Levenberg Kate, Proctor David N, Maman Stephan R, Luck J Carter, Miller Amanda J, Aziz Faisal, Radtka John F, Muller Matthew D
Heart and Vascular Institute, College of Medicine, Penn State University, Hershey, PA, USA.
Noll Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.
SAGE Open Med. 2020 Jun 13;8:2050312120930915. doi: 10.1177/2050312120930915. eCollection 2020.
Patients diagnosed with peripheral artery disease are difficult to recruit into clinical trials. However, there is currently no high-quality, patient-centered information explaining why peripheral artery disease patients choose to participate or not participate in clinical research studies.
The current study was a prospective community engagement initiative that specifically asked patients with and without peripheral artery disease: (1) what motivates them to participate in clinical research studies, (2) their willingness to participate in different research procedures, (3) the barriers to participation, (4) preferences about study design, and (5) demographic and disease-related factors influencing participation. Data were gathered through focus groups ( = 19, participants aged 55-79 years) and mailed questionnaires ( = 438, respondents aged 18-85 years).
More than half of the respondents stated that they would be willing to participate in a study during evening or weekend time slots. Peripheral artery disease patients ( = 45) were more willing than those without peripheral artery disease ( = 360) to participate in drug infusion studies (48% versus 18%, < 0.001) and trials of investigational drugs (44% versus 21%, < 0.001). Motivating factors and barriers to participation were largely consistent with previous studies.
Adults in our geographic region are interested in participating in clinical research studies related to their health; they would like their doctor to tell them what studies they qualify for and they prefer to receive a one-page advertisement that has color pictures of the research procedures. Peripheral artery disease patients are more willing than those without peripheral artery disease to participate in drug infusion studies, trials of investigational drugs, microneurography, and spinal/epidural infusions.
被诊断患有外周动脉疾病的患者很难被招募到临床试验中。然而，目前尚无高质量的、以患者为中心的信息来解释外周动脉疾病患者选择参与或不参与临床研究的原因。
本研究是一项前瞻性社区参与倡议，特别询问了患有和未患有外周动脉疾病的患者：（1）促使他们参与临床研究的动机是什么；（2）他们参与不同研究程序的意愿；（3）参与的障碍；（4）对研究设计的偏好；以及（5）影响参与的人口统计学和疾病相关因素。数据通过焦点小组（共19个，参与者年龄在55 - 79岁之间）和邮寄问卷（共438份，受访者年龄在18 - 85岁之间）收集。
超过一半的受访者表示他们愿意在晚上或周末的时间段参与研究。外周动脉疾病患者（n = 45）比未患有外周动脉疾病的患者（n = 360）更愿意参与药物输注研究（48%对18%，P < 0.001）和研究性药物试验（44%对21%，P < 0.001）。参与的动机因素和障碍在很大程度上与先前的研究一致。
我们所在地理区域的成年人对参与与其健康相关的临床研究感兴趣；他们希望医生告知他们符合哪些研究条件，并且他们更喜欢收到一份带有研究程序彩色图片的单页广告。外周动脉疾病患者比未患有外周动脉疾病的患者更愿意参与药物输注研究、研究性药物试验、微神经ography和脊髓/硬膜外输注。
