Disinvestment in the presence of uncertainty: Description of a novel, multi-group, disinvestment trial design and protocol for an application to reduce or cease use of mobilisation alarms for preventing falls in hospitals.

Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a "Reduced" (<3%) or "Eliminated" (0%) mobilisation alarm condition. Dynamic randomisation will be used to determine which ward in each pair will be allocated to either the reduced or eliminated condition to promote equivalence between wards for the embedded parallel, cluster randomised component of the design. A project governance committee will set non-inferiority margins. The primary outcome will be rates of falls. Secondary clinical, process, safety, and economic outcomes will be collected and a concurrent economic evaluation undertaken.

Accuracy of soft tissue balancing in total knee arthroplasty using surgeon-defined assessment versus a gap-balancer or electronic sensor.

BACKGROUND: Soft tissue balancing is essential for the success of total knee arthroplasty (TKA) and is mainly dependent on surgeon-defined assessment (SDA) or a gap-balancer (GB). However, an electronic sensor has been developed to objectively measure the gap pressure. This study aimed to evaluate the accuracy of soft tissue balancing using SDA and GB compared with a sensor. METHODS: Forty-eight patients undergoing TKA (60 knees) were prospectively enrolled. Soft tissue balancing was sequentially performed using SDA, a GB, and an electronic sensor. We compared the SDA, GB, and sensor data to calculate the sensitivity, specificity, and accuracy at 0°, 45°, 90°, and 120° flexion. Cumulative summation (CUSUM) analysis was performed to assess the surgeon's performance during the sensor introductory phase. RESULTS: The sensitivity of SDA was 63.3%, 68.3%, 80.0%, and 80.0% at 0°, 45°, 90°, and 120°, respectively. The accuracy of the GB compared with sensor data was 76.7% and 71.7% at 0° and 90°, respectively. Cohen's kappa coefficient for the accuracy of the GB was 0.406 at 0° (moderate agreement) and 0.227 at 90° (fair agreement). The CUSUM 0° line achieved good prior performance at case 45, CUSUM 90° and 120° showed a trend toward good prior performance, while CUSUM 45° reached poor prior performance at case 8. CONCLUSION: SDA was a poor predictor of knee balance. GB improved the accuracy of soft tissue balancing, but was still less accurate than the sensor, particularly for unbalanced knees. SDA improved with ongoing use of the sensor, except at 45° flexion.

Use of Electronic Consultation System to Improve Access to Care in Pediatric Hematology/Oncology.

BACKGROUND: Electronic consultations (eConsult) allow for communication between primary care providers and specialists in an asynchronous manner. This study examined provider satisfaction, topics of interest, and efficiency of eConsult in pediatric hematology/oncology in Ottawa, Canada. METHODS: We conducted a cross-sectional assessment of all eConsult cases directed to pediatric hematology/oncology specialists using the Champlain BASE (Building Access to Specialists through eConsultation) eConsult service from June 1, 2014 to May 31, 2016. RESULTS: There were 1064 eConsults to pediatrics during the study timeperiod and pediatric hematology/oncology consults accounted for 8% (85). During the same study timeperiod, 524 consults were seen in the pediatric hematology/oncology clinic. The majority of the eConsults were for hematology (90.5%) in contrast to oncology topics (9.5%). The most common topics were anemia, hemoglobinopathy, bleeding disorder, and thrombotic state. Primary care providers rated the eConsult service very highly, and their comments were very positive. The eConsult service resulted in deferral of 40% of consults originally contemplated to require a face-to-face specialist visit. CONCLUSIONS: This study showed successful implementation and use of the eConsult service for pediatric hematology/oncology and resulted in avoidance of a large number of face-to-face consultation. The common topics identified areas for continuing medical education.

A comparison between indirect and objective wear-time assessment of removable orthodontic appliances.

Background/Objectives: Patients do not always adhere to the wear times prescribed for removable orthodontic appliances. We evaluated the validity and usability of indirect wear-time assessment methods by comparing wear-time estimates with microelectronically measured wear times in patients with removable orthodontic appliances. Methods: Wear times of 33 expansion plates, 34 functional appliances, and 42 retention plates of patients aged 6-20 years (12.3±2.9 years, 50.5% female) were indirectly determined by practitioners using a questionnaire assessing five parameters on a 5-point Likert scale: appliance handling, appliance appearance, bite shift, tooth movement, and appliance fit. The perceived difficulty in assessing each parameter was rated. Actual wear times were evaluated with microelectronic sensors in the appliances. Results: Regression analyses revealed that practitioners' decisions about wear times varied depending on the type of appliance and criteria used, with only one standard criterion best predicting estimated wear time for each appliance. Different standard criteria were better predictors of measured wear time: 22.3% of wear-time variability was explained by expansion plate appearance, 31.2% by functional appliance handling, and 18.8% by retainer fitting. However, practitioners rated the difficulty of assessment in most cases as 'easy'. Limitations: The study was not double blinded for technical reasons, and practitioners may have considered the evaluation criteria more carefully than in normal daily practice. Conclusions: Practitioners' decisions about wear times based on standard criteria strongly vary depending on the type of appliance and criteria used.

