The volatile state of health care today drives change not only in how we practice as neurosurgeons and physicians but also within the clinical setting and hospital systems. With the push for evidence-based, cost-effective health care, the practice styles of surgeons are slowly changing. However, evidence-based medicine and cost-effectiveness tend not to blend well together as randomized clinical trials are costly but may have high impact on a specialized subpopulation. Computerized database research and registries are a way the medical community can obtain large cohort, real-world outcomes about treatments and devices, which then can be developed into guidelines and protocols to help augment evidence-based care. Both private and academic institutional collaboration with these databases and registries is crucial within the neurosurgical community to continually advance our medical field in a more consistent, safe, and monetarily conscientious manner.
KeywordsProtocols, Clinical practice guidelines, Checklists, Evidence-based medicine, Database research, Collaboration
Protocols and Guidelines
As technology advances, the practice of medicine has been rapidly transforming from anecdotal, traditional techniques, and experience to sophisticated data-driven, evidence-based protocols. Significant variability exists in the practice of medicine, including neurosurgery where diseases with relatively low prevalence limit the size and ability to create controlled trials. Variability in practice can generate hypotheses about methods for improved care, but when the results of this variation are not shared or compared, few patients benefit and little is learned. Standardization and the creation of protocols can benefit the practice of medicine through outcomes that can be interpreted in context with the potential for incremental improvements in patient care.
Other disciplines have benefited from standardization of practice, including the often-cited airline industry. Much of the major advancements in the airline industry and military are a product of the establishment of checklists and standard operating procedures. The surgery and neurosurgical community has begun to adopt similar strategies of protocols to enhance operating room safety and to improve effectively patient care. Ideally, protocols and checklists stem from nationally accepted guidelines using the highest level of evidence available to empower neurosurgeons to deliver the safest and most consistent care while minimizing cost.
Developing a standard protocol is challenging when there exists significant variability of preference and opinion between surgeons concerning the same procedure or disease. Protocols and checklists begin with an analysis of current everyday practice directly compared with a systematic review of the literature. Each step and facet of a protocol should be carefully considered with support from the literature or acknowledgment of a gap in knowledge. A considerable amount of effort should be allocated to identify the stakeholders of that procedure or disease early on, including nursing, residents, advanced practice providers, and staff. Each stakeholder should review and comment on the proposed protocol. Inclusion of various staff members allows broad recognition of the protocol as well as buy-in and accountability. Implementing surveys about controversial topics may help resolve disputes about current practice variability in order to create a common protocol. An interdisciplinary and open approach improves the overall likelihood of success and compliance of the established protocol at any particular institution.
At a larger level, national practice guidelines are ideally developed through a consensus of experts informed by a series of systematic reviews. National or international guidelines serve to inform and guide providers about well-accepted practice patterns while setting standards of care that may inform legal precedent. Peer reviewed metaanalyses and systematic reviews often suggest recommendations and propose clinical guidelines for treatment of various disease states. Adoption of guidelines is often slow or absent despite the significant amount of effort that goes into guideline creation by national or international organized medicine. Moreover, many times the quality and amount of evidence available to be summarized (randomized controlled trials (RCTs), cohort vs case-control studies, and case series) may not be sufficient to reach definitive conclusions about an intervention’s effectiveness or comparative effectiveness. Therefore, creation of such protocols and guidelines should be limited to committees of experts formed and backed by professional medical organizations in order to assimilate the necessary knowledge and context to develop and distribute clear clinical practice guidelines (CPGs) to help surgeons and providers make decisions that are based on the highest level of evidence available.
CPGs are defined by the World Health Organization (WHO) as “systematically developed evidence-based statements which assist providers, recipients and other stakeholders in making informed decisions about appropriate health interventions.” Furthermore, the WHO describes these guidelines to encompass enough to meet the unique circumstances of the specific situation to which they are being applied, yet be defined broadly to include not only clinical procedures but also public health actions. The basic objective of guidelines has also been depicted as protocols, best practices, algorithms, consensus statements, expert committee recommendations, and integrated care pathways. CPGs are based on the theory that years of experience and acquired clinical judgment can be combined with scientific evidence to produce clinically valid recommendations and operating procedures that providers utilize to establish a higher level of patient care while reducing variability and cost of health care. However, the guidelines inherently remain suggested practice with the understanding that application will take into account the individuality of each patient. While most studies use population statistics to generate and test hypotheses, the application to individual patients requires significant care and a deep understanding of the generalizability of patient populations from each study.
