ArticleBMJ open2025
Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysis.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Ethical and Linguistic Quality of Participant Information Sheets and Their Association with Recruitment Outcomes : An Empirical Bioethics Study of Clinical Trials.Journal of bioethical inquiry · 2026Article
- Better understanding: can a large language model safely improve readability of patient information leaflets in interventional radiology?BMJ health & care informatics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesPatient information sheets (PISs) and informed consent forms (ICFs) are essential tools to communicate and document informed consent for clinical trial participation. These documents need to be easily understandable, especially when used to take informed consent from acutely unwell patients. Health literacy guidance recommends written information should be at a level between reading ages 9-11. We aimed to assess the readability and complexity of PISs/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.
designRetrospective document analysis.
settingPISs/ICFs used in trials involving pharmaceutical interventions recruiting hospitalised patients with COVID-19 during the first year of the pandemic were sourced from hospitals across the UK. PRIMARY AND SECONDARY OUTCOME MEASURES: PISs/ICFs were assessed for length, approximate reading time and subsection content. Readability and language complexity were assessed using Flesch-Kincaid Grade Level (FKGL) (range 1-18; higher is more complex), Gunning-Fog (GFOG) (range 1-20; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0-100; below 60 is 'difficult' for comprehension).
results13 documents were analysed with a median length of 5139 words (range 1559-7026), equating to a median reading time of 21.4 min (range 6.5-29.3 min) at 240 words per minute. Median FKGL was 9.8 (9.1-10.8), GFOG 11.8 (10.4-13) and FRES was 54.6 (47.0-58.3). All documents were classified as 'difficult' for comprehension and had a reading age of 14 years old or higher.
conclusionsAll PISs/ICFs analysed contained literary complexity beyond both recommendations and the reading level of many in the UK population. Researchers should seek to improve communications to improve trial volunteer comprehension and recruitment.
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.