Trial reportDrug safety2020
The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England.
Trial report in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed.
- Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review.BMJ open · 2024Article
- Article
- Positive Attribute Framing Increases COVID-19 Booster Vaccine Intention for Unfamiliar Vaccines.Vaccines · 2022Article
- The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content.Pharmaceutical medicine · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
introductionReframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility.
methodsWe commissioned Ipsos MORI to conduct an online survey of 16- to 75-year-olds in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n = 356), used positive framing with natural frequencies (n = 356), or positive framing with percentages (n = 355). After reading the leaflet, participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet.
resultsBoth positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (ps > 0.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs.
conclusionPositively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.
Indexed as
Identifiers
32557180What 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.