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Reporting Outcomes (reporting + outcome)
Selected AbstractsAltering Investment Decisions to Manage Financial Reporting Outcomes: Asset-Backed Commercial Paper Conduits and FIN 46JOURNAL OF ACCOUNTING RESEARCH, Issue 5 2008DANIEL A. BENS ABSTRACT We evaluate the manner in which sponsors of highly leveraged asset-backed commercial paper (ABCP) conduits responded to Financial Accounting Standards Board Interpretation No. 46 (FIN 46), Consolidation of Variable Interest Entities an Interpretation of ARB No. 51, and its Canadian counterpart Accounting Standards Board of Accounting Guideline 15 (AcG-15), Consolidation of Variable Interest Entities. By matching commercial paper investors with corporations seeking liquidity, ABCP sponsors facilitate a significant amount of short-term, securitized financing in the United States. FIN 46 and AcG-15 require sponsors to consolidate their ABCP conduits with their financial statements. We demonstrate that the volume of ABCP began to decline when FIN 46 was first proposed, and that this decline is primarily attributable to a reduction in North American banks' sponsorship of ABCP. We also demonstrate that North American banks entered into costly restructuring arrangements to avoid having to consolidate their conduits per the new accounting standards. Our results suggest that, in certain settings, accounting standards appear to have real effects on investment activity and product-market competition. [source] Reporting outcomes in clinical trials for bipolar disorder: a commentary and suggestions for changeBIPOLAR DISORDERS, Issue 5 2008Anabel Martinez-Arán Objective:, Newer outcome measures and statistical reporting that better translate efficacy data to evidence-based psychiatric care are needed when evaluating clinical trials for bipolar disorder. Using efficacy studies as illustrations, the authors review and recommend changes in the reporting of traditional clinical outcomes both in the acute and maintenance phases of bipolar disorder. Methods:, Definitions of response, remission, relapse, recovery, and recurrence are reviewed and recommendations for change are made. These suggestions include reporting the numbers needed to treat or harm (NNT or NNH), and a ratio of the two, likelihood of help or harm (LHH), as an important element of the effect size (ES). Moreover, models of prediction that conduct sensitivity or specificity analyses and utilize decision trees to help predict positive and negative outcomes of interest (for instance, excessive weight gain, or time to remission) using positive or negative predictive values (PPV or NPV) are reviewed for potential value to clinicians. Finally, functional and cognitive assessments are recommended for maintenance studies of bipolar disorder. Results:, The examples provided in this manuscript underscore that reporting the NNT or NNH, or alternative effect sizes, or using PPV or NPV may be of particular value to clinicians. Such reports are likely to help translate efficacy-driven clinical data to information that will more readily guide clinicians on the benefits and risks of specific interventions in bipolar disorder. Conclusions:, The authors opine that reporting these newer outcomes, such as NNT or NNH, area under the receiver operating curve (AUC), or PPV or NPV will help translate the results of clinical trials into a language that is more readily understood by clinicians. Moreover, assessing and evaluating functional and cognitive outcomes will not only inform clinicians about potential differences among therapeutic options, but likely will make it easier to communicate such differences to persons with bipolar illness or to their families. Finally, we hope such scientific and research efforts will translate to optimism for recovery-based outcomes in persons with bipolar disorder. [source] Systematic review of the efficacy of antiretroviral therapies for reducing the risk of mother-to-child transmission of HIV infectionJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2007N. Suksomboon PhD Summary Objective:, To evaluate the efficacy of antiretroviral therapies in reducing the risk of mother-to-child transmission of HIV infection. Methods:, Systematic review and meta-analysis of randomized controlled trials. Clinical trials of antiretrovirals were identified through electronic searches (MEDLINE, EMBASE, BIOSIS, EBM review and the Cochrane Library) up until November 2006. Historical searches of reference lists of relevant randomized controlled trials, and systematic and narrative reviews were also undertaken. Studies were included if they were (i) randomized controlled trials of any antiretroviral therapy aimed at decreasing the risk of mother-to-child transmission of HIV infection, (ii) reporting outcomes in terms of HIV infection in infant, infant death, stillbirth, premature delivery, or low birth weight. The data were extracted by a single investigator and checked by a second investigator. Disagreements were resolved through discussion or a third investigator. The efficacy was estimated using relative risk (RR), risk difference (RD) and number needed to treat (NNT) together with 95% confidence intervals. Results:, Fifteen trials were included in the systematic review. Based on five placebo-controlled trials, a zidovudine regimen reduced the risk of mother-to-child transmission by 43% (95% CI: 29,55%). The incidence of low birth weight seems to be decreased with zidovudine (pooled RR 0·75, 95% CI: 0·57,0·99). The efficacy of short-short course of zidovudine was comparable with that of the long-short course. Nevirapine monotherapy given to mothers and babies as a single dose reduced the risk of vertical transmission compared with an intrapartum and post-partum regimen of zidovudine (RR 0·60, 95% CI: 0·41,0·87). Zidovudine plus lamivudine was effective in reducing the risk of maternal-child transmission of HIV (RR 0·63, 