Assessing the manufacturable 32-channel cochlear electrode array: evaluation results for clinical trials.

Reliability evaluation results of a manufacturable 32-channel cochlear electrode array are reported in this paper. Applying automated laser micro-machining process and a layer-by-layer silicone deposition scheme, authors developed the manufacturing methods of the electrode array for fine patterning and mass production. The developed electrode array has been verified through the requirements specified by the ISO Standard 14708-7. And the insertion trauma of the electrode array has been evaluated based on human temporal bone studies. According to the specified requirements, the electrode array was assessed through elongation & insulation, flexural, and fatigue tests. In addition, Temporal bone study was performed using eight fresh-frozen cadaver temporal bones with the electrode arrays inserted via the round window. Following soaking in saline condition, the impedances between conducting wires of the electrode array were measured over 100 kΩ (the pass/fail criterion). After each required test, it was shown that the electrode array maintained the electrical continuity and insulation condition. The average insertion angle of the electrode array inside the scala tympani was 399.7°. The human temporal bone studies exhibited atraumatic insertion rate of 60.3% (grade 0 or 1). The reliability of the manufacturable electrode array is successfully verified in mechanical, electrical, and histological aspects. Following the completion of a 32-channel cochlear implant system, the performance and stability of the 32-channel electrode array will be evaluated in clinical trials.

Outcomes in kidney transplant recipients treated with immediate-release tacrolimus capsules versus extended-release tacrolimus capsules: A cohort study.

INTRODUCTION: Prior randomized trials and observational studies have generally reported similar outcomes in kidney transplant recipients (KTRs) treated with immediate-release tacrolimus (IR-TAC) versus extended-release tacrolimus (ER-TAC). However, many of these previous studies focused on patients with low immunological risks, had small sample sizes and brief follow-up periods, and excluded outcomes associated with graft loss, such as chronic rejection. METHODS: To address these limitations, we conducted a cohort study of 848 KTRs at a single transplantation center who had generally high immunological risks and were treated with either IR-TAC capsules (589 patients, 65.9%) or ER-TAC capsules (289 patients, 34.1%). All patients received their designated maintenance immunosuppressive regimen for at least 3 months post-transplantation. Afterwards, tacrolimus formulation was at the discretion of each patient's transplant nephrologist. For the two treatment groups, we compared the hazards of experiencing a composite outcome of acute or chronic antibody-mediated rejection (AMR), acute or chronic T-cell-mediated rejection, de novo DSA, and/or graft loss over a 3-year period starting at 3 months post-transplantation. RESULTS: In a multivariable Cox proportional hazards regression model, KTRs treated with IR-TAC capsules had an increased hazard of experiencing the composite outcome when compared to patients treated with ER-TAC capsules; however, this result was not significant (adj HR 1.24, 95% CI .92-1.68, p = .163). Similar results were obtained with inverse probability of treatment weighting (IPTW) using a propensity score (adj HR 1.25, 95% CI .93-1.68, p = .146). CONCLUSION: These findings suggest that when compared to IR-TAC capsules, ER-TAC capsules do not reduce the hazard of poor outcomes in KTRs with generally high immunological risks.

The Healthy Democracy Kit: design, implementation, uptake, and impact of a novel voter registration toolkit for healthcare settings.

