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1.
JAMA Intern Med ; 2020 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-32065600

RESUMO

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.

4.
Lancet ; 394(10211): 1816-1826, 2019 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-31668726

RESUMO

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.


Assuntos
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
6.
PLoS One ; 13(12): e0208082, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30550560

RESUMO

Predicting health outcomes from longitudinal health histories is of central importance to healthcare. Observational healthcare databases such as patient diary databases provide a rich resource for patient-level predictive modeling. In this paper, we propose a Bayesian hierarchical vector autoregressive (VAR) model to predict medical and psychological conditions using multivariate time series data. Compared to the existing patient-specific predictive VAR models, our model demonstrated higher accuracy in predicting future observations in terms of both point and interval estimates due to the pooling effect of the hierarchical model specification. In addition, by adopting an elastic-net prior, our model offers greater interpretability about the associations between variables of interest on both the population level and the patient level, as well as between-patient heterogeneity. We apply the model to two examples: 1) predicting substance use craving, negative affect and tobacco use among college students, and 2) predicting functional somatic symptoms and psychological discomforts.


Assuntos
Interpretação Estatística de Dados , Modelagem Computacional Específica para o Paciente , Teorema de Bayes , Conjuntos de Dados como Assunto , Humanos , Modelos Logísticos , Registros Médicos/estatística & dados numéricos
7.
Philos Trans A Math Phys Eng Sci ; 376(2128)2018 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-30082302

RESUMO

Concerns over reproducibility in science extend to research using existing healthcare data; many observational studies investigating the same topic produce conflicting results, even when using the same data. To address this problem, we propose a paradigm shift. The current paradigm centres on generating one estimate at a time using a unique study design with unknown reliability and publishing (or not) one estimate at a time. The new paradigm advocates for high-throughput observational studies using consistent and standardized methods, allowing evaluation, calibration and unbiased dissemination to generate a more reliable and complete evidence base. We demonstrate this new paradigm by comparing all depression treatments for a set of outcomes, producing 17 718 hazard ratios, each using methodology on par with current best practice. We furthermore include control hypotheses to evaluate and calibrate our evidence generation process. Results show good transitivity and consistency between databases, and agree with four out of the five findings from clinical trials. The distribution of effect size estimates reported in the literature reveals an absence of small or null effects, with a sharp cut-off at p = 0.05. No such phenomena were observed in our results, suggesting more complete and more reliable evidence.This article is part of a discussion meeting issue 'The growing ubiquity of algorithms in society: implications, impacts and innovations'.

8.
Open Access J Contracept ; 9: 29-32, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29720882

RESUMO

Introduction: Substantial evidence suggests that drospirenone-containing oral contraceptives may cause a higher risk of venous thrombotic events than earlier-generation oral contraceptives. Methods: To gain insight into recent real-world implications, we conducted an analysis using the US Food and Drug Administration's Adverse Event Reporting System. Results: Venous thrombotic events continue to be reported at a much higher rate with drospirenone-containing oral contraceptives than the general background. The disproportionality has been rising since 2010. The same behavior is not seen with levonorgestrel-containing oral contraceptives. Conclusion: Our results are consistent with decreased physician and patient awareness of risks associated with drospirenone-containing oral contraceptives.

9.
Proc Natl Acad Sci U S A ; 115(11): 2571-2577, 2018 03 13.
Artigo em Inglês | MEDLINE | ID: mdl-29531023

RESUMO

Observational healthcare data, such as electronic health records and administrative claims, offer potential to estimate effects of medical products at scale. Observational studies have often been found to be nonreproducible, however, generating conflicting results even when using the same database to answer the same question. One source of discrepancies is error, both random caused by sampling variability and systematic (for example, because of confounding, selection bias, and measurement error). Only random error is typically quantified but converges to zero as databases become larger, whereas systematic error persists independent from sample size and therefore, increases in relative importance. Negative controls are exposure-outcome pairs, where one believes no causal effect exists; they can be used to detect multiple sources of systematic error, but interpreting their results is not always straightforward. Previously, we have shown that an empirical null distribution can be derived from a sample of negative controls and used to calibrate P values, accounting for both random and systematic error. Here, we extend this work to calibration of confidence intervals (CIs). CIs require positive controls, which we synthesize by modifying negative controls. We show that our CI calibration restores nominal characteristics, such as 95% coverage of the true effect size by the 95% CI. We furthermore show that CI calibration reduces disagreement in replications of two pairs of conflicting observational studies: one related to dabigatran, warfarin, and gastrointestinal bleeding and one related to selective serotonin reuptake inhibitors and upper gastrointestinal bleeding. We recommend CI calibration to improve reproducibility of observational studies.


