Presentation
PS15 - User Testing Clinical Trial Results Summaries for Laypersons: A Pilot Study
DescriptionBackground:
The EU Clinical Trials Regulation (CTR) 536, adopted in 2014, mandates clinical trials to produce a plain language summary (PLS) of the trial’s purpose, methods, results, and potential impact on patients. To ensure these summaries are easily understood by the target audience, including patients and the general public, they must undergo user testing. During testing, participants are asked to provide feedback on their overall impression and complete comprehension, or usability tasks related to the PLS. Typically, external firms conduct this testing due to a lack of expertise and concerns over conflicts of interest on the part of pharmaceutical companies.
Objective:
Evaluate if industry facilitated user testing can provide an objective and rigorous assessment of the summaries usability, readability and understandability for the target audience, and whether it can address concerns participants may have about the testing process.
Methods:
User testing was conducted for 6 PLS studies during the Third Quarter of 2023.The testing consisted of a semi structured interview to determine if participants could find and understand key points from the summary. After the testing interview, participants were asked for feedback on the process. They were specifically asked about their concerns regarding conflicts of interest, their ability to provide honest feedback, and their trust that their feedback would be used to improve the PLS. Furthermore, we recorded any additional questions asked by participants during the interview, as well as any comments they made about pharmaceutical companies. Thematic analysis was used to determine primary themes and categories arising from user testing transcripts.
Results:
Out of the 19 plain language summaries (PLSs) that were user tested, the majority were from immunology studies (9; 47.4%), followed by aesthetics studies (7; 36.8%) and neurology studies (3; 15.8%). These summaries covered both phase 2 (6; 31.6%) and phase 3 (13; 68.4%) trials.
None of the participants expressed concerns about providing feedback directly to a pharmaceutical company. Two participants (10.5%) expressed a desire to know more about the involvement of the user testing interviewer in the creation of the PLS.
All participants expressed comfort in providing honest feedback on the PLS and had trust that their feedback would be used to improve the summary. Several themes emerged from the interviews, including the importance of establishing a strong rapport between the interviewer and participant to enable honest feedback, the creation of easily understandable PLSs to foster transparency and a sense of care, and the influence of the testing sessions on participants' perception of the company.
The EU Clinical Trials Regulation (CTR) 536, adopted in 2014, mandates clinical trials to produce a plain language summary (PLS) of the trial’s purpose, methods, results, and potential impact on patients. To ensure these summaries are easily understood by the target audience, including patients and the general public, they must undergo user testing. During testing, participants are asked to provide feedback on their overall impression and complete comprehension, or usability tasks related to the PLS. Typically, external firms conduct this testing due to a lack of expertise and concerns over conflicts of interest on the part of pharmaceutical companies.
Objective:
Evaluate if industry facilitated user testing can provide an objective and rigorous assessment of the summaries usability, readability and understandability for the target audience, and whether it can address concerns participants may have about the testing process.
Methods:
User testing was conducted for 6 PLS studies during the Third Quarter of 2023.The testing consisted of a semi structured interview to determine if participants could find and understand key points from the summary. After the testing interview, participants were asked for feedback on the process. They were specifically asked about their concerns regarding conflicts of interest, their ability to provide honest feedback, and their trust that their feedback would be used to improve the PLS. Furthermore, we recorded any additional questions asked by participants during the interview, as well as any comments they made about pharmaceutical companies. Thematic analysis was used to determine primary themes and categories arising from user testing transcripts.
Results:
Out of the 19 plain language summaries (PLSs) that were user tested, the majority were from immunology studies (9; 47.4%), followed by aesthetics studies (7; 36.8%) and neurology studies (3; 15.8%). These summaries covered both phase 2 (6; 31.6%) and phase 3 (13; 68.4%) trials.
None of the participants expressed concerns about providing feedback directly to a pharmaceutical company. Two participants (10.5%) expressed a desire to know more about the involvement of the user testing interviewer in the creation of the PLS.
All participants expressed comfort in providing honest feedback on the PLS and had trust that their feedback would be used to improve the summary. Several themes emerged from the interviews, including the importance of establishing a strong rapport between the interviewer and participant to enable honest feedback, the creation of easily understandable PLSs to foster transparency and a sense of care, and the influence of the testing sessions on participants' perception of the company.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives