Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.

OBJECTIVE: Available guidelines are ambiguous about safe handling monoclonal antibodies (MABs) and whether or not to use a Closed System Drug-Transfer Device (CSTD). In this article we want to describe a standardized working method on handling MABs in a clinical trial setting. DATA SOURCES: The current workflow at the clinical trial unit of the Ghent University Hospital was critically analyzed, after which an extensive literature review was performed using the National Institute for Occupational Safety and Health Working Group guidelines and the database PubMed (Keywords: monoclonal antibodies, closed system transfer devices, safety guidelines, safe handling, management, administration, (bio)compatibility, volume loss, contamination, clinical trial unit. Period: 2020-2022). DATA SUMMARY: Literature data are ambiguous. CSTDs can reduce cross-contamination and minimize exposure to potential hazardous drugs for healthcare professionals. However, in recent years more questions have been raised about their in-use compatibility and their impact on final product quality. This makes the debate on implementing CSTDs a hot topic in daily pharmacy practice and demands a holistic and standardized approach when deciding whether or not to use a CSTD when handling MABs. In a clinical trial setting, where safety data are frequently not available and the compatibility of CSTDs and investigational product is often unknown, this poses additional challenges that need to be taken into account. CONCLUSION: We developed a flowchart which standardizes the use of a CSTD when handling MABs. It allows other healthcare professionals and clinical trial sponsors to define and evaluate the necessary criteria when standardizing the position of a CSTD in their safe handling procedures.

Translating the new International IFOMPT Cervical Framework into a framework flowchart for clinical practice and education.

BACKGROUND: In 2020, a revised version of the International IFOMPT Cervical Framework was published. This framework provides both physical therapists and educators the necessary information to guide the assessment of the cervical spine region for potential vascular pathologies of the neck in advance of planned Orthopaedic Manual Therapy (OMT) interventions. OBJECTIVE: The objective was to develop a framework flowchart which is useful in clinical practice and education to assist physical therapists to improve the safety of OMT, and apply this in a case report. METHODS: The framework was developed in co-creation with manual therapy experts, researchers, educators in manual therapy, patients, medical specialists and the Manual Therapy Association in The Netherlands and Belgium. Manual therapists and patients tested the framework for intelligibility and usefulness. RESULTS: A framework flowchart is developed and presented, that is easy to use in both clinical practice and education. It is a visual representation of the sequence of steps and decisions needed during the process. A case description of a patient with neck pain and headache is added to illustrate the clinical usefulness of the framework flowchart. CONCLUSION: The framework flowchart helps physical therapists in their clinical reasoning to provide safe OMT interventions.

Culturally adapted flowcharts in obstetric emergencies: a participatory action research study.

INTRODUCTION: Maternal mortality is a health problem in developing countries and is the result of several factors such as sociodemographic and economic inequalities and difficulties in accessing the health services. In addition, training strategies in obstetric emergencies targeting the non-medical personnel such as traditional midwives are scarce. The focus of this study is to develop learning and communication bridges on the management of obstetric emergencies and on policies of patients' referral to the biomedical health system in rural areas. METHODOLOGY: A Participant Action Research (PAR) study with a mixed methods approach was set up to elaborate culturally adapted flowcharts. The project lasted approximately 3,5 years, from September 2016 to January 2021. RESULTS: The study was conducted with 94 traditional midwives from southern Ecuador and is divided into 4 phases, namely: 1) Exploration: focus groups and interviews were conducted to document the management of obstetric emergencies through the presentation of "clinical case" scenarios in three important topics, namely: pre-eclampsia, shoulder dystocia and postpartum hemorrhage, 2) Planning: a number of reflective sessions were conducted between the researchers and the healers/midwives to elaborate flowcharts. 3) Action: the training was conducted in rooms dedicated to proficiency in the aforementioned topics and using the flowcharts, 4) Evaluation: 90% of the participants reported having used the flowcharts during the first year after the training. The most frequently used flowchart was that of pre-eclampsia for the recognition of warning signs during pregnancy control. CONCLUSION: This study documents common practices of pregnancy and delivery management by traditional midwives. Furthermore, cultural flowcharts were developed for and together with midwives to improve the clinical response to obstetric emergencies. The preliminary evaluation was favorable; the most frequently used flowchart concerned preeclampsia. In this process, establishing a partnership was crucial for successful intercultural collaboration.

