Patient Safety in Neurosurgery - An Evolving Goal
A Rich Heritage
The specialty of neurosurgery has a long history of maintaining high standards of patient care and safety. Dr. Harvey Cushing was a pioneer in patient care and safety. Among his achievements was the development of the anesthesia record, which had a significant impact on the mortality of surgical procedures in the early 20th century. Today, the two major organized neurosurgical bodies in North America, the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), carry the issue of patient safety as central to their charters. The AANS mission statement speaks of “…advancing the specialty of neurological surgery in order to promote the highest quality of patient care;” while the CNS mission statement mentions “…to enhance health and improve lives.”
Traditionally, the paradigm for achieving patient safety in neurosurgery was the training of clinically and technically excellent neurosurgeons. This method has served neurosurgery well for many decades. However, with the turn of the 21st century came new challenges for health care in general and neurosurgery in particular. Today, health care delivery in the U.S. is undergoing a dramatic metamorphosis. A number of forces have converged to drive this change:
- Unsustainable acceleration of healthcare costs
- Increasing transparency with which medicine must be practiced due to the democratization of medical information
- Technological advances that have altered every aspect of health care delivery
One major focus is the delivery of high quality care. In its crucial report from 2001, “Crossing the Quality Chasm,” the first component of quality defined by the Institute of Medicine (IOM) was safety.
In his presidential address during the 2013 AANS Annual Scientific Meeting, Mitchel S. Berger, MD, PhD, FAANS, framed the modern challenge for neurosurgery. He reiterated the primacy of patient safety to our specialty and highlighted the new challenges in achieving this goal. Central to this new vision of patient safety is the realization that surgery is not the performance of a solo virtuoso, but that the surgeon represents the captain of a complex, highly specialized team. Modern neurosurgeons, he argued, must understand that they are fallible practitioners who must work within a dramatically complex sociotechnical environment. In fact, there are several key issues that must be addressed by neurosurgery as a specialty, and by its individual practitioners, to achieve the highest levels of patient safety in the 21st century. Three issues central to this evolving goal of patient safety are:
- Meaningful outcome measurement;
- Adverse event reduction; and
- Developing and maintaining a culture of safety.
Meaningful Outcome Measurement – Developing the Right Metrics
Patients are not uniform and thus do not easily permit the meaningful scientific analysis that is possible in many scientific disciplines. Practice variability also may serve as a factor driving differences in health care quality and safety. To address these differences, we must first be able to reliably measure them, and a myriad of outcome measures have been developed to accomplish this task. Comparing benchmarks of national data to individual performance may uncover opportunities to improve. Surgical tracking currently includes re-admissions after elective surgery as well as selective postoperative complications (deep vein thromboses (DVT) and wound infections). The theoretical advantage of these efforts is that the quality gains are quantifiable: track an undesired outcome, develop treatment protocols to reduce said outcome and track the downward deflection in its incidence. Nevertheless, the realized benefits of this approach have been less clear-cut.
Meaningful outcomes analysis depends on substantive input from providers. It also requires rigorous risk-stratification. Process measures, such as tracking the timing of antibiotics administration, removal of Foley catheters after surgery and the use of preoperative checklists are easy to track but are of limited value. Thus, the tracking of outcome measures directly is a more reliable indicator of the performance of a health system than process measures. The U.S. health care system is wanting for validated outcome measures to supplant these ubiquitous process measures.
The challenge for today’s neurosurgeons is to ensure direct involvement in outcome tools or be forced to wear whatever ill-fitting garment the regulators weave for the neurosurgery discipline. As a specialty, neurosurgery must develop a consistent way to track meaningfully adverse events that are important to patient outcomes and that can be modified by interventions or care protocols. Furthermore, statistical tools that properly risk-stratify patients will be needed to insure the value of our care. The NeuroPoint Alliance (NPA) and the Quality Outcomes Database (QOD) represent neurosurgery’s response to the need for reliable outcomes measures.
