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Abstract We propose the addition of usability validation to the extended V3 framework, now “V3+”, and describe a pragmatic approach to ensuring that sensor-based digital health technologies can be used optimally at scale by diverse users. Alongside the original V3 components (verification; analytical validation; clinical validation), usability validation will ensure user-centricity of digital measurement tools, paving the way for more inclusive, reliable, and trustworthy digital measures within clinical research and clinical care.

In the present study, co-processed excipients from chitosan, and maize starch were prepared by co-dispersion, and co-granulation methods in 1:1 ratio. The resultant products were then characterized physically by their micrometric properties and hygroscopic characters. The co-processed excipient prepared by co-granulation was chosen and was added to a directly compressible oral sustained-release tablet (Batch F1-F4) containing ibuprofen as a model drug. A well-known marketed ibuprofen tablet (Motrin) was taken for comparison purposes of the dissolution characteristics. Pre-compression parameters, as well as post-compression parameters of all the batches, were performed. The pre-compression parameters, and post-compression parameters of F3, containing chitosan to maize in the ratio of 2:1, were found to be comparable with the marketed product. F3 batch showed 74.7 % of drug release up to 8 h, which reflect the release retardant properties of co-processed excipient. Collectively, co-processed excipients of chitosan, and maize starch improve the physical properties of individual materials, and can be used as a directly compressible excipient as a release retardant material for oral sustained-release tablets.

BackgroundIncreasing adoption of sensor-based digital health technologies (sDHTs) in recent years has cast light on the many challenges in implementing these tools into clinical trials and patient care at scale across diverse patient populations; however, the methodological approaches taken toward sDHT usability evaluation have varied markedly. ObjectiveThis review aims to explore the current landscape of studies reporting data related to sDHT human factors, human-centered design, and usability, to inform our concurrent work on developing an evaluation framework for sDHT usability. MethodsWe conducted a scoping review of studies published between 2013 and 2023 and indexed in PubMed, in which data related to sDHT human factors, human-centered design, and usability were reported. Following a systematic screening process, we extracted the study design, participant sample, the sDHT or sDHTs used, the methods of data capture, and the types of usability-related data captured. ResultsOur literature search returned 442 papers, of which 85 papers were found to be eligible and 83 papers were available for data extraction and not under embargo. In total, 164 sDHTs were evaluated; 141 (86%) sDHTs were wearable tools while the remaining 23 (14%) sDHTs were ambient tools. The majority of studies (55/83, 66%) reported summative evaluations of final-design sDHTs. Almost all studies (82/83, 99%) captured data from targeted end users, but only 18 (22%) out of 83 studies captured data from additional users such as care partners or clinicians. User satisfaction and ease of use were evaluated for 83% (136/164) and 91% (150/164) of sDHTs, respectively; however, learnability, efficiency, and memorability were reported for only 11 (7%), 4 (2%), and 2 (1%) out of 164 sDHTs, respectively. A total of 14 (9%) out of 164 sDHTs were evaluated according to the extent to which users were able to understand the clinical data or other information presented to them (understandability) or the actions or tasks they should complete in response (actionability). Notable gaps in reporting included the absence of a sample size rationale (reported for 21/83, 25% of all studies and 17/55, 31% of summative studies) and incomplete sociodemographic descriptive data (complete age, sex/gender, and race/ethnicity reported for 14/83, 17% of studies). ConclusionsBased on our findings, we suggest four actionable recommendations for future studies that will help to advance the implementation of sDHTs: (1) consider an in-depth assessment of technology usability beyond user satisfaction and ease of use, (2) expand recruitment to include important user groups such as clinicians and care partners, (3) report the rationale for key study design considerations including the sample size, and (4) provide rich descriptive statistics regarding the study sample to allow a complete understanding of generalizability to other patient populations and contexts of use.

Objectives: To describe and compare caregiver perceptions of their emergency department (ED) experiences with and without child life specialist (CLS) involvement in their child's overall care. Study design: A descriptive cross-sectional survey of caregivers of children aged 0-17 years at a tertiary care pediatric ED was completed from March to August 2021. Survey themes included perceived experience and satisfaction and the impact of child life specialists. Results: A total of 179 caregivers completed the survey; mean age was 38.9 years (SD 8.4), and 68.1% (122/179) were mothers. Caregivers of children with CLS involvement (CLS+) ranked their overall experience (P = .021) and satisfaction (P = .009) greater than without CLS involvement (CLS–). More CLS+ caregivers ranked their experience (55.7%, 34/61) and their satisfaction (77.0%, 47/61) as excellent (5/5 Likert scale rating) compared with CLS– caregivers (34.8%, 40/115 and 52.2%, 60/115 respectively). CLS+ families were more likely to be offered nonpharmacologic interventions (eg, iPad, sensory lights, toys) (98.4% vs 31.3%, P = .003); they were also more likely to have a health care worker explore their feelings and fears (52.5% vs 27.0%, P = .0008), help them prepare for a procedure or examination (73.8% vs 31.3%, P

