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The aim of this study was to investigate the prognostic value of 18F-fluoro-deoxyglucose positron emission tomography–computed tomography (18F-FDG-PET/CT) in 37 patients with a history of multiple myeloma (MM) and suspected or confirmed recurrence after stem cell transplantation (SCT). All patients had been heavily pre-treated. Time to progression (TTP) and overall survival (OS) were correlated to a number of different PET-derived as well as clinical parameters. Impact on patient management was assessed.
Absence of FDG-avid MM foci was a positive prognostic factor for both TTP and OS (p<0.01). Presence of >10 focal lesions correlated with both TTP (p<0.01) and OS (p<0.05). Interestingly, presence of >10 lesions in the appendicular skeleton proved to have the strongest association with disease progression. Intensity of glucose uptake and presence of extramedullary disease were associated with shorter TTP (p=0.037 and p=0.049, respectively). Manifestations in soft tissue structures turned out to be a strong negative predictor for both, TTP and OS (p<0.01, respectively). PET resulted in a change of management in 30% of patients.
Our data underline the prognostic value of 18F-FDG-PET/CT in MM patients also in the setting of post-SCT relapse. PET/CT has a significant impact on patient management.
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.
Background
International research for acute myocardial infarction lacks comparisons of whole health systems. We assessed time trends for care and outcomes in Sweden and the UK.
Methods
We used data from national registries on consecutive patients registered between 2004 and 2010 in all hospitals providing care for acute coronary syndrome in Sweden and the UK. The primary outcome was all-cause mortality 30 days after admission. We compared effectiveness of treatment by indirect casemix standardisation. This study is registered with ClinicalTrials.gov, number NCT01359033.
Findings
We assessed data for 119 786 patients in Sweden and 391 077 in the UK. 30-day mortality was 7·6% (95% CI 7·4–7·7) in Sweden and 10·5% (10·4–10·6) in the UK. Mortality was higher in the UK in clinically relevant subgroups defined by troponin concentration, ST-segment elevation, age, sex, heart rate, systolic blood pressure, diabetes mellitus status, and smoking status. In Sweden, compared with the UK, there was earlier and more extensive uptake of primary percutaneous coronary intervention (59% vs 22%) and more frequent use of β blockers at discharge (89% vs 78%). After casemix standardisation the 30-day mortality ratio for UK versus Sweden was 1·37 (95% CI 1·30–1·45), which corresponds to 11 263 (95% CI 9620–12 827) excess deaths, but did decline over time (from 1·47, 95% CI 1·38–1·58 in 2004 to 1·20, 1·12–1·29 in 2010; p=0·01).
Interpretation
We found clinically important differences between countries in acute myocardial infarction care and outcomes. International comparisons research might help to improve health systems and prevent deaths.
Background: Sudden cardiac death is common and accounts largely for the excess mortality of patients on maintenance dialysis. It is unknown whether aldosterone and cortisol increase the incidence of sudden cardiac death in dialysis patients.
Methods and results: We analysed data from 1255 diabetic haemodialysis patients participating in the German Diabetes and Dialysis Study (4D Study). Categories of aldosterone and cortisol were determined at baseline and patients were followed for a median of 4 years. By Cox regression analyses, hazard ratios (HRs) were determined for the effect of aldosterone, cortisol, and their combination on sudden death and other adjudicated cardiovascular outcomes. The mean age of the patients was 66 ± 8 years (54% male). Median aldosterone was <15 pg/mL (detection limit) and cortisol 16.8 µg/dL. Patients with aldosterone levels >200 pg/mL had a significantly higher risk of sudden death (HR: 1.69; 95% CI: 1.06–2.69) compared with those with an aldosterone <15 pg/mL. The combined presence of high aldosterone (>200 pg/mL) and high cortisol (>21.1 µg/dL) levels increased the risk of sudden death in striking contrast to patients with low aldosterone (<15 pg/mL) and low cortisol (<13.2 µg/dL) levels (HR: 2.86, 95% CI: 1.32–6.21). Furthermore, all-cause mortality was significantly increased in the patients with high levels of both hormones (HR: 1.62, 95% CI: 1.01–2.62).
Conclusions: The joint presence of high aldosterone and high cortisol levels is strongly associated with sudden cardiac death as well as all-cause mortality in haemodialysed type 2 diabetic patients. Whether a blockade of the mineralocorticoid receptor decreases the risk of sudden death in these patients must be examined in future trials.
Ambalytics: a scalable and distributed system architecture concept for bibliometric network analyses
(2021)
A deep understanding about a field of research is valuable for academic researchers. In addition to technical knowledge, this includes knowledge about subareas, open research questions, and social communities (networks) of individuals and organizations within a given field. With bibliometric analyses, researchers can acquire quantitatively valuable knowledge about a research area by using bibliographic information on academic publications provided by bibliographic data providers. Bibliometric analyses include the calculation of bibliometric networks to describe affiliations or similarities of bibliometric entities (e.g., authors) and group them into clusters representing subareas or communities. Calculating and visualizing bibliometric networks is a nontrivial and time-consuming data science task that requires highly skilled individuals. In addition to domain knowledge, researchers must often provide statistical knowledge and programming skills or use software tools having limited functionality and usability. In this paper, we present the ambalytics bibliometric platform, which reduces the complexity of bibliometric network analysis and the visualization of results. It accompanies users through the process of bibliometric analysis and eliminates the need for individuals to have programming skills and statistical knowledge, while preserving advanced functionality, such as algorithm parameterization, for experts. As a proof-of-concept, and as an example of bibliometric analyses outcomes, the calculation of research fronts networks based on a hybrid similarity approach is shown. Being designed to scale, ambalytics makes use of distributed systems concepts and technologies. It is based on the microservice architecture concept and uses the Kubernetes framework for orchestration. This paper presents the initial building block of a comprehensive bibliometric analysis platform called ambalytics, which aims at a high usability for users as well as scalability.
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.
Onkologische Patienten sowie klinische Forscher zeigen zunehmendes Interesse an Yogainterventionen als komplementäres Therapieverfahren zur Behandlung psychischer und körperlicher Beschwerden. Kurzzeitige Effekte von Yogatherapien auf die häufig krebsassoziierten Symptome Angst, Depressivität und Fatigue wurden in zahlreichen Studien untersucht. Die Ergebnisse der Untersuchungen legen nahe, dass Tumorpatienten unmittelbar nach einer Yogaintervention eine Verbesserung der genannten Symptome erleben. Allerdings ist bisher unzureichend untersucht, ob ein Rückgang von Angst, Depressivität und Fatigue langfristig besteht.
Ziel der Studie war es daher, nachhaltige Veränderungen von Angst, Depressivität und Fatigue bei Tumorpatienten im Rahmen einer achtwöchigen Yogaintervention zu untersuchen. Wir nahmen an, dass Angst, Depressivität und Fatigue sechs Monate nach einer Yogaintervention genauso niedrig wie unmittelbar nach der Intervention sind und sich signifikant von den Ausgangswerten vor der Intervention unterscheiden. Außerdem sollte untersucht werden, wie viele Teilnehmer die Yogapraxis nach einer Yogaintervention fortführen und ob sich dies auf die Zielparameter auswirkt.
