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Displaying 241 - 250 of 432 in Annals of Internal Medicine
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Effects of Interleukin-1β Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial: Annals of Internal Medicine: Vol 172, No 8
Background: Inflammatory cytokines, such as interleukin (IL)-1β, alter iron homeostasis and erythropoiesis, resulting in anemia, but whether inhibition of IL-1β can reverse these effects is unclear. Objective: To determine whether IL-1β inhibition with canakinumab reduces incident anemia and improves hemoglobin levels among those with prevalent anemia. Design: Exploratory analysis of a randomized controlled trial. (ClinicalTrials.gov: NCT01327846) Setting: Many clinical sites in 39 countries. Participants: 8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry. Intervention: Random assignment to receive placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months. Measurements: Primary outcome was incident anemia (hemoglobin level <130 g/L in men or <120 g/L in women). Results: Anemia incidence increased with rising baseline levels of high-sensitivity C-reactive protein (hsCRP), and both hsCRP and IL-6 decreased among participants receiving canakinumab compared with the placebo group. During a median follow-up of 3.7 years, participants without baseline anemia who received canakinumab at any dosage had significantly less incident anemia than those who received placebo (hazard ratio, 0.84 [95% CI, 0.77 to 0.93]; P < 0.001). Compared with placebo, the greatest benefits of IL-1β inhibition on incident anemia were observed among participants with the most robust anti-inflammatory response, an effect corroborated in formal mediation analyses. Among those with baseline anemia, canakinumab increased mean hemoglobin levels by 11.3 g/L (P < 0.001) compared with placebo after 2 years of treatment. Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher. Limitation: CANTOS was not designed to assess the cause of anemia in individual trial participants. Conclusion: These exploratory analyses of randomized trial data provide proof of principle that inflammation inhibition, at least through the IL-1β/IL-6 signaling pathway, reduces the incidence of anemia and improves hemoglobin levels in patients with anemia. Primary Funding Source: Novartis Pharmaceuticals.
Comparative Accuracy of Focused Cardiac Ultrasonography and Clinical Examination for Left Ventricular Dysfunction and Valvular Heart Disease: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 171, No 4
Background: Incorporating focused cardiac ultrasonography (FoCUS) into clinical examination could improve the diagnostic yield of bedside patient evaluation. Purpose: To compare the accuracy of FoCUS-assisted clinical assessment versus clinical assessment alone for diagnosing left ventricular dysfunction or valvular disease in adults having cardiovascular evaluation. Data Sources: English-language searches of MEDLINE, Embase, and Web of Science from 1 January 1990 to 23 May 2019 and review of reference citations. Study Selection: Eligible studies were done in patients having cardiovascular evaluation; compared FoCUS-assisted clinical assessment versus clinical assessment alone for the diagnosis of left ventricular systolic dysfunction, aortic or mitral valve disease, or pericardial effusion; and used transthoracic echocardiography as the reference standard. Data Extraction: Three study investigators independently abstracted data and assessed study quality. Data Synthesis: Nine studies were included in the meta-analysis. The sensitivity of clinical assessment for diagnosing left ventricular dysfunction (left ventricular ejection fraction <50%) was 43% (95% CI, 33% to 54%), whereas that of FoCUS-assisted examination was 84% (CI, 74% to 91%). The specificity of clinical assessment was 81% (CI, 65% to 90%), and that of FoCUS-assisted examination was 89% (CI, 85% to 91%). The sensitivities of clinical assessment and FoCUS-assisted examination for diagnosing aortic or mitral valve disease (of at least moderate severity) were 46% (CI, 35% to 58%) and 71% (CI, 63% to 79%), respectively. Both the clinical assessment and the FoCUS-assisted examination had a specificity of 94% (CI, 91% to 96%). Limitation: Evidence was scant, persons doing ultrasonography had variable skill levels, and most studies had unclear or high risk of bias. Conclusion: Clinical examination assisted by FoCUS has greater sensitivity, but not greater specificity, than clinical assessment alone for identifying left ventricular dysfunction and aortic or mitral valve disease; FoCUS-assisted examination may help rule out cardiovascular pathology in some patients, but it may not be sufficient for definitive confirmation of cardiovascular disease suspected on physical examination. Primary Funding Source: None. (PROSPERO: CRD42019124318)
Should This Patient Be Screened for Atrial Fibrillation?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 171, No 11
This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Atrial fibrillation (AFib) is the most common type of cardiac arrhythmia, affecting 2.7 million to 6.1 million persons in the United States. Although some persons with AFib have no symptoms, others do. For those without symptoms, AFib may be detected by 12-lead electrocardiogram (ECG), single-lead monitors (such as ambulatory blood pressure monitors and pulse oximeters), or consumer devices (such as wearable monitors and smartphones). Pulse palpation and heart auscultation also may detect AFib. In a systematic review, screening with ECG identified more new cases of AFib than no screening. Atrial fibrillation is an important cause of stroke, and without anticoagulant treatment, patients with AFib have approximately a 5-fold increased risk for stroke. The U.S. Preventive Services Task Force reviewed the benefits and harms of ECG screening for AFib in adults aged 65 years or older and found inadequate evidence that ECG identifies AFib more effectively than usual care. This conclusion is in contrast to guidelines from the European Society of Cardiology and the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand, which found that active screening for AFib in patients older than 65 years may be useful. Here, 2 cardiologists discuss the risks and benefits of screening for AFib, if and when they would recommend screening, and whether they would recommend anticoagulation for a patient with screen-detected AFib.
Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1–Risk Myelodysplastic Syndromes: A Randomized Trial: Annals of Internal Medicine: Vol 172, No 8
Background: Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies. Objective: To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1–risk MDS. Design: Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602) Setting: 60 centers in 16 countries. Participants: 225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities. Intervention: Deferasirox dispersible tablets (10 to 40 mg/kg per day) (n = 149) or matching placebo (n = 76). Measurements: The primary end point was EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first. Results: Median time on treatment was 1.6 years (interquartile range [IQR], 0.5 to 3.1 years) in the deferasirox group and 1.0 year (IQR, 0.6 to 2.0 years) in the placebo group. Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]). Adverse events occurred in 97.3% of deferasirox recipients and 90.8% of placebo recipients. Exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment–years) in deferasirox versus placebo recipients, respectively, were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration. Limitations: The protocol was amended from a phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants. There was differential follow-up between treatment groups. Conclusion: The findings support ICT in iron-overloaded patients with low- to intermediate-1–risk MDS, with longer EFS compared with placebo and a clinically manageable safety profile. Therefore, ICT may be considered in these patients. Primary Funding Source: Novartis Pharma AG.
Cost-Effectiveness Analysis of Lung Cancer Screening in the United States: A Comparative Modeling Study: Annals of Internal Medicine: Vol 171, No 11
Background: Recommendations vary regarding the maximum age at which to stop lung cancer screening: 80 years according to the U.S. Preventive Services Task Force (USPSTF), 77 years according to the Centers for Medicare & Medicaid Services (CMS), and 74 years according to the National Lung Screening Trial (NLST). Objective: To compare the cost-effectiveness of different stopping ages for lung cancer screening. Design: By using shared inputs for smoking behavior, costs, and quality of life, 4 independently developed microsimulation models evaluated the health and cost outcomes of annual lung cancer screening with low-dose computed tomography (LDCT). Data Sources: The NLST; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; SEER (Surveillance, Epidemiology, and End Results) program; Nurses' Health Study and Health Professionals Follow-up Study; and U.S. Smoking History Generator. Target Population: Current, former, and never-smokers aged 45 years from the 1960 U.S. birth cohort. Time Horizon: 45 years. Perspective: Health care sector. Intervention: Annual LDCT according to NLST, CMS, and USPSTF criteria. Outcome Measures: Incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold of $100 000 per quality-adjusted life-year (QALY). Results of Base-Case Analysis: The 4 models showed that the NLST, CMS, and USPSTF screening strategies were cost-effective, with ICERs averaging $49 200, $68 600, and $96 700 per QALY, respectively. Increasing the age at which to stop screening resulted in a greater reduction in mortality but also led to higher costs and overdiagnosis rates. Results of Sensitivity Analysis: Probabilistic sensitivity analysis showed that the NLST and CMS strategies had higher probabilities of being cost-effective (98% and 77%, respectively) than the USPSTF strategy (52%). Limitation: Scenarios assumed 100% screening adherence, and models extrapolated beyond clinical trial data. Conclusion: All 3 sets of lung cancer screening criteria represent cost-effective programs. Despite underlying uncertainty, the NLST and CMS screening strategies have high probabilities of being cost-effective. Primary Funding Source: CISNET (Cancer Intervention and Surveillance Modeling Network) Lung Group, National Cancer Institute.
