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Abstract Background Proton-pump inhibitors (PPI) are liberally prescribed in patients with liver cirrhosis. Observational studies link PPI therapy in cirrhotic patients with an increased risk for infectious complications, hepatic encephalopathy and an increased risk for hospitalization and mortality. However, patients with liver cirrhosis are also considered to be at risk for peptic ulcer bleeding. The STOPPIT trial evaluates if discontinuation of a pre-existing PPI treatment delays a composite endpoint of re-hospitalization and/or death in patients (recently) hospitalized with liver cirrhosis compared to patients on continued PPI medication. Methods The STOPPIT-trial is a prospective, multicentre, randomized, double-blinded, placebo-controlled, parallel-group trial. In total, 476 patients with complicated liver cirrhosis who already receive long-term PPI therapy without evidence-based indication are 1:1 randomized to receive either esomeprazole 20 mg (control group) or placebo (intervention group) for 360 days. Patients with an indication for PPI therapy (such as a recent diagnosis of peptic ulcers, severe reflux esophagitis, severe hemorrhagic gastritis, recent endoscopic therapy for oesophageal varices) are excluded. The primary composite endpoint is the time-to re-hospitalization and/or death. Secondary endpoints include rates of re-hospitalization, mortality, occurrence of infections, hepatic decompensation and acute-on-chronic liver failure. The safety endpoint is defined as manifestation of an evidence-based indication for PPI re-therapy. The impact of PPI continuation or discontinuation on the intestinal microbiota will be studied. The recruitment will take place at 18 study sites throughout Germany. Recruitment has started in April 2021. Discussion The STOPPIT trial is the first clinical trial to study the effects of PPI withdrawal on relevant outcome variables in patients with complicated liver cirrhosis. If the hypothesis that PPI withdrawal improves clinical outcomes of cirrhosis patients is confirmed, this would argue for a strong restriction of the currently liberal prescription practice of PPIs in this population. If, on the other hand, the trial demonstrates an increased risk of gastrointestinal bleeding events in patients after PPI withdrawal, this could create a rationale for a more liberal, prophylactic PPI treatment in patients with liver cirrhosis. Trial registration EU clinical trials register EudraCT 2019-005008-16 (registered December 27, 2019). ClinicalTrials.gov NCT04448028 (registered June 25, 2020). German Clinical Trials Register DRKS00021290 (registered March 10, 2021).

Abstract Background The sample size calculation in a confirmatory diagnostic accuracy study is performed for co-primary endpoints because sensitivity and specificity are considered simultaneously. The initial sample size calculation in an unpaired and paired diagnostic study is based on assumptions about, among others, the prevalence of the disease and, in the paired design, the proportion of discordant test results between the experimental and the comparator test. The choice of the power for the individual endpoints impacts the sample size and overall power. Uncertain assumptions about the nuisance parameters can additionally affect the sample size. Methods We develop an optimal sample size calculation considering co-primary endpoints to avoid an overpowered study in the unpaired and paired design. To adjust assumptions about the nuisance parameters during the study period, we introduce a blinded adaptive design for sample size re-estimation for the unpaired and the paired study design. A simulation study compares the adaptive design to the fixed design. For the paired design, the new approach is compared to an existing approach using an example study. Results Due to blinding, the adaptive design does not inflate type I error rates. The adaptive design reaches the target power and re-estimates nuisance parameters without any relevant bias. Compared to the existing approach, the proposed methods lead to a smaller sample size. Conclusions We recommend the application of the optimal sample size calculation and a blinded adaptive design in a confirmatory diagnostic accuracy study. They compensate inefficiencies of the sample size calculation and support to reach the study aim.

