如何提高动物实验系统评价质量——基于动物实验系统评价与临床试验系统评价的比较研究
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摘要
目的全面对比分析动物实验系统评价与临床试验系统评价在研究特点、方法和报告质量等方面的差异,为今后动物实验系统评价的开展和实施提供参考依据。方法计算机检索PubMed数据库,临床试验系统评价与动物实验系统评价检索时间分别限定在2016年10月和2016年1月至12月间的数据,由五名研究者按纳入与排除标准筛选文献、提取资料,对纳入研究的特征进行描述性分析。结果已发表的动物实验系统评价中,低于1/3的研究检索超过3个以上数据库,仅一半研究实施语种限制、无研究实施补充检索,低于20%的研究报告文献筛选流程图、仅一半的研究(51.8%)评估了纳入研究的偏倚风险、仅1/3的研究评估了发表偏倚。虽然大部分(73.2%)研究进行了数据合成(Meta分析),但仅44.6%的研究评估了研究间异质性分析。结论相比较临床系统评价,动物系统评价发表数量少,增长缓慢,且在方法质量上存在明显不足。今后有必要进一步完善动物实验系统评价方法学,并采取恰当的措施,对目前已经形成的如检索策略的制定、偏倚风险的准确评估等规范加大宣传、教育和推广,以促进动物实验系统评价质量的提高。
Objective To comprehensive comparative analysis of animal experimental system evaluation and clinical trial system evaluation in terms of research characteristics, methods and report quality, etc., to provide reference for the future development and implementation of animal experimental system evaluation.Methods We searched the PubMed database. For systematic review of clinical trials data, time is limited to Oct.2016. For systematic review of animal studies data, time is limited from Jan. 2016 to Dec. 2016. Five researchers independently screened literature according to the inclusion and exclusion criteria, extracted basic characteristic and methodology characteristics of included studies. And then a descriptive analysis was conducted. Results Among the published systematic review of animal studies, less than 1/3 of the studies retrieved more than 3 databases, nearly half of the studies implemented language restrictions, no study implemented supplementary search, less than 20%of the studies reported screening flow chart, only Half of the systematic review of animal studies(51.8%) evaluated the risk of bias in the included studies and only one-third of the systematic review of animal studies evaluated the publication bias. Although most(73.2%) systematic review of animal studies implemented data synthesis(Metaanalysis), only 44.6% of systematic review of animal studies implemented heterogeneity analysis on the included studies. Conclusion Compared with systematic review of clinical trials, the number of systematic review of animal studies published is less and grows slowly. In order to promote quality improvement of systematic review of animal studies, it is necessary to further improve the methodology quality of systematic review of animal studies, and appropriate measures should be taken to propagate making of search strategy and assessment of risk of bias.
Objective To comprehensive comparative analysis of animal experimental system evaluation and clinical trial system evaluation in terms of research characteristics, methods and report quality, etc., to provide reference for the future development and implementation of animal experimental system evaluation.Methods We searched the PubMed database. For systematic review of clinical trials data, time is limited to Oct.2016. For systematic review of animal studies data, time is limited from Jan. 2016 to Dec. 2016. Five researchers independently screened literature according to the inclusion and exclusion criteria, extracted basic characteristic and methodology characteristics of included studies. And then a descriptive analysis was conducted. Results Among the published systematic review of animal studies, less than 1/3 of the studies retrieved more than 3 databases, nearly half of the studies implemented language restrictions, no study implemented supplementary search, less than 20%of the studies reported screening flow chart, only Half of the systematic review of animal studies(51.8%) evaluated the risk of bias in the included studies and only one-third of the systematic review of animal studies evaluated the publication bias. Although most(73.2%) systematic review of animal studies implemented data synthesis(Metaanalysis), only 44.6% of systematic review of animal studies implemented heterogeneity analysis on the included studies. Conclusion Compared with systematic review of clinical trials, the number of systematic review of animal studies published is less and grows slowly. In order to promote quality improvement of systematic review of animal studies, it is necessary to further improve the methodology quality of systematic review of animal studies, and appropriate measures should be taken to propagate making of search strategy and assessment of risk of bias.
引文
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[2]Pound P,Ebrahim S,Sandercock P,et al.Where is the evidence that animal research benefits humans?[J].BMJ,2004,328(7438):514-7.
