Evidence-Based Medicine in Neurosurgery—Other Side of the Coin?

The concept evidence-based medicine (EBM), although in vogue since long, has been gradually making its space in the neurosurgical practice for the past four decades. The proponents propose it as a new paradigm of health care on which every treatment modality must be based, and on the other extreme, there is skepticism in EBM taking a significant role in management of neurosurgical ailments. The debate will vary from deception to the final truth. Nevertheless, this concept will evolve with days to come, but it needs to be understood in all aspects, including its pros and cons with a need to improve it in many aspects. In this article, we focus on unique problems of universal application of this concept in neurosurgery.

Evidence-based medicine is commonly defined as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”[1] The term is loosely used and can refer to anything from conducting a statistical meta-analysis of accumulated research, promoting randomized clinical trials (RCTs), supporting uniform reporting styles for research, and formulating a personal orientation toward critical self-evaluation. EBM was initially defined in opposition to clinical experience, but later definitions have emphasized its complementary character and have aimed to improve clinical experience with better evidence. It was in the late 1970s when a group of researchers in Canada's McMaster University authored a group of manuscripts on how to critically appraise scientific information and the term “evidence-based medicine” made first appearance in 1990 at the same university. The term subsequently appeared in print in the American College of Physicians (ACP) journal club in 1991.[2] In contrast to EBM, comparative effectiveness research (CER) is defined as “The generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care.”[3] All definitions of EBM involve three overlapping processes: systemic review of the available scientific studies, integration of such data with clinical experience, and patient participation in decision making.[4] [5] One common implementation of EBM involves the use of clinical practice guidelines during medical decision making to encourage effective care. The Institute of Medicine (IOM) defines clinical guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”[3]

It is difficult to exaggerate the resonance of EBM in contemporary health care. Many observers have elevated EBM to a new international health care “paradigm.”[6] Many parties have jumped into this subject, and many clinical practice guidelines are being framed by individuals, professional organizations, insurers, and others that the benefits of uniformity may disappear when there are so many overlapping, conflicting, and poorly constructed guidelines. With more than 1,000 guidelines created annually, calls for “guidelines for clinical guidelines” have been issued.[7] [8] This is perhaps what Arthur Doyle in his work stated “There is nothing more deceptive than an obvious fact.” The work on EBM was motivated, in part, as a response to the accusations made by Archibald Cochrane in his book, Effectiveness and Efficiency, which Hill describes as a “a biting scientific critique of medical practice.” In it, Cochrane accuses that many of the treatments, interventions, tests, and procedures used in medicine had no evidence to demonstrate their effectiveness and may, in fact, be doing more harm than good.[9] Cochrane promoted the use of RCTs as the best means of demonstrating the efficacy of a therapy or an intervention, as well as the concept of “efficient health care,” that is, using the available health care resources to “maximize the delivery of effective interventions.”[10] A large group of researchers based in Canada and the United States formed the first international EBM working group and published “The User's Guide to the Medical Literature,” in JAMA between 1993 and 2000, as a 25-part series that still resonates today. These papers were later turned into a textbook on EBM.[2] [10] At the same time, when there was tremendous change in EBM, a need was felt for the applicability of the same to the neurologic surgery.[11]

Evidence-based medicine is informed by hierarchical evidence, and this hierarchy informs clinical decision making. The descending order of evidentiary weight is (1) systemic reviews of multiple high-quality randomized trials, (2) a single high-quality randomized trial, (3) systemic review of observational studies addressing patient important outcome, (4) single observational studies addressing patient important outcome; (5) physiologic studies, and (6) unsystematic clinical observations. It is important to recognize that if treatment effects are sufficiently large and consistent, observational studies may prove compelling evidence than RCTs, particularly in situation where RCTs are not feasible.[10]

