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Transition road maps – an investigative approach to map the daily life consumption of individuals
(2014)
The present paper aims at investigating an innovative approach to guide consumers’ daily life choices in Germany towards a more sustainable way of acting. This should be achieved by introducing a new concept: transition road maps. Transition road maps bear the capability of illustrating courses of consumption behaviour without being prohibitive. These schemes foster self-determined behaviour and encourage the consumer to rethink and restructure his or her habits of consumption, with a focus on sustainability. The innovative thought is, not to simply stick to the usual triad of spheres of activity, consisting of nutrition, mobility and housing. Instead further aspects of consumers’ daily routines are considered, such as leisure activities, time usage or financial activities. Moreover the transition road maps are based on a new ideology of combining and connecting the qualitative algorithm of time use, financial spending and resource impact of social practices in the area of private consumption. In the long-term, the transition road maps could e.g. be used in sustainability communication or consumer counselling.
Background:
Etomidate is typically used as an induction agent in cardiac surgery because it has little impact on hemodynamics. It is a known suppressor of adrenocortical function and may increase the risk for post-operative infections, sepsis, and mortality. The aim of this study was to evaluate whether etomidate increases the risk of postoperative sepsis (primary outcome) and infections (secondary outcome) compared to propofol.
Methods:
This was a retrospective before–after trial (IRB EA1/143/20) performed at a tertiary medical center in Berlin, Germany, between 10/2012 and 01/2015. Patients undergoing cardiac surgery were investigated within two observation intervals, during which etomidate and propofol were the sole induction agents.
Results:
One-thousand, four-hundred, and sixty-two patients, and 622 matched pairs, after caliper propensity-score matching, were included in the final analysis. Sepsis rates did not differ in the matched cohort (etomidate: 11.5% vs. propofol: 8.2%, p = 0.052). Patients in the etomidate interval were more likely to develop hospital-acquired pneumonia (etomidate: 18.6% vs. propofol: 14.0%, p = 0.031).
Conclusion:
Our study showed that a single-dose of etomidate is not statistically associated with higher postoperative sepsis rates after cardiac surgery, but is associated with a higher incidence of hospital-acquired pneumonia. However, there is a notable trend towards a higher sepsis rate.
Background:
Cardiac surgery patients represent a high-risk cohort in intensive care units (ICUs). Central venous pressure (CVP) measurement seems to remain an integral part in hemodynamic monitoring, especially in cardio-surgical ICUs. However, its value as a prognostic marker for organ failure is still unclear. Therefore, we analyzed postoperative CVP values after adult cardiac surgery in a large cohort with regard to its prognostic value for morbidity and mortality.
Methods:
All adult patients admitted to our ICUs between 2006 and 2019 after cardiac surgery were eligible for inclusion in the study (n = 11,198). We calculated the median initial CVP (miCVP) after admission to the ICU, which returned valid values for 9802 patients. An ROC curve analysis for optimal cut-off miCVP to predict ICU mortality was conducted with consecutive patient allocation into a (a) low miCVP (LCVP) group (≤11 mmHg) and (b) high miCVP (HCVP) group (>11 mmHg). We analyzed the impact of high miCVP on morbidity and mortality by propensity score matching (PSM) and logistic regression.
Results:
ICU mortality was increased in HCVP patients. In addition, patients in the HCVP group required longer mechanical ventilation, had a higher incidence of acute kidney injury, were more frequently treated with renal replacement therapy, and showed a higher risk for postoperative liver dysfunction, parametrized by a postoperative rise of ≥ 10 in MELD Score. Multiple regression analysis confirmed HCVP has an effect on postoperative ICU-mortality and intrahospital mortality, which seems to be independent.
Conclusions:
A high initial CVP in the early postoperative ICU course after cardiac surgery is associated with worse patient outcome. Whether or not CVP, as a readily and constantly available hemodynamic parameter, should promote clinical efforts regarding diagnostics and/or treatment, warrants further investigations.
Preoperative medication use and development of postoperative delirium and cognitive dysfunction
(2021)
Postoperative delirium (POD) and postoperative (neuro-)cognitive disorder (POCD) are frequent and serious complications after operations. We aim to investigate the association between pre-operative polypharmacy and potentially inappropriate medications and the development of POD/POCD in elderly patients. This investigation is part of the European BioCog project (www.biocog.eu), a prospective multicenter observational study with elderly surgical patients. Patients with a Mini-Mental State Examination score less than or equal to 23 points were excluded. POD was assessed up to 7 days after surgery using the Nursing Delirium Screening Scale, Confusion Assessment Method (for the intensive care unit [ICU]), and a patient chart review. POCD was assessed 3 months after surgery with a neuropsychological test battery. Pre-operative long-term medication was evaluated in terms of polypharmacy (≥5 agents) and potentially inappropriate medication (defined by the PRISCUS and European list of potentially inappropriate medications [EU(7)-PIM] lists), and associations with POD and POCD were analyzed using logistic regression analysis. Eight hundred thirty-seven participants were included for analysis of POD and 562 participants for POCD. Of these, 165 patients (19.7%) fulfilled the criteria of POD and 60 (10.7%) for POCD. After adjusting for confounders, pre-operative polypharmacy and intake of potentially inappropriate medications could not be shown to be associated with the development of POD nor POCD. We found no associations between pre-operative polypharmacy and potentially inappropriate medications and development of POD and POCD. Future studies should focus on the evaluation of drug interactions to determine whether patients benefit from a pre-operative adjustment.
The benzodiazepine, midazolam, is one of the most frequently used sedatives in intensive care medicine, but it has an unfavorable pharmacokinetic profile when continuously applied. As a consequence, patients are frequently prolonged and more deeply sedated than intended. Due to its distinct pharmacological features, including a cytochrome P450-independent metabolization, intravenous lormetazepam might be clinically advantageous compared to midazolam. In this retrospective cohort study, we compared patients who received either intravenous lormetazepam or midazolam with respect to their survival and sedation characteristics. The cohort included 3314 mechanically ventilated, critically ill patients that received one of the two drugs in a tertiary medical center in Germany between 2006 and 2018. A Cox proportional hazards model with mortality as outcome and APACHE II, age, gender, and admission mode as covariates revealed a hazard ratio of 1.75 [95% CI 1.46–2.09; p < 0.001] for in-hospital mortality associated with the use of midazolam. After additionally adjusting for sedation intensity, the HR became 1.04 [95% CI 0.83–1.31; p = 0.97]. Thus, we concluded that excessive sedation occurs more frequently in critically ill patients treated with midazolam than in patients treated with lormetazepam. These findings require further investigation in prospective trials to assess if lormetazepam, due to its ability to maintain light sedation, might be favorable over other benzodiazepines for sedation in the ICU.
Objective:
The cervical mucus plugs are enriched with proteins of known immunological functions. We aimed to characterize the anti-HIV-1 activity of the cervical mucus plugs against a panel of different HIV-1 strains in the contexts of cell-free and cell-associated virus.
Design:
A cohort of consenting HIV-1-negative and HIV-1-positive pregnant women in labour was recruited from Mthatha General Hospital in the Eastern Cape province of South Africa, from whom the cervical mucus plugs were collected in 6 M guanidinium chloride with protease inhibitors and transported to our laboratories at −80 °C.
Methods:
Samples were centrifuged to remove insoluble material and dialysed before freeze--drying and subjecting them to the cell viability assays. The antiviral activities of the samples were studied using luminometric reporter assays and flow cytometry. Time-of-addition and BlaM-Vpr virus-cell fusion assays were used to pin-point the antiviral mechanisms of the cervical mucus plugs, before proteomic profiling using liquid chromatography-tandem mass spectrometry.
Results:
The proteinaceous fraction of the cervical mucus plugs exhibited anti-HIV-1 activity with inter-individual variations and some degree of specificity among different HIV-1 strains. Cell-associated HIV-1 was less susceptible to inhibition by the potent samples whenever compared with the cell-free HIV-1. The samples with high antiviral potency exhibited a distinct proteomic profile when compared with the less potent samples.
Conclusion:
The crude cervical mucus plugs exhibit anti-HIV-1 activity, which is defined by a specific proteomic profile.
Background
In DNA methylation analyses like epigenome-wide association studies, effects in differentially methylated CpG sites are assessed. Two kinds of outcomes can be used for statistical analysis: Beta-values and M-values. M-values follow a normal distribution and help to detect differentially methylated CpG sites. As biological effect measures, differences of M-values are more or less meaningless. Beta-values are of more interest since they can be interpreted directly as differences in percentage of DNA methylation at a given CpG site, but they have poor statistical properties. Different frameworks are proposed for reporting estimands in DNA methylation analysis, relying on Beta-values, M-values, or both.
Results
We present and discuss four possible approaches of achieving estimands in DNA methylation analysis. In addition, we present the usage of M-values or Beta-values in the context of bioinformatical pipelines, which often demand a predefined outcome. We show the dependencies between the differences in M-values to differences in Beta-values in two data simulations: a analysis with and without confounder effect. Without present confounder effects, M-values can be used for the statistical analysis and Beta-values statistics for the reporting. If confounder effects exist, we demonstrate the deviations and correct the effects by the intercept method. Finally, we demonstrate the theoretical problem on two large human genome-wide DNA methylation datasets to verify the results.
Conclusions
The usage of M-values in the analysis of DNA methylation data will produce effect estimates, which cannot be biologically interpreted. The parallel usage of Beta-value statistics ignores possible confounder effects and can therefore not be recommended. Hence, if the differences in Beta-values are the focus of the study, the intercept method is recommendable. Hyper- or hypomethylated CpG sites must then be carefully evaluated. If an exploratory analysis of possible CpG sites is the aim of the study, M-values can be used for inference.
BACKGROUND:
Intraoperative electroencephalography (EEG) signatures related to the development of postoperative delirium (POD) in older patients are frequently studied. However, a broad analysis of the EEG dynamics including preoperative, postinduction, intraoperative and postoperative scenarios and its correlation to POD development is still lacking. We explored the relationship between perioperative EEG spectra-derived parameters and POD development, aiming to ascertain the diagnostic utility of these parameters to detect patients developing POD.
METHODS:
Patients aged ≥65 years undergoing elective surgeries that were expected to last more than 60 minutes were included in this prospective, observational single center study (Biomarker Development for Postoperative Cognitive Impairment [BioCog] study). Frontal EEGs were recorded, starting before induction of anesthesia and lasting until recovery of consciousness. EEG data were analyzed based on raw EEG files and downloaded excel data files. We performed multitaper spectral analyses of relevant EEG epochs and further used multitaper spectral estimate to calculate a corresponding spectral parameter. POD assessments were performed twice daily up to the seventh postoperative day. Our primary aim was to analyze the relation between the perioperative spectral edge frequency (SEF) and the development of POD.
RESULTS:
Of the 237 included patients, 41 (17%) patients developed POD. The preoperative EEG in POD patients was associated with lower values in both SEF (POD 13.1 ± 4.6 Hz versus no postoperative delirium [NoPOD] 17.4 ± 6.9 Hz; P = .002) and corresponding γ-band power (POD −24.33 ± 2.8 dB versus NoPOD −17.9 ± 4.81 dB), as well as reduced postinduction absolute α-band power (POD −7.37 ± 4.52 dB versus NoPOD −5 ± 5.03 dB). The ratio of SEF from the preoperative to postinduction state (SEF ratio) was ~1 in POD patients, whereas NoPOD patients showed a SEF ratio >1, thus indicating a slowing of EEG with loss of unconscious. Preoperative SEF, preoperative γ-band power, and SEF ratio were independently associated with POD (P = .025; odds ratio [OR] = 0.892, 95% confidence interval [CI], 0.808–0.986; P = .029; OR = 0.568, 95% CI, 0.342–0.944; and P = .009; OR = 0.108, 95% CI, 0.021–0.568, respectively).
CONCLUSIONS:
Lower preoperative SEF, absence of slowing in EEG while transitioning from preoperative state to unconscious state, and lower EEG power in relevant frequency bands in both these states are related to POD development. These findings may suggest an underlying pathophysiology and might be used as EEG-based marker for early identification of patients at risk to develop POD.
Background
Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are frequent and serious complications after surgery. We aim to investigate the association between genetic variants in cholinergic candidate genes according to the Kyoto encyclopedia of genes and genomes - pathway: cholinergic neurotransmission with the development of POD or POCD in elderly patients.
Methods
This analysis is part of the European BioCog project (www.biocog.eu), a prospective multicenter observational study with elderly surgical patients. Patients with a Mini-Mental-State-Examination score ≤ 23 points were excluded. POD was assessed up to seven days after surgery using the Nursing Delirium Screening Scale, Confusion Assessment Method and a patient chart review. POCD was assessed three months after surgery with a neuropsychological test battery. Genotyping was performed on the Illumina Infinium Global Screening Array. Associations with POD and POCD were analyzed using logistic regression analysis, adjusted for age, comorbidities and duration of anesthesia (for POCD analysis additionally for education). Odds ratios (OR) refer to minor allele counts (0, 1, 2).
Results
745 patients could be included in the POD analysis, and 452 in the POCD analysis. The rate of POD within this group was 20.8% (155 patients), and the rate of POCD was 10.2% (46 patients). In a candidate gene approach three genetic variants of the cholinergic genes CHRM2 and CHRM4 were associated with POD (OR [95% confidence interval], rs8191992: 0.61[0.46; 0.80]; rs8191992: 1.60[1.22; 2.09]; rs2067482: 1.64[1.10; 2.44]). No associations were found for POCD.
Conclusions
We found an association between genetic variants of CHRM2 and CHRM4 and POD. Further studies are needed to investigate whether disturbances in acetylcholine release and synaptic plasticity are involved in the development of POD.
Background
In mucosal barrier interfaces, flexible responses of gene expression to long-term environmental changes allow adaptation and fine-tuning for the balance of host defense and uncontrolled not-resolving inflammation. Epigenetic modifications of the chromatin confer plasticity to the genetic information and give insight into how tissues use the genetic information to adapt to environmental factors. The oral mucosa is particularly exposed to environmental stressors such as a variable microbiota. Likewise, persistent oral inflammation is the most important intrinsic risk factor for the oral inflammatory disease periodontitis and has strong potential to alter DNA-methylation patterns. The aim of the current study was to identify epigenetic changes of the oral masticatory mucosa in response to long-term inflammation that resulted in periodontitis.
Methods and results
Genome-wide CpG methylation of both inflamed and clinically uninflamed solid gingival tissue biopsies of 60 periodontitis cases was analyzed using the Infinium MethylationEPIC BeadChip. We validated and performed cell-type deconvolution for infiltrated immune cells using the EpiDish algorithm. Effect sizes of DMPs in gingival epithelial and fibroblast cells were estimated and adjusted for confounding factors using our recently developed “intercept-method”. In the current EWAS, we identified various genes that showed significantly different methylation between periodontitis-inflamed and uninflamed oral mucosa in periodontitis patients. The strongest differences were observed for genes with roles in wound healing (ROBO2, PTP4A3), cell adhesion (LPXN) and innate immune response (CCL26, DNAJC1, BPI). Enrichment analyses implied a role of epigenetic changes for vesicle trafficking gene sets.
Conclusions
Our results imply specific adaptations of the oral mucosa to a persistent inflammatory environment that involve wound repair, barrier integrity, and innate immune defense.
A comparison study on modeling of clustered and overdispersed count data for multiple comparisons
(2021)
Data collected in various scientific fields are count data. One way to analyze such data is to compare the individual levels of the factor treatment using multiple comparisons. However, the measured individuals are often clustered – e.g. according to litter or rearing. This must be considered when estimating the parameters by a repeated measurement model. In addition, ignoring the overdispersion to which count data is prone leads to an increase of the type one error rate. We carry out simulation studies using several different data settings and compare different multiple contrast tests with parameter estimates from generalized estimation equations and generalized linear mixed models in order to observe coverage and rejection probabilities. We generate overdispersed, clustered count data in small samples as can be observed in many biological settings. We have found that the generalized estimation equations outperform generalized linear mixed models if the variance-sandwich estimator is correctly specified. Furthermore, generalized linear mixed models show problems with the convergence rate under certain data settings, but there are model implementations with lower implications exists. Finally, we use an example of genetic data to demonstrate the application of the multiple contrast test and the problems of ignoring strong overdispersion.
Objectives: To measure and assess the economic impact of adherence to a single quality indicator (QI) regarding weaning from invasive ventilation.
Design: Retrospective observational single-centre study, based on electronic medical and administrative records.
Setting: Intensive care unit (ICU) of a German university hospital, reference centre for acute respiratory distress syndrome.
Participants: Records of 3063 consecutive mechanically ventilated patients admitted to the ICU between 2012 and 2017 were extracted, of whom 583 were eligible adults for further analysis. Patients’ weaning protocols were evaluated for daily adherence to quality standards until ICU discharge. Patients with <65% compliance were assigned to the low adherence group (LAG), patients with ≥65% to the high adherence group (HAG).
Primary and secondary outcome measures: Economic healthcare costs, clinical outcomes and patients’ characteristics.
Results: The LAG consisted of 378 patients with a median negative economic results of −€3969, HAG of 205 (−€1030), respectively (p<0.001). Median duration of ventilation was 476 (248; 769) hours in the LAG and 389 (247; 608) hours in the HAG (p<0.001). Length of stay (LOS) in the LAG on ICU was 21 (12; 35) days and 16 (11; 25) days in the HAG (p<0.001). LOS in the hospital was 36 (22; 61) days in the LAG, and within the HAG, respectively, 26 (18; 48) days (p=0.001).
Conclusions: High adherence to this single QI is associated with better clinical outcome and improved economic returns. Therefore, the results support the adherence to QI. However, the examined QI does not influence economic outcome as the decisive factor.
The objective of this article is to prepare for the initial certification according to IFS Global Markets Food V3 at the Landshuter Brauhaus AG private brewery at the Ellermühle site, which is expected in August 2025, and to create the basis for a potential follow-up certification according to IFS Food. The IFS Global Markets Food Program V3 is a standardized, voluntary and non-accredited assessment program for food companies, both for retail and manufacturer brand products (IFS 2023, p. 10 f.). It is based on the specifications of the Global Markets Program developed in 2008 (GFSI 2023a; VDOE 2020, p. 620).
The methodology of the target/actual analysis was used to work on the topic in order to be able to carry out a conformity check with regard to the requirements of IFS Global Markets Food V3 (see Appendix 3; IFS 2023). Observations, document analyses and employee surveys were carried out to obtain the most meaningful information possible. These have been recorded and evaluated within the target-performance analysis. A total of 65 deviations (equivalent to 53.7%) were identified at the basic level, and 60 deviations (equivalent to 82.2%) at the intermediate level. These were either processed as directly implemented corrective actions or formulated as recommendations for continuous improvement in the form of an action plan (see Appendix 15). The presentation of the action plan shows the deviations, the resulting measures, the associated responsibilities, the time period with the starting point and end point of the measures, and the current status. In addition a subdivision into "Basic" and "+Intermediate" was made for a better overview in the subsequent processing by the brewery.
