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Entries from January 2010

Management patterns of non-ST segment elevation acute coronary syndromes in relation to prior coronary revascularization.

January 31st, 2010 · Start a Discussion

Management patterns of non-ST segment elevation acute coronary syndromes in relation to prior coronary revascularization.

Am Heart J. 2010 Jan;159(1):40-6

Authors: Elbarasi E, Goodman SG, Yan RT, Welsh RC, Kornder J, Wong GC, Déry JP, Anderson F, Gore JM, Fox KA, Yan AT, ,

BACKGROUND: Contemporary guidelines support an early invasive strategy for non-ST elevation acute coronary syndrome (NSTE-ACS) patients who had prior coronary revascularization. However, little is known about the management pattern of these patients in "real world." METHODS: We analyzed 3 consecutive Canadian registries (ACS I, ACS II, and Global Registry of Acute Coronary Events [GRACE]/expanded-GRACE) that recruited 12,483 NSTE-ACS patients from June 1999 to December 2007. We stratified the study population according to prior coronary revascularization status into 4 groups and compared their clinical characteristics, in-hospital use of medications, and cardiac procedures. RESULTS: Of the 12,483 NSTE-ACS patients, 71.2% had no prior revascularization, 14.2% had percutaneous coronary intervention (PCI) only, 9.5% had coronary artery bypass graft surgery (CABG) only, and 5% had both PCI and CABG. Compared to their counterparts without prior revascularization, patients with previous PCI and/or CABG were more likely to be male, to have diabetes, myocardial infarction, and heart failure but less likely to have ST-segment deviation or positive cardiac biomarker on presentation. Early use of evidence-based medications was higher among patients with previous PCI only and lower among patients with previous CABG only. After adjusting for possible confounders including GRACE risk score, prior PCI was independently associated with in-hospital use of cardiac catheterization (adjusted odds ratio [OR] 1.18, 95% CI 1.04-1.34, P = .008). In contrast, previous CABG was an independent negative predictor (adjusted OR .77, 95% CI 0.68-0.87, P < .001). There was no significant interaction (P = .93) between previous PCI and CABG. CONCLUSIONS: The NSTE-ACS patients with previous PCI were more likely to be treated invasively. Conversely, patients with prior CABG less frequently received invasive therapy. Future studies should determine the appropriateness of this treatment discrepancy.

PMID: 20102865 [PubMed - in process]

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Tags: Am Heart J

Intensive Insulin Protocol Implementation and Outcomes in the Medical and Surgical Wards at a Veterans Affairs Medical Center(February).

January 31st, 2010 · Start a Discussion

Intensive Insulin Protocol Implementation and Outcomes in the Medical and Surgical Wards at a Veterans Affairs Medical Center(February).

Ann Pharmacother. 2010 Jan 26;

Authors: Chen HJ, Steinke DT, Karounos DG, Lane MT, Matson AW

BACKGROUND: Hyperglycemia is an important marker for clinical outcomes and mortality in hospitalized patients. New national standards have been established emphasizing the importance of improving inpatient glycemic control in individuals with diabetes or new-onset hyperglycemia. Implementation of these new standards is complex and requires a multidisciplinary team approach. A basal-bolus insulin regimen approach has been shown to improve inpatient glycemic control. Few studies have been published regarding basal-bolus insulin protocol outcomes in the non-intensive care unit (ICU) setting. OBJECTIVE: To evaluate the efficacy of a basal-bolus insulin protocol on inpatient glycemic control in a non-ICU setting, as measured by mean blood glucose and number of hypoglycemic episodes per patient admission. METHODS: A retrospective, observational, single-center study was conducted to compare blood glucose control pre- (October 2006-March 2007) and postprotocol (November 2007-January 2008) implementation. Inclusion criteria consisted of patient admission to a medical or surgical ward for at least 72 hours, with a diagnosis of diabetes, or presentation with 2 blood glucose readings greater than 180 mg/dL. Patients admitted to the ICU or those not admitted to a medical or surgical ward were excluded. RESULTS: Following protocol implementation, the mean +/- SD blood glucose level increased from 174 +/- 88 mg/dL to 188 +/- 95 mg/dL (p < 0.001) and the hypoglycemic incidents significantly decreased, from 1.11 to 0.51 events per patient admission (p < 0.0025). CONCLUSIONS: In this pilot study, implementation of a basal-bolus insulin protocol significantly reduced hypoglycemic events; however, mean blood glucose values increased. These results suggest that a basal-bolus insulin protocol can reduce hypoglycemia; however, factors such as protocol compliance, barriers in overcoming the use of the traditional sliding scale insulin regimens, staff education, and change of work-flow habits can influence the overall efficacy and impact of a basal-bolus insulin protocol on inpatient glycemic control.

