Ultrafast Brain MRI with Deep Learning Reconstruction for Suspected Acute Ischemic Stroke.

Background Deep learning (DL)-accelerated MRI can substantially reduce examination times. However, studies prospectively evaluating the diagnostic performance of DL-accelerated MRI reconstructions in acute suspected stroke are lacking. Purpose To investigate the interchangeability of DL-accelerated MRI with conventional MRI in patients with suspected acute ischemic stroke at 1.5 T. Materials and Methods In this prospective study, 211 participants with suspected acute stroke underwent clinically indicated MRI at 1.5 T between June 2022 and March 2023. For each participant, conventional MRI (including T1-weighted, T2-weighted, T2*-weighted, T2 fluid-attenuated inversion-recovery, and diffusion-weighted imaging; 14 minutes 18 seconds) and DL-accelerated MRI (same sequences; 3 minutes 4 seconds) were performed. The primary end point was the interchangeability between conventional and DL-accelerated MRI for acute ischemic infarction detection. Secondary end points were interchangeability regarding the affected vascular territory and clinically relevant secondary findings (eg, microbleeds, neoplasm). Three readers evaluated the overall occurrence of acute ischemic stroke, affected vascular territory, clinically relevant secondary findings, overall image quality, and diagnostic confidence. For acute ischemic lesions, size and signal intensities were assessed. The margin for interchangeability was chosen as 5%. For interrater agreement analysis and interrater reliability analysis, multirater Fleiss κ and the intraclass correlation coefficient, respectively, was determined. Results The study sample consisted of 211 participants (mean age, 65 years ± 16 [SD]); 123 male and 88 female). Acute ischemic stroke was confirmed in 79 participants. Interchangeability was demonstrated for all primary and secondary end points. No individual equivalence indexes (IEIs) exceeded the interchangeability margin of 5% (IEI, -0.002 [90% CI: -0.007, 0.004]). Almost perfect interrater agreement was observed (P > .91). DL-accelerated MRI provided higher overall image quality (P < .001) and diagnostic confidence (P < .001). The signal properties of acute ischemic infarctions were similar in both techniques and demonstrated good to excellent interrater reliability (intraclass correlation coefficient, ≥0.8). Conclusion Despite being four times faster, DL-accelerated brain MRI was interchangeable with conventional MRI for acute ischemic lesion detection. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Haller in this issue.

Age standardization and time-of-day performance for the Oldenburg Sentence Test (OLSA): results from the population-based Gutenberg Health Study.

PURPOSE: The Oldenburg Sentence Test (OLSA) is a German matrix test designed to determine speech recognition thresholds (SRT). It is widely used for hearing-aids and cochlear implant fitting, but an age-adjusted standard is still lacking. In addition, knowing that the ability to concentrate is an important factor in OLSA performance, we hypothesized that OLSA performance would depend on the time of day it was administered. The aim of this study was to propose an age standardization for the OLSA and to determine its diurnal performance. METHODS: The Gutenberg Health Study is an ongoing population-based study and designed as a single-centre observational, prospective cohort study. Participants were interviewed about common otologic symptoms and tested with pure-tone audiometry and OLSA. Two groups-subjects with and without hearing loss-were established. The OLSA was performed in two runs. The SRT was evaluated for each participant. Results were characterized by age in 5-year cohorts, gender and speech recognition threshold (SRT). A time stamp with an hourly interval was also implemented. RESULTS: The mean OLSA SRT was - 6.9 ± 1.0 dB (group 1 male) and - 7.1 ± 0.8 dB (group 1 female) showing an inverse relationship with age in the whole cohort, whereas a linear increase was observed in those without hearing loss. OLSA-SRT values increased more in males than in females with increasing age. No statistical significance was found for the diurnal performance. CONCLUSIONS: A study with 2900 evaluable Oldenburg Sentence Tests is a novelty and representative for the population of Mainz and its surroundings. We postulate an age- and gender-standardized scale for the evaluation of the OLSA. In fact, with an intergroup standard deviation (of about 1.5 dB) compared to the age dependence of 0.7 dB/10 years, this age normalization should be considered as clinically relevant.

Does an instructional video as a stand-alone tool promote the acquisition of practical clinical skills? A randomised simulation research trial of skills acquisition and short-term retention.

