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Children with congenital heart disease and their families are at risk of psychosocial problems. Emotional and behavioural problems, impaired school functioning, and reduced exercise capacity often occur. To prevent and decrease these problems, we modified and extended the previously established Congenital Heart Disease Intervention Program (CHIP)–School, thereby creating CHIP-Family. CHIP-Family is the first psychosocial intervention with a module for children with congenital heart disease. Through a randomised controlled trial, we examined the effectiveness of CHIP-Family.
Ninety-three children with congenital heart disease (age M = 5.34 years, SD = 1.27) were randomised to CHIP-Family (n = 49) or care as usual (no psychosocial care; n = 44). CHIP-Family consisted of a 1-day group workshop for parents, children, and siblings and an individual follow-up session for parents. CHIP-Family was delivered by psychologists, paediatric cardiologists, and physiotherapists. At baseline and 6-month follow-up, mothers, fathers, teachers, and the child completed questionnaires to assess psychosocial problems, school functioning, and sports enjoyment. Moreover, at 6-month follow-up, parents completed program satisfaction assessments.
Although small improvements in child outcomes were observed in the CHIP-Family group, no statistically significant differences were found between outcomes of the CHIP-Family and care-as-usual group. Mean parent satisfaction ratings ranged from 7.4 to 8.1 (range 0–10).
CHIP-Family yielded high program acceptability ratings. However, compared to care as usual, CHIP-Family did not find the same extent of statistically significant outcomes as CHIP-School. Replication of promising psychological interventions, and examination of when different outcomes are found, is recommended for refining interventions in the future.
There is an urgent need to identify and develop cross-sectoral policies which promote and support a healthy, safe and sustainable food system. To help shape the political agenda, a critical first step is a shared definition of such a system among policy makers across relevant sectors. The aim of the present study was to determine how Australian policy actors define, and contribute to, a healthy, safe and sustainable food system.
A Delphi survey, consisting of two rounds, was conducted. Participants were asked how they define, and contribute to, a healthy, safe and sustainable food system (Round 1) and indicate their level of agreement with summary statements (Round 2).
This was an online Delphi survey conducted in Australia.
Twenty-nine and fourteen multisectoral and multilevel policy makers completed Round 1 and Round 2, respectively.
The definition included food processing regulation, environmentally friendly food production and access to nutritious food. All agreed that it was important for them to improve access and supply of healthy food and ensure healthy planning principles are applied.
There were cross-sectoral differences in definitions and contributions; however, critical consensus was achieved. The study contributes to the definition of key elements of a cross-sectoral food and nutrition policy to meet today’s environmental, health, social and economic challenges; however, further research using a more representative multisectoral sample is warranted.
Hemorrhage is the leading cause of preventable death in combat, although early recognition of hemorrhage is still challenging on the battlefield.
The objective of this study was to describe the shock index (SI) in a healthy military population, and to measure its variation during a controlled blood loss, simulated by blood donation.
A prospective observational study that enrolled military subjects, volunteers for blood donation, was conducted. Demographic and clinical information, concerning both the patient and the blood collection, were recorded. Baseline vital signs were measured, before and after donation, in a 45° supine position. Statistical analysis was performed after calculation of SI.
A total of 483 participants were included in the study. The mean blood donation volume was 473mL (SD = 44mL). The median pre- and post-blood donation SI were significantly different: 0.54 (IQR = 0.48-0.63) and 0.57 (IQR = 0.49-0.66), respectively (P = .002). Changes in pre-/post-donation blood pressure (BP) and heart rate (HR) also reached statistical difference but represented a clinically poor relevance. The multivariate analysis showed no significant associations between SI variations and age, sex, body mass index (BMI), sport activities, blood donation volume, and enteral volume replacement (EVR).
In this model of mild hemorrhage, SI exhibited significant variations but failed to reach clinical relevance. Further studies are needed to prove the benefit of SI calculation as a possible parameter for early recognition of hemorrhage in combat casualties at the point of injury.
Pasquier P, Duron S, Pouget T, Carbonnel AC, Boutonnet M, Malgras B, Barbier O, de Saint Maurice G, Sailliol A, Ausset S, Martinaud C. Use of shock index to identify mild hemorrhage: an observational study in military blood donors. Prehosp Disaster Med. 2019;34(3):303–307.
