title: [Validation of a questionnaire to evaluate administrative causes of low reporting of adverse drug reactions].
abstract: Objective Design and validate a survey to determine the administrative causes that can influence low reporting of adverse drug reactions. Methods The questionnaire design was based on a review of the literature and on brainstorming. The variables considered to influence reporting were professional workload and the professional perception of drug surveillance control activities. To validate the hypothesis, 60 professionals were surveyed in a convenience sample. Reliability was calculated using Cronbach's alfa and the Kuder-Richardson coefficient. Content validity was measured using the Kendall coefficient, and criterion validity, through concordance with the established criterion. Results The survey-type questionnaire was composed of 15 questions divided into two parts: general information and administrative causes of low adverse drug reactions reporting. Cronbach's alfa was 0.87, the Kuder-Richardson coefficient was 0.9033, and overall validity was 1.51, resulting from 70% concordance and a rank correlation coefficient of 0.81. Conclusions The reliability of the validated survey was acceptable to high and validity was acceptable.
authors.forename: Lisset Ortiz
authors.initials: LO
authors.lastname: Zamora
authors.forename: Dainuris Usatorres
authors.initials: DU
authors.lastname: Bess
authors.forename: Caridad Ortiz
authors.initials: CO
authors.lastname: Zamora
mesh_terms: D003430:Cross-Sectional Studies; D003462:Cuba; D030881:Disclosure / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016526:Workload