BACKGROUND: The effectiveness of instructional videos as a stand-alone tool for the acquisition of practical skills is yet unknown because instructional videos are usually didactically embedded. Therefore, we evaluated the acquisition of the skill of a humeral intraosseous access via video in comparison to that of a self-study with an additional retention test. METHODS: After ethical approval, we conducted two consecutive studies. Both were designed as randomised controlled two-armed trials with last-year medical students as independent samples at our institutional simulation centre of a tertiary university hospital centre. In Study 1, we randomly assigned 78 participants to two groups: Vid-Self participants watched an instructional video as an intervention, followed by a test, and after seven days did a self-study as a control, followed by a test. Self-Vid ran through the trial in reverse order. In Study 2, we investigated the influence of the sequence of the two teaching methods on learning success in a new sample of 60 participants: Vid-Self watched an instructional video and directly afterward did the self-study followed by a test, whereas Self-Vid ran through that trial in reverse order. In Studies 1 and 2, the primary outcome was the score (worst score = 0, best score = 20) of the test after intervention and control. The secondary outcome in Study 1 was the change in score after seven days. RESULTS: Study 1: The Vid-Self (Participants n = 42) was superior to the Self-Vid (n = 36) (mean score 14.8 vs. 7.7, p < 0.001). After seven days, Self-vid outperformed Vid-Self (mean score 15.9 vs. 12.5, p < 0.001). Study 2: The Vid-Self (n = 30) and Self-Vid (n = 30) scores did not significantly differ (mean 16.5 vs. mean 16.5, p = 0.97). CONCLUSION: An instructional video as a stand-alone tool effectively promotes the acquisition of practical skills. The best results are yielded by a combination of an instructional video and self-study right after each other, irrespective of sequence. TRIAL REGISTRATIONS: ClinicalTrials.gov: NCT05066204 (13/04/2021) (Study 1) and NCT04842357 (04/10/2021) (Study 2).

Sparse Group Penalties for bi-level variable selection.

Many data sets exhibit a natural group structure due to contextual similarities or high correlations of variables, such as lipid markers that are interrelated based on biochemical principles. Knowledge of such groupings can be used through bi-level selection methods to identify relevant feature groups and highlight their predictive members. One of the best known approaches of this kind combines the classical Least Absolute Shrinkage and Selection Operator (LASSO) with the Group LASSO, resulting in the Sparse Group LASSO. We propose the Sparse Group Penalty (SGP) framework, which allows for a flexible combination of different SGL-style shrinkage conditions. Analogous to SGL, we investigated the combination of the Smoothly Clipped Absolute Deviation (SCAD), the Minimax Concave Penalty (MCP) and the Exponential Penalty (EP) with their group versions, resulting in the Sparse Group SCAD, the Sparse Group MCP, and the novel Sparse Group EP (SGE). Those shrinkage operators provide refined control of the effect of group formation on the selection process through a tuning parameter. In simulation studies, SGPs were compared with other bi-level selection methods (Group Bridge, composite MCP, and Group Exponential LASSO) for variable and group selection evaluated with the Matthews correlation coefficient. We demonstrated the advantages of the new SGE in identifying parsimonious models, but also identified scenarios that highlight the limitations of the approach. The performance of the techniques was further investigated in a real-world use case for the selection of regulated lipids in a randomized clinical trial.

Interpretability of bi-level variable selection methods.

Variable selection is usually performed to increase interpretability, as sparser models are easier to understand than full models. However, a focus on sparsity is not always suitable, for example, when features are related due to contextual similarities or high correlations. Here, it may be more appropriate to identify groups and their predictive members, a task that can be accomplished with bi-level selection procedures. To investigate whether such techniques lead to increased interpretability, group exponential LASSO (GEL), sparse group LASSO (SGL), composite minimax concave penalty (cMCP), and least absolute shrinkage, and selection operator (LASSO) as reference methods were used to select predictors in time-to-event, regression, and classification tasks in bootstrap samples from a cohort of 1001 patients. Different groupings based on prior knowledge, correlation structure, and random assignment were compared in terms of selection relevance, group consistency, and collinearity tolerance. The results show that bi-level selection methods are superior to LASSO in all criteria. The cMCP demonstrated superiority in selection relevance, while SGL was convincing in group consistency. An all-round capacity was achieved by GEL: the approach jointly selected correlated and content-related predictors while maintaining high selection relevance. This method seems recommendable when variables are grouped, and interpretation is of primary interest.

Clinical parameters and inflammatory biomarkers among patients with multibracket appliances: a prospective clinical trial.

