Integration of Trusted Third Party Software into an EDC System for Data Protection - Compliant Identity Management, Consent Management and Pseudonymization in Medical Research Studies.

INTRODUCTION: Medical research studies which involve electronic data capture of sensitive data about human subjects need to manage medical and identifying participant data in a secure manner. To protect the identity of data subjects, an independent trusted third party should be responsible for pseudonymization and management of the identifying data. METHODS: We have developed a web-based integrated solution that combines REDCap as an electronic data capture system with the trusted third party software tools of the University Medicine Greifswald, which provides study personnel with a single user interface for both clinical data entry and management of identities, pseudonyms and informed consents. RESULTS: Integration of the two platforms enables a seamless workflow of registering new participants, entering identifying and consent information, and generating pseudonyms in the trusted third party system, with subsequent capturing of medical data in the electronic data capture system, while maintaining strict separation of medical and identifying data in the two independently managed systems. CONCLUSION: Our solution enables a time-efficient data entry workflow, provides a high level of data protection by minimizing visibility of identifying information and pseudonym lists, and avoids errors introduced by manual transfer of pseudonyms between separate systems.

Accessing the free expansion of a crystalline colloidal drop by optical experiments.

We study poly-crystalline spherical drops of an aqueous suspension of highly charged colloidal spheres exposed to a colloid-free aqueous environment. Crystal contours were obtained from standard optical imaging. The crystal spheres first expand to nearly four times their initial volume before slowly shrinking due to dilution-induced melting. Exploiting coherent multiple-scattering by (110) Bragg reflecting crystals, time-dependent density profiles were recorded within the drop interior. These show a continuously flattening radial density gradient and a decreasing central density. Expansion curves and density profiles are qualitatively consistent with theoretical expectations based on dynamical density functional theory for the expansion of a spherical crystallite made of charged Brownian spheres. We anticipate that our study opens novel experimental access to density determination in turbid crystals.

Aesthetic Surgery Fellowship at Akademikliniken Stockholm: Survey among Graduates.

BACKGROUND: Aesthetic Surgery is one of the most competitive fields of plastic surgery. Although there is a certain demand for highly educated surgeons in this field, training in cosmetic procedures remains challenging. Akademikliniken Stockholm offers a highly appreciated fellowship program for aesthetic plastic surgeons and trained more than 200 surgeons from all over the world. OBJECTIVES: The aim of the present work was to provide insights into this fellowship program, analyze what graduates have learned and if this had implications on their further professional orientation. METHODS: Participants of the Akademikliniken fellowship program, who graduated between 10/2008 and 10/2018 (n = 66) were invited to take part in an online survey which included 30 questions about general demographics and about experience before, during and after the fellowship. RESULTS: Thirty-four graduates participated in the survey (52%). Twenty-four graduates (71%) had been already specialists in plastic surgery before commencing the fellowship program. Mean length of fellowship was 7 months (range 3-24months). Numbers of aesthetic procedures performed by the applicants significantly increased after the fellowship, and moreover, the scope of daily clinical practice shifted toward aesthetics in almost all applicants. CONCLUSIONS: A well-designed dedicated aesthetic surgery fellowship can improve the lack of training, aesthetic surgeons have during their residency. Graduates of our fellowship program reported great improvements in confidence in performing aesthetic procedures and a benefit for their future career. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Improvement of Predictive Scores in Burn Medicine through Different Machine Learning Approaches.

The mortality of severely burned patients can be predicted by multiple scores which have been created over the last decades. As the treatment of burn injuries and intensive care management have improved immensely over the last years, former prediction scores seem to be losing accuracy in predicting survival. Therefore, various modifications of existing scores have been established and innovative scores have been introduced. In this study, we used data from the German Burn Registry and analyzed them regarding patient mortality using different methods of machine learning. We used Classification and Regression Trees (CARTs), random forests, XGBoost, and logistic regression regarding predictive features for patient mortality. Analyzing the data of 1401 patients via machine learning, the factors of full-thickness burns, patient's age, and total burned surface area could be identified as the most important features regarding the prediction of patient mortality following burn trauma. Although the different methods identified similar aspects, application of machine learning shows that more data are necessary for a valid analysis. In the future, the usage of machine learning can contribute to the development of an innovative and precise predictive score in burn medicine and even to further interpretations of relevant data regarding different forms of outcome from the German Burn registry.

