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BACKGROUND: Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial. METHODS: A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021. Participants were enrolled through acute unscheduled episodic care (AUEC) enrollment location (emergency department, or urgent care clinic visit) compared to minimal contact (MC) enrollment (electronic contact from test center lists of positive patients).We report the primary composite outcome of cardiopulmonary hospitalizations, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic arterial thromboembolism, or death among stable outpatients stratified by enrollment setting, AUEC versus MC. A propensity score for AUEC enrollment was created, and Cox proportional hazards regression with inverse probability weighting (IPW) was used to compare the primary outcome by enrollment location. RESULTS: Among the 657 ACTIV-4B patients randomized, 533 (81.1%) with known enrollment setting data were included in this analysis, 227 from AUEC settings and 306 from MC settings. In a multivariate logistic regression model, time from COVID test, age, Black race, Hispanic ethnicity, and body mass index were associated with AUEC enrollment. Irrespective of trial treatment allocation, patients enrolled at an AUEC setting were 10-times more likely to suffer from the adjudicated primary outcome, 7.9% vs. 0.7%; p < 0.001, compared with patients enrolled at a MC setting. Upon Cox regression analysis adjustment patients enrolled at an AUEC setting remained at significant risk of the primary composite outcome, HR 3.40 (95% CI 1.46, 7.94). CONCLUSIONS: Patients with clinically stable COVID-19 presenting to an AUEC enrollment setting represent a population at increased risk of arterial and venous thrombosis complications, hospitalization for cardiopulmonary events, or death, when adjusted for other risk factors, compared with patients enrolled at a MC setting. Future outpatient therapeutic trials and clinical therapeutic delivery programs of clinically stable COVID-19 patients may focus on inclusion of higher-risk patient populations from AUEC engagement locations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04498273.
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COVID-19 , Accidente Cerebrovascular , Trombosis de la Vena , Humanos , Anticoagulantes/uso terapéutico , Trombosis de la Vena/tratamiento farmacológico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , HospitalizaciónRESUMEN
Importance: Acutely ill inpatients with COVID-19 typically receive antithrombotic therapy, although the risks and benefits of this intervention among outpatients with COVID-19 have not been established. Objective: To assess whether anticoagulant or antiplatelet therapy can safely reduce major adverse cardiopulmonary outcomes among symptomatic but clinically stable outpatients with COVID-19. Design, Setting, and Participants: The ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19. The trial was conducted at 52 US sites between September 2020 and June 2021; final follow-up was August 5, 2021. Prior to initiating treatment, participants were required to have platelet count greater than 100â¯000/mm3 and estimated glomerular filtration rate greater than 30 mL/min/1.73 m2. Interventions: Random allocation in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days. Main Outcomes and Measures: The primary end point was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause. The primary analyses for efficacy and bleeding events were limited to participants who took at least 1 dose of trial medication. Results: On June 18, 2021, the trial data and safety monitoring board recommended early termination because of lower than anticipated event rates; at that time, 657 symptomatic outpatients with COVID-19 had been randomized (median age, 54 years [IQR, 46-59]; 59% women). The median times from diagnosis to randomization and from randomization to initiation of study treatment were 7 days and 3 days, respectively. Twenty-two randomized participants (3.3%) were hospitalized for COVID-19 prior to initiating treatment. Among the 558 patients who initiated treatment, the adjudicated primary composite end point occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5-mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group. The risk differences compared with placebo for the primary end point were 0.0% (95% CI not calculable) in the aspirin group, 0.7% (95% CI, -2.1% to 4.1%) in the 2.5-mg apixaban group, and 1.4% (95% CI, -1.5% to 5.0%) in the 5-mg apixaban group. Risk differences compared with placebo for bleeding events were 2.0% (95% CI, -2.7% to 6.8%), 4.5% (95% CI, -0.7% to 10.2%), and 6.9% (95% CI, 1.4% to 12.9%) among participants who initiated therapy in the aspirin, prophylactic apixaban, and therapeutic apixaban groups, respectively, although none were major. Findings inclusive of all randomized patients were similar. Conclusions and Relevance: Among symptomatic clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome. However, the study was terminated after enrollment of 9% of participants because of an event rate lower than anticipated. Trial Registration: ClinicalTrials.gov Identifier: NCT04498273.
