Trial reportHealth expectations : an international journal of public participation in health care and health policy2016
Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.
Trial report in Health expectations : an international journal of public participation in health care and health policy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.
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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.
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Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- The Evolving Landscape of Discrete Choice Experiments in Health Economics: A Systematic Review.PharmacoEconomics · 2025Pooled it
- Imprecision and Preferences in Interpretation of Verbal Probabilities in Health: a Systematic Review.Journal of general internal medicine · 2021Pooled it
- 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 · 2020Pooled it
- Communicating treatment risks and benefits to cancer patients: a systematic review of communication methods.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020Pooled it
- Using Separate Single-Outcome Risk Presentations Instead of Integrated Multioutcome Formats Improves Comprehension in Discrete Choice Experiments.Medical decision making : an international journal of the Society for Medical Decision Making · 2024Trial
- Trial
- Presenting Numeric Information with Percentages and Descriptive Risk Labels: A Randomized Trial.Medical decision making : an international journal of the Society for Medical Decision Making · 2015Trial
- Severity or Incidence: Labeling Side-Effect Attributes in Discrete Choice Experiments.The patient · 2026Article
- Thai Patients' Drug Safety Knowledge and Perceptions Relating to Different Forms of Written Medicine Information: A Comparative Study.Patient preference and adherence · 2022Article
- Communicating tailored risk information of cancer treatment side effects: Only words or also numbers?BMC medical informatics and decision making · 2020Article
- Verbal Descriptions Accompanying Numeric Information About the Risk: The Valence of Message and Linguistic Polarity.Journal of psycholinguistic research · 2019Article
- Article
- How does the side-effect information in patient information leaflets influence peoples' side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England.Health expectations : an international journal of public participation in health care and health policy · 2017Article
- People's Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England.Drug safety · 2017Article
- Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey.Drug safety · 2015Article
- How Point (Single-Probability) Tasks Are Affected by Probability Format, Part 2: 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe study evaluated European Medicines Agency (EMA) recommendations on communicating frequency information on side-effect risk.
methodsThe study used a 2 × 2 factorial trial, with random allocation of information about 10 side-effects of paclitaxel (Taxol) expressed using one of four formats. Recruitment was via the CancerHelpUK website. Information was conveyed using numerical frequency bands (e.g. 'may affect up to 1 in 10 people') or combined verbal terms and numerical bands (e.g. 'common: may affect up to 1 in 10 people'); in addition, the risk qualifier verb was manipulated, with risks expressed either as 'will affect…' or 'may affect…'. Participants then made six side-effect frequency estimates indicated their satisfaction with the information and evaluated the side-effects: how bad; how likely; how risky to health; and their influence on taking paclitaxel.
resultsThe sample comprised 339 people, of whom 37.5% had cancer. The combined verbal and numerical risk expressions resulted in higher estimates of side-effects, four of which reached statistical significance (P < 0.05), and participants also said that side-effects would be more likely. Use of 'may affect' or 'will affect' did not result in differences in any estimates.
conclusionsThis is the first evaluation of the full range of combined verbal and numerical risk expressions recommended in EMA guidance; it demonstrates that they can lead to significant risk overestimations when compared to numerical frequency bands alone. The EMA should consider revising its guidance. Government agencies and professional bodies should be cautious about recommendations for risk communication in the absence of empirical evidence.
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