Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries / Miocarditis asociada a la clozapina en la base de datos de farmacovigilancia de la Organización Mundial de la Salud: atención a los reportes de los diferentes países

Introduction: The incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies. Methods: On January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients. The 3572 individual reports were studied using the standard VigiBase logarithmic measure of disproportionality called information component (IC). The IC measures the disproportionality between the expected and the reported rates. After duplicates were eliminated there were 3274 different patients with myocarditis studied in logistic regression models. Results: The first case was published in 1980 but since 1993 the VigiBase clozapine-myocarditis IC has been significant; moreover, currently it is very strong (IC=6.0, IC005–IC995=5.9–6.1) and statistically significantly different from other antipsychotics. Of the 3274 different patients with myocarditis, 43.4% were non-serious cases, 51.8% were serious but non-fatal, and 4.8% were fatal. More than half (1621/3274) of the reports came from Australia, of which 69.2% were non-serious, 27.7% serious but non-fatal, and 3.1% fatal. Asian countries contributed only 41 cases. Conclusions: In pharmacovigilance studies, confounding factors may explain statistical associations, but the strength and robustness of these results are compatible with the hypothesis that myocarditis is definitively associated with early clozapine treatment (84% [1309/1560] and 5% [82/1560] in the first and second months). Myocarditis reports from Australia are over-represented to a major degree. Asian countries may be underreporting myocarditis to their drug agencies. (AU)

Introducción: La incidencia de la miocarditis asociada a clozapina varía en cada país, y esta variación se exploró en VigiBase™, la base de datos de la Organización Mundial de la Salud con más de 25 millones de reportes de reacciones adversas a medicamentos de 145 agencias nacionales de medicamentos. Métodos: El 15 de enero del 2021, se llevó a cabo una búsqueda en VigiBase™ de las miocarditis y clozapina. El componente de información (CI) que es una medida logarítmica de desproporción se usó para estudiar los 3.752 reportes. Con modelos de regresión logística se estudió 3.274 pacientes diferentes después de eliminar los duplicados. Resultados: El primer caso fue publicado en 1980, pero desde 1993 el CI ha sido significativo; ahora es muy alto (CI=6,0; CI005-CI995=5,9-6,1), y estadísticamente significativo de otros antipsicóticos. En los 3.274 pacientes: el 43,4% de los casos fueron no graves, el 51,4% fueron casos graves, pero no letales y el 4,8% fueron casos letales. Australia contribuyó a más de la mitad de los casos (1.621/3.274): con un 69,2% de casos no graves, un 27,7% de casos graves, pero no letales y un 3,1% de casos letales. Cuarenta y un casos fueron de países de Asia. Conclusiones: Los factores de confusión pueden explicar asociaciones estadísticas pero el tamaño y la consistencia de estos resultados son compatibles con que la miocarditis está definitivamente asociada con el tratamiento inicial de la clozapina (el 84% [1.309/1.560] fueron durante el primer mes y otro 5% [82/1.560] durante el segundo). Australia está excesivamente representada, mientras que los países de Asia parecen reportar pocos casos a sus agencias de medicamentos. (AU)

The duty to care and nurses' well-being during a pandemic.

