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Though substantial work has been done on the usability of health information technology, improvements in electronic health record system (EHR) usability have been slow, creating frustration, distrust of EHRs and the use of potentially unsafe work-arounds. Usability standards could be part of the solution for improving EHR usability. EHR system functional requirements and standards have been used successfully in the past to specify system behavior, the criteria of which have been gradually implemented in EHR systems through certification programs and other national health IT strategies. Similarly, functional requirements and standards for usability can help address the multitude of sequelae associated with poor usability. This paper describes the evidence-based functional requirements for usability contained in the Health Level Seven (HL7) EHR System Functional Model, and the benefits of open and voluntary EHR system usability standards., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Vernakalant is a novel, relatively atrial-selective antiarrhythmic drug. This analysis assessed the efficacy and safety of intravenous vernakalant for the rapid conversion of atrial fibrillation (AF) to sinus rhythm in patients with a history of ischemic heart disease (IHD)., Methods: The presence of IHD was extracted from the medical history of patients from four randomized placebo-controlled studies and one open label study. The efficacy analysis included patients with recent onset AF (consistent with the European labeled indication), while the safety analysis included all patients with AF or atrial flutter (AFL) (3h to 45 days duration) who were exposed to study drug., Results: A total of 1052 adult patients were enrolled and treated; 274 patients (91 placebo, 183 vernakalant) with a history of IHD and 778 patients (224 placebo, 554 vernakalant) without IHD. Conversion of AF to sinus rhythm was not influenced by IHD. In patients with recent onset AF, the placebo-subtracted conversion rate with vernakalant was 45.7% in the IHD group and 47.3% in the non-IHD group. In the 24h following treatment, the rate of treatment-emergent serious adverse events and discontinuations due to adverse events was similar in both the IHD and non-IHD groups, and there was no case of torsades de pointes, ventricular fibrillation, or death in patients with IHD., Conclusions: Vernakalant was safe and well tolerated in AF/AFL patients with a history of IHD, and was significantly more effective than placebo for the acute conversion of AF regardless of IHD status., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Recreational ingestion of the drug 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") can result in pathologically elevated body temperature and even death in humans. Such incidents are relatively rare which makes it difficult to identify the relative contributions of specific environmental and situational factors. Although animal models have been used to explore several aspects of MDMA-induced hyperthermia and it is regularly hypothesized that prolonged physical activity (e.g., dancing) in the nightclub environment increases risk, this has never been tested directly. In this study the rectal temperature of male Wistar rats was monitored after challenge with doses of MDMA and methamphetamine (MA), another drug frequently ingested in the rave/nightclub environment, either with or without access to an activity wheel. Results showed that wheel activity did not modify the hyperthermia produced by 10.0mg/kg MDMA. However, individual correlations were observed in which wheel activity levels after a locomotor stimulant dose of MDMA were positively related to body temperature change and lethal outcome. A modest increase in the maximum body temperature observed after 5.6mg/kg MA was caused by wheel access but this was mostly attributable to a drop in temperature relative to vehicle treatment in the absence of wheel activity. These results suggest that nightclub dancing in the human Ecstasy consumer may not be a significant factor in medical emergencies., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: This trial describes a first-in-man evaluation of RH1, a novel bioreductive drug activated by DT-diaphorase (DTD), an enzyme overexpressed in many tumours., Patients and Methods: A dose-escalation phase I trial of RH1 was carried out. The primary objective was to establish the maximum tolerated dose (MTD) of RH1. Secondary objectives were assessment of toxicity, pharmacokinetic determination of RH1 and pharmacodynamic assessment of drug effect through measurement of DNA cross linking in peripheral blood mononuclear cells (PBMCs) and tumour, DTD activity in tumour and NAD(P)H:quinone oxidoreductase 1 (NQO1) polymorphism status., Results: Eighteen patients of World Health Organization performance status of zero to one with advanced refractory solid malignancies were enrolled. MTD was 1430 μg/m(2)/day with reversible bone marrow suppression being dose limiting. Plasma pharmacokinetic analysis showed RH1 is rapidly cleared from blood (t(1/2) = 12.3 min), with AUC increasing proportionately with dose. The comet-X assay demonstrated dose-related increases in DNA cross linking in PBMCs. DNA cross linking was demonstrated in tumours, even with low levels of DTD. Only one patient was homozygous for NQO1 polymorphism precluding any conclusion of its effect., Conclusions: RH1 was well tolerated with predictable and manageable toxicity. The MTD of 1430 μg/m(2)/day is the dose recommended for phase II trials. The biomarkers of DNA cross linking, DTD activity and NQO1 status have been validated and clinically developed.

