- Poster presentation
Use of an online e-learning module to standardise the assessment and reporting of a subjective endpoint in a multicentre rct
Trialsvolume 14, Article number: P64 (2013)
Multicentre trials employing a subjective primary outcome measure have the potential to suffer from significant inter-rater variability which may compromise the validity of findings. The primary outcome for the ROSSINI Trial was surgical site infection. We designed a bespoke online training module with embedded quiz to ensure standardisation and reproducibility of wound assessment.
We designed an online e-learning module comprising an educational review of surgical site infection signs and symptoms, as well as a quiz with high quality digital photos of surgical wounds to ensure optimal and standardised diagnosis. Automated feedback was given instantly to maximise and reinforce learning.
The e-learning module and quiz was completed by the majority of local investigators at the 21 sites that opened for the ROSSINI trial. A total of 769 patients were recruited to the trial and each patient underwent at least two blinded wound reviews as part of the primary outcome assessment.
The online learning resource provided effective training and accreditation to wound reviewers at multiple sites in a convenient and reproducible manner. This adjunct to our trial served to standardise outcome assessment and hopefully reduced inter-observer variability.