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AIMS OF THE STUDY: The Eversense® CGM System is the first and only continuous glucose monitoring system (CGMS) that uses a fully subcutaneous implanted sensor. This study aimed to evaluate effectiveness, safety and patient-reported outcomes in patients using the Eversense® CGM System in a realistic clinical setting, assessed at a single Swiss diabetes centre (Luzerner Kantonsspital) with prolonged follow-up. METHODS: This was a prospective and retrospective observational study that included patients with type 1 diabetes mellitus in whom at least one Eversense® glucose sensor was implanted between 2017 and 2022. The primary endpoint was the change in HbA1c levels from the baseline (before implantation of the sensor) to 6 ± 2 and 12 ± 2 months and the last follow-up (newest available value) after implantation. The secondary outcome measures were the number of premature sensor breakdowns, adverse events related to the implantation procedure (infection, bleeding, difficulties with implantation or explantation) and patient-related outcomes (assessed with a questionnaire). RESULTS: A total of 33 patients participated in this study. The median follow-up time was 50 (IQR 22.3-58.5) months. In total, 178 sensor implantations were performed. Valid HbA1c results were available for 26 participants. Compared to the baseline values, HbA1c levels at 6 and 12 months and the last follow-up changed by -0.25%, -0.45 and -0.2 (p = 0.278, 0.308 and 0.296, respectively). We recorded 16 (9%) premature sensor breakdowns, all occurring between 2019 and 2020. Apart from one late-onset infection and four complicated sensor removals, no major complications were assessed. The results of the questionnaire showed a subjective improvement in hypoglycaemia rates, a better perception of hypoglycaemia and the impression of better diabetes management. Common issues with the device reported by the patients were technical errors (connection problems) and problems with the removal procedure. CONCLUSIONS: The use of the Eversense® CGM System resulted in changes in HbA1c of between -0.2% and -0.45%. The rate of premature sensor breakdown was low. Major complications following sensor implantation or removal were absent, apart from one case of infection and four cases of complicated removal. Patient-reported outcomes with the Eversense® CGM System showed a subjective positive impact on hypoglycaemia rates, greater confidence in managing hypoglycaemia and diabetes in general, and easy handling of the transmitter and mobile app. Technical issues must be considered but are nowadays, with the use of the newest sensor generation, very rare.
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Diabetes Mellitus Tipo 1 , Hipoglucemia , Humanos , Glucemia , Hemoglobina Glucada , Estudios Prospectivos , Automonitorización de la Glucosa Sanguínea/métodos , Monitoreo Continuo de Glucosa , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Medición de Resultados Informados por el PacienteRESUMEN
Background: Depression and treatment with antidepressants SSRI/SNRI are common in people with morbid obesity who are candidates for bariatric surgery. There is few and inconsistent data about the postoperative plasma concentrations of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on depressive symptoms. Methods: Prospective multicenter study including 63 patients with morbid obesity and therapy with fixed doses of SSRI/SNRI: participants filled the Beck Depression Inventory (BDI) questionnaire, and plasma levels of SSRI/SNRI were measured by HPLC, preoperatively (T0), and 4 weeks (T1) and 6 months (T2) postoperatively. Results: The plasma concentrations of SSRI/SNRI dropped significantly in the bariatric surgery group from T0 to T2 by 24.7% (95% confidence interval [CI], -36.8 to -16.6, p = 0.0027): from T0 to T1 by 10.5% (95% 17 CI, -22.7 to -2.3; p = 0.016), and from T1 to T2 by 12.8% (95% CI, -29.3 to 3.5, p = 0.123), respectively.There was no significant change in the BDI score during follow-up (-2.9, 95% CI, -7.4 to 1.0; p = 0.13).The clinical outcome with respect to SSRI/SNRI plasma concentrations, weight change, and change of BDI score were similar in the subgroups undergoing gastric bypass surgery and sleeve gastrectomy, respectively. In the conservative group the plasma concentrations of SSRI/SNRI remained unchanged throughout the 6 months follow-up (-14.7, 95% CI, -32.6 to 1.7; p = 0.076). Conclusion: In patients undergoing bariatric surgery plasma concentrations of SSRI/SNRI decrease significantly by about 25% mainly during the first 4 weeks postoperatively with wide individual variation, but without correlation to the severity of depression or weight loss.
