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The organization and operation of clinical trials have become increasingly complex requiring the coordination of a well-trained workforce to ensure that complicated protocols yield valid results that will advance human health. We hypothesized that formal education in clinical research is equivalent to a number of years of work experience as a clinical research professional in terms of self-perceived clinical research competence. Using REDCap, we conducted a survey of students and recent graduates from academic programs in clinical research in the USA using the CICRP index that consists of 20 clinical research core competencies. We compared the responses of recent graduates to CRCs wording in the USA and Canada in various research settings who responded to a similar survey conducted by the Joint Task Force and to experienced CRCs working at research-intensive CTSA hubs and their affiliated hospitals who were surveyed as part of the NIH funded DIAMOND project. We found that the degree of self-perceived competence to perform advanced core competencies such as those related to regulatory affairs among new graduates of formal academic programs without research experience to be equivalent to as many as five years of on-the-job-training in a research-intensive CTSA setting and more than ten years of experience in less research-intensive community settings. These findings suggest that scores on both forms of the CICRP differentiate CRCs according to formal education in clinical research, years of experience as a CRC and type of research setting in which they work. Further, the self-perceived competency assessed by CICRP acquired by completing an academic program in clinical research is equivalent to years of work experience.

The organization and operation of clinical trials have become increasingly complex requiring the coordination of a well-trained workforce to ensure that complicated protocols yield valid results that will advance human health. We hypothesized that formal education in clinical research is equivalent to a number of years of work experience as a clinical research professional in terms of self-perceived clinical research competence.Using REDCap, we conducted a survey of students and recent graduates from academic programs in clinical research in the USA using the CICRP index that consists of 20 clinical research core competencies. We compared the responses of recent graduates to CRCs wording in the USA and Canada in various research settings who responded to a similar survey conducted by the Joint Task Force and to experienced CRCs working at research-intensive CTSA hubs and their affiliated hospitals who were surveyed as part of the NIH funded DIAMOND project.We found that the degree of self-perceived competence to perform advanced core competencies such as those related to regulatory affairs among new graduates of formal academic programs without research experience to be equivalent to as many as five years of on-the-job-training in a research-intensive CTSA setting and more than ten years of experience in less research-intensive community settings.These findings suggest that scores on both forms of the CICRP differentiate CRCs according to formal education in clinical research, years of experience as a CRC and type of research setting in which they work. Further, the self-perceived competency assessed by CICRP acquired by completing an academic program in clinical research is equivalent to years of work experience.

OBJECTIVE Diabetes elevates cardiovascular disease (CVD) risk more markedly in women than in men. Because the high risk of CVD among women with type 2 diabetes (DM2) may be partly due to increased ovarian androgen production, we investigated whether a history of bilateral salpingo oophorectomy (BSO) is inversely associated with CVD mortality among women with DM2. RESEARCH DESIGN AND METHODS Data were obtained from 7,977 women (a random subset of 564 had measurements of sex-steroid hormones) enrolled in the Study of Osteoporotic Fractures (SOF), a community-based, multicenter study that monitored women aged ≥65 years for a mean of 15.1 years. Adjusted hazard ratios (HRs) and 95% CIs were calculated using Cox proportional hazards regression. RESULTS The average age at baseline was 71.5 years, with 6.3% and 18% of participants reporting a history of diabetes or BSO, respectively. In the subset of the SOF cohort with sex-steroid hormone measurements, those with DM2 had 43.6% significantly higher levels of free testosterone that were partly explained by age and adiposity, whereas total and free testosterone levels were lower in women with BSO than in those with intact ovaries. CVD mortality was elevated in women with DM2 without BSO (HR 1.95, 95% CI 1.62–2.35) as well as in women with DM2 and BSO (HR 2.56, 95% CI 1.79–3.65; P = 0.190 for interaction). Overall, BSO was not associated with CVD mortality (HR 1.05, 95% CI 0.89–1.23). CONCLUSIONS The association of diabetes with CVD was not reduced by BSO, suggesting that ovarian hyperandrogenemia may not be a primary mechanism to explain the high risk for CVD among women with DM2.

Purpose To identify macro-level trends that are changing the needs of epidemiologic research and practice and to develop and disseminate a set of competencies and recommendations for epidemiologic training that will be responsive to these changing needs. Methods There were three stages to the project: (1) assembling of a working group of senior epidemiologists from multiple sectors, (2) identifying relevant literature, and (3) conducting key informant interviews with 15 experienced epidemiologists. Results Twelve macro trends were identified along with associated actions for the field and educational competencies. The macro trends include the following: (1) “Big Data” or informatics, (2) the changing health communication environment, (3) the Affordable Care Act or health care system reform, (4) shifting demographics, (5) globalization, (6) emerging high-throughput technologies (omics), (7) a greater focus on accountability, (8) privacy changes, (9) a greater focus on “upstream” causes of disease, (10) the emergence of translational sciences, (11) the growing centrality of team and transdisciplinary science, and (12) the evolving funding environment. Conclusions Addressing these issues through curricular change is needed to allow the field of epidemiology to more fully reach and sustain its full potential to benefit population health and remain a scientific discipline that makes critical contributions toward ensuring clinical, social, and population health.

Aims Women with type-2 diabetes (DM2) are at high risk of cardiovascular disease (CVD) which may be partly due to increased ovarian androgen production. Since the association of bilateral oophorectomy (BSO) with CVD remains controversial, we evaluated whether BSO is inversely associated with CVD among DM2. Methods Data were obtained from a national sample of 9599 postmenopausal women. Adjusted estimates and 95% confidence intervals (CIs) were calculated using logistic and Cox regression. Results At baseline 2426 women had type-2 diabetes, of whom 580 had BSO. DM2 had adverse CVD risk profiles compared to women without diabetes, as did women with BSO with or without diabetes compared to those with intact ovaries. In DM2, BSO was positively associated with prevalent CVD (odds ratio: 1.63, 95%CI: 1.16–2.30). However, the higher odds were limited to women who had BSO before age 45 years (OR: 2.11, CI: 1.45–3.08). During a mean follow-up of 12.7 years, BSO in DM2 was positively associated with CVD mortality (hazard ratio: 2.23, CI: 1.25–3.99). Among women with BSO, those with family members who had MI before age 50 had elevated odds of CVD (OR: 2.29, CI: 1.56–3.37) compared to those without such family history (OR: 0.90, CI: 0.67–1.20), Pinteraction = 0.04. Conclusions The risk of CVD is increased not decreased with BSO in DM2. Further, we propose that the association of BSO and CVD in young women with diabetes may partly reflect genetic susceptibility to CVD rather than an effect of ovarian hormones.

