Taking Research to New Heights

Taking Research to New Heights

Learn, Share and Aspire.

If I were being really honest, I never expected to be working in the healthcare sector and even more so for the CIRU team. I had initially anticipated working for around 18 months as a Consultant Project Manager for Greater Glasgow and Clyde working with the infrastructure team to aid in the deployment of new hardware and software way back in the ‘Windows 7’ days. I met so many fantastic people, cleaners, porters, nurses, and consultants all with one aim: improving the lives and care of patients. Working for the finance sector across London and Europe, I was accustomed to having all the resources and funding I needed. This was not to be said for the NHS and I felt guilty. I decided then and there I was going to change careers, join the NHS, and make change. Maybe it was fate, but two weeks before I was due to leave, I was asked to apply for a role within the Clinical Trials Unit and so my journey with EDGE and the NHS began.

There I was, zero experience of trials, in fact on my first day I heard the nurses discussing blind trials. Let’s just say I thought they were discussing ophthalmology and that remained a joke for some time. I was tasked with migrating all the patient and trials management information for the Beatson West of Scotland Cancer Centre from the in-house system to EDGE 2, and that’s when clinical trials and all the complexities began to make sense to me. Within 12 months I felt I had never known anything else, and soon thereafter I transferred to the Glasgow CRF to carry out another EDGE implementation and data migration.

The EDGE Aspire Conference 2018 provided the catalyst that propelled my EDGE journey. I listened with enthusiasm to the breakout session by Tracey Hole "Finance- Getting the basics right" and thought we should be doing this. Here I was, back in the office with an old-style costing spreadsheet staring at the ceiling thinking of how to get this square peg into a round hole. I remained undeterred and so the ‘Import Tool‘ was born. That year was amazing, the late nights and long weekends developing, culminated in speaking at the EDGE Connected Conference 2019 and by then I had connected with so many from the EDGE community who saw merit in the work I had completed.

I had not long started working with NHS Lothian when COVID-19 came along, a dreadful time for so many but the research community rallied together to achieve great things. This is when my journey with Mat Davis from UH Dorset NHS Trust began, and having already began work on the new format, I joined forces with Mat. Albeit we were 446 miles apart, it quickly became apparent we had similar life backgrounds and ambitions to help the NHS. In that first 6 months I think we spent more time together than we did with our families and we are both very proud of all we achieved since: the new ICT Tool, the EDGE Assistant, Tracker, and Apportionment Module. He is now someone I consider as a great friend and it’s just a pity we are so far apart, but we do keep each other going. I should also mention a huge thanks to the finance team at Lothian, especially Hugh and Neil and for Monica who works alongside Mat who have been instrumental in the design and features of the tools.

And now to the Clinical Informatics Unit and EDGE. COVID-19 brought a whole new way of remote working and when the opportunity to work with a team I had long admired it was never in doubt. To be honest I have always been part of the team in spirit. I was literally thrown in at the deep end with the launch of EDGE 3 days after joining. It’s been challenging and eventful and there is never a dull moment. My aim here as the Programme Manager is assist the current EDGE user base and attract new Trusts and Networks with a focus on managing their finance. A new area of interest is that of Cybersecurity and maintaining the integrity of the data and improving the process and procedures within the department.

My new role does differ from that of a Lead Admin, but at its core my role still remains the same: to improve patient care and be part of a team where that ethos is already embedded in everything that they do.

My new role, EDGE 3 launch, and looking to the future

My new role, EDGE 3 launch,

and looking to the future

I originally found the prospect of leaving the NHS in which I had spent nearly a decade of my life during my twenties to be extremely daunting, however my passion for research and wanting to deliver change led me joining the EDGE team earlier this year.  Within this very short period of time, we have seen the launch of EDGE 3 throughout the UK, which I will admit has kept the entire team very busy the last few months. It has given me the perfect opportunity to speak to and engage with our Users, and to better understand how they use EDGE daily within their roles, whilst also having the opportunity to see the integration of the wider EDGE community, in regards to how everyone shares ideas an common work practices which has been joyous to see.

