INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care—study protocol for a multicentre randomised controlled trial

BACKGROUND: Hospital-acquired and ventilator-associated pneumonias (HAP and VAP) are common in critical care and can be life-threatening. Rapid microbiological diagnostics, linked to an algorithm to translate their results into antibiotic choices, could simultaneously improve patient outcomes and antimicrobial stewardship. METHODS: The INHALE Randomised Controlled Trial is a multi-centre, parallel study exploring the potential of the BioFire FilmArray molecular diagnostic to guide antibiotic treatment of HAP/VAP in intensive care units (ICU); it identifies pathogens and key antibiotic resistance in around 90 min. The comparator is standard care whereby the patient receives empirical antibiotics until microbiological culture results become available, typically after 48-72 h. Adult and paediatric ICU patients are eligible if they are about to receive antibiotics for a suspected lower respiratory infection (including HAP/VAP) for the first time or a change in antibiotic because of a deteriorating clinical condition. Breathing spontaneously or intubated, they must have been hospitalised for 48 h or more. Patients are randomised 1:1 to receive either antibiotics guided by the FilmArray molecular diagnostic and its trial-based prescribing algorithm or standard care, meaning empirical antibiotics based on local policy, adapted subsequently based upon local microbiology culture results. Co-primary outcomes are (i) non-inferiority in clinical cure of pneumonia at 14 days post-randomisation and (ii) superiority in antimicrobial stewardship at 24 h post-randomisation (defined as % of patients on active and proportionate antibiotics). Secondary outcomes include further stewardship reviews; length of ICU stay; co-morbidity indicators, including septic shock, change in sequential organ failure assessment scores, and secondary pneumonias; ventilator-free days; adverse events over 21 days; all-cause mortality; and total antibiotic usage. Both cost-effectiveness of the molecular diagnostic-guided therapy and behavioural aspects determining antibiotic prescribing are being explored. A sample size of 552 will be required to detect clinically significant results with 90% power and 5% significance for the co-primary outcomes. DISCUSSION: This trial will test whether the potential merits of rapid molecular diagnostics for pathogen and resistance detection in HAP/VAP are realised in patient outcomes and/or improved antibiotic stewardship. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16483855 . Retrospectively registered on 15 July 2019

Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome.

BACKGROUND: Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized. OBJECTIVES: The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. METHODS: Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year. RESULTS: A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01). CONCLUSIONS: Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123)

Atherogenic Dyslipidemia: Cardiovascular Risk and Dietary Intervention

Atherogenic dyslipidemia comprises a triad of increased blood concentrations of small, dense low-density lipoprotein (LDL) particles, decreased high-density lipoprotein (HDL) particles, and increased triglycerides. A typical feature of obesity, the metabolic syndrome, insulin resistance, and type 2 diabetes mellitus, atherogenic dyslipidemia has emerged as an important risk factor for myocardial infarction and cardiovascular disease. A number of genes have now been linked to this pattern of lipoprotein changes. Low-carbohydrate diets appear to have beneficial lipoprotein effects in individuals with atherogenic dyslipidemia, compared to high-carbohydrate diets, whereas the content of total fat or saturated fat in the diet appears to have little effect. Achieving a better understanding of the genetic and dietary influences underlying atherogenic dyslipidemia may provide clues to improved interventions to reduce the risk of cardiovascular disease in high-risk individuals

The association between processes, structures and outcomes of secondary prevention care among VA ischemic heart disease patients

BACKGROUND: Hyperlipidemia and hypertension are well-established risk factors for recurrent cardiovascular events among patients with ischemic heart disease (IHD). Despite national recommendations, concordance with guidelines for LDL cholesterol and blood pressure remains inadequate. The objectives of this study were to 1) determine concordance rates with LDL cholesterol and BP recommendations; and 2) identify patient factors, processes and structures of care associated with guideline concordance among VA IHD patients. METHODS: This was a cross sectional study of veterans with IHD from 8 VA hospitals. Outcomes were concordance with LDL guideline recommendations (LDL<100 mg/dl), and BP recommendations (<140/90 mm Hg). Cumulative logit and hierarchical logistic regression analyses were performed to identify patient factors, processes, and structures of care independently associated with guideline concordance. RESULTS: Of 14,114 veterans with IHD, 55.7% had hypertension, 71.5% had hyperlipidemia, and 41.6% had both conditions. Guideline concordance for LDL and BP were 38.9% and 53.4%, respectively. However, only 21.9% of the patients achieved both LDL <100 mg/dl and BP <140/90 mm Hg. In multivariable analyses, patient factors including older age and the presence of vascular disease were associated with worse guideline concordance. In contrast, diabetes was associated with better guideline concordance. Several process of care variables, including higher number of outpatient visits, higher number of prescribed medications, and a recent cardiac hospitalization were associated with better guideline concordance. Among structures of care, having on-site cardiology was associated with a trend towards better guideline concordance. CONCLUSION: Guideline concordance with secondary prevention measures among IHD patients remains suboptimal. It is hoped that the findings of this study can serve as an impetus for quality improvement efforts to improve upon secondary prevention measures and reduce the morbidity and mortality of patients with known IHD

