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Purpose The Co-HCW study is a prospective, longitudinal, single-center observational study that aims to assess the SARS-CoV-2 seroprevalence and infection status in staff members of Jena University Hospital (JUH) in Jena, Germany. Methods This follow-up study covers the observation period from 19th May 2020 to 22nd June 2021. At each of the three voluntary study visits, participants filled out a questionnaire regarding their SARS-CoV-2 exposure and provided serum samples to detect specific SARS-CoV-2 antibodies. Participants who were tested positive for antibodies against nucleocapsid and/or spike protein without previous vaccination and/or reported a positive SARS-CoV-2 PCR test were regarded to have been infected with SARS-CoV-2. Multivariable logistic regression modeling was applied to identify potential risk factors for infected compared to non-infected participants. Results Out of 660 participants that were included during the first study visit, 406 participants (61.5%) were eligible for the final analysis as their COVID-19 risk area (high-risk n = 76; intermediate-risk n = 198; low-risk n = 132) did not change during the study. Forty-four participants [10.8%, 95% confidence interval (95%CI) 8.0–14.3%] had evidence of a current or past SARS-CoV-2 infection detected by serology (n = 40) and/or PCR (n = 28). No association between SARS-CoV-2 infection and the COVID-19 risk group according to working place was detected. However, exposure to a SARS-CoV-2 positive household member [adjusted OR (AOR) 4.46, 95% CI 2.06–9.65] or colleague (AOR 2.30, 95%CI 1.10–4.79) was found to significantly increase the risk of a SARS-CoV-2 infection. Conclusion Our results demonstrate that non-patient-related SARS-CoV-2 exposure posed the highest infection risk for hospital staff members of JUH.

BackgroundThe Co-HCW study is a prospective, longitudinal single center observational study on the SARS-CoV-2 seroprevalence and infection status in staff members of Jena University Hospital (JUH) in Jena, Germany.Material and MethodsThis follow-up study covers the observation period from 19th May 2020 to 22nd June 2021. At each out of three voluntary study visits, participants filled out a questionnaire on individual SARS-CoV-2 exposure. In addition, serum samples to assess specific SARS-CoV-2 antibodies were collected. Participants with antibodies against nucleocapsid and/or spike protein without previous vaccination and/or a reported positive SARS-CoV-2 PCR test were regarded as participants with detected SARS-CoV-2 infection. Multivariable logistic regression modeling was applied to identify potential risk factors for infected compared to non-infected participants.ResultsOut of 660 participants that were included during the first study visit, 406 participants (61.5%) were eligible for final analysis as they did not change the COVID-19 risk area (high-risk n=76; intermediate-risk n=198; low-risk n=132) during the study. Forty-four participants (10.8%, 95% confidence interval (95%CI) 8.0%-14.3%) had evidence of a current or past SARS-CoV-2 infection detected by serology (n=40) and/or PCR (n=28). No association of any SARS-CoV-2 infection with the COVID-19 risk group according to working place could be detected. But exposure to a SARS-CoV-2 positive household member (adjusted OR (AOR) 4.46, 95%CI 2.06-9.65) or colleague (AOR 2.30, 95%CI 1.10-4.79) significantly increased the risk of a SARS-CoV-2 infection.ConclusionOur results demonstrate that non-patient-related SARS-CoV-2 exposure imposed the highest infection risk in hospital staff members of JUH.

The Co‐HCW study is a prospective cohort study among hospital staff, including healthcare workers (HCWs) and administration staff, at the Jena University Hospital (JUH), Germany. The objectives of this study were to assess SARS‐CoV‐2 IgG seroprevalence, individual exposure risk factors and compliance of HCWs to wear personal protective equipment (PPE). After the first nosocomial COVID‐19 outbreak at JUH, mandatory masking was implemented on 20th March 2020. We evaluated point seroprevalence using two IgG detecting immunoassays and issued a questionnaire to assess COVID‐19 exposure, clinical symptoms and compliance to wear PPE. Antibody retesting was offered to participants with a divergent result of both immunoassays 5–10 weeks after the first test. Between 19th May and 19th June 2020, we analysed 660 participants [out of 3,228; 20.4%]. Among them, 212 participants (32.1%) had received a previous COVID‐19 test. Four of them (1.9%) reported a positive test result. After recruitment, 18 participants (2.7%) had SARS‐CoV‐2 antibodies in at least one immunoassay. Overall, 21 participants (3.2%) had any evidence of a past or current SARS‐CoV‐2 infection. Among them, 13 (61.9%) were not aware of direct COVID‐19 exposure and 9 (42.9%) did not report any clinical symptoms. COVID‐19 exposure at home (adjusted OR (aOR) with 95% CI: 47.82 (5.49, 416.62)) was associated with SARS‐CoV‐2 seroprevalence. We observed no evidence for an association between seroprevalence and exposure at work (aOR 0.48 (0.13, 1.70)) or with COVID‐19 risk area according to the working place (aOR for intermediate‐risk vs. high‐risk: 1.97 (0.42, 9.22), aOR for low‐risk versus high‐risk: 2.10 (0.40, 11.06); p = .655). Reported compliance of HCWs to wear PPE differed (p

