Lack of blinding of outcome assessors in animal model experiments implies risk of observer bias

Journal of Clinical Epidemiology

Volumn 67, Issue 9, 2014, Pages 973-983

  Bello, Segun ^a   Krogsbøll, Lasse T ^a   Gruber, Jan ^b   Zhao, Zhizhuang J ^c   Fischer, Doris ^d   Hróbjartsson, Asbjørn ^a  

^a Rigshospitalet   (Denmark)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^c UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^d UNIVERSITY HOSPITAL FRANKFURT   (Germany)

Author keywords

Animal model; Blinding; Meta analysis; Methods; Observer bias; Translational medicine

Indexed keywords

ANIMAL MODEL; BLINDING; META-ANALYSIS; METHODS; OBSERVER BIAS; TRANSLATIONAL MEDICINE;

ANIMALS; DISEASE MODELS, ANIMAL; EPIDEMIOLOGIC RESEARCH DESIGN; HUMANS; OBSERVER VARIATION; ODDS RATIO;

EID: 84905124428     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2014.04.008     Document Type: Review

References (57)

1. A. Giordano, U. Galderisi, and I.R. Marino From the laboratory bench to the patient's bedside: an update on clinical trials with mesenchymal stem cells J Cell Physiol 211 2007 27 35
2. H.V. Vesterinen, K. Egan, A. Deister, P. Schlattmann, M.R. Macleod, and U. Dirnagl Systematic survey of the design, statistical analysis, and reporting of studies published in the 2008 volume of the Journal of Cerebral Blood Flow and Metabolism J Cereb Blood Flow Metab 31 2011 1064 1072
3. D.G. Hackman, and D.A. Redelmeier Translation of research evidence from animals to humans JAMA 296 2006 1731 1732
4. C. Kilkenny, N. Parsons, E. Kadyszewski, M.F. Festing, I.C. Cuthill, and D. Fry et al. Survey of the quality of experimental design, statistical analysis and reporting of research using animals PLoS One 4 2009 e7634
5. Hanna V. A systematic review and meta-analysis of the efficacy of proteins and peptides used in the treatment of experimental allergic encephalomyelitis. CAMARADES Monogr 2007; No.4. Available at www.camarades.info. Accessed March 22, 2012.
6. M.F. Festing, and D.G. Altman Guidelines for the design and statistical analysis of experiments using laboratory animals ILAR J 43 2002 244 258
7. M. Fisher, G. Feuerstein, D.W. Howells, P.D. Hurn, T.A. Kent, and S.I. Savitz et al. Update of the stroke therapy academic industry roundtable preclinical recommendations Stroke 40 2009 2244 2250
8. L. Partridge, and D. Gems Benchmarks for ageing studies Nature 450 2007 165 167
9. J. Gruber, L.F. Ng, S.K. Poovathingal, and B. Halliwell Deceptively simple but simply deceptive - Caenorhabditis elegans lifespan studies: considerations for ageing and antioxidant effects FEBS Lett 583 2009 3377 3387
10. B. Bebarta, D. Luyten, and K. Heard Emergency medicine animal research: does use of randomization and blinding affect the results? Acad Emerg Med 10 2003 684 687
11. N.A. Crossley, E. Sena, J. Goehler, J. Horn, B. van der Worp, and P.M. Bath et al. Empirical evidence of bias in the design of experimental stroke studies: a metaepidemiological approach Stroke 39 2008 929 934
12. G.L. Currie, A. Delaney, M. Bennett, A.H. Dickenson, K.J. Egan, and H.M. Vesterinen et al. Animal models of bone cancer pain: systematic review and meta-analyses Pain 154 2013 917 926
13. T.C. Hirst, H.M. Vesterinen, E.S. Sena, K.J. Egan, M.R. Macleod, and R. Whittle Systematic review and meta-analysis of temozolomide in animal models of glioma: was clinical efficacy predicted? Br J Cancer 108 2013 64 71
14. H.M. Vesterinen, G.L. Currie, S. Carter, S. Mee, R. Watzlawick, and K.J. Egan et al. Systematic review and stratified meta-analysis of the efficacy of RhoA and Rho kinase inhibitors in animal models of ischaemic stroke Syst Rev 2 2013 33
15. E.D.M. Rooke, H.M. Vesterinen, E.S. Sena, K.J. Egan, and M.R. Macleod Dopamine agonists in animal models of Parkinson's disease: a systematic review and meta-analysis Parkinsonism Relat Disord 17 2011 313 320
