Validación de la versión española del Cuestionario Benign Prostatic Hyperplasia Impact Index. 'Estudio Validart' / Validation of the spanish version of the benign prostatic hyperplasia impact indez questionnaire. 'Validar study'

Introducción: La Hiperplasia Benigna de Próstata (HBP) es una enfermedad crónica que afecta la calidad de vida relacionada con la salud (CVRS). En España no hay cuestionarios específicos para evaluar la CVRS en esta enfermedad. El objetivo del presente estudio fue validar la versión española del cuestionario Benign Prostatic Hyperplasia ImpactIndex (BII). Material y métodos: Participaron hombres mayores de 49 años diagnosticados de HBP evaluados en tres visitas. Se analizaron las propiedades psicométricas del cuestionario en términos de validez, fiabilidad y sensibilidad al cambio. Resultados: Se evaluaron 1.719 hombres con edad media (DE) de 68,36 años (8,07) clasificados según gravedad de la HBP. La validez longitudinal y la validez de constructo (r>0,6) del cuestionario BII fueron moderadas-altas. La consistencia interna (α=0,91), la fiabilidad test-retest (CCI=0,8) y la sensibilidad al cambio (tamaño efecto=0,6) fueron buenas. La CVRS mejoró significativamente durante el seguimiento (p<0,01).Discusión: Hasta ahora no existían cuestionarios específicos de calidad de vida para población española con HBP. La versión española del cuestionario BII cumple las propiedades psicométricas necesarias para evaluar la CVRS en la HBP; confirmando además, el significativo impacto de la enfermedad en la calidad de vida de estos pacientes (AU)

Introduction: Benign Prostatic Hyperplasia is a chronic disease that affects Health related quality of life (HRQL). In Spain there are no specific questionnaires to assess HRQL in patients suffering from BPH. The objective of this study was to validate the Spanish version of the Benign Prostatic Hyperplasia Impact Index (BII) questionnaire. Material and methods: Study participants were men over 49 with confirmed BPH diagnosis and evaluated in three visits. Psychometric properties of the questionnaire were analyzed in terms of validity, reliability and sensitivity to change. Results: A total of 1,719 men with mean (SD) age 68.36 were evaluated and classified according to the BPH severity. Both longitudinal and construct validity (r>0.6) of the BII questionnaire were moderate-high. Internal consistency (α=0.91), test-retest reliability (CCI=0.8) and sensitivity to change (effect size=0.6) showed good results. The HRQL improved significantly during the monitoring period (p<0.01).Discussion: There were no available specific HRQL questionnaires for Spanish population with BPH until now. The Spanish version of the BII questionnaire fulfils with the psychometric properties that are necessary to evaluate HRQL in patients with BPH; furthermore, it has been confirm the considerable impact of this disease in the quality of life of this patients (AU)

Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants.

AIM: To assess the prevalence of mild gastrointestinal disorders in milk-fed infants in paediatric practice, and to evaluate the effectiveness and satisfaction with dietetic treatment. METHODS: A cross-sectional epidemiological study was first carried out. A total of 285 paediatricians included 3487 children seen during a period of one week. In a second phase an observational, prospective and multicentre study was conducted and 2069 milk-fed infants with mild gastrointestinal disorders (colic, constipation, regurgitation and diarrhoea) were included. There was a baseline visit (start of treatment) and a final visit four weeks later. The effectiveness of the various Novalac formulas, as well as the satisfaction of the parents/tutors and paediatricians with the dietetic treatment were assessed at the final visit. RESULTS: The prevalence of mild gastrointestinal disorders was 27.8% of all paediatrician consultations (9.2%, 7.8%, 6.1% and 4.6% in relation to colic, constipation, regurgitation and diarrhoea, respectively). The several Novalac adapted milk formulas resolved 88.4% of the mild gastrointestinal disorders. Depending on the type of disorder, differences in response rate were observed. The highest effectiveness was recorded with respect to diarrhoea (92.6%), followed by constipation (91.6%), colic (87.6%) and regurgitation (81%). Overall, 91% of the paediatricians and 88.8% of the parents/tutors were satisfied or very satisfied with the Novalac adapted milk formulas. CONCLUSION: Mild gastrointestinal disorders show a high prevalence in paediatric practice. The Novalac adapted milk formulas have been shown to be effective in treating mild gastrointestinal disorders in milk-fed infants in the context of routine clinical practice.

