08 December 2020
Patients receiving low dose steroid at increased risk of cardiovascular disease
Glucocorticoids are steroids widely prescribed to treat a range of immune-mediated inflammatory diseases. While high doses of steroids are known to increase the risk of cardiovascular disease, the impact of lower doses is unknown. A study published in PLOS Medcine by Mar Pujades-Rodriguez at Leeds University and colleagues suggests that even low doses of glucocorticoid may increase the risk of cardiovascular diseases.
New £1.3 million national research programme to evaluate coronavirus tests in hospitals, GP surgeries and care homes
24 June 2020
Testing for coronavirus infection could become quicker, more convenient and more accurate, following the launch of a multicentre national programme of research that will evaluate how new diagnostic tests perform in hospitals, general practices and care homes.
Determining who has been infected with the novel coronavirus is a key part of the response to the COVID-19 pandemic. Getting quick and accurate test results when people show symptoms ensures that they receive appropriate care and reduces the chance of the disease being passed on.
The main test currently used to detect coronavirus infection (reverse transcription polymerase chain reaction [RT-PCR]) involves sending samples away to laboratories, which can take up to 72 hours to provide results.
The life sciences industry has rapidly responded to the pandemic by developing brand new diagnostic tests both to detect current coronavirus infection and to find out if someone has previously been infected. These new tests - some of which may be able to provide near immediate results at the bedside in hospitals, in GP surgeries or during home visits - have the potential to increase the speed and convenience of testing.
However, many of these new diagnostic tests have yet to be thoroughly evaluated in the settings where they're likely to be used.
The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) - funded by the National Institute for Health Research, UK Research and Innovation, Asthma UK and the British Lung Foundation - will create a single national route for evaluating new diagnostic tests in hospitals and in community healthcare settings. This programme of research brings together experts who are highly experienced in evaluating diagnostic tests and generating the robust evidence required for a test to be used in the NHS.
Co-primary investigator Professor Gail Hayward, Associate Professor at Oxford University’s Nuffield Department of Primary Care Health Sciences and Deputy Director of the NIHR Community Healthcare MedTech and IVD Co-operative, said: “While a new diagnostic test might work well in a lab under controlled conditions, there are many different factors that could make it less accurate when you take that test out of the lab and into the real world. These include the range of ways that COVID-19 can present itself, from non-symptomatic carriers to post-symptomatic people who have recovered, the range of other illnesses people might have and the challenges of performing tests in a busy clinical environment.
“Right now there’s a critical gap in how we road-test new diagnostics for COVID-19. By robustly evaluating these diagnostics in health and care settings, the CONDOR programme will help the government and clinicians to understand the real-world accuracy of these tests in patients presenting with COVID-19 symptoms in the NHS.”
Lord Bethell, Minister for Innovation at the Department of Health and Social Care, said: “We need the fastest, most accurate tests in the NHS to help keep COVID-19 under control.
“I’m delighted we’re committing £1.3 million to this brilliant new national research programme, to evaluate how new diagnostic tests perform in health and social care settings – so we can track levels of infection and immunity across the country and help keep people safe.”
Professor Fiona Watt, Executive Chair of the Medical Research Council, part of UK Research and Innovation, said: “The life sciences industry is developing faster and more accurate coronavirus tests, but we need to know if they work as well in the difficulties of real-world settings as they do in a controlled lab environment.
“The CONDOR platform will put the new tests through their paces. The best ones can then be chosen for deployment in healthcare settings, care homes and the community, boosting our ability to detect and control the virus that causes COVID-19.”
The programme is led by Manchester University NHS Foundation Trust, the University of Manchester and the University of Oxford, in collaboration with four NIHR Medtech and In vitro diagnostics Co-operatives (MICs) - NIHR Community Healthcare MIC, NIHR Leeds MIC, NIHR London MIC and the NIHR Newcastle MIC - Manchester University NHS Foundation Trust’s Diagnostics and Technology Accelerator (DiTA), the University of Nottingham and the National Measurement Laboratory, hosted at LGC.
The research team will work with the government and its scientific advisors to identify which new commercially developed diagnostic tests could be most valuable in the NHS.
The effectiveness of these prioritised tests will then be evaluated in a number of possible health and care settings - emergency departments, critical care, acute medical care, primary care, care homes and hospital at home teams. The research will assess multiple diagnostic tests at once at sites across the country and can be adapted to add in new tests as they become available.