Assuntos
Viés , Calibragem/normas , Pesquisa sobre Serviços de Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/normas , Estudos Observacionais como Assunto , Intervalos de Confiança , Humanos , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos
10.
Value Health ; 20(8): 1003-1008, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28964430

RESUMO

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.


Assuntos
Pesquisa Comparativa da Efetividade/métodos , Tomada de Decisões , Assistência à Saúde/métodos , Projetos de Pesquisa , Comitês Consultivos , Medicina Baseada em Evidências/métodos , Guias como Assunto , Humanos , Reprodutibilidade dos Testes
11.
Pharmacoepidemiol Drug Saf ; 26(9): 1033-1039, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28913966

RESUMO

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.


Assuntos
Comitês Consultivos/normas , Tomada de Decisões , Assistência à Saúde/normas , Farmacoeconomia/normas , Farmacoepidemiologia/normas , Ensaios Clínicos Pragmáticos como Assunto/normas , Assistência à Saúde/métodos , Humanos , Internacionalidade , Ensaios Clínicos Pragmáticos como Assunto/métodos , Estudos Prospectivos , Estudos Retrospectivos , Sociedades Científicas/normas , Estatística como Assunto/métodos , Estatística como Assunto/normas , Resultado do Tratamento
12.
Heart ; 103(15): 1156-1162, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28455296

RESUMO

Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease.


Assuntos
Doenças Cardiovasculares/terapia , Ensaios Clínicos como Assunto/organização & administração , Consentimento Livre e Esclarecido , Sociedades Médicas , Bases de Dados Factuais , Humanos
13.
Psychometrika ; 82(2): 459-474, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-27388291

RESUMO

We construct a framework for meta-analysis and other multi-level data structures that codifies the sources of heterogeneity between studies or settings in treatment effects and examines their implications for analyses. The key idea is to consider, for each of the treatments under investigation, the subject's potential outcome in each study or setting were he to receive that treatment. We consider four sources of heterogeneity: (1) response inconsistency, whereby a subject's response to a given treatment would vary across different studies or settings, (2) the grouping of nonequivalent treatments, where two or more treatments are grouped and treated as a single treatment under the incorrect assumption that a subject's responses to the different treatments would be identical, (3) nonignorable treatment assignment, and (4) response-related variability in the composition of subjects in different studies or settings. We then examine how these sources affect heterogeneity/homogeneity of conditional and unconditional treatment effects. To illustrate the utility of our approach, we re-analyze individual participant data from 29 randomized placebo-controlled studies on the cardiovascular risk of Vioxx, a Cox-2 selective nonsteroidal anti-inflammatory drug approved by the FDA in 1999 for the management of pain and withdrawn from the market in 2004.


Assuntos
Doenças Cardiovasculares/induzido quimicamente , Inibidores de Ciclo-Oxigenase 2/efeitos adversos , Lactonas/efeitos adversos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Sulfonas/efeitos adversos , Humanos , Masculino , Psicometria , Fatores de Risco
15.
JAMA Pediatr ; 170(8): 780-6, 2016 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-27368110