The heterogeneity of serious emotional disturbance has been thoroughly documented among adolescents with nationally representative data derived from structured interviews, although use of these interviews may not be feasible within the context of brief and self-administered school surveys. This study seeks to identify distinct subtypes of serious emotional disturbance in a large school-based sample. A total of 108,736 students fully completed the K6 scale that was included on the 2012 Kentucky Incentives for Prevention Survey. Latent class analysis was used to derive subtypes of serious emotional disturbance among students receiving a positive screen (n = 15,147). To determine significant predictors of class membership, adjusted rate ratios and 95 % confidence intervals were calculated using multinomial logistic regression. A four-class model was the most parsimonious, with four distinct subtypes emerging that varied by both symptom type and severity: comorbid moderate severity, comorbid high severity, anxious moderate severity, and depressed high severity. Age, gender, race/ethnicity, family structure, substance use, antisocial behavior, role impairments, and peer victimization were significant predictors of class membership, although the magnitude of these effects was stronger for the two high severity groups. Our results suggest heterogeneity of serious emotional disturbance by both symptom type and severity. Prevention programs may benefit by shifting focus from specific disorders to the core features of serious emotional disturbance, including psychological distress, high comorbidity, and role impairments.

Infants with "single ventricle" congenital heart disease are at high risk for sudden death following palliative surgical management. We developed a pilot telemedicine project to evaluate the feasibility of using Web-based daily reporting of clinical data with the goal of reducing unexpected admissions and sudden death.We enrolled 9 subjects (enrolled subjects [ES]) following surgical palliation over 12 months. Parents electronically transmitted ES daily weight and oxygen saturation and then completed an automated 10-point phone questionnaire on nutrition, activity, and distress. Subject enrollment continued until a second surgical palliative procedure (n=5), sudden death (n=2), or disenrollment (n=2). We collected clinical data on all ES and 9 historical controls (HC) from the preceding 18 months and analyzed clinical management, including outpatient telephone surveillance success, scheduled and unscheduled office and emergency department visits, hospitalizations, procedures, and adverse events, including death.Subject recruitment was more difficult than expected. Weight transmission success was high, but there was poor correlation between telemedicine system-measured oxygen saturation and a commercial monitor. The outpatient clinical telephone surveillance success rate for HC and ES was approximately 30%. After technical adjustments, parents of all ES (100%) were able to transmit questionnaire data. There were 9 emergency room visits for ES versus 11 unscheduled emergency room visits for HC. Sudden death occurred in 1 of 9 HC and 2 of 9 ES.Telemedicine monitoring for high-risk congenital heart disease patients is feasible but challenging, may reduce unscheduled visits, but may not impact the primary end point of preventing sudden death in this high-risk pediatric population.

OBJECTIVE Ovarian hormones regulate glucose uptake and insulin sensitivity. Despite the high frequency of surgical menopause, its relationship with diabetes has not been extensively investigated. We assessed the association between hysterectomy with or without bilateral oophorectomy (BSO) status, menopausal age, and reproductive life span with incident diabetes. RESEARCH DESIGN AND METHODS Data were from a cohort of 2,597 postmenopausal women enrolled in the National Health and Nutrition Examination Survey I Epidemiologic Follow-up Study without diabetes mellitus at baseline. Cox proportional hazards regression models were used to calculate adjusted hazard ratios (HRs) and 95% CIs. RESULTS After a median follow-up time of 9.2 years, the incidence of diabetes (in cases per 1,000 person-years) was 7.4 for women with no hysterectomy or BSO, 8.2 for hysterectomy alone, and 8.5 for hysterectomy with BSO. Hysterectomy status was associated positively with diabetes (HR 1.66, 95% CI 1.23–2.23). However, the elevated risk was restricted to women with both hysterectomy and BSO after adjustment for relevant confounders (HR 1.57, 95% CI 1.03–2.41). An earlier age at menopause and a shorter reproductive life span also exhibited a linear relationship with the development of diabetes irrespective of type of menopause (P for trend = 0.001). CONCLUSIONS Women with hysterectomy concomitant with BSO may represent a unique population with elevated risk for diabetes and other chronic diseases. Therefore, the decision to remove the ovaries at the time of hysterectomy for benign conditions during the premenopausal years should be balanced with the risk of diabetes and its potential complications. Furthermore, the mechanism linking BSO to diabetes mellitus needs to be clarified.

Anal malignant melanoma (AMM) is a rare tumor with poor prognosis. We performed a systematic review of reports on wide local excision (WLE) and abdominoperineal resection (APR) for treatment of AMM in an attempt to define a precise set of reporting measures for outcomes of treatment of AMM. A systematic review of the literature was performed. Demographic data, surgical treatment, pathology, and survival rates were recorded. We compared WLE versus APR in terms of the overall survival time, the disease-free survival, and overall survival at 60 months. Twenty-one reports met the inclusion criteria. Notably, of these, 10 did not specify thickness of the primary melanoma. Interestingly, groin lymph node status was described in 19 of 21 reports, whereas location was specified in only 12 papers and thickness (depth in mm) in only 11. The median survival times of patients undergoing WLE (n = 324) and those undergoing APR (n = 369) are comparable (20 and 21 months, respectively). The mean median survival at 60 months was 15 per cent for WLE and 14 per cent for APR. The mean disease-free survival at 60 months was found to be 10 per cent for WLE and 6 per cent for APR. Patient selection for such a rare neoplasm yields very similar outcomes for both conservative and radical treatments. There is a wide variation in the reporting of both clinical and treatment outcomes. More uniformity of reporting of pathologic features and node status is essential before rational assessment of results can be done.

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

Background Publication bias occurs when statistically non-significant (negative) findings are not published. It can profoundly affect the results of systematic reviews and meta-analyses. Methods Qualitative and quantitative methods of detecting publication bias are described, including their advantages and disadvantages. Results and conclusion Accepted quality standards for the reporting of meta-analyses recommend assessment of publication bias, but currently there is no uniform standard for reporting. Quantitative methods are being used with increasing frequency. Authors should take steps to minimize publication bias, and use both qualitative and quantitative assessment methods to determine whether it is present.

