Abstract
Background
Value-based healthcare models rely on quality measures to evaluate the efficacy of healthcare delivery and to identify areas for improvement. Quality measure research in other areas of health care has generally shown that there is a limited number of available quality measures and that those that exist disproportionately focus on processes as opposed to outcomes. The purpose of this study was to assess the current state of quality measures and candidate quality measures in spine surgery.
Questions/purposes
(1) How many quality measures and candidate quality measures are currently available? (2) According to Donabedian domains and National Quality Strategy (NQS) priorities, what aspects or domains of care do the present quality measures and candidate quality measures represent?
Methods
We systematically reviewed the National Quality Forum, the Agency for Healthcare Research and Quality, and the Physician Quality Reporting System for quality measures relevant to spine surgery. A systematic search for candidate quality measures was also performed using MEDLINE/PubMed and Embase as well as publications from the American Academy of Orthopaedic Surgeons, Congress of Neurological Surgeons, and the North American Spine Society. Clinical practice guidelines were included as candidate quality measures if their development was in accordance with Institute of Medicine criteria for the development of clinical practice guidelines, they were based on consistent clinical evidence including at least one Level I study, and they carried the strongest possible recommendation by the developing body. Quality measures and candidate quality measures were then pooled for analysis and categorized by clinical focus, NQS priority, and Donabedian domain. Our initial search yielded a total of 3940 articles, clinical practice guidelines, and quality measures, 74 of which met criteria for inclusion in this study.
Results
Of the 74 measures studied, 29 (39%) were quality measures and 45 (61%) were candidate quality measures. Fifty of 74 (68%) were specific to the care of the spine, and 24 of 74 (32%) were related to the general care of spine patients. The majority of the spine-specific measures were process measures (45 [90%]) and focused on the NQS priority of “Effective Clinical Care” (44 [88%]). The majority of the general care measures were also process measures (14 [58%]), the highest portion of which focused on the NQS priority of “Patient Safety” (10 [42%]).
Conclusions
Given the large number of pathologies treated by spine surgeons, the limited number of available quality measures and candidate quality measures in spine surgery is inadequate to support the transition to a value-based care model. Additionally, current measures disproportionately focus on certain aspects or domains of care, which may hinder the ability to appropriately judge an episode of care, extract usable data, and improve quality. Physicians can steward the creation of meaningful quality measures by participating in clinical practice guideline development, assisting with the creation and submission of formal quality measures, and conducting the high-quality research on which effective guidelines and quality measures depend.
Introduction
Quality measures are tools that measure or quantify healthcare processes, outcomes, patient experience, and organizational structures [10]. Nationally, payers are increasingly using quality measures to evaluate provider-level quality of care and to adjust reimbursement in alternative payment models [17, 20]. Value-based healthcare models such as the Merit-Based Incentive Payment Program by the Centers for Medicare & Medicaid Services (CMS) rely on quality measures to evaluate the effect of healthcare delivery on individual patients and to evaluate the overall health of a population [4, 7, 11]. Outside of the United States, programs such as the Quality of Care and Outcomes from the Canadian Institute for Health and Health Information as well as the Standards and Indicators from the British National Institute for Health and Care Excellence have also been implemented to evaluate and improve quality within their respective systems [5, 22].
The US Patient Protection and Affordable Care Act established the National Quality Strategy (NQS) to provide better, more affordable care for individuals and communities through the use of quality measures. As part of this strategy, the NQS has established six priorities to guide quality measurement and improvement efforts. These NQS priorities, along with the three domains of the Donabedian model, provide a framework for examining healthcare quality (Table 1) [12, 16].
Table 1.
Priorities and domains
Quality measures that address the different aspects of care allow for comprehensive evaluation of care management [1, 14, 24]. Although outcome measures are ultimately the most important, structure and process measures are important precursors that guide management and lead to high-quality outcomes [12, 13, 23]. A predominance of any one domain or NQS priority may hinder the ability to measure and improve quality of care because the success of one measure (eg, obtaining a favorable outcome) may be predicated on another (eg, having the processes in place to achieve this outcome) [12]. For example, process implementation has been shown to improve outcomes in high-performing total joint centers [27].
Quality measures are created via one of two paths. First, quality measures may be developed directly by the CMS through data gathered as part of various administrative programs. Alternatively, the CMS also calls for submissions from third parties such as research groups or specialty societies. These “candidate quality measures” are then reviewed by the CMS and formally endorsed to become quality measures if they are to become operationalized [9]. Clinical practice guidelines often provide the evidentiary support for the development of quality measures, and their inclusion is outlined in both the CMS Quality Measure Development Plan as well as the CMS Measures Management Blueprint [8, 9].
