The methodological and reporting quality of protocols of systematic review on animal experiments: an analysis from PROSPERO platform_Chinese Journal of Evidence-Based Medicine

Authors：

CHEN Fei ^1,2 , ZHAO Li ^1,2 , GAO Qianqian ^1,2 , MEI Fan ^1,2 , ZHAO Bing ² , HU Kaiyan ^1,2 , ZHANG Weiyi ^2,3 ,  MA Bin ^1,2,4

1. Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou 730000, P.R.China;
2. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P.R.China;
3. School of Public Health, Lanzhou University, Lanzhou 730000, P.R.China;
4. Key Laboratory of Preclinical Study for New Drugs of Gansu Province, Department of Pharmacology, School of Basic Medical Science of Lanzhou University, Lanzhou 730000, P.R.China;

Corresponding author：

MA Bin, Email: kittymb2017@163.com

Keywords：

Systematic review on animal experiments; PROSPERO; Registration; Current situation analysis

DOI：

10.7507/1672-2531.202008045

Video：

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Objective To systematically investigate the registration status, methodology and reporting quality of the systematic review protocols for animal experiment registered on PROSPERO platform.Methods Systematic review protocols of animal experiments registered on PROSPERO platform were searched up to December 31^st, 2019. Two reviewers independently screened literature, extracted data, and performed a descriptive analysis of the methodological quality and reporting characteristics of the included studies.Results A total of 351 protocols from 50 countries were included, involving 22 diseases. The intervention measures were primarily "pharmaceutical chemicals". Only approximately 1/3 of the studies reported the search strategy from at least one database, approximately half of the studies were prepared to report heterogeneity analysis and publication bias, and only approximately 1/3 of the studies were prepared to report sensitivity analysis.Conclusions The quantity of systematic reviews of animal experiments registered on the PROSPERO platform is increasing annually, however, there are still some limitations in the methodology and reporting quality.

Citation： CHEN Fei, ZHAO Li, GAO Qianqian, MEI Fan, ZHAO Bing, HU Kaiyan, ZHANG Weiyi, MA Bin. The methodological and reporting quality of protocols of systematic review on animal experiments: an analysis from PROSPERO platform. Chinese Journal of Evidence-Based Medicine, 2021, 21(1): 77-82. doi: 10.7507/1672-2531.202008045 Copy