BACKGROUND: Aim of the presented study was to investigate changes in clinical parameters and active matrix metalloproteinase-8 (aMMP-8) levels in gingival crevicular fluid of patients before and during treatment with multibrackets appliances. METHODS: Fifty-five adolescents scheduled for the treatment were included. Clinical parameters and subgingival samples were obtained at six time points: 1 week before appliance insertion (T0), 3 (T1), 6 (T2) weeks, 3 (T3), 6 (T4) months, and 1 year (T5) after that. Gingival index and plaque index were assessed to evaluated changes on the clinical status. Subgingival samples were collected to analyze changes in aMMP-8. RESULTS: Scores for gingival and plaque index increased after bracket insertion. The gingival index increased from T2 (p < 0.05) until T5 (p < 0.0001). Plaque index also increased, reaching its maximum peak at T3 (p < 0.05). Moreover, an increase of aMMP-8 levels (p < 0.05) was noted. There was no significant between upper and lower jaws. CONCLUSIONS: Treatment with multibracket appliances in adolescents favors dental plaque accumulation and may transitionally increase gingival and plaque index and aMMP-8 levels leading to gingival inflammation, even 1 year after therapy began. TRIAL REGISTRATION: This study was approved by the Ethics Committee of the dental medical association Rheiland-Pfalz, Germany (process no. 837.340.12 (8441-F)), and followed the guidelines of Good Clinical Practices.

Orthodontists' instructions for oral hygiene in patients with removable and fixed orthodontic appliances.

INTRODUCTION: The aim of this questionnaire-based survey was to evaluate information on frequencies, instructions and products relating to oral hygiene (OH) in orthodontic practices. METHODS: Using a computer-generated randomization list, 1000 orthodontists were selected and sent a questionnaire. The size and number of inhabitants of the federal states of Germany were considered. The federal states with the highest return rate (Baden-Wuerttemberg [BW], Bavaria [B], Hesse [H], Lower Saxony [LS], Nordrhein-Westphalia [NRW]) were considered and differences between the 16 federal states were divided into North, South, East and Central Germany. RESULTS: The response rate of the questionnaires was 52.4%. The majority (53.8%) worked in one practice alone. Most (59.1%) have been orthodontists for 5-25 years. For vestibular multibracket appliances (MBA) in BW, B, H and LS over 90% recommended interdental brushes (IDB). In NRW 91.4% recommend fluoride gel. In B and H more than 80% chose electric toothbrush (ETB), in BW, LS and NRW more than 80% manual toothbrush (MTB). For lingual MBA (LMBA) in BW, H, LS and NRW with approximately 50% each fluoride gel, IDB and MTB were chosen. In B fluoride gel, IDB and ETB. For removable apparatus (RA), five federal states recommended MTB (>80%) and ETB (BW, B, H > 80%; NRW > 70%; LS > 60%). CONCLUSION: Electric toothbrushes are recommended for the use with all appliances, only with removable appliances manual toothbrushes are favoured. For vestibular MBA it is strongly advised to use IDB additionally.

Thyroid surgery in children and adolescents: results from a multi-institutional German and Austrian database.

BACKGROUND: Outcomes of paediatric thyroid surgery have only been reported in smaller series or over long intervals. The aim of this multicentre study was to describe the recent outcomes of paediatric thyroid surgery in Germany and Austria. METHODS: Patients aged less than or equal to 18 years who underwent thyroid surgery and were prospectively documented in the StuDoQ|Thyroid registry between March 2017 and August 2022 were studied. RESULTS: In total, 604 patients from 90 institutions were included. The mean age was 15.4 years and 75 per cent of patients were female. The most frequent benign pathologies were nodular goitre (35.6 per cent), follicular adenoma (30.1 per cent), and Graves' disease (28.5 per cent). Among 126 thyroid malignancies, papillary thyroid carcinoma was diagnosed in 77.8 per cent of patients, follicular thyroid carcinoma was diagnosed in 10.3 per cent of patients, and medullary thyroid carcinoma was diagnosed in 8.7 per cent of patients. Lymph node metastases were found in 45.9 per cent of patients with papillary thyroid carcinoma and in 36.4 per cent of patients with medullary thyroid carcinoma. Vascular invasion was found in 62.9 per cent of patients with follicular thyroid carcinoma. The mean tumour diameters were 18, 42, and 13 mm in patients with papillary thyroid carcinoma, follicular thyroid carcinoma, and medullary thyroid carcinoma respectively. Early postoperative recurrent laryngeal nerve injury was seen in 27 of 556 patients (4.9 per cent) (22 of 617 (3.6 per cent) nerves at risk with intermittent intraoperative nerve monitoring and 5 of 237 (2.1 per cent) nerves at risk with continuous intraoperative nerve monitoring). Persistent recurrent laryngeal nerve injury was documented in 4 of 556 patients (0.7 per cent). Early postoperative hypoparathyroidism correlated with Graves' disease, thyroid carcinoma, and lymph node dissection. CONCLUSION: Papillary thyroid carcinoma and follicular thyroid carcinoma in children were often advanced at presentation. Persistent or recurrent lymph node metastases were mainly seen in papillary thyroid carcinoma. Overall survival was excellent, but longer follow-up is needed.

