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1.
Medicine (Baltimore) ; 98(44): e17719, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689809

RESUMO

INTRODUCTION: Mixed urinary incontinence (MUI) is a coexistence of both urgency urinary incontinence and stress urinary incontinence. Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire is a validated and commonly used tool to diagnose predominant components of it and assess the severity, which can offer help in clinic. However, MESA questionnaire is still not available in China. The aim of the study is to translate English MESA questionnaire into a Chinese version, adapt it in Chinese culture, and validate the measurement properties among female patients with MUI and urgency-predominant MUI. METHODS: MESA questionnaire will be translated and culturally adapted in China. The validation will be embedded in a multicentered randomized controlled trial targeted at women with urgency-predominant MUI. Apart from MESA questionnaire, 3 groups of patients are to receive clinical extended assessment, keep 3-day voiding diary, and complete International Consultation on Incontinence Questionnaire Short Form to evaluate the measurement properties of reliability and validity (internal consistence, test-retest reliability, construct validity, and responsiveness). DISCUSSION: If MESA questionnaire is of relatively high reliability and validity in diagnosing subtypes of MUI and assessing the severity, it can help to choose more appropriate therapy for patients and simplify the workload of clinicians. TRIAL REGISTRATION: ClinicalTrials.gov NCT03803878, January 11, 2019.


Assuntos
Inquéritos e Questionários/normas , Incontinência Urinária/diagnóstico , Idoso , Envelhecimento/psicologia , Grupo com Ancestrais do Continente Asiático/psicologia , China , Feminino , Humanos , Linguagem , Pessoa de Meia-Idade , Psicometria , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Projetos de Pesquisa , Índice de Gravidade de Doença , Traduções , Incontinência Urinária/psicologia , Estudos de Validação como Assunto
2.
Medicine (Baltimore) ; 98(42): e17323, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31626087

RESUMO

BACKGROUND: Non-adherence can be highlighted as one of the main contributors to the occurrence of adverse events in patients treated with warfarin. The usefulness of self-reporting measures of drug adherence could be improved by following psychometric properties in the development of the measurement scales. Thus, we aimed to describe the protocol of a systematic literature review designed to investigate and describe validated instruments used to assess adherence to warfarin therapy. METHODS: We will perform a systematic review will include observational and experimental studies involving the use of validated instruments to assess adherence to warfarin therapy. Dimensions of adherence raised by the selected studies will be extracted to be compared. We will systematically search electronic databases including MEDLINE, LILACS, EMBASE, and Cochrane Library using a comprehensive strategy from inception to June 31, 2019. Two reviewers will revise the literature independently using a standardized form and assess the potential bias. After the comparison of results, discrepancies will be solved after the analysis of a third reviewer. RESULT: The development of the present systematic will help to summarize and evaluate the validated instruments that have been previously published to assess adherence to warfarin therapy. CONCLUSION: This review will substantiate the discussion of relevant topics that should be assessed while providing care to patients taking warfarin. This knowledge will enable a comprehensive approach for healthcare professionals to improve treatment outcomes and the design of future investigations. REGISTRATION: The systematic review is registered in the PROSPERO international prospective register of systematic review (PROSPERO# CRD42019128324).


Assuntos
Anticoagulantes/uso terapêutico , Adesão à Medicação , Varfarina/uso terapêutico , Administração Oral , Humanos , Revisão Sistemática como Assunto , Estudos de Validação como Assunto
3.
Nat Neurosci ; 22(11): 1751-1760, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31611705

RESUMO

Cognition and behavior emerge from brain network interactions, such that investigating causal interactions should be central to the study of brain function. Approaches that characterize statistical associations among neural time series-functional connectivity (FC) methods-are likely a good starting point for estimating brain network interactions. Yet only a subset of FC methods ('effective connectivity') is explicitly designed to infer causal interactions from statistical associations. Here we incorporate best practices from diverse areas of FC research to illustrate how FC methods can be refined to improve inferences about neural mechanisms, with properties of causal neural interactions as a common ontology to facilitate cumulative progress across FC approaches. We further demonstrate how the most common FC measures (correlation and coherence) reduce the set of likely causal models, facilitating causal inferences despite major limitations. Alternative FC measures are suggested to immediately start improving causal inferences beyond these common FC measures.


