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The Evidence-based Medicine Paradigm: Where are We 20 Years Later? Part 2

  • Shashi S. Seshia (a1) and G. Bryan Young (a2)
Abstract

In Part 2, we discuss the challenges of keeping up with the ‘literature,’ evidence-based medicine (EBM) in emerging economies and the Neurosciences, and two recent approaches to classifying evidence. We conclude by summarizing information from Parts 1 and 2 which suggest the need to critically re-appraise core elements of the EBM paradigm: (1) the hierarchical ranking of evidence, (2) randomized controlled trials or systematic reviews as the gold standard for all clinical questions or situations, (3) the statistical tests that have become integral to the ‘measurements’ for analyzing evidence, and (4) re-incorporating a role for evidence from basic sciences and pathophysiology. An understanding of how cognitive processes influence clinical decisions is also necessary to improve evidence-based practice. Emerging economies may have to modify the design and conduct of clinical research to their settings. Like all paradigms, EBM must keep improving with input from the grassroots to remain beneficial.

Résumé:

Dans cette deuxième partie, nous discutons des défis que présentent le suivi de la littérature, la médecine fondée sur des données probantes (MFDP) dans les économies émergentes et les neurosciences ainsi que deux approches novatrices de classification des données. Nous concluons par un sommaire de l'information contenue dans les parties 1 et 2 qui suggère que nous devons réévaluer de façon critique des éléments fondamentaux du paradigme de la MFDP: 1) le classement hiérarchique des données; 2) les études randomisées contrôlées ou les revues systématiques comme étalon or en ce qui concerne toutes les questions ou situations cliniques; 3) les tests statistiques qui sont devenus une partie fondamentale des « mesures » utilisées pour analyser les données et 4) le rôle des données des sciences de base et de la physiopathologie qui devrait être rétabli. La compréhension de la façon dont les processus cognitifs influencent les décisions cliniques est également nécessaire pour améliorer la pratique médicale fondée sur des preuves. Les économies émergentes pourraient devoir modifier la conception et la réalisation de la recherche clinique dans leur contexte. Comme tout paradigme, la MFDP doit s'améliorer constamment en tenant compte des contributions du milieu pour demeurer bénéfique.

