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T Vivian Liao,1 Marina Rabinovich,2 Prasad Abraham,2 Sebastian Perez,3 Christiana DiPlotti,4 Jenny E Han,5 Greg S Martin,5 Eric Honig5 1Department of Pharmacy Practice, College of Pharmacy, Mercer Health Sciences Center, 2Department of Pharmacy and Clinical Nutrition, Grady Health System, 3Department of Surgery, Emory University, 4Pharmacy, Ingles Markets, 5Department of Medicine, Emory University, Atlanta, GA, USA Purpose: Patients in the intensive care unit (ICU) are at an increased risk for medication errors (MEs) and adverse drug events from multifactorial causes. ME rate ranges from 1.2 to 947 per 1,000 patient days in the medical ICU (MICU). Studies with the implementation of electronic health records (EHR) have concluded that it significantly reduced overall prescribing errors and the number of errors that caused patient harm decreased. However, other types of errors, such as wrong dose and omission of required medications increased after EHR implementation. We sought to compare the number of MEs before and after EHR implementation in the MICU, with additional evaluation of error severity.Patients and methods: Prospective, observational, quality improvement study of all patients admitted to a single MICU service at an academic medical center. Patients were evaluated during four periods over 2 years: August–September 2010 (preimplementation; period I), January–February 2011 (2 months postimplementation; period II), August–September 2012 (21 months postimplementation; period III), and January–February 2013 (25 months postimplementation; period IV). All medication orders and administration records were reviewed by an ICU clinical pharmacist and ME was defined as a deviation from established standards for prescribing, dispensing, administering, or documenting medication. The frequency and classification of MEs were compared between groups by chi square; p

Naeem A Ali1, David Gutteridge2, Sajid Shahul3, William Checkley4, Jonathan Sevransky4, Greg S Martin2 1The Ohio State University Medical Center, Columbus, OH; 2Emory University, Atlanta, GA; 3Beth Israel Deaconess Medical Center, Boston, MA; 4Johns Hopkins University, Baltimore, MD, USA Abstract: Individual intensive care unit (ICU) characteristics including staffing, expertise, continuity, and team structure, have been associated with patient outcomes. Separately, some aspects of care in ICUs have been implemented through treatment protocols. The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol use in ICUs is associated with hospital survival in a large number of US ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS steering committee. USCIITG-CIOS is a prospective, observational, ecological, multicentered study of mixed ICUs in the US. The data to be collected include organizational information for the ICU (eg, protocol availability and utilization, multidisciplinary staffing assessment), and patient level information (eg, demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high-protocol and low-protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize multivariable regression approaches to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. We anticipate at least 60 ICUs participating in USCIITG-CIOS to enroll approximately 6000 study subjects. USCIITG-CIOS is a multicenter study examining the effect of ICU protocols on patient outcomes. These results will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective and reproducible ICU care and outcomes. Keywords: intensive care, critical care, outcomes, protocols, organization

Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. These articles have spanned many aspects of clinical trials wonderfully, including trial design and management; legal, ethical and regulatory issues of clinical trials; subject participation and retention in clinical trials; and data collection and data management.

Background: Whole genome sequencing is poised to revolutionize personalized medicine, providing the capacity to classify individuals into risk categories for a wide range of diseases. Here we begin to explore how whole genome sequencing (WGS) might be inco

Abstract Background and objectives Pain management is a necessary component of palliative care as most patients suffer from pain during the final phase of life. Due to the complex causation of pain in the last phase of life, it is important to utilize methods other than pharmacotherapeutic options in order to achieve adequate pain control. As little is known about treatment of pain in German hospices, a nationwide survey was conducted. Materials and methods All German hospices (259) were contacted by post in June 2020 and asked to participate in an anonymous cross-sectional survey. Results A total of 148 (57%) German hospices took part in the survey. A broad variety of medication is used in the hospice setting. Metamizole is the most commonly used non-opiod analgesic , hydromorphone the most commonly used opioid, and pregabalin is the most commonly prescribed co-analgesic drug. The pain medication is usually prescribed as an oral slow-release substance. Standardized treatment schemes are rare among the responding hospices. Most of the respondents also use complementary treatment options, such as aroma (oil) therapy or music therapy, in the treatment of pain. Palliative sedation is used by nearly all responding hospices if all other treatment options fail. Conclusion This survey provides an overview of the treatment options for pain management in German hospices. A broad variety of pain medication is used. Compared to international literature, it is debatable whether such a large variety of different types of pain medication is necessary, or whether a reduction in the type of medication available and the use of standardized treatment schemes could benefit everyone involved.

