Emergency medicine animal research: Does use of randomization and blinding affect the results?
Emergency medicine animal research: Does use of randomization and blinding affect the results?
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DOI：
10.1197/aemj.10.6.684
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发表时间：
2003-06-01
影响因子：
4.4
通讯作者：
Heard, K
中科院分区：
文献类型：
--
作者：
Bebarta, V;Luyten, D;Heard, K
目的：事实证明，缺乏随机化（RND）或盲法（BLD）的人体临床试验常常高估治疗效果的程度。然而，尚无研究评估 RND 和 BLD 对动物研究的影响。作者的目标是确定在全国紧急医学学术会议上提出的采用随机、盲法或两者兼而有之的动物研究的比例；并确定不采用这些技术是否会改变观察治疗组之间差异的可能性。方法：两名训练有素的研究人员使用标准数据收集表审查了 1997-2001 年学术急诊医学协会 (SAEM) 年会上提交的摘要。其中包括使用动物或细胞系、比较两个或多个研究组并测量干预措施或药物引起的效果的研究。如果实验的任何部分涉及将受试者随机分配到治疗组，则研究被分类为随机（RND+）；如果对治疗组不知情的研究者对结果进行任何评估，则将研究分类为盲法（BLD+）；如果研究组之间的任何差异符合作者对显着性的定义，则将研究分类为结果阳性（Outcome+）。初步审查后，分类差异以协商一致方式解决。使用优势比 (OR) 和 95% 置信区间 (95% CI) 来测量结果和研究方法（RND、BLD 或两者）之间的关联。结果：共有 2,592 项研究以摘要形式发表。 389 项是动物研究，其中 290 项研究有两个或更多研究组。 RND-和BLD-研究比RND+或BLD+研究更有可能成为结果+（分别为OR = 3.4；95% CI = 1.7至6.9和OR = 3.2；95% CI = 1.3至7.7）。当同时使用 RND 和 BND 的研究与不使用 RND 和 BND 的研究进行比较时，阳性研究的 OR 为 5.2（95% CI = 2.0 至 13.5）。结论：这些结果表明，不使用 RND 和 BLD 的动物研究比使用这些方法的研究更有可能报告研究组之间的差异。
Objectives: It has been shown that human clinical trials that lack randomization (RND) or blinding (BLD) often overestimate the magnitude of treatment effects. However, no studies have evaluated the effect of RND and BLD on animal research. The authors' objectives were to determine the proportion of animal studies presented at a national academic emergency medicine meeting that utilize randomization, blinding, or both; and to determine whether failure to employ these techniques changes the likelihood of observing a difference between treatment groups. Methods: Two trained researchers reviewed abstracts presented at the 1997-2001 Society for Academic Emergency Medicine (SAEM) annual meetings using a standard data collection sheet. Studies that used an animal or cell line, compared two or more study groups, and measured an effect caused by the intervention or drugs were included. Studies were classified as randomized (RND+) if any part of the experiment involved random assignment of subjects to treatment groups, blinded (BLD+) if any assessment of the outcome was made by an investigator blinded to treatment group, and outcome-positive (Outcome+) if any difference between the study groups met the author's definition of significant. Following the initial review, differences in classification were resolved by consensus. The association between outcome and study methodology (RND, BLD or both) was measured using odds ratios (ORs) with 95% confidence intervals (95% CIs). Results: A total of 2,592 studies were published as abstracts. Three hundred eighty-nine were animal studies, and 290 of these studies had two or more study groups. RND- and BLD- studies were more likely to be Outcome+ than RND+ or BLD+ studies (OR = 3.4; 95% CI = 1.7 to 6.9 and OR = 3.2; 95% CI = 1.3 to 7.7, respectively). When studies that used both RND and BND were compared with studies that used neither, the OR for a positive study was 5.2 (95% CI = 2.0 to 13.5). Conclusions: These results suggest that animal studies that do not utilize RND and BLD are more likely to report a difference between study groups than studies that employ these methods.