Gut microbiota has a significant influence on human health and is also involved in the pathogenesis of several disorders. The reconstitution of the healthy gut microbiota is an essential aim in the treatment of disorders associated with microbiota imbalance. Fecal microbiota transplantation (FMT) is the infusion of faces from healthy donors to patients, with the aim of curing a particular disease. This treatment is highly effective in the cure of recurrent Clostridioides difficile infection and has been increasingly evaluated in other disorders associated with microbial dysbiosis. Over time, different FMT working protocols have been investigated and, until now, methodology has not yet been standardized. Future efforts to improve the therapeutic effect of FMT will include the definition of specific protocols for each disease, the application of metagenomic techniques for the assessment of gut microbiota composition into daily practice, and the development of well-designed studies.

OBJECTIVE:The study aims to define the set of Key Performance Indicators (KPIs) required to assess the Value delivered by managing patients with Clostridioides difficile infection through a Critical Pathway. We used the quadruple aim Value-Based approach, and we validated the set of KPIs with the Delphi method.MATERIALS AND METHODS:The study focuses on patients on board a Critical Pathway on Clostridioides difficile Infection and targeted towards a Fecal Microbiota Transplantation (FMT). FMT has been used to successfully treat recurrent Clostridium difficile infection. A two-round e-Delphi survey collecting data was conducted in 2019-2020 to validate the Value-Based evaluation tool. The Value-Based criteria taken into account are Clinical Outcomes, Experience of Care, Per-capita cost, Physician's burnout.RESULTS:The two rounds led to the validation of 50 items, and four primary clinical outcomes (Mortality rate, length of stay, readmission and complications related to the illness).CONCLUSIONS:The evaluation tool included is validated in its totality and can provide a comprehensive overview of the Value created by the Critical pathway for patients with Clostridioides difficile. We can extend the approach illustrated in this study can also to evaluate other Critical pathways.

The need to shed light on the unknown aspects of pathophysiology of common disorders, such as gastrointestinal ones, has led researchers through last decades to study and define the role of microorganisms within the human intestine and their interactions with the host. The progress of technology has permitted the overcoming of culture-based methods to study microbes and paved the way to molecular techniques, which allow the analysis of microbial genome, microbial functions, and metabolism. These progresses opened a window on the world of microbiology and permitted to deepen into the key role played by gut microbiota and dysbiosis in health status and diseases, both gastrointestinal and extraintestinal. So, scientists focused their attention in developing new strategies to restore eubiosis and to manipulate gut microbes by modifying dietary habits, administrating antibiotics, probiotics, and prebiotics and using fecal microbiota transplantation as treatment of gastrointestinal, infectious, cardiovascular, metabolic, immune-mediated, neuro-psychiatric, and oncological disorders. The next challenges will be to elaborate standard protocols with definite outcomes predictors in disease-specific settings.