The evolution of quality measurement efforts in RA, like other examples throughout the health care system, has been a step-wise, gradual process over the last decade. The first effort can be traced back to research performed by Maclean et al. at UCLA/RAND. (17
) In a large national study of RA patients, using process of care measures, researchers demonstrated suboptimal health care quality across the domains of arthritis, co-morbid disease and health maintenance. Higher quality scores were observed if specialists were involved in care. (18
) This study was instrumental in defining the extent of the quality problem for patients with RA and laid the foundation for future studies defining and applying RA QIs.
In 2004, a formal QI set for RA was put forth with funding from the Arthritis Foundation (AF) (19
) This set was rigorously developed using the RAND/UCLA appropriateness method, which combines systematic literature reviews and expert panel ratings for potential QIs. The resulting 27 RA QIs represent a minimal standard to assess quality of care among RA patients, spanning processes of care such as imaging studies, medication use, exercise, surgery, laboratory monitoring and vaccinations.
This QI development effort in the United States also set a precedent for subsequent international efforts. In 2009, RA QIs focusing on disease course monitoring were developed in the Netherlands, using a modified Delphi method. (21
) The 18 final RA QIs were rated according the grade of supporting evidence. (22
) These QIs encompassed process measures (N=10), structure measures (N=5), and outcome measures (N=3) for use in daily clinical rheumatology practice. All of the structure and outcome measures (N=8) were supported by level D evidence, indicating reliance on expert opinion. The primary focus of these QIs was a single aspect of rheumatologic care: management of the RA disease course; the generalizability and feasibility of these QIs remains to be field-tested. (8
Quality measures in RA have been derived largely from two approaches: modifying the early QI efforts outlined above, and developing new measures from clinical guideline recommendations. Many of these efforts were in response to national programs seeking to endorse or apply RA measures in the health care system. RA Quality measures currently used in the U.S. health care system are listed in . These measures were largely derived from the original 2004 AF measure set and the 2008 RA treatment guidelines. (10
) A critical review of this list reveals that many of the measures that have gained early national prominence, have done so because they represent concepts that are easily measured with current data infrastructure. For example, the only measures submitted to the NQF to date reflect data contained within administrative claims. Many broad areas that are critical in evaluating the larger construct of health care quality in RA, such as the appropriate assessment and management of disease activity and functional status are not included, but efforts to examine these important clinical metrics are underway, as discussed below.,
Rheumatoid arthritis (RA) quality measures (QMs) used in the United States
Health Plan Employer Data and Information Set (HEDIS)
The quality measure that has been applied to largest number of Americans with RA pertains to the use of DMARDs. This was the first rheumatology-specific QM incorporated into the Health Plan Employer Data and Information Set (HEDIS). HEDIS encompasses performance measures used in the managed care and insurance industry, providing annual data for QMs across health plans.
A recent analysis of the HEDIS RA DMARD measure by our group has shown that among 90,000 Medicare managed care enrollees with RA, between 2005-2008, 63% received a DMARD. (23
) These data provide a birds-eye view of DMARD use in the United States, and suggest disparities across populations. For example, older individuals, Blacks and those with low socioeconomic status were significantly less likely to use a DMARD. In addition, we found wide variations in performance based on health plan with rates ranging from 16-87% even after adjusting for case-mix. Similarly, performance in different geographic regions ranged from 52-71% after adjustment for patient characteristics. Key questions regarding the role of patient characteristics (patient preference, co-morbidities, disease activity) and health care access (accessibility of subspecialty care, cost-sharing for medications and other health plan policies) remain and can only be answered when more clinically detailed data streams become available.
National Quality Forum (NQF)
Over the last several years, the NQF has played an increasingly important role as a national endorsement body for performance measure sets. The NQF was established by an act of Congress in 1999, and structured as a public-private partnership with broad participation from all parts of the health care system, including national, state, regional and local groups that represent patients, purchasers, employers, health care professionals, provider organizations and health plans, among others. Once measures pass the standardized endorsement process of the NQF, they are often disseminated widely throughout the health care system, with the goal of improving the quality of American health care. There have been nine RA QMs endorsed by NQF (in addition to the original RA DMARD measure), seven regarding drug safety and two evaluating baseline and annual erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) testing.
