国内研究人员对动物实验设计方法与报告标准认知情况的调查
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摘要
目的了解SYRCLE动物实验风险评估工具和动物实验研究报告标准(ARRIVE指南和GSPC清单)在国内动物实验基础研究领域相关科研人员中的认知率和实际应用情况。方法采用自行设计的问卷在全国范围内对动物实验基础研究人员进行调查,调查内容包括调查对象基本信息、SYRCLE动物实验偏倚风险工具、ARRIVE指南和GSPC清单的认知率、动物实验偏倚风险控制因素认知率、已发表动物实验研究的报告现状等。采用Epi Data 3.1软件进行数据录入,Excel(Microsoft Excel 2013)进行统计描述,对分类资料采用例数(n)和百分比(%)进行统计描述,组间(研究生vs.高校教师/医生/研究人员)比较采用卡方检验。结果共发放问卷298份,回收272份,其中有效问卷266份(包括研究生118人、高校教师/医生/研究人员148人)。SYRCLE动物实验偏倚风险工具知晓率仅为15.8%,组间差异有统计学意义(P=0.003),大部分被调查者认为其条目1(85.7%,228/266)和条目8(81.6%,217/266)非常必要,超过半数的被调查者认为其条目3(78.9%,210/266)、条目6(59.4%,158/266)和条目7(64.7%,172/266)非常必要,低于半数的被调查者认为其条目2(40.2%,107)、条目4(30.8%,82/266)、条目5(41.4%,110/266)、条目9(49.6%,132)非常必要。ARRIVE指南和GSPC清单知晓率分别仅为9.4%和9.0%,且58.6%的被调查者认为当前已发表的动物实验相关文献存在报告不充分问题,且组间差异有统计学意义(P=0.004)。此外,大部分被调查者(77.4%,206/266)听说过系统评价/Meta分析这种研究方法,仅1/3左右的人阅读过动物实验系统评价/Meta分析研究,开展/参与和发表过动物实验系统评价/Meta分析研究的人则更少(6.0%,16/266;4.1%,11/266)。结论国内基础医学科研人员对SYRCLE动物实验风险评估工具、ARRIVE指南和GSPC清单的知晓率均较低,实际应用率更低。因此,我们建议有必要采取针对性措施推广与普及这些标准和规范,并尽快在国内相关期刊的"稿约"中的引入这些标准和规范,以提高研究人员、期刊编辑等对其的知晓率,最终促进动物实验方法和报告质量的提升。
Objective Understand the cognitive rate and practical application of SYRCLE animal experiment risk assessment tools and animal experimental research report standards(ARRIVE guidelines and GSPC) among relevant researchers in the field of Chinese animal experiment basic research. Methods The self-designed questionnaire was used to conduct a survey of basic animal research personnel nationwide. The survey included basic information of the respondents, SYRCLE animal experiment bias risk tools, ARRIVE guidelines and GSPC list cognition rate, and animal experiment bias risk control factors. Known rate, status report of published animal experimental research, etc. Data entry was performed using EpiData 3.1 software, and statistical description was performed by Excel(Microsoft Excel 2013). The number of cases(n) and percentage(%) of the classified data were statistically described. Inter-group(postgraduate vs. university teachers/doctors/researchers) Compare the chi-square test. Results A total of 298 questionnaires were distributed, and 272 responses were received,which included 266 valid questionnaires(from 118 current students and 148 research staff).Among the 266 survey participants, only 15.8% was aware of the SYRCLE's risk of bias tool, with significant difference between the two groups(P=0.003), and the awareness rates of ARRIVE guidelines and GSPC were only 9.4% and 9.0%,respectively; 58.6% survey participants believed that the reports of animal experimental studies in Chinese literature were inadequate, with significant difference between the two groups(P=0.004). In addition, only approximately 1/3of the survey participants had read systematic reviews and meta-analysis reports of animal experimental studies; only 16/266(6.0%) had carried out/participated in and 11/266(4.1%) had published systematic reviews/metaanalysis of animal experimental studies. Conclusions The awareness and use rates of SYRCLE's risk-of-bias tool, the ARRIVE guidelines, and the GSPC were low among Chinese basic medical researchers. Therefore, specific measures are necessary to promote and popularize these standards and specifications and to introduce these standards into guidelines of Chinese domestic journals as soon as possible to raise awareness and increase use rates of researchers and journal editors, thereby improving the quality of animal experimental methods and reports.
