Abstract
While most rheumatology practices are characterized by strong commitment to quality of care and continuous improvement to limit disability and optimize quality of life for patients and their families, the actual step toward improvement is often difficult. This is because there are still barriers to be addressed and facilitators to be captured before a satisfying and cost-effective practice management is installed. Therefore, this review aims to assist practicing rheumatologists with quality improvement of their daily practice, focusing on care for rheumatoid arthritis (RA) patients.
First we define quality of care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”. Often quality is determined by the interplay between structure, processes, and outcomes of care, which is also reflected in the corresponding indicators to measure quality of care. Next, a brief overview is given of the current treatment strategies used in RA, focusing on the tight control strategy, since this strategy forms the basis of international treatment guidelines. Adherence to tight control strategies leads, also in daily practice, to better outcomes in patients with regard to disease control, functional status, and work productivity. Despite evidence in favor of tight control strategies, adherence in daily practice is often challenging. Therefore, the next part of the review focuses on possible barriers and facilitators of adherence, and potential interventions to improve quality of care. Many different barriers and facilitators are known and targeting these can be effective in changing care, but these effects are rather small to moderate. With regard to RA, few studies have tried to improve care, such as a study aiming to increase the number of disease activity measures done by a combination of education and feedback. Two out of the three studies showed markedly positive effects of their interventions, suggesting that change is possible. Finally, a simple step-by-step plan is described, which could be used by rheumatologists in daily practice wanting to improve their RA patient care.
Introduction
Musculoskeletal disorders such as gout, osteoarthritis, and rheumatoid arthritis (RA) are considered to be among the most burdensome medical conditions . This has led to the execution of many randomized controlled trials (RCTs) that have provided evidence for the best therapeutic interventions for these diseases. Despite this constant stream of evidence-based recommendations, the translation into daily practice is often suboptimal .
While many practicing rheumatologists will agree that quality of care is an important aspect in rheumatology, the actual step to improve quality of care is often difficult, since rheumatologists do not know where and how to start, and there are no clear strategies available how to approach improvement of quality of care in their clinical practice. This review, with the goal of assisting practicing rheumatologists with their own quality improvement of care, aims to fill this gap. It starts with a brief general introduction on quality of care and its measurement methods. Thereafter, the focus will shift to RA and we will discuss what optimal RA care is, how we can measure whether quality demands are met or not, and how this could be improved. In the latter part, two case descriptions of successful quality improvement projects in RA will be discussed. Finally, we will give practical recommendations to rheumatologists who want to further improve their own performance.
A. What is quality of care and how can you measure it?
Quality of care in itself is a rather abstract term, but more practical descriptions do exist. One of the most commonly used descriptions, developed around 1980 by Donabedian, distinguishes structures, processes, and outcomes of care . The structure of care describes aspects of the setting in which care is delivered, such as the number of rheumatologists or the presence of a treatment protocol. Next, the process of care describes the actions of the health-care professionals, for example, whether the protocol is indeed followed. Finally, the outcome reflects the effect of the given care in terms of mortality, morbidity, and health status. It is believed that more desirable outcomes are obtained if the structure of care provides the opportunity to deliver the most optimal care processes ( Fig. 1 ).
Around 1990, the Institute of Medicine (IOM) defined quality of care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” Furthermore, the IOM formulated the following six criteria that pertain to quality of care: Care should be i) safe, ii) effective, iii) patient-centered, iv) timely, v) efficient, and vi) equitable . When using these criteria, it is important to take into account the different perspectives of the stakeholders (e.g., patients or health insurers) .
Knowing how to describe quality of care is a prerequisite for its measurement. Often quality indicators are used to assess quality of care. A quality indicator is “a measurable element of practice performance for which there is evidence or consensus that it can be used to assess the quality, and hence change the quality of care provided.” Quality indicators are often grouped using the abovementioned quality definition by Donabedian, thus providing structure, process, and outcome indicators. Outcome indicators reflect the result of the care that was provided by the health-care provider, while process indicators reflect the actual care given to patients (“what is done”). Structure indicators, on the other hand, describe organizational aspects (“what is available”) . How these indicators are used within rheumatology will be described later in this review; we will now first describe what optimal care in RA is.
