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

Pharmacy Practice

  • Daniela Duarte-Silva1Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra; & CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Coimbra, Portugal.
  • Adolfo Figueiras2Faculty of Medicine, University of Santiago de Compostela; & Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública - CIBERESP), Santiago de Compostela, Spain.
  • Maria Teresa Herdeiro3CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde; & Center for Cell Biology, University of Aveiro; & Center for Health Technology, Porto, Portugal.
  • António Teixeira Rodrigues4Center for Cell Biology, University of Aveiro; & Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.
  • Fábio Silva Branco5Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.
  • Jorge Polónia6Faculty of Medicine, University of Porto; & Unit of Hypertension, Pedro Hispano General Hospital, Matosinhos, Portugal.
  • Isabel Vitória Figueiredo7Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra; & Center for Pharmaceutical Studies, University of Coimbra; & IBILI - Institute for Biomedical Imaging and Life Sciences, Universidade de Coimbra, Coimbra, Portugal.

Volume 12 Issue 2 Pages 1-7

Abstract

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.

Keywords

  • Antihypertensive Agents
  • Drug-Related Side Effects and Adverse Reactions
  • Medication Adherence
  • Questionnaires
  • Validation Studies as Topic
  • Portugal
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