Rheumatoid Arthritis: Closing the Gap
between Guidelines and Practice
Salahuddin Kazi, MD Medical Grand Rounds UT Southwestern Medical Center
December 14, 2012
This is to acknowledge that Salahuddin Kazi, M.D. has disclosed that he does not have any financial interests or other relationships with commercial concerns related directly or indirectly to this program. Dr. Kazi will not be discussing off-label uses in his presentation.
Letting it
Dr. Kazi is an Associate Professor of Medicine in the Division of Rheumatic Diseases. He also serves as the Program Director for Residency and Fellowship Education in the Department of Internal Medicine. Dr. Kazi’s interests include medical education, innovation in health care delivery, rheumatoid arthritis outcomes, patient registries and health informatics.
Purpose and overview:
Rheumatoid arthritis is a chronic inflammatory autoimmune disease for which we now have very effective treatment and for which remission or low disease activity is a realistic goal. Over the last several years, clinical trials and guidelines as well as incentive-based quality initiative have strongly suggested that the utilization of disease activity measures in rheumatoid arthritis is an important tool to improve outcome. By utilizing a disease activity measure, therapy can be targeted to drive down disease activity in order to achieve these goals. This concept is analogous to the management of diabetes, hypertension and hyperlipidemia. However, in
everyday clinical practice the utilization of a treat to target approach in rheumatoid arthritis only occurs in a minority of clinical practices[3]. In order to implement adoption of treat to target principles, clinical practices have to understand their workflow and use implementation science along with clinical information
technology to effectively deploy such strategies. The adoption of Wagner’s chronic care model [5]for rheumatoid arthritis can help facilitate implementation of clinical guidelines and thereby improve outcomes This presentation will highlight the recent advances in the management of rheumatoid arthritis as well as the utilization of implementation science principles to achieve high quality care with improved outcomes.
A Brief History of Rheumatoid Arthritis
The first description of rheumatoid arthritis was by Landré-Beauvais in 1800 [6]. He described nine long-term residents of hospice in Paris. He designated this form of arthritis as “asthenic gout”, a new form of gout, which was retrospectively
recognized as rheumatoid arthritis. It was Alfred Garrod who was subsequently credited with the first use of the term rheumatoid arthritis in 1859 [7]. Rheumatoid factor was described by Waller in 1940 [8].
There is considerable speculation in the literature that rheumatoid arthritis is a modern disease [9] and originated in the 19th century related to the sugar trade
between the Americas and Europe. It is hypothesized that when increased
consumption of sugar (in the form of tea flavored with sugar) reached the middle class it caused periodontal disease which in turn triggered rheumatoid arthritis [10]. As discussed below, in 2001, the first link between periodontal disease and rheumatoid arthritis was discovered and subsequently it was hypothesized that the humoral immune response to oral bacteria provides a stimulus for the development of rheumatoid arthritis[11].
In 1952 corticosteroids and subsequently prednisone were used to treat
rheumatoid arthritis [12]and in 1957 phenylbutazone was one of the first NSAIDs used to treat rheumatoid arthritis, although side effects were quickly recognized [13]. The American Rheumatism Association published formal criteria for the classification of rheumatoid arthritis in 1958. By 1960 gold therapy was an
established for the treatment of rheumatoid arthritis [14]. In 1979, Dr. Peter Stastny described the association of HLA-DR4 with rheumatoid arthritis [15].
Methotrexate use was described in 1985 [16] and slowly became the cornerstone of therapy for rheumatoid arthritis and has remained in that position. With many patients failing methotrexate therapy combination therapy also began to be
employed but the treatment typically followed a step up approach [17]. In 1987 the American College of Rheumatology developed new criteria for the classification of rheumatoid arthritis. These criteria included late manifestations of rheumatoid arthritis such as subcutaneous nodules and radiographic changes and required the presence of at least four swollen joints in a symmetrical distribution. As a result, a firm diagnoses was usually only possible in patients with clear-cut disease and this classification typically missed patients with early disease especially if they had fewer than four joints involved. As a consequence, the treatment of rheumatoid arthritis was provided well after the diagnosis was well-established. In 1989 the concept of early rheumatoid arthritis and inversion of the therapeutic pyramid began to gain a foothold [18]. In 1996, Dr. James O’Dell published the results of triple therapy with methotrexate, sulfasalazine and hydroxychloroquine indicating considerable improvement in outcome without the addition of any toxicity [19].
