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Sedentary During the Week, but Active on the Weekend … Is the Weekend Warrior Pattern of Activity a Good Recommendation?
No full textFrequency of Preconception and Prenatal Cannabis Use and Nausea and Vomiting in Pregnancy
No full textThis cross-sectional study analyzed associations between preconception and prenatal cannabis use and first-trimester nausea and vomiting in pregnancy (NVP) using data from 356,343 pregnancies in a large health care system (2011-2022). Prevalence of preconception and prenatal cannabis use was 11.3% (2.7% daily, 2.4% weekly, 6.3% monthly or less) and 6.5% (0.7% daily, 0.7% weekly, 1.4% monthly or less, 3.7% positive toxicology with no self-reported use), respectively. Based on International Classification of Diseases diagnostic codes, 3.6% of patients were diagnosed with severe NVP and 16.0% with mild NVP. Self-reported preconception daily cannabis use was associated with greater odds of mild (adjusted odds ratio [aOR] 1.68, 95% CI, 1.59-1.77) and severe (aOR 2.61, 95% CI, 2.40-2.84) NVP when compared with individuals without preconception use. Self-reported weekly cannabis use was associated with greater odds of mild (aOR 1.26, 95% CI, 1.19-1.34) and severe (aOR 1.73, 95% CI, 1.57-1.90) NVP compared with no preconception use. Similarly, self-reported prenatal daily cannabis use was associated with greater odds of mild (aOR 1.97, 95% CI, 1.79-2.17) and severe (aOR 3.80, 95% CI, 3.28-4.39) NVP compared with no prenatal use. Self-reported weekly cannabis use was associated with greater odds of mild (aOR 1.85, 95% CI, 1.68-2.03) and severe (aOR 2.87, 95% CI, 2.47-3.34) NVP compared with individuals without prenatal use. This study found that preconception and prenatal cannabis use were associated with increased odds of both mild and severe NVP during the first trimester, with the highest odds observed among individuals using cannabis daily before or during early pregnancy. Findings underscore the need for patient education and medically appropriate therapies for NVP management
Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials
No full textINTRODUCTION: A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).
OBJECTIVE: To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.
DESIGN, SETTING, AND PARTICIPANTS: This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.
INTERVENTIONS: Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.
MAIN OUTCOMES AND MEASURES: The coprimary efficacy outcomes were (1) proportion of participants with Investigator\u27s Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.
RESULTS: Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P \u3c .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P \u3c .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; P = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; P \u3c .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P \u3c .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P \u3c .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P \u3c .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P \u3c .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.
CONCLUSIONS AND RELEVANCE: In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.
TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT05296629 and NCT05343455
Validation of the Termination of Resuscitation Rules in Detroit
No full textBackground and objective The termination of resuscitation (TOR) criteria - which recommends termination when a non-traumatic arrest in an adult is unwitnessed by emergency medical services (EMS), no shocks are administered, and no return of spontaneous circulation (ROSC) occurs - guide physicians in determining the viability of continuing cardiopulmonary resuscitation (CPR) and transporting patients to the hospital. We examined the level of compliance with the current basic life support (BLS) TOR rule and assessed alternative sets of rules to retrospectively derive improved TOR guidelines for out-of-hospital cardiac arrests (OHCA) in Detroit. Methods This was a retrospective study involving non-traumatic OHCA cases in Detroit from January 1, 2017, to December 31, 2019, which spans the time frame before and after the BLS TOR rule was officially implemented (June 1, 2018). Data were extracted from the Detroit Cardiac Arrest Registry (DCAR). Patients younger than 18 years of age, those with arrests of traumatic origin, or those with no resuscitation attempted were excluded. Results A total of 1,306 individuals were included in our analysis: 656 OHCA cases before the implementation of the BLS TOR rule in Detroit and 650 OHCA after the implementation. BLS TOR criteria were applied to the pre-TOR implementation data with a resulting specificity of 79% (95% CI: 50.7-80.8) and positive predictive value (PPV) of 97.3% (95% CI: 95.5-98.6). Survival to hospital discharge when termination was recommended was projected at 2.9% (13/444). The overall transportation rate was 85% (559/656). Post-TOR implementation, specificity was 88.9% (95% CI: 78.6-99.1) and PPV was 99.1% (95% CI: 98.3-99.9). Survival to hospital discharge was 0.88% (4/453) with a 69% (451/650) overall transportation rate. Post-hoc addition of age or EMS time to the patient side increased transportation rates to 81% (529/650) and 88% (571/650), respectively, and decreased false positive terminations to 0.84% (2/237) and 0% (0/148), respectively. Conclusions Overall survival and futile transportation rates decreased when TOR was applied since the implementation of the BLS TOR rule in Detroit. The addition of EMS time to the patient side or patient age to current TOR guidelines suggested improved performance. Although the additional criteria resulted in higher transportation rates, these factors may be useful for physicians to consider when deciding to transport patients. However, further derivation and validation are needed to create optimal TOR guidelines
A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes
No full textBACKGROUND: Automated insulin delivery (AID) systems have been shown to be beneficial for patients with type 1 diabetes, but data are needed from randomized, controlled trials regarding their role in the management of insulin-treated type 2 diabetes.