16. A. Hróbjartsson, A.S.S. Thomsen, F. Emanuelsson, B. Tendal, J. Hilden, and I. Boutron et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors BMJ 344 2012 e1119
17. A. Hróbjartsson, A.S.S. Thomsen, F. Emanuelsson, B. Tendal, J. Hilden, and I. Boutron et al. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors CMAJ 185 2013 E201 E211
18. A. Hróbjartsson, A.S.S. Thomsen, F. Emanuelsson, B. Tendal, J.V. Rasmussen, and J. Hilden et al. Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors Int J Epidemiol 43 2014 937 948
19. J.A. Roos, C. Jackson-Friedman, and P. Lyden Effects of hyperbaric oxygen on neurologic outcome for cerebral ischemia in rats Acad Emerg Med 5 1998 18 24
20. J.E. Huff, R. Bates, S.L. Eustis, J.K. Haseman, and E.E. McConnell Malathion and malaoxon: histopathology reexamination of the National Cancer Institutes's carcinogenesis studies Environ Res 37 1985 154 173
21. M.D. Reuber Carcinogenicity and toxicity of malathion and malaoxon Environ Res 37 1985 119 153
22. J.O. Frederik, N.K.J. Adhikari, and J. Beyene The ratio of means method as an alternative to mean differences for analyzing continuous outcome variables in meta-analysis: a simulation study BMC Med Res Methodol 8 2008 32
23. B.R. da Costa, A.W.S. Rutjes, B.C. Johnston, S. Reichenbach, E. Nüesch, and T. Tonia et al. Methods to convert continuous outcomes into odds ratios of treatment response and numbers needed to treat: meta-epidemiological study Int J Epidemiol 41 2012 1445 1459
24. H.M. Vesterinen, E.S. Sena, K.J. Egan, T.C. Hirst, L. Churolov, and G.L. Currie et al. Meta-analysis of data from animal studies: a practical guide J Neurosci Methods 221 2014 92 102
25. S.H. Hararson, H.H. Sigurdsson, G.E. Nielsdottir, J. Valgeirsson, T. Loftsson, and E. Stefánsson Ocular powder: dry topical formulations of timolol are well tolerated in rabbits J Ocul Pharmacol Ther 22 2006 340 346
26. X. Yu, W. Zhao, J. Ma, X. Fu, and Z.J. Zhao Beneficial and harmful effects of alcohol exposure on Caenorhabditis elegans worms Biochem Biophys Res Commun 412 2011 757 762
27. J.P. Gibson, J.T. Yarrington, D.E. Loudy, C.G. Gerbig, G.H. Hurst, and J.W. Newberne Chronic toxicity studies with vigabatrin, a GABA-transaminase inhibitor Toxicol Pathol 18 1990 225 238
28. A. Deen, J.D. Benner, T. Kramer, K. Bassichis-Saland, A. Purohit, and S.M. Steidl 2,4-Dinitrophenol pharmacologically promotes retinal detachment in rabbits Retina 25 2005 339 344
29. D. Fischer, M.F. Nold, C.A. Nold-Petry, A. Furlan, and A. Veldman Protein C preserves microcirculation in a model of neonatal septic shock Vasc Health Risk Manag 5 2009 775 781
30. A.J. Dutka, R. Mink, J. McDermott, J.B. Clark, and J.M. Hallenbeck Effect of lidocaine on somatosensory evoked response and cerebral blood flow after canine cerebral air embolism Stroke 23 1992 1515 1521
31. S. Schaffer, J. Gruber, L.F. Ng, S. Fong, Y.T. Wong, and S.Y. Tang et al. The effect of dichloroacetate on health- and lifespan in C. elegans Biogerontology 12 2011 195 209
32. C.S. Moore, N. Earl, R. Frenette, A. Styhler, J.A. Mancini, and D.W. Nicholson et al. Peripheral phosphodiesterase 4 inhibition produced by 4-[2-(3,4-Bis-difluoromethoxyphenyl)-2-[4-(1,1,1,3,3,3-hexafluoro-2- hydroxypropan-2-yl)-phenyl]-ethyl]-3-methylpyridine-1-oxide (L-826,141) prevents experimental autoimmune encephalomyelitis J Pharmacol Exp Ther 319 2006 63 72
33. A.W. Brown, B. Bjelke, and K. Fuxe Motor response to amphetamine treatment, task-specific training, and limited motor experience in a postacute animal stroke model Exp Neurol 190 2004 102 108
34. P.V. Guillot, O. Abass, J.H.D. Bassett, S.J. Shefelbine, G. Bou-Gharios, and J. Chan et al. Intrauterine transplantation of human fetal mesenchymal stem cells from first-trimester blood repairs bone and reduces fractures in osteogenesis imperfecta mice Blood 111 2008 1717 1725
