Project 466553

Approximately 6,900 Canadians are diagnosed with acute leukaemia (AL) each year. AL and its treatments cause patients to bleed more easily. In clinical trials, researchers use bleeding as an outcome to find better ways to prevent and treat bleeding in AL patients. Currently, there are four categories of bleeding outcomes: grades 1 and 2 which are mild types of bleeding, and grades 3 and 4 that are severe types of bleeding (require transfusion or bleeding that could cause death). In clinical studies, grades 2, 3, and 4 bleeding events are combined as one outcome. The grouping of the bleeding events is problematic as grade 2 bleeding events are more frequent and milder and may not be related to severe bleeding. In addition, these outcomes do not consider what bleeding events are important and concerning to patients and providers. This project aims to develop a utility-based bleeding score that defines bleeding and is relevant to AL patients and others involved in their care. Using a mixed-methods approach, I will be integrating two data sources: an analysis from three international studies on signs and symptoms of minor bleeds that may predict severe bleeding; and qualitative interview results from AL patients and providers to create the UBS. Both data sources will be used to identify bleeding events which will be scored for importance by a group of patients and providers. This information will be used to develop the UBS. An international survey will be sent to AL treating physicians to obtain their input and willingness to use this new bleeding outcome in future research. The findings from this project will help clinical researchers use an outcome that will be important and meaningful to patients and providers when performing studies in the acute leukaemia population.