<p>PIL Word count.</p>

A retrospective study of 228 Participant Information Leaflets (PILs) from randomised controlled trials in the UK and Ireland. The dataset, created by Rafaela Carapeto, quantifies the word count of positive and negative reinforcement statements to analyze the balance of communicated benefits and harms/risks. The data was last updated on 2026-05-05.

Use Cases

• Analyze the linguistic balance between benefits and risks in trial information based on the quantified word counts of positive and negative reinforcement statements.
• Study regional or institutional patterns in informed consent communication based on PILs sourced from 26 Clinical Trial Units and Clinical Research Facilities.
• Benchmark the proportion of content dedicated to potential harms versus benefits in participant-facing materials based on the reported median percentages.
• Investigate the relationship between PIL content structure and regulatory requirements for risk communication mentioned in the description.

Strengths

• Includes 228 unique PILs, providing a substantial sample for analysis.
• Quantifies content with specific metrics: median word counts for positive (56 words) and negative (149 words) reinforcement statements.
• Provides proportional analysis, showing negative statements constitute a median of 5.7% of total PIL word count versus 2.3% for positive statements.
• Sourced from a defined set of 26 Clinical Trial Units and Clinical Research Facilities in the UK and Ireland.

Limitations

• Row count is unknown, which may limit suitability assessment for certain statistical methods.
• Column-level documentation is absent; field semantics must be inferred after download.
• The dataset is very small at 5.5 KB, indicating limited scope and likely summary-level data rather than raw text.

Provenance

Source

figshare, author Rafaela Carapeto.

Collection Method

Retrospective study involving systematic extraction and coding of PILs from trials.

Freshness

Last updated 2026-05-05 17:27:18; freshness should be verified.

Geography

United Kingdom and Ireland.