There are a number of instruments that describe severity and progression of multiple sclerosis and they are increasingly used as endpoints to assess the effectiveness of therapeutic interventions. We ...examined to what extent the psychometric properties of two accepted instruments--EDSS and MSFC--meet methodological standards and the value they have in clinical trials.
We conducted a systematic literature search in relevant databases MEDLINE (PubMed), ISI Web of Science, EMBASE, PsycINFO & PSYNDEX, CINAHL yielding 3,860 results. Relevant full-text publications were identified using abstract and then full-text reviews, and the literature was reviewed.
For evaluation of psychometric properties (validity, reliability, sensitivity of change) of EDSS and MSFC, 120 relevant full-text publications were identified, 54 of them assessed the EDSS, 26 the MSFC and 40 included both instruments. The EDSS has some documented weaknesses in reliability and sensitivity to change. The main limitations of the MSFC are learning effects and the z-scores method used to calculate the total score. However, the methodological criterion of validity applies sufficiently for both instruments.For use in clinical studies, we found the EDSS to be preferred as a primary and secondary outcome measure in recent studies (50 EDSS, 9 MSFC).
Recognizing their strengths and weaknesses, both EDSS and MSFC are suitable to detect the effectiveness of clinical interventions and to monitor disease progression. Almost all publications identify the EDSS as the most widely used tool to measure disease outcomes in clinical trials. Despite some limitations, both instruments are accepted as endpoints and neither are discussed as surrogate parameters in identified publications. A great advantage of the EDSS is its international acceptance (e.g. by EMA) as a primary endpoint in clinical trials and its broad use in trials, enabling cross-study comparisons.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Salinity is one of the most severe environmental stresses limiting agricultural crop production worldwide. Photosynthesis is one of the main biochemical processes getting affected by such stress ...conditions. Here we investigated the stomatal and non-stomatal factors during photosynthesis in two Iranian melon genotypes “Ghobadlu” and “Suski-e-Sabz”, as well as the “Galia” F1 cultivar, with an insight into better understanding the physiological mechanisms involved in the response of melon plants to increasing salinity. After plants were established in the greenhouse, they were supplied with nutrient solutions containing three salinity levels (0, 50, or 100 mM NaCl) for 15 and 30 days. With increasing salinity, almost all of the measured traits (e.g. stomatal conductance, transpiration rate, internal to ambient CO2 concentration ratio (Ci/Ca), Rubisco and nitrate reductase activity, carbon isotope discrimination (Δ13C), chlorophyll content, relative water content (RWC), etc.) significantly decreased after 15 and 30 days of treatments. In contrast, the overall mean of water use efficiency (intrinsic and instantaneous WUE), leaf abscisic acid (ABA) and flavonol contents, as well as osmotic potential (ΨS), all increased remarkably with increasing stress, across all genotypes. In addition, notable correlations were found between Δ13C and leaf gas exchange parameters as well as most of the measured traits (e.g. leaf area, biomass, RWC, ΨS, etc.), encouraging the possibility of using Δ13C as an important proxy for indirect selection of melon genotypes with higher photosynthetic capacity and higher salinity tolerance. The overall results suggest that both stomatal and non-stomatal limitations play an important role in reduced photosynthesis rate in melon genotypes studied under NaCl stress. This conclusion is supported by the concurrently increased resistance to CO2 diffusion, and lower Rubisco activity under NaCl treatments at the two sampling dates, and this was revealed by the appearance of lower Ci/Ca ratios and lower Δ13C in the leaves of salt-treated plants.
•DUALEX, an optical sensor, could be applied to assess crop nitrogen status of melon genotypes under salinity condition.•Both the NR and Rubisco activities were significantly reduced under NaCl stress.•A significant positive relationship was observed between Δ13C and Ci/Ca measured by gas exchanges in all genotypes.•Δ13C was negatively correlated with WUE and WUEi in both sampling times.•Using Δ13C would be an important proxy for selection of melon genotypes with higher photosynthetic performance.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Elevated low-density lipoprotein cholesterol (LDL-C) is a causal risk factor for cardiovascular (CV) events. European guidelines recommend reducing LDL-C as the primary lipid target to reduce CV ...risk, using lifestyle modifications and lipid-lowering therapy (LLT). Many European patients do not achieve guideline-recommended LDL-C levels. The present database analysis aimed to assess LLT treatment patterns and LDL-C threshold attainment in Germany in a large, real-world cohort of patients.
Patients from the Cegedim Longitudinal Practice Database in Germany who met selection criteria were included: (a) LDL-C measurement in 2013; (b) ≥20 years of age; (c) high or very-high CV risk conditions: recent acute coronary syndrome (ACS), other coronary heart disease (CHD), ischemic stroke, peripheral arterial disease (PAD) (atherosclerotic cardiovascular disease ASCVD) or diabetes mellitus (DM) (non-ASCVD). LDL-C threshold attainment was assessed based on LDL-C targets from 2011 European guidelines.
42,767 patients met the inclusion criteria; 35% received current statin treatment, and 30% achieved guideline-recommended LDL-C targets. Attainment of LDL-C goals among ASCVD hierarchical categories was 46.7% for recent ACS, 35.8% for ischemic stroke, 34.9% for other CHD, and 26.9% for PAD. Among patients in the non-ASCVD group with DM, 23.6% achieved LDL-C goals. Similar results were observed when patients were grouped by prevalence (patients assigned to every risk group for which they qualified).
In this high/very-high CV risk population in Germany, statin utilization was low; suggesting that LLTs are not prescribed as per European guidelines. These results highlight the need to increase LLT use among high-risk patients.
•In the study, 36.3% of high/very high CV risk patients were treated with LLT.•35.0% of patients received statin therapy and 1.3% received non-statin LLT.•Among patients receiving LLT, 13.5% achieved LDL-C <1.8 mmol/L (<70 mg/dL).•Among patients receiving LLT, 36.8% achieved LDL-C 1.8 to <2.6 mmol/L (70 to <100 mg/dL).•The findings suggest LLTs are not being used in Germany as per ESC/EAS guidelines.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, SBCE, SBJE, UL, UPCLJ, UPUK, ZRSKP
Aim of the study was to assess the incidence of statin‐associated myopathy (SAM) under real‐life conditions in Germany. Database: Administrative data (master data, diagnoses, prescriptions) for all ...individuals in Germany insured with the Statutory Health Insurance. Basic population: individuals 18 years and older who have been insured continually from 2009 to 2011 (52.9 million; 29.9 million men, 23.9 million women). Data access is provided by the German Institute of Medical Documentation and Information, DIMDI) according to the Data Transparency Regulation of 2012. Statins: identification with the ATC–Codes: C10AA, C10BA and C10BX. Study population: incident statin users in 2010 with a diagnosis of lipid disorders (ICD‐10‐GM E78, excluding patients with: E78.1, E78.3, E78.6 in eight quarters before index prescription. Definition of SAM: documentation of myopathy (ICD‐10‐GM G72.0, G72.8; G72.9, M60.8, M60.9, M79.1) in the first statin prescription quarter or in one of the three following quarters. The first event is considered for the incidence estimate. The daily doses included in a package were classified as “days under therapy” (by assuming one DDD) and taken as exposition time. SAM was found in 1.9% of 531 672 incident statin users. The percentage differs according to the patterns of statin use: the lowest incidence is observed in those with only one prescription (1.3%), the highest incidence with 5.0% is observed in those who not only stopped the treatment within 365 days, but who also had their statin changed. Administrative data including diagnoses from ambulatory care provide a realistic estimate of SAM frequency in every day practice.
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FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Triticale is currently grown throughout the world with a wider diffusion in Europe, with Poland, Belarus, Germany, France and Spain as major producers. Although triticale occupies a very small ...fraction of the Italian cultivated land (16,000 ha of harvested area, mean value of the past 5 years), a continuous interest for this crop and its possible uses explains the work and progress made by breeding activities in different periods. The aim of this review is to report some experiences related to the cultivation of triticale in Italy. A general long-term view of the performance of triticale varieties in Italy has been distilled from a large amount of data derived from the pluri-decennial Italian national variety trials network. This activity, historically coordinated by CREA-GB, extends over several decades and examines the agronomic performance, in different Italian environments, of the most widespread and emerging varieties of triticale. Indications on new breeding targets can be deduced from the elaborations in the frame of both climatic change and market demands.
Handwriting learning disabilities, such as dysgraphia, have a serious negative impact on children's academic results, daily life and overall well-being. Early detection of dysgraphia facilitates an ...early start of targeted intervention. Several studies have investigated dysgraphia detection using machine learning algorithms with a digital tablet. However, these studies deployed classical machine learning algorithms with manual feature extraction and selection as well as binary classification: either dysgraphia or no dysgraphia. In this work, we investigated the fine grading of handwriting capabilities by predicting the SEMS score (between 0 and 12) with deep learning. Our approach provided a root-mean-square error of less than 1 with automatic instead of manual feature extraction and selection. Furthermore, the SensoGrip smart pen SensoGrip was used, i.e., a pen equipped with sensors to capture handwriting dynamics, instead of a tablet, enabling writing evaluation in more realistic scenarios.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Regarding the care of older adults, 24-h home-care represents a cornerstone, with > 32,000 service users in Austria. Our research project 24hQuAALity aimed to develop and evaluate a distributed ...client-server software solution for the support and quality assurance of this home-care service. In this trial, we investigated the effects of this intervention on the quality of life and professional skills of paid 24h-caregivers in Austria.
The application used in our study comprises an e-learning platform, an integrated emergency management, networking opportunities, and an electronic care documentation system in the native language of the 24h-caregivers. The trial was conducted using a parallel three-arm study design to evaluate (i) a control group, which performed usual home care, (ii) a partial intervention group, which used the e-learning and networking platforms, and (iii) a full intervention group, which used the entire intervention (e-learning platform, networking platform, and digital care documentation). Primary self-reported outcomes were the standardized ASCOT for Carers score and a score based on responses to project-specific efficacy questions.