Zusammenfassung Zielsetzung In Krankenhausern ist das Fallmanagement (FM) auf den Krankenhausstationen wesentlicher Erfolgsfaktor fur die Sicherstellung einer hohen Qualitat und Wirtschaftlichkeit der zu erbringenden Gesundheitsdienstleistungen. Die vorliegende Studie untersucht mit welchen Potentialen und Moglichkeiten das FM am Point of Care (POC) optimiert werden kann. Methode Mittels eines strukturierten Interviewinventars wurde eine Soll-Analyse von typischen Mikroprozessen des Fallmanagements auf Krankenhausstationen durchgefuhrt. Dazu wurde eine Felduntersuchung an 24 deutschen bettenfuhrenden Krankenhausabteilungen der Maximalversorgung in Form von strukturierten Interviews mit homogenen Fokusgruppen durchgefuhrt, diese mit Hilfe eines erweiterten Balanced-Scorecard-Ansatzes ausgewertet und die Ergebnisse anschliesend mit den Fokusgruppen reflektiert. Ergebnisse Vor allem die Prozessqualitat und -sicherheit des Fallmanagements sowie die Sicherstellung der leistungsrelevanten Dokumentationen am POC bietet deutliche Optimierungspotentiale. Ein wesentlicher Optimierungsansatz wird dabei in der Reduktion der Fragmentierung der Teilprozesse des klinischen Fallmanagements, verbunden mit der Homogenisierung dieses Tatigkeitsspektrums in einer neuen und interdisziplinar agierenden Berufsgruppe, den klinischen Fallmanagern (KFM), gesehen. Schlussfolgerung Die Homogenisierung der Aktivitaten des Fallmanagements auf Krankenhausstationen durch klinische Fallmanager (KFM) bietet Potentiale und Moglichkeiten den arztlichen und pflegerischen Dienst von diesen Tatigkeiten zu entlasten und gleichzeitig die Qualitat und Wirtschaftlichkeit der Gesundheitsdienstleistungen fur Patienten, Mitarbeiter und sektorenubergreifenden Mitbehandlern zu verbessern.

ZusammenfassungDie AWMF und ihre Fachgesellschaften nehmen eine zunehmende Dominanz betriebswirtschaftlicher Ziele im stationären Gesundheitssektor wahr, die sich negativ auf die Patientenversorgung auswirken. Während eine angemessene, effiziente und gerechte Mittelverwendung geboten ist, belastet „Ökonomisierung“ Ärzte und Pflegende sowie die weiteren Gesundheitsberufe.Die AWMF hat zusammen mit Fachgesellschaftsvertretern Ursachen analysiert und Maßnahmen für eine wissenschaftliche, patientenzentrierte und ressourcenbewusste Medizin erarbeitet. Es bestehen Fehlanreize durch Vergütung, Zahl und Ausstattung von Krankenhäusern bzw. Fachabteilungen und deren Grundfinanzierung. Maßnahmen werden für die Patient–Arzt-Ebene, das Krankenhausmanagement, die Planung sowie Finanzierung von Krankenhäusern einschließlich der Vergütung stationärer Leistungen vorgeschlagen. Dabei bedarf es der gemeinsamen Anstrengung aller Akteure, um den Patienten und seine Gesundheit wieder in den Mittelpunkt zu stellen.

BackgroundHealthcare workers (HCWs) are at particular risk to acquire SARS-CoV-2 infections.AimThe objectives of this study were to compare SARS-CoV-2 IgG seroprevalence and compliance to wear personal protective equipment (PPE) between HCWs working within (high-risk) or outside (intermediate-risk) units treating suspected or confirmed COVID-19 patients. In addition, administration staff (low-risk) was included.MaterialsCo-HCW is a prospective cohort study among employees at the Jena University Hospital, Germany. Since 16th March 2020, 50 SARS-CoV-2 inpatients and 73 outpatients were treated in our hospital. Mandatory masking was implemented on 20th March 2020. We here evaluated seroprevalence using two IgG detecting immunoassays, assessed COVID-19 exposure, clinical symptoms and compliance to wear PPE.FindingsBetween 19th May and 19th June 2020 we analysed 660 employees [out of 3,228; 20.4%]. Eighteen participants (2.7%) had SARS-CoV-2 antibodies in at least one immunoassay. Among them, 13 (72.2%) were not aware of direct COVID-19 exposure and 9 (50.0%) did not report any clinical symptoms. We observed no evidence for an association between seroprevalence and risk area (high-risk: 2 of 137 HCWs (1.5%), intermediate-risk: 10 of 343 HCWs (2.9%), low-risk: 6 of 180 administration employees (3.3%); p=0.574). Reported compliance to wear PPE differed (pConclusionNo evidence for higher seroprevalence against SARS-CoV-2 in HCWs working in high-risk COVID-19 areas could be observed, probably due to high compliance to wear PPE. Compared to administration employees, we observed no additional risk to acquire SARS-CoV-2 infections by patient care.

Universal masking the health care setting and in the community to contain the spread of SARS-CoV-2 has been recently recommended by the WHO, but supporting data are rare. The City of Jena was the first community in Germany to issue an order on mandatory public masking. Here, we report the development of the number of novel infections in our hospital and in the city of Jena after implementation of universal masking in our hospital and the city.

Zusammenfassung Hintergrund Wesentliche Ziele von Krankenhäusern sind eine hohe Qualität, Sicherheit, Effektivität und Effizienz der Leistungserbringung. Dies erfordert eine optimale Behandlungssteuerung durch das Fallmanagement auf den Krankenhausstationen (FM). Methoden Für eine Analyse der Mikro- und Makroprozesse des stationären Fallmanagements wurde ein strukturiertes Interviewinventar entwickelt. Anschließend wurde mit dem Interviewinventar eine Felduntersuchung als community based participatory research (CBPR) an homogenen Fokusgruppen von 24 deutschen, aus ökonomischer Sicht als Profitcenter wirkenden, öffentlichen Krankenhausabteilungen der Maximalversorgung durchgeführt. Ergebnisse Mit der CBPR-Feldstudie konnten 1.682 Mikroprozesse des stationären Fallmanagements der untersuchten Krankenhausabteilungen erfasst und beurteilt werden. Die Studie zeigt, dass alle Abteilungen zwar ein umfangreiches klinisches Fallmanagement betreiben, die Mikroprozesse des Fallmanagements allerdings durchgehend weder optimal zur Kostenminimierung noch maximal zur Liquiditäts-, Erlös- und Qualitätsverbesserung durchgeführt werden. Auch zeigt sich, dass die berufsgruppenübergreifende Durchführung der Prozesse des FM durch Ärzte und Pflegekräfte mit einer erheblichen Fragmentierung des FM verbunden ist. Schlussfolgerungen Die intensive Fragmentierung der Tätigkeiten des FM auf Krankenhausstationen legt die Erarbeitung von Strategien nahe, die Prozesse des stationären Fallmanagements zu homogenisieren.

The AWMF and its medical societies perceive an increasing dominance of economic targets in the hospital health care sector, leading to impairment of patient care. While resource use in health care should be appropriate, efficient and fairly allocated, "economization" creates a burdensome situation for physicians, nurses and other health care professionals.The AMWF and the medical societies studied causes and developed measures for a scientific, patient-centred and resource-conscious medical care. Disincentives due to the remuneration system, number and equipment of hospitals resp. specialist departments and their basic funding need to be overcome. Proposed actions relate to the patient-doctor-level, the management level of hospitals and the level of planning and financing hospitals including compensation of hospital care. To place patients and their health in the forefront again, joint efforts of all stakeholders in health care are needed.Die AWMF und ihre Fachgesellschaften nehmen eine zunehmende Dominanz betriebswirtschaftlicher Ziele im stationären Gesundheitssektor wahr, die sich negativ auf die Patientenversorgung auswirken. Während eine angemessene, effiziente und gerechte Mittelverwendung geboten ist, belastet „Ökonomisierung“ Ärzte und Pflegende sowie die weiteren Gesundheitsberufe.Die AWMF hat zusammen mit Fachgesellschaftsvertretern Ursachen analysiert und Maßnahmen für eine wissenschaftliche, patientenzentrierte und ressourcenbewusste Medizin erarbeitet. Es bestehen Fehlanreize durch Vergütung, Zahl und Ausstattung von Krankenhäusern bzw. Fachabteilungen und deren Grundfinanzierung. Maßnahmen werden für die Patient–Arzt-Ebene, das Krankenhausmanagement, die Planung sowie Finanzierung von Krankenhäusern einschließlich der Vergütung stationärer Leistungen vorgeschlagen. Dabei bedarf es der gemeinsamen Anstrengung aller Akteure, um den Patienten und seine Gesundheit wieder in den Mittelpunkt zu stellen.

IntroductionHealthcare-associated infections (HAIs) are a major health concern and have substantial effects on morbidity and mortality and increase healthcare costs. We investigated the effect of a hospital-wide program for the prevention of HAIs on additional length of stay (LOS).MethodsWe analyzed data from a prospective, single-center, quasi-experimental study with two surveillance periods before and after implementation of an infection prevention intervention program. HAI diagnosis was made according to surveillance definition criteria established by the US Centers for Disease Control and Prevention. A multistate model was used to estimate additional LOS for patients with HAI in both surveillance periods.ResultsDuring the first and second periods, 1,568 and 2,336 HAIs were identified among 26,943 and 35,211 patients, respectively. For HAI patients exclusively treated in a general ward, additional LOS was 8.4 (95% confidence interval, CI: 6.8-10.0) days in the first period and 9.6 (95% CI: 8.3-11.0) days in the second period (p = 0.26). For HAI patients treated in both an intensive care unit (ICU) and a general ward, additional LOS was 8.1 (95% CI: 6.3-9.9) days in the first period to 7.3 (95% CI: 6.1-8.5) days in the second period (p = 0.47).ConclusionsHealthcare-associated infections prolong LOS. A hospital-wide infection control program did not alter the prolongation of LOS.

