Aachen smoking cessation and harm reduction (ASCHR) trial study protocol - scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases.

BACKGROUND: Smoking is a major risk factor of cardiovascular diseases, notably peripheral arterial disease (PAD). Despite this link, research on smoking cessation interventions in PAD patients remains scarce and inconclusive regarding the efficacy of such interventions. Therefore, elucidating it is crucial and should address both individuals who smoke that are motivated to quit and individuals who smoke heavily lacking the motivation to quit. METHODS/DESIGN: The Aachen Smoking Cessation and Harm Reduction (ASCHR) trial is a prospective randomized controlled study (RCT) on the benefits of telemedical-psychological support for smoking cessation in patients with PAD, funded by the "Innovation Fund" of the Joint Federal Committee in Germany. This trial aims to scientifically assess the efficacy, feasibility, acceptance, and efficiency of a multi-stage smoking cessation program based on the recommendations of the German guideline for smoking cessation tailored to patients with PAD, compared to a control group receiving no intervention. Central to the program is psychological counseling utilizing motivational interviewing techniques, delivered through telemedicine via video consultations. The primary endpoint of the ASCHR trial is the smoking cessation rate after 8 months of intervention, with a secondary endpoint evaluating sustained abstinence at a further 6 months follow-up. Smoking cessation is defined as a carbon monoxide level in exhaled air of less than 6 ppm. We hypothesize that the group receiving the multi-stage cessation program will yield a cessation rate at least 10 percentage points higher than that of usual care. Anticipating a dropout rate of around 35%, the planned sample size is at least N = 1032 study participants. DISCUSSION: Should the trial demonstrate significant positive outcomes, efforts should be made to integrate the program into routine care in Germany, potentially offering a promising base for future smoking cessation support among PAD patients.

The Effects of Displaying the Time Targets of the Manchester Triage System to Emergency Department Personnel: Prospective Crossover Study.

BACKGROUND: The use of triage systems such as the Manchester Triage System (MTS) is a standard procedure to determine the sequence of treatment in emergency departments (EDs). When using the MTS, time targets for treatment are determined. These are commonly displayed in the ED information system (EDIS) to ED staff. Using measurements as targets has been associated with a decline in meeting those targets. OBJECTIVE: This study investigated the impact of displaying time targets for treatment to physicians on processing times in the ED. METHODS: We analyzed the effects of displaying time targets to ED staff on waiting times in a prospective crossover study, during the introduction of a new EDIS in a large regional hospital in Germany. The old information system version used a module that showed the time target determined by the MTS, while the new system version used a priority list instead. Evaluation was based on 35,167 routinely collected electronic health records from the preintervention period and 10,655 records from the postintervention period. Electronic health records were extracted from the EDIS, and data were analyzed using descriptive statistics and generalized additive models. We evaluated the effects of the intervention on waiting times and the odds of achieving timely treatment according to the time targets set by the MTS. RESULTS: The average ED length of stay and waiting times increased when the EDIS that did not display time targets was used (average time from admission to treatment: preintervention phase=median 15, IQR 6-39 min; postintervention phase=median 11, IQR 5-23 min). However, severe cases with high acuity (as indicated by the triage score) benefited from lower waiting times (0.15 times as high as in the preintervention period for MTS1, only 0.49 as high for MTS2). Furthermore, these patients were less likely to receive delayed treatment, and we observed reduced odds of late treatment when crowding occurred. CONCLUSIONS: Our results suggest that it is beneficial to use a priority list instead of displaying time targets to ED personnel. These time targets may lead to false incentives. Our work highlights that working better is not the same as working faster.

Development and validation of a cadaveric porcine Pseudotumor model for Oral Cancer biopsy and resection training.

