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- Interdisziplinäre Zentrum für Klinische Forschung (IZKF) (1)
- Medizinische Klinik und Poliklinik 1, Abteilung Kardiologie (1)
- Medizinische Klinik und Poliklinik 1, Abteilung Nephrologie (1)
- Servicezentrum Medizin-Informatik (1)
- Servicezentrum Medizin-Informatik (Universitätsklinikum) (1)
- Universitätsklinikum Würzburg (UKW) (1)
Introduction.
Mobile health (mHealth) integrates mobile devices into healthcare, enabling remote monitoring, data collection, and personalized interventions. Machine Learning (ML), a subfield of Artificial Intelligence (AI), can use mHealth data to confirm or extend domain knowledge by finding associations within the data, i.e., with the goal of improving healthcare decisions. In this work, two data collection techniques were used for mHealth data fed into ML systems: Mobile Crowdsensing (MCS), which is a collaborative data gathering approach, and Ecological Momentary Assessments (EMA), which capture real-time individual experiences within the individual’s common environments using questionnaires and sensors. We collected EMA and MCS data on tinnitus and COVID-19. About 15 % of the world’s population suffers from tinnitus.
Materials & Methods.
This thesis investigates the challenges of ML systems when using MCS and EMA data. It asks: How can ML confirm or broad domain knowledge? Domain knowledge refers to expertise and understanding in a specific field, gained through experience and education. Are ML systems always superior to simple heuristics and if yes, how can one reach explainable AI (XAI) in the presence of mHealth data? An XAI method enables a human to understand why a model makes certain predictions. Finally, which guidelines can be beneficial for the use of ML within the mHealth domain? In tinnitus research, ML discerns gender, temperature, and season-related variations among patients. In the realm of COVID-19, we collaboratively designed a COVID-19 check app for public education, incorporating EMA data to offer informative feedback on COVID-19-related matters. This thesis uses seven EMA datasets with more than 250,000 assessments. Our analyses revealed a set of challenges: App user over-representation, time gaps, identity ambiguity, and operating system specific rounding errors, among others. Our systematic review of 450 medical studies assessed prior utilization of XAI methods.
Results.
ML models predict gender and tinnitus perception, validating gender-linked tinnitus disparities. Using season and temperature to predict tinnitus shows the association of these variables with tinnitus. Multiple assessments of one app user can constitute a group. Neglecting these groups in data sets leads to model overfitting. In select instances, heuristics outperform ML models, highlighting the need for domain expert consultation to unveil hidden groups or find simple heuristics.
Conclusion.
This thesis suggests guidelines for mHealth related data analyses and improves estimates for ML performance. Close communication with medical domain experts to identify latent user subsets and incremental benefits of ML is essential.
Beinahe jeder dritte ischämische Schlaganfall ist ursächlich auf Erkrankungen des Herzens zurückzuführen. Daher empfehlen Leitlinien allen Patienten und Patientinnen, bei denen eine kardioembolische Ätiologie des Schlaganfalls vermutet wird und bei denen ein Vorhofflimmern nicht bereits bekannt ist, als Teil der Routinediagnostik eine echokardiographische Untersuchung, um Hinweise auf die Ätiologie des ischämischen Schlaganfalls zu gewinnen und um gegebenenfalls Maßnahmen zur Sekundärprävention einleiten zu können. Jedoch ist der Zugang zu solchen echokardiographischen Untersuchungen oftmals limitiert, besonders für Patienten und Patientinnen auf Stroke Units, denn dort überschreitet die Nachfrage häufig die verfügbaren personellen und instrumentellen Kapazitäten. Zudem stellt der Transport bettlägeriger Patienten und Patientinnen in andere Abteilungen eine Belastung dar.
Daher stellt sich die Frage, ob zukünftig im Rahmen wissenschaftlicher Studien POC-Echokardiographie-Geräte zur Diagnostik bestimmter Herzerkrankungen einschließlich einer systolischen Dysfunktion bei Patienten und Patientinnen mit ischämischem Schlaganfall eingesetzt werden können, mit dem Ziel Patienten und Patientinnen zu identifizieren, die von einer erweiterten echokardiographischen Untersuchung profitieren könnten. Im Rahmen der vorliegenden prospektiven Validierungsstudie untersuchte eine Studentin 78 Patienten und Patientinnen mit akutem ischämischem Schlaganfall mithilfe eines POC-Echokardiographie-Geräts auf der Stroke Unit der Neurologischen Abteilung des Universitätsklinikums Würzburg. Im Anschluss daran erhielten alle 78 Patienten und Patientinnen eine Kontrolluntersuchung durch eine erfahrene Echokardiographie-Raterin mithilfe eines SE-Geräts in einem externen Herzzentrum.
Die diagnostischen Qualitäten des POC-Echokardiographie-Geräts für Forschungszwecke zur fokussierten kardialen Diagnostik nach ischämischem Schlaganfall im Vergleich zu einer SE-Untersuchung konnten mithilfe der Validierungsstudie bestätigt werden. Es zeigte sich insbesondere, dass die POC-Echokardiographie für die Detektion einer LVEF≤55% mit einer Sensitivität von 100% geeignet war.
Um zu evaluieren, ob sich das POC-Echokardiographie-Gerät in Zukunft auch in der klinischen Praxis als Screeninginstrument eignet, mit dem Ziel eine individuelle Behandlung von Schlaganfallpatienten und -patientinnen zu gewährleisten, müssen größere, prospektive Studien durchgeführt werden, in denen die Fallzahl für bestimmte kardiologische Erkrankungen ausreichend hoch ist.
Objectives
Although the vast majority of COVID-19 cases are treated in primary care, patients' experiences during home isolation have been little studied. This study aimed to explore the experiences of patients with acute COVID-19 and to identify challenges after the initial adaptation of the German health system to the pandemic (after first infection wave from February to June 2020).
Methods
A mixed-method convergent design was used to gain a holistic insight into patients experience. The study consisted of a cross-sectional survey, open survey answers and semi-structured telephone interviews. Descriptive analysis was performed on quantitative survey answers. Between group differences were calculated to explore changes after the first infection wave. Qualitative thematic analysis was conducted on open survey answers and interviews. The results were then compared within a triangulation protocol.
Results
A total of 1100 participants from all German states were recruited by 145 general practitioners from August 2020 to April 2021, 42 additionally took part in qualitative interviews. Disease onset varied from February 2020 to April 2021. After the first infection wave, more participants were tested positive during the acute disease (88.8%; 95.2%; P < 0.001). Waiting times for tests (mean 4.5 days, SD 4.1; 2.7days, SD 2.6, P < 0.001) and test results (mean 2.4 days, SD 1.9; 1.8 days, SD 1.3, P < 0.001) decreased. Qualitative results indicated that the availability of repeated testing and antigen tests reduced insecurities, transmission and related guilt. Although personal consultations at general practices increased (6.8%; 15.5%, P < 0.001), telephone consultation remained the main mode of consultation (78.5%) and video remained insignificant (1.9%). The course of disease, the living situation and social surroundings during isolation, access to health care, personal resilience, spirituality and feelings of guilt and worries emerged as themes influencing the illness experience. Challenges were contact management and adequate provision of care during home isolation. A constant contact person within the health system helped against feelings of care deprivation, uncertainty and fear.
Conclusions
Our study highlights that home isolation of individuals with COVID-19 requires a holistic approach that considers all aspects of patient care and effective coordination between different care providers.
Die chronische Niereninsuffizienz (CKD) gilt als wichtiger prognostischer Faktor bei Patienten mit koronarer Herzerkrankung (KHK). Das Bewusstsein (Awareness) für das Vorliegen einer CKD bei Ärzten wie bei Patienten kann bei der Therapie von KHK-Patienten eine entscheidende Rolle spielen. Ziel dieser Arbeit war die Beschreibung der zeitlichen Trends der CKD-Prävalenz sowie der Awareness bei KHK-Patienten und Ärzten im Rahmen der EUROASPIRE (EA) V Studie im Studienzentrum Würzburg. EA V ist eine multizentrische Querschnittsstudie der European Society of Cardiology (ESC) zur Untersuchung der Qualität der Sekundärprävention bei KHK-Patienten, die 6-24 Monate vor dem Studienbesuch stationär behandelt wurden. Nierenfunktion und Nierenerkrankung wurden mit der glomerulären Filtrationsrate (eGFR) und der Urin Albumin-Kreatinin-Ratio abgeschätzt und klassifiziert. Die CKD Awareness der Patienten wurde anhand standardisierter Fragen erhoben. Die CKD Awareness der Ärzte wurde über die ICD-10 Codierung in der Patientenakte sowie die Dokumentation im Entlassungsbrief erfasst. Die Ergebnisse wurden mit der Würzburger EUROASPIRE IV (2012/13) Substudie verglichen. In EA V wurden 219 KHK-Patienten (Median 70 Jahre, 81% Männer) in Würzburg eingeschlossen. Bei Studienbesuch betrug die Prävalenz der CKD 32%, davon waren sich 30% der Patienten der CKD bewusst. Bei 26% der 73 Patienten mit während des Index-Krankenhausaufenthaltes apparenter Nierenfunktionseinschränkung wurde diese auch im Entlassungsbrief dokumentiert und bei 80% korrekt in der Patientenakte codiert. Im Vergleich zu EA IV zeigte sich die eingeschränkte Nierenfunktion während des Krankenhausaufenthaltes (p=0,013) und während des Studienbesuchs (p=0,056) häufiger. Bezüglich der CKD Awareness bei Ärzten und Patienten gab es keine signifikanten Unterschiede bezogen auf die gesamten Kohorten. Im Frühstadium G3a zeigte sich eine statistisch signifikant geringere CKD Awareness der Patienten in EA V verglichen mit EA IV. Die CKD ist eine häufige Komorbidität bei KHK-Patienten. Die CKD Awareness ist bei Patienten, aber auch Ärzten niedrig. Aus dieser Konstellation ergeben sich Handlungsaufträge für eine gezielte Aufklärung von Patienten und nachhaltig wirksame Fortbildung der behandelnden Ärzte.
Wenige Publikationen beschäftigen sich mit der diastolischen Dysfunktion (DD) bei Schlaganfallpatienten. Um diese Datenlücke zu bearbeiten, wurden, im Rahmen der SICFAIL-Kohortenstudie, Schlaganfallpatienten hinsichtlich des Vorhandenseins einer diastolischen Funktionsstörung in Anlehnung an, zum Zeitpunkt des Verfassens dieser Arbeit, aktuelle Empfehlungen anhand echokardiographischer Parameter eingeteilt und charakterisiert. Zudem konnten Erkenntnisse über Einflussfaktoren gewonnen werden, die mit einer DD assoziiert sind.
Dabei zeigte sich, dass Schlaganfallpatienten mit einer diastolischen Funktionsstörung älter sind als Schlaganfallpatienten ohne DD und dass mit steigendem Lebensalter auch die Chance für eine DD ansteigt. Zudem bestand häufiger eine medikamentös behandelte aber auch eine unbehandelte arterielle Hypertonie, die mit dem Auftreten einer DD assoziiert ist. Diese Erkenntnisse decken sich mit den Ergebnissen verschiedener Arbeitsgruppen, die sich mit dem Vorkommen der DD in der Allgemeinbevölkerung beschäftigt haben.