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Aspirina/uso terapéutico , Tratamiento Farmacológico de COVID-19 , Inhibidores del Factor Xa/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Trombosis/prevención & control , Adulto , Aspirina/efectos adversos , COVID-19/complicaciones , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Terminación Anticipada de los Ensayos Clínicos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Femenino , Hemorragia/inducido químicamente , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Pirazoles/administración & dosificación , Pirazoles/efectos adversos , Piridonas/administración & dosificación , Piridonas/efectos adversosRESUMEN
PURPOSE: To evaluate the responsiveness of quality of life (QoL) metrics to ocular and systemic events in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. METHODS: Data on the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), EuroQol Questionnaire (EQ-5D), and Short Form Survey Instrument (SF-36) were evaluated semiannually during the first 3 years after randomization. The impact of ocular (e.g., changes in visual acuity [VA], activity status, cataract surgery) and systemic events (e.g., infections requiring treatment) on the 6-month changes in QoL was assessed for each metric using generalized estimating equations. MAIN OUTCOME MEASURES: The primary outcomes were the 6-month changes in vision-related (NEI-VFQ-25) and general health-related (EQ-5D index, SF-36 physical component summary [PCS]) QoL. RESULTS: Changes in VA (adjusted change [aΔ]: 2.70 units per 5 letter change, P < 0.001), implant placement in at least 1 eye (aΔ: 5.50, P < 0.001), cataract surgery (aΔ: 3.01, P = 0.017), and quieting of all eyes active at the beginning of the interval (aΔ: 2.20, P < 0.010) were associated with improvements in the NEI-VFQ-25. Reductions in VA (aΔ: -0.014 per 5 letter decline, P = 0.003), infections requiring a prescription (aΔ: -0.024, P = 0.021), and incident uveitis activity in at least 1 eye (aΔ: -0.023, P = 0.031) were associated with declines in the EQ-5D index. Hospitalization (aΔ: -2.24, P = 0.019), infections requiring a prescription (aΔ: -1.00, P = 0.024), and vitreous hemorrhage in at least 1 eye (aΔ: -1.92, P = 0.021) were associated with declines in the SF-36 PCS. Declines in VA, initiation in IOP medication, and age were associated with changes in SF-36 PCS; however, the magnitude of the change was less than a single point. CONCLUSIONS: The NEI-VFQ-25 was more sensitive to ocular changes than the general QoL metrics but less sensitive to acute systemic events. When performing QoL or cost-effectiveness analyses, it is important to consider the expected outcomes (e.g., ocular vs. systemic) to ensure that the selected measurement is sensitive enough to detect clinically important changes in disease status or effects of treatment.
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Calidad de Vida/psicología , Uveítis/psicología , Visión Ocular/fisiología , Adulto , Anciano , Benchmarking , Extracción de Catarata , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Glucocorticoides/uso terapéutico , Estado de Salud , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Indicadores de Calidad de la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Perfil de Impacto de Enfermedad , Encuestas y Cuestionarios , Estados Unidos , Uveítis/tratamiento farmacológico , Uveítis/fisiopatología , Agudeza Visual/fisiologíaRESUMEN
PURPOSE: To evaluate longitudinal vision-related quality of life (VRQoL) in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Steroid Treatment Trial and Follow-up Study. METHODS: Data from the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) for the first 3 years after randomization were evaluated semiannually. Analyses were stratified by assigned treatment (129 implants vs. 126 systemic therapies) because of substantial differences in the trajectories of VRQoL. The impact of baseline measurements of visual function (visual acuity and visual field), demographics, and disease characteristics was assessed using generalized estimating equations. MAIN OUTCOME MEASURES: Primary outcome was the NEI-VFQ-25 composite score over 3 years after randomization. RESULTS: Individuals in both treatment groups showed similar improvement in NEI-VFQ-25 scores after 3 years of follow-up (implant: 11.9 points; 95% confidence interval [CI], 8.6-15.2; P < 0.001; systemic: 9.0 points; 95% CI, 5.6-12.3; P < 0.001; P = 0.21 for interaction). Individuals in the implant group showed a substantial improvement during the first 6 months followed by stable scores, whereas individuals in the systemic group showed a steady improvement over the course of follow-up. Worse initial visual acuity and visual fields were associated with lower initial NEI-VFQ-25 scores for both treatment groups. In the systemic group, these differences were maintained throughout follow-up. In the implant group, individuals with initial visual acuity worse than 20/40 showed additional improvement in NEI-VFQ-25 score to come within -7 points (95% CI, -15.0 to 0.9) of those with visual acuity 20/40 or better initially, a clinically meaningful but not statistically significant difference (P = 0.081). Results based on sensitivity analyses showed similar patterns. CONCLUSIONS: Both treatment groups demonstrated significant improvements in NEI-VFQ-25 scores; however, the improvement was immediate for the implant group as opposed to gradual for the systemic group. Poorer visual function was associated significantly with initial differences in NEI-VFQ-25 scores. However, only individuals in the implant group with poor visual acuity were able to overcome their initial deficits by the end of 3 years.
