Abstract

BackgroundFollow-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.MethodsWe 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.ResultsOf 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.ConclusionsThrough 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.

Highlights

  • Follow-up for public health trials may benefit from greater use of routine data

  • We have previously reported on the Building 2–6 study (Blocks) (BB:0–2) trial of a nurse-led home-visiting intervention, the Family Nurse Partnership (FNP) being delivered to teenage first-time mothers living in 18 sites in England [3,4,5,6]

  • Over 1600 women participated in the trial, which randomly allocated women to either usually available supportive health and social care alone or visits provided in addition to usual care from specially trained FNP nurses from the end of the first trimester until their first child was aged 2 years

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Summary

Introduction

Follow-up for public health trials may benefit from greater use of routine data. Our trial of a homevisiting intervention for first-time teenage mothers assessed outcomes to the child’s second birthday. Achieving a successful start in life can be challenging for children born to teenage mothers who themselves may struggle to achieve longer term socio-economic stability [1, 2]. We have previously reported on the Building Blocks (BB:0–2) trial of a nurse-led home-visiting intervention, the Family Nurse Partnership (FNP) being delivered to teenage first-time mothers living in 18 sites in England [3,4,5,6]. The BB:0 trial made use of routinely provided healthcare data which was used solely or in combination with other data for both primary and secondary outcomes, enabling more data to be available for analysis compared with just self-report data

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