Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.
Division of Pulmonary and Sleep Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA.
J Cyst Fibros. 2019 Jul;18(4):530-535. doi: 10.1016/j.jcf.2019.05.001.
Individuals with CF and their parents cite safety concerns as barriers to participating in clinical studies. We assessed whether a brochure/infographic describing patient safety monitoring processes could reduce knowledge and attitude barriers regarding safety monitoring. We also identified factors associated with likely participation in future CF studies.
Respondents from three CF centers in the U.S. were randomly assigned to receive the safety monitoring brochure/infographic or an unrelated brochure. Fifty parents of children with CF <16, 50 adolescents with CF 16-21, and 50 adults with CF ≥22 years old were recruited to complete the study survey. Factors associated with survey responses and with reported likelihood of participating in future studies were assessed.
Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 1.01-5.28), but not in drug studies. Non-Hispanic respondents reported greater likelihood of participating in a future drug study than Hispanic respondents (aOR 3.18, CI 1.30-7.74). Adults with CF (aOR 2.62, CI 1.05-6.51) and parents (aOR 4.49, CI 1.66-12.15) were more likely than adolescents to report they would ask their care team about clinical trials. Confidence in safety monitoring was associated with reported likelihood of future participation in drug studies.
Potential future participation in CF drug and/or non-drug studies was associated with respondent age and ethnicity, receiving the safety monitoring brochure/infographic, and confidence in safety monitoring. Our findings underscore the need for education about safety monitoring, with targeted approaches for the Hispanic CF population and adolescents.
患有 CF 的个体及其父母将安全问题视为参与临床研究的障碍。我们评估了描述患者安全监测过程的小册子/信息图是否可以减少对安全监测的知识和态度障碍。我们还确定了与未来 CF 研究中可能参与相关的因素。
我们从美国的三个 CF 中心随机招募了受访者，他们分别接受了安全监测小册子/信息图或与安全监测无关的小册子。共招募了 50 名年龄<16 岁的 CF 儿童的父母、50 名 16-21 岁的 CF 青少年和 50 名≥22 岁的 CF 成年人来完成研究调查。评估了与调查回复相关的因素以及与报告的未来参与研究的可能性相关的因素。
总体而言，安全监测小册子/信息图与未来参与非药物研究的可能性增加相关（优势比 2.30，CI 1.01-5.28），但与药物研究无关。非西班牙裔受访者比西班牙裔受访者报告更有可能参与未来的药物研究（优势比 3.18，CI 1.30-7.74）。CF 成年患者（优势比 2.62，CI 1.05-6.51）和父母（优势比 4.49，CI 1.66-12.15）比青少年更有可能报告他们会向他们的护理团队询问临床试验。对安全监测的信心与报告未来参与药物研究的可能性相关。
潜在的未来参与 CF 药物和/或非药物研究与受访者年龄和种族、接受安全监测小册子/信息图以及对安全监测的信心相关。我们的研究结果强调了需要针对西班牙裔 CF 人群和青少年进行安全监测教育，并采取有针对性的方法。