Terapia descongestiva como complemento a la cirugía de anastomosis linfáticovenosas y transferencia de linfonodos vascularizados: Una revisión de la literatura / Decongestive therapy as an adjunct to lymphatic-venous anastomosis surgery and vascularized lymph node transfer: A review of the literature

Resumen Introducción: El linfedema es una enfermedad inflamatoria crónica que afecta cerca de 250 millones de personas en el mundo. El tratamiento tradicional es la terapia descongestiva. Últimamente, existe la opción de complementar el tratamiento tradicional con procedimientos quirúrgicos fisiológicos como anastomosis linfáticovenosas y transferencia de linfonodos vascularizados. Sin embargo, la evidencia del uso de la terapia descongestiva en los cuidados pre y posoperatorios en estas cirugías es limitada. Objetivo: Evaluar el uso de terapia descongestiva como complemento a la cirugía de linfedema mediante anastomosis linfáticovenosas y transferencia de linfonodos vascularizados. Materiales y Método: Se realizó una revisión de la literatura en las siguientes bases de datos: Cochrane, Pubmed y Google académico, utilizando los siguientes términos mesh: "anastomosis, surgical", "lymphedema", "perioperative care", "microsurgery", "rehabilitation", "therapy", "lymph nodes", "bypass", "lymphedema and microsurgery". Se incluyó aquellos artículos que describían el uso de la terapia descongestiva en los cuidados pre- y posoperatorios. Resultados: Se identificó un total de 201 artículos y 12 fueron incluidos en el análisis. La evidencia reporta que las terapias más usadas en el cuidado pre- y posoperatorio son compresión, drenaje linfático manual y tratamientos personalizados. Sin embargo, la mayoría de los autores hace una descripción vaga de las terapias mencionadas. Discusión y Conclusión: La evidencia respecto al uso de terapia descongestiva como tratamiento complementario es débil. Los expertos recomiendan su uso, sin embargo, se necesitan futuras investigaciones que describan el uso de cada uno de sus componentes como complemento de procedimientos quirúrgicos fisiológicos para el manejo del linfedema.

Background: Lymphedema is a disease that affects about 250 million people around the world. The traditional treatment is decongestive therapy. In the past years, there is the option to complementing the traditional treatment with physiological surgical procedures such as lymphatic-venous anastomosis (LVA) and vascularized lymph node transfer (VLNT). However, the evidence for the use of decongestive therapy in pre- and post-operative care in these surgeries is limited. Aim: To evaluate the use of decongestive therapy as a complement to lymphedema surgery such a lymphatic-venous anastomosis and transfer of vascularized lymph nodes. Materials and Method: A literature review was carried out in the following databases: Cochrane, Pubmed and Academic Google, using the following mesh terms: "anastomosis, surgical", "lymphedema", "perioperative care", "microsurgery", "rehabilitation", "therapy", "lymph nodes","bypass", "lymphedema and microsurgery". "Those articles that described the use of decongestive therapy in pre- and post-operative care were included. Results: 201 articles were identified and 12 were included in the analysis. The evidence reports that the most used therapies in pre- and post-operative care are compression, manual lymphatic drainage and personalized treatments. However, most of the authors give a vague description of the mentioned therapies. Discussion and Conclusion: The evidence regarding the use of decongestive therapy as a complementary treatment is weak. Experts recommend its use; however, future research is needed to describe the use of each of its components as a complement to physiological surgical procedures for the management of lymphedema.

Engaging African American Parents to Develop a Mobile Health Technology for Breastfeeding: KULEA-NET.

