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Resumen de Predictors and differences in patients’ self-reporting types to adverse symptomatic events

Anmar Al Taie, Hadeer Akram AbdulRazzaq, Zekiye Kübra Yilmaz, Nurgül Koramaz, Kerim Cihan Yılmaz, Fikret V Izzettin

  • Introduction: Symptomatic adverse drug reactions are considered a major cause of morbidity and mortality during therapy. No standard and specific method is available for detection and monitoring of adverse effects.

    Objectives: A study was designed to evaluate and report the differences in patients’ self reporting in two different methods (questionnaires and website), and the predictors that affected on reporting of adverse events.

    Method: A cross-sectional study was used for self-reporting of symptomatic adverse events reported in patients complained different diseases like cardiovascular, gastrointestinal, endocrine and infectious diseases. Validated questionnaire form was used either as a form (for patients who will attend in the clinic) or from a validated website.

    Results: Females (64.3%) with an average age 21-30 years suffering from cardiovascular conditions, and disease state with infectious conditions (12.3%) were among the most predictive factors. Cardiovascular diseases had highest mean rank followed by infections, hormone disturbances and gastrointestinal problems. Flu had the highest infectious conditions (12.3%), gastroesophageal reflux disease had a higher incidence (11%) of the gastrointestinal diseases. Among the hormonal disorders, menstrual irregularities were the most obvious disorder by (12.3%), and hypertension took the higher incidence with (17.5%). The relationship between some symptomatic adverse events and type of reporting showed that reporting by questionnaire had a higher incidence than the website.

    Conclusions: Patient’s self reporting may play a supplementary role in pharmacovigilance, and a combined utilization of electronic health data and questionnaire reporting can improve the ability and reliability for detecting symptomatic adverse drug reactions


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