Assessment Tools for Reporting Quality and Methodological Quality of Animal Experiments: A Cross-sectional Study_Chinese Journal of Evidence-Based Medicine

Authors：

 NIUJun-qiang ¹ ,  WANGYa-nan ^2,3 , ZHUQian-ge ^2,3 , CHENKuang-yang ^2,3 , ZHANGLiu-sheng ^2,3 , WANGYa-ping ^2,3 , SUXu ^2,3 , YANGJia-hui ^2,3 , QINQian ^2,3 , ZHAOYa-qin ^2,3 , ZHENGJian-xun ^2,3 , HUANGCheng-ben ^2,3 , WEIGuo-qiang ^2,3 , CHENChao-hu ^2,3 , ZHENGDe-xiu ^2,3,4 ,  MABin ^2,3

1. Department of Integrative Medicine Pain, First Hospital of Lanzhou University, Gansu Province, Lanzhou 730000, China;
2. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China;
3. Key Laboratory of Evidence-based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China;
4. School of Public Health, Lanzhou University, Lanzhou 730000, China;

Corresponding author：

MABin, Email: kitty_mab@163.com

Keywords：

Animal experiment; Methodological quality; Reporting quality; Guideline/Tool

DOI：

10.7507/1672-2531.20150038

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To provide references for scientific selection of different tools/guidelines by comprehensively collecting international and national tools/guidelines for assessing reporting quality and methodological quality of animal experiments, comparing them in development foundation, application scope, and aims. Methods PubMed, EMbase, CNKI, VIP and WanFang Data were searched up to July 2014, to collect tools/guidelines for reporting quality and methodological quality of primary animal experiments. We extracted data from included guidelines/tools, including the number of items, development foundation, disease models, application scope, and assessment focus. Then descriptive analysis was conducted. Results A total of 32 studies were finally included, of which, 6 were for reporting quality and 26 for methodological quality. The item number of the included tools/guidelines ranged from 2 to 54. Seven tools/guidelines applied score system to assess methodological quality. Fifteen tools/guidelines were designed for specific disease models. Nineteen tools/guidelines were suitable for assessing preclinical drug studies, and 4 were designed to assess environmental toxicology research. Conclusion Although many tools for assessing methodological quality of animal experiments have been published so far, SYRCLE's risk of bias tool is the only one that is used to assess internal validity of animal experiments at present. Besides, although the ARRIVE guidelines and GSPC are not official mandatory reporting criteria at present, they are acknowledged by many researchers as efficient reference checklists and writing guidelines for writing and publishing animal experiments. We recommend the application of SYRCLE's risk of bias tool, ARRIVE guidelines and GSPC, in order to efficiently improve research design, implementation, reporting, differentiation, and evaluation of animal experiments, promote the development of animal experiments, and to promote full application and translation of scientific achievements.

Citation： NIUJun-qiang, WANGYa-nan, ZHUQian-ge, CHENKuang-yang, ZHANGLiu-sheng, WANGYa-ping, SUXu, YANGJia-hui, QINQian, ZHAOYa-qin, ZHENGJian-xun, HUANGCheng-ben, WEIGuo-qiang, CHENChao-hu, ZHENGDe-xiu, MABin. Assessment Tools for Reporting Quality and Methodological Quality of Animal Experiments: A Cross-sectional Study. Chinese Journal of Evidence-Based Medicine, 2015, 15(2): 223-229. doi: 10.7507/1672-2531.20150038 Copy