RESUMO

IMPORTANCE: Although data obtained from regional trauma systems demonstrate improved outcomes for children treated at pediatric trauma centers (PTCs) compared with those treated at adult trauma centers (ATCs), differences in mortality have not been consistently observed for adolescents. Because trauma is the leading cause of death and acquired disability among adolescents, it is important to better define differences in outcomes among injured adolescents by using national data. OBJECTIVES: To use a national data set to compare mortality of injured adolescents treated at ATCs, PTCs, or mixed trauma centers (MTCs) that treat both pediatric and adult trauma patients and to determine the final discharge disposition of survivors at different center types. DESIGN, SETTING, AND PARTICIPANTS: Data from level I and II trauma centers participating in the 2010 National Trauma Data Bank (January 1 to December 31, 2010) were used to create multilevel models accounting for center-specific effects to evaluate the association of center characteristics (PTC, ATC, or MTC) on mortality among patients aged 15 to 19 years who were treated for a blunt or penetrating injury. The models controlled for sex; mechanism of injury (blunt vs penetrating); injuries sustained, based on the Abbreviated Injury Scale scores (post-dot values <3 or ≥3 by body region); initial systolic blood pressure; and Glasgow Coma Scale scores. Missing data were managed using multiple imputation, accounting for multilevel data structure. Data analysis was conducted from January 15, 2013, to March 15, 2016. EXPOSURES: Type of trauma center. MAIN OUTCOMES AND MEASURES: Mortality at each center type. RESULTS: Among 29 613 injured adolescents (mean [SD] age, 17.3 [1.4] years; 72.7% male), most were treated at ATCs (20 402 [68.9%]), with the remainder at MTCs (7572 [25.6%]) or PTCs (1639 [5.5%]). Adolescents treated at PTCs were more likely to be injured by a blunt than penetrating injury mechanism (91.4%) compared with those treated at ATCs (80.4%) or MTCs (84.6%). Mortality was higher among adolescents treated at ATCs and MTCs than those treated at PTCs (3.2% and 3.5% vs 0.4%; P < .001). The adjusted odds of mortality were higher at ATCs (odds ratio, 4.19; 95% CI, 1.30-13.51) and MTCs (odds ratio, 6.68; 95% CI, 2.03-21.99) compared with PTCs but was not different between level I and II centers (odds ratio, 0.76; 95% CI, 0.59-0.99). CONCLUSION AND RELEVANCE: Mortality among injured adolescents was lower among those treated at PTCs, compared with those treated at ATCs and MTCs. Defining resource and patient features that account for these observed differences is needed to optimize adolescent outcomes after injury.


Assuntos
Centros de Traumatologia/estatística & dados numéricos , Ferimentos não Penetrantes/mortalidade , Ferimentos Penetrantes/mortalidade , Adolescente , Distribuição por Idade , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Masculino , Estados Unidos/epidemiologia , Ferimentos não Penetrantes/etiologia , Ferimentos Penetrantes/etiologia , Adulto Jovem
16.
Proc Natl Acad Sci U S A ; 113(27): 7329-36, 2016 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-27274072

RESUMO

Observational research promises to complement experimental research by providing large, diverse populations that would be infeasible for an experiment. Observational research can test its own clinical hypotheses, and observational studies also can contribute to the design of experiments and inform the generalizability of experimental research. Understanding the diversity of populations and the variance in care is one component. In this study, the Observational Health Data Sciences and Informatics (OHDSI) collaboration created an international data network with 11 data sources from four countries, including electronic health records and administrative claims data on 250 million patients. All data were mapped to common data standards, patient privacy was maintained by using a distributed model, and results were aggregated centrally. Treatment pathways were elucidated for type 2 diabetes mellitus, hypertension, and depression. The pathways revealed that the world is moving toward more consistent therapy over time across diseases and across locations, but significant heterogeneity remains among sources, pointing to challenges in generalizing clinical trial results. Diabetes favored a single first-line medication, metformin, to a much greater extent than hypertension or depression. About 10% of diabetes and depression patients and almost 25% of hypertension patients followed a treatment pathway that was unique within the cohort. Aside from factors such as sample size and underlying population (academic medical center versus general population), electronic health records data and administrative claims data revealed similar results. Large-scale international observational research is feasible.


Assuntos
Padrões de Prática Médica/estatística & dados numéricos , Antidepressivos/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bases de Dados Factuais , Depressão/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Registros Eletrônicos de Saúde , Humanos , Hipertensão/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Internacionalidade , Informática Médica
17.
Stat Methods Med Res ; 25(6): 2577-2592, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-24685766

