NEJM Evidence
@NEJMEvidence
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NEJM Evidence, a new journal from NEJM Group, presents innovative #OriginalResearch and fresh, bold ideas in #ClinicalTrial design and clinical decision-making.
Boston
Joined August 2021
Volume 4 Issue 2 of NEJM Evidence is now available! Read the latest original research and specialty articles: #MedTwitter #ClinicalTrials #EBM
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How do we make sense of two “negative” trials in @NEJM and a “positive” meta-analysis of the two trials in NEJM Evidence? @emil_hs and @FralickMike share some insights in this editorial:
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Osmotic demyelination syndrome (ODS) following correction of hyponatremia was studied in 22,858 hospitalizations. There were 12 cases of ODS identified, only half of which occurred following rapid correction of serum sodium. #IMTwitter #NeuroTwitter.
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“A 48-hour limit of sodium correction of 15 to 20mmol/l would be more useful than the current 24-hour limits of between 8 and 10mmol/l per 24 hours, as it would allow more room for active therapy with a safe limit for correction.” . #IMTwitter
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A neonate was delivered at 39 weeks of gestation. He cried immediately after birth, but his whole body appeared blue. A team from @ChildrensPhila reviews their approach to the differential diagnosis in this #MorningReport. @amyjromer #MedEd #NeoTwitter
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“Balanced Crystalloids versus Saline in Critically Ill Adults — A Systematic Review with Meta-Analysis (#PLUS),” an Original Article by @NaomiHammond et al., is now available. @CritCareReviews @GeorgeInstitute #CriticalCare #ClincialTrials
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DREAM trial: In this pragmatic #RCT in active young adults with meniscal tears, early meniscal surgery was not superior to a strategy of supervised exercise therapy and education with the option of later surgery. @STSkou #OrthoTwitter #SurgTwitter
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This prospective study tested use of home waking salivary cortisone levels to predict adrenal insufficiency. Salivary cortisone had diagnostic accuracy similar to that of a standard adrenocorticotropin (ACTH) stimulation test. #EndoTwitter #MedTwitter
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“Hypothermia at 33°C did not decrease 6-month mortality compared with normothermia after out-of-hospital cardiac arrest.” Read more about the recently published meta-analysis by Johan Holgersson, MD, Martin Abild Stengaard Meyer, MD, et al.: #CriticalCare
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“…‘statistically significant’ estimates tend to seriously overestimate actual treatment effects, ‘nonsignificant’ results often correspond to important effects, and efforts to replicate often fail to achieve ‘significance’….” Read the full article:
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Exercise is strongly associated with ⬇ morbidity and mortality. However, large amounts of endurance exercise may have adverse effects. Thompson and colleagues review the evidence on the health effects of high-volume exercise training. #CardioTwitter
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“Exercise is widely considered to be a form of medicine because of substantial evidence that it is associated with a reduction in a wide range of diseases. However, a complimentary…statement is that physical inactivity is a potent risk factor for disease.”
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“Whereas a P value of 0.06 is considered meaningfully different from a P value of 0.04, similar bright-line rules do not exist for posterior probabilities. This is a good thing.” #CardioTwitter #CriticalCare #PedsICU #Tweetiatricians #PedsTwitter
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In the ATTICUS trial, among pts w/ embolic stroke of undetermined source and cardioembolic risk factors, apixaban was not superior to aspirin in preventing new ischemic lesions on MRI and was comparable in rates of clinically relevant bleeding.
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NEJM Evidence welcomes LJ Punch, MD (He/They), to the editorial board. @lj_punch is a trauma surgeon, community health activist, director at the BRIC (Bullet Related Injury Clinic), and founder of The T @TheT5874Delmar in St. Louis.
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Just published: "Proton-Pump Inhibitors to Prevent Gastrointestinal Bleeding — An Updated Meta-Analysis” by Ying Wang, MSc, Deborah Cook, MD, MSc, et al. . @YaseenarabiYa @DogICUma #CCR24
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“An effective host response to an invading pathogen is essential for the resolution of infection. At the same time, an overzealous systemic response to a local insult is fundamental to our understanding of the pathogenesis of sepsis and ARDS.” #CritCare
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#MorningReport: Cyanosis in a Newborn Immediately after Birth. @amyjromer @ChildrensPhila #CardioTwitter #NeoTwitter
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Ever been confused about non-inferiority trials? Watch this explanation of Stats, STAT! #ClinicalTrials #MedEd #MedicalEvidence
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Should a MRSA nasal swab be used to guide empiric antibiotic treatment? Catherine Liu, MD, and @Marisa_Holubar say the answer to this question is “sometimes.” Read more as they tackle the evidence in this #CurbsideConsult: #IDTwitter #MedTwitter
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Molnupiravir, an oral agent to treat #SARSCoV2, was tested in adults hospitalized for #COVID19 who had symptoms for 10 days or less. Patients received placebo (n=75) or varying doses of #molnupiravir (n=218) without an impact of treatment on death.