OBJECTIVE: The gold standard of oral cancer (OC) treatment is diagnostic confirmation by biopsy followed by surgical treatment. However, studies have shown that dentists have difficulty performing biopsies, dental students lack knowledge about OC, and surgeons do not always maintain a safe margin during tumor resection. To address this, biopsies and resections could be trained under realistic conditions outside the patient. The aim of this study was to develop and to validate a porcine pseudotumor model of the tongue. METHODS: An interdisciplinary team reflecting various specialties involved in the oncological treatment of head and neck oncology developed a porcine pseudotumor model of the tongue in which biopsies and resections can be practiced. The refined model was validated in a final trial of 10 participants who each resected four pseudotumors on a tongue, resulting in a total of 40 resected pseudotumors. The participants (7 residents and 3 specialists) had an experience in OC treatment ranging from 0.5 to 27 years. Resection margins (minimum and maximum) were assessed macroscopically and compared beside self-assessed margins and resection time between residents and specialists. Furthermore, the model was evaluated using Likert-type questions on haptic and radiological fidelity, its usefulness as a training model, as well as its imageability using CT and ultrasound. RESULTS: The model haptically resembles OC (3.0 ± 0.5; 4-point Likert scale), can be visualized with medical imaging and macroscopically evaluated immediately after resection providing feedback. Although, participants (3.2 ± 0.4) tended to agree that they had resected the pseudotumor with an ideal safety margin (10 mm), the mean minimum resection margin was insufficient at 4.2 ± 1.2 mm (mean ± SD), comparable to reported margins in literature. Simultaneously, a maximum resection margin of 18.4 ± 6.1 mm was measured, indicating partial over-resection. Although specialists were faster at resection (p < 0.001), this had no effect on margins (p = 0.114). Overall, the model was well received by the participants, and they could see it being implemented in training (3.7 ± 0.5). CONCLUSION: The model, which is cost-effective, cryopreservable, and provides a risk-free training environment, is ideal for training in OC biopsy and resection and could be incorporated into dental, medical, or oncologic surgery curricula. Future studies should evaluate the long-term training effects using this model and its potential impact on improving patient outcomes.

COVID-19 Vaccine-Associated Cerebral Venous Thrombosis in Germany.

OBJECTIVE: We aimed to estimate the incidence of cerebral sinus and venous thrombosis (CVT) within 1 month from first dose administration and the frequency of vaccine-induced immune thrombotic thrombocytopenia (VITT) as the underlying mechanism after vaccination with BNT162b2, ChAdOx1, and mRNA-1273, in Germany. METHODS: A web-based questionnaire was e-mailed to all departments of neurology. We requested a report of cases of CVT occurring within 1 month of a COVID-19 vaccination. Other cerebral events could also be reported. Incidence rates of CVT were calculated by using official statistics of 9 German states. RESULTS: A total of 45 CVT cases were reported. In addition, 9 primary ischemic strokes, 4 primary intracerebral hemorrhages, and 4 other neurological events were recorded. Of the CVT patients, 35 (77.8%) were female, and 36 (80.0%) were younger than 60 years. Fifty-three events were observed after vaccination with ChAdOx1 (85.5%), 9 after BNT162b2 (14.5%) vaccination, and none after mRNA-1273 vaccination. After 7,126,434 first vaccine doses, the incidence rate of CVT within 1 month from first dose administration was 0.55 (95% confidence interval [CI] = 0.38-0.78) per 100,000 person-months (which corresponds to a risk of CVT within the first 31 days of 0.55 per 100,000 individuals) for all vaccines and 1.52 (95% CI = 1.00-2.21) for ChAdOx1 (after 2,320,535 ChAdOx1 first doses). The adjusted incidence rate ratio was 9.68 (95% CI = 3.46-34.98) for ChAdOx1 compared to mRNA-based vaccines and 3.14 (95% CI = 1.22-10.65) for females compared to non-females. In 26 of 45 patients with CVT (57.8%), VITT was graded highly probable. INTERPRETATION: Given an incidence of 0.02 to 0.15 per 100,000 person-months for CVT in the general population, these findings point toward a higher risk for CVT after ChAdOx1 vaccination, especially for women. ANN NEUROL 2021;90:627-639.

Intracranial hemorrhage in COVID-19 patients during extracorporeal membrane oxygenation for acute respiratory failure: a nationwide register study report.