Summary Background Despite numerous guidelines recommending prophylactic antibiotics prior to percutaneous endoscopic gastrostomy, their use remains controversial. Aim To conduct a systematic literature review and performed meta-analyses to determine the benefit of antibiotic prophylaxis for percutaneous endoscopic gastrostomy placement. Methods We performed a systematic literature review by searching healthcare databases and grey literature for randomized-controlled trials of antibiotic prophylaxis against wound infection after percutaneous endoscopic gastrostomy. Relative risks were calculated for individual trials and data pooled using fixed-effects model. Relative risk reduction, absolute risk reduction and number needed to treat were calculated and are reported with 95% confidence intervals. Results Ten randomized-controlled trials met the inclusion criteria and 1059 cases were pooled. Overall findings indicated that antibiotic prophylaxis resulted in a relative risk reduction of 64% and an absolute risk reduction of 15%. Number needed to treat to prevent one wound infection was 8. Cephalosporin prophylaxis was associated with a relative risk reduction of 64%, absolute risk reduction of 10% and number needed to treat of 10, whereas penicillin-based prophylaxis was associated with a relative risk reduction of 62%, absolute risk reduction of 13% and number needed to treat of 8. Conclusions Antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy is effective in reducing the incidence of percutaneous endoscopic gastrostomy site wound infection. Based on sensitivity analyses, penicillin-based prophylaxis should be the prophylaxis of choice.

Background Understanding of data-reporting methods is imperative for correct interpretation of the medical literature as well as for proper performance of future clinical research. Recent developments in biostatistics have greatly changed the types of statistical analyses used and the minimum quality standards that must be maintained. Method Different types of review are described, including systematic review with and without meta-analysis. Minimum reporting standards, sources of bias, both quantitative and qualitative, and references are discussed. Results and Conclusion Meta-analysis has become a clearly defined technique, with reporting standards for both randomized controlled trials and observational studies. It is assuming a wider role in the surgical literature. Although many sources of bias exist, there are clear reporting standards and readers should be aware of these when studying the literature.

Background— Nitroglycerin (NTG) induces delayed preconditioning (PC)-mimetic effects in animal models and in humans during coronary angioplasty. We tested the hypothesis that NTG mitigates ischemia and enhances functional capacity during an exercise tolerance test (ETT) in patients with coronary artery disease. Methods and Results— Twenty-eight patients with stable angina and ischemia documented by a stress test were randomized in a double-masked, crossover design to receive a titrated intravenous infusion of NTG or normal saline over 4 hours. At 24 to 28 hours after study medication infusion, each patient underwent 2 ETTs separated by a 1-week washout period. Compared with control patients, pretreatment with NTG was associated with a dose-dependent increase in exercise duration averaging 40 seconds (412±19 versus 372±24 seconds, P =0.014) and an improvement in ECG manifestations of ischemia, as shown by a decrease in maximal ST-segment depression (1.84±0.14 versus 1.63±0.13 mm, P =0.011), sum of ST-segment depressions in 12 leads (7.64±1.01 versus 6.61±0.83 mm, P =0.027), and time to resolution of ST-segment depression (229±30 versus 207±28 s, P =0.018). These benefits occurred despite an increase in myocardial workload after NTG, as indicated by a higher peak rate-pressure product (24 492±1054 versus 22 536±1019 mm Hg/min, P =0.015). Conclusions— NTG produces a late PC-mimetic effect that mitigates the ECG manifestations of ischemia during exercise and improves exercise capacity. To our knowledge, this is the first study to demonstrate that NTG can alleviate exercise-induced ischemia 24 hours after its administration, long after the hemodynamic effects have subsided. The finding that nitrate-induced late PC ameliorates a common manifestation of coronary artery disease has potentially significant implications for the management of this disorder and for the design of clinical trials.

Aims The purpose of this research was to characterize CYP2D6, GST-M1 and GST-T1 enzyme expression in human parathyroid tissue, and to determine whether or not there is any association between deficiencies in these enzymes and serum parathyroid hormone concentrations in patients with end-stage renal disease. Methods Surgical human parathyroid tissue was obtained and evaluated by immunohistochemistry for cellular localization of CYP2D6, GST-M1 and GST-T1 and colocalization of CYP2D6 with parathyroid hormone. Blood samples were collected from 328 Caucasian patients with end-stage renal disease for genetic testing of CYP2D6*3, *4, *5, *6, *7 and GST-M1*0 and GST-T1*0 alleles. Clinical chemistry data and serum intact parathyroid hormone (iPTH) concentrations were obtained from patient medical records. In 277 of the patients, the same laboratory performed all clinical tests. Results CYP2D6, GST-M1 and GST-T1 were present in human parathyroid tissue. CYP2D6 was colocalized with parathyroid hormone in parathyroid chief cells. Within the end-stage renal disease population, a nonfunctional CYP2D6 genotype was present in 18.2%[95% confidence interval (CI) 8.0, 28.4] of patients in the 1st iPTH concentration quintile (iPTH 347 pg mL−1) (P = 0.001). Out of 12 CYP2D6-deficient females, seven were in the 1st iPTH concentration quintile and the remaining five were in the 5th quintile. Patients deficient in the GST-M1 and GST-T1 enzymes displayed a far more uniform frequency distribution relative to serum iPTH concentrations. Conclusions The presence of CYP2D6, GST-M1 and GST-T1 in parathyroid cells was observed. An association is reported between a lack of CYP2D6 and iPTH concentrations in newly diagnosed end-stage renal disease patients. Gender and concomitant deficiency in GST-M1 and/or GST-T1 appear to define this association further. It remains to be established whether these associations reflect a cause-effect relationship between deficient expression of metabolizing enzymes and severity of secondary manifestation of renal failure.

Background: Clinical research in the 21st century will require a well-trained workforce to ensure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel and others.Methods: We used data collected by the joint task force on the harmonization of core competencies from a survey of research professionals working in the US and Canada to create competency Indices for clinical research professionals. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies.Results: Factor analyzes identified 20 core competencies that defined a competency index for clinical research professionals—general (CICRP-General, i.e., GCPs) and four sub-indices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. Conclusions: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors and other clinical research team members.

Background— Vitamin D supplementation may be an inexpensive intervention to reduce heart failure (HF) incidence. However, there are insufficient data to support this hypothesis. This study evaluates whether vitamin D plus calcium (CaD) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF. Methods and Results— Analyses were restricted to 35 983 (of original 36 282) women aged 50 to 79 years old in the Women’s Health Initiative randomized trial of CaD supplementation who were randomized 1:1 in a double-blinded fashion to receive 1000 mg/d of calcium plus 400 IU/d of vitamin D 3 or placebo. Overall, 744 adjudicated incident HF cases (intervention, 363; control, 381) occurred during a median follow-up of 7.1 (interquartile range, 1.6) years. CaD supplementation, compared with placebo, was not associated with reduced HF risk in the overall population, hazard ratio, 0.95; P =0.46. However, CaD supplementation had differential effects ( P interaction=0.005) in subgroups stratified by baseline risk status of HF defined by the presence (high risk=17 449) or absence (low risk=18 534) of pre-existing HF precursors including coronary heart diseases, diabetes mellitus, or hypertension: 37% (hazard ratio, 0.63 [95% confidence interval, 0.46–0.87]) lower risk of HF in the low-risk versus hazard ratio, 1.06; P =0.51, in the high-risk subgroups. Conclusions— CaD supplementation did not significantly reduce HF incidence in the overall cohort, however, it was beneficial among postmenopausal women without major HF precursors while of little value in high-risk subgroups. Additional studies are warranted to confirm these findings and investigate the underlying mechanism. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00000611.