OBJECTIVES/SPECIFIC AIMS: The University of Washington (UW) CTSA Hub Liaison Team has directed and facilitated work required to bring TIN multisite trials to the CTSA hub and its affiliates by: (1) Connecting hub and affiliate investigators with the services offered by the Trial and Recruitment Innovation Centers, (2) identifying investigators at academic and non-academic institutions to act as co-investigators on multisite trials, (3) supporting the local and affiliate human research protection programs and investigators throughout the life-cycle of the study, (4) maximizing CTSA and local study team resources to develop and monitor study-specific volunteer recruitment and retention plans. The UW CTSA TIN Hub Liaison Team has worked to achieve these objectives via the following methods designed for generalization and dissemination. METHODS/STUDY POPULATION: (1) Providing consultations to investigators interested in the services offered by the Trial and Recruitment Innovation Centers. (2) Hub and affiliate investigators at academic and non-academic institutions are identified by a variety of approaches, including the engagement of existing CTSA hub regional collaboration networks, utilizing EHR data from CTSA developed phenotypes and targeted “Investigator Engagement Packets”. (3) Ensuring regulatory oversight and compliance is challenging in the new age of single IRB review. Establishing a flexible reliance office, engaging with the central TIN IRBs and providing guidance and resources to local study teams ensures investigator confidence in the integrity of the protocol approval and study activity processes. (4) The CTSA Hub Liaison team has developed a Recruitment and Retention Plan template and holds recruitment and retention planning meetings with the CTSA study teams engaging in TIN studies. RESULTS/ANTICIPATED RESULTS: It is anticipated that The Hub Liaison Team: (1) Will contribute to the TIN’s process improvement to bring regionally appropriate studies to the CTSA hub and affiliates. (2) Identify ideal investigators to engage both in proposal submission and co-investigating multisite trials. (3) Collect, compare and improve regulatory and contract approval cycle times. (4) Monitor and support screening, accrual and retention of study volunteers. DISCUSSION/SIGNIFICANCE OF IMPACT: Due to low prevalence of disease, challenges related to identifying and randomizing study volunteers and urgency to address clinical and public health issues, multisite study design is an essential option for NCATS. The Trial Innovation Network is an exciting approach to leverage local and national resources to provide infrastructure to improve multisite clinical and observational trial conduct. The University of Washington CTSA hub has developed and piloted methods to achieve the mission of the TIN, by recruiting investigators and realizing trial objectives, with the hope that these methods could be utilized by other CTSA TIN Hub Liaison Teams.
This study investigated the role of sequential processing in spoken language outcomes for children who are deaf or hard of hearing (DHH), ages 5;3–11;4, by comparing them to children with typical hearing (TH), ages 6;3–9;7, on sequential learning and memory tasks involving easily nameable and difficult-to-name visual stimuli. Children who are DHH performed more poorly on easily nameable sequencing tasks, which positively predicted receptive vocabulary scores. Results suggest sequential learning and memory may underlie delayed language skills of many children who are DHH. Implications for language development in children who are DHH are discussed.
Global land is turning into an increasingly scarce resource. We here present a comprehensive assessment of co-occuring land-use change from 2000 until 2010, compiling existing spatially explicit data sources for different land uses, and building on a rich literature addressing specific land-use changes in all world regions. This review systematically categorizes patterns of land use, including regional urbanization and agricultural expansion but also globally telecoupled land-use change for all world regions. Managing land-use change patterns across the globe requires global governance.
Falls prevention strategies can only be effective in reducing falls amongst older people if they are adopted and enacted in their daily lives. There is limited evidence identifying what older people in residential aged care (RAC) homes understand about falls and falls prevention, or what may limit or enable their adoption of strategies. This study was conducted in two countries and explored older people's knowledge and awareness of falls and their preferences, opportunities and motivation to undertake falls prevention strategies. A cross-sectional survey was administered to participants (N = 70) aged 65 years and over, living in six RAC homes in Perth, Australia and six RAC homes in Swansea, Wales, United Kingdom. Participants had limited knowledge about intrinsic falls risk factors and strategies to address these and frequently expressed self-blame regarding falling. Almost all (N = 67, 95.7%) participants felt highly motivated to maintain their current functional mobility and independence in everyday tasks. Key preferences for receiving falls prevention messages favoured a positive approach promoting wellness and independence (N = 41, 58.6%) via pictorial posters or brochures (N = 37, 52.9%) and small group discussions preferably with demonstrations (N = 18, 25.7%). Findings from this study may assist organisations and staff to more effectively engage with older people living in RAC about falls prevention and design targeted resources to address the motivations and preferences of this population.
