|本期目录/Table of Contents|

[1]熊殷,刘雅琦,刘曼,等.临床试验随机分配的两步法及其参数配置[J].医学研究与战创伤救治(原医学研究生学报),2023,25(2):113-116.[doi:10.3969/j.issn.1672-271X.2023.02.001]
　XIONG Yin,LIU Yaqi,LIU Man,et al.A two-step method for randomized allocation of clinical trials and its parameter configuration[J].JOURNAL OF MEDICALRESEARCH —COMBAT TRAUMA CARE,2023,25(2):113-116.[doi:10.3969/j.issn.1672-271X.2023.02.001]
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临床试验随机分配的两步法及其参数配置()
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《医学研究与战创伤救治》（原医学研究生学报）[ISSN:1672-271X/CN:32-1713/R]

卷:
第25卷
期数:
2023年2期
页码:
113-116
栏目:
临床研究
出版日期:
2023-05-31

文章信息/Info

Title:
A two-step method for randomized allocation of clinical trials and its parameter configuration
作者:
熊殷; 刘雅琦; 刘曼;  陈文松; 许敏怡; 巩浩雯; 李维勤; 刘玉秀
作者单位：210002南京，南京医科大学金陵临床医学院（熊殷、刘玉秀）；211166南京，南京医科大学公共卫生学院生物统计学系（刘雅琦、刘曼、陈文松、许敏怡）；510515广州，南方医科大学公共卫生学院生物统计学系（巩浩雯）；210002南京，东部战区总医院重症医学科（李维勤）
Author(s):
XIONG Yin1;  LIU Yaqi2;  LIU Man2;  CHEN Wensong2;  XU Minyi2;  GONG Haowen3;  LI Weiqin4;  LIU Yuxiu1
(1.Department of Critical Care Medicine,Affiliated Jinling Hospital of Nanjing Medical University，Nanjing 210002，Jiangsu, China；2.Department of Biostatistic, School of Public Health, Nanjing Medical University，Nanjing 211166，Jiangsu, China；3.Department of Biostatistic, School of Public Health, Southern Medical University, Guangzhou 510515，Guangdong, China；4.Department of Critical Care Medicine, General Hospital of Eastern Theater Command，PLA，Nangjing 210002，Jiangsu，China)
关键词:
随机对照试验; 随机分配; 随机性能; 均衡性; 参数配置
Keywords:
randomized controlled trial;  random allocation;  randomization;  equilibrium;  parameter configuration
分类号:
R195.1
DOI:
10.3969/j.issn.1672-271X.2023.02.001
文献标志码:
A
摘要:
目的提出用两步法再造随机分配流程，并探讨其科学性和可行性，以改进随机分配的整体随机性能，减小试验的潜在偏倚。方法文章提出的两步法包括两个步骤:随机分层和随机分组。其关键是在传统随机分配方法的分组之前增加一个随机分层过程。该法可通过分析组间均衡性对把握度（power）及总样本量的影响进行参数大小配置。结果该随机分配及参数配置方法简单易行，增强了整体的随机性能，且只要参数配置不超过4×4，组间例数不均衡性对总例数和把握度的影响微乎其微。结论建立了一种简单易行的随机分配两步法，尤其适用于非盲的随机对照试验。
Abstract:
ObjectiveTo improve the overallrandomization of random allocation and reduce the potential bias of trials though proposing a two-step method to reconstruct the random allocation process and exploring its scientific and feasibility.MethodsThe two-step method included two sequential steps: random stratification and random allocation. The Addition of random stratification process before traditional random allocation was the key point. The two-step method configured parameters by analysing the influence of inter-group equilibrium on power and total sample size.ResultsThe proposed method of random allocation and parameter configuration which is easy to achieve enhanced the overall randomization. The influence of unbalance allocation on the total sample size and power is negligible as long as the parameter configuration does not exceed 4×4.ConclusionA simple and easy two-step randomized allocation method is established, which is especially suitable for non-blind randomized controlled trials.

参考文献/References:

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备注/Memo

备注/Memo:
基金项目：国家自然科学基金（81473066）
更新日期/Last Update: 2023-07-24