Methodological considerations of investigating adherence

     to using offloading devices among people with diabetes


Foot ulcers are a diabetic complication associated with significant morbidity, mortality, and amputation risk. Offloading devices prevent and heal foot ulcers, but adherence to using these devices is low. The reasons for nonadherence are unclear, and study results are difficult to compare due to methodological heterogeneity. This paper explores aspects of investigating adherence to using offloading devices among people with diabetes and provides recommendations for future studies, focusing on study designs, definitions of adherence, measurement methods, and conceptual frameworks. Most studies use a cross-sectional observational study design, limiting the potential to establish the temporal sequence between predictors and adherence, rule out confounding factors, and establish causality. Studies defining adherence as the length of time the device is worn have often used self-report to measure adherence, which may be unreliable. Studies using activity monitors to … read more