Silvia Díaz

Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component.

BackgroundThis study assesses the validity and reliability of the Spanish version of DN4 questionnaire as a tool for differential diagnosis of pain syndromes associated to a neuropathic (NP) or somatic component (non-neuropathic pain, NNP).MethodsA study was conducted consisting of two phases: cultural adaptation into the Spanish language by means of conceptual equivalence, including forward and backward translations in duplicate and cognitive debriefing, and testing of psychometric properties in patients with NP (peripheral, central and mixed) and NNP. The analysis of psychometric properties included reliability (internal consistency, inter-rater agreement and test-retest reliability) and validity (ROC curve analysis, agreement with the reference diagnosis and determination of sensitivity, specificity, and positive and negative predictive values in different subsamples according to type of NP).ResultsA sample of 164 subjects (99 women, 60.4%; age: 60.4 ± 16.0 years), 94 (57.3%) with NP (36 with peripheral, 32 with central, and 26 with mixed pain) and 70 with NNP was enrolled. The questionnaire was reliable [Cronbachs alpha coefficient: 0.71, inter-rater agreement coefficient: 0.80 (0.71–0.89), and test-retest intra-class correlation coefficient: 0.95 (0.92–0.97)] and valid for a cut-off value ≥ 4 points, which was the best value to discriminate between NP and NNP subjects.DiscussionThis study, representing the first validation of the DN4 questionnaire into another language different than the original, not only supported its high discriminatory value for identification of neuropathic pain, but also provided supplemental psychometric validation (i.e. test-retest reliability, influence of educational level and pain intensity) and showed its validity in mixed pain syndromes.

An economic analysis of pharmacological treatment of COPD in Spain

BACKGROUND COPD is a prevalent disease that generates high use of resources. The objective of this study was to quantify the economic consequences of non-adherence to GOLD guidelines for the management of COPD patients. METHOD An economic model was generated to compare different scenarios of observed vs. expected costs of COPD treatment. A pooled analysis of data derived from a systematic review of studies describing treatment of COPD in Spain was combined with drug costs (using different assumptions) to obtain the observed cost of COPD treatment. An expected cost was obtained with the minimum and maximum treatment intensity derived from the GOLD recommendations. RESULTS A total of 8 studies were identified, comprising 6339 patients. Average medication cost of COPD patients was estimated as being between euro 1218 and euro 1314 per patient per year, higher than the ideal expected average cost (between euro 1007 and euro 1021 per patient/year). Thus, implementation of guidelines would result in a mean reduction of euro 198-euro 293 per patient/year. Sensitivity analysis showed that about 13% of patients had higher treatment costs than the maximum expected cost. This proportion is much higher in moderately/severely affected patients than in mildly affected patients (28.0% and 11.1%, respectively). CONCLUSIONS Treatment of COPD allows for the identification of areas of inefficiency. An improvement in the adherence to the GOLD guidelines would imply potential savings of medication costs of about 20% of the observed costs.

Adaptación al castellano y validación psicométrica del cuestionario ID-Pain© para la detección de dolor neuropático

Fundamento y objetivo: El proposito del estudio ha sido realizar la adaptacion cultural al castellano de la escala autoadministrada ID-Pain© y analizar sus propiedades psicometricas como instrumento de deteccion de dolor neuropatico. Material y metodo: Se ha realizado un estudio transversal en 2 fases (adaptacion cultural al castellano y fase de validacion psicometrica), en el que se incluyo consecutivamente a pacientes de ambos sexos mayores de 18 anos, con dolor cronico (> 6 meses) con componente neuropatico (DN) o nociceptivo (DNN). Se valoraron la factibilidad, fiabilidad y validez de la escala con el diagnostico de referencia y con el diagnostico clinico de la escala LANSS (Leeds Assessment of Neuropathic Symptoms and Signs). Se realizaron analisis factorial, curvas de eficacia diagnostica y pruebas de concordancia con el diagnostico de referencia. Se determinaron la sensibilidad, la especificidad y los valores predictivos positivo y negativo. Resultados: Se incluyo en el estudio a 283 pacientes (un 64,4% mujeres), con una edad media (desviacion estandar) de 59,1 (14,9) anos, de los cuales 145 (51,2%) presentaban DN y 138 (48,8%), DNN. El tiempo medio de administracion de la escala fue de 4,2 (3,0) min y solo un 15% de los pacientes necesito ayuda para responder. La escala mostro una unica dimension en el analisis factorial (variancia explicada del 37,5%) y una alta estabilidad en el test-retest (r = 0,98; p < 0,0005). La puntuacion media diferencio claramente entre los pacientes con DN y con DNN: 3,5 (1,2) frente a 1,2 (1,4) puntos (p < 0,0005). El punto de corte optimo se fijo en

