Suchergebnisse

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

BackgroundPOOL 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.
AimWe 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.
MethodsThe 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.
ResultsThe 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(<0.1% missing). The datasets could link using the studyID generated by the third party.
ConclusionThrough study set-up and in this pilot, we provide evidence that the main study is feasible, satisfies governance requirements and likely to generate data of sufficient quality to address our main research questions.

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

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

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

Background
Stillbirths are reported as one of the most neglected tragedies in global health, with around 2m stillbirths occurring annually and the majority occurring in low- and middle income countries (LMICs). Many antenatal stillbirths are due to preventable conditions such as maternal infections and non-communicable diseases. Almost half of all stillbirths occur during the intrapartum period, with many linked to obstetric complications. Known risk factors for stillbirths overall include young or advancing maternal age, fetal infection, maternal hypertensive conditions, perinatal asphyxia, history of previous stillbirth, obstetric complications, intrauterine growth restriction and abruptio placenta/placenta praevia. Common non-clinical risk factors include lack of education, socioeconomic deprivation and substandard antenatal care.
Methods
A single site prospective observational study conducted over three-months was conducted in a tertiary referral hospital in Kano, Nigeria. Eligible participants were mothers presenting at the site in labour and their babies.
Demographic and clinical data were collected by paper-based questionnaires. Data were collected on living environment, health and medical history, pregnancy history and pregnancy/birth factors. Each mother answered pre-delivery questions, with potential follow-on questions dependent on birth outcome. Further data points were collected from clinical observations. Photographs were taken of stillborn babies to support data collected and to aid the UK team on classifying degrees of maceration in an attempt to identify antenatal and intrapartum fetal death.
Findings
Higher odds of stillbirth were associated with low levels of education, a further distance to travel from home to the hospital, living in a shack, maternal hypertension and having had a previous stillbirth after adjusting for all sociodemographic and health features. Higher odds of intrapartum stillbirth included; shoulder presentation, compound presentation and breech presentation compared to cephalic presentation. Other birth related factors associated with higher odds of stillbirth included reported birthing complications, duration of labour being >=18 hours), antepartum haemorrhage, prolonged/obstructed labour, vaginal breech delivery, emergency Caesarean-section delivery, and signs of trauma to the neonate.
ConclusionsIdentified risk factors associated with stillbirths are relatively amenable to intervention and a lot of work has been conducted globally, so the development of intervention with sufficient funding should be a relatively rapid process.
For collaborations please contact: Email: miltonrl1@cardiff.ac.uk