Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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The objective of this report was to address the use and mixing of data collection modes within and between trials in which patient-reported outcome (PRO) end points are intended to be used to support medical product labeling. The report first addresses the factors that should be considered when selecting a mode or modes of PRO data collection in a clinical trial, which is often when mixing is first considered. Next, a summary of how to "faithfully" migrate instruments is presented followed by a section on qualitative and quantitative study designs used to evaluate measurement equivalence of the new and original modes of data collection. ⋯ If proceeding with mixing modes, it is important to implement data collection carefully in the trial itself in a planned manner at the country level or higher and minimize ad hoc mixing by sites or individual subjects. Finally, when mixing occurs, it must be addressed in the statistical analysis plan for the trial and the ability to pool the data must be evaluated to then evaluate treatment effects with mixed modes data. A successful mixed modes trial requires a "faithful migration," measurement equivalence established between modes, and carefully planned implementation to minimize the risk of increased measurement error impacting the power of the trial to detect a treatment effect.
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To evaluate health care-related utilization for critically ill patients receiving parenteral nutrition (PN) administered via a premixed multichamber bag (MCB) or compounded solutions (COM). ⋯ Overall, patients receiving MCB and COM experienced similar LOS, though patients receiving MCB had significantly lower overall costs. Interpretation of the study findings is subject to several limitations, and additional studies that include explicit identification of the method for compounding are needed.
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To ascertain the frequency and types of patient-reported outcome (PRO) violations made in US pharmaceutical promotional materials between 2006 and 2012 and determine whether there were increases in violation warnings after issuance of the Food and Drug Administration (FDA) draft and final PRO Guidance. ⋯ A fifth of the letters issued to companies contained PRO violations, with most related to poor selection of the PRO measure used or trying to broaden the claim. More guidance from the Office of Prescription Drug Promotion about what is considered "substantial evidence" in this area could help reduce the number of letters issued.
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Computerized provider order entry (CPOE) is the process of entering physician orders directly into an electronic health record. Although CPOE has been shown to improve medication safety and reduce health care costs, these improvements have been demonstrated largely in the inpatient setting; the cost-effectiveness in the ambulatory setting remains uncertain. ⋯ Our model suggests that the adoption of CPOE in the ambulatory setting provides excellent value for the investment, and is a cost-effective strategy to improve medication safety over a wide range of practice sizes.
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Back pain imposes a substantial economic and social burden, and treatment decisions are distorted by conflicting evidence. Thus, it is important to include patient preferences in decision making and policy making. ⋯ The majority of the respondents prefer nonsurgical interventions, but patients are willing to wait for more ideal outcomes and preferred interventions. The results show that health care professionals have a very important task in communicating clearly about the expected results of treatment and the basis of their treatment decisions, as patients' preferences are highly individual.