It makes intuitive sense: Setting a specific goal and working quickly and systematically toward it should bring better results than slowly floundering toward an amorphous endpoint.<\/p>\n
That\u2019s the basic idea behind treat-to-target (TTT) strategies in rheumatoid arthritis, and since 2010, data seem to support it: Rheumatologists who pick a therapeutic goal and a related disease activity measure and work in partnership with cooperative patients to achieve it, get better clinical responses. <\/p>\n
So important has this concept become that it\u2019s now being tied to reimbursement. Rheumatologists who submit proof that they record disease activity measures in their patients will get points toward fulfilling quality reporting requirements for the Merit-Based Incentive Payment System (MIPS) option in the Quality Payment Program established by the Medicare Access and CHIP Reauthorization Act of 2015. Those points go toward achieving a bonus in Medicare reimbursement; those who can\u2019t show it will edge toward a financial ding.<\/p>\n
But despite the twin carrots of better patient outcomes and bonus payments from the Centers for Medicare & Medicaid Services and the stick of a 4%-9% Medicare payment penalty during the years 2019-2022 (and 9% thereafter) for quality outcome measures reported in 2017 and beyond, studies show that up to 60% of U.S. rheumatologists don\u2019t regularly incorporate TTT strategies into how they treat their RA patients.<\/p>\n
\u201cIt\u2019s not an easy question, and there\u2019s not a single answer,\u201d said Jeffrey Curtis, MD<\/a> <\/span>, the William J. Koopman Professor of Rheumatology and Immunology at the University of Alabama, Birmingham. <\/p>\n \u201cThere are patient reasons. There are doctor reasons. And there are extrinsic reasons. But I would say the number one reason it\u2019s had limited adoption is that it simply hasn\u2019t been made easy enough.\u201d<\/p>\n The ABCs of TTT<\/p>\n In 2010, Austrian rheumatologist Josef Smolen, MD<\/a> <\/span>, leading an international task force, proposed 10 recommendations for improving the care of patients with RA. These were based on the concept that choosing a therapeutic target \u2013 low disease activity or remission \u2013 and aggressively pursuing it with frequent medication changes accompanied by frequent disease activity measurements would result in improved short- and long-term outcomes.<\/p>\n Disease activity measures (DAMs) were crucial to the concept. In order to treat to a target, one must not only choose a target but also have a validated means to regularly measure progress. The task force didn\u2019t say which DAM would be most appropriate, and research since then suggests that the tool used to measure progress doesn\u2019t matter nearly as much as the target itself.<\/p>\n Shared decision making is also a core tenet of the technique. Physicians work with patients to identify the best treatment target for each individual and decide together how to reach it.<\/p>\n It is not a new concept, Dr. Smolen and his colleagues explained in their landmark paper ( Ann Rheum Dis. 2010 Apr;69[4]:631-7<\/a>)<\/span>. \u201cIn many other areas of medicine, treatment targets have been defined to improve outcomes, leading to a reduction in the risk of organ damage. In the care of patients with diabetes, hyperlipidemia, and hypertension, these aspects have been adopted widely in practice; doctors order laboratory tests for cholesterol and triglycerides, blood glucose and HbA1c<\/sub> [hemoglobin A1c<\/sub>] levels, check blood pressure, and adapt therapy accordingly, and patients know these values and are aware of the treatment targets.\u201d<\/p>\n Yet rheumatologists had not adopted a similar paradigm, despite the surge in availability of effective disease-modifying antirheumatic drugs (DMARDs). Although clinical studies of these new drugs clearly showed that remission was possible for many patients and that achieving remission quickly could prevent irreversible joint damage, few patients were getting those drugs even if they had long-standing disease.<\/p>\n The task force suggested setting a treatment aim of remission or low disease activity, seeing patients every 1-3 months, and switching therapy as often as necessary to reach that goal. Tracking improvement required consistent measurements and recording of a DAM. The recommendations, which were updated in 2014, didn\u2019t specify a certain DAM, saying that the patient\u2019s individual clinical picture should guide that choice ( Ann Rheum Dis. 2016 Jan;75[1]:3-15<\/a> <\/span>). Shared decision making between the patient and rheumatologist was at the foundation of this concept.