In 1997, the biological revolution began in rheumatoid arthritis with the utilization of anti-TNF therapy with remarkable success [20]. The biologic revolution has dominated rheumatoid arthritis management ever since but given the expense of these medications, and the lack of trials comparing combination therapy with biologic therapy, ultimately led to two landmark trials from which emerged the concept of treat to target [1, 4].
The diagnosis of early rheumatoid arthritis was aided by the discovery of anti-cyclic citrinullated peptide (anti-CCP) antibodies in 1998 [21]. Subsequently anti-CCP antibodies were shown to be frequently positive in large cohorts of patients with early disease and that anti-CCP antibodies were very predictive of eventual
progression to rheumatoid arthritis in patients with early undifferentiated arthritis [22]. As mentioned above, periodontitis was associated with rheumatoid arthritis in 2001 [23] specifically with Porphyromonas gingivalis whichcan produce a peptidyl arginine deaminase (PAD) which leads to citrullination of host proteins and the production of putative autoantigens. There is also significant overlap in
pathogenesis between rheumatoid arthritis and periodontitis.
Other notable developments in the history of rheumatoid arthritis include the utilization of genome wide scans identifying possible genetic polymorphisms such as STAT4 with strong associations with rheumatoid arthritis [24]. New guidelines for the management of rheumatoid arthritis which included the utilization of biologic therapy were published in 2008. In 2009, the Physician Quality Reporting System (PQRS) included the rheumatoid arthritis quality measures group allowing the reporting of a rheumatoid arthritis quality bundle [25]. New classification criteria for rheumatoid arthritis were proposed in 2010 [26] in an effort to improve the diagnosis of early rheumatoid arthritis. These criteria were developed as a combined effort between North American and European rheumatology societies. Updated guidelines for the treatment of rheumatoid arthritis [2] and the
measurement of disease activity [3] in rheumatoid arthritis were published in 2012 by the American College of Rheumatology. These guidelines attempted to provide guidance for the treatment of rheumatoid arthritis and the selection of valid disease activity measures in clinical settings.
The Emergence of Treat-to-Target (T2T) in Rheumatoid Arthritis
In the era of established biologic treatment of rheumatoid arthritis with
breakthrough efficacy, a group quietly devised a clinical trial to test the hypothesis that tight control of rheumatoid arthritis can be achieved in most patients with early rheumatoid arthritis using a strategy of intensive treatment without necessarily resorting to the utilization of biological therapy. This group from Glasgow, UK, designed a randomized controlled trial at two National Health Service teaching hospitals between August 1999 and April 2001, enrolling patients who had had rheumatoid arthritis for less than five years. Patients were assigned to either a routine care group supervised in the usual rheumatology follow-up clinics or into an
intensive treatment group followed by one rheumatologist. The patients in the usual rheumatology follow-up clinics were reviewed every three months with no formal composite measure of disease activity used in clinical decision-making. Treatment was commenced with DMARD monotherapy and adjusted as needed. Another group of patients was assigned to the intensive group and were seen every month by the same rheumatologist and their disease activity score was calculated. At every
monthly assessment, any swollen joints were injected and at every assessment after month three, if patients had a disease activity score of more than 2.4, they received an escalation of their oral treatment according to a protocol unless the patient declined or toxic effects occurred. Every three months a metrologist assessed patients from both groups in a masked fashion. At the 18 month assessment, patients in the intensive group had a higher rate of response and remission by all measures. This trial was notable because such high responses were achieved in the absence of anti-TNF therapy. A very small proportion of patients stopped treatment because of drug-related toxic effects in the intensive group [1].
The BeSt study (in Dutch, an acronym for Behandel-Strategieën “treatment
strategies”), also further explored the concept of treatment strategies by designing a randomized clinical trial in which clinical and radiographic outcomes in four
treatment strategies were tested. These strategies included: (1) sequential
monotherapy, (2) step up combination therapy, (3) initial combination therapy with tapered high-dose prednisone and (4) initial combination therapy with the TNF antagonist infliximab. The stated common goal in all arms was to rapidly reduce disease activity by tight monitoring and immediate adjustment of therapy. While patients with initial combination therapy with either prednisone or infliximab had more rapid improvement than patients treated with the other strategies, after one year the differences in scores between the groups was smaller and in reality there was marked improvement in all four groups. This result was presumably due to close monitoring with immediate treatment adjustments. Additionally there were no significant differences in the occurrence of toxic effects or withdrawals between the four treatment groups[4].