Background: Many people want to die at home, but it is often not possible because they do not share their wishes with family members. This study was conducted to find out the extent to which patients with advanced urological malignancies had wishes regarding their final stage of life, made arrangements accordingly, and communicated their wishes to relatives and health care professionals. Methods: We conducted a survey among advanced urological tumor patients during their clinic visit at a German university hospital using a 31-item questionnaire. Inclusion criteria were metastatic or irresectable prostate cancer, urothelial carcinoma, or renal cell carcinoma. Results: In total, 88 patients (76 male, 12 female) completed the questionnaire, and 62 of those respondents (70%) had received their tumor diagnosis within the past 5 years. Symptoms were reported by 80%, and 18% described five or more symptoms. The majority (88%) stated that they had thought about their preferred place of death but 58% had not informed anyone about it. The preference for a hospice as the place of death correlated statistically significantly with the absence of a domestic partnership (p = 0.001) or marriage (p < 0.001) and with a high number of symptoms (≥5; p = 0.009). However, 73% had not talked with their urological oncologist about care options in case their health deteriorated though 36% of those were interested in having a conversation about it. Conclusions: Our results showed that 9 out of 10 patients reflected on their preferred place of death but only a few discussed it with anyone. Based on this finding, physicians and healthcare staff should initiate discussions about early care planning so that patients in incurable situations can express their wishes regarding their preferred place of death.

Human and animal vector-borne diseases, particularly mosquito-borne diseases, are emerging or re-emerging worldwide. Six Aedes invasive mosquito (AIM) species were introduced to Europe since the 1970s: Aedes aegypti, Ae. albopictus, Ae. japonicus, Ae. koreicus, Ae. atropalpus and Ae. triseriatus. Here, we report the results of AIMSurv2020, the first pan-European surveillance effort for AIMs. Implemented by 42 volunteer teams from 24 countries. And presented in the form of a dataset named “AIMSurv Aedes Invasive Mosquito species harmonized surveillance in Europe. AIM-COST Action. Project ID: CA17108”. AIMSurv2020 harmonizes field surveillance methodologies for sampling different AIMs life stages, frequency and minimum length of sampling period, and data reporting. Data include minimum requirements for sample types and recommended requirements for those teams with more resources. Data are published as a Darwin Core archive in the Global Biodiversity Information Facility- Spain, comprising a core file with 19,130 records (EventID) and an occurrences file with 19,743 records (OccurrenceID). AIM species recorded in AIMSurv2020 were Ae. albopictus, Ae. japonicus and Ae. koreicus, as well as native mosquito species.

Over the past three decades, Europe has witnessed an increased spread of invasive aedine mosquito species, most notably Aedes albopictus, a key vector of chikungunya, dengue and Zika virus. While its distribution in southern Europe is well documented, its dispersal modes across the Alps remain poorly investigated, preventing a projection of future scenarios beyond its current range in order to target mosquito control. To monitor the presence and frequency of invasive Aedes mosquitoes across and beyond the Alps we set oviposition and BG-Sentinel traps at potential points of entry with a focus on motorway service areas across Switzerland. We placed the traps from June to September and controlled them for the presence of mosquitoes every other week between 2013 and 2018. Over the six years of surveillance we identified three invasive Aedes species, including Ae. albopictus, Ae. japonicus and Ae. koreicus. Based on the frequency and distribution patterns we conclude that Ae. albopictus and Ae. koreicus are being passively spread primarily along the European route E35 from Italy to Germany, crossing the Alps, while Ae. japonicus has been expanding its range from northern Switzerland across the country most likely through active dispersal.

OBJECTIVE: : To review the current knowledge of common comorbidities in the intensive care unit, including diabetes mellitus, chronic obstructive pulmonary disease, cancer, end-stage renal disease, end-stage liver disease, HIV infection, and obesity, with specific attention to epidemiology, contribution to diseases and outcomes, and the impact on treatments in these patients. DATA SOURCE: : Review of the relevant medical literature for specific common comorbidities in the critically ill. RESULTS: : Critically ill patients are admitted to the intensive care unit for various reasons, and often the admission diagnosis is accompanied by a chronic comorbidity. Chronic comorbid conditions commonly seen in critically ill patients may influence the decision to provide intensive care unit care, decisions regarding types and intensity of intensive care unit treatment options, and outcomes. The presence of comorbid conditions may predispose patients to specific complications or forms of organ dysfunction. The impact of specific comorbidities varies among critically ill medical, surgical, and other populations, and outcomes associated with certain comorbidities have changed over time. Specifically, outcomes for patients with cancer and HIV have improved, likely related to advances in therapy. Overall, the negative impact of chronic comorbidity on survival in critical illness may be primarily influenced by the degree of organ dysfunction or the cumulative severity of multiple comorbidities. CONCLUSION: : Chronic comorbid conditions are common in critically ill patients. Both the acute illness and the chronic conditions influence prognosis and optimal care delivery for these patients, particularly for adverse outcomes and complications influenced by comorbidities. Further work is needed to fully determine the individual and combined impact of chronic comorbidities on intensive care unit outcomes. [ABSTRACT FROM AUTHOR]