Establishing a diagnosis of primary HIV infection (PHI) is important for both the affected individual and public health, because the newly infected individual might readily transmit HIV to others. Unfortunately, diagnosing PHI is hindered by its non-specific presentation, among other factors. We report the case of a patient with extensive multiple organ involvement (fever, rhabdomyolysis, myocarditis, pancreatitis, bilateral renal infarcts, acute renal failure and anemia) in the setting of documented HIV seroconversion as an unusual form of PHI.

Study Objective: To assess the clinical usefulness of blood cultures (BCs) in the management of patients hospitalized with community-acquired pneumonia (CAP)., Design: A prospective, observational study to investigate the contribution of BCs to the management and outcomes of adult patients presenting with CAP., Setting: Nineteen Canadian hospitals., Patients: Adults admitted to the hospital with CAP between January 1, 1998, and July 31, 1998., Interventions: The courses of therapy in patients for whom BC results yielded organisms considered to be clinically significant were analyzed to determine whether the BCs had contributed to management or outcome., Measurements and Results: Forty-three of 760 patients had significantly positive BC results. Patients with CAP who had BCs performed had a 1.97% chance (15 of 760 patients) of having a change of therapy directed by BC results. Patients in whom BCs yielded positive results had a 34.8% chance (15 of 43 patients) of having a change in therapy determined by BC results, and had a 58.1% chance (25 of 43 patients) of having a course of therapy contraindicated by BC results. Severity of illness, as measured by the pneumonia severity index, correlated poorly with the yield of BCs. BC results were positive in 8.0% of patients in risk classes I and II, 6.2% of patients in risk class III, 4.6% of patients in risk class IV, and 5.2% of patients in risk class V., Conclusion: BCs have limited usefulness in the routine management of patients admitted to the hospital with uncomplicated CAP.

Study Objective: To determine whether currently available measurement tools can be used to obtain valid measurements of short-term changes in dyspnea and disease-specific quality of life (QOL) in outpatients with an acute COPD exacerbation., Design: Prospective cohort study., Methods: Sixty-six patients with an acute COPD exacerbation who presented to the emergency department completed the chronic respiratory disease index questionnaire (CRQ) and the baseline dyspnea index (BDI) and were discharged home receiving 10 days of medical therapy. Reassessment with the CRQ and the transitional dyspnea index (TDI) occurred within 48 h of relapse (defined as an urgent hospital revisit within 10 days because of worsening respiratory symptoms), or 10 days later if relapse did not occur., Results: Patients who did not relapse (n = 49) showed moderate-to-large improvements in disease-specific QOL across all four CRQ domains (improvements in each domain of 1.4 to 1.9 U; p < 0.001 for all domains) and large positive changes in the TDI (total TDI score, + 5.02 plus minus 0.55 U; p = 0.0001). In contrast, patients who had a relapse (n = 17) did not have improved CRQ or TDI scores (mean negative change in three of four CRQ domains, total TDI score - 3.06 plus minus 1.14 U; p = 0.02). Changes in the CRQ dyspnea score and TDI correlated with each other (r = 0.78; p = 0.0001) and with changes in FEV(1) (CRQ, r = 0.48 and p = 0.0001; TDI, r = 0.46 and p = 0.0002). Ten control patients with stable COPD showed no changes in the CRQ or TDI over 10 days., Conclusion: The CRQ and BDI/TDI can be used to obtain valid, responsive measures of acute changes in QOL and dyspnea associated with a COPD exacerbation. The direction and magnitude of change in these scores was highly correlated with clinical outcome and with other health measures. Most outpatients treated for a COPD exacerbation experience significant short-term improvements in QOL and dyspnea, with the exception of patients who have a clinical relapse of symptoms.

Disease-specific registries have many important applications in epidemiologic, clinical and health services research. Since 1989 the Department of Veterans Affairs has maintained a national HIV registry. VA's HIV registry is national in scope, it contains longitudinal data and detailed resource utilization and clinical information. To describe the structure, function, and limitations of VA's national HIV registry, and to test its accuracy and completeness. The VA's national HIV registry contains data that are electronically extracted from VA's computerized comprehensive clinical and administrative databases, called Veterans Integrated Health Systems Technology and Architecture (VISTA). We examined the number of AIDS patients and the number of new patients identified to the registry, by year, through December 1996. We verified data elements against information obtained from the medical records at five VA sites. By December 1996, 40,000 HIV-infected patients had been identified to the registry. We encountered missing data and problems with data classification. Missing data occurred for some elements related to the computer programming that creates the registry (e.g., pharmacy files), and for other elements because manual entry is required (e.g., ethnicity). Lack of a standardized data classification system was a problem, especially for the pharmacy and laboratory files. In using VA's national HIV registry we have learned important lessons, which, if taken into account in the future, could lead to the creation of model disease-specific registries.