Based on prior quality measure studies in internal medicine, oncology, emergency medicine, and hand surgery, we completed a systematic review of quality measures and candidate quality measures related to spine surgery [18, 19, 25, 26]. The purpose of this study was to answer two questions: (1) How many quality measures and candidate quality measures are currently available? (2) According to Donabedian domains and NQS priorities, what aspects or domains of care do the present quality measures and candidate quality measures represent?
Materials and Methods
Search Strategy and Criteria
A systematic review was conducted following the methodology from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Statement [21]. We searched MEDLINE/PubMed using the search terms related to quality evaluation and crossreferenced them with search terms specific to spine surgery using the “AND” operator (Table 2). Additional search terms were also included to specify articles relevant to surgery on humans and articles in the English language. Where applicable, medical subject heading terms including subheadings were used in addition to the search keyword. These same search terms were also used to search the EMBASE database using Scopus.
Table 2.
MEDLINE/PubMed search terms
In addition, publications from the American Academy of Orthopaedic Surgeons (AAOS), Congress of Neurological Surgery (CNS), and North American Spine Society (NASS) were searched for high-quality clinical practice guidelines relevant to spine surgery. We also reviewed three national databases (the National Quality Forum Quality Positioning System, the Agency for Healthcare Research and Quality National Quality Measures Clearinghouse, and the Physician Quality Reporting System) using the same spine surgery search terms described previously. These databases contain only quality measures and therefore the keywords related to quality measures were not included as a crossreference (Table 3).
Table 3.
Measure sources
Inclusion and Exclusion Criteria
Two fellowship-trained orthopaedic spine surgeons (SH, KW) and one expert in health care quality measures (RK) reviewed all of the selected studies. Quality measures from each of the three national databases were reviewed and included if relevant to spine surgery or the care of spine patients. Research studies, reviews, and documents from AAOS, CNS, NASS, MEDLINE/PubMed, and Embase/Scopus were reviewed and accepted as candidate quality measures if their development was in accordance with Institute of Medicine criteria for the development of clinical practice guidelines, they were based on consistent clinical evidence including at least one Level I study, and they carried the strongest possible recommendation by the developing body [15]. Any disagreements on which measures to include were resolved through face-to-face discussion among the three reviewers. Our initial search yielded 3940 articles or quality measures, 74 of which met criteria for inclusion in this study (Fig. 1).
Fig. 1.
Three thousand nine hundred forty articles and quality measures were reviewed. Seventy-four met criteria for inclusion in this study as either a quality measure or a candidate quality measure. CPG = clinical practice guideline; IOM = Institute of Medicine.
Data Abstraction and Collection
Quality measures and high-quality clinical practice guidelines that were included as candidate quality measures were then pooled together for analysis and divided into those specific to spine surgery and those pertaining to the general care of patients undergoing spine surgery. For example, several quality measures pertaining to fragility fracture assessment, fall prevention, and deep vein thrombosis prophylaxis were returned by the query, but either did not specifically concern spine pathology or were not specific to spine patients. Quality measures such as these were classified as general care measures.
Each quality measure was further classified according to Donabedian’s model of structure, process, and/or outcome [12]. Quality measures were additionally categorized according to the NQS priority that they addressed. These include (1) person and caregiver-centered experience and outcomes; (2) patient safety; (3) communication and care coordination; (4) community and population health; (5) efficient use of healthcare resources; and (6) effective clinical care.
Results
Of the 74 measures identified, 29 (39%) were quality measures and 45 (61%) were candidate quality measures. Fifty of 74 (68%) were specific to the care of the spine, and 24 of 74 (32%) were related to the general care of spine patients. Of the 50 spine-specific measures, 41 (82%) were candidate quality measures obtained from clinical practice guidelines released by national spine societies, five (10%) were quality measures obtained from the national quality measure databases, and the remaining four (8%) were candidate quality measures obtained from clinical practice guidelines found through the literature search (see Table, Supplemental Digital Content 1). All 24 general care measures came from review of the national quality measure databases (see Table, Supplemental Digital Content 2).
According to Donabedian domain and NQS priorities, what aspects or domains of care do the present quality measures and candidate quality measures represent?
The majority of the 50 spine-specific measures were process measures (45 [90%]) and focused on the NQS priority of “Effective Clinical Care” (44 [88%]). The majority of the 24 general care measures were also process measures (14 [58%]), but they predominantly focused on the NQS priority of “Patient Safety” (10 [42%]) (Table 4). No measures found in the spine-specific nor the general care measures addressed healthcare structure. Only one measure between both groups addressed the NQS priority of “Community and Population Health.” There were several measures that addressed more than one domain or NQS priority.