Evaluation of Different Breast Implant Shapes in the Same Patient: Is There Really a Difference between Round and Anatomical Implants?

Background: The choice of the right implant shape is one of the most frequent debates in cosmetic breast augmentation. In current literature, the question of whether there is a difference in the appearance of different implant shapes is still an argument of highly controversial discussion. The aim of the present work was, therefore, to analyze whether any difference exists in terms of aesthetic outcome between round and anatomical implants, and if they can be distinguished from each other in a like for like swap, making sure the evaluation was made in exactly similar conditions. Methods: Fourteen consecutive patients who underwent aesthetic breast augmentations received primarily an implant of a given volume, projection, and shape (round or anatomical) and then decided to undergo implant replacement to a different shape but maintaining the same volume and projection. At 12-months follow-up, standardized photographs were taken, blinded and randomized. They were evaluated by 10 plastic surgeons and 10 nurses. Results: All 20 observers could distinguish between round and anatomical shape in all 14 cases (100%), which was highly significant (P < 0.0001) for each observer. Conclusions: The present data indicate that there is a clear difference between anatomical and round-shaped implants in terms of aesthetic appearance, when a comparison is properly performed. With the use of both round and anatomical implant shapes, aesthetically appealing results can be achieved in cosmetic breast augmentation. The right implant choice must be made, based on patients' anatomy and desires.

Pharmacological elevation of sphingosine-1-phosphate by S1P lyase inhibition accelerates bone regeneration after post-traumatic osteomyelitis.

Posttraumatic osteomyelitis and the ensuing bone defects are a debilitating complication after open fractures with little therapeutic options. We have recently identified potent osteoanabolic effects of sphingosine-1-phosphate (S1P) signalling and have now tested whether it may beneficially affect bone regeneration after infection. We employed pharmacological S1P lyase inhibition by 4-deoxypyrodoxin (DOP) to raise S1P levels in vivo in an unicortical long bone defect model of posttraumatic osteomyelitis in mice. In a translational approach, human bone specimens of clinical osteomyelitis patients were treated in organ culture in vitro with DOP. Bone regeneration was assessed by µCT, histomorphometry, immunohistology and gene expression analysis. The role of S1P receptors was addressed using S1PR3 deficient mice. Here, we present data that DOP treatment markedly enhanced osteogenesis in posttraumatic osteomyelitis. This was accompanied by greatly improved osteoblastogenesis and enhanced angiogenesis in the callus accompanied by osteoclast-mediated bone remodelling. We also identified the target of increased S1P to be the S1PR3 as S1PR3-/- mice showed no improvement of bone regeneration by DOP. In the human bone explants, bone mass significantly increased along with enhanced osteoblastogenesis and angiogenesis. Our data suggest that enhancement of S1P/S1PR3 signalling may be a promising therapeutic target for bone regeneration in posttraumatic osteomyelitis.

Autologous Reconstruction After Failed Implant-Based Breast Reconstruction: A Comparative Multifactorial Outcome Analysis.

