The current medical reform environment has signified a new era for health care delivery, physician accountability, and care optimization. In this context, outcomes data become a vital component in establishing the value of surgical care and guiding clinical decisions. Prospective clinical registries represent a possible solution that can collect information in a uniform and standardized fashion. Registry-generated data, which represent real-world clinical care, may be more germane than randomized controlled trials in crafting decision-making and health care policies. Registries provide an opportunity for benchmarking, value-based purchasing, disease characterization, comparative effectiveness research, and stimulation for quality improvement efforts. Given the significant ramifications of health care reform, surgical care needs to be successfully measured and integrated in this changing contour of regulatory landscape. For that purpose, participation in prospective clinical registries provides neurosurgeons with access to risk-adjusted measures of the value and benefits of surgical interventions.
KeywordsRegistries, Health care, Value, Evidence-based medicine, Quality, Neurosurgery, Quality Outcomes Database
Health Care Reform in the United States 54
The Role of Registries in the Contemporary Health Care Environment 55
Implications for Neurosurgeons 57
Value-Based Purchasing and Quality Reporting 57
Successful National Registries 58
The Quality Outcomes Database 59
Curbing the Rising Costs 60
The Randomized Registry Trial 60
Device Registries 62
Current Challenges in Registry Implementation and Data Collection 63
Health Care Reform in the United States
Measuring and improving the quality of surgical health care is an increasingly important goal in understanding the overall value, contribution, and impact surgical care has on the American Healthcare system. The current growth rate of health care costs in the United States is unsustainable, and therefore the ability to define real-world effectiveness of health care delivery is of vital importance. The Centers for Disease Control and Prevention (CDC) recently reported that the annual national health care expenditures have reached $3 trillion. Furthermore, according to the Institute of Medicine, it has been estimated that almost 30% of health care spending is provided for approaches that are cost ineffective. As such, there has been an unprecedented call for greater physician accountability and care optimization. The adoption of the Patient Protection and the Affordable Care Act (PPACA) in 2010 established the foundation for the national standardization of health care delivery, ultimately leading to wide-ranging legislative oversight and determination of health care value. Health care value, defined as the ratio of treatment safety and efficacy against cost, is the essence in the new health care environment.
Measuring value-based care has been a long striving task. Researchers have been traditionally relying on the evidence-based medicine paradigm for generating guidelines with regard to safe, cost-effective medical and surgical interventions. According to this hierarchy, randomized controlled trials (RCTs) are considered to generate the highest level of evidence for clinical decision-making, as they minimize confounding variables and protect against various sources of bias. Nevertheless, RCTs are bound by several limitations; first, developing and maintaining randomization in surgical trials can be extremely challenging in satisfying the randomization requirement in clinical trials. In some cases, randomization may be either impractical or unethical, due to the lack of treatment equipoise. Furthermore, most RCTs are inherently discontinuous in nature; this hinders the utilization of data collection and analysis infrastructure for delineating and improving the continuum of care through constant bidirectional information exchange. More importantly, many RCT findings have failed to translate into tangible benefits for the general population.
The Role of Registries in the Contemporary Health Care Environment
Former US President Barack Obama in his 21st-century Cures Act highlighted the need for real-world evidence in order to inform therapeutic approaches and patient care, guide outcomes research, stimulate quality improvement, develop efficient safety surveillance systems, and promote well-controlled effectiveness studies. An important feature of real-worldevidence is that information is gathered not only in academic and research-intensive environments but also in clinical care and home or community settings. In addition, real-world evidence may allow researchers to answer comparative effectiveness research questions efficiently that would be otherwise prohibitively resource- and time-intensive to study with an RCT.
Clinical registries have seen explosive growth in recent years and continue to demonstrate advantages in accessibility and flexibility in data collection ( Fig. 5.1 ). According to the Agency for HealthCare Research and Quality, a registry is “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical, or policy purpose(s).”
From a scientific perspective, the primary expectation of a well-designed registry relates to the strength of its external validity. This can be achieved through a comprehensive design that attempts to evaluate heterogeneous populations as compared to the classic method of interventional analysis that primarily seeks to evaluate homogenous patient groups. As a result of the unique design of clinical registries, the observed health outcomes analyses are often more representative of real-world practice and therefore more likely to draw inferences for broad patient populations and widespread practice settings. This is further enhanced with the popularization of advanced epidemiological methods, including propensity score methods and instrumental variable analysis. These methods allow providers and researchers to be better equipped with research tools that allow them to mitigate confounding and selection bias.
Another asset that is particularly helpful in the setting of hospital data relates to the continuous nature of registries. They can easily adapt to modernizations in surgical care and facilitate small- and large-scale participation in programs that depend on continuous collection of practice quality data for performance improvement, reporting, and specialty-specific certification purposes. However, certain aspects of registry design and implementation need to be well defined, such as the target population intended to be captured, the covariates and the outcomes of interest to be collected, as well as the type of randomized study that is being modeled with the registry.
Klaiman and colleagues reported on six key characteristics for a successful clinical registry based on an exhaustive literature search of registries dedicated to the treatment of cancer, cardiovascular disease, maternity care, and joint replacement therapies. The following domains were identified:
Data standardization : data need to be standardized across multiple clinical practices, given the individual nature of different clinical charting systems.
Transparency : registries should be at the forefront of public data sharing, however, in the case of proprietary registries, that is, those owned by specialty societies, members’ concerns when it comes to publishing report cards should be taken into account. In a similar fashion, state-sponsored cancer registries typically avoid generating reports on provider outcomes for fear of compromising patient confidentiality.
Provider participation : provider motivation is critical to enhance the versatility and robustness of data and participating practices.
Accuracy/completeness of data : robust methods need to be in place in order to minimize the amount of missing data and support meticulous follow-up efforts, particularly for patients who travel out of state for further evaluation or treatment.
Financial sustainability : public and federal support is crucial in terms of registry sustainability given the associated budget constraints. For example, cardiovascular registries have found various methods to maintain financial stability, including subsidies from pharmaceutical companies, fees from participating providers, and collected revenues from registry data sale.
Feedback to providers : sophisticated statistical models have been developed to provide risk-adjusted feedback to providers and make publicly available online risk calculators for predicted length of stay as well as postoperative morbidity and mortality data.
Implications for Neurosurgeons
The PPACA is laden with significant ramifications for surgical practices. As regulations are updated and new policies are adopted, goal-oriented and flexible cooperation is required between governmental bodies, regulatory stakeholders, and the neurosurgical community. Neurosurgical practices are increasingly moving in the direction of value-based medicine requiring physicians to advocate and objectively demonstrate the quality and efficiency of their medical practices. This is particularly important given the recent finding that approximately 25% of all diagnostic and therapeutic spine procedures are unnecessary or ineffective. This reiterates the need that neurosurgeons should define and collect their own metrics and practice data.