| 147 | 0 | 429 |
| 下载次数 | 被引频次 | 阅读次数 |
所罗门四组设计作为提升临床研究内部效度的重要方法，可减少偏倚，控制霍桑效应及前测敏感化对研究结果的干扰，在复杂临床干预效果评估中具有独特优势。系统梳理所罗门四组设计的核心架构与统计分析要点，总结该设计在国内外临床研究领域中的应用，发掘其优点和局限性，并探讨其在中医药临床研究中的应用价值。认为所罗门四组设计在中医药临床研究中可帮助区分测试效应与干预效应，减少主观指标评价偏倚；同时针对所罗门四组设计的复杂性及中医药临床研究的特殊性，提出未来应聚焦于以心理量表、知识、态度、行为测量等作为评价终点的中医药临床研究，倡导加强跨学科协作，为中医药临床研究提供方法学新路径。
Abstract：The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine(TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, knowledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.
[1]CAMPBELL DT, STANLEY JC. Experimental and quasiexperimental designs for research[M]. Chicago:Rand McNally,1963:13-26.
[2]SEDGWICK P,GREENWOOD N. Understanding the Hawthorne effect[J]. BMJ,2015,351:h4672. doi:10. 1136/bmj. h4672.
[3]SOLOMON RL. An extension of control group design[J].Psychol Bull,1949,46(2):137-150.
[4]林丽婷，刘艺，石广霞，等.针灸非特异性效应的影响因素及作用机制[J].中国针灸，2016,36(12):1319-1323.
[5]ZIEGER A,KERN A,BARTH J,et al. Do patients'pretreatment expectations about acupuncture effectiveness predict treatment outcome in patients with chronic low back pain? A secondary analysis of data from a randomised controlled clinical trial[J]. PLoS One,2022,17(5):e0268646.
[6]CAMPBELL DT. Factors relevant to the validity of experiments in social settings[J]. Psychol Bull,1957,54(4):297-312.
[7]BORING EG. The nature and history of experimental control[J]. Am J Psychol,1954,67(4):573-589.
[8]HUCK SW,SANDLER HM. A note on the Solomon 4-group design:appropriate statistical analyses[J]. J Exp Educ,1973,42(2):54-55.
[9]BRAVER MW,BRAVER SL. Statistical treatment of the Solomon four-group design:a meta-analytic approach[J].Psychol Bull,1988,104(1):150-154.
[10]SAWILOWSKY SS,KELLEY DL,BLAIR RC, et al.Meta-analysis and the Solomon four-group design[J]. J Exp Educ,1994,62(4):361-376.
[11]DONG Y, LIU L, ZHANG X, et al. A cross-sectional study on the application of patient-reported outcome measurements in clinical trials of traditional Chinese medicine in China's mainland[J]. Front Pharmacol,2023,14:1159906. doi:10. 3389/fphar. 2023. 1159906.
[12]SARKAR K, DASGUPTA A, SINHA M, et al. Effects of health empowerment intervention on resilience of adolescents in a tribal area:a study using the Solomon fourgroups design[J]. Soc Sci Med,2017,190:265-274.doi:10. 1016/j. socscimed. 2017. 05. 044.
[13]LUDOLPH R,SCHULZ PJ. Tackling the outcome bias related to the effectiveness of antibiotics against the common cold:results of a randomized controlled trial applying the Solomon four-group design[J]. Transl Behav Med, 2020,10(2):325-336.
[14]GOLAKI SP,KAMALI F,BAGHERZADEH R,et al. The effect of Flipped Classroom through Near Peer Education(FC through NPE)on patient safety knowledge retention in nursing and midwifery students:a solomon four-group design[J]. BMC Med Educ,2022,22(1):112.
[15]CHANG TP, PHAM PK, SOBOLEWSKI B, et al. Pediatric emergency medicine asynchronous e-learning:a multicenter randomized controlled Solomon four-group study[J]. Acad Emerg Med,2014,21(8):912-919.
[16]YIN Y，?ZDINC Y. Budget over health unless overweight:a Solomon four-group study[J]. Int J Consum Stud,2018,42(2):232-240.
[17]谢红卫，周扬帆，牟广绪，等.基于所罗门四组准实验设计方案的控烟课程效果评价[J].中国高等医学教育，2016(11):15-16.
[18]王勇，李春，仇琪，等.中药复方多成分多靶点协同增效药理药效评价体系[J].中国科学：生命科学，2016,46(8):1029-1032.
[19]庄铭，安佳丽，钟梦媛，等.中医药临床疗效评价方法研究进展[J].中国中药杂志，2023,48(12):3263-3268.
[20]陈薇，刘建平.临床疗效研究中的患者报告结局[J].中国中西医结合杂志，2009,29(8):746-749.
[21]侯风刚，赵钢.中医证候量化诊断标准研究存在问题的思考[J].中医药学刊，2004,22(9):1622-1623.
基本信息:
DOI：10.13288/j.11-2166/r.2025.16.005
中图分类号:R24
引用信息:
[1]张文倩,李宇飞,林潼,等.所罗门四组设计和统计分析要点及其在中医药临床研究中的应用价值[J].中医杂志,2025,66(16):1649-1655.DOI:10.13288/j.11-2166/r.2025.16.005.
基金信息:
河北省中医药管理局科研计划项目(B2025022)