Among the 110 24h-caregivers who were randomly classified into the three groups, ASCOT for Carers score data were available for 57 and 35 24h-caregivers at 5- and 9-month follow-up examinations, respectively. At 9 months, 24h-caregivers receiving any intervention rated the ASCOT for Carers score (not significantly) better than the controls (p = 0.05, η
= 0.15), mainly in the domain "feeling encouraged and supported". At 9 months, 24h-caregivers receiving any intervention rated the project-specific Efficacy score significantly better than the controls (p = 0.02, η
= 0.20), mainly due to better ratings in the subitems "satisfaction with current docu", "docu supports doing my job", " I'm well prepared for emergencies", "my professional skills are adequate for doing my job", and "communication with contacts".
Providing e-learning and e-documentation devices to 24h-caregivers improved their care-related quality of life, mainly because they felt more encouraged and supported. Moreover, these interventions improved their self-perceived professional skills. As an extrapolation of findings, we found that these interventions could empower 24h-caregivers and improve the quality of home-care services provided by them.
Digital Support for Quality Assurance in 24-h Caregiving at Home was registered and posted on the ClinicalTrials.gov public website (ClinicalTrials.gov Identifier: NCT04581538).
► Comparison of water use efficiency (WUE) of two durum wheat cultivars. ► The old cultivar Cappelli has higher WUE than the modern cultivar Ofanto. ► Differences are constitutive, persist throughout ...all growth stages. ► Higher WUE is associated with lower stomatal conductance. ► Identification of fast phenotyping methods for studies on the segregating population.
This work was focused on the physiological analysis of the response to water availability in two durum wheat (
Triticum turgidum var.
durum) parents of a mapping population, Cappelli and Ofanto, representing an old and a modern cultivar, respectively. We investigated if the two parents are constitutively different for traits related to water use efficiency (
WUE), a key step to prepare further studies on the large segregating population. Integrated
WUE, as recorded by grain
δ
13C, was studied in a 3-year field experiment conducted at Foggia (southern Italy) under irrigated and non-irrigated conditions. A growth chamber experiment was carried out to analyse the cultivars, at leaf and whole plant level in the vegetative growth phase under well watered and drought conditions. All measures consistently showed a higher
WUE of the variety Cappelli than Ofanto. This trait was associated with lower stomatal conductance over a range of relative soil water contents tested in the growth chamber experiment. Carbon isotope discrimination (
CID) was confirmed as useful indicator of
WUE when measured in grains harvested in the field trials. In addition, the consistent results obtained by
CID analysis in the vegetative organs harvested in the growth chamber experiment, can facilitate the development of opportune phenotying approaches that, in perspective, can be employed for high sample numbers, as required for studies of the segregating population. Traits related to growth and biomass allocation in the map parents, indicative of different adaptive strategies for resource use of Cappelli and Ofanto, were also analysed.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
A new methodology was developed for the synthesis of enantiomerically enriched 3,3-disubstituted 3-chlorooxindoles 3 via a Michael addition of 3-chloroxindoles to nitroolefins 2, catalyzed by chiral ...squaramide 10. Products with adjacent quaternary–tertiary centers were isolated in excellent yields (up to 99%), high diastereoselectivities (up to 11:1), and enantiomeric purities (up to 92%). This is the first example where 3-chloroxoindoles 1 have been used as nucleophiles in a highly stereoselective organocatalytic reaction.
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IJS, KILJ, NUK, PNG, UL, UM
Abstract Aims To investigate the frequency and predictors (diabetes care and treatment, comorbidity) of documented hypoglycaemia in primary care patients with insulin-treated type 2 diabetes. Methods ...Data from 32,545 patients (mean age: 70 (SD 11) years, 50.3% males) from 1072 practices were retrospectively analyzed (Disease Analyzer database Germany: 09/2011–08/2012). Logistic regression (≥1 documented hypoglyemia) was used to adjust for confounders (age, sex, practice characteristics, diabetes treatment regimen). Results The prevalence of patients (12 months) with at least one reported hypoglycaemia was 2.2% (95% CI: 2.0–2.4%). The adjusted odds of having hypoglycemia were increased for renal failure (OR; 95% CI: 1.26; 1.16–1.37), autonomic neuropathy (1.34; 1.20–1.49), and adrenocortical insufficiency (3.08; 1.35–7.05). Patients with mental disorders including dementia (1.49; 1.31–1.69), depression (1.24; 1.13–1.35), anxiety (1.18; 1.01–1.37), and affective disorders (1.80; 1.36–2.38) also showed an increased odds of having hypoglycemia. Location of the practice in an urban area was associated with a lower odds ratio (0.74; 0.68–0.80). Conclusions Both individual patient characteristics (e.g. comorbidity) and regional factors (practice location) have a substantial impact on hypoglycaemia in primary care patients with insulin therapy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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