[E-scooter, e-bike and bicycle injuries in the same period-A prospective analysis of a level 1 trauma center]. / E-Scooter­, E-Bike- und Fahrradverletzungen im gleichen Zeitraum ­ eine prospektive Vergleichsstudie eines Level-1-Traumazentrums.

BACKGROUND: The actual number of accidents in e­scooter drivers in Germany seems to be significantly higher than the current figures from the Statistisches Bundesamt suggest. This epidemiological study examines e­scooter injuries and compares them with e­bike and bicycle injuries. OBJECTIVE: In order to create a comparable database on the dangers of e­scooters, e­bikes and bicycles, the typical injury patterns were analyzed and prevention options derived from them. MATERIAL AND METHODS: All accidents involving e­scooters, e­bikes and bicycles that were presented via the university emergency room of a level 1 trauma center between 15 June 2019 and 31 October 2020 were prospectively investigated. RESULTS: In our study, 68 accidents in e­scooter drivers were included, of which only 11.8% (n = 8) were recorded by the police. Significantly more of them were male than female (p = 0.032) with a mean age of 31.1 (±13) years. At the same time, we registered 34 accidents in e­bike riders and 356 in cyclists. In all three groups, most injuries occurred to the head, followed by injuries to the upper extremities. Significantly more e­scooter drivers had an ISS ≥ 16 than in the group of injured cyclists (p = 0.016). E­scooter riders who had an accident had a significantly longer length of stay in hospital, than e­bike riders (p = 0.003) and cyclists (p = 0.001), 52.9% (n = 18) of e­bike riders and 53.3% (n = 113) cyclists wore a helmet, compared to only 1.5% (n = 1) of e­scooter riders. The most common cause of accidents among e­bike riders (17.7%; n = 6) and cyclists (10.4%; n = 37) was slipping away on tram rails, while for e­scooter riders it was colliding with a curb (7.4%; n = 5). CONCLUSION: The three patient collectives examined showed different causes and profiles of injuries. The reasons for an increased proportion of seriously injured people compared to cyclists are electromobility, driving under the influence of alcohol and inadequate wearing of a helmet on e­scooters when head injuries dominate. 73.5% (n = 50) of the e­scooter accidents recorded by us were not registered by the police and therefore do not appear in the current statistics of the statistisches Bundesamt. As a result, a much higher number of e­scooter accidents can be assumed. Preventive measures could include the introduction of compulsory helmets, a higher number of traffic controls and the expansion of bike tracks.

Pilot study of a smartphone-based tinnitus therapy using structured counseling and sound therapy: A multiple-baseline design with ecological momentary assessment.

Tinnitus affects a considerable part of the population and develops into a severe disorder in some sufferers. App-based interventions are able to provide low-threshold, cost-effective, and location-independent care for tinnitus patients. Therefore, we developed a smartphone app combining structured counseling with sound therapy and conducted a pilot study to evaluate treatment compliance and symptom improvement (trial registration: DRKS00030007). Outcome variables were Ecological Momentary Assessment (EMA) measured tinnitus distress and loudness and Tinnitus Handicap Inventory (THI) at baseline and final visit. A multiple-baseline design with a baseline phase (only EMA) followed by an intervention phase (EMA and intervention) was applied. 21 patients with chronic tinnitus (≥ 6 months) were included. Overall compliance differed between modules (EMA usage: 79% of days, structured counseling: 72%, sound therapy: 32%). The THI score improved from baseline to final visit indicating a large effect (Cohens d = 1.1). Tinnitus distress and loudness did not improve significantly from baseline phase to the end of intervention phase. However, 5 of 14 (36%) improved clinically meaningful in tinnitus distress (ΔDistress ≥ 10) and 13 of 18 (72%) in THI score (ΔTHI ≥ 7). The positive relationship between tinnitus distress and loudness weakened over the course of the study. A trend but no level effect for tinnitus distress could be demonstrated by a mixed effect model. The improvement in THI was strongly associated with the improvement scores in EMA of tinnitus distress (r = -0.75; 0.86). These results indicate that app-based structured counseling combined with sound therapy is feasible, has an impact on tinnitus symptoms and reduces distress for several patients. In addition, our data suggest that EMA could be used as a measurement tool to detect changes in tinnitus symptoms in clinical trials as has already been shown in other areas of mental health research.