BACKGROUND: In severe cases, SARS-CoV-2 infection leads to acute respiratory distress syndrome (ARDS), often treated by extracorporeal membrane oxygenation (ECMO). During ECMO therapy, anticoagulation is crucial to prevent device-associated thrombosis and device failure, however, it is associated with bleeding complications. In COVID-19, additional pathologies, such as endotheliitis, may further increase the risk of bleeding complications. To assess the frequency of bleeding events, we analyzed data from the German COVID-19 autopsy registry (DeRegCOVID). METHODS: The electronic registry uses a web-based electronic case report form. In November 2021, the registry included N = 1129 confirmed COVID-19 autopsy cases, with data on 63 ECMO autopsy cases and 1066 non-ECMO autopsy cases, contributed from 29 German sites. FINDINGS: The registry data showed that ECMO was used in younger male patients and bleeding events occurred much more frequently in ECMO cases compared to non-ECMO cases (56% and 9%, respectively). Similarly, intracranial bleeding (ICB) was documented in 21% of ECMO cases and 3% of non-ECMO cases and was classified as the immediate or underlying cause of death in 78% of ECMO cases and 37% of non-ECMO cases. In ECMO cases, the three most common immediate causes of death were multi-organ failure, ARDS and ICB, and in non-ECMO cases ARDS, multi-organ failure and pulmonary bacterial ± fungal superinfection, ordered by descending frequency. INTERPRETATION: Our study suggests the potential value of autopsies and a joint interdisciplinary multicenter (national) approach in addressing fatal complications in COVID-19.

Examining Mental Workload Relating to Digital Health Technologies in Health Care: Systematic Review.

BACKGROUND: The workload in health care is increasing and hence, mental health issues are on the rise among health care professionals (HCPs). The digitization of patient care could be related to the increase in stress levels. It remains unclear whether the health information system or systems and digital health technologies (DHTs) being used in health care relieve the professionals or whether they represent a further burden. The mental construct that best describes this burden of technologies is mental workload (MWL). The measurement methods of MWL are particularly relevant in this sensitive setting. OBJECTIVE: This review aimed to address 2 different but related objectives: identifying the factors that contribute to the MWL of HCPs when using DHT and examining and exploring the applied assessments for the measurement of MWL with a special focus on eye tracking. METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 statement, we conducted a systematic review and processed a literature search in the following databases: MEDLINE (PubMed), Web of Science, Academic Search Premier and CINAHL (EBSCO), and PsycINFO. Studies were eligible if they assessed the MWL of HCPs related to DHT. The review was conducted as per the following steps: literature search, article selection, data extraction, quality assessment (using the Standard Quality Assessment Criteria for Evaluation Primary Research Papers From a Variety of Fields [QualSyst]), data analysis, and data synthesis (narrative and tabular). The process was performed by 2 reviewers (in cases of disagreement, a third reviewer was involved). RESULTS: The literature search process resulted in 25 studies that fit the inclusion criteria and examined the MWL of health care workers resulting from the use of DHT in health care settings. Most studies had sample sizes of 10-50 participants, were conducted in the laboratory, and had quasi-experimental or cross-sectional designs. The main results can be grouped into two categories: assessment methods and factors related to DHT that contribute to MWL. Most studies applied subjective methods for the assessment of MWL. Eye tracking did not play a major role in the selected studies. The factors contributing to a higher MWL were clustered into organizational and systemic factors. CONCLUSIONS: Our review of 25 papers shows a diverse assessment approach toward the MWL of HCPs related to DHT as well as 2 groups of relevant contributing factors to MWL. Our results are limited in terms of interpretability and causality due to methodological weaknesses of the included studies and may be limited by some shortcomings in the search process. Future research should concentrate on adequate assessments of the MWL of HCPs dependent on the setting, the evaluation of quality criteria, and further assessment of the contributing factors to MWL. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021233271; https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42021233271.

Past and Trends in Cough Sound Acquisition, Automatic Detection and Automatic Classification: A Comparative Review.