A systematic review and evaluation of statistical methods for group variable selection.

This review condenses the knowledge on variable selection methods implemented in R and appropriate for datasets with grouped features. The focus is on regularized regressions identified through a systematic review of the literature, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 14 methods are discussed, most of which use penalty terms to perform group variable selection. Depending on how the methods account for the group structure, they can be classified into knowledge and data-driven approaches. The first encompass group-level and bi-level selection methods, while two-step approaches and collinearity-tolerant methods constitute the second category. The identified methods are briefly explained and their performance compared in a simulation study. This comparison demonstrated that group-level selection methods, such as the group minimax concave penalty, are superior to other methods in selecting relevant variable groups but are inferior in identifying important individual variables in scenarios where not all variables in the groups are predictive. This can be better achieved by bi-level selection methods such as group bridge. Two-step and collinearity-tolerant approaches such as elastic net and ordered homogeneity pursuit least absolute shrinkage and selection operator are inferior to knowledge-driven methods but provide results without requiring prior knowledge. Possible applications in proteomics are considered, leading to suggestions on which method to use depending on existing prior knowledge and research question.

Much higher prevalence of keratoconus than announced results of the Gutenberg Health Study (GHS).

Keratoconus appears to be a rare corneal disease with a prevalence previously estimated at 1:2000. The aim of our study was to investigate the prevalence of keratoconus in a large German cohort and to evaluate possible associated factors. METHOD: In the population-based, prospective, monocentric cohort study, Gutenberg Health Study, 12,423 subjects aged 40-80 years were examined at the 5-year follow-up. Subjects underwent a detailed medical history and a general and ophthalmologic examination including Scheimpflug imaging. Keratoconus diagnosis was performed in two steps: all subjects with conspicuous TKC analysis of corneal tomography were included in further grading. Prevalence and 95% confidence intervals were calculated. Logistic regression analysis was carried out to investigate association with age, sex, BMI, thyroid hormone, smoking, diabetes, arterial hypertension, atopy, allergy, steroid use, sleep apnea, asthma, and depression. RESULTS: Of 10,419 subjects, 75 eyes of 51 subjects were classified as having keratoconus. The prevalence for keratoconus in the German cohort was 0.49% (1:204; 95% CI: 0.36-0.64%) and was approximately equally distributed across the age decades. No gender predisposition could be demonstrated. Logistic regression showed no association between keratoconus and age, sex, BMI, thyroid hormone, smoking, diabetes, arterial hypertension, atopy, allergy, steroid use, sleep apnea, asthma, and depression in our sample. CONCLUSION: The prevalence of keratoconus disease in a mainly Caucasian population is approximately tenfold higher than previously reported in the literature using latest technologies (Scheimpflug imaging). Contrary to previous assumptions, we did not find associations with sex, existing atopy, thyroid dysfunction, diabetes, smoking, and depression.

Association of autoantibody levels with different stages of age-related macular degeneration (AMD): Results from the population-based Gutenberg Health Study (GHS).

PURPOSE: Anti-retinal autoantibodies are assumed to be associated with age-related macular degeneration (AMD). To our knowledge, this is the first evaluation of autoantibodies in human sera of participants with different stages of AMD in a large population-based, observational cohort study in Germany. METHODS: The Gutenberg Health Study (GHS) is a population-based, observational cohort study in Germany, including 15,010 participants aged between 35 and 74. Amongst others, non-mydriatic fundus photography (Visucam PRO NM™, Carl Zeiss Meditec AG, Jena, Germany) was performed. Fundus images of the first 5000 participants were graded based on the Rotterdam Eye Study classification. Sera of participants with AMD (n=541) and sera of age-matched participants without AMD (n=490) were analyzed by antigen-microarrays. Besides descriptive statistics, autoantibody-levels were compared by Mann-Whitney-U test and the associations of level of autoantibodies with AMD were calculated by logistic regression analysis. Likewise, possible associations of the autoantibodies and both clinical and laboratory parameters on AMD subjects were analyzed. RESULTS: Autoantibodies against transferrin (p<0.001) were significantly downregulated in participants with early AMD and soft, distinct drusen (≥63 µm) or pigmentary abnormalities only compared to Controls. Mitogen-activated protein kinase 3 (p=0.041), glutathione peroxidase 4 (p=0.048), clusterin (p=0.045), lysozyme (p=0.19), protein kinase C substrate 80K-H (p=0.02), heat shock 70 kDa protein 1A (p=0.04) and insulin (p=0.018) show a trend between Control and participants with early AMD and soft, distinct drusen (≥63 µm) or pigmentary abnormalities only. CONCLUSIONS: This study contributes to a growing knowledge of autoantibodies in association with different AMD stages compared to controls in the context of a large population-based study in Germany. Especially autoantibodies against inflammatory proteins were downregulated in participants with early AMD and soft, distinct drusen (≥63 µm) or pigmentary abnormalities only.

Non-invasive assessment of Pulse Wave Transit Time (PWTT) is a poor predictor for intraoperative fluid responsiveness: a prospective observational trial (best-PWTT study).

BACKGROUND: Aim of this study is to test the predictive value of Pulse Wave Transit Time (PWTT) for fluid responsiveness in comparison to the established fluid responsiveness parameters pulse pressure (ΔPP) and corrected flow time (FTc) during major abdominal surgery. METHODS: Forty patients undergoing major abdominal surgery were enrolled with continuous monitoring of PWTT (LifeScope® Modell J BSM-9101 Nihon Kohden Europe GmbH, Rosbach, Germany) and stroke volume (Esophageal Doppler Monitoring CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia (difference in pulse pressure [∆PP] ≥ 9%, corrected flow time [FTc] ≤ 350 ms) a fluid bolus of 7 ml/kg ideal body weight was administered. Receiver operating characteristics (ROC) curves and corresponding areas under the curve (AUCs) were used to compare different methods of determining PWTT. A Wilcoxon test was used to discriminate fluid responders (increase in stroke volume of ≥ 10%) from non-responders. The predictive value of PWTT for fluid responsiveness was compared by testing for differences between ROC curves of PWTT, ΔPP and FTc using the methods by DeLong. RESULTS: AUCs (area under the ROC-curve) to predict fluid responsiveness for PWTT-parameters were 0.61 (raw c finger Q), 0.61 (raw c finger R), 0.57 (raw c ear Q), 0.53 (raw c ear R), 0.54 (raw non-c finger Q), 0.52 (raw non-c finger R), 0.50 (raw non-c ear Q), 0.55 (raw non-c ear R), 0.63 (∆ c finger Q), 0.61 (∆ c finger R), 0.64 (∆ c ear Q), 0.66 (∆ c ear R), 0.59 (∆ non-c finger Q), 0.57 (∆ non-c finger R), 0.57 (∆ non-c ear Q), 0.61 (∆ non-c ear R) [raw measurements vs. ∆ = respiratory variation; c = corrected measurements according to Bazett's formula vs. non-c = uncorrected measurements; Q vs. R = start of PWTT-measurements with Q- or R-wave in ECG; finger vs. ear = pulse oximetry probe location]. Hence, the highest AUC to predict fluid responsiveness by PWTT was achieved by calculating its respiratory variation (∆PWTT), with a pulse oximeter attached to the earlobe, using the R-wave in ECG, and correction by Bazett's formula (AUC best-PWTT 0.66, 95% CI 0.54-0.79). ∆PWTT was sufficient to discriminate fluid responders from non-responders (p = 0.029). No difference in predicting fluid responsiveness was found between best-PWTT and ∆PP (AUC 0.65, 95% CI 0.51-0.79; p = 0.88), or best-PWTT and FTc (AUC 0.62, 95% CI 0.49-0.75; p = 0.68). CONCLUSION: ΔPWTT shows poor ability to predict fluid responsiveness intraoperatively. Moreover, established alternatives ΔPP and FTc did not perform better. TRIAL REGISTRATION: Prior to enrolement on clinicaltrials.gov (NC T03280953; date of registration 13/09/2017).

Early warning for SpO2 decrease by the oxygen reserve index in neonates and small infants.

