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

SONG Jiamei; CHEN Shaolin; DENG Ting; QIN Zhengji; YU Qingmei; MA Junliang; XIE Peng; LI Jin

doi:10.16460/j.issn2097-6569.2025.12.001

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Journal of Nursing ›› 2025, Vol. 32 ›› Issue (12) : 1-5. DOI: 10.16460/j.issn2097-6569.2025.12.001

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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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.

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factorial randomized trials / consensus statement / interpretation

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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

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