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Abstract Background Within England, children and young people entering police custody are referred to Liaison and Diversion (L&D) teams. These teams liaise with healthcare and other support services aiming to divert children and young people away from the criminal justice system. Although targeted psychological interventions are not typically offered to children and young people by L&D teams, evidence suggests that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems. Methods A two-arm individually randomised controlled trial (RCT) with internal pilot and process evaluation will be conducted with approximately 448 children and young people aged 10–17 years presenting at police custody suites who are referred to the L&D team or recruited via online routes if they have previously presented at any police custody suite in England. The primary outcome is the Self-Report Delinquency Measure (SRDM) at 6 months post-randomisation. Analyses will be performed using intention-to-treat. Results The statistical analysis plan (SAP) for the trial is described. The plan details of analyses to be undertaken which will be reported in the primary and any secondary publications. The plan was developed and published prior to locking our database and unblinding to treatment allocation. Discussion This RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites including testing of moderating factors and sensitivity of the primary analyses. Trial registration ClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023.

Background Synthetic data refers to datasets derived from ‘real’ administrative data records but sufficiently abstracted to minimise disclosure risk. They can be an efficient way for researchers to learn about the properties of datasets and inform data requests, prior to data applications. However, little is understood about how the UK public feel about the creation and use of such datasets for research purposes. Methods We worked with a community engagement agency (Egality Health) to recruit a diverse UK public panel, to discuss issues relating to the use of synthetic data in research. Across four workshops, participants listened to presentations from topic experts, and deliberated on perceived benefits and risks of synthetic data, ethical issues and reflections on how to communicate clearly about synthetic data. Members agreed a set of recommendations for researchers, data custodians and policy makers. Results We will summarise key themes and recommendations from the workshops, explaining how these might help inform future policy. We will reflect on how these results fit with parallel work that has explored the views of researchers and data custodians on the use of synthetic data for research, and discuss potential international implications of our findings. Conclusions and Implications As with any research that seeks to draw on the public’s data, it is vital that researchers and policy-makers engage with and involve the public in any decision making around synthetic data. In presenting findings from this project, we seek to advocate for a public voice in this topic and to ensure that future policy - both in the UK and internationally - is aligned with public attitudes.

Introduction Researchers are increasingly using health systems data to support clinical trials. A recent Delphi study identified a number of remaining challenges across the trial lifecycle and highlighted opportunities to address them through the development of training resources. Objective and Approach We present a programme of work to identify, facilitate and optimise emerging practices for using health systems data in trials, informed by subject matter experts and steered by public input, to begin addressing the ongoing challenges for trial teams. Results Directly addressing a key identified priority for building public trust, we co-developed a series of freely-available online training videos on how public involvement and engagement can impact across the trial lifecycle plus practical tips for such activities. This curriculum was informed by public members who then featured in the training videos. We broadened the training focus to align with trials community needs, whilst retaining the public co-production element. A diverse and purposive group of applicants were selected to contribute to the ongoing work of the HDR UK Transforming Data for Trials workstream. Our presentation reviews how models of involvement have informed our approach including reflections from our public members on what has worked well and what can be improved. We will reflect on the intersection of public involvement in trials and public involvement in healthcare/administrative systems data research. Conclusions & Implications Co-development with a diverse public group ensures all current and future training resources developed reflect a diversity of views, increasing the quality and credibility of materials.