A review as well as assessment of relevant requirements with regard to processes and significant violations after completion of the new building and commissioning at the Ellermühle site with regard to correlation with a potential "major" rating is recommended on the part of the operations manager or brewmaster (IFS 2023, p. 30).
Die vorliegende Bachelorarbeit behandelt das Thema das betriebliche Ideenmanagement. Das Ziel ist den Prozess zur Einreichung, Evaluierung und Umsetzung von Ideen weiterzuentwickeln und zu digitalisieren.
Um das Ziel zu erreichen, werden Primärdaten mit Hilfe von fünf qualitativen Interviews und einer quantitativen Umfrage mit 50 Mitarbeitern erhoben. Abgesehen davon wurden auch Daten aus der Sekundärforschung erfasst, deren Bestandteile die internen Unterlagen zum bestehenden Ideenmanagement dem Status quo, und wissenschaftliche Quellen sind.
Die Anforderungen an Unternehmen in Bezug auf Qualitätsmanagement, Nachhaltigkeitsmanagement sowie Arbeitssicherheit und Gesundheitsschutz sind hoch und immer weiter ansteigend. Gesetzliche Anforderungen, Anforderungen durch Managementsysteme, Anforderungen von Kunden und Anforderungen an Lieferanten stellen Unternehmen dabei vor sehr große Herausforderungen. Die integrierte Durchführung dieser unterschiedlichen Anforderungen sollte Ziel in Unternehmen sein um einen effizienten und erfolgreichen Weg zu gehen (Krieger-Güss & Hannus, 2023). Der enge Zusammenhang der Themen Qualitätsmanagement, Umwelt/ Nachhaltigkeitsmanagement und Arbeitssicherheit ist von immer entscheidender Bedeutung um in einem Unternehmen effizient arbeiten zu können (Krieger. 2008). Qualitätsmanagement bildet die Grundlage für den Aufbau von Strukturen in Unternehmen. An Nachhaltigkeit kommt kein Unternehmen vorbei und es dient der gesellschaftlichen Verantwortung mit den drei Dimensionen ökologisch, sozial und ökonomisch sowie der vierten Dimension Ernährung. Empfohlen wird die Integration der Anforderungen, die für das Thema Nachhaltigkeit von entscheidender Bedeutung sind in die Prozesse in Unternehmen. Gerade die ethische Dimension der Nachhaltigkeit hat einen engen Bezug zum Thema Arbeits- und Gesundheitsschutz. Die Einhaltung der Menschenrechte wird in der ISO 26000 gefordert und ist ebenfalls Bestandteil des Arbeitsschutzes. Des Weiteren wurde die Einhaltung der Menschenrechte und entsprechende Arbeitsbedingungen auch durch das neue Lieferkettengesetz gesetzlich festgelegt. Die vierte Dimension der Nachhaltigkeit “Ernährung” wird in Standards wie den DGE-Qualitätsstandards betrachtet und Vorgaben bezüglich der Ernährung in Gemeinschaftsverpflegungen dargelegt. Eine Kombination der unterschiedlichen Managementsysteme und die Einhaltung der gesetzlichen Anforderungen haben eine zentrale Funktion in erfolgreich agierenden Unternehmen und Gemeinschaftsverpflegungen.
Aktuell liegen noch viele Defizite in diesen Bereichen vor wie folgende Auswertungen zeigen. Im Zeitraum von 01/2023 – 09/2023 wurden in Deutschland 454 Rückrufe durchgeführt, die die Lebensmittelsicherheit gefährdet haben, wobei die meisten Rückrufe bei Obst und Gemüse erfolgt sind (siehe Abbildung 1).
The demands placed on companies in terms of up-to-date quality and sustainability management as well as health and safety measures are high and are becoming increasingly complex. Increased legal requirements, additional industry standards and derived customer requirements constantly present companies and value chains with new challenges. The integrated approach to the implementation of these different requirements has already taken place in companies in recent years. However, small businesses still find it difficult to face the complexity of requirements on their own without an accompanying consultation. Qualint is a support tool, which is currently available in the 3rd version. The tool supports companies in setting up and continuously developing their integrated management system with coordinated hybrid service bundles. The focus is on combining the fields of action of quality, environmental and sustainability management as well as occupational safety and health.The article illustrates how quality management can be used as a basis for building up digital and organizational structures in companies and value chains. The focus is on sustainability aspects and ethical requirements that are closely related to people, such as occupational health and safety. Compliance with human rights is required in ISO 26000 and is also part of occupational safety and health. Furthermore, compliance with human rights and corresponding working conditions is also regulated by the new Supply Chain Duty Act (LkSG). It shows how demands on companies have grown and how the consulting tool Qualint has developed accordingly.
During gestation, the most drastic change in oxygen supply occurs with the onset of ventilation after birth. As the too early exposure of premature infants to high arterial oxygen pressure leads to characteristic diseases, we studied the adaptation of the oxygen sensing system and its targets, the hypoxia-inducible factor- (HIF-) regulated genes (HRGs) in the developing lung. We draw a detailed picture of the oxygen sensing system by integrating information from qPCR, immunoblotting, in situ hybridization, and single-cell RNA sequencing data in ex vivo and in vivo models. HIF1α protein was completely destabilized with the onset of pulmonary ventilation, but did not coincide with expression changes in bona fide HRGs. We observed a modified composition of the HIF-PHD system from intrauterine to neonatal phases: Phd3 was significantly decreased, while Hif2a showed a strong increase and the Hif3a isoform Ipas exclusively peaked at P0. Colocalization studies point to the Hif1a-Phd1 axis as the main regulator of the HIF-PHD system in mouse lung development, complemented by the Hif3a-Phd3 axis during gestation. Hif3a isoform expression showed a stepwise adaptation during the periods of saccular and alveolar differentiation. With a strong hypoxic stimulus, lung ex vivo organ cultures displayed a functioning HIF system at every developmental stage. Approaches with systemic hypoxia or roxadustat treatment revealed only a limited in vivo response of HRGs. Understanding the interplay of the oxygen sensing system components during the transition from saccular to alveolar phases of lung development might help to counteract prematurity-associated diseases like bronchopulmonary dysplasia.
