Poster: Minimizing Bias in a Diabetic Foot Ulcer Clinical Evaluation: Analysis of the HIFLO Trial

In a 2021 poster abstract submitted to SAWC Fall, the authors discuss the steps taken to reduce bias in the HILFO Trial, a randomized, controlled trial that reported increased healing in diabetic foot ulcers (DFUs) using microvascular tissue (PMVT).The authors document minimizing bias within the study.

The methods explained within the poster outline the five main sources of bias within the field of clinical research. Those five main sources of bias are as follows: selection, performance, detection, attrition, and reporting. Detection bias is the most common in wound care due to the lack of a universal definition of healing, resulting in non-comparable healing rates.The authors resolved this by having three blinded adjudicators independently evaluate the DFU cases using a four-part definition of healing. Once some of the patients healed, a minimum of two adjudicators was required to evaluate if all four criteria points were met.

The results of the study showed that investigator training, consistent standard of care, data monitoring, and independent statistical and intent-to-treat only analysis ensured rigor and comparability across sites. The agreement of the adjudicators was ≥90% for each of the four-part healing criteria.

The authors note that there are more biased sources. However, performing a prospective, randomized, blinded, controlled trial reduced some selection and detection bias. The authors state, "High-level agreement by blinded adjudicators assured that HIFLO Trial DFUs were healed, validating the most critical assessment criteria to date.”The authors hoped this study would prove to be beneficial for others working to counteract bias in wound studies/wound care.

Poster CR-037 was featured at SAWC Fall 2021.