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Fluocinolona Acetonida/administración & dosificación , Glucocorticoides/administración & dosificación , Panuveítis/tratamiento farmacológico , Calidad de Vida/psicología , Uveítis Intermedia/tratamiento farmacológico , Uveítis Posterior/tratamiento farmacológico , Adulto , Anciano , Estudios de Cohortes , Implantes de Medicamentos , Femenino , Estudios de Seguimiento , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Panuveítis/psicología , Factores de Riesgo , Perfil de Impacto de Enfermedad , Encuestas y Cuestionarios , Uveítis Intermedia/psicología , Uveítis Posterior/psicología , Visión Ocular/fisiología , Agudeza Visual/fisiología , Campos Visuales/fisiologíaRESUMEN
BACKGROUND: Therapeutic-dose heparin decreased days requiring organ support in noncritically ill patients hospitalized for COVID-19, but its impact on persistent symptoms or quality of life (QOL) is unclear. RESEARCH QUESTION: In the Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV-4a) trial, was randomization of patients hospitalized for COVID-19 illness to therapeutic-dose vs prophylactic heparin associated with fewer symptoms and better QOL at 90 days? STUDY DESIGN AND METHODS: This was an open-label randomized controlled trial at 34 hospitals in the United States and Spain. A total of 727 noncritically ill patients hospitalized for COVID-19 from September 2020 to June 2021 were randomized to therapeutic-dose vs prophylactic heparin. Only patients with 90-day data on symptoms and QOL were analyzed. We ascertained symptoms and QOL by the EQ-5D-5L at 90-day follow-up in a preplanned analysis for the ACTIV-4a trial. Individual domains assessed by the EQ-5D-5L included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Univariate and multivariate analyses were performed. RESULTS: Among 571 patients, 288 (50.4%) reported at least one symptom. Among 410 patients, 148 (36.1%) reported moderate to severe impairment in one or more domains of the EQ-5D-5L. The presence of 90-day symptoms was associated with moderate-severe impairment in the EQ-5D-5L domains of mobility (adjusted OR [aOR], 2.37; 95% CI, 1.22-4.59), usual activities (aOR, 3.66; 95% CI, 1.75-7.65), pain (aOR, 2.43; 95% CI, 1.43-4.12), and anxiety (aOR, 4.32; 95% CI, 2.06-9.02), compared with patients reporting no symptoms There were no differences in symptoms or in the overall EQ-5D-5L index score between treatment groups. Therapeutic-dose heparin was associated with less moderate-severe impairment in all physical functioning domains (mobility, self-care, usual activities) but was independently significant only in the self-care domain (aOR, 0.32; 95% CI, 0.11-0.96). INTERPRETATION: In a randomized controlled trial of hospitalized noncritically ill patients with COVID-19, therapeutic-dose heparin was associated with less severe impairment in the self-care domain of EQ-5D-5L. However, this type of impairment was uncommon, affecting 23 individuals. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04505774; URL: www. CLINICALTRIALS: gov.