As a Client Manager, I oversee several accounts within England along with multiple international accounts. This entails a wide range of responsibilities which include account and project management, listening to User feedback which drives our functionality in an ever-changing clinical research environment, along with offering constant support to our Users through our support email.  But it is the drive and evolution in system functionality where my curiosity truly lies. I really enjoy looking at the ideas that our Users have presented to us, then trying to work out where they sit within the system, and the potential benefit that they could give the community as a whole. This makes us really excited about eventually being able to share with our Users what we have planned for the future, and helping you be able to deliver high quality research work.

Another part of my role that I have really enjoyed is being able to attend research conferences, which has given me a unique position to see multiple aspects of research in both secondary care and the growing research infrastructure within primary care. Coming from a background of conducting research in surgical oncology for nearly 6 years, these conferences have been eye opening to both the successes and difficulties that the wider research communities in the UK face every week. The conversations that occur at these conferences are also incredibly important to how we see change in the continuously evolving research environment. An example of this has been the substantial uptake in Users wishing to learn more about the finance functionality within EDGE and the benefit this will have for their organisations. I am sure finance will be a big focus at the next EDGE conference next year, which I am really looking forward to. It’s going to be my first experience of being part of such a big event and I can’t wait to hear inspiring talks from our Users. I hope to see you there!

The Year Ahead

The Year

Ahead

by Baljinder Gill, Head of Operations & Delivery

I started at the Clinical Informatics Research Unit in 2015 after many conversations with Professor James Batchelor, CIRU Director, who back in 2014 was advising me on the informatics challenges to support the 100,000 Genome project - University Hospital Southampton (UHS) were one of the Genomic Medicine Centres. I remember having a cup of coffee with him and in passing he said he was looking for a new Head of Operations and Delivery to support the rollout of EDGE nationally and internationally. Moving from the Hospital to the University was an important decision for me, and over the 7 years I have been in the CIRU, it’s been a challenging but very exciting role, working with a dynamic and skilled team and the growing EDGE community. I have seen the EDGE Programme go from strength to strength and am very excited for the future of EDGE. Our other CIRU services have developed over the years as well, adding value and opening up exciting times for the Unit as a whole.

We have a big year ahead with the launch of EDGE 3 being our primary focus and are thrilled that the rollout of the LIVE new version has begun with sites in South Africa. The EDGE team are now hard at work preparing things for further EDGE 3 LIVE launches to the rest of our subscribers globally and I know there is much excitement around the subject of EDGE 3. This year will also see changes to the UK’s Clinical Research Networks and the EDGE team will be on hand to support these changes.  

This year we also plan to continue strengthening our team by improving and creating roles across the Unit to ensure we can provide the best service to our clients and improve our offerings to the research and healthcare world. This has already included additional job roles for the EDGE Knowledge team including three new Client Manager posts. The new post holders will be working closely with our CORE team who specialize in eCRF’s and electronic forms for research. CORE are also involved with high profile studies that have been gaining a lot of media attention lately and have expansion plans in place for this year to help opportunities grow further.

The AXIS (Access Extract Integrate Safe Data) team has significantly grown with the inclusion of two new Analysts, expanding their capabilities and skill sets. AXIS are working on and managing 20+ projects from national collaborative projects such as Health Informatics Collaboratives to local ground-breaking research initiatives. Through the delivery of these projects they have formalised data extraction pipelines, workflow processes, and created tools to identify more efficient methods of working. AXIS are also playing a lead role in the Wessex Secure Data Environment pilot and are also in the process of hiring another two analysts over the coming months to continue their trajectory.