95% CI: 0·45,0·90). Adding zidovudine to single-dose nevirapine in babies was no more effective than nevirapine alone (pooled RR 0·88, 95% CI: 0·47,1·63), nor was there any significant difference between zidovudine plus lamivudine and nevirapine. In mothers who were treated with standard antiretroviral therapy, no additional benefit was observed with the addition of a single dose of nevirapine in mothers and newborns. In addition, for mothers who received zidovudine prophylaxis, a two-dose intrapartum/newborn nevirapine reduced the risk of HIV infection and death of babies by 68% (95% CI: 39,83%) and 80% (95% CI: 10,95%), respectively, when compared with placebo. Conclusions:, The available evidence suggests that zidovudine alone or in combination with lamivudine and nevirapine monotherapy is effective for the prevention of mother-to-child transmission of HIV. They may also be beneficial in reducing the risk of infant death. Different antiretroviral regimens appear to be comparably effective in reducing HIV transmission from mothers to babies. In mothers already receiving zidovudine prophylaxis, adding a single dose of nevirapine to mothers during labour and giving the same drug to infants may further decrease the risk of vertical transmission and infant death. [source] A Systematic Review of Gender Differences in Mortality after Coronary Artery Bypass Graft Surgery and Percutaneous Coronary InterventionsCLINICAL CARDIOLOGY, Issue 10 2007Catherine Kim M.D., M.P.H. Abstract Gender differences exist in outcomes, particularly early mortality, for percutaneous interventions (PCI) and coronary artery bypass graft surgery (CABG). Better understanding of this issue may target areas for improvement for all patients undergoing revascularization. Therefore, we summarized the evidence on gender differences in PCI and CABG outcomes, particularly early mortality, and mediators of this difference. Using the key terms "women" or "gender," "revascularization," "coronary artery bypass," "angioplasty," "stent," and "coronary intervention," we searched MEDLINE from 1985 to 2005 for all randomized controlled trials (RCTs) and registries reporting outcomes by gender. Bibliographies and the Web sites of cardiology conferences were also reviewed. The literature was examined to identify gender differences in outcomes and mediators of these differences. We identified 23 studies reporting outcomes by gender for CABG and 48 studies reporting outcomes by gender for PCI. The majority of studies noted greater in-hospital mortality in women than in men, with mortality differences resolving with longer follow-up. Early mortality differences were reduced but not consistently eliminated after adjustment for comorbidities, procedural characteristics, and body habitus. Power to detect gender differences after multivariate adjustment was limited by declining mortality rates and small sample size. Gender was an independent risk factor for complications after both CABG and PCI. Women experience greater complications and early mortality after revascularization. Future exploration is needed of gender differences in quality of care and benefit from combinations of stenting and antiplatelet, and anticoagulant medications in order to optimize treatment. Copyright © 2007 Wiley Periodicals, Inc. [source] What influence do anticoagulants have on oral implant therapy?CLINICAL ORAL IMPLANTS RESEARCH, Issue 2009A systematic review Abstract Objectives: This systematic review aims to assess the risks (both thromboembolic and bleeding) of an oral anticoagulation therapy (OAT) patient undergoing implant therapy and to provide a management protocol to patients under OAT undergoing implant therapy. Material and methods: Medline, Cochrane Data Base of Systematic Reviews, the Cochrane Central Register of Controlled Trials and EMBASE (from 1980 to December 2008) were searched for English-language articles published between 1966 and 2008. This search was completed by a hand research accessing the references cited in all identified publications. Results: Nineteen studies were identified reporting outcomes after oral surgery procedures (mostly dental extractions in patients on OAT following different management protocols and haemostatic therapies). Five studies were randomized-controlled trials (RCTs), 11 were controlled clinical trials (CCTs) and three were prospective case series. The OAT management strategies as well as the protocols during and after surgery were different. This heterogeneity prevented any possible data aggregation and synthesis. The results from these studies are very homogeneous, reporting minor bleeding in very few patients, without a significant difference between the OAT patients who continue with the vitamin K antagonists vs. the patients who stopped this medication before surgery. These post-operative bleeding events were controlled only with local haemostatic measures: tranexamic acid mouthwashes, gelatine sponges and cellulose gauzes's application were effective. Post-operative bleeding did not correlate with the international normalised ratio (INR) status. In none of the studies was a thromboembolic event reported. Conclusions: OAT patients (INR 2,4) who do not discontinue the AC medication do not have a significantly higher risk of post-operative bleeding than non-OAT patients and they also do not have a higher risk of post-operative bleeding than OAT patients who discontinue the medication. In patients with OAT (INR 2,4) without discontinuation, topical haemostatic agents were effective in preventing post-operative bleeding. OAT discontinuation is not recommended for minor oral surgery, such as single tooth extraction or implant placement, provided that this does not involve autogenous bone grafts, extensive flaps or osteotomy preparations extending outside the bony envelope. Evidence does not support that dental implant placement in patients on OAT is contraindicated. [source] | ||||||||||