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COVID-19 , Humanos , COVID-19/terapia , Calidad de Vida , Heparina/uso terapéutico , Hospitalización , Dolor , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To describe the prevalence of postarrest hyperthermia among children during the first 24 hrs after inhospital cardiac arrest and to determine the association of persistent postarrest hyperthermia with neurologic outcome and death before hospital discharge. DESIGN: Multicenter, national registry of inhospital cardiopulmonary resuscitation. SETTING: A total of 196 hospitals reporting to the American Heart Association's National Registry of Cardiopulmonary Resuscitation from January 1, 2005 to December 31, 2007. PATIENTS: A total of 547 pediatric patients who suffered inhospital pulseless cardiac arrests reported to the National Registry of Cardiopulmonary Resuscitation, who survived resuscitative efforts and who had the maximum and the minimum temperature in the first 24 hrs postresuscitation reported to the National Registry of Cardiopulmonary Resuscitation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 547 children with pulseless cardiac arrests, 238 (43.5%) had at least one temperature of ≥38°C, and 30 (5.5%) had "persistent hyperthermia" (i.e., both the minimum and the maximum temperature of ≥38°C) during the first 24 hrs postarrest. After adjusting for potential confounders by multivariate logistic regression, persistent hyperthermia in the first 24 hrs postarrest was associated with unfavorable neurologic outcome (adjusted odds ratio, 2.7; 95% confidence interval, 1.1-6.7), but not with death before hospital discharge (adjusted odds ratio, 1.2; 95% confidence interval, 0.4-3.4). CONCLUSIONS: Despite current guidelines to avoid postarrest hyperthermia, a temperature of ≥38°C occurred commonly among children in the first 24 hrs postarrest. Persistent postarrest hyperthermia was associated with unfavorable neurologic outcomes, even after controlling for potential confounding factors.
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Temperatura Corporal/fisiología , Reanimación Cardiopulmonar , Fiebre/epidemiología , Paro Cardíaco/terapia , Adolescente , Niño , Preescolar , Femenino , Fiebre/fisiopatología , Fiebre/prevención & control , Paro Cardíaco/fisiopatología , Humanos , Lactante , Recién Nacido , Modelos Logísticos , Masculino , Prevalencia , Estudios Prospectivos , Sistema de Registros , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Heart fat deposition has been linked to atherosclerosis, and both accelerate after menopause. Hormone therapy (HT) may differentially slow heart fat deposition and progression of atherosclerosis, depending on the specific HT agent or its route of administration. Our objective was to evaluate the effects of different HT agents, oral and transdermal, on associations between heart fat accumulation and atherosclerosis progression, measured by carotid intima-media thickness (CIMT), in recently menopausal women from the Kronos Early Estrogen Prevention Study (KEEPS) trial. METHODS: KEEPS was a randomized, placebo-controlled trial of the effects of 0.45âmg/d oral conjugated equine estrogens (o-CEE) or 50âmcg/d transdermal 17ß-estradiol (t-E2), compared with placebo, on 48 months progression of CIMT. Epicardial adipose tissue (EAT) and paracardial adipose tissue (PAT) volumes were quantified by computed tomography. RESULTS: In all, 467 women (mean age [SD] 52.7 [2.5]; 78.2% White; 30% on o-CEE, 30.8% t-E2, 39.2% placebo) with heart fat volumes and CIMT at baseline and 48 months were included. EAT and PAT changes were not associated with CIMT progression; however, the assigned treatment significantly modified the association between PAT (but not EAT) change and CIMT progression. In the o-CEE group, adjusted CIMT progression was 12.66âµm (95% confidence interval [CI] 1.80, 23.52) lower than in t-E2 group (Pâ=â0.02), and 10.09âµm (95% CI 0.79, 19.39) lower than in placebo group (Pâ=â0.03), as per 1-SD increase in PAT. CONCLUSION: Compared with t-E2, o-CEE appears to slow down the adverse effect of increasing PAT on progression of atherosclerosis. Whether this beneficial association is specific to CEE or to the oral route of CEE administration is unclear and should be assessed further.
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Aterosclerosis/prevención & control , Enfermedades de las Arterias Carótidas/prevención & control , Estradiol/administración & dosificación , Terapia de Reemplazo de Estrógeno/métodos , Estrógenos Conjugados (USP)/administración & dosificación , Estrógenos/administración & dosificación , Administración Cutánea , Administración Oral , Aterosclerosis/etiología , Enfermedades de las Arterias Carótidas/etiología , Grosor Intima-Media Carotídeo , Progresión de la Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Miocardio/patología , Posmenopausia/efectos de los fármacos , Resultado del TratamientoRESUMEN
Background Heart fats (epicardial and paracardial adipose tissue [PAT]) are greater after menopause. Endogenous estrogen may regulate these fat depots. We evaluated the differential effects of hormone therapy formulations on heart fat accumulations and their associations with coronary artery calcification (CAC) progression in recently menopausal women from KEEPS (Kronos Early Estrogen Prevention Study). Methods and Results KEEPS was a multicenter, randomized, placebo-controlled trial of the effects of 0.45 mg/d oral conjugated equine estrogens and 50 µg/d transdermal 17ß-estradiol, compared with placebo, on 48-month progression of subclinical atherosclerosis among 727 early menopausal women. CAC progression was defined if baseline CAC score was 0 and 48-month CAC score was >0 or if baseline CAC score was >0 and <100 and annualized change in CAC score was ≥10. Of 727 KEEPS participants, 474 (mean age: 52.7 [SD: 2.6]; 78.1% white) had computed tomography-based heart fat and CAC measures at both baseline and 48 months. Compared with women on placebo, women on oral conjugated equine estrogens were less likely to have any increase in epicardial adipose tissue (odds ratio for oral conjugated equine estrogens versus placebo: 0.62 [95% CI, 0.40-0.97]; P=0.03). PAT did not change in any group. Changes in epicardial adipose tissue and PAT did not differ by treatment group. CAC increased in 14% of participants. The assigned treatment modified the association between PAT changes and CAC progression (P=0.02) such that PAT increases were associated with CAC increases only in the transdermal 17ß-estradiol group. Conclusions In recently menopausal women, oral conjugated equine estrogens may slow epicardial adipose tissue accumulation, whereas transdermal 17ß-estradiol may increase progression of CAC associated with PAT accumulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00154180.
