title: Proposed core set of outcome measures in patients with primary Sjögren's syndrome: 5 year follow up.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Rheumatology, Malmö University Hospital, Sweden. elke.theander@medforsk.mas.lu.se
authors.forename: Elke
authors.initials: E
authors.lastname: Theander
authors.forename: Sven Ingmar
authors.initials: SI
authors.lastname: Andersson
authors.forename: Rolf
authors.initials: R
authors.lastname: Manthorpe
authors.forename: Lennart T H
authors.initials: LT
authors.lastname: Jacobsson
mesh_terms: D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use; D001323:Autoantibodies / Q000097:blood; D015897:Comorbidity; D004232:Diuretics / Q000627:therapeutic use; D015352:Dry Eye Syndromes / Q000453:epidemiology; D005221:Fatigue / Q000453:epidemiology; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008137:Longitudinal Studies; D008875:Middle Aged; D011237:Predictive Value of Tests; D011788:Quality of Life; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D016896:Treatment Outcome; D014987:Xerostomia / Q000453:epidemiology
chemical_list: D000319:Adrenergic beta-Antagonists; D000928:Antidepressive Agents; D001323:Autoantibodies; D004232:Diuretics; D007074:Immunoglobulin G