A previous survey found that residents near a hazardous waste incinerator reported more respiratory symptoms than residents of a nearby community. To explore the possibility that these findings might have been due to the use of a rural control site, far removed from urban pollution, we expanded the analysis to include reports of respiratory symptoms from residents of six additional communities. Residents of each of four study communities were exposed to the plumes of biomedical, municipal or hazardous waste combustors. For each study community, a comparison community was surveyed that was distant from major point sources of air pollution. Over 4200 respondents were queried by telephone about respiratory symptoms, smoking and other risk factors such as chemical exposures in the workplace and home, and provided a subjective assessment of air quality in their neighborhoods. Differences in symptom prevalence between each study community and its respective control community, as well as a combined control group...

OBJECTIVE: To assess the relationship between ethnicity and decision-makers expressing healthcare wishes in a group of frail older persons enrolled in the Program of All-inclusive Care for the Elderly (PACE). DESIGN: A retrospective chart review of 1193 participants in the PACE program. SETTING: Program of All-inclusive Care for the Elderly, a comprehensive managed care demonstration program serving frail older participants at 10 sites across the nation. PARTICIPANTS: A total of 1193 older adults, all of whom met state criteria for nursing home level of care. Three hundred were non-Hispanic whites, 364 were black, 156 were Hispanic, and 288 were Asian. MEASUREMENTS: Demographic characteristics of the patients and the presence or absence of an alternative decision-maker; the characteristics of alternative decision-makers included the relationship to the participant as recorded in the patient's medical record. RESULTS: Ninety-one percent of white patients expressed their own healthcare wishes in contrast to only 85% of Hispanic, 83% of Asian, and 67% of black patients. An alternative decision-maker was identified for about 15% of Asians and Hispanics and for one-third of blacks, but only about 8% of whites had an alternative decision-maker. Black and Hispanic patients were most likely to have a daughter as an alternative decision-maker, Asians were most likely to have a son, and whites patients were most likely to have a spouse as an alternative decision-maker. Blacks, particularly black men, were the most likely to have a relative other than a spouse or child as an alternative decision-maker. CONCLUSIONS: In this population, we found significant ethnic variation in the person identified to be the decision-maker in a group of frail older people. Ethnic variation reflected sociodemographic as well as cultural differences. However, there are important limitations to this study, and caution should be used in extrapolating the results to other populations or in attributing the results to ethnicity alone. An awareness of cross-cultural patterns in identified or de facto decision-makers can be significant for healthcare workers when they approach patients and their families about issues surrounding end of life decisions.

ContextInfluenza vaccination lowers, but does not eliminate, the risk of influenza. Making a reliable, rapid clinical diagnosis is essential to appropriate patient management that may be especially important during shortages of antiviral agents caused by high demand.ObjectivesTo systematically review the precision and accuracy of symptoms and signs of influenza. A secondary objective was to review the operating characteristics of rapid diagnostic tests for influenza (results available in

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Objective: To investigate the relationship between regular exercise and plasma lipid profiles in free-living men. Methods: Seven hundred eighty men between the ages of 25 and 65 years were included in this study. The medical history, physical examination, and blood tests were obtained at baseline and 1 year later. At the end of the study, 430 (55.1%) men reported the same amount of regular exercise as a year earlier; 199 (25.5%) men reported an increased level, and 151 (19.4%) men reported a decreased level. Results: Compared to the group with same exercise, men who increased their level of regular exercise had a significant increase in high-density lipoprotein cholesterol (HDLC) (mean 4.76 versus 2.83 mg/dL, p < 0.005) and significant decreases in the ratio of total cholesterol/HDLC (mean −0.72 versus −0.42, p < 0.001) and triglycerides (mean −18.2 versus −6.27 mg/dL, p < 0.001). The changes in lipid profiles appeared to have a dose-response relationship from the increased exercise, same exercise, to decreased exercise groups. Overweight and normal-weight men had a similar tendency to improve their lipid profiles by exercise. The improvement in plasma lipid profile associated with increased regular exercise persisted after controlling for potential confounders. Conclusions: The results indicate that the relationship between physical activity and favorable lipid profiles exists in men with mild-to-moderate physical activity.

Purpose Recreational physical activity (PA) reduces the risk of cardiovascular disease (CVD) morbidity and mortality. Outdoor-based recreational physical activities (ORA) have been reported to be associated with elevated 25(OH)D levels. We investigate the joint effects of frequent ORA and 25(OH)D levels on the risk of CVD mortality and the modifying effects of 25(OH)D. Methods Our sample consisted of 13,031 nationally representative adults (20 - 90 years old) free from CVD and cancer at baseline in the NHANES III (1988 - 1994) linked mortality dataset with follow-up mortality data through 2006. CVD mortality was based on reported deaths with corresponding ICD-10 codes for CVD as underlying cause of death. ORA was defined as self-reported participation in recreational physical activities considered to have occurred outdoors in the past month. Time to CVD mortality was estimated from multivariable adjusted Cox proportional hazards (CPH) models. A joint effects model was used in estimating multiplicative and additive interaction between ORA and 25(OH)D. Results A crude unweighted CVD mortality rate of 7.4% (964/13,031) occurred during a median follow-up of 14.33 years. Frequency of ORA Conclusion Lower frequency of ORA and serum 25(OH)D levels were jointly associated with elevated risk of CVD mortality. Serum 25(OH)D modified the risk of CVD mortality associated with lower frequency of outdoor-based recreational activities.