BACKGROUND: African Americans breastfeed less than other groups, which has implications for health throughout the life course. Little is known about mobile health technologies to support breastfeeding. RESEARCH AIMS: This study proceeded in two phases. The aim of Phase 1 was to identify ideal technological components and content of a mobile health intervention. The aim of Phase 2 was to determine the usability of a prototype, KULEA-NET, based on the Phase 1 findings. METHODS: For this mixed-methods study, we used community-based participatory research methods and user-centered technology design methods. We used open coding in NVivo 11 to organize data from focus groups and in-depth interviews, then we analyzed the data. We then developed a prototype and tested the prototype's usability with the System Usability Scale. Fifty pregnant and postpartum African Americans from the District of Columbia participated. RESULTS: Participants preferred an app with text messaging technology and identified areas for intervention: self-efficacy, parent-child attachment beliefs, social support, public breastfeeding and social desirability, and returning to work. Desired features included local resources, support person access, baby care logs, identification of public breastfeeding venues, and peer discussions. The System Usability Scale score was 73.8, which indicates above average usability. CONCLUSIONS: A mobile health technology like KULEA-NET can be used to meet the breastfeeding needs of African Americans, build social desirability, and complement traditional health care. The appeal of an African American-specific intervention is unclear. Responding to mixed feeding practices is challenging. KULEA-NET is a mobile breastfeeding intervention guided by the preferences of African American parents and offers promising usability metrics.

Applying Medical Device Informatics to Enable Safe and Secure Interoperable Systems: Medical Device Interface Data Sheets.

This article describes the concept of Medical Device Interface Data Sheets (MDIDSs) to document and characterize medical device interface data requirements, the processes for creating MDIDSs, and its role in supporting patient safety and cybersecurity of current systems while enabling innovation in the area of next-generation medical Internet of Things (IoT) platforms for integrating sensors, actuators, and applications (apps).

Development and evaluation of a tablet-based diagnostic audiometer.

Objective: To develop and evaluate a software application capable of conducting Pure-Tone Audiometry tests in clinical practice. Design: We designed and developed a mobile software application for iPad devices that performs Pure-Tone Audiometry according to ANSI and IEC standards. The application is proposed to be operated by a trained audiologist inside a sound booth. No extra equipment is required. Hence, it updates the procedure by showing the versatility of the proposed system. Particularly, it provides manual and automated measurement, including air- and bone-conduction audiometry. Study sample: Twenty-nine participants-patients of Papageorgiou Hospital, Thessaloniki, Greece were tested, with all degrees of hearing sensitivity. Manual air- and bone-conduction Pure-Tone Audiometry was conducted inside a sound booth. Participants were tested with conventional audiometry and the audiometric application, in order to validate the tablet-based audiometer for measuring hearing thresholds. Results: The majority (90.9%) of air-conduction estimated hearing thresholds and (90.8%) of air-bone gaps were within 5 dB, compared to results obtained by conventional audiometry. Thus, threshold differences were not significant. Conclusions: The proposed audiometer is a reliable and valid tool for hearing assessment. Owing to certain limitations, mobile devices can provide a feasible substitute for conventional audiometry in clinical practice.

The Brain Imaging Collaboration Suite (BrICS): A Cloud Platform for Integrating Whole-Brain Spectroscopic MRI into the Radiation Therapy Planning Workflow.

Glioblastoma has poor prognosis with inevitable local recurrence despite aggressive treatment with surgery and chemoradiation. Radiation therapy (RT) is typically guided by contrast-enhanced T1-weighted magnetic resonance imaging (MRI) for defining the high-dose target and T2-weighted fluid-attenuation inversion recovery MRI for defining the moderate-dose target. There is an urgent need for improved imaging methods to better delineate tumors for focal RT. Spectroscopic MRI (sMRI) is a quantitative imaging technique that enables whole-brain analysis of endogenous metabolite levels, such as the ratio of choline-to-N-acetylaspartate. Previous work has shown that choline-to-N-acetylaspartate ratio accurately identifies tissue with high tumor burden beyond what is seen on standard imaging and can predict regions of metabolic abnormality that are at high risk for recurrence. To facilitate efficient clinical implementation of sMRI for RT planning, we developed the Brain Imaging Collaboration Suite (BrICS; https://brainimaging.emory.edu/brics-demo), a cloud platform that integrates sMRI with standard imaging and enables team members from multiple departments and institutions to work together in delineating RT targets. BrICS is being used in a multisite pilot study to assess feasibility and safety of dose-escalated RT based on metabolic abnormalities in patients with glioblastoma (Clinicaltrials.gov NCT03137888). The workflow of analyzing sMRI volumes and preparing RT plans is described. The pipeline achieved rapid turnaround time by enabling team members to perform their delegated tasks independently in BrICS when their clinical schedules allowed. To date, 18 patients have been treated using targets created in BrICS and no severe toxicities have been observed.