BACKGROUND: The coronavirus disease 2019 pandemic is impacting the delivery of healthcare worldwide, creating dilemmas related to the duty to care. Although understanding the ethical dilemmas about the duty to care among nurses is necessary to allow effective preparation, few studies have explored these concerns. AIM: This study aimed to identify the ethical dilemmas among clinical nurses in Spain and Chile. It primarily aimed to (1) identify nurses' agreement with the duty to care despite high risks for themselves and/or their families, (2) describe nurses' well-being and (3) describe the associations between well-being and the duty to care. RESEARCH DESIGN: Cross-sectional self-reported anonymous data were collected between May and June 2020 via electronic survey distribution (snowball sampling). ETHICAL CONSIDERATIONS: The Institutional Ethical Review Committees in both countries approved the study (CHUC_2020_33 and 27/2020). FINDINGS: In total, 345 clinical nurses answered the primary question about the duty to care for the sick. Although in the total sample 77.4% agreed they have a duty to care for the sick, significant differences were found between the Spanish and Chilean samples. Overall, 53.6% of the nurses reported low levels of well-being; however, among those reporting low well-being, statistically significant differences were found between Spanish and Chilean nurses as 19.4% and 37.8%, respectively, disagreed with the statement regarding the duty to care. DISCUSSION: Participants in both countries reported several ethical dilemmas, safety fears, consequent stress and low well-being. These results suggest that prompt actions are required to address nurses' ethical concerns, as they might affect their willingness to work and psychological well-being. CONCLUSION: Our findings shed light on the ethical dilemmas nurses are facing related to the duty to care. Not only has the coronavirus disease 2019 pandemic given rise to ethical challenges, but it has also affected nurses' well-being and willingness to work during a pandemic.

Assessment of shared decision-making in community mental health care: Validation of the CollaboRATE / Evaluación de la toma de decisiones compartidas en la atención comunitaria de salud mental: validación de CollaboRATE

BACKGROUND/OBJECTIVE: CollaboRATE is a 3-item self-report measure of the patient experience of shared decision-making (SDM) process. The objective of this study is to assess the psychometric properties of CollaboRATE in community mental health care. METHOD: A cross-sectional study was conducted at a Community Mental Health Center of the Canary Islands Health Service. Two hundred and fifty consecutive psychiatric outpatients were invited to participate. Of those, 191 accepted (76.40% of response rate) and completed the CollaboRATE, the Control Preferences Scale (CPS), and a form with sociodemographic and clinical variables. RESULTS: Exploratory factor analysis ratified the unidimensionality of the measure. High internal consistency was found (Alpha Cronbach = .95, Guttman's Lambda = .93, and Omega = .95). Strong positive correlations (p < .0001) were found between the CollaboRATE and the CPS. Only 39.80% of respondents gave the best possible score on CollaboRATE. CONCLUSIONS: This study provides evidence for the reliability and validity of the Spanish version of the CollaboRATE as a measure of SDM. The measure is quick to complete and feasible for use in outpatient mental health care. At present, a significative number of psychiatric outpatients are not involved in SDM. The use of this measure in psychiatric routine care can be a key tool in assessing and implementing SDM

ANTECEDENTES/OBJETIVO: CollaboRATE es un autoinforme de tres ítems que permite al paciente valorar su experiencia en la toma de decisiones compartidas (TDC) sobre su tratamiento. El objetivo de este estudio fue evaluar las propiedades psicométricas de CollaboRATE en la atención comunitaria de salud mental. MÉTODO: Se realizó un estudio transversal en una Unidad de Salud Mental del Servicio Canario de la Salud. Doscientos cincuenta pacientes psiquiátricos ambulatorios consecutivos fueron invitados a participar y 191 aceptaron (76,40%). Los pacientes completaron el CollaboRATE, la Escala de Preferencias de Control (EPC), y un formulario con variables sociodemográficas y clínicas. RESULTADOS: El análisis factorial exploratorio ratificó la unidimensionalidad de la medida. Se encontró una alta consistencia interna (alfa Cronbach = 0,95; Guttman's lambda = 0,93; y omega = 0,95). Se registraron significativas correlaciones positivas (p < 0,0001) entre CollaboRATE y el EPC. Solo el 39,80% de los encuestados dieron la mejor puntuación posible en CollaboRATE. CONCLUSIONES: La versión en español de CollaboRATE es una medida fiable y válida de TDC, rápida de completar y factible para su uso en Psiquiatría comunitaria. En la actualidad, pocos pacientes psiquiátricos son involucrados en TDC. CollaboRATE puede ser una herramienta clave para evaluar e implementar la TDC en la atención psiquiátrica ambulatoria

