Key points

Introduction

Despite rising and unsustainable US health care costs, many stakeholders feel that the quality of medical services is limited and inconsistent. Value-based reforms are touted as the key to achieving health care system sustainability. Health care value is defined as quality delivered divided by cost incurred. Unfortunately, quality in health care is difficult to accurately define, and methods to reliably assess and report health care quality are often lacking. Clinical registries have emerged as important mechanisms to define, measure, and promote health care quality. The purpose of this article is to describe the role of registries in neurosurgical quality improvement.

Introduction

Despite rising and unsustainable US health care costs, many stakeholders feel that the quality of medical services is limited and inconsistent. Value-based reforms are touted as the key to achieving health care system sustainability. Health care value is defined as quality delivered divided by cost incurred. Unfortunately, quality in health care is difficult to accurately define, and methods to reliably assess and report health care quality are often lacking. Clinical registries have emerged as important mechanisms to define, measure, and promote health care quality. The purpose of this article is to describe the role of registries in neurosurgical quality improvement.

The rise of value-based care—implications for surgical evidence generation

Influential reports issued by the Institute of Medicine in 1999 and 2001 generated significant public concern about the quality and safety of US medical care. Subsequent media and regulatory attention on health care cost, safety, and quality have led to calls for greater physician accountability and care optimization. The financial crisis of 2007, plus economic projections suggesting that health care expenditures may exceed 20% of the gross domestic product within another decade, has added considerable momentum to the drive for health care reform and cost control. Passage of the Patient Protection and Affordable Care Act also dramatically shifted the focus of national, public attention to quality and cost in health care delivery. Many resulting public and private programs make health professionals directly accountable for the overall value of care they deliver.

Value-based care is now a permanent feature of medical practice. Health care value is measured by comparing quality delivered against expenditure (costs) and is optimally examined in the context of various consensus-based health care outcomes. The acquisition of valid and reliable outcomes data is critical to achieving effective and efficient health care. Providers can use these data to guide clinical decisions, examine the care outcomes, and identify opportunities for improvement. Policy makers can use outcomes data to intelligently allocate increasingly scarce health care resources.

Demonstration of the value of surgical care is challenging because of a relative lack of high-quality data along with inadequate standardization of care across care settings and practitioners. Traditional evidence-based medicine (EBM) algorithms for clinical decision making define a hierarchy of evidence based on methodology of data collection and analysis. Randomized clinical trials (RCTs) are generally accepted as the gold standard for clinical research and evidence generation related to answering single-study questions. Well-conducted RCTs are powerful evidence tools and remain the most practical method of limiting the influence of all sources of experimental bias (known and unknown). The use of RCTs to study surgical interventions, however, suffers from significant practical limitations. First, patient randomization in surgical trials is tremendously challenging due to lack of therapeutic equipoise and/or to clinical heterogeneity. Even when randomization can be performed, an ethical obligation exists to allow patients to cross over between medical and surgical therapies as clinically indicated. Subsequent intent-to-treat or as-treated analyses are often associated with confounding bias, a condition that challenges the equipoise RCTs are intended to promote. Second, group mean efficacy observed in ideal-world (controlled) clinical research settings often fails to translate into real-world (or more generalizable) clinical effectiveness when applied to patients, physicians, or health care settings dissimilar to those in tightly controlled research settings. 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 need for high-quality data requires re-evaluating the traditional EBM paradigm. The complexity and breadth of medical decision making preclude any realistic possibility of using RCTs to answer most causal questions. Furthermore, RCTs are typically time-limited data collection efforts involving unidirectional information flow from participants to a central data repository without timely or constructive feedback to the care setting. As such, the structure of RCTs renders them inadequate to facilitate continuous quality improvement, a process that necessitates bidirectional information exchange.

Individuals from the scientific, clinical, and regulatory communities now advocate expanded use of observational techniques for developing and using medical evidence. In addition, recent advances in health information technology, such as the electronic medical record along with Web-based and mobile tools, have supported the use of observational methods for evidence generation. Statistical methodologies have increased the overall practicality, relevance, and scientific reliability of observational data, in particular patient care registries.

The role of registries in the emerging value-based medicine paradigm

The majority of systematic medical data tracking is devoted to hospital or payer/purchaser claims and billing records. The resulting data sets are easily available and have low marginal collection costs. Claims-based systems can provide large-scale population assessments as well as more granular cost information. Claims data are notoriously inaccurate, however, when serving as proxies for clinical endpoints of safety or effectiveness of care.

