It is the habit not the handle that affects tooth brushing - a randomised counterbalanced cross over study with young and healthy adults.

OBJECTIVE: To assess the effect of the toothbrush handle on video-observed toothbrushing behaviour and toothbrushing effectiveness. METHODS: This is a randomized counterbalanced cross-over study. N = 50 university students and employees brushed their teeth at two occasions, one week apart, using either a commercial ergonomically designed manual toothbrush (MT) or Brushalyze V1 (BV1), a manual toothbrush with a thick cylindrical handle without any specific ergonomic features. Brushing behaviour was video-analysed. Plaque was assessed at the second occasion immediately after brushing. Participants also rated their self-perceived oral cleanliness and directly compared the two brushes regarding their handling and compared them to the brushed they used at home. RESULTS: The study participants found the BV1 significantly more cumbersome than the M1 or their brush at home. (p < 0.05). However, correlation analyses revealed a strong consistency of brushing behavior with the two brushes (0.71 < r < 0.91). Means differed only slightly (all d < 0.36). These differences became statistically significant only for the brushing time at inner surfaces (d = 0.31 p = 0.03) and horizontal movements at inner surfaces (d = 0.35, p = 0.02). Plaque levels at the gingival margins did not differ while slightly more plaque persisted at the more coronal aspects of the crown after brushing with BV1 (d = 0.592; p 0.042). DISCUSSION: The results of the study indicate that the brushing handle does not play a major role in brushing behavior or brushing effectiveness.

[Why you should know the "nose cycle" as a pneumologist and sleep medicine specialist]. / Warum man auch als Pneumologe und Schlafmediziner den "Nasenzyklus" kennen sollte.

The nasal cycle refers to the anticyclic swelling and decongestion of the two nasal cavities that occur during the day and during sleep, while the overall nasal flow remains constant. The nasal cycle was first described by R. Kayser in 1895. Each cycle consists of a working phase and a subsequent resting phase, the purpose of which is the rehydration and regeneration of the mucosa. A nasal cycle occurs in about 70-90% of people. The duration of the phase is affected by age, body position, physical activity, mucociliary clearance and time of day. Typically, the cycle lengthens during sleep. Long-term rhinoflowmetry enables assessment of the circadian course of the alternating cyclic changes of the nasal mucosa.

Reliability of Vibroarthrography to Assess Knee Joint Sounds in Motion.

Knee acoustic emissions provide information about joint health and loading in motion. As the reproducibility of knee acoustic emissions by vibroarthrography is yet unknown, we evaluated the intrasession and interday reliability of knee joint sounds. In 19 volunteers (25.6 ± 2.0 years, 11 female), knee joint sounds were recorded by two acoustic sensors (16,000 Hz; medial tibial plateau, patella). All participants performed four sets standing up/sitting down (five repetitions each). For measuring intrasession reliability, we used a washout phase of 30 min between the first three sets, and for interday reliability we used a washout phase of one week between sets 3 and 4. The mean amplitude (dB) and median power frequency (Hz, MPF) were analyzed for each set. Intraclass correlation coefficients (ICCs (2,1)), standard errors of measurement (SEMs), and coefficients of variability (CVs) were calculated. The intrasession ICCs ranged from 0.85 to 0.95 (tibia) and from 0.73 to 0.87 (patella). The corresponding SEMs for the amplitude were ≤1.44 dB (tibia) and ≤2.38 dB (patella); for the MPF, SEMs were ≤13.78 Hz (tibia) and ≤14.47 Hz (patella). The intrasession CVs were ≤0.06 (tibia) and ≤0.07 (patella) (p < 0.05). The interday ICCs ranged from 0.24 to 0.33 (tibia) and from 0 to 0.82 (patella) for both the MPF and amplitude. The interday SEMs were ≤4.39 dB (tibia) and ≤6.85 dB (patella) for the amplitude and ≤35.39 Hz (tibia) and ≤15.64 Hz (patella) for the MPF. The CVs were ≤0.14 (tibia) and ≤0.08 (patella). Knee joint sounds were highly repeatable within a single session but yielded inconsistent results for the interday reliability.

Time course of nocturnal cough and wheezing in children with acute bronchitis monitored by lung sound analysis.