Technologies for Prolonging Cardiac Implantable Electronic Device Longevity.

Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.

Design and assessment of novel artificial anal sphincter with adaptive transcutaneous energy transfer system.

This paper presents the in vitro assessment of a novel elastic scaling artificial anal sphincter system (ES-AASS) with an adaptive transcutaneous energy transfer system (TETS) for treatment of severe faecal incontinence (FI). The proposed adaptive TETS has a phase control, which can maintain the output voltage at ∼7 V across the full range of the coupling coefficient variation (from 0.09-0.31) during the whole process of charging with a phase shift of 177.5° to 79.1°. A maximum surface temperature of 42.2 °C was measured above the secondary coil during an energy transmission of 3.5 W in air. The specific absorption rate (SAR) and current density analysis of the biological three-layers structure, including the skin, fat and muscle) surrounding the coil pair were analysed and the results of simulation analysis showed that the value of SAR and current density were very small at any given transmission condition compared with the basic restrictions of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). In conclusion, in vitro experimental results showed that the ES-AASS can control simulated faecal behaviour effectively and the performance of TETS was validated.

Instrumented hip joint replacements, femoral replacements and femoral fracture stabilizers.

This paper reviews instrumented hip joint replacements, instrumented femoral replacements and instrumented femoral fracture stabilizers. Examination of the evolution of such implants was carried out, including the detailed analysis of 16 architectures, designed by 8 research teams and implanted in 32 patients. Their power supply, measurement, communication, processing and actuation systems were reviewed, as were the tests carried out to evaluate their performance and safety. These instrumented implants were only designed to measure biomechanical and thermodynamic quantities in vivo, in order to use such data to conduct research projects and optimize rehabilitation processes. The most promising trend is to minimize aseptic loosening and/or infection following hip or femoral replacements or femoral stabilization procedures by using therapeutic actuators inside instrumented implants to apply controlled stimuli in the bone-implant interface.

Flexible polymer transistors with high pressure sensitivity for application in electronic skin and health monitoring.

Flexible pressure sensors are essential parts of an electronic skin to allow future biomedical prostheses and robots to naturally interact with humans and the environment. Mobile biomonitoring in long-term medical diagnostics is another attractive application for these sensors. Here we report the fabrication of flexible pressure-sensitive organic thin film transistors with a maximum sensitivity of 8.4 kPa(-1), a fast response time of <10 ms, high stability over >15,000 cycles and a low power consumption of <1 mW. The combination of a microstructured polydimethylsiloxane dielectric and the high-mobility semiconducting polyisoindigobithiophene-siloxane in a monolithic transistor design enabled us to operate the devices in the subthreshold regime, where the capacitance change upon compression of the dielectric is strongly amplified. We demonstrate that our sensors can be used for non-invasive, high fidelity, continuous radial artery pulse wave monitoring, which may lead to the use of flexible pressure sensors in mobile health monitoring and remote diagnostics in cardiovascular medicine.

A dinâmica inovativa do subsistema de base mecânica, eletrônica e de materiais / The innovative dynamic of the mechanics, electronics and materials subsystem / La dinámica innovadora del subsistema de base mecánica, electrónica y de materiales

O subsistema de base mecânica, eletrônica e de materiais, um dos subsistemas do complexo produtivo da saúde, reúne diferentes atividades, usualmente agregadas na designada indústria de equipamentos e materiais médico-hospitalares e odontológicos, uma área estratégica para a saúde por representar uma fonte contínua de mudanças nas práticas assistenciais. Além de exercer influência na prestação de serviços de saúde, possui potencial de promover o adensamento do sistema nacional de inovação e de ampliar a competitividade da indústria como um todo, dado que articula tecnologias portadoras de futuro. Apesar do crescimento significativo dessa indústria no Brasil nos últimos anos, esses equipamentos e materiais têm apresentado um crescente déficit na balança comercial. Essa incompatibilidade entre as necessidades nacionais de saúde e a base produtiva e inovativa da indústria aponta fragilidades estruturais do subsistema. Utilizando o arcabouço da economia política, o objetivo do artigo foi discutir o desenvolvimento dessa indústria no Brasil e seus desafios.

