Successful Patient Recruitment in CT Imaging Clinical Trials

• Published in: Academic radiology Vol. 21; no. 1; pp. 52 - 57
• Main Authors: Hollada, Jacqueline, BA, Marfori, Wanda, MD, Tognolini, Alessia, MD, Speier, William, MS, Ristow, Lindsey, BS, Ruehm, Stefan G., MD, PhD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 2014
• Subjects: benefits; clinical trial; Radiology; recruitment; risks; benefits; clinical trial; CT; risks; recruitment
• DOI: 10.1016/j.acra.2013.09.016
• EISSN: 1878-4046
• ISSN: 1076-6332

Rationale and Objectives Analyze factors that influence participation in research studies that use coronary computed tomography (CT) imaging. Materials and Methods A 12-point survey using a questionnaire was conducted on 80 subjects, of whom 40 agreed to participate in a cardiovascular CT imaging research study (enrolling subjects) and 40 declined participation (non-enrolling subjects). Potential factors that motivated the acceptance or refusal of enrollment were evaluated using a 5-point Likert scale. The following aspects were addressed: (1) additional health information, (2) free imaging, (3) altruistic benefit to society, (4) monetary compensation, (5) radiation exposure, (6) role as an experimental subject, (7) possible loss of confidentiality, (8) contrast or investigational drug use, (9) premedication use, (10) blood draw or intravenous placement, (11) time commitment, and (12) personal medical opinion. Response distributions were obtained for each question and compared between enrolling and non-enrolling groups. Results Enrolling subjects gave significantly higher ratings than non-enrolling subjects for the following factors: additional health information ( P < .001), free imaging ( P < .001), and the altruistic benefit to society ( P < .001). For non-enrolling subjects, concern for possible drug use or contrast injection ( P < .001), concern for possible premedication ( P < .001), and personal availability or time commitment ( P  < .001) were all given significantly higher ratings. Concern for radiation exposure ( P = .002) and personal medical opinion ( P  < .001) received significantly high ratings among both groups but did not differ between groups. Conclusions Several influential concerns and benefits were identified from potential research subjects. Knowledge of what influences patient participation in studies involving CT imaging may allow researchers to effectively address concerns and highlight the potential benefits related to participation.