Cough and wheezing are the predominant symptoms of acute bronchitis. Hitherto, the evaluation of respiratory symptoms was limited to subjective methods such as questionnaires. The main objective of this study was to objectively determine the time course of cough and wheezing in children with acute bronchitis. The impact of nocturnal cough on parent's quality of life was assessed as secondary outcome. In 36 children (2-8 years), the frequency of nocturnal cough and wheezing was recorded during three nights by automated lung sound monitoring. Additionally, parents completed symptom logs, i.e., the Bronchitis Severity Score (BSS), as well as the Parent-proxy Children's Acute Cough-specific Quality of Life Questionnaire (PAC-QoL). During the first night, patients had 34.4 ± 52.3 (mean ± SD) cough epochs, which were significantly reduced in night 5 (13.5 ± 26.5; p < 0.001) and night 9 (12.8 ± 28.1; p < 0.001). Twenty-two patients had concomitant wheezing, which declined within the observation period as well. All subjective parameters (BSS, Cough log and PAC-QoL) were found to be significantly correlated with the objectively assessed cough parameters.Conclusion: Long-term recording of cough and wheezing offers a useful opportunity to objectively evaluate the time course of respiratory symptoms in children with acute bronchitis. To assess putative effects of pharmacotherapy on nocturnal bronchitis symptoms, future studies in more homogeneous patient groups are needed. What is Known: • Cough and wheezing are the predominant symptoms of acute bronchitis. • There is a diagnostic gap in long-term assessment of these respiratory symptoms, which needs to be closed to optimize individual therapies. What is New: • Long-term recording of nocturnal cough and wheezing allows for objective evaluation of respiratory symptoms in children with acute bronchitis and provides a tool to validate the efficacy of symptomatic bronchitis therapies.

Long-term Recording of Night-Time Respiratory Symptoms in Patients with Stable COPD II-IV.

INTRODUCTION: Night-time respiratory symptoms have a considerable impact on sleep and life quality in patients with chronic obstructive pulmonary disease (COPD). Lack of awareness of night-time symptoms can lead to worsened COPD control. Automated long-term monitoring of respiratory symptoms with LEOSound enables assessment of nocturnal wheezing and cough. METHODS: In this observational study we investigated the prevalence and severity of cough and wheezing in patients with stable COPD [Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV] disease for two consecutive nights with the LEOSound system. 48 patients (30 males, 63%) were eligible for inclusion, median age was 67 years, and body mass index (BMI) was 25.3 kg/m2. RESULTS: In 15 out of 48 patients (31%), we found wheezing periods for at least 10-minute duration. Wheezing periods >30 minutes were monitored in seven patients and wheezing periods >60 minutes were monitored in three patients. The maximum duration of wheezing was 470 minutes in one patient with COPD II. The median wheezing rate differed between the COPD stages and between active and non-active smokers. Cough was found in 42 patients (87.5%) with a range of 1-326 events. The cough-period-index in night one was 0.83 n/hour (P25:0.33||P75: 2.04) and night two 0.97 n/hour (P25:0.25||P75: 1.9). Most of the cough events were non-productive with a median of 0.86. CONCLUSIONS: Night-time symptoms are common in COPD patients. LEOSound offers an opportunity to evaluate objectively night-time symptoms like wheezing and cough in patients with COPD which remain otherwise unnoticed. We found a high incidence of night-time wheezing in these patients, which was related to persistant smoking.

Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis.

BACKGROUND: Clinical trials (CTs) are crucial for medical research; however, they frequently fall short of the requisite number of participants who meet all eligibility criteria (EC). A clinical trial recruitment support system (CTRSS) is developed to help identify potential participants by performing a search on a specific data pool. The accuracy of the search results is directly related to the quality of the data used for comparison. Data accessibility can present challenges, making it crucial to identify the necessary data for a CTRSS to query. Prior research has examined the data elements frequently used in CT EC but has not evaluated which criteria are actually used to search for participants. Although all EC must be met to enroll a person in a CT, not all criteria have the same importance when searching for potential participants in an existing data pool, such as an electronic health record, because some of the criteria are only relevant at the time of enrollment. OBJECTIVE: In this study, we investigated which groups of data elements are relevant in practice for finding suitable participants and whether there are typical elements that are not relevant and can therefore be omitted. METHODS: We asked trial experts and CTRSS developers to first categorize the EC of their CTs according to data element groups and then to classify them into 1 of 3 categories: necessary, complementary, and irrelevant. In addition, the experts assessed whether a criterion was documented (on paper or digitally) or whether it was information known only to the treating physicians or patients. RESULTS: We reviewed 82 CTs with 1132 unique EC. Of these 1132 EC, 350 (30.9%) were considered necessary, 224 (19.8%) complementary, and 341 (30.1%) total irrelevant. To identify the most relevant data elements, we introduced the data element relevance index (DERI). This describes the percentage of studies in which the corresponding data element occurs and is also classified as necessary or supplementary. We found that the query of "diagnosis" was relevant for finding participants in 79 (96.3%) of the CTs. This group was followed by "date of birth/age" with a DERI of 85.4% (n=70) and "procedure" with a DERI of 35.4% (n=29). CONCLUSIONS: The distribution of data element groups in CTs has been heterogeneously described in previous works. Therefore, we recommend identifying the percentage of CTs in which data element groups can be found as a more reliable way to determine the relevance of EC. Only necessary and complementary criteria should be included in this DERI.