Improving Dental Students Fine Motor Skills by Visualization and Mental Imagery: A Pilot Randomized Clinical Trial / Mejora de las Habilidades Motoras Finas de los Estudiantes de Odontología Mediante Visualización e Imaginería: Ensayo Clínico Aleatorizado Piloto

ABSTRACT: Clinical motor skills are essential to train dental students. There is evidence that imagery serves to acquire and improve motor skills, since imagining an action, activates the same neural areas as when this is physically performed. The aim of this pilot randomized clinical trial was to examine the feasibility of tridimensional visualization associated with mental imagery on the development of fine motor skills of dental students compared to conventional training. Seventeen dental students without previous preclinical experiences, between 18-25 years old were recruited. After giving a theoretical lecture on the inlay preparation, participants were randomly allocated in two groups. The Experimental Group (N=9) performed daily 30 minutes of "mental practice" after visualizing a video showing the execution of an ideal inlay preparation alternating it with black screen periods to facilitate the imagery. The Control Group (N= 8) performed a 30 minutes "hands on practice" daily of the same preparation. On the fifth day, both groups carried out an inlay preparation physically, which was scanned and overlapped to the virtual preparation to assess accuracy. The execution time and accuracy of the preparation performed with regard to an ideal preparation were compared between groups. The learning style and fine motor skills at baseline were similar in all participants (P>0.001). No statistically significant differences were found between the groups in terms of accuracy. The time of execution in the experimental group was significantly lower than the control group. This pilot study showed that visualization associated to mental imagery could develop fine motor skills in dental students, requiring less execution time than physical practice.

RESUMEN: Las habilidades motoras clínicas son esenciales para entrenar a los estudiantes de odontología. Existe evidencia que la imaginería sirve para adquirir y mejorar las habilidades motoras, ya que al imaginar una acción, se activan las mismas áreas neuronales que cuando la acción se realiza físicamente. El objetivo de este ensayo clínico aleatorizado piloto fue examinar la factibilidad del uso de visualización tridimensional asociada con imaginería para el desarrollo de las habilidades motoras finas en estudiantes de odontología comparado con el entrenamiento convencional. Se reclutaron diecisiete estudiantes de odontología, entre 18-25 años de edad, sin experiencias preclínicas previas. Después de recibir una clase teórica sobre la preparación de una incrustación, los participantes fueron asignados aleatoriamente a dos grupos. El grupo experimental (N = 9) realizó diariamente 30 minutos de "práctica mental" después de visualizar un video que muestra la ejecución de una preparación de incrustación ideal alternando con períodos de pantalla negra para facilitar la imaginación. El grupo de control (N = 8) realizó una práctica diaria de 30 minutos de la misma preparación. El quinto día, ambos grupos llevaron a cabo físicamente una preparación de incrustación, que fue escaneada y esta imagen se superpuso a la preparación virtual ideal para evaluar la precisión. El tiempo de ejecución y la precisión de la preparación realizada con respecto a una preparación ideal se compararon entre ambos grupos. El estilo de aprendizaje y las habilidades motoras finas al inicio del estudio fueron similares en todos los participantes (P > 0,001). No se encontraron diferencias estadísticamente significativas entre los grupos en términos de precisión. El tiempo de ejecución en el grupo experimental fue significativamente menor que en el grupo control. Este estudio piloto mostró que la visualización asociada a imaginería podría desarrollar habilidades motoras finas en estudiantes de odontología, requiriendo menos tiempo de ejecución que la práctica física.

Implementation of alcohol and drug screening, brief intervention, and referral to treatment: Nurse practitioner learner perspectives on a mobile app.

