Implementation and Value of Using a Split-Plot Reader Design in a Study of Digital Breast Tomosynthesis in a Breast Cancer Assessment Clinic

摘要

The rapid evolution in medical imaging has led to an increased number of recurrent trials, primarily to ensure that the efficacy of new imaging techniques is known. The cost associated with time and resources in conducting such trials is usually high. The recruitment of participants, in a medium to large reader study, is often very challenging as the demanding number of cases discourages involvement with the trial. We aim to evaluate the efficacy of Digital Breast Tomosynthesis (DBT) in a recall assessment clinic in Australia in a prospective multi-reader-multi-case (MRMC) trial. Conducting such a study with the more commonly used fully crossed MRMC study design would require more cases and more cases read per reader, which was not viable in our setting. With an aim to perform a cost effective yet statistically efficient clinical trial, we evaluated alternative study designs, particularly the alternative split-plot MRMC study design and compared and contrasted it with more commonly used fully crossed MRMC study design. Our results suggest that 'split-plot', an alternative MRMC study design, could be very beneficial for medium to large clinical trials and the cost associated with conducting such trials can be greatly reduced without adversely effecting the variance of the study. We have also noted an inverse dependency between number of required readers and cases to achieve a target variance. This suggests that split-plot could also be very beneficial for studies that focus on cases that are hard to procure or readers that are hard to recruit. We believe that our results may be relevant to other researchers seeking to design a medium to large clinical trials.