Table 1: A summary of the three case studies – BB:0-2 Trial, BB:2-6 Study and LUCI Study.
1At the time of approval; 2The duration of time between submission and signing the data sharing agreement (at which point data can be released); 3Section 251 of the Health and Social Care Act 2012.
| BB:0-2 Trial | BB:2-6 Study | LUCI Study | |
|---|---|---|---|
| Ethical Approval Ref. | 09/MRE09/08 | 14/WA/0062 | 16/WA/0166 |
| Legal basis for linking data1 | Explicit consent | s2513 Ref. CAG 10-08(b)/2014 s42(4) of the Statistics and Registration Service Act 2007 6 (1) of Schedule 2 of the 1998 Data Protection Act | s251 Ref. 16/CAG/0114 |
| Primary Outcome(s) | Subsequent pregnancy; Smoking in late pregnancy; Emergency hospital attendance and admissions; Birthweight | Child in Need status | Renal Scarring |
| Funder | Department of Health Policy Research Programme. | National Institute for Health Research, Public Health Research Programme (NIHR PHR) | Health and Care Research Wales |
| Population | Young mothers and their first-born child(ren) | Children <5 years presenting with acute illness in Primary Care | |
| Study design | RCT | RCT with longer term follow-up using routine data | Cohort with longer term follow-up using routine data |
| Location of data for analysis | Cardiff University server | SAIL data safe haven | SAIL data safe haven |
| Data providers & Timelines2 | |||
| NHS Digital (including ONS) | 5 months (2013-2014) | 18 months (2014-2016) | 4.5 months (2017) |
| Abortion Statistics team | 1 month (2012) | 2 months (2017) | N/A |
| National Pupil Database | N/A | 7 months (2016) | N/A |
| SAIL | N/A | N/A | 5 months (2016) |