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The patient history often provides the most important information in diagnosis and management of rheumatoid arthritis (RA) and other rheumatic diseases. A multidimensional health assessment questionnaire (MDHAQ)--with templates to score RAPID3 (routine assessment the patient index data), an index of three patient self-report measures, physical function, pain, and patient global estimate--provides a "scientific" patient history. MDHAQ/RAPID3 scores meet criteria for the scientific method seen for laboratory tests: standard format, quantitative data, protocol for collection, and recognition of prognostic implications of levels for management decisions. Extensive evidence supports a scientific rationale for MDHAQ/RAPID3 scores, which are as efficient as joint counts, laboratory tests, DAS28, and CDAI to distinguish active from control treatments in clinical trials and correlated significantly with DAS28 and CDAI scores in clinical trials and usual clinical care, including categories for high, moderate, low severity, and remission. Pragmatic advantages of MDHAQ/RAPID3 include that the patient does almost all the work and prepares for the encounter to focus on concerns to discuss with the doctor. MDHAQ/RAPID3 improves doctor-patient communication and saves time for the doctor with a 10 to 15 second overview of medical history data that otherwise would require 10 to 15 minutes of conversation. RAPID3 is scored in 5 seconds, compared to almost 2 minutes for a CDAI or DAS28, and can be used effectively for treat-to-target in RA. MDHAQ/ RAPID3 is informative in all rheumatic diseases, including systemic lupus erythematosus, osteoarthritis, ankylosing spondylitis, psoriatic arthritis, fibromyalgia, gout, and others. All rheumatologists may include MDHAQ/RAPID3 in all patients in the infrastructure of clinical care. [ABSTRACT FROM AUTHOR]

Kinase inhibitors have now been shown to work in various types of patients and have potential to be additional weapons in our armamentarium in rheumatoid arthritis treatment. This review will go over the currently available data and discuss potential uses for these new agents. [ABSTRACT FROM AUTHOR]

The management of rheumatoid arthritis (RA) depends more on the patient history than most other chronic diseases. A patient questionnaire provides a uniform, quantitative, protocolized, "scientific " patient history, with documented prognostic significance for work disability and mortality in RA greater than radiographs and laboratory tests and capacity to distinguish active from control treatment in clinical trials and to monitor clinical care with equivalent or greater significance than joint counts or laboratory tests. Therefore, a "scientific" approach to care of a person with a rheumatic disease involves review of patient function, pain, global status, fatigue, RAPID3, review of systems, self-report joint count, and recent medical history on an MDHAQ before conversation with the patient. This practice may be viewed as analogous to a doctor reviewing blood pressure, hemoglobin Ale, viral load, or radiograph before meeting with a patient who has hypertension, diabetes, HIV, or a healing fracture to provide a roadmap or agenda for the visit. Some sites have implemented RAPID3 without the remainder of MDHAQ, a practice that is discouraged. The MDHAQ requires only 5 to 10 minutes of the patient's time and involves a single sheet of paper, which is needed for a simple RAPID3, or even a patient global estimate of status to score a DAS28 or CDAI. Completion of MDHAQ/RAPID3 by each patient at each visit in the infrastructure of care with review by the doctor helps prepare the patient for the visit, improves doctor-patient communication, saves time for the doctor, and provides a roadmap or agenda for the visit. [ABSTRACT FROM AUTHOR]

Three major advances over the last decade have impacted the way we treat rheumatoid arthritis; early and aggressive treatment, use of disease activity measures leading to treat to target, and availability of biologic agents. No oral biologic agents are available at this time but promising data is emerging for two drugs, tofacitinib and fostamatinib, inhibitors of JAK and Syk kinases, respectively. This paper will review some of the relevant published data for these agents and discuss where they may be placed in our treatment options for RA. [ABSTRACT FROM AUTHOR]

A guide to RAPID3 (routine assessment of patient index data), all index of three patient self report measures--physical function, pain and patient global estimate of stands--on a multidimensional health assessment questionnaire (MDAQ) is presented, including development, scoring, use in standard care, and rationale. RAPID3 and its individual components are regarded as "vital signs," which may alert a health professional to unsuspected patient problems, provide a baseline measure to support a change in therapy, and numerically document improvement or worsening over time to complement clinical impressions. MDHAQ-RAPID3 can be incorporated into the infrastructure of standard rheumatology care for completion in the waiting room by every patient with any rheumatic disease at every visit: if there is a reason for a visit, there is a reason for RAPID3 vital signs. RAPID3 is calculated in 5 to 10 seconds, providing similar information to DAS28 (disease activity score) and CDAI (clinical disease activity index), which require a mean of 114 and 106 seconds, respectively. MDHAQ-RAPID3 presents an additional advantage for the patient to optimize the office encounter by completion of the questionnaire in the waiting room. The MDHAQ also includes a review of systems and recent medical history, which can save 2 to 3 minutes per visit for other patient concerns. A physician's clinical decisions ultimately require synthesis and interpretation of all available data, ranging from laboratory tests to patient questionnaire scores. RAPID3 vital signs can contribute to this synthesis toward improved quality outcomes, and documentation of rheumatology care. [ABSTRACT FROM AUTHOR]