BACKGROUND: Access to voting is increasingly recognized as a social determinant of health. Health equity could be improved if healthcare workers (HCWs) routinely assessed the voter registration status of patients during clinical encounters and helped direct them towards appropriate resources. However, little consensus exists on how to achieve these tasks efficiently and effectively in healthcare settings. Intuitive and scalable tools that minimize workflow disruptions are needed. The Healthy Democracy Kit (HDK) is a novel voter registration toolkit for healthcare settings, featuring a wearable badge and posters that display quick response (QR) and text codes directing patients to an online hub for voter registration and mail-in ballot requests. The objective of this study was to assess national uptake and impact of the HDK prior to the 2020 United States (US) elections. METHODS: Between 19 May and 3 November 2020, HCWs and institutions could order and use HDKs to help direct patients to resources, free of cost. A descriptive analysis was conducted to summarize the characteristics of participating HCWs and institutions as well as the resultant total persons helped prepare to vote. RESULTS: During the study period, 13,192 HCWs (including 7,554 physicians, 2,209 medical students, and 983 nurses) from 2,407 affiliated institutions across the US ordered 24,031 individual HDKs. Representatives from 604 institutions (including 269 academic medical centers, 111 medical schools, and 141 Federally Qualified Health Centers) ordered 960 institutional HDKs. Collectively, HCWs and institutions from all 50 US states and the District of Columbia used HDKs to help initiate 27,317 voter registrations and 17,216 mail-in ballot requests. CONCLUSIONS: A novel voter registration toolkit had widespread organic uptake and enabled HCWs and institutions to successfully conduct point-of-care civic health advocacy during clinical encounters. This methodology holds promise for future implementation of other types of public health initiatives. Further study is needed to assess downstream voting behaviors from healthcare-based voter registration.

Evaluation of a Mobile Health Approach to Tuberculosis Contact Tracing in Botswana.

Tuberculosis (TB) contact tracing is typically conducted in resource-limited settings with paper forms, but this approach may be limited by inefficiencies in data collection, storage, and retrieval and poor data quality. In Botswana, we developed, piloted, and evaluated a mobile health (mHealth) approach to TB contact tracing that replaced the paper form-based approach for a period of six months. For both approaches, we compared the time required to complete TB contact tracing and the quality of data collected. For the mHealth approach, we also administered the Computer System Usability Questionnaire to 2 health care workers who used the new approach, and we identified and addressed operational considerations for implementation. Compared to the paper form-based approach, the mHealth approach reduced the median time required to complete TB contact tracing and improved data quality. The mHealth approach also had favorable overall rating, system usefulness, information quality, and interface quality scores on the Computer System Usability Questionnaire. Overall, the mHealth approach to TB contact tracing improved on the paper form-based approach used in Botswana. This new approach may similarly benefit TB contact tracing efforts in other resource-limited settings.

Crowdsourcing--harnessing the masses to advance health and medicine, a systematic review.

OBJECTIVE: Crowdsourcing research allows investigators to engage thousands of people to provide either data or data analysis. However, prior work has not documented the use of crowdsourcing in health and medical research. We sought to systematically review the literature to describe the scope of crowdsourcing in health research and to create a taxonomy to characterize past uses of this methodology for health and medical research. DATA SOURCES: PubMed, Embase, and CINAHL through March 2013. STUDY ELIGIBILITY CRITERIA: Primary peer-reviewed literature that used crowdsourcing for health research. STUDY APPRAISAL AND SYNTHESIS METHODS: Two authors independently screened studies and abstracted data, including demographics of the crowd engaged and approaches to crowdsourcing. RESULTS: Twenty-one health-related studies utilizing crowdsourcing met eligibility criteria. Four distinct types of crowdsourcing tasks were identified: problem solving, data processing, surveillance/monitoring, and surveying. These studies collectively engaged a crowd of >136,395 people, yet few studies reported demographics of the crowd. Only one (5 %) reported age, sex, and race statistics, and seven (33 %) reported at least one of these descriptors. Most reports included data on crowdsourcing logistics such as the length of crowdsourcing (n = 18, 86 %) and time to complete crowdsourcing task (n = 15, 71 %). All articles (n = 21, 100 %) reported employing some method for validating or improving the quality of data reported from the crowd. LIMITATIONS: Gray literature not searched and only a sample of online survey articles included. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Utilizing crowdsourcing can improve the quality, cost, and speed of a research project while engaging large segments of the public and creating novel science. Standardized guidelines are needed on crowdsourcing metrics that should be collected and reported to provide clarity and comparability in methods.

The 2013 US Government Shutdown (#Shutdown) and health: an emerging role for social media.