Die im Rahmen dieser Arbeit ermittelte Prävalenz der diastolischen Funktionsstörung bei Schlaganfallpatienten ist deutlich niedriger als diejenige, die in anderen Forschungsarbeiten herausgefunden wurde. Unterschiedliche Definitionen der DD können ein Grund dafür sein.
Es bedarf aber weitere Forschungsarbeit in diese Richtung genauso wie eine stärkere Etablierung der aktuellen Definitionsgrundlagen der DD um umfassende und einheitliche Erkenntnisse über die diastolische Funktionsstörung bei Schlaganfallpatienten und auch in der Allgemeinbevölkerung zu erlangen. Zudem sollte ein weiteres Forschungsziel sein, mögliche Einflüsse der DD auf das Outcome der Patienten nach ischämischem Schlaganfall zu identifizieren, um diese gezielt in die Erarbeitung von Präventionsmaßnahmen aufzunehmen.
We assume that a specific health constraint, e.g., a certain aspect of bodily function or quality of life that is measured by a variable X, is absent (or irrelevant) in a healthy reference population (Ref0), and it is materially present and precisely measured in a diseased reference population (Ref1). We further assume that some amount of this constraint of interest is suspected to be present in a population under study (SP). In order to quantify this issue, we propose the introduction of an intuitive measure, the population comparison index (PCI), that relates the mean value of X in population SP to the mean values of X in populations Ref0 and Ref1. This measure is defined as PCI[X] = (mean[X|SP] − mean[X|Ref0])/(mean[X|Ref1] − mean[X|Ref0]) × 100[%], where mean[X|.] is the average value of X in the respective group of individuals. For interpretation, PCI[X] ≈ 0 indicates that the values of X in the population SP are similar to those in population Ref0, and hence, the impairment measured by X is not materially present in the individuals in population SP. On the other hand, PCI[X] ≈ 100 means that the individuals in SP exhibit values of X comparable to those occurring in Ref1, i.e., the constraint of interest is equally present in populations SP and Ref1. A value of 0 < PCI[X] < 100 indicates that a certain percentage of the constraint is present in SP, and it is more than in Ref0 but less than in Ref1. A value of PCI[X] > 100 means that population SP is even more affected by the constraint than population Ref1.
Now that mechanical thrombectomy has substantially improved outcomes after large-vessel occlusion stroke in up to every second patient, futile reperfusion wherein successful recanalization is not followed by a favorable outcome is moving into focus. Unfortunately, blood-based biomarkers, which identify critical stages of hemodynamically compromised yet reperfused tissue, are lacking. We recently reported that hypoxia induces the expression of endoglin, a TGF-β co-receptor, in human brain endothelium in vitro. Subsequent reoxygenation resulted in shedding. Our cell model suggests that soluble endoglin compromises the brain endothelial barrier function. To evaluate soluble endoglin as a potential biomarker of reperfusion (-injury) we analyzed its concentration in 148 blood samples of patients with acute stroke due to large-vessel occlusion. In line with our in vitro data, systemic soluble endoglin concentrations were significantly higher in patients with successful recanalization, whereas hypoxia alone did not induce local endoglin shedding, as analyzed by intra-arterial samples from hypoxic vasculature. In patients with reperfusion, higher concentrations of soluble endoglin additionally indicated larger infarct volumes at admission. In summary, we give translational evidence that the sequence of hypoxia and subsequent reoxygenation triggers the release of vasoactive soluble endoglin in large-vessel occlusion stroke and can serve as a biomarker for severe ischemia with ensuing recanalization/reperfusion.
(1) Background: The health-related quality of life (HRQOL) of colorectal cancer (CRC) survivors >10 years post-diagnosis is understudied. We aimed to compare the HRQOL of CRC survivors 14–24 years post-diagnosis to that of age- and sex-matched non-cancer controls, stratified by demographic and clinical factors. (2) Methods: We used data from 506 long-term CRC survivors and 1489 controls recruited from German population-based multi-regional studies. HRQOL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Core-30 (EORTC QLQ-C30) questionnaire. We estimated differences in the HRQOL of CRC survivors and controls with multiple regression, adjusted for age at survey, sex, and education, where appropriate. (3) Results: CRC survivors reported poorer social functioning but better health status/QOL than controls. CRC survivors, in general, had higher levels of symptom burden, and in particular diarrhea and constipation, regardless of demographic or clinical factors. In stratified analyses, HRQOL differed by age, sex, cancer type, and having a permanent stoma. (4) Conclusions: Although CRC survivors may have a comparable health status/QOL to controls 14–24 years after diagnosis, they still live with persistent bowel dysfunction that can negatively impact aspects of functioning. Healthcare providers should provide timely and adapted follow-up care to ameliorate potential long-term suffering.
The Internet of Things (IoT) enables a variety of smart applications, including smart home, smart manufacturing, and smart city. By enhancing Business Process Management Systems with IoT capabilities, the execution and monitoring of business processes can be significantly improved. Providing a holistic support for modeling, executing and monitoring IoT-driven processes, however, constitutes a challenge. Existing process modeling and process execution languages, such as BPMN 2.0, are unable to fully meet the IoT characteristics (e.g., asynchronicity and parallelism) of IoT-driven processes. In this article, we present BPMNE4IoT—A holistic framework for modeling, executing and monitoring IoT-driven processes. We introduce various artifacts and events based on the BPMN 2.0 metamodel that allow realizing the desired IoT awareness of business processes. The framework is evaluated along two real-world scenarios from two different domains. Moreover, we present a user study for comparing BPMNE4IoT and BPMN 2.0. In particular, this study has confirmed that the BPMNE4IoT framework facilitates the support of IoT-driven processes.
Background
Patients with coronary heart disease (CHD) with and without diabetes mellitus have an increased risk of recurrent events requiring multifactorial secondary prevention of cardiovascular risk factors. We compared prevalences of cardiovascular risk factors and its determinants including lifestyle, pharmacotherapy and diabetes mellitus among patients with chronic CHD examined within the fourth and fifth EUROASPIRE surveys (EA-IV, 2012–13; and EA-V, 2016–17) in Germany.
Methods
The EA initiative iteratively conducts European-wide multicenter surveys investigating the quality of secondary prevention in chronic CHD patients aged 18 to 79 years. The data collection in Germany was performed during a comprehensive baseline visit at study centers in Würzburg (EA-IV, EA-V), Halle (EA-V), and Tübingen (EA-V).
Results
384 EA-V participants (median age 69.0 years, 81.3% male) and 536 EA-IV participants (median age 68.7 years, 82.3% male) were examined. Comparing EA-IV and EA-V, no relevant differences in risk factor prevalence and lifestyle changes were observed with the exception of lower LDL cholesterol levels in EA-V. Prevalence of unrecognized diabetes was significantly lower in EA-V as compared to EA-IV (11.8% vs. 19.6%) while the proportion of prediabetes was similarly high in the remaining population (62.1% vs. 61.0%).
Conclusion
Between 2012 and 2017, a modest decrease in LDL cholesterol levels was observed, while no differences in blood pressure control and body weight were apparent in chronic CHD patients in Germany. Although the prevalence of unrecognized diabetes decreased in the later study period, the proportion of normoglycemic patients was low. As pharmacotherapy appeared fairly well implemented, stronger efforts towards lifestyle interventions, mental health programs and cardiac rehabilitation might help to improve risk factor profiles in chronic CHD patients.
Psychosocial factors affect mental health and health-related quality of life (HRQL) in a complex manner, yet gender differences in these interactions remain poorly understood. We investigated whether psychosocial factors such as social support and personal and work-related concerns impact mental health and HRQL differentially in women and men during the first year of the COVID-19 pandemic. Between June and October 2020, the first part of a COVID-19-specific program was conducted within the “Characteristics and Course of Heart Failure Stages A-B and Determinants of Progression (STAAB)” cohort study, a representative age- and gender-stratified sample of the general population of Würzburg, Germany. Using psychometric networks, we first established the complex relations between personal social support, personal and work-related concerns, and their interactions with anxiety, depression, and HRQL. Second, we tested for gender differences by comparing expected influence, edge weight differences, and stability of the networks. The network comparison revealed a significant difference in the overall network structure. The male (N = 1370) but not the female network (N = 1520) showed a positive link between work-related concern and anxiety. In both networks, anxiety was the most central variable. These findings provide further evidence that the complex interplay of psychosocial factors with mental health and HRQL decisively depends on gender. Our results are relevant for the development of gender-specific interventions to increase resilience in times of pandemic crisis.
Long-term sequelae in hospitalized Coronavirus Disease 2019 (COVID-19) patients may result in limited quality of life. The current study aimed to determine health-related quality of life (HRQoL) after COVID-19 hospitalization in non-intensive care unit (ICU) and ICU patients. This is a single-center study at the University Hospital of Wuerzburg, Germany. Patients eligible were hospitalized with COVID-19 between March 2020 and December 2020. Patients were interviewed 3 and 12 months after hospital discharge. Questionnaires included the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), patient health questionnaire-9 (PHQ-9), the generalized anxiety disorder 7 scale (GAD-7), FACIT fatigue scale, perceived stress scale (PSS-10) and posttraumatic symptom scale 10 (PTSS-10). 85 patients were included in the study. The EQ5D-5L-Index significantly differed between non-ICU (0.78 ± 0.33 and 0.84 ± 0.23) and ICU (0.71 ± 0.27; 0.74 ± 0.2) patients after 3- and 12-months. Of non-ICU 87% and 80% of ICU survivors lived at home without support after 12 months. One-third of ICU and half of the non-ICU patients returned to work. A higher percentage of ICU patients was limited in their activities of daily living compared to non-ICU patients. Depression and fatigue were present in one fifth of the ICU patients. Stress levels remained high with only 24% of non-ICU and 3% of ICU patients (p = 0.0186) having low perceived stress. Posttraumatic symptoms were present in 5% of non-ICU and 10% of ICU patients. HRQoL is limited in COVID-19 ICU patients 3- and 12-months post COVID-19 hospitalization, with significantly less improvement at 12-months compared to non-ICU patients. Mental disorders were common highlighting the complexity of post-COVID-19 symptoms as well as the necessity to educate patients and primary care providers about monitoring mental well-being post COVID-19.
Stress experiences of healthcare assistants in family practice at the onset of the COVID-19 pandemic
(2023)
Background: At the beginning of the pandemic in 2020, healthcare assistants in general practices were confronted with numerous new challenges. The aim of the study was to investigate the stress factors of healthcare assistants in March/April 2020 as well as in the further course of the pandemic in 2020.
Methods: From August to December 2020, 6,300 randomly selected healthcare assistants in four German states were invited to participate in the study. We performed a mixed methods design using semi-structured telephone interviews and a cross-sectional survey with quantitative and open questions. The feeling of psychological burden was assessed on a 6-point likert-scale. We defined stress factors and categorized them in patient, non-patient and organizational stress factors. The results of the three data sets were compared within a triangulation protocol.
Results: One thousand two hundred seventy-four surveys were analyzed and 28 interviews with 34 healthcare assistants were conducted. Of the participants, 29.5% reported experiences of a very high or high feeling of psychological burden in March/April 2020. Worries about the patients’ health and an uncertainty around the new disease were among the patient-related stress factors. Non-patient-related stress factors were problems with the compatibility of work and family, and the fear of infecting relatives with COVID-19. Organizational efforts and dissatisfaction with governmental pandemic management were reported as organizational stress factors. Support from the employer and team cohesion were considered as important resources.