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Wemple et al. continue their review of oxygen therapy, discussing the acute and chronic indications for oxygen, delivery of supplemental oxygen and its potential adverse effects and toxicity. #CriticalCare #MedTwitter #MedEd @uwpccm @MGH_PCCM
Review Article: “Oxygen Therapy Part 1 — History, Physiology, and Evaluation,” by Matthew L. Wemple, MD, Kai E. Swenson, MD, and Erik R. Swenson, MD #CriticalCare #PulmTwitter
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Just published: “Meta-Analysis of Glucocorticoids for Covid-19 Patients Not Receiving Oxygen,” by Remo Daniel Covello, MD, @giovannilandoni, et al. Read the Original Article: #IDTwitter #ARDS #CriticalCare.
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Original Article: “Parenteral Vitamin C in Patients with Severe Infection: A Systematic Review,” by @ArnavAgarwalMD et al. #VitaminC #CriticalCare #MedTwitter @McMasterGIM @MacDeptMed @machealthsci @McMasterU
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NEJM Evidence welcomes Michael Fralick, MD, PhD, to the editorial board. @FralickMike is an assistant professor and clinician scientist @UofT_DoM, general internist @SinaiHealth and @SaultAreaHosp and, as a true Canadian, once had dreams of being a professional hockey player 🍁
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Presented at #AHA23:. “Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure” by Stefan James, MD, PhD, et al.: . @AHAScience #cardiology
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Stats, STAT! Watch this animated video that explores the basis for non-inferiority trials, the meaning of non-inferiority margins, and the interpretation of a non-inferiority trial’s results. #MedEd #ClinicalTrials
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Durvalumab plus a single dose of tremelimumab increased overall survival by just over 2.5 months in patients with unresectable hepatocellular carcinoma who had not received previous systemic therapy. Read more about the HIMALAYA trial by @GABOUALFA et al.:
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Stats, STAT! This animated video reviews the problem of multiple comparisons in clinical trials and explains how performing multiple statistical hypothesis tests can produce associations simply by chance. #MedStats #ClinicalTrials #MedTwitter
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Four pts who developed shortness of breath, chest pain, and mild progressive airway obstruction with #ecigarette use had lung biopsies. Small airway-centered fibrosis, including constrictive bronchiolitis and MUC5AC overexpression, was seen in all pts.
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“Intestinal ischemia can result from various pathologic conditions that lead to one of three basic mechanisms: inadequate delivery, high intestinal transmural pressure, or inadequate outflow.” Full review: . #Surgery #CriticalCare
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Many individuals fall short of their biological need for sleep many nights of the week.️ In this article, the authors review the architecture of sleep, evidence for sleep health & strategies for improving sleep health. 🔗 @harvardsleepmed @rebeccasrobbins
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Researchers perform an individual patient data meta-analysis of TTM and TTM2 trials of hypothermia after cardiac arrest and find no difference in 6-month mortality with hypothermia to 33°C versus normothermia. #CardioTwitter #CriticalCare #MedTwitter
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Theodore et al. provide an overview of intestinal anatomy and the pathophysiology and etiology of intestinal ischemia. Read the full review: #Surgery #CriticalCare
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In this double-blind RCT of adults with heart failure and a defibrillator, the SGLT2i ertugliflozin led to an ~80% relative risk reduction of VTach/VFib. 💊👩🔬 Full article by @MartinBene1994 et al.: . @HaraldSou @DanielScherr3
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"This review covers the epidemiology of #OUD (opioid use disorder) and its common complications, screening and diagnosis, treatment, and #HarmReduction interventions to reduce the negative consequences of ongoing opioid use." - @DrSarahWakeman #EBM
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ICYMI Balanced Crystalloids versus Saline in Critically Ill Adults — A Systematic Review with Meta-Analysis (#PLUS trial). @NaomiHammond @GeorgeInstitute #CriticalCare #ClinicalTrials
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“. it is important to recognize that the fluctuations mediated by changes in intraglomerular pressure in the context of decongestion may not represent true kidney injury. ” Read the review by @KevinBryanLo and @RangaswJ: #NephTwitter #CardioTwitter
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“Our analyses … provide contemporary evidence that cessation of smoking at any age, but particularly before 40 years of age, is associated with lower excess risk of mortality, both overall and from the major diseases made more common by smoking.”
