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Asthma, the most common chronic disease in children, affects more than 4 million children in the United States, disproportionately affecting those who are economically disadvantaged and racial and ethnic minorities. Studies have shown that the racial and ethnic disparities in asthma outcomes can be largely explained by environmental, socioeconomic and other social determinants of health (SDoH). Utilizing new approaches to stratify disease severity and risk, which focus on the underlying SDoH that lead to asthma disparity, provides an opportunity to disentangle race and ethnicity from its confounding social determinants. In particular, with the growing use of geospatial information systems, geocoded data can enable researchers and clinicians to quantify social and environmental impacts of structural racism. When these data are systematically collected and tabulated, researchers, and ultimately clinicians at the bedside, can evaluate patients' neighborhood context and create targeted interventions toward those factors most associated with asthma morbidity. To do this, we have designed a view (mPage in the Cerner electronic health record) that centralizes key clinical information and displays it alongside SDoH variables shown to be linked to asthma incidence and severity. Once refined and validated, which is the next step in our project, our goal is for emergency medicine clinicians to use these data in real time while caring for patients with asthma. Our multidisciplinary, patient-centered approach that leverages modern informatics tools will create opportunities to better triage patients with asthma exacerbations, choose the best interventions, and target underlying determinants of disease.
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INTRODUCTION: Better interoperability is essential to derive maximum benefit from connected wireless diabetes devices. The need for this feature of diabetes devices is supported by trends in designing better performance for three types of devices: nonmedical devices, medical devices, and diabetes devices. FRAMEWORK: First, interoperability is a standard attribute for the performance of nonmedical devices contained in smart systems that can sense and actuate. Second, interoperability is now mandated by the US Department of Health and Human Services as carried out by the Office of the National Coordinator for Health Information technology (ONC) and the US Food and Drug Administration (FDA) to improve the performance of all medical devices. Third, new guidance from the FDA and nongovernmental professional organizations are intended to promote interoperability because this feature will improve the performance of all diabetes devices. RECOMMENDATIONS: Wireless devices perform best when they are interoperable, and this is particularly true for diabetes devices.
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OBJECTIVES: This study assessed the state of pediatric medical device (PMD) development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999 to 2022. METHODS: The site www.clinicaltrials.gov was used to identify and quantify both PMD clinical trials and pediatric trials for drugs and biologics. Clinical specialty was also assessed. The institutions included were the 7 children's hospitals primarily affiliated with the Food and Drug Administration (FDA) Pediatric Device Consortia (PDC) grant program between 2018 and 2023. For a national comparison, an additional search assessed PMD trials across all US medical institutions. RESULTS: A total of 243 PMD clinical trials were identified at the FDA-PDC institutions on the basis of the year of initiation; the average number of PMD trials initiated per year per institution was 1.5 from 1999 to 2022. However, PMD trials significantly increased during the period 2014 to 2022 compared with 1999 to 2013 (P < .001); the rate of initiation of drug and biologic pediatric trials demonstrated no significant differences between these time periods. A national survey of all institutions initiating PMD trials, and drugs and biologics trials, identified 1885 PMD trials out of a total 12 943. A comparable trend was noted in the national survey with initiation of PMD trials increasing significantly from 2014 to 2022 (P < .001), compared with 1999 to 2013, whereas the rate of initiation of drug and biologic trials during these periods did not demonstrate a significant change. CONCLUSIONS: Although pediatric clinical trial initiation for drugs and biologics remained stable from 1999 to 2022, the rate of new PMD trials significantly increased during the period 2014 to 2022 at FDA-PDC institutions and nationally.