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BACKGROUND: Despite the widespread use of glucocorticoids in inflammatory and autoimmune disorders, there is uncertainty about the safe cessation of long-term systemic treatment, as data from prospective trials are largely missing. Due to potential disease relapse or glucocorticoid-induced hypocortisolism, the drug is often tapered to sub-physiological doses rather than stopped when the underlying disease is clinically stable, increasing the cumulative drug exposure. Conversely, the duration of exposure to glucocorticoids should be minimized to lower the risk of side effects. METHODS: We designed a multicenter, randomized, triple-blinded, placebo-controlled trial to test the clinical noninferiority of abrupt glucocorticoid stop compared to tapering after ≥28 treatment days with ≥420 mg cumulative and ≥7.5 mg mean daily prednisone-equivalent dose. 573 adult patients treated systemically for various disorders will be included after their underlying disease has been stabilized. Prednisone in tapering doses or matching placebo is administered over 4 weeks. A 250 mg ACTH-test, the result of which will be revealed a posteriori, is performed at study inclusion; all patients are instructed on glucocorticoid stress cover dosing. Follow-up is for 6 months. The composite primary outcome measure is time to hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis. Secondary outcomes include the individual components of the primary outcome, cumulative glucocorticoid doses, signs and symptoms of hypocortisolism, and the performance of the ACTH test in predicting the clinical outcome. Cox proportional hazard, linear, and logistic regression models will be used for statistical analysis. CONCLUSION: This trial aims to demonstrate the clinical noninferiority and safety of abrupt treatment cessation after ≥28 days of systemic glucocorticoid therapy in patients with stabilized underlying disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03153527; EUDRA-CT: 2020-005601-48 https://clinicaltrials.gov/ct2/show/NCT03153527?term=NCT03153527&draw=2&rank=1.
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Insuficiencia Suprarrenal , Glucocorticoides , Adulto , Humanos , Insuficiencia Suprarrenal/inducido químicamente , Hormona Adrenocorticotrópica , Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia/tratamiento farmacológico , Prednisona/efectos adversos , Prednisona/uso terapéutico , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Privación de TratamientoRESUMEN
BACKGROUND & AIM: CT-derived measures of muscle mass may help to identify patients with sarcopenia. We investigated the prognostic significance of CT-derived sarcopenia and muscle attenuation with nutritional markers, clinical outcomes and response to nutritional support in medical in-patients at nutritional risk. METHOD: Within this secondary analysis of the randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) comparing individualized nutritional support with usual care nutrition in medical inpatients, we investigated associations of CT-based sarcopenia and muscle attenuation at the level L3 with different nutritional and clinical outcomes, and the response to the nutritional intervention. The primary composite endpoint was adverse clinical outcome within 30 days of hospital admission. RESULTS: We included 573 of 2028 EFFORT patients with available CT scans, of which 68.4% met the CT-based definition of sarcopenia and 72.9% had low muscle attenuation. In multivariate analysis, low skeletal muscle index was associated with higher nutritional risk (coefficient per NRS class -0.94 (95%CI -1.87 to -0.01) p = 0.049) and higher risk for adverse clinical outcomes (adjusted odds ratio 1.59 (95% CI 1.06 to 2.38), p = 0.024). Low muscle attenuation was also associated with adverse clinical outcome (adjusted odds ratio 1.67 (95%CI 1.08 to 2.58), p = 0.02). Nutritional support tended to be more effective in reducing mortality in non-sarcopenic patients compared to patients with CT-based sarcopenia (p for interaction 0.058). CONCLUSIONS: Within a population of medical patients at nutritional risk, CT-based sarcopenia and muscle attenuation were associated with several nutritional parameters and predicted adverse clinical outcomes. Information from CT scans, thus may help to better characterize these patients, and may be helpful in guiding therapeutic interventions.