Variations in the prevalence of point (pre)hypertension in a Nigerian school-going adolescent population living in a semi-urban and an urban area

<p>Abstract</p> <p>Background</p> <p>Hypertension has been shown to start in early life and to track into adulthood. Detecting adolescents with hypertension and prehypertension will aid early intervention and reduce morbidity and mortality from the disorders. This study reports the point-prevalence of the two disorders in a semi-urban and an urban population of school-going adolescents in Nigeria.</p> <p>Methods</p> <p>A total of 843 adolescents from two places of domicile were studied. Their blood pressures and anthropometric indices were measured using standard protocol. Point-hypertension and point-prehypertension were defined with respect to each subject's gender, age and height. The prevalence of the disorders was calculated and reported age-wise and nutritional status-wise.</p> <p>Results</p> <p>The prevalence of point-prehypertension in the semi-urban area was 22.2% (20.7% for girls and 23.1% for boys) while it was 25.0% (21.8% for girls and 29.2% for boys) in the urban area. The prevalence of point-hypertension was 4.6% (4.1% for girls and 4.8% for boys) in the semi-urban area and 17.5% (18.0% for girls and 16.9% for boys) in the urban area. Point-prehypertension was not detected among the thin subjects of both places of domicile. The prevalence of point-prehypertension was similar in both the urban and semi-urban areas among the subjects who had normal BMI-for-age, and over-weight/obese subjects respectively. From the semi-urban to the urban area, the prevalence of point-hypertension increased approximately 3-folds among thin and normal BMI-for-age subjects, and 10-folds among overweight/obese subjects. Systolic hypertension was more preponderant in both the semi-urban and urban areas.</p> <p>Conclusions</p> <p>The prevalence of both disorders is considerably high in the studied populations. Urgent pediatric public health action is needed to address the situation.</p

Insulin resistance and its association with the components of the metabolic syndrome among obese children and adolescents

<p>Abstract</p> <p>Background</p> <p>Insulin resistance is the primary metabolic disorder associated with obesity; yet little is known about its role as a determinant of the metabolic syndrome in obese children. The aim of this study is to assess the association between the degree of insulin resistance and the different components of the metabolic syndrome among obese children and adolescents.</p> <p>Methods</p> <p>An analytical, cross-sectional and population-based study was performed in forty-four public primary schools in Campeche City, Mexico. A total of 466 obese children and adolescents between 11-13 years of age were recruited. Fasting glucose and insulin concentrations, high density lipoprotein cholesterol, triglycerides, waist circumference, systolic and diastolic blood pressures were measured; insulin resistance and metabolic syndrome were also evaluated.</p> <p>Results</p> <p>Out of the total population studied, 69% presented low values of high density lipoprotein cholesterol, 49% suffered from abdominal obesity, 29% had hypertriglyceridemia, 8% presented high systolic and 13% high diastolic blood pressure, 4% showed impaired fasting glucose, 51% presented insulin resistance and 20% metabolic syndrome. In spite of being obese, 13% of the investigated population did not present any metabolic disorder. For each one of the components of the metabolic syndrome, when insulin resistance increased so did odds ratios as cardiometabolic risk factors.</p> <p>Conclusions</p> <p>Regardless of age and gender an increased degree of insulin resistance is associated with a higher prevalence of disorders in each of the components of the metabolic syndrome and with a heightened risk of suffering metabolic syndrome among obese children and adolescents.</p

Project FIT: Rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children

<p>Abstract</p> <p>Background</p> <p>This paper describes Project FIT, a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA.</p> <p>Methods/design</p> <p>There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones.</p> <p>Discussion</p> <p>At baseline, there was generally low physical activity (70% do not meet recommendation of 60 minutes per day), excessive screen time (75% do not meet recommendation of < 2 hours per day), and low intake of vegetables and whole grains and high intake of sugar-sweetened beverages, French fries and chips and desserts as well as a high prevalence of overweight and obesity (48.5% including 6% with severe obesity) among low income, primarily Hispanic and African American 3^rd-5^thgrade children (n = 403).</p> <p>Trial registration</p> <p><b>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01385046">NCT01385046</a></b></p

Better Palliative Care for people with a Dementia: Summary of InterdisciplinaryWorkshop Highlighting Current Gaps and Recommendations for Future Research