Objective Understand the cognitive rate and practical application of SYRCLE animal experiment risk assessment tools and animal experimental research report standards(ARRIVE guidelines and GSPC) among relevant researchers in the field of Chinese animal experiment basic research. Methods The self-designed questionnaire was used to conduct a survey of basic animal research personnel nationwide. The survey included basic information of the respondents, SYRCLE animal experiment bias risk tools, ARRIVE guidelines and GSPC list cognition rate, and animal experiment bias risk control factors. Known rate, status report of published animal experimental research, etc. Data entry was performed using EpiData 3.1 software, and statistical description was performed by Excel(Microsoft Excel 2013). The number of cases(n) and percentage(%) of the classified data were statistically described. Inter-group(postgraduate vs. university teachers/doctors/researchers) Compare the chi-square test. Results A total of 298 questionnaires were distributed, and 272 responses were received,which included 266 valid questionnaires(from 118 current students and 148 research staff).Among the 266 survey participants, only 15.8% was aware of the SYRCLE's risk of bias tool, with significant difference between the two groups(P=0.003), and the awareness rates of ARRIVE guidelines and GSPC were only 9.4% and 9.0%,respectively; 58.6% survey participants believed that the reports of animal experimental studies in Chinese literature were inadequate, with significant difference between the two groups(P=0.004). In addition, only approximately 1/3of the survey participants had read systematic reviews and meta-analysis reports of animal experimental studies; only 16/266(6.0%) had carried out/participated in and 11/266(4.1%) had published systematic reviews/metaanalysis of animal experimental studies. Conclusions The awareness and use rates of SYRCLE's risk-of-bias tool, the ARRIVE guidelines, and the GSPC were low among Chinese basic medical researchers. Therefore, specific measures are necessary to promote and popularize these standards and specifications and to introduce these standards into guidelines of Chinese domestic journals as soon as possible to raise awareness and increase use rates of researchers and journal editors, thereby improving the quality of animal experimental methods and reports.
引文
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[11]陈匡阳,马彬,王亚楠,等.SYRCLE动物实验偏倚风险评估工具简介[J].中国循证医学杂志,2014,(10):1281-5.
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[14]白皙,杨晶晶,许家科,等.ARRIVE指南和GSPC清单在国内期刊的引入:对期刊“稿约”和编辑的调查研究[J].中国循证医学杂志,2016,16(9):1020-5.
[15]方泽萍,冷曦,刘雅莉,等.兰州市动物实验研究人员对ARRIVE指南及GSPC知晓情况调查[J].中国循证医学杂志,2015,(7):797-801.
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[21]Vanderschuren LJMJ,Niesink RJ,Spruijt BM,et al.Influence of environmental factors on social play behavior of juvenile rats[J].Physiol Behav,1995,58(1):119-23.
[22]Clough G.Environmental-effects on animals used in biomedicalresearch[J].Biol Rev Camb Philos Soc,1982,57(Pt3):487-523.
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[24]Bruguerolle B.Circadian changes in pharmacokinetics[J].Therapie,1983,38(3):223-35.
[25]Bruguerolle B,Valli M,Bouyard L,et al.Effect of the hour of administration on the pharmacokinetics of lidocaine in the rat[J].Eur J Drug Metab Pharmacokinet,1983,8(3):233-8.
[26]Marrino P,Gavish D,Shafrir E,et al.Diurnal variations of plasma lipids,tissue and plasma lipoprotein lipase,and VLDL secretion rates in the rat.A model for studies of VLDL metabolism[J].Biochim Biophys Acta,1987,920(3):277-84.
[27]Mcgrath JC,Drummond GB,Mclachlan EM,et al.Guidelines for reporting experiments involving animals:the ARRIVE guidelines[J].Br J Pharmacol,2010,160(7):1573-6.
[28]贾赤宇,白峰,王耘川,等.2000-2004年《中华烧伤杂志》动物实验论文分析和评价[J].中华烧伤杂志,2006,22(4):285-7.
[29]Improving bioscience research reporting:the ARRIVE guidelines for reporting animal research[EB/OL].Available at:http://www.equatornetwork.org/reporting-guidelines/improving-bioscience-researchreporting-the-arrive-guidelines-for-reporting-animal-research/.
[30]Liu Y,Zhao X,Mai Y,et al.Adherence to ARRIVE Guidelines in Chinese Journal Reports on Neoplasms in Animals[J].Plos One,2016,11(5):e0154675.
[2]Sandercock P,Roberts I.Systematic reviews of animal experiments[J].Lancet,2002,360(9333):586.
[3]Sena E,van der Worp HB,Howells D,et al.How can we improve the pre-clinical development of drugs for stroke?[J].Trends Neurosci,2007,30(9):433-9.
[4]Perel P,Roberts I,Sena E,et al.Comparison of treatment effects between animal experiments and clinical trials:systematic review[J].BMJ,2007,334(7586):197-200.
[5]KR Hess.Statistical design considerations in animal studies published recently in cancer research[J].Cancer Res,2011,71(2):625.