In hospitals, case management (CM) on hospital wards is essential for maintaining a high level of quality and efficiency of care. The present study examined how CM at the Point of Care (POC) can be optimized and which potentials exist.The potentials for optimization of typical case management processes performed on hospital wards were analyzed using a structured interview guide. For this purpose, a field study was performed in 24 German hospital departments of tertiary care. Structured interviews were conducted with homogeneous focus groups. The results were evaluated using an extended Balanced Score Card approach and discussed afterwards with the focus groups.Above all, the process quality and safety of case management as well as ensuring the relevant documentation at the POC appears to offer significant potential for optimization. An essential approach to eventually realize the potential for optimization is the reduction of fragmentation of the micro-processes associated with the case management duties on inpatient wards. This homogenization of these activities ideally requires a new and interdisciplinary acting profession, the clinical case managers.The homogenization of the case management activities on hospital wards by clinical case managers has the potential and possibilities to relieve both medical and nursing staff of these activities, while improving the quality and efficiency of care for patients, staff and cross-sectoral healthcare provider at the same time.

ObjectivesBreast milk (BM) is the primary source of cytomegalovirus (CMV) transmission to premature infants with potentially harmful consequences. We therefore wanted to evaluate temperature and duration of short-term BM pasteurisation with respect to CMV inactivation, effect on CMV-IgG antibodies and BM enzyme activities.Methods116 artificially CMV-spiked BM and 15 wild-type virus-infected samples were subjected for 5 s to different temperatures (55°C–72°C). CMV-IE-1 expression in fibroblast nuclei was assessed using the milk whey fraction in short-term microculture. BM lipase and alkaline phosphatase (AP) activities and CMV binding using CMV-recomLine immunoblotting and neutralising antibodies using epithelial target cells were analysed before and after heating.ResultsA minimum of 5 s above 60°C was necessary for CMV inactivation in both CMV-AD-169 spiked and wild-type infected BM. Lipase was very heat sensitive (activities of 54% at 55°C, 5% at 60°C and 2% at 65°C). AP showed activities of 77%, 88% and 10%, respectively. CMV-p150 IgG antibodies were mostly preserved at 62°C for 5 s.ConclusionOur results show that short-term pasteurisation of BM at 62°C for 5 s might be efficient for CMV inactivation and reduces loss of enzyme activities, as well as CMV binding, and functional CMV antibodies.

Objectives This study aimed to determine the additional costs and length of stay (LOS) due to surgical site infections (SSIs) after coronary artery bypass grafting (CABG) at Jena University Hospital. Methods The data of 999 consecutive patients who underwent CABG from January 2013 to December 2014 were collected. We extracted the number, type and duration of antimicrobial therapy and V.A.C.® therapy (negative pressure wound therapy) treatments and calculated the additional SSI-related costs based on the hospital's perspective. We also evaluated the prolongation of LOS using a multistate model and calculated the costs due to the additional LOS. Results In total, 983 patients were included in our analysis, and 126 patients with SSIs following CABG were identified during the study period; 124 patients with SSIs (98.4%) were discharged alive. The mean cost of antimicrobial therapy to treat the SSIs was €818 [95% confidence interval (CI) 392-1245], and the mean cost of V.A.C. therapy was €1179 (95% CI 748-1610) per infected patient. The mean additional LOS due to SSIs (±standard error) was estimated to be 9.3 ± 2.6 days. The cost per SSI-infected patient attributable to the additional LOS was €9444 (95% CI 4242-14 645). Conclusions SSIs following CABG are associated with an additional LOS and a significant economic burden depending on the classification of SSI. A very important component of the additional cost is the prolongation of LOS. Therefore, it is essential to shorten the hospital stay due to SSIs as far as possible.

Background Postnatally acquired cytomegalovirus (pCMV) infection through breast milk (BM) may cause severe illness and even death, yet BM is advantageous for preterm infants. Therefore, effective methods to prevent CMV transmission are needed. Methods To assess the effectiveness of short-term pasteurization (62°C for 5 seconds) in preventing CMV transmission via BM in preterm infants. Design: Prospective interventional bicentric cohort study with infant enrollment between 6/2010 and 1/2012. A cohort from the Tuebingen neonatal intensive care unit (NICU) from 1995–1998 served as historical controls. Differences in CMV transmission were compared with reference to the cumulative time at risk for CMV transmission. Setting: Two German level-3 NICUs. Eighty-seven preterm infants of 69 CMV immunoglobulin G-positive mothers with birth weight Results Two of 87 (2.3%) study infants had a pCMV transmission. This compared to 17 of 83 (20.5%) controls. Total time under risk for infection was 9.6 years vs 10.0 years in controls, yielding an incidence of 0.21/year (95% confidence interval [CI], 0.03 to 0.75/year) vs 1.70/year (95% CI, 0.99 to 2.72/year), respectively. The risk ratio controls vs study infants was 8.3 (95% CI, 2.4 to 52.4) according to Cox proportional hazard model (P = .0003). Conclusions Short-term pasteurization significantly reduces the incidence of pCMV infection through BM in the NICU. Clinical Trials Registration NCT01178905.

