Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context

<p>Abstract</p> <p>Background</p> <p>Many investigators are concerned that the modes of implementation and enforcement of the federal regulations designed to protect children are unduly impeding pediatric clinical research.</p> <p>Objective</p> <p>To assess regulatory impediments to clinical research involving children and to develop recommendations to ameliorate them.</p> <p>Participants</p> <p>The Pediatric Endocrine Society and The Endocrine Society convened a consensus conference involving experts and stakeholders in patient-oriented research involving children and adolescents in 2008.</p> <p>Consensus process</p> <p>Following presentations that reviewed problematic issues around key regulations, participants divided into working groups to develop potential solutions that could be adopted at local and federal levels. Presentations to the full assembly were then debated. A writing committee then drafted a summary of the discussions and main conclusions, placing them in historical context, and submitted it to all participants for comment with the aim of developing consensus.</p> <p>Conclusions</p> <p>Recommendations designed to facilitate the ethical conduct of research involving children addressed the interpretation of ambiguous regulatory terms such as "minimal risk" and "condition" and called for the development by professional societies of best practice primers for common research procedures that would be informative to both investigators and institutional review boards. A call was issued for improved guidance from the Office for Human Research Protections and Food and Drug Administration as well as for the development by professional societies of a process to monitor progress in improving human subject research regulation. Finally, a need for systematic research to define the nature and extent of institutional obstacles to pediatric research was recognized.</p

Identifying Metocean Drivers of Turbidity Using 18 Years of MODIS Satellite Data: Implications for Marine Ecosystems under Climate Change

Turbidity impacts the growth and productivity of marine benthic habitats due to light limitation. Daily/monthly synoptic and tidal influences often drive turbidity fluctuations, however, our understanding of what drives turbidity across seasonal/interannual timescales is often limited, thus impeding our ability to forecast climate change impacts to ecologically significant habitats. Here, we analysed long term (18-year) MODIS-aqua data to derive turbidity and the associated meteorological and oceanographic (metocean) processes in an arid tropical embayment (Exmouth Gulf in Western Australia) within the eastern Indian Ocean. We found turbidity was associated with El Niño Southern Oscillation (ENSO) cycles as well as Indian Ocean Dipole (IOD) events. Winds from the adjacent terrestrial region were also associated with turbidity and an upward trend in turbidity was evident in the body of the gulf over the 18 years. Our results identify hydrological processes that could be affected by global climate cycles undergoing change and reveal opportunities for managers to reduce impacts to ecologically important ecosystems

Local habitat composition and complexity outweigh seascape effects on fish distributions across a tropical seascape

Context: The distribution of animals is influenced by a complex interplay of landscape, environmental, habitat, and anthropogenic factors. While the effects of each of these forces on fish assemblages have been studied in isolation, the implications of their combined influence within a seascape remain equivocal. Objectives: We assessed the importance of local habitat composition, seascape configuration, and environmental conditions for determining the abundance, diversity, and functional composition of fish assemblages across a tropical seascape. Methods: We quantified fish abundance in coral, macroalgal, mangrove, and sand habitats throughout the Dampier Archipelago, Western Australia. A full-subsets modelling approach was used that incorporated data from benthic habitat maps, a hydrodynamic model, in situ measures of habitat composition, and remotely sensed environmental data to evaluate the relative influence of biophysical drivers on fish assemblages. Results: Measures of habitat complexity were the strongest predictors of fish abundance, diversity, and assemblage composition in coral and macroalgal habitats, with seascape effects playing a secondary role for some functional groups. Proximity to potential nursery habitats appeared to have minimal influence on coral reef fish assemblages. Consequently, coral, macroalgal, and mangrove habitats contained distinct fish assemblages that contributed to the overall diversity of fish within the seascape. Conclusions: Our findings underscore the importance of structural complexity for supporting diverse and abundant fish populations and suggest that the value of structural connectivity between habitats depends on local environmental context. Our results support management approaches that prioritise the preservation of habitat complexity, and that incorporate the full range of habitats comprising tropical seascapes

Percent body fat prediction equations for 8- to 17-year-old American children: Percent body fat prediction equations

Percent body fat equations are usually developed in specific populations and have low generalizability

Off-label Utilization of Antihypertensive Medications in Children

Objective— To examine off-label utilization and costs of antihypertensive drugs in children using a national sample of prescription claims. Design— Cross-sectional study. Setting— 2002 Medstat MarketScan Database, a national sample of outpatient prescription claims of children ≥18 years old enrolled in private, employer-sponsored health plans. Main Outcome Measures— Off-label use of antihypertensive drugs by patient age and costs of antihypertensives calculated as mean cost per child per 30-day fill. Results— One-half of the index antihypertensive prescription claims were off-label, based on minimum age criteria. Boys were more likely (56%) than girls (46%) to be prescribed off-label antihypertensives (p<0.001). Children aged ≥12 years were more likely to be prescribed off-label antihypertensives (53%) compared with children aged ≥5 (46%) and 6–11 years (42%, p<0.001). Off-label use varied significantly by class of antihypertensive drugs (p<0.001). Overall, off-label antihypertensives were significantly more expensive than on-label antihypertensives. Conclusions— Despite availability of often less expensive on-label alternatives for the same class of antihypertensive drugs, off-label antihypertensive drugs were prescribed frequently in children. These findings underscore the potential clinical and economic implications of common off-label prescribing, for children, their parents, physicians and payers. Originally published Ambulatory Pediatrics, Vol. 7, No. 4, July 200

