Tag: statistics

Clin Microbiol Infect. 2021 Oct;27(10):1422-1430. doi: 10.1016/j.cmi.2021.05.051. Epub 2021 Jul 2.

ABSTRACT

BACKGROUND: There are several prognostic models to estimate the risk of mortality after surgery for active infective endocarditis (IE). However, these models incorporate different predictors and their performance is uncertain.

OBJECTIVE: We systematically reviewed and critically appraised all available prediction models of postoperative mortality in patients undergoing surgery for IE, and aggregated them into a meta-model.

DATA SOURCES: We searched Medline and EMBASE databases from inception to June 2020.

STUDY ELIGIBILITY CRITERIA: We included studies that developed or updated a prognostic model of postoperative mortality in patient with IE.

METHODS: We assessed the risk of bias of the models using PROBAST (Prediction model Risk Of Bias ASsessment Tool) and we aggregated them into an aggregate meta-model based on stacked regressions and optimized it for a nationwide registry of IE patients. The meta-model performance was assessed using bootstrap validation methods and adjusted for optimism.

RESULTS: We identified 11 prognostic models for postoperative mortality. Eight models had a high risk of bias. The meta-model included weighted predictors from the remaining three models (EndoSCORE, specific ES-I and specific ES-II), which were not rated as high risk of bias and provided full model equations. Additionally, two variables (age and infectious agent) that had been modelled differently across studies, were estimated based on the nationwide registry. The performance of the meta-model was better than the original three models, with the corresponding performance measures: C-statistics 0.79 (95% CI 0.76-0.82), calibration slope 0.98 (95% CI 0.86-1.13) and calibration-in-the-large -0.05 (95% CI -0.20 to 0.11).

CONCLUSIONS: The meta-model outperformed published models and showed a robust predictive capacity for predicting the individualized risk of postoperative mortality in patients with IE.

PROTOCOL REGISTRATION: PROSPERO (registration number CRD42020192602).

PMID:34620380 | DOI:10.1016/j.cmi.2021.05.051

J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.

ABSTRACT

BACKGROUND: REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE.

OBJECTIVES: The purpose of this study was to determine the effects of IPE on investigator-reported events.

METHODS: Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance.

RESULTS: There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P < 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P < 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints.

CONCLUSIONS: IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA – Intervention Trial]; NCT01492361).

PMID:34620410 | DOI:10.1016/j.jacc.2021.08.009

Clin Nutr ESPEN. 2021 Oct;45:75-90. doi: 10.1016/j.clnesp.2021.07.027. Epub 2021 Aug 8.

ABSTRACT

BACKGROUND & AIM: Probiotics in the gut have been suggested to have a beneficial effect on anxiety response and depressive disorder. Hence we conducted a systematic review and meta-analysis to summarize the effects of probiotics associated with or without pharmacological or psychological therapies in patients with depressive and/or anxiety symptoms or disorders.

METHODS: We conducted searches of MEDLINE, EMBASE, CENTRAL, PsycINFO, CINAHL, ProQuest, LILACS, and Web of Science up to February 2020 to identify randomized controlled trials (RCTs) investigating the efficacy of probiotics associated with or without pharmacological or psychological therapies for patient-important outcomes including relief of depressive, anxiety and stress symptoms, cognitive functions, adverse events and quality of life. We used the GRADE approach to rate the overall certainty of the evidence by outcome. The protocol of the systematic review was registered with PROPSERO and published under the number CRD4202016329.

