Validity, sensitivity and specificity of a measure of medication adherence instrument among patients taking oral anticoagulants.

Although self-report instruments are currently considered a valuable tool for measuring adherence, due to their low cost and ease of implementation, there are still important factors that impact measurement accuracy, such as social desirability and memory bias. Thus, the Global Assessment of Medication Adherence Instrument (GEMA) was developed to provide an accurate measure of this construct. The aim of this study was to evaluate the properties of the measurement of the Global Evaluation of Medication Adherence Instrument (GEMA) among patients with chronic diseases. A methodological study was conducted in the public hospital of the state of São Paulo, Brazil. The adherence to anticoagulants as well as the international normalized ratio (INR) was assessed on 127 patients. Besides GEMA, two other instruments were used to assess adherence: the Morisky Medication Adherence Scale-8 (MMAS-8) and the Measurement of Adhesion to Treatments (MAT). The GEMA presented a satisfactory level of specificity (0.76) to identify adherents among those with a stable INR, low sensitivity (0.43) for the identification of non-adherents among those with an unstable INR, and a Positive Predictive Value of 0.70. Positive and weak to moderate correlations were observed between the proportion of doses assessed with GEMA and the scores on the MMAS-8 (r = .26 and r = .22, respectively) and the MAT (r = .22 and r = .30, respectively). The GEMA presented good practicality, acceptability, and evidence of specificity regarding the stability of the INR. The validity of the construct was partially supported by the relationship with self-reported measures of adherence.

A Mobile Phone App Intervention to Promote Healthy Salt Intake Among Adults: Protocol for a Randomized Controlled Study.

BACKGROUND: There is sound evidence associating high salt intake and a greater risk of cardiovascular and noncardiovascular diseases. High salt intake has been observed in several populations worldwide. Therefore, promoting healthier salt consumption has been encouraged as a low-cost strategy to reduce this risk factor. However, these strategies need to be sound, built on theoretical and methodological bases, and consider the target population's context. OBJECTIVE: This protocol aims to describe a mobile phone app intervention to promote healthy salt intake among adults. METHODS: This is an experimental and longitudinal study protocol conducted in three modules. Module 1 refers to the planning of the intervention based on the Behaviour Change Wheel framework. Module 2 is the development of the mobile phone app intervention based on the date of module 1. In module 3, the intervention will be evaluated using a randomized controlled study, with three steps of data collection in a 2-month follow-up in a sample of 86 adults (43 participants for each group: the control group and intervention group) recruited from the primary health care centers of a Brazilian town. The discretionary salt intake questionnaire will assess salt consumption, the app usability will be assessed using the System Usability Scale, and psychosocial variables (habit, intention, and self-efficacy) will also be measured. RESULTS: Recruitment began in October 2021, and the follow-up will end in August 2022. The results of this study are expected to be published in 2023. CONCLUSIONS: Results from this study will help people to control salt intake when cooking at home, will stimulate self-care, will work as an alternative or supportive method in the relationship between health care professionals and patients, and will contribute to implementing the app intervention to promote healthy salt intake on a large scale. TRIAL REGISTRATION: The Brazilian Clinical Trials Registry RBR-4s8qyyq; https://ensaiosclinicos.gov.br/rg/RBR-4s8qyyq. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37853.

Impact of a Theory-Based Intervention to Promote Medication Adherence in Patients With a History of Myocardial Infarction.

BACKGROUND: Patient discontinuation of cardioprotective medications after a cardiac ischemic event commonly occurs early after hospital discharge. Theory-based interventions could be effective in promoting better patient self-regulation of health-related behaviors and positive intentions to adhere to the recommended medical regimen. OBJECTIVE: The aim of this study was to evaluate the potential efficacy and feasibility of a theory-based intervention to promote adherence to cardioprotective medications. METHODS: In this mixed-methods quasi-experimental study with 3 time points, we recruited 45 participants with a positive intention to adhere and a history of myocardial infarction. They were recruited in primary care units in Brazil. Data collection occurred in 2 waves (Tb and T60). The intervention consisted of developing action and coping plans, delivered in a 30-minute face-to-face session, with face-to-face reinforcement at a 30-day interval. Quantitative data were submitted to descriptive, Wilcoxon, and McNemar analyses; qualitative data were submitted to content analysis. RESULTS: An increase in the proportion of patients adhering to medications at the end of follow-up was found (T60 - Tb, +60.0%; P < .001). In addition, a significant reduction was found for blood pressure (T60 - Tb, -8.6 mm Hg; P < .001), heart rate (T60 - Tb, -6.6 bpm; P < .001), and low-density lipoprotein (T60 - Tb, -6.2 mg/dL; P < .05). Qualitative results revealed that the intervention was feasible, with an attrition rate of zero. The intervention was found to be easy to apply to patients' daily lives, and there was adequate time for implementation. CONCLUSIONS: Our data confirm the potential efficacy of a theory-based intervention on the promotion of adherence to cardioprotective medications and on the related clinical end points, as well as its feasibility in the clinical context (Universal Trial Number: U1111-1189-9967).

