Faculty Bibliography

Rheumatologists generally use few quantitative measures in making clinical decisions. In the US, fewer than 10% use questionnaires in routine clinical care, and fewer than 15% perform a formal joint count at each visit. Patient questionnaires are the quantitative tools 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. The Brooklyn Outcomes of Arthritis Registry Database was initiated with the aim of collecting quantitative data using a multi-dimensional health assessment questionnire (MDHAQ) from all rheumatology patients seen as part of routine care, each and every time the patient was seen. Data that are feasible to collect in routine 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. If there is a reason for the visit, there is a reason to complete a questionnaire

The HAQ has become the pre-eminent patient questionnaire used in rheumatology. It is easily completed by patients, but not easily reviewed and scored in standard clinical care and has some minor psychometric limitations, as do all questionnaires. Modifications of the HAQ been made to facilitate use in standard care, particularly to include 8-10 activities of daily living, along with scores for pain and global status and other information on one side of one page for rapid review by the clinician. A patient questionnaire for standard care should be limited to 2 sides of 1 page, in a format amenable to 'eyeball' review by the clinician in 5 seconds or less. It can be scored formally in 15-20 seconds or less, and is useful in patients with all rheumatic diseases. The current version of a multi-dimensional HAQ (MDHAQ) includes scoring templates on the questionnaire to allow formal scoring in less than 15 seconds by a rheumatologist or an assistant, for possible entry onto a paper and/or computerized flow sheet. Various versions of the MDHAQ may also include a 'constant' region of physical function, pain and patient global status, and 'variable' regions of fatigue, morning stiffness, psychological distress, change in status, a review of systems, a rheumatoid arthritis disease activity self-report joint count (RADAI), review of recent health events, and review of medications. The MDHAQ can be used in the infrastructure of rheumatology care to include quantitative data in standard care of all patients with all rheumatic diseases

The purpose of this report is to provide suggested guidance concerning the monitoring of TNF blocker therapy. Since the completion of randomized trials, several new long-term safety concerns have arisen, involving mycobacterial and opportunistic infections, cytopenias, lymphoma, demyelinating disease, drug-induced lupus, congestive heart failure and hepatotoxicity. Since these serious events are rare, widespread post-marketing use and prolonged follow-up have been required to analyze their prevalence. Monitoring of TNF inhibitors is necessary to reassure physicians and patients of the continued efficacy and safety of these drugs. No published recommendations on monitoring are available. The clinician must weigh the potential clinical benefits of TNF inhibition against potential adverse effects. Patients should be evaluated carefully for the risk or presence of infection, tuberculosis and other serious adverse events by regular visits, careful clinical assessments, and an assiduous, high index of suspicion for these rare events. Tuberculin skin testing using PPD is recommended before starting treatment with any TNF inhibitor.

OBJECTIVE: To identify the proportion of patients fulfilling the inclusion criteria widely used in most clinical trials for rheumatoid arthritis (RA)--including the recent clinical trials of anti-Tumor Necrosis Factor alpha (TNFalpha) agents--in a Turkish cohort. METHODS: 186 consecutive RA patients attending a routine tertiary rheumatology clinic were evaluated in 2 groups: Early RA group (group E): 31 patients with a disease duration of < or = 3 years (mean: 1.9 +/- 0.9 years); late RA group (group L): 155 patients with a disease duration of > 3 years (mean: 13.3 +/- 8.6 years). Patients were evaluated according to 2 different sets of inclusion criteria: (i) The widely used common inclusion criteria for RA clinical studies, as outlined by Sokka and Pincus; (ii) the criteria of two major anti-TNF clinical studies, ERA and ATTRACT. RESULTS: No patients in group E, and 9 (6%) patients in group L fulfilled the common criteria used in clinical studies for RA. In group E, 28 patients had already been started on methotrexate; 2 patients were on sulphasalazine and one patient was on leflunomide. Nevertheless, even if the criterion for previous use of methotrexate was not applied patients did not fulfill the rest of the criteria of ERA study. In group L, 9 out of 155 patients (6%) met the criteria for the ATTRACT study. CONCLUSION: Only few patients met the widely used inclusion criteria for most RA clinical trials and the recent clinical trials of TNFalpha agents in this Turkish cohort. This may be explained by the milder disease activity in this geographical region, which further emphasizes the need to consider development of new criteria for inclusion in clinical trials.