A. What is quality of care and how can you measure it?
Quality of care in itself is a rather abstract term, but more practical descriptions do exist. One of the most commonly used descriptions, developed around 1980 by Donabedian, distinguishes structures, processes, and outcomes of care . The structure of care describes aspects of the setting in which care is delivered, such as the number of rheumatologists or the presence of a treatment protocol. Next, the process of care describes the actions of the health-care professionals, for example, whether the protocol is indeed followed. Finally, the outcome reflects the effect of the given care in terms of mortality, morbidity, and health status. It is believed that more desirable outcomes are obtained if the structure of care provides the opportunity to deliver the most optimal care processes ( Fig. 1 ).
Around 1990, the Institute of Medicine (IOM) defined quality of care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” Furthermore, the IOM formulated the following six criteria that pertain to quality of care: Care should be i) safe, ii) effective, iii) patient-centered, iv) timely, v) efficient, and vi) equitable . When using these criteria, it is important to take into account the different perspectives of the stakeholders (e.g., patients or health insurers) .
Knowing how to describe quality of care is a prerequisite for its measurement. Often quality indicators are used to assess quality of care. A quality indicator is “a measurable element of practice performance for which there is evidence or consensus that it can be used to assess the quality, and hence change the quality of care provided.” Quality indicators are often grouped using the abovementioned quality definition by Donabedian, thus providing structure, process, and outcome indicators. Outcome indicators reflect the result of the care that was provided by the health-care provider, while process indicators reflect the actual care given to patients (“what is done”). Structure indicators, on the other hand, describe organizational aspects (“what is available”) . How these indicators are used within rheumatology will be described later in this review; we will now first describe what optimal care in RA is.
B. What is optimal RA care?
The treatment of RA has substantially improved during the last two decades. Until 1990, the use of disease-modifying anti-rheumatic drugs (DMARDs) was limited, due to the belief that DMARDs were too toxic to use for a non-life-threatening disease such as RA . However, these assumptions have changed and the use of DMARDs, both synthetic and biological, in the management of RA has gained prominence. Treatment methods such as a step-up approach, combination therapy and treat-to-target strategies have been developed .
Improvements in care for RA patients have not only been the result of an increase in the number of effective therapeutic options, but also because of the broader insight into the course of the disease and its prognosis. For example, it is evident that active RA is associated with a high risk of cardiovascular morbidity and mortality. Furthermore, it was found that RA treatment should be started at the earliest (in the so-called “window of opportunity”) in order to prevent the occurrence of irreversible joint damage or at least to halt progression of the disease Another terminology used in this context is “hit hard, hit early” (intensive treatment early in the disease course) and “tight control”. Tight control, though being the mainstay of optimal clinical RA care, is not the only facet of good RA care. Shared care with specialized nurses or physician assistants, cardiovascular risk management and the management of comorbidities are some other important aspects of RA care. However, all these aspects cannot be elucidated in detail. Hence, we focus on the tight control principle that currently forms the basis of major treatment guidelines .
Tight control, also called ‘treat to target’, can be defined as “frequent assessment of disease activity combined with an objective structured protocol to make treatment changes that maintain low disease activity or remission at an agreed target.” Recently, an international task force provided an update of the 2010 treat-to-target recommendations . These recommendations describe a generic principle or strategy, not necessarily advocating a particular type of intervention, that should be adhered to in order to achieve disease remission or low disease activity in RA patients. The four overarching principles and 10 recommendations focus around shared decision making, the importance of setting a treatment target, measuring disease activity, changing treatment until the desired goal is reached, and maintaining the treatment goal thereafter .
Various studies have proven the effectiveness of the tight control regime, with the Tight Control of Rheumatoid Arthritis (TICORA) study being one of the first to show the beneficial effects of tight control. In the TICORA study, patients in the tight control group had a significantly better disease outcome after 18 months as compared to the control group with regard to the European League Against Rheumatism (EULAR) good response criteria (82% vs. 44%, p < 0.0001) and the mean decrease in disease activity score (DAS; −3.5 vs. −1.5, p < 0.0001) .
After the TICORA study, several studies have replicated these findings, and in 2010 a meta-analysis on the effects of tight control was published. This meta-analysis concluded that patients treated according to the tight control principles had significantly better DAS-28 responses as compared to patients treated with usual care (mean difference = 0.59; p < 0.001) . In addition, they also compared tight control with and without protocolized treatment adjustments. These comparisons showed a beneficial effect of protocolized treatment adjustments, with a 0.66-point decrease in the DAS-28 response (95% CI: 0.72–1.11; P < 0.0001) if a specific treatment protocol was used. Besides, there was an improvement in functionality and a decrease in joint damage .