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Corresponding author
Department of Pediatrics, Division of Pediatric Neurology, University of Saskatchewan, Royal University Hospital, 108 Hospital Drive, Saskatoon, Saskatchewan, S7N 0W8, Canada. Email: sseshia@yahoo.ca
References
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1. Bastian, H, Glasziou, P, Chalmers, I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep u.p? PLoS Med. 2010;7:e1000326.
2. Straus, SE, Glasziou, P, Richardson, WS, Haynes, RB. Evidence-based Medicine; 4th ed. Toronto: Churchill Livingstone Elsevier, 2011.
3. Montori, VM, Guyatt, GH. Progress in evidence-based medicine. JAMA. 2008;300:1814–6.
4. Feinstein, AR, Horwitz, RI. Problems in the “evidence” of “evidence-based medicine”. Am J Med. 1997;103:529–35.
5. Schulz, KF, Altman, DG, Moher, D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.
6. Hirst, A, Altman, DG. Are peer reviewers encouraged to use reporting guidelines? survey of 116 health research journals. PLoS One. 2012;7:e35621.
7. CONSORT, group. [cited 2012 Dec 13]. Available from: http://www.consort-statement.org.
8. Berwanger, O, Ribeiro, RA, Finkelsztejn, A, et al. The quality of reporting of trial abstracts is suboptimal: survey of major general medical journals. J Clin Epidemiol. 2009;62:387–92.
9. Shukralla, AA, Tudur-Smith, C, Powell, GA, Williamson, PR, Marson, AG. Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteri for reporting harms. Epilepsy Res. 2011;97:20–9.
10. Assadi, R, Zarghi, N, Sapehri, Shamloo A, Nikooiyan, Y. Evidence-based abstracts: what research summaries should contain to support evidence-based medicine. Int J Evid Based Healthc. 2012;10:154–8.
11. DeMauro, SB, Giaccone, A, Kirpalani, H, Schmidt, B. Quality of reporting of neonatal and infant trials in high-impact journals. Pediatrics. 2011;128:e63944.
12. Kiehna, EN, Starke, RM, Pouratian, N, Dumont, AS. Standards for reporting randomized controlled trials in neurosurgery. J Neurosurg. 2011;114:280–5.
13. Rutjes, AW, Reitsma, JB, Di Nisio, M, Smidt, N, van Rijn, JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ. 2006;174:469–76.
14. STARD. [Update April 2008; cited 2012 Dec 13]. Available from: http://www.stard-statement.org.
15. Bossuyt, PM. STARD statement: still room for improvement in the reporting of diagnostic accuracy studies. Radiology. 2008;248:713–4.
16. Schunemann, HJ, Oxman, AD, Brozek, J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336:1106–10.
17. Hess, AS, Shardell, M, Johnson, JK, et al. Methods and recommendations for evaluating and reporting a new diagnostic test. Eur J Clin Microbiol Infect Dis. 2012;31:2111–6.
18. Atkins, D, Best, D, Briss, PA, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490.
19. Atkins, 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;4:38.
20. Atkins, D, Briss, PA, Eccles, M, et al. Systems for grading the quality of evidence and the strength of recommendations II: pilot study of a new system. BMC Health Serv Res. 2005;5:25.
21. Guyatt, GH, Oxman, AD, Vist, GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–6.
22. Guyatt, GH, Oxman, AD, Kunz, R, et al. What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336:995–8.
23. Guyatt, GH, Oxman, AD, Kunz, R, et al. Going from evidence to recommendations. BMJ. 2008;336:1049–51.
24. Guyatt, GH, Oxman, AD, Kunz, R, et al. Incorporating considerations of resources use into grading recommendations. BMJ. 2008;336:1170–3.
25. Guyatt, G, Oxman, AD, Akl, EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383–94.
26. Thornton, J, Alderson, P, Tan, T, et al. Introducing GRADE across the NICE clinical guideline program. J Clin Epidemiol. 2013 Feb;66(2):124–31.
27. Nakagawa, TA, Ashwal, S, Mathur, M, Mysore, M, Committee For Determination Of Brain Death In Infants Children. Guidelines for the determination of brain death in infants and children: an update of the 1987 task force recommendations-executive summary. Ann Neurol. 2012;71:573–85.
28. Pringsheim, T, Davenport, W, Mackie, G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012;39:S159.
29. Goldenberg, MJ, Borgerson, K, Bluhm, R. The nature of evidence in evidence-based medicine: guest editors’ introduction. Perspect Biol Med. 2009;52:164–7.
30. Upshur, R. Making the grade: assuring trustworthiness in evidence. Perspect Biol Med. 2009;52:264–75.
31. Hartling, L, Fernandes, RM, Seida, J, Vandermeer, B, Dryden, DM. From the trenches: a cross-sectional study applying the GRADE tool in systematic reviews of healthcare interventions. PLoS One. 2012;7:e34697.
32. Centre for Evidence-Based Medicine, University of Oxford. Oxford, UK. [cited 2012 Dec 12]. Available from: http://www.cebm.net.
33. Oricha, BS, Yauri, MB. Uncertainty principle versus clincal equipoise in clinical trials in Sub-Saharan Africa: Are they really tenable? Ann African Med. 2003;2(2):99100.
34. Jadad, AR, Enkin, MW. Randomized controlled trials. Oxford, UK: Blackwell Publishing BMJI Books, 2007.
35. Burneo, JG, Demaerschalk, BM, Jenkins, ME, editors. Neurology: An evidence-based approach. New York: Springer 2012.
36. Wiebe, S, Demaerschalk, B. Evidence based care in the neurosciences. Can J Neurol Sci. 2002;29:115–9.
37. Gronseth, G, French, J. Practice parameters and technology assessments: what they are, what they are not, and why you should care. Neurology. 2008;71:1639–43.
38. French, J, Gronseth, G. Lost in a jungle of evidence: we need a compass. Neurology. 2008;71:1634–8.
