NEJM Evidence, a new journal from NEJM Group, presents innovative
#OriginalResearch
and fresh, bold ideas in
#ClinicalTrial
design and clinical decision-making.
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
“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
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
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
“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
“…‘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:
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
“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.”
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.
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.
“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
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.
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
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
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 🍁
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
Presented at
#AHA23
:
“Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure” by Stefan James, MD, PhD, et al.:
@AHAScience
#cardiology
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.:
Whether thromboprophylaxis prevents symptomatic venous thromboembolism in medically ill, hospitalized older adults remains debated. In this
#RCT
, older adults hospitalized for acute medical conditions were randomized to receive daily enoxaparin or placebo.
#ISTH2023
#VTE
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
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.
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
“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
Theodore et al. provide an overview of intestinal anatomy and the pathophysiology and etiology of intestinal ischemia. Read the full review:
#Surgery
#CriticalCare
"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
“... 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
This RCT tested oral azithromycin vs placebo to reduce recurrent wheeze (RW) in 1-18-month-olds hospitalized with acute severe RSV bronchiolitis. Azithromycin did not reduce occurrence of RW and may increase risk of RW in some groups.
#AAAAI22
#Asthma
#EBM
“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.”
“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
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.
Just published: “Severe Hyponatremia Correction, Mortality, and Central Pontine Myelinolysis,” by
@BetterCallSeeth
, M.D., et al. Read the Original Article:
@MGHKidneys
@MassGeneral
“...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
.
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
“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
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
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.
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
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.
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
"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:
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
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
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:
In this
#RCT
, Devanand et al. compared training with online games vs crossword puzzles in adults with mild cognitive impairment. Over 78 wks, online crossword puzzle training was associated with improved cognition compared to cognitive games.
#Dementia
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
“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
📢 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:
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:
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
Low dose hypomethylating agent therapy led to an overall response rate of 60% in pts with low- or intermediate-risk myelodysplastic syndromes or chronic myelomonocytic leukemia who had not received prior hypomethylating agents.
#MDS
#LeuSM
#CMML
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:
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.
.
@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
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
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
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
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.
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
“...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
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
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.
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
Original Article: Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis by Avraham Beigelman, MD, et al.
@WUSTLPeds
#Asthma
#PedsICU
#EBM
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
.
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.
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
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
"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
“People who are denied abortion and continue unwanted pregnancies have worse financial, health, and family outcomes than those who are not denied this care."
#MFMtwitter
#OBtwitter
In older patients and/or those with comorbidities with untreated
#CLL
, treatment with ibrutinib-venetoclax was superior to chlorambucil-obinutuzumab, with fewer events and longer PFS after just over 2 yrs of follow-up. Read about the GLOW trial:
#LeuSM
NEJM Evidence welcomes Giselle Corbie-Smith, MD, MSc (NAM), to the editorial board.
@gcsmd
is a Kenan Distinguished Professor and the Director of the UNC Center for Health Equity Research.
@uncCHER
@UNCDeptMedicine
@UNC_SOM
“...it is often clear when to start a treatment but not as obvious when to stop it. This uncertainty has particular relevance, for example, in the context of polypharmacy or management of a chronic disease.” Read the editorial by Dr. Teixeira-Pinto:
Protection from
#COVID19
disease and death, during delta spread, by the RNA based vaccine wanes over 6 months, while the protection from the Johnson and Johnson vaccine had lower overall efficacy but the protection was more stable over time.
#IDTwitter
In the DAPA-MI trial, 4017 patients w/ acute MI were randomized to daily dapagliflozin or placebo for 1 year. The analysis of the primary composite outcome resulted in more wins for dapagliflozin than placebo (win ratio, 1.34). Read the full results:
“Supportive data for [long-term oxygen therapy] come from two major studies in patients with hypoxemic COPD. The first is the Nocturnal Oxygen Therapy Trial (NOTT), performed in 1980.... The second, in 1981, is the British Medical Research Council Domiciliary trial....”
#MedEd
This multi-center, placebo-controlled RCT tested MV140, a sublingual preparation of whole-cell inactivated bacteria, in patients with
#RecurrentUTI
. MV140 demonstrated clinical efficacy and improved quality of life, without major adverse events.
@IBSAL_IIS