INTRODUCTION: Failure of an implant-based breast reconstruction often requires a change to an autologous procedure (salvage autologous breast reconstruction [Salv-ABR]). The aim of this study was to compare surgical and patient-reported outcomes of Salv-ABR to immediate or delayed-immediate ABR (I/DI-ABR), which has hardly been addressed in the existing literature. METHODS: All patients undergoing Salv- or I/DI-ABR between January 2014 and December 2020 were asked to participate in this study. Complication rates, the aesthetic outcome (5-point Likert scale), and quality of life (EORTC QLQ-C30 and -BR23, Breast-Q, Center for Epidemiology Studies Depression Scale) were compared between both procedures. RESULTS: Seventy patients participated in the study (Salv-ABR: n = 23; mean ± SD age, 53.5 ± 9.1 years; follow-up, 28.6 ± 18.5 month; I/DI-ABR: n = 45, mean ± SD age: 50.2 ± 7.3 years; follow-up, 32.8 ± 18.5 month). Main indication for Salv-ABR was a major capsular contracture (n = 14 [60.1%]). Early unplanned reoperation rates were significantly increased in the Salv-ABR (56.5% vs 14.9%; P < 0.01). Patients with I/DI-ABR showed a significantly improved overall aesthetic outcome (2.7 ± 0.9 vs 3.3 ± 0.7; P < 0.01) and scored significantly higher in several subscales of EORTC QLQ-C30/BR23 (Global Health Status, Role Functioning, Body Image; P < 0.05) and the Breast-Q (Psychosocial Well-being, Satisfaction with Breast; P < 0.05) compared with patients with Salv-ABR. CONCLUSIONS: Salvage ABR is associated with a higher complication rate, compromised aesthetic outcome, and quality of life compared with I/DI-ABR. This should be considered and discussed with the patient when planning any kind of reconstructive breast surgery.

Dawn of the Transformer Era in Speech Emotion Recognition: Closing the Valence Gap.

Recent advances in transformer-based architectures have shown promise in several machine learning tasks. In the audio domain, such architectures have been successfully utilised in the field of speech emotion recognition (SER). However, existing works have not evaluated the influence of model size and pre-training data on downstream performance, and have shown limited attention to generalisation, robustness, fairness, and efficiency. The present contribution conducts a thorough analysis of these aspects on several pre-trained variants of wav2vec 2.0 and HuBERT that we fine-tuned on the dimensions arousal, dominance, and valence of MSP-Podcast, while additionally using IEMOCAP and MOSI to test cross-corpus generalisation. To the best of our knowledge, we obtain the top performance for valence prediction without use of explicit linguistic information, with a concordance correlation coefficient (CCC) of. 638 on MSP-Podcast. Our investigations reveal that transformer-based architectures are more robust compared to a CNN-based baseline and fair with respect to gender groups, but not towards individual speakers. Finally, we show that their success on valence is based on implicit linguistic information, which explains why they perform on-par with recent multimodal approaches that explicitly utilise textual information. To make our findings reproducible, we release the best performing model to the community.

Implicit Metaethical Intuitions: Validating and Employing a New IAT Procedure.

Philosophical arguments often assume that the folk tends towards moral objectivism. Although recent psychological studies have indicated that lay persons' attitudes to morality are best characterized in terms of non-objectivism-leaning pluralism, it has been maintained that the folk may be committed to moral objectivism implicitly. Since the studies conducted so far almost exclusively assessed subjects' metaethical attitudes via explicit cognitions, the strength of this rebuttal remains unclear. The current study attempts to test the folk's implicit metaethical commitments. We present results of a newly developed Implicit Association Test (IAT) for metaethical attitudes which indicate that the folk generally tend towards moral non-objectivism on the implicit level as well. We discuss implications of this finding for the philosophical debate.

The Partner Perspective on Autologous and Implant-Based Breast Reconstruction.

