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[New pathways in undergraduate medical education - first experiences with the cross section speciality emergency and intensive care medicine].

OBJECTIVE: On October 1 (st) 2003 Emergency Medicine was recognised for the first time as an independent cross section speciality in the new German "Approbationsordnung fuer Aerzte" (Medical Licensing Regulations). These amendments were made not only to increase the amount of small group teaching sessions but also to encourage a multidisciplinary and rather practical approach to the related topics. This article portrays the realisation of these objectives in form of a multidisciplinary module, as it has been established at University of Göttingen Medical School since the summer semester of 2004. We present the new curriculum, calculate the associated personnel resources and demonstrate the results of the structured evaluation given by the participating students. METHODS: We linked the fields of emergency and intensive care medicine by splitting them up into submodules which the students had to run through according to a set rota. 162 students were allocated to 27 small groups. Every student received a total of 38.5 hours of teaching, with the workshops coming to 46.8 %. The workshops comprised of nine sessions, three in Emergency Medicine, four in Intensive Care Medicine and two at human patient simulators. In addition we scheduled a seminar and an accompanying lecture. The final examination was performed as an Objective Structured Clinical Evaluation (OSCE). RESULTS: The realisation of the new module required a total of 1290 working hours for medical staff and 130 for our student aids. Compared to all other modules of Goettingen University Medical School the module here presented obtained the highest overall evaluation score by the medical students. Lessons with a high amount of practical involvement (i. e. Emergency Medicine and simulator-based workshops) were significantly better evaluated than rather formal teaching techniques, such as the lectures and the seminar. According to the students' self-assessment the simulator-based workshops were seen particularly valuable for the facilitation of knowledge transfer into clinical practice. CONCLUSION: The determined realisation of the new German Medical Licensing Regulations requires considerable time resources. However, its evaluation by the medical students is strikingly positive.

Anesthesiology↗

An improved approach to the patient with metabolic acidosis: a need for four amendments.

Clinicians should identify life-threatening issues in patients with metabolic acidosis. These threats may be present before therapy begins and/or anticipated after therapy commences. By adding four amendments, short-comings in the commonly used clinical approaches for the diagnosis of metabolic acidosis can be overcome. First, a definition of metabolic acidosis should consider not only the concentration of bicarbonate but also the content of bicarbonate in the extra cellular fluid compartment. The latter requires a quantitative estimate of the ECF volume, which can be obtained using the hematocrit and/or the total protein concentration in plasma. Second, to determine if the basis for metabolic acidosis was the addition of acids or the loss of NaHCO 3 , one must hunt for new anions, not only in plasma, but also in the urine. Third, it is important to measure the venous as well as the arterial PCO2 to assess the capacity to buffer H+ while minimizing H + binding to intracellular proteins. Fourth, to assess the role of the kidney in a patient with metabolic acidosis, the urine osmolal gap and the concentration of creatinine in the urine should be measured to provide an estimate of the rate of excretion of ammonium.

Acid-Base Equilibrium↗

Profile of first-line nurse managers in New South Wales, Australia, in the 1990s.

AIMS: To determine a demographic profile, employment history and career plans of a sample of nursing unit managers (first-line managers) in New South Wales (NSW), Australia in 1999. To compare the profile of first-line nurse managers in 1999 with those in 1989. BACKGROUND: This study replicates another undertaken a decade earlier (see Duffield 1992). Tracking the changes to nurse manager positions is important, given changes to the educational preparation of nurses and restructuring within hospitals which have occurred in the past decade. METHOD: The same questionnaire was used in both studies, with minor amendments and the addition of two items to reflect changes to organizational structures, whereby nurse managers are now responsible for non-nursing staff. In 1999 all first-line nurse managers in the largest health service in NSW were invited to participate in the study. RESULTS: A response rate of 77% was achieved. There were few differences of note in the demographic profile from 1989 to 1999. However educationally, first-line nurse managers in 1999 were more highly qualified. A greater proportion had higher degrees and increasingly, in the management discipline. CONCLUSION: Perhaps reflecting these qualifications, more managers in 1999 indicated their intention to move to more senior management positions in the next decade. The mode for experience in this role of 1 year in both 1989 and 1999 reflects a worrying trend of high turnover and inexperience amongst this group of managers. While maternity relief might account for this result, further research needs to determine more precise reasons. The ad hoc bases on which expert clinicians (clinical nurse specialists) act as the manager in his/her absence need to be critically examined. Alternative strategies such as introducing a formal second- in-charge position may ensure more successful recruitment and retention of staff to these critical management positions.