Discussion: It is necessary to reduce stress among healthcare assistants by improving their working conditions and to strengthen their resilience to ensure primary healthcare delivery in future health crises.
During the COVID-19 pandemic, the novel coronavirus had an impact not only on public health but also on the mental health of the population. Public sentiment on mental health and depression is often captured only in small, survey-based studies, while work based on Twitter data often only looks at the period during the pandemic and does not make comparisons with the pre-pandemic situation. We collected tweets that included the hashtags #MentalHealth and #Depression from before and during the pandemic (8.5 months each). We used LDA (Latent Dirichlet Allocation) for topic modeling and LIWC, VADER, and NRC for sentiment analysis. We used three machine-learning classifiers to seek evidence regarding an automatically detectable change in tweets before vs. during the pandemic: (1) based on TF-IDF values, (2) based on the values from the sentiment libraries, (3) based on tweet content (deep-learning BERT classifier). Topic modeling revealed that Twitter users who explicitly used the hashtags #Depression and especially #MentalHealth did so to raise awareness. We observed an overall positive sentiment, and in tough times such as during the COVID-19 pandemic, tweets with #MentalHealth were often associated with gratitude. Among the three classification approaches, the BERT classifier showed the best performance, with an accuracy of 81% for #MentalHealth and 79% for #Depression. Although the data may have come from users familiar with mental health, these findings can help gauge public sentiment on the topic. The combination of (1) sentiment analysis, (2) topic modeling, and (3) tweet classification with machine learning proved useful in gaining comprehensive insight into public sentiment and could be applied to other data sources and topics.
Summary
Blood oxygen saturation is an important clinical parameter, especially in postoperative hospitalized patients, monitored in clinical practice by arterial blood gas (ABG) and/or pulse oximetry that both are not suitable for a long-term continuous monitoring of patients during the entire hospital stay, or beyond. Technological advances developed recently for consumer-grade fitness trackers could—at least in theory—help to fill in this gap, but benchmarks on the applicability and accuracy of these technologies in hospitalized patients are currently lacking. We therefore conducted at the postanaesthesia care unit under controlled settings a prospective clinical trial with 201 patients, comparing in total >1,000 oxygen blood saturation measurements by fitness trackers of three brands with the ABG gold standard and with pulse oximetry. Our results suggest that, despite of an overall still tolerable measuring accuracy, comparatively high dropout rates severely limit the possibilities of employing fitness trackers, particularly during the immediate postoperative period of hospitalized patients.
Highlights
•The accuracy of O2 measurements by fitness trackers is tolerable (RMSE ≲4%)
•Correlation with arterial blood gas measurements is fair to moderate (PCC = [0.46; 0.64])
•Dropout rates of fitness trackers during O2 monitoring are high (∼1/3 values missing)
•Fitness trackers cannot be recommended for O2 measuring during critical monitoring
Objectives
To evaluate whether a multimodal intervention in general practice reduces the proportion of second line antibiotic prescriptions and the overall proportion of antibiotic prescriptions for uncomplicated urinary tract infections in women.
Design
Parallel, cluster randomised, controlled trial.
Setting
General practices in five regions in Germany. Data were collected between 1 April 2021 and 31 March 2022.
Participants
General practitioners from 128 randomly assigned practices.
Interventions
Multimodal intervention consisting of guideline recommendations for general practitioners and patients, provision of regional data for antibiotic resistance, and quarterly feedback, which included individual first line and second line proportions of antibiotic prescribing, benchmarking with regional or supra-regional practices, and telephone counselling. Participants in the control group received no information on the intervention.
Main outcome measures
Primary outcome was the proportion of second line antibiotics prescribed by general practices, in relation to all antibiotics prescribed, for uncomplicated urinary tract infections after one year between the intervention and control group. General practices were randomly assigned in blocks (1:1), with a block size of four, into the intervention or control group using SAS version 9.4; randomisation was stratified by region. The secondary outcome was the prescription proportion of all antibiotics, relative within all cases (instances of UTI diagnosis), for the treatment of urinary tract infections after one year between the groups. Adverse events were assessed as exploratory outcomes.
Results
110 practices with full datasets identified 10 323 cases during five quarters (ie, 15 months). The mean proportion of second line antibiotics prescribed was 0.19 (standard deviation 0.20) in the intervention group and 0.35 (0.25) in the control group after 12 months. After adjustment for preintervention proportions, the mean difference was −0.13 (95% confidence interval −0.21 to −0.06, P<0.001). The overall proportion of all antibiotic prescriptions for urinary tract infections over 12 months was 0.74 (standard deviation 0.22) in the intervention and 0.80 (0.15) in the control group with a mean difference of −0.08 (95% confidence interval −0.15 to −0.02, P<0.029). No differences were noted in the number of complications (ie, pyelonephritis, admission to hospital, or fever) between the groups.
Conclusions
The multimodal intervention in general practice significantly reduced the proportion of second line antibiotics and all antibiotic prescriptions for uncomplicated urinary tract infections in women.
Trial registration
German Clinical Trials Register (DRKS), DRKS00020389
Background
Performance anxiety is the most frequently reported anxiety disorder among professional musicians. Typical symptoms are - on a physical level - the consequences of an increase in sympathetic tone with cardiac stress, such as acceleration of heartbeat, increase in blood pressure, increased respiratory rate and tremor up to nausea or flush reactions. These symptoms can cause emotional distress, a reduced musical and artistical performance up to an impaired functioning. While anxiety disorders are preferably treated using cognitive-behavioral therapy with exposure, this approach is rather difficult for treating music performance anxiety since the presence of a public or professional jury is required and not easily available. The use of virtual reality (VR) could therefore display an alternative. So far, no therapy studies on music performance anxiety applying virtual reality exposure therapy have investigated the therapy outcome including cardiovascular changes as outcome parameters.
Methods
This mono-center, prospective, randomized and controlled clinical trial has a pre-post design with a follow-up period of 6 months. 46 professional and semi-professional musicians will be recruited and allocated randomly to an VR exposure group or a control group receiving progressive muscle relaxation training. Both groups will be treated over 4 single sessions. Music performance anxiety will be diagnosed based on a clinical interview using ICD-10 and DSM-5 criteria for specific phobia or social anxiety. A behavioral assessment test is conducted three times (pre, post, follow-up) in VR through an audition in a concert hall. Primary outcomes are the changes in music performance anxiety measured by the German Bühnenangstfragebogen and the cardiovascular reactivity reflected by heart rate variability (HRV). Secondary outcomes are changes in blood pressure, stress parameters such as cortisol in the blood and saliva, neuropeptides, and DNA-methylation.
Discussion
The trial investigates the effect of VR exposure in musicians with performance anxiety compared to a relaxation technique on anxiety symptoms and corresponding cardiovascular parameters. We expect a reduction of anxiety but also a consecutive improvement of HRV with cardiovascular protective effects.
Trial registration
This study was registered on clinicaltrials.gov. (ClinicalTrials.gov Number: NCT05735860)
Background
Tobacco smoking is accountable for more than one in ten deaths in patients with cardiovascular disease. Thus, smoking cessation has a high priority in secondary prevention of coronary heart disease (CHD). The present study meant to assess smoking cessation patterns, identify parameters associated with smoking cessation and investigate personal reasons to change or maintain smoking habits in patients with established CHD.
Methods
Quality of CHD care was surveyed in 24 European countries in 2012/13 by the fourth European Survey of Cardiovascular Disease Prevention and Diabetes. Patients 18 to 79 years of age at the date of the CHD index event hospitalized due to first or recurrent diagnosis of coronary artery bypass graft, percutaneous coronary intervention, acute myocardial infarction or acute myocardial ischemia without infarction (troponin negative) were included. Smoking status and clinical parameters were iteratively obtained a) at the cardiovascular disease index event by medical record abstraction, b) during a face-to-face interview 6 to 36 months after the index event (i.e. baseline visit) and c) by telephone-based follow-up interview two years after the baseline visit. Parameters associated with smoking status at the time of follow-up interview were identified by logistic regression analysis. Personal reasons to change or maintain smoking habits were assessed in a qualitative interview and analyzed by qualitative content analysis.
Results
One hundred and four of 469 (22.2%) participants had been classified current smokers at the index event and were available for follow-up interview. After a median observation period of 3.5 years (quartiles 3.0, 4.1), 65 of 104 participants (62.5%) were classified quitters at the time of follow-up interview. There was a tendency of diabetes being more prevalent in quitters vs non-quitters (37.5% vs 20.5%, p=0.07). Higher education level (15.4% vs 33.3%, p=0.03) and depressed mood (17.2% vs 35.9%, p=0.03) were less frequent in quitters vs non-quitters. Quitters more frequently participated in cardiac rehabilitation programs (83.1% vs 48.7%, p<0.001). Cardiac rehabilitation appeared as factor associated with smoking cessation in multivariable logistic regression analysis (OR 5.19, 95%CI 1.87 to 14.46, p=0.002). Persistent smokers at telephone-based follow-up interview reported on addiction as wells as relaxation and pleasure as reasons to continue their habit. Those current and former smokers who relapsed at least once after a quitting attempt, stated future health hazards as their main reason to undertake quitting attempts. Prevalent factors leading to relapse were influence by their social network and stress. Successful quitters at follow-up interview referred to smoking-related harm done to their health having had been their major reason to quit.
Interpretation
Participating in a cardiac rehabilitation program was strongly associated with smoking cessation after a cardiovascular disease index event. Smoking cessation counseling and relapse prophylaxis may include alternatives for the pleasant aspects of smoking and incorporate effective strategies to resist relapse.
Background
In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process.
Study design
This multi-center, prospective controlled study has a two-phase cohort design.
Methods
Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD’s outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2).
Outcomes
Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients’ quality of life and evaluation of care; and f) physicians’ satisfaction with the innovative care approach.
Conclusions
This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease.
Background
Non-suicidal self-injury (NSSI) has become a substantial public health problem. NSSI is a high-risk marker for the development and persistence of mental health problems, shows high rates of morbidity and mortality, and causes substantial health care costs. Thus, there is an urgent need for action to develop universal prevention programs for NSSI before adolescents begin to show this dangerous behavior. Currently, however, universal prevention programs are lacking.
Methods
The main objective of the present study is to evaluate a newly developed universal prevention program (“DUDE – Du und deine Emotionen / You and your emotions”), based on a skills-based approach in schools, in 3200 young adolescents (age 11–14 years). The effectiveness of DUDE will be investigated in a cluster-randomized controlled trial (RCT) in schools (N = 16). All groups will receive a minimal intervention called “Stress-free through the school day” as a mental health literacy program to prevent burnout in school. The treatment group (N = 1600; 8 schools) will additionally undergo the universal prevention program DUDE and will be divided into treatment group 1 (DUDE conducted by trained clinical psychologists; N = 800; 4 schools) and treatment group 2 (DUDE conducted by trained teachers; N = 800; 4 schools). The active control group (N = 1600; 8 schools) will only receive the mental health literacy prevention. Besides baseline assessment (T0), measurements will occur at the end of the treatment (T1) and at 6- (T2) and 12-month (T3) follow-up evaluations. The main outcome is the occurrence of NSSI within the last 6 months assessed by a short version of the Deliberate Self-Harm Inventory (DSHI-9) at the 1-year follow-up (primary endpoint; T3). Secondary outcomes are emotion regulation, suicidality, health-related quality of life, self-esteem, and comorbid psychopathology and willingness to change.