RESULTS: 16 RCTs including 1,125 patients proved eligible. Results suggested a significant improvement in using Beck Depression Index (MD, -3.20 [95% CI, -5.91 to -0.49], p = 0.02; I² = 21%, p = 0.28) for depression symptoms and State-Trait Anxiety Inventory (STAI) (MD, -6.88 [95% CI, -12.35 to -1.41], p = 0.01; I² = 24%, p = 0.25) for anxiety with overall certainty in evidence rated as moderate and low, respectively. However, Depression Scale (DASS-Depression) (MD, 2.01 [95% CI, -0.80 to 4.82], p = 0.16; I² = 0%, p = 0.62), Montgomery-Asberg Depression Rating Scale (MADRAS) (MD, -2,41 [95% CI, -10,55 to 5,72], p = 0,56; I² = 87%, p = 0,006), Anxiety scale (DASS-Anxiety) (MD, 0.49 [95% CI, -4.05 to 5.02], p = 0.83; I² = 74%, p = 0.05), and Stress Scale (DASS-Stress) (MD, 0.84 [95% CI, -2.64 to 4.33], p = 0.64; I² = 34%, p = 0.22) showed no significant decrease in the relief of depression, anxiety and stress symptoms of probiotics compared to placebo with overall certainty in evidence rated as very low for all outcomes. We also found no differences in the Beck Anxiety Index (BAI) (MD, -3.21 [95% CI, -6.50 to 0.08], p = 0.06; I² = 0%, p = 0.88) with overall certainty in evidence rated as low. Results suggested a non-statistically significantly effect of probiotics in the adverse events outcomes.

CONCLUSIONS: The current review suggests that probiotics may improve symptoms of depression and anxiety in clinical patients. However, given the limitations in the included studies, RCTs with long-term follow-up and large sample sizes are needed.

PMID:34620373 | DOI:10.1016/j.clnesp.2021.07.027

Clin Nutr ESPEN. 2021 Oct;45:91-101. doi: 10.1016/j.clnesp.2021.07.023. Epub 2021 Jul 31.

ABSTRACT

BACKGROUND: Coronavirus disease-2019 (COVID-19) is a global pandemic. Studies reported dyslipidemia in patients with COVID-19. Herein, we conducted a systematic review and meta-analysis of published articles to evaluate the association of the lipid profile with the severity and mortality in COVID-19 patients.

METHODS: PubMed/Medline, Europe PMC, and Google Scholar were searched for studies published between January 1, 2020 and January 13, 2021. Random or Fixed effects models were used to calculate the mean difference (MD) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using Cochran’s Q test and I² statistics.

RESULTS: This meta-analysis included 19 studies. Of which, 12 studies were categorized by severity, 04 studies by mortality, and 03 studies by both severity and mortality. Our findings revealed significantly decreased levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in the severe group when compared with the non-severe group in a random effect model. Similarly, random effect model results demonstrated significantly lower levels of HDL-C and LDL-C in the non-survivor group when compared with the survivor group. The level of TC was also found to be decreased in the non-survivor group when compared to the survivor group in a fixed-effect model.

CONCLUSION: In conclusion, the lipid profile is associated with both the severity and mortality in COVID-19 patients. Hence, the lipid profile may be used for assessing the severity and prognosis of COVID-19.

PROSPERO REGISTRATION NUMBER: CRD42021216316.

PMID:34620375 | DOI:10.1016/j.clnesp.2021.07.023

Clin Nutr ESPEN. 2021 Oct;45:55-65. doi: 10.1016/j.clnesp.2021.07.029. Epub 2021 Aug 21.

ABSTRACT

BACKGROUND AND AIMS: Sleep, as well as diet and physical activity, plays a significant role in growth, maturation, health, and regulation of energy homeostasis. Recently, there is increasing evidence indicating a possible causal association between sleep duration and energy balance. We aimed to examine the relationship between sleep duration and food consumption, energy intake, anthropometric characteristics, and appetite-regulating hormones by randomized controlled trials (RCTs).