This study reports the only recent characterization of two contrasted wet deposition events collected during the PEACETIME (ProcEss studies at the Air–sEa Interface after dust deposition in the MEditerranean Sea) cruise in the open Mediterranean Sea (Med Sea) and their impact on trace metal (TM) marine stocks. Rain samples were analysed for Al, 12 TMs (Co, Cd, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Ti, V and Zn) and nutrient (N, P, dissolved organic carbon) concentrations. The first rain sample collected in the Ionian Sea (Rain ION) was a typical regional background wet deposition event, whereas the second rain sample collected in the Algerian Basin (Rain FAST) was a Saharan dust wet deposition event. Even in the remote Med Sea, all background TM inputs presented an anthropogenic signature, except for Fe, Mn and Ti. The concentrations of TMs in the two rain samples were significantly lower compared to concentrations in rains collected at coastal sites reported in the literature, due to the decrease in anthropogenic emissions during the preceding decades. The atmospheric TM inputs were mainly dissolved forms, even in dusty Rain FAST. The TM stocks in the mixed layer (ML, 0–20 m) at the FAST station before and after the event showed that the atmospheric inputs were a significant supply of particulate TMs and dissolved Fe and Co for surface seawater. Even if the wet deposition delivers TMs mainly in soluble form, the post-deposition aerosol dissolution could to be a key additional pathway in the supply of dissolved TMs. At the scale of the western and central Mediterranean, the atmospheric inputs were of the same order of magnitude as ML stocks for dissolved Fe, Co and Zn, highlighting the role of the atmosphere in their biogeochemical cycles in the stratified Med Sea. In case of intense dust-rich wet deposition events, the role of atmospheric inputs as an external source was extended to dissolved Co, Fe, Mn, Pb and Zn. Our results suggest that the wet deposition constitutes only a source of some of dissolved TMs for Med Sea surface waters. The contribution of dry deposition to the atmospheric TM inputs needs to be investigated.

Background: Abdominal tumors rarely occur in childhood but are associated with great psychological stress for patients and their families. Parents playing a central role in their children's treatment may experience adverse effects on their Health-Related Quality of Life (HRQoL) and mental health due to the children's illness and required treatment. Given the limited knowledge of the psychosocial burden of parents with children suffering from solid abdominal tumors, this study aims to assess their HRQoL and mental health along with the impact of various psychosocial factors. Methods: A cross-sectional cohort study was carried out involving 54 parents of children with solid abdominal tumors who had surgery at the University Medical Center Hamburg-Eppendorf in Germany. The results were compared with 46 parents of children undergoing routine surgeries without a prior tumor diagnosis, and with normative values. Data were obtained using standardized questionnaires. Results: Parents of the index group showed significantly worse HRQoL and limited mental health. Furthermore, they showed significantly higher parental burden in several subscales and less social support in comparison with the control group. Conclusions: Considering the lower parental HRQoL and the central role parents play in their children's lives, it is crucial to include prevention and intervention measures for parents as part of a multimodal treatment regime for children with solid pediatric abdominal tumors. [ABSTRACT FROM AUTHOR]

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(1) Background: Embryonal abdominal tumors are one of the most common entities of solid childhood cancer. The present study investigates the Health-Related Quality of Life (HRQoL) and the mental health of children to obtain a comprehensive picture of their health status and uncover a possible gap in healthcare. (2) Methods: The sample consisted of 54 children who were treated for embryonal abdominal tumors and a control group of 46 children who received uncomplicated outpatient surgery. The HRQoL and the mental health were assessed by the parent proxy reports of the questionnaires Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). (3) Results: Children with embryonal abdominal tumors showed significantly lower HRQoL and mental health values compared to the norm data. The index group showed lower values in the social subscales of HRQoL and mental health compared to the control group. (4) Conclusions: Embryonal abdominal tumors affect the well-being of children. There is still a gap in healthcare due to children’s HRQoL and mental health, especially regarding social development. It is essential to further advance the psychological care of children and improve their chances to develop social relationships.

We analyzed efficacy of a centralized surveillance infection prevention (CSIP) program in a healthcare system on healthcare-associated infection (HAI) rates amid the coronavirus disease 2019 (COVID-19) pandemic. HAI rates were variable in CSIP and non-CSIP facilities. Central-line–associated bloodstream infection (CLABSI), C. difficile infection (CSI), and surgical-site infection (SSI) rates were negatively correlated with COVID-19 intensity in CSIP facilities.

