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1.
Ann Intern Med ; 2021 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-34516270

RESUMO

BACKGROUND: The long-term risk for major bleeding in patients receiving extended (beyond the initial 3 to 6 months) anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. PURPOSE: To determine the incidence of major bleeding during extended anticoagulation of up to 5 years among patients with a first unprovoked VTE, overall, and in clinically important subgroups. DATA SOURCES: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to 23 July 2021. STUDY SELECTION: Randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding among patients with a first unprovoked VTE who were to receive oral anticoagulation for a minimum of 6 additional months after completing at least 3 months of initial anticoagulant treatment. DATA EXTRACTION: Two reviewers independently abstracted data and assessed study quality. Unpublished data required for analyses were obtained from authors of included studies. DATA SYNTHESIS: Among the 14 RCTs and 13 cohort studies included in the analysis, 9982 patients received a vitamin K antagonist (VKA) and 7220 received a direct oral anticoagulant (DOAC). The incidence of major bleeding per 100 person-years was 1.74 events (95% CI, 1.34 to 2.20 events) with VKAs and 1.12 events (CI, 0.72 to 1.62 events) with DOACs. The 5-year cumulative incidence of major bleeding with VKAs was 6.3% (CI, 3.6% to 10.0%). Among patients receiving either a VKA or a DOAC, the incidence of major bleeding was statistically significantly higher among those who were older than 65 years or had creatinine clearance less than 50 mL/min, a history of bleeding, concomitant use of antiplatelet therapy, or a hemoglobin level less than 100 g/L. The case-fatality rate of major bleeding was 8.3% (CI, 5.1% to 12.2%) with VKAs and 9.7% (CI, 3.2% to 19.2%) with DOACs. LIMITATION: Data were insufficient to estimate incidence of major bleeding beyond 1 year of extended anticoagulation with DOACs. CONCLUSION: In patients with a first unprovoked VTE, the long-term risks and consequences of anticoagulant-related major bleeding are considerable. This information will help inform patient prognosis and guide decision making about treatment duration for unprovoked VTE. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research. (PROSPERO: CRD42019128597).

2.
J Thromb Haemost ; 2021 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-34496121

RESUMO

BACKGROUND: The diagnosis of pulmonary embolism (PE) in pregnant women represents an ongoing challenge. As in the general population, the first step in pregnant women with suspected PE consists of assessing clinical pre-test probability (PTP). However, no dedicated clinical decision rule has been developed in this population. OBJECTIVE: To propose a new version of the Geneva score adapted to pregnant women with suspected PE. METHODS: Data from a multicenter, prospective management outcome study including 395 women with suspected PE, in whom PTP was assessed using the Geneva score, were used. We first removed items which were present in none of the patients (cancer, age >65 years). Receiver operating characteristic (ROC) curve analysis was then performed for quantitative variables and the optimal threshold defined. The obtained Pregnancy-Adapted Geneva Score (PAG Score) comprised seven items, including an age 40 years or older and a heart rate >110 beats per minute. RESULTS: The PAG Score showed a high discriminative power to identify patients with a low, intermediate, or high PTP, associated with increasing prevalence of PE, 2.3%, 11.6%, and 61.5%, respectively. The ROC curves showed an area under the curve of 0.795 for the PAG Score compared to 0.684 for the Geneva score. CONCLUSION: In pregnant women with suspected PE, the PAG Score shows a high discriminative power to identify patients at low, intermediate, or high PTP. It has the strength of being a fully objective decision rule, is clinically relevant, easy to compute, and should now be tested in a prospective outcome study.

3.
Ther Umsch ; 78(7): 369-379, 2021 Sep.
Artigo em Alemão | MEDLINE | ID: mdl-34427111

RESUMO

Smarter Medicine in General Internal Medicine in Hospitals: Where are we now? Abstract. In accordance to the "Choosing Wisely" initiative in the United States, Switzerland has launched the "Smarter Medicine" movement in 2014 with the aim to tackle overdiagnosis and overtreatment. A "Smarter Medicine" Top Five List has been developed for Hospital Medicine, pointing out diagnostic tests and treatments with an unfavorable risk-benefit ratio. The five recommendations include: 1) do not order repetitive blood tests or x-rays without specific clinical questions, 2) avoid urinary catheters for the sole purpose of convenience or monitoring urine output in non-critically ill patients, 3) transfuse only the minimum number of red blood cell units necessary, 4) promote the mobilization of hospitalized older patients, and 5) do not prescribe benzodiazepines or other sedative agents to treat insomnia or agitation in older patients. The following article discusses the rationale for the "Smarter Medicine" recommendations for Hospitalists and provides an overview on various interventions implemented in Switzerland and elsewhere aimed at enforcing these recommendations.


