OPTI-PREM was a mixed-method, longitudinal study comprising five workstreams, underpinned and supported by a Parent Advisory Panel recruited through BLISS, and a Study Steering Committee. Our protocol has been previously published and the project structure is outlined in Figure 1.
FIGURE 1 OPTI-PREM project structure. (Figure not reproduced here; see the original article.)
Research ethics approval
This project was approved by the North East Tyne and Wear South REC 17/NE/0800 on 17 March 2017 [Integrated Research Application System (IRAS) 212304]. Ethics approval for use of the National Neonatal Research Database (NNRD53) for this research was obtained through a proportionate (expedited) review through the NHS Research Ethics Committee (NREC), for workstreams 1, 2, 3 and 5. A full review was conducted for workstream 4. For NNRD data, the National Research Ethics Service (10/H0803/151) and the Ethics and Confidentiality Committee of the National Information Governance Board [ref ECC-05(f)/2010] approved utility of the database. The NNRD was created in 2007 to support activities including audit, evaluation, and research in neonatology, and is maintained by the NDAU at Imperial College, London.53 It is available for use by other investigators. For study purposes, unidentifiable, anonymous data was obtained from the NNRD and transferred to the Wolfson Institute of Preventive Medicine (Queen Mary University of London) using the NHS Net. CAG approval to link the OPTI-PREM data set extracted from the NNRD with NHS Digital Hospital Episode Statistics and mortality was obtained on 7 November 2014 (19/CAG/0104; DARS-NIC-125031-Z3D7S-v0.13).
Consent
All NICU and LNU in England were informed of the study and offered the opportunity to ‘opt out’ of having their unit data included in our analyses. Data on babies from units who opted out were removed before the pseudo-anonymised data set was transferred from NDAU to the study team at the Universities of Oxford and Leicester. Study posters, unit leaflets and parent information leaflets were made available during the study period. Distribution of project details to neonatal units, and unit consent for use of routinely collected unit data captured within the NNRD (for the study period 1 January 2014–31 December 2018), began in July 2017. For the period between August 2017 and August 2018, we were able to include the OPTI-PREM within the UK Clinical Research Network (CRN) Portfolio of research studies. All babies born at 27–31 weeks gestation and admitted for neonatal care were eligible for being recorded as contributing to CRN research activity. As accrual numbers of research participants influence the allocation of CRN research funding to centres, this had a positive effect on unit participation.
Parents of babies who were admitted to neonatal units from the time that we had begun notifying units about the project (July 2017) to the end date of NNRD data capture (31 December 2018) were offered the opportunity to opt out, on behalf of their baby, of the inclusion of their data in the study. Information about opting out was provided through unit posters, unit leaflets and parent information leaflets. It was not feasible to retrospectively seek individual consent from parents whose babies had been discharged from neonatal care before July 2017, when we began groundwork for the project (data period 1 January 2014–31 December 2018). Units displayed information for parents on the NNRD, and the NDAU, which contained information on the general concept of opt-out studies. Additional explicit informed consent was required for the qualitative study in workstream 4, and this is described later.
Study management
Steering Committee
The project was supported by a study steering committee comprising seven members. This was led by a senior academic neonatologist (Birmingham) and included specialists working across England in relevant fields relating to the mixed-methodology study. These were a clinical neonatologist (Bristol), a health economist with expertise in preterm costs of care (Warwick and Oxford), a senior statistician involved in longitudinal follow-up studies in children (Bradford), a senior research engagement officer from BLISS (London), a senior social scientist (Cambridge), and the chief executive of the sponsor trust.
Co-investigators
Co-investigators met 3 monthly initially to refine methodology, and thereafter to share progress within their workstream, and to discuss challenges. Each team worked in parallel. The project team met with the study steering committee 11 times during the project, with additional ad hoc meetings between the project chief investigator and study steering committee chair, to provide updates and share information. Discussions were held about the justification of need for no-cost extensions for the project, and to assist in development of the applications for these extensions. Meetings were co-ordinated through the chief investigator. Workstream 2 supported the development of a PhD studentship, which was successfully completed.