Between 1987 and 1992, 57 patients aged twenty-five to forty (average, 34.0 ±4.5 years) underwent major lower extremity amputations in five community hospitals, including a Level II Trauma Center. Only 19 (33%) patients had traumatic amputations, 3 (5%) had malignant tumors, and 4 (7%) had juvenile-onset diabetes mellitus without atherosclerotic involvement of the large arteries. Thirty (53%) patients had premature atherosclerosis (PAS) of the lower extremities with end-stage renal disease (ESRD) present in half and related to diabetes in 12. All patients with ESRD required continuous dialysis therapy. Overall 19 (33%) patients in this study had diabetes. Of 32 patients < thirty-five years of age, 47% had traumatic amputations, and PAS was diagnosed in 28%. However, PAS was diagnosed in 84% of 25 patients > thirty-six years of age (OR= 14.3; P < 0.001). In total, 67 amputations were done. Twenty-one (68%) of 31 above-knee amputations (AKA) were performed in patients with PAS, and 26% of AKA were related to trauma. Of 10 bilateral amputations, 9 (90%) were done in patients with PAS. Patients with PAS had a high prevalence of risk factors for cardiovascular disease including smoking (87%), diabetes (50%), hypertension (50%), and hyperlipidemia (30%). Nine (30%) of the patients with PAS had hypercoagulable states. PAS was identified as the leading cause for major amputations among young adults in this community and was frequently associated with heavy smoking, diabetes, end-stage renal disease, and hypercoagulability.

To investigate the possible association between changes in coffee consumption and serum cholesterol levels, information was obtained from 2109 healthy nonsmokers aged 25-65 years at two clinic visits to a preventive medical center between 1987 and 1991 (mean interval between visits: 16.7 months). After adjusting for age and changes in other potential confounders, about 2 mg/dl total cholesterol increase was associated with an increase of one cup of regular coffee per day (p0.001). A dose-response was found among those who decreased regular coffee consumption, those who continued the same dose, and those who increased consumption. The same trend was observed among those who quit drinking regular coffee, those who never drank coffee, and those who started to drink coffee. No change in cholesterol level was found among those continuing to consume the same quantity of regular coffee compared to those who never drank coffee. The change in cholesterol level was not related to consumption of decaffeinated coffee, regular tea, decaffeinated tea, or cola with caffeine. To our knowledge, this is the first follow-up study correlating change in coffee consumption with change in serum cholesterol in a large group of men and women.

Although erectile dysfunction is frequently seen in patients with manifestations of arteriosclerotic disease, the independent contribution of serum cholesterol in predicting erectile dysfunction is unclear. The aim of this study was to examine the relation between serum cholesterol and erectile dysfunction. Medical histories, physical examinations, and blood tests were obtained at Cooper Clinic, Dallas, Texas, from 3,250 men aged 26-83 years (mean, 51 years) without erectile dysfunction at their first visit, who had one more clinic visit, all between 1987 and 1991. These men were followed 6-48 months after the first clinic visit (mean, 22 months). Erectile dysfunction was reported in 71 men (2.2%) during follow-up. Every mmol/liter of increase in total cholesterol was associated with 1.32 times the risk of erectile dysfunction (95% confidence interval 1.04-1.68), while every mmol/liter of increase in high density lipoprotein cholesterol was associated with 0.38 times the risk (95% confidence interval 0.18-0.80). Men with a high density lipoprotein cholesterol measurement over 1.55 mmol/liter (60 mg/dl) had 0.30 times the risk (95% confidence interval 0.09-1.03) as did men with less than 0.78 mmol/liter (30 mg/dl). Men with total cholesterol over 6.21 mmol/liter (240 mg/dl) had 1.83 times the risk (95% confidence interval 1.00-3.37) as did men with less than 4.65 mmol/liter (180 mg/dl). Those differences remained essentially unchanged after adjustment for other potential confounders. The authors conclude that a high level of total cholesterol and a low level of high density lipoprotein cholesterol are important risk factors for erectile dysfunction.

The results of routinely performed multigated blood pool studies (MUGA) were compared with the presence of postthoracotomy complications in 46 adult men in a retrospective chart review. Pulmonary function measurements were also examined in relation to the presence of complications experienced. There was only one death, but survivable complications were not predicted by the MUGA results. The addition of MUGA as a routine preoperative cardiac screening technique did not result in increased ability to predict postoperative cardiopulmonary complications.

This paper describes the incorporation of geriatrics into an existing medical school curriculum through the use of a vertical format. This involves incorporating learning objectives and geriatrics material into multiple existing courses throughout the four years of medical education. Results of five surveys of departmental chairmen and/or the directors of existing courses conducted over a seven year period indicate that this approach has allowed for an increase in the total number of hours dedicated to geriatrics without objections from course directors, department chairment, or the curriculum committee.

National studies have documented an excessive rate of cigarette smoking in black men; however, a 1987 survey conducted in two urban areas in South Carolina documents a high rate of smoking in young white men with fewer than 12 years of education (67%; 95% confidence interval [CI] = 58.3, 75.7). Differences in smoking rates by educational level were significant only for those younger than 40. Young blacks were less likely to smoke and smoked fewer cigarettes than whites. As a result, the population burden of cigarettes in young black men with fewer than 12 years of education was only 27% of the burden carried by their white peers. Television, physicians, and radio were all seen as likely sources of health information to prevent heart disease, but newspapers were less likely to be cited by those younger than 40 or by those with fewer than 12 years of education. Reported physician counseling for smoking cessation did not differ significantly by race, sex, or educational level of the patient, but reported counseling was higher for individuals with a personal history of cardiovascular disease (odds ratio [OR] = 2.32, CI = 1.27, 4.25) and somewhat lower for the elderly. We highlight the population burden of cigarettes, a predictor of the eventual disease burden attributable to smoking, as a useful priority measure for smoking intervention efforts.

Objective To conduct a meta-analysis of randomized controlled trials in which high inspired oxygen concentrations were compared with standard concentrations to assess the effect on the development of surgical site infections (SSIs). Data Sources A systematic literature search was conducted using the MEDLINE, EMBASE, and Cochrane databases and included a manual search of references of original articles, poster presentations, and abstracts from major meetings (“gray” literature). Study Selection Twenty-one of 2167 articles met the inclusion criteria. Of these, 5 randomized controlled trials (3001 patients) assessed the effect of perioperative supplemental oxygen use on the SSI rate. Studies used a treatment-inspired oxygen concentration of 80%. Maximum follow-up was 30 days. Data Extraction Data were abstracted by 3 independent reviewers using a standardized data collection form. Relative risks were reported using a fixed-effects model. Results were subjected to publication bias testing and sensitivity analyses. Data Synthesis Infection rates were 12.0% in the control group and 9.0% in the hyperoxic group, with relative risk reduction of 25.3% (95% confidence interval [CI], 8.1%-40.1%) and absolute risk reduction of 3.0% (1.1%-5.3%). The overall risk ratio was 0.742 (95% CI, 0.599-0.919; P = .006). The benefit from increasing oxygen concentration was greater in colorectal-specific procedures, with a risk ratio of 0.556 (95% CI, 0.383-0.808; P = .002). Conclusions Perioperative supplemental oxygen therapy exerts a significant beneficial effect in the prevention of SSIs. We recommend its use along with maintenance of normothermia, meticulous glycemic control, and preservation of intravascular volume perioperatively in the prevention of SSIs.