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In this article, @KevinBryanLo and @RangaswJ review the pathophysiology and management of cardiorenal syndrome with a focus on the assessment of renal venous congestion using biomarkers, imaging and bedside testing. #NephTwitter #CardioTwitter #MedTwitter
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“Use of polymyxins should be limited to cases for which no other active agents exist. They should not be considered an acceptable alternative to novel agents because of cost concerns or any other consideration.” #IDTwitter #CriticalCare #MedTwitter
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This report used data derived and validated from completed randomized phase III trials to demonstrate that an AI-based predictive model could identify pts with predominately intermediate-risk #ProstateCancer who are likely to benefit from short-term androgen deprivation therapy.
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“Despite the strong evidence demonstrating the importance of sleep, many people fall short of sleep health targets.” 🛏 Learn more in a new review by Drs. @rebeccasrobbins and Stuart Quan: . @harvardsleepmed #SleepMedicine
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Just published: “Severe Hyponatremia Correction, Mortality, and Central Pontine Myelinolysis,” by @BetterCallSeeth, M.D., et al. Read the Original Article: @MGHKidneys @MassGeneral.
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In this editorial, Armando Teixeira-Pinto, PhD, discusses key points that should be considered when designing randomized discontinuation trials: noninferiority versus superiority design, cointervention bias, and follow-up time. #ClinicalTrials #MedTwitter
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“There is ample evidence of the relationship of influenza to triggering cardiovascular events and on the effectiveness of influenza vaccine in preventing this.” 📋 Read the full editorial: . #Cardiology #IDTwitter
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"The Evidence for Exercise in Medicine-A New Review Series," by @JSawallaGusehMD, Daniel Lieberman, PhD, and Aaron Baggish, MD, now available. #CardioTwitter #EBM #MedTwitter @MGHHeartHealth @MassGeneralNews @HarvardMed @HarvardHEB.
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“. diagnosis of LTBI [latent TB infection] is clouded by areas of uncertainty intrinsic to LTBI diagnostic tests and the heterogeneity in how TB manifests across individuals.” Dr. Carpenter and @tbold take on this challenge in this #CurbsideConsult.
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“What started as an open question in the mind of a frightened trainee became, two decades later, the WATERFALL trial – an international multicenter randomized controlled trial that showed that aggressive fluid therapy is detrimental in acute pancreatitis.”
Our dream comes true: the #WATERFALLtrial has been published in @NEJM Aggressive fluid resuscitation in acute pancreatitis is not safe & does not improve outcomes #GItwitter #SomosAEG @aegastro .What's behind this publication?.It all started 21 years ago.
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This #RCT evaluated infliximab withdrawal in pts with #Crohns disease in remission on infliximab maintenance therapy. Time to relapse was significantly shorter among patients who discontinued IFX than those who continued therapy. #GITwitter #MedTwitter
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How do investigators know how many participants to enroll in #ClinicalTrials? This animated video explains the considerations behind statistical power. Watch the full video: . #MedEd
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In this series, @LidaHariri et al. associate the histopathologic pattern of small airway-centered fibrosis, including constrictive bronchiolitis, with vaping; potentially defining a clinical and pathologic entity associated with #ecigarette use.
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In this review article in the NEJM Group series on #ClimateChange, Keswani and colleagues review the linkages between climate change and #AirPollution and suggest strategies that clinicians may use to mitigate the adverse health impacts of air pollution.
