CT 影像学临床试验中患者招募的成功因素：哪些因素影响患者参与？

Successful patient recruitment in CT imaging clinical trials: what factors influence patient participation?

机构信息

Department of Radiology, David Geffen School of Medicine, University of California Los Angeles, 10945 LeConte Avenue, Suite 3371, Los Angeles, CA 90024.

出版信息

Acad Radiol. 2014 Jan;21(1):52-7. doi: 10.1016/j.acra.2013.09.016.

DOI:10.1016/j.acra.2013.09.016

PMID:24331264

Abstract

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.

摘要

目的

分析影响使用冠状动脉计算机断层扫描（CT）成像进行研究的因素。

材料和方法

对 80 名受试者进行了 12 点问卷调查，其中 40 名同意参加心血管 CT 成像研究（入组受试者），40 名拒绝参加（非入组受试者）。使用 5 分李克特量表评估影响入组接受或拒绝的潜在因素。研究内容包括：（1）额外的健康信息；（2）免费成像；（3）对社会的利他益处；（4）经济补偿；（5）辐射暴露；（6）作为实验对象的角色；（7）可能失去保密性；（8）对比剂或研究性药物的使用；（9）使用前用药；（10）采血或静脉置管；（11）时间承诺；以及（12）个人医疗意见。对每个问题的回答进行了分布，并比较了入组和非入组组之间的差异。

结果

与非入组组相比，入组组在以下因素方面的评分显著更高：额外的健康信息（P <.001）、免费成像（P <.001）和对社会的利他益处（P <.001）。对于非入组组，对可能的药物使用或对比剂注射的担忧（P <.001）、对可能的预用药的担忧（P <.001）以及个人的可用性或时间承诺（P <.001）均得到了更高的评分。对辐射暴露的担忧（P =.002）和个人医疗意见（P <.001）在两组中均得到了很高的评分，但两组之间没有差异。