Assuntos
Encéfalo/fisiologia , Neuroimagem Funcional/métodos , Modelos Neurológicos , Vias Neurais/fisiologia , Animais , Humanos , Estudos de Validação como Assunto
5.
Actas dermo-sifiliogr. (Ed. impr.) ; 110(7): 554-560, sept. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-185527

RESUMO

Introducción y objetivos: La hidradenitis supurativa (HS) es una enfermedad inflamatoria crónica de la piel que influencia negativamente la calidad de vida. En la actualidad no existen escalas en español que la evalúen. El objetivo del presente estudio fue desarrollar y validar un cuestionario específico para evaluar la calidad de vida en pacientes con HS. Material y métodos: Se desarrolló un estudio multicéntrico en España entre 2016 y 2017 para elaborar un cuestionario. Para ello se consideró tanto el marco conceptual como el conocimiento de la situación del paciente mediante la revisión de la bibliografía, reuniones de profesionales de diferentes áreas y entrevistas con pacientes. El cuestionario resultante se pasó a un grupo de 30 pacientes con 30 ± 10 días de intervalo entre uno y otro. Resultados: El análisis de fiabilidad muestra una buena consistencia interna y reproductibilidad con puntuación alfa de Cronbach de 0,920 (test) y 0,917 (retest) y coeficiente de correlación intraclase con DLQI y Skindex-29 de 0,698 IC 95% (0,456-0,844) y 0,900 IC 95% (0,801-0,951) respectivamente. Se establecieron puntos de corte para su uso y se comprobó que el instrumento es sensible al cambio. Conclusiones: El cuestionario HSQoL-24 es la primera prueba autoadministrada específica para evaluar la calidad de vida en HS en español. Sencillo de usar y puntuar por los profesionales. Este estudio demuestra que el instrumento es fiable, válido y sensible al cambio, pendiente de realizar estudio confirmatorio con una muestra mayor con 100 pacientes con HS


Introduction and objectives: Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the skin with a negative impact on quality of life. Up to now, there are no disease specific instruments in Spanish to assess quality of life in HS. The objective of this study was to develop and validate a questionnaire to evaluate the quality of life in patients with HS. Material and methods: A multicentre study was carried out in Spain between 2016 and 2017 to develop the questionnaire. Both the conceptual framework and understanding of the patient's situation were considered through a review of the literature, consensus of professionals from different related health areas, and in-depth interviews with patients. The resulting questionnaire was passed to a group of 30 patients with 30±10 days of interval between both assessments. Results: The reliability analysis shows a good internal consistency and reproducibility with Cronbach's alpha score of 0.920 (test) and 0.917 (retest) and intraclass correlation coefficient with DLQI and Skindex-29 of 0.698 IC 95% (0.456-0.844) and 0.900 IC 95% (0.801-0.951) respectively. Cut-off points were established for its use and the instrument was found to be sensitive to change. Conclusions: The HSQoL-24 is the first disease-specific self-administered instrument to assess quality of life in patients with HS in Spanish. It is user friendly, and easy to score. This study shows that the instrument is reliable, valid and sensitive to change, pending confirmatory study with a larger sample of 100 patients with HS


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Hidradenite Supurativa/diagnóstico , Qualidade de Vida , Estudos de Validação como Assunto , Psicometria/instrumentação , Reprodutibilidade dos Testes , Inquéritos e Questionários , Correlação de Dados
6.
Actas dermo-sifiliogr. (Ed. impr.) ; 110(7): 561-584, sept. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-185528

RESUMO

Objetivo: Revisar la bibliografía sobre instrumentos específicos de medida de los resultados percibidos por los pacientes (patient reported outcomes, PRO) validados y utilizados en población española con psoriasis, valorar sus propiedades psicométricas y describir los resultados de su aplicación práctica. Materiales y métodos: Revisión sistemática de la literatura científica en bases de datos internacionales (PubMed/Medline) y nacionales (Medes, Ibecs) referente a estudios que validen o implementen instrumentos específicos de valoración de PRO en población española con psoriasis. Se completó la búsqueda en bases de datos específicas de instrumentos para medir PRO (BiblioPRO, PROQOLID). Se incluyeron los estudios publicados en inglés o español hasta el 01/09/2017. Adicionalmente, se revisaron las listas de referencias bibliográficas de las publicaciones clave identificadas. La valoración de la calidad metodológica de los cuestionarios se efectuó con base en sus propiedades psicométricas (constructo, adaptación transcultural, fiabilidad, validez, factibilidad y sensibilidad al cambio). Resultados: Se seleccionaron 18 publicaciones. Seis artículos describieron la validación al español de 5 instrumentos de PRO: 4 cuestionarios de calidad de vida relacionada con la salud (CVRS) específicos de psoriasis/enfermedades dermatológicas y un cuestionario específico de satisfacción con el tratamiento. La valoración psicométrica muestra variabilidad en los criterios alcanzados por cada instrumento; el cuestionario de CVRS PSO-LIFE resultó el más completo. Los 12 artículos restantes correspondían a estudios observacionales que empleaban los instrumentos validados. Su utilización muestra un elevado impacto de la psoriasis en la CVRS, especialmente en pacientes jóvenes, de género femenino y con enfermedad grave. Conclusiones: Se han identificado 5 instrumentos específicos validados en España para valorar los PRO en pacientes con psoriasis. Dada la variedad de sus propiedades psicométricas, resulta esencial conocer las fortalezas y debilidades de cada uno para seleccionar el instrumento apropiado para cada situación. El empleo de estos cuestionarios pone de manifiesto el elevado impacto de la enfermedad en la CVRS de los pacientes. La evaluación de los PRO en el paciente con psoriasis complementa los resultados clínicos tradicionales y puede contribuir a un manejo más óptimo de la enfermedad