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Fragilidad , Desnutrición , Sarcopenia , Humanos , Sarcopenia/diagnóstico por imagen , Sarcopenia/terapia , Sarcopenia/complicaciones , Fragilidad/complicaciones , Pacientes Internos , Desnutrición/diagnóstico , Desnutrición/terapia , Desnutrición/complicaciones , Apoyo Nutricional , Pronóstico , Tomografía Computarizada por Rayos XRESUMEN
Determinants of low bone turnover in type 2 diabetes (T2DM) are poorly understood. To investigate the relationship between markers of bone turnover, glycaemic control, disease duration and calciotropic hormones in T2DM we assessed baseline biochemical data from the DiabOS Study, a prospective multicenter observational cohort study. In a cross-sectional study-design data from 110 postmenopausal women and men aged 50-75 years diagnosed with T2DM for at least 3 years and 92 non-diabetic controls were evaluated. Biochemical markers of bone formation (N-terminal propeptide of type I procollagen [PINP]), bone-specific alkaline phosphatase [BAP]) and resorption (C-terminal cross-linking telopeptide of type I collagen [CTX]), measures of calcium homeostasis (intact parathormone [iPTH], 25-Hydroxyvitamin D, calcium, magnesium) and glycaemic control were assessed. After adjustment for age, gender and body mass index (BMI), patients with T2DM had lower serum levels of PINP (p < 0.001), CTX (p < 0.001), iPTH (p = 0.03) and magnesium (p < 0.001) compared to controls. Serum calcium, creatinine, 25-Hydroxyvitamin D and sclerostin did not differ between both groups. In multivariate linear regression analyses only serum iPTH remained an independent determinant of bone turnover markers in T2DM (PINP: p = 0.02; CTX: p < 0.001 and BAP: p < 0.01), whereas glycated haemoglobin (HbA1c), disease duration, age and BMI were not associated with bone turnover. In conclusion low bone turnover in T2DM is associated with low iPTH. The underlying mechanism remains to be elucidated.
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Diabetes Mellitus Tipo 2 , Masculino , Humanos , Femenino , Diabetes Mellitus Tipo 2/complicaciones , Calcio , Estudios Transversales , Magnesio , Estudios Prospectivos , Remodelación Ósea , Colágeno Tipo I , Biomarcadores , Hormona Paratiroidea , Fosfatasa Alcalina , Procolágeno , Densidad ÓseaRESUMEN
Neuropeptide Y (NPY1-36) is a vasoconstrictor peptide co-secreted with catecholamines by sympathetic nerves, the adrenal medulla, and neoplasms such as pheochromocytomas and paragangliomas (PPGLs). It is produced by the intracellular cleavage of proNPY and metabolized into multiple fragments with distinct biological activities. NPY immunoassays for PPGL have a diagnostic sensitivity ranging from 33 to 100%, depending on the antibody used. We have validated a multiplex micro-UHPLC-MS/MS assay for the specific and sensitive quantification of proNPY, NPY1-39, NPY1-37, NPY1-36, NPY2-36, NPY3-36, NPY1-35, NPY3-35, and the C-flanking peptide of NPY (CPON) (collectively termed NPYs), and determined the NPYs reference intervals and concentrations in 32 PPGL patients before, during, and after surgery. Depending on the peptide measured, NPYs were above the upper reference limit (URL) in 20% to 67% of patients, whereas plasma free metanephrine and normetanephrine, the gold standard for PPGL, were above the URL in 40% and 87% of patients, respectively. Age, sex, tachycardia, and tumor localization were not correlated with NPYs. Plasma free metanephrines performed better than NPYs in the detection of PPGL, but NPYs may be a substitute for an early diagnosis of PPGL for patients that suffer from severe kidney impairment or receiving treatments that interfere with catecholamine reuptake.
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Neoplasias de las Glándulas Suprarrenales , Paraganglioma , Feocromocitoma , Neoplasias de las Glándulas Suprarrenales/diagnóstico , Voluntarios Sanos , Humanos , Metanefrina , Neuropéptido Y/metabolismo , Paraganglioma/diagnóstico , Feocromocitoma/diagnóstico , Precursores de Proteínas , Espectrometría de Masas en TándemRESUMEN
BACKGROUND & AIMS: Screening for malnutrition upon hospital admission is the first crucial step for proper nutritional assessment and treatment. While several nutritional screening and assessment instruments exist, there is a lack of head-to-head validation of these instruments. We studied the ability of five different nutrition screening and assessment instruments to predict 1-year mortality and response to nutritional treatment in participants of the EFFORT randomized trial. METHODS: In this secondary analysis of a Swiss-wide multicenter, randomized clinical trial comparing individualized nutritional support with usual care nutrition in medical inpatients, we prospectively classified patients as low, intermediate, and high nutritional risk based on five nutritional screening and assessment instruments (NRS 2002, SGA, SNAQ, MNA and MUST). RESULTS: Overall mortality at 1-year in the 1866 included patients was 30.4%. There were significant correlations and a significant concordance between all instruments with r-values ranging from 0.23 to 0.55 and kappa values ranging from 0.10 to 0.36. While high nutritional risk was associated with higher mortality in all instruments, SGA and MNA showed the strongest association with adjusted odds ratios of 3.17 (95%CI, 2.18 to 4.61, p < 0.001) and 3.45 (95%CI, 2.28 to 5.22, p < 0.001). When comparing mortality in intervention group patients to control group patients stratified by severity of malnutrition, there was overall no clear trend towards more benefit in patients with more severe malnutrition, with NRS 2002 and SGA showing the most pronounced relationship between the severity of malnutrition and reduction in mortality as a response to nutritional support. CONCLUSION: Among all five screening and assessment instruments, higher nutritional risk was associated with higher risk for mortality and adverse clinical outcome, but not with more or less treatment response from nutritional support with differences among scores. Adding more specific parameters to these instruments is important when using them to decide for or against nutritional support interventions in an individual patient. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517476.