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Ensayos Clínicos como Asunto , Humanos , Estados Unidos , Niño , Equipos y Suministros , United States Food and Drug Administration , Pediatría , Productos Biológicos/uso terapéutico , Hospitales Pediátricos , Aprobación de RecursosRESUMEN
BACKGROUND: Ring chromosome 14 syndrome is a rare disorder primarily marked by early-onset epilepsy, microcephaly, distinctive craniofacial features, hypotonia, intellectual disability, and delay in both development and language acquisition. CASE PRESENTATION: A 21-year-old woman with a history of epileptic seizures since the age of 1.5 years presented with distinctive craniofacial features, including a prominent and narrow forehead, sparse and short eyebrows, palpebral ptosis, horizontal palpebral fissures, a broad nasal bridge, a prominent nasal tip, a flat philtrum, hypertelorism, midfacial hypoplasia, horizontal labial fissures, a thin upper lip, crowded teeth, an ogival palate, retrognathia, and a wide neck. Additional physical abnormalities included kyphosis, lumbar scoliosis, pectus carinatum, cubitus valgus, thenar and hypothenar hypoplasia, bilateral hallux valgus, shortening of the Achilles tendon on the left foot, and hypoplasia of the labia minora. Chromosomal analysis identified a ring 14 chromosome with breakpoints in p11 and q32.33. An aCGH study revealed a ~ 1.7 Mb deletion on chromosome 14qter, encompassing 23 genes. Genomic instability was evidenced by the presence of micronuclei and aneuploidies involving the ring and other chromosomes. CONCLUSION: The clinical features of our patient closely resembled those observed in other individuals with ring chromosome 14 syndrome. The most important point was that we were able to verify an instability of the r(14) chromosome, mainly involving anaphasic lags and its exclusion from the nucleus in the form of a micronucleus.
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INTRODUCTION: The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature. METHODS AND ANALYSIS: The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis. ETHICS AND DISSEMINATION: This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC. STUDY REGISTRATION: Open Science Framework (https://osf.io/k72bn).
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Equipos y Suministros , Humanos , Niño , Pediatría , Proyectos de Investigación , Adolescente , Invenciones , Literatura de Revisión como AsuntoRESUMEN
INTRODUCTION: The use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as a direct bridge to heart transplantation (BTT) is not common in adults worldwide. BTT with ECMO is associated with increased early/mid-term mortality compared with other interventions. In low- and middle-income countries (LMIC), where no other type of short-term mechanical circulatory support is available, its use is widespread and increasingly used as rescue therapy in patients with cardiogenic shock (CS) as a direct bridge to heart transplantation (HT). OBJECTIVE: To assess the outcomes of adult patients using VA-ECMO as a direct BTT in an LMIC and compare them with international registries. METHODS: We conducted a single-center study analyzing consecutive adult patients requiring VA-ECMO as BTT due to refractory CS or cardiac arrest (CA) in a cardiovascular center in Argentina between January 2014 and December 2022. Survival and adverse clinical events after VA-ECMO implantation were evaluated. RESULTS: Of 86 VA-ECMO, 22 (25.5%) were implanted as initial BTT strategy, and 52.1% of them underwent HT. Mean age was 46 years (SD 12); 59% were male. ECMO was indicated in 81% for CS, and the most common underlying condition was coronary artery disease (31.8%). Overall, in-hospital mortality for VA-ECMO as BTT was 50%. Survival to discharge was 83% in those who underwent HT and 10% in those who did not, p < .001. In those who did not undergo HT, the main cause of death was hemorrhagic complications (44%), followed by thrombotic complications (33%). The median duration of VA-ECMO was 6 days (IQR 3-16). There were no differences in the number of days on ECMO between those who received a transplant and those who did not. In the Spanish registry, in-hospital survival after HT was 66.7%; the United Network of Organ Sharing registry estimated post-transplant survival at 73.1% ± 4.4%, and in the French national registry 1-year posttransplant survival was 70% in the VA-ECMO group. CONCLUSIONS: In adult patients with cardiogenic shock, VA-ECMO as a direct BTT allowed successful HT in half of the patients. HT provided a survival benefit in listed patients on VA-ECMO. We present a single center experience with results comparable to those of international registries.