The interactions between cellulose nanocrystals and six different polymers (three anionic, two non-ionic, and one cationic) were investigated using rheological measurements of aqueous solutions of nanocrystals and polymers. The experimental viscosity data could be described adequately by a power-law model. The variations in power-law parameters (consistency index and flow behavior index) with concentrations of nanocrystals and polymers were determined for different combinations of nanocrystals and polymers. The interactions between nanocrystals and the following polymers: anionic sodium carboxymethyl cellulose and non-ionic guar gum, were found to be strong in that the consistency index increased substantially with the addition of nanocrystals to polymer solutions. The interaction between nanocrystals and non-ionic polymer polyethylene oxide was moderate. Depending on the concentrations of nanocrystals and polymer, the consistency index both increased and decreased upon the addition of nanocrystals to polymer solution. The interactions between nanocrystals and the following polymers: anionic xanthan gum, anionic polyacrylamide, and cationic quaternary ammonium salt of hydroxyethyl cellulose, were found to be weak. The changes in rheological properties with nanocrystal addition to these polymer solutions were found to be small or negligible.

Abstract Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED). Designed for real-world use, the Evidence DEFINED Quick Start Guide may help streamline DHI assessment. A checklist is provided summarizing high-priority evidence considerations in digital health. Evidence-to-recommendation guidelines are proposed, specifying degrees of adoption that may be appropriate for a range of evidence quality levels. Evidence DEFINED differs from prior frameworks in its inclusion of unique elements designed for rigor and speed. Rigor is increased by addressing three gaps in prior frameworks. First, prior frameworks are not adapted adequately to address evidence considerations that are unique to digital health. Second, prior frameworks do not specify evidence quality criteria requiring increased vigilance for DHIs in the current regulatory context. Third, extant frameworks rarely leverage established, robust methodologies that were developed for non-digital interventions. Speed is achieved in the Evidence DEFINED Framework through screening optimization and deprioritization of steps that may have limited value. The primary goals of Evidence DEFINED are to a) facilitate standardized, rapid, rigorous DHI evidence assessment in organizations and b) guide digital health solutions providers who wish to generate evidence that drives DHI adoption.

Introduction: Large chunks of the tissue are sacrificed during the surgical procedures for the treatment if oral cancers. Our goal was to assess the viability of “Buccal reconstruction using the anterolateral thigh (ALT) flaps, platysma myocutaneous (PM), and radial forearm free (RFF)”. Material and Methods: Sixty subjects were included in this investigation, and they were divided into 3 groups. The follow-up as accompanied for six months. Comparisons were made for the time for the operations, reduction in the width of the mouth opening and the survival rates of the flaps. The data that was collected for the above two parameters and compared for the significance using the ANOVA, keeping P < 0.05 as significant. Results: In the subjects with the PM, the width of the mouth opening reduced comparatively greater than that of the subjects who received other two flaps. The reduction in the mouth opening in the PM was significantly greater compared to that of the ALT and RFF. Survival was greater for the groups ALT and RFF compared to PM. Time of the surgery was the greatest for the ALT and least for the PF. Conclusion: The observations point to the fact that the PF requires more time than that of the other two flaps. The survival was however better for the ALT and RFF. Further research is suggested for suggesting an appropriative flap design.

Introduction: Over the past ten years, parents have become more involved in choosing the aesthetic restorations for their ward. The strip crown and the prefabricated zirconia crown are some of the common anterior aesthetic complete crowns. The purpose of this study is to examine parental satisfaction over a one-year period in children aged three to five with “Strip Crowns” versus “Preformed Primary Anterior Zirconia Crowns”. Materials and Procedures: Current study included 20 children. Among them their both central incisors were restored using the two varieties of crowns. The distribution of participants was done using the permuted block randomization approach. Twenty parents who participated were called back over a year to complete the questionnaire. The data was collected and compared while the statistics are deemed significant at P < 0.05. Results: Both restoration options received positive feedback from parents. With strip crowns, there was a statistically significant correlation between overall happiness and longevity of the restoration (P = 0.003) and color (P = 0.033) in zirconium crowns. The parents who expressed less pleasure with the strip crowns' longevity and the color of zirconia crowns did so overall, though. Conclusion: In conclusion, prefabricated primary anterior zirconia crowns were more popular with parents than strip crowns. All other criteria were about equally well-liked by parents, with the exception of longevity, which was more common for zirconia crowns.

