Maternal and neonatal outcomes among spontaneous vaginal births occurring in or out of water following intrapartum water immersion: The POOL cohort study.

OBJECTIVE: Warm water immersion during labour provides women with analgesia and comfort. This cohort study aimed to establish among women using intrapartum water immersion analgesia, without antenatal or intrapartum risk factors, whether waterbirth is as safe for them and their babies as leaving the water before birth. DESIGN: Cohort study with non-inferiority design. SETTING: Twenty-six UK NHS maternity services. SAMPLE: A total of 73 229 women without antenatal or intrapartum risk factors, using intrapartum water immersion, between 1 January 2015 and 30 June 2022. The analysis excluded 12 827 (17.5%) women who received obstetric or anaesthetic interventions before birth. METHODS: Non-inferiority analysis of retrospective and prospective data captured in NHS maternity and neonatal information systems. MAIN OUTCOME MEASURES: Maternal primary outcome: obstetric anal sphincter injury (OASI) by parity; neonatal composite primary outcome: fetal or neonatal death, neonatal unit admission with respiratory support or administration of antibiotics within 48 hours of birth. RESULTS: Rates of the primary outcomes were no higher among waterbirths compared with births out of water: rates of OASI among nulliparous women (waterbirth: 730/15 176 [4.8%] versus births out of water: 641/12 210 [5.3%]; adjusted odds ratio [aOR] 0.97, one-sided 95% CI, -∞ to 1.08); rates of OASI among parous women (waterbirth: 269/24 451 [1.1%] versus births out of water 144/8565 [1.7%]; aOR 0.64, one-sided 95% CI -∞ to 0.78) and rates of the composite adverse outcome among babies (waterbirth 263/9868 [2.7%] versus births out of water 224/5078 [4.4%]; aOR 0.65, one-sided 95% CI -∞ to 0.79). CONCLUSION: Among women using water immersion during labour, remaining in the pool and giving birth in water was not associated with an increase in the incidence of adverse primary maternal or neonatal outcomes.

The acceptability of asking women to delay removal of a long-acting reversible contraceptive to take part in a preconception weight loss programme: a mixed methods study using qualitative and routine data (Plan-it).

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.

Assessing predictors of respiratory tract infections in infants born to teenage mothers: secondary analysis of the Building Blocks trial data.

BACKGROUND: Respiratory tract infections (RTIs) are estimated to account for 60% of infants' primary care visits. There is limited research into risk factors for infant RTIs in those born to teenage mothers. AIMS: To identify risk factors for primary and secondary care RTI attendances, in infants of teenage mothers, and to identify risk factors associated with high primary care RTI consultations. METHOD: Secondary analysis of a data set from the Building Blocks trial of special home visiting support in England containing 1510 infants born to teenage mothers recruited to the study. Maternally reported and routinely collected data were examined. Multivariable logistic regression models were performed to determine independent predictors. Primary care data analysis also focused on infant risk factors for RTI consultation. RESULTS: No independently predictive risk factors for infant RTI were identified in primary care. Lower maternal antenatal attendances (odds ratio = 0.96, 95% confidence interval = 0.92-0.99), infants born in autumn (vs. spring; 0.54, 0.36-0.80) and neonatal unit (NNU) admissions (0.51, 0.30-0.89) had increased odds of attending accidents and emergencies with an RTI. Male infants (1.52, 1.03-2.25), NNU admissions (3.21, 1.98-5.22) and birth season had increased odds of RTI-associated hospital admissions. High infant RTI primary care consulters were more likely to have an RTI-associated hospital admission (2.11, 1.17-3.81) and less likely to have breastfed (0.55, 0.38-0.78). CONCLUSION: Risk factors previously found to increase the risk of an RTI infant admission in the broader population have been identified here. This study is one of the first to identify modifiable risk factors of high primary care RTI consulters.

Assessing the impact of a family nurse-led intervention on young mothers' references to internal states.

A mother's propensity to refer to internal states during mother-child interactions is important for her child's developing social understanding. However, adolescent mothers are less likely to reference internal states when interacting with their children. We investigated whether young mothers' references to internal states are promoted by the Family Nurse Partnership (FNP) intervention, an intensive home-visiting programme designed to support adolescent mothers in England. We also investigated family, maternal, and child factors associated with young mothers' references to inner states during interactions with their children. Adolescent mothers (n = 483, aged ≤ 19 years when recruited in pregnancy) and their children participated in an observational substudy of a randomized controlled trial investigating the impact of FNP compared to usual care. Mother-child dyads were video-recorded during free play, and mothers' speech was coded for use of internal state language (references to cognitions, desires, emotions, intentions, preferences, physiology, and perception). We found no differences in mothers' use of internal state language between the FNP and usual care groups. A sample-wide investigation identified that other features of mothers' language and relationship status with the child's father were associated with internal state language use. Findings are discussed with reference to targeted interventions and implications for future research.