Assuntos
Medicina Geral , Sociedades Médicas , Idoso , Hospitais , Humanos , Sobremedicalização/prevenção & controle , Suíça , Estados Unidos
4.
J Thromb Haemost ; 2021 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-34379859

RESUMO

BACKGROUND: The long-term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain. OBJECTIVES: To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE. METHODS: MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person-years, obtained from authors of included studies, were used to calculate study-level incidence rate, and random-effects meta-analysis was used to pool results. RESULTS: Twenty-six studies and 15 603 patients were included in the analysis. During 11 631 person-years of follow-up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person-years was 1.41 (95% CI, 1.03-1.84) and 0.09 (0.04-0.16), with 5-year cumulative incidences of 7.1% (3.0%-13.2%) and 1.2% (0.4%-4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77-1.44) with direct oral anticoagulants and 1.55 (1.01-2.20) with vitamin K antagonists. The case-fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%-8.7%). CONCLUSIONS: In patients with a first unprovoked VTE, the long-term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long-term management of unprovoked VTE.

5.
PLoS One ; 16(7): e0254143, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34292959

RESUMO

BACKGROUND: Among various treatment options for benign prostatic hyperplasia (BPH), surgical therapy is the most invasive. As Switzerland has the highest transurethral prostatectomy rate among OECD countries, we assessed the regional variation in prostate surgery for BPH and explored potential determinants of variation. METHODS: We conducted a population-based analysis using discharge data for men aged ≥40 years with transurethral or simple prostatectomy from all Swiss hospitals during 2013-2018. After excluding patients with genitourinary/prostate cancer, we derived hospital service areas (HSAs) by analyzing patient flows. We calculated age-standardized mean procedure rates and variation indices (extremal quotient [EQ] and systematic component of variation [SCV]). We estimated the reduction in variance across HSAs of prostatectomy rates in multilevel regression models, with incremental adjustment for age, regional cultural and socioeconomic factors, disease burden, density of urologists, and the time since urologists' graduation. RESULTS: Overall, 44,253 prostatectomies (42,710 transurethral and 1543 simple) from 44 HSAs were analyzed. The mean age-standardized prostate surgery rate was 314 (range 166-500) per 100,000 men aged ≥40 years per year. The EQ was 3.01 and the SCV 5.53, indicating a high regional variation. In multivariate models, men aged 75-79 years had an 11.6-fold higher prostatectomy rate than those aged 50-54 years. French/Italian language areas had a 21% lower rate than Swiss German speaking areas. Socioeconomic factors, disease burden, and density of urologist/time since graduation were not associated with prostatectomy rates. After full adjustment, 80% of the variance in prostate surgery across HSAs remained unexplained. CONCLUSION: We found a remarkably high regional variation in prostate surgery rates for BPH within Switzerland.

