Detection of Unusual Increases in MRI Lesion Counts in Individual Multiple Sclerosis Patients
识别个体多发性硬化患者 MRI 病灶计数的异常增加
Data Safety and Monitoring Boards (DSMBs) for multiple sclerosis clinical trials consider an increase of contrast-enhancing lesions on repeated magnetic resonance imaging an indicator for potential adverse events. However, there are no published studies that clearly identify what should be considered an “unexpected increase” of lesion activity for a patient. To address this problem, we consider as an index the likelihood of observing lesion counts as large as those observed…