We begin our term as co-editors of Arthritis Care & Research with the work before us made much easier because of the tenure of Dr. Gene Hunder and colleagues. Dr. Hunder effectively managed the journal through its incorporation as an official section of Arthritis & Rheumatism and improved its reputation, which has led to an increase in the size of the journal and the quality of the journal's content. Arthritis Care & Research is now recognized as one of the premier journals in the field of rheumatology. We thank Dr. Hunder for leaving us such a legacy and will strive to continue the high standards he and his editorial team have set.

We look forward to our upcoming tenure with the journal and especially to working with our new editorial team —Associate Editors Leonard Callabrese, DO; Loreto Carmona, MD, PhD; Marian T. Hannan, DSc, MPH; C. Kent Kwoh, MD; Daniel J. Lovell, MD, MPH; and Carol Oatis, PT, PhD; Assistant Editor Belinda Wong, MPH, at the University of California, San Francisco, and Managing Editor Nancy Vickers at the American College of Rheumatology in Atlanta.

The mission of Arthritis Care & Research is to provide a venue for the best in clinical research related to the rheumatic diseases. However clinical research currently faces a number of challenges, ranging from effects of the changing health care marketplace and health care funding, to the integration and collaboration of the multiple disciplines necessary to address complex issues and funding for re search itself.1

thumbnail image

Figure 1. Patricia P. Katz, PhD and Edward H. Yelin, PhD

Download figure to PowerPoint

We are currently in the midst of a period of flux in the field of rheumatology, marked first by the introduction of biologic agents for the treatment of rheumatoid arthritis and other rheumatic conditions, and more recently by the withdrawal of rofecoxib and valdecoxib and the discontinuation of consumer-oriented advertising for celecoxib. We expect this period of rapid change to continue because of the promise of new agents in the pipeline for the treatment of rheumatic diseases, and also because the diffusion of the existing biologic agents and, to a slightly lesser extent, the coxibs, into the marketplace has caused a profound disequilibrium in the care of patients. The cost of medications for the treatment of various forms of arthritis has doubled in nominal terms and increased by 50% in real terms between 1997 and 2001.

As we write, the US is about to embark on a program of public drug coverage for Medicare recipients, at a time when record numbers of Americans are without any health insurance. The architecture of the Medicare drug program may prove a profound disappointment for persons with severe rheumatic disease. For example, an elderly person with rheumatoid arthritis with a median household income for this age group who does not have a source of drug coverage other than Medicare may have to pay as much as 20% of that income out-of-pocket if taking a biologic agent. For the working person without health insurance, the majority of the uninsured population, the cost of the biologics is either an insurmountable obstacle or a quick route to Medicaid coverage, which have far more restrictions on types of care than the private insurance sector. Although the clinical trials to establish the cost-effectiveness of the biologic agents have not yet been conducted, the form they must take is becoming clear—they must show that treatments reduce the prevalence of total joint replacement and work disability, events that occur many years after disease onset.

We mention the example of the impact of the biologic agents because their diffusion has been the most obvious catalyst for change in the care of persons with rheumatic diseases in recent years, but we could as easily draw upon a dozen other issues affecting patient welfare in the years to come. These issues include the role of genetics in the onset and progression of various rheumatic conditions; the increasing awareness of risk factors that cross-cut major chapters in the International Classification of Diseases, Ninth Revision system of classifying diseases such as the role of inflammation and/or genotype; demographic shifts that put increasing segments of the population at risk for osteoarthritis and osteoporosis; positive behavioral changes, which may reduce the prevalence and impact of specific rheumatic conditions such as the decreased incidence of smoking, and negative behavioral changes such as the increase in the frequency of obesity, which may have the opposite effect; the role of race/ethnicity and social class in access to care and disease progression; and the impact of health system characteristics such as the mix of specialties and health insurance arrangements on outcomes.

In examining the list of issues we face in rheumatology in the coming years, one can see that a wide swath of disciplines are necessary to address these issues, from molecular genetics at one end of the spectrum, to health policy analysis at the other. Increasingly, the most important issues have repercussions so complex that no single discipline can address them. For example, the development of the biologic agents undermined the rationale for the system of copayments and deductibles designed when medication costs were a tenth of what they now are, in turn raising issues of equity of access that will bedevil the minds of health services researchers and bioethicists for years to come. Similarly, the link between obesity and the onset of osteoarthritis has ramifications for those studying such diverse issues as the behavioral risk factors for obesity, access to joint replacement surgery, the importance of arthritis in institutional settings such as nursing homes, and the adequacy of long-term insurance coverage in the elderly.