What methods have been used to estimate salt intake? A systematic review.

The relationship between salt intake and cardiovascular diseases is a contemporary scientific controversy, which has been attributed to the limits of the measures of salt intake used in the studies. Thus, this article sought to systematically review the literature on the methods used to estimate salt intake in different study designs. Of the 124 articles, 60.5% used only biochemical measures, 26.6% only self-report measures and 12.9% reported the combined use of both methods. The 24-hour urinary sodium excretion was the predominant biochemical method (79.1%) and the Food Frequency Questionnaire was the predominant self-report measure (36.4%). Interventional studies used mostly 24-hour urinary sodium excretion; while longitudinal studies used self-report measures. The question guiding the study and its design, as well as constraints related to costs, sample size and feasibility seems to influence the choice of the type of measurement.

Dietary sources of salt intake in adults and older people: a population-based study in a Brazilian town.

OBJECTIVE: To assess salt intake and its dietary sources using biochemical and self-report methods and to characterize salt intake according to sociodemographic and disease-related variables in a sample of the Brazilian population. DESIGN: Population-based cross-sectional survey. SETTING: Salt intake was assessed by biochemical (24 h urinary Na excretion) and self-report methods (sodium FFQ, 24 h dietary recall, seasoned-salt questionnaire, discretionary-salt questionnaire and total reported salt intake).ParticipantsAdults and older people (n 517) aged 20-80 years, living in Artur Nogueira, São Paulo, Brazil. RESULTS: Mean salt intake based on 24 h urinary Na excretion and total reported salt intake was 10·5 and 11·0 g/d, respectively; both measures were significantly correlated. Discretionary salt and seasoned salt were the most important sources of salt intake (68·2 %). Men in the study consumed more salt than women as estimated by 24 h urinary Na excretion (11·7 v. 9·6 g salt/d; P<0·0001). Participants known to be hypertensive added more salt to their meals but consumed less salty ultra-processed foods. Waist circumference in both sexes and BMI were positively correlated with salt intake estimated by 24 h urinary Na excretion. In addition, regression analysis revealed that being a young male or having a high waist circumference was a predictor of higher salt intake. CONCLUSIONS: Salt intake in this population was well above the recommended amount. The main source of salt intake came from salt added during cooking. Salt intake varied according to sex and waist circumference.

An integrative review of the methods used for cortisol assessment in clinical studies investigating the association between Blood Pressure and Cortisol Hormone / Hipertensão Arterial Sistêmica e o Hormônio Cortisol: uma revisão integrativa sobre as associações e os métodos de análises clínicas / Hipertensión Arterial Sistémica y la Hormona Cortisol: una revisión integrativa sobre las asociaciones y los métodos de análisis clínicos

Justificativa e Objetivos: A Hipertensão Arterial Sistêmica (HAS) é uma condição de saúde que representa um problema de saúde pública mundial e sua relação com o hormônio cortisol ainda não está amplamente esclarecida. Dessa forma, esse estudo teve como objetivo identificar na literatura, as circunstâncias de existência de associação entre a HAS com o hormônio cortisol e os métodos clínicos utilizados para esta relação. Métodos: Realizou-se revisão Integrativa da Literatura, a partir de 17 artigos científicos publicados entre 2013 e 2017 identificados nas bases de dados EMBASE e PubMed, com os descritores hypertension e hydrocortisone, no idioma inglês. Resultados: Verificou-se associação da HAS com o aumento do cortisol na idade a partir de 62 anos, aumento de sódio na dieta, o hábito não ingerir o desjejum, aumento do consumo de cafeína, síndrome metabólica, obesidade, excesso de catecolaminas e alguns tipos de hormônios e biomarcadores. Os métodos clínicos mais utilizados para esta relação foram os testes de associação, feitos com a função renal e/ou cardíaca, síndrome metabólica, estresse, doenças crônicas associados com a avaliação de exames laboratoriais. Conclusão: Os resultados indicaram associação entre o cortisol e a Hipertensão no avançar da idade e estilo de vida, sendo os testes de associação os métodos mais utilizados.(AU)

Background and Objectives: Systemic Arterial Hypertension (SAH) is a health condition that represents a global public health problem and its relation with the hormone cortisol is not yet widely understood. Thus, the present study aimed to identify in the literature the association among the SAH, the hormone cortisol and the clinical methods used to evaluate this relationship. Methods: An integrative literature review was carried out, based on 17 scientific articles published between 2013 and 2017 identified in the databases EMBASE and PubMed, with the descriptors hypertension and hydrocortisone in English language. Results: There was an association of SAH with increased cortisol at the age of 62 years, increased sodium in the diet, not eating breakfast, increased caffeine consumption, metabolic syndrome, obesity, excess catecholamine's, some types of hormones, and biomarkers. The most commonly used clinical methods for this relationship were association tests, performed with renal and / or cardiac function, metabolic syndrome, stress, chronic diseases associated with the evaluation of laboratory tests. Conclusion: The results indicated an association between cortisol and SAH with advancing age and lifestyle. Moreover, the association tests were the most used methods.(AU)

