2019年由美国国家科学院召开的公共研讨会,工程与医学(NASEM)健康素养圆桌会议确定了需要为临床试验中的健康素养和患者激活的最佳实践制定基于证据的指导。
为了确定医疗或临床试验环境中与改善健康素养或患者激活相关的健康素养干预措施的研究,以帮助告知临床试验过程中的最佳实践。
文献检索在PubMed中进行,护理和相关健康文献的累积指数,Scopus,科克伦,和WebofScience从2009年1月到2021年6月。
在筛选的3592条记录中,纳入22条记录,调查了随机对照研究中27种独特的健康素养干预措施,以进行定性综合。
根据系统评价和荟萃分析(PRISMA)指南的首选报告项目进行数据筛选和提取。
健康素养干预的类型是基于多媒体或技术的(11项研究),简化书面材料(六项研究)和面对面会议(五项研究)。这些干预措施应用于医疗保健和临床试验过程的各个阶段。所有研究都使用了独特的结果衡量标准,包括病人的理解,知情同意的质量,以及患者的激活和参与。
我们的研究结果表明,最佳实践指南建议在临床试验过程中进行健康素养干预。以多种形式呈现信息,患者参与信息优化,并改进健康素养结果测量的标准化。
A 2019 public workshop convened by the National Academies of Sciences, Engineering and Medicine (NASEM) Roundtable on Health Literacy identified a need to develop evidence-based guidance for best practices for health literacy and patient activation in clinical trials.
To identify studies of health literacy interventions within medical care or clinical
trial settings that were associated with improved measures of health literacy or patient activation, to help inform best practices in the clinical
trial process.
Literature searches were conducted in PubMed, the Cumulative Index to Nursing and Allied Health Literature, SCOPUS, Cochrane, and Web of Science from January 2009 to June 2021.
Of 3592 records screened, 22 records investigating 27 unique health literacy interventions in randomized controlled studies were included for qualitative synthesis.
Data screening and abstraction were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.
Types of health literacy interventions were multimedia or technology-based (11 studies), simplification of written material (six studies) and in-person sessions (five studies). These interventions were applied at various stages in the healthcare and clinical
trial process. All studies used unique outcome measures, including patient comprehension, quality of informed consent, and patient activation and engagement.
The findings of our
study suggest that best practice guidelines recommend health literacy interventions during the clinical
trial process, presentation of information in multiple forms, involvement of patients in information optimization, and improved standardization in health literacy outcome measures.