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.
Clinical research is vital for the progress of medicine and clinical practice . Because clinical trials depend on patient participation, effective recruitment strategies are imperative for trial success . Understanding the factors affecting a patient’s willingness to participate in a clinical trial is beneficial for successful patient recruitment because it allows customization of recruitment strategies to address typical concerns and expectations. Inefficiencies in subject recruitment may result in unwanted extensions of study time frames, typically increasing study costs and challenging the completion of expected site deliverables. The investigators’ ability to address common concerns puts research subjects at ease , which enables the trial to avoid participant attrition and helps achieve the expected recruitment goals for the study .
Several studies have examined factors that affect patients’ decisions to participate in different types of clinical trials. The altruistic feeling of helping society has been shown to have a positive influence on participation . The potential to obtain additional health-related information has been shown to affect participation both positively and negatively . Poor education levels and unfamiliarity with scientific jargon typically have been shown to have a negative impact on study participation . Existing studies focus exclusively on the influencing factors on those patients who participate in clinical trials, providing a biased representation of patients’ concerns. To our knowledge, no study has yet analyzed the concerns of patients who decline participation.
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Materials and methods
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Table 1
Patient Distribution
Accepted Participation Declined Participation Total Patients contacted to participate in CT clinical trial (male, female) 89 (67, 22) 275 (162, 113) 346 (229, 135) Contacted to participate in questionnaire study (male, female) 55 (37, 13) 79 (36, 43) 134 (78, 56) Participated in questionnaire study (male, female) 40 (20, 20) 40 (18, 22) 80 (38, 42)
CT, computed tomography.
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Table 2
Categories and Questions from Questionnaire
Benefits Risks/Discomforts Possible Side Effects Personal Influence The chance to obtain additional health information Concern regarding possible radiation exposure Concern for possible contrast or investigational drug use Personal availability and/or time commitment The opportunity to obtain free imaging Role as an experimental subject (“guinea pig”) Concern for possible premedication use Personal medical opinion regarding your own health Altruistic benefit to society Concern for possible loss of confidentiality Concern for possible blood draw/intravenous placement Monetary compensation
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Results
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Table 3
Average Response Values for Enrolling and Non-enrolling Subjects
Questions Enrolling Non-enrolling Benefits The chance to obtain additional health information 4.5 ± 1.1 2.7 ± 1.7 The opportunity to obtain free imaging 4.1 ± 1.3 2.4 ± 1.7 Altruistic benefit to society 4.5 ± 0.9 2.8 ± 1.5 Monetary compensation 2.1 ± 1.3 1.7 ± 1.4 Risks/discomforts Concern regarding possible radiation exposure 2.7 ± 1.5 3.6 ± 1.6 Role as an experimental subject (“guinea pig”) 1.7 ± 1.2 2.1 ± 1.3 Concern for possible loss of confidentiality 1.6 ± 1.1 2.1 ± 1.5 Possible side effects Concern for possible contrast or investigational drug use 1.8 ± 1.1 3.1 ± 1.7 Concern for possible premedication use 1.6 ± 1.1 2.9 ± 1.6 Concern for possible blood draw/intravenous placement 1.4 ± 0.9 1.4 ± 0.9 Personal influence Personal availability and/or time commitment 2.0 ± 1.2 3.7 ± 1.6 Personal medical opinion regarding your own health 3.2 ± 1.3 3.3 ± 1.6
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Discussion
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