Justificación y objetivos: La Hipertensión Arterial Sistémica (HAS) es una afección de salud que representa un problema de salud pública mundial y su relación con la hormona cortisol aún no se conoce ampliamente. Por lo tanto, el presente estudio tuvo como objetivo identificar en la literatura la asociación entre la HAS, la hormona cortisol y los métodos clínicos utilizados para evaluar esta relación. Métodos: Se realizó una revisión integradora de la literatura, basada en 17 artículos científicos publicados entre 2013 y 2017 identificados en las bases de datos EMBASE y PubMed, con los descriptores hipertensión e hidrocortisona en idioma inglés. Resultados: Hubo una asociación de HAS con aumento de cortisol a la edad de 62 años, aumento de sodio en la dieta, falta de desayuno, aumento del consumo de cafeína, síndrome metabólico, obesidad, exceso de catecolaminas, algunos tipos de hormonas y biomarcadores. Los métodos clínicos más comúnmente utilizados para esta relación fueron las pruebas de asociación, realizadas con función renal y / o cardíaca, síndrome metabólico, estrés, enfermedades crónicas asociadas con la evaluación de pruebas de laboratorio. Conclusión: Los resultados indicaron una asociación entre el cortisol y la HAS con el avance de la edad y el estilo de vida. Además, las pruebas de asociación fueron los métodos más utilizados.(AU)

Reliability and construct validity of the Instrument to Measure the Impact of Valve Heart Disease on the Patient's Daily Life.

Objective: evaluate the practicality, acceptability and the floor and ceiling effects, estimate the reliability and verify the convergent construct's validity with the instrument called the Heart Valve Disease Impact on daily life (IDCV) of the valve disease in patients with mitral and or aortic heart valve disease. Method: data was obtained from 86 heart valve disease patients through 3 phases: a face to face interview for a socio-demographic and clinic characterization and then other two done through phone calls of the interviewed patients for application of the instrument (test and repeat test). Results: as for the practicality and acceptability, the instrument was applied with an average time of 9,9 minutes and with 110% of responses, respectively. Ceiling and floor effects observed for all domains, especially floor effect. Reliability was tested using the test - repeating pattern to give evidence of temporal stability of the measurement. Significant negative correlations with moderate to strong magnitude were found between the score of the generic question about the impact of the disease and the scores of IDCV, which points to the validity of the instrument convergent construct. Conclusion: the instrument to measure the impact of valve heart disease on the patient's daily life showed evidence of reliability and validity when applied to patients with heart valve disease.

Factor analysis of an instrument to measure the impact of disease on daily life. / Análise de fatores do instrumento de medida do impacto da doença no cotidiano.

OBJECTIVE: to verify the structure of factors of an instrument to measure the Heart Valve Disease Impact on Daily Life (IDCV) when applied to coronary artery disease patients. METHOD: the study included 153 coronary artery disease patients undergoing outpatient follow-up care. The IDCV structure of factors was initially assessed by means of confirmatory factor analysis and, subsequently, by exploratory factor analysis. The Varimax rotation method was used to estimate the main components of analysis, eigenvalues greater than one for extraction of factors, and factor loading greater than 0.40 for selection of items. Internal consistency was estimated using Cronbach's alpha coefficient. RESULTS: confirmatory factor analysis did not confirm the original structure of factors of the IDCV. Exploratory factor analysis showed three dimensions, which together explained 78% of the measurement variance. CONCLUSION: future studies with expansion of case selection are necessary to confirm the IDCV new structure of factors.

Análise de fatores do instrumento de medida do impacto da doença no cotidiano / Análisis de factores del instrumento de medición de impacto de la enfermedad en el cotidiano / Factor analysis of an instrument to measure the impact of disease on daily life

RESUMO Objetivo: verificar a estrutura de fatores do Instrumento para Mensuração do Impacto da Doença no Cotidiano do Valvopata (IDCV) quando aplicado em coronariopatas. Método: fizeram parte deste estudo 153 coronariopatas em seguimento ambulatorial. A estrutura de fatores do IDCV foi inicialmente avaliada por meio da análise confirmatória de fatores e, subsequentemente, por meio da análise exploratória de fatores. Utilizou-se o método de estimação dos componentes principais de análise com rotação Varimax e eigenvalues acima de um para extração de fatores e carga fatorial superior a 0,40 para seleção dos itens. A consistência interna foi estimada por meio do coeficiente alfa de Cronbach. Resultados: a análise confirmatória não confirmou a estrutura original de fatores do IDCV. A análise exploratória de fatores evidenciou três dimensões que, em conjunto, explicaram 78% da variância da medida. Conclusão: estudos futuros com ampliação da casuística são necessários para confirmação da nova estrutura de fatores do IDCV.

