Rapid Set Up of Obstetric Bleeding Study: Lessons from the OBS UK

A Unique Trial Set Up Journey – Obstetric Bleeding Study UK (OBS UK)

OBS UK (OBSUK Study) is a National Institute for Health and Care Research (NIHR) funded stepped wedge cluster randomised controlled trial of a complex intervention for postpartum haemorrhage. It is being fully coordinated by the CTR’s Population Health and Social Care Division. The primary outcome is the proportion of women receiving allogenic red blood cell transfusion for postpartum haemorrhage. OBS UK is a large study comprising three sub studies at set up (now has five sub studies) – a process evaluation, an economic analysis and psychological component. The main study aims to captures data from approximately 189,000 women and birthing people without the requirement of individual level consent and has the appropriate regulatory approvals from the different nations in the UK in place. Individual consent for standard care, implementation and OBS UK post-partum haemorrhage  care will not be sought because the change in management will be delivered at a maternity unit level and therefore to everyone giving birth at that site. Aggregate primary outcome data will be reported by sites for all women and birthing people.

I joined the study team formally on the 1^st May 2023 as the Trial Manager, although I had attended some of the study management group meetings prior to this date, I would certainly recommend this prior to formally starting work on a study as it gave me a huge amount of insight into the study and the researchers involved. The study management group was and is very friendly and supportive. In particular the two Chief Investigators and CTR Study Lead are very hands on, helpful and always willing to answer questions. This was particularly important as the trial required a rapid set up.

For example, when one site was struggling with the reimbursement plan for research nurse funding due to the financial restrictions in place for the site the team were able to find a solution and the site were able to join the study.

The first stop go criteria was to have 30 site contracts signed by the 1^st February 2024, so a nine month set up period, there isn’t an internal pilot. This was a rather daunting task as due to the nature of the design of the study all the sites needed to start data collection together on the 1^st February and 30 sites were required to ensure the study had the statistical power to report the outcomes.

In addition to this, as the main study is UK wide we needed to ensure we had sites from England, Scotland and Northern Ireland. Wales was excluded as the maternity units in Wales were already following the OBS care bundle but 4 sites in Wales did undertake the process evaluation sub study. The inclusion criteria for the sites meant they were in general not the very large research active sites which perhaps was an additional challenge.

One of the Chief Investigators had already identified and communicated with potential sites and Principal Investigators. This in my opinion was invaluable in achieving the goal of setting the sites up. Early in May 2023 we met with the interested sites and asked them to return a site assessment form,  we could only have a maximum of 36 sites in the study. Initially these forms were slow to return but they then flooded in and we ended up having to choose 36 sites, the rest who met the inclusion criteria were reserve sites. Right from the start it was made very clear that if they wanted to be in the study they had to be set up and ready to start on the 1^st February 2024, all sites also needed to be ready to start data collection on day 1 too. This was a message that was repeated and repeated throughout the set period.

Approvals

We applied for ethics approval but also had to apply for Confidentiality Advisory Group (CAG) approval to link and access electric health records in England without consent under section 251 of the NHS Act 2006 and Public Benefit and Privacy Panel for Health (PBPP) approval in Scotland to retrieve routinely collected data, from NHS databases, to provide trial outcome data and collect data without consent. As the application for CAG approval is submitted alongside the ethics application we made the decision to apply for CAG approval and then move onto applying for PBPP approval for the Scottish sites. Northern Ireland do not have the equivalent of CAG or PBPP so we spent a lot of time working with the one site there to ensure they could be included and ultimately came up with a solution.

Site set up

Once we had ethics and CAG approval we made sure all the sites had the full Local Information Pack (i.e. all the documents required to complete local R&D review of the site’s capacity and capability to take part in the trial).  We were in constant communication with them to ensure they had all the relevant documentation and information to get to the point where contracts could be signed. A large excel spreadsheet was created in Teams to track the progress of each site and Sponsor, who were well aware of the tight timeframe ensured contracts were signed rapidly when they were returned by the sites.

Although we didn’t have PBPP approval when we had CAG approval, we began setting the Scottish sites up and updated them on the progress of the PBPP application.

Site induction visits were carried out on Teams with multiple sites attending the same site induction visit.

Success

Ultimately, we ended up with 32 signed contracts by the 1^st February and met the stop go criteria. It was a very steep learning curve with regards to CAG and PBPP and a huge amount of work from the whole team.

Conclusion

On reflection, I believe all the following helped in a rapid set up:

1. Team work.
2. Early communication with sites and the timelines made explicitly clear.
3. Good communication with everyone!
4. Early involvement of chief investigators, principal investigators and CTR study lead as appropriate if issues are discovered during the site set up period.
5. Organisation is essential to ensure progress of each site is tracked.
6. A supportive team and a sense of humour!