4.6 3.7 3.4 3.1 2.8 2.7 2.7 4.9 2.7 2.3 2.1 1.8 1.5 1.4 0 1 2 3 4 5 6 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Routine Intensive
Disease activity scores in the TICORA study showed much better improvement in the intensive treatment group as compared to the routine treatment group[1]
These two studies together showed that treatment strategy was more important than drug selection and that tight control of disease activity with rapid and reflexive adjustments in therapy based on disease activity measures was associated with improved intermediate-term outcomes. A subsequent literature review revealed that several other studies also supported the concept of treating to target [27]. That same year (2010), the European League against Rheumatism (EULAR) published guidelines for the treatment of rheumatoid arthritis and articulated overarching principles as well as treatment recommendations [28]. The group emphasized the importance of treatment targeting remission or low disease activity. It was
recommended that disease activity be assessed every 1-3 months in conjunction with strict monitoring. It was recommended that the treatment target should preferably be attained within three months and definitely by six months. Accordingly, expectations were laid out for early diagnosis, rapid escalation of treatment as well as frequent monitoring utilizing a composite measure of disease activity. The authors noted that expert opinion has suggested that composite measures of disease activity which include joint counts should be employed in treatment strategy. The same group launched an international initiative (the International Treat to Target Initiative) endorsed by representatives and patients from over 46 countries. The universal resource locator for this website is at www.t2t-RA.com.
The Physician Quality Reporting System and the RA Measures Group
The Center for Medicare and Medicaid Services (CMS) had launched the physician quality reporting initiative in 2007 (later renamed the Physician Quality Reporting System or PQRS) providing incentive payments for providers who reported on quality measures. The American College of Rheumatology in association with the National Committee for Quality Assurance (NCQA) and the Physician Consortium for Performance Improvement (PCPI) helped design a rheumatoid arthritis measures
0 (482) (462)3 (446)6 (427)9 (373)12 mono 4.5 3.5 3 2.5 2.4 step-up 4.5 3.5 2.8 2.6 2.2 Combination 4.4 2.3 2.1 2.2 2 Infliximab 4.3 2.6 2.1 1.9 1.8 0 1 2 3 4 5 D A S 4 4 S co re
The BeSt study showed that even though patients in initial combination therapy with either prednisone or infliximab had rapid
improvement, at the end of one year all for treatment arms had had considerable significant improvement in disease activity[4]
group for the Physician Quality Reporting System which was introduced in 2009. The American College of Rheumatology developed a point of care registry called the Rheumatology Clinical Registry (RCR) to facilitate reporting of quality measures [29]. The six measures within the rheumatoid arthritis measures group include assessment and classification of disease activity, assessment of functional status, assessment and classification of disease prognosis, disease modifying antirheumatic drug therapy, tuberculosis screening prior to first course of biologic DMARD
therapy, and glucocorticoid management
(http://www.rheumatology.org/practice/office/pqri/2010_measures/measure_gro
up_RA/RA_worksheet.pdf)
A number of rheumatology practices across the country have utilized the
Rheumatology Clinical Registry for the RA measures group reporting. Data from 2011 indicate that less than 50% of practicing rheumatologists who reported the RA measures group assessed disease activity. This provides compelling evidence that disease activity measurement is not in widespread use and that much work is needed in this area if the treat to target international initiative is to be realized in the United States.
Clearly many other disciplines of medicine have done a remarkable job in utilizing process measures such as hemoglobin A1c, LDL levels and blood pressure
measurements to drive improvements in outcome. In rheumatoid arthritis the tools have been developed to achieve similar outcomes. However there exists the need to develop implementation strategies to incorporate disease activity measurement and treat to target pathways within the clinical workflow of rheumatologists working in a variety of clinical settings.
