Efficacy of a Strategy for Implementing Guidelines for the Control of Cardiovascular Risk in Primary Healthcare

Background: A number of strategies exist for the implementation of clinical practice guides (CPGs). Aim: To assess the efficacy of implementing a cardiovascular risk CPG based on an educational method involving opinion leaders, and the habitual method of dissemination among primary healthcare teams. Design and Setting: Controlled, blinded, community intervention trial randomised by clusters. Methods: 21 primary healthcare centres were randomly assigned to either the intervention arm (n = 11) or the control arm (n = 10). The study subjects were patients aged ≥45 years assigned to the centres. The overall impact of the intervention was measured as the difference between the increase in the proportion of patients whose medical records showed the recording of all the variables necessary to calculate cardiovascular risk in both arms. Analyses were performed with Generalized Lineal Model on an intention-to-treat basis. Results: 917 subjects were included at the beginning of the trial (437 in the intervention arm and 480 in the control arm). 826 subjects were included in the final evaluation (436 in the intervention group and 390 in the control arm). At the end of the trial, the recording of the variables necessary for the calculation of the cardiovascular risk in the intervention group had increased more than in the control group (difference between increases 7.49% (95% CI 4.62 - 10.35)) after adjusting for confounding variables. Conclusions: Compared to the habitual method of dissemination, the implementation of this CPG using an educational method involving opinion leaders, improved the recording of the variables needed to calculate patients’ cardiovascular risk.Funding for the trial was provided by the Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica (I+D+I). Instituto de Salud Carlos III—Fondo de Investigación Sanitaria. Expediente N˚ 031216.S

Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry

Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía.Background & Aims: Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensive analysis of 843 patients with DILI enrolled into the Spanish DILI Registry over a 20-year time period. Methods: Cases were identified, diagnosed and followed prospectively. Clinical features, drug information and outcome data were collected. Results: A total of 843 patients, with a mean age of 54 years (48% females), were enrolled up to 2018. Hepatocellular injury was associated with younger age (adjusted odds ratio [aOR] per year 0.983; 95% CI 0.974-0.991) and lower platelet count (aOR per unit 0.996; 95% CI 0.994-0.998). Anti-infectives were the most common causative drug class (40%). Liver-related mortality was more frequent in patients with hepatocellular damage aged ≥65 years (p = 0.0083) and in patients with underlying liver disease (p = 0.0221). Independent predictors of liver-related death/transplantation included nR-based hepatocellular injury, female sex, higher onset aspartate aminotransferase (AST) and bilirubin values. nR-based hepatocellular injury was not associated with 6-month overall mortality, for which comorbidity burden played a more important role. The prognostic capacity of Hy's law varied between causative agents. Empirical therapy (corticosteroids, ursodeoxycholic acid and MARS) was prescribed to 20% of patients. Drug-induced autoimmune hepatitis patients (26 cases) were mainly females (62%) with hepatocellular damage (92%), who more frequently received immunosuppressive therapy (58%). Conclusions: AST elevation at onset is a strong predictor of poor outcome and should be routinely assessed in DILI evaluation. Mortality is higher in older patients with hepatocellular damage and patients with underlying hepatic conditions. The Spanish DILI Registry is a valuable tool in the identification of causative drugs, clinical signatures and prognostic risk factors in DILI and can aid physicians in DILI characterisation and management. Lay summary: Clinical information on drug-induced liver injury (DILI) collected from enrolled patients in the Spanish DILI Registry can guide physicians in the decision-making process. We have found that older patients with hepatocellular type liver injury and patients with additional liver conditions are at a higher risk of mortality. The type of liver injury, patient sex and analytical values of aspartate aminotransferase and total bilirubin can also help predict clinical outcomes