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Do No Harm: The Balance of “Beneficence” and “Non-Maleficence”

Andersson, Gunnar B. J., MD*; Chapman, Jens R., MD; Dekutoski, Mark B., MD; Dettori, Joseph, PhD§; Fehlings, Michael G., MD, PhD, FACS; Fourney, Daryl R., MD, FACS; Norvell, Dan, PhD§; Weinstein, James N., DO, MSc**

doi: 10.1097/BRS.0b013e3181d9c5c5
Editorial
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From *Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL; †Harborview Medical Center, Seattle, WA; ‡Mayo Clinic, Rochester, MN; §Spectrum Research, Inc., Tacoma, WA; ¶University of Toronto, Toronto, ON; ∥Royal University Hospital, Saskatoon, Saskatchewan; and **Dartmouth-Hitchcock Medical Center, Lebanon, NH.

The manuscript submitted does not contain information about medical device(s)/drug(s).

Supported by AOSpine North America. Analytic support for this work was provided by Spectrum Research, Inc. with funding from AOSpine North America. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

Address correspondence and reprint requests to Jens R. Chapman, MD, Harborview Medical Center, 325 Ninth Avenue, Box 359798, Seattle, WA; E-mail: jenschap@u.washington.edu

“… Above all do no harm” launches a career in medicine and throughout their career compels the physician to act in the patient's best interest. It can be said that the potential for complication, its anticipation, and need for mutual trust makes the patient-physician relationship, so unique.

Complications have been associated with the delivery of healthcare since the beginnings of civilization. The earliest transcribed treatment-related complication is probably Case 8 presented in the Edwin Smith papyrus, where it seems that a wrong side craniotomy for a head injury is described in straightforward fashion.1 Since then, the discussion of complications in medicine has evolved into far more complex dimensions, with conflicting interest spheres parrying for primary interpretative rights to this term. With the dawning of the much touted “information age,” the traditional paternalistic model of the heretofore autonomous physician who “knows best” has been replaced with a more democratized process with shared decision making that recognizes the physician's background experience and training while incorporating the patient's values, goals, and preferences into their diagnostic and treatment choices.

With the potential of complications intrinsically associated with any therapy, ethical principles have been formulated to provide guidance in the selection of care whenever various options are available. Beauchamp and Childress2 in their monography on Biomedical Ethics have identified 4 basic principles to guide medical decision making with the domains of “Respect for autonomy,” “Beneficence,” “Non-Maleficence,” and “Justice” (Table 1). Any medically related decision-making process will likely touch on a weighing of “Beneficence” and “Maleficence” in some form or another. This process of weighing the “pros” and “cons” is not at all a straightforward undertaking for both parties involved—physician and patient alike. Physicians are expected to merge objectively taught and thoroughly studied scientific insights with their anecdotal experience into a well-communicated discourse on the risk/benefit ratio of proposed care. Patients and their loved ones arrive in this discussion from the depths of a subjectively traumatic experience with the hope for cure or remedy. A present-day patient has a virtually limitless array of information tools at their disposal (vast) but highly unstructured and uncensored. Nowhere does this become more apparent than in spine where a simple search for “low back pain care” will result in over 19,000,000 “hits” touting anything from informational resources to advertisements for many miracle cures and surgeons. The lack of cogent information is similarly pressing for spine surgeons. Trying to obtain objective and clear data on complications associated with spine care is commonly a frustrating experience filled with ambiguities and author-conveyed biases. Thus, getting to the substance of somewhat objective procedurally related complication numbers is a less than straightforward experience for all.

Table 1

Table 1

This focus issue was developed with 2 goals in mind: (1) to assist surgeons and patients alike in the process of “shared decision making” by providing high-quality data to assist in this effort and (2) to stimulate potential future research into currently less well-explored areas of our present state of knowledge on complication.

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The Communication Gap

Enhanced physician appreciation of complication assessment and management may indeed directly improve care and enhance communication between provider and patient. Lack of an effort in this regard may lead to erosion of the probably most important ingredient of a healthy patient-physician relationship, that of trust.3

