Co-production in distributed generation:Renewable energy and creating space for fitting infrastructure within landscapes

This review describes the infrastructural elements of the socio-technical system of power supply based on renewables and the role of landscape concerns in decision-making about emerging ‘intelligent grids’. The considerable land areas required for energy infrastructure call for sizable ‘distributed generation’ close to energy consumption. Securing community acceptance of renewables’ infrastructure, perceived impacts on the community, and ‘landscape justice’ requires two types of co-production: in power supply and in making space available. With co-production, landscape issues are prominent, for some options dominant. However, ‘objectification’ of landscape, such as the use of ‘visibility’ as proxy for ‘visual impact’, is part of lingering centralised and hierarchical approaches to the deployment of renewables. Institutional tendencies of centralisation and hierarchy, in power supply management as well as in siting, should be replaced by co-production, as follows from common pool resources theory. Co-production is the key to respecting landscape values, furthering justice, and achieving community acceptance

Subclinical giant cell arteritis in new onset polymyalgia rheumatica:A systematic review and meta-analysis of individual patient data

Objectives: To determine the prevalence and predictors of subclinical giant cell arteritis (GCA) in patients with newly diagnosed polymyalgia rheumatica (PMR). Methods: PubMed, Embase, and Web of Science Core Collection were systematically searched (date of last search July 14, 2021) for any published information on any consecutively recruited cohort reporting the prevalence of GCA in steroid-naïve patients with PMR without cranial or ischemic symptoms. We combined prevalences across populations in a random-effect meta-analysis. Potential predictors of subclinical GCA were identified by mixed-effect logistic regression using individual patient data (IPD) from cohorts screened with PET/(CT). Results: We included 13 cohorts with 566 patients from studies published between 1965 to 2020. Subclinical GCA was diagnosed by temporal artery biopsy in three studies, ultrasound in three studies, and PET/(CT) in seven studies. The pooled prevalence of subclinical GCA across all studies was 23% (95% CI 14%-36%, I2=84%) for any screening method and 29% in the studies using PET/(CT) (95% CI 13%-53%, I2=85%) (n=266 patients). For seven cohorts we obtained IPD for 243 patients screened with PET/(CT). Inflammatory back pain (OR 2.73, 1.32-5.64), absence of lower limb pain (OR 2.35, 1.05-5.26), female sex (OR 2.31, 1.17-4.58), temperature >37° (OR 1.83, 0.90-3.71), weight loss (OR 1.83, 0.96-3.51), thrombocyte count (OR 1.51, 1.05-2.18), and haemoglobin level (OR 0.80, 0.64-1.00) were most strongly associated with subclinical GCA in the univariable analysis but not C-reactive protein (OR 1.00, 1.00-1.01) or erythrocyte sedimentation rate (OR 1.01, 1.00-1.02). A prediction model calculated from these variables had an area under the curve of 0.66 (95% CI 0.55-0.75). Conclusion: More than a quarter of patients with PMR may have subclinical GCA. The prediction model from the most extensive IPD set has only modest diagnostic accuracy. Hence, a paradigm shift in the assessment of PMR patients in favour of implementing imaging studies should be discussed

Premature Discontinuation of Pediatric Randomized Controlled Trials : A Retrospective Cohort Study

Objectives To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs. Study design A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists. Results We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants). Conclusion Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.Peer reviewe

Effects of Nutrient Management Scenarios on Marine Eutrophication Indicators: A Pan-European, Multi-Model Assessment in Support of the Marine Strategy Framework Directive

A novel pan-European marine model ensemble was established, covering nearly all seas under the regulation of the Marine Strategy Framework Directive (MSFD), with the aim of providing a consistent assessment of the potential impacts of riverine nutrient reduction scenarios on marine eutrophication indicators. For each sea region, up to five coupled biogeochemical models from institutes all over Europe were brought together for the first time. All model systems followed a harmonised scenario approach and ran two simulations, which varied only in the riverine nutrient inputs. The load reductions were evaluated with the catchment model GREEN and represented the impacts due to improved management of agriculture and wastewater treatment in all European river systems. The model ensemble, comprising 15 members, was used to assess changes to the core eutrophication indicators as defined within MSFD Descriptor 5. In nearly all marine regions, riverine load reductions led to reduced nutrient concentrations in the marine environment. However, regionally the nutrient input reductions led to an increase in the non-limiting nutrient in the water, especially in the case of phosphate concentrations in the Black Sea. Further core eutrophication indicators, such as chlorophyll-a, bottom oxygen and the Trophic Index TRIX, improved nearly everywhere, but the changes were less pronounced than for the inorganic nutrients. The model ensemble displayed strong consistency and robustness, as most if not all models indicated improvements in the same areas. There were substantial differences between the individual seas in the speed of response to the reduced nutrient loads. In the North Sea ensemble, a stable plateau was reached after only three years, while the simulation period of eight years was too short to obtain steady model results in the Baltic Sea. The ensemble exercise confirmed the importance of improved management of agriculture and wastewater treatments in the river catchments to reduce marine eutrophication. Several shortcomings were identified, the outcome of different approaches to compute the mean change was estimated and potential improvements are discussed to enhance policy support. Applying a model ensemble enabled us to obtain highly robust and consistent model results, substantially decreasing uncertainties in the scenario outcom

Deriving pre-eutrophic conditions from an ensemble model approach for the North-West European seas

The pre-eutrophic state of marine waters is generally not well known, complicating target setting for management measures to combat eutrophication. We present results from an OSPAR ICG-EMO model assessment to simulate the pre-eutrophic state of North-East Atlantic marine waters. Using an ecosystem model ensemble combined with an observation-based weighting method we derive sophisticated estimates for key eutrophication indicators. Eight modelling centres applied the same riverine nutrient loads, atmospheric nutrient deposition rates and boundary conditions to their specific model set-up to ensure comparability. The pre-eutrophic state was defined as a historic scenario of estimated nutrient inputs (riverine, atmospheric) at around the year 1900, before the invention and widespread use of industrial fertilizers. The period 2009-2014 was used by all participants to simulate both the current state of eutrophication and the pre-eutrophic scenario, to ensure that differences are solely due to the changes in nutrient inputs between the scenarios. Mean values were reported for winter dissolved inorganic nutrients and total nutrients (nitrogen, phosphorus) and the nitrogen to phosphorus ratio, and for growing season chlorophyll, chlorophyll 90th percentile, near-bed oxygen minimum and net phytoplankton production on the level of the OSPAR assessment areas. Results showed distinctly lower nutrient concentrations and nitrogen to phosphorus ratio’s in coastal areas under pre-eutrophic conditions compared to current conditions (except in the Meuse Plume and Seine Plume areas). Chlorophyll concentrations were estimated to be as much as ~40% lower in some areas, as were dissolved inorganic phosphorus levels. Dissolved inorganic nitrogen levels were found to be up to 60% lower in certain assessment areas. The weighted average approach reduced model disparities, and delivered pre-eutrophic concentrations in each assessment area. Our results open the possibility to establish reference values for indicators of eutrophication across marine regions. The use of the new assessment areas ensures local ecosystem functioning is better represented while political boundaries are largely ignored. As such, the reference values are less associated to member states boundaries than to ecosystem boundaries

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study).

BACKGROUND: Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. METHODS/DESIGN: Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs.We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. DISCUSSION: Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements