This three blinded adjudicator model is one we’ve been using for several years in recent RCTs. Congrats to our amigos Paul Glat, Lisa Gould, Lael Pickett, and Doug Arm for putting it out there for publication and ultimately iteration. This specific analysis was derived from the HIFLO trial.
The article discusses the steps taken to minimize bias in a clinical trial aimed at improving wound care. The trial, called the HIFLO Trial, evaluated the use of microvascular tissue for healing diabetic foot ulcers (DFUs). The lack of a universal definition of healing in wound studies can lead to detection bias, which affects the comparability of healing rates. To address this, three blinded adjudicators independently assessed each DFU using a rigorous four-part definition of healing. The study also included predefined criteria to avoid bias from selection, performance, attrition, and reporting. The results showed high-level agreement among adjudicators, confirming that DFUs in the HIFLO Trial were consistently assessed for healing without bias, validating the most rigorous assessment criteria to date. The findings can be helpful for others seeking to minimize bias in wound studies.