Durch eine klinische Studie im Prä-Post-Design wurden die Hypothesen geprüft. Dazu wurden Daten von 58 Teilnehmern mit unterschiedlichen Tumorerkrankungen vor, unmittelbar nach und sechs Monate nach einer achtwöchigen Gentle Hatha- Yogaintervention mittels standardisierter psychologischer Fragebögen gesammelt.
Die Mehrheit der Studienteilnehmer war weiblich (90%) und wies anamnestisch eine Mammakarzinom-Erkrankung auf (55%). Die Ergebnisse legen nahe, dass Angst und Fatigue zwischen Interventionsende und sechs Monaten später leicht zunahmen, wohingegen depressive Symptome stabil blieben. Im Vergleich zu den Ausgangswerten vor der Intervention waren Angst, Depressivität und Fatigue sechs Monate nach Interventionsende signifikant reduziert. Ein halbes Jahr nach Beendigung der Yogaintervention gaben 69% der Teilnehmer an, weiterhin Yoga zu praktizieren. Befragungen zeigten, dass die Teilnehmer subjektiv von der Yogapraxis profitierten. Die fortgeführte Yogapraxis stand jedoch nicht mit der Ausprägung von Angst, Depressivität und Fatigue zum Follow-up-Zeitpunkt in Zusammenhang.
Die Ergebnisse deuten darauf hin, dass Tumorpatienten langfristig von einer Verbesserung von Angst, Depressivität und Fatigue im Rahmen einer Yogatherapie profitieren könnten. Ein kausaler Zusammenhang zwischen Yogatherapie und der gefundenen Verbesserung sechs Monate nach Therapieende konnte jedoch durch die fehlende Kontrollbedingung nicht belegt werden. In Zukunft sollten große randomisierte kontrollierte Studien die vermutete Kausalität untersuchen.
o build, run, and maintain reliable manufacturing machines, the condition of their components has to be continuously monitored. When following a fine-grained monitoring of these machines, challenges emerge pertaining to the (1) feeding procedure of large amounts of sensor data to downstream processing components and the (2) meaningful analysis of the produced data. Regarding the latter aspect, manifold purposes are addressed by practitioners and researchers. Two analyses of real-world datasets that were generated in production settings are discussed in this paper. More specifically, the analyses had the goals (1) to detect sensor data anomalies for further analyses of a pharma packaging scenario and (2) to predict unfavorable temperature values of a 3D printing machine environment. Based on the results of the analyses, it will be shown that a proper management of machines and their components in industrial manufacturing environments can be efficiently supported by the detection of anomalies. The latter shall help to support the technical evangelists of the production companies more properly.
Process models are crucial artifacts in many domains, and hence, their proper comprehension is of importance. Process models mediate a plethora of aspects that are needed to be comprehended correctly. Novices especially face difficulties in the comprehension of process models, since the correct comprehension of such models requires process modeling expertise and visual observation capabilities to interpret these models correctly. Research from other domains demonstrated that the visual observation capabilities of experts can be conveyed to novices. In order to evaluate the latter in the context of process model comprehension, this paper presents the results from ongoing research, in which gaze data from experts are used as Eye Movement Modeling Examples (EMMEs) to convey visual observation capabilities to novices. Compared to prior results, the application of EMMEs improves process model comprehension significantly for novices. Novices achieved in some cases similar performances in process model comprehension to experts. The study's insights highlight the positive effect of EMMEs on fostering the comprehension of process models.
Background: Tinnitus is often described as the phantom perception of a sound and is experienced by 5.1% to 42.7% of the population worldwide, at least once during their lifetime. The symptoms often reduce the patient's quality of life. The TrackYourTinnitus (TYT) mobile health (mHealth) crowdsensing platform was developed for two operating systems (OS)-Android and iOS-to help patients demystify the daily moment-to-moment variations of their tinnitus symptoms. In all platforms developed for more than one OS, it is important to investigate whether the crowdsensed data predicts the OS that was used in order to understand the degree to which the OS is a confounder that is necessary to consider.
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.
Health-related quality of life (HRQL) among migrant populations can be associated with acculturation (i.e., the process of adopting, acquiring and adjusting to a new cultural environment). Since there is a lack of longitudinal studies, we aimed to describe HRQL changes among adults of Turkish descent living in Berlin and Essen, Germany, and their association with acculturation. Participants of a population-based study were recruited in 2012–2013 and reinvited six years later to complete a questionnaire. Acculturation was assessed at baseline using the Frankfurt acculturation scale (integration, assimilation, separation and marginalization). HRQL was assessed at baseline (SF-8) and at follow-up (SF-12) resulting in a physical (PCS) and mental (MCS) sum score. Associations with acculturation and HRQL were analyzed with linear regression models using a time-by-acculturation status interaction term. In the study 330 persons were included (65% women, mean age ± standard deviation 43.3 ± 11.8 years). Over the 6 years, MCS decreased, while PCS remained stable. While cross-sectional analyses showed associations of acculturation status with both MCS and PCS, temporal changes including the time interaction term did not reveal associations of baseline acculturation status with HRQL. When investigating HRQL in acculturation, more longitudinal studies are needed to take changes in both HRQL and acculturation status into account.
Tinnitus is a phantom sound perception in the ears or head and can arise from many different medical disorders. Currently, there is no standard treatment for tinnitus that reliably reduces tinnitus. Individual patients reported that acupressure at various points around the ear can help to reduce tinnitus, which was investigated here. With this longitudinal observational study, we report a systematic evaluation of auricular acupressure on 39 tinnitus sufferers, combined with a self-help smartphone app. The participants were asked to report on tinnitus, stress, mood, neck, and jaw muscle tensions twice a day using an ecological momentary assessment study design for six weeks. On average, 123.6 questionnaires per person were provided and used for statistical analysis. The treatment responses of the participants were heterogeneous. On average, we observed significant negative trends for tinnitus loudness (Cohen's d effect size: −0.861), tinnitus distress (d = −0.478), stress (d = −0.675), and tensions in the neck muscles (d = −0.356). Comparison with a matched control group revealed significant improvements for tinnitus loudness (p = 0.027) and self-reported stress level (p = 0.003). The positive results of the observational study motivate further research including a randomized clinical trial and long-term assessment of the clinical improvement.
(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.
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.
(1) Background: We aimed to evaluate the effect of proposed “microbiome-stabilising interventions”, i.e., breastfeeding for ≥3 months and prophylactic use of Lactobacillus acidophilus/ Bifidobacterium infantis probiotics on neurocognitive and behavioral outcomes of very-low-birthweight (VLBW) children aged 5–6 years. (2) Methods: We performed a 5-year-follow-up assessment including a strength and difficulties questionnaire (SDQ) and an intelligence quotient (IQ) assessment using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI)-III test in preterm children previously enrolled in the German Neonatal Network (GNN). The analysis was restricted to children exposed to antenatal corticosteroids and postnatal antibiotics. (3) Results: 2467 primary school-aged children fulfilled the inclusion criteria. In multivariable linear regression models breastfeeding ≥3 months was associated with lower conduct disorders (B (95% confidence intervals (CI)): −0.25 (−0.47 to −0.03)) and inattention/hyperactivity (−0.46 (−0.81 to −0.10)) as measured by SDQ. Probiotic treatment during the neonatal period had no effect on SDQ scores or intelligence. (4) Conclusions: Prolonged breastfeeding of highly vulnerable infants may promote their mental health later in childhood, particularly by reducing risk for inattention/hyperactivity and conduct disorders. Future studies need to disentangle the underlying mechanisms during a critical time frame of development.
