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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.
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.
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.
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.
Soldier operational performance is determined by their fitness, nutritional status, quality of rest/recovery, and remaining injury/illness free. Understanding large fluctuations in nutritional status during operations is critical to safeguarding health and well-being. There are limited data world-wide describing the effect of extreme climate change on nutrient profiles. This study investigated the effect of hot-dry deployments on vitamin D status (assessed from 25-hydroxyvitamin D (25(OH)D) concentration) of young, male, military volunteers. Two data sets are presented (pilot study, n 37; main study, n 98), examining serum 25(OH)D concentrations before and during 6-month summer operational deployments to Afghanistan (March to October/November). Body mass, percentage of body fat, dietary intake and serum 25(OH)D concentrations were measured. In addition, parathyroid hormone (PTH), adjusted Ca and albumin concentrations were measured in the main study to better understand 25(OH)D fluctuations. Body mass and fat mass (FM) losses were greater for early (pre- to mid-) deployment compared with late (mid- to post-) deployment (P<0·05). Dietary intake was well-maintained despite high rates of energy expenditure. A pronounced increase in 25(OH)D was observed between pre- (March) and mid-deployment (June) (pilot study: 51 (sd 20) v. 212 (sd 85) nmol/l, P<0·05; main study: 55 (sd 22) v. 167 (sd 71) nmol/l, P<0·05) and remained elevated post-deployment (October/November). In contrast, PTH was highest pre-deployment, decreasing thereafter (main study: 4·45 (sd 2·20) v. 3·79 (sd 1·50) pmol/l, P<0·05). The typical seasonal cycling of vitamin D appeared exaggerated in this active male population undertaking an arduous summer deployment. Further research is warranted, where such large seasonal vitamin D fluctuations may be detrimental to bone health in the longer-term.
Introduction: The effectiveness of intravenous alteplase is highly time dependent, and very short door-to-needle times (DNT) of 30 minutes or less have been reported in single centre hospitals, but never in an entire population. QuICR (Quality Improvement and Clinical Research) Alberta Stroke Program aimed to reduce DNT to a median of 30 minutes across the Canadian province of Alberta. Methods: We used the Improvement Collaborative Methodology from early 2015 to September 2016 with participation from all 17 Stroke Centres in Alberta. This methodology included 4 face-to-face workshops, site visits, webinars, data collection, data feedback, intensive process mapping, and process improvements. We compared data in the pre-intervention period from 2009-2014 (collected during the Alberta Provincial Stroke Strategy) to data in the post-intervention period from March 2016-February 2017 (collected during the QuICR DTN Collaborative). Data from January 2015-February 2016 were excluded, as improvements were being implemented during this time. Results: There were a total of 2,322 treated cases in the pre- and post-intervention periods. The results show that the median DNT dropped from 68 minutes (n=1846) in the pre-intervention period to 36 minutes (n=476) in the post-intervention period (p<0.001). There were reductions in DNT across all hospital types: median DNT dropped from 63 to 32 minutes in Urban Tertiary Centres (p<0.001), from 73 to 32 minutes in Community with 24/7 neurology (p<0.001), from 85 to 62 minutes in Community with limited/no neurology (p<0.001), and from 74 to 52.5 minutes in rural centres (p<0.001). Conclusion: There were 21.5 to 41 minute reductions in median DNT across all hospital types including smaller rural and community hospitals. A targeted multi-site improvement collaborative can be an effective intervention to reduce DNT across an entire population.
In this brief report, computed tomography perfusion (CTP) thresholds predicting follow-up infarction in patients presenting <3 hours from stroke onset and achieving ultra-early reperfusion (<45 minutes from CTP) are reported. CTP thresholds that predict follow-up infarction vary based on time to reperfusion: Tmax >20 to 23 seconds and cerebral blood flow <5 to 7 ml/min−1/(100 g)−1 or relative cerebral blood flow <0.14 to 0.20 optimally predicted the final infarct. These thresholds are stricter than published thresholds.