Abstract Background Within England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams have responsibility for liaising with healthcare and other support services while working to divert CYP away from the criminal justice system but have traditionally not provided targeted psychological interventions to CYP. Considering evidence that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems in CYP, the aim of this randomised controlled trial (RCT) was to determine whether there is a difference between services as usual (SAU) plus SFBT offered by trained therapists working within a L&D team, and SAU alone, in reducing offending behaviours in 10–17-year-olds presenting at police custody. Methods Design: two-arm individually RCT with internal pilot and process evaluation. Participants: N = approximately 448 CYP aged 10–17 years presenting at one of three police custody suites in the area served by Lancashire and South Cumbria NHS Foundation Trust (LSCFT) who are referred to the L&D team. Participants will be recruited and allocated to intervention:control on a 1:1 basis. Interviews will be performed with 30–40 CYP in the intervention arm, 15 CYP in the control arm, up to 20 parents/guardians across both arms, up to 15 practitioners, and up to 10 site staff responsible for screening CYP for the trial. Intervention and control: Those allocated to the intervention will be offered SAU plus SFBT, and control participants will receive SAU only. Primary outcome: CYP frequency of offending behaviours assessed through the Self-Report Delinquency Measure (SRDM) at 12 months post-randomisation. Secondary outcomes: criminal offence data (national police database); emotional and behavioural difficulties (self-report and parent/guardian reported); gang affiliation (self-report). Process evaluation: evaluation of acceptability and experiences of the CYP, parents/guardians, site staff and practitioners; fidelity of SFBT delivery. Discussion This two-arm individually RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites within the area served by LSCFT. Our process evaluation will assess the fidelity of delivery of SFBT, the factors affecting implementation, the acceptability of SFBT in CYP aged 10–17 years and recruitment and reach. We will also examine systems and structures for future delivery, therefore assessing overall scalability. Trial registration ClinicalTrials.gov ISRCTN14195235 . Registered on June 16, 2023.

Background Using 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. Methods Clinical 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. Results Twenty-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. Discussion Piloting 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.

Abstract Background Having a body mass index (BMI) which is classified as overweight (BMI ≥ 25) or obese (BMI ≥ 30) increases the risk of complications during pregnancy and labour. Weight-management interventions which target excess gestational weight gain during pregnancy have had limited success. Women who use long-acting reversible contraception (LARC) are in contact with services as part of their preparation for conception, creating a potential opportunity to offer a preconception weight-loss intervention. The aims of this mixed methods study were to assess the acceptability and practicability of a weight-loss intervention which asked people to delay LARC removal in order to lose weight before conceiving. Methods Routine UK NHS data were analysed to identify pathways from LARC removal to pregnancy. Qualitative surveys and advisory group discussions with service providers and LARC users with experience of being overweight were conducted and analysed thematically. Results Three hundred fifteen thousand seven hundred fifty-five UK women aged 16–48 years between 2009–2018 had at least one LARC-related event (e.g. insertion, removal) and 1.7% of those events were recorded as related to planning a pregnancy. BMI was included in 62% of women’s records, with 54% of those BMI being classified as overweight or obese. Online surveys were completed by 100 healthcare practitioners and 243 LARC users. Stakeholders identified facilitators and barriers associated with the proposed intervention including sensitivities of discussing weight, service-user past experiences, practitioner skills, the setting and ethical implications of the proposed intervention. Conclusions Although women and service providers recognised potential benefits, a preconception weight-loss intervention asking people to delay LARC removal posed many barriers, due mainly to the acceptability of such an intervention to women and healthcare practitioners. Weight-loss interventions that target the general population, together with a focus on improving public knowledge of preconception health, may be more acceptable than interventions which solely focus on LARC users. Many of the barriers identified, including communication, understanding and beliefs about weight and risk, appointment systems and the limitations of routine datasets also have relevance for any preconception weight-loss intervention. Work to improve routine datasets and reducing communication barriers to discussing weight are priorities. Trial registration ISRCTN14733020 registered 10.05.2019.

Abstract Background Young mothers are more likely to provide a suboptimal early language environment for their children who in turn show impairments in their language development, yet few studies have used observational methods to assess the effectiveness of home-visiting programmes in improving the language outcomes of young mothers and their children. The Family Nurse Partnership (FNP) is a licensed home-visiting intervention developed in the USA and introduced into practice in England. The intervention involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained Family Nurses. We assessed the effectiveness of FNP in improving the language outcomes of first-time teenage mothers and their infants. Method We conducted a pragmatic, non-blinded, randomised controlled trial to test whether the FNP programme improved mothers’ and children’s language production at 24 months postpartum. Eligible participants were nulliparous, aged 19 years or younger, and were recruited at less than 25 weeks’ gestation from community midwifery settings (Country). Pregnant young mothers were randomly assigned to FNP plus usual care (n = 243) or usual care alone (n = 233). At 24 months postpartum, mother–child dyads were observed during a standardised free-play task with their first-born child and features of their language production was coded. Data was analysed using multi-level modelling; linear or poisson/negative binomial regression models were used as appropriate. Results A small effect of FNP on mothers’ productive language was detected, where mothers in the FNP group demonstrated higher mean length of utterances than mothers who received usual care alone, mean difference (adjusted by minimisation variables and by site, linear regression) = 0.10, p

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. Objectives We 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. Methods We 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. Results Lessons 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. Conclusions Linked 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.