[Validity of tests for initial diagnosis and its concordance with final diagnosis in patients with suspected benign prostatic hyperplasia]. / Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata.

OBJECTIVE: To assess the validity of diagnostic tools available at the primary care setting [medical history (MH), I-PSS questionnaire, digital rectal examination (DRE) and prostate specific antigen (PSA) evaluation] for the diagnosis of benign prostatic hyperplasia (BPH). SUBJECTS AND METHODS: 363 patients with suspected prostatic disease referred to urology outpatient clinics were included. For every subject initial BPH diagnosis was collected at each of the following sequential procedures: 1) MH; 2) I-PSS; 3) DRE; and 4) PSA. Each of these diagnostic decisions were compared to a final diagnosis (gold standard) reached after the addition of urinary sediment analysis, ultrasonographic assessment of residual volume and prostatic volume, and peak urinary flow measurement. A descriptive analysis was undertaken: validity and concordance between each diagnostic step and the gold standard was calculated. RESULTS: Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis based on MH+I-PSS+DRE+PSA with respect to the gold standard were 91%, 65%, 95% and 50%, respectively. The percentage of agreement and kappa index between both diagnostic strategies were 87.9% and 0.5, respectively. CONCLUSIONS: Concordance between BPH initial diagnosis based on MH+I-PSS+DRE+PSA and diagnosis based on a full range of tests was high, thus allowing recommending the use of this group of initial diagnostic procedures, which are available to the primary care physician, not only as a first diagnostic step in patients with suspected BPH, but also as a valid strategy to prevent unnecessary delay in its initial management and to facilitate appropriate referral from primary to specialized care.

Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata / Validity of tests for initial diagnosis and its concordance with final diagnosis in patients with suspected benign prostatic hyperplasia

Objetivo: Determinar la validez de los métodos diagnósticos al alcance del primer escalón del nivel asistencial [historia clínica (HC), cuestionario I-PSS, tacto rectal (TR) y determinación del antígeno prostático específico (PSA)], para el diagnóstico de la hiperplasia benigna de próstata (HBP). Población y Métodos: Participaron 363 pacientes atendidos en consultas externas de urología por sospecha de HBP. El diagnóstico inicial de HBP se fue realizando tras la aplicación secuencial de cada una de las siguientes pruebas: 1) HC 2) I-PSS 3) TR y 4) PSA. El diagnóstico emitido tras cada uno de los 4 pasos, se contrastó con el diagnóstico final (gold standard) tras la evaluación de sedimento urinario, volumen miccional residual y tamaño prostático por ecografía y flujometría urinaria. Se realizó un análisis descriptivo y se calculó la validez y concordancia entre cada paso diagnóstico y el gold standard. Resultados: La sensibilidad, especificidad, valor predictivo positivo y valor predictivo negativo del diagnóstico basado en HC+IPSS+ TR+PSA con respecto al diagnóstico final fueron 91%, 65%, 95% y 50% respectivamente. El porcentaje de acuerdo y el índice kappa entre ambos diagnósticos fueron 87,9% y 0,5, respectivamente. Conclusiones: La concordancia entre el diagnóstico inicial basada en la historia clínica, cuestionario I-PSS, TR y PSA, y el diagnóstico final de HBP es alta, lo que permite recomendar el uso del conjunto de estas pruebas accesibles en el primero de los escalones asistenciales no sólo como primer paso diagnóstico en los pacientes con sospecha de HBP, sino también como estrategia válida para evitar retrasos innecesarios en su manejo inicial y facilitar la adecuada derivación entre los niveles de atención primaria y especializada

Objective: To assess the validity of diagnostic tools available at the primary care setting [medical history (MH), I-PSS questionnaire, digital rectal examination (DRE) and prostate specific antigen (PSA) evaluation] for the diagnosis of benign prostatic hyperplasia (BPH). Subjects and Methods: 363 patients with suspected prostatic disease referred to urology outpatient clinics were included. For every subject initial BPH diagnosis was collected at each of the following sequential procedures: 1) MH; 2) I-PSS; 3) DRE; and 4) PSA. Each of these diagnostic decisions were compared to a final diagnosis (gold standard) reached after the addition of urinary sediment analysis, ultrasonographic assessment of residual volume and prostatic volume, and peak urinary flow measurement. A descriptive analysis was undertaken; validity and concordance between each diagnostic step and the gold standard was calculated. Results: Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis based on MH+IPSS+ DRE+PSA with respect to the gold standard were 91%, 65%, 95% and 50%, respectively. The percentage of agreement and kappa index between both diagnostic strategies were 87.9% and 0.5, respectively. Conclusions: Concordance between BPH initial diagnosis based on MH+I-PSS+DRE+PSA and diagnosis based on a full range of tests was high, thus allowing recommending the use of this group of initial diagnostic procedures, which are available to the primary care physician, not only as a first diagnostic step in patients with suspected BPH, but also as a valid strategy to prevent unnecessary delay in its initial management and to facilitate appropriate referral from primary to specialized care

