Trials in rheumatoid arthritis: choosing the right outcome measure when minimal disease is achievable

Clinical Epidemiology Unit, Boston University School of Medicine, 650 Albany Street, Boston, MA 02118, USA.
Annals of the rheumatic diseases (Impact Factor: 10.38). 06/2008; 67(5):580-3. DOI: 10.1136/ard.2007.079632
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Available from: Bin Zhang, May 04, 2015
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    ABSTRACT: To examine the role of anti-tumor necrosis factor (anti-TNF) agents in predicting work disability in subjects with rheumatoid arthritis (RA). We studied 953 subjects with rheumatologist-diagnosed RA from a US cohort using a nested, matched, case-control approach. Subjects provided data on medication usage and employment every 6 months for 18 months, were employed at baseline, and were age <65 years at last followup. Cases were subjects who were not employed at followup (n = 231) and were matched approximately 3:1 by time of entry into the cohort to 722 controls who were employed at followup. Risk of any employment loss, or loss attributed to RA, at followup as predicted by use of an anti-TNF agent at baseline was computed using conditional logistic regression. Stratification on possible confounding factors and recursive partitioning analyses were also conducted. Subjects' mean age was 51 years, 82% were female, 92% were white, and 72% had more than a high school education. Nearly half (48%) used an anti-TNF agent at baseline; characteristics of anti-TNF agent users were similar to nonusers. In the main analyses, anti-TNF use did not protect against any or RA-attributed employment loss (odds ratio [95% confidence interval] 1.1 [0.7-1.6] versus 0.9 [0.5-1.5]). However, a protective effect was found for users with disease duration <11 years (odds ratio [95% confidence interval] 0.5 [0.2-0.9]). In recursive partitioning analyses, age, RA global severity, and functional limitation played a much greater role in determining employment loss than anti-TNF agent use. Anti-TNF agent use did not protect against work disability in the main analyses. In stratified analyses, their use was protective among subjects with shorter RA duration, whereas in nonparametric analyses, age and disease factors were the prominent predictors of work disability.
    Arthritis & Rheumatology 08/2008; 59(8):1082-9. DOI:10.1002/art.23923 · 7.76 Impact Factor
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    ABSTRACT: The present longitudinal study of 143 older adults (73-98 years) with serious health problems (arthritis, heart disease, heart attack, stroke) examined the effects of goal engagement, disengagement, and self-protection control strategies on self-rated physical health (condition severity, functional status) and subjective well-being (life satisfaction) at 5 years and survival at 9 years. Main effects and interactions between strategy use and the occurrence of an acute vascular event (no, yes) as well as age (young-old vs. old-old) were assessed. As hypothesized, goal engagement predicted greater survival for individuals with acute conditions but poorer physical health for those with chronic conditions and among old-old adults. In contrast, goal disengagement predicted poorer physical health for those with acute conditions but better health for individuals with chronic conditions and old-old adults. Self-protective strategies (positive reappraisal) predicted greater survival, health, and subjective well-being for those with acute conditions, as well as better physical health for old-old adults.
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