User testing for ethnic minorities to improve the cultural sensitivity of information sheet in clinical research

Problem

People from ethnic minorities have been reported to have higher rates of mental health problems and are less likely to take part in mental health research. This lack of participation inhibits service development for ethnic minorities. A survey was carried out on NIHR mental health portfolio studies examining the barriers within RCT design, primarily focusing on the inability to communicate in English. Overall half of the recruiting studies (64%) excluded participants unable to communicate in English. These obstacles document the need for devising cultural sensitive research procedures. Previous research also indicates that participant information sheets (PIS) are complex and this excessive complexity is likely to intimidate potential participants and impair comprehension and in turn hampers participant recruitment. Research Ethics Committees require all information to be translated into the language of the likely participants. The use of a translator may help, but technical words may have no direct translation into South Asian languages risking misunderstanding. British South Asians may struggle to comprehend research concepts such as randomisation and the need for written consent.This highlights the need for the researchers to facilitate understanding the concepts and make the process of reading information sheets informative and rewarding. Testing the readability of patient information is a relatively recent method and is done through User Testing method. This involves potential participants reading the information, and then being asked to find and show understanding of 12-15 items of information. Our study aims to assess the quality of PIS in lay South Asian people using performance based user testing and to evaluate the readability and understanding of revised Urdu version PIS.

Approach

The performance of the original REACT trial PIS will be tested in South Asian people speaking Urdu. There will be three rounds of testing including 50 participants in total - with the information revised according to its performance after each of the first 2 rounds. The study will explore the understanding of 21 key facts under four categories: the nature and purpose of the trial; processes and meaning of consent; study procedures and effectiveness of the intervention.

Findings

Not available as yet

Consequences

Combining user testing by lay South Asian people when designing study design and information material will result in a greater proportion of participant’s ability to find and understand information about the trial. Not only will this assure valid consent process, but in the longer run by adapting this methodology will enhance the recruitment rates and positivity in participant’s attitudes towards clinical trials. This will also improve evidence base about ethnic minority recruitment to trails