Adult↗

A kinetic approach to evaluate salinity effects on carbon mineralization in a plant residue-amended soil.

The interaction of salinity stress and plant residue quality on C mineralization kinetics in soil is not well understood. A laboratory experiment was conducted to study the effects of salinity stress on C mineralization kinetics in a soil amended with alfalfa, wheat and corn residues. A factorial combination of two salinity levels (0.97 and 18.2 dS/m) and four levels of plant residues (control, alfalfa, wheat and corn) with three replications was performed. A first order kinetic model was used to describe the C mineralization and to calculate the potentially mineralizable C. The CO(2)-C evolved under non-saline condition, ranged from 814.6 to 4842.4 mg CO(2)-C/kg in control and alfalfa residue-amended soils, respectively. Salinization reduced the rates of CO(2) evolution by 18.7%, 6.2% and 5.2% in alfalfa, wheat and corn residue-amended soils, respectively. Potentially mineralizable C (C(0)) was reduced significantly in salinized alfalfa residue-treated soils whereas, no significant difference was observed for control treatments as well as wheat and corn residue-treated soils. We concluded that the response pattern of C mineralization to salinity stress depended on the plant residue quality and duration of incubation.

Carbon↗

Managing ammonia emissions from dairy cows by amending slurry with alum or zeolite or by diet modification.

Animal agriculture is a significant source of atmospheric ammonia. Ammonia (NH3) volatilization represents a loss of plant available N to the farmer and a potential contributor to eutrophication in low-nitrogen input ecosystems. This research evaluated on-farm slurry treatments of alum or zeolite and compared three diets for lactating dairy cows in their effectiveness to reduce NH3 emissions. NH3 emissions were compared using a group of mobile wind tunnels. The addition of 2.5% alum or 6.25% zeolite to barn-stored dairy slurry reduced NH3 volatilization by 60% and 55%, respectively, compared to untreated slurry. The alum conserved NH3 by acidifying the slurry to below pH 5, while the zeolite conserved ammonia by lowering the solution-phase nitrogen through cation exchange. The use of alum or zeolite also reduced soluble phosphorus in the slurry. NH3 loss from fresh manure collected from lactating dairy cows was not affected by three diets containing the same level of crude protein but differing in forage source (orchardgrass silage vs. alfalfa silage) or neutral detergent fiber (NDF) content (30% vs. 35% NDF). NH3 losses from the freshly excreted manures occurred very rapidly and included the urea component plus some unidentified labile organic nitrogen sources. NH3 conservation strategies for fresh manures will have to be active within the first few hours after excretion in order to be most effective. The use of alum or zeolites as an on-farm amendment to dairy slurry offers the potential for significantly reducing NH3 emissions.

Alum Compounds↗

Everolimus versus mycophenolate mofetil in the prevention of rejection in de novo renal transplant recipients: a 3-year randomized, multicenter, phase III study.