Predictive validity of the Sidorkiewicz instrument in Spanish: Assessing individual drug adherence in psychiatric patients / Validez predictiva del instrumento de Sidorkiewicz en español: valorando la adherencia a cada fármaco individual

Background/Objective: Concomitant prescription of two or more psychiatric medications has become the rule and patients could adhere differently to their various drugs prescribed. Sidorkiewicz et al. published a questionnaire for assessing adherence to each specific drug. Method: This study explored the predictive validity of the Spanish version of the Sidorkiewicz questionnaire in a sample of 470 consecutive psychiatric outpatients using 897 psychiatric drugs. Results: The questionnaire showed adequate predictive validity in both univariate and multivariate analyses (logistic regression and CHAID segmentation) since they demonstrated a significant association with the 10-item Drug Attitude Inventory and with the Necessity and Concern Scales of the Beliefs about Medications Questionnaire. Some demographic and clinical variables were significant in the univariate analyses but lost significance in the multivariate analyses. Conclusions: The adherence of the psychiatric patient to his/her prescribed treatment may not be significantly influenced by socio-demographic or clinical characteristics, but rather by attitudes toward medication, perceptions of personal necessity for medication, and concerns about its potential adverse effects. This study's findings suggest that the Spanish version of the Sidorkiewicz questionnaire may be a useful and valid instrument for assessing adherence to each individual drug taken by psychiatric outpatients undergoing polypsychopharmacy

Antecedentes/Objetivo: La prescripción concomitante más de un psicofármaco en un mismo paciente se ha convertido en la regla de la práctica clínica psiquiátrica actual, pudiendo adherirse los pacientes de manera diferente a sus diversos fármacos prescritos. Sidorkiewicz y colaboradores publicaron un cuestionario para evaluar la adherencia a cada fármaco tomado por el paciente. Método: Este estudio valora la validez predictiva de la versión española del cuestionario de Sidorkiewicz en una muestra de 470 pacientes ambulatorios psiquiátricos consecutivos que usaban 897 fármacos psiquiátricos. Resultados: El cuestionario mostró una adecuada validez predictiva, tanto en análisis univariados como multivariados (regresión logística y CHAID), registrándose asociaciones significativas con el DAI-10 y con las escalas de Necesidad y Preocupación del BMQ. Algunas variables sociodemográficas y clínicas fueron significativas en el análisis univariado perdiendo su significación en el multivariado. Conclusiones: La adherencia del paciente psiquiátrico al tratamiento no está condicionada por características sociodemográficas o clínicas, sino por actitudes hacia la medicación y por las percepciones de necesidad personal de la medicación y preocupaciones sobre sus posibles efectos adversos. La versión española del cuestionario de Sidorkiewicz es un instrumento válido para evaluar la adherencia a cada fármaco tomado por pacientes psiquiátricos ambulatorios polimedicados

Validation of the General Self-Efficacy Scale in psychiatric outpatient care / Validación de la Escala General de Autoeficacia en pacientes con trastornos mentales

BACKGROUND: Self-efficacy has been used to explain and predict human characteristics in different domains, including health behavior. The aim of this paper is to study the internal consistency, components, and convergent validity of the Spanish version of the General Self-Efficacy Scale (GSE) in psychiatric outpatients. METHODS: A convenience sample of 966 consecutive psychiatric out patients completed in 2014 the Spanish versions of the General Self-Efficacy Scale (GSE), Form C of the Multidimensional Health Locus of Control Scale (MHLC-C), the Hong Psychological Reactance Scale (HPRS), the Drug Attitude Inventory (DAI-10), and a questionnaire including socio-demographic and clinical variables. RESULTS: The GSE scale attained high internal consistency. Principal component analysis produced a general one-component solution. This structure accounted for more than 50% of the common variance. Further analyses yielded significant results with health locus of control dimensions, attitudes toward psychiatric treatment, age, and affective psychological reactance, but not with other socio-demographic or clinical variables. CONCLUSIONS: The structure of the General Self-efficacy Scale is unidimensional, homogenous and positively related to the constructs examined. The scale is a reliable and valid measure of the perception of self-efficacy in psychiatric outpatient care