Adverse Event Reduction
The first step in reducing adverse events is the development of standardized, unbiased processes of reporting. A dizzying number of performance and process measures have been put forth by regulators and other stakeholders.
Rolston et al. highlighted the problem of error reporting in a critical, systematic analysis of neurosurgical manuscripts aimed at quantifying truly preventable error rates. Only two articles tackled this problem (out of 127). This stresses the need to distinguish between preventable and unavoidable errors and highlighted the need for objective measures of error in order to standardize reporting and fortify the utility of this reporting. The stakes are even higher now, as certain hospital-acquired conditions are considered preventable ‘never events’ by CMS, resulting in no reimbursement for hospitals.
Given legal and professional concerns, it is no surprise that operative sentinel events, such as wrong site surgery, are under reported resulting in a grave loss of learning opportunity in the inability to analyze these cases. It should be noted that the 2005 Patient Safety and Quality Improvement Act allowed for the creation of reporting mechanisms of such errors, without the fear of legal discovery. Under this act, health care facilities can report errors to Patient Safety Organizations whose function is to aggregate and analyze this data. The act provides for federal legal privilege and confidentiality protections to assuage the concerns over legal exposure that could otherwise result from public disclosure of such errors. However, the safe harbor of these reporting mechanisms has come under recent pressure from medical malpractice lawsuits.
Moving forward, neurosurgery must find innovative and consistent mechanisms for error reporting. This process will generate intense debate. Should regulators and payors control the process? Should wearable cameras be mandated in the operating room to record every case? Should patients and their lawyers have access to such recordings? Neurosurgeons must establish their own criteria that are measurable, reasonable and have a meaningful impact on patient outcomes before other entities dictate their own solutions.
Developing and Maintaining a Culture of Safety
Today’s physicians face a challenging environment with high standards for patient safety and quality, which necessitates a unique skill set. The classical training of physicians stresses individual performance, autonomy and a reverence for the apprenticeship style of education. As health care has become more complex, the need has arisen for physicians to acquire additional skills to optimize patient safety. These skills promote teamwork, the reliance on evidence-based medicine, the adoption of standardization and public reporting and the abandonment of steep hierarchy gradients in the work environment.
To this end, the Neurological Surgery Milestones Project has concentrated on the acquisition of skills that modernize neurosurgical training and that bring into focus patient safety training. The milestones project requires all residents to be able to systematically review clinical outcomes and contribute to quality improvement initiatives. Additionally, the Milestones require a working knowledge of system-based thinking, effective communication and the standardization of protocols. There is substantial emphasis on multi-disciplinary patient safety initiatives, error reporting, the reporting of disruptive behavior, the improvement of care processes and the conduction of root-cause analysis and failure mode analysis of system errors. In all, the goal of the project is to graduate neurosurgeons who can become leaders and role models in the new health care environment. There have been a number of recent reports in the neurosurgical literature of resident-initiated quality improvement projects with positive effects on patient outcomes.
Renewing Our Commitment to Patient Safety
Following firmly in the footsteps of Cushing and Dandy, neurosurgeons must work today to promote patient safety. A study of the patterns of adverse events in neurosurgical patients made the following recommendations:
1. Outcomes reporting and monitoring
2. Regionalization and subspecialization
3. The development and implementation of guidelines and protocols
4. Standardization of equipment and technology
5. Implementation of the World Health Organization (WHO) Surgical Safety Checklist
Patient safety demands a systems-based approach where providers design registries to track clinical outcomes, both patient-reported measures as well as complications, to assess and improve the quality of care and eliminate unnecessary variation. Secondly, care delivery processes are needed which can detect preventable error and limit harm to patients through a series of safeguards. These safeguards depend on well-educated and highly trained individuals with expertise in teamwork and communication skills. Team-based care flattens traditional hierarchies when a situation calls for the seamless exchange of roles and responsibilities. The result will be a continued evolution of patient safety in neurosurgery, rather than a revolution, which will be driven by neurosurgeons’ passion for delivering safe quality care, their innovative spirit and their natural leadership roles in the institutions and communities.
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