Self-Assessment of Having COVID-19 With the Corona Check mHealth App.

At the beginning of the COVID-19 pandemic, with a lack of knowledge about the novel virus and a lack of widely available tests, getting first feedback about being infected was not easy. To support all citizens in this respect, we developed the mobile health app Corona Check. Based on a self-reported questionnaire about symptoms and contact history, users get first feedback about a possible corona infection and advice on what to do. We developed Corona Check based on our existing software framework and released the app on Google Play and the Apple App Store on April 4, 2020. Until October 30, 2021, we collected 51,323 assessments from 35,118 users with explicit agreement of the users that their anonymized data may be used for research purposes. For 70.6% of the assessments, the users additionally shared their coarse geolocation with us. To the best of our knowledge, we are the first to report about such a large-scale study in this context of COVID-19 mHealth systems. Although users from some countries reported more symptoms on average than users from other countries, we did not find any statistically significant differences between symptom distributions (regarding country, age, and sex). Overall, the Corona Check app provided easily accessible information on corona symptoms and showed the potential to help overburdened corona telephone hotlines, especially during the beginning of the pandemic. Corona Check thus was able to support fighting the spread of the novel coronavirus. mHealth apps further prove to be valuable tools for longitudinal health data collection.

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).

BACKGROUND: Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. METHODS: Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. DISCUSSION: The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

The Impact of Coping Styles and Gender on Situational Coping: An Ecological Momentary Assessment Study With the mHealth Application TrackYourStress.

The aim of this study was to investigate the impact of different coping styles on situational coping in everyday life situations and gender differences. An ecological momentary assessment study with the mobile health app TrackYourStress was conducted with 113 participants. The coping styles Positive Thinking, Active Stress Coping, Social Support, Support in Faith, and Alcohol and Cigarette Consumption of the Stress and Coping Inventory were measured at baseline. Situational coping was assessed by the question "How well can you cope with your momentary stress level" over 4 weeks. Multilevel models were conducted to test the effects of the coping styles on situational coping. Additionally, gender differences were evaluated. Positive Thinking (p = 0.03) and Active Stress Coping (p = 0.04) had significant positive impacts on situational coping in the total sample. For women, Social Support had a significant positive effect on situational coping (p = 0.046). For men, Active Stress Coping had a significant positive effect on situational coping (p = 0.001). Women had higher scores on the SCI scale Social Support than men (p = 0.007). These results suggest that different coping styles could be more effective in daily life for women than for men. Taking this into account, interventions tailored to users' coping styles might lead to better coping outcomes than generalized interventions.

UNITI Mobile-EMI-Apps for a Large-Scale European Study on Tinnitus.

More and more observational studies exploit the achievements of mobile technology to ease the overall implementation procedure. Many strategies like digital phenotyping, ecological momentary assessments or mobile crowdsensing are used in this context. Recently, an increasing number of intervention studies makes use of mobile technology as well. For the chronic disorder tinnitus, only few long-running intervention studies exist, which use mobile technology in a larger setting. Tinnitus is characterized by its heterogeneous patient's symptom profiles, which complicates the development of general treatments. In the UNITI project, researchers from different European countries try to unify existing treatments and interventions to cope with this heterogeneity. One study arm (UNITI Mobile) exploits mobile technology to investigate newly implemented interventions types, especially within the pan-European setting. The goals are to learn more about the validity and usefulness of mobile technology in this context. Furthermore, differences among the countries shall be investigated. Practically, two native intervention apps have been developed for UNITI and the mobile study arm, which pose features not presented so far in other apps of the authors. Along the implementation procedure, it is discussed whether these features might leverage similar types of studies in future. Since instruments like the mHealth evidence reporting and assessment checklist (mERA), developed by the WHO mHealth technical evidence review group, indicate that aspects shown for UNITI Mobile are important in the context of health interventions using mobile phones, our findings may be of a more general interest and are therefore being discussed in the work at hand.

Bioactive glass S53P4 vs. autologous bone graft for filling defects in patients with chronic osteomyelitis and infected non-unions - a single center experience.

