Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Comparative Study
Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study.
It is common practice for developers of new health care technologies to engage in early dialogue with the major regulatory agencies; such discussions frequently center around the proposed clinical trial designs to support the registration of new interventions and suggestions on their improvement. Pricing and reimbursement agencies are increasingly using the results from health technology assessments to inform their decision making for new technologies. Such assessments are invariably underpinned by the phase 3 clinical trial evidence which may not provide answers to the key questions. ⋯ Although there was some variation in the advice the similarities far outweighed the differences. More experience of early dialogue needs to be accumulated, involving a wider range of pricing and reimbursement agencies and compounds. The conclusion of this study, however, was that early dialogue can be a worthwhile process for all parties and can lead to a common understanding about evidence development for market access.
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Randomized Controlled Trial Multicenter Study Comparative Study
Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT).
Recently, results from the large, randomized study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT) trial suggested a benefit for reamed intramedullary nail insertion in patients with closed tibial shaft fractures largely based on cost-neutral autodynamizations and a potential advantage for unreamed intramedullary nailing in open fractures. We performed an economic evaluation to compare resource use and effectiveness of reamed and unreamed intramedullary nailing using a cost-utility analysis. ⋯ Our economic analysis from a governmental perspective suggests small differences in both cost and effectiveness with large uncertainty between reamed and unreamed intramedullary nailing.
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Comparative Study
The association between statin use and outcomes potentially attributable to an unhealthy lifestyle in older adults.
To explore the "healthy user" and "healthy adherer" effects-hypothetical sources of bias thought to arise when patients who initiate and adhere to preventive therapies are more likely to engage in healthy behaviors than are other subjects. ⋯ These results suggest that patients initiating and adhering to chronic preventive drug therapies are more likely to engage in other health-promoting behaviors. Failure to account for this relationship may introduce bias in any epidemiologic study evaluating the effect of a preventive therapy on clinical outcomes.
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To appraise economic evaluations of health technologies that included quality-adjusted life-years (QALYs) as an outcome measure conducted over the past 20 years in Spain. ⋯ An increasing number of economic evaluations using QALYs had been conducted. Most of them relied on theoretical models. Several methodological issues remain unsolved. Great disparity exists regarding the reporting of the methods used to determine health states and utility values.