Clinical Informatics Research Unit Update

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We would like to take this opportunity to give you all an update on what is happening here at the Clinical Informatics Research Unit (CIRU). 

We would like to warmly welcome Dr Mike Head and Dr Rebecca Brown into the department. They are both Research Fellows at the University of Southampton and are currently running the ResIn study.

The Research Investments in Global Health study (ResIn) is funded by the Bill & Melinda Gates Foundation. The project previously focused on the UK research landscape and published widely on the strengths and gaps in the UK research portfolio for both infectious diseases and oncology. Levels of investment have been compared to global and national burdens of disease to gain an insight into relative levels of spend and inform priority-setting initiatives. Now, ResIn is building a global dataset and analysing funding trends and disease burdens for infectious disease research across the G20 nations and will report findings in 2018. The study, and results to date, have been presented multiple times to many high-level global health stakeholders including the World Health Organisation, European Commission and the Wellcome Trust. Findings have also been cited by others in numerous documents including journal publications and government reports.

See http://researchinvestments.org/ for more about the project.

Written by Dave Osler, Head of Knowledge, CIRU

A trip to the EDGE office

Visveswaran Mallayan, Leicester NHS Trust

We had Viswin Mallayan, Research and Innovation Information Manager at University Hospitals of Leicester NHS Trust join us in the EDGE office a few months back and we thought we would share his story with you:

"I had the great honour of working with the EDGE team in Southampton last month, where I spent my time sharing and gaining knowledge reporting in EDGE and Microsoft Power BI, as well as presenting two webinars on “'Using EDGE and Microsoft Power BI to provide intelligent reports and improved business decisions” to a Canadian Team and all the UK NHS trusts.

I have been an EDGE user for over 18 months and use the system to capture recruitment data and prepare reports for senior management and clinical management groups. I utilise EDGE in conjunction with Microsoft Power BI to provide intelligent reports and help shape and inform clinical management groups’ decisions.

EDGE is one of the best tools with greater flexibility for the end user. This means we are benefiting as we can use the system as an intelligent data management tool to fully integrate information from all departments to produce meaningful and quality data for outcome analysis.

Leicester’s Hospitals uses Microsoft Power BI as a primary reporting tool for research data and we are working with the EDGE team to make common Microsoft Power BI dashboards where any Trust using Edge can see their performance (similar to open data platform).

Since the EDGE Accelerate conference in March of this year, my colleague Carolyn Maloney has guided around 20 NHS trusts in the UK on how to use EDGE for Clinical Research." 

EDGE Case Study by Helene Jones

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The Lincolnshire Clinical Research Facility facilitates the implementation and management of clinical research for the United Lincolnshire Hospitals Trust across its multiple hospital sites within the large rural county of Lincolnshire in the East Midlands. The research undertaken within the trust encompasses a wide range of therapeutic areas including oncology, haematology, stroke, cardiology, paediatric, dermatology, diabetes, midwifery, ophthalmology, respiratory, anaesthesia, gastroenterology, renal and orthopaedics. The breadth of research disciplines managed by the research facility and the diversity of hospital sites within the trust called for a flexible clinical trials management system to support its continued growth and build upon operational processes. In April 2016 ULHT implemented EDGE across all of its sites providing a fully-integrated data platform for the benefit of clinicians, research nurses, radiologists, pharmacists and other research professionals, supporting their clinical research and providing real-time trial data and business intelligence.

The nature of research in the region is influenced by the diverse needs of a population and healthcare system in the large rural county of Lincolnshire, and Lincoln as one of the fastest growing cities in the UK. The trust needed a system to provide the flexibility to manage differing scales of operations and the requirements of individual units within its organisation but maximise communication, and provide consistent metrics and reporting. One of EDGE’s greatest qualities is its adaptability which makes it so flexible in managing the complexities of clinical trials and the range of contexts in which they are conducted. 

