组样本量在非监管的医疗保健干预试验中被描述为随机对照试验，过于相似。

Group sample sizes in nonregulated health care intervention trials described as randomized controlled trials were overly similar.

机构信息

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.

出版信息

J Clin Epidemiol. 2020 Apr;120:8-16. doi: 10.1016/j.jclinepi.2019.12.011. Epub 2019 Dec 19.

DOI:10.1016/j.jclinepi.2019.12.011

PMID:31866472

Abstract

OBJECTIVES

We evaluated whether sample sizes in different arms of two-arm parallel group randomized controlled trials of nonregulated interventions were systematically closer in size than would plausibly occur by chance if simple randomization had been applied.

STUDY DESIGN AND SETTING

We searched PubMed for trials of nonregulated health care interventions that did not report using restricted randomization from journals in behavioral sciences and psychology, nursing, nutrition and dietetics, rehabilitation, and surgery. We emailed trial authors to clarify randomization procedures.

RESULTS

We identified 148 nonregulated intervention trials that indicated they used simple randomization. Difference in trial arm sizes was smaller than would be predicted by chance if simple randomization had occurred in all trials (P < 0.001). Rather than approximately half of the trials being within a 50% prediction interval for the difference, 96% had differences within this interval. Results were similar and statistically significant (P < 0.001) for trials that were published in journals with impact factors ≥ 4 and when stratified by type of nonregulated intervention.

CONCLUSION

There is a need for education and better understanding of clinical trial methods to ensure that randomization procedures are implemented as intended and reported fully and accurately.

摘要

目的

我们评估了，如果采用简单随机化，两臂平行组随机对照试验中非监管干预措施的不同组之间的样本量是否系统地比实际随机发生的更接近。

研究设计和设置

我们在 PubMed 中搜索了未报告使用行为科学和心理学、护理、营养和饮食学、康复和外科学期刊中受限随机化的非监管卫生保健干预措施的试验。我们通过电子邮件向试验作者澄清随机化程序。

结果

我们确定了 148 项表明使用简单随机化的非监管干预试验。如果所有试验都采用简单随机化，则试验组之间的差异小于随机发生的差异（P < 0.001）。只有约一半的试验的差异在 50%预测区间内，而 96%的试验的差异在这个区间内。在具有影响因子≥4 的期刊上发表的试验以及按非监管干预类型分层时，结果相似且具有统计学意义（P < 0.001）。