ArticlePloS one2026
Clinical trial participant information leaflets overstate the harms/risks of participation and understate the benefits.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesParticipant Information Leaflets (PILs) are essential for informed consent in randomised controlled trials (RCTs), detailing the trial's purpose, methods, and potential benefits and harms/risks to aid participant decision-making. The purpose of our study was to establish the balance of benefits and harms/risks communicated to trial participants in PILs. STUDY DESIGN AND
settingA retrospective study of 228 PILs from trials in the UK and Ireland. Benefits and harms/risks were defined and quantified through a systematic extraction and coding process. The analysis included the calculation of mean, median, and ranges for word counts of positive and negative reinforcement statements, and their proportional representation in the overall content of the PILs.
resultsThe study included PILs from 26 Clinical Trial Units and Clinical Research Facilities, covering 228 unique studies in the UK and Ireland. The word count for positive reinforcement statements (median: 56 words, 2.3% of total PIL word count) was significantly lower than for negative reinforcement statements (median: 149 words, 5.7% of total PIL word count). Approximately 72% of PILs contained a higher percentage of words dedicated to negative rather than positive reinforcement, indicating an imbalance in presenting harms/risks over benefits.
conclusionsThe findings suggest that information in participant information leaflets places greater emphasis on potential harms and risks than on potential benefits of trial participation. While regulatory requirements necessitate clear communication of possible harms, the relatively limited emphasis on potential benefits may influence how participants interpret trial information. These findings highlight the importance of ensuring that participant-facing materials present both potential harms and benefits in a balanced and accessible way to support informed decision-making. Greater guidance for trial teams on how to present this information may help improve the clarity and balance of participant information leaflets.
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.