In October 2013, multiple United States (US) federal health departments and agencies posted on Twitter, "We're sorry, but we will not be tweeting or responding to @replies during the shutdown. We'll be back as soon as possible!" These "last tweets" and the millions of responses they generated revealed social media's role as a forum for sharing and discussing information rapidly. Social media are now among the few dominant communication channels used today. We used social media to characterize the public discourse and sentiment about the shutdown. The 2013 shutdown represented an opportunity to explore the role social media might play in events that could affect health.

Hidden in plain sight: a crowdsourced public art contest to make automated external defibrillators more visible.

OBJECTIVES: We sought to explore the feasibility of using a crowdsourcing study to promote awareness about automated external defibrillators (AEDs) and their locations. METHODS: The Defibrillator Design Challenge was an online initiative that asked the public to create educational designs that would enhance AED visibility, which took place over 8 weeks, from February 6, 2014, to April 6, 2014. Participants were encouraged to vote for AED designs and share designs on social media for points. Using a mixed-methods study design, we measured participant demographics and motivations, design characteristics, dissemination, and Web site engagement. RESULTS: Over 8 weeks, there were 13 992 unique Web site visitors; 119 submitted designs and 2140 voted. The designs were shared 48 254 times on Facebook and Twitter. Most designers-voters reported that they participated to contribute to an important cause (44%) rather than to win money (0.8%). Design themes included: empowerment, location awareness, objects (e.g., wings, lightning, batteries, lifebuoys), and others. CONCLUSIONS: The Defibrillator Design Challenge engaged a broad audience to generate AED designs and foster awareness. This project provides a framework for using design and contest architecture to promote health messages.

Use of social media across US hospitals: descriptive analysis of adoption and utilization.

BACKGROUND: Use of social media has become widespread across the United States. Although businesses have invested in social media to engage consumers and promote products, less is known about the extent to which hospitals are using social media to interact with patients and promote health. OBJECTIVE: The aim was to investigate the relationship between hospital social media extent of adoption and utilization relative to hospital characteristics. METHODS: We conducted a cross-sectional review of hospital-related activity on 4 social media platforms: Facebook, Twitter, Yelp, and Foursquare. All US hospitals were included that reported complete data for the Centers for Medicare and Medicaid Services Hospital Consumer Assessment of Healthcare Providers and Systems survey and the American Hospital Association Annual Survey. We reviewed hospital social media webpages to determine the extent of adoption relative to hospital characteristics, including geographic region, urban designation, bed size, ownership type, and teaching status. Social media utilization was estimated from user activity specific to each social media platform, including number of Facebook likes, Twitter followers, Foursquare check-ins, and Yelp reviews. RESULTS: Adoption of social media varied across hospitals with 94.41% (3351/3371) having a Facebook page and 50.82% (1713/3371) having a Twitter account. A majority of hospitals had a Yelp page (99.14%, 3342/3371) and almost all hospitals had check-ins on Foursquare (99.41%, 3351/3371). Large, urban, private nonprofit, and teaching hospitals were more likely to have higher utilization of these accounts. CONCLUSIONS: Although most hospitals adopted at least one social media platform, utilization of social media varied according to several hospital characteristics. This preliminary investigation of social media adoption and utilization among US hospitals provides the framework for future studies investigating the effect of social media on patient outcomes, including links between social media use and the quality of hospital care and services.

The histone deacetylase inhibitor valproic acid lessens NK cell action against oncolytic virus-infected glioblastoma cells by inhibition of STAT5/T-BET signaling and generation of gamma interferon.