Summary Introduction: This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. “Smart Medical Information Technology for Healthcare (SMITH)” is one of four consortia funded by the German Medical Informatics Initiative (MI-I) to create an alliance of universities, university hospitals, research institutions and IT companies. SMITH’s goals are to establish Data Integration Centers (DICs) at each SMITH partner hospital and to implement use cases which demonstrate the usefulness of the approach. Objectives: To give insight into architectural design issues underlying SMITH data integration and to introduce the use cases to be implemented. Governance and Policies: SMITH implements a federated approach as well for its governance structure as for its information system architecture. SMITH has designed a generic concept for its data integration centers. They share identical services and functionalities to take best advantage of the interoperability architectures and of the data use and access process planned. The DICs provide access to the local hospitals’ Electronic Medical Records (EMR). This is based on data trustee and privacy management services. DIC staff will curate and amend EMR data in the Health Data Storage. Methodology and Architectural Framework: To share medical and research data, SMITH’s information system is based on communication and storage standards. We use the Reference Model of the Open Archival Information System and will consistently implement profiles of Integrating the Health Care Enterprise (IHE) and Health Level Seven (HL7) standards. Standard terminologies will be applied. The SMITH Market Place will be used for devising agreements on data access and distribution. 3LGM2 for enterprise architecture modeling supports a consistent development process.The DIC reference architecture determines the services, applications and the standards-based communication links needed for efficiently supporting the ingesting, data nourishing, trustee, privacy management and data transfer tasks of the SMITH DICs. The reference architecture is adopted at the local sites. Data sharing services and the market place enable interoperability. Use Cases: The methodological use case “Phenotype Pipeline” (PheP) constructs algorithms for annotations and analyses of patient-related phenotypes according to classification rules or statistical models based on structured data. Unstructured textual data will be subject to natural language processing to permit integration into the phenotyping algorithms. The clinical use case “Algorithmic Surveillance of ICU Patients” (ASIC) focusses on patients in Intensive Care Units (ICU) with the acute respiratory distress syndrome (ARDS). A model-based decision-support system will give advice for mechanical ventilation. The clinical use case HELP develops a “hospital-wide electronic medical record-based computerized decision support system to improve outcomes of patients with blood-stream infections” (HELP). ASIC and HELP use the PheP. The clinical benefit of the use cases ASIC and HELP will be demonstrated in a change of care clinical trial based on a step wedge design. Discussion: SMITH’s strength is the modular, reusable IT architecture based on interoperability standards, the integration of the hospitals’ information management departments and the public-private partnership. The project aims at sustainability beyond the first 4-year funding period.

Background: Breast milk is the primary source of cytomegalovirus (CMV) transmission to newborns and premature infants. The role of cell-free milk whey in virus transmission is well understood, yet the knowledge about the role of milk cells in this process is scarce. Objective: To preliminarily characterize different breast milk cell types during various stages of lactation to evaluate their potential role in the transmission of CMV. Materials and Methods: Breast milk cells of 18 lactating and 3 CMV-seropositive mothers of preterm infants were isolated and characterized for expression of myeloid markers by flow cytometry. In parallel, cytospin preparations were stained with α-naphthyl acetate esterase to identify milk macrophages and describe the dynamic changes of the macrophage-granulocyte population during lactation. The influence of different time points of lactation was analyzed by FACS analysis of double-stained (CD15/CD66b) milk cells. To characterize CMV target cells in breast milk, we enriched CD14+ cells by MACS (Miltenyi) and monitored cell fractions using CMV IEEx4 nested PCR and pp67 CMV RNA by NASBA. Results: Virolactia, viral DNAlactia, and viral pp67 late mRNA could be detected in breast milk cells only in defined time periods. Granulocytes and macrophages demonstrated an inverse dynamic with neutrophils predominating in the early stages (60 days postpartum) of lactation. Enrichment of CD14-positive cells resulted in viral DNA and pp67 late mRNA detection. Conclusions: Granulocytes and monocytes/macrophages are the predominating cell populations in breast milk with changing frequencies during early lactation. These results demonstrate that CD14-positive breast milk cells seem to be one of the target cells for CMV in breast milk.

Concomitant radiochemotherapy followed by six cycles of temozolomide (= short term) is considered as standard therapy for adults with newly diagnosed glioblastoma. In contrast, open-end administration of temozolomide until progression (= long-term) is proposed by some authors as a viable alternative. We aimed to determine the cost-effectiveness of long-term temozolomide therapy for patients newly diagnosed with glioblastoma compared to standard therapy. A Markov model was constructed to compare medical costs and clinical outcomes for both therapy types over a time horizon of 60 months. Transition probabilities for standard therapy were calculated from randomized controlled trial data by Stupp et al. The data for long-term temozolomide therapy was collected by matching a cohort treated in the Department of Neurosurgery at Jena University Hospital. Health utilities were obtained from a previous cost utility study. The cost perspective was based on health insurance. The base case analysis showed a median overall survival of 17.1 months and a median progression-free survival of 7.4 months for patients in the long-term temozolomide therapy arm. The cost-effectiveness analysis using all base case parameters in a time-dependent Markov model resulted in an incremental effectiveness of 0.022 quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) was €351,909/QALY. Sensitivity analyses showed that parameters with the most influence on ICER were the health state utility of progression in both therapy arms. Although open-ended temozolomide therapy is very expensive, the ICER of this therapy is comparable to that of the standard temozolomide therapy for patients newly diagnosed with glioblastoma.