6.
BMJ ; 374: n1585, 2021 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-34257088

RESUMO

OBJECTIVE: To examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital. DESIGN: Cluster randomised controlled trial. SETTING: 110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belgium, and Republic of Ireland) defined by attending hospital doctors. PARTICIPANTS: 2008 older adults (≥70 years) with multimorbidity (≥3 chronic conditions) and polypharmacy (≥5 drugs used long term). INTERVENTION: Clinical staff clusters were randomised to usual care or a structured pharmacotherapy optimisation intervention performed at the individual level jointly by a doctor and a pharmacist, with the support of a clinical decision software system deploying the screening tool of older person's prescriptions and screening tool to alert to the right treatment (STOPP/START) criteria to identify potentially inappropriate prescribing. MAIN OUTCOME MEASURE: Primary outcome was first drug related hospital admission within 12 months. RESULTS: 2008 older adults (median nine drugs) were randomised and enrolled in 54 intervention clusters (963 participants) and 56 control clusters (1045 participants) receiving usual care. In the intervention arm, 86.1% of participants (n=789) had inappropriate prescribing, with a mean of 2.75 (SD 2.24) STOPP/START recommendations for each participant. 62.2% (n=491) had ≥1 recommendation successfully implemented at two months, predominantly discontinuation of potentially inappropriate drugs. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group. In the intention-to-treat analysis censored for death as competing event (n=375, 18.7%), the hazard ratio for first drug related hospital admission was 0.95 (95% confidence interval 0.77 to 1.17). In the per protocol analysis, the hazard ratio for a drug related hospital admission was 0.91 (0.69 to 1.19). The hazard ratio for first fall was 0.96 (0.79 to 1.15; 237 v 263 first falls) and for death was 0.90 (0.71 to 1.13; 172 v 203 deaths). CONCLUSIONS: Inappropriate prescribing was common in older adults with multimorbidity and polypharmacy admitted to hospital and was reduced through an intervention to optimise pharmacotherapy, but without effect on drug related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimisation interventions that reduce inappropriate prescribing and improve patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02986425.


Assuntos
Hospitalização/estatística & dados numéricos , Prescrição Inadequada/prevenção & controle , Multimorbidade , Polimedicação , Acidentes por Quedas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Análise por Conglomerados , Europa (Continente) , Humanos , Prescrição Inadequada/efeitos adversos
7.
Eur J Endocrinol ; 185(3): 375-385, 2021 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-34228632

RESUMO

Objective: To evaluate if subclinical thyroid dysfunction is associated with cardiovascular (CV) risk in patients with atrial fibrillation (AF). Methods: Swiss-AF is a prospective cohort of community-dwelling participants aged ≥ 65 years with AF. Primary outcome was a composite endpoint of CV events (myocardial infarctions, stroke/transitory ischemic events, systemic embolism, heart failure (HF) hospitalizations, CV deaths). Secondary outcomes were component endpoints, total mortality, and AF-progression. Exposures were thyroid dysfunction categories, TSH and fT4. Sensitivity analyses were performed for amiodarone use, thyroid hormones use, and competing events. Results: 2415 patients were included (mean age: 73.2 years; 27% women). 196 (8.4%) had subclinical hypothyroidism and 53 (2.3%) subclinical hyperthyroidism. Subclinical thyroid dysfunction was not associated with CV events, during a median follow-up of 2.1 years (max 5 years): age- and sex-adjusted hazard ratio (adjHR) of 0.99 (95% CI: 0.69-1.41) for subclinical hypothyroidism and 0.55 (95% CI: 0.23-1.32) for subclinical hyperthyroidism. Results remained robust following multivariable adjustment and sensitivity analyses. In euthyroid patients, fT4 levels were associated with an increased risk for the composite endpoint and HF (adjHR: 1.46, 95% CI: 1.04-2.05; adjHR: 1.70, 95% CI: 1.08-2.66, respectively, for the highest quintile vs the middle quintile). Results remained similar following multivariable adjustment and remained significant for HF in sensitivity analyses. No association between subclinical thyroid dysfunction and total mortality or AF-progression was found. Conclusions: Subclinical hypothyroidism was not associated with increased CV risk in AF patients. Higher levels of fT4 with normal TSH were associated with a higher risk for HF.


Assuntos
Fibrilação Atrial/epidemiologia , Doenças Cardiovasculares/epidemiologia , Doenças da Glândula Tireoide/epidemiologia , Idoso , Fibrilação Atrial/complicações , Doenças Cardiovasculares/complicações , Feminino , Humanos , Hipotireoidismo/complicações , Hipotireoidismo/epidemiologia , Masculino , Estudos Prospectivos , Fatores de Risco , Doenças da Glândula Tireoide/complicações
8.
Nutrition ; 89: 111279, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34090212

RESUMO

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.


Assuntos
Pacientes Internados , Desnutrição , Idoso , Envelhecimento , Idoso Fragilizado , Hospitalização , Humanos , Desnutrição/terapia , Estado Nutricional , Apoio Nutricional , Qualidade de Vida
9.
Clin Nutr ; 40(5): 2762-2771, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33933742

RESUMO

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.


