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Background:  Computerized physician order entry (CPOE) and clinical decision support systems (CDSS) are widespread due to increasing digitalization of hospitals. They can be associated with reduced medication errors and improved patient safety, but also with well-known risks (e.g., overalerting, nonadoption)., Objectives:  Therefore, we aimed to evaluate a commonly used CDSS containing Medication-Safety-Validators (e.g., drug-drug interactions), which can be locally activated or deactivated, to identify limitations and thereby potentially optimize the use of the CDSS in clinical routine., Methods:  Within the implementation process of Meona (commercial CPOE/CDSS) at a German University hospital, we conducted an interprofessional evaluation of the CDSS and its included Medication-Safety-Validators following a defined algorithm: (1) general evaluation, (2) systematic technical and content-related validation, (3) decision of activation or deactivation, and possibly (4) choosing the activation mode (interruptive or passive). We completed the in-depth evaluation for exemplarily chosen Medication-Safety-Validators. Moreover, we performed a survey among 12 German University hospitals using Meona to compare their configurations., Results:  Based on the evaluation, we deactivated 3 of 10 Medication-Safety-Validators due to technical or content-related limitations. For the seven activated Medication-Safety-Validators, we chose the interruptive option ["PUSH-(&PULL)-modus"] four times (4/7), and a new, on-demand option ["only-PULL-modus"] three times (3/7). The site-specific configuration (activation or deactivation) differed across all participating hospitals in the survey and led to varying medication safety alerts for identical patient cases., Conclusion:  An interprofessional evaluation of CPOE and CDSS prior to implementation in clinical routine is crucial to detect limitations. This can contribute to a sustainable utilization and thereby possibly increase medication safety., Competing Interests: M.F.F.: consulting or advisory roles (Boehringer Ingelheim); research funding (Boehringer Ingelheim, Heidelberg Pharma Research GmbH); other relationship (earmarked financial contribution for the first award of the MSD Germany Health Award 2021).F.D.: honoraria (lecture fees from E. Lilly); consulting or advisory roles (Boehringer Ingelheim, Lilly Deutschland, Pfizer Pharma GmbH, SANDOZ AG); other relationship (earmarked financial contribution for the first award of the MSD Germany Health Award 2021).All other authors declare no competing interests. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Objective: Assessment of the effectiveness of protective measures at a tertiary-care hospital during the SARS-CoV-2 infection waves to provide advice for future pandemics., Design: Retrospective cohort study among hospital staff using in-house surveillance data., Setting: University Hospital Erlangen (UKER), a tertiary-care provider in Bavaria, Germany., Methods: We outline the preventive measures introduced at UKER and retrospectively assess their effectiveness using anonymized monitoring data that were collected during the SARS-CoV-2 pandemic from February 2020 to the end of January 2022. Analysed data includes the incidence of SARS-CoV-2 infections among employees, the frequency of high-risk contacts with infected patients or staff members and breakthrough infections considering the context of exposure., Results: The cumulative incidence of SARS-CoV-2 infections among UKER employees was higher before, but lower after the vaccination campaign when compared to the general population. Healthcare workers (HCW), notably physicians and nurses, were especially at risk of infection compared to other UKER employees with less direct patient contact (OR 1.36 [95% CI 1.18-1.57 p < 0.001]). Breakthrough infections mostly occurred after exposure during private life, i.e. in situations without protective equipment. The frequency of high-risk contacts during direct patient care remained stable after SARS-CoV-2 vaccination. Prior to vaccination, 5.2% of HCW with direct patient care tested positive for SARS-CoV-2 within 14 days. After vaccination until the onset of the Omicron wave, conversion rate dropped to 0%., Conclusions: This study provides real-world data on the effectiveness of vaccination, contact tracing, personal protective equipment and general hygiene measures during the SARS-CoV-2 pandemic. Based on our findings, we recommend a protective approach combining all these preventive measures., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

At the start of the SARS-CoV-2 pandemic, healthcare workers had an increased risk of acquiring coronavirus disease (COVID)-19. As tertiary care hospitals are critical for the treatment of severely ill patients, the University Hospital Erlangen offered BNT162b2 mRNA vaccination against COVID-19 to all employees when the vaccine became available in Germany. Here, we performed a survey to assess the age- and sex-dependent reactogenicity and safety of BNT162b2 in a real-life setting with a special emphasis on the rate of vaccine-related incapacity to work amongst the employees. All vaccinated employees were invited to participate in the survey and received access to an electronic questionnaire between 31 March and 14 June 2021, which allowed them to report local and systemic adverse effects after the first or second vaccine dose. A total of 2372 employees completed the survey. After both the first and second dose, women had a higher risk than men for vaccine-related systemic side effects (odds ratio (OR) 1.48 (1.24-1.77) and 1.49 (1.23-1.81), respectively) and for inability to work (OR 1.63 (1.14-2.34) and 1.85 (1.52-2.25), respectively). Compared to employees ≥ 56 years of age, younger vaccinated participants had a higher risk of systemic reactions after the first (OR 1.35 (1.07-1.70)) and second vaccination (OR 2.08 (1.64-2.63)) and were more often unable to work after dose 2 (OR 2.20 (1.67-2.88)). We also recorded four anaphylactic reactions and received two reports of severe adverse effects indicative of vaccine complications. After the first and second vaccination, 7.9% and 34.7% of the survey participants, respectively, were temporarily unable to work, which added up to 1700 days of sick leave in this cohort. These real-life data extend previous results on the reactogenicity and safety of BNT162b2. Loss of working time due to vaccine-related adverse effects was substantial, but was outweighed by the potential benefit of prevented cases of COVID-19.

