| abstract |
People diagnosed with cancer must process complex, unfamiliar medical information under significant emotional distress, which can impair comprehension and decision making. The ClinicalTrials.gov Brief Summary serves as a critical entry point for patients seeking to understand the purpose, design, and relevance of a clinical trial. Nevertheless, trial descriptions frequently contain technical terminology and complex sentence structures that limit their usefulness. To improve accessibility, the National Library of Medicine issued a Plain Language Checklist for Lay Brief Summaries on September 26, 2022, but limited empirical evaluation exists of whether this guidance produced measurable improvement.
This dissertation used a quantitative pre–post design to evaluate the checklist's impact across a representative sample of interventional lung cancer trials posted three years before and after issuance. The Plain Language Checklist Scoring Tool (PLCST) was developed to assess patient-centricity across focus, content, numbers, and structure, alongside validated readability metrics including Flesch–Kincaid Grade Level. The search identified 2,408 trial records. The Brief Summaries showed a mean Flesch–Kincaid Grade Level of 19.66, corresponding to an advanced graduate school reading level, with no significant change after guidance. The mean PLCST score was only 3.93 of 11, and no summary met all criteria. Although exploratory patient-focused content improved modestly, this outcome reflected greater completeness rather than improved readability.
These findings suggest that the passive publication of plain-language guidance without enforcement, workflow integration, or accountability is insufficient to meaningfully change how investigators write Brief Summaries. The problem may not lie in the checklist itself but in the persistent challenge of clearly communicating complex medical information. This study establishes a benchmark for measuring future interventions and argues that treating communication as a core function of the clinical trial enterprise, rather than a compliance footnote, is essential to equitable patient access to research.
|
