Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “First Amendment”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 937 records · Page 52Linked to original sources

Air toxics regulatory issues facing urban settings.

Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of dose/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early waming signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies, both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome.

Air Pollutants↗

From SARA to Homeland Security: the NIEHS Worker Education and Training Program confronts challenges of environmental cleanup.

Section 126(g) of the Superfund Amendments and Reauthorization Act of 1986 mandated the National Institute of Environmental Health Sciences to establish a grant program for the training and education of hazardous waste operations and emergency response workers. This program, originally established as the Superfund Worker Training Program, has evolved into the Worker Education and Training Program (WETP) and is currently in its nineteenth year of successful operation. Beginning with eleven awardees in 1987, it currently supports eighteen awardees that include more than one hundred organizations nationally. The NIEHS WETP built upon the lessons learned from earlier worker health education and training programs to establish a national worker health education intervention that has demonstrated the capacity of and potential for public health excellence. The principles and practices established as the program's foundation in its first five years are detailed, providing a basis for understanding how the program was able to take an active supporting role in response to the national disasters on September 11, 2001.

Community Participation↗

Isolation and characterization of novel denitrifying alkalithermophiles, AT-1 and AT-2.

Two novel denitrifying alkalithermophilic bacteria, AT-1 and AT-2, were isolated from manure-amended soil. The isolates grew at 35-65 degrees C with an optimum temperature at 50-60 degrees C, and pH 6.5-10.0 with an optimum pH at 9.5. Both isolates were Gram-positive, facultative anaerobic, non-motile rod-shaped bacteria. A phylogenetic analysis based on 16S rRNA sequence data indicated that both AT-1 and AT-2 are members of the genus Anoxybacillus. DNA-DNA hybridization revealed moderate relatedness between AT-1 and AT-2 and one phylogenetically related strain, A. pushchinensis K1 (69.5 and 69.1%, respectively). Comparative analysis of morphology and biochemical characteristics of the two isolates also showed similarity to A. pushchinensis K1. Based on these results, we identified AT-1 and AT-2 as A. pushchinensis. To our knowledge, this is the first report of denitrifying bacterium isolated from alkalithermophilic Anoxybacillus spp.

Bacillaceae↗

Nitrogen management in a maize-groundnut crop rotation of humid tropics: effect on N2O emission.

Development of appropriate land management techniques to attain sustainability and increase the N use efficiency of crops in the tropics has been gaining momentum. The nitrous oxides (N2Os) affect global climate change and its contribution from N and C management systems is of great significance. Thus, N transformations and N2O emission during maize-groundnut crop rotation managed with various N sources were studied. Accumulation of nitrate (NO3- ) and its disappearance happened immediately after addition of various N sources, showing liming effect. The mineral N retained for 2-4 weeks depending on the type and amount of N application. The chicken manure showed rapid nitrification in the first week after application during the fallow period, leading to a maximum N2O flux of 9889 g N2O-N m(-2) day(-1). The same plots showed a residual effect by emitting the highest N2O (4053 microg N2O-N m(-2) day(-1)) during maize cultivation supplied with a half-rate of N fertilizer. Application of N fertilizer only or in combination with crop residues exhibited either lowered fluxes or caused a sink during the groundnut and fallow periods due to small availability of substrates and/or low water-filled pore space (<40%). The annual N2O emission ranged from 1.41 to 3.94 kg N2O-N ha(-1); the highest was estimated from the chicken manure plus crop residues and half-rate of inorganic N-amended plots. Results indicates a greater influence of chicken manure on the N transformations and thereby N2O emission.

Agriculture↗

Medicare and Medicaid programs; surety bond and capitalization requirements for home health agencies--HCFA. Final rule with comment period.

The Balanced Budget Act of 1997-(BBA '97) requires each home health agency (HHA) to secure a surety bond in order to participate in the Medicare and Medicaid programs. This requirement applies to all participating Medicare and Medicaid HHAs, regardless of the date their participation began. This final rule with comment period requires that each HHA participating in Medicare must obtain from an acceptable authorized Surety a surety bond that is the greater of $50,000 or 15 percent of the annual amount paid to the HHA by the Medicare program, as reflected in the HHA's most recently accepted cost report. The BBA '97 also requires that provider agreements be amended to incorporate the surety bond requirement; this rule deems such agreements to be amended accordingly. The BBA '97 prohibits payment to a State for home health services under Medicaid unless the HHA has furnished the State with a surety bond that meets Medicare requirements. This final rule with comment period requires that, in order to participate in Medicaid, each HHA must obtain from an acceptable authorized Surety, a surety bond that is the greater of $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services for which Federal Financial Participation (FFP) is available. In addition to the surety bond requirement, an HHA entering the Medicare or Medicaid program on or after January 1, 1998 must demonstrate that it actually has available sufficient capital to start and operate the HHA for the first 3 months. Undercapitalized providers represent a threat to the quality of patient care.