Assuntos
Rim/fisiologia , Inquéritos Nutricionais , Estado Nutricional , Insuficiência Renal Crônica/fisiopatologia , Idoso , Feminino , Taxa de Filtração Glomerular/fisiologia , Humanos , Masculino , Desnutrição/etiologia , Pessoa de Meia-Idade , Fatores de Risco
10.
J Am Coll Cardiol ; 77(18): 2307-2319, 2021 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-33958128

RESUMO

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).

11.
Am J Clin Nutr ; 114(2): 731-740, 2021 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-33829236

RESUMO

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.


Assuntos
Força da Mão , Pacientes Internados , Desnutrição/complicações , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação Nutricional , Terapia Nutricional , Estado Nutricional , Apoio Nutricional , Razão de Chances , Resultado do Tratamento
12.
Thromb Haemost ; 2021 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-33823559

RESUMO

BACKGROUND: The 2019 European Society of Cardiology (ESC) guidelines recommend evaluation for right ventricular dysfunction in all normotensive patients with acute pulmonary embolism (PE). We compared the predictive performance of the 2019 and 2014 ESC risk stratification algorithms and the Pulmonary Embolism Severity Index (PESI). METHODS: We performed a posthoc analysis of normotensive patients aged ≥ 65 years with acute PE from a prospective cohort. The primary outcome was overall mortality; secondary outcomes were PE-related mortality and adverse outcomes (PE-related death, cardiopulmonary resuscitation, intubation, catecholamine use, recurrent venous thromboembolism) at 30 days. We assessed outcomes in intermediate-high, intermediate-low, and low-risk groups according to the 2019 and 2014 ESC algorithms and the PESI. Discriminative power was compared using the area under the receiver operating characteristic curve (AUC). RESULTS: Among 419 patients, 14 (3.3%) died (7 from PE) and 16 (3.8%) had adverse outcomes within 30 days. The 2019 ESC algorithm classified more patients as intermediate-high risk (45%) than the 2014 ESC algorithm (24%) or the PESI (37%), and only 19% as low risk (32% with 2014 ESC or the PESI). Discriminatory power for overall mortality was lower with the 2019 ESC algorithm (AUC: 63.6%), compared with the 2014 ESC algorithm (AUC: 71.5%) or the PESI (AUC: 75.2%), although the difference did not reach statistical significance (p = 0.063). Discrimination for PE-related mortality and adverse outcomes was similar. CONCLUSION: While categorizing more patients in higher risk groups, the 2019 ESC algorithm for PE did not improve prediction of short-term outcomes compared with the 2014 ESC algorithm or the PESI.

13.
Thromb Haemost ; 2021 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-33930905

RESUMO

BACKGROUND: In elderly patients with venous thromboembolism (VTE), the decision to extend anticoagulation beyond 3 months must be weighed against the bleeding risk. We compared the predictive performance of 10 clinical bleeding scores (VTE-BLEED, Seiler, Kuijer, Kearon, RIETE, ACCP, OBRI, HEMORR2HAGES, HAS-BLED, ATRIA) in elderly patients receiving extended anticoagulation for VTE. METHODS: In a multicenter Swiss cohort study, we analyzed 743 patients aged ≥65 years who received extended treatment with vitamin K antagonists after VTE. The outcomes were the time to a first major and clinically relevant bleeding. For each score, we classified patients into two bleeding risk categories (low/moderate vs. high). We calculated likelihood ratios and the area under the receiver operating characteristic (ROC) curve for each score. RESULTS: Over a median anticoagulation duration of 10.1 months, 45 patients (6.1%) had a first major and 127 (17.1%) a clinically relevant bleeding. The positive likelihood ratios for predicting major bleeding ranged from 0.69 (OBRI) to 2.56 (Seiler) and from 1.07 (ACCP) to 2.36 (Seiler) for clinically relevant bleeding. The areas under the ROC curves were poor to fair and varied between 0.47 (OBRI) and 0.70 (Seiler) for major and between 0.52 (OBRI) and 0.67 (HEMORR2HAGES) for clinically relevant bleeding. CONCLUSION: The predictive performance of most clinical bleeding risk scores does not appear to be sufficiently high to identify elderly patients with VTE who are at high risk of bleeding and who may therefore not be suitable candidates for extended anticoagulation.