Background
Pneumonia frequently complicates stroke and has amajor impact on outcome. We derived and internally validated a simple clinical risk score for predicting stroke-associated pneumonia (SAP), and compared the performance with an existing score (A\(^{2}\)DS\(^{2}\)).
Methods and Results
We extracted data for patients with ischemic stroke or intracerebral hemorrhage from the Sentinel Stroke National Audit Programme multicenter UK registry. The data were randomly allocated into derivation (n=11 551) and validation (n=11 648) samples. A multivariable logistic regression model was fitted to the derivation data to predict SAP in the first 7 days of admission. The characteristics of the score were evaluated using receiver operating characteristics (discrimination) and by plotting predicted versus observed SAP frequency in deciles of risk (calibration). Prevalence of SAP was 6.7% overall. The final 22-point score (ISAN: prestroke Independence [modified Rankin scale], Sex, Age, National Institutes of Health Stroke Scale) exhibited good discrimination in the ischemic stroke derivation (C-statistic 0.79; 95% CI 0.77 to 0.81) and validation (C-statistic 0.78; 95% CI 0.76 to 0.80) samples. It was well calibrated in ischemic stroke and was further classified into meaningful risk groups (low 0 to 5, medium6 to 10, high 11 to 14, and very high >= 15) associated with SAP frequencies of 1.6%, 4.9%, 12.6%, and 26.4%, respectively, in the validation sample. Discrimination for both scores was similar, although they performed less well in the intracerebral hemorrhage patients with an apparent ceiling effect.
Conclusions
The ISAN score is a simple tool for predicting SAP in clinical practice. External validation is required in ischemic and hemorrhagic stroke cohorts.
Purpose: To determine the effects of progressive resistance training on mobility, muscle strength, and quality of life in nursing-home residents with impaired mobility.
Methods: Nursing-home residents aged 77 years and older with impaired mobility were recruited in Berlin, Germany. The eight-week exercise program consisted of progressive resistance training twice a week. Mobility (primary outcome) was assessed with the Elderly Mobility Scale (zero = worst, 20 = best) at baseline and after 8 weeks. Muscle strength (secondary outcome) was determined by the eight-repetition maximum. The Short Form-36 Health Survey was used to assess quality of life.
Results: Of the 15 participants (mean age 84 years, range 77-97 years), ten completed the 8-week program. Mobility (Elderly Mobility Scale mean +/- standard deviation pre 14.1 +/- 3.2 and post 17.5 +/- 3.6; P = 0.005) as well as muscle strength of upper and lower limbs improved (from 62% at chest press up to 108% at leg extension machine), whereas most quality of life subscales did not show considerable change.
Conclusion: Resistance training twice a week over 2 months seemed to considerably improve mobility and muscle strength in persons aged 77-97 years with impaired mobility.
Hintergrund: Circa ein Drittel der Patientinnen und Patienten mit fortgeschrittenen Krebserkrankungen ist von psychischen Komorbiditäten betroffen und circa die Hälfte weist eine psychische Belastung im klinisch signifikanten Bereich auf. Zur psychotherapeutischen Behandlung dieser Patientengruppe stehen unterschiedliche psychotherapeutische Interventionen zur Verfügung. Die CALM-Therapie, eine manualisierte Kurzintervention im Einzelsetting, ist eine dieser Interventionen. Hier bilden vier Module, welche auf den wichtigsten Anliegen und Belastungsfaktoren von Patientinnen und Patienten mit fortgeschrittenen Krebserkrankungen basieren, den inhaltlichen Rahmen.
Ziel: Die Treatment Integrity beschreibt das Maß, inwieweit eine psychotherapeutische Intervention wie vorgesehen umgesetzt wurde. Für eine fundierte Interpretation psychotherapeutischer Interventionseffekte sind Kenntnisse über die Treatment Integrity entscheidend. Die vorliegende Arbeit untersuchte Teilaspekte der Treatment Integrity durchgeführter CALM-Therapien im Vergleich zu durchgeführten konventionellen psychoonkologischen Therapien, um einen Beitrag zu einer fundierten Interpretation von Interventionseffekten der CALM-Therapie zu leisten.
Methoden: Transkriptionen von zwei CALM-Therapien und zwei Therapien einer konventionellen psychoonkologischen Intervention wurden anhand einer qualitativen Inhaltsanalyse nach P. Mayring untersucht. Im Zentrum stand hierbei ein selbst entwickeltes Kategoriensystem zur Analyse des gesamten Textmaterials. Zusätzlich wurden Auffälligkeiten bezüglich Ansprachen von Themenbereichen der CALM-Module unsystematisch beobachtet.
Ergebnisse: Die Inhalte der untersuchten CALM-Therapien bezogen sich durchschnittlich zu 99,54% und die der konventionellen psychoonkologischen Therapien durchschnittlich zu 98,71% auf die Themenbereiche der CALM-Module. Die ermittelten Werte für einzelne Therapiesitzungen lagen für CALM-Sitzungen zwischen 98,12% und 100% und für Sitzungen der konventionellen psychoonkologischen Therapie zwischen 96,20% und 100%. Unsystematisch beobachtete Auffälligkeiten zeigten, dass die Themenbereiche der CALM-Module zum Teil sehr spezifisch durch die CALM-Therapeutinnen und -Therapeuten angesprochen und vernetzt wurden.
Schlussfolgerung: Unter Berücksichtigung von methodischen Grenzen zeigte sich bezüglich des Anteils von Themenbereichen der CALM-Module innerhalb der beiden untersuchten Therapiegruppen kein maßgeblicher Unterschied. Zusätzlich liefert die vorliegende Arbeit Hinweise für einen spezifischen therapeutischen Umgang mit den Themenbereichen der CALM-Module innerhalb der untersuchten CALM-Therapien. Um ermittelte Interventionseffekte der CALM-Therapie fundiert interpretieren zu können, sollten zukünftige Untersuchungen unterschiedliche Umgangsweisen von Therapeutinnen und Therapeuten der beiden Therapiegruppen mit den Themenbereichen der CALM-Module genauer in den Blick nehmen.
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: 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.
Background: Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients' groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. Methods: Generation of evidence and search of literature have been described in part 1. Results: Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for “distress management” and “lifestyle changes”. PE is able to increase patients’ knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients’ groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. Conclusions: ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.
