Building Blocks Trial - Data Archive

HES data was supplied to Cardiff University for processing for the purpose of the Building Blocks study.

This study is now completed and closed.

In order to comply with MHRA guidance and policy on good clinical practice, the data will be securely archived to ensure it is possible to verify the conclusions published from this study.

This agreement permits processing of the data for the purpose of secure storage and back up.

This agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement. Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Cardiff University, contact via the publishing journal or an open letter. In such circumstances, Cardiff University may re-run the previously analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published. Cardiff University may not use the data to undertake different analyses to those undertaken during the original analysis.

This agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA maintains a list of all clinical trials registered with them and reserve the right to audit the trial at any point from when the trial is opened until 5 years post trial closure. A sponsoring organisation and/or the data controller itself may also exercise the right to audit.

If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation the applicant must submit an amendment request to NHS Digital before data is accessed.

For reference only, the following describes the objective for processing before the data was archived.

The Family Nurse Partnership programme (or FNP) offers young mothers having their first baby support from a Family Nurse. The nurse visits the woman at home during pregnancy and until the baby’s second birthday. As FNP has been shown to help young families in the USA the government have introduced it in England.

FNP aims to help young mums to:

•have a healthy pregnancy

•improve their child’s health and development

•plan their own future

Building Blocks was a study of how well FNP works in England. 1,645 pregnant teenagers joined the study between 2009 and 2010.

Women were split into two groups. One group was offered FNP and one group had usual care from Health Visitors. All women in the study also had maternity care and any other extra support available to young families in their area.

The study looked at how well the mothers and babies were doing up until the baby’s 2nd birthday.

Actions have been taken to pseudonymise the original Building Blocks trial data. These included converting baby’s date of birth to week and month of birth. Cardiff University separately holds the identifiers and trial data for each participant for the purpose of a separate follow up study, ‘Building Blocks 2-6’. The Building Block 2-6 cohort is a long term follow up of the original Building Blocks cohort. Both use the same cohort but they are separately funded projects, with separate ethics applications. The dataset for the original Building Blocks study is securely archived in a data safe haven which prevents the download of individual data and linkage to identifying data items and will not combined with any data from ‘Building Blocks 2-6’.

This study is now completed and closed.

This agreement permits processing of the data for the purpose of secure storage and back up.

This agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement.

This agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA).

If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation the applicant must submit an amendment request to NHS Digital before data is accessed.

The clinical data (used for analysis and now to be archived) is stored on CU servers with only a trial ID to identify and link participants across datasets. The data subjects' identifying details and contact details are held separately and access permissions do not allow for any staff member to access both clinical and identifying data files.

In line with Cardiff University’s Standard Operating Procedure (SOP), the archived data will be held on Cardiff University, CTR secure server and made available only to the CTR designated Electronic Archivist (EA). Therefore, all project data will be moved from its current location to this archive area on the shared drive. Access permissions will restrict access only to the EA.

In the event that the data needed to be accessed for the purposes of audit or to enable verification of previous findings, the dataset would be transferred back to the CU servers with authorisation from the Principal Investigator where it can be accessed by the study statistician only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.

The data may not be transferred to any other location and may only be accessed by substantive employees of Cardiff University for the purposes described above.

Under the previous Agreement with NHS Digital access to the data was permitted for both Cardiff University and York University. York University is no longer permitted to access the data and has confirmed destruction of any data it accessed under the previous Agreement.

The data originally requested from NHS Digital was for use in the Building Blocks Trial [ISRCTN 23019866]. Inpatient, Outpatient, A&E datasets were used to follow-up mothers recruited into the study and their babies, up until the baby’s second birthday and these were the main source for two of the primary outcomes (and several secondary outcomes).

This archive agreement is required for the following reasons;

(1) The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit;

An audit may be required during the period of this agreement. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.

(2) Further analysis is expected on these datasets in future;

Any further analysis will only take place following an amendment to this Agreement that would allow further processing of the data.

(3) Clinical trial data needs to be retained and accessible for 15 years after trial completion this requirement would be subject to further data extension requests – no data will be retained without an Agreement being in place.

This study is now completed and closed.

The following description of outputs is for information only and the processing of the data occurred before this current Agreement.