The 2012 Updated Rheumatoid Arthritis Treatment Guidelines
In 2012, the American College of Rheumatology published updated guidelines for the treatment of rheumatoid arthritis [2]. In discussing indications for utilization of DMARDs or biologic agents, for both early rheumatoid arthritis and established
0 10 20 30 40 50 60 70 80 90 100 Functional status assessment DMARD
prescribed TB screen,1st course biologic DMARD Assessment of Disease Prognosis Disease activity assessment 257 rheumatology providers in 143 practices submitted data on 8096 patients with RA from January 1, 2011 to
December 31, 2011. Reporting providers practice in sites ranging from solo offices to large academic medical centers Kazi, Salahuddin, Tindall, Elizabeth A., McNiff, Kristen, Barnes, Itara; Early Experience with the American College of Rheumatology (ACR) Rheumatology Clinical Registry (RCR). [abstract]. Arthritis Rheum 2010;62 Suppl 10 :993
rheumatoid arthritis, the panel recommended a target of low disease activity or remission. The panel also made recommendations regarding drug safety, specifically screening for tuberculosis prior to initiation of biologic therapy as well as
rescreening in high-risk individuals. The panel additionally defined poor prognosis factors and recommended that decisions in early rheumatoid arthritis be based initially on an assessment of disease activity combined with an assessment of features of poor prognosis. If disease activity was low, the panel recommended initiation of DMARD monotherapy. If disease activity was moderate, the panel recommended that features of poor prognosis be assessed. If the patients had no features of poor prognosis they could begin therapy with DMARD monotherapy. If features of poor prognosis were present, the panel recommended combination DMARD therapy. On the other hand, if disease activity was high but features of poor prognosis were absent, patients could begin DMARD monotherapy or combination therapy with hydroxychloroquine and methotrexate. The combination of high disease activity along with features a poor prognosis identified a subgroup of
patients who would benefit from anti-TNF therapy with or without methotrexate or combination DMARD therapy.
If after three months of DMARD monotherapy (in patients without poor prognostic features), if disease activity deteriorated from low to moderate/high, a step up regimen was recommended followed by a switch to a different DMARD if needed. In another three months if a patient had moderate a high disease activity after three months of methotrexate monotherapy and DMARD combination therapy the panel recommended either switching to a biologic DMARD or adding a biologic DMARD. Regardless of the treatment strategy used, many of the decisions were predicated on assessing disease activity every three months and making a commitment to reassess patients periodically and adjust therapy accordingly.
Algorithm for initial management of early rheumatoid arthritis from the American College of Rheumatology 2012 guidelines for the treatment of rheumatoid arthritis[2]
Domains of Rheumatoid Arthritis Management
There are clearly many domains in the effective modern management of rheumatoid arthritis. These include access to rheumatologists which enables early diagnosis, early estimation of prognosis and the correct selection of the therapeutic regimen. The ability to achieve remission or low disease activity is predicated on a
commitment to frequent assessment of disease activity. Engaging the patient to understand the importance of disease activity measurement and understanding of the goals of therapy is crucial if patients are to cooperate with the treatment regimens and commit to a partnership with regard to monitoring for drug safety and assessment efficacy. There are additional important domains of care that encompass the mitigation of the risk of medications including the utilization of prophylactic vaccination, screening for chronic infections such as tuberculosis and viral hepatitis (in high-risk patients). Cost issues continue to play an important role in the management of rheumatoid arthritis and the judicious use of expensive medications can be facilitated by a treatment strategy that utilizes assessment of disease activity as well as assessment of prognosis and by the frequent
measurement of current disease activity. Much attention has been paid to comorbid conditions in patients with rheumatoid arthritis with an increased risk of
lymphoma, side effects from glucocorticoids as well as an increase incidence and severity of cardiovascular disease [30]. Lastly, patients with rheumatoid arthritis have considerable health care needs and high utilization of healthcare services. Accordingly a strong partnership is needed between the patient primary care physician, the rheumatologist, the orthopedic surgeon, the physical therapist, the occupational therapist, the social worker, the psychologist and chronic pain management. The most successful models of care utilize a collaborative
communicative model of rheumatoid arthritis treatment typically seen in integrated healthcare settings [31].
Early Diagnosis and Therapy: The Access Barrier
Rheumatoid arthritis occurs in approximately 1% of the population but exists within the larger spectrum of other musculoskeletal conditions. Often both diagnosis and effective treatment are delayed [32]. When patients are eventually seen, such patients can be typically classified in one of three groups: those who never needed to see rheumatologist in the first place, those who ought to have been seen much more quickly and those who should have had a more effective workup prior to consultation.
