Faculty Bibliography

Patient assessment in rheumatology is characterized by an important paradox: many extensively-characterized quantitative measures and indices have been developed for rheumatoid arthritis (RA), psoriatic arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, vasculitis, osteoarthritis, fibromyalgia, and other rheumatic diseases. However, most regular rheumatology care is guided largely by qualitative clinical impressions, without such measures or indices or any quantitative data other than laboratory tests to assess patient status and/or quality of care. This paradox may be explained in part by regarding the development of measures primarily as clinical research activities, while viewing the application of measurements in regular clinical care as continuous quality improvement (CQI) activities. The development of measures has emphasized validity and reliability, but generally ignored feasibility and acceptability to patients and health professionals, both of which are needed for application in regular clinical care. A summary of the application of clinical measurement in patients with RA over 25 years between 1982 and 2007 at a weekly academic rheumatology clinic conducted by the senior author is presented as 20 often contemporaneous CQI cycles. These cycles include development of a user-friendly modified health assessment questionnaire (MHAQ); assessment of psychological status; monitoring of mortality outcomes; comparisons of joint counts, radiographic scores, and laboratory tests to the MHAQ; a 28-joint count; prospective study of the MHAQ to predict mortality when joint counts, radiographic scores, and laboratory tests are available; development of a multidimensional HAQ (MDHAQ) with complex activities; a fatigue scale; a self-report joint count; scoring templates; a computerized data management system; flow sheets to monitor MDHAQ status; visual analog scales as 21 circles rather than 10 cm lines; composite RAPID3 (rheumatology assessment patient index data) scores for 3 patient measures; and defining RAPID categories for high, moderate and low severity, and near remission. The latter cycles remain under study as ongoing CQI activities

Objectives: We analyzed rheumatoid arthritis (RA) patients seen in a cohort from Brooklyn, NY over the last three years to determine what percentage of patients would fulfill common inclusion criteria for RA clinical trials at any time during their care. Patients and Methods: One hundred and twenty-three consecutive patients with RA, seen between April 2001 and December 2003 by a single rheumatologist, were included. Patients were analyzed according to whether they met four common inclusion criteria in most recent RA trials, and according to the inclusion criteria for the recent anti-tumor necrosis factor alpha (anti-TNF alpha) trial involving etanercept and methotrexate in early RA (ERA trial) and the STAR (Safety Trial of Adalimumab in Rheumatoid arthritis) trial. All visits were analyzed to identify any visit where patients fulfilled the inclusion criteria. Results: When the most common inclusion criteria for RA clinical trials were applied, 3/146 (2.1%) visits and two of 72 (2.8%) patients fulfilled these criteria. The inclusion criteria for the ERA and STAR trials were met in 4/123 (3.3%) and 17/123 (13.8%) patients, respectively. Conclusion: A large majority of RA patients seen in this cohort would not have qualified for the most common RA clinical trials and the recent anti-TNFa. trials. It is timely to consider new inclusion criteria for RA clinical trials to reflect the current characteristics of most RA patients. This would increase the applicability of the results of these important and usually very expensive studies and therapies

At the present time, clinical decisions in routine rheumatology practice generally are based on qualitative impressions, rather than on quantitative data, which might lead to improved information for clinical decisions. Patient questionnaires are the quantitative tools whereby rheumatologists have to monitor their patients' health status and response to therapy. 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; they are as good as and usually better predictors than joint counts, radiographs, and laboratory tests. Yet, patient questionnaires, which can be used in all rheumatic diseases including osteoarthritis, systemic lupus erythematosus, fibromyalgia, sclerodenna, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Data that are feasible to collect in clinical care provide the only way to assess quantitatively how our patients are doing. If data are not collected and recorded, an opportunity is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care

