Patient perceptions and willingness to participate in clinical trials.
OBJECTIVE: To evaluate gynecologic oncology patients' perceptions and willingness to participate in randomized clinical trials (RCT) among an inner city population.
METHODS: Informed consent was obtained. Demographics were collected and willingness to participate in a RCT was measured by the Attitudes on Randomized Trials Questionnaire (ARTQ). The Hospital Anxiety and Depression Scale estimated levels of anxiety and depression. A Perception Survey was created and tested as a screening tool for patients considering RCTs. Standard statistical tests were used.
RESULTS: One hundred and one women participated, 54 (53.5%) were black, 31 (30.7%) were white, non-Hispanic and 15 (14.9%) were Hispanic. Screening for anxiety and depression revealed an 18.8% rate of moderate to severe anxiety and an 11.9% rate of moderate to severe depression. Willingness to participate in a RCT as measured by ARTQ scores was not significantly associated with race, levels of anxiety or depression. Twenty-eight percent of women would agree to participate in a clinical trial at baseline. An additional, 33 (32.7%), for a total of 61.4%, indicated agreement after targeted education with no statistical differences by race or psychological stressor. However, sixty-one percent of these women were black. The Perception Survey approximated the results of the ARTQ with reasonable accuracy (AUC 0.758, p
Published In/Presented At
Igwe, E., Woodburn, J., Davolos, J., Shollenberger, C., Miller, S. M., Hernandez, E., & Ferriss, J. S. (2016). Patient perceptions and willingness to participate in clinical trials. Gynecologic oncology, 142(3), 520–524. https://doi.org/10.1016/j.ygyno.2016.06.015
Medicine and Health Sciences
Department of Obstetrics and Gynecology