Objectives: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. Material and methods: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). Results: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools’ psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. Conclusions: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management


Assuntos
Humanos , Medidas de Resultados Relatados pelo Paciente , Psoríase , Avaliação de Processos e Resultados (Cuidados de Saúde)/métodos , Estudos de Validação como Assunto , Inquéritos e Questionários , Qualidade de Vida , Bibliometria
7.
Int J Equity Health ; 18(1): 131, 2019 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-31438952

RESUMO

BACKGROUND: The presence of insufficient effort responding participants (IERPs) in a survey can produce systematic bias. Validation questions are commonly used to exclude IERPs. Participants were defined as IERPs if responding inconsistently to two matched validation questions, and non-insufficient effort responding participants (non-IERPs) if responding consistently. However, it has not been tested whether validation questions themselves could result in selection bias. METHODS: This study was a cross-sectional survey conducted in Guangxi, China. Participants' intentions to use antibiotics for their children when they have self-limiting diseases, including sore throat, cold, diarrhea, and fever, were measured. The Chi-square tests were used to compare the socio-economic status (SES) between non-IERPs and IERPs. Logistic regression was adopted to test the association between intentions to misuse antibiotics and groups (non-IERPs, IERPs with high SES, and IERPs with low SES). RESULTS: Data with 3264 non-IERPs and 1543 IERPs were collected. The results showed IERPs had a lower education level (χ2 = 6.100, p = 0.047) and a higher proportion of rural residence (χ2 = 4.750, p = 0.030) compared with non-IERPs. Rural IERPs reported significantly higher rates of intentions to misuse antibiotics when their children have a sore throat (OR = 1.32; 95% CI = 1.11,1.56; p < 0.01), cold (OR = 1.33; 95%CI = 1.13,1.58; p < 0.01), diarrhea (OR = 1.46; 95%CI = 1.20,1.77; p < 0.001), and fever (OR = 1.22; 95% CI = 1.04,1.43; p < 0.05) compared with non-IERPs. IERPs living in urban areas reported significantly lower rates of intentions to use antibiotics when their children have a sore throat (OR = 0.76; 95%CI = 0.62,0.93; p < 0.01) compared with non-IERPs. IERPs with lower levels of education reported significantly higher rates of intentions to use antibiotics when their children have a sore throat (OR = 1.19; 95%CI = 1.02,1.39; p < 0.05), cold (OR = 1.43; 95% CI = 1.23,1.66; p < 0.001), diarrhea (OR = 1.38; 95%CI = 1.15,1.64; p < 0.01), and fever (OR = 1.25; 95% CI = 1.09,1.44; p < 0.01) compared with non-IERPs. IERPs with higher education levels reported significantly lower rates of intentions to use antibiotics when their children have a sore throat (OR = 0.72; 95% CI = 0.56,0.94; p < 0.05), cold (OR = 0.66; 95% CI = 0.51,0.86; p < 0.01), and fever (OR = 0.74; 95% CI = 0.60,0.92; p < 0.01) compared with non-IERPs. IERPs with low-income reported significantly higher rates of intentions to use antibiotics when their children have a cold (OR = 1.36; 95% CI = 1.13,1.64; p < 0.01) and diarrhea (OR = 1.30; 95% CI = 1.05,1.62; p < 0.05) compared with non-IERPs. CONCLUSIONS: Using validation questions to exclude IERPs can result in selection bias in which participants with lower socio-economic standing and poor antibiotic use intentions were disproportionately excluded.