PMID: 20103610 [PubMed - as supplied by publisher]

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Tags: Ann Pharmacother

Medication Reconciliation and Hypertension Control.

January 31st, 2010 · Start a Discussion

Medication Reconciliation and Hypertension Control.

Am J Med. 2010 Feb;123(2):182.e9-182.e15

Authors: Persell SD, Bailey SC, Tang J, Davis TC, Wolf MS

BACKGROUND: Discrepancies between the medical record and patient medication list are common. The relationship of discrepancies to chronic disease control has not been established. METHODS: To determine the frequency and type of antihypertensive medication discrepancies between patient-named antihypertensive medications and the medical record, we performed a cross-sectional study of 315 adults with medically treated hypertension from 6 safety-net clinics in 3 states. We determined the association between medication discrepancies and uncontrolled blood pressure (>/=140/90 mm Hg or >/=130/80 mm Hg if diabetes) using multivariate logistic regression models. RESULTS: Discrepancies were present for 75.2% of patients; 25.7% of patients could not provide the name of any antihypertensive medication they took; 49.5% could name 1 or more antihypertensive medications but had discrepancies between patient-reported antihypertensive medications and those listed in the medical record. Both patients who were unable to name any of their antihypertensive medications and patients with discrepancies between patient-named medications and the medical record were significantly more likely to have uncontrolled blood pressure than patients who named the same medications as the medical record in adjusted analyses, adjusted risk ratios 1.66 (95% confidence interval, 1.31-2.10) and 1.51 (95% confidence interval, 1.11-2.07), respectively. Twelve percent of patients reporting medications took antihypertensive medication that altered potassium metabolism that was not in their medical record. CONCLUSIONS: Among patients at safety-net clinics, inability to name one's antihypertensive medications and discrepancies between patient-reported medications and the medical record were very common. Both were strongly associated with inadequate hypertension control. Performing medication reconciliation at the point of care may be an important way to identify patients at high risk for inadequate disease control or safety problems.

PMID: 20103029 [PubMed - as supplied by publisher]

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Tags: Am J Med

Vancomycin-Associated Nephrotoxicity: Grave Concern or Death by Character Assassination?

January 31st, 2010 · Start a Discussion

Vancomycin-Associated Nephrotoxicity: Grave Concern or Death by Character Assassination?

Am J Med. 2010 Feb;123(2):182.e1-182.e7

Authors: Hazlewood KA, Brouse SD, Pitcher WD, Hall RG

Vancomycin-associated nephrotoxicity was reported in 0% to 5% of patients in the 1980s. This has been confirmed by numerous clinical trials comparing novel anti-methicillin-resistant Staphylococcus aureus agents with vancomycin at the Food and Drug Administration-approved dosage of 1 g every 12 hours. Treatment failures of vancomycin in patients with methicillin-resistant S. aureus infections have been reported despite in vitro susceptibility. These failures have led to the use of vancomycin doses higher than those approved by the Food and Drug Administration. Higher doses are being administered to achieve goal vancomycin trough concentrations of 10 to 20 mug/mL recommended by several clinical practice guidelines endorsed by the Infectious Diseases Society of America. Recent studies suggest that increased rates of nephrotoxicity are associated with aggressive vancomycin dosing. These increased rates are confounded by concomitant nephrotoxins, renal insufficiency, or changing hemodynamics. These studies also have demonstrated that vancomycin’s nephrotoxicity risk is minimal in patients without risk factors for nephrotoxicity. Clinicians unwilling to dose vancomycin in accordance with clinical practice guidelines should use an alternative agent because inadequate dosing increases the likelihood of selecting heteroresistant methicillin-resistant S. aureus isolates.

PMID: 20103028 [PubMed - as supplied by publisher]

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Tags: Am J Med

Contemporary Trends in Evidence-based Treatment for Acute Myocardial Infarction.

January 31st, 2010 · Start a Discussion

Contemporary Trends in Evidence-based Treatment for Acute Myocardial Infarction.