RESUMEN Objetivo: verificar la estructura de factores del Instrumento para Medición del Impacto de la Enfermedad en el Cotidiano del Valvulópata (IDVC) aplicado a enfermos coronarios. Método: formaron parte de este estudio 153 enfermos coronarios en seguimiento ambulatorio. Estructura de factores del IDVC evaluada inicialmente mediante análisis confirmatorio de factores, y luego por análisis exploratorio de factores. Se aplicó método de estimación de componentes principales de análisis con rotación Varimax y eigenvalues por sobre 1 para extracción de factores, y carga factorial superior a 0,40 para selección de ítems. Consistencia interna estimada mediante coeficiente alfa de Cronbach. Resultados: el análisis confirmatorio no confirmó la estructura original de factores del IDCV. El análisis exploratorio de factores evidenció tres dimensiones que, en conjunto, explicaron el 78% de la diferencia de la medida. Conclusión: estudios futuros con casuística ampliada serán necesarios para confirmación de la nueva estructura de factores del IDCV.

ABSTRACT Objective: to verify the structure of factors of an instrument to measure the Heart Valve Disease Impact on Daily Life (IDCV) when applied to coronary artery disease patients. Method: the study included 153 coronary artery disease patients undergoing outpatient follow-up care. The IDCV structure of factors was initially assessed by means of confirmatory factor analysis and, subsequently, by exploratory factor analysis. The Varimax rotation method was used to estimate the main components of analysis, eigenvalues greater than one for extraction of factors, and factor loading greater than 0.40 for selection of items. Internal consistency was estimated using Cronbach's alpha coefficient. Results: confirmatory factor analysis did not confirm the original structure of factors of the IDCV. Exploratory factor analysis showed three dimensions, which together explained 78% of the measurement variance. Conclusion: future studies with expansion of case selection are necessary to confirm the IDCV new structure of factors.

Satisfaction with medication in coronary disease treatment: psychometrics of the Treatment Satisfaction Questionnaire for Medication.

OBJECTIVE: to psychometrically test the Brazilian version of the Treatment Satisfaction Questionnaire for Medication - TSQM (version 1.4), regarding ceiling and floor effect, practicability, acceptability, reliability and validity. METHODS: participants with coronary heart disease (n=190) were recruited from an outpatient cardiology clinic at a university hospital in Southeastern Brazil and interviewed to evaluate their satisfaction with medication using the TSQM (version 1.4) and adherence using the Morisky Self-Reported Measure of Medication Adherence Scale and proportion of adherence. The Ceiling and Floor effect were analyzed considering the 15% worst and best possible TSQM scores; Practicability was assessed by time spent during TSQM interviews; Acceptability by proportion of unanswered items and participants who answered all items; Reliability through the Cronbach's alpha coefficient and Validity through the convergent construct validity between the TSQM and the adherence measures. RESULTS: TSQM was easily applied. Ceiling effect was found in the side effects domain and floor effect in the side effects and global satisfaction domains. Evidence of reliability was close to satisfied in all domains. The convergent construct validity was partially supported. CONCLUSIONS: the Brazilian TSQM presents evidence of acceptability and practicability, although its validity was weakly supported and adequate internal consistency was observed for one domain.

Influence of sociodemographic and clinical characteristics at the impact of valvular heart disease.

OBJECTIVE: to analyze the sociodemographic and clinical characteristics of patients with valvular heart disease and to verify the influence of these variables on the impact of valve disease in daily life. METHOD: the study involved 86 outpatients. Data collection was performed in two stages - face-to-face interview for sociodemographic and clinical characterization and through telephone contact for the application of the Instrument to Measure the Impact of Valvular Heart Disease on Patient's Everyday Life (IDCV). Data were analyzed through descriptive statistics and multiple regression analysis. RESULTS: it was noticed that the total score of IDCV and its domains were influenced by age, schooling, presence or absence of symptoms, use or not of diuretic. CONCLUSION: The impact of the disease was influenced by sociodemographic and clinical variables. The results provide subsidies for the design of nursing interventions aimed at reducing the impact of the disease on the patient's daily life with valve disease.

Influência das características sociodemográficas e clínicas no impacto da doença em valvopatas / Influencia de las características sociodemográficas y clínicas en el impacto de la enfermedad en válvulas del corazón / Influence of sociodemographic and clinical characteristics at the impact of valvular heart disease

RESUMO Objetivo: analisar as características sociodemográficas e clínicas dos pacientes com valvopatia e verificar a influência dessas variáveis no impacto da valvopatia no cotidiano. Método: participaram do estudo 86 pacientes em seguimento ambulatorial. A coleta de dados foi realizada em duas etapas - entrevista presencial para caracterização sociodemográfica e clínica e por meio de contato telefônico para aplicação do Instrumento para Mensuração do Impacto da Doença no Cotidiano do Valvopata (IDCV). Os dados foram analisados através de estatística descritiva e análise de regressão múltipla. Resultados: constatou-se que o escore total do IDCV e seus domínios foram influenciados pela idade, escolaridade, presença ou não de sintomatologia, uso ou não de diurético. Conclusão: o impacto da doença foi influenciado por variáveis sociodemográficas e clínicas. Os resultados fornecem subsídios para o delineamento de intervenções de enfermagem com vistas à redução do impacto da doença no cotidiano do paciente com valvopatia.

