Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1105C McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7411, USA.
George Warren Brown School, Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO, 63130, USA.
BMC Med Res Methodol. 2021 Jun 26;21(1):133. doi: 10.1186/s12874-021-01326-6.
Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications.
These methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an 'Implementation Support Team' supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.'s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications.
We present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges.
These methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks' components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies.
clinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).
开发有效的实施策略需要对其应用进行充分的跟踪和报告。虽然有用于定义和报告实施策略特征的指南，但没有用于描述策略在实践中如何调整和修改的指南。我们借鉴现有的实施科学方法，提供了跟踪策略修改的新方法。
这些方法是在一项实施策略包的阶梯式试验中制定的，该策略包旨在帮助社区诊所开展与社会决定因素相关的活动：简而言之，一个“实施支持小组”通过多步骤流程为诊所提供支持。这些方法涉及五个组成部分：1）描述计划策略；2）跟踪其使用情况；3）监测障碍；4）描述修改；5）识别/描述新策略。我们使用专家推荐的实施变革分类法对策略进行分类，使用 Proctor 等人的报告框架对其进行描述，使用实施研究综合框架对需要修改的障碍/背景因素进行编码，并使用增强的适应和修改报告框架的元素对策略修改进行描述。
我们展示了这三种方法的应用示例：1）对以促进为重点的策略进行修改（诊所报告说某些会议过于频繁，因此在随后的阶段中减少了会议频率）；2）增加一个诊所层面的策略，涉及将一个寻求社区卫生工作者相关工作流程帮助的研究诊所与另一个已经有此类工作流程的诊所联系起来；3）增加一个研究层面的策略，涉及提供帮助以克服之前遇到的（而不是全新的）挑战。
这些跟踪实施策略修改的方法建立在现有的方法、框架和指南之上；然而，由于没有一个完全合适，我们根据需要对几个框架进行了补充，并选择性地使用了某些框架的组件。虽然这些方法耗时且需要进一步简化，但它们是向实施科学提出的首批此类方法之一。因此，它们可用于评估有效策略修改的研究以及有效策略的复制和推广。我们提供这些方法，以指导其他希望记录实施策略及其对研究的修改的人。
clinicaltrials.gov ID：NCT03607617（首次发布于 2018 年 7 月 31 日）。
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