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Pts with BCG-unresponsive carcinoma in situ and papillary non–muscle-invasive #BladderCancer treated with BCG and a novel IL-15 superagonist achieved a complete response rate of 71% meeting the trial’s primary endpoint. #NMIBC #OncoTwitter @UCLAHealth
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Drinking more water could slow the progression of #PolycysticKidneyDisease. Patients assigned to drink more water successfully increased their intake by ~600 ml per day over control patients, but there was no slowing of kidney disease. #KidneyWk #ADPKD
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"Clinical research is a really complex game. We're going to help readers understand how #ClinicalTrials are put together, run, and analyzed." Check out the welcome video from our editors:
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Durvalumab, with gemcitabine plus cisplatin, increased median overall survival, 12.8 months versus 11.5 months, in patients with previously untreated unresectable, recurrent or metastatic biliary tract cancer. #OncTwitter #MedTwitter #Cholangiocarcinoma
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Review Article: “Immune Modulation in Sepsis, ARDS, and Covid-19 — The Road Traveled and the Road Ahead,” by @LeligdowiczA, @Michael_Harhay, and Carolyn S. Calfee, MD, MAS. #ARDS #CritCare #Immunotherapy @SchulichMedDent @WesternU @PennMedicine @ucsfccm
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In the first of a new series of articles on varying facets of diagnosis, the authors discuss considerations that should be given to the performance of a diagnostic test for individual clinical management or a population’s health outcomes. Read now:
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GDMT is the cornerstone of treatment for #HFrEF, but therapy is often hampered by low BPs or labile renal function. This #CurbsideConsult reviews these challenges to safely delivering maximal therapy. #CardioTwitter @laurenggilstrap @DHHeartVascular
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Physical activity is a powerful tool to improve health. @MeaganWasfy and I-Min Lee, MBBS, ScD, review the evidence supporting a relationship between physical activity and health outcomes, including mortality, and discuss the optimal dose. #CardioTwitter
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E-cigarettes have been promoted as less harmful than cigarettes. @ProfGlantz et al. provide a meta-analysis evaluating associations between current e-cigarette use or dual e-cigarettes and cigarette use and disease outcomes. Read the full article:
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Differences in the effectiveness of treatments across participants in a clinical trial are important to understand when deciding how to apply trial results to clinical practice. Learn more in the latest Stats, STAT! video:
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Just published: "Smoking Cessation and Short- and Longer-Term Mortality" by Eo Rin Cho, PhD, Ilene K. Brill, MPH, @IngerGram, MD, Patrick E. Brown, PhD, and Prabhat Jha, MD #PublicHealth
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📢 New article series: Diagnostic Evidence . The first article in the series describes challenges in assessing diagnostic performance and some of the key approaches to gathering evidence that meet these challenges. Read it now:
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Review Article: “Extracorporeal Support for Acute Respiratory Distress Syndrome in Adults,” by @laveenamunshi, Daniel Brodie, MD, and @efan75. #MedTwitter #PulmTwitter #ARDS @ccmtoronto @UofT @uoftmedicine @ihpmeuoft @ColumbiaCCM @ColumbiaPS @nyphospital
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.@LeligdowiczA et al. consider the history and future of immunomodulating therapies in sepsis and #ARDS and explore the larger challenge of clinical research on therapies for syndromes with profound clinical and biologic heterogeneity. #CritCare
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During a clinical trial, it may become evident that there is little chance that the hoped-for effect will be demonstrated, and the trial is stopped early. This review examines the issues faced by a DSMB in such settings. #ClinicalTrials #MedStats
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“It is important to distinguish between hypoxia and hypoxemia. Hypoxia denotes insufficient oxygen at the cellular level, and hypoxemia refers to reduced blood oxygen content caused by a low arterial partial pressure of oxygen….” #CriticalCare.
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Many formerly deadly diseases are now chronic conditions with multiple non-fatal clinical events. The authors describe a simple, and clinically useful, statistical approach to this problem that is a straightforward extension of the mean survival time.
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🗣️ New clinical trial: Compared to aspirin alone, rivaroxaban + aspirin significantly improves walking distance in high-risk patients with peripheral artery disease who have intermittent claudication. 1/2
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In this systemic review and meta-analysis on early mobilization in the ICU, Paton et al. find no significant effect on days alive and out of hospital. However, they find a possibility that it might increase mortality and adverse events. #CriticalCare
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Hospitals commonly implement contact precautions to reduce transmission of MRSA, but recent studies have challenged the effectiveness of this strategy. Drs. Suellen Li and Molly Paras review the evidence.
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Compared to the International Prognostic Scoring System-Revised (IPSS-R), the IPSS-Molecular (IPSS-M) improved prognostic discrimination across all clinical endpoints, and re-stratified 46% of the 2,678 pts evaluated. @Elsa2Bernard #MDSsm #MDS #EHA2022
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Ever been confused about non-inferiority trials? Watch this explanation of Stats, STAT! #MedStats #MedEd #MedTwitter.
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Original Article: "Exercise during Hemodialysis in Patients with Chronic Kidney Failure," by Kirsten Anding-Rost, MD, et al. #NephTwitter #CKD #ClinicalTrials @ProfessorHalle @TU_Muenchen @UniCologne @UKKoeln @dzhk_germany @Uniklinik_Fr.