Although tight control studies so far have focused on reaching remission or low disease activity, secondary analyses have shown that lower disease activity is also associated with improved work productivity, less comorbidity, and lower cardiovascular risk . This may imply that applying tight control in daily practice benefits RA patients with regard to disease control and other important aspects of their lives such as work.
In summary, due to the complexity of RA and the increasing treatment arsenal, it can be difficult for rheumatologists to provide optimal RA care in all patients. However, it seems that using tight control-based treatment strategies could assist rheumatologists in achieving low disease activity or remission in the majority of their patients, ensuring better clinical outcomes, and promoting better work productivity, less comorbidity, and lower cardiovascular risk .
C. How can we measure whether optimal RA care is provided?
As mentioned in the first section, quality of care can be assessed using predefined quality indicators for the structure, processes, and outcomes of care . With regard to RA, a broadly accepted set of quality indicators is lacking. However, several groups around the world have made an attempt to develop sets of RA quality indicators. Some of these indicator sets are as follows:
Dutch researchers have described one of the first sets, designed to monitor RA disease course in the Dutch Rheumatoid Arthritis Monitoring (DREAM) cohort. This indicator set consists of 10 process, five structure and three outcome indicators and is divided into different subcategories. These subcategories are the measurement of disease activity, structural damage, functionality, follow-up frequency, intensification of pharmacological therapy, prerequisites for measuring disease activity, and patients׳ disease activity (e.g., the percentage of RA patients in remission a year after diagnosis) .
Two other groups in Europe have also developed sets of quality indicators. Firstly, the National Health Service in England (NHS) has developed quality indicators for RA, along with indicators for other diseases, in order to standardize improvements in the delivery of primary care . Management of RA in primary care may include examining and assessing cardiovascular risk and blood pressure, the risk for osteoporosis, and signs of depression. During an annual meeting on primary care, the effects of the disease upon a person׳s life can be assessed, for example, by monitoring the side effects of medication or assessing the psychological situation of the patient. The NHS indicator sets reflect this care and comprise one structural, one outcome, and two process indicators, subdivided in two domains. The first domain is “records” . This domain documents whether the primary-care physician establishes and maintains a register for patients of 16 years and older with RA. The second domain is “ongoing management”. This domain includes the documentation of the percentage of patient who had an annual face-to-face meeting with general practitioner in the preceding 12 months .
The second European indicator set is developed by the European Musculoskeletal Conditions Surveillance and Information Network (EUMUSC.NET) and contains 14 indicators (one outcome, two structural, and 11 process indicators) . To our knowledge, the EUMUSC.NET has not divided these indicators in domains. Therefore, we decided to divide this extensive list of indicators into six domains, namely organization, screening, pharmacological treatment, and non-pharmacological treatment, monitoring, and outcome. These indicators have also been stated in Table 1 , and compared with the American College of Rheumatology (ACR) indicators.