• References

• 1 Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312 7023 71-72
• 2 Sackett DL, Straus SE, Richardson WS, Rosenberg HaynesRB. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed.. New York, NY: Churchill Livingstone; 2000
• 3 Manchikanti L, Falco FJ, Singh V. et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part I: introduction and general considerations. Pain Physician 2013; 16 (02) Suppl S1-S48
• 4 Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines; Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press; 2011
• 5 Field MJ, Lohr KN. Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine: Clinical practice guidelines: directions for a new program. Washington, DC: National Academies Press; 1990
• 6 Bandopadhayay P, Goldschlager T, Rosenfeld JV. The role of evidence-based medicine in neurosurgery. J Clin Neurosci 2008; 15 (04) 373-378
• 7 Jackson R, Feder G. Guidelines for clinical guidelines. BMJ 1998; 317 7156 427-428
• 8 Rosser WW, Davis D, Gilbart E. Guideline Advisory Committee. Assessing guidelines for use in family practice. J Fam Pract 2001; 50 (11) 969-973
• 9 Hill GB. Archie Cochrane and his legacy. An internal challenge to physicians’ autonomy?. J Clin Epidemiol 2000; 53 (12) 1189-1192
• 10 Guyatt G, Sinclair J, Cook D, Jaeschke R, Schünemann H, Pauker S. Moving from evidence to action. In: Guyatt G, Rennie D. eds. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. Chicago, IL: American Medical Association; 2002: 599-608
• 11 Haines SJ. Evidence-based neurosurgery. Neurosurgery 2003; 52 (01) 36-47 discussion 47
• 12 Berg M. Rationalizing Medical Work: Decision-Support Techniques and Medical Practices. Cambridge, MA: The MIT Press; 1997
• 13 Timmermans S, Mauck A. The promises and pitfalls of evidence-based medicine. Health Aff (Millwood) 2005; 24 (01) 18-28
• 14 Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of evidence-based medicine. Int J Med Inform 2004; 73 (01) 35-43
• 15 Charlton BG, Miles A. The rise and fall of EBM. QJM 1998; 91 (05) 371-374
• 16 Robaina-Padrón FJ. [Controversies about instrumented surgery and pain relief in degenerative lumbar spine pain. Results of scientific evidence]. Neurocirugia (Astur) 2007; 18 (05) 406-413
• 17 Haynes RB. What kind of evidence is it that Evidence-Based Medicine advocates want health care providers and consumers to pay attention to?. BMC Health Serv Res 2002; 2 (01) 3
• 18 Harari E. Whose evidence?. Lessons from the philosophy of science and the epistemology of medicine. Aust N Z J Psychiatry 2001; 35 (06) 724-730
• 19 Berg BL. Qualitative Research Methods for the Social Sciences. 4th ed.. Boston, MA: Allyn and Bacon; 2001: 6-11
• 20 Miles A, Bentley P, Polychronis A, Grey J, Melchiorri C. Recent developments in the evidence-based healthcare debate. J Eval Clin Pract 2001; 7 (02) 85-89
• 21 Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. Am J Ophthalmol 2000; 130 (05) 688
• 22 Upshur RE, VanDenKerkhof EG, Goel V. Meaning and measurement: an inclusive model of evidence in health care. J Eval Clin Pract 2001; 7 (02) 91-96
• 23 Jones GW, Sagar SM. Evidence based medicine. No guidance is provided for situations for which evidence is lacking. BMJ 1995; 311 6999 258 author reply 259
• 24 Last J, Spasoff R, Harris S. A Dictionary of Epidemiology. 4th ed.. New York, NY: Oxford University Press; 1995
• 25 Haines SJ, Walters BC. Evidence Based Neurosurgery. New York, NY: Thieme Medical Publishers; 2006
• 26 Abraham NS. Will the dilemma of evidence-based surgery ever be resolved?. ANZ J Surg 2006; 76 (09) 855-860
• 27 Byer A. The practical and ethical defects of surgical randomised prospective trials. J Med Ethics 1983; 9 (02) 90-93
