Building Blocks:2-6 - Evaluating the long-term effectiveness, and the cost and consequences of the Family Nurse Partnership parenting support programme in reducing maltreatment in young children

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Expected measurable benefits

There are no additional expected measure benefits per this amendment / extension request - any The expected benefits listed under previous versions of this Agreement have either been yielded (see section 5.d.iii for further information) or not achieved.

Benefits reported

[10 paragraphs unchanged] No ongoing benefits are expected

Unchanged: Objective for processing, Processing activities, Expected output.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[15 paragraphs unchanged] The Department of Health and Social Care (DHSC) DHSC is committed to strengthening the evidence base for FNP in an English [81 words unchanged] and other early evaluation in England to help improve FNP in England.”. [6 paragraphs unchanged] Cardiff University followed up the cohort of mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from NHS Digital, England, data from Department for Education (DfE) and data from the Department of Health (abortion statistics) and linking these data to the original trial data. The Building Blocks: 2-6 (BB:2-6) study has provided evidence for the medium-term [15 words unchanged] of child maltreatment in a targeted vulnerable population. Specifically, data from NHS Digital England has provided the basis for key study outcomes which are indicators of maltreatment. [1 paragraph unchanged] Cardiff University have a UK GDPR legal basis for processing personal data and special categories of personal data under the following provisions: [2 paragraphs unchanged] This study was approved by both NHS Ethics and Section 251 NHS [61 words unchanged] Cardiff University no longer retain any confidential patient information for which the s.251 Section 251 support was originally sought. There were two waves of data extracted from NHS Digital. England. The first wave was to allow the study to follow up participants [15 words unchanged] data request related to data up to and including 2016/17 financial year. Cardiff University are the sole Data Controller (and sponsor) of the study who also process the NHS Digital England data disseminated and Swansea University are a Data Processor only. disseminated. The NIHR funded this work however they did not make decisions related to how the data was processed (and had no access to the data). [4 paragraphs unchanged] Under DARS-NIC-333498-D1K7G, Data accessed by individuals holding an honorary contract must be under the supervision of a substantive employee of Cardiff University for the purposes described in this DSA only. Cardiff University must maintain records in a single location that cover the following details of each individual given access under an honorary contract: - Their substantive employer; - Their role in respect of the purpose for the processing specified in the DSA; - The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract; - The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA; - Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

Processing activities

[1 paragraph unchanged] Cardiff University provided the following identifiers to NHS Digital: England: [5 paragraphs unchanged] NHS Digital England linked this information to the HES and mortality data, stripped out the identifiers and returned a pseudonymised output to Swansea University’s Secure Anonymised Information Linkage (SAIL) Databank. [2 paragraphs unchanged] The Data will not leave England/Wales at any time. [3 paragraphs unchanged] Mitigating risks of re-identification: all data was maintained in the SAIL databank [23 words unchanged] leave the secure environment at the SAIL databank. Approved, named data users (the research team – all substantive employees of Cardiff University) accessed the portal and defined data views remotely, subject to the appropriate access level being set and secure access keys being provided to them. [7 paragraphs unchanged] Under this Data Sharing Agreement, all data has now been transferred to Cardiff University. Swansea University no longer holds the data and therefore are no longer specified as a processor within this data Sharing Agreement. For the removal of doubt, the data remains pseudonymised as the initial identifiers Cardiff university held have since been destroyed. Data will be accessed by individuals with an honorary contract with the University of Cardiff. The individuals will act as an agent of the University of Cardiff. at all times under supervision from employees of University of Cardiff. A side from this/these individuals, access is restricted to employees or agents of University of Cardiff who have authorisation from the Principal Investigator. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; - Access controls granting users the minimum level of access required are in place; - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Expected output

All expected study outputs have now been produced and disseminated – no further outputs are anticipated. See anticipated for the BB2 study (refer to section 5.d.iii Yielded Benefits for further information on outputs produced and the benefits they have yielded for the health and social care system. UCL are accessing a copy of the data under a separate DSA NIC-374907, and further outputs or analysis will be detailed under NIC-374907.

Unchanged: Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Family Nurse Partnership (FNP) has been was developed and licensed by the University of Colorado. It is a voluntary, preventive programme for vulnerable young first time mothers. It mothers, which offers intensive and structured home visiting, visiting delivered by specially trained nurses, nurses from early pregnancy until age two. It's three aims are: to 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 [10 words unchanged] short, medium and long term across a wide range of outcomes helping to improve social mobility and break the cycle of inter-generational disadvantage and poverty. Proven benefits include: [6 paragraphs unchanged] • increases in fathers’ involvement  The University of Colorado (UC) has licensed the FNP to the Department of Health (DH). (DH) (now the Department of Health and Social Care (DHSC). The model of international replication for FNP specified by UC follows four stages: [4 paragraphs unchanged] 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 the socio-cultural context between England and the US, the relative benefits of the programme need needed to be replicated in England and costs determined before wide-spread widespread implementation can could be recommended. The Department of Health and Social Care (DHSC) is committed to strengthening the [7 words unchanged] context. To that end, DHSC commissioned the ‘Building Blocks’ randomised controlled trial (RCT) (BB:0-2) from Cardiff University to provide independent evidence on the effectiveness of the [8 words unchanged] young parents and their babies. The trial began in 2009 and the findings findings, which cover the period from pregnancy to the child’s second birthday' birthday, were published in October 2015. The FNP described these as “important early [11 words unchanged] Netherlands and other early evaluation in England to help improve FNP in England.” England.”. Article 6:1(e):This project is a task in the public interest because it was commissioned by the Department of Health to evaluate the impact of home-visiting interventions on child maltreatment. The National Institute of Health and Care Research (NIHR) further funded Cardiff University to undertake a follow up study (BB: 2-6) to examine child and maternal outcomes to age six. This builds on the original study examining the longer term impact of FNP intervention. The study objectives were: Article 9:2(j):This is scientific research which uses only the data required to answer these important research aims, using a data safe haven to protect the data and outputs this research will directly influence policy making regarding home visiting programmes to benefit the UK public. 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 services alone. Using a multi-method, multisource approach to maltreatment research the main outcomes were: child in need status, child protection registration, referral to social care. This has been approved by both NHS Ethics and the Confidentiality Advisory Group and no ethical issues were raised. All data has now been transferred and are held in a de-identified format in a secure data safe haven where no individual level data outputs are allowed out – only aggregated data above n=5. 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) [1 paragraph unchanged] 3. To determine the long-term impact of the FNP programme upon on 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 characteristics. [1 paragraph unchanged] Cardiff University will follow followed up the cohort of mothers and children who took part in the first Building Blocks trial [13 words unchanged] for Education (DfE) and data from the Department of Health (abortion statistics) which will be linked with and linking these data to 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 has provided evidence for the medium-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 from NHS Digital has provided the basis for key study outcomes which are indicators of maltreatment. 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 has provided evidence to inform policy about whether to continue implementing a programme. The original proposal presented a unique opportunity to extend learning from the trial by using existing trial outcome data in combination with newly arising routinely recorded data. 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. Cardiff University have a GDPR legal basis for processing personal data and special categories of personal data under the following provisions: There were two waves of data requested and extracted from NHS Digital. The first wave was to allow the study to follow up participants until all the children reach six years of age, which was in March 2017. The second data request related to data up to and including dataset period 2016/17. The study is following up participants until all the children reach six years of age, which was in March 2017. 