EDGE is an application which is logical and scalable. During the implementation of the CTMS within the organisation we were able to train and roll out the application around the busy work schedules of the research teams and do this in a stepped process by site. The software is user-friendly yet provides powerful functionality and the option to adapt the application, at multiple levels, to meet the needs of the organisation. A core strength of the system is its flexibility for end-user process adaption, allowing individuals and trusts to creatively develop their particular instance. This in turn contributes to the evolution of EDGE through the perspective of sites and researchers who understand evolving operational needs the most and builds benefits for the EDGE community. The developers have cleverly, through the provision of an attribute based system, created an application which is future-proofed and keeps pace with evolving processes. We can build on the global knowledge of users across the UK and beyond in how we can better use data and systems in the delivery of efficient clinical trials. The role out of the system within our Trust has also provided the unanticipated yet immeasurable benefit of engagement with the wider community of EDGE users in delivering research and in sharing best practices, both in terms of the application itself and sharing research ideas in general. 

Within the United Lincolnshire Hospitals Trust we use EDGE to support the setup, feasibility and approval process for studies, track recruitment, manage patient visits, record resource, interventions and inter-disciplinary departmental involvement such as logging studies requiring ECGs, RECIST criteria, all blood sciences requirements etc. We also use EDGE for substantive reporting and monitoring of metrics by maximising the use of core EDGE reports alongside bespoke attribute reporting at a study level, site level and patient level. We are also seeking to develop the system as a trial evaluation tool and workforce management application. 

EDGE has provided ULHT with an IT platform to support its strategic planning and growth, enhancing its reporting, communication and trial management to support enhanced participant engagement and patient outcomes. All this supports the delivery of efficient clinical trials. The following principles demonstrate the benefit of EDGE for individuals, trusts, networks and the NHS.  

EDGE provides; 

1. Complete flexibility to support specific needs of trusts, sites and individuals in managing clinical trials.
2. Creative power for trusts and sites to develop their own instances to meet local needs.
3. an EDGE community who collaborate to collectively evolve the system.
4. a system which is developed through the perspective of the end users who understand their individual needs the most.
5. a robust and secure integrated system and data set for enhancing operational delivery at trust, regional and national levels.

Post by Helene Jones, Research Support Officer
United Lincolnshire Hospitals NHS Foundation Trust

Helene.Jones@ULH.nhs.uk

A blog post from an EDGE user- Using EDGE to manage a complex primary care study

My name is Randeep Basra and I am a Clinical Studies Officer for the Clinical Research Network in North West London. I am part of the delivery team that helps with the setup and support at primary care sites and recruitment of participants for research projects that I am assigned to work on.

One of the projects currently in progress is iHealth-T2D, a multicentre, cluster randomised clinic trial on type 2 diabetes in the South Asian population. The study looks to provide evidence that the implementation of lifestyle modifications and health promotion is clinically effective in reducing the onset of type 2 diabetes in South Asians with central obesity or pre-diabetes compared to usual care. Managing the study has brought on some complex and challenging situations in terms of project management, where communication, organisation and team work has been key to the success we have experienced so far.

This has been helped significantly by the use of EDGE. In the early stages, large amounts of information about the study was kept in a number of places that were not so easy to access and were becoming difficult to manage by the team as a whole. An example of such information was the staff involved and their contact details, information about clinics being run at GP practices and patients recruited, just to name a few. When hearing about EDGE, we felt it could work to solve these issues.

Since then, we haven’t looked back. Once the process of uploading all the information to EDGE had taken place, we found it straightforward to access and the layout easy to navigate. We are able to effortlessly store different pieces of information about the project or primary care sites in one place that everyone can see. For example, I can find a particular recruiting site in a couple of clicks and can access information on how many patients were contacted from a particular site and on what date, when screening clinics are running and how many participants have been recruited so far. The outcome is that everyone is able to look at and maintain up-to-date information about the study from a single place from almost any location at any time.

