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JAMA Intern Med ; 2020 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-32065600


Importance: Chlorthalidone is currently recommended as the preferred thiazide diuretic to treat hypertension, but no trials have directly compared risks and benefits. Objective: To compare the effectiveness and safety of chlorthalidone and hydrochlorothiazide as first-line therapies for hypertension in real-world practice. Design, Setting, and Participants: This is a Large-Scale Evidence Generation and Evaluation in a Network of Databases (LEGEND) observational comparative cohort study with large-scale propensity score stratification and negative-control and synthetic positive-control calibration on databases spanning January 2001 through December 2018. Outpatient and inpatient care episodes of first-time users of antihypertensive monotherapy in the United States based on 2 administrative claims databases and 1 collection of electronic health records were analyzed. Analysis began June 2018. Exposures: Chlorthalidone and hydrochlorothiazide. Main Outcomes and Measures: The primary outcomes were acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome including the first 3 outcomes and sudden cardiac death. Fifty-one safety outcomes were measured. Results: Of 730 225 individuals (mean [SD] age, 51.5 [13.3] years; 450 100 women [61.6%]), 36 918 were dispensed or prescribed chlorthalidone and had 149 composite outcome events, and 693 337 were dispensed or prescribed hydrochlorothiazide and had 3089 composite outcome events. No significant difference was found in the associated risk of myocardial infarction, hospitalized heart failure, or stroke, with a calibrated hazard ratio for the composite cardiovascular outcome of 1.00 for chlorthalidone compared with hydrochlorothiazide (95% CI, 0.85-1.17). Chlorthalidone was associated with a significantly higher risk of hypokalemia (hazard ratio [HR], 2.72; 95% CI, 2.38-3.12), hyponatremia (HR, 1.31; 95% CI, 1.16-1.47), acute renal failure (HR, 1.37; 95% CI, 1.15-1.63), chronic kidney disease (HR, 1.24; 95% CI, 1.09-1.42), and type 2 diabetes mellitus (HR, 1.21; 95% CI, 1.12-1.30). Chlorthalidone was associated with a significantly lower risk of diagnosed abnormal weight gain (HR, 0.73; 95% CI, 0.61-0.86). Conclusions and Relevance: This study found that chlorthalidone use was not associated with significant cardiovascular benefits when compared with hydrochlorothiazide, while its use was associated with greater risk of renal and electrolyte abnormalities. These findings do not support current recommendations to prefer chlorthalidone vs hydrochlorothiazide for hypertension treatment in first-time users was found. We used advanced methods, sensitivity analyses, and diagnostics, but given the possibility of residual confounding and the limited length of observation periods, further study is warranted.

PLoS One ; 15(1): e0226718, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31910437


BACKGROUND AND PURPOSE: Hemorrhagic transformation (HT) after cerebral infarction is a complex and multifactorial phenomenon in the acute stage of ischemic stroke, and often results in a poor prognosis. Thus, identifying risk factors and making an early prediction of HT in acute cerebral infarction contributes not only to the selections of therapeutic regimen but also, more importantly, to the improvement of prognosis of acute cerebral infarction. The purpose of this study was to develop and validate a model to predict a patient's risk of HT within 30 days of initial ischemic stroke. METHODS: We utilized a retrospective multicenter observational cohort study design to develop a Lasso Logistic Regression prediction model with a large, US Electronic Health Record dataset which structured to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). To examine clinical transportability, the model was externally validated across 10 additional real-world healthcare datasets include EHR records for patients from America, Europe and Asia. RESULTS: In the database the model was developed, the target population cohort contained 621,178 patients with ischemic stroke, of which 5,624 patients had HT within 30 days following initial ischemic stroke. 612 risk predictors, including the distance a patient travels in an ambulance to get to care for a HT, were identified. An area under the receiver operating characteristic curve (AUC) of 0.75 was achieved in the internal validation of the risk model. External validation was performed across 10 databases totaling 5,515,508 patients with ischemic stroke, of which 86,401 patients had HT within 30 days following initial ischemic stroke. The mean external AUC was 0.71 and ranged between 0.60-0.78. CONCLUSIONS: A HT prognostic predict model was developed with Lasso Logistic Regression based on routinely collected EMR data. This model can identify patients who have a higher risk of HT than the population average with an AUC of 0.78. It shows the OMOP CDM is an appropriate data standard for EMR secondary use in clinical multicenter research for prognostic prediction model development and validation. In the future, combining this model with clinical information systems will assist clinicians to make the right therapy decision for patients with acute ischemic stroke.

Lancet ; 394(10211): 1816-1826, 2019 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-31668726


BACKGROUND: Uncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in the absence of comorbid indications. Randomised trials have not further refined this choice. METHODS: We developed a comprehensive framework for real-world evidence that enables comparative effectiveness and safety evaluation across many drugs and outcomes from observational data encompassing millions of patients, while minimising inherent bias. Using this framework, we did a systematic, large-scale study under a new-user cohort design to estimate the relative risks of three primary (acute myocardial infarction, hospitalisation for heart failure, and stroke) and six secondary effectiveness and 46 safety outcomes comparing all first-line classes across a global network of six administrative claims and three electronic health record databases. The framework addressed residual confounding, publication bias, and p-hacking using large-scale propensity adjustment, a large set of control outcomes, and full disclosure of hypotheses tested. FINDINGS: Using 4·9 million patients, we generated 22 000 calibrated, propensity-score-adjusted hazard ratios (HRs) comparing all classes and outcomes across databases. Most estimates revealed no effectiveness differences between classes; however, thiazide or thiazide-like diuretics showed better primary effectiveness than angiotensin-converting enzyme inhibitors: acute myocardial infarction (HR 0·84, 95% CI 0·75-0·95), hospitalisation for heart failure (0·83, 0·74-0·95), and stroke (0·83, 0·74-0·95) risk while on initial treatment. Safety profiles also favoured thiazide or thiazide-like diuretics over angiotensin-converting enzyme inhibitors. The non-dihydropyridine calcium channel blockers were significantly inferior to the other four classes. INTERPRETATION: This comprehensive framework introduces a new way of doing observational health-care science at scale. The approach supports equivalence between drug classes for initiating monotherapy for hypertension-in keeping with current guidelines, with the exception of thiazide or thiazide-like diuretics superiority to angiotensin-converting enzyme inhibitors and the inferiority of non-dihydropyridine calcium channel blockers. FUNDING: US National Science Foundation, US National Institutes of Health, Janssen Research & Development, IQVIA, South Korean Ministry of Health & Welfare, Australian National Health and Medical Research Council.

Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Adolescente , Adulto , Idoso , Antagonistas de Receptores de Angiotensina/efeitos adversos , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Bloqueadores dos Canais de Cálcio/uso terapêutico , Criança , Estudos de Coortes , Pesquisa Comparativa da Efetividade/métodos , Bases de Dados Factuais , Diuréticos/efeitos adversos , Diuréticos/uso terapêutico , Medicina Baseada em Evidências/métodos , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/prevenção & controle , Humanos , Hipertensão/complicações , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Adulto Jovem
Stud Health Technol Inform ; 264: 1831-1832, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438365


Observational research in cancer requires substantially more detail than most other therapeutic areas. Cancer conditions are defined through histology, affected anatomical structures, staging and grading, and biomarkers, and are treated with complex therapies. Here, we show a new cancer module as part of the OMOP CDM, allowing manual and automated abstraction and standardized analytics. We tested the model in EHR and registry data against a number of typical use cases.

Registros Eletrônicos de Saúde , Modelos Teóricos , Neoplasias , Pesquisa , Bases de Dados Factuais , Sistema de Registros
J Child Fam Stud ; 25(6): 1746-1754, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27186064


Adolescent fighting affects 25% of youth, with the highest rates among African-Americans and Latinos but little is known about parental views on youth fighting. The purpose of this study was to examine African-American and Latino parents' perspectives on adolescent fighting and methods to prevent fighting. We conducted four focus groups with parents of African-American and Latino urban adolescents. Focus groups were stratified by race/ethnicity and fighting status. Groups were audiotaped, transcribed, and analyzed by three independent coders using thematic content analysis. Seventy-six percent of the 17 participants were female. Latino parents condoned fighting only as a last resort, and taught children about consequences of fighting, emotional regulation, and non-violent conflict-resolution strategies. African-American parents endorsed teaching non-violent strategies, but expressed some doubts about their effectiveness. African-American parents also suggested corporal punishment, but acknowledged that this may not be an optimal long-term strategy. Positive role modeling and involvement by teachers and other adults were cited as having important roles in fighting prevention. Suggested interventions included teaching adolescents non-violent conflict-resolution skills, anger management, and alternatives to fighting. Parents recommended that violence prevention programs incorporate the experiences of former fighters and be tailored to community needs. Study findings suggest that youth violence-prevention programs may benefit from addressing parental attitudes towards fighting and parent-child communication about fighting, teaching adolescents non-violent conflict-resolution skills, and tailoring programs by race/ethnicity. Promoting positive modeling and involvement by teachers and other adults also may be beneficial.

Am Heart J ; 170(6): 1161-9, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26678638


BACKGROUND: The treatment for patients with acute myocardial infarction (AMI) was transformed by the introduction of intensive care units (ICUs), yet we know little about how contemporary hospitals use this resource-intensive setting and whether higher use is associated with better outcomes. METHODS: We identified 114,136 adult hospitalizations for AMI from 307 hospitals in the 2009 to 2010 Premier database using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. Hospitals were stratified into quartiles by rates of ICU admission for AMI patients. Across quartiles, we examined in-hospital risk-standardized mortality rates and usage rates of critical care therapies for these patients. RESULTS: Rates of ICU admission for AMI patients varied markedly among hospitals (median 48%, Q1-Q4 20%-71%, range 0%-98%), and there was no association with in-hospital risk-standardized mortality rates (6% all quartiles, P = .7). However, hospitals admitting more AMI patients to the ICU were more likely to use critical care therapies overall (mechanical ventilation [from Q1 with lowest rate of ICU use to Q4 with highest rate 13%-16%], vasopressors/inotropes [17%-21%], intra-aortic balloon pumps [4%-7%], and pulmonary artery catheters [4%-5%]; P for trend < .05 in all comparisons). CONCLUSIONS: Rates of ICU admission for patients with AMI vary substantially across hospitals and were not associated with differences in mortality, but were associated with greater use of critical care therapies. These findings suggest uncertainty about the appropriate use of this resource-intensive setting and a need to optimize ICU triage for patients who will truly benefit.

Infarto Miocárdico de Parede Anterior , Unidades de Cuidados Coronarianos , Admissão do Paciente/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Infarto Miocárdico de Parede Anterior/diagnóstico , Infarto Miocárdico de Parede Anterior/economia , Infarto Miocárdico de Parede Anterior/terapia , Unidades de Cuidados Coronarianos/economia , Unidades de Cuidados Coronarianos/métodos , Unidades de Cuidados Coronarianos/estatística & dados numéricos , Alocação de Recursos para a Atenção à Saúde/estatística & dados numéricos , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Melhoria de Qualidade , Estudos Retrospectivos , Medição de Risco , Triagem/organização & administração , Triagem/normas , Estados Unidos