Suchergebnisse

ObjectivesThe Family Nurse Partnership (FNP) is a specialist home-visiting programme for first-time teenage mothers. Developed in the US, short-term outcomes (by age 2 years) were established in England in the Building Blocks trial. We used routine data (health, education, social care) linked to our trial cohort to assess longer-term impact.
ApproachMothers recruited to the trial and their first-born children were linked to health (Hospital Episode Statistics/HES: NHS Digital; Abortion statistics: Department of Health and Social Care), education/social care (National Pupil Database/NPD: Department for Education) data in England up to age 7-years. Analysis of data within in a trusted-research environment assessed programme impact upon child maltreatment, child development/educational and maternal life course outcomes when compared to usually provided health and social care support alone. Our primary outcome was child in need registration. Planned sub-group analysis included differential effects by maternal age, deprivation level, care experience and for child outcomes, sex.
ResultsMatch rates for 1547 children were 97.4% (NPD) and 98.3% (HES). We found no difference between trial arms in proportion of children assessed as in need (adjusted odds ratio (aOR) OR:0.98, 95% confidence interval (CI): 0.74 to 1.31). Aside from a longer duration in care for children in the usual care arm (two months), there were no other differences in maltreatment outcomes. Children in the FNP arm were more likely to achieve a good level of development at reception age at age 4-5 years (aOR:1.24, 95%CI: 1.01 to 1.52) and, after adjusting for month of birth, to reach the expected standard in reading at Key Stage 1 at age around 7 years (aOR:1.26, 95%CI: 1.02 to 1.57).
ConclusionsWe found programme improvements for child development/educational achievement but not for child maltreatment outcomes. Additional sub-group analysis revealed some evidence of the programme benefiting mothers with greater baseline vulnerability and boys, consistent with previous trials. The study benefits from the linkage of administrative data to a previously randomised trial cohort.

IntroductionFactors that affect public and professionals' attitudes towards the collection and linkage of health and other data have been explored in the literature. Thus far there has been no study exploring attitudes towards the collection of child maltreatment data.
ObjectivesOur aim is to explore attitudes regarding the collection and linkage of maltreatment data for research.
MethodsParticipants included younger mothers, older mothers, care-experienced young people, and professionals who were responsible for recording child maltreatment data. Four face-to-face focus groups were conducted, one with younger mothers (n = 6), one with older mothers (n = 10), and two with care-experienced young people (n = 6 and n = 5). An online focus group was conducted with professionals (n = 10), two of whom additionally participated in telephone interviews. Transcribed audio-recorded data were inductively coded, a portion were double-coded by a second researcher, and thematically analysed.
ResultsThree major themes were identified. The first concerned issues of consent, specifically the conditions for providing consent and factors influencing this. The second concerned trust in data security and validity, the organisations and individuals providing and using the data, and how the information provided shapes attitudes. The third theme explored the benefits of research and the researchers' role in child protection. Participants wanted the choice of providing consent for data collection, especially when consenting on behalf of another, but there were concerns that maltreated children were unidentifiable in anonymised datasets. Care-experienced young people were concerned about data collection from Social Services records due to their sensitivity. There was a general lack of understanding about how research data is viewed and the accuracy of records.
ConclusionsNovel findings in the study were strongly related to the sensitive nature of the topic. The findings may be particularly useful when designing research studies and participant materials and a co-productive approach to this should be taken.

