Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.

BACKGROUND: Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy. OBJECTIVE: The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP < 180 and DBP < 110 mm Hg and patients on monotherapy with SBP < 160 and DBP < 100 mm Hg. METHODS/DESIGN: QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care. DISCUSSION: QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.

Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA).

BACKGROUND: This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management. METHODS AND RESULTS: A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews. At enrollment, 68% of participants (mean [SD] age, 51.7 [11.5] years; 56% self-identified as Hispanic: Mexican ethnicity, 16% as Hispanic: other ethnicity, 16% as Black race, 8% as White race, and 1.6% as South Asian race) reported that their current health depended on blood pressure medications, and 48% were concerned about blood pressure medications. At trial completion, 80% were satisfied with LDQT, 96% were certain the benefits of taking LDQT outweighed the disadvantages, and 96% reported that LDQT was convenient to take. Both patients and health care professionals found LDQT acceptable because it reduced patients' perceived pill burden and facilitated medication adherence. Health care professionals stated that a perceived limitation of LDQT was the inability to titrate doses. Steps to facilitate LDQT implementation include introducing stepped-care combinations and treatment protocols, inclusion in clinical practice guidelines, and eliminating patient cost barriers. CONCLUSIONS: LDQT was an acceptable strategy for hypertension treatment among patients and health care professionals involved in the QUARTET USA clinical trial. Although LDQT was generally perceived as beneficial for maintaining patients' blood pressure control and facilitating adherence, some clinicians perceived limitations in titration inflexibility, adverse effects, and costs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03640312.

Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes.

PURPOSE: Examine a clinic-based approach to improve food security and glycemic control among patients with diabetes. DESIGN: One-group repeated-measures design. SETTING: Federally Qualified Health Centers in a large Midwest city. SAMPLE: Of the 933 patients with diabetes who consented at baseline, 398 (42.66%) returned during the follow-up period for a visit that included Hemoglobin A1c (HbA1c) results. INTERVENTION: Integrated social medicine approach that includes food insecurity screening, nutrition education, and assistance accessing food resources as a standard-of-care practice designed to minimize disruptions in how patients and providers experience medical care. MEASURES: HbA1c collected as part of a standard blood panel. ANALYSIS: Repeated-measure, mixed-effect linear regression models. RESULTS: There was a decrease in mean HbA1c (Δ = -0.22, P = 0.01) over the study period. The model examining change over time, glycemic control (GC), and food security status (F1, 352 = 5.80, P = 0.02) indicated that among participants with poor GC (33.12%), food secure (FS) participants exhibited significantly greater levels of improvement than food insecure (FI) participants (Δ = -0.55, P = 0.04). Among participants with good GC, changes in HbA1c were not significantly different between FS and FI participants (Δ = 0.23, P = 0.21). CONCLUSION: Providing nutrition education and food assistance improved HbA1c profiles among FS and FI participants, but FI participants may face social and structural challenges that require additional support from health care teams.

Takayasu arteritis presenting as postpartum cardiomyopathy.

A case of Takayasu arteritis (TA) presenting as postpartum cardiomyopathy in a puerperal 26-year-old Hispanic female patient is presented. TA is a large-vessel vasculitis affecting young to middle-aged women. TA can result in cardiomyopathy as a direct result of myocardial involvement. The patient had classical clinical and radiographic findings of TA that were previously undiagnosed. She had rapid functional improvement with corticosteroids. The importance of a thorough physical examination of peripheral pulses is stressed in all patients, especially in those with cardiomyopathy.

A Multipronged Initiative to Improve Productivity and Patient Access in a Federally Qualified Health Center Network.

In 2012, Access Community Health Network, a Federally Qualified Health Center (FQHC) network with 36 health centers serving the greater Chicago area, embarked on a 3-year initiative to improve patient access. "Dramatic Performance Improvement" (DPI) included the adoption of modified open access scheduling and practice changes designed to improve capacity and the ability to balance supply and demand. This article describes DPI implementation, strategies, and associated outcomes, including a 20% decrease in no-show rate, a 33% drop in time to the third next available appointment (TNAA), a 37% decrease in cycle time, and a 13% increase in patient satisfaction.