The mechanics, electronics and materials subsystem, one of the subsystems of the health care productive complex, encompasses different activities, usually clustered in what is called the medical, hospital and dental equipment and materials industry. This is a strategic area for health care, since it represents a continuous source of changes in care practices, and influences the provision of health care services. It has, moreover, potential for promoting the progress of Brazil's system of innovation and for increasing the competitiveness of the industry as a whole, given that it articulates future technologies. Despite the significant growth of this industry in Brazil in recent years, such equipment and materials have been presenting a growing deficit in the balance of trade. This incompatibility between national health care needs and the productive and innovative basis of the industry points to structural fragilities in the system. Using the framework of political economy, the article aims to discuss the development of this industry in Brazil and its challenges.

OBJETIVO: El subsistema de base mecánica, electrónica y de materiales, uno de los subsistemas del complejo productivo de la salud, reúne diferentes actividades, usualmente agregadas en la designada industria de equipos y materiales médico-hospitalarios y odontológicos, un área estratégica para la salud por representar una fuente continua de cambios en las prácticas asistenciales. Además de ejercer influencia en la prestación de servicios de salud, posee potencial de promover la saturación del sistema nacional de innovación y de ampliar la competitividad de la industria como un todo, dado que articula tecnologías portadoras de futuro. A pesar del crecimiento significativo de esta industria en Brasil en los últimos años, los equipos y materiales han presentado un creciente déficit en la balanza comercial. Esta incompatibilidad entre las necesidades nacionales de salud y la base productiva e innovadora de la industria señalan fragilidades estructurales del subsistema. Utilizando el armazón de la economía política, el objetivo del artículo fue discutir el desarrollo de ésta industria en Brasil y sus desafíos.

Remote monitoring of cardiovascular implanted electronic devices: a paradigm shift for the 21st century.

Traditional follow-up of cardiac implantable electronic devices involves the intermittent download of largely nonactionable data. Remote monitoring represents a paradigm shift from episodic office-based follow-up to continuous monitoring of device performance and patient and disease state. This lessens device clinical burden and may also lead to cost savings, although data on economic impact are only beginning to emerge. Remote monitoring technology has the potential to improve the outcomes through earlier detection of arrhythmias and compromised device integrity, and possibly predict heart failure hospitalizations through integration of heart failure diagnostics and hemodynamic monitors. Remote monitoring platforms are also huge databases of patients and devices, offering unprecedented opportunities to investigate real-world outcomes. Here, the current status of the field is described and future directions are predicted.

An Electronic Patch for wearable health monitoring by reflectance pulse oximetry.

We report the development of an Electronic Patch for wearable health monitoring. The Electronic Patch is a new health monitoring system incorporating biomedical sensors, microelectronics, radio frequency (RF) communication, and a battery embedded in a 3-dimensional hydrocolloid polymer. In this paper the Electronic Patch is demonstrated with a new optical biomedical sensor for reflectance pulse oximetry so that the Electronic Patch in this case can measure the pulse and the oxygen saturation. The reflectance pulse oximetry solution is based on a recently developed annular backside silicon photodiode to enable low power consumption by the light emitting components. The Electronic Patch has a disposable part of soft adhesive hydrocolloid polymer and a reusable part of hard polylaurinlactam. The disposable part contains the battery. The reusable part contains the reflectance pulse oximetry sensor and microelectronics. The reusable part is 'clicked' into the disposable part when the patch is prepared for use. The patch has a size of 88 mm by 60 mm and a thickness of 5 mm.

[The innovative dynamic of the mechanics, electronics and materials subsystem]. / A dinâmica inovativa do subsistema de base mecânica, eletrônica e de materiais.

The mechanics, electronics and materials subsystem, one of the subsystems of the health care productive complex, encompasses different activities, usually clustered in what is called the medical, hospital and dental equipment and materials industry. This is a strategic area for health care, since it represents a continuous source of changes in care practices, and influences the provision of health care services. It has, moreover, potential for promoting the progress of Brazil's system of innovation and for increasing the competitiveness of the industry as a whole, given that it articulates future technologies. Despite the significant growth of this industry in Brazil in recent years, such equipment and materials have been presenting a growing deficit in the balance of trade. This incompatibility between national health care needs and the productive and innovative basis of the industry points to structural fragilities in the system. Using the framework of political economy, the article aims to discuss the development of this industry in Brazil and its challenges.