ObjectivesDomiciliary care workers (DCWs) continued to provide social care to vulnerable adults in their own homes throughout the COVID-19 pandemic. However, evidence of pandemic impact upon DCWs' health is mixed. The OSCAR study aimed to quantify the impact of COVID-19 upon health outcomes of DCWs in Wales, and explore causes of variation.
ApproachData for all registered DCWs in Wales are newly available via the SAIL Databank using a secured, privacy-protecting encrypted anonymisation process. Occupational registration data for DCWs working during the pandemic was combined with electronic health records data to describe health outcomes within the first two years of the pandemic. Rates of confirmed COVID-19 infections and health outcomes including mental health contacts, fit notes, respiratory infections, and mortality will be reported and explore variation (by factors such as age, sex, ethnicity, deprivation quintile, employer). We will also explore changes over time (pre- and post- onset of COVID-19 pandemic) in outcomes.
ResultsThe OSCAR study used anonymised health records for 15,727 registered DCWs in Wales. PCR-confirmed infection rates in the first full year of the pandemic (March20-February21) were 12% although lower in males (9%) than for females (12%). However, 28% of care workers received care for mental health with large differences observed between males (20%) and females (29%), and between workers from different health board regions (range 22% to 33%). The extent to which these represent pre-pandemic rates overall and how they compare to the broader community will be explored in our remaining work. A qualitative sub-study involving interviews with DCWs has informed our approach to modelling and to interpretation of findings.
ConclusionUsing novel anonymised occupational records at a national level and existing linked EHR data and qualitative interviews, the OSCAR study will quantify the risk of COVID-19 on DCWs' health and explore sources of variation. This will provide a secure base for informing public health policy and occupational guidance.

BackgroundThe use of administrative data in health and social science research continues to expand, with increased availability of data and interest from funders. Researchers, however, continue to experience delays in access, storage and sharing of administrative data. Training opportunities are limited and typically specific to individual data providers or focussed on the analytical aspects of working with administrative data. The CENTRIC study was funded by the Information Commissioners Office, with the aim of developing a broader training curriculum for researchers working with administrative data in the UK.
MethodsA mixed-methods design informed curriculum content, including surveys with researchers, focus group discussions with data providers and workshops with members of the public. Researchers were identified from relevant administrative data networks and invited to participate in an online survey identifying training needs. Data providers were approached with a request to input to a face-to-face or online meeting with two members of the research team about their experiences of working with researchers. Data were analysed within the broad framework of the interview schedule, free text responses in the survey were analysed thematically.
Results107 researchers responded to the online survey and four data providers participated in the focus groups. We identified five main themes, relating to research training needs for UK researchers working with administrative data: communication; timelines; changes & amendments; future-proofing applications; and, the availability of training and support. Data providers either provided additional evidence on these learning needs or ways to address identified challenges. Six modules were developed addressing these training needs. Quotes from the survey and focus groups are used anonymously in the online training modules.
ConclusionThe CENTRIC online training curriculum was launched in September 2020 and is available, free of charge for UK researchers. CENTRIC specifically addresses commonly identified training needs of researchers working with administrative data.

ObjectivesThe Family Nurse Partnership (FNP) is an intensive home visiting service for teenage first-time mothers, developed/trialled in the US and adapted/trialled across Europe. The Scottish Government aims to build on and supplement the existing evidence base for FNP, to assess effectiveness of the programme, for future improvement work in Scotland.
ApproachThe commissioned natural experiment of FNP, takes advantage of existing information infrastructures in Scotland from health, education and social care and FNP programme implementation data. A cohort design was used covering ten Health Boards in Scotland. The cohort included first-time teenage mothers enrolled as FNP Clients between 2010 and 2016 and women who met FNP eligibility criteria but were pregnant when the programme was not recruiting (Controls). Outcomes are mapped to the Scottish FNP logic model and include those being tested statistically (n=34) or, where direction of effect is uncertain, outcomes are rare or data quality poor, descriptively (n=20).
ResultsWe established a model of data linkage to routine Scottish data. Approvals were obtained to access data on over 8000 mothers (FNP Clients and Controls) and their children which formed the study cohort and were mapped to routine health, education and social care data. Outcomes covered maternal (health (smoking, alcohol/drugs), subsequent pregnancies/births, education) and child (health, development, education, protection) domains. Observed baseline imbalances between study arms will be described and adjusted for in modelling. Results will be published by the time of the conference and include sensitivity analyses that explore a priori sub-groups, variation by health board, year of booking and programme dosage.
ConclusionThe impact of this evaluation will establish a robustly matched study cohort, develop the evidence base on FNP in Scotland and internationally, develop a more streamlined linkage and approval process, and identify outcomes for short-term follow-up and importantly for a longer-term follow-up of the mothers and their children.