Cough is a very common symptom and the most frequent reason for seeking medical advice. Optimized care goes inevitably through an adapted recording of this symptom and automatic processing. This study provides an updated exhaustive quantitative review of the field of cough sound acquisition, automatic detection in longer audio sequences and automatic classification of the nature or disease. Related studies were analyzed and metrics extracted and processed to create a quantitative characterization of the state-of-the-art and trends. A list of objective criteria was established to select a subset of the most complete detection studies in the perspective of deployment in clinical practice. One hundred and forty-four studies were short-listed, and a picture of the state-of-the-art technology is drawn. The trend shows an increasing number of classification studies, an increase of the dataset size, in part from crowdsourcing, a rapid increase of COVID-19 studies, the prevalence of smartphones and wearable sensors for the acquisition, and a rapid expansion of deep learning. Finally, a subset of 12 detection studies is identified as the most complete ones. An unequaled quantitative overview is presented. The field shows a remarkable dynamic, boosted by the research on COVID-19 diagnosis, and a perfect adaptation to mobile health.

Causes of adverse events in home mechanical ventilation: a nursing perspective.

BACKGROUND: Adverse events (AE) are ubiquitous in home mechanical ventilation (HMV) and can jeopardise patient safety. One particular source of error is human interaction with life-sustaining medical devices, such as the ventilator. The objective is to understand these errors and to be able to take appropriate action. With a systematic analysis of the hazards associated with HMV and their causes, measures can be taken to prevent damage to patient health. METHODS: A systematic adverse events analysis process was conducted to identify the causes of AE in intensive home care. The analysis process consisted of three steps. 1) An input phase consisting of an expert interview and a questionnaire. 2) Analysis and categorisation of the data into a root-cause diagram to help identify the causes of AE. 3) Derivation of risk mitigation measures to help avoid AE. RESULTS: The nursing staff reported that patient transportation, suction and tracheostomy decannulation were the main factors that cause AE. They would welcome support measures such as checklists for care activities and a reminder function, for e.g. tube changes. Risk mitigation measures are given for many of the causes listed in the root-cause diagram. These include measures such as device and care competence, as well as improvements to be made by the equipment providers and manufacturers. The first step in addressing AE is transparency and an open approach to errors and near misses. A systematic error analysis can prevent patient harm through a preventive approach. CONCLUSION: Risks in HMV were identified based on a qualitative approach. The collected data was systematically mapped onto a root-cause diagram. Using the root-cause diagram, some of the causes were analysed for risk mitigation. For manufacturers, caregivers and care services requirements for intervention offers the possibility to create a checklist for particularly risky care activities.

[Use of emergency services for suicide attempts during the SARS-CoV-2 pandemic-a prevalence study]. / Inanspruchnahme des Rettungsdiensts bei Suizidversuchen im Verlauf der SARS-CoV-2-Pandemie.

Background: The pandemic has caused several changes in the emergency care system. The deployment figures in emergency medical services have shown atypical fluctuations. This has also been explained by changes in behavior and an increased sense of stress among the population. Existing research provides hints for the increased incidence of mental health symptoms in emergency care during ongoing pandemics. Objective: In this context, this paper examines the occurrence of emergency medical services calls related to the keyword suicide in relation to total calls. Methods: This is a retrospective cross-sectional study based on routine documentation from a fire and rescue dispatch center with descriptive and exploratory data analyses. The data are divided by settlement-structural county types and compared with incidences and pandemic phases. Results: Phase 1 and 2a show a decrease in the number of dispatches during the pandemic. In addition, there is a shift in the number of dispatch cases with a context of suicide by structure types in phase 3. A decreased dispatch rate in the sparsely populated rural county is offset by an increase in the metropolitan area. Changes made to the control center system resulted in an increase in the number of dispatch cases in the context of suicide. Conclusion: Continuous mental health surveillance, including data collected by emergency medical services, can provide valuable insight. The study also highlights the need for standardization of emergency dispatch center data.

Data Quality and Cost-effectiveness Analyses of Electronic and Paper-Based Interviewer-Administered Public Health Surveys: Systematic Review.