Introduction: The goals of osteomyelitis therapy are successful control of infection and reconstruction of the bone. The gold standard for filling defects is the autologous bone graft. Bioactive glass S53P4 is an inorganic bone substitute. We compared the outcome of using bioactive glass (BAG) versus autologous bone graft (AB) in patients with infected non-union. Methods: Patients with chronic osteomyelitis and infected non-union who received either bioactive glass or autologous bone grafts between 2013 and 2017 were analyzed retrospectively. The primary endpoint was successful control of infection during follow-up. Secondary endpoints were bone healing, functional outcome, and occurrence of complications. Results: Eighty-three patients were analyzed (BAG n = 51 , AB n = 32 ). Twenty-one patients experienced reinfection (BAG n = 15 , 29 %; AB n = 6 , 19 %). Seventy-eight patients achieved full weight bearing (BAG n = 47 , 92 %; AB n = 31 , 97 %). Sixty-four patients had complete bone healing at the end of the follow-up period (BAG n = 39 , 77 %; AB n = 25 , 78 %). There were no significant differences between the groups with respect to the primary or secondary endpoints. Patients with multidrug-resistant pathogens had a significantly higher rate of incomplete bone healing ( p = 0 .033) and a 3-fold higher risk of complications in both groups. Conclusions: Bioactive glass appears to be a suitable bone substitute not only for successful control of infection and defect filling but also for bone healing in cases of infected non-union. In our study, bioactive glass was neither superior nor inferior to autologous bone graft with regard to the primary and secondary endpoints. Further studies with larger numbers of patients are required.

Geriatric Proximal Femur Fractures During the Covid-19 Pandemic - Fewer Cases, But More Comorbidities.

BACKGROUND: The COVID-19 pandemic is challenging healthcare systems worldwide. This study examines geriatric patients with proximal femur fractures during the COVID-19 pandemic, shifts in secondary disease profile, the impact of the pandemic on hospitalization and further treatment. METHODS: In a retrospective monocentric study, geriatric proximal femur fractures treated in the first six months of 2020 were analyzed and compared with the same period of 2019. Pre-traumatic status (living in a care home, under supervision of a legal guardian), type of trauma, accident mechanism, geriatric risk factors, associated comorbidities, time between hospitalization and surgery, inpatient time and post-operative further treatment of 2 groups of patients, aged 65-80 years (Group 1) and 80+ years (Group 2) were investigated. RESULTS: The total number of patients decreased (70 in 2019 vs. 58 in 2020), mostly in Group 1 (25 vs. 16) while the numbers in Group 2 remained almost constant (45 vs. 42). The percentage of patients with pre-existing neurological conditions rose in 2020. This corresponded to an increase in patients under legal supervision (29.3%) and receiving pre-traumatic care in a nursing home (14.7%). Fractures were mostly caused by minor trauma in a home environment. In 2020, total number of inpatient days for Group 2 was lower compared to Group 1 (p = 0.008). Further care differed between the years: fewer Group 1 patients were discharged to geriatric therapy (69.6% vs. 25.0%), whereas in Group 2 the number of patients discharged to a nursing home increased. CONCLUSIONS: Falling by elderly patients is correlated to geriatric comorbidities, consequently there was no change in the case numbers in this age group. Strategic measures to avoid COVID-19 infection in hospital setting could include reducing the length of hospital stays by transferring elderly patients to a nursing home as soon as possible and discharging independent, mobile patients to return home.

Using Big Data to Develop a Clinical Decision Support System for Tinnitus Treatment.