La tendencia de la madre a referirse a los estados internos durante las interacciones madre-niño es importante para el desarrollo social cognitivo de su niño. Sin embargo, las madres adolescentes están menos propensas a referirse a los estados internos cuando interactúan con sus niños. Investigamos si la tendencia de las madres jóvenes a referirse a estados internos es promovida por la intervención de Asociación entre Familia y Enfermera (FNP), un programa intensivo de visitas a casa diseñado para apoyar a madres adolescentes en el Reino Unido. También investigamos factores de familia, maternos y del niño asociados con las interacciones de las jóvenes madres con sus niños. Las madres adolescentes (n = 483, edad ≤ 19 años) y sus niños participaron en un sub-estudio de observación, un ensayo controlado al azar que investigaba el impacto de FNP comparado con el cuidado usual. Las díadas madre-niño fueron grabadas en video durante el juego libre, y se codificó el habla de las madres en cuanto al uso del lenguaje de estados internos (referencias a cogniciones, deseos, emociones, intenciones, preferencias, fisiología y percepción). No encontramos diferencias en cuanto al uso del lenguaje de estados internos en las madres entre la FNP y los grupos de cuidado usual. Una muestra de investigación amplia identificó que otras características del lenguaje de las madres y condiciones de la relación con el padre del niño estaban asociadas con el uso del lenguaje de estados internos. Los resultados se discuten con referencia a intervenciones elegidas como objetivo e implicaciones para la futura investigación.

La propension d'une mère à faire référence à ses états internes durant les interactions mère-enfant est importante pour le développement social et cognitif de son enfant. Cependant, les mères adolescentes sont moins à même de faire référence à leurs états internes dans leur interaction avec leurs enfants. Notre étude a porté sur si la propension des jeunes mères à faire référence à leurs états internes est promue par l'intervention Partenariat Famille Infirmières (en anglais Family Nurse Partnership, soit FNP), un programme intensif de visite à domicile conçu afin de soutenir les mères adolescentes au Royaume Uni. Nous avons également étudié les facteurs familiaux, maternels, et liés aux enfants, liés aux interactions des jeunes mères avec leurs enfants. Les mères adolescentes (n = 483, âgés ≤ 19 ans) et leurs enfants ont participé à une sous-étude observationnelle d'un essai contrôlé randomisé portant sur l'impact de la FNP comparé aux soins normaux. Les dyades mères-enfant ont été filmées durant un jeu libre et les paroles des mères ont été codées pour son utilisation de langage d'état interne (références aux cognitions, désirs, émotions, intentions, préférences, physiologie et perception). Nous n'avons trouvé aucune différence dans l'utilisation des mères du langage d'état interne entre le groupe FNP et les groupes de contrôle. Une étude de l'échantillon a révélé que d'autres traits du langage des mères et du statut de la relation avec le père de l'enfant étaient liés à l'utilisation de langage de l'état interne. Les résultats sont discutés par rapport aux interventions ciblées et aux implications pour les recherches futures.

Long-term consequences of urinary tract infection in childhood: an electronic population-based cohort study in Welsh primary and secondary care.

BACKGROUND: Childhood urinary tract infection (UTI) can cause renal scarring, and possibly hypertension, chronic kidney disease (CKD), and end-stage renal failure (ESRF). Previous studies have focused on selected populations, with severe illness or underlying risk factors. The risk for most children with UTI is unclear. AIM: To examine the association between childhood UTI and outcomes in an unselected population of children. DESIGN AND SETTING: A retrospective population-based cohort study using linked GP, hospital, and microbiology records in Wales, UK. METHOD: Participants were all children born in 2005-2009, with follow-up until 31 December 2017. The exposure was microbiologically confirmed UTI before the age of 5 years. The key outcome measures were renal scarring, hypertension, CKD, and ESRF. RESULTS: In total, 159 201 children were included; 77 524 (48.7%) were female and 7% (n = 11 099) had UTI before the age of 5 years. A total of 0.16% (n = 245) were diagnosed with renal scarring by the age of 7 years. Odds of renal scarring were higher in children by age 7 years with UTI (1.24%; adjusted odds ratio 4.60 [95% confidence interval [CI] = 3.33 to 6.35]). Mean follow-up was 9.53 years. Adjusted hazard ratios were: 1.44 (95% CI = 0.84 to 2.46) for hypertension; 1.67 (95% CI = 0.85 to 3.31) for CKD; and 1.16 (95% CI = 0.56 to 2.37) for ESRF. CONCLUSION: The prevalence of renal scarring in an unselected population of children with UTI is low. Without underlying risk factors, UTI is not associated with CKD, hypertension, or ESRF by the age of 10 years. Further research with systematic scanning of children's kidneys, including those with less severe UTI and without UTI, is needed to increase the certainty of these results, as most children are not scanned. Longer follow-up is needed to establish if UTI, without additional risk factors, is associated with hypertension, CKD, or ESRF later in life.