Perhaps, the greatest challenges to informed patient consent involve effective communication. The surgeon's perspective and patient's understanding of process, appreciation of risk, and comprehension of outcomes are both largely bent by the subjective nature of life experiences. The surgeon's role is to educate their patients through recognition of a given patient's values, while drawing from the riches of professional experience aided by the insights garnered from relevant quality peer reviewed literature. With the rise in recent debates regarding patient safety and complications, we find ourselves in need of well-defined expectations for complication rates to best inform our patients. However, valid statistics on complications have become more obscured or difficult to extract.4 For a number of reasons, we as surgeons may underreport the incidence of certain complications that the patients are truly worried about. This was demonstrated in a landmark study in which experienced surgeons, who were blinded for the study, and their patients were prospectively evaluated about the occurrence of dysphagia and dysphonia after anterior cervical spine surgery. A significant gap of 80% underreporting of dysphagia rates and 84% of dysphonia in surgeon records was found compared with actual patient reports.5 Although there are a number of possible explanations to consider, findings as these and an increasing number of reports on medical errors and the need to improve patient safety clearly bring about a need to improve our reporting of complications in an accurate and upfront fashion to close the communication gap between us as physicians and our patients without intervention of outsiders. We recognize the collection of topics (Table 2) in this issue may invite secondary review of adverse outcomes, but we wish to highlight that an enhanced discussion of risks and complications in balance with surgeon experience and their grasp of outcomes is the ultimate intent of this set of manuscripts. Despite all attempts at closing the “communication gap” with updated information on complications, even comprehensive preoperative discussion with informed consent may never fully prepare a patient for the actual life impact of some complications.

Table 2

Table 2

Table 2

Table 2

Table 2

Table 2

Table 2

Table 2

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Topic Selection and Choices

The field of complications is vast and covers many dimensions. There is virtually no area in medicine that may not be touched on through a complication originally occurring in another specialty. Of course, this Spine Focus Issue on Patient Safety in Spine Surgery cannot comprehensively cover all major complications covering our specialty. In developing the set of topics and questions for the systematic reviews in this issue, our group took a “frequently asked questions” approach, finally settling on common topics (infection, bone healing, blood clots, intraoperative bleeding, pulmonary deterioration, and dysphagia), which take a front row based on their incidence and impact. Areas of ongoing controversy and focal points of regulatory interest were selected because of acuity and immediate concern in advising patients. Examples of these topics include minimally invasive surgery, electrodiagnostic monitoring, wrong level surgery, and bone healing enhancement with recombinant materials. The methods used are elucidated elsewhere in greater detail in this issue but basically followed an iterative process, which resulted in the formulation of key questions for each topic. We used systematic reviews to answer these key questions and determined the overall grade of evidence based on quality, quantity, and consistency of findings.6 We applied a consistent, systematic framework to each topic with repeat presentations of evidence to a multidisciplinary expert panel.7 Our expert review panel used a modified Delphi technique to generate final recommendations regarding the specific study question in the management of patients with surgical conditions of the spine.8 This modified Delphi technique is a well established iterative prediction tool to allow an open expression of diverse views of a preferred future to take place in a structured fashion without succumbing to the influence of a “Halo” or “bandwagon” effect. However, it is important for the readership to understand that the intent of this supplement is not to establish patient-care guidelines. Such guidelines are traditionally developed after a systematic evaluation of treatment methods and finally culminate in strong or weak recommendations. Guidelines development requires an evaluation of the therapeutic benefits and harms of a given treatment or technology and takes into consideration the quality of evidence, values and preferences of patients, and the cost of the treatment to society.9 The majority of the clinical questions addressed in this issue seek to explore patient safety in spine surgery and, therefore, are prognostic in nature. That is, the objectives were to report complication types, complication rates, and risk factors for complications when data were available to assist the surgeon and patient in understanding the underlying risks of certain types of spine surgery. Given this goal, the systematic searches focused more on studies that reported complications, which may inherently possess weaker study quality than randomized trials that are designed specifically for assessing treatment efficacy. We chose to use the GRADE method for assessing the overall quality of the body of literature with respect to any one topic.10 In addition, in several instances, clinical recommendations were made after balancing of the study evidence with our perception of patient preferences and values through discussion among clinical experts.

In this issue, we evaluate the use of patient safety terms including “complication,” “adverse outcome,” and “sentinel event”. There are a number of general observations which affect the discussion of these terms. The implication of fault in the occurrence of a condition or event that alters the clinical recovery or outcome lies at the heart of this debate. Use of terminology that does not ascribe blame enhances communication and transparency. Undoubtedly, communication is challenged by ascription of fault. Transparency empowers comprehension of system challenges that create risk and empowers mechanisms to reduce it. Media efforts and image management cloud our analysis. Although legislative leaders and the media thrive on the sensationalism and popularity of ascribing fault with adverse outcomes, this media spectacle directly impairs our ability to provide quality care and has not been shown to actually enhance safety in patient care delivery.

