Readability of Public-Facing Urologic Oncology Trial Summaries on ClinicalTrials.gov

Abstract

Purpose: To assess the readability of clinical trial brief summaries for urologic oncology studies listed on ClinicalTrials.gov and evaluate readability variation by cancer type, time, or study sponsor.

Materials and methods: We analyzed all clinical trials related to 6 urologic cancers registered on ClinicalTrials.gov. We extracted the brief summary and calculated surface metrics (word count, sentence length, vocabulary size, and abbreviation count) and 5 standard readability scores including the Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease (FRE). We used interrupted time series analysis to assess readability trends, with 2017 as the intervention point following the NIH's clear language guidance release. We categorized sponsor types (government, academic, and industry) to compare readability across sponsor groups.

Results: We identified 17,175 trials across 6 cancer types. The average FKGL was 18.7 and FRE was 7.4. The median length was 24 (IQR 20-30) words. Interrupted time series analysis showed that from 2000 to 2016, brief summaries became increasingly more complex with FKGL rising and FRE decreasing (both P < .01). After the plain language guidance from the NIH, readability improved with FKGL decreasing and FRE increasing (both P < .01). Government-sponsored trials were most readable (FKGL = 16.0, FRE = 27.3), followed by academic (FKGL 18.1, FRE 8.7) and industry (FKGL 19.1, FRE 7.3); all differences were significant (P < .01).

Conclusions: Brief summaries of urologic oncology trials on ClinicalTrials.gov remain highly complex requiring a graduate level reading ability. There is improvement since NIH's plain language directive. Efforts to enhance the clarity of clinical trial descriptions are needed to support informed patient participation.

Keywords: clinical trials; comprehension; health literacy; patient education; readability.