Background A foodborne outbreak of VIM carbapenemase-expressing Citrobacter freundii (CPC) occurred between February 2016 and June 2016 at a major university hospital in Germany. Methods An explosive increase in CPC isolated from rectal swabs of patients during weekly routine screening led to the declaration of an outbreak. A hospital-wide prevalence screening was initiated as well as screening of all patients on admission and before transfer to another ward, canteen staff, patient rooms, medical and kitchen inventory, and food. Swabs were streaked out on selective plates. All CPC isolates were analyzed using mass spectrometry, and selected isolates were analyzed using whole-genome sequencing. Results A total of 76 were identified; most were unrelated cases in different wards. The CPC was isolated from retained samples of prepared vegetable salads and puddings and from a mixing machine used to prepare these foods only after an overnight culture. The immediate ban on serving potential source food resulted in a sharp decline and finally disappearance of novel cases. Repeated testing of presliced vegetables showed a high degree of contamination with C. freundii without a carbapenemase, indicating a possible source. Conclusions An explosive increase in carbapenemase-expressing Enterobacteriaceae contamination may have been caused by a foodborne source, and presliced vegetables should be taken into account as a putative pathogen repository. These findings underline the importance of appropriate cooling, transport, reheating, and distribution of meals and indicate that probing of nonorganic surfaces is limited by low sensitivity, which may be increased by additional overnight cultivation in appropriate media.

The economic pressure on German hospitals has increased considerably over the last years, mainly because of the introduction of a flat-rate payment system, and it will most likely further increase under the current demographic and political conditions. The growing dominance of economics in the inpatient sector increases the pressure on hospital staff and results in an increased volume of care (with sometimes inappropriate overtreatment) and uncontrolled rationing and a continuous struggle to maintain the quality of patient care. This development is not only alarming from an ethical perspective, but also impairs the hospital's economic performance. To counter the increasing economic pressure with "more ethics" does--according to the line of reasoning adopted in this article--not appear to be very successful. Rather, central ethical values in inpatient care have to become an integral part of hospital management. This value management first requires a clear definition of the normative standards, e.g. within a mission statement. Second, the realisation of the normative standards in routine inpatient care has to be systematically assessed, evaluated and managed. Since normative standards are difficult to measure objectively and on a quantitative scale, (repeated) surveys among hospital staff are the central instrument to secure the "internal quality" of the hospital. It appears very likely that more ethics in the hospital will pay off by improving its economic performance. The empirical proof for this conceptually extremely plausible hypothesis has yet to be provided.

Hintergrund: Vorliegende Arbeit untersucht die Wirksamkeit und Personalkostenneutralitat der am Universitatsklinikum Tubingen entwickelten neuen Dienstmodelle fur die dem Tarifvertrag fur Arzte unterliegenden Beschaftigten hinsichtlich der Einhaltung der durchschnittlichen Wochenarbeitszeit (dWAZ) und der 10h-Tageshochstarbeitszeitgrenze (10h-TAZ). Methodik: In vier Pilotkliniken wurden 2008 neue Dienstmodelle eingefuhrt und seither elektronisch geplant und dokumentiert. Die Auswertung erfolgte deskriptiv (dWAZ) bzw. statistisch mittels einfaktorieller Varianzanalyse (Uberschreitung der 10 h-TAZ) oder mittels Student-t-Test fur Personalkosten- und Leistungsvergleiche. Fur letzteres dienten vier Kliniken ohne Dienstmodellanderung als Kontrollgruppe. Ergebnisse: Die Dienstmodelle erlaubten die Einhaltung der dWAZ in 80 % der Falle. Arzte im Einschichtsystem waren mit 38 % haufiger von 10 h-TAZ-Uberschreitungen betroffen, als Kollegen in Zwei- (15 %) oder Dreischichtsystemen (12 %; p Schlussfolgerungen: Mit den neuen Dienstmodellen konnte die Einhaltung der dWAZ und der 10 h-TAZ gewahrleistet werden, wobei das Einschichtsystem schlechter abschnitt. Hochgerechnet auf das Gesamtklinikum waren Mehrkosten von 1,25 Mio. €/a zu erwarten.

Objectives: To compare complication rates, length of hospital stay, and resulting costs between the use of manual compression and a vascular closing device (VCD) in both diagnostic and interventional catheterization in a German university hospital setting. Methods: A stratified analysis according to risk profiles was used to compare the risk of complications in a retrospective cross-sectional single-center study. Differences in costs and length of hospital stay were calculated using the recycled predictions method, based on regression coefficients from generalized linear models with gamma distribution. All models were adjusted for propensity score and possible confounders, such as age, sex, and comorbidities. The analysis was performed separately for diagnostic and interventional catheterization. Results: The unadjusted relative risk (RR) of complications was not significantly different in diagnostic catheterization when a VCD was used (RR = 0.70; 95% confidence interval [CI] 0.22-2.16) but significantly lower in interventional catheterization (RR = 0.44; 95% CI 0.21-0.93). Costs were on average €275 lower in the diagnostic group (95% CI -€478.0 to -€64.9; P = 0.006) and around €373 lower in the interventional group (95% CI -€630.0 to -€104.2; P = 0.014) when a VCD was used. The adjusted estimated average length of stay did not differ significantly between the use of a VCD and manual compression in both types of catheterization. Conclusions: In interventional catheterization, VCDs significantly reduced unadjusted complication rates, as well as costs. A significant reduction in costs also supports their usage in diagnostic catheterization on a larger scale.

Objective Preterm infants are at risk of acquiring human cytomegalovirus (CMV) infection through breast milk transmission, possibly leading to serious symptoms, as suggested by previous studies. Over a period of 8.5 years, we compared infants infected postnatally with CMV with noninfected controls to determine whether CMV infection transmitted through breast milk poses serious acute risks. Study design CMV monitoring included maternal serologic testing and biweekly viral culture and polymerase chain reaction in breast milk and infant urine. Clinical and laboratory test findings were assessed retrospectively in infected infants and controls matched for gestational age during the initial hospital stay. Results Forty CMV-infected infants met the study criteria. They had lower minimal platelet and neutrophil counts and a higher frequency of C-reactive protein (CRP) elevations to 10 to 20 mg/L than their matched controls ( P ≤ .001). But no association of CMV infection with bronchopulmonary dysplasia, necrotizing enterocolitis, growth, or CRP elevations to > 20 mg/L was found. Cholestasis appeared in 3 infants in the CMV-infected group, but disappeared within 10 weeks. Conclusions Neonatal symptoms related to postnatal CMV infection were transient and had no affect on neonatal outcome in these infants, in contrast with uncontrolled reports. Whether withholding or pasteurizing breast milk is warranted, however, depends on long-term outcome.

The incidence of postnatal human cytomegalovirus (HCMV) reactivation during lactation equals the maternal seroprevalence. Infectious virus, viral DNA and RNA can be isolated from cells and fat free milk whey. Early onset of viral DNAlactia and virolactia as well as high viral load in milk whey are maternal risk factors for virus transmission. Preterm infants below 1000 g birthweight and a gestational age below 30 weeks may be at high risk of acquiring a symptomatic HCMV infection. Several recent studies using frozen milk for feeding describe low transmission rates and mostly asymptomatically infected neonates. However despite different freeze-storing procedures HCMV transmission occurred and severe HCMV infections were observed. Only few data exist on the long-term outcome of postnatally acquired HCMV infection via breast milk. Additional long-term outcome studies are needed. The newly developed short-term pasteurisation may be a reliable alternative to freezing and Holder pasteurisation, since important milk constituents are conserved.

Background: Human cytomegalovirus (HCMV) is reactivated in nearly every seropositive breastfeeding mother during lactation [Lancet 357 (2001) 513]. Conventional tissue culture (TC) and low-speed centrifugation-enhanced microtiter culture methods are not able to detect HCMV from milk during all stages of lactation. Objectives: Development of a sensitive and quantitative microculture technique to describe the dynamics of HCMV reactivation in different milk compartments during lactation. Study design: Milk samples were collected longitudinally from seropositive breastfeeding mothers of preterm infants. Native milk samples were separated into fraction 1 (aqueous extract of milk fat), fraction 2 (cell and fat free milk whey) and fraction 3 (milk cells). Each of these fractions was screened qualitatively (TC, nPCR, pp67 late mRNA) and quantitatively (high-speed centrifugation-based microculture, quantiative PCR). Results: Prior to low-speed centrifugation-enhanced inoculation, virus particles were concentrated by high-speed centrifugation (60 min at 50 000× g , 4 °C). Using fraction 2 we were able to describe the dynamics of viral reactivation during lactation. We present the course of the quantitative virolactia and DNAlactia and qualitative detection of HCMV pp67 late mRNA in milk whey of four mothers (three transmitters and one non-transmitter). In all these cases virolactia described an unimodal and self limited course. Peak levels of virolactia for transmitters (T 1 : day 44; T 2 : day 43; T 3 : day 50) were closely related the onset of viruria of the corresponding preterm infants (U 1 : day 39; U 2a /U 2b : day 44/57; U 3 : day 60). The courses of viral load coincidence with the courses of DNA load. Conclusions: We present a rapid and highly sensitive microculture method for the quantification of cell free HCMV from milk whey and aqueous extracts from milk fat. Viral reactivation during lactation describes an unimodal course. Our findings have strong implications for quality control of any virus inactivation procedure.