No single measure can serve as a 'gold standard' for the diagnosis, prognosis, and monitoring of patients with rheumatic diseases. Therefore, pooled indices of several measures have been developed for patient assessment. Quantitative measures and indices in rheumatology have been used primarily in clinical trials and other clinical research, but not in standard clinical care. Indeed, most standard rheumatology care is conducted without quantitative data other than laboratory tests, which often are uninformative. Some measures used in research have been adapted for standard care. The classical 66/68-joint count with graded scoring for swelling, tenderness, pain on motion, limited motion, and deformity has been shortened for clinical care to a 28-joint count, scored only as 'Yes' or 'No' for swelling or tenderness. Patient questionnaires designed for clinical research can be lengthy, with complex scoring, so that information is not available to help guide clinical decisions. By contrast, patient questionnaires designed for standard care, such as a simple one-page, multi-dimensional health assessment questionnaire (MDHAQ), are short, save time, are easily scored, and are useful in all rheumatic diseases to monitor patient status at each visit and document changes over long periods. More attention to measures for use in standard care could improve care and outcomes for patients with rheumatic diseases

The American College of Rheumatology Core Data Set for rheumatoid arthritis (RA) includes 3 measures which are found on a patient self-report questionnaire, physical function, pain, and patient estimate of global status. These measures are included in all clinical trials, but not assessed at most encounters in standard rheumatology care. Rheumatologists may have experience with lengthy research questionnaires in clinical trials and other clinical research, which (appropriately) are regarded as relatively cumbersome research tools and do not contribute to clinical care. A format of a questionnaire known as the multidimensional health assessment questionnaire (MDHAQ) has been developed for standard rheumatology care to contribute to rheumatology clinical care in daily practice. The 3 scores for physical function, pain, and global status can be 'eyeballed' in a second or two and formally scored into a composite index known as rheumatology assessment patient index data (RAPID) in about 10 seconds. This chapter provides a brief tutorial designed to instruct rheumatologists and their staffs regarding how to use and score the MDHAQ and RAPID in standard clinical care

Patient questionnaires are the quantitative tools available to rheumatologists to monitor their patients' health status and responses 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; generally at higher levels of significance than joint counts, radiographs, and laboratory tests. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Yet patient questionnaires, which can be used in all rheumatic diseases, including osteoarthritis, systemic lupus erythematosus, fibromyalgia, scleroderma, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Questionnaires can be adapted to include a simple subjective-objective-assessment-plan (SOAP) clinical encounter note that helps with data entry and also provides all the necessary information for clinical decision making in one sheet of paper. Data that are feasible to collect in clinical care provide the optimal approach to assessing quantitatively how patients are doing. If data are not collected and recorded, that opportunity, on that day, is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care

A continuous quality improvement approach is proposed for the assessment and management of patients with rheumatoid arthritis (RA) based on scores on a one-page patient self-report multidimensional health assessment questionnaire (MDHAQ), without formal joint counts. The approach includes five simple steps before the patient is seen by the physician: (1) an MDHAQ is completed by every patient at every visit; (2) scores are calculated for patient function, pain, and global estimate, with options for a self-report joint count and other scales; (3) scores are entered on flow sheets with data from prior visits, which might also include laboratory and medication information; (4) scores are compiled into an index termed Routine Assessment of Patient Index Data (RAPID), analogous to a Disease Activity Score (DAS); (5) RAPID scores are classified to guide treatment decisions. RAPID 3 includes the three patient-reported outcome (PRO) measures in the RA Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count, and RAPID 5, a physician global estimate. RAPID 3 can be calculated in about 10 seconds, RAPID 4 in about 19 seconds, and RAPID 5 in about 20 seconds. RAPID 3, RAPID 4, and RAPID 5 give similar results to distinguish active from control treatments in RA clinical trials, at levels similar to American College of Rheumatology or DAS improvement criteria, and are all correlated significantly with DAS28 (rho=0.62-0.64, P<0.001). A proposed classification of RAPID scores, analogous to four DAS28 categories, includes: 'near remission' (0-1), 'low severity' (1.01-2), 'moderate severity' (2.01-4), and 'high severity' (>4). RAPID scoring is feasible in standard clinical care to support continuous quality improvement