Proposed core set of outcome measures in patients with primary Sjögren's syndrome: 5 year follow up.
Author
Summary, in English
Objective. To clarify the spontaneous course of important disease manifestations (a core set of outcome measures) over a period of 5 years in patients with primary Sjögren's syndrome (SS), and to analyze predictors of unfavorable outcome. To test the usefulness of the recently proposed core set of outcome measures.
Methods. A cohort of patients with primary SS according to the American-European consensus criteria (AECC) (n = 58) was followed over a period of 5 years. Measures for subjective and objective disease characteristics, IgG concentrations and health related quality of life were analyzed on 2 occasions and compared.
Results. During followup, symptoms of dry eyes, dry mouth, fatigue, and health related quality of life were stable. Regarding objective signs, there was a modest but statistically significant worsening of the van Bijsterveld score. Seropositivity for anti-SSA and low complement levels predicted further decline in the van Bijsterveld score. Floor/ceiling effects in the outcome measures in the core set complicate documentation of further decline, but may allow monitoring of improvement in established primary SS.
Conclusion. Primary SS, if classified according to the strict AECC criteria, is a bothersome and slowly progressive disease, with fatigue and discomfort developing early. The proposed outcome measures may be suitable for assessing improvement in randomized controlled trials.
Methods. A cohort of patients with primary SS according to the American-European consensus criteria (AECC) (n = 58) was followed over a period of 5 years. Measures for subjective and objective disease characteristics, IgG concentrations and health related quality of life were analyzed on 2 occasions and compared.
Results. During followup, symptoms of dry eyes, dry mouth, fatigue, and health related quality of life were stable. Regarding objective signs, there was a modest but statistically significant worsening of the van Bijsterveld score. Seropositivity for anti-SSA and low complement levels predicted further decline in the van Bijsterveld score. Floor/ceiling effects in the outcome measures in the core set complicate documentation of further decline, but may allow monitoring of improvement in established primary SS.
Conclusion. Primary SS, if classified according to the strict AECC criteria, is a bothersome and slowly progressive disease, with fatigue and discomfort developing early. The proposed outcome measures may be suitable for assessing improvement in randomized controlled trials.
Department/s
Publishing year
2005
Language
English
Pages
1495-1502
Publication/Series
Journal of Rheumatology
Volume
32
Issue
8
Links
Document type
Journal article
Publisher
Journal of Rheumatology Publishing Company Limited
Topic
- Rheumatology and Autoimmunity
Status
Published
Research group
- Internal Medicine - Epidemiology
ISBN/ISSN/Other
- ISSN: 0315-162X