The intent of any surgical intervention is disease amelioration, restoration of normal anatomy, and enabling physiological functioning of the affected system. This endeavor comes at a price—the monetary cost includes the cost of treatment/hospitalization and the charges for any specialized equipment and implants. But the cost in terms of pain and suffering from the surgery is much more difficult to quantify. Any complication that occurs as a consequence of the surgery can cause escalation of both the monetary cost of the intervention and the cost of pain, emotional and physical distress.
In any disease process involving the spine and the spinal cord, the emotional costs attached are already high because of the risk and fear of the attendant disability. Complications that occur in spine surgery, therefore, extract a higher emotional toll on all the stakeholders, especially on the patient and on the surgical team.
The outcome of any surgical intervention must be judged in comparison to the natural history and the expected outcome of medical management of the disease process. It is also fair to judge the complications of any intervention against consequences of natural progression of the disease and the existent comorbidities. This quantification requires the existence of good quality evidence base—both for elucidating the natural history of the disease processes and for the outcomes of any medical or surgical intervention thereof.
Undoubtedly, there is a fair amount of evidence base available for many of the disorders affecting the spine. There is also significant evidence available documenting the outcomes from medical management and from surgical interventions for spinal disorders. Prospective data collection for various disease processes and surgical interventions is being spearheaded by a number of societies and organizations such as the Scoliosis Research Society, the Association of Spine Surgeons of India, the American College of Surgeons among others.[1,2] Studies based on these data banks may provide a better insight into the epidemiology of the disease process and the treatment outcomes, including complications of intervention.[3] However, the evidence base of a significant proportion of these data does not permit unequivocal standards of care to be imposed for even common spine pathologies such as spinal trauma.[4] Much of the available evidence base can, at best, suggest treatment recommendations for some of the defined spine pathologies.
There remains a lack of consensus on the definition of a complication after surgery and the minimum period of follow-up after surgery to ensure adequate data collection even for the accepted adverse events.[3,5] Most studies grade complications as major or minor; some studies report complications as present or absent. There is no accepted consensus or agreement on the measures of severity of a complication. The result of the absence of clear guidelines and definitions on what constitutes a complication makes data collection and data analysis difficult. On the one hand, there exist well-conducted prospective studies to evaluate the incidence of common adverse events such as urinary retention after spine surgery;[6] on the other hand, retention does not find mention as a complication in the vast majority of spine surgery outcome studies!
Studies have attempted to create a complication grading system and to define the severity of complications, but these have not achieved general acceptance in the surgical community.[7] As the word “complication” has negative connotations for the patient and for the health-care providers, efforts have also been made to find substitute terms. The most widely used surrogate term is “adverse event.” An adverse event has been described by Rampersaud as “an undesirable or unexpected incident happening as a result of surgery, either directly or indirectly.”[7]
The net result of the lack of clear definition and consensus on what constitutes a complication is suboptimal reporting of performance and surgical outcomes. This also leads to wide variations in reported complication rates for similar surgical procedures.[5] There is also increasing evidence to suggest that retrospective evaluation of medical records shows lower rates of complications compared to prospective collection of data, suggesting underreporting of complications in chart-based or medical record–based surveys.[5] The need of the hour is to have consensus on a clear definition of complications in spine surgery and for standardized methods of reporting complications.[8] This is likely to lead to better quality of surgical care, lower morbidity and mortality, and improved patient satisfaction.[9]
Although it is intuitive to expect that occurrence of a complication would lead to lower satisfaction with the surgical result,[10] it may not necessarily impact on the measured clinical outcome.[11] Rapid advances in the field of medical technology have enabled the introduction of new surgical techniques of minimally invasive spine surgery, with multiple variations of minimal access surgery and endoscopic surgery. Different modalities of image guidance and robotic assistance are also transforming traditional surgical methods. Although it may be intuitive to accept that these technological advances would translate to better patient outcomes and to lesser surgical complications, conclusive evidence to prove this remains awaited.
Once these technological innovations are proven to improve outcomes, the expectation of matching these outcomes in resource poor countries and provinces will open a can of moral, ethical, and legal dilemma for all the stakeholders—the health-care providers, the treating physicians, and the patients.
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Conflicts of interest
There are no conflicts of interest.
REFERENCES
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