There are busy times ahead for other departments within the Unit who are more research focused, including the IBRN (International Blast Injury Research Network). Following two successful funding applications, the IBRN have two workshops set for 2023 which focus on the health consequences and blast engineering aspects of the 2020 Beirut Blast and mass-casualty explosive events. The IBRN is establishing a World Universities Network dedicated to urban blast research, alongside continuing projects investigating injuries and health system responses following the 2020 Beirut Blast. Early this year, the IBRN will be re-visiting its scope and vision to reflect current and emerging priorities to drive future research and activities of the Network. The IBRN continues to support the activity and research of its members through regular meetings and online seminars.

Resident media savvy Dr Michael Head, Senior Research Fellow and the Lead for RESIN (Research Investments in Global Health), is currently looking at the impact of the pandemic upon funding trends for cancer research. Michael has also been involved in research for COVID-19 and most recently the War in Ukraine, alongside colleague Dr Ken Brackstone. The pair are also leading on several projects in Ghana across 2023, including the priority areas of climate change and health. They will be working with their policy and advocacy networks, including the Ministry of Health, WHO, UNICEF, and the British High Commission. Michael is also working with the Social Impact Lab to take the first cohort of UoS students to Ghana, as part of the new Spark Ghana programme.

CIRU will be welcoming further Digital Health Fellows from Sri Lanka and International Research Fellows from other areas of the world, with whom we will be working in close collaboration. I can see further connections taking place across the globe as our Director James continues to spread the ‘CIRU’ word to whomever he meets throughout his busy work schedule.

It has certainly been a year of highlighting the Power of Data and, more importantly, the aspect of sharing data knowledge and expertise.

Looking back to that cup of coffee with James in 2014, I realise what a fortuitous conversation that was. I have had the pleasure of seeing our dynamic and skilled staff in the Unit develop and flourish supporting the clinical research community, a community which through the COVID-19 pandemic showed how the phrase “Strength through Collaboration” has never been more apt.

Looking forward, I see a very exciting year ahead for us here at CIRU and I look forward to the community joining us on the journey ahead.

The CIRU 2022 Retrospective

The CIRU 2022 Retrospective

2022 wrapped up!

This year has been another busy, exciting, and challenging year within the CIRU with one big focus on everyone’s horizon: EDGE 3!

The year kicked off with a flurry of snow and activity at CIRU with our early phase EDGE 3 user engagement, which involved 15 of our EDGE Super Users from across the globe. We gave these select folks a sneak peek under the hood of what we had been working on for the last two years. From their keen eyes we got fantastic feedback and it helped shape our Development roadmap for the rest of the year. To keep close tabs on this work, our Knowledge Officer Nicky Morris stepped across to work as our Product Manager overseeing all aspects of the EDGE 3 build and launch.

Our Marcomms team, Beth Mathis and Gela Jenssen, have been in full force through the year preparing a plethora of new materials for our Users and EDGE 3. Most excitingly, we have seen the launch of two familiarisation videos for all Admins and Users to help guide them through the new look and feel of EDGE 3.

We completed a significant project in late August when we moved the last of our global hosting structures into the Microsoft Azure Cloud. This last piece of the puzzle completed a two-year project for our Infrastructure Specialist, Lawrence Surey, and Development Team Leads, Dave Miller and Andy Bush.

Since late October our Knowledge Team have been working flat out with each of their UK CRN’s and International partners to demo EDGE 3 UAT. Whilst we would all liked to have been looking at the EDGE 3 launch in the rear-view mirror by Christmas, we are entering 2023 at an exciting time with the production launch only a short while away.

We sadly said goodbye to some fantastically talented members of our team in 2022 as Kim Harris and Richard Munday moved on to new roles. However, we welcomed some new faces into the CIRU with Melanie Williams arriving into our EDGE Knowledge Team in the first of our new Client Manager posts. There was a new arrival in our CORE team with Nadine Nowe-Andrews joining us in mid-summer and shortly after, the Development Team welcomed Ian Blunt in late August.

