6343 Language suitability of the ‘purpose of the study’ in Patient information leaflets (PILs)

Objectives Background: Patient information Leaflets (PILs) are necessary for informed consent forms (ICF). They are essential and ethical cornerstone¹ of all standard healthcare trials.² The information included in any PIL is guided by the International Conference on Harmonization of Good Clinical Practice (ICH GCP). The challenges are that researcher's attempt to comply with heavily regulated PIL guideline can result in a more difficult to understand PIL. There is a gap in the literature and numerous studies that readability, content or structure alone is not enough for adequate understanding. Investigating the language suitability of PILs for only the 'purpose of the study' will be very useful in the assessment of participant's understanding of the trial and a truly informed consent if and when given. Aim To determine if the PILs section detailing the purpose of the study meets recommended readability age and written in lay language. Methods Study-Within-A-Trial (SWAT) on recruitment. Previously collated 215 PILs from another study of PILs in Ireland and United Kingdom from Clinical Trial Units (CTUs) was used. The trial characteristics data and readability score extracted. Readability test via online tool WebFX (https://www.webfx.com/tools/readable/#enter-text-tab) for reading age and compatibility with the plain English UK and NALA guidelines with the 6 common criteria of sentence length, font type, font size, line spacing, use of passive verb, use of justified text and a 7th criteria- use of uppercase and lowercase headings. Results No PIL achieved combined recommended readability age and plain English guideline. The 'purpose of study' heading and text readability score showed that 70% (n-150) were difficult. 25.6% (55) average and only 4.65% (10) were easy and met the recommended reading age of ≤11–12years (tables 1 and 2). 90% (9) of these are PIL written for children. 75% of the children specific PIL did not achieve recommended reading age. Those that attained reading age are still inadequate for targeted age group. Mean reading age is 16.4 years. Conclusion Despite health literacy model previously proposed to improve PIL/ICF, it is discouraging to conclude that all the 'purpose of study' section of PIL in this study did not meet all the plain English language guideline and traditional readability score combined with implied questionable consent and assent. More effort and mandatory readability testing is recommended to achieve the reading age recommendation with active collaboration of researchers, patients and public. References Gillies Katie et al. PILs for UK randomized controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials 2014;15:62. http://www.trialsjournal.com/content/15/1/62 World Medical Association. Ethical principles for medical research involving human subjects. JAMA 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053. https://jamanetwork.com/journals/jama/fullarticle/1760318 (accessed 21 April 2023). EMA 2016. https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf (accessed 30 April 2023).