RESUMEN Objetivo: analizar las características sociodemográficas y clínicas de los pacientes con enfermedad de las válvulas del corazón y verificar la influencia de esas variables en el impacto de la enfermedad en la vida cotidiana. Método: participaron del estudio 86 pacientes con seguimiento ambulatorio. La recolección de datos fue realizada en dos etapas - entrevista presencial para caracterización sociodemográfica y clínica y por medio de contacto telefônico para aplicación del Instrumento para Medición del Impacto en lo Cotidiano de la Enfermedad de Válvula (IDCV). Los datos fueron analizados a través de estadística descriptiva y análisis de regresión múltiple. Resultados: se constató que la puntuación total del IDCV y sus dominios fueron influenciados por la edad, escolaridad, presencia o no de sintomatología, uso o no de diurético. Conclusión: el impacto de la enfermedad fue influenciado por variables sociodemográficas y clínicas. Los resultados otorgan subsidios para el delineamiento de intervenciones de enfermería con vistas a la reducción del impacto de la enfermedad en lo cotidiano del paciente con enfermedad de válvula.

ABSTRACT Objective: to analyze the sociodemographic and clinical characteristics of patients with valvular heart disease and to verify the influence of these variables on the impact of valve disease in daily life. Method: the study involved 86 outpatients. Data collection was performed in two stages - face-to-face interview for sociodemographic and clinical characterization and through telephone contact for the application of the Instrument to Measure the Impact of Valvular Heart Disease on Patient's Everyday Life (IDCV). Data were analyzed through descriptive statistics and multiple regression analysis. Results: it was noticed that the total score of IDCV and its domains were influenced by age, schooling, presence or absence of symptoms, use or not of diuretic. Conclusion: The impact of the disease was influenced by sociodemographic and clinical variables. The results provide subsidies for the design of nursing interventions aimed at reducing the impact of the disease on the patient's daily life with valve disease.

Satisfaction with medication in coronary disease treatment: psychometrics of the Treatment Satisfaction Questionnaire for Medication / Satisfação com tratamento medicamentoso no tratamento de doença coronária: psicometria do Treatment Satisfaction Questionnaire for Medication / Satisfacción con medicación en el tratamiento de enfermedad coronaria: propiedades psicométricas del Treatment Satisfaction Questionnaire for Medication

Abstract Objective: to psychometrically test the Brazilian version of the Treatment Satisfaction Questionnaire for Medication - TSQM (version 1.4), regarding ceiling and floor effect, practicability, acceptability, reliability and validity. Methods: participants with coronary heart disease (n=190) were recruited from an outpatient cardiology clinic at a university hospital in Southeastern Brazil and interviewed to evaluate their satisfaction with medication using the TSQM (version 1.4) and adherence using the Morisky Self-Reported Measure of Medication Adherence Scale and proportion of adherence. The Ceiling and Floor effect were analyzed considering the 15% worst and best possible TSQM scores; Practicability was assessed by time spent during TSQM interviews; Acceptability by proportion of unanswered items and participants who answered all items; Reliability through the Cronbach's alpha coefficient and Validity through the convergent construct validity between the TSQM and the adherence measures. Results: TSQM was easily applied. Ceiling effect was found in the side effects domain and floor effect in the side effects and global satisfaction domains. Evidence of reliability was close to satisfied in all domains. The convergent construct validity was partially supported. Conclusions: the Brazilian TSQM presents evidence of acceptability and practicability, although its validity was weakly supported and adequate internal consistency was observed for one domain.

Resumo Objetivos: realizar o teste psicométrico da versão brasileira do Treatment Satisfaction Questionnaire for Medication - TSQM (versão 1.4) [Questionário Satisfação com Tratamento Medicamentoso] com relação aos efeitos de teto e chão, praticidade, aceitabilidade, confiabilidade e validade. Métodos: os participantes com doença cardíaca coronária (n=190) foram recrutados num ambulatório de cardiologia de um hospital universitário no sudeste do Brasil e entrevistados para avaliar satisfação em relação ao tratamento medicamentoso através da TSQM (versão 1.4) e adesão através da Morisky Self-Reported Measure of Medication Adherence Scale [Medida de Auto-Relato de Adesão ao Tratamento Medicamentoso] e proporção de aderência. Os efeitos Teto e Chão foram analisados considerando os 15% piores e 15% melhores escores possíveis obtidos no TSQM; Praticidade foi avaliada pelo tempo gasto na aplicação do TSQM durante a entrevista; Aceitabilidade foi verificada pela proporção de itens não respondidos e participantes que responderam todos os itens; Confiabilidade foi verificada com o coeficiente alfa de Cronbach e Validade através da validade de construto convergente entre o TSQM e as medidas de adesão. Resultados: o TSQM foi facilmente aplicado. O efeito teto foi encontrado no domínio efeitos colaterais e o efeito chão foi encontrado nos domínios efeitos colaterais e satisfação global. Evidência de confiabilidade foi próxima de satisfatória em todos os domínios. A validade de construto convergente foi parcialmente apoiada. Conclusões: a versão brasileira do TSQM apresenta evidência de aceitabilidade e praticidade embora sua validade tenha sido pouco apoiada e consistência interna adequada foi observada em um domínio.