Assuntos
Antibacterianos/uso terapêutico , Inquéritos Epidemiológicos/normas , Intenção , Pais , Viés de Seleção , Adolescente , Adulto , Criança , Pré-Escolar , China , Resfriado Comum/tratamento farmacológico , Estudos Transversais , Diarreia/tratamento farmacológico , Feminino , Febre/tratamento farmacológico , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Faringite/tratamento farmacológico , População Rural , Classe Social , Estudos de Validação como Assunto
8.
Rev. chil. nutr ; 46(4): 477-484, ago. 2019. tab
Artigo em Espanhol | LILACS | ID: biblio-1013813

RESUMO

RESUMEN Validar instrumentos de medición de datos es fundamental para constituir conocimiento certero y objetivo respecto a los hábitos en ingesta alimentaria. El artículo pretende adaptar y validar para el contexto de educación superior un cuestionario que originalmente es de atención primaria, y que se transforme en un insumo válido para medir hábitos alimentarios en estudiantes universitarios. Basados en un cuestionario validado por Pino, Díaz y López en el 2011, se ajustaron las preguntas para un contexto de educación terciaria. El instrumento se aplicó a una muestra estratificada de 405 estudiantes de pregrado de una universidad perteneciente al Consejo de Rectores de Chile (CRUCH) de la región del Maule. Los datos fueron procesados mediante el paquete estadístico SPSS 20, y contó con los respectivos resguardos éticos mediante consentimiento informado firmado. Siguiendo los pertinentes análisis estadísticos para la validación del instrumento, podemos dar cuenta de un cuestionario confiable y aceptable (α= 0,815), estableciéndose 10 dimensiones con 35 preguntas. Se concluye un instrumento válido y adaptado para ser aplicado en estudiantes con el fin de identificar sus hábitos alimentarios en educación superior.


ABSTRACT Validating data measurement instruments is essential to establish accurate and objective knowledge regarding dietary habits. This article aims to adapt and validate a questionnaire to measure dietary habits originally designed for the primary care setting for use in the context of higher education. Based on a questionnaire validated by Pino, Díaz and López in 2011, the questions were adjusted for a tertiary education context. The instrument was applied to a sample of 405 undergraduate students of a university belonging to the Council of Rectors of Chile (CRUCH) of the Maule region, stratified by college year. Data were analysed using SPSS 20; signed informed consent was obtained. Following the relevant statistical analysis for the validation of an instrument, 10 dimensions with 35 questions were established. Results indicated that the instrument is trustworthy and acceptable (α= 0.815). We conclude that the instrument is a valid adaptation and can be applied to higher education students in order to identify their eating habits.


Assuntos
Humanos , Chile , Inquéritos Nutricionais , Educação Superior , Estudos de Validação como Assunto , Comportamento Alimentar , Inquéritos e Questionários
9.
Int. j. cardiovasc. sci. (Impr.) ; 32(4): 331-342, July-Aug. 2019. tab, graf, ilus
Artigo em Inglês | LILACS | ID: biblio-1012349

RESUMO

Cardiorespiratory (aerobic) fitness is strongly and directly related to major health outcomes, including all-cause mortality. Maximum oxygen uptake (VO2max), directly measured by maximal cardiopulmonary exercise test (CPET), represents the subject's aerobic fitness. However, as CPET is not always available, aerobic fitness estimation tools are necessary. Objectives: a) to propose the CLINIMEX Aerobic Fitness Questionnaire (C-AFQ); b) to validate C-AFQ against measured VO2max; and c) to analyze the influence of some potentially relevant variables on the error of estimate. Methods: We prospectively studied 1,000 healthy and unhealthy subjects (68.6% men) aged from 14 to 96 years that underwent a CPET. The two-step C-AFQ describes physical activities with corresponding values in metabolic equivalents (METs) - ranging from 0.9 to 21 METs. Results: Application of C-AFQ took less than two minutes. Linear regression analysis indicated a very strong association between estimated (C-AFQ) and measured (CPET) maximal METs - r2 = 0.83 (Sy.x = 1.63; p < .001) - with median difference of only 0.2 METs between both values and interquartile range (percentiles 25 and 75) of 2 METs. The difference between estimated and measured METs was not influenced by age, sex, body mass index, clinical condition, ß-blocker use or sitting-rising test scores. Conclusion: C-AFQ is a simple and valid tool for estimating aerobic fitness when CPET is unavailable and it is also useful in planning individual ramp protocols. However, individual error of estimate is quite high, so C-AFQ should not be considered a perfect substitute for CPET's measured VO2max


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Exercícios Respiratórios , Exercício , Estudos de Validação como Assunto , Aptidão Física , Análise Estatística , Estudos Prospectivos , Inquéritos e Questionários , Análise de Variância , Teste de Esforço/métodos , Terapia por Exercício , Hipertensão
11.
Rev Bras Enferm ; 72(3): 780-787, 2019 Jun 27.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31269146

RESUMO

OBJECTIVE: to describe the validation of the booklet on self-care with the feet of people with diabetes. METHOD: methodological study, focusing on the validation of a printed booklet. The content and appearance of the booklet was validated by 23 judges divided into three groups: 11 content and appearance, seven technicians and five of the area of design and marketing. The appearance was validated by 30 people with type 2 Diabetes Mellitus. RESULTS: the judges in the nursing area allowed the validation of material with a Content Validity Index (CVI) of 0.99, judges in the area of design and marketing with Suitability Assessment of Materials (SAM) of 99.2% and the target audience with concordance index of 99.4%. CONCLUSION: the educational booklet proved to be valid and reliable educational material to be used in order to promote compliance with self-care with the feet of people with Diabetes Mellitus.