Centers for Medicare and Medicaid Services, U.S.↗

Reductive dechlorination of carbon tetrachloride in aqueous solutions containing ferrous and copper ions.

Fe(II) associated with iron-containing minerals has been shown to be a potential reductant in natural subsurface environments. While it is known that the surface-bound iron species has the capacity to dechlorinate various chlorinated compounds, the role of transition metals to act as catalysts with these iron species is of importance. We previously observed that the reduction of Cu(II) by Fe(II) associated with goethite enhanced the dechlorination efficiency of chlorinated compound. In this study, the reductive dechlorination of carbon tetrachloride (CCl4) by dissolved Fe(II) in the presence of Cu(II) ions was investigated to understand the synergistic effect of Fe(II) and Cu(II) on the dechlorination processes in homogeneous aqueous solutions. The dechlorination efficiency of CCl4 by Fe(II) increased with increasing Cu(II) concentrations over the range of 0.2-0.5 mM and then decreased at high Cu(II) concentrations. The efficiency and rate of CCl4 dechlorination also increased with increasing dissolved Fe(II) concentration in the presence of 0.5 mM Cu(II) at neutral pH. When the Fe(II)/Cu(II) ratio varied between 1 and 10, the pseudo-first-order rate constant (k(obs)) increased 250-fold from 0.007 h(-1) at 0.5 mM Fe(II) to 1.754 h(-1) at 5 mM Fe(II). X-ray powder diffraction and scanning electron microscopy analyses showed that Cu(II) can react with Fe(II) to produce different morphologies of ferric oxides and subsequently accelerate the dechlorination rate of CCl4 at a high Fe(II) concentration. Amorphous ferrihydrite was observed when the stoichiometric Fe(II)/Cu(II) ratio was 1, while green rust, goethite, and magnetite were formed when the molar ratios of Fe(II)/Cu(II) reached 4-6. In addition, the dechlorination of CCl4 by dissolved Fe(II) is pH dependent. CCl4 can be dechlorinated by Fe(II) over a wide range of pH values in the Cu(II)-amended solutions, and the k(obs) increased from 0.0057 h(-1) at pH 4.3 to 0.856 h(-1) at pH 8.5, which was 9-25 times greater than that in the absence of Cu(II) at pH 7-8.5. The high reactivity of dissolved Fe(II) on the dechlorination of CCl4 in the presence of Cu(II) under anoxic conditions may enhance our understanding of the role of Fe(II) and the long-term reactivity of the zerovalent iron system in the dechlorination processes for chlorinated organic contaminants.

Carbon Tetrachloride↗

Parasuicide in an Arab industrial community: the Arabian-American Oil Company experience, Saudi Arabia.

The parasuicide phenomena was investigated for the first time in a retrospective and prospective way in an Arab industrial community in the Eastern Province of Saudi Arabia during 1985 and 1986. Though the parasuicide rate of 20.7 per 100,000 is substantially lower from the reported rates in the West, underreporting and misdiagnosing of the phenomena may explain the low rate. The results of this study confirm that the act is predominantly the activity of young females, and disordered interpersonal relationships with spouses and parents stand out as precipitating factors. Acute reaction to stress was the commonest diagnosis followed by depression. Deliberate self-poisoning by analgesics and psychotropic drugs was the commonest method used. The findings of this study refute the hypothesis that parasuicide is rare in this part of the world, and time probably has come to amend the law in order to give the opportunity for distressed people to receive help.

Adult↗

Update of guidelines for the prevention and treatment of infection in patients with an absent or dysfunctional spleen.

