The Northern Medical Physics and Clinical Engineering directorate hosts one of seven external assessment groups (EAG) in the UK, supporting the National Institute for Health and Care Excellence (NICE).
The Newcastle EAG, a collaboration between Newcastle Hospitals and Newcastle University, is commissioned by NICE to provide independent assessment of clinical evidence for innovative medical technologies and associated analysis of the economic impact of adopting the technology in the NHS.
Health technology assessment
The health technology assessment team at the Freeman Hospital has been involved in the national programme of medical device assessment for over 40 years. As an EAG for NICE, the team’s work complements other activities in medical physics, including developing innovative devices and bioinformatics.
Collaboration with Newcastle University brings additional expertise in literature searching, systematic review, meta-analysis, health economics and horizon scanning. This range of skills ensures the team’s work as an EAG is well-placed to support the medical technologies evaluation programme at NICE.
- Andrew Sims (Centre director)
- Kim Keltie (Centre manager)
- Emma Belilios (Project co-ordinator)
- Derek Bousfield (Senior clinical technologist)
- Julie Burn (Clinical bioinformatician)
- Humayra Dervin (Clinical Scientist)
- Kathryn Fletcher (Administrator)
- Rachel O’Leary (Clinical scientist)
- Rosalyn Parker (Evaluation healthcare scientist)
- Matthew Reiling (Research scientist)
Early Value Assessments (EVAs): EVAs are a new approach to the assessment of digital products, devices and diagnostics. They offer a rapid assessment based on clinical effectiveness and value for money, allowing patients and services to benefit sooner from promising technologies where the evidence base is still developing.
|GID-MT590 ProKnow Cloud-based system for radiotherapy data archiving, communications and management||Kim Keltie, Rosalyn Parker, Rachel O’Leary, Emma Belilios, Sonia Garcia Gonzalez Moral, Fiona Beyer, Sedighe Hosseinijebeli, Gurdeep Sagoo, Andrew Sims||Guidance in development – expected publication December 2022|
The EAG prepares assessment reports to support NICE’s medical technologies advisory committee.
Companies notifying their technologies to NICE for guidance development, submit summaries of the clinical and economic evidence supporting the adoption of their technology.
The EAG independently assesses this submission, and the wider evidence base, and summarises findings in an assessment report to enable the committee to formulate provisional recommendations in national guidance.
|GID-MT562 FibroScan for assessing liver fibrosis and cirrhosis in primary or community care||Kim Keltie, Rachel O’Leary, Rosalyn Parker, Emma Belilios, Alex Inskip, Fiona Beyer, Andrew Sims||Guidance in development – expected publication December 2022|
|GID-MT564 GreenLight XPS for treating benign prostatic hyperplasia [update]||Kim Keltie, Rosalyn Parker, Rachel O’Leary, Emma Belilios, Humayra Abdul-Razakq, Sonia Garcia Gonzalez Moral, Sheila Wallace, Andrew Sims||Guidance in development – expected publication October 2022|
|MTG72 Magtrace and Sentimag for locating sentinel lymph nodes||Kim Keltie, Rosalyn Parker, Emma Belilios, Joanne Davison, Humayra Abdul-Razakq, Catherine Richmond, Fiona Beyer, Andrew Sims||October 2022|
|MTG64 KardiaMobile for detecting atrial fibrillation||Kim Keltie, Michael Drinnan, Alex Inskip, Fiona Beyer, Rachel O’Leary, Grace Fairlamb, Julie Burn, Derek Bousfield, Andrew Sims||January 2022|
|MTG59 Plus Sutures for preventing surgical site infection||Iain Willits, Kim Keltie, Rachel O’Leary, Catherine Richmond, Fiona Beyer, Andrew Sims||June 2021|
|MTG54 The VAC Veraflo Therapy system for acute infected or chronic wounds that are failing to heal||Iain Willits, Kim Keltie, Catherine Richmond, Fiona Beyer, Helen Cole, Andrew Sims||January 2021|
|MTG49 Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia||Iain Willits, Kim Keltie, Neil Watson, Jo Mullen, Mark Chambers, Joyce Craig, Helen Cole, Andrew Sims||June 2020|
The EAG reports on changes that may affect the validity of published guidance, including additional published evidence and costing updates.
|MTG43 PICO negative pressure wounddressings for closed surgical incisions||Rachel O’Leary, Kim Keltie, Emma Belilios, Andrew Sims||Ongoing|
|MTG40 Mepilex Border Heel and Sacrum dressings for preventing pressure ulcers||Rachel O’Leary, Kim Keltie, Matthew Reiling, Humayra Dervin, Rosalyn Parker, Emma Belilios, Andrew Sims||Awaiting publication|
|MTG41 Senza spinal cord stimulation system for delivering HF10 therapy to treat chronic neuropathic pain||Rachel O’Leary, Kim Keltie, Matthew Reiling, Humayra Dervin, Emma Belilios, Michael Drinnan||Awaiting publication|
|MTG13 WatchBP Home A||Kim Keltie, Rosalyn Parker, Matthew Reiling, Emma Belilios, James Blake||In progress|
|MTG8 MiraQ for assessing graft flow during coronary artery bypass graft surgery||Kim Keltie, Rosalyn Parker, Emma Belilios, Rachel O’Leary, Humayra Abdul-Razakq, Joanne Davison, Andrew Sims||June 2022|
|MTG38 Neuropad for detecting preclinical diabetic peripheral neuropathy||Rachel O’Leary, Kim Keltie, Emma Belilios, Andrew Sims||Awaiting publication|
|MTG34 SecurAcath for securing percutaneous catheters||Rachel O’Leary, Kim Keltie, Andrew Sims||Awaiting publication|
|MTG31 HumiGard for preventing inadvertent perioperative hypothermia||Iain Willits, Kim Keltie||December 2020|
MIBs are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.
|Contrast Enhanced Spectral Mammography (CESM)||Rachel O’Leary, Kim Keltie, Rosalyn Parker, Matthew Reiling, Emma Belilios||August 2022|
|MIB242 Artificial Intelligence in mammography||Rachel O’Leary, Kim Keltie, Helen Cole||January 2021|
|MIB232 KardiaMobile for the ambulatory detection of atrial fibrillation||Kim Keltie, Rachel O’Leary, Andrew Sims||October 2020|
NICE guidance often recommends research to address identified evidence gaps before a positive recommendation can be made. The EAG works with NICE teams (including the NICE observational data unit) to facilitate further research on promising technologies where current evidence is limited.
The EAG has a particular interest in observational data collection and analysis. This includes setting up national clinical registries to collect data about particular technologies or treatments where additional knowledge is needed.
The team also undertakes data analysis based on routinely collected health data to assess safety and efficacy and to study patient pathways. A main source for this work is hospital episodes statistics (HES) data which covers NHS hospital activity in England.
Examples of observational research conducted by the team:
Other work for NICE
Newcastle EAG provides a variety of other services for NICE, including:
- regulatory advice to the interventional procedures (IP) programme on CE marking, including the new UKCA marking of medical technologies
- research ethics advisory service to the NICE science policy and research team
- feasibility assessment of further research to address uncertainties in NICE guidance
- methodological support across all NICE programmes.
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
(Northern Medical Physics and Clinical Engineering, Freeman Hospital)
- Newcastle University
(Evidence Synthesis Group and Health Economics Group)