Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Editorial Comment
Use of economic evaluation in decision making: what needs to change?
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To examine whether sepsis is accurately coded on hospital bills. ⋯ Our findings suggest that use of ICD-9-CM codes for identifying patients with sepsis using hospital bills is only moderately sensitive. Strict reliance on administrative data sources for sepsis surveillance or research planning may therefore be prone to substantial error.
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The impact of economic evaluation studies on health-care decision makers has been shown to be rather limited. However, there is an increasing requirement for the cost-effectiveness of health-care interventions to be considered in formulating and implementing guidelines for clinical practice. This paper reports the findings of recent focus group research among UK health authorities, which examined the usefulness of published economic evaluations within the decision-making processes. The findings are presented and discussed in light of other studies that have addressed this issue. ⋯ Decision makers value information on cost-effectiveness as well as effectiveness alone, but methodological improvements are necessary to increase the reliability of economic studies. A quality-scoring system for published studies would be a useful development as a filtering mechanism for decision makers but would raise a number of challenges for health economists.
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Comparative Study
Regulatory issues for health-related quality of life--PhRMA Health Outcomes Committee workshop, 1999.
Health-related quality-of-life (HRQL) can be defined as the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being. Health-related quality-of-life measures are included in clinical trials of drug treatment to assess the impact of therapy on the patient's functioning. HRQL guidance could allow for use of this data in drug labeling and promotion. ⋯ HRQL provides a patient perspective on the impact of disease and therapy on patients' daily life and functioning. Including HRQL information in promotion could be beneficial to decision making on the use of therapies. HRQL is a measure of effectiveness, not safety, and should be treated as any other clinical end point.
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The National Institute of Clinical Excellence (NICE) has three main roles. It provides guidance to the National Health Service (NHS) on the use of selected new and existing technologies (the appraisal process), provides clinical guidelines for clinicians and physicians in important treatment areas, and develops audit methodologies. This paper discusses the NICE appraisal process. ⋯ An overview of NICE guidelines for manufacturers and sponsors is reported. First-year experience is assessed, reflecting on the quality of submitted evidence, and the content of the forthcoming program is presented. Finally, the impact of NICE appraisals is explored in terms of potential benefits and risks.