Background: Women with overweight (a body mass index of ≥ 25 kg/m2) or obesity (a body mass index of ≥ 30 kg/m2) are at greater risk of experiencing complications during pregnancy and labour than women with a healthy weight. Women who remove their long-acting reversible contraception (i.e. coils or implants) are one of the few groups of people who contact services as part of their preparation for conception, creating an opportunity to offer a weight loss intervention. Objectives: The objectives were to understand if routine NHS data captured the pathway from long-acting reversible contraception removal to pregnancy and included body mass index; to identify the suitable components of a preconception weight loss intervention; and to engage with key stakeholders to determine the acceptability and feasibility of asking women with overweight/obesity to delay the removal of their long-acting reversible contraception in order to take part in a preconception weight loss intervention. Design: This was a preparatory mixed-methods study, assessing the acceptability and feasibility of a potential intervention, using routine NHS data and purposefully collected qualitative data. Participants: The NHS routine data included all women with a long-acting reversible contraception code. There were three groups of participants in the surveys and interviews: health-care practitioners who remove long-acting reversible contraception; weight management consultants; and women of reproductive age with experience of overweight/obesity and of using long-acting reversible contraception. Setting: UK-based health-care practitioners recruited at professional meetings; and weight management consultants and contraceptive users recruited via social media. Data sources: Anonymised routine data from UK sexual health clinics and the Clinical Practice Research Datalink, including the Pregnancy Register; and online surveys and qualitative interviews with stakeholders. Results: The records of 2,632,871 women aged 16–48 years showed that 318,040 had at least one long-acting reversible contraception event, with 62% of records including a body mass index. Given the identified limitations of the routine NHS data sets, it would not be feasible to reliably identify women with overweight/obesity who request a long-acting reversible contraception removal with an intention to become pregnant. Online surveys were completed by 100 health-care practitioners, four weight management consultants and 243 contraceptive users. Ten health-care practitioners and 20 long-acting reversible contraception users completed qualitative interviews. A realist-informed approach generated a hypothesised programme theory. The combination of weight discussions and the delay of long-acting reversible contraception removal was unacceptable as an intervention to contraceptive users for ethical and practical reasons. However, a preconception health intervention incorporating weight loss could be acceptable, and one potential programme is outlined. Limitations: There was very limited engagement with weight management consultants, and the sample of participating stakeholders may not be representative. Conclusions: An intervention that asks women to delay long-acting reversible contraception removal to participate in a preconception weight loss intervention would be neither feasible nor acceptable. A preconception health programme, including weight management, would be welcomed but requires risk communication training of health-care practitioners. Future work: Work to improve routine data sets, increase awareness of the importance of preconception health and overcome health-care practitioner barriers to discussing weight as part of preconception care is a priority. Trial registration: This trial is registered as ISRCTN14733020. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 1.

Objectives The Department for Education funded local authorities (LAs) in England to embed social workers into schools (SWIS) so that they can work more effectively with teachers, children and families. A two-arm cluster randomised-controlled trial is evaluating the effect of SWIS compared to schools without on referrals to Children’s Social Care. Approach LAs collate information about all children who are referred to Children’s Social Care within their authority. A case report form has been developed by the trial team to collect school-level information on child protection enquiries, referrals, child in need assessments and numbers of days children spent in state care. Cost data are also included for an economic evaluation. LAs return a completed dataset each quarter, reporting aggregate numbers by school and year group. Data on attendance and attainment will be requested separately from the National Pupil Database (NPD) in 2023. Results Quarterly (n=6) data was supplied for 291 schools across 21 LAs. We will focus on this method of data collection and its challenges and opportunities. Relying on 21 external parties to provide all trial data in a timely manner brought risks to the collation of trial outcome data but has reduced the overall costs of data collection. LAs work with a number of different (and changing) IT systems, many of which are not compatible with each other. This, along with personnel changes in data teams, has led to delays. Receiving aggregate data limits the amount of quality control possible, therefore detailed guidance mitigated potential data input errors. Working with LAs to develop and refine these guidance materials at the outset paid dividends. Conclusion Using routine LA data is a novel cost-efficient approach to collecting trial outcome data at scale. However, the disjointed and varying data architecture that exists in LAs presents practical challenges. This means we relied on good working relationships with the LAs, including regular communication and collaborative problem solving.

