ReviewDrug safety2017
Pharmaceutical Benefit-Risk Communication Tools: A Review of the Literature.
Review in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed.
- Efficacy of Three Numerical Presentation Formats on Lay People's Comprehension and Risk Perception of Fact Boxes-A Randomized Controlled Pilot Study.International journal of environmental research and public health · 2023Trial
- Physician-reported barriers and facilitators to thyroid hormone deprescribing in older adults.Journal of the American Geriatrics Society · 2025Article
- Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review.BMJ open · 2024Article
- Appeal for Increasing the Impact of Pharmacovigilance.Drug safety · 2024Article
- Review
- Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature.Drug safety · 2021Article
- The Evolving Field of Risk Communication.Risk analysis : an official publication of the Society for Risk Analysis · 2020Article
- Pharmaceutical Benefit-Risk Perception and Age Differences in the USA and Germany.Drug safety · 2020Article
- Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.Pharmacoepidemiology and drug safety · 2020Article
- Barriers and Enablers of Older Patients to Deprescribing of Cardiometabolic Medication: A Focus Group Study.Frontiers in pharmacology · 2020Article
- 'Engagement' of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework.European journal of clinical pharmacology · 2019Review
- Optimizing responses to drug safety signals in pregnancy: the example of dolutegravir and neural tube defects.Journal of the International AIDS Society · 2019Article
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
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature. Three distinct goals are then made explicit before critically examining the evidence for and against tools developed in the US (e.g. at the Food and Drug Administration [FDA]) and Europe (e.g. at the European Medicines Agency [EMA]). These goals are (i) sharing information (e.g. publishing clinical trial and adverse event data online); (ii) changing patients' beliefs by conveying factual knowledge (e.g. patient information leaflets and the drugs facts box); and (iii) changing behaviour (e.g. patient alert cards and warning labels). The mental models approach and traffic-light labelling, developed outside the pharmaceutical context, are then examined. Ultimately, the paper provides a helicopter view of the variety of benefit-risk communication tools that are used, or could be used, by pharmaceutical regulators in the US and Europe.
Indexed as
Identifiers
27743334What 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.