Trial Lay Summaries Were Not Fit for Purpose

Background And Objectives: To establish if trial lay summaries are suitable for lay readers.

Methods: A random sample of 60 randomized controlled trial (RCT) reports (15%) from the National Institute for Health and Care Research (NIHR) Journals Library, UK, were selected from 407 available ones. We extracted the lay summary and determined the readability using the previously validated Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simplified Measure of Gobbledegook (SMOG), Gunning Fog (GF), Coleman-Liau Index (CLI), and Automated Readability Index (ARI) readability scales. This provided us with a reading age. We also assessed the compatibility of the lay summaries with the Plain English UK Guidelines and the National Adult Literacy Agency Guidelines, Ireland.

Results: No lay summary met the recommended reading age for health care information of 11-12 years. None of them were considered "easy" to read, in fact over 85% were considered "difficult" to read.

Conclusion: The lay summary is a key document for disseminating trial results to a broad population who may not necessarily have the medical or technical jargon to read a trial report. Its importance cannot be overstated. Assessing readability in conjunction with plain language guidelines is relatively easy and therefore an immediate change to practice is feasible. However, since specific skills are required to write lay summaries that meet the required standards, it is important that the need for such expertise is recognized and supported by research funders.