IntroductionResearchers are increasingly using routinely collected data in addition to, or instead of, other data collection methods. The UK government continues to invest in research centres to encourage use of these data, and trials and cohort studies utilise data linkage methods in the follow-up of participants. This does not come without its limitations and challenges, such as data access delays.
ObjectiveThis paper outlines the challenges faced by three projects utilising individual-level routinely-collected linked data for the longer-term follow-up of participants.
MethodsThese studies are varied in design, study population and data providers. One researcher was common to the three studies and collated relevant study correspondence, formal documentary evidence such as data sharing agreements and, where relevant, meeting records to review. Key themes were identified and reviewed by other members of the research teams. Mitigating strategies were identified and discussed with a data provider representative and a broader group of researchers to finalise the recommendations presented.
ResultsThe challenges discussed are grouped into five themes: Data application process; Project timelines; Dependencies and considerations related to consent; Information Governance; Contractual. In presenting our results descriptively we summarise each case study, identify the main cross-cutting themes and consider the potential for mitigation of challenges.
ConclusionsWe make recommendations that identify responsibilities for both researchers and data providers for mitigating and managing data access challenges. A continued conversation within the research community and with data providers is needed to continue to enable researchers to access and utilise the wealth of routinely-collected data available. The suggestions made in this paper will help researchers be better prepared to deal with the challenges of applying for data from multiple data providers.

Introduction"Big data" – including linked administrative data – can be exploited to evaluate interventions for maternal and child health, providing time- and cost-effective alternatives to randomised controlled trials. However, using these data to evaluate population-level interventions can be challenging.
ObjectivesWe aimed to inform future evaluations of complex interventions by describing sources of bias, lessons learned, and suggestions for improvements, based on two observational studies using linked administrative data from health, education and social care sectors to evaluate the Family Nurse Partnership (FNP) in England and Scotland.
MethodsWe first considered how different sources of potential bias within the administrative data could affect results of the evaluations. We explored how each study design addressed these sources of bias using maternal confounders captured in the data. We then determined what additional information could be captured at each step of the complex intervention to enable analysts to minimise bias and maximise comparability between intervention and usual care groups, so that any observed differences can be attributed to the intervention.
ResultsLessons learned include the need for i) detailed data on intervention activity (dates/geography) and usual care; ii) improved information on data linkage quality to accurately characterise control groups; iii) more efficient provision of linked data to ensure timeliness of results; iv) better measurement of confounding characteristics affecting who is eligible, approached and enrolled.
ConclusionsLinked administrative data are a valuable resource for evaluations of the FNP national programme and other complex population-level interventions. However, information on local programme delivery and usual care are required to account for biases that characterise those who receive the intervention, and to inform understanding of mechanisms of effect. National, ongoing, robust evaluations of complex public health evaluations would be more achievable if programme implementation was integrated with improved national and local data collection, and robust quasi-experimental designs.

Introduction: Individual, social and economic circumstances faced by young mothers can challenge a successful start in life for their children. Intervening early might enhance life chances for both mother and child. The Family Nurse Partnership (FNP) is an intensive nurse-led home visiting programme developed in the US which aims to improve prenatal health behaviours, birth outcomes, child development and health outcomes, and maternal life course. Establishing evidence of effectiveness beyond the original US setting is important to understand where further adaptation is required within a country specific context.
Objective: This study will form one strand of the Scottish Governments' plan to evaluate the effectiveness of FNP as compared to usual care for mothers and their children in Scotland and will focus only on outcomes that can be identified using routine administrative data systems.
Methods: This study is a natural experiment with a case-cohort design using linked anonymised routine health, educational and social care data. Cases will be women enrolled as FNP Clients in ten NHS Health Boards in Scotland and Controls will be women who met FNP eligibility criteria but were pregnant at a time when the programme was not recruiting. Outcomes are mapped to the Scottish FNP logic model. All comparative analyses will be pre-specified, conducted on an intention to treat basis and will use multilevel regression models to compare outcomes between groups.
Discussion: The study protocol is based upon the specification of FNP commissioned by the Scottish Government. This study design is novel for the evaluation of the FNP/NFP programmes which are primarily evaluated with an RCT. Outcomes included within the study have been selected on the basis that they are outcomes FNP aims to influence and where there is routine data available to assess the outcome.