[6]Bebarta V,Luyten D,Heard K.Emergency medicine animal research:does use of randomization and blinding affect the results?[J].Acad Emerg Med,2003,10(6):684-7.
[7]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.
[8]Kilkenny C,Browne WJ,C uthill IC,et al.Impro ving BioscienceResearch Reporting:the ARRIVE Guidelines for Reporting Animal Research[J].PLoS Biol,2010,8(6):e1000412.
[9]Hooijmans C,de Vries R,Leenaars M,et al.The Gold Standard Publication Checklist(GSPC)for improved design,reporting and scientific quality of animal studies GSPC versus ARRIVEguidelines[J].Lab Anim,2011,45(1):61.
[10]刘雅莉,张鹏,贺万斌,等.提高动物实验报告质量促进动物实验系统评价发展[J].中国循证儿科杂志,2011,6(3):233-6.
[11]陈匡阳,马彬,王亚楠,等.SYRCLE动物实验偏倚风险评估工具简介[J].中国循证医学杂志,2014,(10):1281-5.
[12]Higgins JPT,Green S.Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[EB/OL].The Cochrane Collaboration,2011.http://www.cochrane-handbook.org.
[13]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(1):43.
[14]白皙,杨晶晶,许家科,等.ARRIVE指南和GSPC清单在国内期刊的引入:对期刊“稿约”和编辑的调查研究[J].中国循证医学杂志,2016,16(9):1020-5.
[15]方泽萍,冷曦,刘雅莉,等.兰州市动物实验研究人员对ARRIVE指南及GSPC知晓情况调查[J].中国循证医学杂志,2015,(7):797-801.
[16]Schulz KF,Chalmers I,Hayes RJ,et al.Empirical evidence of bias:Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J].JAMA,1995,273(5):408-12.
[17]Schulz KF,Chalmers I,Grimes DA,et al.Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals[J].JAMA,1994,272(2):125-8.
[18]Beynen ACGK,van Zutphen LFM.Standardization of the animal and its environment.In principles of laboratory animal science[M].Revised Edition.Edited by van Zutphen LFMB V,Beynen AC.Amsterdam and New York:Elsevier BV,2001.
[19]Johnston NA,Nevalainen T.Impact of biotic and abiotic environment on animal experiments.In Handbook of Laboratory Animal Science(Book 1).3 rd edition[J].Edited by Hau JS.Raton B.Florida:CRCPress,2010:343-69.
[20]Donnelly H,Saibaba P.Light intensity and the oestrous cycle in albino and normally pigmented mice[J].Lab Anim,1993,27(4):385-90.
[21]Vanderschuren LJMJ,Niesink RJ,Spruijt BM,et al.Influence of environmental factors on social play behavior of juvenile rats[J].Physiol Behav,1995,58(1):119-23.
[22]Clough G.Environmental-effects on animals used in biomedicalresearch[J].Biol Rev Camb Philos Soc,1982,57(Pt3):487-523.
[23]Clough G.Environmental factors in relation to the comfort and wellbeing of laboratory rats and mice[M].In:Standards in Laboratory Animal Management,Volume 1.Wheathampstead:Universities Federation for Animal Welfare(UFAW).1984:7-24.
[24]Bruguerolle B.Circadian changes in pharmacokinetics[J].Therapie,1983,38(3):223-35.
[25]Bruguerolle B,Valli M,Bouyard L,et al.Effect of the hour of administration on the pharmacokinetics of lidocaine in the rat[J].Eur J Drug Metab Pharmacokinet,1983,8(3):233-8.
[26]Marrino P,Gavish D,Shafrir E,et al.Diurnal variations of plasma lipids,tissue and plasma lipoprotein lipase,and VLDL secretion rates in the rat.A model for studies of VLDL metabolism[J].Biochim Biophys Acta,1987,920(3):277-84.
[27]Mcgrath JC,Drummond GB,Mclachlan EM,et al.Guidelines for reporting experiments involving animals:the ARRIVE guidelines[J].Br J Pharmacol,2010,160(7):1573-6.
[28]贾赤宇,白峰,王耘川,等.2000-2004年《中华烧伤杂志》动物实验论文分析和评价[J].中华烧伤杂志,2006,22(4):285-7.
[29]Improving bioscience research reporting:the ARRIVE guidelines for reporting animal research[EB/OL].Available at:http://www.equatornetwork.org/reporting-guidelines/improving-bioscience-researchreporting-the-arrive-guidelines-for-reporting-animal-research/.
[30]Liu Y,Zhao X,Mai Y,et al.Adherence to ARRIVE Guidelines in Chinese Journal Reports on Neoplasms in Animals[J].Plos One,2016,11(5):e0154675.