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. 实验动物科学与管理杂志, 2005, 22(1):61-64.
2.	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. BMJ, 2002,.
3.	(7335):474-476.
4.	Kilkenny C, Parsons N, Kadyszewski E, et al. Survey of the Quality of Experimental Design, Statistical Analysis and Reporting of Research Using Animals. PLoS ONE, 2009, 4(11):e7824.
5.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8):637-639.
6.	Kilenny C, Browne WJ, Cuthill IC, et al. Improving bioscience research reporting:The ARRIVE guidelines for reporting animal research. PLoS Biol, 2010, 8(6):e1000412.
7.	Hooijmans CR, Leenaars M, Ritskes-Hoitinga M, et al. A gold Standard publication checklist to improve the quality of animal studies, to fully integrate the Three Rs, and to make systematic reviews more feasible. Altern Lab Anim, 2010, 38(2):167-182.
8.	National Research Council (US) Institute for Laboratory Animal Research. Guidance for the Description of Animal Research in Scientific Publications,Washington (DC):National Academies Press (US), 2011.
9.	Vesterinen HM, Egan K, Deister A, et al. Systematic survey of the design, statistical analysis, and reporting of studies published in the.
10.	volume of the Journal of Cerebral Blood Flow and Metabolism. J Cereb Blood Flow Metab, 2011, 31(4):1064-1072.
11.	Lamontagne F, Briel M, Duffett M, et al. Systematic review of reviews including animal studies addressing therapeutic interventions for sepsis. Crit Care Med, 2010, 38(12):2401-2408.
12.	Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early forbenefit:a systematic review. JAMA, 2005, 294(17):2203-2209.
13.	Agerstrand M, Kuster A, Bachmann J, et al. Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environ Pollut, 2011, 159(10):2487-2492.
14.	Conrad JW Jr, Becker RA. Enhancing credibility of chemical safety studies:emerging consensus on key assessment criteria. Environ Health Perspect, 2010, 119:757-764.
15.	Verhagen H, Aruoma OI, van Delft JH, et al. The 10 basic requirements for a scientific paper reporting antioxidant, antimutagenic or anticarcinogenic potential of test substances in in vitro experiments and animal studies in vivo. Food Chem Toxicol, 2003, 41(5):603-610.
16.	Festing MF, Altman DG. Guidelines for the design and statistical analysis of experiments using laboratory animals. ILAR J, 2003, 43(4):244-258.
17.	Altman DG, Gore SM, Gardner MJ, et al. Statistical guidelines for contributors to medical journals. Br Med J (Clin Res Ed), 1983, 286(6376):1489-1493.
18.	Festing MF. Guidelines for the design and statistical analysis of experiments in papers submitted to ATLA. Altern Lab Anim, 2001, 29(4):427-446.
19.	Festing MF, van Zutphen LM. Guidelines for reviewing manuscripts on studies involving live animals. Synopsis of the workship. In:Animal Alternatives, Welfare and Ethics. Amsterdam:Elsevier, 1997:405-410.
20.	Johnson PD, Besselsen DG. Practical aspects of experimental design in animal research. ILAR J, 2002, 43(4):202-206.
21.	de Aguilar-Nascimento JE. Fundamental steps in experi-mental design for animal studies. Acta Cir Bras, 2005, 20(1):2-8.
22.	Festing MF. Principles:the need for better experimental design. Trends Pharmacol Sci, 2003, 24(7):341-345.
23.	Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Medical Research Methodology, 2014, 14:43.
24.	Minnerup J, Wersching H, Diederich K, et al. Methodological quality of preclinical stroke studies is not required for pub-lication in high-impact journals. J Cereb Blood Flow Metab, 2010, 30(9):1619-1624.