mRNA vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), such as BNT162b2 (Comirnaty ® ), have proven to be highly immunogenic and efficient but also show marked reactogenicity, leading to adverse effects (AEs). Here, we analyzed whether the severity of AEs predicts the antibody response against the SARS-CoV-2 spike protein. Healthcare workers without prior SARS-CoV-2 infection, who received a prime-boost vaccination with BNT162b2, completed a standardized electronic questionnaire on the duration and severity of AEs. Serum specimens were collected two to four weeks after the boost vaccination and tested with the COVID-19 ELISA IgG (Vircell-IgG), the LIAISON ® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin-IgG) and the iFlash-2019-nCoV NAb surrogate neutralization assay (Yhlo-NAb). A penalized linear regression model fitted by machine learning was used to correlate AEs with antibody levels. Eighty subjects were enrolled in the study. Systemic, but not local, AEs occurred more frequently after the boost vaccination. Elevated SARS-CoV-2 IgG antibody levels were measured in 92.5% of subjects with Vircell-IgG and in all subjects with DiaSorin-IgG and Yhlo-NAb. Gender, age and BMI showed no association with the antibody levels or with the AEs. The linear regression model identified headache, malaise and nausea as AEs with the greatest variable importance for higher antibody levels (Vircell-IgG and DiaSorin-IgG). However, the model performance for predicting antibody levels from AEs was very low for Vircell-IgG (squared correlation coefficient r 2 = 0.04) and DiaSorin-IgG (r 2 = 0.06). AEs did not predict the surrogate neutralization (Yhlo-NAb) results. In conclusion, AEs correlate only weakly with the SARS-CoV-2 spike protein antibody levels after COVID-19 vaccination with BNT162b2 mRNA.

Background: Today, cancer documentation is still a tedious task involving many different information systems even within a single institution and it is rarely supported by appropriate documentation workflows., Methods: In a comprehensive 14 step analysis we compiled diagnostic and therapeutic pathways for 13 cancer entities using a mixed approach of document analysis, workflow analysis, expert interviews, workflow modelling and feedback loops. These pathways were stepwise classified and categorized to create a final set of grouped pathways and workflows including electronic documentation forms., Results: A total of 73 workflows for the 13 entities based on 82 paper documentation forms additionally to computer based documentation systems were compiled in a 724 page document comprising 130 figures, 94 tables and 23 tumour classifications as well as 12 follow-up tables. Stepwise classification made it possible to derive grouped diagnostic and therapeutic pathways for the three major classes - solid entities with surgical therapy - solid entities with surgical and additional therapeutic activities and - non-solid entities. For these classes it was possible to deduct common documentation workflows to support workflow-guided single-source documentation., Conclusions: Clinical documentation activities within a Comprehensive Cancer Center can likely be realized in a set of three documentation workflows with conditional branching in a modern workflow supporting clinical information system.

Background: Due to the increasing functionality of medical information systems, it is hard to imagine day to day work in hospitals without IT support. Therefore, the design of dialogues between humans and information systems is one of the most important issues to be addressed in health care. This survey presents an analysis of the current quality level of human-computer interaction of healthcare-IT in German hospitals, focused on the users' point of view., Methods: To evaluate the usability of clinical-IT according to the design principles of EN ISO 9241-10 the IsoMetrics Inventory, an assessment tool, was used. The focus of this paper has been put on suitability for task, training effort and conformity with user expectations, differentiated by information systems. Effectiveness has been evaluated with the focus on interoperability and functionality of different IT systems., Results: 4521 persons from 371 hospitals visited the start page of the study, while 1003 persons from 158 hospitals completed the questionnaire. The results show relevant variations between different information systems., Conclusions: Specialised information systems with defined functionality received better assessments than clinical information systems in general. This could be attributed to the improved customisation of these specialised systems for specific working environments. The results can be used as reference data for evaluation and benchmarking of human computer engineering in clinical health IT context for future studies.

This paper presents the concept of an integrated IT infrastructure framework established at the comprehensive cancer center at the University Hospital Erlangen. The framework is based on the single source concept where data from the electronic medical record are reused for clinical and translational research projects. The applicability of the approach is illustrated by two case studies from colon cancer and prostate cancer research projects.