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”. This project is a task in the public interest because it was commissioned by the DHSC to evaluate the impact of home-visiting interventions on child maltreatment. Data are now being analysed and this request is to ensure the data can be retained to conduct these analyses. This is an extension request. No further data has been requested and there is no new purpose. Detail has been added to satisfy new guidance on the purpose section for applications. 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).”. This is scientific research which used only the data required to answer these important research aims. Using a data safe haven to protect the data and outputs, this research has directly influenced policy making regarding home visiting programmes, thus benefitting the UK public. Cardiff University is the Data Controller (and sponsor) of the study and Swansea University (and Cardiff University) are Data Processors of the data. The NIHR fund this work however do not make decisions related how the data are processed (and have no access to the data). This study was approved by both NHS Ethics and Section 251 NHS Act 2006 support from the Health Research Authority (HRA) Confidentiality Advisory Group (CAG). No further analysis is planned for the purposes of the BB: 2-6 study. Section 251 NHS Act 2006 support from HRA CAG has also now been expired as all data transfers ended in 2018, personal data processed for the purposes of this study has now been anonymised and Cardiff University no longer retain any confidential patient information for which the s.251 support was originally sought. There were two waves of data extracted from NHS Digital. The first wave was to allow the study to follow up participants until all children reach six years of age, which was in March 2017. The second data request related to data up to and including 2016/17 financial year. Cardiff University are the sole Data Controller (and sponsor) of the study who also process the NHS Digital data disseminated and Swansea University are a Data Processor only. The NIHR funded this work however they did not make decisions related to how the data was processed (and had no access to the data). For the purposes of this request to extend and amend the Data Sharing Agreement, Cardiff University are the funder and not the NIHR. The data disseminated under this Agreement has also been accessed as part of a separate Data Sharing Agreement, DARS-NIC-374907-Q5W5W, by a research team based at Cardiff University and University College London (UCL). DARS-NIC-374907-Q5W5W reflects the receipt of additional funding to analyse the existing pseudonymised study data already held in the data safe haven for the purposes of a study titled “Exploring the mechanisms through which specialist home visiting produces health and well-being benefits for families.”. The newly funded analyses hope to explore the mechanisms by which specialist home visiting may have its effect for recipient families. Two funders (Nuffield Foundation, European Research Council (ERC)) have provided resource to support the two separate analyses (Nuffield Foundation and ERC funding one set of analyses each) both of which have utilised the same existing data set. The two new project grants are led by a member of staff at UCL and the analyses will be undertaken by this member of staff alongside a research fellow, both of whom are substantive employees of UCL and hold honorary titles with Cardiff University for the duration of the studies. Access will be approved by the study lead at Cardiff University. All analyses will be reviewed and approved by the study lead at Cardiff University. This study lead is the chief investigator and is costed into both grants to provide these approvals and oversee all outputs from the additionally funded work. Under DARS-NIC-374907-Q5W5W, UCL are a joint data controller with Cardiff University. Both organisations will also process the data disseminated under DARS-NIC-333498-D1K7G. Neither of the two funding bodies (Nuffield Foundation and ERC) may make decisions related to how the data are processed and do not have access to the data. They are therefore not considered a data controller or processor. The Chair of the Information Governance Review Panel at SAIL has confirmed that as the data being accessed in relation to the newly funded work are appropriately anonymised, no further ethical review is required.