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Tejido Adiposo/efectos de los fármacos , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Estradiol/farmacología , Estradiol/uso terapéutico , Terapia de Reemplazo de Estrógeno , Estrógenos Conjugados (USP)/farmacología , Estrógenos Conjugados (USP)/uso terapéutico , Estrógenos/farmacología , Estrógenos/uso terapéutico , Pericardio/patología , Calcificación Vascular/tratamiento farmacológico , Progresión de la Enfermedad , Femenino , Humanos , Persona de Mediana EdadRESUMEN
BACKGROUND: Dentistry plays a crucial role in shaping the esthetics of a person and thus boosts the self-esteem of an individual. Whitening of the teeth is the most popular procedure where surface and deep stain removal whitens the teeth. Teeth whitening is achieved by professional application of chemicals and can also be self-administered by numerous products available. The most popular product is teeth whitening paste which is simple in application and easily available. Recently, teeth whitening tooth paste is commercially available where natural ingredients or their derivatives are used instead of chemicals for teeth whitening. AIMS: To investigate and compare the effect of commercially available chemical teeth whitening toothpaste and teeth whitening toothpaste containing ingredients of herbal origin on human enamel (at the Department of Oral and Maxillofacial Pathology, Royal Dental College, Kerala, India). MATERIALS AND METHODS: An in vitro study with a duration of 14 days was conducted. SETTINGS AND DESIGN: An in vitro study was conducted twenty samples were taken and assembled in to two groups of 10 each. Group A for teeth treated with conventional chemical toothpaste and group B for teeth treated with toothpaste containing ingredients of herbal origin. Premolars extracted for orthodontic purpose were checked for shade with Vita 3D shade guide and were observed under a stereomicroscope for surface morphology before the procedure. Each section was cleansed twice daily for 1 min with specified toothpaste and soft bristle toothbrush according to their groups and then cleansed with tap water and stored again in the same solution. After 14 days, the teeth were tested for the shade using vita 3D shade guide and surface morphology using stereomicroscope. STATISTICAL ANALYSIS USED: Student's unpaired t-test. RESULTS AND CONCLUSION: In this 14-day in vitro study, the chemical whitening toothpaste showed better whitening of teeth than toothpaste containing ingredient of herbal origin, whereas the surface irregularities was increased on the surface of the enamel with chemical whitening toothpaste when compared with toothpaste containing ingrtedients of herbal origin.
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INTRODUCTION: Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system. METHODS AND ANALYSIS: mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness. ETHICS AND DISSEMINATION: The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms. TRIAL REGISTRATION: mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).
