Usability Evaluation of the Accubio Bowel Health Self-Test
Research type
Research Study
Full title
Performance and Usability Evaluation of the Accubio Stomach Ulcer Self-Test (product code: GCHP-602a-H1)
IRAS ID
336374
Contact name
Tara Moore
Contact email
Sponsor organisation
Accubio
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Background: The Accubio Bowel Health Self-Test is a qualitative assay for the detection of haemoglobin in stool samples. It is intended to aid in the diagnosis of gastrointestinal disorders, including bowel cancer. Although performance data for the kit has been completed the test is intended for self-testing at home by lay-users and therefore user testing is required.
Aim: To assess the usability of the Accubio Bowel Health Self-Test by untrained lay-users representative of the intended user population in a simulated use environment.
Methods: Forty-five participants (reflecting a variation in age (40-74 years), gender, ethnicity and education attainment) will be recruited using community recruitment strategies and asked to undertaken a simulated Accubio Bowel Health Self-Test. Participants will be given the specific instructions and kit configuration included in the Bowel health Self-Test and a trained researcher will conduct a usability evaluation where use errors will be observed and recorded. In addition, knowledge task assessments will be carried out along with user feed-back on the test. No actual participant or clinical sample is required, and no technical performance attributes of the test will be evaluated.
Outcome: The Bowel Health Self-Test will be considered acceptable if ≥90% of all tasks consolidated across all user groups are completed successfully (to include successes, alternative successes, close calls and difficulties).REC name
London - Bloomsbury Research Ethics Committee
REC reference
23/PR/1413
Date of REC Opinion
21 Dec 2023
REC opinion
Unfavourable Opinion