BACKGROUND: A population-level survey (PLS) is an essential and standard method used in public health research that supports the quantification of sociodemographic events, public health policy development, and intervention designs. Data collection mechanisms in PLS seem to be a significant determinant in avoiding mistakes. Using electronic devices such as smartphones and tablet computers improves the quality and cost-effectiveness of public health surveys. However, there is a lack of systematic evidence to show the potential impact of electronic data collection tools on data quality and cost reduction in interviewer-administered surveys compared with the standard paper-based data collection system. OBJECTIVE: This systematic review aims to evaluate the impact of the interviewer-administered electronic data collection methods on data quality and cost reduction in PLS compared with traditional methods. METHODS: We conducted a systematic search of MEDLINE, CINAHL, PsycINFO, the Web of Science, EconLit, Cochrane CENTRAL, and CDSR to identify relevant studies from 2008 to 2018. We included randomized and nonrandomized studies that examined data quality and cost reduction outcomes, as well as usability, user experience, and usage parameters. In total, 2 independent authors screened the title and abstract, and extracted data from selected papers. A third author mediated any disagreements. The review authors used EndNote for deduplication and Rayyan for screening. RESULTS: Our search produced 3817 papers. After deduplication, we screened 2533 papers, and 14 fulfilled the inclusion criteria. None of the studies were randomized controlled trials; most had a quasi-experimental design, for example, comparative experimental evaluation studies nested on other ongoing cross-sectional surveys. A total of 4 comparative evaluations, 2 pre-post intervention comparative evaluations, 2 retrospective comparative evaluations, and 4 one-arm noncomparative studies were included. Meta-analysis was not possible because of the heterogeneity in study designs, types, study settings, and level of outcome measurements. Individual paper synthesis showed that electronic data collection systems provided good quality data and delivered faster compared with paper-based data collection systems. Only 2 studies linked cost and data quality outcomes to describe the cost-effectiveness of electronic data collection systems. Field data collectors reported that an electronic data collection system was a feasible, acceptable, and preferable tool for their work. Onsite data error prevention, fast data submission, and easy-to-handle devices were the comparative advantages offered by electronic data collection systems. Challenges during implementation included technical difficulties, accidental data loss, device theft, security concerns, power surges, and internet connection problems. CONCLUSIONS: Although evidence exists of the comparative advantages of electronic data collection compared with paper-based methods, the included studies were not methodologically rigorous enough to combine. More rigorous studies are needed to compare paper and electronic data collection systems in public health surveys considering data quality, work efficiency, and cost reduction. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10678.

Cooperative approach of pathology and neuropathology in the COVID-19 pandemic : German registry for COVID-19 autopsies (DeRegCOVID) and German network for autopsies in pandemics (DEFEAT PANDEMIcs).

BACKGROUND: Autopsy is an important tool for understanding the pathogenesis of diseases, including COVID-19. MATERIAL AND METHODS: On 15 April 2020, together with the German Society of Pathology and the Federal Association of German Pathologists, the German Registry of COVID-19 Autopsies (DeRegCOVID) was launched ( www.DeRegCOVID.ukaachen.de ). Building on this, the German Network for Autopsies in Pandemics (DEFEAT PANDEMIcs) was established on 1 September 2020. RESULTS: The main goal of DeRegCOVID is to collect and distribute de facto anonymized data on potentially all autopsies of people who have died from COVID-19 in Germany in order to meet the need for centralized, coordinated, and structured data collection and reporting during the pandemic. The success of the registry strongly depends on the willingness of the respective centers to report the data, which has developed very positively so far and requires special thanks to all participating centers. The rights to own data and biomaterials (stored decentrally) remain with each respective center. The DEFEAT PANDEMIcs network expands on this and aims to strengthen harmonization and standardization as well as nationwide implementation and cooperation in the field of pandemic autopsies. CONCLUSIONS: The extraordinary cooperation in the field of autopsies in Germany during the COVID-19 pandemic is impressively demonstrated by the establishment of DeRegCOVID, the merger of the registry of neuropathology (CNS-COVID19) with DeRegCOVID and the establishment of the autopsy network DEFEAT PANDEMIcs. It gives a strong signal for the necessity, readiness, and expertise to jointly help manage current and future pandemics by autopsy-derived knowledge.