RESUMO

Most approaches used in postmarketing drug safety monitoring, including spontaneous reporting and statistical risk identification using electronic health care records, are primarily suited to pick up only acute adverse drug effects. With the availability of increasingly larger electronic health record and administrative claims databases comes the opportunity to monitor for potential adverse effects that occur only after prolonged exposure to a drug, but analysis methods are lacking. We propose an adaptation of the self-controlled case series design that uses the notion of accumulated exposure to capture long-term effects of drugs and evaluate extensions to correct for age and recurrent events. Several variations of the approach are tested on simulated data and two large insurance claims databases. To evaluate performance a set of positive and negative control drug-event pairs was created by medical experts based on drug product labels and review of the literature. Performance on the real data was measured using the area under the receiver operator characteristics curve. The best performing method achieved an area under the receiver operator characteristics curve of 0.86 in the largest database using a spline model, adjustment for age, and ignoring recurrent events, but it appears this performance can only be achieved with very large data sets.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Projetos de Pesquisa , Bases de Dados Factuais , Rotulagem de Medicamentos , Humanos , Formulário de Reclamação de Seguro , Seguro Saúde/estatística & dados numéricos , Estudos Longitudinais , Estudos Observacionais como Assunto , Curva ROC
18.
Stat Anal Data Min ; 9(4): 260-268, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28503249

RESUMO

Clinical trials often lack power to identify rare adverse drug events (ADEs) and therefore cannot address the threat rare ADEs pose, motivating the need for new ADE detection techniques. Emerging national patient claims and electronic health record databases have inspired post-approval early detection methods like the Bayesian self-controlled case series (BSCCS) regression model. Existing BSCCS models do not account for multiple outcomes, where pathology may be shared across different ADEs. We integrate a pathology hierarchy into the BSCCS model by developing a novel informative hierarchical prior linking outcome-specific effects. Considering shared pathology drastically increases the dimensionality of the already massive models in this field. We develop an efficient method for coping with the dimensionality expansion by reducing the hierarchical model to a form amenable to existing tools. Through a synthetic study we demonstrate decreased bias in risk estimates for drugs when using conditions with different true risk and unequal prevalence. We also examine observational data from the MarketScan Lab Results dataset, exposing the bias that results from aggregating outcomes, as previously employed to estimate risk trends of warfarin and dabigatran for intracranial hemorrhage and gastrointestinal bleeding. We further investigate the limits of our approach by using extremely rare conditions. This research demonstrates that analyzing multiple outcomes simultaneously is feasible at scale and beneficial.

19.
Stud Health Technol Inform ; 216: 574-8, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26262116

RESUMO

The vision of creating accessible, reliable clinical evidence by accessing the clincial experience of hundreds of millions of patients across the globe is a reality. Observational Health Data Sciences and Informatics (OHDSI) has built on learnings from the Observational Medical Outcomes Partnership to turn methods research and insights into a suite of applications and exploration tools that move the field closer to the ultimate goal of generating evidence about all aspects of healthcare to serve the needs of patients, clinicians and all other decision-makers around the world.


Assuntos
Bases de Dados Factuais , Pesquisa sobre Serviços de Saúde/organização & administração , Informática Médica/organização & administração , Modelos Organizacionais , Estudos Observacionais como Assunto , Internacionalidade
20.
J Surg Res ; 199(2): 641-6, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26197948

RESUMO

BACKGROUND: The use of mechanism of injury as a predictor of injury outcome presents practical challenges because this variable may be missing or inaccurate in many databases. The purpose of this study was to determine the importance of mechanism of injury as a predictor of mortality among injured children. METHODS: The records of children (<15-y-old) sustaining a blunt injury were obtained from the National Trauma Data Bank. Models predicting injury mortality were developed using mechanism of injury and injury coding using either abbreviated injury scale post-dot values (low-dimensional injury coding) or injury International Classification of Diseases, Ninth Revision codes and their two-way interactions (high-dimensional injury coding). Model performance with and without inclusion of mechanism of injury was compared for both coding schemes, and the relative importance of mechanism of injury as a variable in each model type was evaluated. RESULTS: Among 62,569 records, a mortality rate of 0.9% was observed. Inclusion of mechanism of injury improved model performance when using low-dimensional injury coding but was associated with no improvement when using high-dimensional injury coding. Mechanism of injury contributed to 28% of model variance when using low-dimensional injury coding and <1% when high-dimensional injury coding was used. CONCLUSIONS: Although mechanism of injury may be an important predictor of injury mortality among children sustaining blunt trauma, its importance as a predictor of mortality depends on the approach used for injury coding. Mechanism of injury is not an essential predictor of outcome after injury when coding schemes are used that better characterize injuries sustained after blunt pediatric trauma.


Assuntos
Ferimentos e Lesões/etiologia , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Classificação Internacional de Doenças , Masculino , Estudos Retrospectivos , Estados Unidos/epidemiologia , Ferimentos e Lesões/mortalidade
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