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.
“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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© 2010 Lippincott Williams & Wilkins, Inc.
10. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