Although the majority of the pages in Arthritis Care & Research will continue to be devoted to topics of the authors' choosing, we are initiating a series of special, themed issues to address some of the complex issues affecting the welfare of people with rheumatic conditions so that multi-disciplinary work on specific issues can be presented in a single forum. The submissions for these themed issues will be peer-reviewed, but in announcing the specific themes in advance we hope to coalesce research related to the themes and to show the range of expertise that can and ought be brought to bear on these subjects. We will inaugurate this series with a special issue devoted to arthritis throughout the lifespan, followed later with an issue on disparities in the rheumatic diseases.

As the complexity of the issues facing rheumatology increases, it may be necessary to rethink the present system of training and retaining clinical researchers to address those issues. During the past decade, the NIH responded to the growing recognition that there were major impediments to junior investigators gaining a toehold in clinical research in general and in the rheumatic diseases in particular. The resulting loan forgiveness program and expanded career development award programs have been a boon to the community of clinical researchers in the rheumatic diseases. However, in a paradox of success, the recipients of the loan forgiveness and career development awards will be competing among themselves and also with more senior researchers for a finite amount of money available for investigator-initiated grants. It would be tragic if, after this wise investment in training, junior investigators find that it is not possible to sustain their research careers or can do so only by withdrawing from research issues such as behavioral interventions or disparities in access for which future profits are not an immediate prospect.

The research operations of more senior investigators may be threatened as well. In the US, after a decade of increasing NIH budgets and effective partnerships between NIH, the Arthritis Foundation, and the American College of Rheumatology's Research and Education Foundation, the prospects are for much slower growth (or none) in the amount of funding from these traditional sources. We are concerned that the substantial clinical research enterprise in rheumatology may be at risk just as the issues in need of our attention are proliferating. This is especially true because the skills of clinical researchers are so easily adaptable to new disease entities when funding for research related to the rheumatic diseases grows more scarce.

In facing some of these challenges, we might profitably ask our international colleagues to provide their insight as to how to best nurture clinical research. They apparently have much insight to offer. Over the last decade, international authors have been responsible for an increasing share of the manuscripts that go through the peer review process in both journals published by the American College of Rheumatology. There are also a number of issues affecting the welfare of persons with rheumatic diseases for which an international dialogue seems appropriate, including the system of drug approval, the mechanisms to foster and/or limit the diffusion of the biologic agents, the mix of providers who treat rheumatic conditions, and the protection against loss of confidentiality as genetic assays proliferate. To encourage cross-cultural discussion of issues of importance to rheumatology, we are initiating a series in Arthritis Care & Research called “Policy Matters.” The initial articles in the series will deal with the drug approval process and post-marketing surveillance.

Rheumatic disease researchers have been in the forefront in numerous clinical research fields. These researchers were among the first to emphasize the importance of developing and validating measures of patient-reported health status measures, have played a prominent role in uncovering practice variations in the treatment of disease, and are currently playing a similar role in describing the role of race, ethnicity, and social class in access to and outcomes of care. Those of us who also conduct clinical research in other clinical entities are repeatedly reminded of the extent to which such research in the rheumatic diseases is more highly developed both in the range of disciplines brought to bear on specific questions and in the rigor of the methods used by qualitative and quantitative scientists alike. We hope to maintain the competitive edge in our research community by publishing articles on emerging methods of analysis. The initial articles in this series will describe the state-of-the-art in methods to assess the strength of association between risk factors and dichotomous outcomes in logistic regression and to assess the evidence-base for clinical treatments as they diffuse from experimental to “real world” settings.

Finally, the rapid pace of new developments in the laboratory that may have an impact on the treatment of individuals with rheumatic conditions is astounding, and has brought us some of the remarkable new treatments that have changed the long-term outlook for individuals with these conditions. But for clinicians and others not directly involved in laboratory work, it may be difficult to stay abreast of that work, particularly while it is in the developmental stage. To address that gap, we are instituting a series called “Clinical aspects of molecular research in rheumatology.” Each of these brief articles will summarize the molecular science of a critical area of research that has had or promises to have translational impact on our ability to diagnose or treat some rheumatic disorder or understand its pathogenesis.

Major strides have been made in rheumatology research over the past several decades in fields as diverse as molecular genetics to assessment of patient-reported outcomes. Rheumatology researchers have also been leaders in multi-disciplinary research, and this multi-disciplinary research has provided the impetus for changes in the care and outcomes of individuals with rheumatic diseases. Although restrictions in funding may present challenges for the future of clinical research, we have every reason to believe that the leadership role of rheumatology researchers will continue.

Progress in rheumatology has been remarkably swift. A decade ago, it would have been considered dreaming to tell patients with newly onset rheumatoid arthritis that they had good prospects to avoid severe joint destruction, or to tell those with systemic lupus erythematosus that the prognosis for survival was as excellent as it is now. We hope that in the years to come, Arthritis Care & Research can continue to provide a venue for making today's dreams tomorrow's every day practice.