Discussion
DUDE is tailored to diminish the incidence of NSSI and to prevent its possible long-term consequences (e.g., suicidality) in adolescents. It is easy to access in the school environment. Furthermore, DUDE is a comprehensive approach to improve mental health via improved emotion regulation.
Background
Troponin elevation is common in ischemic stroke (IS) patients. The pathomechanisms involved are incompletely understood and comprise coronary and non-coronary causes, e.g. autonomic dysfunction. We investigated determinants of troponin elevation in acute IS patients including markers of autonomic dysfunction, assessed by heart rate variability (HRV) time domain variables.
Methods
Data were collected within the Stroke Induced Cardiac FAILure (SICFAIL) cohort study. IS patients admitted to the Department of Neurology, Würzburg University Hospital, underwent baseline investigation including cardiac history, physical examination, echocardiography, and blood sampling. Four HRV time domain variables were calculated in patients undergoing electrocardiographic Holter monitoring. Multivariable logistic regression with corresponding odds ratios (OR) and 95% confidence intervals (CI) was used to investigate the determinants of high-sensitive troponin T (hs-TnT) levels ≥14 ng/L.
Results
We report results from 543 IS patients recruited between 01/2014–02/2017. Of those, 203 (37%) had hs-TnT ≥14 ng/L, which was independently associated with older age (OR per year 1.05; 95% CI 1.02–1.08), male sex (OR 2.65; 95% CI 1.54–4.58), decreasing estimated glomerular filtration rate (OR per 10 mL/min/1.73 m2 0.71; 95% CI 0.61–0.84), systolic dysfunction (OR 2.79; 95% CI 1.22–6.37), diastolic dysfunction (OR 2.29; 95% CI 1.29–4.02), atrial fibrillation (OR 2.30; 95% CI 1.25–4.23), and increasing levels of C-reactive protein (OR 1.48 per log unit; 95% CI 1.22–1.79). We did not identify an independent association of troponin elevation with the investigated HRV variables.
Conclusion
Cardiac dysfunction and elevated C-reactive protein, but not a reduced HRV as surrogate of autonomic dysfunction, were associated with increased hs-TnT levels in IS patients independent of established cardiovascular risk factors.
Background and objectives
Bullous pemphigoid (BP) is associated with neuropsychiatric disorders. Other comorbid diseases are discussed controversially. We evaluated the prevalence of comorbidity in BP patients in a representative area of Germany.
Patients and methods
Medical files of all BP patients treated at the Department of Dermatology, University Hospital Würzburg, Germany, between June 2002 and May 2013 were retrospectively reviewed. Bullous pemphigoid was diagnosed based on established criteria. For each patient, two controls were individually matched. Records were evaluated for age, sex, laboratory values, concomitant medication and comorbidity. Conditional logistic regression, multivariable regression analysis and complex regression models were performed to compare results.
Results
300 BP patients were identified and compared to 583 controls. Bullous pemphigoid was associated with neuropsychiatric disorders as well as laboratory abnormalities including leukocytosis and eosinophilia. Importantly, a highly significant association of BP with anemia (OR 2.127; 95 % CI 1.532–2.953) and renal impairment (OR 2.218; 95 % CI 1.643–2.993) was identified. No association was found with malignancy and arterial hypertension.
Conclusions
Our data revealed an increased frequency of anemia and renal impairment in BP patients. In accordance with previous studies the strong association for neuropsychiatric disorders was confirmed (p < 0.0005).
Individuals with chronic conditions have been faced with many additional challenges during the COVID-19 pandemic. Individual health literacy (HL) as the ability to access, understand, evaluate, and apply pandemic-related information has thus become ever more important in these populations. The purpose of this study was to develop and content-validate a comprehensive HL survey instrument for people with asthma based on an integrated framework, and on previous surveys and other instruments for use in the general population and vulnerable groups. Beside HL, assumed determinants, mediators, and health outcomes were embraced in the framework. A mixed-method design was used. A comprehensive examination of the available literature yielded an initial pool of 398 single items within 20 categories. Based on content validity indices (CVI) of expert ratings (n = 11) and the content analysis of cognitive interviews with participants (n = 9), the item pool was reduced, and individual items/scales refined or modified. The instrument showed appropriate comprehensibility (98.0%), was judged relevant, and had an acceptable CVI at scale level (S-CVI/Ave = 0.91). The final version comprises 14 categories measured by 38 questions consisting of 116 single items. In terms of content, the instrument appears a valid representation of behavioural and psychosocial constructs pertaining to a broad HL understanding and relevant to individuals with asthma during the COVID-19 pandemic. Regular monitoring of these behavioural and psychosocial constructs during the course of the pandemic can help identify needs as well as changes during the course of the pandemic, which is particularly important in chronic disease populations.
Seit Mitte der 1990er Jahre wurden nationale und regionale Schlaganfallregister in Europa etabliert, die Auskunft über die Versorgungsqualität von Schlaganfallpatienten geben. Bislang lagen nur wenige Daten zu zeitlichen Trends der akuten Schlaganfallversorgung vor. Diese sind jedoch essentiell, um beispielsweise Zusammenhänge zwischen der Einführung potentiell qualitätsverbessernder Maßnahmen und der Entwicklung der Versorgungsqualität feststellen zu können. Die Behandlung von Schlaganfallpatienten auf Stroke Units ist aufgrund der eindeutigen Evidenz aus randomisierten- und Beobachtungsstudien zum Standard geworden. Bislang war unklar, ob demografische und klinische Charakteristika die direkte Aufnahme auf eine Stroke Unit beeinflussen. Zudem war nicht bekannt, ob und wenn ja, in welchem Ausmaß strukturelle Kriterien und der Anteil der Patienten, der auf eine Stroke Unit aufgenommen wurde, die Qualität der Stroke Unit Versorgung beeinflussen. Im Anschluss an die Akutbehandlung im Krankenhaus bzw. nach geeigneten Rehabilitationsmaßnahmen übernehmen pflegende Angehörige häufig die Versorgung der Schlaganfallpatienten im häuslichen Umfeld. Die aktuelle Situation der pflegenden Angehörigen von Schlaganfallpatienten in Deutschland ist bisher jedoch nur unzureichend evaluiert.
In der vorliegenden Dissertation wurden zunächst im Rahmen des „European Implementation Score“-Projektes zeitliche Trends der Qualität der akuten Schlaganfallversorgung in fünf nationalen europäischen Schlaganfallregistern aus Deutschland, England/Wales/Nordirland, Polen, Schottland und Schweden nach zuvor definierten evidenzbasierten Qualitätsindikatoren berechnet. Im zweiten Schritt wurde anhand von Daten der Arbeitsgemeinschaft Deutscher Schlaganfall Register (ADSR) evaluiert, ob demografische und klinische Patientencharakteristika die direkte Aufnahme auf eine Stroke Unit in Deutschland beeinflussen. Weiterhin wurde der Einfluss struktureller Charakteristika auf die Erfüllung von 11 evidenzbasierter Qualitätsindikatoren in Krankenhäusern, die über eine regionale oder überregionale Stroke Unit verfügen, untersucht. Abschließend wurden im Rahmen des regionalen Telemedizinnetzwerkes TRANSIT-Stroke demografische und klinische Charakteristika von Schlaganfallpatienten, die 3 Monate nach dem Schlaganfall mit dem Erhalt von Pflege durch einen Angehörigen assoziiert waren, identifiziert. Zusätzlich wurden mit standardisierten Erhebungsinstrumenten positive und negative Erfahrungen der Pflege eines Schlaganfallpatienten sowie die selbsteingeschätzte Belastung (deutsche Version des Caregiver Reaction Assessment und Self-Rated Burden Scale) ausgewertet sowie Faktoren, die mit den Pflegeerfahrungen und Belastungen assoziiert sind, evaluiert.
Auf europäischer Ebene konnten wir einen Zusammenhang zwischen der Einführung eines neuen Qualitätsindikators und der Verbesserung der Qualität beobachten. Dies galt insbesondere für die erstmalige Einführung des Qualitätsindikators Dysphagiescreening im deutschen -(2006) und schwedischen Schlaganfallregister (2007). Somit gibt es Hinweise darauf, dass das Monitoring der Qualität der Schlaganfallversorgung zu Qualitätsverbesserungen bzw. auch zu einer vollständigeren Dokumentation führt.
Insgesamt konnten wir ein qualitativ hohes Niveau der akuten Schlaganfallversorgung auf Stroke Units in Deutschland gemäß evidenzbasierter Qualitätsindikatoren feststellen. Patienten mit einem ischämischen Schlaganfall, die am Wochenende aufgenommen wurden (p<0,0001), innerhalb von 3 Stunden nach Symptombeginn im Krankenhaus aufgenommen wurden (p<0,0001), hypertensiv waren (p<0,0001), unter einer Hyperlipidämie (p<0,0001) litten, wurden mit einer höheren Wahrscheinlichkeit auf einer Stroke Unit aufgenommen. Dagegen hatten Patienten mit einem schwereren Schlaganfall (NIHSS>15) eine geringere Chance, auf einer Stroke Unit aufgenommen zu werden (p<0,0001). Der Einfluss struktureller Charakteristika auf die Qualität der Stroke Unit Versorgung war gering. Eine Verbesserung der Qualität könnte noch durch einen höheren Anteil der auf einer Stroke Unit aufgenommenen Patienten erreicht werden.
Im Rahmen der Nachbefragung von Patienten im regionalen Telemedizinnetzwerk TRANSIT-Stroke stellten Frauen mit 70,1% den größten Anteil der pflegenden Angehörigen dar. 74,4% der pflegenden Angehörigen war älter als 55 Jahre. In univariablen und multivariablen logistischen Regressionsanalysen waren ein hohes Alter, ein niedriger Barthel-Index bei Entlassung sowie das Vorliegen von Diabetes signifikant mit einer höheren Wahrscheinlichkeit assoziiert, Pflege von einem Angehörigen zu erhalten. Der Großteil der pflegenden Angehörigen möchte den Angehörigen pflegen und ist gleichzeitig dem Risiko gesundheitlicher Probleme ausgesetzt. Circa ein Fünftel der pflegenden Angehörigen berichtete finanzielle Belastungen aufgrund der Pflegesituation. Depressive Symptome der Patienten waren mit einer höheren Belastung der pflegenden Angehörigen hinsichtlich der selbsteingeschätzten Belastung und den positiven und negativen Erfahrungen assoziiert. Jüngere, männliche Schlaganfallpatienten, mit einem milderen Schlaganfall, die mit einer Partnerin oder Ehepartnerin zusammenleben, scheinen sich oft nicht bewusst zu sein, dass sie Pflege erhalten. Möglich ist hier, dass sie die Unterstützung und Pflege als „normal“ betrachten, während der Partner bzw. die Partnerin dies als tatsächliche Pflege wertet.