Tinnitus is a common symptom of a phantom sound perception with a considerable socioeconomic impact. Tinnitus pathophysiology is enigmatic and its significant heterogeneity reflects a wide spectrum of clinical manifestations, severity and annoyance among tinnitus sufferers. Although several interventions have been suggested, currently there is no universally accepted treatment. Moreover, there is no well-established correlation between tinnitus features or patients' characteristics and projection of treatment response. At the clinical level, this practically means that selection of treatment is not based on expected outcomes for the particular patient.The complexity of tinnitus and lack of well-adapted prognostic factors for treatment selection highlight a potential role for a decision support system (DSS). A DSS is an informative system, based on big data that aims to facilitate decision-making based on: specific rules, retrospective data reflecting results, patient profiling and predictive models. Therefore, it can use algorithms evaluating numerous parameters and indicate the weight of their contribution to the final outcome. This means that DSS can provide additional information, exceeding the typical questions of superiority of one treatment versus another, commonly addressed in literature.The development of a DSS for tinnitus treatment selection will make use of an underlying database consisting of medical, epidemiological, audiological, electrophysiological, genetic and tinnitus subtyping data. Algorithms will be developed with the use of machine learning and data mining techniques. Based on the profile features identified as prognostic these algorithms will be able to suggest whether additional examinations are needed for a robust result as well as which treatment or combination of treatments is optimal for every patient in a personalized level.In this manuscript we carefully define the conceptual basis for a tinnitus treatment selection DSS. We describe the big data set and the knowledge base on which the DSS will be based and the algorithms that will be used for prognosis and treatment selection.

Corona Health-A Study- and Sensor-Based Mobile App Platform Exploring Aspects of the COVID-19 Pandemic.

Physical and mental well-being during the COVID-19 pandemic is typically assessed via surveys, which might make it difficult to conduct longitudinal studies and might lead to data suffering from recall bias. Ecological momentary assessment (EMA) driven smartphone apps can help alleviate such issues, allowing for in situ recordings. Implementing such an app is not trivial, necessitates strict regulatory and legal requirements, and requires short development cycles to appropriately react to abrupt changes in the pandemic. Based on an existing app framework, we developed Corona Health, an app that serves as a platform for deploying questionnaire-based studies in combination with recordings of mobile sensors. In this paper, we present the technical details of Corona Health and provide first insights into the collected data. Through collaborative efforts from experts from public health, medicine, psychology, and computer science, we released Corona Health publicly on Google Play and the Apple App Store (in July 2020) in eight languages and attracted 7290 installations so far. Currently, five studies related to physical and mental well-being are deployed and 17,241 questionnaires have been filled out. Corona Health proves to be a viable tool for conducting research related to the COVID-19 pandemic and can serve as a blueprint for future EMA-based studies. The data we collected will substantially improve our knowledge on mental and physical health states, traits and trajectories as well as its risk and protective factors over the course of the COVID-19 pandemic and its diverse prevention measures.

Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI.

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.

Flt-1, but not Flk-1 mediates hyperpermeability through activation of the PI3-K/Akt pathway.

Vascular endothelial growth factor (VEGF), a potent mediator of endothelial proliferation and migration, has an important role also in brain edema formation during hypoxia and ischemia. VEGF binds to the tyrosine kinase receptors Flt-1 and Flk-1. Yet, their relative importance for hypoxia-induced hyperpermeability is not well understood. We used an in vitro blood-brain barrier (BBB) model consisting of porcine brain microvascular endothelial cells (BMEC) to determine the role of Flt-1 in VEGF-induced endothelial cell (EC) barrier dysfunction. Soluble Flt-1 abolished hypoxia/VEGF-induced hyperpermeability. Furthermore, selective antisense oligonucleotides to Flt-1, but not to Flk-1, inhibited hypoxia-induced permeability changes. Consistent with these data, addition of the receptor-specific homolog placenta-derived growth factor, which binds Flt-1 but not Flk-1, increased endothelial permeability to the same extent as VEGF, whereas adding VEGF-E, a viral VEGF molecule from the orf virus family activating Flk-1 and neuropilin-1, but not Flt-1, did not show any effect. Using the carcinoma submandibular gland cell line (CSG), only expressing Flt-1, it was demonstrated that activation of Flt-1 is sufficient to induce hyperpermeability by hypoxia and VEGF. Hyperpermeability, induced by hypoxia/VEGF, depends on activation of phosphatidylinositol 3-kinase/Akt (PI3-K/Akt), nitric oxide synthase (NOS) and protein kinase G (PKG). The activation of the PI3-K/Akt pathway by hypoxia was confirmed using an in vivo mice hypoxia model. These results demonstrate that hypoxia/VEGF-induced hyperpermeability can be mediated by activation of Flt-1 independently on the presence of Flk-1 and indicate a central role for activation of the PI3-K/Akt pathway, followed by induction of NOS and PKG activity.