Building blocks 2
A follow up to the Building Blocks study published in the Lancet in 2015, this important data linkage project will not involve any further data collection from individual participants, but, instead, uniquely link pre-existing data to track potential longer term benefits of the initial intervention.
The Building Blocks trial assessed the short-term impact of the Family Nurse Partnership (FNP) programme - an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England.
The FNP programme has been shown to reduce child maltreatment in US studies, however this has largely been evidenced in the longer term (beyond the first two years).
Routinely collected data
The Building Blocks: 2-6 study will assess the long term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme’s impact upon child maltreatment.
We have contacted the trial participants to notify them of this follow-on study and they have had the opportunity to opt-out. To date, less than 10 participants have opted out.
This is a data linkage project and will not involve any further data collection from individual participants. Data instead will be accessed from routine data sources held by information centres – NHS Digital (previously HSCIC), Department of Health and Department for Education. Data currently available includes hospital admissions & attendance, social care data and education data.
Upon approval for access to these data sources, the information centres will:
- Match the study participants to their data sources;
- Link hospital, education and social care data for these participants;
- Send this data to SAIL (Swansea University) - our trusted third party;
- The Secure Anonymised Information Linkage (SAIL) Databank will anonymise the data and then make it available to the BB:2-6 study team for cleaning and analysis.
This model of data-linkage offers potential benefits:
- the possibility for long term evaluation of interventions
- lower costs to conduct the study
- reduced participant burden
- reduced bias associated with differential elective participation and
- potential to extend to other sources of routine data.
Involving the public and patients
A group of care-experienced young people (CASCADE voices) advised on the layout, wording and tone of the letter that was sent to participants. A key consideration was to communicate the focus of this follow-on study in a sensitive manner. Their input helped to shape the letter considerably.
Communicating data linkage and the use of routine data for research is a challenge. It is a complicated method to explain but it is important that participants understand what is happening to their data and are reassured with regards to data security.
The first wave of data collection from routine records will incorporate a formal pilot to develop cleaning and analysis scripts. This first wave will be carried out mid-2016. The second wave will be carried out once all children have reached key stage one – in 2017.
A benefit of this project is the understanding and learning of the governance challenges involved with accessing data from information centres. There is potential to use this method for future trials looking at longer term follow-up. Therefore this study has the potential to contribute greatly to the knowledge of using routine data and data linkage methods in a clinical trial setting in the future.
Funder: National Institute for Health Research Public Health Research Programme (NIHR PHR)
Chief Investigator: Dr Mike Robling
Our portfolio of work includes drugs trials and complex interventions, mechanisms of disease and treatments, cohort studies and informing policy and practice.