In recent years, ISO, IFS, BRC and FSSC 22000 standards in the areas of quality, environment and occupational health and safety have been increas-ingly implemented in companies in various industries. The main focus of these developed standards are the processes. But the past shows that the factor human is another very important factor, which should be much more in the middle in organization. The new developed guideline has the human factor in the foreground. In particular, the attitude and awareness of occupational safe-ty and health protection in the behaviour of employees at all levels of the or-ganisation are at the centre of consideration.
Inspired by this approach, a group of experts from the fields of quality scienc-es, standardisation and certification as well as consulting for system-relevant companies in the agricultural and food industry came together to form a committee during the Corona crisis in spring 2020. The common goal is to develop a new standard. The first step is to establish criteria for a guideline.
and establish an evaluation system for several pillars of a House of Total Safety Culture (HSC) tailored to the entire value chains of the agri-food sec-tor. In addition, the essential building blocks of the guideline must be defined. The attitude of managers and employees, their behaviour and their compe-tence form the roof of the standard. The integrated management system with a continuous improvement process forms the foundation of the House of To-tal Safety Culture across the company in value chains. Qualification and communication are the main pillars and thus further elements of the HSC. Particular attention is paid to the fields of action of occupational safety and health protection, food safety, animal and environmental protection as well as sustainability and digitisation. They form the four inner pillars of the House of Total Safety Culture. The design of the respective certification levels is con-sidered as a “construction phase”. As part of the standardisation process, the coordination of the respective requirements for safety culture has not yet been completed. This article first provides an overview of the state of knowledge in relation to the established standards and norms of the agri-food industry with special consideration of the Safety Culture Ladder model. The procedure for developing and establishing the new guideline is then ex-plained. For this purpose, the composition of the expert forum is presented before the concrete steps to establish the guideline are presented. The model of the House of Total Culture is presented below. Building on this, the proce-dure for assessing the degree of maturity and possible concepts of continuing training are explained before the conclusion of this article.
Dieses Fachbuch ist das Standardwerk für ein professionelles Qualitätsmanagement. Es beschreibt in kompakter und praxisnaher Form, wie Sie ein umfassendes QM in Ihrem Unternehmen aufbauen und optimieren. Sie werden damit mehr Produktsicherheit erreichen und Ihre Mitarbeiter dazu motivieren die Lebensmittelsicherheitskultur zu leben.
Neben der Beschreibung klassischer Managementsystemen gibt es auch Anregungen zu alternativen Systemen und Einblicke in die Arbeit ausgewählter anderer Länder.
This paper investigates four different mobile robots with respect to their drivingcharacteristics and soil preservation properties in an agricultural environment.Thereby, robots of classical design from agriculture as well as systems from spacerobotics with advanced locomotion concepts are considered to determine theindividual advantages of each rover concept with respect to the application domain.Locomotion experiments were conducted to analyze the general driving behavior,tensile force, and obstacle‐surmounting capability and ground interaction of eachrobot. Various soil conditions typical for the area of application are taken intoaccount, which are varied in terms of moisture and density. The presented workcovers the specification of the conducted experiments, documentation of theimplementation as well as analysis and evaluation of the collected data. In theevaluation, particular attention is paid to the change in driving characteristics underdifferent soil conditions, as well as to the soil stress caused by driving, since soilquality is of critical importance for agricultural applications. The analysis shows thatthe advanced locomotion concepts, as used in space robotics, also have positiveimplications for certain requirements in agricultural applications, such as maneuver-ability in wet conditions and soil conservation. The results show potential for designinnovations in agricultural robotics that can be used, to open up new fields ofapplication for instance in the context of precision farming.
Durch die Auswirkungen des Klimawandels – besonders durch Hitze – geraten viele indigene Baumarten innerhalb der nächsten 75 Jahre voraussichtlich an den Rand ihrer Existenz. Der Stadtstandort stellt eine zusätzliche Herausforderung dar, der durch menschliche Aktivitäten negativ, aber auch positiv beeinflusst werden kann. Besonders die Wasserverfügbarkeit kann durch geeignete vegetationstechnische Maßnahmen und intelligente Profilierung von Oberflächen befördert werden. Die Vegetation wird sich verändern. Mit gebietseinheimischen Genotypen und natürlicher Migration hitzeverträglicher Arten alleine lassen sich unsere Probleme nicht lösen. Wir brauchen Bäume in der Stadt, die beschatten und verdunsten.
Lösungsansätze sind die vielfältige Anpflanzung hitzeresistenter Genotypen indigener Arten, neuer, submediterraner Arten aus Süd- und Südosteuropa (assisted migration) sowie klimatoleranter Arten anderer Kontinente. Es ist allerdings davon auszugehen, dass sich diese Arten dann bei uns auch etablieren werden. Und das ist bei der durch die Eiszeiten verarmten Gehölzflora Mitteleuropas und für lebenswerte Städte auch gut so!
Aufgrund vermuteter, negativer Folgen, welche von der Etablierung und Ausbreitung gebietsfremder Art ausgehen können, ist um die Verwendung von Zukunftsbäumen im städtischen Raum eine Diskussion entstanden. Im Rahmen einer Forschungsarbeit an der Hochschule Osnabrück wurde daher untersucht, wie die Ausbreitungstendenz einzelner Arten von Mitarbeiter*innen in Grünflächenämtern und Botanischen Garten eingeschätzt wird.
Background
A peripheral venous catheter (PVC) is the most widely used device for obtaining vascular access, allowing the administration of fluids and medication. Up to 25% of adult patients, and 50% of pediatric patients experience a first-attempt cannulation failure. In addition to patient and clinician characteristics, device features might affect the handling and success rates. The objective of the study was to compare the first-attempt cannulation success rate between PVCs with wings and a port access (Vasofix® Safety, B. Braun, abbreviated hereon in as VS) with those without (Introcan® Safety, B. Braun, abbreviated hereon in as IS) in an anesthesiological cohort.
Methods
An open label, multi-center, randomized trial was performed. First-attempt cannulation success rates were examined, along with relevant patient, clinician, and device characteristics with univariate and multivariate analyses. Information on handling and adherence to use instructions was gathered, and available catheters were assessed for damage.