Family group conferencing for children and families: Evaluation of implementation, context and effectiveness (Family VOICE). Study protocol.

BACKGROUND: Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike professionally led meetings, the aim is for decisions to be made by or with family members. Qualitative and mixed-method research with FGC participants tends to show positive experiences: most participants feel their voices are heard; FGCs facilitate family-driven solutions and closer relationships-within families and with social workers. Although there is existing literature on FGCs, there is a paucity of robust comparative UK evaluations, i.e., randomised controlled trials or quasi-experimental studies. Comparative studies internationally have focused on a narrow range of outcomes, not recognised the importance of context, and paid little attention to the quality of delivery. Some qualitative studies have considered process and context but there is scant measurement of these. The aims of this study are, firstly, to establish how FGCs improve outcomes for families and what factors vary their quality, and, secondly, to assess longer-term outcomes in terms of service use and associated costs. METHODS: Given the importance of process and context, evaluation informed by realist and complex systems approaches is needed. This multi-method evaluation includes a survey of FGC services in all UK local authorities (n = 212) to map service provision; co-design of programme theory and evaluation measures with family members who have experienced an FGC (n = 16-24) and practitioners (n = 16-24) in two sites; a prospective single-arm study of FGC variability and outcomes after six months; and comparison of service use and costs in FGC participants (n≥300 families) and a control group (n≥1000) after two years using a quasi-experiment. DISCUSSION: This is a pragmatic evaluation of an existing intervention, to identify what mechanisms and contexts influence effective process and longer-term outcomes. The study is registered with Research Registry (ref. 7432).

Statistical analysis plan for the SOLUTIONS randomised controlled trial with internal pilot: Solution Focused Brief Therapy (SFBT) in 10-17-year-olds presenting at policy custody.

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.

Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10-17-year-olds presenting at police custody: a randomised controlled trial.

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.

Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials.

BACKGROUND: Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to widespread use include whether healthcare systems data captures sufficiently well the data traditionally captured on case report forms. "Data Utility Comparison Studies" (DUCkS) assess the utility of healthcare systems data for RCTs by comparison to data collected by the trial. Despite their importance, there are few published UK examples of DUCkS. METHODS-AND-RESULTS: Building from ongoing and selected recent examples of UK-led DUCkS in the literature, we set out experience-based considerations for the conduct of future DUCkS. Developed through informal iterative discussions in many forums, considerations are offered for planning, protocol development, data, analysis and reporting, with comparisons at "patient-level" or "trial-level", depending on the item of interest and trial status. DISCUSSION: DUCkS could be a valuable tool in assessing where healthcare systems data can be used for trials and in which trial teams can play a leading role. There is a pressing need for trials to be more efficient in their delivery and research waste must be reduced. Trials have been making inconsistent use of healthcare systems data, not least because of an absence of evidence of utility. DUCkS can also help to identify challenges in using healthcare systems data, such as linkage (access and timing) and data quality. We encourage trial teams to incorporate and report DUCkS in trials and funders and data providers to support them.

Lessons learned from using linked administrative data to evaluate the Family Nurse Partnership in England and Scotland.

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.

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK.

BACKGROUND: Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data. METHODS: This three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups. RESULTS: In the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation). CONCLUSION: This prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised.

The practicalities of adapting UK maternity clinical information systems for observational research: Experiences of the POOL study.

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.

Acceptability and feasibility of a planned preconception weight loss intervention in women with long-acting reversible contraception: the Plan-it mixed-methods study.

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.

If a woman has overweight or obesity when she is pregnant, then there is a greater risk of health problems for her and her baby. About half of women of childbearing age have overweight or obesity, so we need to find ways of supporting women to lose weight before they become pregnant (described here as 'preconception'). This can be difficult because women do not usually talk to a health-care practitioner (e.g. general practitioners, sexual health doctors, nurses) about becoming pregnant, but one group of women who do are those who need to have a long-acting reversible contraceptive (e.g. a coil or an implant) removed. This study was designed as preparatory work for a potential future study of a preconception weight loss intervention. We wanted to answer three questions: (1) would women with experience of overweight and of using a long-acting reversible contraceptive think that it would be acceptable to ask women to delay having their long-acting reversible contraceptive removed to take part in a weight loss intervention before pregnancy; (2) what did health-care practitioners think about that idea, and would they be happy to ask women to take part; and (3) can NHS information (routine data) tell us how many women might potentially take part in such an intervention? We looked at NHS routine data and the research on preconception weight loss interventions. A total of 100 health-care practitioners and 243 users of long-acting reversible contraceptives completed surveys, and 10 health-care practitioners and 20 users of long-acting reversible contraceptives took part in interviews. We found that routine data could not be used to identify people reliably. Designing a weight loss intervention that needed women to delay the removal of a long-acting reversible contraceptive was not acceptable to women. A population-based preconception weight loss intervention with a positive focus was acceptable, but, for such a programme to be delivered by the NHS, health-care practitioners need more knowledge, skills and confidence in talking about weight with patients.