Assuntos
Pé Diabético/terapia , Folhetos , Educação de Pacientes como Assunto/normas , Autocuidado/instrumentação , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/psicologia , Diabetes Mellitus Tipo 2/terapia , Pé Diabético/psicologia , Humanos , Educação de Pacientes como Assunto/métodos , Autocuidado/métodos , Autocuidado/normas , Inquéritos e Questionários , Estudos de Validação como Assunto
12.
Rev. bras. educ. méd ; 43(3): 54-61, jul.-set. 2019. tab, graf
Artigo em Português | LILACS, Repositório RHS | ID: biblio-1003441

RESUMO

RESUMO As desordens do sistema musculoesquelético representam entre 10-25% do motivo das consultas na atenção primária, mas apenas um pequeno percentual do currículo da graduação é dedicado ao estudo desse assunto. Assim, é necessário desenvolver instrumentos objetivos para avaliar essa deficiência na escola médica. O questionário de Freedman e Bernstein é uma ferramenta validada internacionalmente para avaliação dos conhecimentos médicos básicos sobre as desordens musculoesqueléticas e, consequentemente, do ensino durante a formação médica. O objetivo deste estudo foi desenvolver uma versão da escala em língua portuguesa, validada e adaptada transculturalmente para a população brasileira. A tradução e adaptação transcultural do questionário foram conduzidas seguindo as etapas de tradução inicial, retrotradução, composição de uma versão pré-final e seu teste, sendo realizadas as alterações necessárias após essa última fase e a elaboração do modelo final do instrumento. A etapa de teste da versão pré-final consistiu na sua aplicação ao público-alvo da pesquisa - 15 estudantes do último semestre de Medicina. Cada indivíduo respondeu às perguntas do inquérito e, em seguida, foi entrevistado para se analisar o que ele entendeu que era esperado em cada item do questionário. Tanto a interpretação da questão quanto a resposta foram exploradas. Houve dificuldade de compreensão em duas questões, tendo sido preciso substituir alguns termos para facilitar a assimilação. Após as alterações, não houve impedimentos ao entendimento do instrumento final pelos participantes. A validação de conteúdo foi avaliada por um painel de especialistas, que considerou apropriados os termos e a abrangência do questionário traduzido. Essa apreciação foi realizada após o teste final e nenhuma alteração foi recomendada. O questionário encontra-se traduzido para a língua portuguesa, apresentando equivalência semântica, idiomática, conceitual e cultural com o original. Recomenda-se seu uso para a avaliação do ensino das desordens musculoesqueléticas nas escolas de Medicina do País, possibilitando uma comparação do currículo ortopédico brasileiro com os padrões internacionais.


ABSTRACT Disorders of the musculoskeletal system represent between 10-25% of the reasons for consultations in primary care, however, only a small percentage of the undergraduate curriculum is dedicated to the study of this subject. Thus, it is necessary to develop objective instruments to assess this deficiency in medical schools. The Freedman and Bernstein questionnaire is an internationally validated tool for assessing basic medical knowledge of musculoskeletal disorders and, consequently, evaluate medical training. The objective of this study was to develop a version of the scale in the Portuguese language, validated and adapted transculturally for the Brazilian population. Transcultural translation and adaptation of the questionnaire was conducted following the steps of initial translation, back-translation, composition of a pre-final version and its test, making the necessary changes after this last phase and development of the final model of the instrument. The pre-final version was applied to the target audience of the research - 15 students in the last semester of Medicine. Each individual answered the questions from the survey and was then interviewed to analyze their understanding of what was expected in each item of the questionnaire. Both the interpretation of the question and the response were explored. There were difficulties in understanding two questions, making it necessary to substitute some terms to facilitate assimilation. After the changes, there were no impediments to the participants' understanding of the final instrument. Content validation was assessed by a panel of experts who considered the terms and scope of the translated questionnaire appropriate. This assessment was made after the final test and no change was recommended. Thus, the questionnaire is translated into the Portuguese language, presenting semantic, idiomatic, conceptual and cultural equivalence with the original. Its use is recommended for the evaluation of the teaching of musculoskeletal disorders in the country's medical schools, allowing a comparison of the Brazilian orthopedic curriculum with international standards.


