传播非洲神经生物样本库和中风基因组研究中的伦理、法律和社会问题：项目干预工具开发与评估程序
Communicating the ethical, legal, and social issues in neurobiobanking and stroke genomic research in Africa: Project intervention tools development and evaluation procedures.
作者信息
Ojebuyi Babatunde R, Afolami Ibukun, Adigun Muyiwa, Singh Arti, Jenkins Carolyn, Nichols Michelle, Wahab Kolawole, Bello Abiodun, Sarfo Fred S, Owolabi Lukman F, Musbahu Rabiu, Obiako Reginald, Akpalu Albert, Ogunronbi Mayowa, Olorunsogbon Olorunyomi, Calys-Tagoe Benedict, Adesina Deborah, Coleman Nathaniel, Sule Abdullateef G, Mande Aliyu, Uthman Muhammed, Titiloye Musibau, Uvere Ezinne, Bukola Odunola, Laryea Ruth, Fakunle Adekunle, Adeleye Osi, Mensah Nathaniel, Yusuf Jibril, Adeniyi Sunday, Asibey Shadrack, Omotoso Lanre, Melikam Lois, Olujobi Dorcas, Oguike Wisdom, Akinyemi Joshua, Jegede Ayodele, Kalaria Rajesh, Ovbiagele Bruce, Owolabi Mayowa, Arulogun Oyedunni, Akinyemi Rufus
机构信息
Department of Communication and Language Arts, Faculty of Arts, University of Ibadan, Ibadan, Nigeria.
Department of Human Nutrition and Dietetics, College of Medicine, University of Ibadan, Nigeria.
出版信息
J Stroke Cerebrovasc Dis. 2025 Aug;34(8):108378. doi: 10.1016/j.jstrokecerebrovasdis.2025.108378. Epub 2025 Jun 14.
BACKGROUND AND AIM
Issues concerning appropriate Community Engagement (CE) and communication of research outcomes with stakeholders have received the attention of scholars in different sub-fields of clinical research. However, given its novel nature, especially in Sub-Saharan Africa, CE addressing the ethical, legal, and social implications (ELSI) of neurobiobanking and stroke genomic research has not received much scholarly attention. Therefore, this study was designed as a pioneering effort to report the procedures for developing and evaluating intervention tools for the CE component of the African Neurobiobank for Precision Stroke Medicine ELSI Project.
METHODS
A community-based participatory research design was adopted. The intervention tools we developed include general advocacy, educative, and training videos focusing on neurobiobanking, stroke genomics and precision stroke medicine in Africa; infographics; and a policy brief. An adapted Doak and Doak's Suitability Assessment Measure (SAM), the Agency for Healthcare Research and Quality (AHRQ) Patient Education Materials Assessment Tool (PEMAT), and semi-structured interview questions based on Willis' Cognitive Interviewing Techniques were used to evaluate the suitability, actionability, understandability and cultural appropriateness of the tools.
RESULTS
PEMAT mean percentage scores of 71.4 % for actionability and 82.4 % for understandability, and a SAM suitability score of 67.9 % were reported for the videos. Identified weaknesses captured in seven thematic areas after assessment analysis by experts and community members guided the final refinement of the tools.
CONCLUSION
The overall reviewers' reports and evaluation scores indicate that the intervention tools are generally suitable for community deployment in sub-Saharan Africa. Clinical researchers must partner with key stakeholders, define policy objectives and desired behaviour change, and develop appropriate persuasive communication strategies and tools for community engagement.
背景与目的
临床研究不同子领域的学者已关注到社区参与（CE）以及与利益相关者交流研究成果的相关问题。然而，鉴于其新颖性，尤其是在撒哈拉以南非洲地区，针对神经生物样本库和中风基因组研究的伦理、法律和社会影响（ELSI）的社区参与尚未受到太多学术关注。因此，本研究旨在率先报告为非洲精准中风医学ELSI项目神经生物样本库的社区参与部分开发和评估干预工具的程序。
方法
采用基于社区的参与式研究设计。我们开发的干预工具包括聚焦非洲神经生物样本库、中风基因组学和精准中风医学的一般宣传、教育和培训视频；信息图表；以及一份政策简报。采用改编后的多克和多克适宜性评估量表（SAM）、医疗保健研究与质量局（AHRQ）患者教育材料评估工具（PEMAT）以及基于威利斯认知访谈技术的半结构化访谈问题，来评估这些工具的适宜性、可操作性、易懂性和文化适宜性。
结果
视频的PEMAT可操作性平均百分比得分为71.4%，易懂性平均百分比得分为82.4%，SAM适宜性得分为67.9%。专家和社区成员在评估分析后确定的七个主题领域中的薄弱环节，指导了工具的最终完善。
结论
总体评审报告和评估分数表明，这些干预工具总体上适合在撒哈拉以南非洲地区的社区部署。临床研究人员必须与关键利益相关者合作，明确政策目标和期望的行为改变，并制定适当的说服性沟通策略和工具以促进社区参与。
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