电针结合红外线治疗腰椎间盘突出症的前瞻性队列研究设计中几个关键环节的优化

Optimized design of several key aspects of the prospective cohort study about electro acupuncture combined with infrared treatment of lumbar disc herniation

目的:对电针结合红外线治疗腰椎间盘突出症的前瞻性队列研究设计中的几个关键环节进行优化。方法:根据公开发表文献的参数和预试验数据分别进行样本量计算,然后衡量取舍。根据预试验结果分析,对纳入患者的病程和证型进行优化选择。结果:根据公开发表文献参数计算的样本量144明显小于根据预试验参数计算的样本量644,最终确定样本量为644例。根据预试验结果,将纳入患者的病程限制到≤20年,预试验中的血瘀证、寒湿证、湿热证、肝肾亏虚4个证型全部纳入正式试验。结论:根据预试验结果对研究设计中的关键环节样本量、病程、证型进行的优化,完善了研究设计,减少了混杂因素,降低了偏倚。

Objective： To optimize several key aspects of the prospective cohort study about electro acupuncture combined with infrared for the treatment of lumbar disc herniation. Methods： Sample size calculation was carried out according to published literature parameters and pre-test data. According to the results of pre-test analysis, patients＇ disease duration and syndromes were optimized. Results： The sample size calculated by published literature parameters 144 was significantly less than that calculated based on the pre-test parameters 644, so the final sample size was determined as 644. According to the pretest results, the patient＇s disease duration was limited to ≤20 years. All 4 syndromes, including blood stasis syndrome, colddamp syndrome, damp-heat syndrome and liver and kidney deficiency syndrome, were applied to the formal tests. Conclusion： Optimization is mainly based on the pre-test results on the key aspects of the study design, such as sample size, disease duration and syndrome, which improves the study design, reduces the confounding factors and the bias.