Assuntos
Humanos , Educação Médica , Sistema Musculoesquelético , Inquéritos e Questionários , Estudos de Validação como Assunto
13.
Ann Lab Med ; 39(6): 515-523, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31240878

RESUMO

Next-generation sequencing (NGS) is currently used in the clinical setting for targeted therapies and diagnosis of hematologic malignancies. Accurate detection of somatic variants is challenging because of tumor purity, heterogeneity, and the complexity of genetic alterations, with various issues ranging from high detection design to test implementation. This article presents guidelines developed through consensus among a panel of experts from the Korean Society for Genetic Diagnostics. They are based on experiences with the validation processes of NGS-based somatic panels for hematologic malignancies, with reference to previous international recommendations. These guidelines describe basic parameters with emphasis on the design of a validation protocol for NGS-based somatic panels to be used in practice. In addition, they suggest thresholds of key metrics, including minimum coverage, mean coverage with uniformity index, and minimum variant allele frequency, for the initial diagnosis of hematologic malignancies.


Assuntos
Neoplasias Hematológicas/diagnóstico , Sequenciamento de Nucleotídeos em Larga Escala , Frequência do Gene , Neoplasias Hematológicas/genética , Sequenciamento de Nucleotídeos em Larga Escala/normas , Humanos , Limite de Detecção , Mutação , Polimorfismo de Nucleotídeo Único , Controle de Qualidade , Valores de Referência , Reprodutibilidade dos Testes , Estudos de Validação como Assunto
14.
Prensa méd. argent ; 105(5): 259-269, jun 2019. graf, tab
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1024538

RESUMO

El virus Zika, es un arbovirus del género flavivirus (familia Flaviviridae), muy cercano filogenéticamente a virus como el dengue, fiebre amarilla, la encefalitis japonesa, o el virus del Nilo Occidental. El presente estudio es de tipo exploratorio con base en el registro de casos de recién nacidos y lactantes hijos de mujeres embarazadas con infección de virus Zika en la Unidad de Medicina Familiar Nº 60 de Coatzacoalcos, Veracruz, dentro del período de diciembre del 2016 a julio del 2017. Se realizó un estudio polietápico que constó de revisión de casos por medio de uso de expediente clínico en la Consulta Externa en la Unidad Médico Familiar Nº 60 del IMSS de Coatzacoalcos, Veracruz. como primera aproximación epidemiológica en esta región en recién nacidos y lactantes hijos de madres con infección por virus Zika, que posteriormente fueron sometidos a estudios de valoración oftalmológica, neurológica y somatométrica; con ayuda del servicio de Salud Pública de dicha unidad (AU)


Zika virus is an arbovirus of the genusflavivirus (family Flaviviridae), very close phylogenetically to viruses such as denque, yellow fever, japanese encephalitis, or West Nile virus. The present study is exploratory based on the registry of cases of newborns and infants born to pregnant women with zika virus infection in the Family Medicine Unit Nº 60 of Coatzacalcos, Veracruz, within the period of December 2016 to July 2017. A multistage study was carried out that consisted of the review of cases through the use of a clinical file in the Outpatient Consultation in the Family Medical Unit Nº 60 of the IMSS. of Coatzacoalcos, Veracruz. As a first epidemiological approach in this region in newborns and infants born to mothers with Zika virus infection, who were subsequently subjected to ophtalmological, neurological and somatometric assessment studies; with the help of the Public Health service of said unit (AU)


Assuntos
Humanos , Recém-Nascido , Lactente , Prevalência , Estudos Transversais/estatística & dados numéricos , Idade Gestacional , Estudos de Validação como Assunto , Zika virus/imunologia , Infecção por Zika virus/diagnóstico , Infecção por Zika virus/prevenção & controle
15.
Methods Mol Biol ; 1966: 79-99, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31041740

RESUMO

Antibodies are invaluable biological tools that we can use to detect the presence, location, or alteration of nuclear receptors. However, antibodies frequently cross-react with other proteins and their performance can vary from batch to batch, from application to application and from lab to lab. When each lot of antibody is not thoroughly validated for each assay, each sample type, and each lab and user, antibody-based assays can lead to flawed interpretations and reproducibility problems. In this chapter, we describe a scheme for thorough antibody validation, suitable for nuclear receptors. The method is based on using highly characterized positive and negative controls assembled into a validation tissue microarray (TMA). Through correlation of immunohistochemical staining (IHC) and mRNA levels over multiple tissues, use of current public databases, and assessment of binding to intended and nonintended targets using western blotting (WB), immunoprecipitation (IP), and mass spectrometry (MS), we describe a path for thoroughly validation of antibodies.


