为实践改进研究选择楔形步进式随机试验设计前的考虑

P. M. Ann M. Nguyen, PhD Charles M. Cleland, PhD L. Miriam Dickinson, Michael P. Barry, MD Samuel Cykert, M. M. F. Daniel Duffy, M. M. Anton J. Kuzel, PhD Stephan R. Lindner, M. M. Michael L. Parchman, M. M. Donna R. Shelley, PhD Theresa L. Walunas
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引用次数: 6

摘要

尽管在基于实践的研究中,楔形聚类随机试验(sw - crt)越来越受欢迎,但其设计的优势和挑战并没有很好的文献记载。本研究的目的是确定SW-CRT设计在初级保健环境中大规模干预实施的优势和挑战。方法循证now:推进心脏健康计划,由医疗保健研究和质量局资助,包括大量的sw - crt收集。我们对来自evidence - enow受助人的17名关键线人进行了定性访谈,以确定使用SW-CRT设计的优势和挑战。结果所有受访者都认为SW-CRT可以作为大规模干预实施的有效研究设计。优势包括:(1)激励招聘;(2)错开资源分配;(3)统计能力。挑战包括:(1)时间敏感的招募,(2)保留,(3)随机化要求和实践偏好,(4)实现治疗计划的保密性,(5)密集的数据收集,(6)霍桑效应,(7)时间趋势。结论:evidence enow受助人所经历的挑战表明,某些有利的现实条件构成了增加SW-CRT成功几率的环境。现有的基础结构可以支持许多实践的招募。需要强有力的留存计划来继续吸引等待开始干预的网站。最后,研究结果应该是在日常实践中已经获得的;否则,资助者和调查人员应评估数据收集的可行性和成本。视觉文摘
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study
PURPOSE Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design’s advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection. VISUAL ABSTRACT
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