Objectives The 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. Approach The 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). Results We 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. Conclusion The 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.

Objectives We 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. Approach We 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. Results Key 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. Conclusion Linkage 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.

Objectives The 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. Approach Mothers 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. Results Match 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). Conclusions We 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.

Objectives Domiciliary 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. Approach Data 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. Results The 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. Conclusion Using 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.

Abstract Background Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. Methods This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. Discussion The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field. Trial registration ISRCTN70419473

Background: Parents of children with intellectual disability are 1.5–2 times more likely than other parents to report mental health difficulties. There is a lack of clinically effective and cost-effective group well-being interventions designed for family carers of young children with intellectual disability. Aim: To examine the feasibility of a randomised controlled trial of the clinical effectiveness and cost-effectiveness of the Early Positive Approaches to Support (E-PAtS) intervention. Design: A feasibility study (including randomisation of families into a two-arm trial), questionnaires to assess the feasibility of proposed outcome measures (including resource use and health-related quality of life) and practitioner/family carer interviews. An additional question was included in an online UK survey of families, conducted by the research team to assess usual practice, and a survey of provider organisations. Setting: Families recruited from community contexts (i.e. third sector, local authority services, special schools) and self-referral. The E-PAtS intervention was delivered by trained community-based providers. Participants: Families with at least one child aged 1.5–5 years with an intellectual disability. At least one parent had to have English-language ability (spoken) for E-PAtS programme participation and participants had to provide informed consent. Interventions: E-PAtS intervention – two caregivers from each family invited to eight 2.5-hour group sessions with usual practice. Usual practice – other support provided to the family, including other parenting support. Objectives: To assess randomisation willingness/feasibility, recruitment of providers/parents, retention, usual practice, adherence, fidelity and feasibility of proposed outcome measures (including the Warwick–Edinburgh Mental Well-Being Scale as the proposed primary outcome measure, and parent anxiety/depression, parenting, family functioning/relationships, child behavioural/emotional problems and adaptive skills, child and parent quality of life, and family services receipt as the proposed secondary outcome measures). Results: Seventy-four families (95 carers) were recruited from three sites (with 37 families allocated to the intervention). From referrals, the recruitment rate was 65% (95% confidence interval 56% to 74%). Seventy-two per cent of families were retained at the 12-month follow-up (95% confidence interval 60% to 81%). Exploratory regression analysis showed that the mean Warwick–Edinburgh Mental Well-Being Scale well-being score was 3.96 points higher in the intervention group (95% confidence interval –1.39 to 9.32 points) at 12 months post randomisation. High levels of data completeness were achieved on returned questionnaires. Interviews (n = 25) confirmed that (1) recruitment, randomisation processes and the intervention were acceptable to family carers, E-PAtS facilitators and community staff; (2) E-PAtS delivery were consistent with the logic model; and (3) researchers requesting consent in future for routine data would be acceptable. Recorded E-PAtS sessions demonstrated good fidelity (96% of components present). Adherence (i.e. at least one carer from the family attending five out of eight E-PAtS sessions) was 76%. Health-related quality-of-life and services receipt data were gathered successfully. An online UK survey to assess usual practice (n = 673) showed that 10% of families of young children with intellectual disability received any intervention over 12 months. A provider survey (n = 15) indicated willingness to take part in future research. Limitations: Obtaining session recordings for fidelity was difficult. Recruitment processes need to be reviewed to improve diversity and strategies are needed to improve primary outcome completion. Conclusions: Study processes were feasible. The E-PAtS intervention was well received and outcomes for families were positive. A barrier to future organisation participation is funding for intervention costs. A definitive trial to test the clinical effectiveness and cost-effectiveness of E-PAtS would be feasible. Trial registration: Current Controlled Trials ISRCTN70419473. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information.