Introduction Infectious Intracranial Aneurysms (IIAs), commonly referred to as mycotic aneurysms, are a common sequela of infective endocarditis (IE). Approximately 65% of patients found to have IIAs also have IE, and IIAs occur in up to 10% of patients with IE. Currently, there are no guidelines for the management of IIAs due to the small sample size of observational studies and no randomized controlled studies. In addition to management techniques regarding IIAs, strategic cardiac valve surgery planning also remains imperative. Standard recommendations are to delay cardiac surgery by four weeks if patients are treated conservatively and if they remain stable. However, if one is able to embolize and secure IIAs, then that delay between endovascular therapy (EVT) and surgery may be shortened. We present a single‐center experience demonstrating the timing between securing mycotic aneurysms and cardiac surgery. Methods This is a single‐center retrospective observational study of patients admitted with IE who were found to have IIAs at our institute from 2016 to 2022. Descriptive statistics were performed using SAS statistical software and Microsoft Excel. Results Out of a total of 862 patients with IE, 25 patients (3.0%) were identified to have 41 IIAs (single aneurysm in 18 patients and multiple aneurysms in 7 patients). The median (IQR) age of our population was 45 (27‐65) years, with 28/41 (68.3%) male patients. The most common location of IIAs was the distal segments of the posterior and middle cerebral arteries in both groups. Of these 41 IIAs, 24/41 (58.5%) were ruptured and 17/41 (41.5%) were unruptured. A total of 14/24 (58.3%) ruptured IIAs were treated vs. none were treated in the unruptured IIAs group (P=0.001). A total of 8/41 (19.5%) IIAs were secured before undergoing cardiac valve surgery. The median (minimum‐maximum) number of days between securing aneurysms to valvular surgery was 18 (10‐29). Only 2/41 (4.9%) IIAs were detected following valvular surgery. Those were treated on day 3 and day 15 following surgery. There were 4/41 (9.7%) secured IIAs that did not undergo valvular surgery as they did not meet surgical criteria or had surgery planned at another admission. Conclusion Our study demonstrates that a timeframe of 2‐3 weeks from securing IIAs to cardiac surgery is considered safe. However, one should note that our cohort consists of a small sample size. Therefore, additional large multicenter observational studies are warranted to confirm these findings.

Introduction Infectious intracranial aneurysms (IIAs), commonly referred to as mycotic aneurysms, are a common sequela of infective endocarditis (IE). Approximately 65% of patients found to have IIAs also have IE, and IIAs occur in up to 10% of patients with IE. Clinically, it is important to be able to identify IIAs as well as their etiologies to adequately manage these insidious vascular lesions. Mortality rates have been reported up to 30% for unruptured and 80% for ruptured mycotic aneurysms. With upcoming advances in the neuro‐endovascular field, there has been a surge in pursuing endovascular therapies to secure these aneurysms which have yielded positive outcomes. We present a single‐center experience describing the characteristics and outcomes of ruptured and unruptured IIAs. Methods This is a single‐center retrospective observational study of patients admitted with IE who developed IIAs and were admitted at our institute from 2016 to 2022. Descriptive statistics were performed using SAS statistical software and Microsoft Excel. Results Out of a total of 862 patients with IE, 25 patients (3.0%) were identified to have 41 IIAs (single aneurysm in 18 patients and multiple aneurysms in 7 patients). The median (IQR) age of our population was 45 (27‐65) years, with 28/41 (68.3%) male patients. The most common location of IIAs was the distal segments of the posterior and middle cerebral arteries in both groups. The overall mean (minimum‐maximum) size of all IIAs was 2.8 (0.2‐11) mm. Of these 41 IIAs, 24/41 (58.5%) were ruptured and 17/41 (41.5%) were unruptured. A total of 14/24 (58.3%) ruptured IIAs were treated vs. none were treated in the unruptured IIAs group (P=0.001). The average (minimum‐maximum; mm) size of ruptured IIAs was 3.3 (0.2‐11) vs. 2.1 (0.8‐5) in the unruptured IIAs group (P=0.324). More patients died while hospitalized with ruptured aneurysms vs unruptured aneurysms at 29.1% and 11.7%, respectively (P=0.18). Additionally, 16.7% of those in the ruptured group were discharged home, whereas 41.2% in the unruptured IIA group were discharged home (P=0.08). Conclusion This study emphasizes the significant mortality rate observed among patients with ruptured IIAs. Clinicians should remain vigilant when screening patients. Our study suggests that ruptured IIAs should be secured while unruptured IIAs may be monitored closely.

