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BEGIN:VEVENT
DTSTAMP:20240325T185835Z
LOCATION:Salon C
DTSTART;TZID=America/Chicago:20240325T164500
DTEND;TZID=America/Chicago:20240325T181500
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess111_POST130@linklings.com
SUMMARY:PS15 - User Testing Clinical Trial Results Summaries for Layperson
 s: A Pilot Study
DESCRIPTION:Poster Presentation\n\nChandler Coleman, Olivia Dallavo, and J
 ay Duhig (AbbVie) and Owen Jokinen (Ohio University)\n\nBackground:\nThe E
 U 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 summar
 ies are easily understood by the target audience, including patients and t
 he general public, they must undergo user testing. During testing, partici
 pants are asked to provide feedback on their overall impression and comple
 te comprehension, or usability tasks related to the PLS. Typically, extern
 al firms conduct this testing due to a lack of expertise and concerns over
  conflicts of interest on the part of pharmaceutical companies. \nObjectiv
 e:\nEvaluate if industry facilitated user testing can provide an objective
  and rigorous assessment of the summaries usability, readability and under
 standability for the target audience, and whether it can address concerns 
 participants may have about the testing process. \nMethods:\nUser testing 
 was conducted for 6 PLS studies during the Third Quarter of 2023.The testi
 ng consisted of a semi structured interview to determine if participants c
 ould find and understand key points from the summary. After the testing in
 terview, participants were asked for feedback on the process. They were sp
 ecifically asked about their concerns regarding conflicts of interest, the
 ir 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 comm
 ents they made about pharmaceutical companies. Thematic analysis was used 
 to determine primary themes and categories arising from user testing trans
 cripts. \nResults:\nOut of the 19 plain language summaries (PLSs) that wer
 e user tested, the majority were from immunology studies (9; 47.4%), follo
 wed by aesthetics studies (7; 36.8%) and neurology studies (3; 15.8%). The
 se summaries covered both phase 2 (6; 31.6%) and phase 3 (13; 68.4%) trial
 s.\nNone of the participants expressed concerns about providing feedback d
 irectly 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.\nAll participants expressed comfort in providi
 ng honest feedback on the PLS and had trust that their feedback would be u
 sed to improve the summary. Several themes emerged from the interviews, in
 cluding the importance of establishing a strong rapport between the interv
 iewer and participant to enable honest feedback, the creation of easily un
 derstandable PLSs to foster transparency and a sense of care, and the infl
 uence of the testing sessions on participants' perception of the company.\
 n\nTrack: Digital Health, Simulation and Education, Hospital Environments,
  Medical and Drug Delivery Devices, Patient Safety Research and Initiative
 s
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