1. Dr. Simone Borsci DEC London
NIHR Diagnostic Evidence Cooperative (DEC) London Evidence to support diagnostic design
Dr. Simone Borsci
DEC London

2. Diagnostic Evidence Co-operative London
DEC London is a partnership between Imperial College Healthcare NHS Trust and Imperial College London
Centre Director: Professor George Hanna, Head of Division of Surgery, based at St. Mary’s hospital, Paddington
One of four DECs: Oxford, Leeds and Newcastle
Each DEC has an individual focus: DEC London is Point of Care in vitro diagnostic tests

3. Objectives
Act as a catalyst for evidence generation on clinical validity, utility, cost effectiveness and care pathway benefits of commercially supplied IVDs.
Enable collaboration between IVD industry, healthcare professionals, patients and scientists.
Create innovative methods for in-vitro diagnostics

4. Academia and Designers
Strategic Partners
Patients
Commissioners
Academia and Designers
Industry
Regulators
Implementation

5. Working with other NIHR infrastructure
INDUSTRY ENGAGEMENT
STAKEHOLDER & PATIENT ENGAGEMENT
INVENTION
EVALUATION
ADOPTION
DIFFUSION
DEC London
Diagnostic Evidence Cooperative London
NIHR BRC/BRU
Biomedical Research Centre
NIHR CLAHRC
Collaboration for leadership in applied health research and care NW London
NIHR CIPM/HPRU
Health Protection Research Unit
NIHR HTC
Health Technology Co-operative

6. Capabilities Clinical Studies Health Economics Patients and Public
How will the test affect
patients’ lives?
What do people want?
What do people expect?
Do patient support the use?
Human Factors
Mitigation of risks in use
Do people trust the test?
Do people accept it?
Safety and usability?
Patient experience?
Clinical Studies
Access to patient populations and multi-centre sites
Clinical expertise in nine themes
Study design
and management
Health Economics
Cost balanced by effectiveness
Value of the test to whom?
And for whom?
Impact on people?
Impact on budget?
What are the sensitivity/specificity/
negative and positive
predictive value/repeatability/
reproducibility?
Laboratory Validation
Barriers to Adoption
Why is a test not used?
How to facilitate adoption?
What are the main barriers?
Pathways towards adoption?
Scaling up strategy?

7. One-stop shop
2nd Generation
Clinical
assessment
Economic
analysis
Pathways and
adoption
toolkit
Stakeholder
Engagement
strategy
Design
evaluation
For technologies at different stages of development we combine different methods to generate an evidence bundle that support the next stage of decision making

8. Adoption POCKET tool

9. POCKET Potential Dissemination
European Association of Clinical Chemists
NIHR Diagnostic Evidence Co-operatives
National Institute for Health and Care Excellence (NICE)
Medicines and Healthcare products Regulatory Authority (MHRA)
Academic Health Science Network (AHSN)
British In-Vitro Diagnostic Association (BIVDA)
NHS England and Clinical Commissioning Groups
Clinical Chemistry Professional Bodies
US Food and Drug Administration FDA

10. DEC National Strategy NICE+DEC MHRA+DEC BIVDA+DEC BSI+MHRA+DEC
Diagnostic workshop on DEC evaluation methods
MHRA+DEC
Working on strategies to reduce errors in the use of IVD
DEC hosted MHRA workshop on barriers to implementation of IVD
BIVDA+DEC
DEC team actively participate to BIVDA workshops
BSI+MHRA+DEC
Reviewing standards and guidelines on Human factors
DEC White paper on human factors system approach to IVD research and development
Strategic research networking
Universities research centres (Kings, Nottingham and Brunel)
AHSN

11. In the last 3 years we interacted with 100 companies
Working with Industry
NIHR DEC London
In the last 3 years we interacted with 100 companies

12. Engaging with IVD industry
Developers / Innovators
Approach NIHR DEC
Discussion with clinical theme leads, (clinical Champion)
Propose work packages OR support to find the right infrastructure
Agree funding (company funded or grant application)
Carry out work packages
Results and feedbacks
Product development, strategy of inclusion in NHS, more founding
Engaging with IVD industry

13. Evaluation of HF

14. For each project Human Factors, Decision-making, Health Economics
to inform clinical utility, validation, and future clinical study
Current experience with device/assay
Workflow and clinical pathway mapping
Unmet needs and requirements to overcome barriers
Alternative pathways
Cost effectiveness model informed by literature, stakeholder analysis and clinical pathway mapping
Reports
(output)
Task, decision points, attitudes, issues and preferences of use, acceptability, trust and problems in the actual use, features/tech requirements, perceived value of use, clinical utility, perceived value for money, preferences of results presentation, Intention of use and promote etc.
Variables

15. Core DEC Team Members DEC Centre Director Business & Marketing Manager
Professor George Hanna
Research Nurse
Frances Domingo
Methodologist
Melody Zhifang Ni
Professor of Human Factors
Peter Buckle
Business & Marketing Manager
Elias Zapantis
Health Economist
Ijeoma Uchegbu
Human Factor Expert
Simon Walne
Human Factors Expert
Simone Borsci