Background: Treatment of rheumatoid arthritis (RA) has shifted toward earlier and more aggressive therapy with traditional disease-modifying antirheumatic drugs (DMARDs) and biologics. However, the extent to which these agents are used in current clinical practice in the United States (U.S.) has not been systematically evaluated. Materials and Methods: This analysis of a large claims database assessed patterns of use of biologics within clinical practice in a broad U.S. population with RA. We identified two cohorts of adults with RA using Thomson Healthcare MarketScan® Research databases. Patients newly diagnosed with RA between 1999 and 2004 with 12 months or more of continuous enrollment prior to diagnosis and with 24 months or more post-diagnosis were included in one cohort. The second cohort included RA patients who appeared to be newly treated with biologic therapy and had continuous enrollment for 12 months or more prior to first use of a biologic agent and 18 months or more following initial treatment. A total of 16, 752 patients, newly diagnosed with RA, and 8218, new to biologics therapy, were included. Results: Utilization of biologics increased from 3% of patients in 1999 to 26% in 2006. Patients initiated biologics both as monotherapy (30%) and in combination with methotrexate (36%). Regimen modifications were frequent, with a large percentage of patients requiring addition or subtraction of methotrexate. Conclusions: The use of biologics to treat RA is increasing, either as monotherapy or in combination with another DMARD. Modifications to drug regimens are frequent and episodes are often of comparatively short duration. [ABSTRACT FROM AUTHOR]

Rheumatoid arthritis (RA ) treatment has witnessed major advances over the last 10 to 20 years. Methotrexate has emerged as the cornerstone of treatment with new biologic agents being used in addition in severe and resistant patients. New drugs being developed with novel modes of action are promising to expand treatment options and help provide better disease control for RA patients. In addition to medications, equally important is aggresive disease activity monitoring using one of the composite scores available in order to match treatments to disease activity. Disease activity score (DAS), DAS28 (with a 28 joint count), clinical disease activity, index (CDAI), simplified disease activity index (SDAI), and routine assessment of patient index data (RAPID) are valuable tools and should be used in routine care to achieve disease control. [ABSTRACT FROM AUTHOR]

Patient questionnaires are valuable quantitative tools used by rheumatologists to monitor a patient's health status and response to therapy. The health assessment questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality and, generally, at higher levels of significance than joint counts, radiographs, and laboratory tests. Yet, patient questionnaires, which can be used in all rheumatic diseases, are not included in routine care by most rheumatologists. Data that are feasible to collect during clinical care provide the optimal approach to quantitatively assess how patients are doing. [ABSTRACT FROM AUTHOR]

Though quantitative data might lead to improved information for clinical decisions, at the present time decisions in routine rheumatology practice generally are based largely on qualitative impressions, rather than on data. Patient questionnaires are readily accessible tools that the rheumatologist can use to go beyond impressions and to institute evidence-based guidelines appropriate to his or her own patient population and practice style. The Health Assessment Questionnaire (HAQ) and its derivatives have been shown to be the best predictors of functional and work disability, costs, joint replacement surgery, and mortality. Such questionnaires are at least as good as joint counts, radiographs, and laboratory tests in predicting these outcomes. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Based on experience with the Brooklyn Outcomes of Arthritis Registry Database, the author advocates distributing a waiting-room questionnaire to every patient who comes for an office visit. Potential benefits of recording questionnaire-based information include identifying trends or important changes in a patient's pain or physical function, providing a baseline for success with various treatment strategies for conditions of the rheumatologist's own practice, allowing patients an opportunity to express concerns, encouraging patients to disclose information they may feel is too minor to mention, and providing control data for research studies. A short questionnaire designed specifically for clinical, rather than research, use does not create a burden for office staff Consistent use of patient questionnaires and systematic storage of the information gained can help document, track, and improve patient care in routine rheumatology practice. [ABSTRACT FROM AUTHOR]

The current approach to treatment of RA includes early and aggressive treatment with routine monitoring of outcomes to give patients the best chance of decreasing disease activity as much as possible, with low disease activity and remission being a realistic goal for many patients. In this quest, DMARDs, especially MTX, are the anchor treatment, and low dose prednisone should also be considered in combination with MTX as the best initial choice for RA treatment. Current data suggest that corticosteroids are disease modifying agents that enhance the effects of DMARDs with no real impact on adverse events. We are much better positioned now then in earlier times to provide a good outcome for our patients, and every available tool needs to be considered and utilized for this purpose. [ABSTRACT FROM AUTHOR]

Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of ah informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives. [ABSTRACT FROM AUTHOR]

Necrotizing vasculitis continues to be a condition where difficult diagnostic and treatment decisions need to be made, with only a few well-done studies as clinical reference and support. New data suggest that both methotrexate and azathioprine may be effective agents for maintaining remission in antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis after remission is achieved with cyclophosphamide-based therapies. In addition, Behcet's syndrome appears to be more common than previously assumed and is likely more common than a combination of ANCA-associated vasculitis (AAV) syndromes. [ABSTRACT FROM AUTHOR]

