Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

Viktoria Mühlbauer,Roman Prinz,Ingrid Mühlhauser,Odette Wegwarth

doi:10.1371/journal.pone.0203800

Viktoria Mühlbauer, Roman Prinz + Show 2 more

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https://doi.org/10.1371/journal.pone.0203800

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Abstract

BackgroundCurrent German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretations.MethodsIn March 2017, 397 out of 400 laypeople approached completed an online survey. They were randomized to one of four PL formats: three alternative PLs (drug facts box with/without reading instruction, narrative format with numbers) and one standard PL. Each PL listed four side effects for a fictitious drug: two were presented as occurring more often, one as equally often, and one as less often with drug intake. The alternative formats (interventions) included information on frequencies with and without drug intake and included a statement on the causal relation. The standard PL (control) only included information on frequency ranges with drug intake. Questions were asked on general occurrence and causality of side effects.ResultsParticipants randomized to the standard PL were unable to answer questions on causality. For side effects occurring more often (equally; less often) with drug intake, only 1.9% to 2.8% (equally: 1.9%; less often: 1.9%) provided correct responses about the causal nature of side effects, compared to 55.0% to 81.9% (equally: 23.8% to 70.5%; less often: 21.0% to 43.2%) of participants who received alternative PLs. It remains unclear whether one alternative format is superior to the others.ConclusionIn conclusion, information on the frequency of side effects in current package leaflets is misleading. Comparative presentation of frequencies for side effects with and without drug intake including statements on the causal relation significantly improves understanding.

Highlights

Informed decision making requires understandable evidence-based health information for patients
We showed that even health professionals, who should be skilled in understanding health information, misinterpreted the extent of side effects when presented with a current standard package leaflets (PLs) [15]
We showed that currently used standard formats of PLs do not enable laypeople to distinguish which proportion of listed side effects are side effects caused by drug intake or instead are symptoms occurring regardless of drug intake

Summary

Introduction

Informed decision making requires understandable evidence-based health information for patients. Studies document that patients are unlikely to receive such information on the Internet or in patient brochures They are confronted with both a lack of evidence-based decision aids [1,2,3] and physicians who themselves are often insufficiently informed due to statistical illiteracy [4,5,6,7,8,9]. This situation may contribute to the findings of a recent survey of the European Medicines Agency, which showed that the majority of patients and healthcare professionals explicitly require greater amounts of unbiased and transparent information on the benefits and harms of medical interventions [10]. The present study investigated whether (1) these misinterpretations prevail among laypeople and (2) alternative PLs reduce these misinterpretations.

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