Background: At-home bleaching with 10 percent carbamide peroxide in a custom-fitted tray has been reported to change the color of dentin. The purpose of this study was to validate the color change of dentin and to determine whether the color change was uniform or occurred from the outside (the dentinoenamel junction) to the inside (the pulpal wall)., Methods: The authors sectioned 10 extracted human teeth incisogingivally through the midfacial long axis, and sealed their cut surface against glass microscope slides. Identifying marks were placed on the glass over the tooth sections to serve as a color control and in the dentinal areas closest to the dentinoenamel junction and the pulpal wall. Teeth were bleached for 10 days with 10 percent carbamide peroxide. Photographs were taken from the glass-covered side of the teeth, digitized and converted to gray-scale levels (consisting of 256 shades of gray ranging from black to white). Marked areas were measured with a National Institutes of Health Image software program and analyzed statistically for changes in lightness between the control marks and the inner and outer dentinal marks over time., Results: Paired t-tests and analysis of variance indicated a significant increase in lightness (P = .01) for the inner and outer dentinal areas during bleaching compared with the control areas. No significant differences were found in the rate of change for the inner and outer dentinal areas (P = .89)., Conclusions: The increase in lightness confirms that a significant color change occurred in the dentin during bleaching with 10 percent carbamide peroxide. This change occurred throughout the dentin at a uniform rate, rather than from the outside inward., Clinical Implications: The results of this study show that at-home bleaching with 10 percent carbamide peroxide can change the color of dentin, which is important to treat intrinsic stains from tetracycline treatment, trauma and aging or inherited discolorations. The bleaching material easily penetrates the tooth to change the dentin color at the same rate throughout, indicating that the type of stain may be the important factor in determining bleaching success.

For physicians working in emergency departments, optimum management of patients with arrhythmias is an important skill. To assess the learning needs of Canadian emergency physicians with respect to arrhythmias, the members of the Canadian Association of Emergency Physicians (CAEP) were surveyed. The survey assessed perceived learning needs and included 11 scenarios assessing physician knowledge. Of 883 surveys distributed, 278 were returned, a response rate of 31.5%. The topic areas ranked most highly by respondents in terms of perceived learning needs were management of ventricular arrhythmias (especially electrical strom), and clinical use of oral and intravenous antiarrhythmic drugs, particularly the clinical use of intravenous amiodarone. The assessment of knowledge showed that the respondents managed most arrhythmias in accordance with published guidelines, although the management of some wide complex tachyarrhythmias was not optimal. These results will be used to guide an ongoing program of continuing medical education.

Cutaneous myiasis (myia: Greek word for fly) is an infestation of fly maggots in the skin. A case of human botfly (Dermatobia hominis) myiasis presenting to a Canadian emergency department is described. Typically, it presents as an apparent persistently infected skin abscess or insect bite. As the botfly is indigenous only to Central and South America, the condition is unfamiliar to most North American physicians. However, the rapidity of international air travel permits this exotic tropical infestation to present in any region. Obtaining a history of recent travel to an endemic area is the key to making the diagnosis and instituting appropriate treatment.

To examine the effects of a 10 percent carbamide peroxide bleaching gel on the oral soft tissues, the authors conducted a prospective, double-blind, placebo-controlled clinical investigation. Fifty-two patients completed a two-week treatment regimen, applying either a placebo or a 10 percent carbamide peroxide gel in a soft tray for eight hours a day. Clinicians examined the participants' oral soft tissues at baseline and one week, two weeks and six weeks after the first treatment. The examiners recorded the Silness and Löe plaque and gingival indexes, nonmarginal gingival index and nongingival oral mucosal index at each examination. The data collected at these intervals did not indicate that any soft tissue damage had occurred as a result of the bleaching regimen.

Small defects are commonly found on the surfaces of composite restorations--especially in stress-bearing areas. Sealant application may reduce the wear rates of these restorations. This five-year study assesses the effect of sealant application on interfacial staining, clinical wear, marginal integrity and surface texture.

An in vitro dye leakage study was performed to determine the incidence of patent furcal accessory canals following exposure of the pulp chamber to 5.25% sodium hypochlorite. One hundred extracted molars were labeled, endodontically opened, and irrigated for 1 h at 5-min intervals. The external furcations were exposed to 0.5% basic fuchsin for 24 h. Patency was determined by dye presence on the chamber floor. Statistical analysis revealed that first and second molars, regardless of arch position or location, demonstrated a patent accessory canal at a rate of 57% +/- 19.6% in the furcal area. It was concluded that accessory canal exposure to 5.25% sodium hypochlorite in the furcal area of molars produced patency which was demonstrable via passive methods--no vacuum or injection pressures were utilized.