Quantitative Results of a National Intervention to Prevent Clostridioides difficile Infection: A Pre–Post Observational Study: Annals of Internal Medicine: Vol 171, No 7_Supplement
Background: Clostridioides difficile infection (CDI) is on the rise. Objective: To evaluate the effect of a tiered, evidence-based intervention to prevent CDI. Design: Pre–post observational evaluation of a prospective, 12-month, national, nonrandomized, clustered quality improvement project to reduce hospital health care–associated infection. Setting: Acute care, long-term acute care, and critical access hospitals working with state partner organizations (state hospital associations and state health departments) to improve health care–associated infection prevention practices. Participants: Targeted hospitals had a high burden of CDI and another health care–associated infection. Other hospitals that did not meet these criteria volunteered to participate. Intervention: Multimodal intervention that consisted of 1) on-demand educational modules and webinars, 2) in-person meetings facilitated by state-level partners, 3) feedback and recommendations for implementation of evidence-based recommendations (including a CDI-specific guide on which interventions to implement), and 4) guided facilitation through infection prevention resources and site visits. Measurements: Pre- and postintervention CDI rates. Results: Between November 2016 and May 2018, 387 hospitals (366 of which reported CDI data) in 23 states and the District of Columbia participated in the intervention. There was a statistically significant decrease in CDI incidence over the study period, from 7.0 cases per 10 000 patient-days in the preintervention period to 5.7 cases per 10 000 patient-days in the postintervention period. However, this decrease appeared to be part of a temporal trend rather than due to the study intervention. Limitations: Commitment to and adherence with recommended infection prevention practices before and after the intervention were not assessed. The intervention period was relatively brief, and patient-level data were not available. Conclusion: Although a statistically significant decline in hospital-onset CDI was observed, this trend appears to be unrelated to the study intervention. Primary Funding Source: Centers for Disease Control and Prevention.
Quantitative Results of a National Intervention to Prevent Hospital-Onset Methicillin-Resistant Staphylococcus aureus Bloodstream Infection: A Pre–Post Observational Study: Annals of Internal Medicine: Vol 171, No 7_Supplement
Background: Methicillin-resistant Staphylococcus aureus (MRSA) remains one of the most common causes of health care–associated infection (HAI). Objective: To evaluate the effect of education and a tiered, evidence-based infection prevention strategy on rates of hospital-onset MRSA bloodstream infection (BSI). Design: Prospective, national, nonrandomized, interventional, 12-month, multiple cohort, pre–post observational quality improvement project. Setting: Acute care, long-term acute care, and critical access hospitals with a disproportionate burden of HAI. Patients: All patients admitted to participating facilities during the project period. Intervention: A multimodal infection prevention intervention consisting of recommendations and tools for prioritizing and implementing evidence-based infection prevention strategies, on-demand educational videos, Internet-based live educational presentations, and access to content experts. Measurements: Rates of hospital-onset MRSA BSI, overall and stratified by hospital type, during 12-month baseline and postintervention periods. Variation in outcomes across hospital types was examined. Results: Between November 2016 and May 2018, 387 hospitals in 23 states and the District of Columbia participated, 353 (91%) submitted MRSA data, and 172 (49%) indicated that MRSA prevention was a priority. Unadjusted overall rates of hospital-onset MRSA BSI were 0.075 (95% CI, 0.065 to 0.085) and 0.071 (CI, 0.063 to 0.080) per 1000 patient-days in the baseline and postintervention periods, respectively. Limitations: The intervention period was short. Participation and adherence to recommended interventions were not fully assessed. Baseline rates of hospital-onset MRSA BSI were relatively low. Prevention of MRSA was a priority in a minority of participating hospitals. Patient characteristics and other MRSA risk factors were not assessed. Conclusion: In hospitals with a disproportionate burden of HAIs, access to tools to assist with implementation of evidence-based prevention strategies and education resources alone may not be sufficient to prevent MRSA BSI. Primary Funding Source: Centers for Disease Control and Prevention.
Quantitative Results of a National Intervention to Prevent Hospital-Acquired Catheter-Associated Urinary Tract Infection: A Pre–Post Observational Study: Annals of Internal Medicine: Vol 171, No 7_Supplement
Background: Many hospitals struggle to prevent catheter-associated urinary tract infection (CAUTI). Objective: To evaluate the effect of a multimodal initiative on CAUTI in hospitals with high burden of health care–associated infection (HAI). Design: Prospective, national, nonrandomized, clustered, externally facilitated, pre–post observational quality improvement initiative, for 3 cohorts active between November 2016 and May 2018. Setting: Acute care, long-term acute care, and critical access hospitals, including intensive care and non–intensive care wards. Participants: Target hospitals had a high burden of Clostridioides difficile infection plus central line–associated bloodstream infection, CAUTI, or hospital-onset methicillin-resistant Staphylococcus aureus bloodstream infection, defined as cumulative attributable differences above the first tertile in the Targeted Assessment for Prevention (TAP) strategy. Some additional nonrecruited hospitals also joined. Intervention: Multimodal intervention, including Practice Change Assessment tool to identify infection prevention and control (IPC) and HAI prevention gaps; Web-based, on-demand modules involving onboarding, foundational IPC practices, HAI-specific 2-tiered approach to prioritize and implement interventions, and TAP resources; monthly webinars; state partner–led in-person meetings; and feedback. State partners made site visits to at least 50% of their enrolled hospitals, to support self-assessments and coach. Measurements: Rates of CAUTI and urinary catheter device utilization ratio. Results: Of 387 participating hospitals from 23 states and the District of Columbia, 361 provided CAUTI data. Over the study period, the unadjusted CAUTI rate was low and relatively stable, decreasing slightly from 1.12 to 1.04 CAUTIs per 1000 catheter-days. Catheter utilization decreased from 21.46 to 19.83 catheter-days per 100 patient-days from the pre- to the postintervention period. Limitations: The intervention period was brief, with no assessment of fidelity. Baseline CAUTI rates were low. Patient characteristics were not assessed. Conclusion: This multimodal intervention yielded no substantial improvements in CAUTI or urinary catheter utilization. Primary Funding Source: Centers for Disease Control and Prevention.