BACKGROUND AND PURPOSE: Screening, brief Intervention, and referral to treatment (SBIRT) is a widely trained evidence-based strategy to identify and address alcohol and drug use problems. The purpose of this qualitative study was to explore the experience of family nurse practitioner (FNP) learners in the implementation of SBIRT and the perceived clinical utility of an SBIRT mobile app. METHODS: Twenty-two FNP learners completed didactic SBIRT training and orientation to an SBIRT mobile app. At the conclusion of the study, participant focus groups explored overall SBIRT delivery (N = 19) and SBIRT mobile app utilization (N = 14). Focus group data were analyzed within a Theory of Planned Behavior framework. RESULTS: Participants indicated that the mobile app was useful in the ongoing development of SBIRT knowledge, skill confidence, and motivation. Learners identified the clinical context as a major factor in facilitating the delivery of SBIRT overall. Participants who did not deliver SBIRT indicated that the most significant barriers to SBIRT implementation were lack of support from clinical preceptors and health systems. CONCLUSIONS: Findings suggest that a mobile app is an acceptable and feasible tool to improve the delivery of SBIRT. However, collaboration with preceptors and clinical training organizations is essential to optimize clinical translation.

SoftPuntura, software educativo sobre Acupuntura y Digitopuntura / Soft-Puncture, educational software on acupuncture and digital acupuncture

Introducción: la Medicina Natural y Tradicional actualmente se aplica como estrategia curricular en las carreras de las ciencias médicas, responde al lineamiento 138 de la política del partido. Objetivo: diseñar un software educativo sobre los principales puntos de acupuntura y digitopuntura para desarrollar habilidades teóricas y prácticas en los estudiantes de la carrera de medicina. Método: se realizó un estudio de desarrollo tecnológico en la Universidad de Ciencias Médicas de Pinar del Río, de octubre de 2014 a febrero de 2015. Como universo se tuvo en cuenta a todos los estudiantes de la carrera de medicina y profesores que imparten contenidos relacionados con el tema; la muestra de 60 estudiantes y 30 profesores se seleccionó de forma aleatoria simple, se utilizaron métodos teóricos y empíricos, se realizó un análisis estadístico porcentual, se diseñó y aplicó el software teniendo en cuenta las necesidades de aprendizaje. Resultados: se determinó un alto porciento de estudiantes que dominaron los principales contenidos sobre las técnicas de acupuntura y digitopuntura, los cuales eran deficientes antes de su aplicación, además se obtuvo aceptación por el estudiantado y los profesores, por lo que fue considerado como una útil herramienta para el estudio de la Medicina Natural y Tradicional en la carrera de Medicina. Conclusiones: se diseñó un recurso del aprendizaje que permite interactuar con la acupuntura y la digitopuntura, de fácil acceso y transportación, útil a estudiantes y profesores, lo que permitió el perfeccionamiento del proceso docente educativo en las asignaturas de la carrera de medicina(AU)

Introduction: Natural and Traditional Medicine is currently applied as a curricular strategy in medical science studies, it responds to the 138th guideline of the policies of the Cuban Communist Party. Objective: to design educational software on the main points of acupuncture and digital acupuncture to develop theoretical and practical skills in medical students. Method: a study of technological development was carried out at Pinar del Rio University of Medical Sciences, from October 2014 to February 2015. As a target group, all the students of the medical professions and professors who taught contents related to the subject were taken included; the sample of 60 students and 30 professors was chosen in a simple randomized approach, theoretical and empirical methods were used, a percentage statistical analysis was done, the software was designed and applied considering the needs of learning. Results: a high percentage of students who mastered the main contents on the acupuncture and digital acupuncture techniques were determined, which were deficient before their application, besides of having acceptance by the student body and the professors, because it was considered as a useful tool for the study of Natural and Traditional Medicine in medical studies. Conclusions: a learning resource was designed to interact with acupuncture and digital acupuncture, with easy access and transportation, useful to students and professors, which allowed the improvement of the educational process in the subjects of the medical studies(AU)

SoftPuntura, software educativo sobre Acupuntura y Digitopuntura / Soft-Puncture, educational software on acupuncture and digital acupuncture

