People's Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Rebecca K WebsterG James Rubin

Abstract

Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and alternative verbal risk descriptors, in the context of mild and severe side effects. A cross-sectional online survey was carried out by a market research company recruiting participants aged between 18 and 65 years living in England. Data were collected between 18 March and 1 April 2016. Participants were given a hypothetical scenario regarding the risk of mild or severe medication side effects and asked to estimate how many out of 10,000 people would be affected for each of the verbal risk descriptors being tested. A total of 1003 participants were included in the final sample. The risks conveyed by the EC recommended verbal risk descriptors were greatly overestimated by participants. Two distinct distributions were apparent for participant estimates of side effect risks: those for 'high risk' verbal descriptors (e.g. 'common', 'likely', 'high chance') and those for 'low risk' verbal descriptors (e.g. 'uncommon', 'unlikely', 'low chance'). Wit...Continue Reading

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Citations

Apr 14, 2020·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Louise E SmithG James Rubin
Jun 20, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Rebecca K Webster, G James Rubin
Nov 17, 2020·Pharmaceutical Medicine·Giovanni Furlan, David Power
Apr 7, 2021·Annals of Behavioral Medicine : a Publication of the Society of Behavioral Medicine·Rebecca K Webster, G James Rubin
Aug 7, 2021·Journal of General Internal Medicine·Katerina AndreadisJessica S Ancker
Dec 4, 2021·Frontiers in Pharmacology·Mariana Medina-CórdobaValentina Amaya-Giraldo

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