• 28 Michel LA, Johnson P. Is surgical mystique a myth and double standard the reality?. Med Humanit 2002; 28 (02) 66-70
• 29 Singer PA. Resource allocation: beyond evidence-based medicine and cost-effectiveness analysis. ACP J Club 1997; 127 (03) A16-A18 [editorial]
• 30 Sehon SR, Stanley DE. A philosophical analysis of the evidence-based medicine debate. BMC Health Serv Res 2003; 3 (01) 14
• 31 Kenny NP. Does good science make good medicine?. Incorporating evidence into practice is complicated by the fact that clinical practice is as much art as science. CMAJ 1997; 157 (01) 33-36
• 32 Naylor CD. Grey zones of clinical practice: some limits to evidence-based medicine. Lancet 1995; 345 8953 840-842
• 33 Grahame-Smith D. Evidence based medicine: Socratic dissent. BMJ 1995; 310 6987 1126-1127
• 34 Goodman K. Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science. Cambridge, United Kingdom: Cambridge University Press; 2003
• 35 Lomas J, Anderson GM, Domnick-Pierre K, Vayda E, Enkin MW, Hannah WJ. Do practice guidelines guide practice?. The effect of a consensus statement on the practice of physicians. N Engl J Med 1989; 321 (19) 1306-1311
• 36 Adams AS, Soumerai SB, Lomas J, Ross-Degnan D. Evidence of self-report bias in assessing adherence to guidelines. Int J Qual Health Care 1999; 11 (03) 187-192
• 37 Freemantle N, Eccles M, Wood J. et al. A randomized trial of Evidence-Based OutReach (EBOR): rationale and design. Control Clin Trials 1999; 20 (05) 479-492
• 38 Gifford DR, Holloway RG, Frankel MR. et al. Improving adherence to dementia guidelines through education and opinion leaders. A randomized, controlled trial. Ann Intern Med 1999; 131 (04) 237-246
• 39 Stross JK. Guidelines have their limits. Ann Intern Med 1999; 131 (04) 304-306
• 40 Bhandari M, Montori V, Devereaux PJ, Dosanjh S, Sprague S, Guyatt GH. Challenges to the practice of evidence-based medicine during residents’ surgical training: a qualitative study using grounded theory. Acad Med 2003; 78 (11) 1183-1190
• 41 Fessler RG, Papadopoulos S, Anderson P, Heller J, Sasso R. Comparison of Bryan cervical disc arthroplasty with anterior cervical decompression and fusion: Clinical and radiographic results of a randomized controlled clinical trial. Presented at 24th Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves. Orlando: February 27–March 1 2008
• 42 Albin RL. Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls. J Med Ethics 2002; 28 (05) 322-325
• 43 Albin RL. Sham surgery controls are mitigated trolleys. J Med Ethics 2005; 31 (03) 149-152
• 44 Dekkers W, Boer G. Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable?. J Med Ethics 2001; 27 (03) 151-156
• 45 Gnanalingham KK, Tysome J, Martinez-Canca J, Barazi SA. Quality of clinical studies in neurosurgical journals: signs of improvement over three decades. J Neurosurg 2005; 103 (03) 439-443
• 46 Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317 (03) 141-145
• 47 Weinstein JN, Lurie JD, Tosteson TD. et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 2006; 296 (20) 2451-2459
• 48 Ghogawala Z, Krishnaney AA, Steinmetz MP, Batjer HH, Benzel EC. The Evidence of Neurosurgery. New Delhi, India: Jaypee Brothers; 2013: 1-10
• 49 Bracken MB, Shepard MJ, Hellenbrand KG. et al. Methylprednisolone and neurological function 1 year after spinal cord injury. Results of the National Acute Spinal Cord Injury Study. J Neurosurg 1985; 63 (05) 704-713
• 50 Petitjean ME, Pointillart V, Dixmerias F. et al. [Medical treatment of spinal cord injury in the acute stage]. Ann Fr Anesth Reanim 1998; 17 (02) 114-122
• 51 Pointillart V, Petitjean ME, Wiart L. et al. Pharmacological therapy of spinal cord injury during the acute phase. Spinal Cord 2000; 38 (02) 71-76