Introducción: la Medicina Natural y Tradicional actualmente se aplica como estrategia curricular en las carreras de las ciencias médicas, responde al lineamiento 138 de la política del partido. Objetivo: diseñar un software educativo sobre los principales puntos de acupuntura y digitopuntura para desarrollar habilidades teóricas y prácticas en los estudiantes de la carrera de medicina. Método: se realizó un estudio de desarrollo tecnológico en la Universidad de Ciencias Médicas de Pinar del Río, de octubre de 2014 a febrero de 2015. Como universo se tuvo en cuenta a todos los estudiantes de la carrera de medicina y profesores que imparten contenidos relacionados con el tema; la muestra de 60 estudiantes y 30 profesores se seleccionó de forma aleatoria simple, se utilizaron métodos teóricos y empíricos, se realizó un análisis estadístico porcentual, se diseñó y aplicó el software teniendo en cuenta las necesidades de aprendizaje. Resultados: se determinó un alto porciento de estudiantes que dominaron los principales contenidos sobre las técnicas de acupuntura y digitopuntura, los cuales eran deficientes antes de su aplicación, además se obtuvo aceptación por el estudiantado y los profesores, por lo que fue considerado como una útil herramienta para el estudio de la Medicina Natural y Tradicional en la carrera de Medicina. Conclusiones: se diseñó un recurso del aprendizaje que permite interactuar con la acupuntura y la digitopuntura, de fácil acceso y transportación, útil a estudiantes y profesores, lo que permitió el perfeccionamiento del proceso docente educativo en las asignaturas de la carrera de medicina(AU)

Introduction: Natural and Traditional Medicine is currently applied as a curricular strategy in medical science studies, it responds to the 138th guideline of the policies of the Cuban Communist Party. Objective: to design educational software on the main points of acupuncture and digital acupuncture to develop theoretical and practical skills in medical students. Method: a study of technological development was carried out at Pinar del Rio University of Medical Sciences, from October 2014 to February 2015. As a target group, all the students of the medical professions and professors who taught contents related to the subject were taken included; the sample of 60 students and 30 professors was chosen in a simple randomized approach, theoretical and empirical methods were used, a percentage statistical analysis was done, the software was designed and applied considering the needs of learning. Results: a high percentage of students who mastered the main contents on the acupuncture and digital acupuncture techniques were determined, which were deficient before their application, besides of having acceptance by the student body and the professors, because it was considered as a useful tool for the study of Natural and Traditional Medicine in medical studies. Conclusions: a learning resource was designed to interact with acupuncture and digital acupuncture, with easy access and transportation, useful to students and professors, which allowed the improvement of the educational process in the subjects of the medical studies(AU)

MNE Scan: Software for real-time processing of electrophysiological data.

BACKGROUND: Magnetoencephalography (MEG) and Electroencephalography (EEG) are noninvasive techniques to study the electrophysiological activity of the human brain. Thus, they are well suited for real-time monitoring and analysis of neuronal activity. Real-time MEG/EEG data processing allows adjustment of the stimuli to the subject's responses for optimizing the acquired information especially by providing dynamically changing displays to enable neurofeedback. NEW METHOD: We introduce MNE Scan, an acquisition and real-time analysis software based on the multipurpose software library MNE-CPP. MNE Scan allows the development and application of acquisition and novel real-time processing methods in both research and clinical studies. The MNE Scan development follows a strict software engineering process to enable approvals required for clinical software. RESULTS: We tested the performance of MNE Scan in several device-independent use cases, including, a clinical epilepsy study, real-time source estimation, and Brain Computer Interface (BCI) application. COMPARISON WITH EXISTING METHOD(S): Compared to existing tools we propose a modular software considering clinical software requirements expected by certification authorities. At the same time the software is extendable and freely accessible. CONCLUSION: We conclude that MNE Scan is the first step in creating a device-independent open-source software to facilitate the transition from basic neuroscience research to both applied sciences and clinical applications.

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation.

Post-traumatic stress and other problems often occur after combat, deployment, and other military operations. Because techniques such as mindfulness meditation show efficacy in improving mental health, our team developed a mobile application (app) for individuals in the armed forces with subclinical psychological problems as secondary prevention of more significant disease. Based on the Personal Health Intervention Toolkit (PHIT), a mobile app framework for personalized health intervention studies, PHIT for Duty integrates mindfulness-based relaxation, behavioral education in sleep quality and alcohol use, and psychometric and psychophysiological data capture. We evaluated PHIT for Duty in usability and health assessment studies to establish app quality for use in health research. Participants (N = 31) rated usability on a 1 (very hard) to 5 (very easy) scale and also completed the System Usability Scale (SUS) questionnaire (N = 9). Results were (mean ± SD) overall (4.5 ± 0.6), self-report instruments (4.5 ± 0.7), pulse sensor (3.7 ± 1.2), sleep monitor (4.4 ± 0.7), sleep monitor comfort (3.7 ± 1.1), and wrist actigraphy comfort (2.7 ± 0.9). The average SUS score was 85 ± 12, indicating a rank of 95%. A comparison of PHIT-based assessments to traditional paper forms demonstrated a high overall correlation (r = 0.87). These evaluations of usability, health assessment accuracy, physiological sensing, system acceptability, and overall functionality have shown positive results and affirmation for using the PHIT framework and PHIT for Duty application in mobile health research.