BackgroundChild and family social workers in the UK work closely with other agencies including schools and the police, and typically they are based in local authority offices. This study will evaluate the effectiveness of placing social workers in schools (SWIS) on the need for social care interventions. SWIS was piloted in three local authorities in 2018-2020, and findings from a feasibility study of the pilots suggests SWIS may operate through three key pathways: (1) by enhancing schools' response to safeguarding issues, (2) through increased collaboration between social workers, school staff, and parents, and (3) by improving relationships between social workers and young people.MethodsThe study is a two-arm pragmatic cluster randomised controlled trial building on three feasibility studies which found SWIS to be promising. Social workers will work within secondary schools across local authorities in England. 280 mainstream secondary schools will be randomly allocated with a 1:1 ratio to SWIS or a comparison arm, which will be schools that continue as normal, without a social worker. The primary outcome will be the rate of Child Protection (Section 47) enquiries. Secondary outcomes will comprise rate of referrals to children's social care, rate of Child in Need (Section 17) assessments, days spent in care, and educational attendance and attainment. The study also includes an economic evaluation, and an implementation and process evaluation. Social care outcomes will be measured in July 2022, and educational outcomes will be measured in July 2023. Days in care will be measured at both time points.DiscussionFindings will explore the effectiveness and cost-effectiveness of SWIS on the need for social care interventions. A final report will be published in January 2024.Trial registrationThe study was registered retrospectively with the International Standard Randomised Controlled Trial Number registry on 13.11.2020 (ISRCTN90922032).

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS.Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed, such as the Consolidated Standards of Reporting Trials (CONSORT) extension for trials conducted using cohorts and RCD (CONSORT-ROUTINE). Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of the final checklist. Conclusion: The SPIRIT-ROUTINE extension will contribute to improving design of trials using cohorts and RCD and transparency of reporting.

Background: The short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0–2). Objectives: The objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership. Design: Children and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age. Setting: This study was set in 18 partnerships between local authorities and health-care organisations in England. Participants: The participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged ≤ 19 years, in local authority Family Nurse Partnership catchment areas, at

Background Analysis of routine data makes an important contribution to service evaluation and research, providing cost-efficiencies, objective outcomes, burden reduction for patient and the public and is promoted by both policy and funders. Organisational, legal and ethical governance provide a framework for research but there is an onus on researchers to maintain their awareness of good practice when working with routine data. Aim To co-produce with data provider, researcher and public stakeholders a training curriculum for researchers working with routine data. Methods A curriculum for online and face-to-face training will be developed through consultations with three stakeholder groups. The first are researchers with existing interest /experience of using routine data. An online survey will be disseminated via UK research networks encompassing a range of disciplines and sectors. The non-probabilistic survey addresses current challenges, training experiences and learning preferences. Focus groups with three UK data provider organisations (SAIL, NHS Digital, National Pupil Database) will address provider’s experience of working with researchers, any training or support they either require, provide or sign-post to and opportunities to support best practice. Thirdly, a facilitated public consultation exercise using a deliberative enquiry process will be undertaken as a day’s workshop and include lay contributors identified via the HealthWise Wales cohort. Results We will present initial results from each stakeholder engagement activity and show how this has informed the draft training curriculum and our understanding of potential benefits that the training will deliver. Conclusions The public may remain largely unaware of data captured when using public services, how it may contribute to research and the protections that apply. Involving the public in the development of researcher training informs this process and enables researchers to more effectively engage with patients and participants. Training will be promoted through data provider and research networks across sectors in the UK.