Am J Med. 2010 Feb;123(2):166-172

Authors: Fornasini M, Yarzebski J, Chiriboga D, Lessard D, Spencer FA, Aurigemma P, Gore JM, Goldberg RJ

BACKGROUND: Guidelines for the management of patients with acute myocardial infarction recommend the routine use of 4 effective cardiac medications: angiotensin-converting enzyme inhibitors, aspirin, beta-blockers, and lipid-lowering agents. Limited data are available, however, about the contemporary and changing use of these therapies, particularly from a population-based perspective. The study describes differences in the use of these medications during hospitalization for acute myocardial infarction according to age, gender, and period of hospitalization. METHODS: The study population consisted of 6334 women and men treated at 11 hospitals in the Worcester, Mass, metropolitan area for acute myocardial infarction in 6 annual periods between 1995 and 2005. RESULTS: Increases in the use of all 4 cardiac medications during hospitalization for acute myocardial infarction were noted between 1995 and 2005 for all men and in those of different age strata: less than 65 years (4%-47%); 65 to 74 years (4%-46%); 75 to 84 years (2%-48%); and more than 85 years (0%-23%). Increases in the use of all 4 cardiac medications also were observed in all women and in those of all ages over time (2%-42%); 65 to 74 years (8%-47%); 75 to 84 years (1%-44%); and more than 85 years (1%-44%). CONCLUSION: The present results suggest marked increases over time in the use of evidence-based therapies in patients hospitalized with acute myocardial infarction. Educational efforts to augment the use of these effective cardiac therapies, as well as attempts to identify suboptimally treated groups, remain warranted.

PMID: 20103026 [PubMed - as supplied by publisher]

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Tags: Am J Med

Universal problems during residency: abuse and harassment.

January 25th, 2010 · Start a Discussion

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Universal problems during residency: abuse and harassment.

Med Educ. 2009 Jul;43(7):628-36

Authors: Nagata-Kobayashi S, Maeno T, Yoshizu M, Shimbo T

OBJECTIVES: Perceived abuse or harassment during residency has a negative impact on residents’ health and well-being. This issue pertains not only to Western countries, but also to those in Asia. In order to launch strong international preventive measures against this problem, it is necessary to establish the generality and cultural specificity of this problem in different countries. Therefore, we investigated mistreatment among resident doctors in Japan. METHODS: In 2007, a multi-institutional, cross-sectional survey was conducted at 37 hospitals. A total of 619 residents (409 men, 210 women) were recruited. Prevalence of mistreatment in six categories was evaluated: verbal abuse; physical abuse; academic abuse; sexual harassment; gender discrimination, and alcohol-associated harassment. In addition, alleged abusers, the emotional effects of abusive experiences, and reluctance to report the abuse to superiors were investigated. Male and female responses were statistically compared using chi-square analysis. RESULTS: A total of 355 respondents (228 men, 127 women) returned a completed questionnaire (response rate 57.4%). Mistreatment was reported by 84.8% of respondents (n = 301). Verbal abuse was the most frequently experienced form of mistreatment (n = 256, 72.1%), followed by alcohol-associated harassment (n = 184, 51.8%). Among women, sexual harassment was also often reported (n = 74, 58.3%). Doctors were most often reported as abusers (n = 124, 34.9%), followed by patients (n = 77, 21.7%) and nurses (n = 61, 17.2%). Abuse was reported to have occurred most frequently during surgical rotations (n = 98, 27.6%), followed by rotations in departments of internal medicine (n = 76, 21.4%), emergency medicine (n = 41, 11.5%) and anaesthesia (n = 40, 11.3%). Very few respondents reported their experiences of abuse to superiors (n = 36, 12.0%). The most frequent emotional response to experiences of abuse was anger (n = 84, 41.4%). CONCLUSIONS: Mistreatment during residency is a universal phenomenon. Deliberation on the occurrence of this universally wrong tradition in medical culture will lead to the establishment of strong preventive methods against it. Current results indicate that alcohol-associated harassment during residency is a Japanese culture-specific problem and effective preventive measures against this are also urgently required.

PMID: 19573185 [PubMed - indexed for MEDLINE]

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Tags: Med Educ

Acute portal vein thrombosis unrelated to cirrhosis: a prospective multicenter follow-up study.

January 25th, 2010 · Start a Discussion

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Acute portal vein thrombosis unrelated to cirrhosis: a prospective multicenter follow-up study.