Knowing that I can add users and have the contact details of any member of staff from any of the 50+ GP practices taking part is reassuring and allows a smooth stream of communication with everyone involved. Personally, the “notes” section is a highlight for me, as being able to communicate updates about an individual site for everyone to see in a free-text box saves time on administration and permits flexibility depending on what information can be stored here. Although it is not necessary to upload patient information to EDGE for our team, I have found using anonymous codes for each patient recruited at GP practices has been a safe and fool-proof way for me to keep an accurate record of how many participants are engaged with the study. Last, but certainly not least, the “project attribute reports” have been wonderful when requiring a snapshot of the study for team meetings and to assess data quality.

This hasn’t just been useful for me the delivery team – other staff who support the delivery team have found it a great way to pull off information from the system when it comes to arranging financial payments or tracking recruitment. In fact, this study was the first we have tried to store financial information on and while this is work in progress, it has been very useful so far. In this way, the whole team can be singing from the same hymn sheet without the need for endless spreadsheets and hard-to-follow email trails.

We would like to give a special thanks to Kaatje and Sean for all the support we have had in making this system work well for the project. We feel the adaptability and brains of the system, as well as the people behind it, are what make it work for us.

Here is a shot of the team who have all been involved in delivering the study.

Here is a shot of the team who have all been involved in delivering the study.

Post by Randeep Basra, Clinical Studies Officer
CRN North West London
randeep.basra@nihr.ac.uk

Read an article from us

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You can find an article from our director James Batchelor in this months International Clinical Trials magazine. The title of the article is 'Strength through Collaboration', where James promotes research teams coordinating both nationally and internationally, in safely changing routine standards of clinical care to improve patient quality of life. 

This piece can be found here and has been taken from International Clinical Trials May 2017, pages 24-26 © Samedan Ltd

Visit the contents page of the current issue of PMPS here

 

Global Cyber Attack- advice for our users

As you may all be aware, there was a global cyber attack on Friday causing problems across the NHS.

EDGE is hosted at a secure Tier 4 centre at Carelink, one of the highest level of secure centres available. The EDGE service was not impacted by the attack however, as a precaution we decided to temporarily stop access to the EDGE service on Friday evening to allow time for the threat to be better understood and reduce the risk of any impact to the EDGE service. On Saturday morning after further assurances, access to EDGE was resumed.

This was done purely as a precautionary measure.

We would advise that all NHS staff follow the guidance given by their organisation regarding security patches, run windows updates on all machines and continue to keep all computer systems up to date with anti-virus software releases. Further to this we recommend for those trusts who are running Windows XP to contact their IT department to update to Windows 10 as an extra safety precaution.

In general please can all users be extra vigilant when opening emails and do not open any attachments or click on any links if you are not expecting communication from the sender. Malicious emails may appear to come from other NHS employees, so even if you recognise the sender please do not assume that the contents are safe. If you think your computer has been infected by a virus we advise that you immediately disconnect it from the network or shut it down and contact your IT department.

This is also good advice for your personal computers to limit the impact of these cyber attacks.

We will continue to monitor the situation and react appropriately to continue to provide a safe and reliable service.

 

 

EDGE's International Accelerate Conference 2017

EDGE conference at the Grand Harbour Hotel

Firstly, we would like to start with saying a big thank you to all of those who attended our conference on the 29th and 30th March. It is safe to say it was a brilliant two days, in which the EDGE community grew closer together, sharing ideas and best practice.

Thanks to all of our wonderful speakers who shared their EDGE knowledge during numerous breakout sessions and a special thanks to our Canadian friends: Karen Arts, Rebecca Xu and Trina Johnson who gave their international experience with using EDGE. 

We have already received requests for speaker presentations, which will be made available on our website in due course. Along with the video's for each plenary, keynote and breakout session once these have been edited and approved by each speaker. So do keep a look out under our 'News' section for further updates relating to the conference! 

We would like to take this opportunity to share some of the comments we have received regarding our Accelerate conference: 

“The speakers were excellent, I got some brilliant ideas about how to improve local functionality and it was a valuable opportunity to network and improve collaboration with other sites. A very useful conference and I would definitely recommend it!"
Kate May, Research Portfolio Delivery Manager- Brighton & Sussex University Hospitals NHS Trust
“I would like to say a very big thank you and well done from myself and my colleagues at Southend University Hospital NHS Foundation Trust. I have gained a wealth of knowledge from the conference and speaking to such inspiring people as Clare Morgan and Trina Johnson who really empower you to succeed in what you do to improve our services, please pass on my appreciation to them also.”
Siobhan Shearing, Research Midwife- Southend University Hospital NHS Foundation Trust
“It was nice meeting new colleagues and renewing acquaintances with people from the EDGE community. The EDGE team did a fantastic job and a big thank you to them for making me feel so welcome."
Steven Barre, Information Systems Project Manager- NHS Greater Glasgow and Clyde

Keep a look out for updates regarding our next conference in 2018! 

An Improved Research Community in Canada enhanced by EDGE

This post has been written by Rebecca Xu, 3CTN- Canada

Successful clinical trials management for the 3CTN Coordinating Centre (CC) and for 3CTN sites requires a flexible system to track trial-related activities. The system has to work well at two levels: for the CC and the sites. The CC needs to have a system to support the identification and communication of portfolio trials to patients and the public. Also, such a system is important for the evaluation of 3CTN against its milestones and deliverables laid out in its business plan. In addition, to demonstrate an increase in recruitment to academic clinical trials in Canada. 3CTN required each participating site to establish an accurate baseline for recruitment. This is used to continuously evaluate the performance and impact of the Network. A flexible system facilitates this evaluation. Among all Canadian cancer centres responding to the initial 3CTN expression of interest, there was a demand for a clinical trial management system (CTMS) to manage the clinical trial projects, track clinical trial activities, staffing, milestones, metrics and finances centrally and in an organized fashion. The optimal solution to track the metrics and research activities is a common platform for all member sites and the 3CTN Coordinating Centre.

3CTN went looking for a CTMS solution. After consultation with a wide variety and number of stakeholders, and following the recommendation of a working group, based on the positive impact in the UK and first Canadian site (i.e. Juravinski Cancer Centre), the EDGE Clinical Research Management System (EDGE) was selected by 3CTN as the preferred system to roll out at the CC and Canadian cancer centres that expressed interest.

The EDGE system, which was developed in the U.K by the University of Southampton and University Hospitals Southampton National Health Service Foundation Trust, was first introduced in 2001. Since then, EDGE has been used by all the U.K. cancer research networks and several other networks established by the Department of Health in the U.K.  EDGE provides an innovative cloud-based clinical management system that empowers administrators and investigators to make the most of their research data. EDGE is specifically designed to give a real-time view of clinical research activity within a single hospital or across various research networks.
 
The CC formally adopted EDGE in September 2014, with the first goal being the tracking of the portfolio. The CC EDGE hosts a comprehensive listing of all 3CTN-endorsed cancer clinical trials. It allows management of the portfolio, including trial application, and timeline tracking of the review and approval process in a clear, efficient and measurable system. In addition to portfolio tracking, the CC can process all data in EDGE and extract the aggregate and site efficiency metrics with ease. It provides a real time and accurate picture of the high impact academic clinical trials across Canada. The national benchmarking data has also proven to be useful to facilitate ongoing process improvement.

EDGE provides an efficient way to collect and process the data without imposing an excessive burden to 3CTN sites. This common platform limits duplication of data entry and ensures ease of data transfer between 3CTN member sites and the CC. For sites that had already adopted a different CTMS prior to 3CTN, EDGE provides portal capability and flexibility to take-in data from the various systems used by sites.
 
Since the adoption of EDGE by 3CTN, the CC has developed comprehensive implementation supports. These supports include: live demonstrations of the system, project planning, training and first line support to facilitate the roll-out to interested cancer centres. Regional super users were hired to assist with implementation and to ensure sites use EDGE effectively. These super users are situated throughout the Network, and collaborate with the CC to promote best practices, and to determine how EDGE can best be used to benefit all sites across the country.

