Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea.
Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea.
复制标题
DOI：
10.1002/pbc.24486
复制
发表时间：
2013-08
影响因子：
3.2
通讯作者：
Scarinci IC
中科院分区：
文献类型：
--
作者：
Lebensburger JD;Sidonio RF;Debaun MR;Safford MM;Howard TH;Scarinci IC
由于无法招募患者，几项镰状细胞临床试验已关闭。为了限制由于低累积率而导致的拟议临床试验的早期停止，我们试图更好地了解将镰状细胞贫血（SCD）儿童的父母招募到临床试验中的障碍和促进因素。焦点小组（n = 3）由父母/监护人（n = 14）组成，他们以前没有被招募参加临床试验，也没有给他们的孩子服用羟基脲。在焦点组分析期间，确定了与临床试验入组障碍相关的三个主要主题：健康相关研究的一般障碍（对研究的普遍不信任，情感和实际问题），试验设计的障碍（随机化）和羟基脲的障碍（长期未知风险，癌症，骨髓抑制作用）。确定的促进者需要更多的教育，包括要求同伴教育，并改进临床试验或研究原理的解释。SCD儿童的父母/监护人参与确定临床试验入组的障碍和促进因素，对于制定促进SCD试验完成的策略至关重要。
Several sickle cell clinical trials have closed due to inability to enroll patients. To limit the early cessation of a proposed clinical trial due to low accrual rates, we sought to better understand barriers and facilitators to enrolling parents of children with sickle cell anemia (SCD) into clinical trials. Focus groups (n = 3) were conducted with parents/guardians (n = 14) who had not previously been recruited for a clinical trial and were not administering hydroxyurea to their children. Three main themes related to barriers to clinical trial enrollment were identified during analysis of focus groups: general barriers to health related research (general mistrust of research studies, emotional and practical concerns), barriers to trial design (randomization), and barriers to hydroxyurea (long term unknown risks, cancer, myelosuppressive effects). Facilitators identified were need for more education, including request for peer education, and improved explanation of clinical trials or study rationale. Engagement of parents/guardians of children with SCD in identifying barriers and facilitators to clinical trial enrollment may be critical to the development of strategies to enhance SCD trial completion.