Implementation of inclusion and exclusion criteria in clinical studies in OHDSI ATLAS software.

Clinical trials are essential parts of a medical study process, but studies are often cancelled due to a lack of participants. Clinical Trial Recruitment Support Systems are systems that help to increase the number of participants by seeking more suitable subjects. The software ATLAS (developed by Observational Health Data Sciences and Informatics) can support the launch of a clinical trial by building cohorts of patients who fulfill certain criteria. The correct use of medical classification systems aiming at clearly defined inclusion and exclusion criteria in the studies is an important pillar of this software. The aim of this investigation was to determine whether ATLAS can be used in a Clinical Trial Recruitment Support System to portray the eligibility criteria of clinical studies. Our analysis considered the number of criteria feasible for integration with ATLAS and identified its strengths and weaknesses. Additionally, we investigated whether nonrepresentable criteria were associated with the utilized terminology systems. We analyzed ATLAS using 223 objective eligibility criteria from 30 randomly selected trials conducted in the last 10 years. In the next step, we selected appropriate ICD, OPS, LOINC, or ATC codes to feed the software. We classified each criterion and study based on its implementation capability in the software, ensuring a clear and logical progression of information. Based on our observations, 51% of the analyzed inclusion criteria were fully implemented in ATLAS. Within our selected example set, 10% of the studies were classified as fully portrayable, and 73% were portrayed to some extent. Additionally, we conducted an evaluation of the software regarding its technical limitations and interaction with medical classification systems. To improve and expand the scope of criteria within a cohort definition in a practical setting, it is recommended to work closely with personnel involved in the study to define the criteria precisely and to carefully select terminology systems. The chosen criteria should be combined according to the specific setting. Additional work is needed to specify the significance and amount of the extracted criteria.

Fluctuations in Oxygen Saturation during Synchronized Nasal Intermittent Positive Pressure Ventilation and Nasal High-Frequency Oscillatory Ventilation in Very Low Birth Weight Infants: A Randomized Crossover Trial.

BACKGROUND: Very low birth weight (VLBW) infants on noninvasive ventilation (NIV) experience frequent fluctuations in oxygen saturation (SpO2) that are associated with an increased risk for mortality and severe morbidities. METHODS: In this randomized crossover trial, VLBW infants (n = 22) born 22+3 to 28+0 weeks on NIV with supplemental oxygen were allocated on two consecutive days in random order to synchronized nasal intermittent positive pressure ventilation (sNIPPV) and nasal high-frequency oscillatory ventilation (nHFOV) for 8 h. nHFOV and sNIPPV were set to equivalent mean airway pressure and transcutaneous pCO2. Primary outcome was the time spent within the SpO2 target (88-95%). RESULTS: During sNIPPV, VLBW infants spent significantly more time within the SpO2 target (59.9%) than during nHFOV (54.6%). The proportion of time spent in hypoxemia (22.3% vs. 27.1%) and the mean fraction of supplemental oxygen (FiO2) (29.4% vs. 32.8%) were significantly reduced during sNIPPV, while the respiratory rate (50.1 vs. 42.6) was significantly higher. Mean SpO2, SpO2 above the target, number of prolonged (>1 min) and severe (SpO2 <80%) hypoxemic episodes, parameters of cerebral tissue oxygenation using NIRS, number of FiO2 adjustments, heart rate, number of bradycardias, abdominal distension and transcutaneous pCO2 did not differ between both interventions. CONCLUSIONS: In VLBW infants with frequent fluctuations in SpO2, sNIPPV is more efficient than nHFOV to retain the SpO2 target and to reduce FiO2 exposure. These results demand more detailed investigations into cumulative oxygen toxicities during different modes of NIV over the weaning period, particularly with regard to consequences for long-term outcomes.