Resumen Objetivos: testar las propiedades psicométricas de la versión brasileña del Treatment Satisfaction Questionnaire for Medication - TSQM (versión 1.4), considerando los efectos techo y suelo, factibilidad, aceptabilidad, confiabilidad y validez. Métodos: participantes con enfermedad coronaria (n=190) fueron reclutados de una clínica ambulatoria de cardiología en un hospital universitario en el sudeste de Brasil y entrevistados para evaluar su satisfacción con la medicación con el TSQM (versión 1.4) y su adhesión con la Morisky Self-Reported Measure of Medication Adherence Scale y proporción de adhesión. Los efectos techo y suelo fueron analizados considerando los 15% peores y mejores puntuaciones en el TSQM; la factibilidad fue evaluada por el tiempo gasto durante las entrevistas de TSQM; la aceptabilidad por la proporción de ítems no respondidos y participantes que contestaron a todos los ítems; la confiabilidad con el coeficiente alfa de Cronbach y la validez de constructo convergente entre el TSQM y las medidas de adhesión. Resultados: el TSQM fue aplicado con facilidad. El efecto de techo fue encontrado en el dominio de los efectos secundarios y el efecto suelo en los dominios de efectos secundarios y satisfacción global. Las evidencias de confiabilidad fueron aproximadamente satisfechas en todos los dominios. La validez de constructo convergente fue parcialmente apoyada. Conclusiones: la versión brasileña del TSQM presenta evidencias de aceptabilidad y factibilidad, a pesar del soporte débil a su validez y de la observación de consistencia interna adecuada para un dominio.

Reliability and construct validity of the Instrument to Measure the Impact of Valve Heart Disease on the Patient's Daily Life / Confiabilidade e validade de construto do Instrumento para Mensuração do Impacto da Doença no Cotidiano do Valvopata / Confiabilidad y validez de constructo de Instrumento para Medir el Impacto de la Valvulopatía en lo Cotidiano

ABSTRACT Objective: evaluate the practicality, acceptability and the floor and ceiling effects, estimate the reliability and verify the convergent construct's validity with the instrument called the Heart Valve Disease Impact on daily life (IDCV) of the valve disease in patients with mitral and or aortic heart valve disease. Method: data was obtained from 86 heart valve disease patients through 3 phases: a face to face interview for a socio-demographic and clinic characterization and then other two done through phone calls of the interviewed patients for application of the instrument (test and repeat test). Results: as for the practicality and acceptability, the instrument was applied with an average time of 9,9 minutes and with 110% of responses, respectively. Ceiling and floor effects observed for all domains, especially floor effect. Reliability was tested using the test - repeating pattern to give evidence of temporal stability of the measurement. Significant negative correlations with moderate to strong magnitude were found between the score of the generic question about the impact of the disease and the scores of IDCV, which points to the validity of the instrument convergent construct. Conclusion: the instrument to measure the impact of valve heart disease on the patient's daily life showed evidence of reliability and validity when applied to patients with heart valve disease.

RESUMO Objetivos: avaliar a praticabilidade, aceitabilidade e os efeitos teto e chão, estimar a confiabilidade e verificar a validade de construto convergente do Instrumento para Mensuração do Impacto da Doença no Cotidiano do Valvopata em pacientes com valvopatia mitral e/ou aórtica. Método: dados foram obtidos junto a 86 pacientes valvopatas por meio de três etapas: uma entrevista presencial para caracterização sociodemográfica e clínica e as duas outras realizadas por meio de contato telefônico para as aplicações do instrumento (Teste e teste de repetição). Resultados: quanto à praticabilidade e aceitabilidade, o instrumento foi aplicado com tempo médio de 9,9 minutos e com 110% de respostas, respectivamente. Constatados efeitos teto e chão para todos os domínios, principalmente efeito chão. A confiabilidade foi testada por meio do teste-teste de repetição, obtendo-se evidências de estabilidade temporal da medida. Foram constatadas correlações negativas significantes de moderada a forte magnitude entre o escore da questão genérica sobre o impacto da doença e os escores do IDCV, o que aponta para validade de construto convergente do instrumento. Conclusão: o Instrumento para Mensuração do Impacto da Doença no Cotidiano do Valvopata apresentou evidências de confiabilidade e validade quando aplicado em pacientes com valvopatia.

