A Real-World, In-Situ, Evaluation Of The Introduction And Scale-Up Of Robot-Assisted Surgical Services In The NHS: Evaluating Its Impact On Clinical And Service Delivery, Effectiveness And Cost

Research question What is the impact of the introduction and scale-up of robotic-assisted surgery (RAS) on NHS service delivery, clinical effectiveness, budget and cost-effectiveness? Background Over 8 million patients undergo surgery in the UK annually at a cost of £11 billion. It is essential that all new procedures are fully evaluated before their full adoption within the NHS, but many new surgical procedures remain under evaluated. Robot-assisted surgery (RAS) has gained recent prominence as a potentially useful approach to surgery, predominately for cancer surgery. It is reported to reduce variation in surgical performance, the invasiveness of interventions (thereby improving outcome), has health (ergonomic) benefits for the surgeon, and can increase equity of access, but robust evaluation is needed. The recent Royal College of Surgeons (RCS) Future of Surgery Commission Report predicts that RAS will expand in the next decade and stresses the importance of urgent and rigorous evaluation before uncontrolled erratic uptake. Most urgent is assessment of impact on service specification, service delivery and effectiveness across different specialties. Further roll-out can then be optimised to where benefit can be best realised and service implications are explicit. The REINFORCE study aims to address this evidence gap. Aims and objectives To undertake a real-world, large-scale evaluation of impact on the introduction and scale-up of RAS services in the NHS. Specifically to provide evidence on the: • impact of RAS system transformation on clinical and service delivery • budget impact and cost-effectiveness of RAS at scale • potential benefit and harms • mechanisms of change underpinning any change in outcome Methods A system-level evaluation accounting for the complete system transformation that RAS creates (changes to service delivery in clinical pathways, referrals, and care plans) will be undertaken. It will comprise a stepped-wedge evaluation (with integrated process evaluation and economic assessment). The study will evaluate both RAS introduction in sites where there has been no previous RAS and scale-up at existing RAS sites (a new RAS specialty or a new RAS procedure within a RAS active specialty). Patients will be included from 6 specialties (Urology, Colorectal, Orthopaedics, Gynaecology, Thoracic and Upper Gastrointestinal surgery). The needs of multiple stakeholders including policy makers, clinicians, managers and users will be evaluated. The study will be run in approximately 16 clinical sites over 24 months. Timelines for delivery Months 0-6: Trial set up; 6-30: stepped wedge evaluation; 6-33 outcome collection; 6-33: process evaluation; 6-33 economic evaluation; 24-39: analysis; 39: delivery of report. Anticipated impact and dissemination The REINFORCE study will provide clear evidence on the benefits, costs and service impact of RAS roll-out to inform NHS commissioners, clinicians and users on the appropriate size and direction (including whether a slow-down is needed), of future scale-up of RAS. It will also yield understanding of the processes and mechanisms of change at a system level. Findings will be published in medical journals, presented at scientific meetings, national charities, via patient networks and the RCS.