Interventional Treatment of Recurrent Ventricular Septal Defect Planed by 3D-Printed Reconstruction of the Heart.

We report a complex case of a 53-year-old male patient with recurrent ischemic ventricular septal defect that had been occluded by a surgical patch. Treatment was accomplished utilizing a 3-dimensional-printed model for preprocedural planning. In the future, printing of 3-dimensional models could offer new therapeutic strategies on an individual level. (Level of Difficulty: Intermediate.).

Evaluation of a Regulatory Orientation Guide for Young Entrepreneurs in the Field of Digital Health.

BACKGROUND: The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, dose calculation, and analysis of physiological data - apps are popular and commonly used. For young entrepreneurs, it is difficult to recognize and understand the distinction between software as medical product and health software products. A product-related orientation guide was developed to help start-ups to understand the difference and to find the right strategy for placing their product on the market. OBJECTIVES: An initial evaluation of this orientation guide to improve the comprehensibility, the simplicity, and to validate the benefit. METHODS: The evaluation was performed using a questionnaire. In total, 15 employees from start-ups or those in foundation phase and in regulatory affairs positions or comparable were interviewed. RESULTS: the orientation guide was rated as very helpful and comprehensible. 80 % would highly recommend it to others. CONCLUSION: The orientation guide was positively evaluated and can be used in field. Nevertheless, further investigations must be performed, and a post-market surveillance will be necessary.

Development of a Multidimensional Assessment Tool for the Evaluation of Holistic Quality of Life in Parkinson's Disease.

BACKGROUND: Parkinsonian syndromes are heterogeneous chronic neurodegenerative disorders associated with both motor and non-motor symptoms. The symptoms have major psychosocial effects on the quality of life of patients and can be a burden for caregivers. So far, several questionnaires have been developed to assess quality of life in Parkinsonism, but none of these include the positive sides on well-being such as personal and social resilience factors. OBJECTIVE: The aim of this study is to develop a digital framework for a longitudinal assessment of quality of life during the progression of Parkinson's disease. METHODS: The CHAPO model (Challenges and Potentials) has been established in a vast study by Wagner et al. to assess the quality of life of older people. This model includes environmental and individual factors, life chances, and life results, such as individual life evaluation, from a subjective as well as an objective point of view. Therefore, it has been adapted in several development steps to include the specific aspects that affect quality of life in Parkinsonian syndromes. The development process included 6 steps: definition, refinement, operationalization, piloting/debriefing, adjustment, and integration. RESULTS: The development of the CHAPO-PD model has been completed and it represents the first main result of this study. CONCLUSION: By taking a holistic understanding of quality of life into account, we expect to detect previously unrecognized factors, which correlate to the subjective well-being of Parkinson's disease patients, and aim to use these findings to improve the health care structures for patients with Parkinson's disease and related disorders.

Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease - Data from the multicenter CEDATA-GPGE registry study.

Background and aims: In recent years, biological agents, such as anti-TNF-α blockers, have been introduced and have shown efficacy in pediatric patients with inflammatory bowel disease (IBD). Here, the prescription mode differentiated into a first/second line application, and efficacy and side effects are evaluated beginning from 2004 until today. Methods: Statistical analyses of the prospective and ongoing CEDATA multicenter registry data from the Society of Pediatric Gastroenterology and Nutrition (GPGE) were performed for patients receiving a biological agent at least once during the period from June 2004 until November 2020 (n = 487). The analyzed parameters were patient demographics, disease extent and behavior, prior or concurrent therapies, duration and outcome of biological therapy, disease-associated complications, drug-related complications, laboratory parameters and treatment response as determined by the Physician's Global Assessment. Results: Crohn's disease (CD) was present in 71.5% of patients, and 52% were boys. Patients showed high disease activity when receiving a first-line TNF-α blocker. After 2016, patients who failed to respond to anti-TNF-α induction therapy were treated with off-label biologics (vedolizumab 4.3% and ustekinumab 2.1%). Propensity score matching indicated that patients with CD and higher disease activity benefitted significantly more from early anti-TNF-α therapy. This assessment was based on a clinical evaluation and lab parameters related to inflammation compared to delayed second-line treatment. Additionally, first-line treatment resulted in less treatment failure and fewer extraintestinal manifestations during TNF-α blockade. Conclusion: First-line treatment with anti-TNF-α drugs is effective and safe. An earlier start significantly reduces the risk of treatment failure and is associated with fewer extraintestinal manifestations during longitudinal follow-up.