INTRODUCTION: Partner involvement in the decision-making process concerning breast reconstruction (BR) after a breast cancer diagnosis may be very supportive for the patient. So far, no study evaluates partner satisfaction with the outcome after BR and the relationship to patient satisfaction. The aim of this study was to assess and compare partner satisfaction of BR with autologous tissue (ABR) and prosthetic implants (IBR), respectively, and compare it to patient-reported outcomes. PATIENTS AND METHODS: All patients undergoing ABR and IBR between January 2014 and December 2020 were asked to participate with their partners. Patient and partner satisfaction with breast reconstruction, overall outcome as well as patient's perceived and self-reported psychosocial well-being were evaluated using the Breast-Q and a modified partner questionnaire, respectively. RESULTS: Fifty-three couples participated (IBR: n=30, ABR: n = 23). Patient and partner satisfaction with breast (r = 0.552), outcome (r = 0.465) as well as patient's perceived and self-report psychosocial well-being (r = 0.495) were highly correlated with partners scoring significantly higher (p<0.001). In terms of partner satisfaction, both reconstructive procedures achieved satisfactory results. ABR scored higher in terms of softness of breast and how natural the breast feels to touch whereas IBR was rated superior evaluating the breast size. CONCLUSION: Both reconstructive procedures achieve satisfactory results in terms partner satisfaction whereas patient's psychosocial well-being was highly overestimated by their partners. Hence, partner inclusion in the regular psycho-oncological support might further sensitize them of the high psychological burden of a breast cancer diagnosis and therefore stabilize patients private support system. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Anatomical Variations of the Pectoralis Muscle and Its Importance for Breast Implant Surgery.

In breast augmentation, during submuscular or dual plane dissection, anatomical variations of the inferior and costal origin of the pectoralis major muscle (PMM) play a key role to ensure optimal implant coverage. Especially, a short and narrow muscle or surgical release along the sternum increases the risk of irregularities and animation deformities of the implant. Methods: In 84 consecutive aesthetic breast augmentations intraoperatively, measurement of PMM dimensions was performed bilaterally. These PMM measurements were then correlated with the preoperative breast width, the inframammary fold, and the placement of the implant's lower pole. Results: One hundred sixty-eight PMMs of 84 patients were dissected with a dual plane II or III technique for primary aesthetic breast augmentation. In 88% of breasts, the calculated implants' lower pole was below the inferiomedial origin of the pectoralis muscle. In 10% of patients, a separation (more than 1 cm wide and 2 cm wide) in the inferior-medial origin of the PMM was noted. An asymmetry more than 0.5 cm in length between the left and right pectoralis major was noted in 36% of patients. Conclusions: In this series, the anatomy of the PMM demonstrates a substantial variability in width and length and a considerable asymmetry in its dimensions. These findings emphasize the importance of good access and visualization of the origin of the PMM fibers before its division.

Free-flap reconstruction of the lower limb in octogenarians - A comparative analysis of indications, management, and outcomes.

INTRODUCTION: Impaired microcirculation, along with an increase in chronic medical conditions in the geriatric cohort, may favor the development of soft-tissue defects in the lower extremity and equally impair the options for plastic-reconstructive surgery. In particular, outcome analyses in the increasing patient cohort ≥ 80 years (octogenarians) are limited. METHODS: Setting 80 years as the cutoff, we conducted an age-related outcome analysis of all patients undergoing free-flap reconstruction of the lower extremity from 2014 to 2020, comprising the American Society of Anesthesiologists (ASA) score and Charlson Comorbidity Index (CCI) as the possible outcome predicting factors. RESULTS: During the study period, a total of 424 free flaps were performed in 385 patients (∅: 54.7 years ± 16.1; range: 9-89), including 19 octogenarians. Compared with the younger patient cohort, there was a significantly higher rate of early flap revision (p = 0.023) and flap loss (p = 0.028). Furthermore, the mean length of hospital (60.6 ± 37.6 vs. 51.1 ± 37.0) and intensive care unit/intermediate care stay (6.5 ± 15.0 vs. 3.5 ± 8.5) was extended (n.s.). The ASA score presented an independent predictor for major surgical [odds ratio (OR): 1.66; p = 0.041) and medical complications (OR: 3.97; p<0.001). Neither the CCI nor the ASA served as an independent predictor for total flap loss. CONCLUSION: Free-flap reconstruction of the lower extremity in octogenarians is associated with a higher risk of flap revision and flap loss. Considering the prolonged immobilization associated with increased morbidity following limb amputation, it presents still a reasonable option to achieve limb salvage in carefully chosen patients. An adequate tool to predict the success of free-flap survival is still unavailable.

Digital Media Play a Key Role in Influencing Female Breast Perception.