Assuntos
Anticorpos Monoclonais/análise , Western Blotting/métodos , Imuno-Histoquímica/métodos , Receptores Citoplasmáticos e Nucleares/imunologia , Estudos de Validação como Assunto , Perfilação da Expressão Gênica , Humanos , Espectrometria de Massas , Reprodutibilidade dos Testes , Análise Serial de Tecidos/métodos
16.
JMIR Mhealth Uhealth ; 7(5): e13547, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31124470

RESUMO

BACKGROUND: Activity trackers are now ubiquitous in certain populations, with potential applications for health promotion and monitoring and chronic disease management. Understanding the accuracy of this technology is critical to the appropriate and productive use of wearables in health research. Although other peer-reviewed validations have examined other features (eg, steps and heart rate), no published studies to date have addressed the accuracy of automatic activity type detection and duration accuracy in wearable trackers. OBJECTIVE: The aim of this study was to examine the ability of 4 commercially available wearable activity trackers (Fitbits Flex 2, Fitbit Alta HR, Fitbit Charge 2, and Garmin Vívosmart HR), in a controlled setting, to correctly and automatically identify the type and duration of the physical activity being performed. METHODS: A total of 8 activity types, including walking and running (on both a treadmill and outdoors), a run embedded in walking bouts, elliptical use, outdoor biking, and pool lap swimming, were tested by 28 to 34 healthy adult participants (69 total participants who participated in some to all activity types). Actual activity type and duration were recorded by study personnel and compared with tracker data using descriptive statistics and mean absolute percent error (MAPE). RESULTS: The proportion of trials in which the activity type was correctly identified was 93% to 97% (depending on the tracker) for treadmill walking, 93% to 100% for treadmill running, 36% to 62% for treadmill running when preceded and followed by a walk, 97% to 100% for outdoor walking, 100% for outdoor running, 3% to 97% for using an elliptical, 44% to 97% for biking, and 87.5% for swimming. When activities were correctly identified, the MAPE of the detected duration versus the actual activity duration was between 7% and 7.9% for treadmill walking, 8.7% and 144.8% for treadmill running, 23.6% and 28.9% for treadmill running when preceded and followed by a walk, 4.9% and 11.8% for outdoor walking, 5.6% and 9.6% for outdoor running, 9.7% and 13% for using an elliptical, 9.5% and 17.7% for biking, and was 26.9% for swimming. CONCLUSIONS: In a controlled setting, wearable activity trackers provide accurate recognition of the type of some common physical activities, especially outdoor walking and running and walking on a treadmill. The accuracy of measurement of activity duration varied considerably by activity type and tracker model and was poor for complex sets of activity, such as a run embedded within 2 walking segments.


Assuntos
Acelerometria/classificação , Exercício/psicologia , Fatores de Tempo , Dispositivos Eletrônicos Vestíveis/normas , Acelerometria/instrumentação , Acelerometria/normas , Adolescente , Adulto , Ciclismo/classificação , Ciclismo/fisiologia , Ciclismo/estatística & dados numéricos , Feminino , Monitores de Aptidão Física/classificação , Monitores de Aptidão Física/normas , Monitores de Aptidão Física/estatística & dados numéricos , Humanos , Masculino , Corrida/classificação , Corrida/fisiologia , Corrida/estatística & dados numéricos , Natação/classificação , Natação/fisiologia , Natação/estatística & dados numéricos , Estudos de Validação como Assunto , Caminhada/classificação , Caminhada/fisiologia , Caminhada/estatística & dados numéricos , Dispositivos Eletrônicos Vestíveis/estatística & dados numéricos
17.
Crit Care ; 23(1): 192, 2019 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-31142337

RESUMO

BACKGROUND: Quantification of intrinsic PEEP (PEEPi) has important implications for patients subjected to invasive mechanical ventilation. A new non-invasive breath-by-breath method (etCO2D) for determination of PEEPi is evaluated. METHODS: In 12 mechanically ventilated pigs, dynamic hyperinflation was induced by interposing a resistance in the endotracheal tube. Airway pressure, flow, and exhaled CO2 were measured at the airway opening. Combining different I:E ratios, respiratory rates, and tidal volumes, 52 different levels of PEEPi (range 1.8-11.7 cmH2O; mean 8.45 ± 0.32 cmH2O) were studied. The etCO2D is based on the detection of the end-tidal dilution of the capnogram. This is measured at the airway opening by means of a CO2 sensor in which a 2-mm leak is added to the sensing chamber. This allows to detect a capnogram dilution with fresh air when the pressure coming from the ventilator exceeds the PEEPi. This method was compared with the occlusion method. RESULTS: The etCO2D method detected PEEPi step changes of 0.2 cmH2O. Reference and etCO2D PEEPi presented a good correlation (R2 0.80, P < 0.0001) and good agreement, bias - 0.26, and limits of agreement ± 1.96 SD (2.23, - 2.74) (P < 0.0001). CONCLUSIONS: The etCO2D method is a promising accurate simple way of continuously measure and monitor PEEPi. Its clinical validity needs, however, to be confirmed in clinical studies and in conditions with heterogeneous lung diseases.