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Oxigenación por Membrana Extracorpórea , Trasplante de Corazón , Choque Cardiogénico , Humanos , Masculino , Femenino , Trasplante de Corazón/mortalidad , Persona de Mediana Edad , Choque Cardiogénico/terapia , Choque Cardiogénico/etiología , Choque Cardiogénico/mortalidad , Tasa de Supervivencia , Estudios de Seguimiento , Pronóstico , Estudios Retrospectivos , Adulto , Países en Desarrollo , Corazón Auxiliar/estadística & datos numéricos , Mortalidad HospitalariaRESUMEN
Severe tooth wear is related to substantial loss of tooth structure, with dentin exposure and significant loss (≥1/3) of the clinical crown. The objective of this systematic review was to summarize and analyze the scientific evidence regarding the mechanical performance of computer-aided design/computer-aided manufacturing (CAD/CAM) composite resin and CAD/CAM lithium disilicate ceramic occlusal veneers, in terms of fatigue and fracture resistance, on severely worn posterior teeth. Currently, occlusal veneers are an alternative for treating worn posterior teeth. Although scientific evidence demonstrates the good performance of lithium disilicate occlusal veneers, there are less brittle materials with a modulus of elasticity more similar to dentin than ceramics, such as resin CAD/CAM blocks. Therefore, it is important to identify which type of material is best for restoring teeth with occlusal wear defects and which material can provide better clinical performance. This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of the PubMed, Embase, Web of Science, Scopus, Cochrane, OpenGrey, Redalyc, DSpace, and Grey Literature Report databases was conducted and supplemented by a manual search, with no time or language limitations, until January 2022. We aimed to identify studies evaluating the fatigue and fracture resistance of CAD/CAM composite resin and ceramic occlusal veneers. The quality of the full-text articles was evaluated according to the modified Consolidated Standards of Reporting Trials (CONSORT) criteria for in vitro studies, and 400 articles were initially identified. After removing duplicates and applying the selection criteria, 6 studies were included in the review. The results demonstrated that the mechanical performance of CAD/CAM composite resin occlusal veneers is comparable to that of CAD/CAM lithium disilicate occlusal veneers in terms of fatigue and fracture resistance.
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Cerámica , Resinas Compuestas , Diseño Asistido por Computadora , Coronas con Frente Estético , Humanos , Porcelana Dental , Fracaso de la Restauración Dental , Desgaste de los Dientes/etiología , Desgaste de los Dientes/terapiaRESUMEN
Importance: Since the full-scale Russian invasion, hospitals in Ukraine have been compelled to close or operate at reduced capacity due to inadequate supplies, damage, or destruction caused by war. Objective: To analyze hospital services in Ukraine during the period before and after the Russian invasion. Design, Setting, and Participants: Of the 450 hospitals currently functioning in Ukraine, a cross-sectional survey was carried out with the participation of 74 hospitals from 12 oblasts. Hospital administrators responded to an online survey with questions on the use of hospital services. Data were abstracted from hospital databases for the prewar period (before February 23, 2022) and during the war (February 23, 2022, to May 30, 2023). Main Outcomes and Measures: Hospital services (including emergency services, preventive services, screenings, laboratory tests, obstetrics, telehealth, pharmacy, and rehabilitation services) were compared during the prewar and war periods. Results: Of 450 Ukrainian hospitals in operation, 74 hospitals (16.0%) across 12 oblasts provided data for the current analyses. During the war, daily emergency admissions increased to 2830, compared with 2773 before the war. At the same time, hospitals reported reduced laboratory testing (72 [97%] vs 63 [85%]), tobacco education (52 [70%] vs 36 [49%]), cancer screening (49 [66%] vs 37 [50%]), gynecological services (43 [58%] vs 32 [43%]), rehabilitation services (37 [50%] vs 27 [36%]), pharmacy services (36 [49%] vs 27 [36%]), and telehealth programs (33 [45%] vs 21 [28%]). Hospitals reported additional difficulties during the war, including disruptions in the supply chain for essential equipment and pharmaceuticals, shortages of laboratory test kits, delays in the delivery of crucial medications, and problems around appropriate medication storage due to power outages. Conclusions and Relevance: The ongoing war has inflicted profound devastation on Ukraine's hospitals. The findings of this cross-sectional survey offer valuable insights into the formidable challenges that hospitals confront in war-affected regions and underscore the pressing necessity for bolstering support to sustain and enhance hospital services during wartime.