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Desnutrición , Evaluación Nutricional , Humanos , Pacientes Internos , Desnutrición/complicaciones , Desnutrición/diagnóstico , Desnutrición/terapia , Estado Nutricional , Apoyo NutricionalRESUMEN
BACKGROUND & AIMS: The Global Leadership Initiative on Malnutrition (GLIM) recently suggested specific criteria to standardize the diagnosis of malnutrition. There is need for validation of these criteria regarding response to nutrition treatment. Our aim was to validate modified GLIM (mGLIM) criteria among medical inpatients at risk of disease related malnutrition for prediction of outcome and response to nutritional therapy. METHODS: This is a secondary analysis of the Effect of Early Nutritional Support on Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), a multicenter randomized controlled trial conducted between April 2014 and February 2018. Adult medical inpatients at nutritional risk (Nutrition Risk Score 2002 ≥ 3 points) were randomly assigned to receive nutritional therapy according to an algorithm based on individualized nutritional requirements (intervention group) or standard hospital food (control group). We included all participants with available information regarding mGLIM criteria. The primary outcome was adverse clinical outcome, which was a composite of 30-day all-cause mortality, ICU-admission, rehospitalization rate, major complications and decline in functional status. RESULTS: Of 1917 eligible participants at nutritional risk, 1181 (61.6%) met the diagnosis of malnutrition based on mGLIM criteria. The incidence of adverse clinical outcome was significantly higher in mGLIM-positive participants compared with mGLIM-negative participants [330/1181 (27.9%) versus 140/736 (19.0%); multivariable adjusted odds ratio [OR] 1.53; 95% CI 1.22-1.93; p < 0.001]. Regarding the effect of nutritional therapy, the reduction in adverse clinical outcomes was higher in mGLIM-positive participants [180/581 (31.0%) vs. 150/600 (25.0%), OR 0.69; 95% CI 0.53-0.9, p = 0.007], compared with mGLIM-negative participants [75/379 (19.8%) versus 65/357 (18.2%), OR 0.95; 95% CI 0.65-1.40, p = 0.797], a finding that was, however, not significant in interaction analysis (p for interaction = 0.217). CONCLUSION: Data from this secondary analysis of a multicenter randomized trial involving medical inpatients at nutritional risk validate the strong prognostic value of mGLIM criteria regarding adverse clinical outcomes and other long-term outcomes. However, further research is needed to improve the ability of GLIM criteria to predict therapeutic response to nutritional interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02517476.
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Liderazgo , Desnutrición , Adulto , Hospitalización , Humanos , Desnutrición/complicaciones , Desnutrición/diagnóstico , Desnutrición/terapia , Evaluación Nutricional , Estado Nutricional , Apoyo NutricionalRESUMEN
BACKGROUND: Historically, admission serum albumin concentrations have been considered useful biochemical markers for nutrition assessment. However, there is a lack of randomised trial data investigating whether low albumin concentrations are helpful for identifying patients benefitting from nutritional support. METHODS: This study was a secondary analysis of the EFFORT trial, a Swiss-wide multicentre, randomised controlled trial comparing individualised nutritional support with usual care nutrition in medical inpatients from April 1, 2014, to February 1, 2018. 1389 of 2028 patients at nutritional risk with available albumin concentrations on admission were included. The primary endpoint was all-cause mortality within 30 and 180 days. Patients were stratified into groups of low or normal albumin based on the albumin cut-off of 30 g/L. ClinicalTrials.gov number, NCT02517476. FINDINGS: 1389 patients (mean age, 73.1 (SD 3.5) years; 747 (53.8%) men) were included and 676 (48.7%) had low serum albumin concentrations at admission (<30 g/L). Mortality at 180 days was significantly increased in the low albumin group compared with patients with normal albumin concentrations (219/676 (32.4%) vs. 162/713 (22.7%), fully adjusted HR 1.4, 95%CI 1.11 to 1.77, p = 0.005]. Effects of nutritional support on 30-day mortality were similar for patients with low compared to patients with normal albumin concentrations (HR 0.68, 95%CI 0.44 to 1.05 vs. HR 0.70, 95%CI 0.41 to 1.20), with no evidence for a subgroup effect (p for interaction=0.97). INTERPRETATION: Based on this secondary analysis of a randomised trial, low admission serum albumin concentrations in hospitalised, non-critically ill, medical patients at nutritional risk had prognostic implications and indicated higher mortality risk but were not helpful in selecting patients for nutritional interventions. FUNDING: The Swiss National Science Foundation (SNSF) (PP00P3_150531) and the Research Council of the Kantonsspital Aarau (1410.000.058 and 1410.000.044) provided funding for the EFFORT trial.
