This paper describes the process and results of a refinement of a framework to characterize modifications to interventions. The original version did not fully capture several aspects of modification and adaptation that may be important to document and report. Additionally, the earlier framework did not include a way to differentiate cultural adaptation from adaptations made for other reasons. Reporting additional elements will allow for a more precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. We employed a multifaceted approach to develop the updated FRAME involving coding documents identified through a literature review, rapid coding of qualitative interviews, and a refinement process informed by multiple stakeholders. The updated FRAME expands upon Stirman et al.’s original framework by adding components of modification to report: (1) when and how in the implementation process the modification was made, (2) whether the modification was planned/proactive (i.e., an adaptation) or unplanned/reactive, (3) who determined that the modification should be made, (4) what is modified, (5) at what level of delivery the modification is made, (6) type or nature of context or content-level modifications, (7) the extent to which the modification is fidelity-consistent, and (8) the reasons for the modification, including (a) the intent or goal of the modification (e.g., to reduce costs) and (b) contextual factors that influenced the decision. Methods of using the framework to assess modifications are outlined, along with their strengths and weaknesses, and considerations for research to validate these measurement strategies. The updated FRAME includes consideration of when and how modifications occurred, whether it was planned or unplanned, relationship to fidelity, and reasons and goals for modification. This tool that can be used to support research on the timing, nature, goals and reasons for, and impact of modifications to evidence-based interventions.

中文翻译：

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框架：扩大的框架，用于报告对基于证据的干预措施的适应性和修改性

本文描述了框架的改进过程和结果，以描述对干预措施的修改。原始版本未完全涵盖对文档和报告可能很重要的修改和改编的多个方面。此外，较早的框架没有包括将文化适应与其他原因相区别的方法。报告其他要素将允许更精确地了解修改，修改或适应的过程以及不同形式的修改与后续运行状况和实施结果之间的关系。我们采用了多方面的方法来开发更新的FRAME，其中涉及通过文献综述，快速定性访谈编码，以及由多个利益相关者告知的优化过程。更新后的FRAME在Stirman等人的原始框架上进行了扩展，增加了修改的组成部分以报告：（1）在实施过程中何时，如何进行修改；（2）是否计划/主动进行了修改（即， （3）谁决定应进行修改，（4）修改了哪些内容，（5）在什么交付水平上进行了修改，（6）上下文或内容的类型或性质-级别的修改；（7）修改的保真度范围；以及（8）修改的原因，包括（a）修改的意图或目的（例如，降低成本）和（b）上下文相关影响决定的因素。概述了使用框架评估修改的方法，以及它们的优点和缺点，以及用于验证这些测量策略的研究考虑因素。更新的FRAME包括对修改的时间和方式，计划的还是计划的，与保真度的关系以及修改的原因和目标的考虑。该工具可用于支持对基于证据的干预措施进行修改的时间，性质，目标和原因以及影响的研究。