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Hospitales , Ucrania , Humanos , Estudios Transversales , Federación de Rusia , Hospitales/estadística & datos numéricos , Conflictos ArmadosRESUMEN
RESUMEN Introducción: La miectomía septal ampliada (MSA) ha demostrado ser una estrategia útil para mejorar los síntomas de los pacientes con miocardiopatía hipertrófica obstructiva (MCHO). Objetivos: El objetivo de este trabajo fue analizar el impacto de la MSA en parámetros estructurales y funcionales ecocardiográficos a corto y mediano plazo, en pacientes con MCH y obstrucción dinámica del tracto de salida del ventrículo izquierdo (VI). Material y métodos: Se analizaron los ecocardiogramas en los períodos preoperatorio, postoperatorio inmediato (1 mes post cirugía) y posoperatorio alejado (2 a 3 años) de pacientes sometidos a MSA. Resultados: Se intervinieron 94 pacientes con una edad media de 57,6 ± 13,8 años. Se observó una reducción significativa del máximo espesor septal en el postoperatorio inmediato, que se mantuvo en el posoperatorio alejado, y en el tamaño auricular izquierdo en el postoperatorio inmediato que se profundizó en el alejado (p < 0,001). El gradiente intraventricular en reposo pasó de 49,2 mmHg basal a 6,4 mmHg (p < 0,001) y de allí a 4,6 mmHg (p=0,224) en los períodos inmediato y alejado, y con la maniobra de Valsalva de 93,9 mmHg a 8,7 mmHg (p < 0,001) y de allí a 7,2 mmHg (p=0,226) respectivamente. La función diastólica fue valorada como grado II en el 58,5 % de los pacientes en el preoperatorio, 51,7 % en el postoperatorio inmediato y 29 % en el postoperatorio alejado. En la misma línea se evidenció un cambio en la relación E/e´ y la presión sistólica pulmonar, grado de insuficiencia mitral y dimensiones de la aurícula izquierda. Conclusión: En esta cohorte de pacientes con MCHO, la realización de una MSA se asoció a una mejoría significativa de la función diastólica del VI, reducción de las presiones de llenado y pulmonares y grado de insuficiencia mitral, y remodelado reverso de la aurícula izquierda. Es posible que esta combinación de efectos explique los beneficios clínicos de la intervención.
ABSTRACT Background: Extended septal myectomy (ESM) has proven to be a useful strategy to improve symptoms in patients with hypertrophic obstructive cardiomyopathy (HOCM). Objectives: The aim of this study was to analyze the impact of ESM on short and mid-term structural and functional echocardiographic parameters in patients with HCM and left ventricular (LV) outflow tract dynamic obstruction. Methods: Preoperative, immediate postoperative (1 month after surgery) and late postoperative (2 to 3 years) echocardiograms of patients undergoing ESM were analyzed. Results: A total of 94 patients with mean age of 57.6 ± 13.8 years underwent surgery. A significant reduction was observed in maximum septal thickness in the immediate postoperative period, which was sustained in the late postoperative period, and in atrial size in the immediate postoperative period, which deepened in the late postoperative period (p < 0.001). Intraventricular gradient at rest dropped from 49.2 to 6.4 mmHg (p < 0.001) and then to 4.6 mmHg (p=0.224) in the immediate and late periods and with Valsalva maneuver from 93.9 to 8.7 mmHg (p < 0.001), and then to 7.2 mmHg (p=0.226), respectively. Preoperative diastolic function was assessed as grade II in 58.5% of patients, decreasing to 51.7% in the immediate postoperative period and to 29% in the late postoperative period. In agreement with these results, a change was evidenced in the E/e´ ratio and pulmonary artery systolic pressure, degree of mitral regurgitation and left atrial dimensions. Conclusion: In this cohort of patients with HOCM, ESM was associated with a significant improvement in LV diastolic function, reduction in filling and pulmonary pressures and degree of mitral regurgitation, and left atrial reverse remodeling. It is possible that this combination of effects explains the clinical benefits of the intervention.
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Background: This research delves into the confluence of racial disparities and health inequities among individuals with disabilities, with a focus on those contending with both diabetes and visual impairment. Methods: Utilizing data from the TriNetX Research Network, which includes electronic medical records of roughly 115 million patients from 83 anonymous healthcare organizations, this study employs a directed acyclic graph (DAG) to pinpoint confounders and augment interpretation. We identified patients with visual impairments using ICD-10 codes, deliberately excluding diabetes-related ophthalmology complications. Our approach involved multiple race-stratified analyses, comparing co-morbidities like chronic pulmonary disease in visually impaired patients against their counterparts. We assessed healthcare access disparities by examining the frequency of annual visits, instances of two or more A1c measurements, and glomerular filtration rate (GFR) measurements. Additionally, we evaluated diabetes outcomes by comparing the risk ratio of uncontrolled diabetes (A1c > 9.0) and chronic kidney disease in patients with and without visual impairments. Results: The incidence of diabetes was substantially higher (nearly double) in individuals with visual impairments across White, Asian, and African American populations. Higher rates of chronic kidney disease were observed in visually impaired individuals, with a risk ratio of 1.79 for African American, 2.27 for White, and non-significant for the Asian group. A statistically significant difference in the risk ratio for uncontrolled diabetes was found only in the White cohort (0.843). White individuals without visual impairments were more likely to receive two A1c tests, a trend not significant in other racial groups. African Americans with visual impairments had a higher rate of glomerular filtration rate testing. However, White individuals with visual impairments were less likely to undergo GFR testing, indicating a disparity in kidney health monitoring. This pattern of disparity was not observed in the Asian cohort. Conclusions: This study uncovers pronounced disparities in diabetes incidence and management among individuals with visual impairments, particularly among White, Asian, and African American groups. Our DAG analysis illuminates the intricate interplay between SDoH, healthcare access, and frequency of crucial diabetes monitoring practices, highlighting visual impairment as both a medical and social issue.
