Clinical Research Centre Étienne Le Bel and Department of Medicine, University of Sherbrooke, Sherbrooke, Canada.
Crit Care Med. 2010 Dec;38(12):2401-8. doi: 10.1097/CCM.0b013e3181fa0468.
Certain methodologic features of animal experiments such as random assignment have been found to reduce the risk of bias. Because animal research sometimes informs clinical practice, explicit acknowledgment of the risk of bias and clinical relevance cultivates realistic expectations on the part of clinicians reading preclinical studies. We assessed literature reviews of therapeutic interventions for sepsis that include animal experiments for explicit appraisals of the risk of bias and clinical relevance.
MEDLINE and EMBASE.
Systematic reviews or meta-analyses of animal experiments focusing on therapeutic interventions for sepsis.
In teams of two, reviewers independently screened citations and abstracted data. We determined whether the reviews systematically incorporated critical appraisals for the risk of bias and clinical relevance of the underlying studies as well as explicit extrapolations from preclinical research to human patients.
From 164 citations, we retained 45 reviews. Chance-corrected agreement for inclusion was moderate (κ 0.57). Three (7%) met our criteria for a systematic review and one (2%) systematically appraised the risk of bias and the clinical relevance of the primary animal experiments. Thirty-six (80%) were narrative reviews addressing issues related to diverse topics such as pathophysiology and diagnosis as well as multiple therapies and 40 of 45 (89%) included both clinical and animal studies. Twelve (27%) explicitly assumed that data from preclinical studies could apply to human patients.
Although a significant proportion of reviews extrapolated preclinical study results to human patients, most did not systematically appraise the risk of bias or the clinical relevance of preclinical research. Because animal experiments may influence clinical practice, we propose a framework to enhance these features in future reviews of preclinical research.
动物实验的某些方法学特征，如随机分组，已被发现可降低偏倚风险。由于动物研究有时为临床实践提供信息，因此明确承认偏倚风险和临床相关性可以培养临床医生阅读临床前研究的现实期望。我们评估了纳入动物实验的治疗脓毒症干预措施的文献综述，以明确评估偏倚风险和临床相关性。
MEDLINE 和 EMBASE。
系统评价或荟萃分析关注治疗脓毒症的动物实验。
两名评审员组成团队，独立筛选引文和摘录数据。我们确定这些综述是否系统地纳入了对基础研究偏倚风险和临床相关性的关键评估，以及从临床前研究到人类患者的明确推断。
从 164 条引文，我们保留了 45 篇综述。纳入的机会校正一致性为中度（κ0.57）。有 3 篇（7%）符合我们系统评价的标准，有 1 篇（2%）系统地评估了主要动物实验的偏倚风险和临床相关性。36 篇（80%）为叙述性综述，涉及多种主题，如病理生理学和诊断以及多种治疗方法，其中 45 篇中的 40 篇（89%）包括临床和动物研究。12 篇（27%）明确假设临床前研究的数据可应用于人类患者。
尽管很大一部分综述推断了临床前研究结果对人类患者的影响，但大多数综述并没有系统地评估临床前研究的偏倚风险或临床相关性。由于动物实验可能影响临床实践，我们提出了一个框架，以增强未来对临床前研究的这些特征的评价。
