Validation of the parent global assessment as a health-related quality of life measure in juvenile idiopathic arthritis: results from ReACCh-Out.

OBJECTIVES: To (i) validate the JIA parent global assessment (parent global) as a health-related quality of life (HRQoL) instrument; (ii) evaluate measurement properties of accepted HRQoL measures relative to those of the parent global; and (iii) assess causal pathways determining parent global scores. METHODS: Data from the Research in Arthritis in Canadian Children emphasizing outcomes (ReACCh-Out) cohort were used. Measurement properties were assessed in 344 patients at enrolment and 6 months later. Causal pathways were tested by structural equation modelling to understand root causes and mediators leading to parent global scores. RESULTS: Construct validity was supported by Spearman correlations of 0.53-0.70 for the parent global with the Juvenile Arthritis Quality of Life Questionnaire, Quality of My Life health scale (HRQoML), Pediatric Quality of Life Inventory (PedsQL)-Parent, and Child Health Questionnaire (CHQ)-Physical. Exceptions were PedsQL-Child (0.44) and CHQ-Psychosocial (0.31). Correlations were lower (0.14-0.49) with disease activity measures (physician global assessment of disease activity, active joint count, ESR). Responsiveness of the parent global to improvement according to parent ratings (0.51) was acceptable and within the range (0.32-0.71) of that of other measures. Reliability estimates and measurement errors for all measures were unsatisfactory, likely due to the prolonged time between assessments. Causal pathways for the parent global matched those previously reported for HRQoML. CONCLUSIONS: Our results offer support for the parent global as a valid measure of HRQoL for JIA. If confirmed, existing studies using the parent global may be re-interpreted, enhancing our knowledge of HRQoL in children with JIA.

Assessment of musculoskeletal toxicity 5 years after therapy with levofloxacin.

BACKGROUND: Safety concerns for fluoroquinolones exist from animal studies demonstrating cartilage injury in weight-bearing joints, dependent on dose and duration of therapy. For children treated with levofloxacin or comparator in randomized, prospective, comparative studies for acute otitis media and community-acquired pneumonia, this 5-year follow-up safety study was designed to assess the presence/absence of cartilage injury. METHODS: Children enrolled in treatment studies were also enrolled in a 1-year follow-up safety study, which; focused on musculoskeletal adverse events (MSAE). Those with persisting MSAEs, protocol-defined musculoskeletal disorders, or of concern to the Data Safety and Monitoring Committee were requested to enroll in four additional years of follow-up, the subject of this report. RESULTS: Of the 2233 subjects participating in the 12-month follow-up study, 124 of 1340 (9%) of the levofloxacin subjects, and 83 of 893 (9%) of the comparator subjects were continued for 5-year posttreatment assessment. From children identified with an MSAE during years 2 through 5 posttreatment, the number that were "possibly related" to drug therapy was equal for both arms: 1 of 1340 for levofloxacin and 1 of 893 for comparator. Of all cases of MSAE assessed by the Data Safety and Monitoring Committee at 5 years' posttreatment, no case was assessed as "likely related" to study drug. CONCLUSIONS: With no clinically detectable difference between levofloxacin- and comparator-treated children in MSAEs presenting between 1 and 5 years in these safety studies, risks of cartilage injury with levofloxacin appear to be uncommon, are clinically undetectable during 5 years, or are reversible.

Consultation with an arthritis specialist for children with suspected juvenile rheumatoid arthritis: a population-based study.

OBJECTIVES: To describe consultation with an arthritis specialist because of suspected new-onset juvenile rheumatoid arthritis (JRA) and to determine factors associated with prompt consultation. DESIGN: Retrospective cohort study. SETTING: Physician reimbursement administrative data were obtained for all children aged 16 years or younger in the Province of Québec (Canada). PARTICIPANTS: Suspected new-onset cases of JRA in 2000 were defined by a physician visit because of JRA, providing there had been no such claims in the preceding 3 years. MAIN EXPOSURE: First JRA diagnosis made by a non-arthritis specialist. MAIN OUTCOME MEASURES: First consultation with an arthritis specialist subsequent to diagnosis by a non-arthritis specialist and time to first consultation with an arthritis specialist. RESULTS: Of 352 children and adolescents with suspected new-onset JRA identified by non-arthritis specialists, 159 (45.2%) were subsequently seen by an arthritis specialist. Mean (SD) time to consultation for those seen was 115.3 (213.8) days (median, 28 days). Younger children were more likely to obtain care from an arthritis specialist compared with those having JRA first diagnosed by a general practitioner. CONCLUSION: Most patients with suspected new-onset JRA do not obtain prompt care from an arthritis specialist. Further research and action should focus on this issue so that outcomes may be optimized.