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While medical nutrition therapy is an essential part of the care for critically ill patients, uncertainty exists about the right form, dosage, timing and route in relation to the phases of critical illness. As enteral nutrition (EN) is often withheld or interrupted during the ICU stay, combined EN and parenteral nutrition (PN) may represent an effective and safe option to achieve energy and protein goals as recommended by international guidelines. We hypothesize that critically ill patients at high nutritional risk may benefit from such a combined approach during their stay on the intensive care unit (ICU). Therefore, we aim to test if an early combination of EN and high-protein PN (EN+PN) is effective in reaching calorie and protein goals in patients at high nutritional risk, while avoiding overfeeding. This approach will be tested in the here presented EFFORTcombo trial. Nutritionally high-risk ICU patients will be randomized to either high (≥2.2 mg/kg/d) or low protein (≤1.2 mg/kg/d). In the high protein group, the patients will receive EN+PN, in the low protein group, patients will be given EN alone. EN will be started in accordance to international guidelines in both groups. Efforts will be made to reach nutrition goals within 48–96 hours. The efficacy of the proposed nutritional strategy will be tested as an innovative approach by functional outcomes at ICU- and hospital-discharge, as well as at a 6-month follow-up.
Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.
We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.
Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.
Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
There is limited knowledge of how individuals reflect on their involuntary admission.
To investigate, at one year after an involuntary admission,
(i) peoples perception of the necessity of their involuntary admission
(ii) the enduring impact on the relationship with their family, consultant psychiatrist and employment prospects
(iii) readmission rates to hospital and risk factors for readmission.
People that were admitted involuntarily over a 15 month period were re-interviewed at one year following discharge.
Sixty eight people were re-interviewed at one year and this resulted in a follow-up rate of 84%. Prior to discharge, 72% of people reported that their involuntary admission had been necessary however this reduced to 60% after one year. Over one third of people changed their views and the majority of these patients reflected negatively towards their involuntary admission.
One quarter of people continued to experience a negative impact on the relationship with a family member and their consultant psychiatrist one year after an involuntary admission, while 13% reported a positive impact. A similar proportion perceived that it had negative consequences in their employment.
Within one year, 43% of all patients involuntarily admitted in the study period were readmitted to hospital and half of these admissions were involuntary. Involuntary readmission was associated with a sealing over recovery style.
Peoples’ perception of the necessity of their involuntary admissions changes significantly over time. Involuntary admissions can have a lasting negative impact on the relationship with family members and treating consultant psychiatrist.
The use of physical coercion and involuntary admission is one of the most controversial practices in medicine, it is now understood that perceived coercion is multidimensional and is associated with procedural justice and perceived pressures, and not simply related to the legal status of the patient.
We sought to determine the rate of physical coercion used and the perceived pressures and procedural justice experienced by the person at the time of involuntary admission and whether this influenced future engagement with the mental health services.
Over a 15 month period, people admitted involuntarily were interviewed prior to discharge and at one year follow-up.
81 people participated in the study and 81% were interviewed at one year follow-up. At the time of involuntary admission, over half of people experienced at least one form of physical coercion and it was found that the level of procedural justice experienced was unrelated to the use of physical coercive measures. A total of 20% of participants intended not to voluntarily engage with the mental health services upon discharge and they were more likely to have experienced lower levels of procedural justice at the time of admission. At one year following discharge, 65% of participants were adherent with outpatient appointments and 18% had been readmitted involuntarily. The level of procedural justice experienced at admission did not predict future engagement with services.
This study demonstrates that the use of physical coercive measures is a separate entity from procedural justice and perceived pressures.
Despite the scientific evidence, most families of people with schizophrenia in Europe never receive a carer education programme. We evaluated whether a carer education course delivered by telepsychiatry was as effective as a carer education course delivered in situ.
We delivered the carer education course for schizophrenia simultaneously to a carers group in rural north west Ireland (remote) via three ISDN lines and live to a carers group in a city (host). We compared knowledge gains using the Knowledge Questionnaire before and after each course.
Fifty-six carers of people with schizophrenia participated in the trial. At baseline, participants at the remote and host centers did not differ in terms of knowledge about schizophrenia. After the course, carers at both centers improved significantly and the knowledge gains between groups were equivalent at 6 weeks.