[Cooperative approach of pathology and neuropathology in the COVID-19 pandemic : German registry for COVID-19 autopsies (DeRegCOVID) and German network for autopsies in pandemics (DEFEAT PANDEMIcs)]. / Kooperatives Vorgehen der Pathologie und Neuropathologie in der COVID-19-Pandemie : Deutsches Register für COVID-19-Obduktionen (DeRegCOVID) und Deutsches Netzwerk für Autopsien in Pandemien (DEFEAT PANDEMIcs).

BACKGROUND: Autopsy is an important tool for understanding the pathogenesis of diseases, including COVID-19. MATERIAL AND METHODS: On 15 April 2020, together with the German Society of Pathology and the Federal Association of German Pathologists, the German Registry of COVID-19 Autopsies (DeRegCOVID) was launched ( www.DeRegCOVID.ukaachen.de ). Building on this, the German Network for Autopsies in Pandemics (DEFEAT PANDEMIcs) was established on 1 September 2020. RESULTS: The main goal of DeRegCOVID is to collect and distribute de facto anonymized data on potentially all autopsies of people who have died from COVID-19 in Germany in order to meet the need for centralized, coordinated, and structured data collection and reporting during the pandemic. The success of the registry strongly depends on the willingness of the respective centers to report the data, which has developed very positively so far and requires special thanks to all participating centers. The rights to own data and biomaterials (stored decentrally) remain with each respective center. The DEFEAT PANDEMIcs network expands on this and aims to strengthen harmonization and standardization as well as nationwide implementation and cooperation in the field of pandemic autopsies. CONCLUSIONS: The extraordinary cooperation in the field of autopsies in Germany during the COVID-19 pandemic is impressively demonstrated by the establishment of DeRegCOVID, the merger of the registry of neuropathology (CNS-COVID19) with DeRegCOVID and the establishment of the autopsy network DEFEAT PANDEMIcs. It gives a strong signal for the necessity, readiness, and expertise to jointly help manage current and future pandemics by autopsy-derived knowledge.

[Requirements for a sustainable standardization and digitalization in clinical emergency and acute medicine]. / Anforderungen an eine nachhaltige Standardisierung und Digitalisierung in der klinischen Notfall- und Akutmedizin.

Digitalization and standardization of documentation in medicine are increasingly progressing. In the decision of the Federal Joint Committee (G-BA) for a staged system of emergency structures in hospitals and in the report of the expert committee for development in the healthcare system on needs-oriented guidance of healthcare, the actuality of the topic is underlined with concrete naming of future tasks. The section on emergency admission protocols of the German Interdisciplinary Association of Intensive and Emergency Care Medicine (DIVI) has been working for years on this topic and has repeatedly reported on the progress of the topic in clinical emergency care. Standardization and digitalization represent the foundation for health services research spread across locations as well as the possibility for benchmarking. Digitalization makes the secondary use of primary clinical routine data possible. Digitalization decreases redundancies of data transmission by avoiding manual data input in, for example registers.

[Mechanical ventilation in neurological organizational units in Germany]. / Beatmung in neurologischen Organisationseinheiten in Deutschland.

BACKGROUND: Mechanical ventilation is provided for neurological patients in the following settings: in neurointensive care units, in centers providing weaning and early rehabilitation and in home mechanical ventilation. In the last decade there has been a sharp rise in treatment and bed capacities for mechanically ventilated neurological patients in specialized centers in Germany in the areas of weaning and neurological neurosurgical early rehabilitation of ventilated patients. Neither the number of beds nor details about structures in these centers with respect to bed capacity, personnel and qualifications, equipment, treatment methods and concepts are known. OBJECTIVE: The aim of this survey was to generate detailed numbers regarding structural criteria of specialized centers for mechanically ventilated neurology patients, regarding hospital beds, technical infrastructure, personnel and qualifications as well as treatment methods and concepts. MATERIAL AND METHODS: An online survey with 48 questions on the type and size of the institution, structural criteria, equipment and personnel was developed and supported by the German Society for Neurology (DGN), the German Interdisciplinary Society of Out-of-Hospital Ventilation (DIGAB) and the German Society of Neurorehabilitation (DGNR). RESULTS: A total of 63 centers took part in the survey and reported a total of 687 beds for mechanically ventilated neurological patients. Furthermore, they reported complex structures regarding personnel and qualifications, medical devices, methods and concepts but neurophysiological electrophysiology was the only technical method provided in all centers. Of the institutions 49% (n = 27/55) provided the initiation of home mechanical ventilation, 18% (n = 18/55) provided inpatient control of home mechanical ventilation, 9% (n = 5/55) had an outpatient department for home mechanical ventilation and 18% (n = 10/55) extracted data from home ventilators. CONCLUSION: Mechanical ventilation in neurological units offers vast and complex treatment and bed capacities for severely ill patients in Germany. The structures are inhomogeneous and a consensus on specific criteria should be established. This is especially true for the treatment of patients needing out-of-hospital mechanical ventilation, also with respect to a possible weaning in the long-term duration of the disease.