14.
Diagnostics (Basel) ; 11(4)2021 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-33808169

RESUMO

Acute aortic dissection (AAD) is a rare condition, but together with acute myocardial infarction (AMI) and pulmonary embolism (PE) it belongs to the most relevant and life-threatening causes of acute chest pain. Until now, there has been no specific blood test in the diagnostic workup of AAD. To identify clinically relevant biomarkers for AAD, we applied Proseek® Multiplex assays to plasma samples from patients with AAD, AMI, PE, thoracic aortic aneurysm (TAA), and non-cardiovascular chest pain (nonCVD). Subsequently, we validated top hits using conventional immunoassays and examined their expression in the aortic tissue. Interleukin 10 (IL-10) alone showed the best performance with a sensitivity of 55% and a specificity of 98% for AAD diagnosis. The combination of D-dimers, high-sensitive troponin T (hs-TnT), interleukin 6 (IL-6), and plasminogen activator inhibitor 1 (PAI1) correctly classified 75% of AAD cases, delivering a sensitivity of 83% and specificity of 95% for its diagnosis. Moreover, this model provided the correct classification of 77% of all analyzed cases. Our data suggest that IL-10 shows potential to be a rule-in biomarker for AAD. Moreover, the addition of PAI1 and IL-6 to hs-TnT and D-dimers may improve the discrimination of suspected AAD, AMI, and PE in patients presenting with acute chest pain.

15.
Palliat Med ; 35(6): 1108-1117, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33908288

RESUMO

BACKGROUND: International oncology societies recommend early palliative care. Specific models to integrate early palliative care efficiently into clinical practice are debated. The authors designed a study to look at the quantitative and qualitative outcomes of an early palliative care intervention in oncological care to decrease stress and improve quality of life. AIMS: To compare a single structured early palliative care intervention added to a usual oncology care in terms of distress and health-related quality of life at baseline compared to 6 months after enrollment. DESIGN: This multicenter randomized controlled trial (NCT01983956) enrolled adult patients with advanced cancer. Participants were either randomly assigned to usual oncology care alone or usual care plus a structured early palliative care intervention. SETTING/PARTICIPANTS: One hundred fifty adult patients with a variety of advanced cancer diagnoses were randomized. Seventy-four participants were in the intervention and 76 participants in the control group. The primary outcome was the change in patient distress assessed by the National Comprehensive Cancer Network distress thermometer at 6 months. Health-related quality of life, the secondary outcome, was assessed by the Functional Assessment of Cancer Therapy-General Questionnaire. RESULTS: The results showed no significant effect of the early palliative care intervention neither on patient distress nor on health-related quality of life. CONCLUSION: The addition of an early intervention to usual care for patients with advanced cancer did not improve distress or quality of life. Thus, patients may need more intensive early palliative care with continuous professional support to identify and address their palliative needs early.


Assuntos
Enfermagem de Cuidados Paliativos na Terminalidade da Vida , Neoplasias , Adulto , Humanos , Neoplasias/terapia , Cuidados Paliativos , Qualidade de Vida
16.
JAMA Netw Open ; 4(2): e2036645, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33566107