So as 2022 rounds off it must be said that we are extremely grateful to all you out there who have helped us evaluate EDGE 3 and have provided us with your experience, knowledge, and time to help ensure we are building you a product we are all proud of.

We look forward to working with you more in 2023 and wish everyone a very Happy Christmas and New Year.

My NHS & Research Journey

My NHS & Research Journey

Read about the latest new team member, Melanie Williams, who joins us from 20 years in the NHS!

Having just completed my twentieth year working for the NHS, I decided to take up the challenge of joining the CIRU team and becoming part of the EDGE Programme as a Client Manager. What led me here? I thought I’d share my journey.

I started out in the NHS as an Appointment Coordinator for two-week wait cancer referrals and after a couple of years, I progressed to become the first UHS Multi-disciplinary Team Co-ordinator for the breast team. I enjoyed this very much, but research came-a-calling when some folks who attended the MDT meetings picked up on my organisational skills, love of lists, and ‘chattiness’, and I’ve never really looked back.

I became a Clinical Trials Assistant and started out working on breast and haematology cancer studies, mainly completing clinical report forms, resolving data queries, and managing site files. As my confidence in the role grew, I asked to attend clinics and became patient-facing, leading recruitment on observational and quality of life studies, as well as working with a fantastic team of research nurses on CTIMP trials.

This is where my love for research really grew. I’ve seen research reap rewards – it works. Being able to contribute towards research that has changed ‘best’ practice and improved the lives of patients and their families has been incredibly rewarding. I think really, I should say I’m passionate about research. I believe all patients should be invited to take part in research if possible. Research gives patients a chance to learn more about their condition and to try new treatments or devices. For most patients, it also helps them to know that their engagement in research provides future patients with a better chance of improved health and social care. 

Research introduced me to EDGE through working on observational, QoL, and CTIMP studies. I found EDGE invaluable whilst working on these – not only did I have immediate access to patient-related documents like PIS, consent forms, and GP letters, I could also update my recruitment data in real-time with patient demographics as well as study-specific identifiers and keep the patient status updated from pre-screened through to completed or off study. This was really time saving when I could complete this data whilst in clinic between patients. It was also super handy being able to download reports via the Excel and PDF features to prepare recruitment reports which I presented at study meetings.

Now that I have moved to CIRU, I’m hoping my experience of being an end user of EDGE can help when dealing with client and user needs. I can see the importance of innovation in the clinical research setting (the roll out of EDGE 3 being one of these), and how fast paced research has become, which is vital to organisations, staff, and all research participants.

Patient information & data linkage

Across the UK I don’t think there are 2 hospitals that collect exactly the same information about patients and participants on EDGE, each organisation varies. This is usually dependent upon a number of factors including size of the organisation, what their research portfolio looks like, other IT infrastructure already in place and lastly the depth of the implementation of EDGE within clinical teams.

There is also a clear emerging trend in interest from the Department of Health about what the national research portfolio looks like in depth, originating out of reports such as the Children, Teenage and Young Adults Cancers report, collated by the National Cancer Registration and Analysis Service.

Collecting Dates of birth, or age, on EDGE in order to comply with the CTYA reports as well as to expand this further than Cancer have come up in more and more discussions over the past year and this has often raised the question about collecting the data in EDGE. Some Hospitals allow their staff to collect patient identifiable information in EDGE, others do not and this is wherein part of the challenge lies. Whilst EDGE is capable of collecting the data, the next challenge is getting the Caldecott Guardian to understand and authorise this process. Even once you are at this point, the final challenge is to ensure clinical staff actually enter the data.

Capturing patient information on EDGE has often been misconstrued, a few examples of which I will give:

We once had a call to our office from a Chief Investigator demanding that we delete all the data relating to their research from EDGE, because it was their data, not ours. We explained that it is actually the hospitals data, not the CI’s and certainly not the EDGE teams. The data is collected by the hospital in a system they contract the University of Southampton to provide, in order to manage the delivery of their research services.

