Health care costs in developed nations across the world continue to rise. For example, Americans' annual national health care expenditures will soon top $3 trillion. The Institute of Medicine, among other observers, estimates that up to 30% of that spending is directed toward cost-ineffective approaches.1 In this environment, many health care stakeholders have adopted value-based purchasing, hoping to promote and objectively demonstrate health care quality, and efficiency.
Unfortunately, most present value incentives are based on largely inaccurate or irrelevant health care metrics. Process measures are assumed to be accurate proxies for true patient outcome, despite the fact that many lack proven validity. Administrative data generally used to document performance is often inaccurate or incomplete. Furthermore, many large data repositories and programs often emphasize only the cost side of the value equation. Simply put, existing value measurement tools do not reflect aspects of care relevant to patients, and have yet been demonstrated to improve care.
Despite these obvious and substantial limitations, value-based care is now a permanent element of international medical practice. In particular, the prevalence, cost, and rapid growth of surgical procedures for disorders of the spine have made this an area of special opportunity for enhancing the overall value of US health care. The most viable strategy for spine care practitioners then, is to define relevant and meaningful measures of true value, along with methods to effectively improve patient care.
Obstacles to addressing the requirement for objective demonstration of health care value in surgical disorders include a relative lack of high-quality data to enable evidence-based approaches along with an inadequate array of standard techniques to meaningfully apply that information to daily clinical care. Traditional evidence-based medicine algorithms for clinical decision making define a hierarchy of evidence based on methodology of data collection and analysis with randomized clinical trials (RCTs) accepted as the “gold standard” for clinical research and evidence generation. Although well-conducted RCTs are powerful evidence tools that remain the only practical method to limit the influence of all sources of experimental bias (known and unknown), these techniques have a number of limitations that limit their practical use in surgical contexts. First, developing and maintaining randomization of representative subjects in surgical trials is tremendously challenging. In many instances, due to lack of therapeutic equipoise or based on significant clinical heterogeneity, randomization of surgical patients is neither practical nor ethical. Second, group mean efficacy observed in “ideal world” settings of interventional approaches often fails to translate into “real-world” clinical effectiveness. Third, RCTs are inherently discontinuous processes that preclude use of the data collection and analysis infrastructure for other essential processes such as measuring and improving ongoing care. Finally, RCTs are expensive, time consuming, and impractical for all but large and/or academic centers.
The editors of this Spine Focus Issue reaffirm the importance of traditional, experimental methods for medical evidence development. However, the rapid pace of technological development, the pressing need for evidence to demonstrate value of health care services combined with a growing requirement for practitioners in all care settings to continuously improve the quality and efficiency of care mandates the development of newer methods for generating and applying high-quality medical evidence. In that regard, we think that it is time to reconceptualize the traditional evidence-based medicine paradigm. Specifically, it is time to re-evaluate the role and relative value of various observational techniques for evidence development, particularly in light of recent advances in health information technologies as well as statistical methodologies that have increased their overall practicality, relevance, and scientific reliability. Among these approaches, patient care registries are increasingly recognized for their value in powering health care–quality improvement.2
Clinical registries use observational study methods to collect uniform data to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure. Registries are remarkably cost efficient compared with other methods of evidence development and are easily scaled. The primary advantage of well-designed registries from a scientific perspective relates to their strong external validity. This validity is achieved through an inclusive design that seeks to evaluate heterogeneous populations as opposed to the more proscriptive method of interventional analysis that specifically strives to evaluate homogenous patient groups. As a consequence of this design, the observed outcomes from registry analyses are often more representative of what is achieved in real-world practice and can be generalized to broad patient populations. In this respect, registry data may be more relevant than clinical trials for decision making and health care policy development.3 An added advantage of registries relates to their continuous nature that allows them to adapt to innovations in care and facilitate participation in programs that require ongoing collection of practice quality data such as performance improvement, public and private reporting, and specialty-specific certification programs. Furthermore, registry infrastructure can be combined with other study designs to produce comprehensive “hybrid” approaches to evidence development. Some investigators have even suggested that innovative registry trials may represent the next “disruptive technology” for advancing comparative effectiveness research.4
Every data source and study design has its drawbacks, and registries are subject to the limitations faced by all observational formats, particularly those related to bias. Although it is impossible to eliminate all forms of bias in the collection and analysis of registry data, challenges to data quality can be addressed through a variety of novel design and analysis tools that reduce the probability of both systematic error and errors in inference. Data collection burdens (particularly for longitudinal data) also remain a challenge to wide-spread implementation of registry formats, but efforts to achieve a “lowest energy state” for data collection, including the development of novel technologies designed to facilitate electronic health record integration and automate longitudinal data collection are progressing rapidly.