Telepsychiatry can deliver effective carer education programmes about schizophrenia and may provide one solution to bridging the chasm between scientific evidence and clinical reality.
We sought to establish if a brief psychoeducational intervention for relatives is effective in improving relatives’ knowledge about schizophrenia and reducing rehospitalization. We evaluated 101 relatives of 55 patients with schizophrenia before and after an 8-week psychoeducational group using a self-report method. We also conducted a matched case-control study of the effects on rehospitalisation for 28 of these patients. We calculated the number of hospital days for each index case and control in the 1 and 2 years before and after the intervention.
Relatives made significant gains in their knowledge about schizophrenia, particularly about medication. Patients whose relatives attended the group had significantly fewer days in hospital and days per admission compared to controls in the year after the programme but the effect waned in the second year after the intervention. Controls were almost four times more likely to be readmitted at 2 years than cases. Median time to readmission was significantly longer in cases compared to controls. We conclude that a psychoeducational group, which is valued by carers, is effective in increasing their knowledge about schizophrenia as well as reducing and forestalling the rehospitalization of their affected relatives. Such programmes deliver what carers frequently request in a cost-effective manner.
We sought to determine the level of procedural justice experienced by individuals at the time of involuntary admission and whether this influenced future engagement with the mental health services.
Over a 15-month period, individuals admitted involuntarily were interviewed prior to discharge and at one-year follow-up.
Eighty-one people participated in the study and 81% were interviewed at one-year follow-up. At the time of involuntary admission, over half of individuals experienced at least one form of physical coercion and it was found that the level of procedural justice experienced was unrelated to the use of physical coercive measures. A total of 20% of participants intended not to voluntarily engage with the mental health services upon discharge and they were more likely to have experienced lower levels of procedural justice at the time of admission. At one year following discharge, 65% of participants were adherent with outpatient appointments and 18% had been readmitted involuntarily. Insight was associated with future engagement with the mental health services; however, the level of procedural justice experienced at admission did not influence engagement.
This study demonstrates that the use of physical coercive measures is a separate entity from procedural justice and perceived pressures.
There is evidence that psycho-education courses for caregivers of individuals with schizophrenia improve the short-term outcome of the condition. However, most of the outcome studies are limited to two-year follow-up.
Materials and methods
This study is a five-year retrospective case-control follow-up of an original cohort of 63 patients and their 101 caregivers who completed a six-week Caregiver Psycho-education Programme (CPP) for schizophrenia and psychosis between 2002 and 2005, and 60 controls, matched for age, gender and severity of their psychotic illness.
Patients whose caregivers learned more from the six-week psycho-education course had a significantly longer time to relapse (P = 0.04) and a significantly shorter length of stay during their first relapse (P < 0.05). Patients whose caregivers attended the six-week psycho-education course (regardless of how much the caregivers learned) had a significantly better outcome than controls. This included a significantly smaller number of relapses (P < 0.01), longer time to relapse (P < 0.01), shorter length of stay during their first relapse (P < 0.01) and smaller number of bed days over five years (P < 0.01). The odds ratio of controls relapsing, although insignificant at one year, was 4.13 (1.85–9.21) at five years. Outcome was not affected by either the numbers of caregivers attending for each patient, or caregiver gender.
Discussion and conclusions
This study, which is among the first to examine outcome over five years, supports the efficacy of psycho-education for caregivers in improving outcome for patients. Caregivers should be encouraged to take up psycho-education where it is available.
In a RCT of family psychoeducation, 47 carers of 34 patients were allocated to one of three groups; Multifamily Group Psychoeducation, Solution Focussed Group Therapy or Treatment as Usual. Carers in both the MFGP intervention and the SFGP arm demonstrated greater knowledge and reduction in burden than those in the TAU arm.
Impaired insight is commonly seen in psychosis and some studies have proposed that is a biologically based deficit. Support for this view comes from the excess of neurological soft signs (NSS) observed in patients with psychoses and their neural correlates which demonstrate a degree of overlap with the regions of interest implicated in neuroimaging studies of insight. The aim was to examine the relationship between NSS and insight in a sample of 241 first-episode psychosis patients.
Total scores and subscale scores from three insight measures and two NSS scales were correlated in addition to factors representing overall insight and NSS which we created using principal component analysis.
