《析因随机试验方案共识声明&#x02014;&#x02014;SPIRIT 2013扩展版》解读

宋佳美; 谌绍林; 邓婷; 秦正积; 余庆美; 马军亮; 谢鹏; 李金

doi:10.16460/j.issn2097-6569.2025.12.001

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护理学报 ›› 2025, Vol. 32 ›› Issue (12) : 1-5. DOI: 10.16460/j.issn2097-6569.2025.12.001

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《析因随机试验方案共识声明——SPIRIT 2013扩展版》解读

宋佳美^1a,2, 谌绍林^1a,2, 邓婷^1a,2, 秦正积³, 余庆美^1a,2, 马军亮^1b, 谢鹏⁴, 李金^1b

作者信息 +

Interpretation of the Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement

SONG Jiamei^1a,2, CHEN Shaolin^1a,2, DENG Ting^1a,2, QIN Zhengji³, YU Qingmei^1a,2, MA Junliang^1b, XIE Peng⁴, LI Jin^1b

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文章历史 +

摘要

目的对《析因随机试验方案共识声明——SPIRIT 2013扩展版》进行解读,旨在促进研究人员的理解和应用以提升析因随机试验方案的规范性。方法结合案例对《析因随机试验方案共识声明——SPIRIT 2013扩展版》核心内容进行解读,并分析提出应用建议。结果该扩展版声明共涉及33个条目,根据析因随机试验特点对9个条目进行扩展,其中特别对析因设计中交互作用的统计学处理进行了详细描述。结论《析因随机试验方案共识声明——SPIRIT 2013扩展版》为规范报告析因随机试验提供了科学指导,建议在今后相关研究中推广使用,以期为更多研究者提供借鉴和帮助。

Abstract

Objective To interpret the Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement, and to promote researchers’ understanding and its application to enhance the standardization of factorial randomized trial protocols. Methods The core content of the extension statement was analyzed based on case studies, and practical recommendations were proposed. Results The extension statement comprises 33 items, with 9 items specifically expanded to address the characteristics of factorial randomized trials. Notably, it provides detailed guidance on the statistical handling of interaction effects in factorial designs. Conclusion The Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement provides scientific guidance for standardizing the reporting of factorial randomized trials. It is recommended to promote its use in future research, so as to provide reference and assistance for more researchers.

导出引用

宋佳美, 谌绍林, 邓婷, 秦正积, 余庆美, 马军亮, 谢鹏, 李金. 《析因随机试验方案共识声明——SPIRIT 2013扩展版》解读[J]. 护理学报. 2025, 32(12): 1-5 https://doi.org/10.16460/j.issn2097-6569.2025.12.001

SONG Jiamei, CHEN Shaolin, DENG Ting, QIN Zhengji, YU Qingmei, MA Junliang, XIE Peng, LI Jin. Interpretation of the Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement[J]. Journal of Nursing. 2025, 32(12): 1-5 https://doi.org/10.16460/j.issn2097-6569.2025.12.001

中图分类号： R47

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