Abstract Inhaled corticosteroid (ICS) therapy is widely prescribed without a history of exacerbations and consensus guidelines suggest withdrawal of ICS in these patients would reduce the risk of side effects and promote cost-effective prescribing. The study describes the prescribing behaviour in the United Kingdom (UK) in relation to ICS withdrawal and identifies clinical outcomes following withdrawal using primary and secondary care electronic health records between January 2012 and December 2017. Patients with a history ≥12 months’ exposure who withdrew ICS for ≥6 months were identified into two cohorts; those prescribed a long-acting bronchodilator maintenance therapy and those that were not prescribed any maintenance therapy. The duration of withdrawal, predictors of restarting ICS, and clinical outcomes were compared between both patient cohorts. Among 76,808 patients that had ≥1 prescription of ICS in the study period, 11,093 patients (14%) withdrew ICS therapy at least once during the study period. The median time without ICS was 9 months (IQR 7–14), with the majority (71%) receiving subsequent ICS prescriptions after withdrawal. Patients receiving maintenance therapy with a COPD review at withdrawal were 28% less likely to restart ICS (HR: 0.72, 95% CI 0.61, 0.85). Overall, 69% and 89% of patients that withdrew ICS had no recorded exacerbation event or COPD hospitalisation, respectively, during the withdrawal. This study provides evidence that most patients withdrawing from ICS do not experience COPD exacerbations and withdrawal success can be achieved by carefully planning routine COPD reviews whilst optimising the use of available maintenance therapies.

Introduction The Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial published in 2010 showed aggressive medical therapy is superior to percutaneous transluminal angioplasty and stenting (PTAS) for intracranial atherosclerotic disease (ICAD). Following the pivotal positive mechanical thrombectomy (MT) trials in 2015, MT utilization in the United States (US) has increased. Rescue ICAD stenting may be needed in MT patients with underlying ICAD but it remains uncertain whether PTAS use for ICAD has changed over this time. The aim of this study is to describe national trends in the utilization of PTAS for ICAD in the US before and after SAMMPRIS and following the pivotal MT trials. Methods We used a constellation of International Classification of Diseases ninth and tenth revision diagnostic/procedural codes to identify all elective and non‐elective adult (> = 18 years) ICAD admissions with or without infarction containing concomitant codes for PTAS in the 2007–2019 National Inpatient Sample. Admissions containing codes for subarachnoid hemorrhage, unruptured intracranial aneurysms or benign intracranial hypertension were excluded. We combined weighted counts of PTAS admissions with annual US adult census data to obtain prevalence of PTAS. We used joinpoint regression to evaluate trends in PTAS use over time. Results Across the study period, there were 16,477 weighted admissions for ICAD undergoing PTAS in the US. 52.4% of these admissions were in patients 60–79years and 43.2% were in women. 74.3% of these admissions were non‐elective and this proportion increased over time (P = 0.019). 26.5% of all admissions had concurrent codes for MT but this proportion increased by almost ten‐fold over time from 4.3% in 2007 to 40.0% in 2019. On join point regression, PTAS utilization increased but insignificantly from 3.0/million population in 2007 to 5.7/million population in 2010 (Annualized percentage change, APC 11.2%, 95%CI ‐11.8 to 40.3, p = 0.290), declined also insignificantly from 2010–2013 (APC ‐13.2, 95%CI ‐48.4 to 45.8, p = 0.514) and increased significantly from 3.55/million in 2013 to 3.80/million in 2014 and exponentially across the rest of the period to 8.4 cases/million in 2019 (APC 15.4, 95%CI 9.2 to 22.0, p = 0.001). Upon stratification by admission type, most of the increase across the period 2013/2014 to 2019 occurred in non‐elective admissions (Figure 1). Utilization in elective admissions varied from 0.92 to 1.96 cases per million population but this did not change significantly across the study period. Conclusions PTAS utilization for ICAD declined in the US after SAMMPRIS but has increased following publication of pivotal MT trials mainly in non‐elective admissions. PTAS utilization increased significantly following publication of pivotal MT trials likely in ICAD patients who required rescue stenting.. Additional prospective studies are needed to determine the long‐term outcomes of concurrent PTAS and MT as this is not a group of patients that was studied in SAMMPRIS.

Introduction Chronic subdural hematoma (cSDH) is one of the most common neurosurgical diagnoses with a high recurrence rate in the aging population. The primary pathologic process is repeated micro bleeding from fragile neo‐vessels supplied by peripheral branches of the middle meningeal artery (MMA). MMA embolization is an efficacious minimally invasive neuroendovascular technique for the management of chronic subdural hematoma. It has demonstrated reduced incidence of re‐bleeding and recurrence of cSDH in elderly patients. Particle and liquid embolic materials are commonly used to devascularize the MMA however studies comparing the safety and outcomes between these two materials are limited. Our objective was to perform a descriptive analysis to investigate differences and outcomes among two most frequently employed materials for MMA embolization. Methods We performed a single center retrospective review of patients ≥ 18 years who had MMA embolization for cSDH between July 2020 and May 2022. The primary safety, radiation dosage, fluoroscopy time, radiographic and clinical outcomes were compared between particle and liquid embolization. A descriptive analysis for continuous and categorical variables was performed using SAS 9.4 version. Results In a cohort of 116, 48 (41.38%) were treated with liquid embolic material and 68 (58.62%) were treated with particle. The median age of the cohort was 73 years in particle group and 73.5 years in liquid embolic group. There was no significant difference in radiation dose or duration among both groups. There was no reported mortality associated to procedure. One patient experienced non‐disabling ischemic stroke in the particle group. Based on imaging follow‐up, three patients in particle group and one in liquid embolic group had asymptomatic recurrence. One patient in each group had symptomatic recurrence requiring hematoma evacuation. Index median size of hematoma was 12 mm in particle group and 11 mm in liquid embolic group. At approximately one month follow up, the median size of hematoma reduced to 6 mm in both groups. Conclusions Our series demonstrates that liquid embolic and particle embolization are equally safe and effective among patients undergoing MMA embolization for management of cSDH.