INTRODUCTION: Continuously assessing the oxygenation levels of patients to detect and prevent hypoxemia can be advantageous for safe anesthesia, especially in neonates and small infants. The oxygen reserve index (ORI) is a new parameter that can assess oxygenation through a relationship with arterial oxygen partial pressure (PaO2 ). The aim of this study was to examine whether the ORI provides a clinically relevant warning time for an impending SpO2 (pulse oximetry hemoglobin saturation) reduction in neonates and small infants. METHODS: ORI and SpO2 were measured continuously in infants aged <2 years during general anesthesia. The warning time and sensitivity of different ORI alarms for detecting impending SpO2 decrease were calculated. Subsequently, the agreement of the ORI and PaO2 with blood gas analyses was assessed. RESULTS: The ORI of 100 small infants and neonates with a median age of 9 months (min-max, 0-21 months) and weight of 8.35 kg (min-max, 2-13 kg) were measured. For the ORI/PaO2 correlation, 54 blood gas analyses were performed. The warning time and sensitivity of the preset ORI alarm during the entire duration of anesthesia were 84 s (25th-75th percentile, 56-102 s) and 55% (95% CI 52%-58%), and those during anesthesia induction were 63 s (40-82 s) and 56% (44%-68%), respectively. The positive predictive value of the preset ORI alarm were 18% (95% CI 17%-20%; entire duration of anesthesia) and 27% (95% CI 21%-35%; during anesthesia induction). The agreement of PaO2 intervals with the ORI intervals was poor, with a kappa of 0.00 (95% CI = [-0.18; 0.18]). The weight (p = .0129) and height (p = .0376) of the infants and neonates were correlated to the correct classification of the PaO2 interval with the ORI interval. CONCLUSIONS: The ORI provided an early warning time for detecting an impending SpO2 decrease in small infants and neonates in the defined interval in this study. However, the sensitivity of ORI to forewarn a SpO2 decrease and the agreement of the ORI with PaO2 intervals in this real-life scenario were too poor to recommend the ORI as a useful early warning indicator for this age group.

Project DECIDE, part II: decision-making places for people with dementia in Alzheimer's disease: supporting advance decision-making by improving person-environment fit.

BACKGROUND: The UN Convention on the Rights of Persons with Disabilities, and the reformed guardianship law in Germany, require that persons with a disability, including people with dementia in Alzheimer's disease (PwAD), are supported in making self-determined decisions. This support is achieved through communication. While content-related communication is a deficit of PwAD, relational aspects of communication are a resource. Research in supported decision-making (SDM) has investigated the effectiveness of different content-related support strategies for PwAD but has only succeeded in improving understanding, which, although one criterion of capacity to consent, is not sufficient to ensure overall capacity to consent. The aim of the 'spatial intervention study' of the DECIDE project is to examine an innovative resource-oriented SDM approach that focuses on relational aspects. We hypothesise that talking to PwAD in their familiar home setting (as opposed to a clinical setting) will reduce the complexity of the decision-making process and enhance overall capacity to consent. METHODS: People with a suspected or confirmed diagnosis of dementia in Alzheimer's disease will be recruited from two memory clinics (N = 80). We will use a randomised crossover design to investigate the intervention effect of the decision-making place on capacity to consent. Besides reasoning capacity, which is part of overall capacity to consent and will be the primary outcome, various secondary outcomes (e.g., other aspects of capacity to consent, subjective task complexity, decisional conflict) and suspected moderating or mediating variables (e.g., meaning of home, demographic characteristics) will be assessed. DISCUSSION: The results of the study will be used to develop a new SDM strategy that is based on relational resources for PwAD. If a change in location achieves the anticipated improvement in capacity to consent, future research should focus on implementing this SDM strategy in a cost-effective manner in clinical practice. TRIAL REGISTRATION: DRKS00030799 .

Action competence in obstetric emergencies-can this be achieved via e-learning? Interprofessional blended learning module on diagnostics and emergency treatment of shoulder dystocia.

BACKGROUND: Due to the rarity of shoulder dystocia, an obstetric emergency, it is difficult even for experts to develop the appropriate routine in this emergency. Regular further training is therefore recommended for obstetricians and midwives. Evidence is lacking on the extent to which e-learning as a teaching method can be successfully used to acquire these skills and put them into practice. The purpose of this study is to demonstrate how the learning objectives for shoulder dystocia, listed in the National Competence Based Learning Objectives Catalog for Medicine (NKLM, Germany) can be successfully taught in medical studies using a blended learning concept (e-learning and practical application on a birth simulator). METHODS: After completing an e-learning course, final year medical students and midwife trainees demonstrated their action competence for shoulder dystocia procedure on a birth simulator. This transfer of the theoretical knowledge to the case study was assessed using an evaluation form oriented to the recommendations for action. RESULTS: One hundred sixty medical students and 14 midwifery trainees participated in the study from April to July 2019. Overall, 95.9% of the study participants met the required standards, i.e. achieved very good to adequate performance (Ø good) in simulation training. CONCLUSIONS: E-learning with annotated high-quality learning videos is an excellent way to transfer theoretical knowledge about shoulder dystocia procedures into medical practice on a birth simulator. The learning objectives required by the NKLM for shoulder dystocia can be successfully conveyed to students via the applied blended learning concept.