There were only four significant associations when we controlled for symptoms. “Softer” Condensed Neurological Evaluation (CNE) signs were associated with our overall insight factor (r = 0.19, P = 0.02), with total Birchwood (r = −0.24, P<0.01), and the Birchwood subscales; recognition of mental illness (r = −0.24, P<0.01) and need for treatment (r = −0.18, P = 0.02). Total Neurological Evaluation Scale (NES) and recognition of the achieved effects of medication were also weakly correlated (r = 0.14, P = 0.04).
This study does not support a direct link between neurological dysfunction and insight in psychosis. Our understanding of insight as a concept remains in its infancy.
Covert brain infarcts (CBIs) are five times more prevalent than symptomatic brain infarcts. CBIs are associated with cognitive impairment and therefore may be a target for preventing cognitive decline and dementia. This review focuses on strategies for preventing CBI-related cognitive impairment, either by preventing incident or recurrent CBI or by enhancing cognitive reserve. CBIs begin to become prevalent during midlife and are highly prevalent in later life. The distribution of vascular pathologies of CBI differs from those that cause symptomatic stroke; therefore, preventive treatments may need to differ as well. Only a few randomized clinical trials have provided data on CBI prevention, without conclusive results. Limited data suggest that higher early-life education, hypothesized to enhance cognitive reserve, can protect the brain from effects of CBI.
The development of laser performance models having real-time prediction capability for the OMEGA EP laser system has been essential in meeting requests from its user community for increasingly complex pulse shapes that span a wide range of energies. The laser operations model PSOPS provides rapid and accurate predictions of OMEGA EP laser-system performance in both forward and backward directions, a user-friendly interface and rapid optimization capability between shots. We describe the model’s features and show how PSOPS has allowed real-time optimization of the laser-system configuration in order to satisfy the demands of rapidly evolving experimental campaign needs. We also discuss several enhancements to laser-system performance accuracy and flexibility enabled by PSOPS.
The Single Ventricle Reconstruction Trial randomised neonates with hypoplastic left heart syndrome to a shunt strategy but otherwise retained standard of care. We aimed to describe centre-level practice variation at Fontan completion.
Centre-level data are reported as median or median frequency across all centres and range of medians or frequencies across centres. Classification and regression tree analysis assessed the association of centre-level factors with length of stay and percentage of patients with prolonged pleural effusion (>7 days).
The median Fontan age (14 centres, 320 patients) was 3.1 years (range from 1.7 to 3.9), and the weight-for-age z-score was −0.56 (−1.35 + 0.44). Extra-cardiac Fontans were performed in 79% (4–100%) of patients at the 13 centres performing this procedure; lateral tunnels were performed in 32% (3–100%) at the 11 centres performing it. Deep hypothermic circulatory arrest (nine centres) ranged from 6 to 100%. Major complications occurred in 17% (7–33%). The length of stay was 9.5 days (9–12); 15% (6–33%) had prolonged pleural effusion. Centres with fewer patients (<6%) with prolonged pleural effusion and fewer (<41%) complications had a shorter length of stay (<10 days; sensitivity 1.0; specificity 0.71; area under the curve 0.96). Avoiding deep hypothermic circulatory arrest and higher weight-for-age z-score were associated with a lower percentage of patients with prolonged effusions (<9.5%; sensitivity 1.0; specificity = 0.86; area under the curve 0.98).
Fontan perioperative practices varied widely among study centres. Strategies to decrease the duration of pleural effusion and minimise complications may decrease the length of stay. Further research regarding deep hypothermic circulatory arrest is needed to understand its association with prolonged pleural effusion.
Analysis of human remains and a copper band found in the center of a Late Archaic (ca. 5000–3000 cal BP) shell ring demonstrate an exchange network between the Great Lakes and the coastal southeast United States. Similarities in mortuary practices suggest that the movement of objects between these two regions was more direct and unmediated than archaeologists previously assumed based on “down-the-line” models of exchange. These findings challenge prevalent notions that view preagricultural Native American communities as relatively isolated from one another and suggest instead that wide social networks spanned much of North America thousands of years before the advent of domestication.