Background: Acute lung injury (ALI) is a frequent complication of sepsis. It is unclear if a pulmonary vs nonpulmonary source of sepsis affects mortality in patients with sepsis-induced ALI.Methods: Two hundred eighty-eight consecutive patients with sepsis-induced ALI from 14 ICUs at four hospitals in Baltimore, MD were prospectively classified as having a pulmonary vs nonpulmonary source of sepsis. Multiple logistic regression was conducted to evaluate the independent association of a pulmonary vs nonpulmonary source of sepsis with inpatient mortality.Results: In an unadjusted analysis, in-hospital mortality was lower for pulmonary vs nonpulmonary source of sepsis (42% vs 66%, p < 0.0001). Patients with pulmonary sepsis had lower acute physiology and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores, shorter ICU stays prior to the development of ALI, and higher lung injury scores. In the adjusted analysis, several factors were predictive of mortality: age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01 to 1.06), Charlson comorbidity index (OR, 1.15; 95% CI, 1.02 to 1.30), ICU length of stay prior to ALI diagnosis (OR, 1.19; 95% CI, 1.01 to 1.39), APACHE II score (OR, 1.07; 95% CI, 1.03 to 1.12), lung injury score (OR, 1.64; 95% CI, 1.11 to 2.43), SOFA score (OR, 1.15; 95% CI, 1.06 to 1.26), and cumulative fluid balance in the first 7 days after ALI diagnosis (OR, 1.06; 95% CI, 1.03 to 1.10). A pulmonary vs nonpulmonary source of sepsis was not independently associated with mortality (OR, 0.72; 95% CI, 0.38 to 1.35).Conclusions: Although lower mortality was observed for ALI patients with a pulmonary vs nonpulmonary source of sepsis, this finding is likely due to a lower severity of illness in those with pulmonary sepsis. Pulmonary vs nonpulmonary source of sepsis was not independently predictive of mortality for patients with ALI. [ABSTRACT FROM AUTHOR]

Objective: Sepsis is an increasingly common and lethal medical condition that occurs in people of all ages. The influence of age on sepsis risk and outcome is incompletely understood. We sought to determine the independent effect of age on the incidence, severity, and outcome of adult sepsis.Design: Longitudinal observational study using national hospital discharge data.Setting: Approximately 500 geographically separated nonfederal acute care hospitals in the United States.Patients: Patients were 10,422,301 adult sepsis patients hospitalized over 24 yrs, from 1979 to 2002.Interventions: None.Measurements and Main Results: Incident sepsis cases were age adjusted and characterized by demographics, sources and types of infection, comorbid medical conditions, and hospital discharge status. Elderly patients (> or = 65 yrs of age) accounted for 12% of the U.S. population and 64.9% of sepsis cases, yielding a relative risk of 13.1 compared with younger patients (95% confidence interval, 12.6-13.6). Elderly patients were more likely to have Gram-negative infections, particularly in association with pneumonia (relative risk, 1.66; 95% confidence interval, 1.63-1.69) and to have comorbid medical conditions (relative risk, 1.99; 95% confidence interval, 1.92-2.06). Case-fatality rates increased linearly by age; age was an independent predictor of mortality in an adjusted multivariable regression (odds ratio, 2.26; 95% confidence interval, 2.17-2.36). Elderly sepsis patients died earlier during hospitalization, and elderly survivors were more likely to be discharged to a nonacute health care facility.Conclusions: The incidence of sepsis is disproportionately increased in elderly adults, and age is an independent predictor of mortality. Compared with younger sepsis patients, elderly nonsurvivors of sepsis die earlier during hospitalization and elderly survivors more frequently require skilled nursing or rehabilitative care after hospitalization. These findings have implications for patient care and health care resource prioritization and provide insights for expanded scientific investigations and potential patient interventions. [ABSTRACT FROM AUTHOR]