METHODS: Electronic literature searches were conducted on Medline, Web of Science, and Google Scholar until July 2020. The search was conducted with the following words: “Sleep Duration”, “Circadian Rhythm”, “Sleep Disorders” in combination with “Obesity”, “Overweight”, “Abdominal Obesity”, “Physical Activity”, “Energy Intake”, “Body Mass Index”, “Lipid Metabolism”, “Caloric Restriction”, Leptin, “Weight Gain”, and “Appetite Regulation” using human studies.methods RESULTS: After screening 708 abstracts, 50 RCTs (7 on children or adolescents and 43 on adults) were identified and met the inclusion criteria. In general, the findings suggested that sleep restriction may leads to a significant increment in energy intake, fat intake, body weight, appetite, hunger, eating occasions, and portion size, while protein and carbohydrate consumption, total energy expenditure, and respiratory quotient remained unaffected as a result of sleep restriction. Serum leptin, ghrelin, and cortisol concentrations were not influenced by sleep duration as well.

CONCLUSION: Insufficient sleep can be considered as a contributing factor for energy imbalance, weight gain, and metabolic disorders and it is suggested that to tackle disordered eating it may be necessary to pay more attention to sleep duration.

PMID:34620371 | DOI:10.1016/j.clnesp.2021.07.029

Clin Nutr ESPEN. 2021 Oct;45:503-506. doi: 10.1016/j.clnesp.2021.07.017. Epub 2021 Jul 27.

ABSTRACT

BACKGROUND & AIMS: Muscle atrophy is a public health issue and inflammation is a major cause of muscle atrophy. While docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), which are typical ω-3 polyunsaturated fatty acids, are reported to have anti-inflammatory effects on endotoxin-induced inflammatory responses, their effects on inflammatory muscle atrophy have not been clarified. In this study, we aimed to investigate the effects of DHA and EPA on inflammatory muscle atrophy.

METHODS: DHA or EPA was added to C2C12 myotubes at a concentration of 25, 50, or 100 μM, and 1 h later, lipopolysaccharide (LPS) was added at a concentration of 1 μg/mL. Two hours after the first LPS addition, mRNA expression of atrogin-1 and Murf-1 in C2C12 myotubes was measured. The second LPS addition was performed 24 h after the first LPS addition, and myotube diameter, myofibrillar protein, and cell viability were measured. One-way ANOVA and Tukey’s multiple comparison test were used for statistical processing of the results, and the significance level was set to less than 5 %.

RESULTS: The LPS-added group significantly decreased the myotube diameter and the myofibrillar protein content compared to the control group. The myotube diameter was significantly higher in the 25 μM, 50 μM DHA and 25 μM EPA-added groups compared to the LPS group. In the 25 μM DHA and EPA-added groups, the myofibrillar protein content was significantly higher than that in the LPS group. The mRNA expression levels of atrogin-1 and murf-1 were significantly suppressed in the 25 μM DHA and EPA-added groups compared to the LPS group. The cell viability did not change by the addition of LPS, DHA, and EPA.

CONCLUSIONS: The addition of DHA or EPA suppressed the decrease in myotube diameter and myofibrillar protein content and suppressed the increase in atrogin-1 and murf-1 induced by LPS. This study showed the preventive effect of DHA and EPA on endotoxin-induced muscle atrophy.

PMID:34620362 | DOI:10.1016/j.clnesp.2021.07.017

Clin Nutr ESPEN. 2021 Oct;45:507-510. doi: 10.1016/j.clnesp.2021.07.005. Epub 2021 Jul 16.

ABSTRACT

BACKGROUND AND AIMS: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) severely impacted the management of critically ill patients, including nutritional therapy. This study aimed to verify an association between mortality and the energy and protein provided to critically ill patients affected by the SARS-CoV-2 and receiving enteral nutrition support.

METHODS: Patients with confirmed COVID-19, with >7 days of stay in the ICU, on enteral nutrition were followed from the moment of hospitalization until discharge from the ICU or death. Data about age, gender, Simplified Acute Physiology Score III (SAPS3), intensive care unit (ICU) length of stay, days on mechanical ventilation (MV), clinical endpoint outcome (discharge or death), and daily energy and protein provision were collected from electronic medical records. Cox regression analyses and Kaplan-Meyer curves were used in statistical analysis.

