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[version 1; peer review: awaiting peer review] Background: People from ethnic minorities in the UK have higher rates of mental health problems and are less likely to take part in mental health research. Previous research indicates that participant information sheets (PIS) are complex, and this complexity may impair comprehension more significantly for ethnic minority participants. Improving the readability of patient information can be achieved through user testing. We aimed to improve the readability of a PIS through user testing in an ethnic minority group in an ongoing trial (ROSHNI-2). Methods: An independent groups design was used to test the readability of the ROSHNI-2 PIS among South Asian women. There were two rounds of testing (n=31 women in total). South Asian women were asked to read the original PIS, then find and demonstrate an understanding of 19 key aspects of the trial. Based on the findings from the first round, the PIS was rewritten, redesigned, and retested. Results: Using the original PIS, only 2 of the 19 (11%) questions were found and understood by at least 80% of participants. In the revised PIS, 6 of the 19 (32%) questions were found and understood by at least 80% of participants. Conclusions: User testing and re-writing of a PIS resulted in a higher proportion of participants comprehending important information about a trial. This approach could improve participation in trials among ethnic minority communities.

More information Original publication



Journal article


f1000 research


F1000Research 2022, 11:1064



Publication Date





Yumna Masood had a SPCR capacity fellowship


User Testing, Participant Information Sheets, South Asian, participation in research