Objective. The purpose of this report is to put the dueling factors of risk and prevention for melanoma in perspective for the thoughtful pediatric specialist to facilitate preteen preventive health counseling. Study Design. We examined the rate of malignant melanoma among Kentucky residents and compared this rate with indicators of tanning bed prevalence in a large metropolitan area and sunscreen sales from a major distributor. We obtained malignant melanoma annual incidence data from the Kentucky Cancer Registry, which recorded Kentucky population incidence rates over the years 1995 to 2004. The rates reflected 2 malignant melanoma classifications: pre-invasive cancer only, or both invasive and noninvasive cancers combined. Results. The age-adjusted incidence rate per hundred thousand for combined invasive and pre-invasive malignant melanoma swelled from 21.9 in 1995 to 31.3 in 2004. The respective invasive-only malignant melanoma incidence rates increased less dramatically, from 17.3 to 20.7, during this same 10-year time period. Since 1983, the number of separate tanning bed businesses increased from 1 in 1983 to 119 by the mid-1990s, and then declined to about 74 separate businesses by 2003. Sunscreen sales data is uneven between states and is currently inconclusive. Conclusions. Although current data cannot draw a precise link between melanoma and the use of tanning beds, the associated risk is implicit, as the ultraviolet A (UVA) and ultraviolet B (UVB) radiation in tanning bed usage is a well-established melanoma risk factor. In advising patients, the pediatric specialist should consider that melanoma rates are poised as a balance of some known risk factors and a few potential preventive factors.

The results of a clinically performed preoperative stair climb was compared to the presence of postthoracotomy complications in the retrospective hospital record review of 54 adult men. The stair climb was a maximum of five flights (125 steps) performed at the patient's rate and terminated at his request. Pulmonary function measurements and facets of the stair climb physiology were also examined in reference to the presence, type, and severity of complications experienced. Most minor complications such as transient arrhythmias, atelectasis, and pneumonia were clearly not predicted by the stair climb performance. The ability to climb three flights preoperatively most clearly separated those patients having the longer postoperative intubation and hospital stay, greater frequency of complications, and cumulative complication score (p (Chest 1991; 99:587–90)

Although left ventricular (LV) aneurysm is associated with increased mortality, its independent prognostic significance is controversial. To determine the effect of LV aneurysm on risk, 121 patients with healed myocardial infarction (MI), 55 manifesting akinesia on ventriculography (MI group) and 66 with LV aneurysm characterized by diastolic deformity (eccentricity) and systolic dyskinesia (LV aneurysm group) were studied. At a mean follow-up of 5.7 years, there were 32 cardiac deaths (12 MI vs 20 LV aneurysm), including 9 sudden deaths (1 MI vs 8 LV aneurysm). Multivariate analysis revealed decreasing ejection fraction to be the best predictor of total cardiac death, and revascularization to be protective. Nonsudden cardiac death was predicted by ejection fraction, absence of revascularization and right coronary artery disease, whereas sudden cardiac death was predicted by LV aneurysm and the frequency of ventricular ectopic complexes on Holter monitoring. In the MI group, ejection fraction was the only significant predictor of total cardiac death and nonsudden cardiac death. In the LV aneurysm group, total cardiac death, as well as nonsudden cardiac death, were predicted by ejection fraction, ventricular tachycardia and right coronary artery disease, whereas ventricular tachycardia predicted sudden cardiac death. It is concluded that the risk profile for total cardiac death differs between LV aneurysm and MI patients, and that LV aneurysm constitutes an independent predictor of late sudden cardiac death after MI. Moreover, on a substrate of LV aneurysm, the risk factors for sudden cardiac death and nonsudden cardiac death differ, with ventricular tachycardia being the sole predictor of sudden cardiac death. Furthermore, Holter monitoring is valuable in Identifying patients at persistent risk of sudden cardiac death.

The use of prophylactic systemic antibiotics to prevent infection and reduce mortality in severe acute pancreatitis (SAP) remains a contentious issue. We assessed the clinical outcome of patients with SAP treated with prophylactic antibiotics compared with that of patients not treated with antibiotics.We performed a systematic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials, using PubMed, Google Scholar, and Ovid as search engines without language restriction until the end of May 2008. We also manually searched the references of original/review articles and evaluated symposia proceedings, poster presentations, and abstracts from major gastrointestinal and surgical meetings. Relative risks were calculated for individual trials and data were pooled using a fixed-effects model. Relative risk (RR) reduction, absolute risk reduction, and number needed to treat were calculated and are reported with 95% confidence intervals.Results were subjected to sensitivity analysis to determine heterogeneity among studies. We pooled 502 patients from 8 studies. Patient age ranged from 43 to 59 years, and length of stay ranged from 18 to 95 days. There were 253 patients with SAP who received prophylactic antibiotics, and 249 patients were randomized to the placebo arm. Overall, there was no protective effect of antibiotic treatment with respect to mortality (RR, .76; 95% confidence interval [CI], .49-1.16). With respect to morbidity, antibiotic prophylaxis did not protect against infected necrosis (RR, .79; 95% CI, .56-1.11) or surgical intervention (RR, .88; 95% CI, .65-1.20). There was, however, an apparent benefit in regards to nonpancreatic infections (RR, .60; 95% CI, .44-.82), with a RR reduction of 40% (95% CI, 18%-56%), absolute risk reduction of 15% (95% CI, 6%-23%), and number needed to treat of 7 (95% CI, 4-17).Antibiotic prophylaxis of SAP does not reduce mortality or protect against infected necrosis, or frequency of surgical intervention.

The home telehealth market is rapidly expanding. The technology and capabilities currently available have the potential to significantly affect the clinical management of an aging population, particularly, the large number with multiple coexisting disease processes. Potential benefits of home-monitoring systems for patients with heart failure range from decreased rates of mortality and improved quality of life to providing third party payers, including the federal government (ie, Centers for Medicare and Medicaid Services), with significant long-term cost savings. The current regulatory process does not provide adequate oversight and standards for these systems that transmit and process data (telehealth systems) critical for patient management. Home telehealth vendors must address the possibility that increased utilization increases their risk of liability due to patient safety issues. In all, 5 major areas need to be addressed to maximize the benefits and safety of this technology: effectiveness of patient management; evidence-based outcomes; regulation; cost, including cost effectiveness and reimbursement; and certification to ensure reliability.