The insertion of all patient details in one clinical information system (CIS) provides an enormous potential to rationalize and accelerate the administrative procedures in primary patient care. A successful data management system has to record not only the entire spectrum of the patient's medical data, but also the patient's personal data like name, address, date of birth, as well as names and addresses of other involved physicians. In addition, all aspects of the database gathered from varying sources must be compatible. The program has to be user-friendly enough that many different workers with varying backgrounds can effectively employ it. We investigated the effective saving of time in preparing a patient's discharge report based on conventional dictation using the clinical information system (Soarian) compared to a conventional, isolated word-processing program (Word). Existing potentials and limitations concerning the use of the CIS are presented. The objective analysis of measured processing times demonstrated a reduction for the typist, but no benefit for the physician dictating the discharge report. In the subjective perception of all users, the processing time appeared to have increased due to awkward editing and navigation functions. Improvements are required to increase the acceptance of the program by the users.

Objectives: To describe and comment on functionality and architecture of the software product Soarian developed by Siemens, to identify key differentiators to related products, and to comment on predecessor systems and beta versions. This has been done in the framework of a conference on health information systems of the IMIA., Methods: Analyzing existing literature. Site visit of a predecessor system at Haukeland Sykehus, Bergen. Pilot of a beta version at the Erlangen University Medical Center, elaborating on major characteristics in discussion rounds., Results: Soarian is a functional comprehensive, clinically oriented software product to support health care processes and to be used for health care professional workstations. It is a software product, designed and written completely new. Three major key differentiators were identified in comparison to related software products: Soarian's workflow engine, its embedded analytics, and its 'smart' user interface. The targeted reduced installation time is stated to be 12 months or less., Conclusions: Soarian has good chances to become one of the major software products for health care professional workstations in the international market to support patient-centered, shared care. Its global design may help to better support and maintain national or language specific versions. The first installations of Soarian will be critical, as they will show how the system will be accepted. To use such software products efficiently, organizational aspects within hospitals as well as between health care institutions have to be considered, e.g. strategic IT planning.

The University of Erlangen-Nuremberg contains 22 hospitals and 11 autonomous medical departments which are spread out over a large area in the city of Erlangen. The necessary connections of these units and their computer based subsystems to each other and to the medical computer centre via fibre optics cables is complete. The internal cabling of the individual units is largely completed. Based on this network the Erlangen communication hub allows medical subsystems of the Erlangen university hospitals to exchange data by two completely different methods. Since 1995 a communication data base, which is implemented using the relational data base system ADABAS D, contains data from the most important hospital systems. This data can be accessed by other medical systems. Thus the communication data base allows subsystems which do not have a standardised interface to implement proprietary system interconnections via access based on SQL. The capabilities of this interconnection are dependent on both the implementation and the data which is made available by the communication data base. This contains mainly basic patient data and the results of tests performed by various laboratory systems. In addition to this proprietary communication system we have since the end of 1996 a communication server which can also handle standardised message formats such as HL7, EDIFACT, DICOM3. Future subsystems which possess standard interfaces will be connected via this server. The connection of the patient management system IS-H and the central laboratory system to the database has been proceeding since the beginning of 1997.

The Erlangen communication hub allows medical subsystems to exchange data by two completely different methods. Since 1995 a communication data base, which is implemented using the relational data base system ADABAS D, contains data from the most important hospital systems. This data can be accessed by other medical systems. Thus, the communication data base allows subsystems which do not have a standardised interface to implement proprietary system interconnections via access based on SQL. The capabilities of this interconnection are dependent on both the implementation and the data which is made available by the communication data base. This contains mainly basic patient data and the results of tests performed by various laboratory systems. In addition to this proprietary communication system we have since the end of 1996 a communication server which can also handle standardised message formats such as HL7, EDIFACT, DICOM3. Future subsystems which possess standard interfaces will be connected via this server. The connection of the patient management system IS-H and the central laboratory system to the database has been proceeding since the beginning of 1997.

The University of Erlangen-Nürnberg contains a large medical faculty with many hospitals, laboratories, and other departments distributed in the town of Erlangen, and it is necessary to exchange medical data between them. For example the basic patient data which are held on central computers, must be distributed to various stations and departments. In addition medical reports which are prepared on or generated by computers in central departments must be transmitted to various points in the hospitals [1]. When the network, based on ethernet cabling within the hospitals and a glass fiber backbone, has been completed, the Erlangen hospital communication system will support an electronic exchange of medical information. Two separate communication methods are used: data exchange via electronic mail according to the international standard X.400 and remote access to central databases using the software product NET-WORK.

A major problem for many Hospital Information Systems is separating modules to meet the information requirements of specialized parts before integration into one system. In most cases the interfaces are proprietary, leading to an enormous amount of implementation work for access to other systems. International Standards, such as a common language in Medical Communication, offer the possibility of reducing this variety and enhancing the information interchange by connecting more systems in shorter time with less cost.