Guidelines for the prevention and treatment of infection in patients with an absent or dysfunctional spleen were first published by the British Committee for Standards in Haematology in 1996. Key aspects of these guidelines related to anti-infective prophylaxis, immunisation schedules and treatment of proven or suspected infection. A recent review of the guidelines was undertaken, with a view to updating the recommendations where necessary The guideline review process did not reveal any major change in patient groups considered at risk. Occupational exposure to certain pathogens may, however, be a new risk factor for some infections. The recommendations for anti-infective prophylaxis remain unchanged. New recommendations for vaccination include the use of meningococcal group C vaccine in previously non-immunised hyposplenic patients and a need to consider the use of seven-valent pneumococcal vaccine. Recommendations for treatment of suspected or proven infection have not been significantly amended, but a local protocol should take into account relevant resistance patterns. There is an identified urgent need for further research into the effectiveness of varying vaccination strategies in the hyposplenic patient, and audit of infective episodes in this patient group should continue long term. Key guidelines are summarised below, together with grades of recommendation.

Antibiotic Prophylaxis↗

Influence of the arbuscular mycorrhizal fungus Glomus mosseae on uptake of arsenate by the As hyperaccumulator fern Pteris vittata L.

We report for the first time some effects of colonization by an arbuscular mycorrhizal (AM) fungus (Glomus mosseae) on the biomass and arsenate uptake of an As hyperaccumulator, Pteris vittata. Two arsenic levels (0 and 300 mg As kg(-1)) were applied to an already contaminated soil in pots with two compartments for plant and hyphal growth in a glasshouse experiment. Arsenic application had little or no effect on mycorrhizal colonization, which was about 50% of root length. Mycorrhizal colonization increased frond dry matter yield, lowered the root/frond weight ratio, and decreased frond As concentration by 33-38%. Nevertheless, transfer of As to fronds showed a 43% increase with mycorrhizal colonization at the higher soil As level. Frond As concentrations reached about 1.6 g kg(-1) (dry matter basis) in non-mycorrhizal plants in the As-amended soil. Mycorrhizal colonization elevated root P concentration at both soil As levels and mycorrhizal plants had higher P/As ratios in both fronds and roots than did non-mycorrhizal controls.

Arsenates↗

[Reporting of patient deaths and grave injury incidental to clinical practice].

The Japan Surgical Society has developed guidelines for the reporting of patient deaths and grave injury incidentally occurring in their clinical courses, following its declaration in March 2001 in reference to practitioners' duty to notify the police under Article 21 of the Medical Act. These guidelines can be summarized into three points. First, they are ethical guidelines for practitioners and are not concerned with the legal duty required under the Medical Act. Second, they require reporting of patient deaths even if the cause is still not confirmed as medical malpractice, and reporting of grave injury due to apparent medical malpractice, not mention deaths due to apparent medical malpractice. Third, it is emphasized that the guidelines be applicable for the time being until some generalized system is established, which is specialized to accept reports about patient deaths and grave injury incidentally occurring in their clinical course from every hospital nationwide and to collect data concerning small incidents and risks in medical practice. The Japan Surgical Society strongly requests that such a general system start to function as soon as possible. In advance, the current guidelines should be amended repeatedly in reference to problems occurring in actual cases.

General Surgery↗

Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.

