Trial reportQuality & safety in health care2004
Comparison of two methods of presenting risk information to patients about the side effects of medicines.
Trial report in Quality & safety in health care, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 6 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
45 citing papers in PubMed, 6 syntheses or guidelines pooled it, 161 citations in OpenAlex.
- Verbal Probability Terms for Communicating Clinical Risk - a Systematic Review.The Ulster medical journal · 2024Pooled 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
- 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
- Using alternative statistical formats for presenting risks and risk reductions.The Cochrane database of systematic reviews · 2011Pooled it
- Written information about individual medicines for consumers.The Cochrane database of systematic reviews · 2009Pooled it
- 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
- Risk communication methods in hip fracture prevention: a randomised trial in primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2011Trial
- Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations.Drug safety · 2009Trial
- Strategies for communicating scientific evidence on healthcare to managers and the population: a scoping review.Health research policy and systems · 2023Article
- Key concepts for informed health choices. 2.3: descriptions of effects should clearly reflect the size of the effects.Journal of the Royal Society of Medicine · 2023Article
- Evaluation of Patient's Knowledge of Atorvastatin Information in Patient Information Leaflets: A Pre-Post Intervention Study in Thailand.Patient preference and adherence · 2021Article
- Communicating tailored risk information of cancer treatment side effects: Only words or also numbers?BMC medical informatics and decision making · 2020Article
- Diabetes patient's pharmacovigilance knowledge and risk perception: the influence of being part of a patient organisation.Therapeutic advances in drug safety · 2020Article
- Experiences and Views of Medicine Information Among the General Public in Thailand.Patient preference and adherence · 2020Article
- Do people with intellectual disabilities understand their prescription medication? A scoping review.Journal of applied research in intellectual disabilities : JARID · 2019Article
- Article
- How Do Women Interpret the NHS Information Leaflet about Cervical Cancer Screening?Medical decision making : an international journal of the Society for Medical Decision Making · 2019Article
- What Factors Influence Women's Perceptions of their Systemic Recurrence Risk after Breast Cancer Treatment?Medical decision making : an international journal of the Society for Medical Decision Making · 2018Article
- Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine.BMC public health · 2017Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine whether the use of verbal descriptors suggested by the European Union (EU) such as "common" (1-10% frequency) and "rare" (0.01-0.1%) effectively conveys the level of risk of side effects to people taking a medicine.
designRandomised controlled study with unconcealed allocation.
participants120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction.
settingCardiac rehabilitation clinics at two hospitals in Leeds, UK.
interventionA written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, "common" or 2.5%; for pancreatitis, "rare" or 0.04%).
main outcome measureThe estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine.
resultsThe mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors.
conclusionsPatients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine.
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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.