Assessment of the Decision-Making Capacity for Clinical Research Participation in Patients With Advanced Cancer in the Last Weeks of Life

Abstract

ContextFew studies have examined how clinicians assess decision-making capacity for research in the last weeks of life. ObjectivesWe examined the decision-making capacity for participation in a research study and its association with clinician impression and delirium among patients with cancer with days to weeks of life expectancy. MethodsPatients admitted to our palliative and supportive care unit were approached for a prospective observational study. We assessed for their decision-making capacity based on clinical impression of physician and nurse, Memorial Delirium Assessment Scale (MDAS), and the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR). ResultsAmong the 206 patients, 131 patients (64%) did not require MacCAT-CR assessment because they were overtly delirious or unresponsive; 37 (18%) patients were alert but did not complete the MacCAT-CR assessment for other reasons, and 38 patients (18%) completed the MacCAT-CR assessment. Among these 38 patients, five (13%) patients were incapable and had normal albeit significantly higher MDAS scores compared with those who were capable (1.8 vs. 4.2; P = 0.002). Compared against MacCAT-CR and MDAS, the overall agreement with capacity assessment with a clinician was 88% (95% CI 82–93) for physicians and 90% (95% CI 82–94) for nurses. The area under the receiver operating characteristics curve was 0.93 (95% CI 0.88–0.96) for physicians and 0.94 (95% CI 0.89–0.97) for nurses, suggesting high discrimination. ConclusionMost patients in the palliative and supportive care unit lacked decision-making capacity for participation in clinical research. Clinician impression had high accuracy. Few patients with normal MDAS were found to be incapable with MacCAT-CR assessment.