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OBJECTIVES/SPECIFIC AIMS: The Clinical Research Operations Program is a free educational program designed to educate clinical research personnel on the conduct of clinical research (CR). The participant completes 16 required core sessions (24 h), 4 elective sessions (4 h), and passes the final exam to receive a certification in CR operations at Stanford. Sessions focus on the 9 domains of CR (established by the Joint Task Force for Clinical Trial Competency), such as Ethical & Participant Safety Considerations, Clinical Study Operations, & Data Management/Informatics. METHODS/STUDY POPULATION: Sessions are taught by volunteer lecturers. Participants may also attend the sessions without pursuing the certification. The program objective is to provide easy-access education in CR in order to increase regulatory compliance, staff retention, and improve CR at Stanford. The program targets CR coordinators, however, staff, postdocs, fellows, and faculty also participate. RESULTS/ANTICIPATED RESULTS: Since the program’s launch in January 2017, 119 individuals have enrolled in the certification program. The most represented group is the Department of Medicine. Sessions consistently reach their maximum with a waiting list. Each core session requires that the participant complete an evaluation (Likert scale, 1–5) of the registration process (4.5/5), the class environment (4.6/5), the presented content (4.5/5), and the instructor (4.6/5). Data from these evaluations are positive to date and is used to continually refine the program. DISCUSSION/SIGNIFICANCE OF IMPACT: N/A.
To analyze whether electronically available comorbid conditions are risk factors for Centers for Disease Control and Prevention (CDC)-defined, hospital-onset Clostridium difficile infection (CDI) after controlling for antibiotic and gastric acid suppression therapy use.
Patients aged ≥18 years admitted to the University of Maryland Medical Center between November 7, 2015, and May 31, 2017.
Comorbid conditions were assessed using the Elixhauser comorbidity index. The Elixhauser comorbidity index and the comorbid condition components were calculated using the International Classification of Disease, Tenth Revision, Clinical Modification (ICD-10-CM) codes extracted from electronic medical records. Bivariate associations between CDI and potential covariates for multivariable regression, including antibiotic use, gastric acid suppression therapy use, as well as comorbid conditions, were estimated using log binomial multivariable regression.
After controlling for antibiotic use, age, proton-pump inhibitor use, and histamine-blocker use, the Elixhauser comorbidity index was a significant risk factor for predicting CDI. There was an increased risk of 1.26 (95% CI, 1.19–1.32) of having CDI for each additional Elixhauser point added to the total Elixhauser score.
An increase in Elixhauser score is associated with CDI. Our study and other studies have shown that comorbid conditions are important risk factors for CDI. Electronically available comorbid conditions and scores like the Elixhauser index should be considered for risk-adjustment of CDC CDI rates.
Risk adjustment is needed to fairly compare central-line–associated bloodstream infection (CLABSI) rates between hospitals. Until 2017, the Centers for Disease Control and Prevention (CDC) methodology adjusted CLABSI rates only by type of intensive care unit (ICU). The 2017 CDC models also adjust for hospital size and medical school affiliation. We hypothesized that risk adjustment would be improved by including patient demographics and comorbidities from electronically available hospital discharge codes.
Using a cohort design across 22 hospitals, we analyzed data from ICU patients admitted between January 2012 and December 2013. Demographics and International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) discharge codes were obtained for each patient, and CLABSIs were identified by trained infection preventionists. Models adjusting only for ICU type and for ICU type plus patient case mix were built and compared using discrimination and standardized infection ratio (SIR). Hospitals were ranked by SIR for each model to examine and compare the changes in rank.
Overall, 85,849 ICU patients were analyzed and 162 (0.2%) developed CLABSI. The significant variables added to the ICU model were coagulopathy, paralysis, renal failure, malnutrition, and age. The C statistics were 0.55 (95% CI, 0.51–0.59) for the ICU-type model and 0.64 (95% CI, 0.60–0.69) for the ICU-type plus patient case-mix model. When the hospitals were ranked by adjusted SIRs, 10 hospitals (45%) changed rank when comorbidity was added to the ICU-type model.
Our risk-adjustment model for CLABSI using electronically available comorbidities demonstrated better discrimination than did the CDC model. The CDC should strongly consider comorbidity-based risk adjustment to more accurately compare CLABSI rates across hospitals.
Few decision aids are available for patients with a serious illness who face many treatment and end-of-life decisions. We evaluated the Looking Ahead: Choices for Medical Care When You're Seriously Ill® patient decision aid (PtDA), one component of an early palliative care clinical trial.