Another common large repository of patient-related data is generated by hospital-based quality programs that track compliance with a set of mandated, generally national, standards. Whether resulting process measures truly incentivize hospitals and providers to adopt best care approaches is an open question. They do not, however, provide high-level evidence for effective medical decision making. Hence, the Institute of Medicine, Agency for Healthcare Research and Quality, and Patient-Centered Outcomes Research Institute (PCORI) have called for evolution of well-designed, patient-centered outcome registries to generate evidence that will more effectively guide health care reform.

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, which 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 or specifically to unique patient or disease subgroups. In this respect, registry data may be more relevant than clinical trials for decision-making and health care policy development. An added advantage of registries relates to their continuous nature, which allows them to adapt to innovations in care and facilitate participation in programs that require ongoing collection of quality data from practice, 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.

Innovative registry-based trials may represent a disruptive technology for advancing comparative effectiveness research. Well-constructed prospective registries with appropriate a priori design can produce level 1 prognostic evidence (predictive analysis) and level 2 evidence on effectiveness of care. Characteristics of quality registries are outlined in Box 1 . A high-quality registry possesses many of the same characteristics as an RCT, including prospective data collection (as opposed to retrospectively retrieving data from administrative data sets), clinical (ie, nonclaims) sources, patient-reported outcomes (PROs) (and not process measures), high follow-up rates, quality control and data validation, and study designs that control for confounding biases.

Clinical registry uses are reviewed in Box 2 . Four major classes of use can be described: disease and/or treatment characterization, determination of clinical/cost-effectiveness, measuring safety/harm of care, and quality improvement. There has been an explosive growth in clinical registries for a variety of clinical, reporting, and scientific applications, in large part due to the relevance and versatility of this data collection method ( Box 3 ). Specific programs range from Food and Drug Administration (FDA) postapproval studies and Centers for Medicare and Medicaid Services (CMS) coverage determinations to specialty-based quality-improvement initiatives, certification programs, and comparative effectiveness research initiatives. Increasingly, registries are used for value-based reimbursement (such as Physician Quality Reporting System). Several of these applications are reviewed in the context of neurosurgery’s national registry programs.

The Registry of Patient Registries effort is a comprehensive listing of patient registries. Several specialty-based national surgical organizations have developed registries. Among these programs, the STS National Database is the most developed surgical platform and serves as a useful illustration of the value of clinical registry programs.

Using clinical outcomes databases to advance quality care in surgery: the Society of Thoracic Surgeons experience

Among existing surgical registries, the STS National Database has most dramatically shown the power of national practice data collection programs in advancing patient-centered quality care ; 95% of all US thoracic surgery practices now use this well-established database, which is unquestionably the most established surgical registry in existence. The STS has used its database to define its own measures of quality and performance, 23 of which have been endorsed by the National Quality Forum. As a direct result, the STS has reduced the likelihood of thoracic surgeons being forced to comply with arbitrary performance standards created by outside stakeholders. For each of these measures, the STS has developed risk-adjusted national and regional benchmarks for the safety and quality of their procedures. Individual surgeons and practice groups have the tools to analyze their own morbidity and clinical outcomes in real time and compare these data with the national benchmarks, allowing surgeons to determine which areas of their practice should be targeted for quality improvement. It also allows them to satisfy public reporting requirements and develop practice-specific quality and efficiency data to support claims made to public and private payers. The STS has pioneered voluntary public reporting of outcomes data to promote accountability in care, and approximately 50% of registry sites participate in this specific program.

The STS has used aggregate national efficacy data to inform discussions with the Relative Value Scale Update Committee, private payers, and large purchasers of care. In doing so, they have successfully protected patient access to surgical care and have defended the value of their procedures. The STS has developed sophisticated risk models to determine subgroups of patients most likely to benefit from specific therapies. Finally, and perhaps most importantly, the STS National Database has been used to advance scientific discovery and improve patient care. For example, the STS database helped establish the superiority of internal thoracic artery bypass grafting and made this method standard care in thoracic surgery.

As early adopters of practice science methodologies, thoracic surgeons effectively demonstrated the value and safety of their care, increased public trust in their science, and provided other surgical specialties with a road map for pursuing their own quality-improvement efforts.