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PURPOSE: Hyperparathyroidism (HPT) is a common disorder. A cure can only be achieved by removing all diseased glands. It is critical to localize the hyperfunctioning glands exactly to prevent extensive surgical exploration. The number of false negative/inconclusive results in standard imaging techniques is high. We aimed to evaluate the diagnostic accuracy of 18F-Fluorocholine-PET in combination with contrast-enhanced CT (FCH-PET/CT) and its sensitivity in patients with primary, secondary/tertiary, and familial HPT with negative and/or discordant findings in ultrasound and/or 99mTc-sestamibi scintigraphy/SPECT/CT. METHODS: A total of 96 patients with HPT and negative/equivocal conventional imaging were referred for FCH-PET/CT. In this retrospective, single institution study, 69 patients, who have undergone surgery and histopathologic workup, were analyzed. Of the 69 patients included, 60 patients suffered from primary HPT, four from secondary or tertiary HPT, and five from familial HPT. Sensitivities, positive predictive values, and accuracies were calculated. RESULTS: Sensitivity/positive predictive value (PPV) per lesion was 87.5/98.3% for primary HPT, 75/100% for secondary/tertiary HPT and 25/66.7% for familial HPT. Sensitivity/PPV per patient was 91.5/98.2% for primary HPT, 100/100% for secondary/tertiary HPT and 50/100% for familial HPT. All patients showed normalized serum calcium levels in the postoperative period. The follow-up rate was 97%. Of the patients included in the study, 58 of 60 patients with primary HPT, and four of four patients with secondary/tertiary HPT showed normal calcium and parathyroid hormone (PTH) levels after six months and were cured. Of the patients with familial HPT, four of five patients were cured. CONCLUSION: Diagnostic accuracy of 18F-Fluorocholine-PET/CT for patients with pHPT is excellent. 18F-Fluorocholine-PET/CT is a valuable tool for endocrine surgeons to optimize the surgical treatment of patients with hyperparathyroidism.
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Hiperparatiroidismo Primario , Glándulas Paratiroides , Colina/análogos & derivados , Humanos , Hiperparatiroidismo Primario/diagnóstico por imagen , Hiperparatiroidismo Primario/patología , Hiperparatiroidismo Primario/cirugía , Glándulas Paratiroides/diagnóstico por imagen , Glándulas Paratiroides/patología , Glándulas Paratiroides/cirugía , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Estudios Retrospectivos , Tecnecio Tc 99m SestamibiRESUMEN
INTRODUCTION: Due to the aging population the incidence of Low Energy Fractures (LEF) increases. LEF have high mortality and morbidity rates and often cause elderly to lose independence. Patient-reported outcomes, such as Quality of Life (QoL) and patient satisfaction (PS) are needed to evaluate treatment, estimate cost-benefit analyses, and to improve clinical decision-making and patient-centered care. OBJECTIVE: The primary goal was to evaluate QoL and PS in patients with LEF, and to compare QoL scores to the community dwelling population. Second, we observed the amount and type of physiotherapy (PT) sessions the patients conducted. METHODS: A single-center cohort study was conducted in Switzerland. Patients between 50 and 85 years, who were treated in the hospital for LEF, were followed 1 year after initial fracture. Data on QoL were obtained through the Euroqol-5-Dimension questionnaire-3-Level (EQ-5D-3L) and the EQ VAS (visual analog scale). PS was measured by a VAS on satisfaction with treatment outcome. Data on PT sessions, mobility and use of analgesics were collected by telephone interviews and written surveys. Results were compared between the different fracture locations and subgroup analyses were performed for age categories. RESULTS: 411 patients were included for analysis. The median scores of the EQ-5D-3L index-VAS and PS were 0.90 (0.75-1.0), 90 (71.3-95) and 100 (90-100). Significant differences in all scores were found between fracture location (P < .05), with hip fracture patients and patients with a malleolar fracture scoring lowest in all measures. QoL index in hip fracture patients was 0.76 (0.70-1.00), QoL VAS 80 (70-90), and PS 95 (80-100). Median amount of PT sessions in all patients was 18 (9-27) and a significant difference was found between fracture locations. Patients with a fracture of the humerus received the highest amount of PT sessions 27 (18-36), hip fracture patients had a median of 18 (9-27) sessions. CONCLUSION: At follow-up, QoL throughout all patients with a LEF was comparable to a normal population. Remarkably, though hip fracture patients seem to suffer from a clinically relevant loss of QoL, they received fewer PT sessions and performed fewer long-lasting home training than patients with a humerus fracture. Intensive, progressive rehabilitation with a high frequency of supervised training is recommended after hip fracture. The low frequency of PT sessions found in this study is unsatisfying. In hip fracture patients and in patients with a malleolar fracture, especially when aged over 75 years, more efforts are required to improve rehabilitation and subsequently QoL.
