GRADE在动物实验系统评价中的应用与挑战
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摘要
动物实验系统评价证据体的分级评价,有助于提高动物实验结果向临床试验和临床实践转化的可行性,高质量的动物实验证据更有可能作为可靠证据来支持进行下一步的临床研究(即更强的转化信心)和突发公共事件的卫生决策。本研究将详细介绍GRADE在动物实验系统评价中应用的原理、方法和面临的挑战。
Grading the evidence of systematic reviews on animal studies will contribute to the improvement in the feasibility of transforming the results of animal studies into clinical trials or clinical practice. High quality evidence from animal studies is more likely to be successfully applied into clinical practice(i.e. more confident). Therefore, the present study will introduce the principles, methods and challenges of the application of GRADE in systematic reviews on animal studies.
Grading the evidence of systematic reviews on animal studies will contribute to the improvement in the feasibility of transforming the results of animal studies into clinical trials or clinical practice. High quality evidence from animal studies is more likely to be successfully applied into clinical practice(i.e. more confident). Therefore, the present study will introduce the principles, methods and challenges of the application of GRADE in systematic reviews on animal studies.
引文
1Pound P, Ebrahim S, Sandercock P, et al. Where is the evidence that animal research benefits humans? BMJ, 2004, 328(7438):514-517.
2 Kroll MW, Anderson KM, Supino CG, et al. Decline in defibrillation thresholds. Pacing&Clinical Electrophysiology Pace,1993, 16(2):213-217.
3Weed DL, Hursting SD. Biologic plausibility in causal inference:current method and practice. Am J Epidemiol, 1998, 147(5):415-425.
4 Weed DL. Interpreting epidemiological evidence:how metaanalysis and causal inference methods are related. Int J Epidemiol,2000, 29(3):387-390.
5Mignini LE, Latthe PM, Villar J, et al. Mapping the theories of preeclampsia:the role of homocysteine. Obstet Gynecol, 2005,105(2):411-425.
6 Mignini L, Villar J, Khan KS. Mapping the theories of preeclampsia:systematic reviews of mechanisms of diseases. Am J Obstet Gynecol, 2005, 194(2):317-321.
7Carter RE, Woolson RF. Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside. J Transl Med, 2004, 2(1):37.
8 Hooijmans CR, Ritskes-Hoitinga M. Progress in using systematic reviews of animal studies to improve translational research. Plos Med, 2013, 10(7):e1001482.
9Roberts 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. BMJ,2002, 324(7335):474.
10 De Vries R, Hooijmans CR, Langendam MW, et al. A protocol format for the preparation, registration and publication of systematic reviews of animal intervention studies. Evidence-based Preclinical Medicine, 2015, 2(1):1-9.
11Hooijmans CR, Tillema A, Leenaars M, et al. Enhancing search efficiency by means of a search filter for finding all studies on animal experimentation in PubMed. Lab Anim, 2010, 44(3):170-175.
12 Leenaars M, Hooijmans CR, van Veggel N, et al. A step-by-step guide to systematically identify all relevant animal studies. Lab Anim, 2012, 46(1):24-31.
13Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE’s risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14(1):43.
14 Vesterinen HM, Sena ES, Egan KJ, et al. Meta-analysis of data from animal studies:a practical guide. J Neurosci Methods, 2014,221(15):92-102.
15Hooijmans CR, Inthout J, Ritskes-Hoitinga M, et al. Meta-analyses of animal studies:an introduction of a valuable instrument to further improve healthcare. ILAR J, 2014, 55(3):418-426.
16 Petticrew M. Systematic reviews from astronomy to zoology:myths and misconceptions. BMJ, 2001, 322(7278):98-101.
17Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I:critical appraisal of existing approaches the GRADE working group. BMC Health Serv Res, 2004, 4(1):38.
18Wei D, Tang K, Wang Q, et al. The use of GRADE approach in systematic reviews of animal studies. J Evid Based Med, 2016, 9(2):98-104.
19Hooijmans CR, de Vries RBM, Ritskes-Hoitinga M, et al. GRADE Working Group. Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies. PLoS One, 2018, 13(1):e0187271.
20 Katsamakis S, Slot DE, Van der Sluis LW, et al. Histological responses of the periodontium to MTA:a systematic review. J Clin Periodontol, 2013, 40(4):334-344.
21Khatib MN, Shankar A, Kirubakaran R, et al. Effect of ghrelin on mortality and cardiovascular outcomes in experimental rat and mice models of heart failure:a systematic review and meta-analysis.PLoS One, 2015, 10(5):e0126697.
22Leung MCP, Yip KK, Lam CT, et al. Acupuncture improves cognitive function:a systematic review. Neural Regen Res, 2013,8(18):1673-1684.
23 Festing MF, Altman DG. Guidelines for the design and statistical analysis of experiments using laboratory animals. Ilar J, 2002,43(4):244.
24Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines:introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4):383-394.
25 Krauth D, Woodruff TJ, Bero L. Instruments for assessing risk of bias and other methodological criteria of published animal studies:a systematic review. Environ Health Perspect, 2013, 121(9):985-992.
26Hooijmans CR, Van der Zee CE, Dederen PJ, et al. DHA and cholesterol containing diets influence Alzheimer-like pathology,cognition and cerebral vasculature in APPswe/PS1dE9 mice.Neurobiol Dis, 2009, 33(3):482-498.
27 Sena ES, van der Worp HB, Bath PM, et al. Publication bias in reports of animal stroke studies leads to major overstatement of efficacy. Plos Biol, 2010, 8(3):e1000344.
28Korevaar DA, Hooft L, ter Riet G. Systematic reviews and metaanalyses of preclinical studies:publication bias in laboratory animal experiments. Lab Anim, 2011, 45(4):225-230.