OBJECTIVES: As hospitals rapidly implement mechanical thrombectomy (MT) into stroke protocols following the pivotal trials in 2015, access to and outcomes from MT may be poorer for weekend-admitted patients. We sought to investigate whether a “weekend effect” influences MT outcomes nationally. MATERIALS AND METHODS: We identified stroke patients from 2010–2014 (pre-trials) to 2015–2017 (posttrials) using the Nationwide Readmissions Database. On multivariate analyses, we determined factors independently associated with receiving MT. Among MT patients, we then determined whether weekend admission was independently associated with inpatient mortality and unfavorable discharge. RESULTS: We identified 2,121,462 patients from 2010 to 2014, of whom 1.11% of weekday-admitted and 1.08% of weekend-admitted patients underwent MT. Of the 1,286,501 patients identified from 2015 to 2017, MT was performed in 2.82% and 2.91%, respectively. In the earlier cohort, weekend admission was independently associated with reduced odds of MT (odds ratio [OR] = 0.92, 95% confidence interval [CI]: 0.89–0.95, P < 0.0001), although this was not statistically significant in the later cohort. During both periods, age >80 years was independently associated with a reduced likelihood of receiving MT, and status as a teaching or large bed-size hospital was associated with a greater likelihood. Weekend admission was independently associated with unfavorable discharge only in the 2015–2017 cohort (OR = 1.11, 95% CI: 1.02–1.22, P = 0.02). CONCLUSIONS: While nationwide access to MT has improved for weekend-admitted patients, the elderly and those at smaller, nonteaching hospitals remain underserved. Although we found no effect of weekend admission on inpatient mortality, since the major shift in practice, an emerging “weekend effect” may influence discharge outcomes. Data suggest that some hospitals are being challenged to provide this new standard of care efficiently and equitably.

IntroductionAneurysmal subarachnoid hemorrhage (aSAH) is a rare event associated with significant pregnancy-associated maternal and neonatal morbidity and mortality. The optimal treatment strategy and clinical outcome of aSAH in pregnancy remains unclear. We aimed to investigate the treatment utilizations and outcomes of aSAH in pregnant people.MethodsUsing the 2010-2018 National Inpatient Sample, we identified all birth hospitalizations of women between ages of 18 to 45 associated with subarachnoid hemorrhage and aneurysm treatment were included. Multivariate analyses were used to evaluate the effect of pregnancy state, mode of treatment of aneurysms, severity of subarachnoid hemorrhage on mortality and discharge destination of this cohort. Trends in mode of treatment utilized for aneurysmal treatment in this time interval was evaluated.Results13,351 aSAH with treatment were identified, of which 440 were associated with pregnancy. There was no significant difference in mortality or rate of discharge to home in pregnancy related hospitalization. Worse aSAH severity, chronic hypertension, and smaller hospital size was associated with significantly higher rate of mortality from aSAH during pregnancy. Worse aSAH severity was associated with lower rate of discharge to home. Like the non-pregnant cohort, the treatment of ruptured aneurysms in pregnancy are increasingly through endovascular approaches. The mode of treatment does not change the mortality or discharge destination.ConclusionsPregnancy does not alter mortality or the discharge destination for aSAH. Ruptured aneurysms during pregnancy are increasingly treated endovascularly. Mode of aneurysm treatment does not affect mortality or discharge destination in pregnancy.

Although health care delivery is becoming increasingly digitized, driven by the pursuit of improved access, equity, efficiency, and effectiveness, progress does not appear to be equally distributed across therapeutic areas. Oncology is renowned for leading innovation in research and in care; digital pathology, digital radiology, real-world data, next-generation sequencing, patient-reported outcomes, and precision approaches driven by complex data and biomarkers are hallmarks of the field. However, remote patient monitoring, decentralized approaches to care and research, “hospital at home,” and machine learning techniques have yet to be broadly deployed to improve cancer care. In response, the Digital Medicine Society and Moffitt Cancer Center convened a multistakeholder roundtable discussion to bring together leading experts in cancer care and digital innovation. This viewpoint highlights the findings from these discussions, in which experts agreed that digital innovation is lagging in oncology relative to other therapeutic areas. It reports that this lag is most likely attributed to poor articulation of the challenges in cancer care and research best suited to digital solutions, lack of incentives and support, and missing standardized infrastructure to implement digital innovations. It concludes with suggestions for actions needed to bring the promise of digitization to cancer care to improve lives.

