Ethical and legal implications of implementing risk algorithms for early detection and screening for oesophageal cancer, now and in the future

BACKGROUND: Oesophageal cancer has significant morbidity and mortality but late diagnosis is common since early signs of disease are frequently misinterpreted. Project DELTA aims to enable earlier detection and treatment through targeted screening using a novel risk prediction algorithm for oesophageal cancer (incorporating risk factors of Barrett’s oesophagus including prescriptions for acid-reducing medications (CanPredict)), together with a non-invasive, low-cost sampling device (Cytosponge(TM)). However, there are many barriers to implementation, and this paper identifies key ethical and legal challenges to implementing these personalised prevention strategies for Barrett’s oesophagus/oesophageal cancer. METHODS: To identify ethical and legal issues relevant to the deployment of a risk prediction tool for oesophageal cancer into primary care, we adopted an interdisciplinary approach, incorporating targeted informal literature reviews, interviews with expert collaborators, a multidisciplinary workshop and ethical and legal analysis. RESULTS: Successful implementation raises many issues including ensuring transparency and effective risk communication; addressing bias and inequity; managing resources appropriately and avoiding exceptionalism. Clinicians will need support and training to use cancer risk prediction algorithms, ensuring that they understand how risk algorithms supplement rather than replace medical decision-making. Workshop participants had concerns about liability for harms arising from risk algorithms, including from potential bias and inequitable implementation. Determining strategies for risk communication enabling transparency but avoiding exceptionalist approaches are a significant challenge. Future challenges include using artificial intelligence to bolster risk assessment, incorporating genomics into risk tools, and deployment by non-health professional users. However, these strategies could improve detection and outcomes. CONCLUSIONS: Novel pathways incorporating risk prediction algorithms hold considerable promise, especially when combined with low-cost sampling. However immediate priorities should be to develop risk communication strategies that take account of using validated risk algorithms, and to ensure equitable implementation. Resolving questions about liability for harms arising should be a longer-term objective.