METHODS: In this 13-week, multicenter trial, adults with insulin-treated type 2 diabetes were randomly assigned in a 2:1 ratio to receive AID or to continue their pretrial insulin-delivery method (control group); both groups received continuous glucose monitoring (CGM). The primary outcome was the glycated hemoglobin level at 13 weeks.
RESULTS: A total of 319 patients underwent randomization. Glycated hemoglobin levels decreased by 0.9 percentage points (from 8.2±1.4% at baseline to 7.3±0.9% at week 13) in the AID group and by 0.3 percentage points (from 8.1±1.2% to 7.7±1.1%) in the control group (mean adjusted difference, -0.6 percentage points; 95% confidence interval [CI], -0.8 to -0.4; P\u3c 0.001). The mean percentage of time that patients were in the target glucose range of 70 to 180 mg per deciliter increased from 48±24% to 64±16% in the AID group and from 51±21% to 52±21% in the control group (mean difference, 14 percentage points; 95% CI, 11 to 17; P\u3c 0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia that were measured were significantly better in the AID group than in the control group. The frequency of CGM-measured hypoglycemia was low in both groups. A severe hypoglycemia event occurred in one patient in the AID group.
CONCLUSIONS: In this 13-week, randomized, controlled trial involving adults with insulin-treated type 2 diabetes, AID was associated with a greater reduction in glycated hemoglobin levels than CGM alone. (Funded by Tandem Diabetes Care; 2IQP ClinicalTrials.gov number, NCT05785832.)
Agile 3+ and 4 Scores Accurately Predict Major Adverse Liver Outcomes, Liver Transplant, Progression of MELD Score, the Development of Hepatocellular Carcinoma, and Death in NAFLD
No full textBACKGROUND AND AIMS: Based on liver stiffness measurement by vibration controlled transient elastography (LSM by VCTE), the Agile 3+ and 4 are novel noninvasive scores that accurately identify advanced fibrosis (≥ F3) and cirrhosis (F4), respectively. We investigated and compared the Agile 3+ and 4 scores\u27 performances in predicting adverse events to LSM alone, FIB-4 and Fibroscan-AST (FAST) score.
METHOD: This retrospective analysis included NAFLD patients with LSM by VCTE and laboratory testing from a tertiary care center from 2013 to 2022. Adverse events were defined as major adverse liver outcomes (MALO), hepatocellular carcinoma, liver transplant, and death. MALO was defined as ascites, hepatic encephalopathy, or esophageal variceal bleeding. We used the Cox proportional hazard rate model and the Harrell\u27s concordance (C) statistic to compare predictive performances.
RESULTS: 733 total subjects with median follow-up of 27.0 months were included. Average age was 58.1 years and 32.8% had type 2 diabetes. Average alanine aminotransferase was 46.6 IU/L, aspartate aminotransferase: 34.5 IU/L, albumin: 4.4 g/dL, and platelets: 241.1 × 10(9)/L. Fourteen subjects had 21 adverse outcomes, including 10 MALO, 5 HCC, 4 liver transplants, 3 progression of MELD score, and 6 deaths. Agile 3+ and 4 respectively had the highest C stats of 0.911 (C stat SE 0.028) and 0.909 (C stat SE 0.029) compared to LSM (C stat 0.857, C stat SE 0.045), FIB-4 (C stat 0.843, C stat SE 0.037) or FAST (C stat 0.703, C stat SE 0.085).
CONCLUSION: The Agile 3+ and 4 scores had the highest likelihood of accurately predicting adverse outcomes including MALO and death compared to LSM alone, FIB-4 or FAST score
Reply to \u27Incorporating genetic variations in alcohol-associated liver disease trials for East Asian populations\u27
No full textClinical Spectrum of Toxocariasis: A Retrospective Study From a Tertiary Care Center in Lebanon
No full textAIMS: Toxocariasis is a prevalent zoonotic disease worldwide caused primarily by Toxocara canis and Toxocara cati. Despite its prevalence, studies focusing on clinical manifestations, and laboratory findings of toxocariasis in the Middle East North African (MENA) region are limited, highlighting a significant gap in research. The aim of this study is to describe the spectrum of toxocariasis observed at a tertiary center in Lebanon and review the geographic distribution of infected individuals and their demographics.
METHODS: The medical records of 225 patients who tested positive for Toxocara IgG via ELISA between 2002 and 2022 at the American University of Beirut Medical Center (AUBMC) were reviewed.
RESULTS: 141/225 patients had confirmed positive Toxocara-specific IgG by Western blot. These patients were mostly middle-aged, with a mean of 46 years and predominantly males. Most were Lebanese (95.3%), residing in Mount Lebanon or Beirut governates. Patients were mainly symptomatic (78.5%), and the most common presenting symptoms were neurological complaints. For those with Toxocara myelitis (23 patients), spine magnetic resonance imaging (MRI) findings showed focal lesions (54.5%) mostly at the thoracic vertebrae.
CONCLUSIONS: Given the challenges associated with diagnosing this disease, further studies are essential to enhance our understanding of toxocariasis in the region. Toxocariasis is a common parasitic disease caused by Toxocara worms. These worms infect dogs and cats. Our study looked at the cases of toxocariasis at a hospital in Lebanon between 2002 and 2022 and reported 141 cases. Most patients (78.5%) had symptoms on presentation, with many complaining of neurological symptoms including headache, numbness or weakness. Among these patients, 23 had signs of infection in their spine. The majority of the infected patients were Lebanese (95.3%) and lived in specific areas of Lebanon. Because diagnosing this disease can be difficult, more research is needed to better understand toxocariasis in Lebanon and the wider Middle East and North Africa (MENA) region
A pilot survey into the landscape of neuro-oncology care in the community
No full textBACKGROUND: The complexities of the field of neuro-oncology require multidisciplinary collaboration in order to deliver contemporary comprehensive care. There is increasing awareness that much of neuro-oncology care occurs in the community setting. In 2022, the Society for Neuro-Oncology (SNO) created the Community Neuro-Oncology Committee (CNO) in an inaugural attempt to formally acknowledge community neuro-oncology practitioners.
METHODS: A 19 question survey was developed by SNO-CNO to gather initial data on the current landscape of neuro-oncology care in the community. The survey was distributed via the SNO newsletter and email blasts as well as through partnerships with multiple advocacy groups. Results were analyzed and tabulated through R2.
RESULTS: There were 112 responses from providers in the United States and Canada. Most providers were physicians and represented multiple disciplines including neurology, neuro-oncology, medical oncology, neurosurgery, and radiation oncology. Sixty-four (57%) described themselves as neuro-oncology-focused. Eighty-eight (79%) reported access to neuro-oncology tumor boards. Sixty-eight (73%) stated they had access to molecular tumor boards. Most respondents felt that they were adequately supported to manage neuro-oncology patients. When dividing responses based on a neuro-oncology-focused practice compared to a less neuro-oncology-focused practice, there were significant differences between access to molecular tumors boards (85% vs 63%, P = .023) and access to clinical trials (98% vs 82%, P = .022).
CONCLUSION: This qualitative and quantitative hypothesis-generating data is the start of understanding the challenges faced by community neuro-oncology providers. These results will guide future studies and recommendations aimed toward better supporting them and their patients
Lung cancer disparities in rural, persistent poverty counties: a secondary data analysis
No full textBACKGROUND: In the US, lung cancer burden is greater in counties that are either rural or in persistent poverty. This study examined lung cancer risk (e.g., smoking), incidence, and mortality across four county types defined by cross-classification of rurality and persistent poverty.
METHODS: We conducted a secondary analysis of county characteristics and lung cancer risk, incidence and mortality. We used data from USDA to classify counties according to rurality (using rural-urban continuum codes) and persistent poverty (i.e., 20% + of residents living below the poverty line for 30 + years). We used publicly-available data to calculate mean county-level prevalence of smoking among adults (in 2019), lung cancer incidence (2015-2019), and lung cancer mortality (2015-2019) across county types. Beta and binomial regression models assessed differences in smoking, lung cancer incidence, and lung cancer mortality by rurality and persistent poverty.
RESULTS: Among U.S. counties, 1,115 were urban, non-persistent poverty, 1,675 were rural, non-persistent poverty, 52 were urban, persistent poverty, and 301 were rural, persistent poverty. Smoking, lung cancer incidence, and lung cancer mortality were higher in rural counties and in persistent poverty counties than in their comparison counties. Counties that were both rural and persistent poverty had the highest rates of smoking, lung cancer incidence, and lung cancer mortality. Persistent poverty and rurality interacted in their relationship with smoking prevalence (p \u3c 0.01), and lung cancer mortality (p \u3c 0.10).
CONCLUSIONS: Smoking, lung cancer incidence, and lung cancer mortality are highest in counties that are both rural and persistent poverty, suggesting an urgent need to develop targeted lung cancer interventions in these communities