A stepped-wedge randomised controlled trial to assess efficacy and cost-effectiveness of a care-bundle to prevent falls in older hospitalised patients.

BACKGROUND: Patient accidental falls in a hospital environment are a serious problem for patient safety, and for the additional costs due to associated medical interventions. OBJECTIVE: The endpoints of this study were the assessment of the fall incidence in the hospital before and after the implementation of a multidisciplinary care-bundle, along with a cost-effectiveness evaluation. DESIGN: A stepped-wedge trial was conducted between April 2015 and December 2016 in Bologna University Hospital. METHODS: Incidence rates (IRs) of falls in both the control and intervention periods were calculated. A multilevel mixed-effects generalised linear model with logit link function, adjusted for age, sex, cluster cross-over timing and patients' clinical severity was used to estimate odds ratios (OR) of fall risk of patients of the intervention group respect to the controls.Intervention costs associated with the introduction of the care-bundle intervention were spread between patients per cluster-period-group of exposure. Incremental cost-effectiveness ratio was evaluated using total costs in the intervention and control groups. RESULTS: IRs of falls in control and intervention periods were respectively 3.15 and 2.58 for 1,000 bed-days. After adjustment, the subjects receiving the intervention had a statistically significant reduced risk of falling with respect to those who did not (OR = 0.71, 95% confidence interval: 0.60-0.84). According to the cost-effectiveness analysis, the incremental cost per fall prevented was €873.92 considering all costs, and €1644.45 excluding costs related falls. CONCLUSIONS: Care-bundle had a protective effect on patients, with a statistically significant reduction of the fall risk. This type of intervention appears cost-effective compared to routine practices.

Relationship between inflammatory laboratory parameters and severity of adolescent idiopathic scoliosis: A pilot study.

BACKGROUND: Adolescent idiopathic scoliosis is a complex condition whose pathogenesis may include inflammation and signs of joint and bone degeneration. OBJECTIVE: The main objective of this study is to evaluate the relationship between the severity of adolescent idiopathic scoliosis and inflammatory blood parameters. METHODS: The study recruited patients with adolescent idiopathic scoliosis who attended the Rehabilitation Center of the Apostolo Foundation in Merate (LC). The scoliosis curve (Cobb's angle) was used as a severity index to compare with inflammatory blood parameters (white blood cells subpopulations, immunoglobulins, protein electrophoresis). In addition, the study used an overall severity grading called "Scoliosis Score" which includes all spine angles and Risser's score (bone development index). RESULTS: Thirty-four subjects were recruited (mean age 14 years, 2 months), 30 females and 2 males. A significant correlation was found between Cobb's angle and the percentage values of beta-2 globulins in a directly proportional manner (r= 0.42, p= 0.01), and gamma globulins in an inversely proportional manner (r=-0.366, p= 0.04). However, no significant correlation between Cobb's angle and the absolute values of white blood cells and percentage subpopulations was found (r= 0.0821 p= 0.655). A moderate, inverse correlation was found between the Scoliosis Score and the percentage of neutrophils (r=-0.385, p= 0.02), a direct correlation was found between the Scoliosis Score and the percentage of lymphocytes (r= 0.404, p= 0.02). In addition, there was a strong correlation of the Scoliosis Score with alpha-2 globulin (r= 0.564, p= 0.0012), beta-1 globulin (r= 0.478, p= 0.0074), and beta-2 globulin (r= 0.370, p= 0.044) and an inverse relationship with gamma globulin (r=-0.625, p= 0.0002). The main correlations were confirmed by regression analysis. CONCLUSION: The correlation between beta-2 globulins and gamma globulins with Cobb's angle and the Scoliosis Score suggests a link between spinal curvature and inflammation in scoliosis patients, This link may indicate the significance of these parameters for diagnosing, staging the disease, and monitoring therapies.