Faculty Bibliography

OBJECTIVE: To analyze visual analog scales (VAS) for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ) in formats other than a traditional 10 cm horizontal line, designed to facilitate scoring on MDHAQ in usual clinical care. METHODS: The MDHAQ with VAS for pain and global estimate was completed by each patient at each visit. VAS formats other than a traditional (unnumbered) 10 cm horizontal line based on 21 circles at 0.5 intervals were analyzed. Formats included unnumbered, symbol at the 11th circle, numbers and/or squares (instead of circles) at selected intermittent scores, and numbers at each circle. Analyses were performed to study the time to score MDHAQ with different VAS formats, possible 'clustering' of responses in any format, particularly with intermittent numbers and/or symbols, and test-retest reliability of various formats. RESULTS: The median time to score MDHAQ with a 10 cm line VAS was 15.6 seconds, compared to 7.4 seconds for the 21 numbered circle VAS. No other format was scored in fewer seconds. Clustering was seen for scores of VAS formats with intermittent numbers or symbols, which rendered them unsuitable for use. No clustering was seen for the 21 numbered circle VAS format, for which test-retest agreement was significant, and similar to the 10 cm line VAS format. CONCLUSION: A 21 numbered circle VAS may be a desirable alternative to a 10 cm horizontal line, yielding similar results and requiring less than half the time to score

OBJECTIVE:To determine the patterns and correlation of elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels with outcome measures in rheumatoid arthritis (RA), and compare it to systemic lupus erythematosus (SLE) and osteoarthritis (OA) patients.METHODS:Brooklyn Outcomes Arthritis Registry Database (BOARD) was analyzed to determine both first visit and mean values of ESR and CRP, along with disease activity measures in each patient. Data were analyzed with descriptive statistics and correlations.RESULTS:Among all patients half of all (n=377) ESR results were elevated. In RA patients the proportions of having both ESR and CRP elevated, both within normal levels, and only one elevated and the other normal were similar. For all diagnosis, both ESR and CRP have weak positive correlations with disease activity measures measured at first visits. ESR and CRP have a modest positive correlation with each other across all three disease groups.CONCLUSION:In this cohort of RA, SLE and OA patients, ESR and CRP values were modestly correlated with each other and they were weakly correlated with disease activity measures. These data suggest that another look at the role of ESR and CRP as markers of inflammation in RA patients seen in routine care may be in order

OBJECTIVES: Many randomized clinical trials (RCTs) are labelled efficacy and safety while due consideration for power is provided only for efficacy outcomes. This in turn necessitates a discussion of the inadequacy of sample size (type II error) for identifying harm. This is particularly important in RCTs of TNF inhibitors as harm related to these agents is still a matter of debate. METHODS: PubMed was searched for all RCTs published examining TNF inhibitors in RA, PsA and AS. Only original study reports were surveyed for whether: (i) they were labelled as efficacy, safety or both; (ii) the methods sections included safety as a primary or secondary end point; (iii) power calculations were adequately explained; (iv) statistical tests of significance were given for harm; and finally (v) any discussion of type II error for harm was present. RESULTS: Of the 34 articles surveyed, 24 (71%) were labelled as efficacy and safety. Among these, 23 (96%) did not include safety as a formal primary or secondary end point. In only 2/24 (8%) power calculations were given for safety. Finally, in only 3/22 (14%) any discussion about the inadequate sample size (type II error) for detecting harm could be found. CONCLUSIONS: Most reports of RCTs of TNF inhibitors in rheumatological diseases are inappropriately labelled as addressing efficacy and safety. Their lack of power in detecting harm is not adequately discussed, either.

OBJECTIVE: Current tools for assessing Behcet's syndrome (BS) do not include patient-reported outcomes such as functional disability, pain or fatigue. We examined various outcome measures using the multi-dimensional Health Assessment Questionnaire (MDHAQ) and compared them between BS patients with and without arthritis. We also compared the results to those for patients with rheumatoid arthritis (RA), the disease in relation to which the MDHAQ has been most thoroughly studied. METHODS: We conducted a comparative review of BS and early RA patients being followed at the New York University Hospital for Joint Diseases (NYU HJD) and the Behcet's Syndrome Center. All patients completed an MDHAQ at each visit, which included functional disability, pain, morning stiffness, fatigue, and patient and physician global assessments of disease activity. A chart review for BS manifestations and treatments was also carried out. All patient evaluations reported here represent the baseline values at first visit. RESULTS: 129 patients with BS and 116 with early RA were surveyed. BS patients had similar pain levels and physician global assessment of disease activity to the RA patients and higher functional disability, fatigue and patient assessments of global disease activity. Among BS patients, those with arthritis had significantly higher scores for all the outcome measures examined except the physician global assessment of disease activity. CONCLUSION: Using the MDHAQ could reveal previously under-recognized problems in BS, as was observed in this survey of BS patients with arthritis. Such information might be helpful in the management of patients with BS