Abstract
BACKGROUND: A bundle is a set of three to five evidence-based interventions designed to improve the quality and outcomes of care processes. Numerous international studies have evaluated the effectiveness of Bundles/Care Bundles (BCB) in reducing morbidity and mortality. The Institute for Healthcare Improvement (IHI) has defined the concept of a bundle but has not outlined the development process. OBJECTIVE: To identify the BCB development process in clinical risk scenarios from September 2005 to September 2023. METHODS: A systematic review was conducted following PRISMA guidelines to identify studies describing the BCB development process in managing clinical risk situations. The databases consulted included PubMed, Embase, and CINAHL, along with manual searches on institutional websites. Relevant studies concerning the BCB development process were included. RESULTS: A total of 1372 studies were retrieved, of which 16 were included. Duplicates were removed, and titles and abstracts were analyzed. The identified methods for BCB development include IHI guidelines, expert opinions, international guidelines, and flowcharts. The most common BCBs relate to the prevention of ventilator-associated pneumonia, surgical site infections, catheter-associated infections, and sepsis. CONCLUSIONS: This study has identified the development processes of Care Bundles (BCBs) in clinical risk scenarios, highlighting how these tools facilitate compliance monitoring among members of the healthcare team. The review has revealed effective methods for designing evidence-based BCBs. However, the scarcity of studies on the methodology for developing BCBs is a limitation, suggesting the need for further research. In Italy, there is a growing interest in the use of care packages. It is essential to encourage research that optimizes the effectiveness of intervention strategies.