39. Brigo, F. New anti-epileptic drugs: overcoming the limits of randomised controlled trials. Int J Evid Based Healthc. 2011;9:440–3.
40. Mattson, RH, Cramer, JA, Delgado, Escuet AV, Smith, DB, Collins, JF. A design for the prospective evaluation of the efficacy and toxicity of antiepileptic drugs in adults. Neurology. 1983;33:1425.
41. Mattson, RH, Cramer, JA, Collins, JF, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985;313:145–51.
42. Anonymous. Clobazam has equivalent efficacy to carbamazepine and phenytoin as monotherapy for childhood epilepsy. Canadian Study Group for Childhood Epilepsy. Epilepsia. 1998;39:952–9.
43. Wiebe, S, Blume, WT, Girvin, JP, Eliasziw, M, Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group. randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345:311–8.
44. Barnett, HJM. Experiences with the execution of intercultural, intercontinental trials - Part I. Can J Neurol Sci. 2013;40:324–9.
45. Goodin, DS, Reder, AT. Evidence-based medicine: promise and pitfalls. Mult Scler. 2012;18:947–8.
46. Gronseth, GS, Ashman, E. The AAN response to evidence-based medicine: promise and pitfalls. Mult Scler. 2012;18:949–50.
47. Mendelson, AA, Gillis, C, Henderson, WR, Ronco, JJ, Dhingra, V, Griesdale, DE. Intracranial pressure monitors in traumatic brain injury: a systematic review. Can J Neurol Sci. 2012;39:571–6.
48. Cooper, DJ, Rosenfeld, JV, Murray, L, et al. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med. 2011;364:1493–502.
49. Honeybul, S, Ho, KM. The influence of clinical evidence on surgical practice. J Eval Clin Pract 2012; May 8[Epub ahead of print]. PMID:22568805
50. Honeybul, S, Ho, KM, Lind, CR. What Can Be Learned from the DECRA Study. World Neurosurg. 2013;79:159–61.
51. Iaccarino, C, Schiavi, P, Servadei, F. Decompressive Craniectomies: Time to Discuss Not the DECR Study but the Comments to the DECRA Study. World Neurosurg. 2013;79:78–9.
52. Hutchinson, PJ, Timofeev, I, Kolias, AG, et al. Decompressive craniectomy for traumatic brain injury: the jury is still out. Br J Neurosurg. 2011;25:441–2.
53. Lemcke, J. Taming tyrannosaur: the decompressive craniectomy for traumatic brain injury has to become an evidence-based procedure. Eur J Neurol. 2011;18:543–4.
54. Chi, JH. Craniectomy for traumatic brain injury: results from the DECRA trial. Neurosurgery. 2011;68:N1920.
55. Torres, R. DECRA…Where do we go from here? Surg Neurol Int. 2012;3:54.
56. Kitagawa, RS, Bullock, MR. Lessons from the DECRA Study. World Neurosurg. 2013;79:82–4.
57. Cooper, DJ, Rosenfeld, JV, Wolfe, R. DECRA Investigators’ Response to “The Future of Decompressive Craniectomy for Diffuse Traumatic Brain Injury” by Honeybul et al. J Neurotrauma. 2012;29:2595–6.
58. Drazen, JM. Believe the data. N Engl J Med. 2012;367:1152–3.
59. Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. 1992;268:2420–5.
60. Kahlon, G, Mansi, IA, Banks, DE. Educating medical students in evidence-based medicine: what we should expect as a starting point for our house officers. South Med J. 2012;105:184–8.
61. Booth, A. Evidence-based practice: triumph of style over substance? Health Info Libr J. 2011;28:237–41.
62. Rawlins, M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet. 2008;372:2152–61.
63. Rawlins, MD. De Testimonio: On the evidence for decisions about the use of therapeutic interventions. London, UK: Royal College of Physicians, 2008.
64. Patsopoulos, NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13:217–24.
65. Sackett, DL, Rosenberg, WM, Gray, JA, Haynes, RB, Richardson, WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71–2.
66. Mills, JL. Dat torturing. N Engl J Med. 1993;329:1196–9.
67. Greenhalgh, T. How to read a paper. Statistics for the non-statistician. II: “Significant” relations and their pitfalls. BMJ. 1997;315:422–5.
68. Senn, S, Julious, S. Measurement in clinical trials: a neglected issue for statisticians? Stat Med. 2009;28:3189–209.
69. Hartling, L, Hamm, M, Milne, A, et al. Validity and inter-rater reliability testing of quality assessment instruments. Rockville (MD): Agency for health care research and policy, US department of health and human services, 2012.
70. Matcham, J, Julious, S, Pyke, S, et al. Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials. Pharm Stat. 2011;10:70–3.
71. Mansi, BA, Clark, J, David, FS, et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87:424–9.
72. Drazen, JM. Transparency for Clinical Trials - The TEST Act. N Engl J Med. 2012;367(9):863–4.
73. Strech, D, Littmann, J. Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data. Trials. 2012;13:100.
74. Kesselheim, AS, Wang, B, Studdert, DM, Avorn, J. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures. PLoS Med. 2012;9:e1001280.
75. Crosskerry, P, Nimmo, GR. Better clinical decision making and reducing diagnostic error. J R Coll Physicians Edinb. 2011;41:155–62.
76. Croskerry, P, Abbass, AA, Wu, AW. How doctors feel: affective issues in patients’ safety. Lancet. 2008;372:1205–6.
77. Croskerry, P. Context is everything or how could I have been that stupid? Healthc Q. 2009;12 Spec No Patient:e1716.
78. Croskerry, P. A universal model of diagnostic reasoning. Acad Med. 2009;84:1022–8.
79. Crosskerry, P. Perspectives on diagnostic failure and patient safety. Healthc Q. 2012;15 suppl:50–6.
80. Hill, AB. Medical ethics and controlled trials. Br Med J. 1963;1:1043–9.
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