BACKGROUND: This 36-month, randomized, parallel-group study compared safety and efficacy of two doses of everolimus with mycophenolate mofetil (MMF) in de novo renal-transplant recipients. METHODS: Renal-allograft recipients received 1.5 mg/day or 3 mg/day of everolimus or 2 g/day of MMF, plus full-dose cyclosporine (CsA) and corticosteroids after randomization. For at least their first year, patients received study medication according to a double-blinded, double-dummy design. Concerns over nephrotoxicity led to a protocol amendment to an open-label design with reduced CsA troughs. RESULTS: Incidences of primary efficacy failure at 36 months (biopsy-proven acute rejection, graft loss, death, or loss to follow-up) were everolimus 1.5 mg/day, 33.7% (65/193); everolimus 3 mg/day, 34.0% (66/194); and MMF, 31.1% (61/196) (P=0.810). Antibody-treated acute rejection at 36 months was significantly lower with everolimus 1.5 mg (9.8%) than MMF (18.4%, P=0.014). Discontinuation for adverse events was more frequent with everolimus and hemolytic uremic syndrome, lymphoproliferative disease, and proteinuria, and higher serum creatinine occurred at increased frequency relative to the MMF arm. Creatinine levels in the everolimus arms were stable in follow-up: the mean rise in creatinine over the first 6 months of the open-label phase was 3 micromol/L or greater with everolimus and 7 micromol/L with MMF. However, serum creatinine levels were lower in the MMF group throughout. Death and graft loss were higher in the everolimus arms (not significant). CONCLUSIONS: As part of triple-drug immunosuppression, everolimus (1.5 or 3 mg/day) was as efficacious as MMF, although the side-effect profile featured increased adverse events. Nephrotoxicity/calcineurin-inhibitor-related adverse events will require judicious lowering of CsA exposure with monitoring of everolimus troughs.

Adolescent↗

The application of 1H HR-MAS NMR spectroscopy for the study of structures and associations of organic components at the solid-aqueous interface of a whole soil.

High resolution-magic angle spinning nuclear magnetic resonance (HR-MAS NMR) allows the application of solution-state NMR experiments to samples that are not fully soluble and contain solids. Only the species in contact with the solvent system employed become NMR observable. In this study utilizing D2O as the solvent system we show it is possible to examine the structures at the solid-aqueous interface of a whole soil. Combining one- and two-dimensional HR-MAS NMR allowed, for the first time, the identification of fatty acids, aliphatic esters, and ethers/ alcohols as prominent species at the solid-aqueous interface of the soil with signals from sugars and amino acids also apparent. Few, if any signals from aromatic protons were observed when the soil was swollen in aqueous media, although these signals are observed in extracts from the same soil and when the soil is swollen with a more penetrating solvent(DMSO-d6)which is known to disassociate hydrogen bonds. These findings indicate that the soil aromatic moieties are protected in hydrophobic regions which are not water accessible. Furthermore, when the soil was amended with a herbicide (trifluralin), direct observations of interactions between the protons on a xenobiotic and the surrounding soil matrix were possible for the first time. HR-MAS promises to be a method that can be widely applicable to a range of complex environmental samples without the need for extraction, pretreatment, or purification.

Environmental Monitoring↗

The European Community classification of chemicals for reproductive toxicity.

The classification and labelling of dangerous substances was first introduced in 1967 in the European Community with Council Directive 67/548/EEC known as the Dangerous Substances Directive. The "6th Amendment" to this directive in 1979 introduced a notification procedure and a requirement for labelling chemicals for toxicity. Three special categories for labelling were for "Carcinogenicity, Mutagenicity and Teratogenicity". The teratogenicity classification was restricted to chemicals inducing "teratogenic" effects in the classical sense of the word ie. producing only gross structural malformations. Discussions by expert advisors to the European Commission over several years has lead to a widening of concern in this area of toxicology and under the forthcoming "7th Amendment" the classification of "Teratology" will be changed to "Toxic to Reproduction". This will include adverse effects on fertility, pre- and postnatal development and lactation and will encompass not only structural but also functional deficits. This will bring about a major change in the testing requirements to allow adequate classification of chemicals for these other aspects of reproductive toxicity.

Animals↗

Tightening the screw: statutory and legal supervision of interhospital patient transfers.