Hepatology. 2010 Jan;51(1):210-8

Authors: Plessier A, Darwish-Murad S, Hernandez-Guerra M, Consigny Y, Fabris F, Trebicka J, Heller J, Morard I, Lasser L, Langlet P, Denninger MH, Vidaud D, Condat B, Hadengue A, Primignani M, Garcia-Pagan JC, Janssen HL, Valla D,

Current recommendations for early anticoagulation in acute portal vein thrombosis unrelated to cirrhosis or malignancy are based on limited evidence. The aim of this study was to prospectively assess the risk factors, outcome, and prognosis in patients managed according to these recommendations. We enrolled 102 patients with acute thrombosis of the portal vein, or its left or right branch. Laboratory investigations for prothrombotic factors were centralized. Thrombus extension and recanalization were assessed by expert radiologists. A local risk factor was identified in 21% of patients, and one or several general prothrombotic conditions in 52%. Anticoagulation was given to 95 patients. After a median of 234 days, the portal vein and its left or right branch were patent in 39% of anticoagulated patients (versus 13% initially), the splenic vein in 80% (versus 57% initially), and the superior mesenteric vein in 73% (versus 42% initially). Failure to recanalize the portal vein was independently related to the presence of ascites (hazard ratio 3.8, 95% confidence interval 1.3-11.1) and an occluded splenic vein (hazard ratio 3.5, 95% confidence interval 1.4-8.9). Gastrointestinal bleeding and intestinal infarction occurred in nine and two patients, respectively. Two patients died from causes unrelated to thrombosis or anticoagulation therapy. CONCLUSION: Recanalization occurs in one-third of patients receiving early anticoagulation for acute portal vein thrombosis, whereas thrombus extension, intestinal infarction, severe bleeding, and death are rare. Alternative therapy should be considered when ascites and splenic vein obstruction are present.

PMID: 19821530 [PubMed - indexed for MEDLINE]

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Tags: Hepatology

Protecting healthcare workers from pandemic influenza: N95 or surgical masks?

January 25th, 2010 · Start a Discussion

Protecting healthcare workers from pandemic influenza: N95 or surgical masks?

Crit Care Med. 2010 Feb;38(2):657-67

Authors: Gralton J, McLaws ML

OBJECTIVE: The successful management of an influenza pandemic will be reliant on the expertise of healthcare workers at high risk for occupationally acquired influenza. Recommended infection control measures for healthcare workers include surgical masks to protect against droplet-spread respiratory transmissible infections and N95 masks to protect against aerosol-spread infections. A literature review was undertaken for evidence of superior protective value of N95 masks or surgical masks for healthcare workers against influenza and extraneous factors influencing conferred protection. METHODS: Four scientific search engines using 12 search sequences identified 21 mask studies in healthcare settings for the prevention of transmission of respiratory syncytial virus, Bordetella pertussis, and severe acute respiratory syndrome. Each was critically assessed in accordance with Australian National Health Medical Research Council guidelines. An additional 25 laboratory-based publications were also reviewed. RESULTS: All studies reviewed used medium or lower level evidence study design. In the majority of studies, important confounders included the unrecognized impact of concurrent bundling of other infection control measures, mask compliance, contamination from improper doffing of masks, and ocular inoculation. Only three studies directly compared the protective value of surgical masks with N95 masks. The majority of laboratory studies identified both mask types as having a range of filtration efficiency, yet N95 masks afford superior protection against particles of a similar size to influenza. CONCLUSIONS: World Health Organization guidelines recommend surgical masks for all patient care with the exception of N95 masks for aerosol generating procedures. Because of the paucity of high-quality studies in the healthcare setting, the advocacy of mask types is not entirely evidence-based. Evidence from laboratory studies of potential airborne spread of influenza from shedding patients indicate that guidelines related to the current 1-meter respiratory zone may need to be extended to a larger respiratory zone and include protection from ocular inoculation.

PMID: 20095070 [PubMed - in process]

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Tags: Crit Care Med

Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage — United States, October-December 2009.

January 25th, 2010 · Start a Discussion

Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage — United States, October-December 2009.

MMWR Morb Mortal Wkly Rep. 2010 Jan 22;59(2):44-8

Authors:

In July 2009, the Advisory Committee on Immunization Practices (ACIP) issued recommendations for use of the influenza A (H1N1) 2009 monovalent vaccine. Recognizing that the vaccine supply would not be ample immediately but would grow over time, ACIP identified 1) initial target groups, consisting of approximately 160 million persons, and 2) a limited vaccine subset of the target groups, initially estimated at 42 million persons (and more recently estimated at 62 million persons), to receive first priority while the 2009 H1N1 vaccine supply was limited. ACIP recommended expanding vaccination to the rest of the population as vaccine supplies increased. To estimate 2009 H1N1 vaccination coverage to date for the 2009–10 influenza season, CDC analyzed results from the National 2009 H1N1 Flu Survey (NHFS) and the Behavioral Risk Factor Surveillance System (BRFSS) survey, conducted during December 27, 2009-January 2, 2010, and December 1-27, 2009, respectively. The results indicated that, as of January 2, an estimated 20.3% of the U.S. population (61 million persons) had been vaccinated, including 27.9% of persons in the initial target groups and 37.5% of those in the limited vaccine subset. An estimated 29.4% of U.S. children aged 6 months–18 years had been vaccinated. Now that an ample supply of 2009 H1N1 vaccine is available, efforts should continue to increase vaccination coverage among persons in the initial target groups and to offer vaccination to the rest of the U.S. population, including those aged >or=65 years.

PMID: 20094027 [PubMed - in process]

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Tags: MMWR Morb Mortal Wkly Rep

Update: influenza activity — United States, August 30, 2009-January 9, 2010.

January 25th, 2010 · Start a Discussion

Update: influenza activity — United States, August 30, 2009-January 9, 2010.

MMWR Morb Mortal Wkly Rep. 2010 Jan 22;59(2):38-43

Authors:

The emergence and spread of the 2009 pandemic influenza A (H1N1) virus (2009 H1N1) resulted in extraordinary influenza activity in the United States throughout the summer and fall months of 2009. During this period, influenza activity reached its highest level in the week ending October 24, 2009, with 49 of 50 states reporting geographically widespread disease. As of January 9, 2010, overall influenza activity had declined substantially. Since April 2009, the dominant circulating influenza virus in the United States has been 2009 H1N1. This report summarizes U.S. influenza activity from August 30, 2009, through January 9, 2010.

PMID: 20094026 [PubMed - in process]

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Tags: MMWR Morb Mortal Wkly Rep

New drugs for the treatment of coronary artery syndromes: otamixaban and ticagrelor.

January 25th, 2010 · Start a Discussion

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New drugs for the treatment of coronary artery syndromes: otamixaban and ticagrelor.

Expert Opin Pharmacother. 2010 Feb;11(2):325-9

Authors: Doggrell SA

Acute coronary syndromes are a major cause of mortality and morbidity. The objective of this evaluation is to review the clinical trials of two new drugs being developed for the treatment of acute coronary syndromes. The first drug is the anticoagulant otamixaban, and the trial compared otamixaban with unfractionated heparin and eptifibatide in acute coronary syndromes. The second drug is the antiplatelet ticagrelor, and the trial compared ticagrelor with clopidogrel in acute coronary syndromes. In the SEPIA-ACS1 TIMI 42 trial, the primary efficacy endpoint occurred in 6.2% of subjects treated with unfractionated heparin and eptifibatide, and to a significantly lesser extent with otamixaban. In the PLATO trial, the primary efficacy endpoint had occurred less in the ticagrelor group (9.8%) than in the clopidogrel group (11.7%) at 12 months. Two new drugs for acute coronary syndromes, otamixaban and ticagrelor, have recently been shown to have benefits in subjects undergoing percutaneous interventions compared to the present standard regimens for this condition.

PMID: 20088750 [PubMed - in process]

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Tags: Expert Opin Pharmacother

Clevidipine butyrate: a promising new drug for the management of acute hypertension.

January 25th, 2010 · Start a Discussion

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Clevidipine butyrate: a promising new drug for the management of acute hypertension.

Expert Opin Pharmacother. 2010 Feb;11(2):281-95

Authors: Bergese SD, Puente EG

Clevidipine butyrate is an ultrashort-acting intravenous dihydropyridine calcium-channel blocker that has been approved by the FDA for the reduction of blood pressure when oral therapy is not feasible. Hypertension is a global disease that affects more than 1 billion people worldwide and 75 million people in the USA. There are multiple agents available for the management of hypertension. The acute setting is where the challenge arises for developing new agents that not only decrease, but more importantly, optimally control blood pressure. Many drugs lower blood pressure; however, only a few have the capacity to precisely control hypertension in the acute phase. Clevidipine has unique pharmacodynamic and pharmacokinetic properties that enable the fast, safe and adequate reduction of blood pressure in hypertensive emergencies, with unique precision necessary to maintain the target blood pressure range. Its use in different clinical settings has been evaluated in several Phase I, II and III clinical studies. It is easily administered and titrated with minimal side effects, achieves fast control with low doses, is highly successful as monotherapy and allows excellent transition to oral medication. Thus, clevidipine is a promising new agent for the management of acute hypertension in a variety of clinical settings.