INTRODUCTION:
B cells are attracting increasing attention in the pathogenesis of multiple sclerosis (MS). B cell-targeted therapies with monoclonal antibodies or plasmapheresis have been shown to be successful in a subset of patients. Here, patients with either relapsing-remitting (n = 24) or secondary progressive (n = 6) MS presenting with an acute clinical relapse were screened for their B cell reactivity to brain antigens and were re-tested three to nine months later. Enzyme-linked immunospot technique (ELISPOT) was used to identify brain-reactive B cells in peripheral blood mononuclear cells (PBMC) directly ex vivo and after 96 h of polyclonal stimulation. Clinical severity of symptoms was determined using the Expanded Disability Status Scale (EDSS).
RESULTS:
Nine patients displayed B cells in the blood producing brain-specific antibodies directly ex vivo. Six patients were classified as B cell positive donors only after polyclonal B cell stimulation. In 15 patients a B cell response to brain antigens was absent. Based on the autoreactive B cell response we categorized MS relapses into three different patterns. Patients who displayed brain-reactive B cell responses both directly ex vivo and after polyclonal stimulation (pattern I) were significantly younger than patients in whom only memory B cell responses were detectable or entirely absent (patterns II and III; p = 0.003). In one patient a conversion to a positive B cell response as measured directly ex vivo and subsequently also after polyclonal stimulation was associated with the development of a clinical relapse. The evaluation of the predictive value of a brain antigen-specific B cell response showed that seven of eight patients (87.5%) with a pattern I response encountered a clinical relapse during the observation period of 10 months, compared to two of five patients (40%) with a pattern II and three of 14 patients (21.4%) with a pattern III response (p = 0.0005; hazard ratio 6.08 (95% confidence interval 1.87-19.77).
CONCLUSIONS:
Our data indicate actively ongoing B cell-mediated immunity against brain antigens in a subset of MS patients that may be causative of clinical relapses and provide new diagnostic and therapeutic options for a subset of patients.
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.
A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.
Chronic Kidney Disease as an Important Co-morbid Condition in Coronary Heart Disease Patients
(2019)
In patients with coronary heart disease (CHD) the control of the modifiable “traditional” cardiovascular risk factors such as hypertension, dyslipidemia, diabetes, achieving/maintaining normal body weight and smoking cessation is of major importance to improve prognosis. Guideline recommendations for secondary CHD prevention include specific treatment targets for blood pressure, lipid levels, and markers of glucose metabolism for both younger and older patients. Chronic kidney disease (CKD) has been identified as a “non-traditional” risk factor for worse outcome in CHD patients, as it is associated with a markedly increased risk for subsequent CV events and mortality.
The specific objectives of the current thesis-project are to investigate (a) the quality of care in a recent sample of German CHD patients and to investigate variation of risk factor control between younger and elder patients (≤70 versus >70 years), (b) to analyze the prevalence of CKD across Europe in stable CHD patients in the outpatient setting and during a hospital stay for CHD, (c) to investigate the level of awareness of CKD in German CHD patients and their treating physicians.
Data from the European-wide EUROASPIRE IV study were used that include data on 7998 CHD patients in the ambulatory setting (study visit) and during a hospital stay for CHD (index). The German EUROASPIRE IV study center in Würzburg recruited 536 patients in 2012-2013. Risk factor control was compared against the current recommendations of the European Society of Cardiology. CKD was described by stages of glomerular filtration rate (eGFR) and albuminuria. German patients were asked in an additional kidney specific module whether they have ever been told by a physician about renal impairment. The fact that CKD or acute kidney injury (AKI) was mentioned in prominent parts of the hospital discharge letter as well as correct ICD-coding of CKD or AKI served as a proxy for physician’s awareness of CKD.
The majority of German CHD patients was treated with the recommended drug therapies including e.g. β-blockers, anti-platelets and statins. However, treatment targets for blood pressure and LDL-cholesterol levels were not achieved in many patients (45% and 53%, respectively) and glycemic control in diabetic CHD patients with HbA1-levels <7% was insufficient (61%). A minority of patients reported on current smoking (10%), but unhealthy life-styles e.g. overweight/obesity (85%/37%) were frequent. Patterns of care differed between younger and older CHD patients while older patients were less likely to receive the recommended medical CHD-therapy, were more likely to have uncontrolled blood pressure and also to be diabetic. However, a greater proportion of diabetic patients >70 years was achieving the HbA1c target, and less elder patients were current smokers or were obese. About 17% of patients on average had CKD (eGFR< 60 ml/min/1.73m²) in the entire European sample at the study visit, and an additional 10% had albuminuria despite preserved eGFR, with considerable variation among countries. Impaired kidney function was observed in every fifth patient admitted for CHD in the entire European dataset of the EUROASPIRE IV study. Of the German CHD patients with CKD at the study visit, only a third were aware of their renal impairment. A minority of these patients was being seen by nephrologists, however, with a higher likelihood of CKD awareness and specialist care in more advanced stages of CKD. About a third of patients admitted for CHD showed either CKD or AKI during the hospital stay, but the discharge letter mentioned chronic or acute kidney disease only in every fifth of these patients. In contrast, correct ICD coding of CKD or AKI was more complete, but still suboptimal.
In summary, quality of secondary prevention in German CHD patients indicates considerably room for improvement, with life-style modifications may become an even greater factor in prevention campaigns than medical treatment into certain target ranges. Preventive therapies should also consider different needs in older individuals acknowledging physical and mental potential, other comorbidities and drug-interactions with co-medication. CKD is common in CHD patients, not only in the elderly. Since CHD and CKD affect each other and impact on worse prognosis of each other, raising the awareness of CKD among patients and physicians and considering CKD in medical therapy may improve prognosis and slow disease progression of CHD as well as CKD.
Die chronische Niereninsuffizienz (CKD) ist ein weltweites Gesundheitsproblem. Insbesondere in den Industrienationen stellt es aufgrund des demographischen Wandels eine große gesundheitliche und finanzielle Herausforderung dar, da besonders ältere Menschen an einer eingeschränkten Nierenfunktion leiden. Hypertonie und Diabetes mellitus sind wichtige Risikofaktoren sowohl für die Entstehung der CKD, als auch für die koronare Herzerkrankung (KHK). Die Wahrnehmung der CKD in der Bevölkerung ist niedrig, wodurch eine frühzeitige Diagnose erschwert wird.
Die EUROASPIRE IV Studie hat es ermöglicht, die Prävalenz der CKD in einer Studienpopulation von KHK-Patienten im Raum Würzburg zu beschreiben. Nach den KDIGO-Leitlinien wurden die Patienten mit einer eGFRCKD-EPI<60ml/min als CKD-Patienten eingestuft. Zusätzlich wurde der Albumin/Kreatinin-Quotient (ACR) bestimmt. Zusammenhänge zwischen der Nierenfunktion und möglichen Determinanten wurden untersucht. Mit Hilfe eines Fragebogens wurde die Patienten-Awareness beschrieben. Retrospektiv erfolgte die Recherche, ob die Diagnose der CKD bei Aufnahme und/oder Entlassung des Indexaufenthalts im Arztbrief vermerkt wurde, dies wurde als Awareness der CKD seitens des behandelnden Arztes im Krankenhaus gewertet.
