Current medical research and opinion
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Randomized Controlled Trial
A Medicine Adoption Model for Assessing the Expected Effects of Additional Real-World Evidence (RWE) at Product Launch.
The optimal launch and adoption of novel medicines require effective navigation of the commercial and regulatory landscape, including three key gatekeeper groups: regulators, payors, and prescribers. Traditionally, despite lacking generalisability, the pharmaceutical industry provides Phase III randomized controlled trial evidence to gatekeepers. Despite additional real-world evidence (RWE) improving the generalisability of evidence, the provision of RWE remains in its infancy. The industry may use a multiple stakeholder approach to RWE generation to address each group's priorities and expectations effectively. ⋯ The proposed model provides an intuitive temporal framework within which subsystem logic can be further researched to identify and address stakeholder groups' needs and weigh those needs. Preliminary results appear to support adopting a multiple stakeholder approach to RWE for augmenting the uptake of novel medicines.
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Multicenter Study
A multicenter retrospective study on evaluation of predicative factors for positive biopsy of prostate cancer in real-world setting.
This study aimed to evaluate the predictors for positive biopsy in prostate cancer (PCa) patients and develop a risk-stratification score model for positive biopsy rate in patients with prostate specific antigen (PSA) in the gray zone. ⋯ Our study evaluated the significant predicative factors for positive biopsy and the PCa risk prediction model developed might help Clinicians to avoid unnecessary biopsy in patients with PSA in gray zone.
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Left ventricular assist device (LVAD) implantation improves outcomes in advanced heart failure, however, the optimal frequency of outpatient assessments to improve cost-effectiveness and potentially avert readmissions is unclear. ⋯ An initial IFU strategy, followed by a period of de-escalation at the 6-month post-implant mark in lower-risk patients, may be a more cost-effective strategy to provide follow-up care while not predisposing patients to a higher risk of readmission.
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The aim of this study was to evaluate the efficacy and safety of empirical anti-tuberculous therapy (ATT) in patients with massive pericardial effusion (MPE) of unknown etiology in China. ⋯ Empirical ATT should be considered in MPE of unknown etiology in countries with a high burden of TB.
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Human papillomavirus (HPV) cause cancers in a variety of anatomic sites presenting at various stages of disease. Current economic assessments rely on HPV-related cancer cost estimates from data prior to the launch of the nonavalent HPV vaccine (2014). The goal of the present study was to assess and describe the current direct medical care burden of HPV-related cancers in the US. ⋯ HPV-related cancers are responsible for substantial health care expenditure each year.