Initial development and testing of an instrument for patient self-assessment of adverse drug reactions

Pharmacoepidemiology and Drug Safety
Narumol JarernsiripornkulJanet Krska

Abstract

To develop and conduct preliminary testing of a causality assessment tool for patients, for potential use in encouraging both discussions with clinicians about suspected adverse drug reactions (ADRs) and reporting to authorities. Ten causality statements, developed from qualitative studies involving patients, with a scoring system allowing categorization, were embedded in a questionnaire which also included a symptom checklist and additional details about one suspected ADR and medicine, selected for causality assessment. Patients with experiences of suspected ADRs were involved in cognitive interviews (15), piloting (20) and psychometric testing (120). Test-retest reliability, construct validity and criterion-related validity were evaluated, through repeated causality assessment, comparison with a visual analogue scale assessing certainty of causality and comparison with causality assessment using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, respectively. The study involved outpatients at a university hospital in northeast Thailand. Ninety-eight patients completed causality assessment twice: both causality scores (Spearman rs  = 0.715; p < 0.001) and causality classification [percentage of positive ag...Continue Reading

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Citations

Oct 28, 2018·International Journal of Clinical Pharmacy·Sirinya KampichitNarumol Jarernsiripornkul
Jan 10, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Nanno SchreuderEugène P van Puijenbroek

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