A federal statute governing the transfer of indigent patients from Medicare-enrolled hospitals was first enacted in 1986. Review of the statutory and other legal controls over interhospital transfers is precipitated by its recent amendment and the fining of a Texas physician for transferring a high-risk obstetric patient without following the statutory guidelines. These events are part of a pattern of increasing regulation of the practice of medicine. Physicians and hospital administrators responsible for hospital transfer policies should be aware of regulatory developments. Hospitals contemplating transfer of patients must develop transfer policies that comply with governing law, including state law. A transfer policy should provide guidelines as to when a patient is "stable for transfer". Patients may not be transferred unless a physician can certify that delay attendant to transfer will not be detrimental. Furthermore, the policy should specify the procedures to be followed to effect a transfer and any documentation that the physician will have to complete.

Clinical Protocols↗

ISHAGE bone marrow processing survey: report on an international information gathering process. International Society for Hematotherapy Graft Engineering.

Significant amounts of information are currently available within the database generated by the responses to the Bone Marrow Processing Survey. As additional Surveys are returned, the data will continue to be entered into a Lotus spreadsheet, until a more sophisticated database with a programmed interface becomes available. The readership is encouraged to enter or edit the databank by returning a completed or amended Survey to the Society. Copies of the form are available from the Society or can be found in the first issue of the Journal of Hematotherapy.

Blood Transfusion, Autologous↗

The European Community Directive on the classification and labeling of chemicals for reproductive toxicity.

The classification and labeling of dangerous substances was first introduced in 1967 in the European Community with Council Directive 67/548/EEC, known as the Dangerous Substances Directive. The Sixth Amendment to this directive in 1979 introduced a notification procedure for new chemicals and a requirement for labeling chemicals for toxicity. Three special categories for labeling were for carcinogenicity, mutagenicity, and teratogenicity. The teratogenicity classification was restricted to chemicals inducing teratogenic effects in the classical sense of the word, ie, producing only gross structural malformations. Discussions by expert advisors to the European Commission over several years led to a widening of concern in this area of toxicology and, under the recent Seventh Amendment, the classification of "teratology" has been changed to "toxic to reproduction." This includes adverse effects on fertility, pre- and postnatal development, and lactation, and encompasses not only structural but also functional deficits. This will bring about a major change in the testing requirements to allow adequate classification of chemicals for these other aspects of reproductive toxicity.

European Union↗

Heavy metal mobility in biosolids-amended glaciated soils.

The mobility of heavy metals from one-time application of biosolids (i.e., compost, pellet, and cement kiln dust stabilized biosolids) onto glaciated soils (Paxton soil) was studied because previous work on metal leachate characteristics from different biosolids is limited for glaciated soils. Two types of batch tests were performed: first, a pH-edge adsorption study to evaluate the effect of pH on heavy metal adsorption to Paxton soil and, second, a pH-edge leaching study to evaluate the effect of pH on the leaching potential of heavy metals from biosolids-amended Paxton soil. Finally, a semicontinuous soil column study was performed to assess the mobility of heavy metals from biosolids-amended Paxton soil. The pH-edge leaching results showed that the leaching potential of heavy metals was lower with the compost product. Desorption concentrations for arsenic, chromium, and lead were found to be greatest in the cement kiln dust stabilized product whereas cadmium, copper, and nickel were present at the greatest concentrations in the pellets. The total organic carbon results measured during the pH-edge leaching study indicated that there is a minimum leachable concentration in the pH range of 4 to 5 for all three biosolids. Overall, the column studies indicated that heavy metals were not readily leached from the three biosolids-amended Paxton soils. The results from this study suggest that a one-time land application of these biosolids will not adversely affect groundwater quality.

Conservation of Natural Resources↗

Environmental Protection Agency--Hazardous waste and consolidated permit regulations, Parts II-IX. Revisions to final rule and interim final rule and requests for comments.

