Early Mortality After the First Dose of COVID-19 Vaccination: A Target Trial Emulation.

BACKGROUND: Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans. METHODS: We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects. RESULTS: We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1). CONCLUSIONS: Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

Development of a Flavor Ingredient Wheel Linking E-Liquid Additives to the Labeled Flavor of Vaping Products.

E-liquids contain combinations of chemicals, with many enhancing the sensory attractiveness of the product. Studies are needed to understand and characterize e-liquid ingredients, particularly flavorings, to inform future research and regulations of these products. We identified common flavor ingredients in a convenience sample of commercial e-liquids using gas chromatography-mass spectrometry. E-liquid flavors were categorized by flavor descriptors provided on the product packaging. A Flavor Ingredient Wheel was developed to link e-liquid flavor ingredients with flavor categories. An analysis of 109 samples identified 48 flavor ingredients. Consistency between the labeled flavor and ingredients used to produce such flavor was found. Our novel Flavor Ingredient Wheel organizes e-liquids by flavor and ingredients, enabling efficient analysis of the link between ingredients and their flavor profiles and allowing for quick assessment of an e-liquid ingredient's flavor profile. Investigating ingredient profiles and identifying and classifying commonly used chemicals in e-liquids may assist with future studies and improve the ability to regulate these products.

Complexity of patients with mental healthcare needs cared for by mental health clinical pharmacist practitioners in Veterans Affairs.

PURPOSE: The complexity of patients with mental healthcare needs cared for by clinical pharmacists is not well delineated. We evaluated the complexity of patients with schizophrenia, bipolar disorder, and major depressive disorder (MDD) in Veterans Affairs (VA) cared for by mental health clinical pharmacist practitioners (MH CPPs). METHODS: Patients at 42 VA sites with schizophrenia, bipolar disorder, or MDD in 2016 through 2019 were classified by MH CPP visits into those with 2 or more visits ("ongoing MH CPP care"), those with 1 visit ("consultative MH CPP care"), and those with no visits ("no MH CPP care"). Patient complexity for each condition was defined by medication regimen and service utilization. RESULTS: For schizophrenia, more patients in ongoing MH CPP care were complex than those with no MH CPP care, based on all measures examined: the number of primary medications (15.3% vs 8.1%), inpatient (13.7% vs 9.1%) and outpatient (42.6% vs 29.7%) utilization, and receipt of long-acting injectable antipsychotics (36.7% vs 25.8%) and clozapine (20.5% vs 9.5%). For bipolar disorder, more patients receiving ongoing or consultative MH CPP care were complex than those with no MH CPP care based on the number of primary medications (27.9% vs 30.5% vs 17.7%) and overlapping mood stabilizers (10.1% vs 11.6% vs 6.2%). For MDD, more patients receiving ongoing or consultative MH CPP care were complex based on the number of primary medications (36.8% vs 35.5% vs 29.2%) and augmentation of antidepressants (56.1% vs 54.4% vs 47.0%) than patients without MH CPP care. All comparisons were significant (P < 0.01). CONCLUSION: MH CPPs provide care for complex patients with schizophrenia, bipolar disorder, and MDD in VA.

Type 1 Diabetes Genetic Risk in 109,954 Veterans With Adult-Onset Diabetes: The Million Veteran Program (MVP).