RESUMEN Objetivos: evaluar la viabilidad, aceptabilidad y los efectos techo y suelo, estimar la confiabilidad y verificar la validez de constructo convergente del Instrumento para Medir el Impacto en lo Cotidiano (IDCV) del sujeto con valvulopatías mitral y/o aórtica. Método: los datos fueron obtenidos de 86 pacientes con valvulopatías por medio de tres etapas: una entrevista presencial para caracterización sociodemográfica y clínica y las otras dos realizadas por medio de contacto telefónico para las aplicaciones del instrumento (test y test de repetición). Resultados: en cuanto a la viabilidad y aceptabilidad, el instrumento fue aplicado con un tiempo promedio de 9,9 minutos y con 110% de respuestas, respectivamente. Fueron constatados los efectos techo y suelo para todos los dominios, principalmente el efecto suelo. La confiabilidad fue comprobada por medio del test de repetición, obteniéndose evidencias de estabilidad temporal de la medida. Fueron constatadas correlaciones negativas significativas de moderada a fuerte magnitud entre el puntaje de la pregunta genérica sobre el impacto de la enfermedad y los puntajes del IDCV, lo que apunta para la validez de constructo convergente del instrumento. Conclusión: el instrumento para medir el impacto de la valvulopatía en lo cotidiano del sujeto, presentó evidencias de confiabilidad y validez cuando aplicado en pacientes con esa enfermedad.

Validity of the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.

This study provides evidence of construct validity for the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), a 1-item instrument used among 236 participants referred for cardiopulmonary exercise testing. The Baecke Habitual Physical Activity Questionnaire (Baecke-HPA) was used to evaluate convergent and divergent validity. The self-reported measure of walking (QCAF) evaluated the convergent validity. Cardiorespiratory fitness assessed convergent validity by the Veterans Specific Activity Questionnaire (VSAQ), peak measured (VO2peak) and maximum predicted (VO2pred) oxygen uptake. Partial adjusted correlation coefficients between the GSLTPAQ, Baecke-HPA, QCAF, VO2pred and VSAQ provided evidence for convergent validity; while divergent validity was supported by the absence of correlations between the GSLTPAQ and the Occupational Physical Activity domain (Baecke-HPA). The GSLTPAQ presents level 3 of evidence of construct validity and may be useful to assess leisure-time physical activity among patients with cardiovascular disease and healthy individuals.

Validity of the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire / Validade da versão brasileira do Godin-Shephard Leisure-Time Physical Activity Questionnaire / Validez de la versión brasileña del Godin-Shephard Leisure-Time Physical Activity Questionnaire

This study provides evidence of construct validity for the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), a 1-item instrument used among 236 participants referred for cardiopulmonary exercise testing. The Baecke Habitual Physical Activity Questionnaire (Baecke-HPA) was used to evaluate convergent and divergent validity. The self-reported measure of walking (QCAF) evaluated the convergent validity. Cardiorespiratory fitness assessed convergent validity by the Veterans Specific Activity Questionnaire (VSAQ), peak measured (VO2peak) and maximum predicted (VO2pred) oxygen uptake. Partial adjusted correlation coefficients between the GSLTPAQ, Baecke-HPA, QCAF, VO2pred and VSAQ provided evidence for convergent validity; while divergent validity was supported by the absence of correlations between the GSLTPAQ and the Occupational Physical Activity domain (Baecke-HPA). The GSLTPAQ presents level 3 of evidence of construct validity and may be useful to assess leisure-time physical activity among patients with cardiovascular disease and healthy individuals.

Este estudo fornece evidências de validade de construto da versão brasileira do Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), instrumento de 1 item usado entre 236 participantes encaminhados ao teste de esforço cardiopulmonar. O Questionário de Atividade Física Habitual de Baecke (AFH-Baecke) avaliou a validade convergente e divergente. A medida de autorrelato de caminhada (QCAF) acessou a validade convergente. A aptidão cardiorrespiratória avaliou a validade convergente por meio do Veterans Specific Activity Questionnaire (VSAQ), consumo pico (VO2pico) e máximo (VO2pred) de oxigênio. Coeficientes de correlação parciais ajustados entre o GSLTPAQ, Baecke-HPA, QCAF, VO2pred e VSAQ forneceram evidências de validade convergente; enquanto a validade divergente foi apoiada pela ausência de correlações entre a GSLTPAQ e o domínio Atividade Física Ocupacional (AFH-Baecke). O GSLTPAQ apresenta nível 3 de evidência de validade de construto e parece útil para avaliar a atividade física no tempo de lazer entre pacientes com doença cardiovascular e indivíduos saudáveis.

Este estudio proporciona evidencia de validez de constructo de la versión brasileña del Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), instrumento de 1 ítem utilizado entre 236 participantes referidos a la prueba de esfuerzo cardiopulmonar. El Cuestionario de Actividad Física Habitual de Baecke (AFH-Baecke) se utilizó para evaluar la validez convergente y divergente. La medida de auto-reporte de caminar (QCAF) evaluó la validez convergente. Aptitud cardiorrespiratoria fue evaluada por el Veterans Specific Activity Questionnaire (VSAQ), medida pico (VO2pico) y máximo (VO2pred) del consumo de oxígeno. Coeficientes de correlación parciales ajustados entre el GSLTPAQ, AFH-Baecke, QCAF, VO2pred y VSAQ investigaran la validez convergente; y la validez divergente fue apoyada por ausencia de correlación entre GSLTPAQ y la Actividad Física Ocupacional (AFH-Baecke). El GSLTPAQ presenta nivel 3 de evidencia de validez de constructo y puede ser útil para valorar la actividad física en el tiempo libre entre los pacientes con enfermedad cardiovascular y individuos sanos.

