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：
10.1111/j.1553-2712.2003.tb00056.x
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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：研究表明，缺乏随机化（RND）或盲化（BLD）的人体临床试验往往高估了治疗效果的程度。然而，尚无研究评估RND和BLD对动物研究的影响。作者的目的是确定在国家急诊医学学术会议上采用随机化、盲法或两者兼有的动物研究的比例；并确定不使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回顾了1997-2001年急诊医学学术学会（SAEM）年会上发表的摘要。使用动物或细胞系，比较两个或多个研究组，并测量干预或药物引起的影响的研究包括在内。如果实验的任何部分涉及随机分配受试者到治疗组，则将研究分类为随机（RND+），如果研究者对治疗组进行任何结果评估，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定义的显著性，则将研究分类为结果阳性（outcome +）。在最初的审查之后，在分类上的分歧得到了一致的解决。结果与研究方法（RND、BLD或两者都有）之间的相关性采用比值比（ORs）和95%置信区间（95% ci）进行测量。结果：共发表论文摘要2592篇。389项是动物研究，其中290项有两个或两个以上的研究小组。与RND+或BLD+研究相比，RND-和BLD-研究更有可能是Outcome+ （or = 3.4; 95% CI = 1.7 - 6.9和or = 3.2; 95% CI = 1.3 - 7.7）。将同时使用RND和BND的研究与不使用RND的研究进行比较，阳性研究的OR为5.2 （95% CI = 2.0 ~ 13.5）。结论：这些结果表明，与采用这些方法的研究相比，不使用RND和BLD的动物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.