Initial development of a questionnaire evaluating perceived benefits and barriers to pediatric clinical trials participation
Initial development of a questionnaire evaluating perceived benefits and barriers to pediatric clinical trials participation
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DOI：
10.1016/j.cct.2012.11.001
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发表时间：
2013-03-01
影响因子：
2.2
通讯作者：
Cohen, Robyn
中科院分区：
文献类型：
--
作者：
Barakat, Lamia P.;Patterson, Chavis A.;Cohen, Robyn
目的：评估参与儿科临床试验的感知益处和障碍，以改善决策并增强患有慢性疾病（镰状细胞病、哮喘）的少数族裔青少年及其护理人员的招募和保留。方法：根据医学专家和社区公共卫生组织的意见，根据社会生态模型制定了一份调查问卷。平行看护者、青少年/年轻人（AYA；16-39 岁）和儿童（8-15 岁）版本进行了现场测试。患者和护理人员完成了调查问卷，其中包括人口统计项目、感知生活压力和社会期望指标。结果：探索性因素分析为护理人员版本（直接治疗益处、对研究/研究人员的不信任、对医疗团队参与安全研究的信任和机会成本）和 AYA 版本（不信任/无直接益处安全、直接治疗益处/实际考虑和研究的社会支持）提供了四因素解决方案。 SCD 和哮喘护理人员的因素结构不同；儿童版本的结果是模棱两可的。总的子量表与患者人口统计或社会期望没有显着相关，但与感知的生活压力和之前参与研究的显着相关性被确定。结论：虽然因素结构应该用更大的样本来确认，但研究结果表明潜在的益处、由于对研究人员的不信任和后勤造成的感知伤害是参与儿科临床试验决策的主要因素。通过调整招募和知情同意程序来解决这些好处/障碍，研究人员可以解决对研究的误解，改进决策，并增加招募和保留，特别是针对患有慢性疾病的少数民族儿童。 (C) 2012 Elsevier Inc. 保留所有权利。
Objective: To evaluate perceived benefits and barriers to pediatric clinical trials participation to improve decision-making and enhance recruitment and retention among minority youth with chronic health conditions (sickle cell disease, asthma) and their caregivers.Methods: A questionnaire was developed based on the social ecological model using input from medical experts and community-based public health organizations. Parallel caregiver, adolescent/young adult (AYA; 16-39 years old), and child (8-15 years old) versions were field tested. Patients and caregivers completed the questionnaire, which included demographic items, perceived life stress and social desirability measures.Results: Exploratory factor analysis rendered a four-factor solution for the caregiver version (direct treatment benefit, mistrust of research/researchers, trust in healthcare team to engage in safe research, and opportunity cost) and the AYA version (mistrust/no direct benefit safety, direct treatment benefit/practical considerations, and social support for research). Factor structures differed for SCD and asthma caregivers; results were equivocal for the child version. Summated subscales were not significantly associated with patient demographics or social desirability, but significant correlations with perceived life stress and prior participation in research were identified.Conclusions: While the factor structure should be confirmed with larger samples, findings indicate potential benefit, perceived harm due to mistrust of researchers, and logistics are primary factors in decision-making about participation in pediatric clinical trials. By addressing these benefits/barriers through adjustments to recruitment and informed consent procedures, researchers may address misperceptions of research, improve decision-making, and increase recruitment and retention particularly for ethnic minority children with chronic health conditions. (C) 2012 Elsevier Inc. All rights reserved.