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This #RCT examined the use of rivaroxaban to reduce risk of venous thromboembolism (VTE) in pts with non-cirrhotic chronic portal vein thrombosis (PVT). Daily rivaroxaban reduced incidence of VTE and did not increase major bleeding events. #LiverTwitter
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“Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery,” an Original Article by @DLBHATTMD, et al., is now available. @BrighamWomens #CardioTwitter
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Just published: "Determinants of Effect of Extracorporeal CO2 Removal in Hypoxemic Respiratory Failure," by @jdianti, MD, @ecgoligher, MD, PhD, et al. #CriticalCare #MedTwitter #ClinicalTrials #MedEd.
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In 2020, nearly 10 million US adolescents met diagnostic criteria for a substance use disorder (SUD). @DrKMSimon et al. review the most recent published data on adolescent SUD and the implications for clinical practice.
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“. in this post hoc analysis of. the DAPA-CKD trial. dapagliflozin treatment was associated with an increase in hematocrit, with correction of anemia in patients with anemia at baseline, and with a lower risk of anemia in patients without anemia at baseline.”. #NephTwitter.
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Management of anticoagulant or antiplatelet drugs for patients who require a surgery or invasive procedure is a common clinical problem. James Douketis, MD, and @AlexSpyropoul, MD, provide an evidence-based approach to managing anticoagulation in the perioperative setting. #VTE.
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In this systematic review, intensive glucose control in critically ill patients did not reduce mortality but significantly raised severe hypoglycemia risk. No patient subgroup benefited from this approach. Read the full article: . @georgeinstitute
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NEJM Evidence welcomes Fola May, MD, PhD, MPhil, to the editorial board. @drfolamay is an assistant professor and quality director with the Division of Digestive Diseases @UCLAHealth, staff physician @LosAngelesVA, and advisor @Seed_Global.
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“Intensive glucose control was not associated with reduced mortality risk but increased the risk of severe hypoglycemia. We did not identify a subgroup of patients in whom intensive glucose control was beneficial.” Read the full results: @georgeinstitute
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“Video-Assisted Thoracoscopic or Open Lobectomy in Early-Stage #LungCancer (VIOLET trial),” an Original Article by @ekslim et al., now available. #VATS #OncoAlert
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In a case series of 101 patients from Japan with newly diagnosed Type 2 Diabetes Mellitus, about half the patients had elevated rates of metabolic insulin clearance. These data could describe a novel endotype of #T2DM. #CardioTwitter #EndoTwitter
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“Harm-to-Benefit of Three Decades of #ProstateCancer Screening in Black Men,” an Original Article by @SBasourakos et al. #PCSM #UroSoMe @WCMUrology @jeshoag @CaseUrology @nyphospital @Chris_Barbieri1 @jimhumd @fredhutch @UMichUrology @DrSpratticus
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In 2 RCTs of pts with recurrent vulvovaginal candidiasis, treatment with Oteseconzole significantly lowered the average percentage of pts with a recurrent episode and increased mean time to recurrence among those who did experience recurrent infection.
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#CurbsideConsult: “How Do I Optimize Heart Failure Medications for Patients with Hypotension or Chronic Kidney Disease?,” by @laurenggilstrap and Amanda R. Vest, MBBS, MPH. #HFrEF #CardioTwitter @DHHeartVascular @DartmouthHealth @DHMCandClinics
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"This review provides an evidence-based but practical approach to common clinical scenarios involving patients who require an elective surgery/procedure and are receiving either a vitamin K antagonist, a direct oral anticoagulant, or single or dual antiplatelet therapy.”. #VTE.
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Stats, STAT! Watch this animated video that explores the basis for non-inferiority trials, the meaning of non-inferiority margins, and the interpretation of a non-inferiority trial’s results. #MedEd #StatsSTAT #MedTwitter
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Glucocorticoids have been evaluated as a therapy for septic shock for 50+ years. Still, uncertainty persists about their effects on mortality. @pirracchior, @DjillaliAnnane, et al. undertake a patient-level meta-analysis to answer this question. #CriticalCare #Sepsis #ICU.
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“Early Surgery or Exercise and Education for Meniscal Tears in Young Adults (DREAM),” an Original Article by @STSkou et al., now available in the second issue of @NEJMEvidence. @SyddanskUni @SUND_SDU #OrthoTwitter #RCT #SurgTwitter
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There is a subset of pts who develop severe #ARDS for whom mechanical ventilation within the current standard of care may not be possible. @laveenamunshi et al. review the use of ECMO for these pts. #MedTwitter #PulmTwitter @efan75 @ccmtoronto @UofT
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