Many integrated healthcare organizations have taken novel approaches to improve access to subspecialty care [31]. In the VA Healthcare System, an E consultation initiative has been launched which utilizes the electronic health record to rapidly consult a subspecialist and often helps triage patients effectively or helps direct pre-consultation workup. There is the additional benefit of education imparted from the subspecialist to the referring primary care provider. Similarly, Geisinger Healthcare has piloted an “Ask a Doc” program within the electronic health record that allows
rapid consultation or even real-time telephonic consultation with the subspecialist. User satisfaction with both of these systems is relatively high although these are both pilot programs and long-term outcomes are yet to be determined. In a fee-for-service model, such nonrevenue generating interactions are likely to be unpopular and will only be effective in integrated healthcare models or in accountable care settings. It is expected that telemedicine will continue to grow as it has in other nations with increasing adoption and expansion of electronic health care records.
Disease Activity Measurement: Defining the Target in Rheumatoid Arthritis
With remission becoming a realistic goal for patients with rheumatoid arthritis, surrogate measures of outcome have become increasingly important in achieving these recommended goals. External drivers such as the Physician Quality Reporting System as well as parallel efforts to measure quality (and pay-for-performance) by commercial insurance plans has made it critically important that disease activity measurement is successfully and routinely performed in a variety of clinical settings but most importantly in outpatient practices where the majority of care for
rheumatoid arthritis occurs. The American College of Rheumatology convened a working group to review the published disease activity measures and to make recommendations for those that would be useful in clinical practice. The group conducted a systematic literature review and identified 63 published disease activity measures. The group used the OMERACT filter (truth, discrimination, feasibility) [33] to select a continuous composite measure for point of care
utilization in clinical practice. Several measures were excluded because they either measured radiographic changes only or did not report a continuous value or retained only to joint damage and disability or had insufficient information for further analysis. The remaining measures were reviewed by an expert panel who excluded many more and the final group of measures were submitted for review to the American College of Rheumatology membership from which a group of six disease activity measures was chosen.
Three of these measures can be derived by patient derived information alone. These included the Routine Assessment of Patient Index Data 3 (RAPID 3), Patient Activity Score (PAS) and Patient Activity Score II (PAS II). Most experts prefer composite measures that also include joint counts. The Disease Activity Score with 28 joint counts or DAS 28 (ESR or CRP), Simplify Disease Activity Index (SDAI) or the Clinical Disease Activity Index (CDAI) include joint counts.
External Drivers of Improving Performance
As mentioned above, a number of incentive programs such as the CMS Physician Quality Reporting System and various commercial insurance-based
pay-for-performance programs are driving improvements in pay-for-performance in diseases such as rheumatoid arthritis. There is an emerging emphasis on Patient Centered
Outcomes Research (PCORI) and a strong initiative by the American Board of Internal Medicine called Choosing Wisely. Both programs are helping drive changes in healthcare environments and seek to inform both patients and providers
regarding treatment choices. Patients must be empowered to choose the wisest options and providers must be able to plans treatments in a collaborative patient centered manner and both patient and provider should choose diagnostic and therapeutic approaches which are evidence-based, effective and not wasteful. There is increasing consensus that such approaches are crucial to achieving global
improvements in outcomes for a variety of chronic diseases.
The adoption of electronic health records and the subsequent increasing
implementation of electronic health records is propelled by the HITECH act [34]. This act provides incentives to practitioners and healthcare systems for adoption of electronic health records with meaningful use. This adoption has created both benefits and barriers to optimization of workflow. The core principles of the Federal Health IT Strategic Plan (2011-2015) are to utilize better technology and better information to transform healthcare. The Office of the National Coordinator was established to promote interoperability and sharing of healthcare information [35]. The development of patient portals in electronic health records also provides yet another opportunity to engage patients in management of chronic diseases.
