Trial reportDrug safety2009
Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations.
Trial report in Drug safety, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 5 of them syntheses that pooled 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.
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
25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- 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
- Readability of medicinal package leaflets: a systematic review.Revista de saude publica · 2015Pooled it
- Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis.BMC medical informatics and decision making · 2014Pooled it
- Risk as an attribute in discrete choice experiments: a systematic review of the literature.The patient · 2014Pooled it
- 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
- Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.Health expectations : an international journal of public participation in health care and health policy · 2016Trial
- Severity or Incidence: Labeling Side-Effect Attributes in Discrete Choice Experiments.The patient · 2026Article
- Positive Attribute Framing Increases COVID-19 Booster Vaccine Intention for Unfamiliar Vaccines.Vaccines · 2022Article
- Thai Patients' Drug Safety Knowledge and Perceptions Relating to Different Forms of Written Medicine Information: A Comparative Study.Patient preference and adherence · 2022Article
- Visual images of prescription drug benefits in direct-to-consumer television advertisements.Patient education and counseling · 2021Article
- Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature.Drug safety · 2021Article
- Can Positive Framing Reduce Nocebo Side Effects? Current Evidence and Recommendation for Future Research.Frontiers in pharmacology · 2019Review
- 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
- Medication Risk Communication in Rheumatology: Where Are We and Where Do We Go from Here?Current rheumatology reports · 2017Review
- Effect of Communication Style on Perceptions of Medication Side Effect Risk among Pharmacy Students.American journal of pharmaceutical education · 2016Article
- Factors influencing subjects' comprehension of a set of medicine package inserts.International journal of clinical pharmacy · 2016Article
- Exploring consumer opinions on the presentation of side-effects information in Australian Consumer Medicine Information leaflets.Health expectations : an international journal of public participation in health care and health policy · 2016Article
- Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers.Deutsches Arzteblatt international · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAll licensed medicines in the European Union must be provided with a Patient Information Leaflet that includes a list of all known side effects. Among patients who read the leaflet, the side effects section is the most often read. A UK government regulatory publication recommends providing medicine side effect risk information in a combined format, using verbal descriptors accompanied by numerical information.
objectivesThis study, with users of an existing popular patient information website, investigates the effectiveness of presenting medicine side effect risk information in different forms.
designParticipants were randomly allocated to one of the three formats for representing risk information (verbal descriptors, e.g. 'common'; absolute frequencies, e.g. 'less than 1 in 10 people'; and a combination of verbal descriptors and frequency bands, e.g. 'common (affects less than 1 in 10 people)'.
methodsParticipants (n = 187) were recruited from users of the Cancer Research UK patient information website. They were asked to imagine that they had to take a cancer treatment (tamoxifen), estimate the risks of four side effects occurring, and complete Likert scales relating to their satisfaction with the information supplied and perceived likelihood of various outcomes.
resultsThose in the absolute frequency format demonstrated greater accuracy in estimating the likelihood of having two of four side effects than the other two formats. They were also more accurate at estimating the likelihood of themselves or the average person having any side effect from taking tamoxifen. Participants in the absolute frequency format rated the risk to health from tamoxifen as lower than those in the other two formats, were more satisfied with the information they received than those in the verbal format, and felt there would be less impact of the information on tamoxifen use than those in the combined format.
conclusionsThese findings fail to confirm that the recommended use of combined descriptors for medicine side effects is unequivocally superior to absolute frequency alone. They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptors for conveying side effect risk, and the strength of using absolute frequency descriptors.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.