Running Behind "POPO"-Impact of Predictors of Poor Outcome for Treatment Stratification in Pediatric Crohn's Disease.

Background and Aims: Intensifying therapy for Paediatric Crohn's Disease (CD) by early use of immunomodulators and biologics has been proposed for cases in which predictors of poor outcome (POPO) were present. We investigated therapy stratifying potential comparing POPO-positive and -negative CD patients from CEDATA-GPGE®, a German-Austrian Registry for Paediatric Inflammatory Bowel disease. Methods: CD patients (1-18 years) registered in CEDATA-GPGE® (2004-2018) within 3 months of diagnosis and at least two follow-up visits were included. Disease course and treatments over time were analysed regarding positivity of POPO criteria and test statistical properties. Results: 709/1084 patients included had at least one POPO criterion (65.4%): 177 patients (16.3%) had persistent disease (POPO2), 581 (53.6%) extensive disease (POPO3), 21 (1.9%) severe growth retardation POPO4, 47 (4.3%) stricturing/penetrating disease (POPO6) and 122 (11.3%) perianal disease (POPO7). Patients with persistent disease differed significantly in lack of sustained remission >1 year (Odd Ratio (OR) 1.49 [1.07-2.07], p = 0.02), patients with initial growth failure in growth failure at end of observation (OR 51.16 [19.89-131.62], p < 0.0001), patients with stricturing and penetrating disease as well as perianal disease in need for surgery (OR 17.76 [9.39-33.58], p < 0.001; OR 2.56 [1.58-4.15], p < 0.001, respectively). Positive Predictive Value for lack of sustained remission was >60% for patients with initial growth failure, persistent or stricturing/penetrating disease. Conclusion: Predictors of poor outcome with complicated courses of disease were common in CEDATA-GPGE®. An early intensified approach for paediatric CD patients with POPO-positivity (POPO2-4, 6-7) should be considered, because they have an increased risk to fare poorly.

Machine Learning Classification of Inflammatory Bowel Disease in Children Based on a Large Real-World Pediatric Cohort CEDATA-GPGE® Registry.

Introduction: The rising incidence of pediatric inflammatory bowel diseases (PIBD) facilitates the need for new methods of improving diagnosis latency, quality of care and documentation. Machine learning models have shown to be applicable to classifying PIBD when using histological data or extensive serology. This study aims to evaluate the performance of algorithms based on promptly available data more suited to clinical applications. Methods: Data of inflammatory locations of the bowels from initial and follow-up visitations is extracted from the CEDATA-GPGE registry and two follow-up sets are split off containing only input from 2017 and 2018. Pre-processing excludes patients in remission and encodes the categorical data numerically. For classification of PIBD diagnosis, a support vector machine (SVM), a random forest algorithm (RF), extreme gradient boosting (XGBoost), a dense neural network (DNN) and a convolutional neural network (CNN) are employed. As best performer, a convolutional neural network is further improved using grid optimization. Results: The achieved accuracy of the optimized neural network reaches up to 90.57% on data inserted into the registry in 2018. Less performant methods reach 88.78% for the DNN down to 83.94% for the XGBoost. The accuracy of prediction for the 2018 follow-up dataset is higher than those for older datasets. Neural networks yield a higher standard deviation with 3.45 for the CNN compared to 0.83-0.86 of the support vector machine and ensemble methods. Discussion: The displayed accuracy of the convolutional neural network proofs the viability of machine learning classification in PIBD diagnostics using only timely available data.

Confirmation of Calcium Phosphate Cement Biodegradation after Jawbone Augmentation around Dental Implants Using Three-Dimensional Visualization and Segmentation Software.

The use of autologous bone graft for oral rehabilitation of bone atrophy is considered the gold standard. However, the available grafts do not allow a fast loading of dental implants, as they require a long healing time before full functionality. Innovative bioactive materials provide an easy-to-use solution to this problem. The current study shows the feasibility of calcium phosphate cement paste (Paste-CPC) in the sinus. Long implants were placed simultaneously with the cement paste, and provisional prosthetics were also mounted in the same sessions. Final prosthetics and the full loading took place within the same week. Furthermore, the study shows for the first time the possibility to monitor not only healing progression using Cone Beam Computer tomography (CBCT) but also material retention, over two years, on a case study example. The segmented images showed a 30% reduction of the cement size and an increased mineralized tissue in the sinus. Mechanical testing was performed qualitatively using reverse torque after insertion and cement solidification to indicate clinical feasibility. Both functional and esthetic satisfaction remain unchanged after one year. This flowable paste encourages the augmentation procedure with less invasive measure through socket of removed implants. However, this limitation can be addressed in future studies.