Background: Dementia is the most common neurological disorder worldwide and is a life-limiting condition, but very often is not recognised as such. People with dementia, and their carers, have been shown to have palliative care needs equal in extent to those of cancer patients. However, many people with advanced dementia are not routinely being assessed to determine their palliative care needs, and it is not clear why this is so. Main body: An interdisciplinary workshop on "Palliative Care in Neurodegeneration, with a focus on Dementia", was held in Cork, Ireland, in May 2016. The key aim of this workshop was to discuss the evidence base for palliative care for people with dementia, to identify 'gaps' for clinical research, and to make recommendations for interdisciplinary research practice. To lead the discussion throughout the day a multidisciplinary panel of expert speakers were brought together, including both researchers and clinicians from across Ireland and the UK. Targeted invitations were sent to attendees ensuring all key stakeholders were present to contribute to discussions. In total, 49 experts representing 17 different academic and practice settings, attended. Key topics for discussion were pre-selected based on previously identified research priorities (e.g. James Lind Alliance) and stakeholder input. Key discussion topics included: i. Advance Care Planning for people with Dementia; ii. Personhood in End-of-life Dementia care; iii. Topics in the care of advanced dementia at home. These topics were used as a starting point, and the ethos of the workshop was that the attendees could stimulate discussion and debate in any relevant area, not just the key topics, summarised under iv. Other priorities. Conclusions: The care experienced by people with dementia and their families has the potential to be improved; palliative care frameworks may have much to offer in this endeavour. However, a solid evidence base is required to translate palliative care into practice in the context of dementia. This paper presents suggested research priorities as a starting point to build this evidence base. An interdisciplinary approach to research and priority setting is essential to develop actionable knowledge in this area

Risk factors for overweight and obesity, and changes in body mass index of Chinese adults in Shanghai

<p>Abstract</p> <p>Background</p> <p>Over the past two decades, the prevalence of overweight or obesity has increased in China. The aims of this study were to firstly assess the baseline prevelences and the risk factors for overweight and obesity, and secondly to detect the changes of body mass index (BMI) over a follow-up period in Chinese adults in Shanghai.</p> <p>Methods</p> <p>The data set of a population-based longitudinal study was analyzed. Anthropometric and biochemical data were collected for 5364 subjects (aged 25–95 years) during a period of 1998–2001. Among those individuals, 3032 subjects were interviewed and reexamined at the second survey from 2003 to 2004. Then the standardized prevalences for overweight and obesity were calculated using baseline data; the possible contributing factors of overweight and obesity were detected using binary logistic regression analysis; and the changes of BMI were evaluated after an average of 3.6-year follow-up period.</p> <p>Results</p> <p>(1) According to the WHO standard and the Chinese standard, the sex- and age-standardized prevalences were 27.5% and 32.4% for overweight, and 3.7% and 9.1% for obesity, respectively. (2) The risks of overweight and obesity differed among different age groups. Family history of obesity increased the risk of overweight and obesity by about 1.2-fold for both genders. Current male smokers had a lower risk of overweight and obesity (OR = 0.76, <it>p </it>< 0.05) than nonsmokers. In contrast, current male drinkers had a higher risk of overweight and obesity (OR = 1.42, <it>p </it>< 0.05) than nondrinkers. Compared with low-educated women, medium- and high- educated women were at lower risk of overweight and obesity, and the corresponding ORs (95% CIs) were 0.64 (0.52–0.79) and 0.50(0.36–0.68), respectively. (3) The annual changes of BMI means ranged from an increase of 0.1 kg/m²to a decrease of 0.2 kg/m²(by genders and age groups). Meanwhile, the BMI increase was statistically significant in the 35–44 years age group, and the BMI decrease was significant above 65 years for both genders.</p> <p>Conclusion</p> <p>This study showed high prevalence of overweight and obesity in Shanghai metropolis populations. The risk factors of overweight and obesity were multifactorial and gender specific. After 3.6 years, BMI means changed slightly, BMI increased mainly in middle-aged individuals and decreased in old individuals.</p

Identifying priority healthcare trainings in frozen conflict situations: The case of Nagorno Karabagh

<p>Abstract</p> <p>Introduction</p> <p>Health care in post-war situations, where the system's human and fixed capital are depleted, is challenging. The addition of a frozen conflict situation, where international recognition of boundaries and authorities are lacking, introduces further complexities.</p> <p>Case description</p> <p>Nagorno Karabagh (NK) is an ethnically Armenian territory locked within post-Soviet Azerbaijan and one such frozen conflict situation. This article highlights the use of evidence-based practice and community engagement to determine priority areas for health care training in NK. Drawing on the precepts of APEXPH (Assessment Protocol for Excellence in Public Health) and MAPP (Mobilizing for Action through Planning and Partnerships), this first-of-its-kind assessment in NK relied on in-depth interviews and focus group discussions supplemented with expert assessments and field observations. Training options were evaluated against a series of ethical and pragmatic principles.</p> <p>Discussion and Evaluation</p> <p>A unique factor among the ethical and pragmatic considerations when prioritizing among alternatives was NK's ambiguous political status and consequent sponsor constraints. Training priorities differed across the region and by type of provider, but consensus prioritization emerged for first aid, clinical Integrated Management of Childhood Illnesses, and Adult Disease Management. These priorities were then incorporated into the training programs funded by the sponsor.</p> <p>Conclusions</p> <p>Programming responsive to both the evidence-base and stakeholder priorities is always desirable and provides a foundation for long-term planning and response. In frozen conflict, low resource settings, such an approach is critical to balancing the community's immediate humanitarian needs with sponsor concerns and constraints.</p