<\/p>\n Fast-forward to 2015. As TTT was increasingly embraced in Europe, data began to emerge supporting its clinical validity. A study<\/a> <\/span> presented at the American College of Rheumatology (ACR) annual meeting in San Francisco that year showed that treating RA patients toward a target of remission or low disease activity worked immediately and resulted in higher remission rates.<\/p>\n Sofia Ramiro, MD,<\/a> <\/span>of Leiden (Netherlands) University Medical Center found that employing a TTT strategy increased the likelihood that a patient would achieve remission by 52%. She also found that TTT strategies lowered disease activity and even improved remission rates for patients who had never received DMARDs.<\/p>\n But in 2017, a meta-analysisfound conflicting results among the 16 published randomized, controlled trials comparing TTT against usual care (Health Technol Assess 2017. doi: 10.3310\/hta21710<\/a> <\/span>). The authors concluded that TTT was more effective for newly diagnosed patients, in whom it increased the chance of remission by about 50%. For those with longstanding disease, TTT was not significantly different from usual care.<\/p>\n Despite limited, and somewhat contradictory, clinical evidence, TTT is becoming increasingly accepted, especially in Europe. In 2016, the European League Against Rheumatism updated its recommendations for RA management (Ann Rheum Dis. 2017 Jun;76[6]:960-77<\/a>)<\/span>. The document contained a recommendation to use low disease activity or sustained remission as the treatment target for every patient, to monitor disease activity with a validated measure every 1-3 months, and to change therapy as often as every 3 months in the case of no improvement or by 6 months if the target hasn\u2019t been reached.<\/p>\n In its most recent 2015 RA treatment guidelines,<\/span> the ACR also endorsed the strategy, though somewhat obliquely, and did not require rheumatologists to conform to it ( Arthritis Care Res. 2016 Jan;68[1]:1-25<\/a> <\/span>).<\/p>\n The concept of TTT, if not the explicit demand to practice it, now appears in the list of quality indicators<\/a> <\/span> rheumatologists can choose from in order to fulfill quality performance reporting requirements in Merit-Based Incentive Payment System. Periodic assessment of disease activity in RA patients with a validated DAM is one of the acceptable quality measures for rheumatology. It\u2019s not designated as a high-priority measure, but there it is, item No. 177, tying clinicians at least indirectly to a TTT approach for their Medicare patients: The percentage of patients aged 18 years and older with a diagnosis of RA who have an assessment and classification of disease activity within 12 months.<\/p>\n Slow on the uptake<\/p>\n Despite the data and the dictum, however, TTT remains an outlier in the United States. The most recent studies suggest that most U.S. rheumatologists do not employ it.<\/p>\n Dr. Curtis is the primary author on one of the newest studies, which employed a 26-question survey about the use of a quantitative measurement in RA patients and attitudes about using it ( J Rheumatol. 2018 Jan;45[1]:40-4<\/a> <\/span>). The survey went out to almost 2,000 rheumatologists; 439 returned it.<\/p>\n Overall, just 44% said they \u201calways practice in a treat-to-target manner, regularly using a scoring metric.\u201d Younger physicians, those in group practices, and those who made regular use of TNF inhibitors were more likely to practice this way. A total of 35% said they never used a quantitative metric for their RA patients.<\/p>\n \u201cThe No. 1 reason given about not using them is that it\u2019s too time-consuming and not easy enough,\u201d Dr. Curtis said in an interview. \u201cLogistics is a key barrier.\u201d Busy clinicians don\u2019t want to spend time entering data into an electronic medical record, and there aren\u2019t easy ways to merge a specific DAM with a practice\u2019s chosen EHR. \u201cThere\u2019s a hassle factor, for sure.\u201d<\/p>\n The age gap was interesting but not unexpected, he said. \u201cOlder rheumatologists say they like to go by their gut, by a clinical gestalt,\u201d Dr. Curtis said, while younger physicians without decades of experience are more comfortable with such clinical tools. For some, age contributes to a kind of clinical inertia. \u201cDoctors trained in an earlier era might be more tolerant of patients not doing as well. I\u2019m a younger physician, and I have never known the era of not having biologics. They lived and practiced in that era, so their spectrum of what\u2019s \u2018normal\u2019 and acceptable for patient progress may be wider.