Processing activities

Previously approved information has been updated in line with updated guidance however, please note, all data transfers have now concluded and data now is being analysed in the data safe haven. Any reference to data flows are now historic. All data transfers and data analyses have now concluded. Any references to data flows are historic - no additional data will flow under this iteration of the Agreement. Cardiff University provided the following fields identifiers to NHS Digital: [5 paragraphs unchanged] NHS Digital linked this information to the HES and mortality data, stripped out the identifiers and returned a pseudonymised output to the data processor, the Swansea University’s Secure Anonymised Information Linkage (SAIL) Databank. Cardiff University also sent SAIL a copy of the original study (BB:0-2) data to the SAIL databank and separately sent participant identifiers to the Department for Education which who supplied linked pseudonymised data from its their records to SAIL. the SAIL databank. In addition addition, data has been requested and approved was received from the Department of Health DH abortion statistics team to link to the mothers in this cohort. The study will be using Cardiff University used the abortion data to calculate whether a mother had a subsequent pregnancy and the study will be creating pregnancy. Cardiff University also created a composite outcome so that if they have the mothers had an abortion record and/or a record in their the HES dataset that indicates indicated a pregnancy(including pregnancy (including birth, termination, miscarriage) this will be was used to report the rates of subsequent pregnancies between the two groups (control and intervention). The only identifier provided to SAIL from each of the 4 sources was the unique Study ID. ID assigned to each participant. The SAIL assign databank assigned an anonymous linking field (ALF) to each individual to replace the study Study ID. The study Study ID-ALF key is was encrypted and stored securely by SAIL. the SAIL databank. The individuals analysing who analysed the data will did not have access to this key. The key will be was the same for each of the datasets so that all data can could be linked up without using identifiers to do so. The key will be was retained by the SAIL databank for two reasons – firstly, reasons: (1) any individual who expresses expressed at a later date a wish to be removed from the study can then could be removed from the dataset. Secondly, Cardiff University are following up dataset; (2) as these individuals were followed for four years therefore years, a refresh/update of the data will be was required (this current request) when all children are aged turned 6 years old and SAIL will need needed to assign the same ALF to these the refresh of data. The individuals who will be cleaning and analysing the de-identified data includes 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. This work is currently being written up as a chapter in the thesis and is due to complete in March 2018 and will be using the data provided as part of the pilot data extract. This is the work required to complete as described above. The research team worked within the United Kingdom Clinical Research Collaboration (UKCRC) fully registered clinical trials unit - Centre for Trials Research at Cardiff University. For the purposes of DARS-NIC-374907-Q5W5W, the research team work within the UKCRC at Cardiff University and at UCL. The research team work within the United Kingdom Clinical Research Collaboration (UKCRC) fully registered clinical trials unit - Centre for Trials Research at Cardiff University. Mitigating risks of re-identification: all data was maintained in the SAIL databank within which all analyses were undertaken. Access to the pseudonymised dataset was provided via a secure remote portal. No data was allowed to leave the secure environment at the SAIL databank. Approved, named data users (the research team – all substantive employees of Cardiff University) accessed the portal and defined data views remotely, subject to the appropriate access level being set and secure access keys being provided to them. Mitigating risks of re-identification: 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. In addition, data could not be downloaded from the portal. All exports of data were approved by the SAIL databank, who ensured raw data and results with small numbers (and therefore a risk of identification) were not exported. Only graphs, statistical analyses outputs and aggregated tables were exported out of the secure portal. All staff who accessed the data completed the Medical Research Council (MRC) safe researcher training which covers areas such as data protection and confidentiality. 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. All staff who access the data have completed the MRC Safe researcher training which covers areas such as data protection and confidentiality. Completed analysis: Baseline data and follow-up data from the Building Blocks trial will be was included in the main analysis, analysis so that the total follow-up period for each participant will be just over six was up to seven years. The following is a high level high-level summary of the main analysis of the linked pseudonymised dataset: Participants who received FNP during the trial (intervention arm) will be were compared with those who did not (Control (control arm). Rates of maltreatment will be were compared between the two groups as well as describing and differences in education, health and social care outcomes. outcomes were described. Standard costings will be were applied to episodes of healthcare and an economic analysis will compare compared costs between the groups. More detail of the analysis plan is outlined below: Following analysis, aggregated results / publishable information were requested out of the secure environment for wider disclosure (subject to the data file being approved by data guardians at the SAIL databank). Data guardians checked for sensitive data and small numbers that could lead to re-identification before approving the file. • 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). 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 had access to that data). For the purposes of DARS-NIC-374907-Q5W5W, the members of staff holding the honorary title with Cardiff University are contractually bound to the Data Sharing Agreement between UCL and Cardiff University. This contract refers to both the Framework and project-level Data Sharing Agreement as well as the User agreement with the SAIL databank which covers disclosure requirements. • 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. 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).

Expected output

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 report to funder is due March 2019 and all other dissemination described above will begin from April 2019. All expected study outputs have now been produced and disseminated – no further outputs are anticipated. See section 5.d.iii for further information on outputs produced and the benefits they have yielded for the health and social care system. 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 published in the 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 has been published in BMC Pilot & Feasibility Studies. 3. A paper on main results of the study to be published in the Lancet is planned for mid-2019. 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. 4. A paper on the secondary outcomes and planned exploratory analysis will be drafted late 2019 / 2020 and an appropriate journal will be identified once the main paper has been accepted. 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. This work is currently being written up as a chapter in the thesis and is due to complete in March 2019 and will be using the data provided as part of the pilot data extract. 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. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Expected measurable 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. There are no additional expected measure benefits per this amendment / extension request - any expected benefits listed under previous versions of this Agreement have either been yielded (see section 5.d.iii for further information) or not achieved. The original study (BB:0-2) has already been viewed by the relevant DHSC Policy team. The policy team within the Department of Health are fully aware of the follow-on study and have been meeting with the study team regularly (Autumn 2018) to discuss emerging results (all results presented in aggregate). The academic research team and DHSC 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 DHSC 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. The emerging results from this study have already informed policy decisions in Winter 2018/19 related to the re-commissioning of the FNP National Unit, of which the outcome remains confidential at this point. There is a list of stakeholders (primarily Local Authorities) who are awaiting the study results as soon as publicly available. The main reason for wanting to know the results is to inform their own decisions regarding continuing the funding for FNP in their area. 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 as well as other developmental and educational outcomes. 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 DHSC 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. If the results from this study indicate an evidence of an intervention effect in the medium-long term this will directly influence the decisions made by DHSC and Local Authorities to continue funding FNP in England. This will affect all FNP sites across England and all FNP nurses.