In the past I have spoken to an R&D department who would not let clinical staff enter any patient identifiable information because the R&D department did not need that information. This is in itself a very interesting point and one that is easily misunderstood. Historically R&D systems have been silo’s of information only capturing information relevant to R&D. EDGE expands across the boundary from R&D to Clinical teams, providing a platform for clinical staff to track and manage their patients through the life of the project, aiding those clinical staff in providing their legal duty of care to that patient. Therefore clinical staff entering patient identifiable data is not for R&D, but for their own duty of care.

Interestingly, this leads on to the discussion of consent. A number of Caldecott Guardians that I have spoken to who have prevented staff from capturing patient identifiable information on EDGE have done so with the justification that the patient has not consented to have their information stored. This is where there can be an easily confused line between patient care and research. The patient data being stored on EDGE is not answering the research question, the data for which goes into the Case Report Form and subsequently to the sponsor. The data in EDGE allows the clinical staff to provide direct care to the patient, the terms and legal justification of which can often found under an organisations Privacy Notice. The data is also not being given to the University of Southampton, we are simply providing a contracted service for the provision of the system.

Once you reach the point that R&D and the Caldecott guardian are on board, now the real challenge comes to engage the clinical teams. This can be extremely challenging and can vary on a team by team basis, for example, some teams may already have access to IT systems that meet all their needs, whether these are bespoke systems or products such as the calendar in Microsoft Outlook. A misconception is that the Electronic Health Record system in a hospital captures all the information needed for patients. In standard care that might be the case, but often not in research, leading to clinical staff keeping having to find combinations of other systems to use. From my experience, clinical research staff tend to keep a lot of spread sheets to meet these needs and this is where, when implemented in depth, EDGE can replace the need for a lot of those other systems. Thereby providing a useful tool to the clinical staff and cutting down on data duplication.

Now, if the clinical staff are able to use EDGE to facilitate them in managing their research, and NHS numbers can be recorded, this opens up the door to many opportunities for data linkage to answer the questions from the Department of Health and other bodies. A simple NHS number, combined with NHS Spine could mean that supplementary information such as Date of Birth do not need to be captured on EDGE (if the clinical staff  don’t need it for the patients care) as this can be provided through data linkage.

Using the NHS number alongside patient records is something that has been encouraged for a long time, with the Information Governance Alliance advising ‘The NHS Number should be used in Health and Social Care Organisations and environments as long as the purpose is to communicate with those who are involved in providing care’.

Or alternatively the previous NHS Medical Director Professor Sir Bruce Keogh, who was the Senior Responsible Officer for the NHS Number Programme, saying: “We should no longer accept the level of misallocated records and the misidentification of patients as inevitable or normal.  We must change the way we work and identify all patients by their NHS Number which will reduce potential errors and harm in the future.”

The NHS Business Services Authority takes a similar stance in their ‘Pseudonymisation and anonymisation of data policy’, ‘If patient data is required the NHS Number is the most secure form of identifiable data. The NHS Number should be included within all patient records and documentation in line with the current Connecting for Health NHS Number Campaign.

And finally, in the NHS Standard Contract 2017/19 and 2018/19 Service conditions, it states:

‘NHS Number

23.4 Subject to and in accordance with Law and Guidance the Provider must:

23.4.1 ensure that the Service User Health Record includes the Service User’s verified NHS Number;

23.4.2 use the NHS Number as the consistent identifier in all clinical correspondence (paper or electronic) and in all information it processes in relation to the Service User; and

23.4.3 be able to use the NHS Number to identify all Activity relating to a Service User.’

I have written this not to enforce any organisation to use the system in any particular format, but instead to show that there is a legitimate argument to collect certain information which in turn could provide benefit to system users, as well as being able to easily link data to provide reporting capabilities that future proof research reporting, both locally and nationally. However, it is up to each organisation to choose the functions within EDGE they use, and I hope that if this is a path you wish to take, that this has been helpful.