\u201d<\/p>\n The research of Daniel H. Solomon, MD<\/a> <\/span>, of Brigham and Women\u2019s University, Boston, tells a similar story. <\/p>\n He and his colleagues investigated whether a 9-month group-based learning collaborative could improve TTT numbers among 46 rheumatologists at 11 practices. The endpoint was a combination of four TTT principles: recording a disease target, recording a disease activity measure, engaging in shared decision-making, and changing treatment if disease target hasn\u2019t been reached. <\/p>\n At baseline, 64% of visits to these rheumatologists had none of the TTT components present, 33% had one component, and 2.3% had two components; just 3% of the visits included all of the components (Arthritis Care Res. 2017 Aug 22. doi: 10.1002\/acr.23343<\/a> <\/span>).<\/p>\n The project consisted of nine sessions, most conducted by webinar. The entire practice team took part, learning the principles and practices of TTT, identifying their unique barriers to implementing it, and coming up with their unique way of integrating TTT into their practice. It was fairly successful, Dr. Solomon said in an interview. After the intervention, 57% of the exposed practices had incorporated TTT.<\/p>\n In January, Dr. Solomon published a follow-up study of the stability of those changes (Arthritis Care Res. 2018 Jan 5. doi: 10.1002\/acr.23508<\/a> <\/span>). He was impressed with the results. Most sites from the first cohort had sustained the improvement during the second training period (52%). <\/p>\n \u201cWe found that people could implement it effectively when we gave them the tools to do it,\u201d he said. \u201cIt\u2019s definitely achievable, but it takes some commitment and guidance, and the realization that everyone can contribute to success in a collaborative manner.\u201d<\/p>\n Technology, or the lack of it<\/p>\n Many rheumatologists view TTT and the consistent measuring it involves as just one more headache-inducing time suck, said John Cush, MD<\/a> <\/span>.<\/p>\n Dr. Cush, director of clinical rheumatology at Baylor Scott & White Research Institute, Dallas, does employ TTT strategies. \u201cI believe TTT makes you a smarter doctor and gives your patient the best chances of improvement. It pushes both of us out of complacency when we\u2019re tempted to go with the devil we know. Yes, change is a radical thing, but in RA change is almost always good. I think until people are forced to do that, they won\u2019t realize the benefit.\u201d<\/p>\n But at the same time, he freely admits that the time spent ticking boxes on a paper form or a computer, and being forced to report those to a federal agency, could be the camel-breaking straw for many.<\/p>\n \u201cIt\u2019s going down the path of what makes medicine sucky,\u201d he said in an interview. \u201cBean counters telling me how to practice medicine, who think they can use this TTT to manage what I do. I don\u2019t need more people trying to regulate my life.\u201d <\/p>\n Dr. Cush has conducted surveys on physician burnout and depression. \u201cAdministrative tasks and electronic records are a large part why 24% of people are burning out in medicine.\u201d<\/p>\n Right now, there\u2019s no easy way for many rheumatologists to incorporate regular DAM measures into their EHR system. The extra steps needed to get them there impede physician compliance with the strategy, he and Dr. Curtis agreed. But, Dr. Curtis said, there\u2019s an app for that.<\/p>\n He is the developer of the Rheumatic Disease Activity (READY) measure<\/a> <\/span>. The iPad\/iPhone app, which is free to download in the app store, is an electronic measurement tool that efficiently captures patient-reported outcomes in RA and other rheumatic conditions. <\/p>\n \u201cThis tool really makes it much easier to collect DAM from patients,\u201d Dr. Curtis said. \u201cIt is designed for the doc who says, \u2018I would take data from patients, just make it easy for me to do that.\u2019 It takes 5-10 minutes to complete, and you get information about pain, fatigue, anxiety, and social interactions and, he said, can be easily integrated into work flow.<\/p>\n On a practice-provided device, the patient answers questions validated on the National Institutes of Health Patient-Reported Outcomes Measurement Information System. It includes a number of electronically scored and validated DAMs and provides trend charts to visualize longitudinal score data and track patient health status over multiple encounters. There are also places to record data about current and past medications.<\/p>\n \u201cThe docs input no data, which is the usual deal-killer. All they have to do is figure out how to integrate it into the work flow.\u201d<\/p>\n The ACR is also working on the technology issue, said Kaleb Michaud, PhD<\/a> <\/span>, of the University of Nebraska in Omaha.