Developing CPGs should include several steps: (1) ensuring sufficient evidence in both quality and quantity that a guideline can be built upon; (2) guidelines are developed and funded by organizations that are reliable and free from conflicts of interest; (3) stakeholders have the opportunity to search, support, and adopt the recommendations to their clinical practice to positively change practice behavior and enhance uniformity within patient care; (4) guidelines that are produced have a favorable and significant outcome on patient care; (5) guidelines help foster the value of practices by physicians, patients, and health systems; (6) continuing to expand and enlarge various guidelines to provide updates and limit overall health-care cost. This last point is critical to maintain the confidence in the guidelines and organizations from which they were developed. In addition, the guideline’s recommendations should not exceed the level of evidence supporting itself, which will ultimately limit bias and preserve the physician’s autonomy to practice.
CPGs are ongoing efforts requiring planned periodic review of the literature in anticipation of progressively changing results that will require ongoing consideration of existing guidelines and protocols. Timelines for decisions to update guidelines need to be weighed against the need for stability of a guideline. Constant changes to guidelines may create doubt in the guideline and make implementation challenging. Garcia et al. report in a review of updated guidelines in the United Kingdom that the median time between guideline updates is 7.2 year (4.3–9 year) with the majority of evidence being classified as a “weak” recommendation (83.7%).
Currently, the Congress of Neurological Surgeons (CNS) and the American Association of Neurological Surgeons (AANS) have 12 internally produced/endorsed and 13 externally produced/endorsed evidence-based guidelines. Many of these general guidelines are broken down into several chapters, including the management of acute cervical spine and spinal cord injuries, which has 22 chapters alone. In addition, 12 consensus statements can be found that outline several topics with the hope of providing background information on particular subjects as well as facilitating future research in a productive fashion. The first practice guideline in neurosurgery was approved in 1995 by AANS/CNS for Management of Severe Traumatic Brain Injury with several revisions since. Additional guidelines have been added ranging from cervical spine and spinal cord injury (original version accepted in 2002) to lumbar fusion guidelines (original version accepted in 2005). Recently, however, the neurosurgical community has been bombarded with CPGs for approval and publication. These extensive guidelines pose as general recommendations to neurosurgeons in hopes of reducing treatment variability for the same disease state within the general population.
Linskey and Kalkanis write that a feasibility study in 2005 conducted by the CNS showed that each CPG took an average of three years to produce. The exhaustive effort is largely attributed to volunteer physicians within the field. Since the time to produce a guideline (average of 3 year) is similar to the proposed 5–7 year shelf life of the guideline, the revision cycle of guidelines is frequent and may become burdensome. In addition, the cost of each guideline, ranging from $20,000–$100,000, can put a strain on guideline productivity. The CNS/AANS has since partnered with evidence-based practice centers to help relieve the burden of developing CPGs. However, funding for these agencies is still needed to produce continually the highest-quality guidelines for medical practice.
Overall, guidelines should be based upon the highest-quality data available in an attempt to curtail the restriction of provider autonomy and freedom to practice medicine in order to obtain ideal care for patients. In their position statement on guidelines, the AANS/CNS “agree with the National Academy of Medicine that the highest-quality clinical practice parameter guidelines have recommendations supported by adequate levels of evidence; are produced by inclusive, balanced, and appropriately trained panels of clinical practice stakeholders that are multidisciplinary when appropriate; follow a validated and strict evidence-based methodology; and are updated at reasonable time intervals.” As a result, high-quality evidence-based practice guidelines should supersede lower-quality consensus statements. The AANS/CNS reserves consensus statements for “health policies, regulatory measures, government and third-party payer demonstration projects, and reimbursement policies” when current high-quality evidence-based clinical guidelines do not exist for a particular disease state. Lastly, to preserve physician autonomy, the AANS/CNS highlight that exception criteria and flexible independence be present to allow for subspecialty expertise as well as complex clinical circumstances.