| Subject | Indicator a | Source a |
|---|---|---|
| Organization | Rheumatology practices should provide information (written or website) on how a patient can contact the practitioner for urgent consultations (in case of flares/worsening of the disease, serious side effects). | EUMUSC.net |
| If a patient is referred to a physician for a new diagnosis of rheumatoid arthritis, then the patient should be seen by the physician within 3 months. | EUMUSC.net | |
| If a patient presents with suspected rheumatoid arthritis, then he/she should be referred to and seen by a specialist (preferably a rheumatologist) for confirmation of diagnosis within 6 weeks after the onset of symptoms. | EUMUSC.net | |
| If a patient is diagnosed with RA and there are joint damage/soft tissue problems that may be solved by surgery, then the patient should be assessed by an orthopedic surgeon within 3 months. | EUMUSC.net | |
| Education | If a patient is newly diagnosed with RA, then he or she should be given individually tailored education by relevant health professionals about the natural history, treatment, and self-management of the disease within 3 months. | EUMUSC.net |
| Screening | Percentage of patients 18 years and older with a diagnosis of rheumatoid arthritis who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a first course of therapy using a biologic disease-modifying anti-rheumatic drug (DMARD | EUMUSC.net; ACR |
| Non-pharmacological treatment | If a patient is newly diagnosed with RA, then a referral to a relevant health professional for instruction on an individualized exercise programme including advice for physical activity, range of motion, muscle strengthening, and aerobic exercises should be provided within 3 months. | EUMUSC.net |
| Pharmacological treatment | If a patient has rheumatoid arthritis and is being treated with a DMARD and there is evidence of increased disease activity or there is evidence of progression of RA bony damage over a 6-month period of time, then one of the following should be done: change DMARD dose or route of administration, change DMARD, add an additional DMARD, start or increase dose of glucocorticoids or provide local glucocorticoid injection(s), unless the patient refuses or all of the above are contraindicated | ACR |
| A rheumatologist should intensify disease-modifying medication when disease activity is moderate or high (according to EULAR recommendations) | EUMUSC.net | |
| If a patient has RA, then he/she should have a treatment plan developed between him/her and his/her clinician/health professionals at each visit. | EUMUSC.net | |
| Monitoring | If a patient is diagnosed with RA, then a rheumatologist and/or relevant health professionals from the multidisciplinary team should assess and document the following variables: 1) a measure of disease activity such as composite scores like DAS-28 or any of its variants CDAI or S-DAI, 2) structural damage (using the best available method, e.g., X-ray, MRI, ultrasound), 3) functional status (e.g., HAQ), and 4) labor force participation. The assessment and documentation should occur at baseline and thereafter at appropriate time intervals, at least annually for first, third, and fourth examination. | EUMUSC.net |
| If a patient has a diagnosis of rheumatoid arthritis, then baseline radiographs of the hands or feet should be performed within 3 months of the initial diagnosis and every 3 years. | EUMUSC.net | |
| Percentage of patients 18 years and older with a diagnosis of rheumatoid arthritis who have an assessment and classification of disease activity at least once within 12 months | ACR | |
| Percentage of patients 18 years and older with a diagnosis of rheumatoid arthritis who have an assessment and classification of disease prognosis at least once within 12 months. | ACR | |
| Percentage of patients 18 years and older with a diagnosis of rheumatoid arthritis who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone >10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid management plan within 12 months. | ACR | |
| Percentage of patients 18 years and older with a diagnosis of rheumatoid arthritis for whom a functional status assessment was performed at least once within 12 months. | ACR | |
| Outcome | If a patient is diagnosed with active RA (i.e., DAS-28 over 3.2), then the disease activity should be low (i.e., DAS-28 below 3.2), 6 months after treatment has started | EUMUSC.net |
| Follow up | If a patient is diagnosed with RA and the target (remission or low disease activity) is not attained then follow up visit should be scheduled by a rheumatologist within 3 months and when the target is attained a rheumatologist or a specialized nurse in rheumatology should schedule follow up visits at least once a year. | EUMUSC.net |
a Indicators are reported precisely as used by corresponding authors of each published set.
In the United States, the Arthritis Foundation and the ACR have also developed sets of indicators. The extensive set from the Arthritis Foundation comprises 27 process indicators and they can be divided into 17 domains such as time to referral, history and examination, regular follow-up, radiographs of hand and feet, radiographs of cervical spine, DMARDs, folic acid with methotrexate (MTX), osteoporosis prophylaxis, use of glucocorticoids, exercise, assistive devices, surgery, baseline and follow-up studies, methotrexate transminitis (increase in aminotransferases), informing patients about risks (such as risks regarding the use of non-steroidal anti-inflammatory drugs (NSAIDs), DMARDs, glucocorticoids and narcotics), reproductive issues, and finally vaccines . The set developed by the ACR includes five process indicators and one outcome indicator. We have grouped these indicators in the following domains: screening, pharmacological treatment, and monitoring; to our understanding, no domains were proposed by the research team. The indicators from this set are also stated in Table 1 for illustrative purposes .
An international task force developed a set of 10 quality indicators, using the Measurement of Efficacy of Treatment in the Era of Outcome in Rheumatology (METEOR) database. This set consists of seven process indicators and three outcome indicators: time to diagnosis, antibodies and radiographic assessment, frequency of visits, disease activity assessment, functional status assessment, remission of disease activity (clinical remission), low disease activity, level of functional limitation, time to first DMARD, and type of first DMARD .