n-3 Fatty acids are associated with better cardiovascular and cognitive health. However, the concentration of EPA, DPA and DHA in different plasma lipid pools differs and factors influencing this heterogeneity are poorly understood. Our aim was to evaluate the association of oily fish intake, sex, age, BMI and APOE genotype with concentrations of EPA, DPA and DHA in plasma phosphatidylcholine (PC), NEFA, cholesteryl esters (CE) and TAG. Healthy adults (148 male, 158 female, age 20–71 years) were recruited according to APOE genotype, sex and age. The fatty acid composition was determined by GC. Oily fish intake was positively associated with EPA in PC, CE and TAG, DPA in TAG, and DHA in all fractions (P≤0·008). There was a positive association between age and EPA in PC, CE and TAG, DPA in NEFA and CE, and DHA in PC and CE (P≤0·034). DPA was higher in TAG in males than females (P<0·001). There was a positive association between BMI and DPA and DHA in TAG (P<0·006 and 0·02, respectively). APOE genotype×sex interactions were observed: the APOE4 allele associated with higher EPA in males (P=0·002), and there was also evidence for higher DPA and DHA (P≤0·032). In conclusion, EPA, DPA and DHA in plasma lipids are associated with oily fish intake, sex, age, BMI and APOE genotype. Such insights may be used to better understand the link between plasma fatty acid profiles and dietary exposure and may influence intake recommendations across population subgroups.
The growing prevalence of obesity explains the rising interest in bariatric surgery. Compared with non-surgical treatment options, bariatric surgery results in greater and sustained improvements in weight loss, obesity associated complications, all-cause mortality and quality of life. These encouraging metabolic and weight effects come with a downside, namely the risk of nutritional deficiencies. Particularly striking is the risk to develop iron deficiency. Postoperatively, the prevalence of iron deficiency varies between 18 and 53 % after Roux-en-Y gastric bypass and between 1 and 54 % after sleeve gastrectomy. Therefore, preventive strategies and effective treatment options for iron deficiency are crucial to successfully manage the iron status of patients after bariatric surgery. With this review, we discuss the risks and the contributing factors of developing iron deficiency after bariatric surgery. Furthermore, we highlight the discrepancy in the diagnosis of iron deficiency, iron deficiency anaemia and anaemia and highlight the evidence supporting the current nutritional recommendations in the field of bariatric research. In conclusion, we advocate for more nutrition-related research in patient populations in order to provide strong evidence-based guidelines after bariatric surgery.
For this study, we adapted the Montgomery Borgatta Caregiver Burden Scale, used widely in the United States, to the Saudi Arabian context. To produce an Arabic, culturally sensitive version of the scale, we conducted semi-structured interviews with 20 Saudi family caregivers. The Arabic version of the scale was tested, and participants were asked to comment on the appropriateness of items for the construct of “caregiver burden” using the repertory grid technique and laddering procedure – two constructivist methods derived from personal construct theory. From interview findings, we examined the content of the items and the caregiver burden construct itself. Our findings suggest that the use of constructivist methods to refine constructs and quantitative instruments is highly informative. This strategy is feasible even when little is known about the investigated constructs in the target culture and further elucidates our understanding of cross-cultural variations or invariance of different versions of the scale.
To date no studies have explored the effectiveness of written cognitive–behavioural therapy (CBT) resources for low mood and stress delivered via a course of self-help classes in a community setting.
To assess the effectiveness of an 8-week community-based CBT self-help group classes on symptoms of depression, anxiety and social function at 6 months (trial registration: ISRCTN86292664).
In total, 142 participants were randomly allocated to immediate (n = 71) or delayed access to a low-intensity CBT intervention (n = 71). Measures of depression, anxiety and social function were collected at baseline and 6 months.
There was a significant improvement for the primary outcome of Patient Health Questionnaire-9 (PHQ-9) score (mean between-group difference: –3.64, 95% CI –6.06 to –1.23; P = 0.004). The percentage of participants reducing their PHQ-9 score between baseline and 6 months by 50% or more was 17.9% for the delayed access group and 43.8% for the immediate access group. Secondary outcomes also improved including anxiety and social function. The intervention was cost neutral. The probabilities of a net benefit at willingness to pay thresholds of £20 000, £25 000 or £30 000 were 0.928, 0.944 and 0.955, respectively.
Low-intensity class-based CBT delivered within a community setting is effective for reducing depression, anxiety and impaired social function at little additional cost.
Declaration of interest
C.W. is president of British Association for Behavioural & Cognitive Psychotherapies (BABCP) – the lead body for CBT in the UK. He is also author of a range of CBT-based resources available commercially. He is developer of the LLTTF classes evaluated in this study. He receives royalty, and is shareholder and director of a company that commercialises these resources.