Methods for Adventitious Respiratory Sound Analyzing Applications Based on Smartphones: A Survey.

Detection and classification of adventitious acoustic lung sounds plays an important role in diagnosing, monitoring, controlling and, caring the patients with lung diseases. Such systems can be presented as different platforms like medical devices, standalone software or smartphone application. Ubiquity of smartphones and widespread use of the corresponding applications make such a device an attractive platform for hosting the detection and classification systems for adventitious lung sounds. In this paper, the smartphone-based systems for automatic detection and classification of the adventitious lung sounds are surveyed. Such adventitious sounds include cough, wheeze, crackle and, snore. Relevant sounds related to abnormal respiratory activities are considered as well. The methods are shortly described and the analyzing algorithms are explained. The analysis includes detection and/or classification of the sound events. A summary of the main surveyed methods together with the classification parameters and used features for the sake of comparison is given. Existing challenges, open issues and future trends will be discussed as well.

Pilot study on nocturnal monitoring of crackles in children with pneumonia.

BACKGROUND: The clinical diagnosis of pneumonia is usually based on crackles at auscultation, but it is not yet clear what kind of crackles are the characteristic features of pneumonia in children. Lung sound monitoring can be used as a "longtime stethoscope". Therefore, it was the aim of this pilot study to use a lung sound monitor system to detect crackles and to differentiate between fine and coarse crackles in children with acute pneumonia. The change of crackles during the course of the disease shall be investigated in a follow-up study. PATIENTS AND METHODS: Crackles were recorded overnight from 22:00 to 06:00 h in 30 children with radiographically confirmed pneumonia. The data for a total of 28 800 recorded 30-s epochs were audiovisually analysed for fine and coarse crackles. RESULTS: Fine crackles and coarse crackles were recognised in every patient with pneumonia, but the number of epochs with and without crackles varied widely among the different patients: fine crackles were detected in 40±22% (mean±sd), coarse crackles in 76±20%. The predominant localisation of crackles as recorded during overnight monitoring was in accordance with the radiographic infiltrates and the classical auscultation in most patients. The distribution of crackles was fairly equal throughout the night. However, there were time periods without any crackle in the single patients so that the diagnosis of pneumonia might be missed at sporadic auscultation. CONCLUSION: Nocturnal monitoring can be beneficial to reliably detect fine and coarse crackles in children with pneumonia.

Automatic detection and monitoring of abnormal skull shape in children with deformational plagiocephaly using deep learning.

Craniofacial anomaly including deformational plagiocephaly as a result of deformities in head and facial bones evolution is a serious health problem in newbies. The impact of such condition on the affected infants is profound from both medical and social viewpoint. Indeed, timely diagnosing through different medical examinations like anthropometric measurements of the skull or even Computer Tomography (CT) image modality followed by a periodical screening and monitoring plays a vital role in treatment phase. In this paper, a classification model for detecting and monitoring deformational plagiocephaly in affected infants is presented. The presented model is based on a deep learning network architecture. The given model achieves high accuracy of 99.01% with other classification parameters. The input to the model are the images captured by commonly used smartphone cameras which waives the requirement to sophisticated medical imaging modalities. The method is deployed into a mobile application which enables the parents/caregivers and non-clinical experts to monitor and report the treatment progress at home.

Comparison of Formative Evaluation Methods in the Usability Process on the Example of a Medical App.

BACKGROUND: The process of developing a medical device has become increasingly complex, not least because of the Medical Device Regulation. Some of the associated changes affect in particular the software development companies. One of the challenges to provide safe software products is the usability engineering process. Adequate methods must be identified to find severe usability issues effectively and efficiently. OBJECTIVES: The aim of this study was a comparison of normative recommended formative evaluation methods. METHODS: Two expert-based methods and two user-based methods were compared regarding effectiveness in finding issues, the level of detail and the temporal effort. RESULTS: The heuristics and the isometrics, both showed a significant advantage regarding the effectiveness and similarity in level of detail and temporal effort. CONCLUSION: Based on this paper, the heuristics and the isometrics, both can be recommended, but further studies are necessary to consolidate this statement. Also, further methods should be considered, and more test persons must be involved to give an overall comparison of formative evaluation methods in the usability process of medical apps.