Iodine-131 tositumomab [B1, Bexxar , iodine-131 anti-B1 antibody] is a murine antibody conjugated to iodine 131 that recognises and binds to the B1 (CD20) antigen which is found specifically on B lymphocytes. Iodine-131 tositumomab has a dual mechanism of action. It is capable of initiating a host immune response to those B cells to which it is attached, and it also triggers apoptosis in a significant proportion of the cells to which it binds. The product was first discovered by Coulter Corporation, Miami, in collaboration with the Dana-Farber Cancer Institute and the University of Michigan. The spin-off company Coulter Pharmaceutical, upon its formation, obtained worldwide rights to iodine-131 tositumomab. (Coulter Corporation was acquired subsequently by Beckman Instruments in October 1997. The union of the two companies produced Beckman Coulter.) In December 2000, Coulter Pharmaceutical was acquired by, and merged into, Corixa Corporation.Iodine-131 tositumomab is available for licencing in Japan. Corixa Corporation and GlaxoSmithKline signed an agreement to jointly develop and commercialise iodine-131 tositumomab. The total agreement has a potential value of up to $US132 million, plus shared profits and royalties. The two companies will jointly market the antibody in the US following regulatory approval. Corixa Corporation has announced it expects iodine-131 tositumomab to be approved in the US for non-Hodgkin's lymphoma (NHL). Under the terms of the original agreement, GlaxoSmithKline will receive exclusive marketing rights outside the US, excluding Japan. However, an amended agreement between the two companies will allow Corixa Corporation to also market the product outside the US. In February 2003, the European Commission granted iodine-131 tositumomab orphan-drug designation. Corixa Corporation and GlaxoSmithKline also intend to jointly investigate the use of the product in other indications. GlaxoSmithKline may also receive access to second generation anti-CD20 compounds under its agreement with Corixa Corporation. In May 2003, Corixa Corporation entered into an agreement that will see GlaxoSmithKline market Bexxar in Canada. Under the terms of the agreement, Corixa Corporation will manufacture and supply the product to GlaxoSmithKline, who will register, market and sell it in Canada. In October 2001, Amersham PLC, a supplier of medical equipment, announced that its Amersham Health unit had signed a marketing agreement with Corixa Corporation. The agreement allows Amersham Health to market iodine-131 tositumomab in Europe. Corixa Corporation formed agreements with Boehringer Ingelheim Pharma KG and Lonza Biologics to produce the B1 antibody and radiolabelling of the antibody has been contracted out to MDS Nordion.Iodine-131 tositumomab has received orphan drug and fast track designation for the treatment of NHL. Corixa Corporation submitted a Biologics Licence Application (BLA) to the US FDA in 1999, seeking permission to market Bexxar in the US for the treatment of relapsed or refractory, low grade or transformed low grade B-cell NHL. Following a priority review, the US FDA requested that Corixa Corporation reformat certain sections and perform additional analyses of existing data in its BLA. Corixa Corporation and GlaxoSmithKline resubmitted their BLA to the US FDA in September 2000. The BLA was subsequently accepted by the US FDA in November 2000. However, in March 2001, the US FDA requested additional information in its complete review letter to Corixa Corporation and marketing partner GlaxoSmithKline. The two companies submitted data pertaining to the chemistry, manufacturing and controls section of the BLA, and to the majority of the questions regarding the clinical section of the BLA in August 2001. Corixa Corporation and GlaxoSmithKline submitted the remainder of the response to the US FDA in September 2001, following an independent review of clinical trial data. In March 2002, Corixa Corporation received another complete review letter from the US FDA, which stated that additional clinical trials would have to be conducted in order to provide adequate evidence of the safety and clinical benefit of Bexxa. The US FDA also denied Corixa Corporation's request for accelerated approval, stating that the data provided was inadequate to show that Bexxar filled an unmet medical need. Corixa Corporation has met formally with the US FDA but the two were unable to resolve their differences. Corixa Corporation will now file a formal request for dispute resolution under the Food and Drug Administration Modernisation Act. Corixa Corporation also requested a presentation of Bexxa data to the US FDA's scientific advisors. In June 2002, the US FDA granted the company's appeal for additional regulatory review. In December 2002, the US FDA's Oncologic Drugs Advisory Committee agreed that Bexxar has clinical benefit for patients with NHL. In May 2003, Corixa Corporation and GlaxoSmithKline announced that they had fulfilled many of the steps required for US FDA approval, however the US FDA has extended its review of the application for another 3 months. This extension will allow for further refinement of post marketing commitments and package insert language, and to ensure they are consistent with an updated safety database requested by the US FDA and submitted by Corixa Corporation in early April. GlaxoSmithKline was waiting for the outcome of the situation before deciding on marketing plans for Bexxar. Corixa Corporation and GlaxoSmithKline will conduct a head-to-head study of Bexxar and Idec's Zevalin, planned for mid-2003. The trial will likely be one of three phase IV studies that the US FDA requires for accelerated approval of Bexxar. Corixa Corporation initiated its Expanded Access Program for Bexxar in response to requests from physicians and patients for continued access to Bexxar during the period prior to potential US FDA marketing approval.A phase II multicentre trial of Bexxar in combination with CHOP chemotherapy is underway in the US as first-line therapy in patients with intermediate-grade NHL. Corixa Corporation has initiated a phase II trial of iodine-131 tositumomab in combination with cyclophosphamide, vincristine and prednisone for the treatment of previously untreated low-grade NHL. The trial was initiated while the company was preparing its BLA for Bexxar for use as a single agent for relapsed or refractory NHL. Corixa Corporation intends to pursue additional trials to expand the potential use of iodine-131 tositumomab to other indications, including chronic lymphocytic leukaemia. The agent is also in a clinical trial for preparation in autologous bone marrow transplant patients. The trial is designed to test the combination of iodine-131 tositumomab and chemotherapy. The trial began in 1995 and has so far enrolled 40 patients. In addition, a phase II dose-escalation trial has begun at the University of Nebraska for the combined use of iodine-131 tositumomab and chemotherapy as preparation for autologous bone marrow transplant. Corixa Corporation has received an issued US patent covering methods for administering and dosing radioimmunotherapy for the treatment of B-cell lymphomas. The patent covers iodine-131 tositumomab and other anti-CD20 antibodies used to aid in selective tumour targeting. Corixa Corporation has exclusive rights to the patent.A February 2000 media release from GlaxoSmithKline and Corixa Corporation stated that they had been issued a composition patent relating to radiolabelled monoclonal antibodies (including Bexxar) for the treatment of B-cell lymphomas. On 11 September 2001, IDEC announced that it had filed two separate lawsuits. The first lawsuit is against Corixa Corporation and the University of Michigan on six patents pertaining to products and processes related to radioimmunotherapy. They seek a declaration that Zevalin does not infringe Corixa Corporation's issued US patents. The second lawsuit involves two patents relating to cell culture media, and is against GlaxoSmithKline. IDEC's lawsuit in this case, seeks a declaration that its manufacture of Zevalin does not infringe GlaxoSmithKline's issued US patents. Corixa Corporation and GlaxoSmithKline have also filed a complaint for patent infringement against IDEC. These actions however, should have no effect on the regulatory process that Zevalin is completing, or prevent IDEC from launching the drug before iodine-131 tositumomab.A year earlier, in March 2001, the Financial Times reported that Bexxar could reach peak sales of $US120 million. In 1998, Coulter Pharmaceutical received a licencee fee payment of $US34 million from SmithKline Beecham (now GSK) in the fourth quarter of the year, as part of the joint development and commercialisation agreement for Bexxar.