Labor productivity in migraine patients: primary care contribution to occupational medicine.

3 puntos (area bajo la curva = 0,89; p < 0,0005; sensibilidad: 0,81; especificidad: 0,84; kappa = 0,65, con el diagnostico de referencia). La escala mostro una buena validez concurrente con el diagnostico realizado con la escala LANSS (kappa = 0,61; p < 0,0005). Conclusiones: La version adaptada al castellano del ID-Pain© muestra propiedades psicometricas adecuadas como instrumento autoadministrado de deteccion de dolor con componente neuropatico.

Adaptación cultural, validación y desarrollo de un cuestionario abreviado sobre el miedo a la inyección y al autoanálisis de glucosa para pacientes diabéticos

Objective:To estimate the impact of migraine on labor productivity and health resources utilization in an active population attending Primary Care settings in Spain. Methods:An observational, cross-sectional, and multicenter study was designed. Productivity, loss workdays equivalents and previous 3-months health resources utilization were calculated. Results:Four thousand four hundred twenty six patients were evaluated. The migraine group showed the lowest productivity, highest loss workdays equivalents and health resources utilization compared with non-migraine headaches and subjects without headaches (P < 0.05 in all cases). Within the migraine group, lower productivity values were observed in female patients compared to male (64.04 vs 59.69; P < 0.05), while emergency room visits were more frequent for male patients (0.71 vs 076; P < 0.05). Conclusions:Subjects with migraine showed higher impact on health resources utilization and productivity when evaluated at Primary care level.

Cost-Effectiveness Analysis of Ziprasidone versus Haloperidol in Sequential Intramuscular/Oral Treatment of Exacerbation of Schizophrenia

OBJECTIVE To develop and validate in Spain a test to measure fear of injecting and selftesting [HIAT-I](c) in diabetic patients by translating and adapting the original English version of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). PATIENTS AND METHOD Forward-backward translations in duplicate were carried out and were revised by an expert and a nonexpert panel. Men and women with type 1 and type 2 diabetes aged more than 18 years old were enrolled in three primary care centers. The Spanish version of the D-FISQ was administered on two separate occasions at a 15-day interval. The trait-anxiety scale of the Stait-Trait Anxiety Inventory (STAI) and five specific questions on glycemic control, insulin injection, pain and worry were administered. Sociodemographic and clinical data were also collected. Feasibility, construct validity, concept validity and reliability were assessed. RESULTS A 32-item version of the D-FISQ was developed by an expert panel and was administered to 93 (35 Type 1, 58 Type 2) insulin-treated diabetic patients. Ninetynine per cent of the patients answered all items in 5 minutes (median). Item-total correlation and factor analysis led to an abridged, 19-item version, maintaining the two original dimensions, and explaining 47.4% percent of the total variance: fear of self-injecting (FSI), accounting for 29.5% of the variance, and fear of self-testing (FST), accounting for 17.9%. Test-retest correlation coefficients were 0.85 (FSI) and 0.94 (FST). The correlations between STAI and FSI and FST were not statistically significant (p=0.771). The correlation coefficient between FSI and time under insulin treatment was -0.546 (p=0.023). CONCLUSIONS We developed a newrecalibrated version of the Spanish D-FISQ called the MIAT-D. The feasibility, dimensionality, construct validity and reliability of this questionnaire were accurate. The concept validity of this test should be explored in further studies.