1.	Sandercock P, Roberts I. Systematic reviews of animal experiments. Lancet, 2002, 360(9333): 586.
2.	Weed DL, Hursting SD. Biologic plausibility in causal inference: current method and practice. Am J Epidemiol, 1998, 147(5): 415-425.
3.	Weed DL. Interpreting epidemiological evidence: how meta-analysis and causal inference methods are related. Int J Epidemiol, 2000, 29(3): 387-390.
4.	Mignini LE, Latthe PM, Villar J, et al. Mapping the theories of preeclampsia: the role of homocysteine. Obstet Gynecol, 2005, 105(2): 411-425.
5.	Mignini LE, Villar J, Khan KS. Mapping the theories of preeclampsia: the need for systematic reviews of mechanisms of the disease. Am J Obstet Gynecol, 2006, 194(2): 317-321.
6.	Carter RE, Woolson RF. Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside. J Transl Med, 2004, 2(1): 37.
7.	Petticrew M. Systematic reviews from astronomy to zoology: myths and misconceptions. BMJ, 2001, 322(7278): 98-101.
8.	Chalmers I, Glasziou P. Systematic reviews and research waste. Lancet, 2016, 387(10014): 122-123.
9.	Stewart L, Moher D, Shekelle P. Why prospective registration of systematic reviews makes sense. Syst Rev, 2012, 1: 7.
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11.	Light RJ, Pillemer DB. Summing up: the science of reviewing research. 1985.
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15.	张婷, 胡凯燕, 张维益, 等. 动物实验系统评价在 PROSPERO 的注册现状及注册流程简介. 中国循证心血管医学杂志, 2019, 11(4): 391-394.
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19.	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.
20.	Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14: 43.
21.	Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (Version 5.1.0). The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
22.	Kilkenny C, Browne WJ, Cuthi I, et al. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. Vet Clin Pathol, 2012, 41(1): 27-31.
23.	Mokkink LB, de Vet HCW, Prinsen CAC, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Qual Life Res, 2018, 27(5): 1171-1179.
24.	National Heart Lung and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services. Study quality assessment tools: Quality assessment tool for observational cohort and cross‐sectional studies. Available at: https://www.nhlbi.nih.gov/health‐topics/study‐quality‐assessment‐tools.
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26.	Kirkham JJ, Altman DG, Williamson PR. Bias due to changes in specified outcomes during the systematic review process. PLoS One, 2010, 5(3): e9810.
27.	Silagy CA, Middleton P, Hopewell S. Publishing protocols of systematic reviews: comparing what was done to what was planned. JAMA, 2002, 287(21): 2831-2834.
28.	Moher D, Booth A, Stewart L. How to reduce unnecessary duplication: use PROSPERO. BJOG, 2014, 121(7): 784-786.
29.	Sideri S, Papageorgiou SN, Eliades T. Registration in the international prospective register of systematic reviews (PROSPERO) of systematic review protocols was associated with increased review quality. J Clin Epidemiol, 2018, 100: 103-110.
30.	Ma B, Xu JK, Wu WJ, et al. Survey of basic medical researchers on the awareness of animal experimental designs and reporting standards in China. PLoS One, 2017, 12(4): e0174530.
31.	Kaplan RM, Irvin VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS One, 2015, 10(8): e0132382.
32.	Heinl C, Chmielewska J, Olevska A, et al. Rethinking the incentive system in science: animal study registries: Preregistering experiments using animals could greatly improve transparency and reliability of biomedical studies and improve animal welfare. EMBO Rep, 2020, 21(1): e49709.
33.	PLoS Medicine Editors. Best practice in systematic reviews: the importance of protocols and registration. PLoS Med, 2011, 8(2): e1001009.
34.	Schiavo JH. PROSPERO: An international register of systematic review protocols. Med Ref Serv Q, 2019, 38(2): 171-180.
35.	Grey P, Grey A, Bolland MJ. Outcomes, interventions and funding in randomised research published in high-impact journals. Trials, 2018, 19(1): 592.
36.	Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol, 2015, 65(10): 963-972.
37.	Zeymer U, Hochadel M, Thiele H, et al. Immediate multivessel percutaneous coronary intervention versus culprit lesion intervention in patients with acute myocardial infarction complicated by cardiogenic shock: results of the ALKK-PCI registry. EuroIntervention, 2015, 11(3): 280-285.
38.	周为文, 葛龙, 徐俊峰, 等. 《中国循证医学杂志》发表的干预类系统评价/Meta 分析报告质量评价. 中国循证医学杂志, 2013, 13(4): 482-488.
39.	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. 中国循证医学杂志, 2017, 17(11): 1357-1364.
40.	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 Environ Sci Health B, 2006, 41(7): 1245-1258.
41.	赵霏, 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. 中国循证医学杂志, 2018, 18(8): 871-877.
42.	牛军强, 王亚楠, 朱芊各, 等. 动物实验方法学和报告质量评估工具的横断面研究. 中国循证医学杂志, 2015, 15(2): 223-229.
43.	Rombey T, Doni K, Hoffmann F, et al. More systematic reviews were registered in PROSPERO each year, but few records' status was up-to-date. J Clin Epidemiol, 2020, 117: 60-67.