25% der 536-Teilnehmer wiesen am Tag der Untersuchung eine CKD auf. Das mediane Alter betrug 69 Jahre und die mediane eGFR lag bei 74 ml/min. Der ACR war mit 8,3 mg/g in der CKD-Gruppe deutlich erhöht (p<0,01). Das mediane Alter (p<0,01) und auch der prozentuale Anteil an Diabetikern (<0,01) waren in der CKD-Gruppe signifikant höher. 42,7% der Patienten mit CKD wussten von ihrer Nierenfunktionseinschränkung Bescheid. Bei 34 der 79 Patienten, die zum Zeitpunkt der Entlassung eine eGFR <60ml/min aufwiesen, wurde eine CKD im Arztbrief erwähnt.
Die vorliegende Studie zeigt eine hohe Prävalenz von CKD und klassischen kardiovaskulären Risikofaktoren wie beispielsweise Diabetes Mellitus. Trotz dieses hohen CKD-Anteils war sich nur ein geringer Teil der Patienten ihrer Nierenfunktionseinschränkung bewusst und wurde nur in geringem Maße von Ärzten im Entlassungsbrief erwähnt. Insgesamt war sowohl eine vermehrte Wahrnehmung der CKD seitens der Patienten als auch eine häufigere Erwähnung von CKD im Arztbrief mit zunehmendem Schweregrad der CKD assoziiert.
Background
Though risk for recurrent vascular events is high following ischemic stroke, little knowledge about risk factors for secondary events post‐stroke exists.
Objectives
Coagulation factors XII, XI, and VIII (FXII, FXI, and FVIII) have been implicated in first thrombotic events, and our aim was to estimate their effects on vascular outcomes within 3 years after first stroke.
Patients/Methods
In the Prospective Cohort with Incident Stroke Berlin (PROSCIS‐B) study, we followed participants aged 18 and older for 3 years after first mild to moderate ischemic stroke event or until occurrence of recurrent stroke, myocardial infarction, or all‐cause mortality. We compared high coagulation factor activity levels to normal and low levels and also analyzed activities as continuous variables. We used Cox proportional hazards models adjusted for age, sex, and cardiovascular risk factors to estimate hazard ratios (HRs) for the combined endpoint.
Results
In total, 94 events occurred in 576 included participants, resulting in an absolute rate of 6.6 events per 100 person‐years. After confounding adjustment, high FVIII activity showed the strongest relationship with the combined endpoint (HR = 2.05, 95% confidence interval [CI] 1.28–3.29). High FXI activity was also associated with a higher hazard (HR = 1.80, 95% CI 1.09–2.98), though high FXII activity was not (HR = 0.86, 95% CI 0.49–1.51). Continuous analyses yielded similar results.
Conclusions
In our study of mild to moderate ischemic stroke patients, high activity levels of FXI and FVIII but not FXII were associated with worse vascular outcomes in the 3‐year period after first ischemic stroke.
The increasing prevalence of smart mobile devices (e.g., smartphones) enables the combined use of mobile crowdsensing (MCS) and ecological momentary assessments (EMA) in the healthcare domain. By correlating qualitative longitudinal and ecologically valid EMA assessment data sets with sensor measurements in mobile apps, new valuable insights about patients (e.g., humans who suffer from chronic diseases) can be gained. However, there are numerous conceptual, architectural and technical, as well as legal challenges when implementing a respective software solution. Therefore, the work at hand (1) identifies these challenges, (2) derives respective recommendations, and (3) proposes a reference architecture for a MCS-EMA-platform addressing the defined recommendations. The required insights to propose the reference architecture were gained in several large-scale mHealth crowdsensing studies running for many years and different healthcare questions. To mention only two examples, we are running crowdsensing studies on questions for the tinnitus chronic disorder or psychological stress. We consider the proposed reference architecture and the identified challenges and recommendations as a contribution in two respects. First, they enable other researchers to align our practical studies with a baseline setting that can satisfy the variously revealed insights. Second, they are a proper basis to better compare data that was gathered using MCS and EMA. In addition, the combined use of MCS and EMA increasingly requires suitable architectures and associated digital solutions for the healthcare domain.
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).
(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.
Background
The objective of this trial was to evaluate whether the regular consumption of probiotics may improve the known deterioration of periodontal health in navy sailors during deployments at sea.
Methods
72 healthy sailors of a naval ship on a practicing mission at sea were recruited and randomly provided with a blinded supply of lozenges to be consumed twice daily for the following 42 days containing either the probiotic strains Lactobacillus reuteri (DSM 17938 and L. reuteri (ATTC PTA 5289) (test n = 36) or no probiotics (placebo n = 36). At baseline, at day 14 and day 42 bleeding on probing (primary outcome), gingival index, plaque control record, probing attachment level, and probing pocket depth were assessed at the Ramfjord teeth.
Results
At baseline there were no significant differences between the groups. At day 14 and day 42 test group scores of all assessed parameters were significantly improved (P < 0.001) compared to baseline and to the placebo group which by contrast showed a significant (P < 0.001) deterioration of all parameters at the end of the study.
Conclusions
The consumption of probiotic L. reuteri‐lozenges is an efficacious measure to improve and maintain periodontal health in situations with waning efficacy of personal oral hygiene.
Tinnitus is a complex and heterogeneous psycho-physiological disorder responsible for causing a phantom ringing or buzzing sound albeit the absence of an external sound source. It has a direct influence on affecting the quality of life of its sufferers. Despite being around for a while, there has not been a cure for tinnitus, and the usual course of action for its treatment involves use of tinnitus retaining and sound therapy, or Cognitive Behavioral Therapy (CBT). One positive aspect about these therapies is that they can be administered face-to-face as well as delivered via internet or smartphone. Smartphones are especially helpful as they are highly personalized devices, and offer a well-established ecosystem of apps, accessible via respective marketplaces of differing mobile platforms. Note that current therapeutic treatments such as CBT have shown to be effective in suppressing the tinnitus symptoms when administered face-to-face, their effectiveness when being delivered using smartphones is not known so far. A quick search on the prominent market places of popular mobile platforms (Android and iOS) yielded roughly 250 smartphone apps offering tinnitus-related therapies and tinnitus management. As this number is expected to steadily increase due to high interest in smartphone app development, a contemporary review of such apps is crucial. In this paper, we aim to review scientific studies validating the smartphone apps, particularly to test their effectiveness in tinnitus management and treatment. We use the PRISMA guidelines for identification of studies on major scientific literature sources and delineate the outcomes of identified studies.
Background:
While data from primary care suggest an insufficient control of vascular risk factors, little is known about vascular risk factor control in the general population. We therefore aimed to investigate the adoption of adequate risk factor control and its determinants in the general population free of cardiovascular disease (CVD).
Methods:
Data from the Characteristics and Course of Heart Failure Stages A-B and Determinants of Progression (STAAB) Cohort Study, a population-based study of inhabitants aged 30 to 79 years from the general population of Würzburg (Germany), were used. Proportions of participants without established CVD meeting targets for risk factor control recommended by 2016 ESC guideline were identified. Determinants of the accumulation of insufficiently controlled vascular risk factors (three or more) were assessed.