The Middle East respiratory syndrome coronavirus (MERS-CoV) is caused by a novel coronavirus discovered in 2012. Since then, 1806 cases, including 564 deaths, have been reported by the Kingdom of Saudi Arabia (KSA) and affected countries as of 1 June 2016. Previous literature attributed increases in MERS-CoV transmission to camel breeding season as camels are likely the reservoir for the virus. However, this literature review and subsequent analysis indicate a lack of seasonality. A retrospective, epidemiological cluster analysis was conducted to investigate increases in MERS-CoV transmission and reports of household and nosocomial clusters. Cases were verified and associations between cases were substantiated through an extensive literature review and the Armed Forces Health Surveillance Branch's Tiered Source Classification System. A total of 51 clusters were identified, primarily nosocomial (80·4%) and most occurred in KSA (45·1%). Clusters corresponded temporally with the majority of periods of greatest incidence, suggesting a strong correlation between nosocomial transmission and notable increases in cases.
Parasites can exert strong effects on population to ecosystem level processes, but data on parasites are limited for many global regions, especially tropical marine systems. Characterizing parasite diversity and distributions are the first steps towards understanding the potential impacts of parasites. The Panama Canal serves as an interesting location to examine tropical parasite diversity and distribution, as it is a conduit between two oceans and a hub for international trade. We examined metazoan and protistan parasites associated with ten oyster species collected from both Panamanian coasts, including the Panama Canal and Bocas del Toro. We found multiple metazoan taxa (pea crabs, Stylochus spp., Urastoma cyrinae). Our molecular screening for protistan parasites detected four species of Perkinsus (Perkinsus marinus, Perkinsus chesapeaki, Perkinsus olseni, Perkinsus beihaiensis) and several haplosporidians, including two genera (Minchinia, Haplosporidium). Species richness was higher for the protistan parasites than for the metazoans, with haplosporidian richness being higher than Perkinsus richness. Perkinsus species were the most frequently detected and most geographically widespread among parasite groups. Parasite richness and overlap differed between regions, locations and oyster hosts. These results have important implications for tropical parasite richness and the dispersal of parasites due to shipping associated with the Panama Canal.
Introduction: Patients with asthma frequently present to the emergency department (ED) with exacerbations; however, a select number of patients require admission to hospital. The objective of this study was to summarize the evidence regarding asthma-related hospital admissions and factors associated with these admissions following ED presentation. Methods: Comprehensive literature searches were conducted in seven electronic databases (database inception to 2015); manual and grey literature searches were also performed. Studies reporting disposition for adults after ED presentation were included. Study quality was assessed using the Newcastle-Ottawa Scale (NOS); standardized data-collection forms were used for data extraction. Admission proportions and factors associated with admission at a statistical significance level (p<0.05) were reported. Results: Out of an initial 5865 identified articles, 37 articles met full inclusion criteria. Admission proportions were reported in 25/37 studies, ranged from 1% to 37%, and collectively demonstrated a decline of ~9% in admissions between 1993 and 2012. Studies including a >50% Caucasian ethnicity were found to have a median admission proportion of 13% (interquartile range [IQR]= 7, 20) versus studies with >50% non-Caucasian ethnicity at 22% (IQR=20, 28). Age, female sex, and previous hospitalizations for asthma exacerbation were the most individually identifiable factors associated with admission. Presenting features and medication profile were the most frequent domains associated with admission. Conclusion: Admission rates have decreased approximately 9% in a nearly 20-year span and seem to be higher in studies involving mostly non-Caucasian ethnic groups. Demographic factors, markers of severity obtained by history or at ED presentation, and medication profile could be assessed by ED clinicians to effectively discern patients at high risk for admission.
Legislative actions and advanced technologies, particularly dissemination of safety-engineered devices, have aided in protecting healthcare personnel from occupational blood and body fluid exposures (BBFE).