Background: The impact of the European Working Time Directive and subsequent collective wage agreements for doctors from 2006 onwards were substantial. So far, no systematic evaluation of their application in Germany has been performed. We evaluated the impact four years after implementation of new shift models in a University Hospital for Gynaecology and Obstetrics (UHGO). Methods: A new shift model was created together with doctors of Tubingen UHOG in 2007 and implemented in 2008. Documentation of working hours has hence been done electronically. Adherence to the average weekly working time limit (AWTL) and the maximum of 10 h daily working time (10 h-dwt) was evaluated, as well as staffing costs in relation to case-weight points gathered within the German DRG (diagnosis related groups) System. Results: Staff increased from a mean of 44.7 full time equivalent (FTE) doctors in 2007 to 52.5 FTE in 2009, 50.8 in 2010, and 54.5 in 2011. There was no statistically significant difference of the monthly staff expenditures per case-weight between the years 2009 or 2010 vs. 2007. 2011, however, was significantly more expensive than 2007 (p = 0.02). The internal control group (five other departments of the university hospital) did not show an increase during the same period. AWTL were respected by 90, 96, and 98 % in 2009, 2010, and 2011, respectively. Of all shifts 10 h-dwt was exceeded by 7.4 % in 2009, 1.3 % in 2010, and 2.6 % in 2011, with significant differences between 2009 and both, 2010 and 2011 (p Discussion: AWTL and 10 h-dwt could be continuously respected quite well after implementation of the new shift model without increasing the cost/earnings ratio for the first two years. However, in 2011 the ratio increased significantly (p = 0.02).

The economic pressure on German hospitals has increased considerably over the last years, mainly because of the introduction of a flat-rate payment system, and it will most likely further increase under the current demographic and political conditions. The growing dominance of economics in the inpatient sector increases the pressure on hospital staff and results in an increased volume of care (with sometimes inappropriate overtreatment) and uncontrolled rationing and a continuous struggle to maintain the quality of patient care. This development is not only alarming from an ethical perspective, but also impairs the hospital's economic performance. To counter the increasing economic pressure with "more ethics" does--according to the line of reasoning adopted in this article--not appear to be very successful. Rather, central ethical values in inpatient care have to become an integral part of hospital management. This value management first requires a clear definition of the normative standards, e.g. within a mission statement. Second, the realisation of the normative standards in routine inpatient care has to be systematically assessed, evaluated and managed. Since normative standards are difficult to measure objectively and on a quantitative scale, (repeated) surveys among hospital staff are the central instrument to secure the "internal quality" of the hospital. It appears very likely that more ethics in the hospital will pay off by improving its economic performance. The empirical proof for this conceptually extremely plausible hypothesis has yet to be provided.

Due to the European Working Time Directive (EWTD) and a new collective agreement for doctors working at University hospitals in 2006 new shift models had to be designed in the Department of Neurosurgery of the University Hospital Tubingen, Germany. The aim of the study was to show the fit of the models regarding the average weekly working time limits (aWTL), the daily maximum of 10-h working time (10-h dWT), and the staff expenditures 3 years after implementation. The new shift model was implemented in 2008, and hence planning and documentation were done electronically. Adherence to the work schedules was measured, and aWTL adherence rates were compared. The relative number of 10-h dWT violations in 2009 and 2010 was analysed. Staff costs relative to performance before and after implementation were calculated and tested using analysis of variance (ANOVA). Four other departments without alteration of shift models served as a control group in cost trend analysis. In 2010 all doctors in the Department of Neurosurgery were able to stay within the limit of 54 h/week; one doctor without opt-out exceeded the 48 h/week limit (50.1 h/week). The median per capita rate of 10-h dWT violations in 2009 was 20.3 % of all eligible working days and further declined to 10.7 % in 2010 (p

Freezing human milk is recommended to inactivate cytomegalovirus (CMV). A case of a preterm infant exclusively receiving frozen breast milk from his CMV seropositive mother showed that storage of breast milk for two months at -20 degrees C did not prevent symptomatic postnatal CMV infection.

We investigated the reactivation of cytomegalovirus during lactation and analysedthe role of human milk whey and milk cells in mother-to-child-transmission. In contrast to term infants, preterm infants may be infected symptomatically by breastfeeding. Human milk whey is the material of choice for detection of maternal DNA lactia and virolactia, whereas milkcells not necessarily have to be infected in transmitters.

Breastfeeding practices strongly influence the epidemiology of human cytomegalovirus infection. By contrast with term neonates, few data are available on transmission of infection from mothers to preterm infants during breastfeeding.151 mothers and their 176 preterm infants (gestational age at birth32 weeks or birthweight1500 g) were prospectively screened for cytomegalovirus infection by serology, virus culture, and PCR. The roles of cell-free and cell-associated cytomegalovirus excretion during lactation were analysed longitudinally in relation to transmission, by maximum-likelihood estimates.Of the 69 seronegative breastfeeding control mothers, none had detectable cytomegalovirus DNA in breastmilk and none of their 80 infants shed the virus in urine. The proportion of cytomegalovirus reactivation in seropositive breastfeeding mothers was 96% (73 of 76). The early appearance of viral DNA in milk whey (median 3.5 days post partum in transmitters; 8 days in non-transmitters; p=0.025) and infectious virus in milk whey (10 days and 16 days, respectively; p=0.005) were risk factors for transmission. The cumulative rate of transmission was 37% (27 of 73 mothers; 33 infants). The infection of the neonates had a mean incubation time of 42 days (95% CI 28-69). About 50% of the infected infants had no symptoms, but four had sepsis-like symptoms.The proportion of cytomegalovirus reactivation during lactation almost equals maternal seroprevalence. Breastfeeding as a source of postnatal cytomegalovirus infection in preterm infants has been underestimated and may be associated with a symptomatic infection.