Currently, there are movements of some government and insurance payers under way to define “never” events, withhold payment, and ascribe monetary penalties to occurrence of certain complications. Examples that are represented in the following text are wrong level or wrong-side surgeries, infections, and thrombembolic events. Although the institution of “never” events with ideas borrowed from the airline industry may bring attention to a small spectrum of occurrences, this is actually unlikely to improve overall patient care or outcome. Although complete elimination of these events flies in the face of medical reality in regards to infections or thrombembolic events, our current knowledge on prevention methods and causation deserves further scrutiny. In several areas, enhanced definition of the problem may lead to better proactive management. This is particularly true for dysphagia and intraoperative hemorrhage. Dysphagia after anterior neck surgery has an enormous range of reporting that may be solely related to the operational definition used.5 Surprisingly, little data regarding vascular injuries in spinal access surgery are available, and there is currently no definition for major hemorrhage in spine surgery. Definition of metrics for study and outcome can be improved in these areas. Decisions affecting patient survival and end-of-life discussion involving care of spine injury patients remain an unresolved area of concern for spine surgeons and their patients. For traumatic conditions in multiply injured and elderly patients, timing of surgery and use of surgical or nonoperative care remain more intuitively managed, rather than protocol driven. Again, having a complication-based foundation for discussions pertaining to protocol-driven approaches may facilitate a more straightforward communication flow. Both, overreporting and underreporting of complications as they relate to devastating problems remain a challenge. Fear of litigation and image management are paramount challenges to fair and objective analysis. Examples include posterior ischemic optic neuropathy, wrong site surgery, and the occurrence of neurologic events. There is also limited reporting of neurologic deficits associated with postoperative prophylaxis for deep venous thrombosis and the potential for prevention or amelioration of intraoperative neurologic events using intraoperative monitoring. Regarding therapeutic options, we did not weigh outcome factors to determine efficacy but focused on observational studies that reported complications. Examples of such articles include the application of new technologies in spine surgery, such as use of biologics in spine surgery and minimal access spine surgery. Bone morphogenic protein has demonstrated a distinct complication profile that has been highlighted by the recent FDA warnings regarding its use in the anterior cervical spine.11 Increasingly, questions have also arisen about potential interactions of surgical technique and possible bone morphogenic protein-related observations. “Minimally invasive surgery” techniques have held a great deal of appeal to some surgeons, many patients and virtually all manufacturers for a number of reasons. A formal review of our current state of knowledge on complications regarding these topics seemed to establish a platform for further study and discussions.

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“If One Never Does Surgery One Never Has a Complication”

On cursory review, an uninformed individual could look at this collection of articles as a condemnation of spine surgery or feel inclined to call for more restrictions on surgery, for instance in its utilization of osteobiologics. Such a position would be irresponsible by omitting the potentially considerable benefits directly gained by the intervention itself compared with alternative care options or enhancement to patient outcome and quality of life. Realistically compiled complication data need to drive us to improve what we recommend, when we intervene, and help guide by what techniques and preparation we may choose to positively impact on our patient's lives.

The endeavor to provide safe and effective care for patients is encumbered by several factors, many of which are beyond surgeon control. These include patient disability, comorbidity, and patient participation in their care. The patient's background, understanding, and expectations all play a role as well. Beyond physician skill and judgment are issues of available resources, diagnostic limitations, and other care system factors. It is hoped that the articles provided in this Spine Focus Issue are helpful for the treating surgeon to improve their understanding of complications, available methods of prevention, and their ability to educate patients to improved patient informed consent. Perhaps, the current communications gap between patients and physicians can be closed and trust reestablished by us physicians first and foremost taking the high road through openness and transparency regarding complications and by taking the moral high ground in the discussion of “Beneficence” and “Non-Maleficence” of care options.2

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References

1. El-Assal GS. Ancient egyptian medicine. Lancet 1972;300:272–4.
2. Beauchamp L, Childress JF. Principles of Biomedical Ethics. New York, NY: Oxford University Press; 2001.
3. Rosahl S, Sanii M. The issue of leadership in health care. Healthcare Papers 2003;4:78–8.
4. Wong DA, Herndon JH, Brooks RL, et al. Medical errors in orthopaedics. Results of an AAOS member survey. J Bone Joint Surg Am 2009;91:547–7.
5. Edwards II CC, Karpitskaya Y, Cha C, et al. Accurate idenitification of adverse outcomes after cervical spine surgery. J Bone Joint Surg Am 2004;86:251–6.
6. van Tulder M, Furlan A, Bombardier C, et al. Updated method guidelines for systematic reviews in the Cochrane collaboration back review group. Spine 2003;28:1290–9.
7. The Delphi Method. Listone H and Turoff M. Addison-Wesley, Mass, 1975.
8. Custer RL, Scarcella JA, Stewart BR. The modified Delphi Technique. A rotational modification. J Voc Techn Educ 1999;15.
9. West S, King V, Carey TS, et al. Systems to Rate the Strength of Scientific Evidence. Evidence Report/Technology Assessment No. 47 (Prepared by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center, Contract No. 290–97–0011). Rockville, MD: Agency for Healthcare Research and Quality; 2002.
10. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.
11. FDA Public Health notification: Life-threatening Complications associated with Bone Morphogenic Protein used in Cel spine fusion. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062000 (accessed April 2nd, 2010).
© 2010 Lippincott Williams & Wilkins, Inc.