Subtitle C of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended (RCRA), directs the Environmental Protection Agency (EPA) to promulgate regulations to protect human health and the environment from the improper management of hazardous waste. The first phase of EPA's regulations implementing this directive are contained in Parts 262 and 263 of this chapter (which were promulgated on February 26, 1980) and Parts 261, 264, 265, 122, 123, and 124 of this chapter (which are being promulgated today). This regulation (Part 260) sets forth definitions of words and phrases which appear in Parts 261 through 265 and contains provisions which are generally applicable to all those regulations. It was originally published on February 26, 1980, concurrent with the promulgation of EPA's Part 262 and 263 regulations. It is now being amended to add new provisions required by today's publication of Parts 261, 264 and 265 and to revise one of the definitions published in February.

Government Agencies↗

Comparison of anticoagulant effects and safety of argatroban and heparin in healthy subjects.

STUDY OBJECTIVE: To evaluate and compare the relationship between dosage and coagulation parameters, as well as safety profiles, of ascending bolus and infusion dosages of argatroban versus heparin in three phase I studies. DESIGN: Two randomized, double-blind studies compared argatroban and heparin, and one open-label, dose-escalation study further evaluated argatroban. SETTING: University teaching hospital clinical research unit. PATIENTS: Healthy men (aged 22-62 yrs). INTERVENTION: In the first study, 36 subjects received an argatroban 30-, 60-, 120-, or 240-microg/kg bolus, or a heparin 30-, 60-, 120-, or 240-U/kg bolus for three subjects, then amended to 15, 30, 60, or 120 U/kg. In the second study, 37 subjects received argatroban 1.25, 2.5, 5, or 10 microg/kg/minute with or without a 250-microg/kg bolus, or heparin 0.15, 0.20, 0.25, or 0.30 U/kg/minute with or without a 125-U/kg bolus. In the third study (open-label), nine subjects received an argatroban 250-microg/kg bolus plus an infusion of 15, 20, 30, and 40 microg/kg/minute. MEASUREMENTS AND MAIN RESULTS: When administered as a bolus dose in the first study, argatroban and heparin both produced dose-related increases in activated clotting time (ACT) and activated partial thromboplastin time (aPTT) within 10 minutes of administration. Dissipation of anticoagulant effect was approximately 4-fold faster for argatroban than for heparin. When administered by infusion with or without a bolus in the second study, argatroban, but not heparin, produced predictable dose-related increases in ACT and aPTT that were generally consistent across both effect measures and modes of administration. Effect steady state was attained by five or more subjects per dosing group receiving argatroban (5-9) but typically two or fewer subjects per group receiving heparin (0-7). Furthermore, upon cessation of infusion, anticoagulant effects dissipated faster for argatroban (effect half-life 18-41 min) than for heparin (effect half-life 23-134 min). When argatroban was infused without a bolus, peak and effect steady-state values for ACT and aPTT generally were attained within 1-3 hours. Data from the second and third studies show that for argatroban dosages up to 40 microg/kg/minute, plasma drug concentrations attained at 4 hours of infusion increased linearly with dose, and weight-adjusted plasma clearance was dose independent. In all studies, argatroban and heparin were well tolerated. CONCLUSION: Anticoagulation was more predictable with argatroban than with heparin as measured by ACT and aPTT, with comparable safety profiles.

Adult↗

Regulation, coverage, and reimbursement of medical technologies.

Two major barriers to the introduction and diffusion of medical devices exist. First, devices must be cleared for marketing by The United States Food and Drug Administration, as mandated by the Medical Device Amendments of 1976. Second, third party payers are now making explicit determinations about whether or not to cover the specific applications of medical devices and about appropriate levels of reimbursement. This paper illustrates these processes which are based upon the evaluation of the safety and effectiveness of medical devices and examines the implications of the processes for the innovation and availability of such technology.

Diffusion of Innovation↗

A marked increase in organ donation in Puerto Rico.