OBJECTIVES/SPECIFIC AIMS: o To review the community’s recommendations on how to rebuild trust in the Flint community. o To review effective community engagement strategies utilized with the Flint Special Projects for project conceptualization, participant recruitment, data analysis, project oversight, and dissemination. METHODS/STUDY POPULATION: The study population includes nearly two hundred residents representing seniors, youth and diverse ethnicities recruited to participate in eleven focus group meetings. The population also represents the general public who attended informational meetings in Flint, Michigan to learn about the crisis and allow residents to voice their opinions and concerns during the onset of the crisis. The project is a mixed methods community based participatory research effort that utilized community decision making in all phases of the effort such as pre-conception, implementation, dissemination and advocacy to encourage the community’s recommendations are adopted at policy and institutional responsiveness levels. It includes three community engaged research efforts: (project 1) A qualitative analysis of community sentiment provided during 17 recorded legislative, media and community events, and (projects 2-3) two mixed methods efforts utilizing purposive sampling of stakeholders whose voice may not have been heard. RESULTS/ANTICIPATED RESULTS: The project presents a qualitative analysis of the community’s voice during the onset of the man-made disaster when the community first became aware of the emergency manager’s plans to switch the water source. It also reflects current perspectives of community voice since the projects are scheduled to end late February 2019. Findings from a trust measure administered to nearly two hundred residents will be presented, along with a qualitative analysis of focus group findings among segments of the population (seniors, youth, and diverse ethnicities) who may have been left out of narratives on the water crisis. Finally, the project will compare empowerment and resiliency approaches being utilized in Flint, Michigan to recover from the disaster with other approaches grounded in literature and theory. DISCUSSION/SIGNIFICANCE OF IMPACT: Communities of color often experience social determinants of health which negatively impact their health, well-being and human rights. Some Flint citizens are experiencing negative health consequences (i.e., rashes, brain and behavioral sequelle, fertility, etc.) as a result of the disaster, and are uncertain of health outcomes in the future. This is the first project to rigorously document and analyze levels of trust and mistrust in the city of Flint since the water disaster occurred. The qualitative research will guide future clinical research that will benefit this traumatized community experiencing high levels of mistrust (i.e., government, elected officials, etc.). The community engaged methodology involved residents and study participants in all phases of the project including project oversight, validating and analyzing data, and dissemination. This methodology will contribute to existing literature and theory on community based participatory research, community engaged research, team science and citizen science. The approaches empowered a call to action among residents, for example, seniors who attended two senior focus group sessions shared “they are hopeful and have a purpose,” resulting in the creation of a council (with officers) at their housing complex to advocate for the well-being of seniors during the recovery process. Recruitment methodologies were extremely successful due to resident level trust in community leaders and community partner organizations. Finally, the project’s examination of approaches encouraging empowerment and resiliency will provide lessons learned for other communities challenged with crisis.
OBJECTIVES/SPECIFIC AIMS: More men than women develop urinary stones and their prevalence alters in women with menopause suggesting a steroidal influence. In men the incidence of stones is highest during July and August suggesting that environmental factors such as Vitamin D (VitD), a steroid, may affect stone formation. Previous studies have found differences in the development of stones between men and women; however, the reasons for sex differences in stone formation and type remain unclear. METHODS/STUDY POPULATION: We examined VitD levels in men and women (n = 18,753) that had no diseases based on a lack of an ICD-9 or ICD-10 code in their electronic medical record. We found that normal, healthy women had significantly higher levels of sera VitD compared to men (p = 6x10-6). We then examined whether sex differences existed for key endpoints/data from the Mayo Clinic Urinary Stone Disease (USD) Registry, which has around 1,600 urinary stone patients that are well-phenotyped according to sex, age and stone type. RESULTS/ANTICIPATED RESULTS: Control women were found to have higher sera VitD levels than men, but the sex difference no longer exists in kidney stone disease patients. When we further separated by race, we found that differences in VitD levels reappeared; this suggests that race also plays a role in sera VitD variances. DISCUSSION/SIGNIFICANCE OF IMPACT: We are developing a disease severity score, which we will use to correlate to sera VitD levels in patients according to sex, age and race. Future analyses will take into account whether subjects had VitD and calcium supplementation. This project begins to explore the mechanism behind the sex differences known to exist in urinary stone disease, which is critically needed to provide improved diagnosis and therapy for this debilitating disease.