OrQA-UK (Organ Quality Assessment): novel clinical trial of an AI enabled photograph assessment tool to improve organ utilisation in the United Kingdom

Research question The OrQA-UK study is designed to analyse whether a point of donation AI powered visual assessment tool can safely reduce the number of deceased donor organs not used for transplantation. Background Organ transplantation is lifesaving, but limited by the availability of suitable organs. Up to 40% of the organs donated which are suitable in theory are not used because of concerns around quality and potential harm in the recipient. Visual assessment of donor organ quality remains the most common reason for non-utilisation of liver, kidney and pancreas organs for transplantation. We have designed 3 specific tools OrQA-L (liver), OrQA-P (pancreas), OrQA-K (kidney) to standardise the assessment and remove inherent human biases which compromise the assessment. Aims and Objectives The primary aim of the project is to deliver the OrQA-UK liver utilisation study (Objective 1; Work Packages 1,2,3) which has been powered to reduce the number of livers discarded for transplantation from the current 21% to 15.8% (25% reduction, 60 extra livers a year). In addition, there are 3 secondary objectives: Objective 2: Technical development of the OrQA-K and OrQA-P tools. Objective 3: International commercialisation and regulatory approvals Objective 4: Professional, Patient and Public engagement These work packages are designed to support the trial set-up, evolve the pancreas and kidney evaluation studies, progress the commercial and regulatory work and deliver a complex PPI co-production package. Methods At the core of this project is the OrQA-UK study, an RCT in which the photographs displayed to decision makers are randomised in a 1:1 ratio to receive an OrQA score or not. Over two years we will randomise 1970 photographs and use NHS Blood and Transplant registry returns to examine the secondary outcomes including primary non-function and retransplantation. Alongside the trial, the technical development team will develop functioning OrQA-K and OrQA-P tools for scientific testing, whilst the commercial and regulatory teams engage with the relevant authorities and formalise a "route to market". Professional and public engagement will be key to the success of the trial and prioritised in the initial work packages. Timelines for delivery This is a 36 month project including an initial setup phase (STOP/GO month 5), 2 year recruitment period (STOP/GO at month 18) and then 7 month follow-up phase. Work will continue concurrently on the OrQA-K and P tools with performance milestones to underpin the technical, regulatory and commercial work packages as well. The PPI work package is front loaded and designed to support the set up phase ensuring that clinicians and the public are comprehensively informed before the trial phase commences. Anticipated Impact and Dissemination We anticipate that OrQA-L will have facilitated an extra 120 liver transplants. At the end of the project the OrQA-L tool will have transitioned from technology readiness level 7 to level 10 and be ready for marketing internationally after approval as a medical device or AI decision support tool. The results will be published in traditional media channels, online social media and presented at national and international conferences to ensure maximal impact.