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Medical practitioners are facing increasing scrutiny by both the public and by regulatory bodies.1- 3 Nowhere is this more the case than in spine care.4,5 At the heart of this scrutiny is the influence of physician relationships on ethical decision making. Questions have been raised as to whether a free dinner, tickets to a play or a casual speaker’s contract with a manufacturer can affect clinical decision making. Most practitioners would deny they do, but research suggests otherwise. Something as benign as a drug company sponsoring grand rounds has been shown to influence physician prescribing habits.6 Stronger relationships such as significant stock ownership in a medical company or a highly paid “consulting” relationship with, for example, an implant manufacturer used extensively by a practitioner, only raises further, more serious questions.5

To help maintain the ethical standards of medical practice, many state credentialing bodies require annual proof of completion of a minimum degree of ethical training for health care providers. Often this requirement can be met with as little as one hour of continuing medical education (CME). Little information exists on the effectiveness of such requirements, but intuitively, as MasonCooley has noted, “Reading about ethics is about as likely to improve one’s behavior as reading about sports is to make one into an athlete.”7

Close adherence to evidence-based medicine guidelines may provide a more active method for reduction of inadvertent bias in clinical decision making. Most practitioners of contemporary medicine wish to, try to and, indeed, think they are making the best possible decisions with their patients.Nonetheless, all physicians and surgeons are subject to subtle influences and bias that can shift their decision-making process out of its appropriate clinical context into something potentially more self-serving than patient-serving.

As an example, consider the Maine Lumbar Spine Study. The Maine Lumbar Spine Study provides an excellent example of the effect of subtle differences in clinical perception and decision making.8 In this report, 655 patients with lumbar herniated nucleus pulposus (HNP) or spinal stenosis were studied prospectively. Based on the cohort’s patterns of hospital admission, small area analysis was used to develop three distinct service areas in the state of Maine In this cohort of HNP patients, the resultsof surgery were superior to medical/interventional treatment.

A closer reading of the study, however, uncovers significant differences in the operative rates for HNP (p<.001). These differences, which varied three-fold between the lowest and highest rates of surgical intervention, did not correlate with each areas’ population.

When questioned, the surgeons in the study reported they felt they had used similar indications and had similar outcomes as did all their surgical colleagues. However, the patients from the area with the lowest operative rate had significantly better outcomes than those who lived in areas with higher operative rates. Furthermore, the patients in areas with a higher surgical rate had less severe symptoms prior to their surgeries. These findings illustrate the impact that subtle influences had on the decision-making practices of the surgeons in the areas with higher operative rates. Yet,when the participating surgeons were informed of the study’s findings, they did not dispute the findings; rather, they asked what they could do to rectify the disparities. They then acted upon these recommendations.

A more active means of promoting ethical decisionmaking in patient care, reducing the potential for inadvertent bias in the clinical decision-making process, can be found in implementing the principles of evidence-based medicine (EBM).

Using the best current research evidence in clinical practice will lead to a “best practices” model of clinical care and help to reduce the undue influence of factors outside the physician-patient relationship.

Evidence-Based Practice

The Maine Lumbar Spine Study demonstrates that surgeons, even acting in good faith, can still be biased in their clinical decision-making. Yet when presented with data on best care, these same surgeons will modify their practices and improve their decision-making. Although the authors did not intend it as such, this study embodies a currently accepted definition of evidence-based practice (EBP): “The integration of the best research evidence with the practitioner’s expertise and the patient’s values.”9 This definition of EBP has three components, each equally important, much like the legs of a three-legged stool:

The first leg, clinical expertise, is a composite of the practitioner’s formal education and training prior to entering practice, the experience gained while in practice and the continuing efforts at education throughout the physician’s career through reading and CME.

But this expertise has potential limits. The longer a physician is in practice, the more likely it is that much of his or her early training will be proven incomplete or even wrong. And, while experience can be a great educator, investigations in human learning have shown the brain is vulnerable to remembering and valuing many events and experiences more as a function of their uniqueness than as a function of their usefulness. Thus, the unexpected diagnosis or unusual presentation of a common disease in a past patient can influence future diagnostic conduct out of proportion to the likelihood of that kind of finding ever being encountered
again. Finally, no matter how dedicated to the pursuit of continuing medical education, no single physician can realistically absorb all of the information available in even a single area of expertise. 

The second leg of the stool, patient values, is also an important part of EBP. Each patient brings his or her own knowledge of the medical condition, a unique social experience and a set of preexisting beliefs to the physician-patient relationship. Yet while these important and often complex interactions within patient values play a role in making patient care decisions, patients continue to rely heavily on the opinions of their physicians in selecting diagnostic and
treatment choices.

The third leg of the stool that serves as the foundation for EBP is perhaps the most critical: the use of the best available current clinical evidence. Note that not all clinical research evidence is used in EBP, just the best clinical evidence. The best evidence is found by reading and rating the clinical literature into hierarchical levels of evidence and accepting and using only the most strongly recommended evidence in clinical decision-making. Note also, that while it is optimal for the best evidence in treatment decisions to be a high quality RCT, such a study may not be available, or possible to conduct. Thus it may often be the case that the best
available evidence to use in the clinical decision-making process may be a case study or expert consensus.

The practitioner can identify the best available evidence by using evidence based treatment guidelines, such as those currently being developed by NASS and its collaborative partners, by seeking out clinical literature rated as to its level of evidence and by reading systematic reviews as opposed to traditional, opinion based reviews of a clinical topic. Using the best current research evidence in clinical practice will lead to a “best practices” model of clinical care and help to reduce the undue influence of factors outside the physician-patient relationship. Thus, the three legs of EBP include a self correcting mechanism that can reduce
bias in clinical decision-making and promote the practice of ethical medicine.

References
1. Armstrong D. Delicate operation: how a famed hospital invests in device it uses and promotes. Wall Street Journal. December 12, 2005:A1.
2. Rundle R, Hensley S. Backfire: J&J’s new device for spine surgery raises questions: artificial disk aims to help body’s natural movement; some see risk if it slips. Big
money riding on this. Wall Street Journal. July 7, 2001:A1.
3. Abelson R, Petersen M. An operation to ease back pain bolsters the bottom line too. New York Times. December 31, 2003.
4. Rutchick J. Surgeon kept quiet about stake in company. Cleveland Plain Dealer. December 10, 2006..
5. Abelson R. The spine as profit center. New York Times. December 30, 2006.
6. Dana J, Lowenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290:252-255.
7. Cooley, Mason. City Aphorisms. Fifth Selection. New York, NY; 1988.
8. Keller R, Atlas S, Soule D, Singer D, Deyo R. The relationship between rates and outcomes of operative treatment for lumbar disc herniation and spinal stenosis. JBJS.
1999;81-A:752-762.
9. Straus S, Richardson W, Glasziou P, Haynes B. Evidence-based Medicine. 3rd Edition. London; Elsevier Churchill Livingston; 2005.