update

A SHED Update

SHED Update here.

Good morning everyone,

Many thanks, again, for all of the time and effort you have put into the Subarachnoid Haemorrhage in the Emergency Department (SHED) study. We have been delighted to see so much enthusiasm and engagement for this study, especially after delays due to the first peak of the pandemic.

However, this new viral variant and resultant third wave of COVID-19 is a further challenge to observational research. A new national lockdown has been enacted. Patients from Kent are being transferred to intensive care units in Devon for capacity. The urgent public health research prioritisation template has been recirculated and it is clear that any level 3 studies will receive little or no R&D support regarding set up, governance, oversight and recruitment.

As a consequence, we have discussed again with the sponsor to review delivery of the SHED study. Unfortunately, we all feel it will be difficult to proceed; the majority of sponsor R&D staff are working from home and are being prioritised to support urgent public health COVID-19 research. Your local R&D departments are likely facing similar challenges. Redeployment of nursing & clinical staff is happening, which will affect both research nurse support and clinical delivery of the study. It appears untenable to proceed at present and we remain concerned about the validity of the research within the current NHS pandemic setting.

We are therefore proposing a further deferral for SHED. We plan to defer until September 2021 for the earlier sites and October 2021 for the majority of sites.

We share your disappointment and can only apologise if rotational placement means you will now struggle to participate. However, we now have a 6-month opportunity to develop research opportunities at further sites, make the necessary amendments and ensure the protocol is deliverable in the context of any recent local changes. We have over 110 sites signed up, so chances are the ED you move to will already be involved. If it isn’t, let us know, and we can work with you to get local approvals set-up so you can hit the ground running.

It is a very difficult decision to have to do this, especially a second time, but we are certain this is the right thing to do. In addition to the above, we will be using the next 6 months to work on our website and consolidate & publish the outputs from recent TERN projects. We will also press ahead with the recently commenced Delphi project, as discussed at the December EMTA conference. You'll receive a SHED update confirming details regarding SHED nearer the time, and we'll work with you throughout.

The infrastructure and funding behind TERN provided by RCEM means that background work can continue and our administrative team can take the hit on paperwork, rather than this falling on the shoulders of enthusiastic individual researchers. This remains a big step forward for EM network research and should help us to deliver on the ideas you put forward, even if there are future hurdles to navigate.

For now, good luck, stay safe and get in touch if you have any queries.

Robert Hirst & Dan Horner