Table 4.
Distribution of measures
Other Findings
There were several instances in which clinical practice guidelines from major societies provided starkly different recommendations. For example, although their methodology and expertise were similar, the AAOS (2010) issued a strong recommendation against vertebroplasty for the treatment of osteoporotic compression fractures, whereas CNS (2013) issued a strong recommendation in favor of the use of vertebroplasty as a safe and effective option for the management of these same fractures. Both reflect the current stance of their respective developers.
Discussion
Quality measures are increasingly being used to evaluate care, compare providers, and to adjust reimbursement. As a result, the US healthcare system is transitioning to the use of quality measures that not only define high-quality care, but that also standardize quality assessment. The goal of operationalizing quality measures is to use them as a lever to improve health through value-based reimbursement models. For this strategy to work, an adequate number of thoughtful quality measures in each field must be available to guide and objectively assess and improve care. As a result of the many conditions seen by spine surgeons, the limited number of available quality measures and candidate quality measures in spine surgery is inadequate to support the transition to a value-based care model. Additionally, current quality measures and candidate quality measures do not comprehensively measure the different aspects of care described by Donabedian nor are they well distributed among NQS priorities.
Because the number of quality measures and candidate quality measures is limited, many conditions are left nearly unaccounted for. For example, cervical stenosis is one of the most common pathologies managed by spine surgeons. However, there is only a single candidate quality measure and no formal quality measures addressing its management. The existing candidate measure states that “The Neck Disability Index (NDI), SF-36, SF-12 and VAS are recommended outcome measures for assessing treatment of cervical radiculopathy from degenerative disorders” [2]. There is no information pertaining to the proper workup, diagnosis, or management of this condition. Although the guideline does state which outcome tools should be used, there is no information on what exactly constitutes a good outcome.
Measures related to the general care of spine patients are also lacking in quantity and completeness. Quality measure 218 from the National Quality Forum, one of only two measures pertaining to the use of deep venous thrombosis, states: “Percentage of surgery patients who received appropriate Venous Thromboembolism (VTE) Prophylaxis within 24 hours prior to Anesthesia Start Time to 24 hours after Anesthesia End Time” [6]. Although this measure does specify acceptable agents for VTE prophylaxis, it does not outline dosages, therapeutic ranges, or offer guidance on exclusion criteria for patients at high risk for bleeding. Similarly, although there were two quality measures related to the incidence of surgical site infection in spine surgery, neither states the preferred methods to reduce surgical site infection. Both of these examples highlight that although it is necessary to quantify the incidence of complications (outcome measure), developing process measures that outline best practices is just as critical.
This study also identified instances in which clinical practice guidelines from competing specialty societies were in direct opposition to one another. Similar conflicts were seen during the long-standing disagreement between the AAOS and American College of Chest Physicians guidelines on VTE prophylaxis after hip and knee arthroplasty. In this case, recommendations conflicted with one another as a result of a difference in underlying definitions, study methodologies, and treatment goals [3]. These examples highlight the importance of a meaningful and reproducible approach to quality measure development that addresses scientific soundness, clinical importance, feasibility, and usability. When expert panels draw opposite conclusions, it is exceedingly difficult for individual providers, patients, payers, and regulatory agencies to understand best practices. This also highlights the importance of postvalidation testing to ensure a quality measure does indeed improve patient health.
There were several limitations to this study. First, clinical practice guidelines from only three major spine organizations were reviewed. Any other guidelines, however, should have been found by the systematic review. Second, NQS priorities are directly applicable only to the US healthcare system; however, the NQS priorities should be relevant to any major healthcare system focused on improving health. Finally, we chose to group quality measures and candidate quality measures. From a regulatory perspective, candidate quality measures are not operationalizable or actionable quality measures; however, they often serve as a precursor for future measure development and are referred to throughout the Measures Management System Blueprint [8, 9].
A successful transition to a value-based healthcare system depends on an underlying network of measures that enables physicians, patients, and payers to correctly assess care. The field of spine surgery lacks a sufficient number of these tools to cover the breadth and complexity of the problems that spine surgeons treat. Additionally, current measures disproportionately focus on certain aspects or domains of care, which may hinder the ability to appropriately judge an episode of care, extract usable data, and ultimately improve quality. Physicians can steward the creation of meaningful quality measures by participating in clinical practice guideline development, assisting with the creation and submission of formal quality measures, and conducting the high-quality research on which effective guidelines and quality measures are based.
Footnotes
Each author certifies that he or she, or a member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.
All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.
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