Background Guidelines recommend the prompt diagnosis and treatment of UTI in young children to reduce the risk of renal scarring and possible long-term complications. However, the evidence for this association is weak and has been questioned. There is an urgent need to clarify this as the correct approach to urine sampling and diagnosis of UTI in children hinges on this association. Main Aim Determine outcomes following UTI in childhood (1 microbiologically confirmed UTI (mcUTI) aged 1 mcUTI. The overall prevalence of renal scarring in the cohort by age 7 was 0.16%; 1.26% in those with >1 mcUTI; 0.08% in those with no mcUTI. The unadjusted odds ratio (OR) was 16.62 (12.91-21.39) and adjusted 3.64 (2.57-5.14). Among the group with >1 mcUTI, predictors of renal scarring were VUR, younger age of first UTI, and greater number of UTIs 1 mcUTI was lower than expected. Possible explanations include poor coding in routine data, different patient populations or missed renal scarring diagnoses. We are currently validating our results using radiology data. If renal scarring diagnoses are being missed, a more proactive urine sampling and imaging strategy may be indicated. However, if renal scarring rates are low following UTI, this may not be necessary.

Background POOL is a cohort study designed to establish whether waterbirth, compared to leaving a pool prior to birth, is as safe for mothers and infants. It is a novel case study using routine maternity and neonatal data for research purposes, including the adaptation and addition of locally collected electronic data at sites. Aim We aimed to establish the feasibility of the study design, which combines data from maternity information systems(MIS) and neonatal data using a dissent-based linkage model and the addition of new variables into the MIS. Methods The study will utilise individual level data entered into local MIS at 30 NHS Trusts linked with the National Neonatal Research Database(NNRD). New variables were added to one pilot site before rolling out to the remaining sites. A third party added the new variables, extracted data from the MIS to send to the study team and transferred data for matching to the NNRD, ensuring the study team receive only anonymised data. The feasibility study aimed to establish the quality and completion of the newly added variables, the levels of missingness for key outcomes from an extract of 4 years of retrospective data, and ensured the datasets could link using the study ID generated by our third party. Results The new variables were added into the MIS and data were extracted after a 10week pilot. New variables were present and had been entered as per specified metadata requirements. 23,140 records were extracted from the retrospective data and key variables assessed for missingness e.g.place of birth(

Abstract Background Follow-up for public health trials may benefit from greater use of routine data. Our trial of a home-visiting intervention for first-time teenage mothers assessed outcomes to the child’s second birthday. To examine its medium-term impact, particularly upon maltreatment outcomes, we designed a study using routine records. Methods We aimed to establish the feasibility of our study design, which combines trial data with routine health, social care and education data using a dissent-based linkage model. Trial participant identifiers were linked to routine health, social care and education data if women did not dissent. Data were forwarded to a safe haven and further linked to de-identified trial outcome data. The feasibility study aimed first to establish the acceptability of data linkage through a discussion group of young mothers and by levels of dissent received by the research team. Second, we assessed levels of accurate linkage to both health (via NHS Digital) and education and social care (both via National Pupil Database, NPD). Third, we assessed the availability of data and levels of missingness for key outcomes received for a sample of target study years. Results Of 1545 mother-child dyads contacted, eight women opted out. The engagement exercise with stakeholders found support for the principle of data linkage, including in the context of maltreatment. Some contributors preferred opt-in consent. Most (99.9%) health records were matched on either three or all four identifiers. Fifty participants were not matched to any health data. Primary outcome data from NPD are derived from any one of three fields, all of which were satisfactorily returned and provided an indication of cases for analysis. Missing data for secondary outcomes varied from 0% (Child looked after status) to 70% (Anatomical Area A&E diagnosis) however when combined with other variables the levels of missingness for outcome decrease. Conclusions Through study set-up and in this pilot, we provide evidence that the main study is feasible, satisfies governance requirements and is likely to generate data of sufficient quality to address our main research questions. Observed levels of missingness or low event rates are likely to affect some secondary analysis (e.g. state transition modelling) although overall were satisfactory.

This consensus statement reflects the deliberations of an international group of stakeholders with a range of expertise in public involvement and engagement (PI&E) relating to data-intensive health research. It sets out eight key principles to establish a secure role for PI&E in and with the research community internationally and ensure best practice in its execution. Our aim is to promote culture change and societal benefits through ensuring a socially responsible trajectory for innovations in this field. Our key premise is that the public should not be characterised as a problem to be overcome but a key part of the solution to establish socially beneficial data-intensive health research for all.