Finally, the Australian Rheumatoid Association has proposed a set of three process indicators. These indicators cover measurement of disease activity and comorbidities .
It is evident from these seven sets that the majority of these indicators include process measures. Of the 82 indicators, only nine were outcome indicators . The majority report the “number of times” a certain outcome is measured (process), rather than the actual outcomes themselves. Referring to the triad suggested by Donabedian, which links process, structure, and outcome of care to each other, an imbalance between the different types of indicators in the current sets is quite apparent . Furthermore, the availability of many sets for selection may further jeopardize the implementation in daily practice. In conclusion, a better-balanced (more outcome, less process) and more widely accepted indicator set would be instrumental in achieving a uniform measurement of RA care. In the meantime, a rheumatologist willing to measure the quality of his own practice should choose one of the available indicator sets which best reflects what one wants to measure.
D. Is optimal care delivered to RA patients?
As described in this review, the use of tight control strategies is beneficial to RA patients and major treatment guidelines have embraced the tight control strategy . Unfortunately, the existence of these guidelines and the underlying evidence for their efficacy seem to be insufficient to ensure application of tight control in daily practice. This issue has been addressed by several studies, with rather underwhelming results. Here we will briefly summarize some of these studies.
Benhamou et al. assessed the potential gap between daily practice and recommendations on first DMARD prescription in RA in the French multicenter ESPOIR cohort . This cohort included early RA patients between 2002 and 2005, and during this period two guidelines on DMARD treatment in early RA were introduced: the national guideline by the French Society of Rheumatologists (STPR guideline) and the international set of management recommendations by the EULAR. Benhamou et al. observed that the first DMARD prescriptions in early RA were followed according to STPR recommendations in 58% of the patients, while 54% of the prescriptions adhered to the EULAR guidelines. As both guidelines were presented at international conferences at the end of the ESPOIR inclusion period, the authors concluded that the potential gap between evidence and practice was substantial .
Around the same time, another European study assessed treatment patterns in early RA patients (ERAN cohort) . In this cohort, 97% of the patients were prescribed a DMARD; however, median time between onset of the RA symptoms and DMARD prescription was 8 months. Most often, the first DMARD was prescribed as monotherapy (91%) and the addition of a second DMARD later in the treatment course was observed in 48%. Despite the high percentage of DMARD users, only 33% of the patients met the DAS-28 remission criteria after 3 years .
Furthermore, in the United States, the prescribing practices of rheumatologists were assessed. In contrast to the ESPOIR and ERAN cohort, this study also included biologic DMARD (bDMARD) prescriptions and compared adherence before and after the publication of the ACR treatment recommendations . In this study, 43% and 51% of the MTX monotherapy users with moderate disease activity as well as poor prognosis and high disease activity, respectively, received care according to the ACR guideline. In patients using multiple conventional synthetic DMARDs (csDMARDs), 43% and 51% of those with moderate and high disease activity, respectively, received care consistent with the ACR guideline. Interestingly, the publication of the ACR guidelines did not result in improved guideline adherence in patients with active disease .
The results of these three studies may seem rather disappointing. However, a Dutch study on guideline adherence in the DREAM remission induction cohort yielded more positive results . In this early RA cohort, adherence to adequate monitoring of disease activity (DAS-28 assessed at least every 3 months) and a predefined treatment protocol was assessed. The researchers observed that adequate monitoring of disease activity took place in 88% of the visits and the rheumatologist adhered to the treatment recommendations in 69%. According to the authors, these results point to the feasibility of using a tight control strategy in daily practice .
Finally, in another study using data from the ESPOIR cohort, it was observed that adherence to tight control strategies in daily practice may have real benefits for patients . It was found that early-RA patients who were not treated according to the 2007 EULAR recommendations on early RA were at an increased risk of radiographic progression at 1 year and functional impairment at 2 years (odds ratio (OR) 1.98; 1.08–3.62) and (OR 2.36; 1.17–4.67 respectively) . In addition, two studies presented at the 2014 ACR annual meeting concluded that RA disease control was better in patients in whom a tight control strategy was actively applied than in patients in whom this was not the case. .
From the above-described literature data, we can conclude that application of a tight control strategy in daily practice is feasible, but general adherence is not yet optimal . In addition, it was observed that suboptimal adherence may have negative consequences for patients with regard to disease control, radiographic progression, and functional status.
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