Flexible and incentive benefits: a guide to program development.
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BACKGROUND: Pooled data from New Drug Applications (NDAs) submitted to the U.S. Food and Drug Administration (FDA) provide an opportunity to study the incidence of and risk factors for rare events. OBJECTIVE: To examine the incidence and causes of mortality in patients with epilepsy participating in clinical trials of antiepileptic drugs (AEDs); and to examine the incidence of and risk factors for sudden unexplained death in such patients. METHODS: Exposure data and death narratives were obtained from the NDAs of five recently reviewed AEDs. Deaths were classified as sudden unexplained, accidental, or other cause using the 1993 Burroughs-Wellcome expert panel criteria, and mortality rates were calculated for each category. Add-on trials were analyzed separately from monotherapy initiation trials. RESULTS: Among 9,144 patients in the add-on trial database, the all-cause and sudden unexplained mortality rates were 9.1 and 3.8 deaths per 1,000 person-years (124 and 52 deaths in 13,617.1 person-years of drug exposure). Sixty-five percent of all deaths were related to the underlying epilepsy. Of the examined risk factors, only age was associated with the incidence of sudden unexplained death. Among 1,293 patients in the monotherapy initiation trials, the all-cause and sudden unexplained mortality rates were 7.1 and 0 deaths per 1,000 person-years (7 and 0 deaths in 982.5 person-years of drug exposure). CONCLUSIONS: A large proportion of the deaths in the add-on cohort was attributable to epilepsy-related causes. Mortality due to sudden death in the add-on cohort falls into the high end of the reported range for patients with epilepsy. The difference in mortality due to sudden death between the add-on and monotherapy initiation cohorts suggests that disease severity is the primary determining factor for risk of sudden unexplained death.
Between 1992 and 2003, services for homeless veterans at the Veterans Affairs Greater Los Angeles Healthcare System went from inappropriate utilization of hospital medical and psychiatric beds, to a continuum of residential treatment, transitional housing, and employment programs through arrangements with private agencies. The authors use elements of Hasenfeld and Brock's Political Economy Model (1991) to explain this transformation in service delivery that was spearheaded by a VA social work leadership team. It is argued that three driving forces crucial to program implementation were present: technological certainty, economic stability, and concentration of power. Evidence of the implementation's impact includes creation of new homeless program beds, a reduction in use of medical/psychiatric beds, and a large number of formerly homeless veterans with housing and employment at program discharge. Study limitations and implications for future studies are discussed.
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Growth hormone (GH) secretagogues are becoming increasingly attractive alternatives to GH or insulin-like growth factor-I (IGF-I) for the treatment of conditions that may benefit from activation of the GH/IGF-I axis. This stems from the realization that (1) GH secretagogues stimulate the pulsatile release of endogenous GH; (2) feedback control of endogenous GH and IGF-I is preserved, guarding against imbalances between GH and IGF-I levels; and (3) GH treatment is associated with adverse effects in the elderly. Of the GH secretagogues, growth hormone-releasing hormone (GHRH) remains the best characterized, in terms of identity of the ligand-receptor pair and its exclusive somatotropic activity at the level of the pituitary. Full-length natural GHRH (1-44) amide can now be produced by recombinant technologly on a commercially viable scale, and is currently being evaluated in early phase clinical trials. The purpose of these studies is to evaluate the efficacy and tolerability of chronic subcutaneous administration of GHRH over a range of doses in elderly subjects. Therapeutic areas that are being investigated in the elderly include congestive heart failure, osteoporosis, and improvements in body composition and function in the frail elderly.
Planning hybrid coronary artery revascularization--a combination of cardiac surgery with percutaneous procedures--requires, at first sight, a very complex logistical setup. Technical and equipment related details should be defined as early as possible in order to have time for training of all OR personnel involved. The most challenging aspect in OR-located hybrid coronary revascularization remains a very close cooperation of cardiac surgeons and interventional cardiologists. This teamwork does include indication findings and subsequent referral of multivessel coronary artery disease patients to hybrid procedures, as well as high individual flexibility of interventionalists and surgeons. The major prerequisite for this cooperation is a mutual acceptance of different revascularization approaches and the intent to combine their most striking advantages. Intraoperative graft angiography during coronary artery bypass grafting (CABG) procedures is one important step toward simultaneous hybrid coronary revascularization procedures. We describe our experience with on table angiography using a mobile C-arm for intraoperative imaging. This fluoroscopy system can in selected cases be used for simultaneous hybrid procedures.
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The purpose of this study was to evaluate the effectiveness of a teleconferenced program by comparing multiple program outcomes of learners enrolled at three off-campus sites to Chicago-based learners. An adaptation of the Stake (1967) countenance model guided the evaluation. The data analysis consisted of descriptive statistics, cross-tabulations, and content analyses of comments. The results indicated no statistical differences between groups in grade point average, satisfaction with the program generally or with the teleconferencing process, tenure in school nursing, job stability, adoption of management strategies, and school health programs directed to aggregates.