OBJECTIVES : Sepsis is a life-threatening medical emergency affecting 48.9 millions of people worldwide, accounting for 20% of global deaths in 2017. Early identification able to reduce Time To Antibiotics (TTA) may significantly reduce disease severity and mortality. However, serious delays still affect the management of septic patients and make urgent the need for a diagnostic test. Monocyte Distribution Width (MDW) is a new biomarker recently developed for the early detection of sepsis. This study aims to conduct a multidimensional and multi-stakeholder assessment of the MDW technology being at the stage-gate between clinical validation and translation into the Italian National Health System.

METHODS : We collected Real-World evidence (RWE) alongside the clinical validation study in San Donato Hospital located in Arezzo, Italy. A mixed-methodology was adopted to incorporate within the clinical study a multi-stakeholder perspective. First, semi-structured interviews were conducted to a variety of key stakeholders for technology adoption including clinicians, health managers, and policy-makers to capture their views on the likely technology utility, economic sustainability, impact of adoption in hospital practice and alternative adoption scenarios. Second, standard questionnaires to collect professional experience, satisfaction, and perceptions on the likely organizational impact were administered to health professionals. Finally, a multidisciplinary-facilitated workshop was piloted to discuss the results of the previous stages.

RESULTS : A series of visual maps synthesized the organizational impact of the new MDW technology in two complex and integrated pathways – Emergency Department and Clinical Pathology – through a comparison before and after the introduction.

CONCLUSIONS : The adoption of biomedical technological innovation into clinical practice is still slow and faces many challenges. There is an urgent need to understand barriers and facilitators to accelerate the adoption of the new MDW technology, whose traditional uncertainty in terms of human factors is further amplified by the peculiarity of sepsis as a time-dependent disease.