25.	van der Worp HB, Howells DW, Sena ES, et al. Can animal models of disease reliably inform human studies? PLoS Med, 2010, 7(3):e1000245.
26.	Macleod MR, Fisher M, O'Collins V, et al. Good Laboratory Practice:preventing introduction of bias at the bench. Stroke, 2009, 40(3):e50-52.
27.	Fisher M, Feuerstein G, Howells DW, et al. Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke, 2009, 40(6):2244-2250.
28.	Sena E, vander Worp HB, Howells D, et al. How can we improve the pre-clinical development of drugs for stroke? Trends Neurosci, 2007, 30(9):433-439.
29.	Macleod MR, O'Collins T, Howells DW, et al. Pooling of animal experimental data reveals influence of study design and publication bias. Stroke, 2004, 35(5):1203-1208.
30.	Horn J, de Haan RJ, Vermeulen M, et al. Nimodipine in animal model experiments of focal cerebral ischemia:a systematic review. Stroke, 2001, 32(10):2433-2438.
31.	Jonas S, Ayigari V, Viera D, et al. Neuroprotection against cerebral ischemia. A review of animal studies and correlation with human trial results. Ann NY Acad Sci, 1999, 890:2-3.
32.	van der Worp HB, de Haan P, Morrema E, et al. Methodological quality of animal studies on neuroprotection in focal cerebral ischemia. J Neurol, 2005, 252(9):1108-1114.
33.	Hsu CY. Criteria for valid preclinical trials using animal stroke models. Stroke, 1993, 24(5):633-636.
34.	Maria Philip, Michael Benatar, Marc Fisher, et al. Methodological quality of animal studies of neuroprotective agents currently in phase ii/iii acute ischemic stroke trials. Stroke. 2009, 40(2):577-581.
35.	Vesterinen HM, Sena ES, ffrench-Constant C, et al. Improving the translational hit of experimental treatments in multiple sclerosis. Mult Scler, 2010, 16(9):1044-1055.
36.	Rice AS, Cimino-Brown D, Eisenach JC, et al. Animal models and the prediction of efficacy in clinical trials of analgesic drugs:a critical appraisal and call for uniform reporting standards. Pain, 2008, 139(2009):243-247.
37.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials:is blinding necessary? Control Clin Trials, 1996, 17(1):1-12.
38.	Sniekers YH, Weinans H, Bierma-Zeinstra SM, et al. Animal models for osteoarthritis:the effect of ovariectomy and estrogen treatment:a systematic approach. Osteoarthritis Cartilage, 2008, 16(5):533-541.
39.	Unger EF. All is not well in the world of translational research. Journal of the American College of Cardiology, 2007, 50(8):738-740.
40.	Marshall JC, Deitch E, Moldawer LL, et al. Preclinical models of shock and sepsis:what can they tell us? Shock, 2005, 24(Suppl 1):1-6.
41.	Bebarta V, Luyten D, Heard K. Emergency medicine animal research:does use of randomization and blinding affect the results? Acad Emerg Med, 2003, 10(6):684-687.
42.	Lucas C, Criens-Poublon LJ, Cockrell CT, et al. Wound healing in cell studies and animal model experiments by low level laser therapy were clinical studies justified? A systematic review. Lasers Med Sci, 2002, 17(2):110-134.
43.	Durda JL, Preziosi DV. Data quality evaluation of toxicological studies used to derive ecotoxicological benchmarks. Human and Ecological Risk Assessment, 2000, 6(5):747-765.
44.	Klimisch HJ, Andreae M, Tillmann U. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol, 1997, 25(1):1-5.
45.	Hobbs DA, Warne MSJ, Markich SJ. Evaluation of criteria used to assess the quality of aquatic toxicity data. Integr Environ Assess Manag, 2005, 1(3):174-180.
46.	STAIR (Stroke Therapy Academic Industry Roundtable). Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke, 1999, 30(12):2752-2758.