[The German Thorax Registry: Implementation of an Established Tool of Perioperative Health Care Research]. / Deutsches Thoraxregister ­ Implementierung eines etablierten Werkzeugs der perioperativen Versorgungsforschung.

The collection of clinical treatment data in registry databases is an important aspect of health services research. It allows for a critical evaluation of the safety, efficacy and cost-effectiveness of clinical treatment concepts in large patient populations. The findings of registry research represent real-world patients and treatment structures as they are not limited by strict inclusion criteria or unrealistic conditions as applied in prospective clinical trials. The implementation of the German Thorax Registry has enabled the collection and analysis of data on the interdisciplinary care (thoracic surgery, anaesthesiology, intensive care, pain management) of patients undergoing thoracic surgery. Under the auspices of the German Society of Anaesthesiology and Intensive Care Medicine and the German Society of Thoracic Surgery, a registry of the Hospital of the University Witten/Herdecke-Cologne, purely surgical at first, was expanded in close cooperation with the University Hospital of Freiburg. After a comprehensive data protection concept was drafted and a test phase completed, the German Thorax Registry was officially launched in January 2016. Most notably, participating hospitals profit from the registry's "benchmarking" services. "Benchmarking", i.e. the comparison of treatment quality between different hospitals, enables participants to identify individual profiles, strengths and weaknesses on a nation-wide level and follow their own progress over the course of several years. An online database for data entry and benchmarking is always accessible (www.thoraxregister.de). In October 2016, the spectrum of participants was expanded to include all hospitals performing at least 50 thoracic operations a year.

Prospective evaluation of regional oxygen saturation to estimate central venous saturation in sepsis.

Current treatment guidelines for sepsis claim an early goal-directed hemodynamic optimization including fluid resuscitation, use of vasopressors and inotropic agents. We investigated the correlation between the prominent treatment goal central venous saturation (ScvO2) and the frontal and the thenar regional oxygen saturation (rSO2) measured by near infrared spectroscopy. Secondary, we examined the value of ScvO2, lactate levels and rSO2 as surrogate markers of an impaired tissue oxygenation for outcome prediction in sepsis. This prospective, observational study was performed at the surgical intensive care unit of the University Hospital Giessen. A total of 50 patients with sepsis, severe sepsis or septic shock were included. ScvO2, rSO2 and lactate were measured at sepsis diagnosis (baseline), 24 and 48 h, thereafter. We investigated the predictive value of frontal and thenar rSO2 for a decreased SvcO2 under 70%. For survivor and non-survivors ScvO2, rSO2 and lactate were analysed. Patients with ScvO2 >70% showed a trend to higher levels of fontal rSO2 (62.81 ± 8.06 vs. 53.54 ± 15.48; p = 0.058). ROC-analysis revealed a minor prediction of a decreased ScvO2 by frontal rSO2 levels at baseline (AUC = 0.687; 95% CI 0.511-0.863; p = 0.047). Combined measurements of lactate and ScvO2 showed significantly elevated mortality for patients with ScvO2 ≥70% and lactate levels ≥2.5 mmol/l (log rank test p = 0.004). In the group with ScvO2 <70% and lactate levels <2.5 mmol/l no patients died during the observation period. Frontal rSO2 correlates with ScvO2 but both frontal and thenar rSO2 do not exactly discriminate between patients with high or low ScvO2 in sepsis. The combination of elevated lactate >2.5 mmol/l and ScvO2 >70 % is highly associated with poor outcome in ICU patients with sepsis, severe sepsis and septic shock.