Co-primary investigator Professor Richard Body, Professor of Emergency Medicine at the University of Manchester, Consultant at Manchester University NHS Foundation Trust and Director of DiTA, said: “By validating the accuracy of new clinical tests through CONDOR, we can get novel tests out across the health and care system that are more convenient for patients and get more accurate results. This will mean that patients get better care and we can make more informed, early decisions about how to control spread of the virus.”
One application of CONDOR will be to follow up on patients who test positive with an antibody test, he adds, to find out whether they develop new infections, thus helping to understand whether people with antibodies are immune to reinfection and how long this immunity might last.
Dissemination and national rollout of promising tests will be led by the Academic Health Science Networks in North East and North Cumbria and in Yorkshire and Humber. The networks have established a patient and public involvement group to support this project, with over 20 contributors with a wide variety of healthcare experience. They have already provided helpful insights into concerns about care home diagnostics and ensuring inclusion of samples from black, Asian and minority ethnic groups.
The £1.3 million research programme will also have an analytical validation workstream that will evaluate the accuracy of tests in laboratory settings, a workstream to assess the benefits of these new tests within patient pathways (in collaboration with NICE), and a workstream evaluating the practical suitability and feasibility of tests.
“For example, we’re going to look at tests that use different approaches to collecting samples other than the nose and throat swabs, which are uncomfortable,” said Prof Body. “Some tests in development at the moment measure the virus in saliva, which is much easier and more convenient to collect.”
The partnership with the National Measurement Laboratory, hosted at LGC, will enable the independent validation of new molecular point-of-care tests against an international reference measurement procedure and of emerging serological tests against an assay developed using validated antibodies.
This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care, to expedite its delivery in the health and care system.
The research will be supported by the expertise of NIHR MICs, existing teams in NHS organisations and universities that work with companies and specialise in evaluating, and generating high quality evidence on, in vitro diagnostic tests.
Dr Michael Messenger, Deputy Director of the NIHR Leeds MIC and now seconded to the government as a Scientific Advisor to the COVID-19 Testing Programme, said: “We’ve got a wealth of expertise in the NIHR MICs, with Newcastle providing care pathway analysis expertise, the experts in Oxford leading on evaluating tests in community settings, Leeds and Newcastle advising on analytical validation of tests, and London specialising in human factors in diagnostic testing. We’ve also brought in DiTA, which has expertise in evaluating tests in acute care environments.
“The MICs allow us to instantly access a network of experts across the country who specialise in evaluating in vitro diagnostics and provide a valuable infrastructure in the government response to COVID-19.”
Professor George Hanna, Director of the NIHR London MIC at Imperial College that is leading on the human factors issues in test development, said: “CONDOR provides an evaluation route not just for laboratory validity but also for real world use. In the past, the absence of a proper focus on end-user needs has meant that many failures and safety issues have occurred with diagnostics. We can now overcome these barriers by applying our unique human factors approach within CONDOR.”
Dr Ashley Price, Lead for Infection at the NIHR Newcastle MIC, which is leading on the care pathway analysis workstream, said: “The care pathway analysis workstream will map out patients’ journeys with suspected COVID-19, ensuring that the diagnostic tests are evaluated in the most suitable clinical setting, such as hospitals or care homes, and the evidence developed by CONDOR will be appropriate for the practical use of the test. Working with the National Institute for Health and Care Excellence, we believe this will speed up the delivery of these tests into practice.”
Dr Samantha Walker, Director of Research and Innovation at Asthma UK and British Lung Foundation, said: “We are delighted to be able to support this national research programme in the search to find fast and reliable diagnostic tests for COVID-19. Reducing viral outbreaks through effective testing could help to protect the millions of people in the UK with a lung condition who are more likely to experience severe symptoms.
“It has been incredible to see such a fast response to the coronavirus from the life sciences industry and we look forward to seeing the results of this study.”
27 January 2020
Blood Test To Speed Lung Cancer Diagnosis is Highly Cost Effective, Study Finds
A study funded by The National Institute for Health Research (NIHR) SBRI programme and led by Leeds University Academic Unit of Health Economics, supported by the NIHR Leeds In-vitro Diagnostics Co-operative (NIHR Leeds MIC), shows that using a blood test in the cancer risk assessment of indeterminate pulmonary nodules is highly cost-effective and could speed the time to diagnosis.
3 October 2018
New framework to accelerate development of biomarker tools
A framework that will help scientists research and develop new biomarkers as diagnostic tools has been published. This work was undertaken as part of an NIHR Applied Programme and the NIHR Diagnostic Evidence Co-operative (DEC) Leeds.
