Hughson Jo-Anne, Woodward-Kron Robyn, Parker Anna, Hajek John, Bresin Agnese, Knoch Ute, Phan Tuong, Story David
School of Languages and Linguistics, The University of Melbourne, Parkville, VIC, 3010, Australia.
Department of Medical Education, Melbourne Medical School, University of Melbourne, Parkville VIC, 3010, Australia.
Trials. 2016 May 26;17(1):263. doi: 10.1186/s13063-016-1384-3.
The under-representation of culturally and linguistically diverse participants in clinical trials is an ongoing concern for medical researchers and the community. The aim of this review is to examine the complex issue of recruiting culturally and linguistically diverse (CALD) older people to medical research and to examine responses to these issues. The review focuses on (1) trends in the existing literature on barriers to and strategies for recruiting CALD and older people to clinical research, (2) issues with informed consent for CALD populations, and (3) the efficacy of innovative approaches, including approaches incorporating multimedia in research and consent processes. The literature indicates that predominant barriers to greater involvement of CALD patients in clinical trials are communication, including literacy and health literacy considerations; English language competence; and cultural factors in the research setting such as mistrust of consent processes, as well as considerable practical and logistical barriers, including mobility considerations. Some evidence exists that incorporating multimedia resources into the informed consent process can improve patient understanding and is preferred by patients, yet these findings are inconclusive. A multi-methodological approach, including the use of culturally and linguistically sensitive multimedia tools, may help address the issue of low inclusion of CALD groups in clinical research. Researcher education needs to be taken into account to address preconceptions about CALD resistance to research participation and to raise awareness of cultural concerns in regard to research participation.
临床试验中文化和语言背景多样的参与者代表性不足，这一直是医学研究人员和社会关注的问题。本综述的目的是研究招募文化和语言背景多样（CALD）的老年人参与医学研究这一复杂问题，并审视对这些问题的应对措施。该综述聚焦于：（1）现有文献中关于招募CALD老年人参与临床研究的障碍和策略的趋势；（2）CALD人群知情同意方面的问题；（3）创新方法的效果，包括在研究和同意过程中纳入多媒体的方法。文献表明，CALD患者更多参与临床试验的主要障碍包括沟通，涉及识字能力和健康素养；英语语言能力；以及研究环境中的文化因素，如对同意过程的不信任，还有诸多实际和后勤障碍，包括行动能力方面的考虑。有证据表明，在知情同意过程中纳入多媒体资源可提高患者理解程度且为患者所青睐，但这些结果尚无定论。一种多方法途径，包括使用文化和语言敏感的多媒体工具，可能有助于解决CALD群体在临床研究中纳入率低的问题。需要考虑研究人员的教育，以消除对CALD群体抗拒参与研究的先入之见，并提高对研究参与方面文化问题的认识。
