agreed protocol. 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).

Objectives:

This application seeks to provide a list clean of a subset of participants from the Building Blocks study who have been lost to follow up to ascertain whether they are still eligible to be included in the study. The request for HES/ONS data has already been submitted and approved under a separate application and agreement (NIC-333498-D1K7G) this application is looking for updated identifiers and any death notifications for approx 110 participants for who the study cannot match with when sending them to the National Pupil Database. The cardiff study team will use the updated identifiers to send to The National Pupil Database (Dept. for Education) (NPD) for matching to their records to extract routine education and social care data. Where the study update details using the tracing service they will be using these details to then match to NPD. Details of the wider study are below; The Family Nurse Partnership (FNP) has been developed and licenced by the University of Colorado. It is a voluntary, preventive programme for vulnerable young first time mothers. It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two. Its three aims are: to improve pregnancy outcomes, improve child health and development and improve parents’ economic self-sufficiency. A strong and rigorous US evidence base, developed over 30 years, has shown FNP benefits the most needy young families in the short, medium and long term across a wide range of outcomes helping improve social mobility and break the cycle of inter-generational disadvantage and poverty. Proven benefits include: • improvements in antenatal health • reductions in children’s injuries, neglect and abuse • improved parenting practices and behaviour • fewer subsequent pregnancies and greater intervals between births • improved early language development, school readiness and academic achievement • increased maternal employment and reduced welfare use • increases in fathers’ involvement  The University of Colorado (UC) has licensed the FNP to the Department of Health (DH). The model of international replication for FNP specified by UC follows four stages: (i) adaptation to local context; (ii) pilot testing of feasibility and acceptability; (iii) randomised controlled trial, and (iv) replication and expansion. The programme was adapted for implementation and introduced in England in 2007. Due to the greatly differing nature of publicly funded health and social care service provision and socio-cultural context between England and the US, the relative benefits of the programme need to be replicated in England and costs determined before wide-spread implementation can be recommended. Department of Health (DH) is committed to strengthening the evidence base for FNP in an English context. To that end, DH commissioned the ‘Building Blocks’ randomised controlled trial (RCT) from Cardiff University to provide independent evidence on the effectiveness of the FNP programme in improving short term outcomes for young parents and their babies. The trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015. The FNP described these as “important early findings and add to the evidence we have from the US, Netherlands and other early evaluation in England to help improve FNP in England.” The National Institute of Health Research has now funded Cardiff University to undertake a follow up study to examine child outcomes to age six. This will build on the original study examining the longer term impact of FNP intervention. The study objectives are: 1. To determine the effectiveness of the FNP programme in reducing objectively measured long-term maltreatment outcomes when compared to usually provided health and social care alone. Using a multi-method multisource approach to maltreatment research main outcomes will be: Child in need status, child protection registration, referral to social care (overall; child protection; Child in Need) 2. To determine the long-term effectiveness of the FNP programme in reducing maltreatment when assessed using associated measures of injuries and ingestions, hospital DNA rates and immunisation rates. 3. To determine the long-term impact of the FNP programme upon intermediate programme outcomes, most notably subsequent pregnancies. 4. To explore the impact of theoretical moderators of programme effect, including domestic abuse and baseline client characteristics 5. To determine the costs and consequences of the FNP programme over the full period of available follow-up. Cardiff University will follow up the mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from NHS Digital and data from Department for Education (DfE) which will be linked with the original trial data. The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study will provide evidence for the long-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Specifically, data requested from NHS Digital will provide the basis for key study outcomes which are indicators of maltreatment. The study will provide evidence to inform policy about whether to continue implementing a programme. The proposal presents a unique opportunity to extend learning from the trial by using existing trial outcome data in combination with newly arising routinely recorded data.