Adjuvants, Immunologic↗

Benzene degradation coupled with chlorate reduction in a soil column study.

Perchlorate and chlorate are electron acceptors that during reduction result in the formation of molecular oxygen. The produced oxygen can be used for activation of anaerobic persistent pollutants, like benzene. In this study chlorate was tested as potential electron acceptor to stimulate benzene degradation in anoxic polluted soil column. A chlorate amended benzene polluted soil column was operated over a period of 500 days. Benzene was immediately degraded in the column after start up, and benzene removal recovered completely after omission of chlorate or a too high influent chlorate concentration (22 mM). Mass balance calculations showed that per mole of benzene five mole of chlorate were reduced. At the end of the experiment higher loading rates were applied to measure the maximal benzene degradation rate in this system; a breakthrough of benzene was not observed. The average benzene degradation rate over this period was 31 micromol l(-1) h(-1) with a maximal of 78 micromol l(-1) h(-1). The high degradation rate and the necessity of chlorate indicate that oxygen produced during chlorate reduction indeed is used for the activation of benzene. This is the first column study where benzene biodegradation at a high rate coupled with anaerobic chlorate reduction is observed.

Anaerobiosis↗

Reactivity of Fe(II)/cement systems in dechlorinating chlorinated ethylenes.

Ferrous iron (Fe(II)) in combination with Portland cement is effective in reductively dechlorinating chlorinated organics and can be used to achieve immobilization and degradation of contaminants simultaneously. Reactivities of chlorinated ethylenes (perchloroethylene (PCE), trichloroethylene (TCE), 1,1-dichloroethylene (1,1-DCE), vinyl chloride (VC)) in Fe(II)/cement systems were characterized using batch slurry reactors. Reduction kinetics of the chlorinated ethylenes were sufficiently fast to be utilized for the proposed treatment scheme, and were described by a pseudo-first-order rate law. The order of reactivity of the chlorinated ethylenes was TCE>1,1-DCE>PCE>VC. Reduction of TCE and PCE mainly yielded acetylene, implying that the transformation of the two compounds occurred principally via reductive beta-elimination pathways. Transformation of 1,1-DCE and VC gave rise to primarily ethylene, implying that major degradation pathways were a reductive alpha-elimination for the former and a hydrogenolysis for the latter. The reactivity of the Fe(II)/cement systems in dechlorinating TCE was proportional to Fe(II) dose when the Fe(II)/cement mass ratio varied between 5.6 and 22.3%. The Fe(II)/cement systems with a higher Fe(II) loading were less extensively affected by pH in reductive reactions for TCE than in the previous experiments with PCE or chlorinated methanes. Amendment of Fe(II)/cement systems with Fe(III) addition was found effective in increasing the reactivity in the previous study, but the current findings indicated that the extent to which the reaction rate increased by the amendment might be dependent on the source of the cement and/or the compounds tested.