Creation of virtual patients for midwifery education.

OBJECTIVE: The objective of the study was to create several new, original virtual patients (VPs) in the Slovak language, especially for educational purposes in midwifery. SETTING: Virtual patients have been created for the needs of university midwifery education in Slovakia. MODEL: The creation of the six virtual patients basically consisted of three fixed stages: preparation, design and development, implementation into the virtual environment. We used the Open Labyrinth (OL) virtual environment, an open-source system for creating VPs. The VPs include six various scenarios of the most common problems seen in midwifery practice: preterm birth, perinatal loss, gestational diabetes, ineffective breastfeeding, postpartum bleeding and sudden home birth. FINDINGS: Currently, six original virtual patients are used in university midwifery education in Slovakia. We use them for contact teaching as well as self-study of students. They present the first VPs in Slovakia and the Czech Republic created in academic settings in these countries. CONCLUSIONS: The future perspective of a virtual patient as an interactive process between the student and the medium is that it can deepen and improve learning outcomes, solve specific midwifery issues, and reduce mistakes in the clinical environment.

Music Distraction Effectiveness in Dental Anxiety and Treatment Adherence in 6-Year-Old Children: A Randomized Clinical Trial / Efectividad de la Distracción Musical Sobre la Ansiedad Dental y Adherencia a Tratamiento en Niños de 6 Años: Ensayo Clínico Aleatorizado

ABSTRACT: Dental anxiety can be a barrier to following healthy behaviours. Musical distraction is an effective strategy to reduce dental anxiety and improve treatment adherence. The aim was to determine the effect of musical distraction on dental anxiety and treatment adherence in 6-year-old children. Multicenter randomized control trial with 176 children who were allocated into two parallel groups. One group received usual dental care (N 88), and the other was exposed to musical distraction during usual dental care (N 88). The primary outcome was dental anxiety and secondary was oral health status and oral health care behaviours. Both were assessed at baseline, discharged and six-month follow-up. Mid/high dental anxiety was exhibited by 16.1 % of the children. Musical distraction had no effect on dental anxiety levels in the experimental compared with the control group at any of the time points assessed. The size effect was 0.35 and 0.15 (Cliff's Delta) for baseline-discharge and 0.57 and 0.35 for baseline-six month. Only 47.7 % of the sample attended at 6-month follow-up. Dental anxiety is not prevalent in the sample and is not beneficially reduced by musical distraction. The educational actions of the dental care programme are not sufficient to attain permanent long-term changes in oral health behaviour.

RESUMEN: La ansiedad dental puede ser una barrera para seguir conductas saludables. La distracción musical es una estrategia efectiva para reducir la ansiedad dental y mejorar la adherencia al tratamiento. El objetivo fue determinar el efecto de la distracción musical sobre la ansiedad dental y la adherencia al tratamiento en niños de 6 años. Ensayo multicéntrico de control aleatorizado con 176 niños asignados a dos grupos paralelos. Un grupo recibió atención dental habitual (n 88) y el otro estuvo expuesto a distracción musical durante el cuidado dental habitual (N 88). El resultado primario fue la ansiedad dental y secundaria fue el estado de salud oral y las conductas de salud oral. Ambos fueron evaluados al inicio, dados de alta y seguidos durante seis meses. La ansiedad dental media / alta fue exhibida por 16,1 % de los niños. La distracción musical no tuvo ningún efecto sobre los niveles de ansiedad dental en el grupo experimental en comparación con el grupo control en ninguno de los momentos evaluados. El efecto del tamaño fue 0,35 y 0,15 (Cliff's Delta) para el inicio y el alta y 0,57 y 0,35 para el inicio y los seis meses de seguimiento. Solo el 47,7 % de la muestra asistió a los 6 meses de seguimiento. La ansiedad dental no prevalece en la muestra y no se ve beneficiada por la distracción musical. Las acciones educativas del programa de atención dental no son suficientes para lograr cambios permanentes a largo plazo en el comportamiento de salud oral.