Six disease activity measures recommended by the
American College of Rheumatology for use in clinical practice: PAS, PAS II, RAPID3, CDAI, SDAI and DAS 28 (ESR or CRP)[3]
Implementation Science
Implementation science or implementation research is the scientific study of methods to promote the systematic uptake of proven clinical treatments, practices, organizational and management interventions into routine practice and hence to improve health [36]. In this context it includes the study of influences on patient, healthcare professional and organizational behavior in either healthcare or
population settings. Implementation science seeks to understand and facilitate the adoption of best practices and attempts to translate research findings into practice. Implementation science recognizes that there are three approaches implementation [37] The first is a passive approach (letting it happen) wherein evidence-based guidelines are published and practitioners are expected to adopt these new
guidelines. A more proactive approach (helping it happen) involves the creation of toolkits by professional societies as well as the development of clinical decision support tools within electronic health records. Another mechanism by which adoption is stimulated is the institution of incentives/penalties by external
regulatory agencies. The most effective strategy involves a commitment on the part of an organization to very actively redesign healthcare delivery systems and
optimizes core elements of workflow to ensure the successful and sustainable adoption of these best practices (making it happen).
Improvement Strategies
Some of the barriers that prevent consistent use of an innovation include lack of sustained leadership support, inadequate resources allocated for implementation or even insufficient staff time to participate. Additionally, innovation will not succeed unless there is concurrent development of robust measurement and feedback systems. In 2001, the Institute of Medicine’s report “Crossing the Quality Chasm” strongly recommended the use of systems redesign and techniques used in non-healthcare industries to take a systematic approach to redesigning clinical processes. Some of these techniques that have been very successful in non-healthcare systems include Lean and Six Sigma. Many non-healthcare systems have adopted such strategies to improve healthcare processes. Lean is derived from the Japanese automobile industry and attempts to identify and eliminate operational barriers and sources of variability within a process or a system. Some of the key principles of lean production also include the concept of maximizing flow by pulling production from customer demand and “doing it right” the first time. The
empowerment of workers who are primed for rapid change and who embrace a culture of continuous improvement are crucial to the success of Lean. In the healthcare world the application of the tools utilized in Lean generally identify wasteful or non-value added steps within the system and empower workers and to foster a culture of continuous improvement.
System Redesign Tools
One of the most robust tools for system redesign is Lean Six Sigma [38]. The process typically includes a clear definition of the problem which results in the creation of a project charter and includes the “voice of the customer”. A measurement phase develops a process map as well as a check sheet to identify the baseline current process. Continued measurement includes the identification of operational barriers and typically a spaghetti diagram is created to visualize these barriers. In the analyze phase a number of tools may be used to develop future processes and smaller PDSA cycles may be generated for problems that can be resolved quickly. The improve phase also utilizes a variety of improvement strategies. This is followed by a process control strategy to prevent recurrence of initial problems. Smaller projects are more amenable to PDSA cycles (Plan, Do, Study, Act) and can generally be performed without specialized training or access to specialized software. Such cycles are particularly helpful in small clinical settings such as a rheumatology clinic. An improvement team is typically selected from front line staff who typically map a particular process (a value stream map) and understand the relative contribution of errors in the process (a Pareto chart). The top two or three contributors or barriers to effective management of a process can then be subject to individual PDSA cycles. The PDSA model allows the testing of ideas in rapid cycles and is expected to create improvement. It is very important that three preliminary questions be satisfactorily answered: “What are we trying to accomplish?” “How will we know that the changes in improvement?” And “What changes can we make that will result in improvement?” The planning stage clearly identifies who will do the work and when and what equipment and training will be needed. Crucially the planning phase additionally determines how information will be used for assessing success. The Plan phase also stipulates when progress will be reviewed. The Do phase essentially involves completing the work according to the plan. The study phase comprises an assessment of the information that had been gathered and attempts to determine if the desired outcome was achieved and, if it not achieved, determines what actually happened. The last phase of the PDSA cycle (Act) will decide what action is needed next. The most favorable outcome would be to adopt the change permanently whereas the least favorable would be to abandon the change. In most cases some adjustments are made and a new cycle starts. Talent management is another very important instrument that focuses on the development of the workforce. In general the principles include the concept of placing the right person in the right role and empowering people to function at their highest level of knowledge and skill. The creation of champions (people with unique skills) is important to sustain initial gains and to create further innovation. Finally, healthcare workers should receive formal training in process improvement. Clinical Microsystems work best when there is an appropriate talent pool and
well-organized workgroups who have the opportunity to train in system redesign principles. Such principles are increasingly utilized in patient centered medical
homes where care coordination and open access scheduling requires considerable workflow refinement [39].