Quality of Life on Arterial Hypertension: Validity of Known Groups of MINICHAL.

INTRODUCTIONS: In the care of hypertension, it is important that health professionals possess available tools that allow evaluating the impairment of the health-related quality of life, according to the severity of hypertension and the risk for cardiovascular events. Among the instruments developed for the assessment of health-related quality of life, there is the Mini-Cuestionario of Calidad de Vida en la Hipertensión Arterial (MINICHAL) recently adapted to the Brazilian culture. OBJECTIVE: To estimate the validity of known groups of the Brazilian version of the MINICHAL regarding the classification of risk for cardiovascular events, symptoms, severity of dyspnea and target-organ damage. METHODS: Data of 200 hypertensive outpatients concerning sociodemographic and clinical information and health-related quality of life were gathered by consulting the medical charts and the application of the Brazilian version of MINICHAL. The Mann-Whitney test was used to compare health-related quality of life in relation to symptoms and target-organ damage. The Kruskal-Wallis test and ANOVA with ranks transformation were used to compare health-related quality of life in relation to the classification of risk for cardiovascular events and intensity of dyspnea, respectively. RESULTS: The MINICHAL was able to discriminate health-related quality of life in relation to symptoms and kidney damage, but did not discriminate health-related quality of life in relation to the classification of risk for cardiovascular events. CONCLUSION: The Brazilian version of the MINICHAL is a questionnaire capable of discriminating differences on the health-related quality of life regarding dyspnea, chest pain, palpitation, lipothymy, cephalea and renal damage.

Visão, qualidade de vida e adesão medicamentosa em idosos com retinopatia diabética / Vision, quality of life and medication adherence in older adults with diabetic retinopathy / Visión, calidad de vida y adhesión a la terapia medicamentosa en los ancianos con retinopatía diabética

O estudo objetivou analisar a influência da qualidade de vida relacionada à função visual (QVRFV) sobre a adesão medicamentosa e o efeito moderador da acuidade visual (AV) na relação QVRFV – adesão em idosos com retinopatia diabética. Trata-se de uma pesquisa transversal envolvendo idosos em uso de antidiabéticos orais/ insulina e anti-hipertensivos. Avaliou-se aproporção de adesão e os cuidados no uso dos medicamentos. Utilizou-se o National Eye Institute Visual Function Questionnaire para avaliação da QVRFV. Empregou-se a análise de relação conjunta e a variância bivariada para testar o efeito moderador da AV na relação QVRFV – adesão. Dos 100 idosos avaliados, 58% foram classificados como aderentes. Aqueles com pior QVRFV e baixa visão grave para longe mostraram 3.34 e 2.95 mais chance de não adesão, respectivamente. O efeito moderador estudado, entretanto, não foi observado. Os resultados ratificam que o efeito da AV e da QVRFV sobre a adesão ocorre de forma independente.

This cross-sectional study examined the influence of vision-related quality of life (VRQoL) on medication adherence,and the moderator effect of visual acuity (VA) in the relationship of VRQoL to adherence, in older adults with diabetic retinopathy. The study sample comprised elderly patients taking oral antidiabetic/ insulin and antihypertensive drugs. Medication adherence rate, and its association with care taken in drug administration, were assessed. The National Eye Institute Visual Function Questionnaire was used to evaluate VRQoL. Analysis of the joint relationship and bivariate analysis of variance were applied to test the moderator effect of VA in the relationship between VRQoL and adherence. Of the 100 patients tested, 58% classified as adherent. Those with worse VRQoL and severe visual impairment or blindness showed, respectively, 3.34 and 2.95 higher probability of non-adherence. However, the moderator effect studied was not observed. The data confirmed thatthe effects of VA and VRQoL on adherence were independent of each other.

Este estudio tuvo como objetivo analizar la influencia de la calidad de vida relacionada con la función visual (CVRFV) sobre la adhesión a la terapéutica medicamentosa y el efecto moderador de la agudeza visual (AV) en relación CVRFV – adhesión en los ancianos con retinopatía diabética. Se trata de un estudio transversal involucrando a ancianos que usaban antidiabéticos orales/ insulina y fármacos antihipertensivos. Se evaluó la proporción de la adhesión y los cuidados en cuanto al uso de medicamentos. Se utilizó el National Eye Institute Visual Function Questionnaire para evaluar CVRFV. Se utilizaron análisis de prueba conjunta y varianza bivariada para evaluar el efecto moderador de la AV en relación CVRFV – adhesión. De los 100 ancianos evaluados, un 58% fue clasificado como adherentes. Los que obtuvieron peor CVRFV y discapacidad visual severa de distancia mostraron de 3.34 y 2.95 más posibilidad de no adhesión, respectivamente. No se observó, sin embargo, el efecto moderador estudiado. Estos datos confirman que el efecto de AV y CVRFV sobre la adhesión se produce de forma independiente.