EDGE CLINICAL RESEARCH

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

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.

 

 

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 

EDGE News

The past month has followed the standard school holidays trend, whereby the volume of calls received by the EDGE team drops which allows us to turn our attentions to the plethora of other tasks that we are working away on in the background.

One of our objectives over the past year has been to try and encourage our users to upgrade their browsers in order to see improved performance speeds on EDGE, especially when running large reports that return a lot of data.  Just a few of the benefits of browser upgrades can be found on the NHS Supply Chain website:

‘Why should you update your browser?

Old browsers are more prone to viruses, spyware, malware and other security issues. Whilst you will be protected by your trust’s firewalls there are other reasons why you should upgrade your Internet browser…

  • Old browsers are slow - In comparison to newer browsers, old browsers such as IE 6, 7 and 8 can take longer to display the web page you want to view as browsers are trying to perform several complicated tasks at once.
  • Old browsers are more likely to crash - When a web page downloads, your browser is performing several tasks and interpreting new programming information that was not available when the browser was originally launched.  
  • You can’t view websites properly with old browsers - As web design and development becomes more sophisticated, you may not be able to view some websites as intended e.g. images may not be displayed, video may not play and content displayed may appear misaligned’

Supporting EDGE across multiple browsers also increases the time it takes for us to develop and test current and new functionality. The more redundant software we have to support, the more development time each feature requires, this in turn has an additional effect on testing each function within each browser. The overall effect being that new functionality is held up by the use of older browsers.

Microsoft’s dominance in the web browsing market really started with Internet explorers inclusion in Windows 95, where it surpassed Netscape Navigator as the most used browser on the web back in 1998. Microsoft has held that position of dominance for almost two decades until April this year when statistics firm Netmarketshare said that Google Chrome had overtaken it with 41.7 per cent of desktop browsing, compared with Internet explorers 41.3 per cent.

A statement released from Microsoft at the end of last year notified Internet explorer users that ‘Starting from 12 January 2016, only the most current version of Internet Explorer available for a supported operating system will receive technical supports and security updates. Internet Explorer 11 is the last version of Internet Explorer, and will continue to receive security updates, compatibility fixes and technical support on Windows 7, Windows 8.1 and Windows 10’

This ties in with the recently released Review of Data Security, Consent and Opt-Outs, published by Dame Fiona Caldicott https://www.gov.uk/government/publications/review-of-data-security-consent-and-opt-outs within which she highlights under the ‘Leadership Obligation 3: Technology: Ensure Technology is secure and up-to-date’, ‘Data Security Standard 8. No unsupported operating systems, software internet browsers are used within the IT estate’

This guidance is correct, browsers should be updated for security purposes. This is put in no uncertain terms by Ed Bott, an award winning technology writer:

“Any IT professional who is still allowing IE6 to be used in a corporate setting is guilty of malpractice. Think that judgment is too harsh? Ask the security experts at Google, Adobe, and dozens of other large corporations that are cleaning up the mess from a wave of targeted attacks that allowed source code and confidential data to fall into the hands of well-organized intruders. The entry point? According to Microsoft, it’s IE6”

Is this easier said than done though? Well it used to be the case that a number of core applications i.e Spine, and e-RS (formerly choose & book) used to be limited to access from IE 6 and IE 7 browsers, but recently that has changed and the Health & Social Care Information Centre (now NHS Digital) released their new Spine Warranted Environment Specification in 2015 which introduced components for MS Internet Explorer 11, Mozilla Firefox and Google Chrome. Therefore compatibility with current technology is improving but there are no doubt other applications still reliant on older technology.

We have been reviewing EDGE users browser access over the past six months and have seen a significant trend in users upgrading their existing legacy browser to more current versions of the software. These can be seen on the graph below. The only exception is IE7, which has increased from 3.1% of EDGE users to 5%. We believe this increase is probably down to new users introduced onto the system rather than users actually downgrading their browser.

 

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Browser usage of EDGE users

These statistics are positive, identifying a downward trend in use of IE8 and IE9, very little change in IE10 use, but a good increase in use of newer browsers such as IE11, Chrome and Firefox.