Schlaganfallregister eignen sich, um die Qualität der Akutversorgung im Zeitverlauf zu monitorieren und Zusammenhänge zwischen der Einführung potentiell qualitätsverbessernder Maßnahmen und der tatsächlichen Qualität darstellen zu können. Die Qualität der Stroke Unit Versorgung in Deutschland ist auf einem hohen Niveau. Eine Verbesserung der Qualität könnte noch durch einen höheren Anteil der auf einer Stroke Unit aufgenommenen Patienten erreicht werden. Ein Großteil der Schlaganfallpatienten lebt im Anschluss an die Akutversorgung im häuslichen Umfeld, in dem pflegende Angehörige eine wichtige Rolle bei der Versorgung spielen. Pflegenden Angehörigen ist ihre Aufgabe wichtig, sind jedoch aufgrund der Pflege zugleich Belastungen hinsichtlich ihrer Gesundheit, der Gestaltung ihres täglichen Zeitplans und der Finanzen ausgesetzt.
Prediction of tinnitus perception based on daily life mHealth data using country origin and season
(2022)
Tinnitus is an auditory phantom perception without external sound stimuli. This chronic perception can severely affect quality of life. Because tinnitus symptoms are highly heterogeneous, multimodal data analyses are increasingly used to gain new insights. MHealth data sources, with their particular focus on country- and season-specific differences, can provide a promising avenue for new insights. Therefore, we examined data from the TrackYourTinnitus (TYT) mHealth platform to create symptom profiles of TYT users. We used gradient boosting engines to classify momentary tinnitus and regress tinnitus loudness, using country of origin and season as features. At the daily assessment level, tinnitus loudness can be regressed with a mean absolute error rate of 7.9% points. In turn, momentary tinnitus can be classified with an F1 score of 93.79%. Both results indicate differences in the tinnitus of TYT users with respect to season and country of origin. The significance of the features was evaluated using statistical and explainable machine learning methods. It was further shown that tinnitus varies with temperature in certain countries. The results presented show that season and country of origin appear to be valuable features when combined with longitudinal mHealth data at the level of daily assessment.
Background
The Dermatophagoides pteronyssinus molecule Der p 23 is a major allergen whose clinical relevance has been shown in cross‐sectional studies. We longitudinally analysed the trajectory of Der p 23‐specific IgE antibody (sIgE) levels throughout childhood and youth, their early‐life determinants and their clinical relevance for allergic rhinitis and asthma.
Methods
We obtained sera and clinical data of 191 participants of the German Multicentre Allergy Study, a prospective birth cohort. Serum samples from birth to 20 years of age with sIgE reactivity to Der p 23 in a customised semiquantitative microarray were newly analysed with a singleplex quantitative assay. Early mite exposure was assessed by measuring the average content of Der p 1 in house dust at 6 and 18 months.
Results
Der p 23‐sIgE levels were detected at least once in 97/191 participants (51%). Prevalence of Der p 23 sensitisation and mean sIgE levels increased until age 10 years, plateaued until age 13 years and were lowest at age 20 years. Asthma, allergic rhinitis (AR) and atopic dermatitis (AD) were more prevalent in Der p 23‐sensitised children, including those with monomolecular but persistent sensitisation (11/97, 11%). A higher exposure to mites in infancy and occurrence of AD before 5 years of age preceded the onset of Der p 23 sensitisation, which in turn preceded a higher incidence of asthma.
Conclusions
Der p 23 sensitisation peaks in late childhood and then decreases. It is preceded by early mite exposure and AD. Asthma and AR can occur in patients persistently sensitised to Der p 23 as the only mite allergen, suggesting the inclusion of molecular testing of Der p 23‐sIgE for subjects with clinical suspicion of HDM allergy but without sIgE to other major D.pt. allergens.
Tinnitus is an auditory phantom perception in the ears or head in the absence of a corresponding external stimulus. There is currently no effective treatment available that reliably reduces tinnitus. Educational counseling is a treatment approach that aims to educate patients and inform them about possible coping strategies. For this feasibility study, we implemented educational material and self-help advice in a smartphone app. Participants used the educational smartphone app unsupervised during their daily routine over a period of four months. Comparing the tinnitus outcome measures before and after smartphone-guided treatment, we measured changes in tinnitus-related distress, but not in tinnitus loudness. Improvements on the Tinnitus Severity numeric rating scale reached an effect size of 0.408, while the improvements on the Tinnitus Handicap Inventory (THI) were much smaller with an effect size of 0.168. An analysis of user behavior showed that frequent and intensive use of the app is a crucial factor for treatment success: participants that used the app more often and interacted with the app intensively reported a stronger improvement in the tinnitus. Between study allocation and final assessment, 26 of 52 participants dropped out of the study. Reasons for the dropouts and lessons for future studies are discussed in this paper.
Die Erhebung der alltäglichen Funktionsfähigkeit mithilfe von Skalen zu instrumentellen
Aktivitäten des täglichen Lebens (IADL) ist essenziell zur Erfassung der individuellen und
gesellschaftlichen Konsequenzen von klinischen und subklinischen Erkrankungen. Im
deutschsprachigen Raum existieren jedoch nur wenige validierte Instrumente zur Erfassung von
IADL. Da all diese Skalen für ein geriatrisches Patientenkollektiv entwickelt wurden, haben sie
wichtige Schwächen in der Anwendung bei jüngeren Patientengruppen (insbesondere die
fehlende Erfassung beruflicher Funktionsfähigkeit). Aus diesem Grund wurde im Rahmen der
vorliegenden Arbeit mit dem Functioning Assessment Short Test (FAST) ein bereits in
mehreren Sprachen validiertes, für erwachsene Patienten jedweden Alters konzipiertes
Instrument mit sehr guten psychometrischen Kennwerten ins Deutsche übertragen und
hinsichtlich Validität und Reliabilität untersucht. Die deutschsprachige Variante des FAST
wurde durch standardisierte vorwärts-rückwärts-Übersetzung aus dem Englischen erstellt und
ist als Selbstausfüllerfragebogen konzipiert. Die Skala enthält 23 ordinal skalierte Einzelitems,
aus denen sich ein Summenscore berechnen lässt, wobei höhere Werte für eine schlechtere
alltägliche Funktionsfähigkeit stehen. Der Fragebogen wurde zwischen 2017 und 2018 an
insgesamt 120 Teilnehmern in Würzburg und Münster getestet, von denen 60 aus
bevölkerungsbasierten Kohortenstudien stammten und je 30 Patienten aufgrund eines
ischämischen Schlaganfalls oder einer akuten Depression stationär behandelt wurden. Als Maß
für die Reliabilität des Instrumentes wurde die Übereinstimmung zwischen Selbst- und
Fremdeinschätzung der alltäglichen Funktionsfähigkeit (Fremdeinschätzung durch Angehörige
der Teilnehmer bzw. behandelnde Ärzte / Psychologen) mithilfe des FAST gewählt. Die
Validität der Skala wurde durch die Messung von Korrelationen des FAST Summenscores mit
gängigen Skalen zu Depressivität (PHQ-D-9, CES-D), Angstsymptomatik (PHQ-GAD-7),
gesundheitsbezogener Lebensqualität (SF-12, EQ-5D) und kognitiver Leistungsfähigkeit
(MOCA) erhoben. Daneben erfolgte eine uni- und multivariate Regression zur Erhebung des
Einflusses der o.g. Skalen und relevanter Vorerkrankungen auf den Summenscore des FAST.
Die Reliabilitätsanalyse zeigte für die Probanden aus der Allgemeinbevölkerung ein moderates
(ICC 0.50 (95%-CI 0.64 – 0.54), für die Patienten mit akutem ischämischem Schlaganfall ein
gutes (ICC 0.65 (95%-CI 0.55 – 0.75) und für die stationär behandelten Patienten mit
Depression ein schlechtes Ergebnis (ICC 0.11 (95%-CI 0.02 – 0.20). Hinsichtlich der
Konstruktvalidität zeigte sich in der bevölkerungsbasierten Stichprobe eine signifikante
Korrelation des FAST Summenscores mit PHQ-D-9, CES-D, PHQ-GAD-7 und psychischer
Summenskala der SF-12. In der univariablen Regression waren PHQ-D9, PHQ-GAD-7,
psychische Summenskala des SF-12 und das Vorliegen von chronischem Rückenschmerz
signifikante Prädiktoren für den FAST Summenscore. In der multivariablen Analyse verblieben
SF-12 und chronischer Rückenschmerz als signifikante Einflussfaktoren. In der Stichprobe von
Patienten mit akutem ischämischem Schlaganfall zeigte sich eine signifikante, negative
Korrelation des FAST Summenscores mit dem MOCA.
Zusammenfassend zeigte die deutschsprachige Variante des FAST moderate bis gute
psychometrische Kennwerte in der Allgemeinbevölkerung und bei Patienten mit akutem
ischämischem Schlaganfall, während die Ergebnisse bei stationär behandelten Patienten mit
Depression schlecht waren. Aufgrund der kleinen Fallzahl der untersuchten Stichproben und
des fehlenden Assessment von Test-Retest-Reliabilität sollten vor der breiten Anwendung des
FAST im deutschsprachigen Raum weitere psychometrische Prüfungen des Instruments
erfolgen.
(1) Background: The aim of this study is to assess perioperative therapy in stage IA-III pancreatic cancer cross-validating the German Cancer Registry Group of the Society of German Tumor Centers — Network for Care, Quality, and Research in Oncology, Berlin (GCRG/ADT) and the National Cancer Database (NCDB). (2) Methods: Patients with clinical stage IA-III PDAC undergoing surgery alone (OP), neoadjuvant therapy (TX) + surgery (neo + OP), surgery+adjuvantTX (OP + adj) and neoadjuvantTX + surgery + adjuvantTX (neo + OP + adj) were identified. Baseline characteristics, histopathological parameters, and overall survival (OS) were evaluated. (3) Results: 1392 patients from the GCRG/ADT and 29,081 patients from the NCDB were included. Patient selection and strategies of perioperative therapy remained consistent across the registries for stage IA-III pancreatic cancer. Combined neo + OP + adj was associated with prolonged OS as compared to neo + OP alone (17.8 m vs. 21.3 m, p = 0.012) across all stages in the GCRG/ADT registry. Similarly, OS with neo + OP + adj was improved as compared to neo + OP in the NCDB registry (26.4 m vs. 35.4 m, p < 0.001). (4) Conclusion: The cross-validation study demonstrated similar concepts and patient selection criteria of perioperative therapy across clinical stages of PDAC. Neoadjuvant therapy combined with adjuvant therapy is associated with improved overall survival as compared to either therapy alone.
1 Summary
Left ventricular (LV) ejection fraction (EF) and global longitudinal strain (GLS) are the most commonly used measures of LV function. Yet, they are highly dependent on loading conditions since higher afterload yields lower systolic deformation and thereby a lower LVEF and GLS – despite presumably unchanged LV myocardial contractile strength. Invasive pressure-volume loop measurements represent the reference standard to assess LV function, also considering loading conditions. However, this procedure cannot be used in serial investigations or large sample populations due to its invasive nature. The novel concept of echocardiography-derived assessment of myocardial work (MyW) is based on LV pressure-strain loops, may be a valuable alternative to overcome these challenges, and may also be used with relative ease in large populations. As MyW also accounts for afterload, it is considered less load-dependent than LVEF and GLS.
The current PhD work addresses the application and clinical characterization of MyW, an innovative echocardiographic tool. As the method is new, we focused on four main topics:
(a) To establish reference values for MyW indices, i.e., Global Work Index (GWI), Global Constructive Work (GCW), Global Wasted Work (GWW), and Global Work Efficiency (GWE); we addressed a wide age range and evaluated the association of MyW indices with age, sex and other clinical and echocardiography parameters in apparently cardiovascular healthy individuals.