RESULTS: Fifty-two patients (66.2 ± 13.1 years; 53.8% women) were enrolled in the present study. The mean length of hospitalizations and SAPS3 score were 17.8 ± 9.8 days and 78.7 ± 14.7, respectively; all patients needed mechanical ventilation (mean of days was 16.42 ± 9.1). For most patients (73.1%) the endpoint was death. Twenty-five percent of patients had protein supply >0.8 g/IBW/day. Survival during COVID-19 hospitalization at ICU was significantly different among patients according to protein supply (p = 0.005). Hazard Ratios (HR) for protein supply showed that a protein intake >0.8 g/IBW/day was associated with significantly lower mortality (HR 0.322, p = 0.049).

CONCLUSION: Our study suggests that a protein supply at least > 0.8 g/IBW/day could be related to reduced mortality in ICU patients with COVID-19.

PMID:34620363 | DOI:10.1016/j.clnesp.2021.07.005

Clin Nutr ESPEN. 2021 Oct;45:412-419. doi: 10.1016/j.clnesp.2021.07.009. Epub 2021 Jul 24.

ABSTRACT

BACKGROUND AND AIMS: Dysphagia is a prevalent disorder in acute geriatric patients. This observational prospective study aimed at investigating adverse clinical outcomes linked to signs of dysphagia, including mortality, length of hospital stay (LOS), readmissions, among patients aged ≥ 65 years at a Danish acute medical unit (AMU).

METHODS: Signs of dysphagia were assessed using bedside screening tools including the Eating Assessment Tool (EAT-10), a 30 mL Water Swallowing Test (WST) and the Gugging Swallowing Screen tool (GUSS), as described in the preceding cross-sectional study. Data for the follow-up was twice retrieved from electronic medical charts 30 days and 90 days after the patients’ primary admission to the hospital. Statistical analysis included non-parametric tests of independence and proportional hazards modelling.

RESULTS: 444 patients were recruited, 334 of whom completed the dysphagia screening with 144 (43.1 %) showing signs of dysphagia. Patients with signs of dysphagia, compared to those without, experienced higher mortality after 30 days (12.5 % vs. 1.6 %, p < 0.001) and 90 days (21.5 % vs. 5.8 %, p < 0.001), longer LOS (median [Q1; Q3]: 4 [2; 8] vs. 3 [1; 6] days, p = 0.004), more total hospital days (THD) during both the 30-day and 90-day follow-up (for 90d: median [Q1; Q3]: 6 [2.25; 12] vs. 4 [2; 9] days, p = 0.007), but no significant difference in frequency of readmissions. Multivariate proportional hazards modelling revealed signs of dysphagia, low performance status and high comorbidity to be independent risk factors for mortality. High comorbidity and low hemoglobin, but not signs of dysphagia, were revealed as independent risk factors for readmission.

CONCLUSION: Dysphagia is a notable risk factor linked to increased mortality and length of hospital stay (LOS) for acute geriatric patients in general, not just those suffering from stroke, head and neck cancer or neurodegenerative diseases. Further research is needed to investigate the effectiveness and feasibility of systematic dysphagia screening within this population.

PMID:34620348 | DOI:10.1016/j.clnesp.2021.07.009

Clin Nutr ESPEN. 2021 Oct;45:420-425. doi: 10.1016/j.clnesp.2021.07.008. Epub 2021 Jul 24.

ABSTRACT

BACKGROUND: Physical health status may be predictive of readmissions, psychological health and mortality in patients with short bowel syndrome.

AIMS: This study aimed to investigate the feasibility and effect of an individualized exercise intervention and secondary, oral nutrition intake counseling on Timed-Up-and-Go (TUG) and 30 s Chair Stand Test (CST) as well as body-composition and EuroQol (EQ)-5D-5L, in patients with chronic intestinal failure (IF) type III receiving HPN and/or fluid therapy.