[3]Kroll MW,Anderson KM,Supino CG,et al.Decline in defibrillation thresholds[J].Pacing Clin Electrophysiol,1993,16(1 Pt 2):213-7.
[4]Weed DL,Hursting SD.Biologic plausibility in causal inference:current method and practice[J].Am J Epidemiol,1998,147(5):415-25.
[5]Weed DL.Interpreting epidemiological evidence:how meta-analysis and causal inference methods are related[J].Int J Epidemiol,2000,29(3):387-90.
[6]Mignini LE,Latthe PM,Villar J,et al.Mapping the theories of preeclampsia:the role of homocysteine[J].Obstet Gynecol,2005(2),105:411-25.
[7]Mignini L,Villar J,Khan KS.Mapping the theories of preeclampsia:the need for systematic reviews of mechanisms of the disease[J].Am JObstet Gynecol,2005,105(2):411-25.
[8]Carter RE,Woolson RF.Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside[J].JTransl Med,2004,2(1):37.
[9]Petticrew M.Systematic reviews from astronomy to zoology:myths and misconceptions[J].BMJ,2001,322(7278):98-101.
[10]Ma B,Xu J,Wu W,et al.Survey of basic medical researchers on the awareness of animal experimental designs and reporting standards in China[J].Plos One,2017,12(4):e0174530.
[11]Roberts I,Kwan I,Evans P,et al.Does animal experimentation inform human healthcare?Observations from a systematic review of international animal experiments on fluid resuscitation[J].BMJ,2002,324(7335):474.
[12]Kilkenny C,Parsons N,Kadyszewski E,et al.Survey of the Quality of Experimental Design,Statistical Analysis and Reporting of Research Using Animals[J].Plos One,2009,4(11):e7824.
[13]Whiting P,Westwood M,Burke M,et al.Systematic reviews of test accuracy should search a range of databases to identify primary studies[J].J Clin Epidemiol,2008,61(4):357-364.
[14]Abuzidan FM.Systematic reviews:Minimizing search bias[J].Saudi Med J,2015,36(10):1250.
[15]陈匡阳,屈丽娜,胡芳,等.动物实验系统评价/Meta分析检索策略报告情况调查[J].中国循证医学杂志,2016,16(3):348-53.
[16]Peters JL,Sutton AJ,Jones DR,et al.A Systematic Review of Systematic Reviews and Meta-Analyses of Animal Experiments with Guidelines for Reporting[J].J Environ Sci Health B,2006,41(7):1245-58.
[17]Hooijmans CR,Rovers MM,de Vries RB,et al.SYRCLE’s risk of bias tool for animal studies[J].BMC Med Res Methodol,2014,14:43
[18]赵菲,唐晓宇,寇城坤,等.动物实验系统评价/Meta分析的质量和报告特征[J].中国循证医学杂志,2018,18(8):871-7.
[19]Sutton AJ,Duval SJ,Tweedie RL,et al.Empirical assessment of effect of publication bias on meta-analyses[J].BMJ,2000,320(7249):1574-7.
[20]Korevaar DA,Hooft L,Ter RG.Systematic reviews and metaanalyses of preclinical studies:publication bias in laboratory animal experiments[J].Lab Anim,2011,45(4):225-30.
[21]Peters JL,Sutton AJ,Jones DR,et al.A Systematic Review of Systematic Reviews and Meta-Analyses of Animal Experiments with Guidelines for Reporting[J].J Environ Sci Health B,2006,41(7):1245.
[22]Jansen of Lorkeers SJ,Doevendans PA,Chamuleau SA.All preclinical trials should be registered in advance in an online registry[J].Eur JClin Invest,2014,44(9):891-2.
[23]Engels EA,Schmid CH,Terrin N,et al.Heterogeneity and statistical significance in meta-analysis:an empirical study of 125 metaanalyses[J].Stat Med,2015,19(13):1707-28.
[24]Higgins JPT,Green S.Cochrane handbook for systematic reviews of interventions.Version 5.1.0[updated March 2011].The Cochrane Collaboration[EB/OL].Available at:https://handbook-5-1.cochrane.org/.
[25]许家科,赵璐璐,廖绪亮,等.循证构建动物实验系统评价制作流程[J].中国循证医学杂志,2017,17(11):1357-64.
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