Validación aparente de un Instrumento para la Notificación de Eventos Adversos Asociados a la Atención de la Salud / Apparent validation of a Health Care Adverse Event Notification Instrument

Resumen El objetivo de este estudio fue validar la apariencia de un instrumento de notificación de eventos adversos (EA) basado en el "Sistema de Notificación y Aprendizaje para la Seguridad del Paciente" propuesto por el Ministerio de Sanidad Español, desde la percepción de enfermeras y enfermeros de las Áreas de Medicinas y Cirugías del Hospital Rafael Ángel Calderón Guardia durante el I semestre del año 2017. A partir de un diseño cualitativo, participaron en la validación aparente del instrumento 15 enfermeros(as). No se registraron aportes en cuanto a la redacción y la secuencia lógica de la información. Se agregaron tres ítemes. Lo anterior, al considerar que las ideas expresadas estuvieran en concordancia con los principios de voluntariedad de la notificación, la no punibilidad, la confidencialidad, la orientación sistémica, la promoción del análisis para el aprendizaje y la implementación de mejoras. Se concluye que el instrumento es considerado adecuado para la notificación de eventos adversos asociados a la atención de la salud en dicho centro hospitalario.

Abstract The objective of this study was to validate the appearance of an adverse event notification (EA) instrument based on the "System of Notification and Learning for Patient Safety" proposed by the Spanish Ministry of Health, from the perception of nurses of the Medicine and Surgery Areas of the Rafael Ángel Calderón Guardia Hospital during the first semester of 2017. Based on a qualitative design, 15 nurses participated in the apparent validation of the instrument. No contributions were recorded regarding the writing and logical sequence of the information. Three items were added. The foregoing, considering that the ideas expressed were in accordance with the principles of voluntary reporting, non-punishability, confidentiality, systemic orientation, promotion of analysis for learning and implementation of improvements. It is concluded that the instrument is considered adequate for the notification of adverse events associated with health care in that hospital center.

Resumo O objetivo deste estudo foi validar o aparecimento de um instrumento de notificação de eventos adversos (EA) baseado no "Sistema de Notificação e Aprendizado para Segurança do Paciente" proposto pelo Ministério da Saúde da Espanha, a partir da percepção dos enfermeiros. das Áreas de Medicina e Cirurgia do Hospital Rafael Ángel Calderón Guardia durante o primeiro semestre de 2017. Com base em um desenho qualitativo, 15 enfermeiros participaram da aparente validação do instrumento. Não foram registradas contribuições quanto à escrita e sequência lógica das informações. Três itens foram adicionados. O exposto, considerando que as idéias expressas estavam de acordo com os princípios de denúncia voluntária, não punibilidade, confidencialidade, orientação sistêmica, promoção de análises para aprendizado e implementação de melhorias. Conclui-se que o instrumento é considerado adequado para a notificação de eventos adversos associados aos cuidados de saúde naquele centro hospitalar.

Motor skills assessments: support for a general motor factor for the Movement Assessment Battery for Children-2 and the Bruininks-Oseretsky Test of Motor Proficiency-2 / Avaliação de habilidades motoras: suporte a um fator motor geral para o Movement Assessment Battery for Children-2 e o Bruininks-Oseretsky Test of Motor Proficiency-2

Abstract Objective To evaluate the construct validity and model-based reliability of general and specific contributions of the subscales of the Movement Assessment Battery for Children-2 (MABC-2) and Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) when evaluating motor skills across a range of psychiatric disorders. Methods Confirmatory factor analysis (CFA) and bifactor analysis were conducted on BOT-2 data from 187 elementary school students (grades 1 to 6) (mean age: 113 ± 20 months; boys: n = 117, 62.56%) and on MABC-2 data from 127 elementary school students (grade 1) (mean age: 76 ± 2 months; boys: n = 58, 45.67%). Results The results of the CFA fit the data for multidimensionality for the BOT-2 and presented poor fit indices for the MABC-2. For both tests, the bifactor model showed that the reliability of the subscales was poor. Conclusions The BOT-2 exhibited factorial validity with a multidimensional structure among the current samples, but the MABC-2 showed poor fit indices, insufficient to confirm its multidimensional structure. For both tests, most of the reliable variance came from a general motor factor (M-factor), therefore the scoring and reporting of subscale scores were not justified for both tests.

Resumo Objetivo Avaliar a validade de construto e a confiabilidade das subescalas do Movement Assessment Battery for Children-2 (MABC-2) e do Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) com base em modelos das contribuições gerais e específicas ao avaliar habilidades motoras em transtornos psiquiátricos. Métodos Foram realizadas análise fatorial confirmatória (AFC) e análise bifatorial em dados de 187 escolares do primeiro ao sexto ano do ensino fundamental (idade média: 113 ± 20 meses; meninos: n = 117, 62,56%) que foram avaliados com o BOT-2, e em dados de 127 escolares do primeiro ano do ensino fundamental (idade média: 76 ± 2 meses; meninos: n = 58, 45,67%) avaliados com o MABC-2. Resultados Os resultados da AFC apresentaram índices de ajuste satisfatórios de multidimensionalidade para o BOT-2 e apresentaram índices de ajuste insatisfatórios para o MABC-2. Para ambos os testes, o modelo bifatorial mostrou que a confiabilidade das subescalas era ruim. Conclusão O BOT-2 apresentou validade fatorial com uma estrutura multidimensional entre as amostras utilizadas, mas o MABC-2 apresentou índices de ajuste insatisfatórios, insuficientes para confirmar sua estrutura multidimensional. Para ambos os testes, a maior parte da variância confiável veio de um fator motor geral (fator-M), portanto, a pontuação e o relato dos escores das subescalas não se justificaram para ambos os testes.