Results:
Between December 2013 and April 2015, 1379 participants without CVD were included; mean age was 53.1 ± 11.9 years and 52.9% were female; 30.8% were physically inactive, 55.2% overweight, 19.3% current smokers. Hypertension, dyslipidemia, and diabetes mellitus were prevalent in 31.8%, 57.6%, and 3.9%, respectively. Treatment goals were not reached despite medication in 52.7% of hypertensive, in 37.3% of hyperlipidemic and in 44.0% of diabetic subjects. Insufficiently controlled risk was associated with male sex (OR 1.94, 95%CI 1.44–2.61), higher age (OR for 30–39 years vs. 70–79 years 4.01, 95%CI 1.94–8.31) and lower level of education (OR for primary vs. tertiary 2.15, 95%CI 1.48–3.11).
Conclusions:
In the general population, prevalence of vascular risk factors was high. We found insufficient identification and control of vascular risk factors and a considerable potential to improve adherence to cardiovascular guidelines for primary prevention. Further studies are needed to identify and overcome patient- and physician-related barriers impeding successful control of vascular risk factors in the general population.
Background: Proportions of patients dying from the coronavirus disease-19 (COVID-19) vary between different countries. We report the characteristics; clinical course and outcome of patients requiring intensive care due to COVID-19 induced acute respiratory distress syndrome (ARDS).
Methods: This is a retrospective, observational multicentre study in five German secondary or tertiary care hospitals. All patients consecutively admitted to the intensive care unit (ICU) in any of the participating hospitals between March 12 and May 4, 2020 with a COVID-19 induced ARDS were included.
Results: A total of 106 ICU patients were treated for COVID-19 induced ARDS, whereas severe ARDS was present in the majority of cases. Survival of ICU treatment was 65.0%. Median duration of ICU treatment was 11 days; median duration of mechanical ventilation was 9 days. The majority of ICU treated patients (75.5%) did not receive any antiviral or anti-inflammatory therapies. Venovenous (vv) ECMO was utilized in 16.3%. ICU triage with population-level decision making was not necessary at any time. Univariate analysis associated older age, diabetes mellitus or a higher SOFA score on admission with non-survival during ICU stay.
Conclusions: A high level of care adhering to standard ARDS treatments lead to a good outcome in critically ill COVID-19 patients.
Background and purpose
Improving understanding of study contents and procedures might enhance recruitment into studies and retention during follow-up. However, data in stroke patients on understanding of the informed consent (IC) procedure are sparse.
Methods
We conducted a cross-sectional study among ischemic stroke patients taking part in the IC procedure of an ongoing cluster-randomized secondary prevention trial. All aspects of the IC procedure were assessed in an interview using a standardized 20-item questionnaire. Responses were collected within 72 h after the IC procedure and analyzed quantitatively and qualitatively. Participants were also asked their main reasons for participation.
Results
A total of 146 stroke patients (65 ± 12 years old, 38% female) were enrolled. On average, patients recalled 66.4% (95% confidence interval = 65.2%–67.5%) of the content of the IC procedure. Most patients understood that participation was voluntary (99.3%) and that they had the right to withdraw consent (97.1%); 79.1% of the patients recalled the study duration and 56.1% the goal. Only 40.3% could clearly state a benefit of participation, and 28.8% knew their group allocation. Younger age, higher graduation, and allocation to the intervention group were associated with better understanding. Of all patients, 53% exclusively stated a personal and 22% an altruistic reason for participation.
Conclusions
Whereas understanding of patient rights was high, many patients were unable to recall other important aspects of study content and procedures. Increased attention to older and less educated patients may help to enhance understanding in this patient population. Actual recruitment and retention benefit of an improved IC procedure remains to be tested in a randomized trial.
Background: Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18-60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e. g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. Methods/Design: DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS <= 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. Discussion: The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies.
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
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.
Bei Patienten mit einer kolorektalen Krebserkrankung zeigt sich ein deutlicher Zusammenhang zwischen Angst und Depressivität und dem psychosozialen Unterstützungsbedarf. Zwischen Angst und Depressivität und unbefriedigten Informationsbedürfnissen scheint ebenfalls ein schwacher Zusammenhang zu bestehen. Für eine mögliche Präferenz von anonymen Informationsquellen bei Patienten mit Angst oder Depressivität findet sich im Untersuchten Patientenkollektiv kein Anhaltspunkt.
Ziel der vorliegenden Arbeit ist es soziodemografische, krankheitsbezogene und psychosozi¬ale Variablen, die in Zusammenhang mit der psychischen Belastung und dem Wunsch nach psychosozialer Unterstützung stehen, von Brustkrebspatientinnen zu identifi¬zieren. Dabei werden in der vorliegenden Arbeit die Art der Erkrankung, die körperli¬che Leistungsfähigkeit, die funktionelle soziale Unterstützung, unterteilt in posi-tive Unterstützung und belastende Interaktionen, der Familienstand bzw. die Partner-schaft und das Vorhandensein von Kindern als unabhängige Variablen näher untersucht.
Aus einer Baseline-Erhebung einer Längsschnittstudie aus Deutschland, die unter ande-rem auch Patienten in der Universitäts-Frauenklinik in Würzburg rekrutiert hat, gehen 27 Brustkrebspatientinnen in die Auswertung der vorliegenden Arbeit mit ein. Zudem entstammen weitere Daten von 202 Brustkrebspatienten aus einer vorangegangenen multizentrischen Querschnittsstudie, deren Rekrutierung ebenfalls in der Frauenklinik stattfand. Die Stichprobe umfasst insgesamt 229 Patienten mit einem Altersdurchschnitt von 55,22 Jahren. Die Erfassung des Wunsches nach psychosozialer Unterstützung er-folgte mittels 3 spezifischen Fragen.
Diese beinhalten das Bedürfnis nach psychosozialer Unterstützung und erfragen die Akzeptanz eines solchen Angebots sowie den Wunsch, mit jemandem über die psychi-sche Belastung durch die Erkrankung zu sprechen.
Die psychische Belastung wurde mit dem PHQ-9-Fragebogen zur Erfassung der Depressivi¬tät und dem GAD-7-Fragebogen zur Erfassung der Angst, gemessen.
Die Untersuchung brachte folgende Ergebnisse: Die belastenden Interaktionen der sozia¬len Unterstützung stehen in signifikantem Zusammenhang mit dem Schwergrad der psychischen Belastung, sowohl im PHQ-9-Fragebogen über Depressivität als auch beim GAD-7- Selbstbeurteilungsinstrument zur Erfassung der Angst. Ebenso ist ein signifikanter negativer Zusammenhang mit schwach bis mittelstarker Effektstärke zwischen der positiven funktionellen Unterstützung und dem Ausmaß der Angst-symptomatik vorhanden.
