ArticleBMJ open2020
Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.
What it found
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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
40 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- What's out there for parents? A systematic review of online information about prenatal microarray and exome sequencing.Prenatal diagnosis · 2022Pooled it
- Trial
- Review
- How well do we write for patients? Longitudinal analysis of the readability and complexity of 4.6 million ophthalmic clinical letters.BMJ health & care informatics · 2026Article
- Optimizing Development of Plain Language Summaries of Clinical Trial Results.Health literacy research and practice · 2026Article
- Article
- Readability of patient information leaflets for commonly used medicines in the UK, Germany and Türkiye: a cross-sectional document analysis.BMC health services research · 2026Article
- Evaluating large language models for simplifying non-English medical consent with clinician involvement.NPJ digital medicine · 2026Article
- The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.Trials · 2026Article
- Effectiveness and Validity of Informed Consent in Patients Undergoing Surgery in Cameroon: A Prospective Survey.The Journal of surgical research · 2026Article
- Evaluating the Readability of Clinical Trial Content for Patients on Pharmaceutical Company Websites.Pharmaceutical medicine · 2026Article
- Clinical trial participant information leaflets overstate the harms/risks of participation and understate the benefits.PloS one · 2026Article
- Readability of paediatric participant information leaflets in research studies.Pediatric research · 2025Article
- Reducing inequalities through greater diversity in clinical trials - As important for medical devices as for drugs and therapeutics.Contemporary clinical trials communications · 2025Article
- Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania.BMC medical ethics · 2025Article
- Article
- The use of large language models to enhance cancer clinical trial educational materials.JNCI cancer spectrum · 2025Article
- Content assessment and readability of online injury prevention resources on firearm safety: a cross-sectional analysis of hospital and national injury prevention literature.Trauma surgery & acute care open · 2025Article
- Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.
designRetrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.
settingPILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.
interventionNot applicable.
main outcome measuresPILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.
resultsA total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of
conclusionsWhen assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.
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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.