OriginalesAdaptación cultural, validación y desarrollo de un cuestionario abreviado sobre el miedo a la inyección y al autoanálisis de glucosa para pacientes diabéticosCultural adaptation, validation and development of a spanish brief version of the diabetes fear of injecting and self-testing questionnaire

AbstractObjective: This study aimed to assess the cost effectiveness of ziprasidone versus haloperidol in sequential intramuscular (IM)/oral treatment of patients with exacerbation of schizophrenia in Spain. Methods: A cost-effectiveness analysis from the hospital perspective was performed. Length of stay, study medication and use of concomitant drugs were calculated using data from the ZIMO trial. The effectiveness of treatment was determined by the percentage of responders (reduction in baseline Brief Psychiatric Rating Scale [BPRS] negative symptoms subscale ≥30%). Economic assessment included estimation of mean (95% CI) total costs, cost per responder and the incremental cost-effectiveness ratio (ICER) per additional responder. The economic uncertainty level was controlled by resampling and calculation of cost-effectiveness acceptability curves. Results: A total of 325 patients (ziprasidone n = 255, haloperidol n = 70) were included in this economic subanalysis. Ziprasidone showed a significantly higher responder rate compared with haloperidol (71% vs 56%, respectively; p = 0.023). Mean total costs were €3582 (95% CI 3226, 3937) for ziprasidone and €2953 (95% CI 2471, 3436) for haloperidol (p = 0.039), mainly due to a higher ziprasidone acquisition cost. However, costs per responder were lower with ziprasidone (€5045 [95% CI 4211, 6020]) than with haloperidol (€5302 [95% CI 3666, 7791], with a cost per additional responder (ICER) for ziprasidone of €4095 (95% CI −130, 22 231). The acceptability curve showed an ICER cut-off value of €13 891 at the 95% cost-effectiveness probability level for ≥30% reduction in BPRS negative symptoms. Conclusions: Compared with haloperidol, ziprasidone was significantly better at controlling psychotic negative symptoms in acute psychoses. The extra cost of ziprasidone was offset by a higher effectiveness rate, yielding a lower cost per responder. In light of the social benefit (less family burden and greater restoration of productivity), the incremental cost per additional responder with sequential IM/ oral ziprasidone should be considered cost effective in patients with exacerbation of schizophrenia in Spain.

Cost-effectiveness analysis of sunitinib in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) after progression or intolerance with imatinib

OBJECTIVE To develop and validate in Spain a test to measure fear of injecting and selftesting [HIAT-I](c) in diabetic patients by translating and adapting the original English version of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). PATIENTS AND METHOD Forward-backward translations in duplicate were carried out and were revised by an expert and a nonexpert panel. Men and women with type 1 and type 2 diabetes aged more than 18 years old were enrolled in three primary care centers. The Spanish version of the D-FISQ was administered on two separate occasions at a 15-day interval. The trait-anxiety scale of the Stait-Trait Anxiety Inventory (STAI) and five specific questions on glycemic control, insulin injection, pain and worry were administered. Sociodemographic and clinical data were also collected. Feasibility, construct validity, concept validity and reliability were assessed. RESULTS A 32-item version of the D-FISQ was developed by an expert panel and was administered to 93 (35 Type 1, 58 Type 2) insulin-treated diabetic patients. Ninetynine per cent of the patients answered all items in 5 minutes (median). Item-total correlation and factor analysis led to an abridged, 19-item version, maintaining the two original dimensions, and explaining 47.4% percent of the total variance: fear of self-injecting (FSI), accounting for 29.5% of the variance, and fear of self-testing (FST), accounting for 17.9%. Test-retest correlation coefficients were 0.85 (FSI) and 0.94 (FST). The correlations between STAI and FSI and FST were not statistically significant (p=0.771). The correlation coefficient between FSI and time under insulin treatment was -0.546 (p=0.023). CONCLUSIONS We developed a newrecalibrated version of the Spanish D-FISQ called the MIAT-D. The feasibility, dimensionality, construct validity and reliability of this questionnaire were accurate. The concept validity of this test should be explored in further studies.