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Randomized Controlled Trial
. 2018 Sep 13;13(9):e0203800.
doi: 10.1371/journal.pone.0203800. eCollection 2018.

Alternative Package Leaflets Improve People's Understanding of Drug Side effects-A Randomized Controlled Exploratory Survey

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Free PMC article
Randomized Controlled Trial

Alternative Package Leaflets Improve People's Understanding of Drug Side effects-A Randomized Controlled Exploratory Survey

Viktoria Mühlbauer et al. PLoS One. .
Free PMC article

Abstract

Background: Current 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.

Methods: In 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.

Results: Participants 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.

Conclusion: In 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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Example of an alternative package leaflet: Drug facts box with reading instructions.
Fig 2
Fig 2. Control: Standard package leaflet.
Fig 3
Fig 3. Participants’ response distribution on the general occurrence of side effects per format.
(Format 1 = drug facts box, format 2 = drug facts box with reading instruction, format 3 = narrative with numbers, format 4 = standard PL).
Fig 4
Fig 4. Participants’ response distribution on the causal extent of side effects per format.
(Format 1 = drug facts box, format 2 = drug facts box with reading instruction, format 3 = narrative with numbers, format 4 = standard PL).

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Grant support

Allowance for participants was paid from budgetary resources of the Center for Adaptive Behavior and Cognition at the Max Planck Institute for Human Development (Germany). There was no further funding of the study.
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