Background: Diabetes and older age are associated with an increased risk of malnutrition and mortality. Recently, the Global Leadership Initiative on Malnutrition (GLIM) provided a 2-step approach for the malnutrition diagnosis. In this study, we aimed to determine whether GLIM nutrition status at admission was associated with long-term survival in elderly patients with type 2 diabetes mellitus (T2DM). Additionally, we aimed to identify which GLIM criteria were more able to become prognostic indicators of early or late death. Methods: Our study included a convenience sample of 159 patients with T2DM older than 65 years and admitted to the internal medicine wards of different Spanish hospitals: the VIDA-survival cohort. Nutrition status was retrospectively assessed with the new GLIM criteria. The main outcome was long-term mortality in the cohort during an 8-year follow-up. Bivariate tables summarized the variables of interest. Kaplan-Meier survival curves and adjusted Cox regressions were also performed. Results: According to the GLIM criteria, we observed that the 35.8% and 16.3% of the VIDA-survival cohort were categorized as having moderate and severe malnutrition, respectively. Severe malnutrition was associated with increased mortality (hazard ratio [HR] = 2.09; 95% CI, 1.29-3.38), compared with nonmalnourished participants. Moderate malnutrition had a neutral effect on all-cause mortality (HR = 1.30; 95% CI, 0.88-1.92). Low plasma albumin levels, a surrogate marker of inflammation, were strongly associated with early mortality. Conclusion: Our study provides evidence that severe malnutrition according to GLIM criteria is associated with increased long-term all-cause mortality among elderly individuals with T2DM.
ObjectiveThis study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient.DesignA PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale.ResultsPAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test–retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale.ConclusionThe PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up.Trial registration numberNCT03650062
Background: Hepatitis C virus (HCV) produces changes at multiple levels in host metabolism, especially in lipid profile and cardio-metabolic risk. It is unclear how HCV eradication by direct-acting antivirals (DAAs) modifies those changes. Objective: To evaluate the impact of DAA treatment on different risk factors associated with cardiovascular disease. Methods: Prospective study with two-year follow-up. All patients treated with DAAs in the Liver Clinic of a tertiary hospital were included. Patients co-infected with HBV or HIV, with other causes of liver disease, on lipid-lowering treatment, pregnant, or with previous HCV treatment were excluded. The results were analyzed using linear mixed models. Results: 167 patients (53% female, 9.6% cirrhosis) were included. Low plasma lipid levels were observed before initiating HCV eradication. During the first year after treatment with DAA, we observed a sustained increase in cholesterol, triglycerides, HDL cholesterol (only in men), and LDL-cholesterol levels. An ameliorated glycemic control was also observed with a decrease in fasting insulin and reduced HOMA. Iron metabolism and coagulation function also improved with lower levels of serum ferritin and prothrombin activity; these biochemical changes resulted in a new diagnosis of hypercholesterolaemia in 17.4% of patients, requiring initiation of statins in 15%. Two non-fatal cardiovascular events were observed during the first 2 years of follow-up. Conclusions: DAA treatments returned plasma lipids to the normal range without increasing either the occurrence of cardiovascular events or the consumption of lipid-lowering medication beyond what is normal in a sex- and age-matched population.
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