Each of these nine NQF-endorsed measures was submitted by Resolution Health, Inc., a private company that provides services to both health insurance plans and employers. The drug safety measures are summarized in . Most of these drug safety QMs can be easily measured through claims (billing) data available to health insurance companies, thus increasing their feasibility.
Although feasible to measure, several methodological questions remain regarding these recently endorsed measures. For instance, consideration of the measurement period around a particular QM cannot be understated. A study assessing a QM for follow-up lab monitoring through the EHR for RA patients initiating DMARDs, found that performance on this QM was 35%, 48% or 60% depending on the lab interval measurement methodology used. (24
) This study illustrates the importance of developing and standardizing the methodology used in lab monitoring QMs.
Questions such as the appropriate interval for patients taking various doses remain unanswered (e.g. do patients with no co-morbidities taking 7.5 mg of methotrexate a week require identical monitoring to those with co-morbid conditions taking 20 mg per week?). In a recent systematic review, the scientific basis for most laboratory monitoring practices for rheumatic drugs was found to be weak and largely based on expert consensus. (25
) In order to utilize lab monitoring QMs in routine clinical practice, several steps must occur: first is the development of a rigorous scientific evidence base to support monitoring recommendations, second is the determination of the appropriate modality (i.e. CBC and LFTs) and timing (the minimal interval for performing testing) of monitoring, and third is the methodologic research on measure specification. These considerations are crucial in defining the next generation of drug safety monitoring QMs in RA.
Physician Quality Reporting System (PQRS) and Registry reporting for RA QIs
PQRS is a Centers for Medicare and Medicaid Services (CMS) voluntary quality reporting program with bonus payment incentives. (26
) There are six RA QIs that comprise the RA measure set for PQRS (). Five of the six PQRS RA measures are not yet endorsed by the NQF; they were developed in collaboration between the ACR and NCQA as well as the AMA’s PCPI and based on the ACR’s 2008 recommendations for RA.
Physician Quality Reporting System (PQRS) RA QI measure set and snapshot of 2009 PQRS data
The role of clinical registries in facilitating quality reporting is growing. A clinical patient registry is an electronic system that helps record key aspects of patient care, including QMs. Collecting meaningful clinical data through the use of registries is a powerful way to measure and improve quality as the data captured is richer than administrative data. The strengths of utilizing clinical registries are patient tracking over time, observation of trends for directed quality improvement initiatives, and participation in national quality reporting programs such as PQRS. Since claims (billing) data can be fraught with error and manual chart review can be expensive and time-consuming, registries offer the ability to more readily capture the fundamental data elements required for quality reporting. That being said, in order to report to registries, manual chart review is required and understanding how EHRs can successfully interface with registries for ease of reporting is an important area.
Many specialty societies, the American College of Cardiology and the American Thoracic Society for example, are participating in registry reporting. They have conducted research and implemented impressive quality improvement programs through their registries, and these can certainly serve as a useful model for the field of rheumatology moving forward. The ACR has developed and launched the Rheumatology Clinical Registry (RCR) to facilitate quality reporting for PQRS for practicing rheumatologists. (27
) Data from 2009 PQRS reporting reflects over 7,800 RA patients cared for by 240 providers from 125 practices. (28
) A snapshot of five of the six RA QIs reported in the measure set is shown (). The RCR carries great promise for facilitating quality reporting and providing an overall representation of the quality of RA care. The RCR currently is not a nationally representative sample of RA patients that may inform clinical research since the sample derives from self-selected practices that participate in quality reporting. As participation grows, the role of the RCR in both quality initiatives and research will likely grow.
Many of the measures included in the PQRS RA measure set have not been extensively field-tested or validated, and several challenges in the measurement of the existing RA measures have emerged. Concerns have been raised about both the scientific soundness and feasibility of some of the PQRS RA measure set. outlines some of the challenges encountered to date applying the PQRS RA measures, in the context of importance, scientific soundness (reliability, validity), and feasibility.