1. Sandercock P, Roberts I. Systematic reviews of animal experiments. Lancet, 2002, 360(9333): 586.
2. Weed DL, Hursting SD. Biologic plausibility in causal inference: current method and practice. Am J Epidemiol, 1998, 147(5): 415-425.
3. Weed DL. Interpreting epidemiological evidence: how meta-analysis and causal inference methods are related. Int J Epidemiol, 2000, 29(3): 387-390.
4. Mignini LE, Latthe PM, Villar J, et al. Mapping the theories of preeclampsia: the role of homocysteine. Obstet Gynecol, 2005, 105(2): 411-425.
5. Mignini LE, Villar J, Khan KS. Mapping the theories of preeclampsia: the need for systematic reviews of mechanisms of the disease. Am J Obstet Gynecol, 2006, 194(2): 317-321.
6. Carter RE, Woolson RF. Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside. J Transl Med, 2004, 2(1): 37.
7. Petticrew M. Systematic reviews from astronomy to zoology: myths and misconceptions. BMJ, 2001, 322(7278): 98-101.
8. Chalmers I, Glasziou P. Systematic reviews and research waste. Lancet, 2016, 387(10014): 122-123.
9. Stewart L, Moher D, Shekelle P. Why prospective registration of systematic reviews makes sense. Syst Rev, 2012, 1: 7.
10. Green S, Higgins JPT. Preparing a Cochrane review. In Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions (Version 5.1. 0). The Cochrane Collaboration, 2011. Available at: www.Cochranehandbook.org.
11. Light RJ, Pillemer DB. Summing up: the science of reviewing research. 1985.
12. De Vries RBM, Hooijmans CR, Langendam MW, et al. A protocol format for the preparation, registration and publication of systematic reviews of animal intervention studies. Evid based Precl Med, 2015, 2(1): 1-9.
13. CAMARADES. Protocols. Available at: http://www.dcn.ed.ac.uk/camarades/research.html#protocols.
14. SYRCLE. Protocols. Available at: https://www.radboudumc.nl/en/research/departments/health-evidence/systematic-review-centerfor-laboratory-animal-experimentation/protocols.
15. 张婷, 胡凯燕, 张维益, 等. 动物实验系统评价在 PROSPERO 的注册现状及注册流程简介. 中国循证心血管医学杂志, 2019, 11(4): 391-394.
16. PROSPERO. Centre for Reviews and Dissemination. York: University of York. Available at http://www.crd.york.ac.uk/PROSPERO/.
17. Macleod M, Howells D. Protocols for laboratory research. Evid based Precl Med, 2016, 3(2): 28-29.
18. 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.
19. 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.
20. Hooijmans CR, Rovers MM, de Vries RB, et al. SYRCLE's risk of bias tool for animal studies. BMC Med Res Methodol, 2014, 14: 43.
21. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (Version 5.1.0). The Cochrane Collaboration, 2011. Available at: http://www.cochrane-handbook.org.
22. Kilkenny C, Browne WJ, Cuthi I, et al. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. Vet Clin Pathol, 2012, 41(1): 27-31.
23. Mokkink LB, de Vet HCW, Prinsen CAC, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Qual Life Res, 2018, 27(5): 1171-1179.
24. National Heart Lung and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services. Study quality assessment tools: Quality assessment tool for observational cohort and cross‐sectional studies. Available at: https://www.nhlbi.nih.gov/health‐topics/study‐quality‐assessment‐tools.
25. Albers GW, Bogousslavsky J, Bozik MA, et al. Stroke therapy academic industry roundtableⅡ (STAIR-Ⅱ), writing committee. Recommendations for clinical trial evaluation of acute stroke therapies. Stroke, 2001, 32(7): 1598.
26. Kirkham JJ, Altman DG, Williamson PR. Bias due to changes in specified outcomes during the systematic review process. PLoS One, 2010, 5(3): e9810.
27. Silagy CA, Middleton P, Hopewell S. Publishing protocols of systematic reviews: comparing what was done to what was planned. JAMA, 2002, 287(21): 2831-2834.
28. Moher D, Booth A, Stewart L. How to reduce unnecessary duplication: use PROSPERO. BJOG, 2014, 121(7): 784-786.
29. Sideri S, Papageorgiou SN, Eliades T. Registration in the international prospective register of systematic reviews (PROSPERO) of systematic review protocols was associated with increased review quality. J Clin Epidemiol, 2018, 100: 103-110.
30. Ma B, Xu JK, Wu WJ, et al. Survey of basic medical researchers on the awareness of animal experimental designs and reporting standards in China. PLoS One, 2017, 12(4): e0174530.
31. Kaplan RM, Irvin VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS One, 2015, 10(8): e0132382.
32. Heinl C, Chmielewska J, Olevska A, et al. Rethinking the incentive system in science: animal study registries: Preregistering experiments using animals could greatly improve transparency and reliability of biomedical studies and improve animal welfare. EMBO Rep, 2020, 21(1): e49709.
33. PLoS Medicine Editors. Best practice in systematic reviews: the importance of protocols and registration. PLoS Med, 2011, 8(2): e1001009.
34. Schiavo JH. PROSPERO: An international register of systematic review protocols. Med Ref Serv Q, 2019, 38(2): 171-180.
35. Grey P, Grey A, Bolland MJ. Outcomes, interventions and funding in randomised research published in high-impact journals. Trials, 2018, 19(1): 592.
36. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol, 2015, 65(10): 963-972.
37. Zeymer U, Hochadel M, Thiele H, et al. Immediate multivessel percutaneous coronary intervention versus culprit lesion intervention in patients with acute myocardial infarction complicated by cardiogenic shock: results of the ALKK-PCI registry. EuroIntervention, 2015, 11(3): 280-285.
38. 周为文, 葛龙, 徐俊峰, 等. 《中国循证医学杂志》发表的干预类系统评价/Meta 分析报告质量评价. 中国循证医学杂志, 2013, 13(4): 482-488.
39. 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. 中国循证医学杂志, 2017, 17(11): 1357-1364.
40. 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 Environ Sci Health B, 2006, 41(7): 1245-1258.
41. 赵霏, 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. 中国循证医学杂志, 2018, 18(8): 871-877.
42. 牛军强, 王亚楠, 朱芊各, 等. 动物实验方法学和报告质量评估工具的横断面研究. 中国循证医学杂志, 2015, 15(2): 223-229.
43. Rombey T, Doni K, Hoffmann F, et al. More systematic reviews were registered in PROSPERO each year, but few records' status was up-to-date. J Clin Epidemiol, 2020, 117: 60-67.

Chinese Journal of Evidence-Based Medicine

The methodological and reporting quality of protocols of systematic review on animal experiments: an analysis from PROSPERO platform

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