The below graph consolidates these statistics into simply ‘old browsers v new browsers’

Comparison of old browser useage v new browser useage

After initial analysis of browser usage in September 2015, we implemented a formal browser policy for development and test in order to support our customers’ needs and maintain EDGE as a safe and reliable system, and is highlighted in the following points:

·         The new browser policy ceases any support for IE6 due to the lack of users

·         IE7 is now only offered reduced support*

·         IE8, 9, 10, 11 are fully supported however we are aiming to reduce support for IE8 by (date TBC)

·         Google Chrome, Mozilla Firefox, and MS Edge are fully supported.

*reduced support means that functionality will be supported, but any cosmetic issues will not be fixed.

EDGE Team & CIRU Away day

On the 14th July we headed out to Brockenhurst for our away day to the grand and beautiful Rhinefield House Hotel. Using the hotel’s conference facilities our current team of 23 spent the day learning more about each other, developing team skills and building on working relationships. This was beneficial to all as our unit CIRU (Clinical Informatics Research Unit) keeps on expanding with more staff coming on board. 

The day started with presentations from all the team where we each talked about our individual departments and gave knowledge on topics which everyone at CIRU would benefit from. The Knowledge team talked about the Clinical Trials Process which included how R&D and Pharmacy work which of course relates to our customer base. From the development team we learnt about the development journey from when an idea is first initiated right through to when it becomes live on EDGE. We also got to hear from our team of Associate Software Developers who talked about new products they have been working on such as exciting new apps to help with research and patient visits to hospital. Other topics of the day included customer support and communications within the department including our brand and marketing strategy. We also got the chance to hear results from a recent staff and customer survey which gave us the opportunity to discuss as a team. We were also very lucky to have Professor Topher Woelk present to us, who talked about his work and Bioinformatics.

After all of the presentations and after being fed and watered we began the afternoon activities which certainly tested our team work skills. This included team lego building on things related to CIRU and to EDGE, which meant we got to be kids again (it was great). We also took part in a dressing up video challenge which literally got us laughing out loud at the end result!

I would certainly say the day brought us more together as a team as we discovered more about each other and definitely shared some laughs!

The EDGE team

EDGE users and the importance of ORCID identification

EDGE ORCID identification

The launch of ORCID in 2012 has provided unique benefits to both individual researchers and their institutions worldwide. Millions of researchers and clinicians at various institutions around the world currently reap the benefits of having an ORCID ID. Here at EDGE HQ, we have fully embraced ORCID IDs in our line of work, and have recently begun a quest to urge all of our users to obtain one as soon as possible. In this blog post, we highlight what an ORCID ID is, and why it is crucial for our users.

 What is ORCID?

 ORCID (Open Researcher and Contributor ID) is a global, free-to-use registry that provides research staff with unique persistent identifiers (ORCID IDs). Most immediately, ORCID makes a fundamental difference to a researcher’s ability to gain full credit for their work as they track, evaluate, and publish research.

 What does ORCID do?

 With millions of researchers worldwide, it is inevitable that many of these will share the same name. Adding to this confusion, individuals may change their name at some point during their careers (for example, after one gets married), which may result in different variations of the same name. Therefore, it seems obvious that a researcher’s name is simply not enough to identify an author of a paper or a dataset uploaded to a research repository. However, a unique identifier – as provided by an ORCID ID – works to ensure that links can be made accurately and efficiently irrespective of repeated names and name variations. As a result, James Smith from a research facility in Wessex can be uniquely identified as the author of his recent research paper published in Nature.

 ORCID IDs are now embedded in most workflows, such as manuscript submission or grant application processes. As such, it has become a vital part of the metadata associated with research outputs, and ultimately reduces administrative burden for researchers. Universities and research facilities are encouraged to note the take-up of ORCID IDs due to their power to recognise researchers irrespective of who and where they are in the globe.

 How does ORCID ID relate to EDGE?

 As you know, an ORCID ID solves the name ambiguity problem in research and allows researchers to easily and uniquely attach their identity to research objects. In relation to EDGE, objects include experiments and uploaded datasets. As such, we have recently implemented ORCID IDs as part of our identification process, whereby we will now ask our users to provide their unique ORCID ID when consulting with our help team. Due to the volume of EDGE users in the UK (with hundreds of the same names being used across various institutions), we have found that asking users to provide an ORCID ID speeds up the identification process and helps us deliver the assistance that our users need quickly and more efficiently.

Please get your unique ORCID ID code by clicking the link below. It only takes 30 seconds! Then, assign it to your profile on the EDGE database.

http://orcid.org/