OBJECTIVE: To characterize high type 1 diabetes (T1D) genetic risk in a population where type 2 diabetes (T2D) predominates. RESEARCH DESIGN AND METHODS: Characteristics typically associated with T1D were assessed in 109,594 Million Veteran Program participants with adult-onset diabetes, 2011-2021, who had T1D genetic risk scores (GRS) defined as low (0 to <45%), medium (45 to <90%), high (90 to <95%), or highest (≥95%). RESULTS: T1D characteristics increased progressively with higher genetic risk (P < 0.001 for trend). A GRS ≥90% was more common with diabetes diagnoses before age 40 years, but 95% of those participants were diagnosed at age ≥40 years, and their characteristics resembled those of individuals with T2D in mean age (64.3 years) and BMI (32.3 kg/m2). Compared with the low-risk group, the highest-risk group was more likely to have diabetic ketoacidosis (low GRS 0.9% vs. highest GRS 3.7%), hypoglycemia prompting emergency visits (3.7% vs. 5.8%), outpatient plasma glucose <50 mg/dL (7.5% vs. 13.4%), a shorter median time to start insulin (3.5 vs. 1.4 years), use of a T1D diagnostic code (16.3% vs. 28.1%), low C-peptide levels if tested (1.8% vs. 32.4%), and glutamic acid decarboxylase antibodies (6.9% vs. 45.2%), all P < 0.001. CONCLUSIONS: Characteristics associated with T1D were increased with higher genetic risk, and especially with the top 10% of risk. However, the age and BMI of those participants resemble those of people with T2D, and a substantial proportion did not have diagnostic testing or use of T1D diagnostic codes. T1D genetic screening could be used to aid identification of adult-onset T1D in settings in which T2D predominates.

Hacia una mayor transparencia y exactitud de los reportes científicos en las revistas biomédicas / Towards enhanced transparency and accuracy of scientific reporting in biomedical journals

Me siento profundamente agradecido por la oportunidad de compartir mis observaciones personales y reflexionar sobre un tema medular en el ámbito médico científico; me refiero a la exactitud y transparencia en la presentación de informes de investigación. El presente artículo no se refiere a las violaciones intencionales de las buenas prácticas de publicación a manera de infracciones científicas o éticas que, lamentablemente se han venido observando cada vez con mayor frecuencia en los últimos años. Los temas que nos ocupan se refieren a la presentación de informes incompletos o inexactos. No se trata de problemas nuevos, sin embargo siguen estando en la palestra y son de gran importancia, ya que con demasiada frecuencia las limitaciones en la presentación de informes comprometen a muchos artículos enviados a revistas biomédicas para su publicación. Descuidos en la presentación de los informes suelen ser la razón por la cual se rechazan artículos. Reconocemos que si un estudio jamás se publica, los resultados no se diseminarán y de hecho el estudio "no existe". El registro obligatorio de estudios clínicos pudiera ser de utilidad para evitar sesgos de publicación. Sin embargo, sin publicación, se habría violado un principio ético fundamental relativo al reclutamiento y aleatorización de los pacientes para un estudio clínico. Un principio rector relacionado con las publicaciones científicas es que para lograr validez externa, los resultados de un experimento (o de un estudio controlado aleatorizado) tienen que ser reproducibles. De manera que con los métodos y los resultados de un estudio clínico descritos en suficiente detalle, un lector conocedor tenga acceso a los datos originales y así podría replicar los resultados.

Uso de estrogênio näo-anticoncepcional e risco de câncer mamário / The use of non anticonceptive estrogens and risk of breast neoplasms

A relaçäo entre o risco de câncer mamário e uso de estrogênios näo-anticoncepcionais foi investigada num estudo hospitalar em 1.610 mulheres com câncer mamário e 1.606 com outras condiçöes. A estimativa do risco relativo global para os estrogênios conjugados, tomados pela primeira vez 18 meses, pelo menos, antes da hospitalizaçäo, em comparaçäo com ausência de uso de quaisquer estrogênios näo-anticoncepcionais foi 0,9 (intervalo de confiança 95% - 0,7 a 1,1). Para outros estrogênios, tomados pelo menos 18 meses antes da hospitalizaçäo, a estimativa foi 0,8 (0,6 a 1,1). Quando levados em conta os fatores conhecidos de câncer mamário, os resultados foram semelhantes. Entre as mulheres pós-menopáusicas, os estrogênios conjugados näo pareceram aumentar o risco de câncer mamário, mesmo quando tomados por muitos anos, no passado distante. Näo houve prova de maior risco devido ao uso de estrogênios conjugados entre os subgrupos de mulheres definidos segundo os vários fatores de risco de câncer mamário. Os resultados deste estudo sugerem que os estrogênios näo anticoncepcionais näo aumentam o risco de câncer mamário