[Inspection validation of prescription: guaranteeing proper use of medicines or a cost-control measure?]. / Visados de inspección: garantía del uso adecuado de los medicamentos o medida de control del gasto?

OBJECTIVE: To assess the views of primary care physicians (PCPs) in Spain regarding the purpose of inspection validation of prescriptions (IVP) and its impact on prescription and patients, as well as doctors' acceptance of this measure. DESIGN: Cross-sectional study through a telephone survey. SETTING: Primary care centres. PARTICIPANTS: PCPs prescribing oral diabetes drugs requiring IVP, or who were familiar with IVP. METHODS: Telephone survey conducted in October-November, 2003, of 1471 PCPs. Sample size was calculated to ensure accuracy to 10% in each autonomous region. RESULTS: 91.9% of the 1600 PCPs contacted who agreed to participate in the study met the inclusion criteria. On average, they prescribed 30.6 drugs requiring IVP per month (95% CI, 28.0-33.2), requiring an additional 4.6 minutes per prescription (95% CI, 4.4-4.8). 64.7% of PCPs increased their clinical work-time for this reason. 71.3% of PCPs (95% CI, 69.0-73.6) considered IVP an obstacle when prescribing a drug that requires it and 44.5% (95% CI, 42.0-47.0) believed that the IVP puts patients' right to receive the appropriate treatment at risk. PCPs considered that inspectors refuse authorization of their prescriptions requiring IVP for administrative (43.3%), economic (36.5%), or clinical (13.2%) reasons. 87.1% of PCPs stated that medical prescription is a sufficient control system and that IVP is not necessary for medicines for diseases managed in primary care such as Type-2 DM. 76.2% believed that the health authorities imposed the IVP requirement for some oral diabetes drugs in order to control expenditure on drugs, and 75.4% supported its withdrawal. CONCLUSION: According to PCPs, the objective of the IVP is mainly economic and may affect negatively their clinical practice and patients. Therefore, in general, they do not support it, at least for drugs for diseases mainly managed in primary care.

Visados de inspección: ¿garantía del uso adecuado de los medicamentos o medida de control del gasto? / Inspection validation of prescription: guaranteeing proper use of medicines or a cost-control measure?

Objetivo. Conocer la opinión de los médicos de atención primaria (MAP) en España acerca de la finalidad del visado de inspección (visado) y su impacto en la prescripción y en los pacientes, así como la aceptación de esta medida. Diseño. Estudio transversal mediante encuesta telefónica. Emplazamiento. Centros de atención primaria. Participantes. Médicos de atención primaria que utilizaban antidiabéticos orales con visado o estaban familiarizados con ellos. Mediciones. Se realizó una encuesta telefónica en octubre-noviembre de 2003 a 1.471 MAP españoles. La muestra se calculó para asegurar una precisión del 10% en cada comunidad autónoma. Resultados. Un 91,9% de los 1.600 MAP contactados que accedieron a participar en el estudio cumplió los criterios de inclusión. Los MAP realizan una media mensual de 30,6 (intervalo de confianza [IC] del 95%, 28,0-33,2) prescripciones de medicamentos con visado, requiriendo un tiempo medio adicional de 4,6 minutos por prescripción (IC del 95%, 4,4-4,8). El 64,7% de los MAP aumenta, por esa razón, el tiempo de trabajo clínico. Un 71,3% (IC del 95%, 69,0-73,6) de los MAP considera el visado un impedimento para prescribir medicamentos que lo requieren y un 44,5% (IC del 95%, 42,0-47,0) de los MAP opina que el visado puede poner en riesgo el derecho del paciente a recibir el tratamiento más adecuado. Los MAP consideran que los inspectores rechazan sus prescripciones de medicamentos con visado por razones administrativas (43,3%), económicas (36,5%) o clínicas (13,2%). Un 87,1% de los MAP declara que para enfermedades tratadas en atención primaria, como la diabetes mellitus tipo 2, la prescripción médica es un sistema de control suficiente y no es necesario el visado. Un 76,2% opina que las autoridades sanitarias impusieron el visado a algunos antidiabéticos orales para controlar el gasto farmacéutico, y un 75,4% está a favor de su retirada. Conclusión. Según los MAP, el visado parece responder a una finalidad fundamentalmente económica y puede tener un impacto negativo en su práctica clínica y en los pacientes. Por tanto, en general, no respaldan su aplicación, al menos en medicamentos para enfermedades mayoritariamente tratadas en atención primaria