Ceftazidima/avibactam frente a otros antimicrobianos para el tratamiento de bacteriemias por Enterobacterales productores de carbapenemasa KPC: datos de la vida real en un hospital universitario de Argentina / Ceftazidime/avibactam versus other antibiotics for the treatment of KPC carbapenemase-producing Enterobacterales bacteremia: real-life data from a university hospital in Argentina

INTRODUCCIÓN: Las bacteriemias por Enterobacterales productores de carbapenemasa KPC (EPC-KPC) presentan una mortalidad elevada y opciones terapéuticas limitadas. OBJETIVOS: Describir y comparar la evolución de los pacientes con bacteriemia por EPC-KPC tratados con ceftazidima/avibactam (CA) frente a otros antimicrobianos (OA). PACIENTES Y MÉTODOS: Estudio prospectivo y retrospectivo de casos y controles. Se incluyeron pacientes adultos con bacteriemia por EPC-KPC, con una proporción entre casos tratados con CA y controles tratados con OA. de 1:2. Se analizaron variables clínicas, epidemiológicas y de evolución. RESULTADOS: Se incluyeron 48 pacientes (16 CA y 32 OA). Los casos se encontraban más frecuentemente neutropénicos (50 vs.16%, p = 0,012); asimismo, presentaron medianas de score de APACHE II más altas y de score de Pitt más bajas. El 65% de la cohorte total presentó un foco clínico y Klebsiellapneumoniae fue el microorganismo más frecuentemente aislado. Los casos recibieron una mayor proporción de tratamiento antimicrobiano empírico adecuado (81 vs. 53%, p = 0,05). La antibioterapia dirigida en casos y controles fue combinada en 38 y 91%, p = 0,009. Los casos presentaron menor mortalidad al día 7 y al día 30 relacionada a infección (0 vs. 22%, p = 0,04 y 0 vs. 34%, p = 0,008). Solo los controles desarrollaron shock, ingresaron a la unidad de cuidados intensivos y presentaron bacteriemia de brecha. CONCLUSIÓN: CA mostró beneficio clínico frente a OA para el tratamiento de pacientes con bacteriemia por EPC-KPC.

BACKGROUND: KPC-producing Enterobacterales bacteremia (KPCCPE) is associated with a high mortality rate and limited therapeutic options. AIM: To describe and compare the outcome of patients with KPC-CPE bacteremia treated with ceftazidime/avibactam (CA) versus other antibiotics (OA). METHODS: Prospective and retrospective cases and control study performed in adult patients with KPC-CPE bacteremia, with a 1:2 ratio between cases treated with CA. and controls treated with OA. Clinical, epidemiological, and outcome variables were analyzed. RESULTS: Forty-eight patients (16 CA and 32 OA) were included. Cases were more frequently neutropenic (50 vs. 16%, p = 0.012), presented higher median APACHE II score and lower Pitt score. Of the total cohort, 65% had a clinical source, and Klebsiella pneumoniae was the most frequently isolated microorganism. Cases received more adequate empirical antibiotic treatment (81 vs. 53%, p = 0.05). Targeted antibiotic therapy in cases and controls was combined in 38 and 91%, p = 0.009. Cases had a lower 7-day mortality and 30-day infection-related mortality (0 vs. 22%, p = 0.04 and 0 vs. 34%, p = 0.008). Only controls developed shock, were admitted to the intensive care unit, and had breakthrough bacteremia. CONCLUSION: CA. showed clinical benefit over OA in the treatment of patients with EPC-KPC bacteremia.