Impact of the COVID-19 pandemic on domiciliary care workers in Wales, UK: a data linkage cohort study using the SAIL Databank.

OBJECTIVES: To quantify population health risks for domiciliary care workers (DCWs) in Wales, UK, working during the COVID-19 pandemic. DESIGN: A population-level retrospective study linking occupational registration data to anonymised electronic health records maintained by the Secure Anonymised Information Linkage Databank in a privacy-protecting trusted research environment. SETTING: Registered DCW population in Wales. PARTICIPANTS: Records for all linked DCWs from 1 March 2020 to 30 November 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome was confirmed COVID-19 infection; secondary outcomes included contacts for suspected COVID-19, mental health including self-harm, fit notes, respiratory infections not necessarily recorded as COVID-19, deaths involving COVID-19 and all-cause mortality. RESULTS: Confirmed and suspected COVID-19 infection rates increased over the study period to 24% by 30 November 2021. Confirmed COVID-19 varied by sex (males: 19% vs females: 24%) and age (>55 years: 19% vs <35 years: 26%) and were higher for care workers employed by local authority social services departments compared with the private sector (27% and 23%, respectively). 34% of DCWs required support for a mental health condition, with mental health-related prescribing increasing in frequency when compared with the prepandemic period. Events for self-harm increased from 0.2% to 0.4% over the study period as did the issuing of fit notes. There was no evidence to suggest a miscoding of COVID-19 infection with non-COVID-19 respiratory conditions. COVID-19-related and all-cause mortality were no greater than for the general population aged 15-64 years in Wales (0.1% and 0.034%, respectively). A comparable DCW workforce in Scotland and England would result in a comparable rate of COVID-19 infection, while the younger workforce in Northern Ireland may result in a greater infection rate. CONCLUSIONS: While initial concerns about excess mortality are alleviated, the substantial pre-existing and increased mental health burden for DCWs will require investment to provide long-term support to the sector's workforce.

Identifying researcher learning needs to develop online training for UK researchers working with administrative data: CENTRIC training.

Background: The 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. Methods: A 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. Results: 107 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. Conclusion: The 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.

The impact of a specialist home-visiting intervention on the language outcomes of young mothers and their children: a pragmatic randomised controlled trial.

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 < .05, 95% CI (0.004-0.20), d = .18. No differences were detected between groups regarding other characteristics of maternal language or children's language outcomes. CONCLUSION: This observational study conducted within the context of a randomised-controlled trial suggests that the FNP home-visiting programme may have a small, but potentially important impact on young mothers' speech to their toddlers. Exploratory analyses identified family environment, maternal, and child related predictors of the language outcomes of young mothers and their offspring. Trial registration This trial is registered with ISRCTN, number ISRCTN23019866, 20/04/2009.

"I don't mean to be rude, but could you put a mask on while I'm here?" A qualitative study of risks experienced by domiciliary care workers in Wales during the COVID-19 pandemic.

Domiciliary care workers (DCWs) continued to provide care to adults in their own homes throughout the COVID-19 pandemic. The evidence of the impact of COVID-19 on health outcomes of DCWs is currently mixed. The OSCAR study will quantify the impact of COVID-19 upon health outcomes of DCWs in Wales, explore causes of variation and extrapolate to the rest of the UK DCW population. An embedded qualitative study aimed to explore DCW experiences during the pandemic, including factors that may have varied risk of exposure to COVID-19 and adverse health and wellbeing outcomes. Registered DCWs working throughout Wales were invited to participate in a semi-structured telephone interview. 24 DCWs were interviewed between February and July 2021. Themes were identified through inductive analysis using thematic coding. Several themes emerged relating to risk of exposure to COVID-19. First, general changes to the role of the DCW during the pandemic were identified. Second, practical challenges for DCWs in the workplace were reported, including staff shortages, clients and families not following safety procedures, initial shortages of personal protective equipment (PPE), DCW criticism of standard use PPE, client difficulty with PPE and management of rapid antigen testing. Third, lack of government/employer preparation for a pandemic was described, including the reorganisation of staff clients and services, inadequate or confusing information for many DCWs, COVID-19 training and the need for improved practical instruction and limited official standard risk assessments for DCWs. Pressure to attend work and perceptions of COVID-19 risk and vaccination was also reported. In summary, this paper describes the risk factors associated with working during the pandemic. We have mapped recommendations for each problem using these qualitative findings including tailored training and better support for isolated team members and identified the required changes at several socio-ecological levels.