Results
Two thousand three hundred four patients were included in the intention to treat analysis. First-attempt success rate was significantly higher with winged and ported catheters (VS) than with the non-winged, non-ported design (IS) (87.5% with VS vs. 78.2% with IS; PChi < .001). Operators rated the handling of VS as superior (rating of “good” or “very good: 86.1% VS vs. 20.8% IS, PChi < .001). Reinsertion of the needle into the catheter after partial withdrawal—prior or during the catheterization attempt—was associated with an increased risk of cannulation failure (7.909, CI 5.989–10.443, P < .001 and 23.023, CI 10.372–51.105, P < .001, respectively) and a twofold risk of catheter damage (OR 1.999, CI 1.347–2.967, P = .001).
Conclusions
First-attempt cannulation success of peripheral, ported, winged catheters was higher compared to non-ported, non-winged devices. The handling of the winged and ported design was better rated by the clinicians. Needle reinsertions are related to an increase in rates of catheter damage and cannulation failure.
Background: New ischaemic brain lesions on magnetic resonance imaging (MRI) are reported in up to 86% of patients after transcatheter edge-to-edge repair of the mitral valve (TEER-MV). Knowledge of the exact procedural step(s) that carry the highest risk for cerebral embolisation may help to further improve the procedure.
Aims: The aim of this study was to identify the procedural step(s) that are associated with an increased risk of cerebral embolisation during TEER-MV with the MitraClip system. Furthermore, the risk of overt stroke and silent brain ischaemia after TEER-MV was assessed.
Methods: In this prospective, pre-specified observational study, all patients underwent continuous transcranial Doppler examination during TEER-MV to detect microembolic signals (MES). MES were assigned to specific procedural steps: (1) transseptal puncture and placement of the guide, (2) advancing and adjustment of the clip in the left atrium, (3) device interaction with the MV, and (4) removal of the clip delivery system and the guide. Neurological examination using the National Institutes of Health Stroke Scale (NIHSS) and cerebral MRI were performed before and after TEER-MV.
Results: Fifty-four patients were included. The number of MES differed significantly between the procedural steps with the highest numbers observed during device interaction with the MV. Mild neurological deterioration (NIHSS ≤3) occurred in 9/54 patients. New ischaemic lesions were detected in 21/24 patients who underwent MRI. Larger infarct volume was significantly associated with neurological deterioration.
Conclusions: Cerebral embolisation is immanent to TEER-MV and predominantly occurs during device interaction with the MV. Improvements to the procedure may focus on this procedural step.
Background
To detect changes in biological processes, samples are often studied at several time points. We examined expression data measured at different developmental stages, or more broadly, historical data. Hence, the main assumption of our proposed methodology was the independence between the examined samples over time. In addition, however, the examinations were clustered at each time point by measuring littermates from relatively few mother mice at each developmental stage. As each examination was lethal, we had an independent data structure over the entire history, but a dependent data structure at a particular time point. Over the course of these historical data, we wanted to identify abrupt changes in the parameter of interest - change points.
Results
In this study, we demonstrated the application of generalized hypothesis testing using a linear mixed effects model as a possible method to detect change points. The coefficients from the linear mixed model were used in multiple contrast tests and the effect estimates were visualized with their respective simultaneous confidence intervals. The latter were used to determine the change point(s). In small simulation studies, we modelled different courses with abrupt changes and compared the influence of different contrast matrices. We found two contrasts, both capable of answering different research questions in change point detection: The Sequen contrast to detect individual change points and the McDermott contrast to find change points due to overall progression. We provide the R code for direct use with provided examples. The applicability of those tests for real experimental data was shown with in-vivo data from a preclinical study.
Conclusion
Simultaneous confidence intervals estimated by multiple contrast tests using the model fit from a linear mixed model were capable to determine change points in clustered expression data. The confidence intervals directly delivered interpretable effect estimates representing the strength of the potential change point. Hence, scientists can define biologically relevant threshold of effect strength depending on their research question. We found two rarely used contrasts best fitted for detection of a possible change point: the Sequen and McDermott contrasts.
BACKGROUND: Postoperative delirium (POD) is an acute and common complication after surgery that can increase morbidity and mortality. Few previous studies with inconsistent findings have examined the association of preoperative pain and POD. Our purpose is to investigate the association of preoperative chronic pain and POD.
METHODS: This prospective observational cohort study included 200 patients ≥ 18 years scheduled for elective surgery under general anaesthesia in a tertiary care hospital. POD was defined as meeting diagnostic criteria during the study visits (according to delirium screening tests and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), or by diagnosis of the responsible physicians. Chronic pain was defined as pain lasting six months or longer. Features of chronic pain were assessed with the German Pain Questionnaire, including the Depression Anxiety and Stress Scale-21 (DASS-21). Associations with POD were assessed using logistic regression analysis adjusting for confounding factors.
RESULTS: Thirty-nine (22%) out of 176 patients developed POD. Chronic pain was not associated with POD after adjustment for ASA physical status, duration of anesthesia and DASS-21 Anxiety score (Odds ratio [OR], 95%-Confidence Interval [CI], 2.216 [0.968;5.070], P=0.060). A subgroup analysis of chronic pain patients revealed that current pain intensity was higher in patients with POD.
CONCLUSIONS: Preoperative chronic pain was no independent predictor for POD. Current pain intensity was higher in chronic pain patients with POD. This indicates that certain features of pain might be influential. Further research is needed to examine different forms of preoperative pain and their possible influence on POD.
Trotz wachsender Bedeutung von Talent Management (TM) in Unternehmen gelingt es nicht, der Talentknappheit zu begegnen. Die Corona-Pandemie verschärft die Situation. Denn der bislang nicht ausgeschöpfte Anteil qualifizierter Frauen auf dem Arbeitsmarkt wächst u. a., weil sich anteilig mehr Frauen als Männer zur Erfüllung von Sorgeaufgaben vom Arbeitsmarkt zurückziehen. Gleichzeitig werden Maßnahmen zur Vereinbarung von Berufs- und Privatleben bislang bei der Rekrutierung und Bindung von Talenten nicht oder unzureichend thematisiert. Auf der Basis der wissenschaftlichen Diskussion wird daher die Frage untersucht, inwiefern sich Vereinbarkeitsangebote von Talenten karriereunschädlich nutzen lassen.