29 Ter Riet G, Korevaar DA, Leenaars M, et al. Publication bias in laboratory animal research:a survey on magnitude, drivers,consequences and potential solutions. Plos One, 2012, 7(9):e43404.
30Lorkeers SJ, Doevendans PA, Chamuleau SA. All preclinical trials should be registered in advance in an online registry. Eur J Clin Invest, 2014, 44(9):891-892.
31 Woodruff TJ, Sutton P. The navigation guide systematic review methodology:a rigorous and transparent method for translating environmental health science into better health outcomes. Environ Health Perspect, 2014, 122(10):1007-1104.
2 Kroll MW, Anderson KM, Supino CG, et al. Decline in defibrillation thresholds. Pacing&Clinical Electrophysiology Pace,1993, 16(2):213-217.
3Weed DL, Hursting SD. Biologic plausibility in causal inference:current method and practice. Am J Epidemiol, 1998, 147(5):415-425.
4 Weed DL. Interpreting epidemiological evidence:how metaanalysis and causal inference methods are related. Int J Epidemiol,2000, 29(3):387-390.
5Mignini LE, Latthe PM, Villar J, et al. Mapping the theories of preeclampsia:the role of homocysteine. Obstet Gynecol, 2005,105(2):411-425.
6 Mignini L, Villar J, Khan KS. Mapping the theories of preeclampsia:systematic reviews of mechanisms of diseases. Am J Obstet Gynecol, 2005, 194(2):317-321.
7Carter RE, Woolson RF. Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside. J Transl Med, 2004, 2(1):37.
8 Hooijmans CR, Ritskes-Hoitinga M. Progress in using systematic reviews of animal studies to improve translational research. Plos Med, 2013, 10(7):e1001482.
9Roberts 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. BMJ,2002, 324(7335):474.
10 De Vries R, Hooijmans CR, Langendam MW, et al. A protocol format for the preparation, registration and publication of systematic reviews of animal intervention studies. Evidence-based Preclinical Medicine, 2015, 2(1):1-9.
11Hooijmans CR, Tillema A, Leenaars M, et al. Enhancing search efficiency by means of a search filter for finding all studies on animal experimentation in PubMed. Lab Anim, 2010, 44(3):170-175.
12 Leenaars M, Hooijmans CR, van Veggel N, et al. A step-by-step guide to systematically identify all relevant animal studies. Lab Anim, 2012, 46(1):24-31.
13Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE’s risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14(1):43.
14 Vesterinen HM, Sena ES, Egan KJ, et al. Meta-analysis of data from animal studies:a practical guide. J Neurosci Methods, 2014,221(15):92-102.
15Hooijmans CR, Inthout J, Ritskes-Hoitinga M, et al. Meta-analyses of animal studies:an introduction of a valuable instrument to further improve healthcare. ILAR J, 2014, 55(3):418-426.
16 Petticrew M. Systematic reviews from astronomy to zoology:myths and misconceptions. BMJ, 2001, 322(7278):98-101.
17Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I:critical appraisal of existing approaches the GRADE working group. BMC Health Serv Res, 2004, 4(1):38.
18Wei D, Tang K, Wang Q, et al. The use of GRADE approach in systematic reviews of animal studies. J Evid Based Med, 2016, 9(2):98-104.
19Hooijmans CR, de Vries RBM, Ritskes-Hoitinga M, et al. GRADE Working Group. Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies. PLoS One, 2018, 13(1):e0187271.
20 Katsamakis S, Slot DE, Van der Sluis LW, et al. Histological responses of the periodontium to MTA:a systematic review. J Clin Periodontol, 2013, 40(4):334-344.
21Khatib MN, Shankar A, Kirubakaran R, et al. Effect of ghrelin on mortality and cardiovascular outcomes in experimental rat and mice models of heart failure:a systematic review and meta-analysis.PLoS One, 2015, 10(5):e0126697.
22Leung MCP, Yip KK, Lam CT, et al. Acupuncture improves cognitive function:a systematic review. Neural Regen Res, 2013,8(18):1673-1684.
23 Festing MF, Altman DG. Guidelines for the design and statistical analysis of experiments using laboratory animals. Ilar J, 2002,43(4):244.
24Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines:introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4):383-394.
25 Krauth D, Woodruff TJ, Bero L. Instruments for assessing risk of bias and other methodological criteria of published animal studies:a systematic review. Environ Health Perspect, 2013, 121(9):985-992.
26Hooijmans CR, Van der Zee CE, Dederen PJ, et al. DHA and cholesterol containing diets influence Alzheimer-like pathology,cognition and cerebral vasculature in APPswe/PS1dE9 mice.Neurobiol Dis, 2009, 33(3):482-498.
27 Sena ES, van der Worp HB, Bath PM, et al. Publication bias in reports of animal stroke studies leads to major overstatement of efficacy. Plos Biol, 2010, 8(3):e1000344.
28Korevaar DA, Hooft L, ter Riet G. Systematic reviews and metaanalyses of preclinical studies:publication bias in laboratory animal experiments. Lab Anim, 2011, 45(4):225-230.
29 Ter Riet G, Korevaar DA, Leenaars M, et al. Publication bias in laboratory animal research:a survey on magnitude, drivers,consequences and potential solutions. Plos One, 2012, 7(9):e43404.
30Lorkeers SJ, Doevendans PA, Chamuleau SA. All preclinical trials should be registered in advance in an online registry. Eur J Clin Invest, 2014, 44(9):891-892.
31 Woodruff TJ, Sutton P. The navigation guide systematic review methodology:a rigorous and transparent method for translating environmental health science into better health outcomes. Environ Health Perspect, 2014, 122(10):1007-1104.