[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?] / Abgrenzung und Klassifizierung von Medical Apps : Was ist zu beachten und welche Unterstützung bietet das BfArM?

Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.

Novel automated point collection software facilitates rapid, high-density electroanatomical mapping with multiple catheter types.

INTRODUCTION: Manual, point-by-point electroanatomical mapping requires the operator to directly evaluate each point during map construction. Consequently, point collection can be a slow process. An automated 3D mapping system was developed with the goal of improving key mapping metrics, including map completion time and point density. METHODS: Automated 3D mapping software that includes morphology and cycle length discrimination functions for surface and intracardiac electrograms was developed. In five swine, electroanatomical maps (EAMs) of all four cardiac chambers were generated in sinus rhythm. Four catheters were used: two different four-pole ablation catheters, a 20-pole circular catheter, and a 64-pole basket catheter. Automated and manual 3D mapping were compared for 12 different catheter-chamber combinations (paired sets of 10 maps for most combinations, for a total of 156 maps). RESULTS: Automated 3D mapping produced more than twofold increase in the number of points per map, as compared with manual 3D mapping (P ≤0.007 for all catheter-chamber combinations tested). Automated 3D mapping also reduced map completion time by an average of 29% (P < 0.05 for all comparisons). The amount of manual editing of the maps acquired with automated 3D mapping was minimal. CONCLUSION: Automated 3D mapping with the open-platform mapping software described in this study is significantly faster than manual, point-by-point 3D mapping. This resulted in shorter mapping time and higher point density. The morphology discrimination functions effectively excluded ectopic beats during mapping in sinus rhythm and allowed for rapid mapping of intermittent ventricular ectopic beats.

[Application of a shared interdisciplinary and multiprofessional cardio-oncology in-hospital pathway]. / Applicazione di un percorso diagnostico-terapeutico assistenziale di cardioncologia per la rilevazione e la gestione del danno cardiaco da trattamenti oncologici in ambito ospedaliero.

The burden of cardiac side effects in oncology patients will dramatically increase in the near future as a result of the widespread use of anticancer agents affecting the cardiovascular system, the general population aging, the heightened attention in the detection of cardiac toxicity and the absolute gain in terms of overall survival. The relationship between cardiologists and oncologists should therefore be closer leading to the definition of cardio-oncology. The increased number of such patients requires the creation of a dedicated patient assistance program in order to guarantee every patient the possibility of an interdisciplinary and multiprofessional approach. A dedicated care pathway needs a reorganization of internal resources to ensure high standards of care. The proposed pathway is actually active at our institution and has been implemented taking into account available facilities and planned work amount. Our patient cardio-oncology program could be adapted with minimal changes to different hospitals.

Development and implementation of a psychotherapy tracking database in primary care.

INTRODUCTION: Although there is a rapid increase in the integration of behavioral health services in primary care, few studies have evaluated the effectiveness of these services in real-world clinical settings, in part due to the difficulty of translating traditional mental health research designs to this setting. Accordingly, innovative approaches are needed to fit the unique challenges of conducting research in primary care. The development and implementation of one such approach is described in this article. METHOD: A continuously populating database for psychotherapy services was implemented across 5 primary care clinics in a large health system to assess several levels of patient care, including service utilization, symptomatic outcomes, and session-by-session use of psychotherapy principles by providers. RESULTS: Each phase of implementation revealed challenges, including clinician time, dissemination to clinics with different resources, and fidelity of data collection strategy across providers, as well as benefits, including the generation of useful data to inform clinical care, program development, and empirical research. DISCUSSION: The feasible and sustainable implementation of data collection for routine clinical practice in primary care has the potential to fuel the evidence base around integrated care. The current project describes the development of an innovative approach that, with further empirical study and refinement, could enable health care professionals and systems to understand their population and clinical process in a way that addresses essential gaps in the integrated care literature. (PsycINFO Database Record