Auch der Kar¬nofsky-Index weist einen signifikanten Zusammenhang mit der Depressivität auf und einen nicht-signifikanten Trend bezüglich Angstsymptomen. Keine Zusammenhänge finden sich mit der Art der Erkrankung, dem Familien¬stand bzw. dem Vorhandensein einer Partnerschaft, sowie dem Vorhandensein von Kindern. In Bezug auf das Bedürfnis, die Akzeptanz und den Wunsch nach psychosozia¬ler Unterstützung konnten ebenfalls keine signifikanten Zusammenhänge mit den oben genannten soziodemografischen, psychosozialen und krankheitsbezoge¬nen Variablen festgestellt werden.
Die Ergebnisse stimmen teilweise mit bisherigen Studien überein. Die Abweichungen, die zu anderen Publikationen bestehen, sind weitestgehend auf Unterschiede im Rahmen der Stichproben und der Messinstrumente zurückzuführen.
Zukünftige Publikationen sollten in Form von Longitudinalstudien den zeitlichen Verlauf der Einflussfaktoren auf die abhängigen Variablen näher untersuchen. Zudem wäre eine Vereinheitlichung der Messmethoden für einen besseren Vergleich der Ergebnisse unter¬schiedlicher Studien untereinander ratsam.
Außerdem sollte auch für den klinischen Bereich zukünftige Bestrebungen sein, weitere Leitlinien zum Thema psychoonkologische Unterstützung zu etablieren, Wege zu finden dem medizinischen Personal das Erkennen psychischer Belastung bei Patienten und deren Bedürfnis nach Unterstützung zu erleichtern und die Integration psychosozialer Betreuungs- und Unterstützungsangebote im klinischen Alltag zu verstärken
Diese Schrift befasst sich mit der Fragestellung, welche Determinanten einen signifikanten Zusammenhang mit der selbstberichteten körperlichen Funktionsfähigkeit der Probanden aufweisen. Es werden im Folgenden die Hintergründe und die Bedeutung der Koronaren Herzkrankheit mit Pathogenese, Klinik und Therapiemöglichkeiten aufgezeigt. Diese weltweit verbreitete Erkrankung führt seit Jahren die Statistik der häufigsten Todesursachen nicht nur in Deutschland an. Werden die Hauptrisikofaktoren Diabetes mellitus, Hypercholesterinämie, arterielle Hypertonie, Nikotinkonsum und Adipositas nicht beseitigt, können sich Arteriosklerose und eine Koronarinsuffizienz entwickeln, die schlimmstenfalls zum Myokardinfarkt oder Tod führen. Im weiteren Verlauf wird erläutert, warum nach den Studien EUROASPIRE I bis III noch eine weitere multizentrische Querschnittsstudie notwendig ist. Bei den vorangegangenen Studien hatte sich gezeigt, dass die Ziele zur Minimierung der Risikofaktoren im Alltag von KHK-Patienten noch nicht erreicht wurden, sondern es in der letzten Zeit vielmehr zu einem Anstieg von Risikopatienten gekommen war. Die EUROASPIRE IV Studie wurde daher zur Bewertung der Qualität der Sekundärprävention bei KHK-Patienten in der heutigen Zeit initiiert.
Des Weiteren wird auf die Definition der selbstberichteten körperlichen Funktionsfähigkeit eingegangen, die in dieser Arbeit anhand des HeartQoL-Fragebogens bei KHK-Patienten untersucht wird. Dabei ist im Unterschied zu einer objektiven Beurteilung von Bedeutung, dass jeder Patient anhand seiner individuellen Lebensumstände seine eigene physische Verfassung einschätzt. Dass die körperliche Funktionsfähigkeit von KHK-Patienten tatsächlich eingeschränkt ist, wird anhand einer Auflistung von Studien belegt, die sich bereits mit diesem Thema auseinandergesetzt haben. In der vorliegenden Promotionsarbeit wurden die Determinanten der selbstberichteten körperlichen Funktionsfähigkeit von 528 Würzburger Teilnehmern der europaweit durchgeführten EUROASPIRE IV Studie anhand von verschiedenen Fragebögen ermittelt. Primärer Endpunkt war dabei die körperliche Skala des 14-teiligen HeartQoL-Fragebogens. Die Probanden wurden für die Analyse in Tertile eingeteilt, wobei diejenigen mit der größten selbstberichteten körperlichen Funktionsfähigkeit dem dritten Tertil zugeordnet wurden. In der Analyse der Basisvariablen des Kollektivs zeigte sich, dass unter den Probanden des dritten Tertils die Risikofaktoren Adipositas, Hypertension und Herzinsuffizienz seltener vertreten waren, als bei denen des ersten Tertils. Zudem wurde seltener über Angst und Depressionen berichtet. Bei der körperlichen Untersuchung wiesen die Probanden des dritten Tertils häufiger eine niedrige Herzfrequenz und einen geringeren Taillenumfang auf. Auch die Laborwerte wie niedriges HDL, hohe Triglyceride, ein hoher HbA1c, hohes NT-proBNP, niedriges Hämoglobin und hohe Serum-Insulinwerte traten in dieser Gruppe seltener auf. Medikamente wie Antikoagulantien, Diuretika und Insulin wurden nicht so häufig eingenommen wie bei den Probanden des ersten Tertils. Zudem bestand meist eine bessere Lungenfunktion. In die multiple Regressionsanalyse flossen nur die signifikanten Werte aus der Analyse der Basisvariablen des Kollektivs ein. Betrachtet man die Ergebnisse der multiplen Regressionsanalyse, fällt auf, dass die Angstvariable den größten Effekt auf die selbstberichtete körperliche Funktionsfähigkeit der Probanden hatte. Wie auch in der Literatur beschrieben, haben Angst und Depressionen einen stark negativen Einfluss auf die physische Funktion von KHK-Patienten. Als stark negative Prädiktoren der körperlichen Funktionsfähigkeit stellten sich in der Regressionsanalyse auch die Einnahme von Diuretika und ein hoher NT-proBNP-Wert heraus. Herzinsuffizienz-Patienten berichteten folglich häufiger über eine nachlassende physische Fitness. Bestanden eine gute Lungenfunktion und ein niedriger Serum-Insulinwert, wirkte sich dies positiv auf die Funktionsfähigkeit aus. Ein niedriger Hämoglobinwert oder das Vorhandensein von Depressionen hatten einen negativen Einfluss. Somit kann zusammenfassend festgehalten werden, dass Probanden, die weniger ängstlich waren und über eine durch apparative und laboratorisch objektivierte gesündere körperliche Verfassung verfügten, ihre körperliche Funktionsfähigkeit als höher einschätzten. In der Korrelationsanalyse wurde beleuchtet, welche der Variablen, die nach der Regressionsanalyse noch im Modell verblieben waren, sich für die Verdrängung der anderen Variablen verantwortlich zeigten. Dabei waren die Einnahme von Diuretika und der Wert für die Lungenfunktion FEV1 diejenigen Variablen, die für die Entfernung der meisten anderen Variablen aus dem Modell verantwortlich waren. Zudem wurde in der Korrelationsanalyse gezeigt, welche Variablen starke Zusammenhänge zeigten.