3 October 2018
PPIE group member Dr Claire Corps featured in the Guardian
NIHR Leeds MIC Patient and Public Involvement and Engagement Group (PPIE) member Dr Claire Corps was recently featured in the Guardian as part of their Organ Donation series.
3 October 2018
NIHR Feedback on Diagnostics Evidence Co-operatives
The NIHR have recently provided feedback on the final report of the Diagnostic Evidence Co-operative Leeds (DEC Leeds). We would like to share some of the highlights from the report.
3 October 2018
Analysis of cost-effectiveness of a new urine-based diagnostic test to diagnose bladder cancer in haematuria patients
NIHR Leeds MIC researchers have recently published a paper examining the cost effectiveness of a new urine-based diagnostic test, the DCRSHP, as a triage diagnostic tool in diagnosing Urothelial bladder cancer (UBC) in haematuria patients.
26 June 2018
Tackling the challenges of test uncertainty
NIHR Leeds MIC researchers attended the Health Technology Assessment International (HTAi) Annual Meeting, held in Vancouver (Canada) in June, to discuss their work in the field of measurement uncertainty in precision medicine.
26 June 2018
Report identifies promising AKI tests
A report that could help NHS decision-makers select effective diagnostic tests for acute kidney injury (AKI) has been published by researchers including experts from NIHR Leeds MIC.
26 June 2018
PinPoint Cancer joins forces with Leeds big data experts
NIHR Leeds MIC is pleased to welcome biotech company, PinPoint Cancer Ltd into the Leeds Institute for Data Analytics to work on a new project aimed at addressing the burden of the cancer Two Week Wait referral pathway.
26 June 2018
SME roadshow promotes collaboration
The National Institute for Health Research joined forces with the Yorkshire & Humber Academic Health Science Network (AHSN) to host a roadshow aimed at improving collaboration opportunities for SMEs.
26 June 2018
International Clinical Trials Day
NIHR Leeds MIC joined with teams throughout the Leeds Teaching Hospitals NHS Trust to take part in International Clinical Trials Day, held at the end of May.
26 June 2018
In memoriam: Professor Doug Altman
We were deeply saddened to hear of the death of Professor Doug Altman, whose influential work in the field of medical statistics provided the foundation for organisations like NIHR Leeds MIC.
16 April 2018
NIHR Leeds MIC launched!
NIHR Leeds MIC held its official launch event on 7 March 2018. Our audience included MIC theme leads, academics, industry partners and members of our Patient and Public Involvement and Engagement group who joined us to discuss the future of NIHR Leeds MIC and current opportunities within the sector.
17 April 2018
Measurement uncertainty in Health Technology Assessments
A review of Health Technology Assessments (HTAs) by NIHR Leeds MIC researchers has shown variable and often limited evaluation of measurement uncertainty within HTAs of in vitro tests.
17 April 2018
Funding for global health research
The MRC Cancer Research Global Health Workshop was held in London in January. Its aim was to disseminate information about upcoming funding opportunities for global health research across the MRC’s funding streams and also provide an opportunity for researchers of different disciplines to network and identify potential projects for collaboration.
17 April 2018
AHSN Innovation, Improvement and Impact Conference
The Yorkshire & Humber Academic Health Science Network (AHSN) held its annual Innovation, Improvement & Impact Conference and Awards at the Royal Armouries Museum in Leeds on January 31, 2018.
NIHR Leeds MIC attended the event, which offered a great opportunity to find out about innovation across the region.
17 April 2018
Focus on Pharmacogenomics
NIHR Leeds MIC Health economics researcher Dr Gurdeep Sagoo attended the NHS England and Genomics England joint workshop on Pharmacogenomics in the NHS, held in London in February.
This event, hosted by the UK Pharmacogenetics & Stratified Medicine Network, provided an update on progress made by the 100,000 Genomes Project and set out the landscape for the new Genomic Medicine service.
20 February 2018
Save the date!
We have successfully been awarded funding to host one of the NIHR Medtech and In Vitro Diagnostic Co-operatives (MICs) here in Leeds, effective from January 2018. This follows on from our success with hosting the NIHR Diagnostic Evidence Co-operative Leeds (DEC). The launch event for the NIHR Leeds In Vitro Diagnostics Co-operative, will take place on Wednesday 7th March at Leeds City Museum.