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Teléfono Celular/estadística & datos numéricos , Sistemas de Apoyo a Decisiones Clínicas/tendencias , Diabetes Mellitus/sangre , Hipertensión/sangre , Atención Primaria de Salud , Población Rural , Telemedicina , Glucemia , Enfermedades Cardiovasculares/prevención & control , Análisis por Conglomerados , Análisis Costo-Beneficio , Sistemas de Apoyo a Decisiones Clínicas/economía , Diabetes Mellitus/fisiopatología , Medicina Basada en la Evidencia , Hemoglobina Glucada , Adhesión a Directriz/estadística & datos numéricos , Humanos , Hipertensión/fisiopatología , India , Evaluación de Resultado en la Atención de Salud , Atención Primaria de Salud/economía , Atención Primaria de Salud/tendencias , Evaluación de Programas y Proyectos de Salud , Telemedicina/economía , Telemedicina/estadística & datos numéricos , Telemedicina/tendenciasRESUMEN
BACKGROUND: The high burden of undetected and undertreated hypertension and diabetes mellitus is a major health challenge worldwide. The mPower Heart Project aimed to develop and test a feasible and scalable intervention for hypertension and diabetes mellitus by task-sharing with the use of a mobile phone-based clinical decision support system at Community Health Centers in Himachal Pradesh, India. METHODS AND RESULTS: The development of the intervention and mobile phone-based clinical decision support system was carried out using mixed methods in five Community Health Centers. The intervention was subsequently evaluated using pre-post evaluation design. During intervention, a nurse care coordinator screened, examined, and entered patient parameters into mobile phone-based clinical decision support system to generate a prescription, which was vetted by a physician. The change in systolic blood pressure, diastolic blood pressure, and fasting plasma glucose (FPG) over 18 months of intervention was quantified using generalized estimating equations models. During intervention, 6797 participants were enrolled. Six thousand sixteen participants had hypertension (mean systolic blood pressure: 146.1 mm Hg, 95% CI: 145.7, 146.5; diastolic blood pressure: 89.52 mm Hg, 95% CI: 89.33, 89.72), of which 3152 (52%) subjects were newly detected. Similarly, 1516 participants had diabetes mellitus (mean FPG: 177.9 mg/dL, 95% CI: 175.8, 180.0), of which 450 (30%) subjects were newly detected. The changes in systolic blood pressure, diastolic blood pressure, and FPG observed at 18 months of follow-up were -14.6 mm Hg (95% CI: -15.3, -13.8), -7.6 mm Hg (CI: -8.0, -7.2), and -50.0 mg/dL (95% CI: -54.6, -45.5), respectively, and were statistically significant even after adjusting for age, sex, and Community Health Center. CONCLUSIONS: A nurse-facilitated, mobile phone-based clinical decision support system-enabled intervention in primary care was associated with improvements in blood pressure and blood glucose control and has the potential to scale-up in resource poor settings. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01794052. Clinical Trial Registry-India: CTRI/2013/02/003412.
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Glucemia/análisis , Presión Sanguínea/fisiología , Diabetes Mellitus/diagnóstico , Manejo de la Enfermedad , Hipertensión/diagnóstico , Atención Primaria de Salud/métodos , Teléfono Inteligente , Adulto , Sistemas de Apoyo a Decisiones Clínicas , Diabetes Mellitus/sangre , Diabetes Mellitus/epidemiología , Medicina Basada en la Evidencia/métodos , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/epidemiología , Hipertensión/fisiopatología , India/epidemiología , Masculino , Persona de Mediana Edad , Morbilidad/tendencias , Estudios RetrospectivosRESUMEN
BACKGROUND: The Johns Hopkins Children's Medical and Surgery Center developed a Web-based Antimicrobial Stewardship Program (ASP) in 2005. The present study aimed to assess longitudinal antimicrobial request and approval patterns for this ASP. METHODS: We analyzed a total of 16,229 antimicrobial requests for 3,542 patients between June 1, 2005, and June 30, 2009. Antimicrobial approval was the outcome of interest. We assessed gaming by studying trends in automatically approved requests. Nonparametric tests for trend were performed to detect changes in approval patterns. Multiple logistic regression was used to identify factors associated with approval. RESULTS: The vast majority (91.3%) of antimicrobial requests were approved, with an increase of 6.1% over time (P < .01). Renewal requests were more likely than primary requests (adjusted odds ratio [aOR], 1.72; 95% confidence interval [CI], 1.45-2.04) to be approved. Antiviral requests had higher odds of approval than antibiotic requests (aOR, 1.27; 95% CI, 1.04-1.56). Compared with requests by medical services, requests by surgical services had lower odds of approval (aOR, 0.70; 95% CI, 0.59-0.83), whereas pediatric intensive care requests had higher odds of approval (aOR, 1.18; 95% CI, 1.00-1.40). The number of auto-approved requests remained consistent. CONCLUSIONS: The Web-based ASP allows management of a large number of antimicrobial requests, without apparent gaming. Observed differences in approval patterns based on patient, requestor, and antimicrobial factors may inform the development of ASPs and evaluation of provider education and training.