At the site level, most sites using EDGE are tracking recruitment. Many sites are starting to use EDGE to track regulatory processes and finances for their active recruiting trials, as well as legacy data. The EDGE users are especially pleased with the powerful reporting capabilities of EDGE, which allows them to follow trends in research activities over time. Prior to the implementation of EDGE, sites had numerous files, over a number of file directories to keep track of the progress of trial activation, ethics submissions, contract processes, budgets, and trial metrics (screening and accrual reports).  From a logistics standpoint, having one place to access all clinical trial information is very efficient, and ultimately improves patient care as it enables everyone to use the most up to date documents and information. All members of the patient care team are able to see the progress of a trial from delivery of the protocol to trial activation, and the screening and accrual of patients.  “EDGE provides us with a wealth of knowledge to know which trials are accruing and which are not and why not” states Richard McClelland from London Regional Cancer Centre. Being a network-customized and web-based application, EDGE has led to better communication and collaboration within the cancer clinical trial community, and across the country.

As a result of CC and site level implementation, the EDGE system is helping to improve the conduct of cancer clinical trials across Canada. It enables reliable and real-time measurement of trial metrics and improves the ability of sites and the CC to analyze and use trial data to advantage which should lead to more efficient activity across the Network.

Source of article from: Canadian Cancer Clinical Trial Network 3CTN Pulse Newsletter February 2017 

A Blog with Gratitude

As 2016 draws to a close, it will soon become a time of delicate reflection on the year that has passed. For some of us, the Christmas holidays leaves us with a distinct feeling of bittersweetness, which is often combined with inner determination that “next year will be better.” What could have gone better this year, and how? What should I do to become happier and more satisfied next year? These feelings do not just apply to our personal lives, but they also sometimes cross over to our professional lives, too.

Many researchers are currently exploring the role of gratitude in the workplace; that is, when one expresses appreciation for what one has, or what went right, at work. First off, it is worth noting that, on average, people who regularly express gratitude are better off psychologically. For instance, grateful people are happier, they experience more positive moods,[1] and they report greater perceived support from other people compared to people who do not regularly express gratitude.[2] The chances are, however, that gratitude is not part of your workplace culture, and expressing appreciation in the workplace is not something that occurs very frequently.[3] A lack of gratitude increases the risk of low performance and dissatisfaction in the workplace.[4]

In a recent study conducted in Canada, researchers tested what happens when workers are encouraged to reflect on the things they are grateful for at work[5]. In a study of employees (aged 18-82), half were encouraged to focus on and describe three things that they were grateful for at work, while the other half described three things that they were grateful for in life. After, the employees completed surveys about how satisfied they currently felt with their job, and how satisfied they expected to be with their job in 6 months’ time. Results indicated that employees who described three things that they were thankful for at work reported significantly higher levels of work satisfaction and greater anticipatory work satisfaction in 6 months’ time (compared to those who reflected on things that they were grateful for in life; see graphs below).

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Whilst we are not always able to control what happens in the workplace, good or bad, these results demonstrate that we can control how we choose to perceive what happens in the workplace, and which aspects we choose to focus on. We can either focus on the negative aspects of the workplace, or we can actively choose to find things that we like about our workplace and express gratitude toward them frequently, which, in turn, maximises fulfilment and bolsters optimism for the future.

As 2016 draws to a close, it will soon become a time of delicate reflection on the year that has passed. For some of us, the Christmas holidays leaves us with a distinct feeling of bittersweetness, combined with inner determination that “next year will be better.” What could have gone differently this year, and how? What should I do to become happier and more satisfied next year? Well, why not let this Christmas be a time for gratitude. By reflecting on just three things that you are grateful for at work (e.g., things that have gone well this year), you will heighten the likelihood of starting 2017 full of optimistic thoughts and boosted satisfaction. Make gratitude a habit, and the rewards shall be reaped.