This project was funded by the Scottish Government Children and Families Directorate [project reference CASE/290185]. ; Peer reviewed ; Publisher PDF

BackgroundUsing routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods.
MethodsClinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden.
Wellbeing Software® provider of the Euroking® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site.
ResultsTwenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records.
DiscussionPiloting the data extraction and linkage highlighted the need for additional governance arrangements, training at NHS sites and new processes for the study team to ensure data quality and confidentiality are upheld during the study. Amending existing NHS electronic information systems and accessing clinical data at scale, is possible, but continues to be a time consuming and a technically challenging exercise.

ObjectivesWe describe the challenges and lessons learned from two studies using linked administrative data from health, education and social care sectors to evaluate the Family Nurse Partnership (FNP), an intervention supporting adolescent mothers in England(E) and Scotland(S). We present recommendations for studies using linked administrative data to evaluate complex interventions.
ApproachWe constructed two cohorts of all mothers aged 13-19 giving birth in NHS hospitals in England and Scotland between 2010-2016/17 using linkage of mothers and babies in hospital admissions data (E:Hospital Episode Statistics/S:Maternity Inpatient and Day Case), and identified FNP participation through linkage to FNP programme data. We additionally linked to health, educational and social care data for mothers and their babies (E:National Pupil Database/S:eDRIS). We used these data to identify key risk factors for enrolment in the FNP, assess the effect of the FNP on maternal and child outcomes, and determine programme characteristics modifying the effect of the FNP.
ResultsKey challenges: characterising the intervention and usual care, understanding quality of multi-sector data linkage, data access delays, constructing appropriate comparator groups and interpreting outcomes captured in administrative data. Lessons learned: evaluations require detailed data on intervention activity (dates/geography), and assessment of usual care, which are rarely readily available and are time-consuming to gather; data linkage quality is variable/not available, making defining denominators challenging; data access delays impeded on data analysis time; unmeasured confounders not captured in administrative data may prevent generation of an appropriate comparator group. Recommendations: Characteristics informing targeting should be explicitly documented, and could be enhanced using linked primary care data and information on household members (e.g. fathers). Process evaluation and qualitative research could help to provide better understanding of mechanisms of effect.
ConclusionLinkage of administrative data presents exciting opportunities for efficient evaluation of large-scale, complex public health interventions. However, sufficient information is needed on programme meta-data, targeting and important confounders in order to generate meaningful results. Study findings should help stimulate exploration with practitioners about how programmes can be improved.

AbstractChildren and young people with care-experience (e.g. foster, kinship and residential care) report poorer mental health and wellbeing than the general population. Despite an emerging evidence-base for intervention, it is not clear if current approaches create, exacerbate or mitigate outcome inequities between different types of participants. We conducted a systematic review of international interventions targeting mental health, subjective wellbeing and suicide-related outcomes amongst care-experienced children and young people aged up to 25 years old. The review included a narrative synthesis of intervention inequities, exploring if they were more or less effective for different participant groups. Eight interventions, with 14 study reports, presented relevant data. Overall, there was no clear evidence that intervention participation could lead to inequitable impacts, being more or less effective for different groups. However, there was some tentative indication that individuals with lower exposure to maltreatment, fewer care placements, and increased baseline mental health problems, might be more responsive to intervention than other participants. There was limited evidence for wellbeing and no data availability for suicide. Future intervention evaluation should focus on assessing if there is potential to create, sustain or exacerbate inequities, and how approaches may be designed to mitigate this risk.