Our participants included individuals with advanced cancer and their caregivers who had participated in the ENABLE (Educate, Nurture, Advise, Before Life Ends) early palliative care telehealth randomized controlled trial (RCT) conducted in a National Cancer Institute-designated cancer center, a U.S. Department of Veterans Affairs medical center, and affiliated outreach clinics in rural New England. ENABLE included six weekly patient and three weekly family caregiver structured sessions. Participants watched the Looking Ahead PtDA prior to session 3, which covered content on decision making and advance care planning. Nurse coaches employed semistructured interviews to obtain feedback from consecutive patient and caregiver participants approximately one week after viewing the Looking Ahead PtDA program (booklet and DVD).
Between April 1, 2011, and October 31, 2012, 57 patients (mean age = 64), 42% of whom had lung and 23% gastrointestinal cancer, and 20 caregivers (mean age = 59), 80% of whom were spouses, completed the PtDA evaluation. Participants reported a high degree of satisfaction with the PtDA format, as well as with its length and clarity. They found the format of using patient interviews “validating.” The key themes were: (1) “the earlier the better” to view the PtDA; (2) feeling empowered, aware of different options, and an urgency to participate in advance care planning.
Significance of results:
The Looking Ahead PtDA was well received and helped patients with a serious illness realize the importance of prospective decision making in guiding their treatment pathways. We found that this PtDA can help seriously ill patients prior to the end of life to understand and discuss future healthcare decision making. However, systems to routinely provide PtDAs to seriously ill patients are yet not well developed.
To identify comorbid conditions associated with surgical site infection (SSI) among patients undergoing renal transplantation and improve existing risk adjustment methodology used by the Centers for Disease Control and Prevention National Healthcare Safety Network (NHSN).
Patients (≥18 years) who underwent renal transplantation at University of Maryland Medical Center January 1, 2010-December 31, 2011.
Trained infection preventionists reviewed medical records to identify surgical site infections that developed within 30 days after transplantation, using NHSN criteria. Patient demographic characteristics and risk factors for surgical site infections were identified through a central data repository. International Statistical Classification of Disease, Ninth Revision, Clinical Modification codes were used to analyze individual component comorbid conditions and calculate the Charlson and Elixhauser comorbidity indices. These indices were compared with the current NHSN risk adjustment methodology.
A total of 441 patients were included in the final cohort. In bivariate analysis, the Charlson components of cerebrovascular disease, peripheral vascular disease, and rheumatologic disorders and Elixhauser components of obesity, rheumatoid arthritis, and weight loss were significantly associated with the outcome. A model utilizing the variables from the NHSN methodology had a c-statistic of 0.56 (95% CI, 0.48–0.63), whereas a model that also included comorbidities from the Charlson and Elixhauser indices had a c-statistic of 0.65 (95% CI, 0.58–0.73). The model with all 3 risk adjustment scores performed best and was statistically different from the NHSN model alone, demonstrated by improvement in the c statistic (0.65 vs 0.56).
Risk adjustment models should incorporate electronically available comorbid conditions.
We evaluated the collective impact of several infection prevention and control initiatives aimed at reducing acute respiratory infections (ARIs) in a pediatric long-term care facility. ARIs did not decrease overall, though the proportion of infections associated with outbreaks and average number of cases per outbreak decreased. Influenza rates decreased significantly.
Quantum information and computing are at the forefront of computer science, but their implementation relies on significant developments in materials science. In particular, suitable, lattice-matched substrates for two promising approaches—electrostatically defined quantum dots in Si/SiGe heterostructures, and superconducting circuits containing Josephson junctions—do not exist. Instead, these approaches rely on metamorphic substrates. In this article, we focus on the general structure and requirements of SiGe quantum dot heterostructures, the demands they impose on the underlying substrate, and the impact that properties of the metamorphic substrate have on device performance. Superconductor Josephson junction materials are briefly discussed in a similar fashion, and opportunities for future developments in both systems are described.
To determine the prevalence of Pseudomonas aeruginosa colonization on intensive care unit (ICU) admission, risk factors for P. aeruginosa colonization, and the incidence of subsequent clinical culture with P. aeruginosa among those colonized and not colonized.
We conducted a cohort study of patients admitted to a medical or surgical intensive care unit of a tertiary care hospital. Patients had admission perirectal surveillance cultures performed. Risk factors analyzed included comorbidities at admission, age, sex, antibiotics received during current hospitalization before ICU admission, and type of ICU.
