Quality Metric, Johnston, RI, USA.
Qual Life Res. 2024 Nov;33(11):2941-2948. doi: 10.1007/s11136-024-03773-2. Epub 2024 Aug 29.
Mapping or matching the items in a clinical outcome assessment (COA) to concepts that define a condition is a common method for evaluating a COA's concept coverage. The purpose of this research was to address the lack of formal guidance for conducting this task by developing a framework for best practices in COA concept mapping and applying it to a case study.
To develop the framework, we examined the literature and created a draft set of best practices which was then reviewed by experienced researchers through focus groups before being finalized. To conduct the case study, we extracted data from a systematic review of knee osteoarthritis (KO) symptoms and impacts and used the framework to map relevant concepts to items in the SF-36v2 Health Survey (SF-36v2).
The framework guides researchers in defining the purpose of and data sources for the mapping, establishing guiding principles and decision-making thresholds, and conducting the mapping exercise. The results of the case study demonstrate the usefulness of the framework in identifying 27/36 items (75%) in the SF-36v2 that addressed concepts that define KO.
This case study illustrates how the framework for best practices in COA concept mapping may be used, highlighting how establishing clear concept definitions and guiding principles and following a structured process throughout can help produce consistent, reliable, and reproducible results. The results from this rigorous approach can provide valuable evidence to support decisions about the appropriateness of a COA for the intended patient population.
将临床结局评估（COA）中的项目与定义疾病的概念相匹配或映射，是评估 COA 概念覆盖范围的常用方法。本研究旨在通过开发 COA 概念映射最佳实践框架并将其应用于案例研究来解决缺乏该任务正式指导的问题。
为了开发该框架，我们查阅了文献，并创建了一套最佳实践草案，然后通过焦点小组由经验丰富的研究人员进行了审查，最后定稿。为了进行案例研究，我们从膝关节骨关节炎（KO）症状和影响的系统评价中提取数据，并使用该框架将相关概念映射到 SF-36v2 健康调查（SF-36v2）中的项目。
该框架指导研究人员定义映射的目的和数据源，建立指导原则和决策阈值，并进行映射练习。案例研究的结果表明，该框架在确定 SF-36v2 中 27/36 项（75%）可用于定义 KO 的概念方面非常有用。
本案例研究说明了 COA 概念映射最佳实践框架的使用方法，突出了如何明确概念定义和指导原则，并在整个过程中遵循结构化流程，有助于产生一致、可靠和可重复的结果。这种严格方法的结果可以为评估 COA 是否适合目标患者群体提供有价值的证据。