Process Improvement in Rheumatoid Arthritis Management
in order to improve the outcome of patients with rheumatoid arthritis and to implement recently published guidelines, treating the disease to target can be achieved by focusing on processes that facilitate the assessment of disease activity (measuring the target), respond to changes in disease activity in an agile fashion by making appropriate therapeutic changes (managing the target) as well as by
focusing on processes that help identify outliers (improving the target).
In order to understand the processes involved in collecting and assimilating the individual measures that are components of any composite measure of disease activity in rheumatoid arthritis, a first step would be to determine the current workflow. This can be accomplished by creating a value stream map, which delineates the flow of the patient through the system and identifies which person collects what information. It is also important to be cognizant of competing priorities (other activities that typically are unaccounted for and can interrupt or disrupt workflow). A very useful next step is to develop a cause-and-effect diagram (Ishikawa diagram) to make an exhaustive list of possible causes of failure of the normal workflow. This should be followed by a measurement phase where baseline metrics are collected to identify which cause contributed at what rate to the
“failure” and to track the cumulative percentage of each cause. Typically, the top 3 to 4 causes account for 80% of process failure. Such a graph is called a Pareto chart and is useful for visualizing processes that would give the greatest payoff when remedied.
It is also important for individual practices to generally select one disease activity measure that is consistent with their particular clinical microsystems. If laboratory results are not readily available, the Simplify Disease Activity Index (SDAI) and the
120 65 42 21 18 14 11 41.2 63.5 77.9 85.1 91.3 96.1 100 0 20 40 60 80 100 120 140
Pareto Chart for Reasons Disease Activity Not Recorded
Count Cumulative Percent
A Pareto chart can be used to quickly visualize the most common causes of "defects" in any workflow process. The Pareto principle states that 20% of the causes account for 80% of the cumulative output.
Disease Activity Score with 28 Joint Counts (DAS 28) cannot be calculated at the point of care. Physicians who do not routinely perform joint counts may prefer to depend on patient derived composite measures of disease activity in rheumatoid arthritis.
Once a rheumatology clinic has selected a particular disease activity measure, the next step would be to create clinical pathways to rapidly escalate therapy. In the TICORA trial patients were seen monthly in the intensive arm [1]. In most clinical practices patients are typically seen monthly for the first few months and then typically every 2-3 months often determined by intervals recommended for
monitoring of drug toxicity and often limited by access issues. Managing therapeutic escalation has traditionally been a physician driven activity. With suitable training and the development of appropriate disease management protocols, it should be possible to create patient care pathways that do not exclusively involve physician work. For example, a patient beginning an initial dose of methotrexate could be seen in follow-up in four weeks by a nurse who could review laboratory work, obtain an inventory of side effects and review a patient completed disease activity score and escalate therapy to the next appropriate dose. The protocol would be sophisticated enough to create decision points for when either symptoms, side effects, disease activity score or laboratory results indicate that physician assessment is required. By pre-specifying these decision points and their timings and clearly delineating appropriate next steps, both safety and quality of care can be assured.
In more advanced systems, much of the usual physician work could be delegated to a specially trained nurse metrologist who has been validated in performing accurate tender and swollen joint counts. Such a person could essentially perform the routine aspects of disease assessment and expedite clinical workflow while preserving physician time to review information and make therapeutic decisions.
Leveraging patient portals, a further enhancement is the creation of patient driven treatment escalation protocols. In such a scheme, a patient would be able to arrive at a point of care laboratory facility, complete a disease questionnaire, undergo appropriate testing, return home, review lab results online and then message the clinic for further instructions. In insulin treated diabetes patients are often
empowered to manage their own disease by making therapeutic changes based on predefined clinical protocols. The success of both patient and nurse driven care would be critically dependent on ready access to physician input and
communication.
As reimbursement systems in healthcare evolve, the current disincentives to utilize non-face-to-face visits to deliver care may recede as new models of healthcare and/or reimbursement are developed. In integrated healthcare environments such as the VA Healthcare System or Geisinger Health, such models are already in use.