(b) To investigate the impact of cardiovascular (CV) risk factors on MyW indices and characterize the severity of subclinical LV deterioration in the general population.
(c) To assess the association of the LV geometry, i.e., LV mass and dimensions, with MyW indices.
(d) To evaluate in-hospital dynamics of MyW indices in patients hospitalized for acute heart failure (AHF).
For the PhD thesis, we could make use of two larger cohorts:
The STAAB population-based cohort study prospectively recruited and phenotyped a representative sample (5,000 individuals) of the general population of the City of Würzburg, aged 30-79 years and free from symptomatic heart failure at the time of inclusion. We focused on the first half of the study sample (n=2473 individuals), which fulfilled the anticipated strata regarding age and sex.
The Acute Heart Failure (AHF) Registry is a prospective clinical registry recruiting and phenotyping consecutive patients admitted for decompensated AHF to the Department of Medicine I, University Hospital Würzburg, and observing the natural course of the disease. The AHF Registry focuses on the pathophysiological understanding, particularly in relation to the early phase after cardiac decompensation, with the aim to improve diagnosis and better-tailored treatment of patients with AHF. For the current study, we concentrated on patients who provided pairs of echocardiograms acquired early after index hospital admission and prior to discharge.
The main findings of the PhD thesis were:
From the STAAB cohort study, we determined the feasibility of large-scale MyW derivation and the accuracy of the method. We established reference values for MyW indices based on 779 analyzable, apparently healthy participants (mean age 49 ± 10 years, 59% women), who were in sinus rhythm, free from CV risk factors or CV disease, and had no significant LV valve disease. Apart from GWI, there were no associations of other MyW indices with sex. Further, we found a disparate association with age, where MyW showed stable values until the age of 45 years, with an upward shift occurring beyond the age of 45. A higher age decade was associated with higher GWW and lower GWE, respectively. MyW indices only correlated weakly with common echocardiographic parameters, suggesting that MyW may add incremental information to clinically established parameters.
Further analyses from the STAAB cohort study contributed to a better understanding of the impact of CV risk factors on MyW indices and the association of LV geometry with LV performance. We demonstrated that CV risk factors impacted selectively on GCW and GWW. Hypertension appears to profoundly compromise the work of the myocardium, in particular, by increasing both GCW and GWW. The LV in hypertension seems to operate at a higher energy level yet lower efficiency. Other classical CV risk factors (Diabetes mellitus, Obesity, Dyslipidemia, Smoking) – independent of blood pressure – impacted consistently and adversely on GCW but did not affect GWW. Further, all CV risk factors affected GWE adversely.
We observed that any deviation from a normal LV geometric profile was associated with alterations on MyW. Of note, MyW was sensitive to early changes in LV mass and dimensions. Individuals with normal LV geometry yet established arterial hypertension exhibited a MyW pattern that is typically found in LV hypertrophy. Therefore, such a pattern might serve as an early sign of myocardial damage in hypertensive heart disease and might aid in risk stratification and primary prevention.
From the AHF Registry, we selected individuals with serial in-hospital echocardiograms and described in-hospital changes in myocardial performance during recompensation. In patients presenting with a reduced ejection fraction (HFrEF), decreasing N-terminal pro-natriuretic peptide (NT-proBNP) levels as a surrogate of successful recompensation were associated with an improvement in GCW and GWI and consecutively in GWE. In contrast, in patients presenting with a preserved ejection fraction (HFpEF), there was no significant change in GCW and GWI. However, unsuccessful recompensation, i.e., no change or an increase in NT-proBNP levels, was associated with an increase in GWW. This suggests a differential myocardial response to de- and recompensation depending on the HF phenotype.
Further, GWW as a surrogate of inappropriate LV energy consumption was elevated in all patients with AHF (compared to reference values) and was not associated with conventional markers as LVEF or NT-proBNP. In an exploratory analysis, GWW predicted the risk of death or rehospitalization within six months after discharge. Hence, GWW might carry incremental information beyond conventional markers of HF severity.
Für die Diagnose und Therapie von Brustkrebs existiert die nationale evidenz- und konsensbasierte S3-Leitlinie. Die klinischen Krebsregister stellen sektor- und facharztübergreifende Diagnose- und Therapiedaten zur Qualitätssicherung bereit. Bislang fehlen jedoch Daten bezüglich patient-reported outcome measures (PROMs). Aufgrund des demographischen Wandels werden Brustkrebserkrankungen vor allem in ländlichen Regionen weiter zunehmen, weshalb Versorgungsstrukturen für alle Patientinnen erreichbar sein sollten. Es wurde ein patientenorientiertes Registerkonzept (Breast Cancer Care for patients with metastatic disease (BRE-4-MED)) für den metastasierten Brustkrebs entwickelt und hinsichtlich vordefinierter Machbarkeitskriterien pilotiert. An der BRE-4-MED-Pilotstudie nahmen 31 Patientinnen (96.8% weiblich) teil. Die bayernweite Erreichbarkeit zu brustkrebsspezifischen Versorgungsstrukturen wurde mithilfe einer Geographic Information System (GIS)-Analyse untersucht. Anhand von Leitlinienempfehlungen und Ergebnissen der BRE-4-MED-Pilotstudie wurden relevante Versorgungsstrukturen identifiziert. Die Ergebnisse der Pilotstudie zeigen, dass die Integration von Primär- und Sekundärdaten aus verschiedenen Quellen in ein zentrales Studienregister machbar ist und die erforderlichen organisatorischen Prozesse (z. B. data linkage mit Krebsregister) funktionieren. Die Ergebnisse der Erreichbarkeitsanalyse verdeutlichen, dass es keine bayernweite Erreichbarkeit zu brustkrebsspezifischen Versorgungsstrukturen gibt. Am stärksten war dieser Zusammenhang in grenznahen Regionen ausgeprägt. Die vorliegende Arbeit zeigt Chancen für eine patientenorientierte, qualitätsgesicherte Brustkrebsversorgung unabhängig vom Wohnort auf.
Impact of cardiovascular risk factors on myocardial work-insights from the STAAB cohort study
(2022)
Myocardial work is a new echocardiography-based diagnostic tool, which allows to quantify left ventricular performance based on pressure-strain loops, and has been validated against invasively derived pressure-volume measurements. Myocardial work is described by its components (global constructive work [GCW], global wasted work [GWW]) and indices (global work index [GWI], global work efficiency [GWE]). Applying this innovative concept, we characterized the prevalence and severity of subclinical left ventricular compromise in the general population and estimated its association with cardiovascular (CV) risk factors. Within the Characteristics and Course of Heart Failure STAges A/B and Determinants of Progression (STAAB) cohort study we comprehensively phenotyped a representative sample of the population of Würzburg, Germany, aged 30-79 years. Indices of myocardial work were determined in 1929 individuals (49.3% female, mean age 54 ± 12 years). In multivariable analysis, hypertension was associated with a mild increase in GCW, but a profound increase in GWW, resulting in higher GWI and lower GWE. All other CV risk factors were associated with lower GCW and GWI, but not with GWW. The association of hypertension and obesity with GWI was stronger in women. We conclude that traditional CV risk factors impact selectively and gender-specifically on left ventricular myocardial performance, independent of systolic blood pressure. Quantifying active systolic and diastolic compromise by derivation of myocardial work advances our understanding of pathophysiological processes in health and cardiac disease.
Risk prediction in patients with heart failure (HF) is essential to improve the tailoring of preventive, diagnostic, and therapeutic strategies for the individual patient, and effectively use health care resources. Risk scores derived from controlled clinical studies can be used to calculate the risk of mortality and HF hospitalizations. However, these scores are poorly implemented into routine care, predominantly because their calculation requires considerable efforts in practice and necessary data often are not available in an interoperable format. In this work, we demonstrate the feasibility of a multi-site solution to derive and calculate two exemplary HF scores from clinical routine data (MAGGIC score with six continuous and eight categorical variables; Barcelona Bio-HF score with five continuous and six categorical variables). Within HiGHmed, a German Medical Informatics Initiative consortium, we implemented an interoperable solution, collecting a harmonized HF-phenotypic core data set (CDS) within the openEHR framework. Our approach minimizes the need for manual data entry by automatically retrieving data from primary systems. We show, across five participating medical centers, that the implemented structures to execute dedicated data queries, followed by harmonized data processing and score calculation, work well in practice. In summary, we demonstrated the feasibility of clinical routine data usage across multiple partner sites to compute HF risk scores. This solution can be extended to a large spectrum of applications in clinical care.
Background
Long-term support of stroke patients living at home is often delivered by family caregivers (FC). We identified characteristics of stroke patients being associated with receiving care by a FC 3-months (3 M) after stroke, assessed positive and negative experiences and individual burden of FC caring for stroke patients and determined factors associated with caregiving experiences and burden of FC 3 M after stroke.
Methods
Data were collected within TRANSIT-Stroke, a regional telemedical stroke-network comprising 12 hospitals in Germany. Patients with stroke/TIA providing informed consent were followed up 3 M after the index event. The postal patient-questionnaire was accompanied by an anonymous questionnaire for FC comprising information on positive and negative experiences of FC as well as on burden of caregiving operationalized by the Caregiver Reaction Assessment and a self-rated burden-scale, respectively. Multivariable logistic and linear regression analyses were performed.
Results
Between 01/2016 and 06/2019, 3532 patients provided baseline and 3 M-follow-up- data and 1044 FC responded to questionnaires regarding positive and negative caregiving experiences and caregiving burden. 74.4% of FC were older than 55 years, 70.1% were women and 67.5% were spouses. Older age, diabetes and lower Barthel-Index in patients were significantly associated with a higher probability of receiving care by a FC at 3 M. Positive experiences of FC comprised the importance (81.5%) and the privilege (70.0%) of caring for their relative; negative experiences of FC included financial difficulties associated with caregiving (20.4%). Median overall self-rated burden was 30 (IQR: 0–50; range 0–100). Older age of stroke patients was associated with a lower caregiver burden, whereas younger age of FC led to higher burden. More than half of the stroke patients in whom a FC questionnaire was completed did self-report that they are not being cared by a FC. This stroke patient group tended to be younger, more often male with less severe stroke and less comorbidities who lived more often with a partner.
Conclusions
The majority of caregivers wanted to care for their relatives but experienced burden at the same time. Elderly patients, patients with a lower Barthel Index at discharge and diabetes are at higher risk of needing care by a family caregiver.
Trial registration
The study was registered at “German Clinical Trial Register”: DRKS00011696. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011696
Background
Cancer patients' mental health and quality of life can be improved through professional support according to their needs. In previous analyses of the UNSAID study, we showed that a relevant proportion of cancer patients did not express their needs during the admission interview of inpatient rehabilitation. We now examine trajectories of mental health, quality of life, and utilization of professional help in cancer patients with unexpressed needs.
Methods
We enrolled 449 patients with breast, prostate, and colon cancer at beginning (T0) and end (T1) of a 3-week inpatient rehabilitation and 3 (T2) and 9 (T3) months after discharge. We explored depression (PHQ-2), anxiety (GAD-2), emotional functioning (EORTC QLQ-C30), fear of progression (FoP-Q-SF), and global quality of life (EORTC QLQ-C30) using structuring equation models. Furthermore, we evaluated self-reports about expressing needs and utilization of professional help at follow-up.
