Side Effects of Side Effect Information in Drug Information Leaflets

Maat, Henk Pander; Klaassen, R.

doi:10.2190/lek9-vujp-l3b9-v2ld

Cited by 10 publications

(3 citation statements)

References 7 publications

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“…Participants who were told that the side effects were "very common" 1 (1.6) 4.2 (1.4) F(1,110)=18. 22 believed that the side effects were more severe and more likely to occur, and that there was a greater risk to their health, than those who were told that the side effects occurred in "15% of people" who took the medicine. Importantly, use of the EU designated descriptor not only resulted in increased perceived risk, but also in significantly lower ratings of intention to comply.…”

Section: Discussionmentioning

confidence: 99%

Is 15 per cent very common? Informing people about the risks of medication side effects

Berry

Knapp

Raynor

2002

International Journal of Pharmacy Practice

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Objectives — To assess the general public's interpretation of the verbal descriptors for side effect frequency recommended for use in medicine information leaflets by a European Union (EU) guideline, and to examine the extent to which differences in interpretation affect people's perception of risk and their judgments of intention to comply with the prescribed treatment. Method — Two studies used a controlled empirical methodology in which people were presented with a hypothetical, but realistic, scenario about visiting their general practitioner and being prescribed medication. They were given an explanation that focused on the side effects of the medicine, together with information about the probability of occurrence using either numerical percentages or the corresponding EU verbal descriptors. Interpretation of the descriptors was assessed. In study 2, participants were also required to make various judgments, including risk to health and intention to comply. Key findings — In both studies, use of the EU recommended descriptors led to significant overestimations of the likelihood of particular side effects occurring. Study 2 further showed that the “overestimation” resulted in significantly increased ratings of perceived severity of side effects and risk to health, as well as significantly reduced ratings of intention to comply, compared with those for people who received the probability information in numerical form. Conclusion — While it is recognised that the current findings require replication in a clinical setting, the European and national authorities should suspend the use of the EU recommended terms until further research is available to allow the use of an evidence‐based approach.

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Section: Discussionmentioning

confidence: 99%

Is 15 per cent very common? Informing people about the risks of medication side effects

Berry

Knapp

Raynor

2002

International Journal of Pharmacy Practice

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“…Consumers' estimated level of incidence for each imprecise frequency descriptor was determined by averaging all responses to the same imprecise frequency descriptor across all DTC prescription drug ads that used that descriptor. On average, consumers' average incidence levels for imprecise frequency descriptors reflected common usage (as exemplified in dictionary definitions) and prior research [7,8]. Consumers believe that level of risk is lowest in "rare" conditions (see Table 2).…”

Section: Resultsmentioning

confidence: 87%

Imprecise Frequency Descriptors and the Miscomprehension of Prescription Drug Advertising: Public Policy and Regulatory Implications

Davis

1999

Journal of Technical Writing and Communication

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Two separate studies, conducted among a total sample of 147 adults, explored the communicative effectiveness of imprecise frequency descriptors within the context of direct to consumer prescription drug advertising. Study One used imprecise frequency descriptors to describe level of side effect occurrence and then asked consumers to numerically estimate the frequency of side effect occurrence. A comparison of consumers' estimated to actual level of incidence indicated that they are unable to accurately estimate level of side effect occurrence when those levels are described by an imprecise frequency descriptor. Study Two presented consumers with a list of side effects preceded by an imprecise frequency descriptor. Consumers were then asked to estimate the relative likelihood of side effect occurrence. The results indicated that consumers are unable to accurately estimate the relative likelihood of side effect occurrence when a list of side effects are preceded by an imprecise frequency descriptor. The pattern of consumer response across both studies indicates that when imprecise frequency descriptors are used to describe the incidence of side effects within the context of direct to consumer prescription drug advertising, consumers estimate likelihood of side effect occurrence on the basis of an intuitive judgment of the side effect's commonness/severity within the general population.

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“…The findings of studies investigating the use of qualitative descriptions of risk, i.e. those using adverbs and adjectives of frequency in place of ratios or percentages, show that patients not only frequently over-estimate risk when they read frequency descriptors (Blalock, Sage, Bitonti, Patel, Dickinson & Knapp, 2016;Berry et al, 2004) they also show great individual variation in their interpretation and express this variation with irregular consistency (Pander Maat & Klaassen, 1994;Knapp, Gardener & Woolf, 2015).…”

Section: Risk In Patient Informationmentioning

confidence: 99%

A corpus based, lexical analysis of patient information for radiography

Golini¹

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Despite the importance and the ubiquity of medical patient information in many healthcare systems in the world, we know very little about the lexical characteristics of the register. We do not know how patients perceive the information in the leaflets or whether the messages are transmitted effectively and fully understood. How a medical authority instructs and obliges patients in written information is also unclear.While the number of radiographic examinations performed globally increases year on year, studies consistently show that patients lack basic knowledge regarding the commonly-performed exams and show very poor understanding of the concomitant risks associated with radiation. There is, then, a pressing need to investigate radiography patient information in order to better understand why, and where, it is less effective.This thesis applies three approaches common to the field of corpus linguistics to uncover some of the lexical characteristics of patient information for radiography. The approaches used in this thesis are a keyword extraction, a lexical bundles analysis and an investigation of modal verbs used to express obligation.The findings suggest that patient information for radiography possesses characteristics more common to academic prose than conversation, although the high informational content of the register goes some way to explaining this and suggests that the reliance on these structures may, to a certain extent, be unavoidable. Results also suggest that the reliance on should to oblige and instruct is problematic as it may cause interpretation problems for certain patients, including those for whom English is not a primary language.Certain other characteristics of patient information revealed by the analyses may also cause comprehension, and while further research is needed, none of these characteristics would be evaluated as problematic by standard readability measures, furthering doubts about the suitability of such measures for the evaluation of medical information.An additional factor behind the increase in healthcare discourse studies is the huge rise in the use of the internet to search for healthcare information, to talk about healthcare both as a patient and as a professional, and to practise medicine. The ehealth or digital health market, which has a projected growth rate of more than 15% in the US, is driven by the prevalence of chronic diseases and government initiatives to deploy e-health (Grand View Research, 2018). In the UK, more than 80% of adults use the internet regularly with just over half reporting that they use the internet to search for health-related information, a figure that has grown by more than 30% over the preceding decade. (Office of National Statistics, 2018). The use of the internet for health reasons is of particular interest to language researchers who have studied patient-professional exchanges, including medical advice sites (e.g. Harvey, Locher & Mullany, 2013) as well as patient-patient communication via forums (e.g. Angouri & Sanderson, 2016; Seale, ...

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Side Effects of Side Effect Information in Drug Information Leaflets

Cited by 10 publications

References 7 publications

Is 15 per cent very common? Informing people about the risks of medication side effects

Is 15 per cent very common? Informing people about the risks of medication side effects

Imprecise Frequency Descriptors and the Miscomprehension of Prescription Drug Advertising: Public Policy and Regulatory Implications

A corpus based, lexical analysis of patient information for radiography

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