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Bridging Strategy (bridging + strategy)
Selected AbstractsA framework for evidence-based mental health care and policyACTA PSYCHIATRICA SCANDINAVICA, Issue 2006L. Salvador-Carulla Objective:, Care planning integrates a growing number of disciplines, research fields and analysis techniques. A framework of the main areas of interest with regard to evidence-based health care in mental health is provided here. Method:, The framework is based on the experience of working with data analysts and health and social decision makers at the PSICOST/RIRAG network, a Spanish research association which includes psychiatrists, health economists and health policy experts, as well as on a review of the literature. Results:, Three main areas have been identified and described here: outcomes management, knowledge discovery from data, and decision support systems. Their use in mental health care is reviewed. Conclusion:, It is important to promote bridging strategies among these new fields in order to enhance communication and information transfer between the different parts involved in mental health decision making: i) clinicians and epidemiologists, ii) data analysts, iii) care policy makers and other end-users. [source] Bridging therapy in patients on long-term oral anticoagulants who require surgery: the Prospective Peri-operative Enoxaparin Cohort Trial (PROSPECT)JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 11 2007A. S. DUNN Summary., Background:, The peri-operative management of patients on oral anticoagulants (OACs) is a common clinical problem. Our aim was to determine the incidence of major bleeding during peri-operative administration of treatment-dose enoxaparin and the impact of the extensiveness of the procedure on the risk of bleeding. Methods:, We performed a prospective cohort study of 260 patients at 24 North American sites on OACs for atrial fibrillation or a history of deep vein thrombosis (DVT) requiring invasive or surgical procedures whose treating physician felt that bridging therapy was required. Warfarin was withheld, and once-daily s.c. enoxaparin (1.5 mg kg,1) was given peri-operatively. Patients were followed for 28 days after OAC was therapeutic. Results:, Major bleeding was observed in nine of 260 patients (3.5%, 95% CI: 1.6,6.5). The bleeding risk varied markedly by extensiveness of procedure: the incidence of major bleeding for invasive procedures, minor surgery and major surgery was 0.7% (95% CI: 0.02,3.7), 0% (95% CI: 0,5.0), and 20.0% (95% CI: 9.1,35.7), respectively. There were five thromboembolic events in total (1.9%, 95% CI: 0.6,4.4). There were four arterial events (2.3%, 95% CI: 0.6,5.7) in 176 patients with atrial fibrillation, and one venous event (1.0%, 95% CI: 0.03,5.7) in 96 patients with prior DVT. Conclusions:, Bridging therapy with once-daily therapeutic-dose enoxaparin administered primarily in an outpatient setting has a low incidence of major bleeding for patients undergoing invasive procedures and minor surgery. Further studies are needed to optimize the bridging strategy for patients undergoing major surgery. [source] Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidancePHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 2 2010Hui Quan Abstract Since the publication of the International Conference on Harmonization E5 guideline, new drug approvals in Japan based on the bridging strategy have been increasing. To further streamline and expedite new drug development in Japan, the Ministry of Health, Labour and Welfare, the Japanese regulatory authority, recently issued the ,Basic Principles on Global Clinical Trials' guidance to promote Japan's participation in multi-regional trials. The guidance, in a Q&A format, provides two methods as examples for recommending the number of Japanese patients in a multi-regional trial. Method 1 in the guidance is the focus of this paper. We derive formulas for the sample size calculations for normal, binary and survival endpoints. Computations and simulation results are provided to compare different approaches. Trial examples are used to illustrate the applications of the approaches. Copyright © 2009 John Wiley & Sons, Ltd. [source] Case Report: Extracorporeal Membrane Oxygenation in Nonintubated Patients as Bridge to Lung TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2010K. M. Olsson We report on the use of veno-arterial extracorporeal membrane oxygenation (ECMO) as a bridging strategy to lung transplantation in awake and spontaneously breathing patients. All five patients described in this series presented with cardiopulmonary failure due to pulmonary hypertension with or without concomitant lung disease. ECMO insertion was performed under local anesthesia without sedation and resulted in immediate stabilization of hemodynamics and gas exchange as well as recovery from secondary organ dysfunction. Two patients later required endotracheal intubation because of bleeding complications and both of them eventually died. The other three patients remained awake on ECMO support for 18,35 days until the time of transplantation. These patients were able to breathe spontaneously, to eat and drink, and they received passive and active physiotherapy as well as psychological support. All of them made a full recovery after transplantation, which demonstrates the feasibility of using ECMO support in nonintubated patients with cardiopulmonary failure as a bridging strategy to lung transplantation. [source] | ||||||||||