Results
Patients with unexpressed needs (24.3%, n = 107) showed decreased mental health compared to other patients (e.g., depression: d T0 = 0.32, d T1-T3 = 0.39). They showed a significant decline in global quality of life at discharge and follow-up (d = 0.28). Furthermore, they had a higher need for support (Cramer's V T2 = 0.10, T3 = 0.15), talked less about their needs (Cramer’s V T2 = 0.18), and made less use of different health care services at follow-up.
Conclusion
Unexpressed needs in cancer patients may be a risk factor for decreased mental health, quality of life, and non-utilization of professional help in the long term. Further research should clarify causal relationships and focus on this specific group of patients to improve cancer care.
Background and purpose
Impaired kidney function is associated with an increased risk of vascular events in acute stroke patients, when assessed by single measurements of estimated glomerular filtration rate (eGFR). It is unknown whether repeated measurements provide additional information for risk prediction.
Methods
The MonDAFIS (Systematic Monitoring for Detection of Atrial Fibrillation in Patients with Acute Ischemic Stroke) study randomly assigned 3465 acute ischemic stroke patients to either standard procedures or an additive Holter electrocardiogram. Baseline eGFR (CKD‐EPI formula) were dichotomized into values of < versus ≥60 ml/min/1.73 m\(^{2}\). eGFR dynamics were classified based on two in‐hospital values as “stable normal” (≥60 ml/min/1.73 m\(^{2}\)), “increasing” (by at least 15% from baseline, second value ≥ 60 ml/min/1.73 m\(^{2}\)), “decreasing” (by at least 15% from baseline of ≥60 ml/min/1.73 m\(^{2}\)), and “stable decreased” (<60 ml/min/1.73 m\(^{2}\)). The composite endpoint (stroke, major bleeding, myocardial infarction, all‐cause death) was assessed after 24 months. We estimated hazard ratios in confounder‐adjusted models.
Results
Estimated glomerular filtration rate at baseline was available in 2947 and a second value in 1623 patients. After adjusting for age, stroke severity, cardiovascular risk factors, and randomization, eGFR < 60 ml/min/1.73 m\(^{2}\) at baseline (hazard ratio [HR] = 2.2, 95% confidence interval [CI] = 1.40–3.54) as well as decreasing (HR = 1.79, 95% CI = 1.07–2.99) and stable decreased eGFR (HR = 1.64, 95% CI = 1.20–2.24) were independently associated with the composite endpoint. In addition, eGFR < 60 ml/min/1.732 at baseline (HR = 3.02, 95% CI = 1.51–6.10) and decreasing eGFR were associated with all‐cause death (HR = 3.12, 95% CI = 1.63–5.98).
Conclusions
In addition to patients with low eGFR levels at baseline, also those with decreasing eGFR have increased risk for vascular events and death; hence, repeated estimates of eGFR might add relevant information to risk prediction.
A systematic overview of mental and physical disorders of informal caregivers based on population-based studies with good methodological quality is lacking. Therefore, our aim was to systematically summarize mortality, incidence, and prevalence estimates of chronic diseases in informal caregivers compared to non-caregivers. Following PRISMA recommendations, we searched major healthcare databases (CINAHL, MEDLINE and Web of Science) systematically for relevant studies published in the last 10 years (without language restrictions) (PROSPERO registration number: CRD42020200314). We included only observational cross-sectional and cohort studies with low risk of bias (risk scores 0–2 out of max 8) that reported the prevalence, incidence, odds ratio (OR), hazard ratio (HR), mean- or sum-scores for health-related outcomes in informal caregivers and non-caregivers. For a thorough methodological quality assessment, we used a validated checklist. The synthesis of the results was conducted by grouping outcomes. We included 22 studies, which came predominately from the USA and Europe. Informal caregivers had a significantly lower mortality than non-caregivers. Regarding chronic morbidity outcomes, the results from a large longitudinal German health-insurance evaluation showed increased and statistically significant incidences of severe stress, adjustment disorders, depression, diseases of the spine and pain conditions among informal caregivers compared to non-caregivers. In cross-sectional evaluations, informal caregiving seemed to be associated with a higher occurrence of depression and of anxiety (ranging from 4 to 51% and 2 to 38%, respectively), pain, hypertension, diabetes and reduced quality of life. Results from our systematic review suggest that informal caregiving may be associated with several mental and physical disorders. However, these results need to be interpreted with caution, as the cross-sectional studies cannot determine temporal relationships. The lower mortality rates compared to non-caregivers may be due to a healthy-carer bias in longitudinal observational studies; however, these and other potential benefits of informal caregiving deserve further attention by researchers.
Aims
We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke.
Methods
The post hoc analysis included 1080 patients of the investigator-initiated, multicenter prospective Berlin Atrial Fibrillation Registry, designed to analyze medical stroke prevention in AF patients after acute ischemic stroke.
Results
At stroke onset, an off-label daily dose was prescribed in 61 (25.5%) of 239 NOAC patients with known AF and CHA2DS2-VASc score ≥ 1, of which 52 (21.8%) patients were under-dosed. Under-dosing was associated with age ≥ 80 years in patients on rivaroxaban [OR 2.90, 95% CI 1.05-7.9, P = 0.04; n = 29] or apixaban [OR 3.24, 95% CI 1.04-10.1, P = 0.04; n = 22]. At hospital discharge after the index stroke, NOAC off-label dose on admission was continued in 30 (49.2%) of 61 patients. Overall, 79 (13.7%) of 708 patients prescribed a NOAC at hospital discharge received an off-label dose, of whom 75 (10.6%) patients were under-dosed. Rivaroxaban under-dosing at discharge was associated with age ≥ 80 years [OR 3.49, 95% CI 1.24-9.84, P = 0.02; n = 19]; apixaban under-dosing with body weight ≤ 60 kg [OR 0.06, 95% CI 0.01-0.47, P < 0.01; n = 56], CHA2DS2-VASc score [OR per point 1.47, 95% CI 1.08-2.00, P = 0.01], and HAS-BLED score [OR per point 1.91, 95% CI 1.28-2.84, P < 0.01].
Conclusion
At stroke onset, off-label dosing was present in one out of four, and under-dosing in one out of five NOAC patients. Under-dosing of rivaroxaban or apixaban was related to old age. In-hospital treatment after stroke reduced off-label NOAC dosing, but one out of ten NOAC patients was under-dosed at discharge.
Hintergrund und Fragestellung
Die Entwöhnung von Beatmungsgeräten wird nicht immer auf der primär behandelnden Intensivstation abgeschlossen. Die Weiterverlegung in andere Behandlungseinrichtungen stellt einen sensiblen Abschnitt in der Behandlung und Rehabilitation des Weaningpatienten dar. Ziel der vorliegenden Studie war die Untersuchung des Überleitungsmanagements und des Interhospitaltransfers von Weaningpatienten unter besonderer Berücksichtigung der Dokumentationsqualität.
Methodik
Es erfolge eine retrospektive Datenanalyse eines Jahrs (2018) auf 2 Intensivstationen eines Universitätsklinikums. Eingeschlossen wurden alle beatmeten Patienten mit folgenden Tracerdiagnosen: COPD, Asthma, Polytrauma, Pneumonie, Sepsis, ARDS und Reanimation (Beatmung > 24 h).
Ergebnisse
Insgesamt konnten 750 Patienten in die Untersuchung eingeschlossen werden (Alter 64 [52, 8–76; Median, IQR]; 32 % weiblich). Davon waren 48 (6,4 %) Patienten zum Zeitpunkt der Verlegung nicht entwöhnt (v. a. Sepsis und ARDS). Die Routinedokumentation war bei den Abschnitten „Spontaneous Breathing Trial“, „Bewertung der Entwöhungsbereitschaft“ und „vermutete Entwöhnbarkeit“ ausreichend, um die Erfüllung der Parameter der S2k-Leitlinie „Prolongiertes Weaning“ adäquat zu beurteilen. Vorwiegend wurden diese Patienten mit Tracheostoma (76 %) in Rehabilitationskliniken (44 %) mittels spezialisierten Rettungsmitteln des arztbegleiteten Patiententransports verlegt (75 %).
Diskussion
Die Verlegung nicht entwöhnter Patienten nach initialem Intensivaufenthalt ist ein relevantes Thema für den Interhospitaltransfer. Die Routinedokumentation eines strukturierten Weaningprozesses ist in Kernelementen ausreichend, um den Weaningprozess lückenlos zu beschreiben. Dies ist für die Kontinuität in der Weiterbehandlung dieser Patienten von großer Bedeutung.
Background
Severe COVID-19 induced acute respiratory distress syndrome (ARDS) often requires extracorporeal membrane oxygenation (ECMO). Recent German health insurance data revealed low ICU survival rates. Patient characteristics and experience of the ECMO center may determine intensive care unit (ICU) survival. The current study aimed to identify factors affecting ICU survival of COVID-19 ECMO patients.
Methods
673 COVID-19 ARDS ECMO patients treated in 26 centers between January 1st 2020 and March 22nd 2021 were included. Data on clinical characteristics, adjunct therapies, complications, and outcome were documented. Block wise logistic regression analysis was applied to identify variables associated with ICU-survival.
Results
Most patients were between 50 and 70 years of age. PaO\(_{2}\)/FiO\(_{2}\) ratio prior to ECMO was 72 mmHg (IQR: 58–99). ICU survival was 31.4%. Survival was significantly lower during the 2nd wave of the COVID-19 pandemic. A subgroup of 284 (42%) patients fulfilling modified EOLIA criteria had a higher survival (38%) (p = 0.0014, OR 0.64 (CI 0.41–0.99)). Survival differed between low, intermediate, and high-volume centers with 20%, 30%, and 38%, respectively (p = 0.0024). Treatment in high volume centers resulted in an odds ratio of 0.55 (CI 0.28–1.02) compared to low volume centers. Additional factors associated with survival were younger age, shorter time between intubation and ECMO initiation, BMI > 35 (compared to < 25), absence of renal replacement therapy or major bleeding/thromboembolic events.
Conclusions
Structural and patient-related factors, including age, comorbidities and ECMO case volume, determined the survival of COVID-19 ECMO. These factors combined with a more liberal ECMO indication during the 2nd wave may explain the reasonably overall low survival rate. Careful selection of patients and treatment in high volume ECMO centers was associated with higher odds of ICU survival.
Background: Over the recent years, technological advances of wrist-worn fitness trackers heralded a new era in the continuous monitoring of vital signs. So far, these devices have primarily been used for sports.
Objective: However, for using these technologies in health care, further validations of the measurement accuracy in hospitalized patients are essential but lacking to date.
Methods: We conducted a prospective validation study with 201 patients after moderate to major surgery in a controlled setting to benchmark the accuracy of heart rate measurements in 4 consumer-grade fitness trackers (Apple Watch 7, Garmin Fenix 6 Pro, Withings ScanWatch, and Fitbit Sense) against the clinical gold standard (electrocardiography).
Results: All devices exhibited high correlation (r≥0.95; P<.001) and concordance (rc≥0.94) coefficients, with a relative error as low as mean absolute percentage error <5% based on 1630 valid measurements. We identified confounders significantly biasing the measurement accuracy, although not at clinically relevant levels (mean absolute error<5 beats per minute).