Quality Evaluation of Domestic Pharmacoeconomic Literatures Based on PEERs in Recent Years / 中国药房

OBJECTIVE： To investigate current status and quality of domestic pharmacoeconomic literatures， and to provide reference for the standardization of pharmacoeconomic research. METHODS： Retrieved from CNKI， Wanfang， VIP and other database， the pharmacoeconomic literatures published from Jan. 2017 to May 2018 were collected. The qualities of literatures were evaluated with Guidelines for Quality Evaluation of Pharmacoeconomics Evaluation Reports （“PEERs” for short）. RESULTS： Totally 160 domestic pharmacoeconomic research literatures were included. The results of PEERs evaluation showed of which the coincidence rate was 32.5％ （52/160）. The literatureswhich were in full compliance （the report had a certain reference value） accounted for 1.3％ （2/160）， which were in basic compliance （the report had certain reference value after being revised） accounted for 31.3％（50/160），which were in non-conformity （the report did not had reference value） accounted for 67.5％（108/160）. Domestic pharmacoeconomic researches were of high quality in terms of research object， evaluation method and content，research purpose，  research design and design type， etc.； but the researches were of low quality in terms of research angle， incremental cost/incremental output analysis， sensitivity analysis and other aspects， and there was no explanation or unclear elaboration. CONCLUSIONS： The quality of domestic pharmacoeconomic research literatures are uneven， and their research quality needs to be further improved. It is recommended to standardize the evaluation of pharmacoeconomics， making the evaluation of pharmacoeconomics more scientific and objective.

Study on the Disclosure System of the Evaluation and Approval Information of Medical Device Review in Japan / 中国医疗器械杂志

In order to carry out the "opinions on deepening the reform of the evaluation and approval system and encouraging the innovation of drugs and medical devices" and push on governing by law, it is imperative to disclose the evaluation and approval information of medical device and protect citizens' right to know and right to supervision. In addition, while protecting the applicants' business secrets and technical secrets, the disclosure of technical evaluation reports will also help to break down technical barriers and promote the development of medical device industry in China that will be connecting with the world. Therefore, through the study on the disclosure system of the evaluation and approval information of medical device review in Japan, it provides references for disclosure of the evaluation and approval information of medical device in our country.

La autoevaluacinn de la carrera, una via para el mejoramiento de la calidad academica / Self- evaluation of the career, a road for the improvement of the academic quality

En América Latina, incluyendo Cuba, se observa un incremento cuantitativo de los procesos de evaluación y la calidad se ha convertido en tema de preocupación por parte de las instituciones. La experiencia mundial combina mecanismos de autoevaluación y de evaluación externa, en la casi totalidad de sistemas de acreditación, aunque se reconoce que la autoevaluación es una de las formas más adecuadas para asegurar el avance constante hacia una mayor calidad. Pretendimos como objetivos de este trabajo: proponer las principales etapas por las que debe transitar la autoevaluación, así como argumentar la estructura que debe tener el informe de autoevaluación. A partir de la bibliografía consultada y de nuestra propia experiencia, hicimos la propuesta de cinco etapas en el proceso de autoevaluación:1) fase preparatoria, 2) recopilación de información a partir de indicadores seleccionados previamente, 3) interpretación y valoración de la información obtenida, 4) elaboración del plan mejora derivado de las fortalezas y debilidades identificadas previamente,5) fase de monitoreo y seguimiento de la implementación del plan de acción. En relación con la estructura del informe de la autoevaluación se propone la siguiente: Presentación, Introducción, Características del proceso de la autoevaluación, Síntesis evaluativa, Anexos, Plan de Mejoras.

A quantitative increase in the evaluation process is observed in Latin America including Cuba. Quality has become an important topic in different institutions. In the system of accreditation, world experience combines self- evaluation mechanism and external evaluation; although it is recognized that self-evaluation is one of the most adequate form to ensure the constant advance to a higher quality. The objective of this work is to suggest the principal phases of self-evaluation, and at the same time to justify the structure that the self-evaluation report should have. Taking into consideration the bibliographic review and our own experience, five steps in the evaluation process were proposed: 1) preparatory phase, 2) collecting information according to the previous indicator selected, 3) analysis and assessment of the information obtained, 4) elaboration of the plan as a result of the strengthens and weakness previously identified, 5) monitored and followed phase of the action plan implementation. In relation to the structure of the self-evaluation report, the following aspects are suggested: Presentation, Introduction, Characteristics of the self-evaluation process, Evaluative Synthesis, Appendices, Plan to be better.