Auf der einen Seite stellten sich die psychischen Komponenten wie Angst oder Depressionen als essentiell für die eigene Einschätzung der körperlichen Funktionsfähigkeit heraus. Zum anderen waren auch objektiv bestimmbare Parameter wie die Blutwerte NT-proBNP, Insulin und Hämoglobin und die Einnahme von Diuretika dafür entscheidend. Somit ist es von großer Bedeutung, bei der Therapie von Patienten mit Koronarer Herzkrankheit die Ängste und Stimmungslage zu berücksichtigen und eine möglicherweise vorhandene Depression in die Therapie mit einzubeziehen. Ferner ist es wichtig, diese Patienten ausführlich über ihre Krankheit mit den Risikofaktoren und möglichen Folgeschäden aufzuklären und sie zu einem gesunden, aktiven Lebensstil zu motivieren.
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.
Background:
The German quality assurance programme for evaluating work capacity is based on peer review that evaluates the quality of medical experts' reports. Low reliability is thought to be due to systematic differences among peers. For this purpose, we developed a curriculum for a standardized peer-training (SPT). This study investigates, whether the SPT increases the inter-rater reliability of social medical physicians participating in a cross-institutional peer review.
Methods:
Forty physicians from 16 regional German Pension Insurances were subjected to SPT. The three-day training course consist of nine educational objectives recorded in a training manual. The SPT is split into a basic module providing basic information about the peer review and an advanced module for small groups of up to 12 peers training peer review using medical reports. Feasibility was tested by assessing selection, comprehensibility and subjective use of contents delivered, the trainers' delivery and design of training materials. The effectiveness of SPT was determined by evaluating peer concordance using three anonymised medical reports assessed by each peer. Percentage agreement and Fleiss' kappa (κ\(_m\)) were calculated. Concordance was compared with review results from a previous unstructured, non-standardized peer-training programme (control condition) performed by 19 peers from 12 German Pension Insurances departments. The control condition focused exclusively on the application of peer review in small groups. No specifically training materials, methods and trainer instructions were used.
Results:
Peer-training was shown to be feasible. The level of subjective confidence in handling the peer review instrument varied between 70 and 90%. Average percentage agreement for the main outcome criterion was 60.2%, resulting in a κ\(_m\) of 0.39. By comparison, the average percentage concordance was 40.2% and the κ\(_m\) was 0.12 for the control condition.
Conclusion:
Concordance with the main criterion was relevant but not significant (p = 0.2) higher for SPT than for the control condition. Fleiss' kappa coefficient showed that peer concordance was higher for SPT than randomly expected. Nevertheless, a score of 0.39 for the main criterion indicated only fair inter-rater reliability, considerably lower than the conventional standard of 0.7 for adequate reliability.
Background: Patients with metastatic breast cancer (MBC) are treated with a palliative approach with focus oncontrolling for disease symptoms and maintaining high quality of life. Information on individual needs of patients andtheir relatives as well as on treatment patterns in clinical routine care for this specific patient group are lacking or arenot routinely documented in established Cancer Registries. Thus, we developed a registry concept specifically adaptedfor these incurable patients comprising primary and secondary data as well as mobile-health (m-health) data.
Methods: The concept for patient-centered “Breast cancer care for patients with metastatic disease”(BRE-4-MED)registry was developed and piloted exemplarily in the region of Main-Franconia, a mainly rural region in Germanycomprising about 1.3 M inhabitants. The registry concept includes data on diagnosis, therapy, progression, patient-reported outcome measures (PROMs), and needs of family members from several sources of information includingroutine data from established Cancer Registries in different federal states, treating physicians in hospital as well as inoutpatient settings, patients with metastatic breast cancer and their family members. Linkage with routine cancerregistry data was performed to collect secondary data on diagnosis, therapy, and progression. Paper and online-basedquestionnaires were used to assess PROMs. A dedicated mobile application software (APP) was developed to monitorneeds, progression, and therapy change of individual patients. Patient’s acceptance and feasibility of data collection inclinical routine was assessed within a proof-of-concept study.
Results: The concept for the BRE-4-MED registry was developed and piloted between September 2017 and May 2018.In total n= 31 patients were included in the pilot study, n= 22 patients were followed up after 1 month. Recordlinkage with the Cancer Registries of Bavaria and Baden-Württemberg demonstrated to be feasible. The voluntary APP/online questionnaire was used by n= 7 participants. The feasibility of the registry concept in clinical routine waspositively evaluated by the participating hospitals.
Conclusion: The concept of the BRE-4-MED registry provides evidence that combinatorial evaluation of PROMs, needsof family members, and raising clinical parameters from primary and secondary data sources as well as m-healthapplications are feasible and accepted in an incurable cancer collective.
Background
Breast cancer (BC), which is most common in elderly women, requires a multidisciplinary and continuous approach to care. With demographic changes, the number of patients with chronic diseases such as BC will increase. This trend will especially hit rural areas, where the majority of the elderly live, in terms of comprehensive health care.
Methods
Accessibility to several cancer facilities in Bavaria, Germany, was analyzed with a geographic information system. Facilities were identified from the national BC guideline and from 31 participants in a proof‐of‐concept study from the Breast Cancer Care for Patients With Metastatic Disease registry. The timeframe for accessibility was defined as 30 or 60 minutes for all population points. The collection of address information was performed with different sources (eg, a physician registry). Routine data from the German Census 2011 and the population‐based Cancer Registry of Bavaria were linked at the district level.
Results
Females from urban areas (n = 2,938,991 [ie, total of females living in urban areas]) had a higher chance for predefined accessibility to the majority of analyzed facilities in comparison with females from rural areas (n = 3,385,813 [ie, total number of females living in rural areas]) with an odds ratio (OR) of 9.0 for cancer information counselling, an OR of 17.2 for a university hospital, and an OR of 7.2 for a psycho‐oncologist. For (inpatient) rehabilitation centers (OR, 0.2) and genetic counselling (OR, 0.3), women from urban areas had lower odds of accessibility within 30 or 60 minutes.
Conclusions
Disparities in accessibility between rural and urban areas exist in Bavaria. The identification of underserved areas can help to inform policymakers about disparities in comprehensive health care. Future strategies are needed to deliver high‐quality health care to all inhabitants, regardless of residence.
Background:
Heart failure (HF) patient education aims to foster patients’ self-management skills. These are assumed to bring about, in turn, improvements in distal outcomes such as quality of life. The purpose of this study was to test the hypothesis that change in self-reported self-management skills observed after participation in self-management education predicts changes in physical and mental quality of life and depressive symptoms up to one year thereafter.
Methods:
The sample comprised 342 patients with chronic heart failure, treated in inpatient rehabilitation clinics, who received a heart failure self-management education program. Latent change modelling was used to analyze relationships between both short-term (during inpatient rehabilitation) and intermediate-term (after six months) changes in self-reported self-management skills and both intermediate-term and long-term (after twelve months) changes in physical and mental quality of life and depressive symptoms.
Results:
Short-term changes in self-reported self-management skills predicted intermediate-term changes in mental quality of life and long-term changes in physical quality of life. Intermediate-term changes in self-reported self-management skills predicted long-term changes in all outcomes.
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.
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.