OBJECTIVES/SPECIFIC AIMS: Clostridium difficile is the most common cause of infectious antibiotic associated diarrhea. It is often refractory to antimicrobial therapy and fecal microbiota transplantation (FMT) is emerging as a therapeutic option. The objective is to characterize the direct effects of FMT on the gut microbiota. METHODS/STUDY POPULATION: Fecal specimens were obtained from a cohort of 29 subjects with recurrent C. difficile infection who received FMTs from 1 of 4 healthy donors as part of a phase 2 trial (Rebiotix). Fecal specimens were collected from the subject before FMT and up to 6 months post FMT. 16S rRNA sequencing and whole-genome shotgun sequencing were used to assess microbial community composition as compared by weighted Unifrac. RESULTS/ANTICIPATED RESULTS: Before treatment, the microbial community of subjects with C. difficile infection was highly distinct from the composition of the healthy donors in terms of metabolic profile. Quantification of phylogenetic community distance from donor by weighted Unifrac distance showed a significant decrease within the 1st week (Wilcoxon rank sum, p<0.01). This metric was predictive of both treatment failures and antibiotic resistance gene count (LR=22.45, p<0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: We conclude that distance from donor is a useful metric to quantify FMT success and that FMTs are a promising treatment for otherwise untreatable carriage of antibiotic resistance genes and organisms.
Regulatory impact analyses (RIAs) weigh the benefits of regulations against the burdens they impose and are invaluable tools for informing decision makers. We offer 10 tips for nonspecialist policymakers and interested stakeholders who will be reading RIAs as consumers.
1.Core problem: Determine whether the RIA identifies the core problem (compelling public need) the regulation is intended to address.
2.Alternatives: Look for an objective, policy-neutral evaluation of the relative merits of reasonable alternatives.
3.Baseline: Check whether the RIA presents a reasonable “counterfactual” against which benefits and costs are measured.
4.Increments: Evaluate whether totals and averages obscure relevant distinctions and trade-offs.
5.Uncertainty: Recognize that all estimates involve uncertainty, and ask what effect key assumptions, data, and models have on those estimates.
6.Transparency: Look for transparency and objectivity of analytical inputs.
7.Benefits: Examine how projected benefits relate to stated objectives.
8.Costs: Understand what costs are included.
9.Distribution: Consider how benefits and costs are distributed.
10.Symmetrical treatment: Ensure that benefits and costs are presented symmetrically.
Sediments deposited from the Permian–Triassic boundary (~252 Ma) until the end-Smithian (Early Triassic; c. 250.7 Ma) in the Sonoma Foreland Basin show marked thickness variations between its southern (up to c. 250 m thick) and northern (up to c. 550 m thick) parts. This basin formed as a flexural response to the emplacement of the Golconda Allochthon during the Sonoma orogeny. Using a high-resolution backstripping approach, a numerical model and sediment thickness to obtain a quantitative subsidence analysis, we discuss the controlling factor(s) responsible for spatial variations in thickness. We show that sedimentary overload is not sufficient to explain the significant discrepancy observed in the sedimentary record of the basin. We argue that the inherited rheological properties of the basement terranes and spatial heterogeneity of the allochthon are of paramount importance in controlling the subsidence and thickness spatial distribution across the Sonoma Foreland Basin.
Electroconvulsive therapy (ECT) is a non-pharmacological treatment that is effective in treating severe and treatment-resistant depression. Although the efficacy of ECT has been demonstrated to treat major depressive disorder (MDD), the brain mechanisms underlying this process remain unclear. Structural–functional changes occur with the use of ECT as a treatment for depression based on magnetic resonance imaging (MRI). For this reason, we have tried to identify the changes that were identified by MRI to try to clarify some operating mechanisms of ECT. We focus to brain changes on MRI [structural MRI (sMRI), functional MRI (fMRI) and diffusion tensor imging (DTI)] after ECT.
A systematic search of the international literature was performed using the bibliographic search engines PubMed and Embase. The research focused on papers published up to 30 September 2015. The following Medical Subject Headings (MESH) terms were used: electroconvulsive therapy AND (MRI OR fMRI OR DTI). Papers published in English were included. Four authors searched the database using a predefined strategy to identify potentially eligible studies.
There were structural changes according to the sMRI performed before and after ECT treatment. These changes do not seem to be entirely due to oedema. This investigation assessed the functional network connectivity associated with the ECT response in MDD. ECT response reverses the relationship from negative to positive between the two pairs of networks.
We found structural–functional changes in MRI post-ECT. Because of the currently limited MRI data on ECT in the literature, it is necessary to conduct further investigations using other MRI technology.
The recently introduced concept of
-variation unifies previous concepts of variation of multivariate functions. In this paper, we give an affirmative answer to the open question from  whether every function of bounded Hardy–Krause variation is Borel measurable and has bounded
-variation. Moreover, we show that the space of functions of bounded
-variation can be turned into a commutative Banach algebra.