The female breast is a symbol of femininity and plays a key role in the female body image. However, factors influencing the preferences for different breast shapes and sizes are still not elucidated. In particular, the role of the emerging social media in breast perception has not been analyzed yet. A representative cohort of 1,049 adults completed a web-based questionnaire containing hyperrealistic 3D models of the female breast in the United States. A machine-learning algorithm (Classification and Regression Tree [CART]) was implemented to identify the most influential factors. The study was able to identify the frequency of pornographic and social media consumption as the most influencing factor for altered breast preferences. Although digital media exposure did not alter satisfaction with the own breast among female participants, the tendency to undergo or history of conducted aesthetic surgery correlated with higher access frequency to digital media. Taken together, the overpowering impact of social media and pornographic consumption on the own body image was shown in preference alterations for different anatomical aspects of the breast in the whole population and distorted self-perception about the breast in female participants.

Standardized Quantitative Sensory Testing to Assess Insufficient Recovery of Touch Discrimination in Free Flap Surgery.

BACKGROUND: With major advances in microsurgical techniques, free tissue transfer has become a widely adopted approach to treat complex soft-tissue defects. However, sensory recovery is poor, leaving the anesthetic skin prone to injuries. METHODS: Twenty-eight patients with 22 anterior lateral thigh flaps and six latissimus dorsi flaps on their extremities participated in the study. Quantitative sensory testing and two-point discrimination was performed in three test areas and one control on the contralateral unaffected extremity. Physical disability, mental health, quality of life, and characteristics of pain were assessed by the painDetect, Disabilities of the Arm, Shoulder, and Hand, Lower Extremity Functional Scale, and 12-Item Short Form questionnaires, respectively. RESULTS: Somatosensory profiles of all flaps were characterized by an overall loss of nerve function. Small-fiber function was mostly recovered, whereas large-fiber function, and thus touch discrimination, was severely impaired. Mechanical detection thresholds improved over time and from center to the periphery. Reported pain was mild to moderate and correlated with decreased physical function. CONCLUSIONS: Standardized quantitative sensory testing provides a useful tool kit to assess the sensory regeneration after surgical treatment of soft-tissue defects. After free tissue transfer, small-fiber function recovers with nerve ingrowth in a centripetal direction from the flap margins to the center, likely by way of collateral axonal sprouting from the undamaged nerves surrounding the flap. Myelinated fibers recover slowly and inefficiently. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

How droplets move on laser-structured surfaces: Determination of droplet adhesion forces on nano- and microstructured surfaces.

HYPOTHESIS: Lateral adhesion forces are a fundamental property of liquid-solid interactions and a key aspect of dynamic droplet mobility. But, commonly applied conventional wetting analysis is limited to static and quasi-static methods and cannot resolve dynamic and spatial liquid-solid interactions. However, droplet mobility is assumed to be affected by chemical and topographic surface inhomogeneities introduced by femtosecond laser treatment. EXPERIMENTS: In this study, we used a customized droplet adhesion force instrument to determine lateral adhesion forces on various femtosecond laser-structured surface designs to obtain a deeper understanding of the dynamic droplet motion with regard to chemical and topographic surface features. FINDINGS: We show that the droplet motion was highly affected by the chemical and topographical surface design and local inhomogeneities. The droplet mobility on femtosecond laser-structured surfaces could be classified into a static, a transfer, and a kinetic regime, which is essential for designing surfaces with extreme wetting characteristics and a wide range of scientific and industrial processes. Furthermore, with proper tailoring of surface structures and chemical modification, we were able to provoke adhesion forces on self-organized laser microstructures similar to those found on the natural lotus leaves.

Human trust in otherware - a systematic literature review bringing all antecedents together.

