Selected Principles of the Measurement and Setting of Priorities of Death, Disability, and Suffering in Clinical Trials

Measurements of the cause of death and of disability and suffering caused by nonfatal events add important dimensions to clinical trials even when mortality is the major outcome event. Assessing the cause of death requires special attention to criteria, documentation, and adjudication. Disability is measured through having patients perform objective tasks and functions, such as those related to "daily living," and assesses health from the perspective of the provider. Suffering is measured from the patient's viewpoint by multiple attribute measures and profiles, goal attainment scaling, and utility ratings, in which the patient's preferences for various health states are assessed. Having collected information on death, disability and suffering, the investigator faces decisions concerning setting their priorities when one measure (such as death) precludes the assessment of another or when there are disagreements among the measures.