Development and validation of a new instrument to measure health-related quality of life in patients with psoriatic arthritis: the VITACORA-19.

OBJECTIVE: To develop/validate an instrument to measure health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA), for use in clinical studies. METHODS: An item pool of 35 items was generated following standardized procedures. Item reduction was performed using clinimetric and psychometric approaches after administration to 66 patients with PsA. The resulting instrument, the VITACORA-19, consists of 19 items. Its validity content, internal consistency, test-retest reliability, known groups/convergent validity, and sensitivity to change were tested in a longitudinal and multicenter study conducted in 10 hospitals in Spain, with 323 patients who also completed the EuroQol 5-dimensional questionnaire (EQ-5D) and a health status transition item. There were 3 study groups: group A (n = 209, patients with PsA), group B (n = 71, patients with arthritis without psoriatic aspect, patients with arthrosis, and patients with dermatitis), and group C (n = 43, healthy controls). RESULTS: The questionnaire was considered easy/very easy to answer by 94.7% of the patients with PsA. The factorial analysis clearly identified only 1 factor. Cronbach's alpha coefficient and interclass correlation coefficients exceeded 0.90. Statistically significant differences (p < 0.001) were observed between groups: subjects from group C had better HRQoL, followed by group B, and finally group A had the worst HRQoL. The VITACORA-19 scores showed significant correlations (p < 0.001) to PsA disease activity, EQ-5D, and perceived health state, scoring the patients with better health state higher. The minimum important difference was established as an 8-point change in the global score. CONCLUSION: The Spanish-developed VITACORA-19, designed to measure HRQoL in patients with PsA, has good validity, reliability, and sensitivity to change.

Aplicabilidad de la herramienta FRAX® en pacientes con Osteporosis / Applicability of FRAX® tool in osteoporotic patients

Objetivo. Describir las características de los pacientes en tratamiento para la osteoporosis que no recibirían dicho tratamiento basándose en los resultados del FRAX®. Diseño. Estudio observacional descriptivo transversal. Emplazamiento. Atención Primaria - Centro de Especialidades de Toledo. Participantes. Pacientes diagnosticados de osteoporosis en tratamiento con fármacos antirresortivos, osteoformadores o mixtos vistos en las consultas de Reumatología (Metabolismo Óseo) en abril y mayo de 2009. Intervenciones. Revisión de historias clínicas obteniendo los datos del momento en que se inició el tratamiento antiosteoporótico, aplicando el índice de riesgo FRAX® con y sin densitometría (en los casos en que la tengan). Mediciones y resultados. 99 pacientes (88,9% mujeres), edad media (± desviación estándar) 62,3 ± 9,33 años. 62,6% presentaban un índice FRAX® < 20%/3%, siendo más jóvenes (58,95 vs. 67,92 años; p<0,001), y sin diferencias por sexo e IMC. Los pacientes “FRAX® (-)” tenían menor porcentaje de fracturas previas (33,9% vs. 83,8%; p<0,001), sobre todo vertebrales y de húmero, en menor número (0,55 vs. 1,75; p<0,001) y a edad más temprana (54,88 vs. 63 años; p=0,02). Además, tenían una puntuación T en cuello femoral superior (-1,87 vs. -2,50; p<0,001). La probabilidad de fractura a 10 años era menor en los pacientes “FRAX® (-)” sin densitometría (4,18% vs. 12,72% en fractura osteoporótica mayor; p<0,001; 0,91% vs. 5,43% en fractura de cadera; p<0,001) y con densitometría (4,70 vs. 14,30 en fractura osteoporótica mayor; p<0,001; 1,14 vs. 6,62 en fractura de cadera; p<0,01). La densitometría no afecta significativamente el porcentaje de pacientes que supera el límite del 20%/3%. Conclusiones. La herramienta FRAX® puede tener relativa utilidad en Atención Primaria, especialmente en aquellos pacientes sin osteoporosis densitométrica o establecida. Sin embargo, no parece que el criterio de coste-efectividad obtenido por los anglosajones pueda adoptarse de forma directa y única en nuestro medio (AU)

Aim. To describe the characteristics of the patients treated for osteoporosis that could not been treated according to FRAX® scores. Design. Observational, descriptive, cross-sectional study. Setting. Primary Care – Toledo Speciality Centre. Participants. Outpatients with osteoporosis diagnosis treated with antirresortive, osteogenic or mixed drugs and visited in Rheumatology Service (Bone Metabolism) in april-may 2009. Intervention. Clinical charts review extracting the data from the antiosteoporotic treatment starting date, and applying the FRAX® risk index with and without bone densitometry (in that patients with it). Measurements and results. 99 patients (88.9% women), medium age (± standard deviation) 62.3 ± 9.33 years old. 62.6% had a FRAX® index <20%/3%; these patients were younger (58.95 vs. 67.92 years old) than those with a FRAX® ≥20%/3%, with neither gender nor BMI differences. “FRAX® (-)” patients had less previous fractures (33.9% vs. 83.8%; p<0.001), specially from spine and humerus; these patients also had a smaller fracture number (0.55 vs. 1.75; p<0.001), and their fractures were produced at a younger age (54.88 vs. 63% years old; p=0.02). Also, their T-score of hip was bigger (-1.87 vs. -2.50; p<0.001). The 10-year probability of fracture was smaller in the “FRAX® (-)” patients without densitometry (4.18% vs. 12.72% in major osteoporotic fracture; p<0.001; 0.91% vs. 5.43% in hip fracture; p<0.001) and with it (4.70% vs. 14.30% in major osteoporotic fracture; p<0.001; 1.14% vs. 6.62% in hip fracture; p<0.01). Bone densitometry does not significantly affect the percentage of patients that surpass the 20%/3% limit. Conclusions. The FRAX® tool can be relatively useful in Primary Care, especially in those patients without densitometry or established osteoporosis. However, the NOF cost-effectivity criteria cannot be adopted directly in our environment (AU)