BackgroundTrans-radial access (TRA) for MMA embolization has grown due to lower access site complications and greater patient satisfaction. Here, we describe the feasibility of utilizing a 6F Envoy Simmons 2 (6F-SIM2) as a guide catheter with TRA and compare outcomes with trans-femoral approach (TFA) in a single center case series.MethodsWe performed a retrospective review of patients who underwent MMA embolization for management of chronic subdural hematoma (cSDH). TRA was performed by utilizing a combination of 6F 90cm Envoy (Codman & Shurtleff, Inc., Rayham, MA) Simmons 2 guide catheter and 5F 125cm Sofia (Microvention, Aliso Viejo, CA) intermediate catheter. Outcomes measured are Modified Rankin Score (mRS) at 90 days, inpatient mortality, post-embolization recurrence, fluoroscopy time and radiation exposure.ResultsA total of 71 patients underwent 97 MMA embolization overall with 65 (67%) in trans-femoral access group, 11 (11.3%) in trans-radial access without use of Simmons 2 Guide catheter group and 21 (21.6%) in trans-radial access with use of Simmons 2 Guide catheter group. There were no direct access-related complications in either group. One patient had thromboembolic stroke in trans-femoral group. There was no difference in average procedure-related total fluro time or radiation dose among all three groups.ConclusionTrans-radial approach using 6F-SIM2 guide catheter coupled with 5F Sofia intermediate catheter is safe and effective. It provides an alternative approach to access distal branches of bilateral anterior circulation in elderly patients with difficult anatomy undergoing MMA embolization.

Summary: In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.

Poor aqueous solubility besides extensive hepatic first effect significantly decreases the oral absorption of levosulpiride, which in turn minimizes its therapeutic effectiveness. Niosomes have been extensively investigated as a transdermal vesicular nanocarrier to increase the delivery of low permeable compounds into and across the skin. This research work was to design, develop and optimize levosulpiride-loaded niosomal gel and to evaluate its prospects for transdermal delivery. The Box-Behnken design was used to optimize niosomes by analyzing the impact of three factors (cholesterol; X1, Span 40; X2, and sonication time; X3) on the responses (particle size, Y1, and entrapment efficiency, Y2). Optimized formulation (NC) was incorporated into gel and evaluated for pharmaceutical properties, drug release study, ex vivo permeation, and in vivo absorption. The design experiment data suggest that all three independent variables influence both response variables significantly (p < 0.01). Pharmaceutical characteristics of NC vesicles showed the absence of drug excipient interaction, nanosize (~102.2 nm), narrow distribution (~0.218), adequate zeta potential (−49.9 mV), and spherical shape, which are suitable for transdermal therapy. The levosulpiride release rates varied significantly (p < 0.01) between niosomal gel formulation and control. Greater flux (p < 0.01) was observed with levosulpiride-loaded niosomal gel than with control gel formulation. Indeed, the drug plasma profile of niosomal gel was significantly higher (p < 0.005), with ~3 folds higher Cmax and greater bioavailability (~500% higher; p < 0.0001) than its counterpart. Overall, these findings imply that the use of an optimized niosomal gel formulation can increase the therapeutic efficacy of levosulpiride and may represent a promising alternative to conventional therapy.

Background: Despite limited randomized trial data demonstrating clinical efficacy, the utilization of Impella in ST-elevation myocardial infarction (STEMI) patients complicated with cardiogenic shock (CS) has increased over time. Methods: We identified 75,769 hospitalizations with STEMI complicated by CS between October 2015 and December 2018 using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. From this cohort, hospitalizations were stratified according to IABP or Impella placement. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were divided into efficacy, safety, and device-related complications. Propensity-score matching was used to account for differences in the baseline characteristics between the groups. Logistic regression was performed to get the odds ratio and confidence intervals. Results: Among 75,769 admissions with STEMI and CS, hospitalizations with

Introduction: Chronic subdural hematoma (cSDH) is a common neurosurgical condition with a high recurrence rate. Middle meningeal artery (MMA) embolization has been shown to reduce the incidence of re‐bleeding and prevent recurrence of cSDH by devascularizing the subdural membranes and shifting the balance from continued leakage and accumulation of blood and proteinaceous material to reabsorption. We report our single center experience of MMA embolization for treatment of chronic and subacute subdural hematoma. Methods: We performed a retrospective chart review of all patients ≥18 years who underwent MMA embolization between 01/01/2020‐03/01/2021 for cSDH. We looked at the outcomes, rate of recurrence and possible complications after MMA embolization. A descriptive analysis for continuous and categorical variables was performed using SAS 9.4 version. Results: A total of 41 MMA embolizations were performed on 32 patients with a median age of 75 (Q1‐Q3 70–83). Median hematoma thickness was 12 mm. Among them, 52% patients underwent particle embolization while 48% underwent liquid embolization. One patient had recurrence on follow up imaging and required drainage with burr hole. Three patients underwent hematoma evacuation after MMA embolization without evidence of recurrence on imaging. Three cases were aborted due to high risk or difficult access. There were no procedure related complications in the whole study population. 65% patient achieved mRS 0–2 on 90 day follow up visit. There was no significant difference between particles and liquid embolizations. Conclusions: Middle meningeal artery embolization could be used as a safe and effective intervention for prevention of recurrence and improving outcomes of subacute or chronic subdural hematoma.