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Please let us take this opportunity to express our gratitude to you – our users. We wish you all a very Merry Christmas and an exceedingly Happy and EDGEtastic New Year.

Most importantly – thank you.

 

 

[1] Watkins, P. C., Woodward, K., Stone, T., & Kolts, R. L. (2003). Gratitude and happiness: Development of a measure of gratitude, and relationships with subjective wellbeing. Behaviour and Personality, 31, (5), 431-452.

[2] Wood, A. M., Maltby, J., Gillett, R., Linley, P.A., & Joseph, S. (2008). The role of gratitude in the development of social support, stress, and depression: Two longitudinal studies. Journal of Research in Personality, 42, 854-871.

[3] Simon-Thomas, E. R., & Smith, J. A. (2013). How Grateful are Americans. Retreived from http://www.greatergood.berkeley.edu/article/item/how_grateful_are_americans

[4] Judge, T. A., Thoresen, C. J., Bono, J. E., & Patton, G. K. (2001). The job satisfaction-job performance relationship: A qualitative and quantitative review. Psychological Bulletin, 127, (3), 376-407.

[5] Buote, V. (2014). Being thankful at work: The impact of gratitude in the workplace. 

EDGE Usability Survey 2016

Positive results!

In May, we, the team at EDGE HQ, administered our first ever usability survey. We collected responses from an astounding 251 of our users, who each took the time to complete a wide series of questions relating to the functionality of EDGE. The survey aimed to examine the overall usability of EDGE, the extent to which users understood what EDGE is used for and why it was implemented by their institution, and, most crucially, users’ general satisfaction with EDGE.

The results from the survey were overwhelmingly positive. A staggering 80% of users (whom we quite appropriately labelled “Masters of the Universe”) agreed that they found EDGE intuitive and easy to use, 87% percent agreed that they felt confident using EDGE, and almost 80% were satisfied with the ease and the amount of time that it takes to complete tasks using EDGE. This provided us with reassurance regarding the things that we are doing well, including the specific functions of EDGE that our users find useful in their work.

There is, however, still some room for improvement, and your responses in the survey have helped us to identify what these niggles are and what we need to do about them. As a primary example, results from the survey revealed that almost 30% of respondents did not receive any formal training to use the system. We also received a number of comments regarding specific functions of EDGE that users could not work out or understand, some of which we categorised as training issues. Whilst it is likely that some of the untrained users were new staff members or researchers that were assigned to projects using EDGE, we truly rely on everybody using and understanding the EDGE system well. We aim for each and every one of you to experience the excellent benefits that the system offers, as this will ultimately impact positively on your work.

What are we doing about training?

Based on your responses and feedback, we have recently deployed a number of key changes to training, which we will implement over the course of the next few months. The Knowledge Team at EDGE have commenced work on some exciting new training modules, which we aim to provide online for users who may have missed out on formal training, or for users who would simply like to brush up on their EDGE skills. We also aim to create a batch of short 2-3 minute training "bite" videos. While we already have a number of training videos that you can find under the EDGE support tab, these shorter videos will quickly, yet effectively explain some of the quirky functions that EDGE provides. The training and expertise (EDGEpertise) of our users is of fundamental importance to us, and our immediate aim is to make training as effective and accessible as possible. We will keep you updated regarding our progress via this blog.

We wish to offer a huge thank you to those of you who completed the survey – your feedback is invaluable to us. We look forward to administering the survey again next year to pick your brains further regarding the overall usability of EDGE. We have no doubt that our next survey will lead to further excellent ideas regarding how to make the work of our users easier, satisfying, and more efficient (as it has done this year after just one survey). As always, we gratefully appreciate your input.

Meanwhile, if you identify as one of our EDGE Masters, or if you have any tales about how EDGE has made your research quicker and more efficient, we would be very interested in hearing all about them. Please get in contact with the EDGE researcher, Dr. Kenny Brackstone, at K.Brackstone@soton.ac.uk or tweet us at @edgeclinical.

Once again, thank you.

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