Current medical research and opinion
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The purpose of this study was to estimate costs and quality of life (QoL) of late-stage glaucoma patients in 4 European countries. ⋯ The study was limited by its observational, uncontrolled design. The finding that late-stage glaucoma is associated with higher home help costs than health care maintenance costs suggests that potential savings from a better preventive treatment are to be found for social care payers rather than health care payers.
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Recently enacted federal legislation, the Food and Drug Administration Amendments Act of 2007 (FDAAA), mandates public registration and disclosure of results of "applicable" clinical trials of drugs, biologics and devices on www.clinicaltrials.gov. The law calls for registering more information about more trials than has been the policy of many medical journal editors to date. Beginning December 2007, results disclosure will occur in three stages initially with links to information from the FDA and NIH about FDA-approved products, as well as to Medline citations. A Basic Results Database will appear in September 2008, and an Expanded Results Database two years later. Results for trials of FDA-approved products must be posted within 12 months of trial completion. Such postings will not be peer reviewed or contain explanatory text or discussion. Sponsors who file regulatory submissions (IND, NDA, 510(k), PMA, etc.) to the FDA must certify compliance with FDAAA's registration and disclosure provisions. The FDA's determination of such compliance will be made public, and if non-compliance is not cured within 30 days, sponsors may be fined up to $10,000/day. ⋯ FDAAA requirements differ in a number of ways from those of the International Committee of Medical Journal Editors (ICMJE) and other journal editors, creating potential conflicts for sponsors and investigators who must comply with the law, and a need for better alignment of editors' policies with the law. The public will have access to massive amounts of clinical trial data as a result of FDAAA but it is unclear this will be useful to patients and prescribing physicians.
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Randomized Controlled Trial Multicenter Study
Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone.
This long-term prospective study was conducted in African Americans with persistent asthma to examine the safety and effectiveness of the combination of the inhaled corticosteroid, fluticasone propionate (FP), and the long-acting beta-agonist, salmeterol, compared with FP alone. ⋯ In this large, prospective study among African Americans with asthma, the addition of salmeterol to FP resulted in a similar low rate of exacerbations and improved other markers of asthma control. Both FSC 100/50 mcg and FP 100 mcg were well-tolerated, and the overall safety-profiles were similar over 1 year of treatment.
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Randomized Controlled Trial Comparative Study
Paper versus electronic rating scales for pain assessment: a prospective, randomised, cross-over validation study with 200 chronic pain patients.
Following the recent introduction of hand-held computers to be used by patients instead of conventional pencil-and-paper questionnaires, a validation study under 'real-life' conditions was conducted, in order to compare these two clinical instruments when used by chronic pain patients to describe their pain using visual and numerical rating scales. ⋯ Under conditions of routine clinical practice, the hand-held computer questionnaire can give results equivalent to those obtained with the conventional paper questionnaire.
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Hyponatremia, the most frequent electrolyte derangement identified among hospitalized patients, is associated with worsened outcomes in patients with pneumonia, heart failure and other disorders. ⋯ Hyponatremia is common at admission among hospitalized patients and is independently associated with a 55% increase in the risk of death, substantial hospital resource utilization and costs. Potential for bias inherent in the retrospective cohort design is the main limitation of our study. Studies are warranted to explore how prompt normalization of [Na(+)] may impact these outcomes.