Hintergrund
Die Anämie hat eine hohe Prävalenz bei Patienten vor Hüftgelenkrevisionsoperation und ist mit einer erhöhten Komplikationsrate assoziiert. Die vorliegende Arbeit untersucht erstmals den Zusammenhang von Kosten, realen DRG-Erlösen und Falldeckung der präoperativen Anämie bei elektiven Hüftgelenkrevisionsoperationen.
Methoden
Für alle Patienten, die sich von 2010 bis 2017 an 2 Campi der Charité – Universitätsmedizin Berlin einer Hüftgelenkrevisionsoperation unterzogen, wurden Daten zu Patienten sowie Transfusionen, Kosten und Erlösen gesammelt. Subgruppen- und lineare Regressionsanalysen untersuchten die Falldeckung anämischer und nichtanämischer Patienten.
Ergebnisse
Von 1187 eingeschlossenen Patienten waren 354 (29,8 %) präoperativ anämisch. Insgesamt wurden 565 (47,6 %) Patienten, mit einem deutlichen Überwiegen anämischer Patienten (72,6 % vs. 37,0 %, p < 0,001), transfundiert. Kosten (12.318 € [9027;20.044 €] vs. 8948 € [7501;11.339 €], p < 0,001) und Erlöse (11.788 € [8992;16.298 €] vs. 9611 € [8332;10.719 €], p < 0,001) waren für anämische Patienten höher, die Fallkostendeckung defizitär (−1170 € [−4467;1238 €] vs. 591 € [−1441;2103 €] €, p < 0,001). Bei anämischen Patienten nahm die Falldeckung mit zunehmender Transfusionsrate ab (p ≤ 0,001). Komorbiditäten hatten keinen signifikanten ökonomischen Einfluss.
Schlussfolgerung
Die präoperative Anämie und perioperative Transfusionen bei Hüftgelenkrevisionsoperationen sind mit erhöhten Behandlungskosten und einer finanziellen Unterdeckung für Kostenträger im Gesundheitswesen verbunden. Konzepte zur Behandlung der präoperativen Anämie (z. B. Patient Blood Management) könnten mittelfristig Behandlungskosten senken.
Intensive care units (ICU) are often overflooded with alarms from monitoring devices which constitutes a hazard to both staff and patients. To date, the suggested solutions to excessive monitoring alarms have remained on a research level. We aimed to identify patient characteristics that affect the ICU alarm rate with the goal of proposing a straightforward solution that can easily be implemented in ICUs. Alarm logs from eight adult ICUs of a tertiary care university-hospital in Berlin, Germany were retrospectively collected between September 2019 and March 2021. Adult patients admitted to the ICU with at least 24 h of continuous alarm logs were included in the study. The sum of alarms per patient per day was calculated. The median was 119. A total of 26,890 observations from 3205 patients were included. 23 variables were extracted from patients' electronic health records (EHR) and a multivariable logistic regression was performed to evaluate the association of patient characteristics and alarm rates. Invasive blood pressure monitoring (adjusted odds ratio (aOR) 4.68, 95%CI 4.15–5.29, p < 0.001), invasive mechanical ventilation (aOR 1.24, 95%CI 1.16–1.32, p < 0.001), heart failure (aOR 1.26, 95%CI 1.19–1.35, p < 0.001), chronic renal failure (aOR 1.18, 95%CI 1.10–1.27, p < 0.001), hypertension (aOR 1.19, 95%CI 1.13–1.26, p < 0.001), high RASS (aOR 1.22, 95%CI 1.18–1.25, p < 0.001) and scheduled surgical admission (aOR 1.22, 95%CI 1.13–1.32, p < 0.001) were significantly associated with a high alarm rate. Our study suggests that patient-specific alarm management should be integrated in the clinical routine of ICUs. To reduce the overall alarm load, particular attention regarding alarm management should be paid to patients with invasive blood pressure monitoring, invasive mechanical ventilation, heart failure, chronic renal failure, hypertension, high RASS or scheduled surgical admission since they are more likely to have a high contribution to noise pollution, alarm fatigue and hence compromised patient safety in ICUs.
This study reported the impact of electron beam (e-beam) treatment on microbiota and mycotoxins naturally present in red pepper powder and physicochemical quality changes. Treatment at 6 kGy indicated significant (p < 0.05) decontamination of yeasts and molds by 3.0 and 4.4 log CFU/g, respectively. A reduction of 4.5 log CFU/g of total plate counts (TPC) was observed at 10 kGy for 23 s. Fungal inactivation followed first-order kinetics while TPC better fitted with Gompertz function (R2 = 0.9912). E-beam treatment was not efficient for the degradation of aflatoxins but indirectly controlled their production by inactivation of mycotoxigenic molds. Indeed, reduction of 25% ochratoxin A was recorded at 30 kGy retaining >85% of total phenols, carotenoids and antioxidants activity. Moreover, treatment impact on total color difference (ΔE*) indicated ‘slight differences’. Overall, e-beam treatments up to 10 kGy were efficient in decontaminating the natural microbiota without detrimental effects on the physicochemical qualities of red pepper powder.
The study aimed for the analysis of the impact of pulsed electric field (PEF) pre-treatment on convection (CD) and microwave (MW-CD) assisted air drying. Drying kinetics acceleration and retention of bioactive compounds of PEF pre-treated carrots and apples has been demonstrated. Moreover, the direct and indirect environmental energy impacts of CD and MW-CD technologies with consideration of bioactive compounds preservation has been evaluated. PEF assisted CD and MW-CD demonstrated lower energy use, especially for indirect energy consumption, in the case of carotenoids preservation in dried carrots.
The influence of oil content and droplet size of oil-in-water emulsions on the heat development in an ohmic heating system was investigated. The setup was run with constant power or voltage. Emulsions consisted of sunflower oil (10–50 wt%), aqua dest. (90–50 wt%) and whey protein isolate (1.25/ 2.5/ 3.75/ 5.0 and 6.25 wt%) Two different droplet size distributions were produced, large (d0.5 ≈ 2.0 μm) and small (d0.5 ≈ 0.3 μm), for each oil mass fraction. The emulsions were ohmically heated from 10 to 80 °C at a constant power of 3.0 kW and constant voltage of 15 V/cm. The electrical conductivity decreased with an increasing oil content, resulting in longer or shorter heating time for constant voltage or constant power input, respectively. The droplet size only affected the heating process at the highest oil content.