Manejo de la temperatura en el perioperatorio y frecuencia de hipotermia inadvertida en un hospital general / Temperature management during the perioperative period and frequency of inadvertent hypothermia in a general hospital

Introducción: La hipotermia perioperatoria está asociada con mayor morbimortalidad, por lo que la temperatura del paciente quirúrgico debería ser una preocupación fundamental; sin embargo, es el parámetro fisiológico menos valorado. Objetivos: Evaluar el manejo de la temperatura en el perioperatorio, determinar la frecuencia de hipotermia inadvertida y los factores relacionados. Material y métodos: Estudio prospectivo observacional en pacientes adultos programados para procedimiento quirúrgico con tiempo > 30 min de anestesia. La hipotermia se definió como una temperatura de la piel de la frente <35,9°C. Se planteó la hipótesis nula de no diferencia entre los pacientes con normotermia e hipotermia. La comparación de las variables cuantitativas fue analizada con la prueba t de Student y las cualitativas con la prueba del Chi cuadrado, y después se realizó un análisis de regresión logística. Resultados: Se incluyeron 167 pacientes consecutivos; la monitorización intraoperatoria de la temperatura se usó en el 10% de los pacientes, el uso de líquidos intravenosos tibios y calentamiento con aire forzado en el 78 y el 63%, respectivamente. La frecuencia de hipotermia inadvertida fue del 56,29%, asociada a edad > 65 años, sexo femenino e índice de masa corporal >30kg/m². Esta última variable podría estar influenciada por el método de medición de la temperatura. Conclusiones: Las medidas de calentamiento sin monitorización de la temperatura no tienen el efecto esperado. La frecuencia elevada de hipotermia inadvertida hace necesaria una guía de actuación de prevención y manejo en especial en pacientes de riesgo, que en este estudio fueron edad > 65 años y sexo femenino.

Introduction: Perioperative hypothermia is associated with increased morbidity and mortality. Consequently, surgical patient temperature should be the fundamental concern but, nonetheless, it is still the least valued physiological parameter. Objectives: To assess temperature management during the perioperative period and determine the frequency of inadvertent hypothermia and related factors. Material and methods: Prospective observational study in adult patients scheduled for surgical procedure with anesthesia time ≥30 minutes. Hypothermia is defined as a forehead skin temperature ≤35.9 ◦C. The null hypothesis of no difference between patients with normothermia and hypothermiawas proposed. Comparison of quantitative variableswas analyzed with the Student “t” test, and the Chi square was used for the qualitative variables. The analysis was followed by a logistic regression analysis. Results:We included 167 consecutive patients; intraoperative monitoring of temperaturewas used in 10% of patients, and the use ofwarm intravenous fluids and forced air heating in 78% and 63%, respectively. The frequency of inadvertent hypothermia was 56.29%, associated with age ≥65 years, female gender and BMI≥30 kg/m². This last variable might have been influenced by the method of temperature measurement. Conclusion:Warming measures without temperature monitoring do not result in the desired effect. The high frequency of inadvertent hypothermia requires action guidelines for prevention and management, especially in high-risk patients who, in this study, were patients≥65 years of age and females.

Variabilidad cardiaca de cinco minutos. Diferencia entre estudiantes deportistas y sedentarios / Heart rate variability of five minutes

Se llevó a cabo un estudio descriptivo de corte transversal en 37 estudiantes de sexo masculino de la Facultad de Ciencias de la Salud de la Universidad del Cauca en Popayán, Colombia. El grupo se dividió en dos subgrupos de acuerdo a la práctica deportiva o historia de sedentarismo. En los dos grupos de jóvenes se realizó monitoria Holter cardíaca digital de tres canales durante cinco minutos, observando la variabilidad de frecuencia cardíaca en dominio tiempo tomando para el análisis la variable desviación estándar del intervalo NN (SDNN) en milésimas de segundo. La variabilidad se clasificó como baja (menor de 50 mseg), normal (50-75 mseg) y excelente (mayor de 75 mseg). Se encontró una correlación positiva entre el hábito de practicar deporte aeróbico en forma regular y niveles de variabilidad en dominio tiempo normales o excelentes. Se concluyó que la variabilidad cardíaca en dominio tiempo es una variable modificable en edades tempranas y podría representar una estrategia económica y reproducible de evaluación cardiovascular