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.