Objective. To assess the views of primary care physicians (PCPs) in Spain regarding the purpose of inspection validation of prescriptions (IVP) and its impact on prescription and patients, as well as doctors' acceptance of this measure. Design. Cross-sectional study through a telephone survey. Setting. Primary care centres. Participants. PCPs prescribing oral diabetes drugs requiring IVP, or who were familiar with IVP. Methods. Telephone survey conducted in October-November, 2003, of 1471 PCPs. Sample size was calculated to ensure accuracy to 10% in each autonomous region. Results. 91.9% of the 1600 PCPs contacted who agreed to participate in the study met the inclusion criteria. On average, they prescribed 30.6 drugs requiring IVP per month (95% CI, 28.0-33.2), requiring an additional 4.6 minutes per prescription (95% CI, 4.4-4.8). 64.7% of PCPs increased their clinical work-time for this reason. 71.3% of PCPs (95% CI, 69.0-73.6) considered IVP an obstacle when prescribing a drug that requires it and 44.5% (95% CI, 42.0-47.0) believed that the IVP puts patients' right to receive the appropriate treatment at risk. PCPs considered that inspectors refuse authorisation of their prescriptions requiring IVP for administrative (43.3%), economic (36.5%), or clinical (13.2%) reasons. 87.1% of PCPs stated that medical prescription is a sufficient control system and that IVP is not necessary for medicines for diseases managed in primary care such as Type-2 DM. 76.2% believed that the health authorities imposed the IVP requirement for some oral diabetes drugs in order to control expenditure on drugs, and 75.4% supported its withdrawal. Conclusion. According to PCPs, the objective of the IVP is mainly economic and may affect negatively their clinical practice and patients. Therefore, in general, they do not support it, at least for drugs for diseases mainly managed in primary care

Visados de inspección: ¿garantía del uso adecuado de los medicamentos o medida de control del gasto?

Objetivo. Conocer la opinión de los médicos de atención primariam (MAP) en España acerca de la finalidad del visado de inspección (visado) y su impacto en la prescripción y en los pacientes, así como la aceptación de esta medida. Diseño. Estudio transversal mediante encuesta telefónica. Emplazamiento. Centros de atención primaria. Participantes. Médicos de atención primaria que utilizaban antidiabéticos orales con visado o estaban familiarizados con ellos. Mediciones. Se realizó una encuesta telefónica en octubre-noviembre de 2003 a 1.471 MAP españoles. La muestra se calculó para asegurar una precisióndel 10 por ciento en cada comunidad autónoma. Resultados. Un 91,9 por ciento de los 1.600 MAP contactados que accedieron a participar en el estudio cumplió los criterios de inclusión. Los MAP realizan una media mensual de 30,6 (intervalo de confianza [IC] del 95 por ciento, 28,0-33,2) prescripciones de medicamentos con visado, requierendo un tempo adicional de 4,6 minutos por prescripción (IC del 95 por ciento, 4,4-4,8). El 64,7 por ciento de los MAP aumenta, por esa razón, el tiempo de trabajo clínico. Un 71,3 por ciento (IC del 95 por ciento, 69,0-73,6) de los MAP considera el visado un impedimiento para prescribir medicamentos que lo requieren y un 44,5 por ciento (IC del 95 por ciento, 42,0-47,0) de los MAP opina que el visado puede poner en riesgo el derecho del paciente a recibir el tratamiento más adecuado. Los MAP consideran que los inspectores rechazan sus prescripciones de medicamentos con visado por razones administrativas (43,3 por ciento), económicas (36,5 por ciento) o clínicas (13,2 por ciento). Un 87,1 por ciento de los MAP declara que para enfermedades tratadas en atención primaria, como la diabetes mellitus tipo 2, la prescripción médica es un sistema de control suficiente y no es necesario el visado. Un 76,2 por ciento opina que las autoridades sanitarias impusieron el visado a algunos antidiabéticos orales para controlar el gasto farmacéutico, y un 75,4 por ciento está a favor de su retirada. Conclusión. Según los MAP, el visado parece responder a una finalidad fundamentalmente económica y puede tener un impacto negativo en su práctica clínica y en los pacientes. Por tanto, en genral, no respaldan su aplicación, al menos en medicamentos para enfermedades mayoritariamente tratadas en atención primária.(AU)

