Keusch Florian, Rao Rohini, Chang Lawrence, Lepkowski James, Reddy Pavan, Choi Sung Won
Institute for Social Research, University of Michigan, Ann Arbor, Michigan.
Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Biol Blood Marrow Transplant. 2014 Oct;20(10):1604-11. doi: 10.1016/j.bbmt.2014.06.020. Epub 2014 Jun 24.
Despite major improvements over the past several decades, many patients undergoing hematopoietic stem cell transplantations (HSCT) continue to suffer from significant treatment-related morbidity and mortality. Clinical research studies (trials) have been integral to advancing the standard of care in HSCT. However, 1 of the biggest challenges with clinical trials is the low participation rate. Although barriers to participation in cancer clinical trials have been previously explored, studies specific to HSCT are lacking. The current study was undertaken to examine the knowledge, attitudes, and perceptions of HSCT patients regarding clinical trials. As members of focus groups, participants responded to open-ended questions that assessed factors influencing decision-making about HSCT clinical trials. Suggestions for improvements in the recruitment process were also solicited among participants. Seventeen adult HSCT patients and 6 parents of pediatric HSCT patients participated in the study. The median age was 56 years (range, 18 to 70) and 44 years (range, 28 to 54) for adult patients and parents, respectively. Participants universally indicated that too much information was provided within the informed consents and they were intimidated by the medical and legal language. Despite the large amount of information provided to them at the time of study enrollment, the participants had limited knowledge retention and recall of study details. Nevertheless, participants reported overall positive experiences with clinical trial participation and many would readily choose to participate again. A common concern among participants was the uncertainty of study outcome and general lack of feedback about results at the end of the study. Participants suggested that investigators provide more condensed and easier to understand informed consents and follow-up of study findings. These findings could be used to help guide the development of improved consent documents and enhanced participation in research studies, thereby affecting the future design of HSCT research protocols.
尽管在过去几十年中有了重大改进，但许多接受造血干细胞移植（HSCT）的患者仍遭受与治疗相关的严重发病率和死亡率。临床研究（试验）对于提高HSCT的护理标准至关重要。然而，临床试验面临的最大挑战之一是参与率低。虽然之前已经探讨了参与癌症临床试验的障碍，但缺乏针对HSCT的具体研究。当前的研究旨在调查HSCT患者对临床试验的知识、态度和看法。作为焦点小组的成员，参与者回答了开放式问题，这些问题评估了影响HSCT临床试验决策的因素。参与者还被征求了关于改善招募过程的建议。17名成年HSCT患者和6名儿科HSCT患者的父母参与了该研究。成年患者和父母的中位年龄分别为56岁（范围18至70岁）和44岁（范围28至54岁）。参与者普遍表示，知情同意书中提供的信息过多，他们被医学和法律语言吓倒。尽管在研究入组时向他们提供了大量信息，但参与者对研究细节的知识保留和回忆有限。尽管如此，参与者报告了参与临床试验的总体积极经历，许多人愿意再次选择参与。参与者共同关心的问题是研究结果的不确定性以及研究结束时普遍缺乏关于结果的反馈。参与者建议研究人员提供更简洁、更易于理解的知情同意书，并对研究结果进行跟进。这些发现可用于帮助指导改进同意书的制定和加强对研究的参与，从而影响HSCT研究方案的未来设计。