Aligner therapy in adolescents: first-year results on the impact of therapy on oral health-related quality of life and oral hygiene.

OBJECTIVES: The aim of this multicenter clinical study was to examine the oral health-related quality of life and oral hygiene in adolescents before and during aligner therapy. MATERIALS AND METHODS: Forty subjects (18 ♀, 22 ♂; mean age: 13.6 years) scheduled for aligner therapy (Invisalign® Teen) were given oral health-related quality of life questionnaires, Oral Health Impact Profile (OHIP-G14) and Psychosocial Impact of Dental Aesthetic Questionnaire (PIDAQ), to complete within their treatment (visit 1: 0 start of therapy; visit 2: 0 + 4 weeks; visit 3: 0 + 10 weeks; visit 4: 0 + 6 months; visit 5: 0 + 1 year). To assess oral hygiene, a questionnaire to take home was used, and plaque level was evaluated with the Quigley-Hein Plaque Index (TMQH) modified by Turesky et al. RESULTS: The OHIP-G14 mean score before aligner therapy was 3.3 ± 3.2, and 4.9 ± 5.4 after 1 year. The PIDAQ showed a positive psychological change in the well-being, as well as a more effective at-home oral hygiene regime. On average, the TMQH remained at a low level (grade 2 of 0-5). The initial insertion of the aligners caused the most significant changes in all parameters (except TMQH). CONCLUSION: Oral health-related quality of life is only slightly affected during the first year of aligner therapy in adolescents. Oral hygiene at home is intensified and there is no increased dental plaque accumulation. CLINICAL RELEVANCE: Dentofacial esthetics is a subset of the so-called Oral H-Related Quality of Life (OHRQoL) which should be considered more during orthodontic therapy.

Randomized multicenter study on the plaque removal efficacy of 2 interdental brushes around the base of orthodontic brackets.

INTRODUCTION: The objective of this multicenter study was to analyze the efficacy of cleaning 2 interdental brushes (IDBs) around brackets in patients with fixed orthodontic appliances. METHODS: The study design was a multicenter, randomized, examiner-blinded crossover study with 3 interventions, the first of which was a baseline intervention. This study included 20 patients (12 females, 8 males) aged 12-18 years with fixed orthodontic devices examined at the Department of Orthodontics, University Medical Center of the Johannes Gutenberg University Mainz, and the Children's Dental Clinic St. Gallen. The outcome was a conventional, cylindrically shaped IDB (IDBG-S [IB]; Top Caredent GmbH, Schönau, Germany) was examined in comparison with an innovative waist-shaped IDB (Circum, CDB-8 [CB]; Top Caredent GmbH). The participants did not use the IDB themselves. The brushing procedure was performed professionally by 1 operator (C.E.). Each buccal tooth surface with a bracket was split into 8 areas, the main areas being 1 and 8. These main areas, which were difficult for toothbrushes to reach, were mesial (area 1) and distal (area 8) of the bracket edges in the gingival direction. Plaque index (PI) scores were assessed at 2 examinations before and after the cleaning procedure on 8 tooth surfaces in the area with orthodontic brackets. A computer-generated program randomly allocated the IDB sequence to the participants. Examiners (L.Z.-G. and Y.W.) assessing the outcomes were blinded to the intervention and the randomized allocation of participants to the different IDBs. RESULTS: Both IDBs showed a plaque removal effect (CB, 0.68 [interquartile range, 0.63-0.77]; IB, 0.43 [interquartile range, 0.33-0.55]). The difference between the 2 IDB was statistically significant (P = 0.002). In particular, the CB yielded a higher plaque removal efficacy (CB effect, 0.68; IB effect, 0.21) at the main areas 1 and 8, which were difficult to reach. Ten participants were randomized to each sequence, and all 20 completed the study. No side effects or adverse events were reported or observed. CONCLUSION: The waist-shaped brush head of the CB significantly enhanced plaque reduction in total and particularly in problem areas. REGISTRATION: This trial was registered at the German Clinical Trials Registry (no. DRKS00014088; https://www.drks.de/drks_web/navigate.xxdo?navigationId=trial.HTML&TRIAL_ID=DRKS00014088) PROTOCOL: The protocol was not published before trial commencement. FUNDING: This study was supported by the manufacturer Top Caredent GmbH, Schönau, Germany, which provided all interdental brushes used in this study.