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This study evaluated the effect of zero-valent iron nanoparticles (NZVI) on the anaerobic digestion of swine manure. A wide range of doses of NZVI was evaluated (5, 10, 15, 20, 25, 50, and 100 mgFe°/gVS). The maximum methane yield of 0.4506 L/gVSremoved was obtained with the concentration of 10 mgFe°/gVS representing an increase of 58.99% than the control system with 0.2834 L/gVSremoved, indicating that Fe° improves the methanogenic activity. However, when using doses greater than 20 mgFe°/gVS, there were decreases in the methane yield of 34.4-47.98%. Also, to observe the effect of NZVI in anaerobes was evaluated the activity in the electron transport system (ETS), where the control reactor showed an activity of 31.91 µg INTred/gVSâ¢h, while in reactors with NZVI showed values of 39.48 µg INTred/gVSâ¢h (10 Fe°mg/gVS), observing a stimulation of Fe° in microbial activity. However, the dose of 100 mgFe°/gVS showed the greatest decrease in methane yield (0.1474 L/gVSremoved) and a reduction in ETS was observed by 8.5% compared to the control. The effect on the composition of the volatile fatty acids was observed, where the control system obtained a maximum production of acetic acid of 639â mg/L, which was exceeded with the dose of 10â mg Fe°/gVS by 215% and a decrease of 41.15% with the inhibitory concentration of 100â mg Fe°/gVS. As a result, higher doses of NZVI affect the metabolic activity of anaerobes as well as the acetoclastic pathway causing a decrease in the methane production.
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INTRODUCTION: Diabetes Technology Society virtually hosted the first meeting of the Integration of Connected Diabetes Device Data Into the Electronic Health Record #2 (iCoDE-2) Standards Project on May 31, 2023, via Zoom. METHODS: Clinicians, patients, data aggregators, informaticists, manufacturers, attorneys, and cybersecurity experts discussed dosing data currently available from insulin delivery devices and data aggregators and the types of information that patients and clinicians want to see. This information along with technical and regulatory aspects of (1) data standards and (2) integration into the electronic health record (EHR) are the basis of iCoDE-2. RESULTS: Six sessions were hosted discussing themes including (1) What's Currently Available: The Continuous Glucose Monitor Experience; (2) What's Currently Available: The Aggregator Experience; (3) What's Currently Available: The Insulin Pump Experience; (4) What's Currently Available: The Insulin Pen Experience; (5) What Do Clinicians and Patients Want Out of iCoDE-2 Data?; and (6) Technical and Regulatory Aspects of Data Aggregation. CONCLUSION: Additional working group meetings to discuss data standard and clinical workflow will be held to create additional technical specifications and clinical workflows to aid in insulin dosing data integration into the EHR. A mid-project meeting will convene in the second half of 2023.
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Diabetes Mellitus , Registros Electrónicos de Salud , Humanos , Diabetes Mellitus/tratamiento farmacológico , Insulina/uso terapéutico , GlucemiaRESUMEN
Colorectal cancer (CRC) is one of the most common cancers worldwide. Its etiopathogenesis is complex, mainly influenced by genetic instability caused by the accumulation of mutations. The XRCC1 gene, which is involved in DNA repair, has been associated with CRC through the R194W (C194T) and R399Q (G399A) polymorphisms, but the results are inconsistent. Here, we analyzed the association of these polymorphisms with sporadic CRC in a northeastern Mexican population, including 155 male CRC patients and 155 male controls. Genotyping was performed using the RFLP method. An association with CRC was found for the 399A allele (G vs A; OR = 1.48 (1.03-2.13), P=0.034) and for the 399AA genotype in a codominant model (AA vs GG; OR = 3.11 (1.06-9.10), P=0.031). In contrast, there were no significant differences between CRC patients and controls for the C194T polymorphism (C vs T; OR = 0.82 (0.52-1.31), P=0.41). These results are consistent with many similar studies, but further research is needed to verify whether the XRCC1 R194W and R399Q polymorphisms play a role in CRC etiology. The functional significance of these polymorphisms is unclear, but some studies suggest that they influence DNA repair capacity and, thus, cancer risk.