ANTECEDENTES: la autoeficacia ha sido utilizada para explicar y predecir las conductas de salud. El objetivo de este trabajo es estudiar la consistencia interna, componentes y la validez convergente de la escala general de Autoeficacia (GSE) en pacientes psiquiátricos. MÉTODO: una muestra de conveniencia de 966 pacientes psiquiátricos ambulatorios consecutivos cumplimentó, a lo largo del año 2014, las versiones en español de la GSE, del Formulario C de la escala Multidimensional de Locus de Control de Salud, la escala de Reactancia Psicológica de Hong, el Inventario de Actitudes hacia la Medicación, y un cuestionario con variables socio-demográficas y clínicas. RESULTADOS: la consistencia interna de la escala GSE fue alta. El análisis de componentes principales ofreció una solución de un único componente, explicando más del 50% de la varianza común. Se registraron relaciones significativas con el locus de control de salud, las actitudes hacia la medicación, la edad y la reactancia psicológica afectiva, pero no con otras variables socio-demográficas o clínicas estudiadas. CONCLUSIONES: la estructura de la escala general de auto-eficacia es unidimensional, homogénea y se relaciona positivamente con los constructos examinados. La escala es una medida fiable y válida en la atención ambulatoria psiquiátrica

Psychometric properties of the eight-item Morisky Medication Adherence Scale (MMAS-8) in a psychiatric outpatient setting / Propiedades psicométricas de la Escala Morisky de Adherencia a los Medicamentos (MMAS-8-ítems) en pacientes psiquiátricos ambulatorios

The eight-item Morisky Medication Adherence Scale (MMAS-8) is a structured self-report measure of medication-taking behavior that has been widely used in various cultures. In Spain, no studies to date have analyzed the psychometric properties of the scale in psychiatric care. The purpose of the present instrumental study was to determine the psychometric properties of the Spanish version of the MMAS-8 in a sample of 967 consecutive psychiatric outpatients. The scale showed adequate construct validity and results pointed to a one-factor solution in which all the items contributed to the final index of adherence. The MMAS-8 exhibited significant correlation coefficients with the 10-item Drug Attitude Inventory, Form C of the Multidimensional Health Locus of Control scale, and the Hong Psychological Reactance Scale. Moreover, the MMAS-8 was able to differentiate between various mental disorder diagnosis groups. The findings of this study suggest that the Spanish version of the MMAS-8 is a reliable and valid measure of medication adherence that can be used in a psychiatric outpatient setting (AU)

La Escala de Adherencia a la Medicación de Morisky-8 ítems (MMAS-8) es una medida auto-informada estructurada de la conducta de toma de la medicación ampliamente utilizada en diferentes culturas. No existen estudios en España que analicen sus propiedades psicométricas en población psiquiátrica. El objetivo de este estudio es determinar las propiedades psicométricas de la versión española de la MMAS-8 en una muestra de 967 pacientes psiquiátricos en régimen ambulatorio. Los resultados mostraron una adecuada validez de constructo, con una clara tendencia a una solución monofactorial, donde todos los ítems colaboraron en el índice final de adherencia. MMAS-8 alcanzó correlaciones significativas con el Inventario de Actitudes hacia la Medicación-10 ítems, con la forma C de la Escala Multidimensional de Locus de Control sobre la Salud y la Escala de Reactancia Psicológica. También la MMAS-8 permitió diferenciar el nivel de adherencia entre diferentes trastornos psicopatológicos. Los hallazgos de este estudio indican que la MMAS-8 es una medida fiable y válida para evaluar la adherencia a la medicación y que puede ser utilizada con muestras de pacientes psiquiátricos (AU)

Versión española consensuada de la Severity of Dependence Scale (SDS) / No disponible

No disponible

Telepsiquiatría: utopía o realidad asistencial / Telepsychiatry: utopia or welfare reality

No disponible