As many stakeholders have pointed out, the creation of meaningful evidence is only the first step in the development of a sustainable health care system oriented to the consistent delivery of patient-focused, value-based care. Medical evidence ultimately must be used to create evidence-based practice protocols based on “best care” as defined by those care processes that routinely produce safe, effective care, and are validated in real-world settings. When such evidence is applied to clinical workflows, it can serve to reduce variability in care and promote more efficient allocation of health care resources; these complimentary processes are essential to value-based care delivery. Registry formats can facilitate the evaluation and development and evidence-based care pathways. They can also provide the essential function of tracking the short- and long-term outcomes of these processes and allow for their iterative refinement.
In this issue of Spine Focus, a several investigators describe their experience with novel value-evidence paradigms. McGirt et al5 review existing spine surgical registries and discuss their preliminary experience using a large single-institution registry to describe and evaluate the clinical and cost-effectiveness of various therapeutic approaches. They go on to provide examples of quality improvement, practice-based learning, and value (patient benefit per dollar spent) measurement at the procedure level. Asher et al2 review their preliminary experience with a national spine-care registry. Their descriptive analysis of 12 months of follow-up data on patients entering the registry during its first full year of operation has identified conspicuous opportunities to promote value in the surgical care of patients with lumbar spine disorders. Finally, Wilgenbusch et al6 describe their initial experience using evidence-based pathways to effect multidisciplinary triage of spine surgery referrals. This approach was demonstrated to enhance resource utilization and reduce care variability.
On the basis of the analyses presented here, along with observations of similar ongoing efforts in value-based spine care paradigms, the editors of this issue make the following observations/recommendations:
- The time for incremental change in health care quality has passed. In the present health care environment, practice scientists must focus their limited investigative resources on achieving deep understanding of priority health care conditions and the identification of conspicuous opportunities to effect meaningful change at the care delivery level. Spine care represents precisely the type of high cost, high variability, high-impact services that demand priority consideration in value investigations.
- As a community of health care providers, spine care clinicians have a lack of certain assets/elements essential to the creation and application of value-based care approaches. These gaps include standardized definitions of pathological spine conditions, uniform indications for potentially high-value spine treatments, clear direction for the value proposition related to those spine conditions and treatments, and tools to efficiently develop and apply evidence on cost and patient benefit to daily practice.
- To address the gaps for both measuring and improving value in spine care services, spine care practitioners should (1) work in multidisciplinary settings to produce uniform definitions of comparable spine conditions that can be readily applicable to a variety of prospective data collection tools; (2) define the expected/optimal outcomes of best spine care, along with the value proposition related to those services using outcomes that matter most to patients; and (3) embrace new paradigms of evidence generation such as prospective clinical registries that allow for participation of clinicians in all practice environments, efficiently produce high-quality data related to real-world care, and are adaptable to numerous practice data requirements such as quality improvement, public reporting, and comparative effectiveness research.
- Efficient resource utilization will be critical in the development of sustainable data solutions to support value-based health care. In that regard, spine care practitioners should (1) encourage cross-specialty collaboration to maximize use of resources by sharing and harmonizing health information technology infrastructure, data collection methodologies, and data analysis/reporting assets; (2) seek the commitment of payers to support the creation of quality data systems along with developing incentives for patient and physician participation in value data collection; (3) request commitment of federal funding agencies to support registry science development and novel value-based spine care paradigms; and finally (4) pursue the creation of novel, national, open-source methods to facilitate integration of electronic health records with registries and other quality data repositories.
In conclusion, it is essential that spine care practitioners respond to the medical needs of society with practical solutions that are responsive to existing knowledge gaps, defined by clinical and scientific experts, and which are generalizable to clinical practice. Achieving that goal will require the development and iterative refinement of systems to make novel evidence-based practice part of the fabric of daily care. Clinical registries and care pathways represent 2 key solutions that are practical, feasible, and generalizable to real-world clinical practices.
1. Reilly BM, Evans AT. Much ado about (doing) nothing. Ann Int Med 2009;150:270–1.
2. Asher AL, McCormick PC, Selden NR, et al. The National Neurosurgery Quality and Outcomes Database and NeuroPoint Alliance: rationale, development, and implementation. Neurosurg Focus 2013;34:E2.
3. AHRQ. Registries for Evaluating Patient Outcomes: A User's Guide. 3rd ed. Rockville, MD: Agency for Healthcare Research and Quality. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?productid=1897&pageaction=displayproduct
. Accessed July 15, 2014.
4. Lauer MS, D'Agostino RB Sr. The randomized registry trial—the next disruptive technology in clinical research? N Engl J Med 2013;369:1579–81.
5. McGirt MJ, Resnick D, Edwards N, et al. Background to understanding value-based surgical spine care. Spine. 2014;39(suppl):S51–S52.
6. Wilgenbusch CS, Adam S., Wu AS, Fourney DR. Triage of spine surgery referrals through a multidisciplinary care pathway: a value-based comparison with conventional referral processes. Spine. 2014;39(suppl):S129–S135.