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Comparison of External Control Arm Critiques in Regulatory and Health Technology Assessment of Oncology Submissions
Objectives: The development of accelerated approval programs for high morbidity and unmet ...
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Erratum: high-dimensional propensity score adjustment in studies of treatment effects using health care claims data
In the article titled “High-dimensional Propensity Score Adjustment in Studies of ...
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Measuring prevalence and incidence of chronic conditions in claims and electronic health record databases
Background Health care databases are natural sources for estimating prevalence and ...
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Annual health care resource utilization and cost among type 2 diabetes patients with newly recognized chronic kidney disease within a large US administrative claims database
BACKGROUND: Chronic kidney disease (CKD) is one of the most common complications of type ...
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[REPEAT] Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nature Communications
Studies that generate real-world evidence on the effects of medical products through ...
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Disease frequency, patient characteristics, comorbidity outcomes and immunosuppressive therapy in systemic sclerosis and systemic sclerosis-associated interstitial lung disease: a US cohort Study
Objectives To investigate prevalence estimates and incidence rates (IRs) for SSc and ...
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Impact of season and other factors on initiation, discontinuation and switching of systemic drug therapy in patients with psoriasis - a retrospective study
This study investigated whether systemic drug prescribing for psoriasis varies by season ...
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Predictors of cardio-kidney complications and treatment failure in patients with chronic kidney disease and type 2 diabetes treated with SGLT2is
Background: Clinical practice guidelines recommend sodium-glucose co-transporter 2 ...
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High unmet treatment needs in patients with chronic kidney disease and type 2 diabetes: real-world evidence from a US claims database
Background Chronic kidney disease (CKD), a serious complication of type 2 diabetes (T2D) ...
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High-dimensional propensity scores for empirical covariate selection in secondary database studies
Real-world evidence used for regulatory, payer, and clinical decision-making requires ...
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Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance
Decision-makers have become increasingly interested in incorporating real-world evidence ...
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Key Learnings from ICER’s Real World Evidence Reassessment Pilot
Health technology assessment (HTA) agencies are considering adopting a lifecycle approach ...
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Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study
Objective To estimate the incidence rates (IR) of prespecified outcomes of interest in ...
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Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis
Regulators wish to understand whether real world evidence can be used for secondary ...
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Prevalence and Incidence of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype in the United States Estimated in a Large Claims Database Analysis
Introduction Many fibrosing interstitial lung diseases (ILDs) develop a chronic ...
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Real-world effectiveness of early intervention with fixed-dose tiotropium/olodaterol vs tiotropium in Japanese patients with COPD: a high-dimensional propensity score–matched cohort analysis
Background Escalation to triple therapy (long-acting muscarinic antagonist/β2-agonist, ...
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Clinical features and diagnosis of multiple myeloma: a population-based cohort study in primary care
Objectives Patients with multiple myeloma (MM) experience significant delays in diagnosis ...
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Real‐world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK‐based electronic health records database
Purpose We evaluated the reproducibility of a study characterizing newly-diagnosed ...
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Fournier's gangrene in patients with type 2 diabetes using second‐line antidiabetic medications
Cases of a rare but serious infection called Fournier's gangrene have been reported with ...
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COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients
Background The COVID-19 pandemic remains a significant global threat. However, despite ...
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Chronic opioid use and complication risks in women with endometriosis: a cohort study in US administrative claims
Background Women with endometriosis are prescribed opioids for pain relief but may be ...
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Using primary care data to assess comparative effectiveness and safety of apixaban and rivaroxaban in patients with nonvalvular atrial fibrillation in the UK: an observational cohort study
Objective To compare real-world effectiveness and safety of direct oral anticoagulants ...
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Availability of comparative real-world evidence research in Medicare patients: Implications for CMS drug price negotiations
To evaluate the availability of published comparative real-world evidence (RWE) studies ...
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Statin Use and Severe Acute Liver Injury Among Patients with Elevated Alanine Aminotransferase
While serious liver injury among statin users is extremely rare, baseline liver enzyme ...