Tumor virotherapy has been and continues to be used in clinical trials. One barrier to effective viral oncolysis, consisting of the interferon (IFN) response induced by viral infection, is inhibited by valproic acid (VPA) and other histone deacetylase inhibitors (HDACi). Innate immune cell recruitment and activation have been shown to be deleterious to the efficacy of oncolytic herpes simplex virus (oHSV) infection, and in this report we demonstrate that VPA limits this deleterious response. VPA, administered prior to oHSV inoculation in an orthotopic glioblastoma mouse model, resulted in a decline in NK and macrophage recruitment into tumor-bearing brains at 6 and 24 h post-oHSV infection. Interestingly, there was a robust rebound of recruitment of these cells at 72 h post-oHSV infection. The observed initial decline in immune cell recruitment was accompanied by a reduction in their activation status. VPA was also found to have a profound immunosuppressive effect on human NK cells in vitro. NK cytotoxicity was abrogated following exposure to VPA, consistent with downmodulation of cytotoxic gene expression of granzyme B and perforin at the mRNA and protein levels. In addition, suppression of gamma IFN (IFN-γ) production by VPA was associated with decreased STAT5 phosphorylation and dampened T-BET expression. Despite VPA-mediated immune suppression, mice were not at significantly increased risk for HSV encephalitis. These findings indicate that one of the avenues by which VPA enhances oHSV efficacy is through initial suppression of immune cell recruitment and inhibition of inflammatory cell pathways within NK cells.

What is the current status of global health activities and opportunities in US orthopaedic residency programs?

BACKGROUND: Interest in developing national health care has been increasing in many fields of medicine, including orthopaedics. One manifestation of this interest has been the development of global health opportunities during residency training. QUESTIONS/PURPOSES: We assessed global health activities and opportunities in orthopaedic residency in terms of resident involvement, program characteristics, sources of funding and support, partner site relationships and geography, and program director opinions on global health participation and the associated barriers. METHODS: An anonymous 24-question survey was circulated to all US orthopaedic surgery residency program directors (n = 153) by email. Five reminder emails were distributed over the next 7 weeks. A total of 59% (n = 90) program directors responded. RESULTS: Sixty-one percent of responding orthopaedic residencies facilitated clinical experiences in developing countries. Program characteristics varied, but most used clinical rotation or elective time for travel (76%), which most frequently occurred during Postgraduate Year 4 (57%) and was used to provide pediatric (66%) or trauma (60%) care. The majority of programs (59%) provided at least some funding to traveling residents and sent accompanying attendings on all ventures (56%). Travel was most commonly within North America (85%), and 51% of participating programs have established international partner sites although only 11% have hosted surgeons from those partnerships. Sixty-nine percent of residency directors believed global health experiences during residency shape future volunteer efforts, 39% believed such opportunities help attract residents to a training program, and the major perceived challenges were funding (73%), faculty time (53%), and logistical planning (43%). CONCLUSIONS: Global health interest and activity are common among orthopaedic residency programs. There is diversity in the characteristics and geographical locations of such activity, although some consensus does exist among program directors around funding and faculty time as the largest challenges.

Morphology and stability of mineralized carbon influenced by magnesium ions.

Ex situ mineralization of CO2 is a promising technology that employs Ca- and Mg-rich industrial wastes but it simultaneously produces end products. Although Mg is a major mineralization source, it can adversely impact carbonate precipitation and crystal stability during co-precipitation in combination with Ca2+. In this study, the effects of Mg2+ ions on the mineralization process and its products were investigated using precipitates formed at different aqueous concentrations of Mg2+. The final phases of the precipitates were quantitatively evaluated at the end of each process. The alterations undergone by the calcite crystals, which constituted the dominant carbonate phase in each experiment, were analyzed using a sophisticated crystallographic approach. Aragonite was detected at high Mg2+ concentrations (Mg2+/Ca2+ ratio of 2.00), although brucite was the sole phase of the Mg crystal. The increase in Mg2+ ion concentration induced the formation of an amorphous solid. The results revealed that a drastic transformation of the calcite lattice occurred when the ratio of Mg2+/Ca2+ exceeded 1.00, agreeing with the shifts observed in the calcite structure upon comparing the precipitates formed at the Mg2+/Ca2+ ratios of 1.00 and 2.00, wherein microstrain and crystallite sizes changed from 0.040 and 55.33 nm to 0.1533 and 12.35 nm, respectively. At a Mg2+/Ca2+ ratio of 2.00, 6.51% of the Ca2+ ions in the calcite structure were substituted by Mg2+, increasing the surface energy of the crystal and the solubility of the carbonate. Therefore, Mg2+ is a potential hindrance that can impede the precipitation of carbonates and increase instability at certain concentrations.

