RESUMEN
Background:Malnutrition is highly prevalent and strongly associated with clincial outcomes of medical inpatients. Still, the benefit of nutritional treatment to prevent adverse outcomes in medical inpatients at risk for malnutrition remains unproven. We describe the trial methods of the largest yet nutritional trial in medical inpatients including the rationale for key design decisions regarding the nutritional strategy, eligibility criteria, choice of control arm, and endpoints.Methods:The Effect of early nutritional therapy on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial(EFFORT) is an investigator-initiated, non-commercial, open-labelRCT to compare the effects of an intensified nutritional therapy (intervention group) with acontrol group on medical outcomes. We include adult medical inpatients at risk of malnutrition based on a Nutritional Risk Screening 2002 (NRS) score of ?3 points with an expected length of stay of ?5 days. An individualized systematic nutritional assessment by study dieticians is done to define nutritional targets and to establish an implementation plan. Patients in the intervention group receive individualized early nutritional therapy based on a previously published consensus algorithm, while control group patients receive standard hospital nutrition. The study is powered to compare clinical outcomes (composite adverse outcome and mortality) in the 2 study arms as well as to address several mechanistical questions.Conclusion:EFFORT aims to close important gaps in the literature regarding the controversy about benefit and possible harm of nutritional therapy in medical inpatients at risk for malnutrition.Trial Registration: ClinicalTrials.gov NCT02517476; registered July 30, 2015.
RESUMEN
BACKGROUND AND PURPOSE: Micro ribonucleic acid-150-5p (miR-150-5p) regulates proinflammatory cytokines as well as vessel integrity. We evaluated the incremental prognostic value of logarithm (log) of miR-150-5p plasma levels after ischemic stroke. METHODS: In a prospective cohort study, levels of miR-150-5p were measured within 72 hours of symptom onset in 329 ischemic stroke patients. The outcome measures were unfavorable functional outcome (assessed by the modified Rankin Scale score >2) and mortality within 90 days. Logistic regression and Cox proportional hazards models were fitted to estimate odds ratio (OR), respectively hazard ratio (HR) and 95% confidence interval (CI) for the association between log-miR-150-5p and the outcome measures. The discriminatory accuracy was assessed with the area under the receiver-operating-characteristic curve (AUC) and the incremental prognostic value was estimated with the net reclassification index. RESULTS: After adjusting for demographic and vascular risk factors, lower log-miR-150-5p levels were independently associated with mortality (HR 0.21 [95% CI, 0.08–0.51], P=0.001) but not functional outcome (OR 1.10 [95% CI, 0.54–2.25], P=0.79). Adding log-miR-150-5p improved the discriminatory accuracy of the best multivariate model to predict mortality from an AUC of 0.91 (95% CI, 0.88–0.95) to 0.92 (95% CI, 0.88–0.96 Likelihood-ratio test-P < 0.001), and resulted in a net reclassification index of 37.3% (95% CI, 0.28–0.52). CONCLUSIONS: In patients with ischemic stroke, log-miR-150-5p is a novel prognostic biomarker, highly associated with mortality within 90 days, improving risk classification beyond traditional risk factors.