Quantitative Results of a National Intervention to Prevent Central Line–Associated Bloodstream Infection: A Pre–Post Observational Study: Annals of Internal Medicine: Vol 171, No 7_Supplement
Background: Central line–associated bloodstream infection (CLABSI) remains prevalent in hospitals in the United States. Objective: To evaluate the impact of a multimodal intervention in hospitals with elevated rates of health care–associated infection. Design: Pre–post observational evaluation of a prospective, national, clustered, nonrandomized initiative of 3 cohorts of hospitals. Setting: Acute care, long-term acute care, and critical access hospitals, including intensive care units and medical/surgical wards. Participants: Target hospitals had a cumulative attributable difference above the first tertile of performance for Clostridioides difficile infection and another health care–associated infection (such as CLABSI). Some hospitals that did not meet these criteria also participated. Intervention: A multimodal intervention consisting of recommendations and tools for prioritizing and implementing evidence-based infection prevention strategies, on-demand educational videos, webinars led by content experts, and access to content experts. Measurements: Rates of CLABSI and device utilization ratio pre- and postintervention. Results: Between November 2016 and May 2018, 387 hospitals in 23 states and the District of Columbia participated. Monthly preimplementation CLABSI rates ranged from 0 to 71.4 CLABSIs per 1000 catheter-days. Over the study period, the unadjusted CLABSI rate was low and decreased from 0.88 to 0.80 CLABSI per 1000 catheter-days. Between the pre- and postintervention periods, device utilization decreased from 24.05 to 22.07 central line–days per 100 patient-days. However, a decreasing trend in device utilization was also observed during the preintervention period. Limitations: The intervention period was brief. Participation in and adherence to recommended interventions were not fully assessed. Rates of CLABSI were low. Patient characteristics could not be assessed. Conclusion: In hospitals with a disproportionate burden of health care–associated infection, a multimodal intervention did not reduce rates of CLABSI. Primary Funding Source: Centers for Disease Control and Prevention.
Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study: Annals of Internal Medicine: Vol 170, No 11
Background: Pulmonary embolism (PE) is associated with increased risk for ischemic stroke, but the underlying mechanism remains unclear. The authors hypothesized that paradoxical embolism through patent foramen ovale (PFO) should be the main mechanism. Objective: To determine the frequency of recent ischemic stroke in patients with symptomatic PE according to whether PFO was detected. Design: Prospective cohort study with masked assessment of stroke outcomes. (ClinicalTrials.gov: NCT01216423) Setting: 4 French hospital centers. Participants: 361 consecutive patients with symptomatic acute PE from 13 November 2009 through 21 December 2015. Intervention: Systematic contrast transthoracic echocardiography (TTE) and cerebral magnetic resonance imaging (MRI) within 7 days after enrollment. Measurements: Recent symptomatic or silent ischemic stroke was diagnosed on the basis of clinical examination and cerebral MRI showing a hypersignal on the trace diffusion-weighted image with reduction or pseudonormalization of apparent diffusion coefficient. Results: Contrast TTE was conclusive in 324 of 361 patients and showed PFO in 43 patients (13%). The median age was 66 years (interquartile range, 54 to 77 years). In total, 51% of patients (145/284) had associated deep venous thrombosis, 91% (279/306) had cardiovascular risk factors, and 10% (16/151) presented with arrhythmia (no difference between PFO and non-PFO groups). Cerebral MRI was conclusive in 315 patients. Recent ischemic stroke was more frequent in the PFO group than in the non-PFO group (9 of 42 patients [21.4%] vs. 15 of 273 patients [5.5%]; difference in proportions, 15.9 percentage points [95% CI, 4.7 to 30.7 percentage points]). Limitation: Because of inconclusive contrast TTE or MRI, 46 patients were excluded from analysis. Conclusion: Frequency of recent ischemic stroke in patients with symptomatic PE was higher in patients with PFO than in those without PFO. This finding supports the hypothesis that paradoxical embolism is an important mechanism of ischemic stroke in patients with PFO. Primary Funding Source: French Ministry of Health.