Influence of cold atmospheric-pressure-plasma in combination with different pretreatment methods on the pull-off tensile load in two-piece abutment-crowns: an in-vitro study.

BACKGROUND: In implant prosthetic dentistry, the adhesive connection of individualized ceramic crowns and prefabricated titanium bases leads to several benefits. However, the durability of the bonding could be a weak point and especially depends on sufficient surface pretreatment. Cold atmospheric-pressure plasma (CAP) is a pretreatment method that should improve the surface properties without physical damage. Thus, the purpose of this study was to investigate the influence of CAP treatment on pull-off tensile load in two-piece abutment crowns. METHODS: Eighty zirconia crowns and titanium bases were divided into eight groups (n = 10) according to their surface pretreatment prior to cementation with Panavia V5: no treatment (A); sandblasting (B); 10-MDP primer (C); sandblasting and primer (D); CAP (AP); sandblasting and CAP (BP); CAP and primer (CP); sandblasting, CAP and primer (DP). The specimens were thermocycled (5°/55°, 5000 cycles), and then the pull-off tensile load (TL) was measured. Statistical analyses were performed using three-way ANOVA with Tukey post-hoc and Fisher's exact tests. RESULTS: The results showed that the TL was highest in group D (p < 0.0001). Some combinations of different treatments led to effects that were greater than the sum of the individual effects. These effects were modified by interactions. Only in combination with primer, CAP treatment had a small but positive significant effect (group CP vs. C and CP vs. AP, p < 0.0001) which however did not come close to the strong interaction effect that resulted from the combination of sandblasting and primer. CONCLUSION: Within the limitations of this study, CAP treatment cannot be recommended in this specific field of indication due to its unreliable influence on TL in combination with other pretreatment methods.

Tinnitus Prevalence in the Adult Population-Results from the Gutenberg Health Study.

Background and Objectives: Tinnitus is a common symptom in medical practice, although data on its prevalence vary. As the underlying pathophysiological mechanism is still not fully understood, hearing loss is thought to be an important risk factor for the occurrence of tinnitus. The aim of this study was to assess tinnitus prevalence in a large German cohort and to determine its dependence on hearing impairment. Materials and Methods: The Gutenberg Health Study (GHS) is a population-based cohort study and representative for the population of Mainz and its district. Participants were asked whether they suffer from tinnitus and how much they are burdened by it. Extensive audiological examinations using bone- and air-conduction were also performed. Results: 4942 participants (mean age: 61.0, 2550 men and 2392 women) were included in the study. The overall prevalence of tinnitus was 26.1%. Men were affected significantly more often than women. The prevalence of tinnitus increased with age, peaking at ages 75 to 79 years. Considering only annoying tinnitus, the prevalence was 9.8%. Logistic regression showed that participants with severe to complete hearing loss (>65 dB) were more likely to have tinnitus. Conclusions: Tinnitus is a common symptom, and given demographic changes, its prevalence is expected to increase.

Survival after secondary liver resection in metastatic colorectal cancer: Comparing data of three prospective randomized European trials (LICC, CELIM, FIRE-3).

Metastatic colorectal cancer (mCRC) patients with liver-limited disease (LLD) have a chance of long-term survival and potential cure after hepatic metastasectomy. However, the appropriate postoperative treatment strategy is still controversial. The CELIM and FIRE-3 studies demonstrated that secondary hepatic resection significantly improved overall survival (OS). The objective of this analysis was to compare these favorable outcome data with recent results from the LICC trial investigating the antigen-specific cancer vaccine tecemotide (L-BLP25) as adjuvant therapy in mCRC patients with LLD after R0/R1 resection. Data from mCRC patients with LLD and secondary hepatic resection from each study were analyzed for efficacy outcomes based on patient characteristics, treatment and surveillance after surgery. In LICC, 40/121 (33%) patients, in CELIM 36/111 (32%) and in FIRE-3-LLD 29/133 (22%) patients were secondarily resected, respectively. Of those, 31 (77.5%) patients in LICC and all patients in CELIM were R0 resected. Median disease-free survival after resection was 8.9 months in LICC, 9.9 months in CELIM. Median OS in secondarily resected patients was 66.1 months in LICC, 53.9 months in CELIM and 56.2 months in FIRE-3-LLD. Median age was about 5 years less in LICC compared to CELIM and FIRE-3. Secondarily resected patients of LICC, CELIM and FIRE-3 showed an impressive median survival with a tendency for improved survival for patients in the LICC trial. A younger patient cohort but also more selective surgery, improved resection techniques, deep responses and a close surveillance program after surgery in the LICC trial may have had a positive impact on survival.