Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Francie Van Zijl Drive, Parow, Cape Town, 7505, South Africa.
Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
Trials. 2022 Oct 29;23(1):918. doi: 10.1186/s13063-022-06767-y.
Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting.
We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation.
Application of the Gibbs Framework found that the trial scored '2' for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner.
Comprehensive evaluation of the trial's cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence.
PACTR201610001825403. Registered on 17 October 2016.
在试验方案制定和实施过程中，如果不考虑相关的文化、种族和多样性参数（以及这些参数之间的交叉），可能会对招募、干预措施的制定和实施以及参与者的依从性和保留率产生负面影响，从而降低整体内部有效性。本案例研究旨在评估在非洲环境中进行的一项复杂临床试验中，使用 9 项 Gibbs 框架来衡量文化能力和 GRIPP-2（短版）（SF）5 分检查表评估患者和公众参与的实用性和可比性。
我们确定并整理了与试验相关的所有相关出版物、来源和程序数据，并将这些文件整合到一个动态的试验时间表中。两名独立的调查员应用 Gibbs 框架和 GRIPP-2（SF）检查表对来自试验的四篇出版物进行评分，记录工具之间的功能和可比性。在未满足文化能力的情况下，第三名调查员筛选了所有程序和来源数据，并确定是否在出版物中报告了文化能力，或者根据文件判断试验是否未满足适当的文化能力。
应用 Gibbs 框架发现，该试验在九个 Gibbs 项目中的七个项目上得分为“2”，表明这些问题的文化能力完全符合要求。框架表明，试验的研究问题不是由患者明确的需求驱动的，患者、护理人员和临床医务人员也没有参与干预措施的制定。与 GRIPP-2（SF）检查表的可比性表明，Gibbs 在评估与社区的伙伴关系、确定文化能力强的数据源和目标人群以及以包容的方式任命试验人员方面表现更好。
对试验的文化能力进行全面评估需要仔细审查已发表的手稿以及来源和程序数据，这表明当前试验报告标准在文化能力方面存在差距。
PACTR201610001825403. 于 2016 年 10 月 17 日注册。