PMID: 20088748 [PubMed - in process]

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Tags: Expert Opin Pharmacother

Systematic Review of Studies on Compliance with Hand Hygiene Guidelines in Hospital Care.

January 25th, 2010 · Start a Discussion

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Systematic Review of Studies on Compliance with Hand Hygiene Guidelines in Hospital Care.

Infect Control Hosp Epidemiol. 2010 Jan 20;

Authors: Erasmus V, Daha TJ, Brug H, Richardus JH, Behrendt MD, Vos MC, van Beeck EF

Objectives. To assess the prevalence and correlates of compliance and noncompliance with hand hygiene guidelines in hospital care. Design. A systematic review of studies published before January 1, 2009, on observed or self-reported compliance rates. Methods. Articles on empirical studies written in English and conducted on general patient populations in industrialized countries were included. The results were grouped by type of healthcare worker before and after patient contact. Correlates contributing to compliance were grouped and listed. Results. We included 96 empirical studies, the majority ([Formula: see text]) in intensive care units. In general, the study methods were not very robust and often ill reported. We found an overall median compliance rate of 40%. Unadjusted compliance rates were lower in intensive care units (30%-40%) than in other settings (50%-60%), lower among physicians (32%) than among nurses (48%), and before (21%) rather than after (47%) patient contact. The majority of the time, the situations that were associated with a lower compliance rate were those with a high activity level and/or those in which a physician was involved. The majority of the time, the situations that were associated with a higher compliance rate were those having to do with dirty tasks, the introduction of alcohol-based hand rub or gel, performance feedback, and accessibility of materials. A minority of studies ([Formula: see text]) have investigated the behavioral determinants of hand hygiene, of which only 7 report the use of a theoretical framework with inconclusive results. Conclusions. Noncompliance with hand hygiene guidelines is a universal problem, which calls for standardized measures for research and monitoring. Theoretical models from the behavioral sciences should be used internationally and should be adapted to better explain the complexities of hand hygiene.

PMID: 20088678 [PubMed - as supplied by publisher]

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Tags: Infect Control Hosp Epidemiol

Clinical practice. Systolic heart failure.

January 25th, 2010 · Start a Discussion

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Clinical practice. Systolic heart failure.

N Engl J Med. 2010 Jan 21;362(3):228-38

Authors: McMurray JJ

PMID: 20089973 [PubMed - in process]

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Tags: N Engl J Med

Treatment with monoclonal antibodies against Clostridium difficile toxins.

January 25th, 2010 · Start a Discussion

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Treatment with monoclonal antibodies against Clostridium difficile toxins.

N Engl J Med. 2010 Jan 21;362(3):197-205

Authors: Lowy I, Molrine DC, Leav BA, Blair BM, Baxter R, Gerding DN, Nichol G, Thomas WD, Leney M, Sloan S, Hay CA, Ambrosino DM

BACKGROUND: New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection. METHODS: We performed a randomized, double-blind, placebo-controlled study of two neutralizing, fully human monoclonal antibodies against C. difficile toxins A (CDA1) and B (CDB1). The antibodies were administered together as a single infusion, each at a dose of 10 mg per kilogram of body weight, in patients with symptomatic C. difficile infection who were receiving either metronidazole or vancomycin. The primary outcome was laboratory-documented recurrence of infection during the 84 days after the administration of monoclonal antibodies or placebo. RESULTS: Among the 200 patients who were enrolled (101 in the antibody group and 99 in the placebo group), the rate of recurrence of C. difficile infection was lower among patients treated with monoclonal antibodies (7% vs. 25%; 95% confidence interval, 7 to 29; P<0.001). The recurrence rates among patients with the epidemic BI/NAP1/027 strain were 8% for the antibody group and 32% for the placebo group (P=0.06); among patients with more than one previous episode of C. difficile infection, recurrence rates were 7% and 38%, respectively (P=0.006). The mean duration of the initial hospitalization for inpatients did not differ significantly between the antibody and placebo groups (9.5 and 9.4 days, respectively). At least one serious adverse event was reported by 18 patients in the antibody group and by 28 patients in the placebo group (P=0.09). CONCLUSIONS: The addition of monoclonal antibodies against C. difficile toxins to antibiotic agents significantly reduced the recurrence of C. difficile infection. (ClinicalTrials.gov number, NCT00350298.)

PMID: 20089970 [PubMed - in process]

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Tags: N Engl J Med