Introduction The Family Nurse Partnership(FNP) is an intensive home-visiting service for teenage first-time mothers (and children), developed/trialled in the US and adapted/trialled across Europe.The Scottish Government(SG) aims to build on and supplement the existing national/international evidence base for FNP, to assess effectiveness and opportunities for optimisation of the programme, for future decision making in Scotland. Objectives and Approach The evaluation commissioned is a natural experiment of FNP, taking advantage of the existing information infrastructure in Scotland. This natural experiment represents an important opportunity to determine programme impact upon many key programme outcomes using routinely collected data at a lower cost than a comparably sized effectiveness trial. Key objectives are: to identify clients in receipt of FNP-support and a control sample of matched families who would meet criteria for FNP but did not receive support, to obtain approval and through anonymised data linkage link to health and other data, and to determine the effect of FNP across a range of maternal and child outcomes. Results The succes of the natural experiment design in trying to replicate the gold standard design of the RCT will be presented and will cover the following topics: (how cases and a comparable group of first-time teenage women have been identified across 10 Health Boards (HBs) between 2009 and 2016 using data made available by the electronic Data Research and Innovation Service (eDRIS) from FNP, NHS Scotland and SG; the matching process of the cases and controls using propensity score methods to ensure an unbiased comparison; the linkage to health, social care and educational datasets and the approval processes involved, and the strengths and limitations of using routine data to evaluate relevant study outcomes that map to a logic model. Conclusion/Implications The impact of this evaluation into the effectiveness of FNP in Scotland will establish a robustly matched study cohort, a more strealmined linkage and approval process, and identification of outcomes not only for a short-term follow-up but also for a longer-term follow-up of the teenage mothers and their children.

Introduction The method used to define a GP-consultation using routine data will vary depending on the data source and research question. However, without consensus the approach will be tackled by numerous researchers and invariably result in different definitions. The LUCI study is assessing outcomes of childhood UTI using routine data sources. Objectives and Approach We are interested in GP urine sampling rate and re-consultation rate. The GP dataset includes multiple clinical (acute, routine monitoring, prescribing, results) and administrative codes. A GP consultation therefore needed to be defined. GP read code frequencies for our study cohort of children were produced. One researcher reviewed the codes that represented 80% of the data and classified them as a consultation or not. Where there was uncertainty this was independently reviewed by two clinicians and discrepancies agreed by the management team. Results We will present the decisions and assumptions made for this study in defining a GP consultation. 25,623 Read Codes represented the consultations for our study cohort of which 460 codes represented 80% of the consultations. The remaining 20% of codes represented

Introduction While public engagement activity in healthcare may include a focus on uses of patient data, use of social care/ education data may be relatively overlooked. The public may be less aware about how their social care data may be used. Some concepts such as benefits and risks may also differ. Objectives and Approach Our objective is to co-produce with members of the public a package of materials that researchers may then use to promote public understanding of and engagement in research that uses routine data from health and social care settings. We are running workshops with two groups of young families (teenage mothers, some of whom have received specialist home-visiting support) to explore key concepts and messages about routine data use, including sensitive data such as maltreatment and regulatory child protection interventions. The workshop includes completing a story board for an animated video. This will be co-produced by the same young people. Results Our recent work with young families has shown a preference for visual based methods over text-based approaches to explain routine data linkage. This represents a key opportunity for innovation. We have explored how members of the public understand and make sense of routine data from various settings (health/social care) and its use in research. Working with a professional animator, the co-production of a prototype animation aims to engage members of the public about the nature, benefits and safeguards of using routine public records in health and social care research. The presentation will summarise the method of co-production, review the prototype animation and associated materials for researchers (‘toolkit’). Finally, we will recap key messages identified from the workshops that underpin the animation and other dissemination plans. Conclusion/Implications Our existing understanding of public views (e.g. from consumer panels) may not represent well perspectives from population groups, such as teenage parents. Working with young families who may otherwise rarely engage in such work provides their unique perspectives, adding richness to our understanding of public views on routine data usage.