Multidisciplinary team approach to traumatic spinal cord injuries: a single institution's quality improvement project.

BACKGROUND: A stepwise multidisciplinary team (MDT) approach to the injured trauma patient has been reported to have an overall benefit, with reduction in mortality and improved morbidity. Based on clinical experience, we hypothesized that implementation of a dedicated Spinal Cord Injury Service (SCIS) would impact outcomes of a patient specific population on the trauma service. METHODS: The trauma center registry was retrospectively queried, from January 2011 through December 2015, for patients presenting with a spinal cord injury. In 2013, a twice weekly rounding SCIS MDT was initiated. This new multidisciplinary service, the post-SCIS, was compared to the 2011-2012 pre-SCIS. The two groups were compared across patient demographics, mechanism of injury, surgical procedures, and disposition at discharge. The primary outcome was mortality. Secondary endpoints also included the incidence of complications, hospital length of stay (HLOS), ICU LOS, ventilator free days, and all hospital-acquired infectious complications. Logistic regression and Student's t test were used to analyze data. RESULTS: Ninety-five patients were identified. Of these patients, 41 (43%) pre-SCIS and 54 (57%) post-SCIS patients were compared. Mean age was 46.9 years and 79% male. Overall, adjusted mortality rate between the two groups was significant with the implementation of the post-SCIS (p = 0.033). In comparison, the post-SCIS revealed shorter HLOS (23 vs 34.8 days, p = 0.004), increased ventilator free days (20.2 vs 63.3 days, p < 0.001), and less nosocomial infections (1.8 vs 22%, p = 0.002). While the post-SCIS mean ICU LOS was shorter (12 vs 17.9 days, p = 0.089), this relationship was not significant. CONCLUSIONS: The application of an SCIS team in addition to the trauma service suggests that a structured coordinated approach can have an expected improvement in hospital outcomes and shorter length of stays. We believe that this clinical collaboration provides distinct specialist perspectives and, therefore, optimizes quality improvement. Level of evidence Epidemiologic study, level III.

Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research.

BACKGROUND AND AIM: Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA supported (NAS) trials were used as a benchmark. METHODS: The two AIFA-supported trials were FATA-GIM3 (optimal adjuvant hormonal treatment for breast cancer) and TOSCA (duration of adjuvant FOLFOX in colorectal cancer). The five NAS trials focused on lung or ovarian cancer. The following were measured for all trials: date of submission of trial documentation to peripheral IEC, date of IEC opinion and date trial contracts were signed. Times are reported in months. RESULTS: 106 centres applied to participate in FATA-GIM3 and 137 in TOSCA. An IEC opinion was issued by 100/106 (1 negative opinion) and 137/137 (2 negative opinions) centres, with a median time from submission of 3.6 months (range 0.1-60.2). After a positive IEC opinion, the median time before signing the trial contract was 3.3 months (0.1-59.2). Contracts were signed with 93/99 and 135/135 centres, with a median time from submission of study documentation of 8.4 months (0.5-61.1). Times for NAS trials were not substantially different. CONCLUSIONS: FATA-GIM3 and TOSCA centres were opened after a median of 8 months, consisting of nearly 4 months each for IEC opinion and administrative signature, similar to the NAS trials. The process of trial activation in Italy remains inefficient and takes far longer than legally allowed.