Background and Purpose: Aneurysmal subarachnoid hemorrhage (SAH) is associated with high mortality. Prophylactic treatment of the unruptured intracranial aneurysm (UIA) is considered in a select group of patients thought to be at high for aneurysmal rupture. Hospital readmission rates can serve as a surrogate marker for the safety and cost-effectiveness of treatment options for UIAs; we present an analysis of the 30-day rehospitalization rates and predictors of readmission following UIA treatment with surgical and endovascular approaches.Methods: We retrospectively analyzed data from the National Readmission Database (NRD) derived from the Healthcare Cost and Utilization Project for the year 2014. The cohort included patients with a primary discharge diagnosis of a treated unruptured aneurysm. The primary outcome variable was the 30-day readmission rate in open surgical vs. endovascularly treated groups. The secondary outcomes included predictors of readmissions, and causes of 30-day readmissions in these two groups.Results: The 30-day readmission rate for the surgical group was 8.37% compared to 4.87% for the endovascular group. The index hospitalization duration was longer in the surgical group. A larger proportion of the patients readmitted following surgical treatment were hypertensive (76.35, vs. 63.43%), but the prevalence of other medical comorbidities was comparable in the two treatment groups.Conclusions: There is a higher likelihood for 30-day readmission, longer duration of initial hospitalization and a lower likelihood of discharge home following surgical treatment of UIAs when compared to endovascular treatment. These findings, however, do not demonstrate long-term superiority of one specific treatment modality.

Medically underserved areas (MUA) or health professional shortage areas (HPSA) designations are based on primary care health services availability. These designations are used in recruiting international medical graduates (IMGs) trained in primary care or subspecialty (e.g., oncology) to areas of need. Whether the MUA/HPSA designation correlates with Oncologist Density (OD) and supports IMG oncologists' recruitment to areas of need is unknown. We evaluated the concordance of OD with the designation of MUAs/HPSAs and evaluated the impact of OD and MUA/HPSA status on overall survival. We conducted a retrospective cohort study of patients diagnosed with hematological malignancies or metastatic solid tumors in 2011 from the Surveillance Epidemiology and End Results (SEER) database. SEER was linked to the American Medical Association Masterfile to calculate OD, defined as the number of oncologists per 100,000 population at the county level. We calculated the proportion of counties with MUA or HPSA designation for each OD category. Overall survival was estimated using the Kaplan-Meier method and compared between the OD category using a log-rank test. We identified 68,699 adult patients with hematologic malignancies or metastatic solid cancers in 609 counties. The proportion of MUA/HPSA designation was similar across counties categorized by OD (93.2%, 95.4%, 90.3%, and 91.7% in counties with 8.4 oncologists per 100K population, p = 0.7). Patients' median survival in counties with the lowest OD was significantly lower compared to counties with the highest OD (8 vs. 11 months, p

The unique conditions of space harbor considerable challenges for astronauts to overcome. Namely, the ionizing content of space radiation and the effects of microgravity have been implicated in the pathogenesis of cardiovascular disease. Post-flight carotid arterial stiffness was demonstrated in astronaut studies while early arteriosclerosis has been linked with microgravity-induced oxidative stress in cellular studies. Similarly, radiation has been shown to disrupt molecular pathways, enhance reactive oxygen species and increase risk of cardiovascular disease in exposed populations. These results may bear even more significance in space owing to the propensity for microgravity and space radiation to yield synergistic and/or additive interactions. Potential countermeasures such as α-tocopherol and captopril target these oxidative pathways and may help to protect against the effects of microgravity and radiation-induced cardiac damage. However, more research needs to be conducted in this area to facilitate a safe passage for humans to the Moon, Mars and beyond.

