Evidence map›Paper›PMID 28497250›Full record

ArticleDrug safety2017

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

Rebecca K Webster, John Weinman, G James Rubin

Abstract read
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. A systematic review of factors associated with side-effect expectations from medical interventions.Health expectations : an international journal of public participation in health care and health policy · 2020
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Rebecca K WebsterNIHR Health Protection Research Unit in Emergency Preparedness and Response, King's College London, London, UK. rebecca.webster@kcl.ac.uk.ORCID http://orcid.org/0000-0002-5136-1098
John WeinmanNIHR Health Protection Research Unit in Emergency Preparedness and Response, King's College London, London, UK.
G James RubinNIHR Health Protection Research Unit in Emergency Preparedness and Response, King's College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEvidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated.

objectivesThe 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.

methodsA 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.

resultsA 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'). Within these two groups, the distributions were near to identical regardless of what adverb (e.g. very, high, fair) or adjective (e.g. common, likely, chance) was used. The EC recommended verbal risk descriptors were more likely to be understood in accordance with their intended meanings when describing severe side effects. Very few demographic or psychological factors were consistently associated with how well participants understood the EC recommended verbal risk descriptors. DISCUSSION: The current verbal risk descriptors used in PILs are ineffective at best and misleading at worst. Discontinuing the use of verbal risk descriptors would limit the likelihood of people overestimating the risk of side effects.

Indexed as

ComprehensionPamphletsAdolescentAdultAgedAge FactorsCross-Sectional StudiesDrug LabelingDrug-Related Side Effects and Adverse ReactionsEnglandFemaleHumansMaleMiddle AgedRisk AssessmentRisk Factors

Identifiers

PMID28497250
PMCPMC5519649

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.