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BACKGROUND: Real world data have an important role to play in the evaluation of epidemiology and burden of disease; and in assisting health-care decision-makers, especially related to coverage and payment decisions. However, there is currently no overview of the existing longitudinal real world data sources in Parkinson's disease (PD) in the USA. Such an assessment can be very helpful, to support a future effort to harmonize real world data collection and use the available resources in an optimal way. METHODS: The objective of this comprehensive literature review is to systematically identify and describe the longitudinal, real world data sources in PD in the USA, and to provide a summary of their measurements (categorized into 8 main dimensions: motor and neurological functions, cognition, psychiatry, activities of daily living, sleep, quality of life, autonomic symptoms and other). The literature search was performed using MEDLINE, EMBASE and internet key word search. RESULTS: Of the 53 data sources identified between May and August 2016, 16 were still ongoing. Current medications (81%) and comorbidities (79%) were frequently collected, in comparison to medical imaging (36%), genetic information (30%), caregiver burden (11%) and healthcare costs (2%). Many different measurements (n = 108) were performed and an interesting variability among used measurements was revealed. CONCLUSIONS: Many longitudinal real world data sources on PD exist. Different types of measurements have been performed over time. To allow comparison and pooling of these multiple data sources, it will be essential to harmonize practices in terms of types of measurements.
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Conjuntos de Datos como Asunto , Enfermedad de Parkinson , HumanosRESUMEN
BACKGROUND: Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. METHODS: In this randomised, double-blind, controlled trial, we recruited patients aged 18-60 years with severe and medically refractory Tourette's syndrome from eight hospitals specialised in movement disorders in France. Enrolled patients received surgery to implant bilateral electrodes for aGPi DBS; 3 months later they were randomly assigned (1:1 ratio with a block size of eight; computer-generated pairwise randomisation according to order of enrolment) to receive either active or sham stimulation for the subsequent 3 months in a double-blind fashion. All patients then received open-label active stimulation for the subsequent 6 months. Patients and clinicians assessing outcomes were masked to treatment allocation; an unmasked clinician was responsible for stimulation parameter programming, with intensity set below the side-effect threshold. The primary endpoint was difference in Yale Global Tic Severity Scale (YGTSS) score between the beginning and end of the 3 month double-blind period, as assessed with a Mann-Whitney-Wilcoxon test in all randomly allocated patients who received active or sham stimulation during the double-blind period. We assessed safety in all patients who were enrolled and received surgery for aGPi DBS. This trial is registered with ClinicalTrials.gov, number NCT00478842. FINDINGS: Between Dec 6, 2007, and Dec 13, 2012, we enrolled 19 patients. We randomly assigned 17 (89%) patients, with 16 completing blinded assessments (seven [44%] in the active stimulation group and nine [56%] in the sham stimulation group). We noted no significant difference in YGTSS score change between the beginning and the end of the 3 month double-blind period between groups (active group median YGTSS score 68·5 [IQR 34·0 to 83·5] at the beginning and 62·5 [51·5 to 72·0] at the end, median change 1·1% [IQR -23·9 to 38·1]; sham group 73·0 [69·0 to 79·0] and 79·0 [59·0 to 81·5], median change 0·0% [-10·6 to 4·8]; p=0·39). 15 serious adverse events (three in patients who withdrew before stimulation and six each in the active and sham stimulation groups) occurred in 13 patients (three who withdrew before randomisation, four in the active group, and six in the sham group), with infections in DBS hardware in four patients (two who withdrew before randomisation, one in the sham stimulation group, and one in the active stimulation group). Other serious adverse events included one electrode misplacement (active stimulation group), one episode of depressive signs (active stimulation group), and three episodes of increased tic severity and anxiety (two in the sham stimulation group and one in the active stimulation group). INTERPRETATION: 3 months of aGPi DBS is insufficient to decrease tic severity for patients with Tourette's syndrome. Future research is needed to investigate the efficacy of aGPi DBS for patients over longer periods with optimal stimulation parameters and to identify potential predictors of the therapeutic response. FUNDING: French Ministry of Health.
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Estimulación Encefálica Profunda/efectos adversos , Globo Pálido , Evaluación de Resultado en la Atención de Salud , Índice de Severidad de la Enfermedad , Síndrome de Tourette/terapia , Adulto , Estimulación Encefálica Profunda/métodos , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Insuficiencia del Tratamiento , Adulto JovenRESUMEN
Waste recovery is an integrated part of municipal solid waste management systems but its strategic planning is still challenging. In particular, the service area size of facilities is a sensitive issue since its calculation depends on various factors related to treatment technologies (output products) and territorial features (sources waste production and location). This work presents a systemic approach for the estimation of a chain's service area size, based on a balance between costs and recovery profits. The model assigns a recovery performance value to each source, which can be positive, neutral or negative. If it is positive, the source should be included in the facility's service area. Applied to the case of Montreal for food waste recovery by anaerobic digestion, the approach showed that at most 23 out of the 30 districts should be included in the service area, depending on the indicator, which represents around 127,000 t of waste recovered/year. Due to the systemic approach, these districts were not necessarily the closest to the facility. Moreover, for the Montreal case, changing the facility's location did not have a great influence on the optimal service area size, showing that the distance to the facility was not a decisive factor at this scale. However, replacing anaerobic digestion by a composting plant reduced the break-even transport distances and, thus, the number of sources worth collecting (around 68,500 t/year). In this way, the methodology, applied to different management strategies, gave a sense of the spatial dynamics involved in the recovery chain's design. The map of optimal supply obtained could be used to further analyse the feasibility of multi-site and/or multi-technology systems for the territory considered.
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Eliminación de Residuos , Residuos Sólidos , Administración de Residuos/economía , Costos y Análisis de CostoRESUMEN
The design of waste management systems rarely accounts for the spatio-temporal evolution of the demand. However, recent studies suggest that this evolution affects the planning of waste management activities like the choice and location of treatment facilities. As a result, the transport structure could also be affected by these changes. The objective of this paper is to study the influence of the spatio-temporal evolution of the demand on the strategic planning of a waste transport structure. More particularly this study aims at evaluating the effect of varying spatial parameters on the economic performance of hierarchical structures (with one transfer station). To this end, three consecutive generations of three different spatial distributions were tested for hierarchical and non-hierarchical transport structures based on costs minimization. Results showed that a hierarchical structure is economically viable for large and clustered spatial distributions. The distance parameter was decisive but the loading ratio of trucks and the formation of clusters of sources also impacted the attractiveness of the transfer station. Thus the territories' morphology should influence strategies as regards to the installation of transfer stations. The use of spatial-explicit tools such as the transport model presented in this work that take into account the territory's evolution are needed to help waste managers in the strategic planning of waste transport structures.