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Background and objective: Falls in elderly cause injury, mortality, and loss of independence, making Fear of Falling (FoF) a common health problem. FoF relates to activity restriction and increased fall risk. A voluntary intervention including fall risk assessment and prevention strategies was implemented to reduce falls in elderly patients with low energy fractures (LEF). The primary purpose of this study was to evaluate FoF and the number of subsequent falls in trauma patients one year after a LEF. The secondary aim was to examine how FoF affects patients' lives in terms of Quality of Life (QoL), mobility, and activity levels. Finally, participation in the voluntary fall prevention program (FPP) was evaluated. Materials and Methods: Observational cohort study in one Swiss trauma center. LEF patients, treated between 2012 and 2015, were analyzed one year after injury. Primary outcomes were Falls-Efficacy Score-International (FES-I) and number of subsequent falls. Secondary outcomes were EuroQoL-5-Dimensions-3-Levels (EQ5D-3L), mobility, activity levels, and participation in the FPP. Subgroup analysis was performed for different age categories. Results: 411 patients were included for analysis. Mean age was 72 ± 9.3, mean FES-I was 21.1 ± 7.7. Forty percent experienced FoF. A significant negative correlation between FoF and QoL (R = 0.64; p < 0.001) was found. High FoF correlated with lower activity levels (R= -0.288; p < 0.001). Six percent visited the FPP. Conclusions: At follow-up, 40% suffered from FoF which seems to negatively affect patients' QoL. Nevertheless, participation in the FPP was low. Simply informing patients about their susceptibility to falls and recommending participation in FPPs seems insufficient to motivate and recruit patients into FPPs. We suggest implementing repeated fall risk- and FoF screenings as standard procedures in the follow-up of LEF, especially in patients aged over 75 years.
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Fracturas Óseas , Calidad de Vida , Anciano , Anciano de 80 o más Años , Miedo , Humanos , Persona de Mediana Edad , Recurrencia Local de NeoplasiaRESUMEN
OBJECTIVES: Malnutrition is highly prevalent in patients with aging-related vulnerability defined by very old age (≥80 y), physical frailty or cognitive impairment, and increases the risks for morbidity and mortality. The effects of individualized nutritional support for patients with aging-related vulnerability in the acute hospital setting on mortality and other clinical outcomes remains understudied. METHODS: For this secondary analysis of the randomized-controlled Effect of Early Nutritional Support on Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), we analyzed data of patients at a nutritional risk (Nutritional Risk Screening 2002 score ≥3 points) with aging-related vulnerability, randomized to receive protocol-guided individualized nutritional support to reach specific protein and energy goals (intervention group) or routine hospital food (control group). The primary endpoint was all-cause 30-d mortality. RESULTS: Of the 881 patients with aging-related vulnerability, 23.4% presented with a frailty syndrome, 81.8% were age ≥80 y and 15.3% showed cognitive impairment. Patients with aging-related vulnerability receiving individualized nutritional support compared with routine hospital food showed a >50% reduction in the risk of 30-day mortality (60 of 442 [13.6%] versus 31 of 439 [7.1%]; odds ratio: 0.48; 95% confidence interval, 0.31-0.76; P = 0.002). Significant improvements were also found for long-term mortality at 180 days, as well as functional outcomes and quality of life measures. CONCLUSIONS: Malnourished patients with aging-related vulnerability show a significant and clinically relevant reduction in the risk of mortality and other adverse clinical outcomes after individualized in-hospital nutritional support compared to routine hospital nutrition. These data support the early screening of patients with aging-related vulnerability for nutritional risk, followed by a nutritional assessment and implementation of individualized nutritional interventions.
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Pacientes Internos , Desnutrición , Anciano , Envejecimiento , Anciano Frágil , Hospitalización , Humanos , Desnutrición/terapia , Estado Nutricional , Apoyo Nutricional , Calidad de VidaRESUMEN
BACKGROUND: Patients with chronic kidney disease (CKD) are at substantial risk of malnutrition, which negatively affects clinical outcomes. We investigated the association of kidney function assessed at hospital admission and effectiveness of nutritional support in hospitalized medical patients at risk of malnutrition. METHODS: This is a secondary analysis of an investigator-initiated, randomized-controlled, Swiss multicenter trial (EFFORT) that compared individualised nutritional support with usual hospital food on clinical outcomes. We compared effects of nutritional support on mortality in subgroups of patients stratified according to kidney function at the time of hospital admission (estimated glomerular filtration rates [eGFR] <15, 15-29, 30-59, 60-89 and ≥ 90 ml/min/1.73 m2). RESULTS: We included 1943 of 2028 patients (96%) from the original trial with known admission creatinine levels. Admission eGFR was a strong predictor for the beneficial effects of nutritional support in regard to lowering of 30-day mortality. Patients with an eGFR <15, 15-29 and 30-59 had the strongest mortality benefit (odds ratios [95%CI] of 0.24 [0.05 to 1.25], 0.37 [0.14 to 0.95] and 0.39 [0.21 to 0.75], respectively), while patients with less severe impairment in kidney function had a less pronounced mortality benefits (p for interaction 0.001). A similar stepwise association of kidney function and response to nutritional support was found also for other secondary outcomes. CONCLUSION: In medical inpatients at nutritional risk, admission kidney function was a strong predictor for the response to nutritional therapy. Initial kidney function may help to individualize nutritional support in the future by identification of patients with most clinical benefit. CLINICAL TRIAL REGISTRATION: Registered under ClinicalTrials.gov Identifier no. NCT02517476.
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Riñón/fisiología , Encuestas Nutricionales , Estado Nutricional , Insuficiencia Renal Crónica/fisiopatología , Anciano , Femenino , Tasa de Filtración Glomerular/fisiología , Humanos , Masculino , Desnutrición/etiología , Persona de Mediana Edad , Factores de RiesgoRESUMEN
BACKGROUND: Deterioration of nutritional status during hospitalization in patients with chronic heart failure increases mortality. Whether nutritional support during hospitalization reduces these risks, or on the contrary, may be harmful due to an increase in salt and fluid intake, remains unclear. OBJECTIVES: The purpose of this trial was to study the effect of nutritional support on mortality in patients hospitalized with chronic heart failure who are at nutritional risk. METHODS: A total of 645 patients with chronic heart failure (36% [n = 234] with acute decompensation) participated in the investigator-initiated, open-label EFFORT (Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients) trial. Patients were randomized to protocol-guided individualized nutritional support to reach energy, protein, and micronutrient goals (intervention group) or standard hospital food (control group). The primary endpoint was all-cause mortality at 30 days. RESULTS: Mortality over 180 days increased with higher severity of malnutrition (odds ratio per 1-point increase in Nutritional Risk Screening 2002 score: 1.65; 95% confidence interval [CI]: 1.21 to 2.24; p = 0.001). By 30 days, 27 of 321 intervention group patients (8.4%) died, compared with 48 of 324 (14.8%) control group patients (odds ratio: 0.44; 95% CI: 0.26 to 0.75; p = 0.002). Patients at high nutritional risk showed the most benefit from nutritional support. Mortality effects remained significant at 180-day follow-up. Intervention group patients also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; odds ratio: 0.50; 95% CI: 0.34 to 0.75; p = 0.001). CONCLUSIONS: Among hospitalized patients with chronic heart failure at high nutritional risk, individualized nutritional support reduced the risk for mortality and major cardiovascular events compared with standard hospital food. These data support malnutrition screening upon hospital admission followed by an individualized nutritional support strategy in this vulnerable patient population. (Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial [EFFORT]; NCT02517476).
