Background/Purpose:  To determine the readability of written information (Participant Information and Consent Forms [PICS]) provided to clinical trial participants prior to enrolment into a clinical trial. General recommendations for reading age are that reading materials should be at educational level of year 8 or below

Methods: PICS over a time frame 2003-2013 from a dedicated clinical trials site were assessed for reading age.  81 industry derived PICs for musculoskeletal studies , 4 investigator initiated PICS and 3 non–drug study PICS were reviewed using a number of validated reading age tools -Flesch Reading Ease; Gunning FOG; Flesch-Kincaid Grade Level; The Coleman Liau Index; The SMOG Index; Automated Reading Index; Linsear Write Formula readability scores – to estimate readability of specific subsections. Specific sub-sections of the PICs from industry sponsored studies were reviewed – confidentiality/privacy section and the Risk Section.

Results: Only 4% of documents conformed to a recommended reading age of year 8 or below. The majority of documents had high reading ages with 93-96% pitched at year 10 or greater. 34 – 70% required reading levels of college graduate or postgraduate. A study of a small number of non-industry studies demonstrated similar results

Conclusion:

Current information materials provided to potential clinical trial participants fall far short of recommended readability levels potentially compromising the process of informed consent. Further attention needs to be paid to this aspect of clinical trials

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/readability-of-participant-information-and-consent-forms-for-rheumatology-clinical-trial-participants/