Abstract Objective: To develop, implement, and evaluate the effectiveness of a unique centralized surveillance infection prevention (CSIP) program. Design: Observational quality improvement project. Setting: An integrated academic healthcare system. Intervention: The CSIP program comprises senior infection preventionists who are responsible for healthcare-associated infection (HAI) surveillance and reporting, allowing local infection preventionists (LIPs) a greater portion of their time to non-surveillance patient safety activities. Four CSIP team members accrued HAI responsibilities at 8 facilities. Methods: We evaluated the effectiveness of the CSIP program using 4 measures: recovery of LIP time, efficiency of surveillance activities by LIPs and CSIP staff, surveys characterizing LIP perception of their effectiveness in HAI reduction, and nursing leaders’ perception of LIP effectiveness. Results: The amount of time spent by LIP teams on HAI surveillance was highly variable, while CSIP time commitment and efficiency was steady. Post-CSIP implementation, 76.9% of LIPs agreed that they spend adequate time on inpatient units, compared to 15.4% pre-CSIP; LIPs also reported more time to allot to non-surveillance activities. Nursing leaders reported greater satisfaction with LIP involvement with HAI reduction practices. Conclusion: CSIP programs are a little-reported strategy to ease burden on LIPs with reallocation of HAI surveillance. The analyses presented here will aid health systems in anticipating the benefit of CSIP programs.

IntroductionPituitary pars intermedia dysfunction (PPID) and dental disorders are of major concern in horses older than 15 years. Although PPID in geriatric horses and dental disorders in all age groups are well described, a connection between this endocrine disease and pathological changes in equine dental structures has not yet been investigated. In humans, periodontitis is considered to be a complication of systemic diseases like diabetes mellitus type 2, obesity and various conditions leading to an impaired immune response. In PPID, cross links to insulin and immune dysregulations are proven. The aim of this study was to compare histological findings of the gingiva and the sub gingival periodontal ligament of PPID affected horses with control horses.MethodsIn a case-control morphometric descriptive study, 145 dental locations of 10 PPID affected horses (27.3 ± 2.06 years) were compared with 147 dental locations of 10 controls (21.4 ± 4.12 years). Histological parameters were leukocyte infiltration, keratinization of gingival epithelium, blood vessel supply of the periodontium and structure of cementum.ResultsThe distribution and localization of gingival leukocyte infiltrations (LI) in PPID affected horses was more often multifocal to coalescing (p = 0.002) and reached into deeper parts of the periodontium, sometimes down to the sub gingival periodontal ligament (PDL). Aged animals of both groups showed higher prevalence (PPID: OR 1.66; controls: OR 1.15) for severe leukocyte infiltration in the PDL. PPID was not significantly associated with increased LI. The cementum bordering the soft tissue in interdental locations showed four times more irregularities in PPID affected horses than in controls which predisposes for interdental food impaction and periodontal diseases.DiscussionIn summary, multifocal to coalescing leukocytes and irregular cementum are seen more often in PPID than in controls - however our findings mainly reflect an association of older age with periodontal disease.

This pilot study aimed to evaluate the association of plasma ubiquitin C-terminal hydrolase-L1 (UCH-L1), glial fibrillary acidic protein (GFAP), and S100 calcium-binding protein B (S100B) with intracranial abnormalities visible on a computed tomography (CT) scan (CT positive) and injury severity in acute traumatic brain injury (TBI). For these purposes, a cohort of 109 adult TBI patients was recruited within 6?h from the injury event. A hyperacute subcohort of 20 patients who had their blood collected within 2?h from injury was analyzed separately for early acute biomarker levels. Levels of GFAP and UCH-L1 were analyzed using the prototype Abbott i-STAT? TBI Plasma Test (Abbott Laboratories, Abbot Park, IL), alongside S100B measurement (Elecsys; Roche Diagnostics, Penzberg, Germany). In the hyperacute subcohort, GFAP and UCH-L1, but not S100B, levels were significantly higher in the CT-positive group compared to CT-negative patients. AUC values for differentiation between CT-positive and CT-negative patients were 0.97 for GFAP, 0.87 for UCH-L1, and 0.60 for S100B. Severity discrimination, defined by Glasgow Coma Scale (GCS) score, was then analyzed in the total patient cohort. Levels of all three biomarkers were significantly different between mild (GCS, 13?15) and moderate/severe (GCS, 3?12) injury groups. UCH-L1 showed the highest area under the curve value for severity discrimination (0.94), followed by GFAP (0.91) and S100B (0.83). These results support the clinical utility of GFAP and UCH-L1 as TBI biomarkers able to rule out CT-positive injury in acute TBI. Moreover, excellent differentiation of GFAP and UCH-L1 between mild and moderate/severe TBI groups affirms their close association with the underlying pathology.