No new outputs will be produced using the data under this agreement.

The results have already been presented to the funder (in Spring 2015), the main trial paper has been submitted for publication and results have been presented at conferences from September 2015. Further methodological papers and exploratory analyses were published throughout 2016-2017.

The analysis and paper on infections using A&E and Inpatients data and subsequent pregnancies has been drafted and will be published in 2017/18.

To date the conferences in which the trial results were presented include the Public Health Wales Conference on Nov 3rd and the Royal College of Midwifery Conference on 10th/11th November 2017

Journal articles include;

• Corbacho B, Bell K, Stamuli E, Richardson G, Ronaldson S, Hood K, Sanders, Robling M, Torgerson D. Cost-effectiveness of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial. Journal of Evaluation in Clinical Practice 2017; 1-8. 2017 doi: 10.1111/jep

• Channon S, Bekkers M-J, Sanders J, Cannings-John R, Robertson L, Bennert K, Butler C, Hood K, Robling M. Motivational interviewing competencies among UK family nurse partnership nurses: a process evaluation component of the building blocks trial. BMC Nursing 2016 15:55. DOI: 10.1186/s12912-016-0176-0

• Robling M, Bekkers M, Bell K, Butler CC, Cannings-John R, Channon S, Corbacho Martin B, Gregory JW, Hood K, Kemp A, Kenkre J, Montgomery AA, Moody G, Owen-Jones E, Pickett K, Richardson G, Roberts ZES, Ronaldson S, Sanders J, Stamuli E, Torgerson D. Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial. The Lancet, vol. 387, Issue 10014, pages: 146-155. 2016.

• Stamuli E, Richardson G, Duffy S, Robling M, Hood K. Systematic review of the economic evidence on home visitation programmes for vulnerable pregnant women. British Medical Bulletin 2015 115:19-44

• Robling M et al. Evaluating the Family Nurse Partnership Programme: Main Results of The Building Blocks Trial. Presentation to the Welsh Public Health Conference, November 2015, Cardiff.

• Confidential results consultation with Policy, Practice and Academic Stakeholders (England, Scotland, Northern Ireland, US), June 2015

• Public stakeholder meeting on Building Blocks Trial Results, January 2016

• Foundation Years Information and Research: Seminar Series (x3 meetings): Portcullis House, Westminster 2017

• Feedback of main trials findings to Building Blocks Study participants (mailed leaflets), October 2015

• Evaluating the long-term effectiveness, and the cost and consequences of the Family Nurse Partnership parenting support programme in reducing maltreatment in young children. Robling MR et al.

Lugg-Widger F, Cannings-John R, Channon S, Fitzsimmons D, Hood K, Jones KH, Kemp A, Kenkre J, Longo M, McEwan K, Moody G, Owen-Jones E, Sanders J, Segrott J, Robling M. Assessing the medium-term impact of a home-visiting programme on child maltreatment in England: protocol for a routine data linkage study. BMJ Open 2017; 7:e015728. doi:10.1136/bmjopen-2016-015728.

• BABBLE: Establishing the impact of specialist home-visiting on children’s language development and parent-child interaction: development pathways to later adverse outcomes

This data will be retained to comply with guidance and policy on good clinical practice and regulations. It also preserves a unique database which could still yield future benefits for young families by looking at the effects on children in the longer term.

The main findings were;

•FNP did not reduce the number of women that smoked in pregnancy. In both groups 56 women out of every 100 smoked late in pregnancy.

•FNP did not reduce the number of small or premature babies. In both groups the average baby weighed 7lb 1oz.

•FNP did not reduce the number of women getting pregnant again within two years. In both groups 66 women out of every 100 were pregnant again within two years.

•In both groups nearly 80 out of every 100 children were seen in hospital as an emergency before their second birthday.

•FNP was found to be more expensive than usual care.

Other findings were;

•About four in every 10 mothers in both groups breastfed their baby.

•By two years of age around one in 10 children had needed a trip to A&E because of an accident or swallowing something they shouldn’t have.

•Social services had been involved with 14% of children allocated to FNP and 8% of children allocated to usual care.

•Children in the FNP group had better language skills than children who got usual care only.

These findings were used by the department of health to decide how best to support young families in England.