Chlorine Compounds↗

Act to amend the Immigration Act, 1976 and the Criminal Code in consequence thereof, 21 July 1988.

This Act is designed "1) to preserve for persons in genuine need of protection access to the procedures for determining refugee claims; 2) to control widespread abuse of the procedures for determining refugee claims, particularly in light of organized incidents involving large-scale introduction of persons into Canada to take advantage of those procedures; 3) to deter those who assist in the illegal entry of persons into Canada and thereby minimize the exploitation of and risks to persons seeking to come to Canada; and 4) to respond to security concerns, including the fulfillment of Canada's obligations in respect of internationally protected persons." The Act contains provisions that 1) increase powers of authorities to detain persons considered to be "security risks;" 2) authorize for six months the relevant minister to turn back ships if the Minister believes on "reasonable grounds" that a ship is bringing in persons in violation of immigration legislation; 3) prohibit persons from organizing, inducing, aiding, or abetting illegal immigration, or from attempting to do so; 4) prohibit transportation companies from bringing persons into Canada without first ascertaining that they have a valid visa, passport, or travel document; and 5) facilitate the seizure of vehicles and evidence.

Americas↗

[Development of ultrasonography in a radiological university department from 1994 to 2001].

BACKGROUND: In 1994, 5 % of a total of 25 718 examinations and 7 % of all 4630 B-mode sonograms performed in the Radiology Department, University of Cologne was classified as not indicated. In light of these results, the health care policy guidelines for sonographic indications have been amended. PURPOSE: The aim of this study was to establish the current rate of non-indicated sonographic examinations performed in routine diagnostics by radiology departments at university hospitals, to determine the reasons for such over-diagnosis and identify which regulatory mechanisms can be implemented to prevent his. METHOD: We counted the number of 1) B-mode and 2) color-flow Doppler ultrasound imaging procedures carried out in patients who had had no change in symptoms within the previous 4 weeks or who were scheduled without reference to an existing sonogram (double examinations). 3) The reasons for over-diagnosis were analyzed. 4) The 1994 survey was repeated in 2000 with an identical protocol and 5) additionally, a modified survey of the diagnostic questions was conducted. RESULTS: 1) Out of 4,119 patients presenting for the first time to receive a B-mode sonogram, 443 prior sonograms (11 %), 305 CT scans (7 %) and 57 MRI scans (1 %) were documented. 2) Double sonograms were carried out in 6 % of the 1,118 patients presenting for the first time for color-flow Doppler ultrasounds and in 16 % of the 651 patients assigned to receive catheter angiographies with arterial color-flow Doppler. 2) 41 out of 55 (75 %) prior sonograms from non-university settings stated by 94 surgery patients were listed in the medical records. 36 out of 43 (84 %) prior sonograms from the university hospital were repeated in the same patients despite the fact that the medical report with the findings was available. None of the 48 sonograms indicated to confirm a plausible finding yielded any information that was additionally relevant to therapy. 4) In the period April - June, 2000, 12 % of all 15,921 tests and interventions, 26 % of 3,569 B-mode sonograms and 58 % of 1,033 abdominal sonograms performed in adults were classified as having not been indicated. 5) Staging and follow-up were stated as the most common reasons that a sonography was carried out in 46 % of the 1,017 adults who were given B-mode sonograms conducted from Jan - Mar, 2000 and comprised 62 % of the 410 sonograms classified as not or probably not medically indicated. CONCLUSION: The results showed that a multidisciplinary consensus was required to establish the diagnostic value of sonographic procedures. Therefore, this research group drafted a hospital-internal interdisciplinary guideline for "abdominal transcutaneous B-mode sonography in oncological questions".

Diagnostic Imaging↗

Development of a case report review instrument.