A National Voter Registration Campaign.

Research suggests that increased voting among adults is associated with improved child health. Despite the benefits of voting, the United States has low voter turnout compared with peer nations. Turnout is especially low among marginalized people in the United States. Voter registration is essential for increasing voter turnout, and registration efforts have been successfully carried out in clinical settings. Working with a nonprofit called Vot-ER, we advocated for nonpartisan voter registration efforts in pediatric settings nationwide preceding the November 2020 US elections. We describe lessons learned from these efforts. Using data obtained from Vot-ER, we also provide the first estimates of participation in a national voter registration campaign in pediatric settings. There was widespread engagement in voter registration efforts among pediatricians in 2020. Many lessons were learned from these efforts, including the benefits of advanced planning because registration deadlines can be up to 1 month in advance of Election Day. Obtaining buy-in from numerous stakeholders (e.g., health center leadership, public relations teams) supports widespread staff participation. Also important is to consider the tradeoffs between active voter registration (in which staff can broach the topic of voting with patients and families) and passive efforts (in which voting is discussed only if patients or families inquire about it). These and other lessons can inform future voter registration efforts in diverse pediatric settings across the country.

The Vot-ER Healthy Democracy Campaign: A National Medical Student Competition to Increase Voting Access.

PROBLEM: Voting affords citizens a direct say in the leaders and policies that affect their health. However, less than 20% of eligible U.S. citizens have been offered the chance to register to vote at a government-funded agency like a hospital or clinic that provides Medicaid or Medicare services. Medical students are well positioned to increase voting access due to their interactions with multiple actors in health care settings, including patients, visitors, colleagues, and others. APPROACH: Vot-ER, a nonpartisan, nonprofit organization that aims to promote civic engagement in health care settings, launched the inaugural Healthy Democracy Campaign from July 20 to October 9, 2020. As part of this national, gamification-based competition, medical student captains were recruited to lead teams of health care trainees and professionals that helped eligible adults start the voter registration and/or mail-in ballot request process before the November 2020 elections. Post competition, medical student captains were surveyed about their motivations for participating and skills and knowledge gained. OUTCOMES: In total, 128 medical student captains at 80 medical schools in 31 states and the District of Columbia formed teams that helped 15,692 adults start the voter registration and/or mail-in ballot request process. Eighty-two (64.1%) captains responded to the post competition survey, representing 56 (70.0%) of the participating schools. The top-ranked motivation for participating in the campaign was the desire to address social and racial inequities (37, 45.1%). Respondents reported gaining skills and knowledge in several aspects of civic engagement, including community organizing (67, 81.7%) and voting rights (63, 76.8%). The majority of respondents planned to incorporate voter registration into their future practice (76, 92.7%). NEXT STEPS: Future Healthy Democracy Campaigns will aim to continue closing the voting access gap and promote the long-term inclusion of hands-on civic engagement in medical education and practice.

Manufacturable 32-Channel Cochlear Electrode Array and Preliminary Assessment of Its Feasibility for Clinical Use.