[Prescription medicines information: Spanish general population survey]. / Información de medicamentos de prescripción: encuesta a la población general Española.

OBJECTIVE: To assess Spanish general population opinion on prescription medicine information which they currently access or would like to. Design. Cross-sectional descriptive study through telephone interviews. Setting. Spanish general population. February-March 2003. PARTICIPANTS: A total of 1069 subjects from 16 to 90 years old were interviewed. Main measures. Questionnaire developed after reviewing legislation and literature, and validated by an expert panel in medical information. RESULTS: A total of 87.7% of subjects usually obtain medicines upon medical prescription. The most important prescription medicine information sources are drug information leaflet (75.9%; 95% CI, 73.3-78.5), physicians (54.9%; 95% CI, 51.8-58.0), pharmacists (17.4%; 95% CI, 15.1-19.7 and nurses (6.7%; 95% CI, 5.2-8.2). Less than 3% of subjects obtain prescription medicine information through Internet. A total of 52.9% (95% CI, 49.9-55.8) of subjects feel they are inadequately informed about prescription medicine and would like to have more access to it through sources different than health care staff. A total of 45.6% (95% CI, 42.6-48.6) of subjects would find convenient to receive information from pharmaceutical companies. This information should be qualified and supervised by health authorities. Brief written materials provided by physicians or pharmacists, would be the most appropriate way for patients to obtain prescription medicine information from pharmaceutical companies. CONCLUSIONS: Spanish general population feel they have poor information on prescription medicine and would like to get access to qualified information from different sources, including the one provided by the pharmaceutical industry.

Información de medicamentos de prescripción: encuesta a la población general española / Prescription Medicines Information: Spanish General Population Survey

Objetivo. Conocer la opinión de los ciudadanos españoles acerca de la información de medicamentos de prescripción a la que actualmente tienen acceso y a la que les gustaría acceder. Diseño. Estudio descriptivo, transversal, a través de encuesta telefónica. Emplazamiento. Población general española. Febrero-marzo de 2003. Participantes. Se entrevistó a 1.069 individuos entre 16 y 90 años de edad. Mediciones principales. Cuestionario elaborado tras una revisión de la legislación y la bibliografía que ha sido validado por representantes de diferentes colectivos involucrados en información médica. Resultados. El 87,7% de los individuos obtiene medicamentos con receta médica. Las principales fuentes de información de medicamentos de prescripción para el ciudadano son el prospecto (75,9%; intervalo de confianza [IC] del 95%, 73,3-78,5), los médicos (54,9%; IC del 95%, 51,8-58,0), los farmacéuticos (17,4%; IC del 95%, 15,1-19,7) y las enfermeras (6,7%; IC del 95%, 5,2-8,2). Menos de un 3% de los ciudadanos consulta internet para buscar información sobre medicamentos. Un 52,9% (IC del 95%, 49,9-55,8) se considera poco informado y demanda mayor acceso a la información de medicamentos de prescripción. Un 45,6% (IC del 95%, 42,6-48,6) cree que se debería permitir que las compañías farmacéuticas proporcionasen información de medicamentos de prescripción, que debería ser de calidad y estar supervisada por las autoridades sanitarias. Los ciudadanos encuestados citan la entrega de folletos o material escrito a través del médico o el farmacéutico como los medios principales para la distribución al paciente de información acerca de los medicamentos por parte de las compañías farmacéuticas. Conclusiones. La población general española declara estar poco informada sobre los medicamentos de prescripción y está interesada en obtener mayor acceso a una información de calidad de diversas fuentes, incluida la que procede de la industria farmacéutica

