Differences in Defining “Clinically Meaningful” in Metastatic Breast Cancer Care

Stephanie Graff, M.D., FACP, FASCO, director of breast oncology at the Lifespan Cancer Institute and author of "Investigating the Salience of Clinical Meaningfulness and Clinically Meaningful Outcomes in Metastatic Breast Cancer Care Delivery" explained that the definition of clinical meaningfulness is dependent on setting. A clinician may describe it as a statistically significant change, but a patient may reference their quality of life.

“The goal of this research was to dive in and explore how different members of the collective view this language,” Graff explained. “In the research itself, we defined clinical meaningfulness as the practical and applied value or importance of an intervention, and is related to whether or not treatment results in a clinician observed change.”

However, a patient may have a different view.

“If, for example, a cancer treatment is going to extend life, and as a result of extending life is going to cause a certain amount of side effects, how does that scale balance?” Graff explained. “If it extends life by three days and carries a 50% risk of grade three diarrhea, is that clinically meaningful to the patient? My guess is that a lot of patients would probably say no.”

In the study, 115 individuals participated in at least one of 22 focus groups. Participants included patients with metastatic breast cancer, informal caregivers, oncologists and oncology nurses.

Participants in all groups described clinical meaningfulness as a the patient’s ability to complete life goals and maintain a desirable quality of life.