Benefits reported

Following the "pilot phase" where data were received from data providers the study team has established a regulatory compliant model of linking health, social care and education data to clinical data. Results from the final analyses (following the second data extraction) have been reported to the DHSC (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 the FNP and is commissioned by the DHSC and Office for Health Improvement and Disparities (previously Public Health England) who hold the license in England and have the lead role for its strategic policy direction. All local authorities in England were notified of the results as, since October 2015, local authorities have responsibility for commissioning public health services for children aged 0-5. All reports and publications have been made available in full on the Cardiff University website and the Evidencing Home Visiting Website (https://evidencinghomevisiting.co.uk/). The research team have convened and met with a number of stakeholder groups, including relevant policy leads from each country in the UK delivering FNP (England, Scotland, Northern Ireland) between 2018 – 2020. The report has been published, following independent review, by the funder via NIHR journals and can be found here: https://www.journalslibrary.nihr.ac.uk/phr/phr09020/#/full-report. The pilot phase comprised 1) Writing and running data cleaning scripts for both the HES data (from NHS Digital) and NPD data (from Dept. for Education); 2) Assessing quality of data received and match rates; 3) A pilot report to document the governance; participant opt-out; linking to Information Centres; linkage within SAIL; preparing data for analysis; analysis considerations; and development of the consort flow diagram; 4) Development of the statistical and health economic analysis plans. In addition to the policy and public outputs, there are also a number of academic outputs which are outlined below. The purpose of these academic outputs is to report the methods used in answering the research question and to report the results of the study. These have been or will be presented both in writing and at conferences for the purpose of sharing knowledge to aid other researchers using these methods, data and topic areas. Publishing in scientific journals involves rigorous independent scientific peer review. This provides additional reassurance to the funder, the public and other researchers that the methods and results presented are high quality, credible and scientifically robust. All of the above work demonstrated the feasibility of delivering this study to achieve the intended outputs and measurable benefits. Study publications: Since receiving the final data extract we have been cleaning and analysing the data. Results are being interpreted ready for reporting to the funder in Spring 2019. 1. A ‘protocol’ paper has been published in the BMJ Open. This describes the aims, objectives and research design of the study. This exposes Cardiff University’s approach to the scrutiny of other academics, raises awareness of the work taking place and provides an indication of when to expect the results. https://bmjopen.bmj.com/content/7/7/e015728.info. As described in the expected measurable benefits, Cardiff University have been meeting with DHSC and FNP National Unit to discuss the emerging results. This has influenced their decisions and recommendations made regarding funding for the FNP National Unit which remain confidential at this stage. 2. A paper describing the piloting process of the study, data quality, the success of data matching at multiple information centres and the linkage conducted at the SAIL databank. Academics will learn from the methodology of this work and use this to inform their own research. This has been published in BMC Pilot & Feasibility Studies. https://doi.org/10.1186/s40814-018-0294-4. 3. A paper on the main results of the study was published in the BMJOpen in February 2022. This is an international journal which will reach academics across the UK and in other countries with the results of the medium-term outcomes of FNP. https://bmjopen.bmj.com/content/12/2/e049960.abstract. A paper on the secondary outcomes and planned exploratory analysis was also planned / noted in the last application, however all outcomes and analyses were instead included in the main paper (mentioned above). One of the individuals based at Cardiff University involved in cleaning and analysing the pseudonymised data was also studying for a PhD. In their PhD thesis, they outlined how a variety of data sources could 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 focused on confirmed cases of maltreatment only. Results presented as part of the PhD research also included the availability and validity of linking fields from different data sources to facilitate the measuring of maltreatment. This work has now been completed. No further publications are planned. In summary, Cardiff University have met with the Department of Health and Social Care, the FNP National Unit and FNP nurses and local authorities to present and discuss the results. Results shared early on influenced the decision making of the Secretary of State and recommendations made regarding funding for the FNP National Unit. The study, which reports on the medium-term impacts of the FNP programme, focusing primarily on maltreatment, found no difference between arms however did report evidence of advantages in school readiness and attainment up to the age of 7 years. These results add to the evidence base of this international programme and will inform the policy decisions of the UK and beyond to invest in this programme.