To investigate the trends in BBFE among healthcare personnel over 15 years and the impact of safety-engineered devices on the incidence of percutaneous injuries as well as features of injuries associated with these devices.
Retrospective cohort study at University of North Carolina Hospitals, a tertiary care academic facility. Data on BBFE in healthcare personnel were extracted from Occupational Health Service records (2000–2014). Exposures associated with safety-engineered and conventional devices were compared. Generalized linear models were applied to measure the annual incidence rate difference by exposure type over time.
A total of 4,300 BBFE, including 3,318 percutaneous injuries (77%), were reported. The incidence rate for overall BBFE was significantly reduced during 2000–2014 (incidence rate difference, 1.72; P=.0003). The incidence rate for percutaneous injuries was also dramatically reduced during 2001–2006 (incidence rate difference, 1.37; P=.0079) but was less changed during 2006–2014. Percutaneous injuries associated with safety-engineered devices accounted for 27% of all BBFE. BBFE was most commonly due to injecting through skin, placing intravenous catheters, and blood drawing.
Our study revealed significant overall reduction in BBFE and percutaneous injuries likely due in part to the impact of safety-engineered devices but also identified that a considerable proportion of percutaneous injuries is now associated with these devices. Additional prevention strategies are needed to further reduce percutaneous injuries and improve design of safety-engineered devices.
Common beans (Phaseolus vulgaris L.) are a nutrient-dense, low glycemic index food that supports healthy weight management in people and was examined for dogs. The objectives of this study were to evaluate the apparent total tract digestibility (ATTD) and nutrient utilisation of navy (NB) and black (BB) bean-based diets in overweight or obese companion dogs undergoing a weight loss intervention. A nutritionally complete, dry extruded dog food was used as the control (CON) diet and two isocaloric, nutrient matched bean diets, containing either 25% w/w cooked BB or NB powder formed the test diets. Diets were fed to adult, overweight companion dogs for either four weeks (short-term study, n = 30) or for twenty-six weeks (long-term study, n = 15) at 60% of maintenance calories for ideal weight. Apparent weight loss increased over time in both the short- and long-term studies (p < 0.001) but was not different between the three study groups: apparent weight loss was between 4.05% – 6.14% for the short-term study and 14.0% – 17.9% in the long-term study. The ATTD was within expected ranges for all groups, whereby total dry matter and crude protein ATTD was 7–8% higher in the BB diet compared to CON (P < 0.05), crude fat ATTD was similar across all diets, and nitrogen free extract ATTD was 5–6% higher in both BB and NB compared to CON (P < 0.05). Metabolisable energy was similar for all diets, and ranged from 3,434–3,632 kcal/kg. At the end of each study period, dogs had haemoglobin levels ≥12 g/dl, packed cell volume ≥36%, albumin ≥2.4 g/dl, ALP ≤ 300 IU/l and all median values for each group were within defined limits for nutritional adequacy. This investigation demonstrated that BB and NB diets were safe, digestible, and supported weight loss in calorically restricted, overweight or obese, adult companion dogs.
The first observations by a worldwide network of advanced interferometric gravitational wave detectors offer a unique opportunity for the astronomical community. At design sensitivity, these facilities will be able to detect coalescing binary neutron stars to distances approaching 400 Mpc, and neutron star–black hole systems to 1 Gpc. Both of these sources are associated with gamma-ray bursts which are known to emit across the entire electromagnetic spectrum. Gravitational wave detections provide the opportunity for ‘multi-messenger’ observations, combining gravitational wave with electromagnetic, cosmic ray, or neutrino observations. This review provides an overview of how Australian astronomical facilities and collaborations with the gravitational wave community can contribute to this new era of discovery, via contemporaneous follow-up observations from the radio to the optical and high energy. We discuss some of the frontier discoveries that will be made possible when this new window to the Universe is opened.