RESUMO

Importance: Previous trials on the effect of levothyroxine on depressive symptom scores in patients with subclinical hypothyroidism were limited by small sample sizes (N = 57 to 94) and potential biases. Objective: To assess the effect of levothyroxine on the development of depressive symptoms in older adults with subclinical hypothyroidism in the largest trial on this subject and to update a previous meta-analysis including the results from this study. Design, Setting, and Participants: This predefined ancillary study analyzed data from participants in the Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism (TRUST) trial, a double-blind, randomized, placebo-controlled, parallel-group clinical trial conducted from April 2013 to October 31, 2016. The TRUST trial included adults aged 65 years or older diagnosed with subclinical hypothyroidism, defined as the presence of persistently elevated thyroid-stimulating hormone (TSH) levels (4.6-19.9 mIU/L) with free thyroxine (T4) within the reference range. Participants were identified from clinical and general practitioner laboratory databases and recruited from the community in Switzerland, the Netherlands, Ireland, and the UK. This ancillary study included a subgroup of 472 participants from the Netherlands and Switzerland; after exclusions, a total of 427 participants (211 randomized to levothyroxine and 216 to placebo) were analyzed. This analysis was conducted from December 1, 2019, to September 1, 2020. Interventions: Randomization to either levothyroxine or placebo. Main Outcomes and Measures: Depressive symptom scores after 12 months measured with the Geriatric Depression Scale (GDS-15), with higher scores indicating more depressive symptoms (minimal clinically important difference = 2). Results: A total of 427 participants with subclinical hypothyroidism (mean [SD] age, 74.52 [6.29] years; 239 women [56%]) were included in this analysis. The mean (SD) TSH level was 6.57 (2.22) mIU/L at baseline and decreased after 12 months to 3.83 (2.29) mIU/L in the levothyroxine group; in the placebo group, it decreased from 6.55 (2.04) mIU/L to 5.91 (2.66) mIU/L. At baseline, the mean (SD) GDS-15 score was 1.26 (1.85) in the levothyroxine group and 0.96 (1.58) in the placebo group. The mean (SD) GDS-15 score at 12 months was 1.39 (2.13) in the levothyroxine and 1.07 (1.67) in the placebo group with an adjusted between-group difference of 0.15 for levothyroxine vs placebo (95% CI, -0.15 to 0.46; P = .33). In a subgroup analysis including participants with a GDS-15 of at least 2, the adjusted between-group difference was 0.61 (95% CI, -0.32 to 1.53; P = .20). Results did not differ according to age, sex, or TSH levels. A previous meta-analysis (N = 278) on the association of levothyroxine with depressive symptoms was updated to include these findings, resulting in an overall standardized mean difference of 0.09 (95% CI, -0.05 to 0.22). Conclusions and Relevance: This ancillary study of a randomized clinical trial found that depressive symptoms did not differ after levothyroxine therapy compared with placebo after 12 months; thus, these results do not provide evidence in favor of levothyroxine therapy in older persons with subclinical hypothyroidism to reduce the risk of developing depressive symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT01853579.


Assuntos
Doenças Assintomáticas , Depressão/psicologia , Hipotireoidismo/tratamento farmacológico , Tiroxina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Humanos , Hipotireoidismo/sangue , Hipotireoidismo/psicologia , Masculino , Tireotropina/sangue , Tiroxina/sangue , Resultado do Tratamento
17.
Swiss Med Wkly ; 151: w20421, 2021 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-33641108

RESUMO

AIMS OF THE STUDY: Anticoagulation of patients with screen-detected atrial fibrillation may prevent ischaemic strokes. The STAR-FIB study programme aims to determine the age- and sex-specific prevalence of silent atrial fibrillation and to develop a clinical prediction model to identify patients at risk of undiagnosed atrial fibrillation in a hospitalised patient population. METHODS: The STAR-FIB study programme includes a prospective cohort study and a case-control study of hospitalised patients aged 65–84 years, evenly distributed for both age and sex. We recruited 795 patients without atrial fibrillation for the cohort study (49.2% females; median age 74.8 years). All patients had three serial 7-day Holter ECGs to screen for silent atrial fibrillation. The primary endpoint will be any episode of atrial fibrillation or atrial flutter of ≥30 seconds duration. The age- and sex-specific prevalence of newly diagnosed atrial fibrillation will be estimated. For the case-control study, 120 patients with paroxysmal atrial fibrillation were recruited as cases (41.7% females; median age 74.6 years); controls will be randomly selected from the cohort study in a 2:1 ratio. All participants in the cohort study and all cases were prospectively evaluated including clinical, laboratory, echocardiographic and electrical parameters. A clinical prediction model for undiagnosed atrial fibrillation will be derived in the case-control study and externally validated in the cohort study. CONCLUSIONS: The STAR-FIB study programme will estimate the age- and sex-specific prevalence of silent atrial fibrillation in a hospitalised patient population, and develop and validate a clinical prediction model to identify patients at risk of silent atrial fibrillation.

