Title: 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
Funder: Department of Health and Social Care

Abstract: What is this research about?_x000D_ _x000D_ This study (known as REINFORCE) aims to work out if robot assisted surgery, a relatively new development, should be routinely available in the NHS._x000D_ _x000D_ Why this project?_x000D_ _x000D_ Over the next 20 years, surgery performed with the help of a robot (called “robot-assisted surgery”) is expected to increase rapidly around the world, especially for cancer conditions. Previous research shows that when robot-assisted surgery has been introduced in some clinical areas, like urology, it can help surgeons be more precise and can reduce a patient’s hospital stay. Using robot-assisted surgery may also speed up training for surgeons to enable them to become experts more quickly. However, robot assisted surgery has not been tested in all clinical areas and is very expensive with each robot costing over £1million). Also, when robot-assisted surgery is introduced into hospitals it requires special consideration as the set-up can be disruptive. The robot can take up a lot of space requiring physical modifications to operating theatres. The surgeons and the wider surgical team have to change how they operate, and the way patients move through their patient journey also has to change. It is not yet clear whether the benefits to patients or the health system of doing surgery this way is worth the cost and the disruption. The REINFORCE study aims to answer that question and provide guidelines for the best way of doing it if robotic surgery is shown to be useful._x000D_ How will the research be done?_x000D_ _x000D_ We have designed the research to be able to measure the impact of robot-assisted surgery as it is introduced in the UK and scaled up in other hospitals currently performing robotic surgery but planning to expand services. It uses a scientific method called a “stepped wedge” study which involves introducing robot assisted surgery at different sites in a planned way. It will measure the safety and benefit of the new treatment as it is being rolled out. We will measure what happens to patients who get robot-assisted surgery as part of the service and compare their outcomes (e.g., complications, recovery time) to conventional surgery. We will also track how introducing robot-assisted surgery impacts on the staff and the surgeons, and how it affects wider care in hospitals across the country. We will also work out how much robot-assisted surgery really costs and whether the benefits are value for money._x000D_ _x000D_ Who has been involved in the design of the project?_x000D_ _x000D_ We have consulted widely about how best to design the research. Patients, surgeons, nurses, NHS managers, scientists, and industry have been involved and will continue to advise on the project. We will involve patients throughout the project._x000D_ _x000D_ How will the results of this research be used?_x000D_ _x000D_ This research will provide the NHS the information needed on the benefits of robot-assisted surgery and how it affects the wider health system. It will help decide whether the benefits of robot-assisted surgery are worth the cost and the disruption to services and whether robot-assisted surgery should be available routinely in the UK. It will also provide important guiding information on how best to provide robotic surgery, if found to be useful._x000D_ _x000D_ Who are the research team?_x000D_ _x000D_ We have assembled a team of surgeons, researchers, patient partners, economists, NHS commissioners and managers. The team has a very strong track record of working together in this type of research, especially providing decision making information for the NHS.

Lay abstract: Research question_x000D_ _x000D_ 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?_x000D_ _x000D_ Background_x000D_ _x000D_ 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._x000D_ _x000D_ Aims and objectives_x000D_ _x000D_ 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:_x000D_ _x000D_ • impact of RAS system transformation on clinical and service delivery_x000D_ • budget impact and cost-effectiveness of RAS at scale_x000D_ • potential benefit and harms_x000D_ • mechanisms of change underpinning any change in outcome_x000D_ _x000D_ Methods_x000D_ _x000D_ 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._x000D_ _x000D_ Timelines for delivery_x000D_ _x000D_ 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._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ _x000D_ 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.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: MUSCULOSKELETAL;ORAL AND GASTROINTESTINAL;RENAL AND UROGENITAL;REPRODUCTIVE HEALTH AND CHILDBIRTH