Standard proton-pump inhibitor-based therapy for Helicobacter pylori infection fails in up to one quarter of patients. Sequential therapy may be more efficacious.To compare sequential therapy with standard triple therapy for H. pylori infection.MEDLINE, EMBASE (1981 to October 2007), the Cochrane Central Register of Controlled Trials, and Google Scholar. PubMed and Ovid were the search engines used.Randomized, controlled trials (RCTs) comparing sequential and standard triple therapies in treatment-naive patients with documented H. pylori infection.3 reviewers independently assessed trial eligibility and quality and extracted data on eradication.The crude rates of H. pylori eradication in 10 RCTs involving 2747 patients were 93.4% (95% CI, 91.3% to 95.5%) for sequential therapy (n = 1363) and 76.9% (CI, 71.0% to 82.8%) for standard triple therapy (n = 1384) (relative risk reduction, 71% [CI, 64% to 77%]; absolute risk reduction, 16 percentage points [CI, 14 to 19 percentage points]). The median rates of adherence were 97.4% (range, 90.0% to 98.9%) for sequential therapy and 96.8% (range, 93.0% to 100%) for standard therapy. Sequential therapy appeared superior in prespecified sensitivity (subgroup) analyses stratified by trial quality; smoking status; diagnosis (ulcer disease or nonulcer dyspepsia); resistance to clarithromycin, imidazoles, or both; duration of triple therapy; and method of diagnosis. Both treatments had similar side effect profiles.Only 1 study was double-blinded. Most patients were from Italy. There was clear evidence of publication bias.Sequential therapy appears superior to standard triple therapy for eradication of H. pylori infection. If RCTs in other countries confirm these findings, 10-day sequential therapy could become a standard treatment for H. pylori infection in treatment-naive patients.

Occurrence rates and determinants of infection with herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) were measured in first- and fourth-year undergraduate students at a state university. This cross-sectional multistage probability sample survey included sociodemographic characteristics, sexual behavior patterns, disease history, and HSV type-specific antibody status. The prevalence of HSV-1 antibody was 37.2% in freshmen and 46.1% in fourth-year students; that for HSV-2 antibody was 0.4% and 4.3%, respectively. A history of cold sores was obtained in 25.6% of the freshmen; none had a history of manifest genital herpes. A history of cold sores was obtained in 28% and a history of genital herpes in 1.1% of the fourth-year students. The case-weighted prevalence of HSV-1 and HSV-2 antibodies was found to be significantly elevated for a number of student characteristics. However, multiple logistic regression analyses indicated that the significant predictors of HSV-1 antibodies in this population were female gender, black race, first intercourse at age less than or equal to 15 years, total years of sexual activity, history of a partner with oral sores, and a personal history of a non-HSV sexually transmitted disease (STD). Predictors of HSV-2 antibody were black race, duration of sexual activity, and history of a non-HSV STD.

Background and aims: To investigate if frequency of outdoor recreational activity (ORA) predicts cardiovascular disease (CVD) mortality, independent of serum 25(OH)D concen- tration. Methods and results: Baseline data on ORA and serum 25(OH)D, collected from 11,746 partici- pants aged 30e90 years in the Third National Health and Nutrition Examination Survey during 1988e1994, were linked to the National Death Index for assessment of CVD deaths from baseline through December 2006. CVD mortality as a primary cause of death was assessed during a mean follow up of 12.9 (SD, 4.2) years. There were 1519 CVD deaths during follow up. A strong positive association was observed be- tween frequency of ORA in the last month and serum 25(OH)D (p < 0.001). Compared to partic- ipants who did no ORA in the last month, the hazard ratio (HR) of CVD mortality was 0.72 (95% confidence interval 0.58e0.90) for those doing ORA 1e4 times, 0.64 (0.47e0.89) for 5e12 times, 0.70 (0.56e0.89) for 13e30 times and 0.63 (0.47e0.84) for � 30 times (p-trend < 0.001), in a Cox proportional hazards regression model which included 25(OH)D and CVD risk factors. Serum 25(OH)D was inversely associated with CVD mortality (p-trend, 0.01) in this same model. Conclusions: An inverse association between ORA and CVD mortality was observed independent of 25(OH)D. The underlying mechanism for this association may not involve 25(OH)D hence, further studies are warranted to confirm and investigate the underlying mechanism.

OBJECTIVE To assess whether there is a true effect of smoking on the 2 most prevalent forms of inflammatory bowel disease (IBD): Crohn disease (CD) and ulcerative colitis (UC). METHODS For this meta-analysis, we searched multiple health care databases, including MEDLINE and EMBASE (January 1980 to January 2006), to examine the relationship between smoking and IBD. Keywords searched included smoking, inflammatory bowel disease, Crohn's disease , and ulcerative colitis . Data were abstracted using predefined inclusion and exclusion criteria. An odds ratio (OR) was recalculated for each study using the random-effects model, and a combined OR was calculated. RESULTS A total of 245 articles were obtained through an electronic search of health care databases. Thirteen studies examined the relationship between UC and smoking, whereas 9 examined the relationship between CD and smoking. We found evidence of an association between current smoking and CD (OR, 1.76; 95% confidence interval [CI], 1.40-2.22) and former smoking and UC (OR, 1.79; 95% CI, 1.37-2.34). Current smoking had a protective effect on the development of UC when compared with controls (OR, 0.58; 95% CI, 0.45-0.75). CONCLUSION This is the first meta-analysis, to our knowledge, to evaluate the relationship between smoking and IBD using accepted quality standards for meta-analysis reporting. Our meta-analyses confirm that smoking is an important environmental factor in IBD with differing effects in UC and CD. By using predefined inclusion criteria and testing for homogeneity, the current analysis provides an estimate of the effect of smoking on both these forms of IBD.

The proliferation of clandestine methamphetamine laboratories (meth labs) as a result of the growing popularity of the drug has resulted in an increasing incidence of burn injuries associated with laboratory accidents. We undertook this study to characterize these injuries. Fifteen consecutive patients were identified and case-matched by age and TBSA to 45 control subjects. Most meth lab patients were men, Caucasian, unemployed, and positive for polysubstance abuse. Resuscitation requirements were 1.8 times greater in these patients. There was a higher incidence of inhalational injury corresponding to higher intubation and tracheostomy rate and longer ventilator days among meth lab patients. The rate of nosocomial pneumonia, skin graft loss, and mortality were not different between the two groups. Meth lab injury is unique and requires more critical care resources. It also is associated with lack of insurance coverage and poor follow-up after injury. This injury has a significant impact not only on patients but also on the healthcare system.

