Project R. Evolution for improving clinical research in Italy: challenges and strategies.

OBJECTIVE: The R.Evolution project aimed to reach a consensus on the main challenges of conducting clinical research in Italy and possible strategies and approaches to address them and optimize clinical research management. METHODS: A scientific board of experts initially discussed potentially critical areas in clinical research conduct and further explored them through an online national survey. The survey results were further examined by a group of 35 panelists representing different clinical research stakeholders. A Nominal Group Technique and a Delphi approach (two rounds) were used to generate a consensus on critical factors, tools and strategies in clinical research. RESULTS: Four main critical areas were identified: study feasibility, authorization procedures, operational aspects and patient management. The main issues are scarce awareness of the value of clinical research, lack of trained workforce and excessive complexity of protocols and administrative procedures. The Delphi panel identified six intervention areas: culture and patient involvement; procedures; staff, contracts, training and incentives; organization and infrastructure; administrative procedures; and ethics committee. CONCLUSION: According to the R.Evolution project, possible strategies to improve clinical research management in Italy include a deeper understanding of the value of clinical research, the creation of long-term plans for hiring, training, organizing and motivating clinical trial staff, the simplification and harmonization of administrative procedures, as well as protocol design, and the development of stronger networks of centers and stakeholders.

Early discharge of infectious disease patients: an opportunity or extra cost for the Italian Healthcare System?

In order to assess the economic benefits of an early discharge (ED) programme for patients with complicated skin and soft tissue infections (cSSTIs) in terms of hospital and regional authority costs, an economic analysis was conducted comparing two possible alternatives: standard hospital management vs. an ED strategy followed by a period of outpatient management. Utilization of resources and costs were derived from the literature and expert panel evaluation. Patients were classified into four groups: low-intensity non-walking (LINW), low-intensity walking (LIW), high-intensity non-walking (HINW) and high-intensity walking (HIW). The overall costs (inpatient/outpatient) of hospitalization with ED for cSSTIs range from Euros 2,079 for LIW to Euros 2,193 for HINW, with the most expensive regimen (HINW) being 50% lower than the costs for 12.6 days of hospitalization alone (Euros 4,619). The weighted average Diagnosis Related Group (DRG) reimbursement for cSSTIs (Euros 2,042) does not cover the costs of such hospitalization. In conclusion, when a patient's conditions allow for early discharge there is an economic advantage for the hospital with an outpatient management plan, especially for patients requiring low-intensity care. However, this could be disadvantageous in terms of regional costs if outpatient management has to be paid in addition to payment by the DRG.