College Student Mental Health: An Evaluation of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure

© 2018 American Psychological Association. The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure was developed to aid in clinical decision-making for clients seeking psychiatric services and to facilitate empirical investigation of the dimensional nature of mental health issues. Preliminary evidence supports its utility with clinical samples. However, the brief, yet comprehensive structure of the DSM-5 Level 1 measure may benefit a high-risk population that is less likely to seek treatment. College students have high rates of hazardous substance use and co-occurring mental health symptoms, yet rarely seek treatment. Therefore, the current study evaluated the psychometric properties (i.e., construct and criterion-related validity) of the DSM-5 Level 1 measure with a large, diverse sample of non-treatment-seeking college/university students. Data from 7,217 college students recruited from 10 universities in 10 different states across the United States evidenced psychometric validation of the DSM-5 Level 1 measure. Specifically, we found acceptable internal consistency across multi-item DSM-5 domains and moderate to strong correlations among domains (internal validity). Further, several DSM-5 domains were positively associated with longer, validated measures of the same mental health construct and had similar strengths of associations with substance use outcomes compared to longer measures of the same construct (convergent validity). Finally, all DSM-5 domains were negatively associated with self-esteem and positively associated with other theoretically relevant constructs, such as posttraumatic stress (criterion-related validity). Taken together, the DSM-5 Level 1 measure appears to be a viable tool for evaluating psychopathology in college students. Several opportunities for clinical application and empirical investigation of the DSM-5 Level 1 measure are discussed

Reducing unhealthy weight gain in children through community capacity−building: results of a quasi−experimental intervention program, Be Active Eat Well

Background:Be Active Eat Well (BAEW) was a multifaceted community capacity-building program promoting healthy eating and physical activity for children (aged 4&ndash;12 years) in the Australian town of Colac.Objective:To evaluate the effects of BAEW on reducing children\u27s unhealthy weight gain.Methods:BAEW had a quasi-experimental, longitudinal design with anthropometric and demographic data collected on Colac children in four preschools and six primary schools at baseline (2003, n=1001, response rate: 58%) and follow-up (2006, n=839, follow-up rate: 84%). The comparison sample was a stratified random selection of preschools (n=4) and primary schools (n=12) from the rest of the Barwon South Western region of Victoria, with baseline assessment in 2003&ndash;2004 (n=1183, response rate: 44%) and follow-up in 2006 (n=979, follow-up rate: 83%).Results:Colac children had significantly lower increases in body weight (mean: -0.92 kg, 95% CI: -1.74 to -0.11), waist (-3.14 cm, -5.07 to -1.22), waist/height (-0.02, -0.03 to -0.004), and body mass index z-score (-0.11, -0.21 to -0.01) than comparison children, adjusted for baseline variable, age, height, gender, duration between measurements and clustering by school. In Colac, the anthropometric changes were not related to four indicators of socioeconomic status (SES), whereas in the comparison group 19/20 such analyses showed significantly greater gains in anthropometry in children from lower SES families. Changes in underweight and attempted weight loss were no different between the groups.Conclusions:Building community capacity to promote healthy eating and physical activity appears to be a safe and effective way to reduce unhealthy weight gain in children without increasing health inequalities.<br /

Predicting Responses of Geo-ecological Carbonate Reef Systems to Climate Change: A Conceptual Model and Review

[Chapter Abstract] 230Coral reefs provide critical ecological and geomorphic (e.g. sediment production for reef-fronted shoreline maintenance) services, which interact in complex and dynamic ways. These services are under threat from climate change, requiring dynamic modelling approaches that predict how reef systems will respond to different future climate scenarios. Carbonate budgets, which estimate net reef calcium carbonate production, provide a comprehensive ‘snap-shot’ assessment of reef accretionary potential and reef stability. These budgets, however, were not intended to account for the full suite of processes that maintain coral reef services or to provide predictive capacity on longer timescales (decadal to centennial). To respond to the dual challenges of enhancing carbonate budget assessments and advancing their predictive capacity, we applied a novel model elicitation and review method to create a qualitative geo-ecological carbonate reef system model that links geomorphic, ecological and physical processes. Our approach conceptualizes relationships between net carbonate production, sediment transport and landform stability, and rates knowledge confidence to reveal major knowledge gaps and critical future research pathways. The model provides a blueprint for future coral reef research that aims to quantify net carbonate production and sediment dynamics, improving our capacity to predict responses of reefs and reef-fronted shorelines to future climate change.https://nsuworks.nova.edu/occ_facbooks/1116/thumbnail.jp