Industrial relevance
Emulsions occur in a wide range of food products (e.g. sauces, dressings, desserts) and have properties giving structure to the food system. Ohmic heating is an emerging thermal process with improved (e.g. faster or less energy required) heating characteristics. The influence of physical changes due to different droplet sizes are of interest because these might also affect the heating characteristic. In addition, the direct comparison of two different process regulations (constant power and constant voltage) indicate which set up is expedient to a successful heating process. This study aims to identify the influence of emulsion-induced structural changes and process changes on the heating rates, which is of interest for the food industry and the related machine building industry.
Red pepper (Capsicum annuum L.) is one of the major spices consumed globally, recognized for its aroma and nutrient properties, and it has a major economic value for high producing countries. However, characterization of its techno-functional properties and in-depth understanding of oxidative stability is needed to produce food of high quality and stability. Thus, this work focused on the chemical, functional, thermal, oxidative stability and rheological properties of red pepper powder and paste. Experiment was designed in a Completely Randomized Design (CRD) fashion. The red pepper powder contained 14.50 g/100 g, 44.00 g/100 g and 7.57 g/100 g of crude fat, crude fiber and ash, respectively. The concentration of total phenols, carotenoids and antioxidants activity of the powder were 1.04 g GAE/100 g, 374 mg βc/100 g and 38.61 μmol TE/g, respectively. Functional properties showed lower bulk density (395.1 kg/m3) and higher tapped density (583.4 kg/m3) indicating the higher compressibility of the powder. In contrast, Hausner ratio (1.48), Carr’s index (32%) and angle of repose (45°) indicated poor flowability of the powder. Particle size distribution also indicated that the volume weighted mean values D[4,3] of the powder and paste were 262.20 and 201.46, respectively. Emulsifying capacity of the powder was 47.5%. Oil and water absorption capacities varied from 1.41 to 1.73 and 0.86 to 2.29 g/g of initial weight, respectively. Higher glass transition temperature was observed for the powder (62.54°C) than the paste (45.64°C). The induction period indicated that red pepper was more stable against oxidation in powder (5.2 h) than in the paste form (3.2 h). Rheological analysis revealed that the paste exhibited shear-thinning behavior. Overall, understanding of the properties of red pepper could contribute to enhance quality.
The increased consumption of reduced-fat or non-fat products leads to a reduced intake of fat-soluble bioactive substances, such as fat-soluble vitamins. Due to their natural role as transport systems for hydrophobic substances, casein micelles (CM) might depict a viable system. The structure of CM is characterized by a lipophilic core stabilized by an electric double layer-like structure. Modification allows accessibility of the core and, therefore, the inclusion of fat-soluble bioactive substances. Well-known modifications are pH reduction and use of rennet enzyme. A completely new procedure to modify CM structure is offered by pulsed electrical fields (PEF). The principle behind PEF is called electroporation and affects the electric double layer of CM so that it is interrupted. In this way, lipophilic substances can be incorporated into CM. In this work, we evaluated integration of β-carotene into native CM by an industry-compatible process to overcome disadvantages associated with the use of Na-caseinate and avoid great technical effort, e.g., due to treatment with high hydrostatic pressure. Our research has shown that PEF can be used for disintegration of CM and that significant amounts of β-carotene can be incorporated in CM. Furthermore, after disintegration using PEF, a combination of another PEF and thermal treatment was applied to restructure CM and trap significant amounts of β-carotene, permanently, ending up with an encapsulation efficiency of 78%.
Currently, the modelling of drying processes of plant tissues pre-treated by pulsed electric field (PEF) is following experimentally identified curves or separate heat and mass transfer and diffusion models with different levels of accuracy. This research had two major objectives: mathematical modeling and control of drying process of different vegetables pretreated by PEF during convective drying. The mathematical modeling was based on Luikov's heat and mass transfer model along with properties of different vegetables. Computer modelling was done using the difference method for predicting moisture and the temperature potentials of untreated and PEF-treated vegetables. The formulation and the solution procedures were applied to simulate the simultaneous heat and mass transfer in selected vegetables subjected to the convective drying. Suggested model had a good correlation with experimental results. Moreover, cell disintegration index can be used as a controllable parameter in heat and mass transfer models to predict drying behavior of potato, onion, and carrot tissues. Obtained drying models can be used as a mathematical tool to predict drying behavior for various types of agricultural products pre-treated by pulsed electric field.
The study aimed to investigate inactivation of naturally occurring microorganisms and quality of red pepper paste treated by high pressure processing (HPP). Central composite rotatable design was employed to determine the impacts of pressure (100–600 MPa) and holding time (30–600 s). HPP at 527 MPa for 517 s reduced aerobic mesophilic bacteria count by 4.5 log CFU/g. Yeasts and molds counts were reduced to 1 log CFU/g at 600 MPa for 315 s. Total phenols, carotenoids and antioxidants activity ranged from 0.28 to 0.33 g GAE/100 g, 96.0–98.4 mg βc/100 g and 8.70–8.95 μmol TE/g, respectively. Increase (2.5–6.7%) in these variables was observed with increasing pressure and holding time. Total color difference (ΔE∗) values (0.2–2.8) were within the ranges of ‘imperceptible’ to ‘noticeable’. Experimental results were fitted satisfactorily into quadratic model with higher R2 values (0.8619–0.9863). Optimization process suggested treatment of red pepper paste at 536 MPa for 125 s for maximum desirability (0.622). Validation experiments confirmed comparable percentage of relative errors. Overall, this technique could be considered as an efficient treatment for the inactivation of microorganisms that naturally occur in red pepper paste with minimal changes in its characteristics.
The impact of Pulsed Electric Fields (PEF) on the peeling ability of different fruits and vegetables in particular tomatoes, peaches, peppers, and oranges were investigated. Samples were exposed to a fixed electric field strength of 2.15 kV/cm. The specific energy ranged from 0.6 kJ/kg to 50.3 kJ/kg. The treated raw materials were analysed regarding to the peeling ability, skin size and weight and firmness. The best result for tomatoes at a specific energy of 1.2 kJ/kg induced a high score of peeling ability that led to less product loss and could therefore increase the yield by 33.84%–41.53% compared to untreated samples. Moreover, an increased skin size by a factor of 3.7 was observed. However, PEF had no significant impact on peeling ability of oranges, peppers, and peaches. Although oranges showed an improvement in peeling ability by up to 32%, this cannot be traced back to the PEF treatment. The different properties and structures of the raw materials were discussed and provided indications about the limitation of PEF.