Innovative photoplethysmography technology for rapid non-invasive assessment of peripheral arterial disease in primary care

Refer to Gantt and milestones, Section 10. WP1 Product Development, months 1-36 Takes the MPPG device from prototype to NICE submission through the stages: Production of 6 CE marked devices, months 1-6, for the WP3 clinical utility studies. Design for adoption, months 7-24 is iterative with WP2, assessment and revision of the training package, WP3 outcomes from the qualitative studies and WP4 completion of DCE and the draft health economic model. This stage encompasses 2 IP & innovation deliverables, Securing a device manufacturer at month12 to ensure their input into design. A review of the options to protect IP on device design. Design modification for manufacture months 25-30 culminating in design freeze which aligns with securing IP. Rapid prototyping to build and CE mark the final medical device. Prepare NICE MTEP submission, months 33-36 which requires a CE marked device and the health economic model for adoption from WP4. WP2 Training Package Development months 1-24 An initial training package will be consolidated by month 6 for the clinical utility studies in WP3. Over the next 18 months, the training package will be assessed and revised iteratively with WP1 Design modifications for adoption and WP3, the outcomes of quantitative studies. WP3 Clinical Utility Studies. months 1–24. PPI is essential in all stages of WP3 In months1-6 approvals will be obtained and end users trained. Quantitative and qualitative studies will run in parallel from month7 as they utilise different patient and end user groups. A. Quantitative Studies months 7-18 To determine the diagnostic performance of MPPG compared with ABPI and the questionnaire evaluation of PAD, for repeatability, sensitivity and specificity in an equivalent of primary care and end users. B. Qualitative Studies months 7-24 To identify the barriers and facilitators to implementation of MPPG (including feedback on training package and device). Months 1-6 Exploratory work - focus groups and GP staff survey. Months 7-24 - three sequential 6 month phases of iterative qualitative work in a range (e.g. urban/rural; large/small) of GP practices (5 each phase; total 15). WP4 Health Economic model, months 1-36 A. Health economic analysis and model, months 1-12 A draft economic model will be developed in parallel with WP5 primary care commissioning requirements and will include outcomes from WP3 utility studies. This will be used when securing a manufacturing partner in WP5. B. Discrete choice experiments (DCE), months 12-24. The device attributes will be defined from literature, focus groups and expert opinion then tested in a survey of 100 primary care practitioners to identify those which will maximise test uptake for PAD and non-PAD applications. The outcomes will be incorporated into the health economic model and report for technology adoption required for the NICE submission in WP1 and will guide the final plan for commercial roll-out in WP5 at month 33. WP5 Market Preparation. months 1-36 A. Primary Care Commissioning, months 1–24 The current commissioning situation will be investigated in months 1-12 in conjunction with WP4 development of the initial health economic model. By month18, the barriers and facilitators to commissioning will be identified and the route for commissioning the diagnostic in primary care defined months 19-24. This will contribute to the deliverable to identify key sites for roll out at month 24. B. IP and Innovation, months 1-36 Deliverables (Gantt chart) with links to the relevant WPs as described above. Patient and Public Involvement (in all work packages): Steering group panel led by Professor G Stansby. PPI input will be sought particularly in WP3 and WP1 (indicated by hatching). A major role for the panel will be to disseminate progress for device adoption.