Trial reportPloS one2018
Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements.Medical decision making : an international journal of the Society for Medical Decision Making · 2019Trial
- Could paper package leaflet be left out from hospital products?Exploratory research in clinical and social pharmacy · 2022Article
- Visual images of prescription drug benefits in direct-to-consumer television advertisements.Patient education and counseling · 2021Article
- The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content.Pharmaceutical medicine · 2020Article
- Article
- How Difference Tasks Are Affected by Probability Format, Part 1: A Making Numbers Meaningful Systematic Review.MDM policy & practiceReview
- How Point (Single-Probability) Tasks Are Affected by Probability Format, Part 1: A Making Numbers Meaningful Systematic Review.MDM policy & practiceReview
- Scope, Methods, and Overview Findings for the Making Numbers Meaningful Evidence Review of Communicating Probabilities in Health: A Systematic Review.MDM policy & practiceReview
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.