NSFC资助中医药领域发表的中文动物实验方法学质量的回顾性分析
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摘要
目的基于SYRCLE动物实验偏倚风险评估工具,对国内中医药领域发表的由国家自然科学基金资助的动物实验的方法学质量及其存在的问题进行回顾性分析,为后续研究的设计和实施提供参考依据,以促进国内动物实验研究质量的提升。方法计算机检索中国科学引文数据库,检索时间限定为2011-2016年。由4名研究者独立筛选和提取资料,并交叉核对。组间比较采用卡方检验,检验水准α=0.05。结果最终纳入971篇研究,其中50.8%的研究被引次数为零,资助类型和学科中所占比例最高分别为面上项目(57.0%,553/971)和中医药领域H27(32%,316/971)。基于SYRCLE工具的评价结果显示:超过一半的亚条目(68.2%,15/22)的"低风险"符合率低于60%,甚至其中73.3%(11/15)的亚条目的"低风险"符合率低于10%。此外,随着SYRCLE工具的发布,大部分亚条目的"低风险"符合率并未得到提高(P>0.05)。结论国内中医药领域目前发表的由国家自然科学基金资助的动物实验的方法学质量较低,而且随着SYRCLE动物试验偏倚风险评估工具的发布,其方法学质量并未得到改善和提高。
Objective To provide references for the design and implementation of follow-up animal experiments and finally promote the transformation and utilization of its results,we made a retrospective analysis entirely of the quality of animal experiment methods and the existing problems in NSFC-funded Chinese medicine field by means of SYRCLE bias risk tool. Methods Four independent researchers extracted the data and cross-checked. Chi-square test were used for comparison between groups,and level of test was α=0.05. Results The final results include 971 researches in which the proportion of researches that weren.t cited was 50.8%. The proportion of general program(57.0%,553/971)and H27(32%,316/971)were the highest in the funding categories and disciplines. Based on the results,we can see a majority of the sub-entries(68.2%,15/22)are below 60% of the"low risk"compliance rate,and even 73.3%(11/15)of the sub-entries are below 10%. Besides,with the publication of the SYRCLE bias risk tool,a majority of the sub-entries have not been improved at the"low risk"compliance rate(P>0.05). Conclusions Our result show that the quality of animal methods in NSFC-funded Chinese medicine field is low,and the methodological quality has not been improved with the publication of SYRCLE bias risk tool.
Objective To provide references for the design and implementation of follow-up animal experiments and finally promote the transformation and utilization of its results,we made a retrospective analysis entirely of the quality of animal experiment methods and the existing problems in NSFC-funded Chinese medicine field by means of SYRCLE bias risk tool. Methods Four independent researchers extracted the data and cross-checked. Chi-square test were used for comparison between groups,and level of test was α=0.05. Results The final results include 971 researches in which the proportion of researches that weren.t cited was 50.8%. The proportion of general program(57.0%,553/971)and H27(32%,316/971)were the highest in the funding categories and disciplines. Based on the results,we can see a majority of the sub-entries(68.2%,15/22)are below 60% of the"low risk"compliance rate,and even 73.3%(11/15)of the sub-entries are below 10%. Besides,with the publication of the SYRCLE bias risk tool,a majority of the sub-entries have not been improved at the"low risk"compliance rate(P>0.05). Conclusions Our result show that the quality of animal methods in NSFC-funded Chinese medicine field is low,and the methodological quality has not been improved with the publication of SYRCLE bias risk tool.
引文
[1]贺争鸣,邢瑞昌,方喜业,等.论实验动物福利、动物实验与动物实验替代方法[J].实验动物科学,2005,22(1):61-64.
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[9]2016年度国家自然科学基金资助项目统计资料[EB/OL].国家自然科学基金委员会,2016.
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[12]陈匡阳,王亚楠,赵雅琴,等.国内动物实验系统评价/Meta分析研究的现状分析[J].中国循证医学杂志,2015,15(4):414-418.
[13]双梅,赵晨,张莉,等.运用SYRCLE工具评价中文期刊发表卒中/中风动物实验的方法学质量[J].中国循证医学杂志,2016,16(5):592-597.
[14]HIGGINS J,GREEN S E.Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0.[DB/OL].The Cochrane Collaboration,https://training.cochrane.org/handbook
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[16]DONNELLY H,SAIBABA P.Light intensity and the oestrous cycle in albino and normally pigmented mice[J].Lab Anim,1993,27(4):385-390.
[17]VANDERSCHUREN L J,NIESINK R J,SPRUIJT B M,et al.Influence of environmental factors on social play behavior of juvenile rats[J].Physiol Behav,1995,58(1):119-123.
[18]WASSENAAR P N H,TRASANDE L,LEGLER J.Systematic review and meta-analysis of early-life exposure to bisphenol a and obesity-related outcomes in rodents[J].Environ Health Perspect,2017,125(10):106001.
[19]MA B,XU J K,WU W J,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.
[20]孙咏梅.动物的生物节律及其机制[J].丹东师专学报,1997(1):28-29.
[21]CURROW D C,PLUMMER J L,KUTNER J S.Analyzing phaseⅢstudies in hospice/palliative care.A solution that sits between intention-to-treat and per protocol analyses:The palliative-modified ITT analysis[J].J Pain Symptom Manage,2012,44(4):595-603.
[22]SURKONT G,WLA?LAK E,DUNICZ-SOKOLOWSKA A,et al.The efficacy of SUI treatment with Burch colposuspension evaluated with use of ITT analysis[J].Ginekol Pol,2007,78(5):378.
[23]ZHOU X H,LI S M.ITT analysis of randomized encouragement design studies with missing data[J].Stat Med,2006,25(16):2737-2761.
[24]KRLEZA-JERI?K.Clincial trial registration:The differing views of industry,the WHO,and the Ottawa group[J].Plos Medicine,2005,2(11):e378.
[25]GODLEE F.An international standard for disclosure of clinical trial information[J].BMJ,2006,332(7550):1107-1108.
[26]KIMBALL A B,WEINSTOCK M A.Mandatory registration of clinical trials:A major step forward for evidence-based medicine[J].J Am Acad Dermatol,2005,52(5):890-892.
[2]HOOIJMANS C R,ROVERS M M,de VRIES,R B,et al.SYRCLE.s risk of bias tool for animal studies[J].BMC Med Res Methodol,2014,14(1):43.
[3]SANDERCOCK P,ROBERTS I.Systematic reviews of animal experiments[J].Lancet,2002,360(9333):586.
[4]FESTING M F.The scope for improving the design of laboratory animal experiments[J].Labo Anim,1992,26(4):256-268.
[5]ESTABROOK G F.The Design and Statistical Analysis of Animal Experiments[A]//A computational approach to statistical arguments in ecology and evolution[M].England:Cambridge University Press,2011.
[6]MACLEOD M R,EBRAHIM S,ROBERTS I.Surveying the literature from animal experiments:Systematic review and meta-analysis are important contributions[J].BMJ,2005,331(7508):110.
[7]MACLEOD M R,O.COLLINS T,HORKY L L,et al.Systematic review and meta analysis of the efficacy of FK506 in experimental stroke[J].J Cereb Blood Flow Metab,2005,25(6):713-721.
[8]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.
[9]2016年度国家自然科学基金资助项目统计资料[EB/OL].国家自然科学基金委员会,2016.
[10]董建军.中国知网收录的国家自然科学基金论文的被引情况分析[J].中国科技期刊研究,2012,23(5):776-778.
[11]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):233-236.
[12]陈匡阳,王亚楠,赵雅琴,等.国内动物实验系统评价/Meta分析研究的现状分析[J].中国循证医学杂志,2015,15(4):414-418.
[13]双梅,赵晨,张莉,等.运用SYRCLE工具评价中文期刊发表卒中/中风动物实验的方法学质量[J].中国循证医学杂志,2016,16(5):592-597.
[14]HIGGINS J,GREEN S E.Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0.[DB/OL].The Cochrane Collaboration,https://training.cochrane.org/handbook
[15]JOHNSTON N,NEVALAINEN T.Impact of the biotic and abiotic environment on animal experiments[A]//HAU J,SCHAPIRO S J.Handbook of laboratory animal science,volume 1,third edition.essential principles and practices[M].Ohio:CRC Press Inc,2010:343-368.
[16]DONNELLY H,SAIBABA P.Light intensity and the oestrous cycle in albino and normally pigmented mice[J].Lab Anim,1993,27(4):385-390.
[17]VANDERSCHUREN L J,NIESINK R J,SPRUIJT B M,et al.Influence of environmental factors on social play behavior of juvenile rats[J].Physiol Behav,1995,58(1):119-123.
[18]WASSENAAR P N H,TRASANDE L,LEGLER J.Systematic review and meta-analysis of early-life exposure to bisphenol a and obesity-related outcomes in rodents[J].Environ Health Perspect,2017,125(10):106001.
[19]MA B,XU J K,WU W J,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.
[20]孙咏梅.动物的生物节律及其机制[J].丹东师专学报,1997(1):28-29.
[21]CURROW D C,PLUMMER J L,KUTNER J S.Analyzing phaseⅢstudies in hospice/palliative care.A solution that sits between intention-to-treat and per protocol analyses:The palliative-modified ITT analysis[J].J Pain Symptom Manage,2012,44(4):595-603.
[22]SURKONT G,WLA?LAK E,DUNICZ-SOKOLOWSKA A,et al.The efficacy of SUI treatment with Burch colposuspension evaluated with use of ITT analysis[J].Ginekol Pol,2007,78(5):378.
[23]ZHOU X H,LI S M.ITT analysis of randomized encouragement design studies with missing data[J].Stat Med,2006,25(16):2737-2761.
[24]KRLEZA-JERI?K.Clincial trial registration:The differing views of industry,the WHO,and the Ottawa group[J].Plos Medicine,2005,2(11):e378.
[25]GODLEE F.An international standard for disclosure of clinical trial information[J].BMJ,2006,332(7550):1107-1108.
[26]KIMBALL A B,WEINSTOCK M A.Mandatory registration of clinical trials:A major step forward for evidence-based medicine[J].J Am Acad Dermatol,2005,52(5):890-892.
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