A low-cost, portable, micro-controlled device for multi-channel LED visual stimulation.

Light emitting diodes (LEDs) are extensively used as light sources to investigate visual and visually related function and dysfunction. Here, we describe the design of a compact, low-cost, stand-alone LED-based system that enables the configuration, storage and presentation of elaborate visual stimulation paradigms. The core functionality of this system is provided by a microcontroller whose ultra-low power consumption makes it well suited for long lasting battery applications. The effective use of hardware resources is managed by multi-layered architecture software that provides an intuitive and user-friendly interface. In the configuration mode, different stimulation sequences can be created and memorized for ten channels, independently. LED-driving current output can be set either as continuous or pulse modulated, up to 500 Hz, by duty cycle adjustments. In run mode, multiple-channel stimulus sequences are automatically applied according to the pre-programmed protocol. Steady state visual evoked potentials were successfully recorded in five subjects with no visible electromagnetic interferences from the stimulator, demonstrating the efficacy of combining our prototyped equipment with electrophysiological techniques. Finally, we discuss a number of possible improvements for future development of our project.

Objective assessment of laparoscopic suturing skills using a motion-tracking system.

BACKGROUND: Laparoscopic suturing skills are important for advanced laparoscopic surgery. However, objective assessment of these skills has not yet been established. The aim of this study was to assess the laparoscopic suturing skills of novice and experienced surgeons using an electromagnetic motion-tracking system. METHODS: A total of 18 surgeons, who were all right-handed, were divided into the following two groups according to their experience as an operator in laparoscopic surgery: 9 novice surgeons (fewer than 10 laparoscopic procedures) and 9 experienced surgeons (more than 50 laparoscopic procedures). The subjects performed an intracorporeal suturing task in an inanimate box laparoscopic trainer while the movements of their forceps were evaluated using an electromagnetic motion-tracking system. Their laparoscopic skills were assessed on the basis of the time, path length, and average speed of the forceps in each hand. RESULTS: Experienced surgeons completed the suturing task significantly faster than novice surgeons did. The left path length was significantly shorter for experienced surgeons than for novice surgeons, whereas the right path lengths did not differ. The right average speed of knot tying was significantly faster for experienced surgeons than for novice surgeons, whereas the left average speeds did not differ. CONCLUSIONS: Evaluation of psychomotor skills in laparoscopic suturing using an electromagnetic motion-tracking system revealed better results for experienced surgeons than for novice surgeons in terms of the time taken, left path length, and right speed of knot-tying. Furthermore, surgical proficiency due to experience can affect surgical dexterity of each hand differently. The present study also demonstrates the efficacy of this system for objective evaluation of laparoscopic suturing skills.

Development of cost-effective biocompatible packaging for microelectronic devices.

A cost-effective, miniaturized and biocompatible packaging method for medical devices is proposed, resulting in a small, soft and comfortable implantable package. Towards this end, the barrier materials and fabrication process for the individual die encapsulation are largely explored. We demonstrate that various common clean room materials are good candidates for preventing metal leaching into body. In accelerated tests at higher temperature, several conductive barrier materials are damaged by the test bio-fluid, suggesting insufficient resistance to body fluids in long term. Covering electrodes by noble metals will solve this problem. For metallization, noble metals as Pt are best candidates. CoO calculations showed that selective plating of Pt is more cost-effective than sputtering. To reduce the cost of a sputter process, Pt recycling is very important.

A portable system for the assessment of neuromuscular diseases with electrical impedance myography.

PRIMARY OBJECTIVE: To create a system for the acquisition of multi-angle, multifrequency muscle impedance data. RESEARCH DESIGN: Device development and preliminary testing. METHODS AND PROCEDURES: The system presented here employs an interrogating signal composed of multiple tones with frequencies between 10 kHz and 300 kHz. The use of a composite signal makes possible measurement of impedance at multiple frequencies simultaneously. In addition, this system takes impedance measurements at multiple orientations with respect to the muscle fibres by means of an electronically reconfigurable electrode array. The required measurement time is reduced by taking advantage of muscle's linearity with respect to the flow of electrical current. MAIN OUTCOMES AND RESULTS: The system was tested in normal subjects, a patient with amyotrophic lateral sclerosis, and one with inclusion body myositis; unique impedance signatures were identified the two patients. CONCLUSIONS: Early data suggest that this system is capable of high-quality data collection and may detect changes in neuromuscular disease; study of additional normal subjects and patients with a variety of neuromuscular diseases is warranted.