METHODS: A 12-week individualized exercise intervention consisting on three weekly home based sessions, and nutrition counselling focusing on protein intake and reducing high stoma output, was performed. Weekly follow-up by phone was done on motivation to exercise.

RESULTS: The study invited 71 patients, 44 accepted the invitation (62%), 37(52%) were included, and 31 (84%) completed the intervention. The exercise intervention was well tolerated. TUG improved from 8.9(SD 5.5) to 7.7(SD 3.8) (p = 0.033). CST improved by four repetitions (<0.001∗). A statistical, however not clinically relevant improvement was seen in muscle mass. No improvement was seen in (EQ)-5D-5L total, but insignificantly (p = 0.055) for physical function only. Protein intake improved by 10.6 g/day (p = 0.008).

CONCLUSIONS: A 12 weeks individualized exercise intervention showed very feasible and beneficial in HPN patients. Physical function improved statistically and clinically, and oral protein intake improved. QoL overall did not improve, however COVID-19 was an uninvited partner throughout the study period, which may have influenced general QoL. As only 62% accepted the invitation to participate, home based exercise intervention may not apply to all patients.

PMID:34620349 | DOI:10.1016/j.clnesp.2021.07.008

Clin Nutr ESPEN. 2021 Oct;45:351-355. doi: 10.1016/j.clnesp.2021.07.020. Epub 2021 Aug 2.

ABSTRACT

BACKGROUND & AIMS: The effect of the COVID-19 infection on nutritional status is not well established. Worldwide epidemiological studies have begun to investigate the incidence of malnutrition during hospitalization for COVID-19. The prevalence of malnutrition during follow-up after COVID-19 infection has not been investigated yet. The primary objective of the present study was to estimate the prevalence of the risk of malnutrition in hospitalized adult patients with COVID-19, re-evaluating their nutritional status during follow-up after discharge. The secondary objective was to identify factors that may contribute to the onset of malnutrition during hospitalization and after discharge.

METHODS: We enrolled 142 COVID-19 patients admitted to Careggi University Hospital. Nutritional parameters were measured at three different timepoints for each patient: upon admission to hospital, at discharge from hospital and 3 months after discharge during follow-up. The prevalence of both the nutritional risk and malnutrition was assessed. During the follow-up, the presence of nutritional impact symptoms (NIS) was also investigated. An analysis of the association between demographic and clinical features and nutritional status was conducted.

RESULTS: The mean unintended weight loss during hospitalization was 7.6% (p < 0.001). A positive correlation between age and weight loss during hospitalization was observed (r = 0.146, p = 0.08). Moreover, for elderly patients (>61 years old), a statistically significant correlation between age and weight loss was found (r = 0.288 p = 0.05). Patients admitted to an Intensive Care Unit (ICU) or Intermediate Care Unit (IMCU) had a greater unintended weight loss than patients who stayed in a standard care ward (5.46% vs 1.19%; p < 0.001). At discharge 12 patients were malnourished (8.4%) according to the ESPEN definition. On average, patients gained 4.36 kg (p < 0.001) three months after discharge. Overall, we observed a weight reduction of 2.2% (p < 0.001) from the habitual weight measured upon admission. Patients admitted to an ICU/IMCU showed a higher MUST score three months after discharge (Cramer’s V 0.218, p = 0.035). With regard to the NIS score, only 7 patients (4.9%) reported one or more nutritional problems during follow-up.

CONCLUSIONS: The identification of groups of patients at a higher nutritional risk could be useful with a view to adopting measures to prevent worsening of nutritional status during hospitalization. Admission to an ICU/IMCU, age and length of the hospital stay seem to have a major impact on nutritional status. Nutritional follow-up should be guaranteed for patients who lose more than 10% of their habitual weight during their stay in hospital, especially after admission to an ICU/IMCU.

PMID:34620339 | DOI:10.1016/j.clnesp.2021.07.020