Assuntos
Dióxido de Carbono/análise , Respiração por Pressão Positiva Intrínseca/classificação , Animais , Modelos Animais de Doenças , Cinética , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/métodos , Suínos/fisiologia , Estudos de Validação como Assunto
18.
Adv Clin Chem ; 90: 215-281, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31122610

RESUMO

Although the measures to improve quality in the clinical laboratory have been enormous in the past years, not least of all due to the introduction of the ISO standards 15189 and 17025, the handling of validation and verification of method performance often still differs widely from laboratory to laboratory. Much of what is published on the topic contains complex statistics and is difficult to implement in routine laboratories. The result is, that this point is often neglected or implemented incorrectly, which in turn can lead to false conclusions about method performances, potentially compromising patient safety or contributing to incorrect diagnoses. As it has long become a standard requirement for accredited laboratories to evaluate and document the analytical performance of all methods not only prior to their first implementation, but also during ongoing operation, there is a need for clear, standardized and practical guidelines on the subject. This review summarizes the current literature on the topic, focusing on the requirements for method validations, or as the case may be, verifications and describes when to validate, when to verify and which statistical tests are appropriate for each. Proper interpretation of statistical test results and acceptance criteria for each procedure are alluded to. Specific topics, which are addressed, are precision and bias verification of quantitative, qualitative and semi-quantitative procedures, method comparisons with Bland-Altman Plots, Passing-Bablok regression analysis, 2×2 contingency tables and bubble charts, linearity studies, analytical sensitivity and specificity, performing carry-over studies and establishing and confirming reference ranges.


Assuntos
Técnicas de Laboratório Clínico/normas , Estudos de Validação como Assunto , Humanos , Reprodutibilidade dos Testes
19.
Food Chem ; 294: 46-55, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31126488

RESUMO

LC-MS/MS is the mainstream technique for the analysis of naturally occurring compounds in food. Because of the complex chemical composition of food, the most challenging validation parameters are those related to the matrix - linearity (calibration) and trueness. The influence of the interfering compounds on the analytical results is reflected in the extraction efficiency and matrix effect. These effects must be compensated for, if they cannot be removed or reduced by optimizing the extraction and the LC-MS/MS method. The calibration strategy is selected on the basis of the analytical conditions - complexity of matrix, and chemical structure and number of analytes. It is advisable to estimate trueness - both extraction efficacy and matrix effect during the preliminary experiments in order to select the right type of calibration. Finally, it is essential to describe the validation procedure in detail and refer to the used guidelines in order to provide a reproducible method.


Assuntos
Cromatografia Líquida/normas , Análise de Alimentos/normas , Espectrometria de Massas em Tandem/normas , Calibragem , Cromatografia Líquida/métodos , Solventes/química , Espectrometria de Massas em Tandem/métodos , Estudos de Validação como Assunto
20.
JMIR Mhealth Uhealth ; 7(5): e13421, 2019 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-31099340

RESUMO

BACKGROUND: Modern smartphone use is pervasive and could be an accessible method of evaluating the circadian rhythm and social jet lag via a mobile app. OBJECTIVE: This study aimed to validate the app-recorded sleep time with daily self-reports by examining the consistency of total sleep time (TST), as well as the timing of sleep onset and wake time, and to validate the app-recorded circadian rhythm with the corresponding 30-day self-reported midpoint of sleep and the consistency of social jetlag. METHODS: The mobile app, Rhythm, recorded parameters and these parameters were hypothesized to be used to infer a relative long-term pattern of the circadian rhythm. In total, 28 volunteers downloaded the app, and 30 days of automatically recorded data along with self-reported sleep measures were collected. RESULTS: No significant difference was noted between app-recorded and self-reported midpoint of sleep time and between app-recorded and self-reported social jetlag. The overall correlation coefficient of app-recorded and self-reported midpoint of sleep time was .87. CONCLUSIONS: The circadian rhythm for 1 month, daily TST, and timing of sleep onset could be automatically calculated by the app and algorithm.


Assuntos
Ritmo Circadiano/fisiologia , Aplicativos Móveis/normas , Adolescente , Humanos , Masculino , Aplicativos Móveis/estatística & dados numéricos , Projetos Piloto , Autorrelato/normas , Autorrelato/estatística & dados numéricos , Sono/fisiologia , Inquéritos e Questionários , Fatores de Tempo , Estudos de Validação como Assunto , Adulto Jovem
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