<\/p>\n \u201cACR has been communicating with the major EMR providers out there to make this easier. We are seeing some tools for iPads and smartphones, as well as paper tools.\u201d<\/p>\n The ACR RISE Registry<\/a> <\/span>is another option, said Evan Leibowitz, MD<\/a> <\/span>, a rheumatologist in Midland Park, N.J., and an ACR spokesperson.<\/p>\n \u201cRISE is open to all rheumatologists in this country, and ACR has tried to make it as easy as possible. It can interface with most EMRs. All the physician does is collect the data, and it gets transferred to a HIPAA-protected database where it\u2019s analyzed and presented back to the doctors so they can look at all their metrics. It\u2019s currently the least painful way to get involved in a registry, I think.\u201d<\/p>\n But just as techies are rolling out ways to interface DAMs and EHRs, medicine is marching forward. A new blood test called VECTRA DA<\/a> <\/span> measures 12 inflammatory biomarkers and may provide all the information needed to make treatment escalation decisions, Dr. Leibowitz said.<\/p>\n \u201cThe least painful option will probably be the VECTRA DA score. It\u2019s a single blood test, which we can do easily since we already draw blood. Rather than filling out a RAPID3 [Routine Assessment of Patient Index Data 3] or a CDAI [Clinical Disease Activity Index], we draw the blood, send it to the company, [and] they return us a score that indicates low, moderate, or high disease activity.\u201d<\/p>\n Studies have found that not only is the VECTRA DA score a good clinical management tool, predicting responses, it can also predict impending relapse.<\/p>\n TTT challenges patients, too<\/p>\n Rheumatologists are not the only ones reluctant to embrace TTT. It challenges patients as well, in a number of ways.<\/p>\n \u201cPatients have to be willing to change treatments as often as you need them to, and that can be every 3-6 months, or even more quickly,\u201d Dr. Curtis said. \u201cThe cost can be a factor. And a lot of patients are risk averse. They feel there may be more of a downside to switching than a benefit to be gained, especially if they\u2019ve had RA for a while. Maybe they\u2019re feeling a lot better than they were; their disease is still active, but they don\u2019t feel bad enough to want to change medications.\u201d<\/p>\n Researchers have explored these questions.<\/p>\n Last year, Dr. Michaud published a survey of 48 RA patients who were interviewed about their experiences with DMARDs and the feelings that would prompt them to comply with a treatment regimen \u2013 or resist one (Arthritis Care Res. 2017 June 2. doi: 10.1002\/acr.23301<\/a> <\/span>).<\/p>\n \u201cFor patients\u2019 motivations to accept treatment regimens, two themes emerged,\u201d said Dr. Michaud, who is also codirector of the National Data Bank for Rheumatic Diseases<\/a>.<\/span> \u201cOne, the desire to return to a \u2018normal\u2019 life and, two, the fear of future disability due to RA. For motivations to resist treatment regimens, five themes emerged: fear of medications, maintaining control over health, denial of sick identity, disappointment with treatment, and feeling overwhelmed by the cognitive burden of deciding.\u201d <\/p>\n The findings confirm one of TTT\u2019s core tenets: involving patients in treatment decisions, Dr. Michaud said in an interview. \u201cA lot of patients in my studies have reached a place of \u2018OK-ness\u2019 with their RA. The don\u2019t want to change what they feel is working. They\u2019re afraid of getting worse because they\u2019ve been there and know what that can be.\u201d<\/p>\n Rapid change-ups to new medications are especially intimidating to long-term patients, he said. \u201cThis is a very important aspect of resistance to change. The side effects of these medications, both major and minor, are not something that people want to experience.\u201d<\/p>\n Physicians and patients often differ in their interpretation of a side effect, said Liana Fraenkel, MD<\/a>,<\/span> another rheumatologist who\u2019s exploring this area.<\/p>\n \u201cAs a physician, I\u2019m worried about the rare and extremely rare adverse events \u2013 things that are really dreaded, that can be fatal. However, these happen in only a couple out of tens of thousands of patients. On the other hand, there are common side effects that occur in up to 20% of our patients. They\u2019re not a serious threat to health, but they impact quality of life every day with nausea, dizziness, diarrhea, headache, and brain fog. As rheumatologists, we really undervalue these, and guess what? When we ask patients, it turns out that nausea and dizziness and diarrhea are not things that they want in their daily lives.\u201d<\/p>\n