Conclusions: Consumer-grade fitness trackers appear promising in hospitalized patients for monitoring heart rate.
(1) Background: Global incidence of type 1 diabetes (T1D) is rising and nearly half occurred in adults. However, it is unclear if certain early-life childhood T1D risk factors were also associated with adult-onset T1D. This study aimed to assess associations between birth order, delivery mode or daycare attendance and type 1 diabetes (T1D) risk in a population-based cohort and whether these were similar for childhood- and adult-onset T1D (cut-off age 15); (2) Methods: Data were obtained from the German National Cohort (NAKO Gesundheitsstudie) baseline assessment. Self-reported diabetes was classified as T1D if: diagnosis age ≤ 40 years and has been receiving insulin treatment since less than one year after diagnosis. Cox regression was applied for T1D risk analysis; (3) Results: Analyses included 101,411 participants (100 childhood- and 271 adult-onset T1D cases). Compared to “only-children”, HRs for second- or later-born individuals were 0.70 (95% CI = 0.50–0.96) and 0.65 (95% CI = 0.45–0.94), respectively, regardless of parental diabetes, migration background, birth year and perinatal factors. In further analyses, higher birth order reduced T1D risk in children and adults born in recent decades. Caesarean section and daycare attendance showed no clear associations with T1D risk; (4) Conclusions: Birth order should be considered in both children and adults’ T1D risk assessment for early detection.
Introduction: 2–8% of all gastric cancer occurs at a younger age, also known as early-onset gastric cancer (EOGC). The aim of the present work was to use clinical registry data to classify and characterize the young cohort of patients with gastric cancer more precisely. Methods: German Cancer Registry Group of the Society of German Tumor Centers—Network for Care, Quality and Research in Oncology (ADT)was queried for patients with gastric cancer from 2000–2016. An approach that stratified relative distributions of histological subtypes of gastric adenocarcinoma according to age percentiles was used to define and characterize EOGC. Demographics, tumor characteristics, treatment and survival were analyzed. Results: A total of 46,110 patients were included. Comparison of different groups of age with incidences of histological subtypes showed that incidence of signet ring cell carcinoma (SRCC) increased with decreasing age and exceeded pooled incidences of diffuse and intestinal type tumors in the youngest 20% of patients. We selected this group with median age of 53 as EOGC. The proportion of female patients was lower in EOGC than that of elderly patients (43% versus 45%; p < 0.001). EOGC presented more advanced and undifferentiated tumors with G3/4 stages in 77% versus 62%, T3/4 stages in 51% versus 48%, nodal positive tumors in 57% versus 53% and metastasis in 35% versus 30% (p < 0.001) and received less curative treatment (42% versus 52%; p < 0.001). Survival of EOGC was significantly better (five-years survival: 44% versus 31% (p < 0.0001), with age as independent predictor of better survival (HR 0.61; p < 0.0001). Conclusion: With this population-based registry study we were able to objectively define a cohort of patients referred to as EOGC. Despite more aggressive/advanced tumors and less curative treatment, survival was significantly better compared to elderly patients, and age was identified as an independent predictor for better survival.
Das Bullöse Pemphigoid (BP) ist eine blasenbildende Autoimmunerkrankung der Haut, die durch subepidermale Blasenbildung und Antikörper (AK) gegen bestimmte hemidesmosomale Proteine der Basalmembran (BM) charakterisiert ist. Zielantigene sind BP180 und BP230. Im Fokus dieser Arbeit stand die retrospektive Identifikation und Datenerhebung von Patienten mit BP, die in der Dermatologie der Uniklinik Würzburg behandelt wurden. Zudem wurde eine Kontrollgruppe aus Patienten mit Basalzellkarzinom etabliert. Es konnten (hoch-)signifikante Assoziationen zwischen dem BP und verschiedenen Laborparametern (u.a. Leukozytose, Eosinophilie, Thrombozytose, Anämie, Kreatinin erhöht) sowie Erkrankungen (u.a. neurologische Erkrankungen (Schlaganfall, Demenz, MP, MS und Epilepsie) sowie psychiatrischen Erkrankungen (HOPS, Depression) und Diabetes mellitus) nachgewiesen werden.
In several countries, a decline in mortality, case-fatality and recurrence rates of stroke was observed. However, studies investigating sex-specific and subtype-specific (pathological and etiological) time trends in stroke mortality, case-fatality and recurrence rates are scarce, especially in Germany. The decline in ischemic stroke mortality and case-fatality might be associated with the high quality of acute care of ischemic stroke, but the exact determinants of early outcome remains unknown for Germany.
Therefore, as first step of this thesis, we investigated the time trends of subtype- and sex-specific age- standardized stroke mortality rates in Germany from 1998 to 2015, by applying joinpoint regression on official causes of death statistics, provided by the Federal Statistical Office. Furthermore, a regional comparison of the time trends in stroke mortality between East and West was conducted. In the second step, time trends in case-fatality and stroke recurrence rates were analyzed using data from a population- based stroke register in Germany between 1996 and 2015. The analysis was stratified by sex and etiological subtype of ischemic stroke. In the third step, quality of stroke care and the association between adherence to measures of quality of acute ischemic stroke care and in-hospital mortality was estimated based on data from nine regional hospital-based stroke registers in Germany from the years 2015 and 2016.
We showed that in Germany, age-standardized stroke mortality declined by over 50% from 1998 to 2015 both, in women and men. Stratified by the pathological subtypes of stroke, the decrease in mortality was larger in ischemic stroke compared to hemorrhagic stroke. Different patterns in the time trends of stroke were observed for stroke subtypes, regions in Germany (former Eastern part of Germany (EG), former Western part of Germany (WG)) and sex, but in all strata a decline was found. By applying joinpoint regression, the number of changes in time trend differed between the regions and up to three changes in the trend in ischemic stroke mortality were detected. Trends in hemorrhagic stroke were in parallel between the regions with up to one change (in women) in joinpoint regression. Comparing the regions, stroke mortality was higher in EG compared to WG throughout the whole observed time period, however the differences between the regions started to diminish from 2007 onwards.
Further it was found that, based on the population-based Erlangen Stroke Project (ESPro), case-fatality and recurrence rates in ischemic stroke patients are still high in Germany. 46% died and 20% got a recurrent stroke within the first five years after stroke. Case-fatality rates declined statistically significant from 1996 to 2015 across all ischemic stroke patients and all etiological subtypes of ischemic stroke. Based on Cox regression no statistically significant decrease in stroke recurrence was observed.
Based on the pooled data of nine regional hospital-based stroke registers from the years 2015 and 2016 covering about 80% of all hospitalized stroke patients in Germany, a high quality of care of acute ischemic stroke patients, measured via 11 evidence-based quality indicators (QI) of process of care, was observed. Across all registers, most QI reached the predefined target values for good quality of stroke care. 9 out of 11 QI showed a significant association with 7-day in-hospital mortality. An inverse linear association between overall adherence to QI and 7-day in-hospital mortality was observed.
In conclusion, stroke mortality and case-fatality showed a favorable development over time in Germany, which might partly be due to improvements in acute treatment. This is supported by the association between overall adherence to quality of care and in-hospital mortality. However, there might be room for improvements in long-term secondary prevention, as no clear reduction in recurrence rates was observed.
Digital anamorphosis is used to define a distorted image of health and care that may be viewed correctly using digital tools and strategies. MASK digital anamorphosis represents the process used by MASK to develop the digital transformation of health and care in rhinitis. It strengthens the ARIA change management strategy in the prevention and management of airway disease. The MASK strategy is based on validated digital tools. Using the MASK digital tool and the CARAT online enhanced clinical framework, solutions for practical steps of digital enhancement of care are proposed.
Background: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. Methods: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the “Association of the Scientific Medical Societies in Germany” (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. Results: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on “treatment intensity” including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. Conclusions: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.
Occurrence of mental illness and mental health risks among the self-employed: a systematic review
(2021)
We aimed to systematically identify and evaluate all studies of good quality that compared the occurrence of mental disorders in the self-employed versus employees. Adhering to the Cochrane guidelines, we conducted a systematic review and searched three major medical databases (MEDLINE, Web of Science, Embase), complemented by hand search. We included 26 (three longitudinal and 23 cross-sectional) population-based studies of good quality (using a validated quality assessment tool), with data from 3,128,877 participants in total. The longest of these studies, a Swedish national register evaluation with 25 years follow-up, showed a higher incidence of mental illness among the self-employed compared to white-collar workers, but a lower incidence compared to blue-collar workers. In the second longitudinal study from Sweden the self-employed had a lower incidence of mental illness compared to both blue- and white-collar workers over 15 years, whereas the third longitudinal study (South Korea) did not find a difference regarding the incidence of depressive symptoms over 6 years. Results from the cross-sectional studies showed associations between self-employment and poor general mental health and stress, but were inconsistent regarding other mental outcomes. Most studies from South Korea found a higher prevalence of mental disorders among the self-employed compared to employees, whereas the results of cross-sectional studies from outside Asia were less consistent. In conclusion, we found evidence from population-based studies for a link between self-employment and increased risk of mental illness. Further longitudinal studies are needed examining the potential risk for the development of mental disorders in specific subtypes of the self-employed.
The new coronavirus (COVID-19) pandemic and the resulting response measures have led to severe limitations of people's exercise possibilities with diminished physical activity (PA) and increased sedentary behavior (SB). Since for migrant groups in Germany, no data is available, this study aimed to investigate factors associated with changes in PA and SB in a sample of Turkish descent. Participants of a prospective cohort study (adults of Turkish descent, living in Berlin, Germany) completed a questionnaire regarding COVID-19 related topics including PA and SB since February 2020. Changes in PA and SB were described, and sociodemographic, migrant-related, and health-related predictors of PA decrease and SB increase were determined using multivariable regression analyses. Of 106 participants, 69% reported a decline of PA, 36% reported an increase in SB. PA decrease and SB increase seemed to be associated with inactivity before the pandemic as well as with the female sex. SB increase appeared to be additionally associated with educational level and BMI. The COVID-19 pandemic and the response measures had persistent detrimental effects on this migrant population. Since sufficient PA before the pandemic had the strongest association with maintaining PA and SB during the crisis, the German government and public health professionals should prioritize PA promotion in this vulnerable group.
For COVID-19 patients who remain symptomatic after the acute phase, pulmonary rehabilitation (PR) is recommended. However, only a few studies have investigated the effectiveness of PR, especially considering the duration between the acute phase of COVID-19 and the onset of rehabilitation, as well as the initial severity. This prospective observational study evaluated the efficacy of PR in patients after COVID-19. A total of 120 still-symptomatic patients referred for PR after overcoming acute COVID-19 were asked to participate, of whom 108 (mean age 55.6 ± 10.1 years, 45.4% female) consented. The patients were assigned to three groups according to the time of referral and initial disease severity (severe acute; severe after interval; mild after interval). The primary outcome was dyspnea. Secondary outcomes included other respiratory disease symptoms, physical capacity, lung function, fatigue, quality of life (QoL), depression, and anxiety. Furthermore, patients rated the overall effectiveness of PR and their subjective change in health status. At the end of PR, we detected improvements with large effect sizes in exertional dyspnea, physical capacity, QoL, fatigue, and depression in the overall group. Other parameters changed with small to medium effect sizes. PR was effective after acute COVID-19 in all three groups analyzed.