Assessing the prognoses on Health care in the information society 2013--thirteen years after.

Health care and information technology in health care is advancing at tremendous speed. We analysed whether the prognoses by Haux et al. - first presented in 2000 and published in 2002 - have been fulfilled in 2013 and which might be the reasons for match or mismatch. Twenty international experts in biomedical and health informatics met in May 2013 in a workshop to discuss match or mismatch of each of the 71 prognoses. After this meeting a web-based survey among workshop participants took place. Thirty-three prognoses were assessed matching; they reflect e.g. that there is good progress in storing patient data electronically in health care institutions. Twenty-three prognoses were assessed mismatching; they reflect e.g. that telemedicine and home monitoring as well as electronic exchange of patient data between institutions is not established as widespread as expected. Fifteen prognoses were assessed neither matching nor mismatching. ICT tools have considerably influenced health care in the last decade, but in many cases not as far as it was expected by Haux et al. in 2002. In most cases this is not a matter of the availability of technical solutions but of organizational and ethical issues. We need innovative and modern information system architectures which support multiple use of data for patient care as well as for research and reporting and which are able to integrate data from home monitoring into a patient centered health record. Since innovative technology is available the efficient and wide-spread use in health care has to be enabled by systematic information management.

Past and next 10 years of medical informatics.

More than 10 years ago Haux et al. tried to answer the question how health care provision will look like in the year 2013. A follow-up workshop was held in Braunschweig, Germany, for 2 days in May, 2013, with 20 invited international experts in biomedical and health informatics. Among other things it had the objectives to discuss the suggested goals and measures of 2002 and how priorities on MI research in this context should be set from the viewpoint of today. The goals from 2002 are now as up-to-date as they were then. The experts stated that the three goals: "patient-centred recording and use of medical data for cooperative care"; "process-integrated decision support through current medical knowledge" and "comprehensive use of patient data for research and health care reporting" have not been reached yet and are still relevant. A new goal for ICT in health care should be the support of patient centred personalized (individual) medicine. MI as an academic discipline carries out research concerning tools that support health care professionals in their work. This research should be carried out without the pressure that it should lead to systems that are immediately and directly accepted in practice.

[Functional requirements of patient data management systems in intensive care medicine]. / Funktionelle Anforderungen an Patientendatenmanagementsysteme in der Intensivmedizin.

BACKGROUND: As part of the German government's digitization initiative, the paper-based documentation that is still present in many intensive care units is to be replaced by digital patient data management systems (PDMS). In order to simplify the implementation of such systems, standards for basic functionalities that should be part of basic configurations of PDMS would be of great value. PURPOSE: This paper describes functional requirements for PDMS in several categories. METHODS: Criteria for standardized data documentation were defined by the authors and derived functional requirements were classified into two priority categories. RESULTS: Overall, general technical requirements, functionalities for intensive care patient care, and additional functionalities for PDMS were defined and prioritized. DISCUSSION: Using this paper as a starting point for a discussion about basic functionalities of PDMS, it is planned to develop and obtain consensus on definitive standards with representatives from medical societies, medical informatics and PDMS manufacture.

Visualising Data Models of Patient Registries and Clinical Studies - A Method for Quality Check of EDC Systems.

INTRODUCTION: The configuration of electronic data capture (EDC) systems has a relevant impact on data quality in studies and patient registries. The objective was to develop a method to visualise the configuration of an EDC system to check the completeness and correctness of the data definition and rules. METHODS: Step 1: transformation of the EDC data model into a graphical model, step 2: Checking the completeness and consistency of the data model, step 3: correction of identified findings. This process model was evaluated on the patient registry EpiReg. RESULTS: Using the graphical visualisation as a basis, 21 problems in the EDC configuration were identified, discussed with an interdisciplinary team, and corrected. CONCLUSION: The tested methodological approach enables an improvement in data quality by optimising the underlying EDC configuration.