18.
J Thromb Haemost ; 19(4): 931-940, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33501722

RESUMO

OBJECTIVE: Balancing bleeding risk and stroke risk in patients with atrial fibrillation (AF) is a common challenge. Though several bleeding risk scores exist, most have not included patients on direct oral anticoagulants (DOACs). We aimed at developing a novel bleeding risk score for patients with AF on oral anticoagulants (OAC) including both vitamin K antagonists (VKA) and DOACs. METHODS: We included patients with AF on OACs from a prospective multicenter cohort study in Switzerland (SWISS-AF). The outcome was time to first bleeding. Bleeding events were defined as major or clinically relevant non-major bleeding. We used backward elimination to identify bleeding risk variables. We derived the score using a point score system based on the ß-coefficients from the multivariable model. We used the Brier score for model calibration (<0.25 indicating good calibration), and Harrel's c-statistics for model discrimination. RESULTS: We included 2147 patients with AF on OAC (72.5% male, mean age 73.4 ± 8.2 years), of whom 1209 (56.3%) took DOACs. After a follow-up of 4.4 years, a total of 255 (11.9%) bleeding events occurred. After backward elimination, age > 75 years, history of cancer, prior major hemorrhage, and arterial hypertension remained in the final prediction model. The Brier score was 0.23 (95% confidence interval [CI] 0.19-0.27), the c-statistic at 12 months was 0.71 (95% CI 0.63-0.80). CONCLUSION: In this prospective cohort study of AF patients and predominantly DOAC users, we successfully derived a bleeding risk prediction model with good calibration and discrimination.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Estudos de Coortes , Feminino , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/epidemiologia , Humanos , Masculino , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Suíça
19.
Clin Nutr ; 40(3): 812-819, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32919819

RESUMO

BACKGROUND: Among medical inpatients at risk of malnutrition, the use of individualized nutritional support during the hospital stay was found to reduce complications and improve mortality at short-term. We evaluated clinical outcomes at 6-months follow-up. METHODS: We randomly assigned 2028 patients to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or hospital food as usual (control group) during the hospital stay. The intervention was discontinued at hospital discharge and further nutritional support was based on the discretion of the treating team. We had complete follow-up information of 1995 patients (98%), which were included in the final analysis. The primary endpoint was all-cause mortality at 6-months. Prespecified secondary end points included non-elective hospital readmissions, functional outcome and quality of life. RESULTS: At 6-month, 231 of 994 (23.2%) intervention group patients had died compared to 246 of 999 (24.6%) control group patients, resulting in a hazard ratio for death of 0.90 (95%CI 0.76 to 1.08, p = 0.277). Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores. INTERPRETATION: While individualized nutritional support during the hospital stay significantly reduced short-term mortality, there was no legacy effect on longer term outcomes. Future trials should investigate whether continuation of nutritional support after hospital discharge reduces the high malnutrition-associated mortality rates in this vulnerable patient population. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02517476.

20.
Thromb Haemost ; 121(5): 641-649, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33202448

RESUMO

OBJECTIVE: In patients with cancer-associated venous thromboembolism (VTE), the risk of recurrence is similar after incidental and symptomatic events. It is unknown whether the same applies to incidental VTE not associated with cancer. METHODS AND RESULTS: We compared baseline characteristics, anticoagulation therapy, all-cause mortality, and VTE recurrence rates at 90 days between patients with incidental (n = 131; 52% without cancer) and symptomatic (n = 1,931) VTE included in the SWIss Venous ThromboEmbolism Registry (SWIVTER). After incidental VTE, 114 (87%) patients received anticoagulation therapy for at least 3 months. The mortality rate was 9.2% after incidental and 8.4% after symptomatic VTE for hazard ratio (HR) 1.10 (95% confidence interval [CI] 0.49-2.50). After adjustment for competing risk of death, recurrence rate was 3.1 versus 2.8%, respectively, for sub-HR 1.07 (95% CI 0.39-2.93). These results were consistent among cancer (mortality: 15.9% vs. 12.6%; HR 1.32, 95% CI 0.67-2.59; recurrence: 4.8% vs. 4.7%; HR 1.02, 95% CI 0.30-3.42) and noncancer patients (mortality: 2.9% vs. 2.1%; HR 1.37, 95% CI 0.33-5.73; recurrence: 1.5% vs. 2.3%; HR 0.63, 95% CI 0.09-4.58). Patients with incidental VTE who received anticoagulation therapy for at least 3 months had lower mortality (4% vs. 41%) and recurrence rate (1% vs. 18%) compared with those who did not. CONCLUSION: In SWIVTER, more than half of incidental VTE events occurred in noncancer patients who often received anticoagulation therapy. Among noncancer patients, early mortality and recurrence rates were similar after incidental versus symptomatic VTE. Our findings suggest that anticoagulation therapy for incidental VTE may be beneficial regardless of the presence of cancer.

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