PERSYVE - Design and validation of a questionnaire about adverse effects of antihypertensive drugs.

OBJECTIVE: The aim of this study was to design and validate a questionnaire to measure perceived symptoms associated with antihypertensive drugs (PERSYVE). METHODS: THE PERSYVE DEVELOPMENT AND VALIDATION INCLUDED FOUR STAGES: 1) item development (bibliographic review and questionnaire elaboration); 2) face and content validation; 3) field testing (pre-test); and 4) test-retest validation, assessment of internal consistency (Cronbach's alpha) and reproducibility over time (intraclass correlation coefficient and Cohen's kappa coefficient). RESULTS: PERSYVE IS DIVIDED INTO SIX SECTIONS ACCORDING TO RESULTS OBTAINED FROM THE LITERATURE REVIEW: (1) drug adherence, (2) perceived symptoms and how they affect quality of life (five-point Likert scale), (3) communication with health professionals, (4) perception of symptoms as adverse reactions, (5) influence on therapy compliance, and (6) adoption of non-pharmacological methods for blood pressure control. Content and face validation of the questionnaire led to some vocabulary changes and the introduction of section 2.1. Field-testing (n=26) revealed high comprehensibility of the questions. The Cronbach's alpha, calculated for section 2 (five-point Likert scale) was 0.850. PERSYVE was reproducible (n=167): kappa values presented fair to substantial reproducibility and, in section 2, ICC values resulted in good to excellent reproducibility. CONCLUSION: Results showed that PERSYVE is a well-structured, objective, patient-friendly, valid and reliable questionnaire. PERSYVE can be a very useful instrument in hypertensive patients' monitoring and in the screening of adverse effects.

PERSYVE - Design and validation of a questionnaire about adverse effects of antihypertensive drugs / PERSYVE - Diseño y validación de un cuestionario sobre efectos adversos de antihipertensivos

Objective: The aim of this study was to design and validate a questionnaire to measure perceived symptoms associated with antihypertensive drugs (PERSYVE). Methods: The PERSYVE development and validation included four stages: 1) item development (bibliographic review and questionnaire elaboration); 2) face and content validation; 3) field testing (pre-test); and 4) test-retest validation, assessment of internal consistency (Cronbach’s alpha) and reproducibility over time (intraclass correlation coefficient and Cohen’s kappa coefficient). Results: PERSYVE is divided into six sections according to results obtained from the literature review: (1) drug adherence, (2) perceived symptoms and how they affect quality of life (five-point Likert scale), (3) communication with health professionals, (4) perception of symptoms as adverse reactions, (5) influence on therapy compliance, and (6) adoption of non-pharmacological methods for blood pressure control. Content and face validation of the questionnaire led to some vocabulary changes and the introduction of section 2.1. Field-testing (n=26) revealedhigh comprehensibility of the questions. The Cronbach's alpha, calculated for section 2 (five-point Likert scale) was 0.850. PERSYVE was reproducible (n=167): kappa values presented fair to substantial reproducibility and, in section 2, ICC values resulted in good to excellent reproducibility. Conclusion: Results showed that PERSYVE is a wellstructured, objective, patient-friendly, valid and reliable questionnaire. PERSYVE can be a very useful instrument in hypertensive patients’ monitoring and in the screening of adverse effects (AU)

Objetivo: El objetivo de este estudio fue diseñar y validar un cuestionario para medir los síntomas percibidos asicados a medicamentos antihipertensivos (PERSYVE). Métodos: El desarrollo y validación de PERSYVE incluyó cuatro etapas: 1) desarrollo de ítems (revisión bibliográfica y elaboración del cuestionario); 2) validación de rostro y de contenido; 3) prueba de campo (pre-test); y 4) validación test-retest, evaluación de la consistencia interna (alfa de Chronbach) y reproductibilidad en el tiempo (coeficiente de correlación intra-clases y coeficiente kappa de Cohen). Resultados: De acuerdo con los resultados obtenidos de la revisión de la literatura, PERSYVE se divide en seis secciones: (1) adherencia a medicamentos, (2) síntomas percibidos y como afectan a la calidad de vida (escala Likert de cinco puntos), (3) comunicación con los profesionales de la salud, (4) percepción de síntomas como reacciones adversas, (5) influencia en el cumplimiento del tratamiento, y (6) adopción de métodos no farmacológicos para el control de la presión arterial. La validación de rostro y de contenido del cuestionario llevaron a algunos cambios de vocabulario y a la introducción de la sección 2.1. El ensayo de campo (n=26) reveló una alta comprensibilidad de las preguntas. El alfa de Cronbach calculado para la sección 2 (escala de Likert de 5 puntos) fue de 0,850. PERSYVE fue reproducible (n=167): valores de kappa presentaron una reproductibilidad sustancial y, en la sección 2, los valores de ICC resultaron de buenos a excelentes. Conclusión: Los resultados demostraron que PERSYVE es un cuestionario bien estructurado, objetivo, fácil de usar para el paciente, válido y confiable. PERSYVE puede ser un instrumento muy útil en la monitorización de pacientes hipertensos y en el rastreo de efectos adversos (AU)