Objective: Hypoproteinemia is a common condition in critically ill patients, associated with the development of acute lung injury and acute respiratory distress syndrome and subsequent worse clinical outcomes. Albumin with furosemide benefits lung physiology in hypoproteinemic patients with acute lung injury/acute respiratory distress syndrome, but the independent pharmacologic effects of these drugs are unknown.Design: Randomized, double-blinded, placebo-controlled multicentered trial.Setting: Eleven medical, surgical, and trauma intensive care units including 190 beds within two university hospital systems.Patients: Forty mechanically ventilated patients with acute lung injury/acute respiratory distress syndrome, whose serum total protein concentrations were <6.0 g/dL were included. Patients were excluded for hemodynamic instability or significant renal or hepatic failure.Interventions: Subjects were equally randomly allocated to receive furosemide with albumin or furosemide with placebo for 72 hrs, titrated to fluid loss and normalization of serum total protein concentration.Measurements and Main Results: The primary outcome was change in oxygenation from baseline to day 1, with secondary physiologic and clinical outcomes. There were no differences in baseline characteristics of the subjects in relation to group assignment. Albumin-treated patients had greater increases in oxygenation (mean change in Pao2/Fio2: +43 vs. -24 mm Hg at 24 hrs and +49 vs. -13 mm Hg at day 3), serum total protein (1.5 vs. 0.5 g/dL at day 3), and net fluid loss (-5480 vs. -1490 mL at day 3) throughout the study period (all p < .05). Fluid bolus administration to control patients reduced net negative fluid balance; control patients more frequently developed hypotension and had fewer shock-free days, which translated to differences in organ failure at study end.Conclusions: The addition of albumin to furosemide therapy in hypoproteinemic patients with acute lung injury/acute respiratory distress syndrome significantly improves oxygenation, with greater net negative fluid balance and better maintenance of hemodynamic stability. Additional randomized clinical trials are necessary to examine mechanisms and determine the effect on important clinical outcomes, such as the duration of mechanical ventilation. [ABSTRACT FROM AUTHOR]

Background: Sepsis represents a substantial health care burden, and there is limited epidemiologic information about the demography of sepsis or about the temporal changes in its incidence and outcome. We investigated the epidemiology of sepsis in the United States, with specific examination of race and sex, causative organisms, the disposition of patients, and the incidence and outcome.Methods: We analyzed the occurrence of sepsis from 1979 through 2000 using a nationally representative sample of all nonfederal acute care hospitals in the United States. Data on new cases were obtained from hospital discharge records coded according to the International Classification of Diseases, Ninth Revision, Clinical Modification.Results: Review of discharge data on approximately 750 million hospitalizations in the United States over the 22-year period identified 10,319,418 cases of sepsis. Sepsis was more common among men than among women (mean annual relative risk, 1.28 [95 percent confidence interval, 1.24 to 1.32]) and among nonwhite persons than among white persons (mean annual relative risk, 1.90 [95 percent confidence interval, 1.81 to 2.00]). Between 1979 and 2000, there was an annualized increase in the incidence of sepsis of 8.7 percent, from about 164,000 cases (82.7 per 100,000 population) to nearly 660,000 cases (240.4 per 100,000 population). The rate of sepsis due to fungal organisms increased by 207 percent, with gram-positive bacteria becoming the predominant pathogens after 1987. The total in-hospital mortality rate fell from 27.8 percent during the period from 1979 through 1984 to 17.9 percent during the period from 1995 through 2000, yet the total number of deaths continued to increase. Mortality was highest among black men. Organ failure contributed cumulatively to mortality, with temporal improvements in survival among patients with fewer than three failing organs. The average length of the hospital stay decreased, and the rate of discharge to nonacute care medical facilities increased.Conclusions: The incidence of sepsis and the number of sepsis-related deaths are increasing, although the overall mortality rate among patients with sepsis is declining. There are also disparities among races and between men and women in the incidence of sepsis. Gram-positive bacteria and fungal organisms are increasingly common causes of sepsis. [ABSTRACT FROM AUTHOR]

Background: This study assesses the relative validity of a diet history interview in 56 free-living individuals with Type II diabetes mellitus.Methods: The diet history interview was compared to a 3-day food record in a 1-year dietary intervention trial. The plausibility of energy intake data was examined throughout the trial. Paired data were compared for differences and the presence of systematic error was determined by Bland Altman analysis. Changes in accuracy and responsiveness were assessed over time.Results: The proportion of underreporters was larger in the diet history at baseline. Underrecording with the food record was more common in subjects with BMIs > 30 kg/m(2). There was no difference between paired dietary data from the two methods; however, data on fatty acids failed to correlate. These correlations improved when outliers were removed. There was no evidence of a relationship between bias and mean intake of dietary variables. Accuracy of diet history measurement did not change during the trial for energy or macronutrients, but data on protein and monounsaturated fat were both affected by BMI. The diet history was more responsive than the food record to changes in monounsaturated fatty acid intake after 3 months, but this changed at the end of the trial.Conclusion: The diet history provided good estimates of energy and macronutrient intakes in a sample group with Type II diabetes mellitus. However, energy intake data revealed a high prevalence of underreporting especially in people with higher BMIs. [ABSTRACT FROM AUTHOR]