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. 实验动物科学与管理杂志, 2005, 22(1):61-64.
2. 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. BMJ, 2002,.
3. (7335):474-476.
4. Kilkenny C, Parsons N, Kadyszewski E, et al. Survey of the Quality of Experimental Design, Statistical Analysis and Reporting of Research Using Animals. PLoS ONE, 2009, 4(11):e7824.
5. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8):637-639.
6. Kilenny C, Browne WJ, Cuthill IC, et al. Improving bioscience research reporting:The ARRIVE guidelines for reporting animal research. PLoS Biol, 2010, 8(6):e1000412.
7. Hooijmans CR, Leenaars M, Ritskes-Hoitinga M, et al. A gold Standard publication checklist to improve the quality of animal studies, to fully integrate the Three Rs, and to make systematic reviews more feasible. Altern Lab Anim, 2010, 38(2):167-182.
8. National Research Council (US) Institute for Laboratory Animal Research. Guidance for the Description of Animal Research in Scientific Publications,Washington (DC):National Academies Press (US), 2011.
9. Vesterinen HM, Egan K, Deister A, et al. Systematic survey of the design, statistical analysis, and reporting of studies published in the.
10. volume of the Journal of Cerebral Blood Flow and Metabolism. J Cereb Blood Flow Metab, 2011, 31(4):1064-1072.
11. Lamontagne F, Briel M, Duffett M, et al. Systematic review of reviews including animal studies addressing therapeutic interventions for sepsis. Crit Care Med, 2010, 38(12):2401-2408.
12. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early forbenefit:a systematic review. JAMA, 2005, 294(17):2203-2209.
13. Agerstrand M, Kuster A, Bachmann J, et al. Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environ Pollut, 2011, 159(10):2487-2492.
14. Conrad JW Jr, Becker RA. Enhancing credibility of chemical safety studies:emerging consensus on key assessment criteria. Environ Health Perspect, 2010, 119:757-764.
15. Verhagen H, Aruoma OI, van Delft JH, et al. The 10 basic requirements for a scientific paper reporting antioxidant, antimutagenic or anticarcinogenic potential of test substances in in vitro experiments and animal studies in vivo. Food Chem Toxicol, 2003, 41(5):603-610.
16. Festing MF, Altman DG. Guidelines for the design and statistical analysis of experiments using laboratory animals. ILAR J, 2003, 43(4):244-258.
17. Altman DG, Gore SM, Gardner MJ, et al. Statistical guidelines for contributors to medical journals. Br Med J (Clin Res Ed), 1983, 286(6376):1489-1493.
18. Festing MF. Guidelines for the design and statistical analysis of experiments in papers submitted to ATLA. Altern Lab Anim, 2001, 29(4):427-446.
19. Festing MF, van Zutphen LM. Guidelines for reviewing manuscripts on studies involving live animals. Synopsis of the workship. In:Animal Alternatives, Welfare and Ethics. Amsterdam:Elsevier, 1997:405-410.
20. Johnson PD, Besselsen DG. Practical aspects of experimental design in animal research. ILAR J, 2002, 43(4):202-206.
21. de Aguilar-Nascimento JE. Fundamental steps in experi-mental design for animal studies. Acta Cir Bras, 2005, 20(1):2-8.
22. Festing MF. Principles:the need for better experimental design. Trends Pharmacol Sci, 2003, 24(7):341-345.
23. Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Medical Research Methodology, 2014, 14:43.
24. Minnerup J, Wersching H, Diederich K, et al. Methodological quality of preclinical stroke studies is not required for pub-lication in high-impact journals. J Cereb Blood Flow Metab, 2010, 30(9):1619-1624.
25. van der Worp HB, Howells DW, Sena ES, et al. Can animal models of disease reliably inform human studies? PLoS Med, 2010, 7(3):e1000245.
26. Macleod MR, Fisher M, O'Collins V, et al. Good Laboratory Practice:preventing introduction of bias at the bench. Stroke, 2009, 40(3):e50-52.
27. Fisher M, Feuerstein G, Howells DW, et al. Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke, 2009, 40(6):2244-2250.
28. Sena E, vander Worp HB, Howells D, et al. How can we improve the pre-clinical development of drugs for stroke? Trends Neurosci, 2007, 30(9):433-439.
29. Macleod MR, O'Collins T, Howells DW, et al. Pooling of animal experimental data reveals influence of study design and publication bias. Stroke, 2004, 35(5):1203-1208.
30. Horn J, de Haan RJ, Vermeulen M, et al. Nimodipine in animal model experiments of focal cerebral ischemia:a systematic review. Stroke, 2001, 32(10):2433-2438.
31. Jonas S, Ayigari V, Viera D, et al. Neuroprotection against cerebral ischemia. A review of animal studies and correlation with human trial results. Ann NY Acad Sci, 1999, 890:2-3.
32. van der Worp HB, de Haan P, Morrema E, et al. Methodological quality of animal studies on neuroprotection in focal cerebral ischemia. J Neurol, 2005, 252(9):1108-1114.
33. Hsu CY. Criteria for valid preclinical trials using animal stroke models. Stroke, 1993, 24(5):633-636.
34. Maria Philip, Michael Benatar, Marc Fisher, et al. Methodological quality of animal studies of neuroprotective agents currently in phase ii/iii acute ischemic stroke trials. Stroke. 2009, 40(2):577-581.
35. Vesterinen HM, Sena ES, ffrench-Constant C, et al. Improving the translational hit of experimental treatments in multiple sclerosis. Mult Scler, 2010, 16(9):1044-1055.
36. Rice AS, Cimino-Brown D, Eisenach JC, et al. Animal models and the prediction of efficacy in clinical trials of analgesic drugs:a critical appraisal and call for uniform reporting standards. Pain, 2008, 139(2009):243-247.
37. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials:is blinding necessary? Control Clin Trials, 1996, 17(1):1-12.
38. Sniekers YH, Weinans H, Bierma-Zeinstra SM, et al. Animal models for osteoarthritis:the effect of ovariectomy and estrogen treatment:a systematic approach. Osteoarthritis Cartilage, 2008, 16(5):533-541.
39. Unger EF. All is not well in the world of translational research. Journal of the American College of Cardiology, 2007, 50(8):738-740.
40. Marshall JC, Deitch E, Moldawer LL, et al. Preclinical models of shock and sepsis:what can they tell us? Shock, 2005, 24(Suppl 1):1-6.
41. Bebarta V, Luyten D, Heard K. Emergency medicine animal research:does use of randomization and blinding affect the results? Acad Emerg Med, 2003, 10(6):684-687.
42. Lucas C, Criens-Poublon LJ, Cockrell CT, et al. Wound healing in cell studies and animal model experiments by low level laser therapy were clinical studies justified? A systematic review. Lasers Med Sci, 2002, 17(2):110-134.
43. Durda JL, Preziosi DV. Data quality evaluation of toxicological studies used to derive ecotoxicological benchmarks. Human and Ecological Risk Assessment, 2000, 6(5):747-765.
44. Klimisch HJ, Andreae M, Tillmann U. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol, 1997, 25(1):1-5.
45. Hobbs DA, Warne MSJ, Markich SJ. Evaluation of criteria used to assess the quality of aquatic toxicity data. Integr Environ Assess Manag, 2005, 1(3):174-180.
46. STAIR (Stroke Therapy Academic Industry Roundtable). Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke, 1999, 30(12):2752-2758.

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