Friedman Daniela B, Kim Sei-Hill, Tanner Andrea, Bergeron Caroline D, Foster Caroline, General Kevin
Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina, USA; Statewide Cancer Prevention and Control Program, University of South Carolina, Columbia, South Carolina, USA.
School of Journalism and Mass Communications, University of South Carolina, Columbia, South Carolina, USA.
Contemp Clin Trials. 2014 Jul;38(2):275-83. doi: 10.1016/j.cct.2014.05.004. Epub 2014 May 14.
Clinical trials (CTs) are important for advancing public health and medical research, however, CT recruitment is challenging. The high reading level of CT information and the technical language of providers or researchers can serve as barriers to recruitment. Prior studies on the informed consent process found that consent documents often contain complicated terms. Limited research has examined resources specifically used to recruit individuals into CTs. The purpose of this study was to examine the content and readability of CT recruitment education resources in one U.S. state. Convenience sampling was employed for the collection of CT recruitment materials. A codebook was developed based on previous content analyses and emergent themes from statewide focus groups about CTs. A total of 127 materials were collected and analyzed (37.8% print; 62.2% Web). Most content was focused on treatment-related CTs (60.6%). Inclusion criteria related to specific disease conditions (88.9%) and age (73.6%) were described most often. Only 30% of resources had an explicit call to action. Overall mean readability level was Grade 11.7. Web-based materials were significantly more likely to be written at a higher grade level than print materials (p ≤ .0001). Readability also differed significantly according to resource distributor/creator, CT type, person quoted, and presence or absence of inclusion criteria and an explicit call to action. Our study provides insight into the content and difficulty level of recruitment materials intended to provide initial information about a CT. Future studies should examine individuals' comprehension of recruitment materials and how participation intentions are associated with recruitment messages.
临床试验(CTs)对于推进公共卫生和医学研究很重要,然而,临床试验的招募工作具有挑战性。临床试验信息的高阅读水平以及提供者或研究人员使用的专业术语可能成为招募的障碍。先前关于知情同意过程的研究发现,同意文件通常包含复杂的术语。针对专门用于招募个体参与临床试验的资源开展的研究有限。本研究的目的是调查美国一个州的临床试验招募教育资源的内容和可读性。采用便利抽样法收集临床试验招募材料。基于先前的内容分析以及全州关于临床试验的焦点小组中出现的主题制定了一份编码手册。总共收集并分析了127份材料(37.8%为印刷品;62.2%为网络资源)。大多数内容聚焦于与治疗相关的临床试验(60.6%)。最常描述的纳入标准涉及特定疾病状况(88.9%)和年龄(73.6%)。只有30%的资源有明确的行动呼吁。总体平均可读性水平为11.7年级。与印刷材料相比,网络材料更有可能以较高年级水平编写(p≤0.0001)。根据资源分发者/创作者、临床试验类型、被引用的人以及是否存在纳入标准和明确的行动呼吁,可读性也存在显著差异。我们的研究为旨在提供关于临床试验初步信息的招募材料的内容和难度水平提供了见解。未来的研究应调查个体对招募材料的理解以及参与意愿与招募信息之间的关联。