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

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

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

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

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

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?

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

Adoption POCKET tool

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

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

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

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

Evaluation of HF

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

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