During its first years of existence, the Puerto Rico Transplant Program barely reached 18 to 20 renal transplants per year. A brain death amendment to the law improved the numbers but only to a stable thirty/year. Polls and studies showed that, although people knew about transplantation and expressed willingness to donate, the powerful emotional grief reaction, as well as a peculiar decision-making process, all militated against effective donation. In 1995, LifeLink of Puerto Rico was created as part of the very successful LifeLink Foundation of Tampa, staffed by local professionals. Cadaveric donation increased exponentially by 1227% and in 2004, 22.4 donors per million population were recovered, up from 1.5, one of the steepest growth curves in the United States. As a result, kidney transplantation increased, a cardiac transplant program was inaugurated, a pancreas transplant program has started, and liver will follow. The success is the result of well-trained, culturally sensitive coordinators and requestors; continuous education to the public, hospitals, administrators, neurospecialists, and critical care units; hospital development; implementation of federal law; and a sensitive approach the deceased donor family, and not only to the waiting list patients. The results demonstrate that organizational and educational factors can override cultural obstacles.

Brain Death↗

The effect of polymer addition on granulation in an anaerobic baffled reactor (ABR). Part II: compartmentalization of bacterial populations.

The microbial ecology of wastewater treatment plants remains one of the least understood aspects in both aerobic and anaerobic systems, despite the fact that both processes are ultimately dependent on an active biomass for operational efficiency. Ultimately, future developments in anaerobic treatment processes will require a much greater understanding of the fundamental relationships between bacterial populations within the biomass if optimum process efficiency is to be fully realised. This study assesses the influence of polymer addition on granule formation within an ABR and compares the ecology of the biomass in each compartment of two ABRs treating ice-cream wastewater. To our knowledge, this is the first reported characterisation of the microbiology of acidogenic and methanogenic bacteria in the individual compartments of an ABR. The polymer-amended reactor contained sludge that had a greater density of anaerobic bacteria and larger and denser granules than the control reactor, indicating that polymer addition possibly contributed to the retention of active biomass within the ABR. The average fraction of autofluorescent methanogens was lower, with 1.5% being in the initial compartments of the ABRs, compared to the last compartment which had 15%, showing that each compartment of an ABR had a unique microbial composition. Partial spatial separation of anaerobic bacteria appeared to have taken place with acidogenic bacteria predominating in the initial compartments and methanogenic bacteria predominating in the final compartments. Scanning electron micrographs have revealed that the dominant bacteria in the initial compartments of the ABR (Compartments 1 and 2) were those which could consume H2/CO2 and formate as substrate, i.e. Methanobrevibacter, Methanococcus, with populations shifting to acetate utilisers, i.e. Methanosaeta, Methanosarcina, in the final compartments (Compartments 3 and 4). In addition, there appeared to be a stratified structure to the bacterial genera present within the granules.

Bacteria, Anaerobic↗

The direction of end-stage renal disease reimbursement in the United States.

In the 1960s, care of the end-stage renal disease (ESRD) patient changed. Either through transplantation or intermittent hemodialysis ESRD patients were able to live longer. The Gottschalk Committee issued the "Report of the Committee on Chronic Kidney Disease" to the Bureau of Budget. This report established that hemodialysis and kidney transplantation were the standard of care for the treatment of ESRD patients. Section 2991 of the Social Security Amendment of 1972 provided that patients with ESRD who qualified for Medicare were entitled to receive dialysis and/or transplantation nationwide. The first Medicare hearing held in 1975 regarding the Medicare ESRD program found that the cost of the program was much greater than had been predicted in 1972. Ever since 1975, accelerating cost has been a concern of the government. Quality of care for ESRD patients has been a major focus of the renal community and the Centers for Medicare and Medicaid Services (CMS) over the past 10 years. Consensus for entitlement has remained, but the staggering cost of the program as a whole has become a major problem that must be addressed. Since 1978, Congress and the CMS have passed laws and developed demonstration projects to improve quality of care and reduce costs in the Medicare ESRD program. Kt/V, urea reduction ratio (URR), and hemoglobin levels have all improved, but hospital admissions have remained unchanged and mortality rates have increased. Do the renal community and CMS need to rethink how they will improve the quality of care for ESRD patients and reduce costs in the Medicare ESRD program?

Cost Control↗