Abstract Background COVID-19 has affected our society at large, particularly vulnerable groups, such as children suffering from rare diseases and their parents. However, the psychosocial influences of COVID-19 on these have yet to be investigated. As such, the study’s goal was to evaluate the health-related quality of life (HRQoL), quality of life (QoL), and mental health of children with rare congenital surgical diseases and their parents during the COVID-19 pandemic and lockdown measures. Methods A survey of n = 210 parents of children with rare congenital surgical diseases and a control group of n = 88 parents of children without rare diseases was conducted cross-sectionally between April 2020 to April 2021. Data on HRQoL, QoL, and mental health was collected using standardized psychometric questionnaires for children and parents presenting to the pediatric surgery department at a university hospital. Results Mothers of children with rare pediatric surgical diseases showed significantly lower QoL and significantly higher impairment in mental health than a control group and norm data. For fathers, this was solely the case for their QoL. Children’s parent-reported HRQoL and mental health were partially impaired. Social and disease-specific risk factors of the respective outcomes in affected families were identified through regression analysis models. Conclusion Parents of children with rare diseases report severe psychosocial impairment regarding themselves and their children during the COVID-19 pandemic. Therefore, affected families should receive attention and supportive care in the form of a family-center approach to alleviate the additional burden of the COVID-19 pandemic.

One approach to strengthening the involvement of farmers or stockpersons in the evaluation and improvement of animal welfare is the implementation of an on-farm self-assessment. A valid comparison of the results with reference values, between or within farms, requires that training of the farmers and reliability testing have taken place. We investigated two different training methods (online vs. live) with a total of 146 livestock farmers from farms with dairy cows and calves, beef cattle, sows and suckling piglets, weaners and fattening pigs, laying hens, broiler chickens, and turkeys from all over Germany. Online tests were conducted by assessing photos/videos of each indicator of the assessment scheme to estimate the inter-rater reliability (prevalence-adjusted and bias-adjusted kappa, PABAK). The farmers were requested to provide information on their professional background and rate their motivation to participate in the training and their subjective training success, meaning their confidence in assessing each indicator later on-farm. They evaluated the feasibility of the training and its impact on their views and attitudes. In general, farmers achieved at least substantial inter-rater reliability (PABAK ≥ 0.61) in 86.8% of all initial tests; 13.4% of the tests were repeated once or more times, resulting in a significant improvement of the agreement, with 90.9% of the tests reaching a PABAK ≥ 0.61. However, reliability was higher for indicators with a lower number of score levels. The subjective evaluation of training success was, on average, positive (score = 74.8 out of 100). No effects of the training method or the farmers’ professional background on the inter-rater reliability or the subjective training success were detected. Furthermore, for both methods, farmers moderately agreed that the training had sharpened their views on the animals, encouraged them to implement the assessment on their farm, and made it clear that self-assessment supports animal management. Although the reported costs and time investment for the online training were significantly lower, the effort required for both methods and the ease of integration into the workflow were ranked as similarly acceptable. Overall, both training methods appear feasible for the training of farmers/stockpersons on the assessment of animal-based indicators.

In this work, we review single mode SiO₂ fiber Bragg grating techniques for dilatometry studies of small single-crystalline samples in the extreme environments of very high, continuous, and pulsed magnetic fields of up to 150 T and at cryogenic temperatures down to