Objectives: To assess differences in patterns of carbohydrate consumption between women diagnosed with gestational diabetes mellitus (GDM) and a group of glucose tolerant pregnant women.Design: A cross-sectional survey of the usual dietary intakes of a sample of women with GDM, newly diagnosed and taken at the first clinic visit, and a sample of women without GDM, matched for age and prepregnancy weight, at the beginning of the third trimester of pregnancy.Subjects: 16 women newly diagnosed with GDM and 24 healthy pregnant women. Subjects with a diagnosis of GDM in a previous pregnancy and other risk factors for GDM were not excluded.Setting: The Illawarra area health service, Diabetes service and prenatal clinic at the Wollongong hospital.Main outcome measures: Reported patterns of carbohydrate consumption in terms of total intakes, amounts of carbohydraterich food groups and foods grouped according to glycaemic index (GI) values. These were expressed as energy (kJ) or amount of carbohydrate (g), and frequency of consumption. An average diet GI score was calculated.Statistical analyses: Differences in dietary intake variables between groups were assessed using independent two tailed ttests.Results: There were no significant differences between the two groups for total intakes of carbohydrate in kJ or g. Women with GDM, however, reported significantly less carbohydrate (g) From pasta, fruit juice and milk products (P < 0.05) and from foods with low GI values (P < 0.05). The GDM group reported less frequent intakes of foods with higher GI values (P < 0.05). The average diet GI was significantly higher for the GDM group when adjusted for total energy intake (P < 0.05).Conclusions: This small qualitative study of the food habits of free-living pregnant women assessed patterns of carbohydrate consumption not readily identifiable using a nutrient approach. Compared to glucose tolerant pregnant controls, women with GDM reported lower intakes of carbohydrate-rich foods with low GI values and a reduced frequency of consumption of foods with higher GI values. These 'non-beneficial' patterns of intake likely impact on blood glucose control and have implications for the dietary management of this group. [ABSTRACT FROM AUTHOR]

Objective: To assess the validity and reliability of a research diet history for use in clinical studies of gestational diabetes mellitus (GDM) in the Illawarra region, New South Wales.Design: Diet history interviews conducted at the diabetes service for women with GDM and the prenatal clinic for matched normal glucose tolerant women. The glucose tolerant women provided a repeat diet history two weeks later along with a seven-day weighed food record.Subjects: Fourteen women with GDM and 19 normal glucose tolerant women provided a diet history. Seventeen glucose tolerant women provided food records, and 17 glucose tolerant women provided a repeat diet history.Setting: Illawarra area diabetes service and prenatal clinic, Wollongong hospital, NSW.Main outcome measures: Reported energy and macronutrient intakes.Statistical analysis: Differences in under-reporting in GDM and normal glucose tolerant women assessed by Chi square analysis. Reliability and relative validity assessed using paired t-tests and Pearson's product moment correlation. The number and percent of paired diet history-food record values with > 20% discrepancy were examined. Bland-Altman plots were established to view agreement between diet history and food record data and subsequent regression analysis was applied to assess the extent of systematic bias.Results: The data from the first diet history were plausible. There was no difference between energy and macronutrient data (P > 0.05) and there were correlations between measures (P < 0.05) from repeat diet histories and between diet history and food record data. The degree of discrepancy between diet history and food record data pairs was reasonable. There was no evidence of systematic bias between the diet history and sevenday weighed food record for energy and macronutrient intake measurements.Conclusions: In the absence of dietary counselling, the diet history in this setting was reliable and provided valid results relative to seven-day weighed food record data and with reference to cut-off limits for plausible reporting of energy intakes. [ABSTRACT FROM AUTHOR]

Background: Non-specific elevations of creatine kinase isoenzymes (CK-MB) and cardiac troponin-T may be seen in renal failure, confusing the diagnosis of myocardial infarction. Cardiac troponin-I (cTn-I) has been shown to be specific for myocardial damage in several disease states, but has not been prospectively evaluated in the setting of renal failure. [ABSTRACT FROM PUBLISHER]