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Insuficiencia Cardíaca/mortalidad , Hospitalización , Apoyo Nutricional , Anciano , Anciano de 80 o más Años , Enfermedad Crónica , Femenino , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Persona de Mediana EdadRESUMEN
CONTEXT: Glucocorticoids regulate hemostatic and endothelial function, and they are critical for adaptive functions during surgery. No data regarding the impact of adrenal function on hemostasis and endothelial function in the perioperative setting are available. OBJECTIVE: We assessed the association of adrenal response to adrenocorticotropic hormone (ACTH) and markers of endothelial/hemostatic function in surgical patients. METHODS: This prospective observational study, conducted at a tertiary care hospital, included 60 patients (35 male/25 female) undergoing abdominal surgery. Adrenal function was evaluated by low-dose ACTH stimulation test on the day before, during, and the day after surgery. According to their stimulated cortisol level (cutoff ≥ 500 nmol/L), patients were classified as having normal hypothalamic-pituitary-adrenal (HPA)-axis function (nHPA) or deficient HPA-axis function (dHPA). Parameters of endothelial function (soluble vascular cell adhesion molecule-1, thrombomodulin) and hemostasis (fibrinogen, von Willebrand factor antigen, factor VIII [FVIII]) were measured during surgery. RESULTS: Twenty-one patients had dHPA and 39 had nHPA. Compared with nHPA, patients with dHPA had significantly lower peak cortisol before (median 568 vs 425 nmol/L, Pâ <â 0.001) and during (693 vs 544 nmol/L, Pâ <â 0.001) surgery and lower postoperative hemoglobin levels (116 g/L vs 105 g/L, Pâ =â 0.049). FVIII was significantly reduced in patients with dHPA in uni- and multivariable analyses; other factors displayed no significant differences. Coagulation factors/endothelial markers changed progressively in relation to stimulated cortisol levels and showed a turning point at cortisol levels between 500 and 600 nmol/L. CONCLUSIONS: Patients with dHPA undergoing abdominal surgery demonstrate impaired hemostasis which can translate into excessive blood loss.
RESUMEN
BACKGROUND: Disease-related malnutrition is associated with loss of muscle mass and impaired functional status. Handgrip strength (HGS) has been proposed as an easy-to-use tool to assess muscle strength in clinical practice. OBJECTIVES: We investigated the prognostic implications of HGS in patients at nutritional risk with regard to clinical outcomes and response to nutritional support. METHODS: This was a secondary analysis of the randomized controlled, multicenter, Effect of Early Nutritional Support on Frailty, Functional Outcome, and Recovery of Malnourished Medical Inpatients Trial, which compared the effects of individualized nutritional support with usual hospital food in medical inpatients at nutritional risk. Our primary endpoint was 30-d all-cause mortality. The association between sex-specific HGS and clinical outcomes was investigated using multivariable regression analyses, adjusted for randomization, age, weight, height, nutritional risk, admission diagnosis, comorbidities, interaction terms, and study center. We used interaction terms to investigate possible effect modification regarding the nutritional support intervention. RESULTS: Mean ± SD HGS in the 1809 patients with available handgrip measurement was 17.0 ± 7.1 kg for females and 28.9 ± 11.3 kg for males. Each decrease of 10 kg in HGS was associated with increased risk of 30-d mortality (female: adjusted OR: 2.11; 95% CI: 1.23, 3.62, P = 0.007; male: adjusted OR: 1.44; 95% CI: 1.07, 1.93, P = 0.015) and 180-d mortality (female: adjusted OR: 1.45; 95% CI: 1.0, 2.10, P = 0.048; male: adjusted OR: 1.55; 95% CI: 1.28, 1.89, P < 0.001). Individualized nutritional support was most effective in reducing mortality in patients with low HGS (adjusted OR: 0.29; 95% CI: 0.10, 0.82 in patients in the ≤10th percentile compared with OR: 0.98; 95% CI: 0.66, 1.48 in patients in the >10th percentile; P for interaction = 0.026). CONCLUSIONS: In medical inpatients at nutritional risk, HGS provided significant prognostic information about expected mortality and complication risks and helps to identify which patients benefit most from nutritional support. HGS may thus improve individualization of nutritional therapy.This trial was registered at clinicaltrials.gov as NCT02517476.