The Chronic Care Model
Dr. Edward Wagner developed a model for the primary care of patients with chronic illnesses, which has been utilized to develop effective chronic care [5, 40]. The model embraces the concept of self-management support with patients becoming the principal caregivers themselves. The self-measurement of disease activity by using patient derived composite measures of disease activity would certainly be consistent with the element of self-management support. Another key component of the chronic care model is the redesign of the healthcare delivery system. Planned visits and visit preplanning are considered essential elements of successful management of chronic conditions. This proactive approach results in a prepared team. The utilization of reminders integrated in daily practice provides the
necessary decision support to prevent common omission errors. Designing workflow to include such checklists and reminders is consistent with the modern and effective management of rheumatoid arthritis. Even as early as 2002, Dr. Wagner correctly predicted that computerized information systems would play three important roles in the chronic care model. Firstly they would act as reminder systems that would help clinical teams comply with practice guidelines, secondly these systems would also provide feedback to physicians and finally as registries for planning individual care and improving population-based care. The chronic care model also emphasized the importance of the structure, goals and values of provider organizations as well as linkages with community-based resources.
Disease Registries
Disease registries have been important tools in achieving improvements in both longitudinal individual patient care as well as longitudinal population care. The best example of this comes from the disease registry for cystic fibrosis supported by the Cystic Fibrosis Foundation [41]. Increasingly disease registries will play an
important role not simply in improving healthcare but in comparative effectiveness research. In rheumatoid arthritis a number of disease registries have yielded
significant increase in knowledge regarding the epidemiology of disease, the range of comorbidities, the degree of symptom control as well as the utilization of various therapies [42].
The best known of these registries is the National Databank of Rheumatic Diseases (NDB), which is mainly comprised of information collected through patient
questionnaires. Other important registries include The Consortium of Rheumatology Researchers in North America (CORRONA), a Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN), The Rheumatology Clinical Registry (RCR) and a planned registry called the rheumatology informatics system for effectiveness (RISE).
The principle behind disease registries is to collect information in a uniform fashion in order to improve the quality of care, demonstrate the value of care, enable
comparative effectiveness research and detect low frequency drug safety events. The ideal registry would collect information concurrently from clinical information systems at the point of care. Such an arrangement would require that discrete elements (lab values and terminology for tender and swollen joint counts for example) would be predefined and used in a uniform manner by participants. Concerns regarding security and ownership of data can be resolved by utilizing a federated system, which is the planned design of the RISE registry.
The RISE system will consist of a federated nationwide grid of interconnected clinical data repositories. The data themselves would reside within participants’ clinical information systems ensuring maximal control of data locally. A central query-processing grid will have appropriate security, data access policies and well-designed computational workflow support. Additionally it will be pre-populated with data models and dictionaries. Such a central system could query connected systems with ease. A typical query might be to find patients across sites with a particular disease activity state or on a particular drug regimen. The local clinical information system will be connected to an appliance that can map data elements
By collecting discrete data at the point of care, and
integrating these data with external data in utilizing the principles of data
warehousing, data are transformed into knowledge which facilitates both the deployment and development of improved practice.
using computational workflow models employing semantic annotations and utilizing data dictionaries. The power of such a design is the ability to integrate information from ever-increasing and potentially clinically rich information systems to create a virtual clinical data repository.
Conclusions
In summary, new biomedical knowledge continues to act as the engine for the design and conduct of clinical trials to answer clinical questions and test the feasibility of new knowledge. High-quality clinical trials yielding significant new clinical knowledge can result in the development of clinical guidelines. At this juncture there is typically a translational block with two possible outcomes. If
diffusion of the new clinical knowledge occurs effectively the end result is often high quality care and good outcomes. More often than not, diffusion does not occur because the infrastructure, motivation and tools to incorporate new clinical guidelines in clinical practice do not exist and usual care is often the result. The emerging discipline of implementation science and the increasing utilization of tools used by non-healthcare industries can help implement new clinical knowledge at the bedside and in the clinic. The story of rheumatoid arthritis is that of a chronic disabling disease for which not only more effective treatments are available but for which there are new treatment strategies available and both remission and low disease activity are now achievable goals. The measurement of disease activity when implemented in clinical microsystems along with strategies to improve disease activity (treat to target) is potentially achievable in most clinical settings. The management of rheumatoid arthritis fits in well with the chronic care model as described by Dr. Wagner. Drivers of performance improvement have developed the necessary incentives to improve the delivery of healthcare to patients with chronic diseases. Population management is increasingly expected for quality reporting and process improvement. The collective emergence of disease registries is an
important new tool for the management of chronic conditions. Additionally disease registries can drive improvement, permit comparative effectiveness research and provide a platform for continuous quality improvement as well as the creation of new knowledge.
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