Technological systems are becoming increasingly smarter, which causes a shift in the way they are seen: from tools used to execute specific tasks to social counterparts with whom to cooperate. To ensure that these interactions are successful, trust has proven to be the most important driver. We conducted an extensive and structured review with the goal to reveal all previously researched antecedents influencing the human trust in technology-based counterparts. In doing so, we synthesised 179 papers and uncovered 479 trust antecedents. We assigned these antecedents to four main groups. Three of them have been explored before: environment, trustee, and trustor. Within this paper, we argue for a fourth group, the interaction. This quadripartition allows the inclusion of antecedents that were not considered previously. Moreover, we critically question the practice of uncovering more and more trust antecedents, which already led to an opaque plethora and thus becomes increasingly complex for practitioners.Practitioner summary: Future designers of intelligent and interactive technology will have to consider trust to a greater extent. We emphasise that there are far more trust antecedents - and interdependencies - to consider than the ethically motivated discussions about "Trustworthy AI" suggest. For this purpose, we derived a trust map as a sound basis.

Postoperative Remote Ischemic Conditioning (RIC) significantly improves entire flap microcirculation beyond 4 hours.

OBJECTIVE: Free flap transfer is a safe and reliable technique for soft tissue reconstruction. However, impaired flap perfusion with consecutive microcirculatory failure leading to partial or total flap failure remains a clinically relevant problem. Remote ischemic conditioning (RIC) has been shown to improve microcirculation in adipo-cutaneous tissues in healthy humans as well as in free flaps. Yet, little is known about its effects on different perfusion zones in free flaps and the duration of these effects. METHODS: Twenty-five patients with free perforator-based adipo-cutaneous flap transfer were included in the study. RIC (3 cycles: 10/10 min ischemia/reperfusion) was applied via an inflatable tourniquet placed on the upper arm. Continuous measurement of flaps' microcirculation on postoperative day (POD) 1, 3, and 5 was performed by utilizing an O2C device ("Oxygen-to-see" ©LEA Medizintechnik Germany) during RIC and for the following 4 h. Probes were located both in the flaps' center and on its distal edge. RESULTS: Twenty patients were included in the final analysis. RIC significantly improved flaps' blood flow (BF) by a max. of + 19.6% and oxygen saturation of + 15.7%. Changes affected the entire flap, without significant difference between zones. The increase in flap perfusion could be observed for at least 4 h after the completion of RIC. CONCLUSION: Postoperative application of RIC might serve as an additional treatment to enhance whole flap perfusion and prevent microcirculatory disorders, therefore reducing the risk for potential tissue necrosis, especially in the distal parts of the flaps.

[Analysis of Efficency, Cost Structure and Revenues of ALT Free Flaps in Extremity Reconstruction]. / Analyse der Effizienz, Kostenstruktur und Erlössituation von freien ALT-Lappenplastiken zur Extremitätenrekonstruktion.

Microvascular reconstructions can be lengthy procedures lasting the entire day. As a result of unforeseeable events, the standardization of these procedures can be challenging. Moreover, the length of these procedures varies strongly, which impedes adequate scheduling and, therefore, optimal capacity utilization. Within the years 2018-2020, the duration of ALT free flap extremity reconstructions was correlated with the experience of the microsurgeon (category 1:<50 free flaps life-time experience, category 2: 50-200, category 3:>200) and comorbidities. The resulting costs were compared with the matrix of the German DRG Institute InEK. The surgical experience of the microsurgeon had a significant impact on the duration of surgery in extremity reconstruction. In due consideration of potential complications, category 2 microsurgeons were 45 minutes faster and category 3 microsurgeons were 167 minutes faster than category 1 microsurgeons. Comorbidities, by contrast, did not have a significant impact on procedure duration. Cost analysis revealed deficits for these procedures in relation to the InEK matrix. However, an additional analysis showed that the duration of surgery was within the German average while costs for personnel/OR minute were slightly below the average. According to this calculation, costs for microsurgical training were approximately 1000€/case. The reimbursement for flaps in extremity reconstruction is not entirely mapped in the German DRG system. Given the longer procedure times, microsurgical training is associated with higher costs. Defining the duration of microsurgery based on the level of expertise should result in improved adherence to schedule and more efficient utilization of the valuable operating room time.