Vasculitic syndromes are among the most complicated diseases for primary care physicians and rheumatologists to diagnose and treat. There are a myriad of symptoms that can be mimicked by other conditions, and choice of medications can be complex. Some agents are toxic and determining which to prescribe and for how long can be a multifaceted, complex decision process. Developing new treatments and new ways of using already available therapies, while minimizing potential side effects, are of paramount importance. This review will focus on recently published data that could have an impact on the way we treat systemic vasculitis patients. [ABSTRACT FROM AUTHOR]

Reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking and with limited application in the real world, as RCTs are of short duration, include small numbers of patients, and are selective for subjects lacking in comorbid conditions. It is not surprising that new and unexpected safety concerns emerge with any new drug after it has been launched and used by many more patients. Part of the problem is inherent to the way safety data are reported in RCTs. This article focuses on some of the shortcomings of AE reporting in RCTs, especially those involving tumor necrosis factor (TNF) inhibitors. Discussion focuses on reporting of "time-to-event" issues, use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient-years" when reporting AEs, and the problem of adequate sample size and power calculations that are lacking in safety outcome data trials. [ABSTRACT FROM AUTHOR]

Vasculitic syndromes are among the most complicated diseases to treat and manage. New medications and new ways of using old medications have provided us with new therapies to treat our patients. This review focuses on recent date that may have an impact on the way vasculitis is treated. [ABSTRACT FROM AUTHOR]

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs. [ABSTRACT FROM AUTHOR]

The article presents some details on the clinical research methodology course "Databases and Registries in Rheumatology: Complementing Randomized Clinical" Trials held on December 15, 2006 at New York University (NYU) Hospital for Joint Diseases. It states that aside from the articles, lectures as podcasts are also available. Speakers' slides can also be viewed on its web site.

This article presents a letter which contains the changes in the contents of a bulletin about orthopedics. Starting with the October 2006 issue of the bulletin, it will include clinical and topical issues in rheumatology. The publication will undergo some changes due to the need for a clinical rheumatology journal that used several technological advances. The first rheumatology issue features some presentations at the 2006 Seminar in Advanced Rheumatology.

A multidimensional health assessment questionnaire (MDHAQ) can enhance doctor-patient communication beyond the important function of providing RAPID3 scores, preparing the patient for the encounter and saving time for the doctor. Optimal use of the MDHAQ should include the following actions: 1. the MDHAQ should be distributed to each patient at each visit in the infrastructure of care; 2. the MDHAQ helps the patient prepare for the visit by completing it in the waiting area prior to seeing the physician; 3. the clinician prepares for the visit and saves time by reviewing the MDHAQ before seeing the patient; 4. the clinician scans the review of systems and records the number of positives on the symptom checklist; 5. the clinician reviews the recent medical history information to save time and improve accuracy and completeness of critical information; and 6. routine Assessment of Patient Index Data 3 (RAPID3) scores are recorded in the medical record and entered into a flowsheet, which also includes other MDHAQ scores, laboratory tests, and medications.

Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of an informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives.

Necrotizing vasculitis continues to be a condition where difficult diagnostic and treatment decisions need to be made, with only a few well-done studies as clinical reference and support. New data suggest that both methotrexate and azathioprine may be effective agents for maintaining remission in antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis after remission is achieved with cyclophosphamide-based therapies. In addition, Behcet's syndrome appears to be more common than previously assumed and is likely more common than a combination of ANCA-associated vasculitis (AAV) syndromes.

Rheumatoid arthritis (RA) treatment has witnessed major advances over the last 10 to 20 years. Methotrexate has emerged as the cornerstone of treatment with new biologic agents being used in addition in severe and resistant patients. New drugs being developed with novel modes of action are promising to expand treatment options and help provide better disease control for RA patients. In addition to medications, equally important is aggressive disease activity monitoring using one of the composite scores available in order to match treatments to disease activity. Disease activity score (DAS), DAS28 (with a 28 joint count), clinical disease activity index (CDAI), simplified disease activity index (SDAI), and routine assessment of patient index data (RAPID) are valuable tools and should be used in routine care to achieve disease control.

Tocilizumab, humanized monoclonal antibody to sIL-6R, is a promising new agent for the treatment of rheumatoid arthritis. Safety data from randomized controlled trials (RCT) to date have been overall reassuring with no evidence of increased opportunistic infections or malignancies, and some signals for elevated liver function tests and changed lipid profiles. The true implications of these signals in RCTs must be addressed in larger numbers of RA patients with longer term exposure before firm conclusions are reached.

Rheumatoid arthritis treatment is a fast changing and advancing area. Current drugs are now better utilized and new medications continue to be developed. The main challenge is to identify which patients are responding to treatment and to objectively quantify their response or nonresponse. There is a need for more rheumatologists to pursue use of an objective assessment tool in routine clinical care. Therefore, knowledge of the various tools available to rheumatologists in clinical trials and routine care and their practical differences is important to progress in patient evaluation and management. The tool that is easiest for both the patient and the physician to use and that still provides important treatment response and prognostic information has the best chance to be consistently and successfully applied by busy clinicians.