(1) Background: In this study, we introduce a manufacturable 32-channel cochlear electrode array. In contrast to conventional cochlear electrode arrays manufactured by manual processes that consist of electrode-wire welding, the placement of each electrode, and silicone molding over wired structures, the proposed cochlear electrode array is manufactured by semi-automated laser micro-structuring and a mass-produced layer-by-layer silicone deposition scheme similar to the semiconductor fabrication process. (2) Methods: The proposed 32-channel electrode array has 32 electrode contacts with a length of 24 mm and 0.75 mm spacing between contacts. The width of the electrode array is 0.45 mm at its apex and 0.8 mm at its base, and it has a three-layered arrangement consisting of a 32-channel electrode layer and two 16-lead wire layers. To assess its feasibility, we conducted an electrochemical evaluation, stiffness measurements, and insertion force measurements. (3) Results: The electrochemical impedance and charge storage capacity are 3.11 ± 0.89 kOhm at 1 kHz and 5.09 mC/cm2, respectively. The V/H ratio, which indicates how large the vertical stiffness is compared to the horizontal stiffness, is 1.26. The insertion force is 17.4 mN at 8 mm from the round window, and the maximum extraction force is 61.4 mN. (4) Conclusions: The results of the preliminary feasibility assessment of the proposed 32-channel cochlear electrode array are presented. After further assessments are performed, a 32-channel cochlear implant system consisting of the proposed 32-channel electrode array, 32-channel neural stimulation and recording IC, titanium-based hermetic package, and sound processor with wireless power and signal transmission coil will be completed.

Correction: Ha, Y. et al. Hemispherical Microelectrode Array for Ex Vivo Retinal Neural Recording. Micromachines 2020, 11, 538.

The authors would like to make the following changes to the published paper [...].

Hemispherical Microelectrode Array for Ex Vivo Retinal Neural Recording.

To investigate the neuronal visual encoding process in the retina, researchers have performed in vitro and ex vivo electrophysiological experiments using animal retinal tissues. The microelectrode array (MEA) has become a key component in retinal experiments because it enables simultaneous neural recording from a population of retinal neurons. However, in most retinal experiments, it is inevitable that the retinal tissue is flattened on the planar MEA, becoming deformed from the original hemispherical shape. During the tissue deforming process, the retina is subjected to mechanical stress, which can induce abnormal physiological conditions. To overcome this problem, in this study, we propose a hemispherical MEA with a curvature that allows retinal tissues to adhere closely to electrodes without tissue deformation. The electrode array is fabricated by stretching a thin, flexible polydimethylsiloxane (PDMS) electrode layer onto a hemispherical substrate. To form micro patterns of electrodes, laser processing is employed instead of conventional thin-film microfabrication processes. The feasibility for neural recording from retinal tissues using this array is shown by conducting ex vivo retinal experiments. We anticipate that the proposed techniques for hemispherical MEAs can be utilized not only for ex vivo retinal studies but also for various flexible electronics.

Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial.

BACKGROUND: Regular physical activity reduces the risk of cardiovascular events, but most ischemic heart disease (IHD) patients do not obtain enough. METHODS AND RESULTS: ACTIVE REWARD (A Clinical Trial Investigating Effects of a Randomized Evaluation of Wearable Activity Trackers with Financial Rewards) was a 24-week home-based, remotely monitored, randomized trial with a 16-week intervention (8-week ramp-up incentive phase and 8-week maintenance incentive phase) and an 8-week follow-up. Patients used wearable devices to track step counts and establish a baseline. Patients in control received no other interventions. Patients in the incentive arm received personalized step goals and daily feedback for all 24 weeks. In the ramp-up incentive phase, daily step goals increased weekly by 15% from baseline with a maximum of 10 000 steps and then remained fixed. Each week, $14 was allocated to a virtual account; $2 could be lost per day for not achieving step goals. The primary outcome was change in mean daily steps from baseline to the maintenance incentive phase. Ischemic heart disease patients had a mean (SD) age of 60 (11) years and 70% were male. Compared with control, patients in the incentive arm had a significantly greater increase in mean daily steps from baseline during ramp-up (1388 versus 385; adjusted difference, 1061 [95% confidence interval, 386-1736]; P<0.01), maintenance (1501 versus 264; adjusted difference, 1368 [95% confidence interval, 571-2164]; P<0.001), and follow-up (1066 versus 92; adjusted difference, 1154 [95% confidence interval, 282-2027]; P<0.01). CONCLUSIONS: Loss-framed financial incentives with personalized goal setting significantly increased physical activity among ischemic heart disease patients using wearable devices during the 16-week intervention, and effects were sustained during the 8-week follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02531022.