Objective. To assess Spanish general population opinion on prescription medicine information which they currently access or would like to. Design. Cross-sectional descriptive study through telephone interviews. Setting. Spanish general population. February-March 2003. Participants. A total of 1069 subjects from 16 to 90 years old were interviewed. Main measures. Questionnaire developed after reviewing legislation and literature, and validated by an expert panel in medical information. Results. A total of 87.7% of subjects usually obtain medicines upon medical prescription. The most important prescription medicine information sources are drug information leaflet (75.9%; 95% CI, 73.3-78.5), physicians (54.9%; 95% CI, 51.8-58.0), pharmacists (17.4%; 95% CI, 15.1-19.7 and nurses (6.7%; 95% CI, 5.2-8.2). Less than 3% of subjects obtain prescription medicine information through Internet. A total of 52.9% (95% CI, 49.9-55.8) of subjects feel they are inadequately informed about prescription medicine and would like to have more access to it through sources different than health care staff. A total of 45.6% (95% CI, 42.6-48.6) of subjects would find convenient to receive information from pharmaceutical companies. This information should be qualified and supervised by health authorities. Brief written materials provided by physicians or pharmacists, would be the most appropriate way for patients to obtain prescription medicine information from pharmaceutical companies. Conclusions. Spanish general population feel they have poor information on prescription medicine and would like to get access to qualified information from different sources, including the one provided by the pharmaceutical industry

[Quality of life, time commitment and burden perceived by the principal informal caregiver of Alzheimer's patients]. / Calidad de vida, tiempo de dedicación y carga percibida por el cuidador principal informal del enfermo de Alzheimer.

OBJECTIVE: To evaluate the impact in Health Related Quality of Life (HRQoL), the time commitment and the burden perceived by the principal informal caregiver (PIC) of Alzheimer's patients (AP) in Spain, as well as the type and amount of external help received. DESIGN: Multicentric descriptive cross-sectional study. PATIENTS: A randomised sample of 268 PIC were included from 19 Alzheimer's Patient Family Associations (APFA) randomly selected from all Spanish regions. MEASURES: Data were collected using a structured telephone interview with the CATI system. HRQoL was measured using the questionnaire EuroQoL-5D. Information was also collected on the health problems of the PIC, the burden perceived (using the specific Zarit scale), the time commitment of PICs (hours per day), type of activity, as well as the amount and type of external help received. RESULTS: The HRQoL of the PIC showed to be worse than the general population in the EQ-5D, except in the self-care dimension. A total of 84% of PIC had physical problems related to the care given to the AP and 94.4% had psychological problems. The Zarit scale showed that 46.5% of caregivers had a level of burden between severe and moderated, while in 34.7% was severe. Time commitment was more than 8 hours per day in 72.1% of them and more than 20 hours per day in 39.6%. Only 26.9% of the PIC received some sort of socio-sanitary help and 76.5% received help from the APFA. CONCLUSIONS: Caregivers of AP suffer a negative impact on their health state and HRQoL; the time they dedicate to the patient is very high.

[Effect of type-2 diabetes mellitus on the quality of life of patients treated at primary care consultations in Spain]. / Impacto de la diabetes mellitus tipo 2 en la calidad de vida de los pacientes tratados en las consultas de atención primaria en España.

OBJECTIVES: To evaluate the impact of type-2 diabetes mellitus (DM2) on the health-related quality of life (HRQL) of patients and to analyse the impact of social-demographic and clinical variables and of resource use. DESIGN: Cross-sectional study with retrospective and prospective information gathering (HRQL questionnaire). Setting. 29 primary care centres from the whole of Spain. PARTICIPANTS: 1041 patients diagnosed with DM2 after the age of 30, chosen at random from patients' records at participating centres. Main measurements. HRQL evaluated through the general questionnaire EQ-5D, which enabled HRQL of patients to be compared with that of the general Spanish population, obtained from a sample of 8963 people. RESULTS: Patients with DM2 had worse HRQL (mean EVA index of 0.71) than people in the general population of the same age and gender (mean EVA index of 0.81). Women, older patients and obese patients had worse HRQL. In clinical terms, patients with some DM2-related complication, deficient glycaemic control and in receipt of insulin treatment had worse HRQL than patients without complications, acceptably controlled patients or those receiving non-pharmacological or oral anti-diabetes treatment. CONCLUSIONS: DM2 is associated with worse HRQL for patients, and more so for patients with complications, poor control of glucaemia or under insulin treatment.

