The development of a new diagnostic test ideally follows a sequence of stages which, amongst other aims, evaluate technical performance. This includes an analytical validity study, a diagnostic accuracy study and an interventional clinical utility study. Current approaches to the design and analysis of the diagnostic accuracy study can suffer from prohibitively large sample sizes and interval estimates with undesirable properties. In this paper, we propose a novel Bayesian approach which takes advantage of information available from the analytical validity stage. We utilise assurance to calculate the required sample size based on the target width of a posterior probability interval and can choose to use or disregard the data from the analytical validity study when subsequently inferring measures of test accuracy. Sensitivity analyses are performed to assess the robustness of the proposed sample size to the choice of prior, and prior-data conflict is evaluated by comparing the data to the prior predictive distributions. We illustrate the proposed approach using a motivating real-life application involving a diagnostic test for ventilator associated pneumonia. Finally, we compare the properties of the proposed approach against commonly used alternatives. The results show that by making better use of existing data from earlier studies, the assurance-based approach can not only reduce the required sample size when compared to alternatives, but can also produce more reliable sample sizes for diagnostic accuracy studies.
Bayesian sample size determination for diagnostic accuracy studies