Physicians routinely discuss pulmonary function and its impact on prognosis or operative risk. Although many studies have related various measures of pulmonary function to postoperative outcome, there has been no study designed to determine which of the spirometric measures of pulmonary function tests reflects the actual abstract idea of pure pulmonary function. A homogeneous population of 70 male patients was subjected to pulmonary function tests and a simple stair climb. Measures of pulmonary function (including FEV1, FEV1%, FVC, FVC%, and MVV%) were factor analyzed in a measurement model of pulmonary function to obtain reliability and validity estimates in predicting performance on a simple stair-climb test. The analysis revealed several interesting aspects concerning the relative importance of the various spirometric measures of pulmonary function tests. The validity estimates of the pulmonary function measures were as follows: FEV1% = 0.917; FEV1 = 0.886; MVV% = 0.769; FVC% = 0.715; FVC = 0.694. Analysis indicates that the FEV1% was the single best spirometric indicator of pulmonary function when predicting the physiologic outcome (followed closely by the FEV1). In addition, the various spirometric measures of pulmonary function were not equally valid nor interchangeable in such analysis. Although the number of stairs climbed correlates well with pulmonary function (r = 0.626), the coefficient of non-determination (i.e., 1-r2) suggests that about 61% of the performance on the stair climb may be explained by other parameters (i.e., cardiac function, determination, altitude, etc.).

To compare the frequency and severity of systemic disease in patients with subacute cutaneous lupus erythematosus (SCLE) followed up in a dermatology practice vs patients with systemic lupus erythematosus (SLE) followed up in a rheumatology practice.Case-control comparison of patients matched for age, sex, and ethnicity.University-affiliated dermatology and rheumatology practices.Seventy-six patients with SCLE were compared with 24 patients with SLE.All medical records were reviewed and the patients were interviewed.Systemic and serologic findings were compared between patients with SCLE and those with SLE.Hematologic disorders were present in 6 patients (8%) with SCLE and in 13 patients (54%) with SLE (P.001). Serositis was present in 1 patient (1%) with SCLE and in 3 patients (12%) with SLE (P =.04). Renal involvement was present in 12 patients (16%) with SCLE and in 6 patients (25%) with SLE (P =.36). Antinuclear antibodies were found in 52 patients (68%) with SCLE compared with 23 patients (96%) with SLE (P =.006). Anti-Ro antibodies were found in 37 patients (49%) with SCLE compared with 10 patients (42%) with SLE (P =.64). Other serologic abnormalities (anti-native DNA, anti-Sm antibody, or anti-U(1)RNP) were present in 6 patients (8%) with SCLE compared with 15 patients (62%) with SLE (P.001). Photosensitivity was present in 65 patients (86%) with SCLE, compared with 11 patients (46%) with SLE (P.001).This analysis reveals a dissimilar frequency of internal organ involvement between patients with SCLE and SLE. Renal disease was similar in frequency and severity, and documented central nervous system involvement was rare in both groups.

Background: Following myocardial infarction, the ejection fraction (EF) is an indiscriminate predictor of both non-sudden cardiac death (NSCD) and sudden cardiac death (SCD). However, development of a left ventricular aneurysm (LVA) confers independent risk only for SCD. Thus, we tested the hypothesis that mechanical factors, other than the global left ventricular performance, are causally related to SCD in the presence of LVA. Methods: A secondary analysis was conducted from a longitudinal, prospective, long-term follow-up cohort study of 66 patients with LVA (diastolic eccentricity and systolic dyskinesia) diagnosed by ventriculography. The left ventricular contour was divided into five segments and contractility scores for the residual myocardium and the segments adjacent to the aneurysm were allocated along with assessment of the EF. A normal adjacent segment was considered present when at least one segment adjacent to the aneurysm exhibited normokinesia. Presence of ventricular tachycardia was documented by Holter recording. Results: At a 5.2-year median follow-up, there were 12 NSCD and 8 SCD. The EF was lower among patients who died vs. survivors (31.5% vs. 39.7%, P-0.01). Patients with NSCD and SCD, exhibited similar EF but disparate residual contractility scores (3.0 vs. 4.1, P

The aim of this study was to identify independent predictors of acquiring a nosocomial bloodstream infection (BSI) during extracorporeal membrane oxygenation (ECMO).This retrospective cohort consisted of 202 neonates treated with ECMO from 1989 to 1998 at the author' institution. Data collected included patient demographics, primary and secondary diagnoses, white blood cell counts, antibiotic usage, presence of central lines, operative procedures, and outcome. Surveillance blood cultures were drawn daily from the circuit using sterile technique to identify acquired pathogens. Statistical analyses included logistic regression, Cox proportional regression analysis, and discriminate analysis.There were 1,245 blood cultures drawn on 202 patients (6.2 cultures per patient), and a nosocomial BSI was identified in 7 patients (3.4%) during this 10-year span. These were infections that were neither present nor incubating on admission. Pre-ECMO diagnoses of patients who had a nosocomial BSI while on bypass included group B beta-hemolytic streptococcal sepsis (n = 2), herpes simplex viral sepsis (n = 1), congenital diaphragmatic hernia (n = 2), persistent pulmonary hypertension (n = 1), and congenital heart disease (n = 1). The median time on ECMO before obtaining a positive culture was 390 hours. The infectious agents responsible for these BSIs included Staphylococcus epidermidis (n = 5), Staphylococcus aureus (n = 1), and Escherichia coli (n = 1). The major factor associated with acquiring a nosocomial BSI on ECMO was the duration of bypass (391 v 141 hours, P =.002). Additionally, patients in the BSI group were more likely to have had an arterial catheter in place (16 v 7 days, P =.009) and to have received more screening blood cultures (16 v 6 cultures, P001). White blood cell counts, absolute neutrophil counts, and immature/total (I/T) ratios were not useful in predicting a nosocomial BSI. Of the 31 patients who required ECMO for more than 10 days, 7 (23%) had a positive blood culture, and 5 of these 7 infants (71%) died (P =.03).The only predictor of acquiring a nosocomial BSI on ECMO was the duration of support for greater than 10 days. Because classical predictors of infection are unreliable while the patient is on ECMO, the authors suggest that obtaining daily surveillance blood cultures beginning on the tenth day should be performed with prolonged ECMO courses. The authors confirmed previous reports of the association between a prolonged ECMO course and a high mortality rate. However, the authors speculate that, in actuality, the primary diagnosis leads to the prolonged course of support and is the major factor in the infant' demise.