35. F. Sterz, P. Safar, S. Tisherman, A. Radovsky, and K. Kuboyama Mild hypothermic cardiopulmonary resuscitation improves outcome after prolonged cardiac arrest in dogs Crit Care Med 19 1991 379 389
36. T. Scholz, J. Waltzman, G.A. Wirth, S.W. Dyson, W.J. Owens, and E. Shanbrom et al. Novel cryoprecipitate for wound healing and skin grafts in rats Int Wound J 5 2008 490 501
37. S.C. Apfel, J.C. Arezzo, L.A. Lipson, and J.A. Kressler Nerve growth factor prevents experimental cisplatin neuropathy Ann Neurol 31 1992 76 80
38. P.M. Scheufele, M.M. Faraday, and N.E. Grunberg Nicotine administration interacts with housing conditions to alter social and non-social behaviours in male and female Long-Evans rats Nicotine Tob Res 2 2000 169 178
39. A.C.L.M. Vendramini, C. Soo, and D.A. Sullivan Testosterone-induced suppression of autoimmune disease in lacrimal tissue of a mouse model (NZB/NZWFI) of Sjögren's syndrome Invest Ophthalmol Vis Sci 32 1991 3002 3006
40. H. Ariga, J. Edwards, and D.A. Sullivan Androgen control of autoimmune expression in lacrimal glands of mrl/mp-lpr/pr mice Clin Immunol Immunopathol 53 1989 499 508
41. D.G. Altman, and M.J. Bland Interaction revisited: the difference between two estimates BMJ 326 2003 219
42. National Cancer Institute Bioassay of malathion for possible carcinogenicity. CAS No. 121-75-5 Natl Toxicol Program Tech Rep Ser 24 1978 1 24
43. National Cancer Institute Bioassay of malathion for possible carcinogenicity. CAS No. 121-75-5 Natl Toxicol Program Tech Rep Ser 192 1979 1 87
44. National Cancer Institute Bioassay of malaoxon for possible carcinogenicity. CAS No. 1634-78-2 Natl Toxicol Program Tech Rep Ser 135 1979 102
45. A.W. Chan, A. Hróbjartsson, M.T. Haahr, P.C. Gøtzsche, and D.G. Altman Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles JAMA 291 2004 2457 2485
46. E.S. Sena, B. van der Worp, P.M.W. Bath, D.W. Howells, and M.R. Macleod Publication bias in reports of animal stroke studies leads to major overestimation of efficacy PLoS Biol 8 2010 e1000344
47. Deeks JJ, Higgins JPT, Altman DG. Analysing data and undertaking meta-analysis. In: Higgins JPT, Green S (Eds). Cochrane Handbook for Systematic Reviews of Interventions. 2011. Available at www.cochrane-handbook.org. Accessed September 10, 2012.
48. K.J. Heard, S. Krier, and N.R. Cleveland Knowledge of treatment group does not bias assessment of time to seizure in an animal model of cocaine poisoning Acad Emerg Med 17 2010 E75 E77
49. K.C.P. Li, L.R. Pelc, S.A. Napel, M.L. Goris, D.T. Lin, and C.K. Song et al. MRI of pulmonary embolism using Gd-DTPA-polyethylene glycol polymer enhanced 3D fast gradient echo technique in a canine model Magn Reson Imaging 15 1997 543 550
50. A.J. Dutka, P. Kochanek, J.M. Hallenbeck, and J.R. Storey Air embolism may cause unrecognized ischemia of the gray-white junction Undersea Biomed Res 15 1988 99 106
51. B. Martin Critics of pesticides: whistleblowing or suppression of dissent? Philos Soc Action 22 1996 33 35
52. J.W. Crissman, D.G. Goodman, P.K. Hildebrandt, R.R. Maronpot, D.A. Prater, and J.H. Riley et al. Best practices guideline: toxicologic histopathology Toxicol Pathol 32 2004 126 131
53. H.B. van der Worp, D.W. Howells, E.S. Sena, M.J. Porritt, S. Rewell, and V. O'Collins et al. Can animal models of disease reliably inform human studies? PLoS Med 7 2010 e1000245
54. A. Knight Systematic review of animal experiments demonstrate poor contribution toward human healthcare Rev Recent Clin Trials 3 2008 89 96
55. E.F. Unger All is not well in the world of translational research J Am Coll Cardiol 50 2007 738 740
56. D.G. Contopoulos-Ioannidis, E.E. Ntzani, and J.P.A. Ioannidis Translation of highly promising basic science research into clinical applications Am J Med 114 2003 477 484
57. T. Holland, and C. Holland Unblinded histological examinations in toxicological experiments (or, the informed leading the blinded examination) Toxicol Pathol 39 2011 711 714