Objective: To determine if outcome of Pneumocystis carinii prophylaxis is related to total lung dose of aerosolized pentamidine., Setting: AIDS treatment centers at a VA and University Hospital., Patients: Fifty-eight HIV-infected patients receiving P carinii prophylaxis with aerosolized pentamidine using a nebulizer (CIS-US AeroTech II) were followed up over a 90-week period. Treatment consisted of 60 to 90 mg every two weeks., Measurements: In all patients, deposition of pentamidine aerosol was measured using a radioaerosol filter technique. Factors thought to be important in deposition, nebulizer output and breathing pattern were also measured. Six months later, repeated deposition studies were performed in 20 patients. Pentamidine dose to the lung was related to occurrence of P carinii pneumonia and correlated with nebulizer function and breathing parameters. Outcome was assessed in terms of pentamidine deposition and patient characteristics, including demographic, immunologic, physiologic, and medical variables., Results: Ten patients (17.2 percent) had development of P carinii pneumonia. However, pentamidine deposited in the failures (8.18 +/- 4.74 mg) was no different than deposition in protected patients (6.39 +/- 3.07 mg, p = NS). Most of the variability in deposition was accounted for by variability in nebulizer output (r = 0.919, p less than 0.001). Deposition did not significantly correlate with any of the measured breathing parameters. Serial deposition measurements were not significantly different by paired analysis. The incidence of P carinii pneumonia did not correlate with any measured patient characteristic., Conclusions: Failure of aerosolized pentamidine prophylaxis is not related to total lung dose of pentamidine. Other factors such as inadequate microscopic deposition between alveoli, pentamidine clearance, or drug resistance may be important. In HIV-infected patients, interpatient variability in aerosol deposition can be reduced by reducing variability in nebulizer output rather than control of breathing pattern.

Single dose studies have assessed the utility of ipratropium bromide alone or with beta agonists in the short- and long-term management of chronic obstructive lung disease and asthma. We performed a randomized, double-blind trial to assess the incremental benefit over 24 hours of adding ipratropium vs placebo to a standardized regimen of medications commonly used in the acute and subsequent hospital management of COPD and asthma. Sixty-eight subjects received nebulized salbutamol, intravenous methylprednisolone, intravenous aminophylline, and antibiotics and were randomized to receive either 80 micrograms of ipratropium or placebo via metered dose inhaler and spacing device with each salbutamol treatment (6 to 8 times per day). Among the 50 patients who completed the study, there were no significant differences between ipratropium and placebo groups with respect to baseline FEV1, FVC, and PaCO2. The improvement of FEV1 from baseline to 24 hours was 294 (SD = 568) ml in the ipratropium group vs 393 (SD = 622) ml in placebo group. Adjusting FEV1 by age, gender, and smoking did not significantly alter the findings. Those with an admission diagnosis of asthma showed larger 24 hour FEV1 responses (487 ml in ipratropium vs 801 ml in placebo) than those with COPD (149 ml ipratropium vs 102 ml in placebo). However, within these two strata, there were no significant differences in FEV1 improvement between ipratropium and placebo groups. This study suggests that if ipratropium is used in the initial emergency treatment of COPD or asthma, it could safely be discontinued by 24 hours in order to reduce the cost and complexity of therapy.

Although posterior composite resins have been improved considerably, secondary caries and wear continue to be a major concern. Recent studies suggested that microstructural defects such as voids and microcracks contribute to a weakened surface. The purpose of this study was to evaluate the effect of an experimental surface-penetrating sealant on the wear resistance of a posterior composite resin. At the end of 1 year, the rate of wear of the treated restorations was one-half of those not receiving the surface penetrating sealant.

Thirty-six patients with AIDS and culture-proven nontuberculous mycobacteriosis were compared to 20 patients with acquired immunodeficiency syndrome (AIDS) and tuberculosis with regard to clinical signs, symptoms, and diagnostic methods. Patients with nontuberculous mycobacteriosis were more often younger and homosexuals, while patients with tuberculosis were usually Haitian-American or users of intravenous drugs. A majority of patients with tuberculosis presented with fever and weight loss. These symptoms were seen in approximately 50 percent of the patients with nontuberculous mycobacteriosis. A distinct syndrome of dyspnea, chills, hemoptysis, and chest pain was seen in a significant minority of patients with nontuberculous mycobacteriosis. Lymphadenopathy was seen almost exclusively in patients with tuberculosis. Pulmonary sources (expectorated sputum or bronchoscopy specimens) were the most common source of diagnosis in both groups. Patients in both groups in whom the diagnosis was obtained from pulmonary sources frequently had negative chest x-ray films on presentation. Cavitary disease was absent from both groups.