Impacto de la diabetes mellitus tipo 2 en la calidad de vida de los pacientes tratados en las consultas de atención primaria en España / Effect of type-2 diabetes mellitus on the quality of life of patients treated at primary care consultations in Spain

Objetivo. Evaluar el impacto de la diabetes mellitus tipo 2 (DM2) en la calidad de vida relacionada con la salud (CVRS) de los pacientes y analizar la influencia de las variables sociodemográficas, clínicas y de uso de recursos. Diseño. Estudio transversal con recogida de información retrospectiva y prospectiva (cuestionario de CVRS).Emplazamiento. Un total de 29 centros de atención primaria de todo el territorio español. Participantes. Participaron en el estudio 1.041 pacientes diagnosticados de DM2 después de los 30 años de edad, seleccionados aleatoriamente de los registros de pacientes de los centros participantes. Mediciones principales. CVRS valorada mediante el cuestionario genérico EQ-5D, lo que permitió comparar la CVRS de los pacientes con la de la población general española, obtenida de una muestra de 8.963 sujetos. Resultados. Los pacientes con DM2 presentaron peor CVRS (media índice EVA de 0,71) que los sujetos de la población general de la misma edad y género (media índice EVA de 0,81). Los pacientes de género femenino, de mayor edad y obesos presentaron peor CVRS. En términos clínicos, los pacientes que presentaban alguna complicación relacionada con la DM2, un deficiente control glucémico y que recibían tratamiento con insulina presentaban peor CVRS que los pacientes sin complicaciones, aceptablemente controlados o que recibían tratamiento no farmacológico o antidiabéticos orales. Conclusiones. La DM2 se asocia con una peor CVRS de los pacientes, y de forma más importante en los pacientes con complicaciones, con bajo control glucémico y tratados con insulina (AU)

La evaluación de la calidad de vida en la osteoporosis / Quality of Life evaluation for osteoporosis

No disponible

Reflexiones sobre la investigación de resultados en salud / Reflections on research into health results

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[Instruments for measuring health-related quality of life in children and adolescents with asthma]. / Instrumentos de evaluación de la calidad de vida relacionada con la salud en niños y adolescentes con asma.

OBJECTIVES: Measures of health-related quality of life (HRQOL) are proving to be useful in providing a comprehensive evaluation of illness and its effects on patients' daily lives. The aim of this review is to describe HRQOL instruments that are currently available to measure the HRQOL in children and adolescents with asthma. METHODS: The MEDLINE database from 1980to 2000was reviewed, as well as the website of the American Thoracic Society and the Quality of Life Research journal. Studies that included instruments measuring HRQOL in children with asthma were included as long as the instruments included met the selection criteria of multidimensionality, scoring was through standardized ordinal scales and psychometric properties were evaluated. RESULTS: Of the 21instruments initially identified 7were excluded because they did not meet one or more of the selection criteria. Fourteen instruments were included in the final review, 6were generic instruments for children (CHQ, KINDL, PedsQL, FS-IIR, RAND and CHIP-AE) and eight were specific to children with asthma (SSES, ASDQ, AMA, CAQ, LAQCA, PACQLQ, PAQLQ and APBC). The generic instruments measured the four basic aspects of HRQOL (symptoms, physical, mental and social functioning), whilst the majority of the specific instruments focused more closely on symptom measurement and physical functioning. Reliability (Cronbach's alpha) and construct validity were the most widely tested psychometric properties. In general, sensitivity to change was the least widely tested property, and only three disease-specific instruments were sensitive to change (LAQCQ, PACQLQ and PAQLQ). All the instruments could be self-administered. Only two of the generic instruments (FS-IIR and RAND) had been validated for use in Spain. At present two more generic instruments (PedsQL and CHIP-AE) and two specific instruments (PACQLQ and PAQLQ) are currently being validated. CONCLUSION: The availability of instruments to measure the HRQOL of children with asthma in Spain is currently limited. Validated versions of the PedsQL (generic) and PAQLQ (specific) instruments, both of which have been demonstrated to be useful in other countries, should shortly be available to measure the HRQOL of children with asthma in Spain.

