School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
PLoS Negl Trop Dis. 2010 Jul 20;4(7):e749. doi: 10.1371/journal.pntd.0000749.
Obtaining informed consent for clinical trials is especially challenging when working in rural, resource-limited areas, where there are often high levels of illiteracy and lack of experience with clinical research. Such an area, a remote field site in the northeastern part of the state of Minas Gerais, Brazil, is currently being prepared for clinical trials of experimental hookworm vaccines. This study was conducted to assess whether special educational tools can be developed to increase the knowledge and comprehension of potential clinical trial participants and thereby enable them to make truly informed decisions to participate in such research.
METHODOLOGY/PRINCIPAL FINDINGS: An informational video was produced to explain the work of the research team and the first planned hookworm vaccine trial, using a pedagogical method based on analogies. Seventy-two adults living in a rural community of Minas Gerais were administered a structured questionnaire that assessed their knowledge of hookworm, of research and of the planned hookworm vaccine trial, as well as their attitudes and perceptions about the researchers and participation in future vaccine trials. The questionnaire was administered before being shown the educational video and two months after and the results compared. After viewing the video, significant improvements in knowledge related to hookworm infection and its health impact were observed: using a composite score combining related questions for which correct answers were assigned a value of 1 and incorrect answers a value of 0, participants had a mean score of 0.76 post-video compared to 0.68 pre-video (p = 0.0001). Similar improvements were seen in understanding the purpose of vaccination and the possible adverse effects of an experimental vaccine. Although 100% of participants expressed a positive opinion of the researchers even before viewing the film and over 90% said that they would participate in a hookworm vaccine trial, an increase in the number who expressed fear of being vaccinated with a novel vaccine was seen after viewing the video (51.4% post-video versus 29.2% pre-video). Increases were also seen in the proportion who thought that participation in a vaccine trial would be inconvenient or disrupt their daily activities.
CONCLUSIONS/SIGNIFICANCE: Even in rural, resource-limited populations, educational tools can be specially designed that significantly improve understanding and therefore the likelihood of obtaining truly informed consent for participation in clinical research. The observed changes in the knowledge and perceptions of the research participants about hookworm infection and the experimental hookworm vaccine demonstrate that the video intervention was successful in increasing understanding and that the subjects acquired knowledge pertinent to the planned research.
在农村和资源有限的地区开展临床试验时，获得知情同意尤其具有挑战性，因为这些地区通常存在较高的文盲率和缺乏临床研究经验。巴西米纳斯吉拉斯州东北部的一个偏远野外地点就是这样一个地区，目前正在为钩虫实验疫苗的临床试验做准备。本研究旨在评估是否可以开发特殊的教育工具，以提高潜在临床试验参与者的知识和理解能力，从而使他们能够真正知情地决定参与此类研究。
方法/主要发现：制作了一个信息视频，用基于类比的教学方法解释研究团队的工作和首次计划的钩虫疫苗试验。对米纳斯吉拉斯州一个农村社区的 72 名成年人进行了一项结构化问卷调查，评估他们对钩虫、研究和计划中的钩虫疫苗试验的了解，以及他们对研究人员和参与未来疫苗试验的态度和看法。在观看教育视频之前和之后两个月进行了问卷调查，并比较了结果。观看视频后，与钩虫感染及其健康影响相关的知识有了显著提高：使用一个综合分数，将正确答案赋值为 1，错误答案赋值为 0，对相关问题进行组合评分，参与者在观看视频后的平均得分为 0.76，而在观看视频前的平均得分为 0.68（p=0.0001）。对疫苗接种目的和实验性疫苗可能产生的不良反应的理解也有类似的提高。尽管 100%的参与者在观看影片之前就对研究人员表示了积极的看法，超过 90%的人表示他们将参与钩虫疫苗试验，但观看影片后，对新型疫苗接种感到恐惧的人数有所增加（观看后 51.4%，观看前 29.2%）。认为参与疫苗试验会不方便或扰乱他们日常生活的人数也有所增加。
结论/意义：即使在农村和资源有限的人群中，也可以专门设计教育工具，显著提高理解能力，从而更有可能获得真正知情同意参与临床研究。研究参与者对钩虫感染和实验性钩虫疫苗的知识和看法的变化表明，视频干预成功地提高了理解能力，受试者获得了与计划研究相关的知识。