Of 1,840 patients, 213 (11.6%) were colonized with P. aeruginosa on ICU admission. Significant risk factors in the multivariable analysis for colonization were age (odds ratio, 1.02 [95% CI, 1.01–1.03]), anemia (1.90 [1.05–3.42]), and neurologic disorder (1.80 [1.27–2.54]). Of the 213 patients colonized with P. aeruginosa on admission, 41 (19.2%) had a subsequent clinical culture positive for P. aeruginosa on ICU admission and 60 (28.2%) had a subsequent clinical culture positive for P. aeruginosa in the current hospitalization (ICU period and post-ICU period). Of these 60 patients, 49 (81.7%) had clinical infections. Of the 1,627 patients not colonized on admission, only 68 (4.2%) had a subsequent clinical culture positive for P. aeruginosa in the current hospitalization. Patients colonized with P. aeruginosa were more likely to have a subsequent positive clinical culture than patients not colonized (incidence rate ratio, 6.74 [95% CI, 4.91–9.25]).
Prediction rules or rapid diagnostic testing will help clinicians more appropriately choose empirical antibiotic therapy for subsequent infections.
Dementia is an emerging health priority in Australian Aboriginal communities, but substantial gaps remain in our understanding of this issue, particularly for the large urban section of the population. In remote Aboriginal communities, high prevalence rates of dementia at relatively young ages have been reported. The current study is investigating aging, cognitive decline, and dementia in older urban/regional Aboriginal Australians.
We partnered with five Aboriginal communities across the eastern Australian state of New South Wales, to undertake a census of all Aboriginal men and women aged 60 years and over residing in these communities. This was followed by a survey of the health, well-being, and life history of all consenting participants. Participants were also screened using three cognitive instruments. Those scoring below designated cut-offs, and a 20% random sample of those scoring above (i.e. “normal” range), completed a contact person interview (with a nominated family member) and medical assessment (blind to initial screening results), which formed the basis of “gold standard” clinical consensus determinations of cognitive impairment and dementia.
This paper details our protocol for a population-based study in collaboration with local Aboriginal community organizations. The study will provide the first available prevalence rates for dementia and cognitive impairment in a representative sample of urban Aboriginal people, across city and rural communities, where the majority of Aboriginal Australians live. It will also contribute to improved assessment of dementia and cognitive impairment and to the understanding of social determinants of successful aging, of international significance.
Incentives used to encourage local residents to support conservation range from integrated conservation and development projects (ICDPs), which indirectly connect improved livelihoods with biodiversity protection, to direct payments for ecosystem services (PES). A unique hybrid between these two strategies, the Arabuko-Sokoke Schools and Ecotourism Scheme (ASSETS), provides secondary-school bursaries to encourage stewardship of a biodiverse highly-imperiled Kenyan forest. Household surveys and semi-structured interviews were used to assess the effectiveness of ASSETS by comparing attitudes and perceptions toward the forest among scheme beneficiaries and non-beneficiaries. The most commonly identified benefit of the forest was resource extraction (for example fuelwood), followed by ecosystem services (such as source of rain). Those in favour of forest clearing tended not to be ASSETS beneficiaries, were less-educated, and were less likely to mention ecosystem services and tourism as forest benefits. ASSETS appears to shape pro-conservation attitudes among beneficiaries and foster a sense of responsibility toward the forest. Challenges for ASSETS are similar to those faced by many conservation and development projects, namely unsteady funding and the risk that the extremely poor may be overlooked. ASSETS may serve as an effective hybrid between the PES and ICDP approaches, and such educational support provides a promising conservation incentive.
Mechanisms underlying the lipodystrophy syndrome associated with antiretroviral therapy (ART) for HIV infection are not completely understood. We investigated the effect of ART on blood lipid concentrations in the fasting state and after consumption of a meal containing [1-13C]palmitic acid in HIV-positive men receiving nucleoside reverse transcriptase inhibitors (NRTI, n 7), NRTI combined with protease inhibitors (PI; NRTIPI, n 6), in HIV-positive but therapy-naïve men (noART, n 5) and in HIV-seronegative men (controls, n 6). HIV-positive subjects had higher fasting TAG concentrations and resting energy expenditure than controls. Subjects receiving NRTIPI therapy had higher fasting NEFA concentrations than the other groups. There were no significant differences in postprandial lipid metabolism between noART subjects and controls. NRTI therapy impaired hydrolysis of meal-derived TAG, most evidently when combined with PI (the NRTIPI group). Accumulation of 13C-label in the NEFA fraction was not different between groups. In the NRTIPI group, fasting and postprandial NEFA concentrations were significantly higher than other groups. Postprandial glucose and insulin responses in HIV-positive subjects did not differ from controls. These findings suggest that ART dyslipidaemia is associated with impaired postprandial TAG clearance, which is exacerbated by NRTIPI therapy. If dyslipidaemia is to be minimised in ART, the specific adverse effects of particular combinations during the fed state should be considered.