Case reports are valued components of the medical literature. The assessment of case reports by editors of medical journals and peer reviewers is largely subjective. The purpose of this study was to develop a reliable instrument to evaluate the quality of written case reports. Instrument development involved review of the literature and the materials provided to peer reviewers who review manuscripts, communications with journal editors and discussions of the study team. After multiple amendments, the instrument was pilot tested on both published and unpublished case reports. Further revisions resulted in the final 11-item tool. Four independent reviewers evaluated 28 case reports in their original submission format that had been submitted to five medical journals. The reviewers were blinded to the specific journal that the manuscripts had been submitted and to whether the case reports had been accepted for publication. Inter-rater reliability was assessed using multirater kappa. Inter-rater reliability ranged from 0.03 to 0.90. The four variables with the highest agreement between raters were (i) rationale for writing the case report; (ii) implications of the case report; (iii) adequacy of the literature review; and (iv) overall impression about whether to accept or reject the manuscript (kappas of 0.67, 0.67, 0.90 and 0.67, respectively). Six of the instrument's first 10 variables were highly correlated with the reviewers' decision about whether to accept or reject the case report for publication (item 11) (all p < 0.001). No correlation existed between the reviewers' decision to accept or reject the manuscript and the actual decision that had been made by the various journals. The case report review instrument is the first such tool for objectively evaluating case reports and appears to have reasonable reliability. Medical journals may wish to incorporate the use of this instrument into the decision making about a case report's suitability for publication.

Humans↗

Mineralization of surfactants by the microbiota of submerged plant detritus.

In wetlands and canopied bodies of water, plant detritus is an important source of carbon and energy. Detrital materials possess a large surface area for sorption of dissolved organics and are colonized by a large and diverse microbiota. To examine the biodegradation of surfactants by these microorganisms, submerged oak leaves were obtained from a laundromat wastewater pond, its overflow, and a pristine control pond. Leaves were cut into disks and incubated in sterile water amended with 50 mug of C-labeled linear alkylbenzene sulfonate (LAS), linear alcohol ethoxylate, stearyltrimethyl ammonium chloride, distearyldimethyl ammonium chloride, benzoic acid, or mixed amino acids per liter. Sorption of the test compounds to the detritus and evolution of CO(2) were followed with time. All of the compounds sorbed to the detritus to various degrees, with LAS and stearyltrimethyl ammonium chloride the most sorptive and benzoic acid the least. All compounds were mineralized without a lag. With leaves from the laundromat wastewater pond, half-lives were 12.6 days for LAS, 8.4 days for linear alcohol ethoxylate, 14.2 days for stearyltrimethyl ammonium chloride, 1.0 days for benzoic acid, and 2.7 days for mixed amino acids. Mineralization of LAS and linear alcohol ethoxylate by control pond leaves was slower and exhibited an S-shaped rather than a typical first-order pattern. This study shows that detritus represents a significant site of surfactant removal in detritus-rich systems.

Journal Article↗

Comparison between human cytomegalovirus pUL97 and murine cytomegalovirus (MCMV) pM97 expressed by MCMV and vaccinia virus: pM97 does not confer ganciclovir sensitivity.

The UL97 protein (pUL97) of human cytomegalovirus (HCMV) is a protein kinase that also phosphorylates ganciclovir (GCV), but its biological function is not yet clear. The M97 protein (pM97) of mouse cytomegalovirus (MCMV) is the homolog of pUL97. First, we studied the consequences of genetic replacement of M97 by UL97. Using the infectious bacterial plasmid clone of the full-length MCMV genome (M. Wagner, S. Jonjic, U. H. Koszinowski, and M. Messerle, J. Virol. 73:7056-7060, 1999), we replaced the M97 gene with the UL97 gene and constructed an MCMV M97 deletion mutant and a revertant virus. In addition, pUL97 and pM97 were expressed by recombinant vaccinia virus to compare both for known functions. Remarkably, pM97 proved not to be the reason for the GCV sensitivity of MCMV. When expressed by the recombinant MCMV, however, pUL97 was phosphorylated and endowed MCMV with the capacity to phosphorylate GCV, thereby rendering MCMV more susceptible to GCV. We found that deletion of pM97, although it is not essential for MCMV replication, severely affected virus growth. This growth deficit was only partially amended by pUL97 expression. When expressed by recombinant vaccinia viruses, both proteins were phosphorylated and supported phosphorylation of GCV, but pUL97 was about 10 times more effective than pM97. One hint of the functional differences between the proteins was provided by the finding that pUL97 accumulates in the nucleus, whereas pM97 is predominantly located in the cytoplasm of infected cells. In vivo testing revealed that the UL97-MCMV recombinant should allow evaluation of novel antiviral drugs targeted to the UL97 protein of HCMV in mice.

Animals↗