Instrumentos de evaluación de la calidad de vida relacionada con la salud en niños y adolescentes con asma / Instruments for measuring health-related quality of life in children and adolescents with asthma

Objetivos: Los instrumentos de evaluación de la calidad de vida relacionada con la salud (CVRS) están demostrando ser útiles para valorar de una forma más integral la enfermedad y su repercusión en la vida diaria del paciente. En esta revisión se pretende describir los instrumentos disponibles en estos momentos para la valoración de la CVRS en niños y adolescentes con asma. Métodos: Se ha revisado la base documental MEDLINE desde 1980 hasta 2000, así como la página web de la American Thoracic Society y la revista Quality of Life Research. Se han seleccionado aquellos trabajos que incluían instrumentos que medían la CVRS en niños con asma y que cumpliesen con los criterios de selección de multidimensionalidad, puntuación mediante escalas ordinales estandarizadas y que evaluasen las propiedades psicométricas. Resultados: De los 21 instrumentos inicialmente identificados se excluyeron siete por no cumplir alguno de los criterios de selección, quedando finalmente en la revisión 14 instrumentos, 6 genéricos para niños (CHQ, KINDL, PedsQL, FS-IIR, RAND y CHIP-AE) y ocho específicos para niños con asma (SSES, ASDQ, AMA, CAQ, LAQCA, PACQLQ, PAQLQ y APBC). Los instrumentos genéricos miden las cuatro dimensiones básicas (síntomas, función física, emocional y social), mientras que la mayoría de los específicos están enfocados más en la sintomatología y la función física. La fiabilidad (alfa de Cronbach) y la validez de constructo son las propiedades psicométricas mejor medidas en todos los cuestionarios. La sensibilidad al cambio es la propiedad menos valorada en general, y únicamente han demostrado ser sensibles a los cambios tres instrumentos específicos (LAQCQ, PACQLQ y PAQLQ). Todos los instrumentos tienen la opción de ser autocumplimentados. Sólo hay dos genéricos (FS-IIR y RAND) validados en la cultura española. En la actualidad están en proceso de validación dos genéricos (PedsQL y CHIP-AE) y dos específicos (PACQLQ y PAQLQ). Conclusión: Actualmente la disponibilidad de instrumentos que midan la CVRS en niños con asma en nuestro medio es limitada. En breve se dispondrá de la versión validada en nuestra cultura del PedsQL (genérico) y del PAQLQ (específico), que son dos instrumentos que ya han demostrado en otros países ser útiles para medir la CVRS en niños asmáticos (AU)

[Validation of the quality of life questionnaire in arterial hypertension (HQALY) for its use in Spain. Relationship between clinical variables and quality of life. Investigator Group of the HQALY study]. / Validación del cuestionario de calidad de vida en hipertensión arterial (CHAL) para su uso en España. Relación entre variables clínicas y calidad de vida. Grupo de Investigadores del Estudio CHAL.

OBJECTIVE: To evaluate the measurement properties of the Hypertension Quality of Life (HQALY) questionnaire, under normal clinical practice conditions, and the relationship between quality of life and clinical variables in patients with hypertension. DESIGN: Observational, prospective and multi-centred study. SETTING: 92 primary care centres in Spain. PARTICIPANTS: 269 patients, of both sexes and over 17, with hypertension, stratified by age (18-44, 45-64 and over 64), sex and organic complaint. 106 individuals over 17 with normal tension were chosen at random. INTERVENTIONS: Intensification of treatment in hypertense patients. MEASUREMENTS: Administration of the HQALY and the EuroQol-5D at every attendance (patients, basal and at a month; controls, basal). In addition, at the basal attendance social-demographic and clinical features were recorded, and at the attendance at a month the clinical features and changes in health status. MAIN RESULTS: Mean time of administration was 28 (23) minutes. VALIDITY: factor analysis showed two dimensions, state of mind and somatic manifestations, which correlated most closely with the dimensions of anxiety/depression (0.64) and pain/discomfort (0.55) on the EQ-5D, respectively. HQALY scores were higher (worse quality of life) in patients than in controls without hypertension (p < 0.01). Reliability: intraclass correlation coefficient was 0.88 in state of mind and 0.76 in somatic manifestations. Cronbach's alpha was 0.96 and 0.89, respectively. Sensitivity: the "size of the effect" at a month from starting treatment for hypertension was 0.40. Hypertension for over 10 years, more organs affected, gravity and morbid obesity were associated with worse quality of life, especially in the state-of-mind dimension. Cardiac frequency correlated closer with state of mind than somatic manifestations. CONCLUSIONS: The HQALY is the first specific hypertension questionnaire developed in Spain which has been shown valid, reliable and sensitive to changes. However, the number of items on it must be reduced for routine use in clinical practice.