A recent study found that approximately 1 in every 6 patients hospitalized for the 1st episode of syncope had an underlying pulmonary embolism (PE). As current guidelines do not strongly emphasize evaluation for PE in the workup of syncope, we hypothesize that there might be a higher rate of 30-day readmission due to untreated venous thromboembolism (VTE). The objective of this study is to measure the 30-day readmission rate due to VTE and identify predictors of 30-day readmission with VTE among syncope patients. We identified patients admitted with syncope with ICD9 diagnoses code 780.2 in the Nationwide Readmission Database (NRD-2013), Healthcare Cost and Utilization Project (HCUP). The 30-day readmission rate was calculated using methods described by HCUP. Logistic-regression was used to identify predictors of 30-day readmission with VTE. Discharge weights provided by HCUP were used to generate national estimates. In 2013, NRD included 207,339 eligible patients admitted with syncope. The prevalence rates of PE and DVT were 1.1% and 1.4%, respectively. At least one syncope associated condition was present in 60.9% of the patients. Among the patients who were not diagnosed with VTE during index admission for syncope (N = 188,015), 30-day readmission rate with VTE was 0.5% (0.2% with PE and 0.4% with DVT). In conclusion, low prevalence of VTE in patients with syncope and extremely low 30-day readmission rate with VTE argues against missed diagnoses of VTE in index admission for syncope. These results warrant further studies to determine clinical impact of work up for PE in syncope patients without risk factors.

Only a small subset of all the transcribed RNAs are used as a template for protein translation, whereas RNA molecules that are not translated play a very important role as regulatory non-coding RNAs (ncRNAs). Besides traditionally known RNAs (ribosomal and transfer RNAs), ncRNAs also include small non-coding RNAs (sncRNAs) and long non-coding RNAs (lncRNAs). The lncRNAs, which were initially thought to be junk, have gained a great deal attention because of their regulatory roles in diverse biological processes in animals and plants. Insects are the most abundant and diverse group of animals on this planet. Recent studies have demonstrated the role of lncRNAs in almost all aspects of insect development, reproduction, and genetic plasticity. In this review, we describe the function and molecular mechanisms of the mode of action of different insect lncRNAs discovered up to date.

The prairie provinces of Canada.To characterize tuberculosis (TB) transmission among the Indigenous and non-Indigenous Canadian-born peoples of the prairie provinces of Canada.A prospective epidemiologic study of consecutively diagnosed adult (age ≥ 14 years) Canadian-born culture-positive pulmonary TB cases on the prairies, hereafter termed "potential transmitters," and the transmission events generated by them. "Transmission events" included new positive tuberculin skin tests (TSTs), TST conversions, and secondary cases among contacts.In the years 2007 and 2008, 222 potential transmitters were diagnosed on the prairies. Of these, the vast majority (198; 89.2%) were Indigenous peoples who resided in either an Indigenous community (135; 68.2%) or a major metropolitan area (44; 22.2%). Over the 4.5-year period between July 1st, 2006 and December 31st 2010, 1085 transmission events occurred in connection with these potential transmitters. Most of these transmission events were attributable to potential transmitters who identified as Indigenous (94.5%). With a few notable exceptions most transmitters and their infected contacts resided in the same community type. In multivariate models positive smear status and a higher number of close contacts were associated with increased transmission; adjusted odds ratios (ORs) and 95% confidence intervals (CIs), 4.30 [1.88, 9.84] and 2.88 [1.31, 6.34], respectively. Among infected contacts, being Indigenous was associated with disease progression; OR and 95% CI, 3.59 [1.27, 10.14] and 6.89 [2.04, 23.25] depending upon Indigenous group, while being an infected casual contact was less likely than being a close contact to be associated with disease progression, 0.66 [0.44, 1.00].In the prairie provinces of Canada and among Canadian-born persons, Indigenous peoples account for the vast majority of cases with the potential to transmit as well as the vast majority of infected contacts. Active case finding and preventative therapy measures need to focus on high-incidence Indigenous communities.

Adolescent smokers are more likely to be addicted to nicotine and develop a chronic habit. Chronic smoking has a direct impact on quality of life and life expectancy. Repeated environmental exposure and smoke inhalation can be deleterious to health. In order to evaluate the core functioning of the lungs, Pulmonary Function Tests (PFTs) are conducted. This panel of tests should be advised for all patients complaining of shortness of breath. Since clinical features resulting from chronic smoking tend to appear late in the course of the disease, PFTs are immensely useful for early identification of abnormalities in asymptomatic adult smokers. Numerous studies have shown that normal PFT parameters begin to deteriorate immediately after smoking is initiated. However, most physicians prefer to wait for characteristic signs and symptoms of Chronic Obstructive Pulmonary Disease (COPD) to develop before proceeding with PFTs in the patients. This leads to inadvertent and often dangerous delay in reaching a definitive diagnosis and initiating treatment. Therefore, we undertook this review to determine whether conducting PFTs in asymptomatic adult smokers can facilitate the early detection and/or prevention of COPD. We reviewed and analyzed articles from PubMed, Google Scholar, Index Medicus, WHO Global Health Library and Scopus, which specifically demonstrated the presence of abnormal PFT changes in asymptomatic adult smokers. With PFTs, we now have the advantage of diagnosing early changes in the lung volumes. Hence, we conclude that PFTs should be performed early in smokers and cessation of smoking should be encouraged to check the increasing incidence of COPD.