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Neoplasias Colorrectales , Proteínas de Unión al ADN , Proteína 1 de Reparación por Escisión del Grupo de Complementación Cruzada de las Lesiones por Rayos X , Humanos , Masculino , Estudios de Casos y Controles , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Proteínas de Unión al ADN/genética , Predisposición Genética a la Enfermedad , Genotipo , Polimorfismo Genético , Polimorfismo de Nucleótido Simple/genética , Proteína 1 de Reparación por Escisión del Grupo de Complementación Cruzada de las Lesiones por Rayos X/genéticaRESUMEN
The annual Virtual Hospital Diabetes Meeting was hosted by the Diabetes Technology Society on April 14 and 15, 2023, with the goal of reviewing the progress made in the hospital use of continuous glucose monitors (CGMs). Meeting topics included (1) Nursing Issues, Protocols, Order Sets, and Staff Education for Using CGMs, (2) Implementing CGM Programs for Use in the Wards, (3) Quality Metrics and Financial Implications of CGMs in the Hospital, (4) CGMs in the Critical Care Setting, (5) Special Situations: Labor/Delivery and Hemodialysis, (6) Research Session on CGMs in the Hospital, (7) Starting a CGM on Hospitalized Patients, (8) Automated Insulin Delivery Systems in the Hospital, (9) CGMs in Children, (10) Data Integration of CGMs for Inpatient Use and Telemetry, (11) Accuracy of CGMs/Comparison with Point-of-care Blood Glucose Testing, and (12) Discharge Planning with CGMs. Outcome data as well as shared collective real-life experiences were reviewed, and expert recommendations for CGM implementation were formulated.
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Glucemia , Diabetes Mellitus , Niño , Humanos , Automonitorización de la Glucosa Sanguínea/métodos , Diabetes Mellitus/diagnóstico , Hospitales , Pacientes InternosRESUMEN
OBJECTIVES: The development of medical devices for children faces unique challenges that have contributed to a paucity of devices specifically designed and tested for children. Increased knowledge on research activities for pediatric devices can guide optimal study design and ensure timely dissemination of clinical findings. METHODS: We performed a cross-sectional analysis of interventional studies registered on ClinicalTrials.gov, initiated January 1, 2017, through December 12, 2022, evaluating a Food and Drug Administration-regulated class II or III device, and enrolling any pediatric patients (aged ≤17 years). Data were extracted from ClinicalTrials.gov on study characteristics and from Devices@FDA on device features. For completed studies, we determined whether results were reported in a peer-reviewed publication as of December 27, 2022. RESULTS: Among 482 studies, 406 (84.2%) examined a class II device and 76 (15.8%) a class III device. The most common device types were diabetes-related devices (N = 57, 11.8%) and monitors and measurement devices (N = 39, 8.1%). Most studies were single-center (N = 326, 67.6%), used a nonrandomized (N = 255, 52.9%), open label (N = 350, 72.6%) design, and were funded by academic institutions (N = 278, 57.7%) or industry (N = 142, 29.5%). A total of 291 (60.4%) studies included a primary outcome of only efficacy without safety endpoints. Among completed studies, more than half (N = 64, 51.6%) enrolled <50 participants and 71.0% (N = 88) <100. After median follow-up of 3.0 years, results were available in publications for 27 (21.8%) completed studies. CONCLUSIONS: Our findings serve to inform programs and initiatives seeking to increase pediatric-specific device development. In addition to considerations on ensuring rigorous trial design, greater focus is needed on timely dissemination of results generated in pediatric device studies.
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Proyectos de Investigación , Niño , Humanos , Estudios Transversales , Estados Unidos , United States Food and Drug Administration , AdolescenteRESUMEN
Objective: Patient-reported outcome measures (PROMs) are critical to drive patient-centered care and to understanding patients' perspectives on their health status, quality of life, and the overall effectiveness of the care they receive. PROMs are increasingly being used in clinical and research settings, but the mechanisms to aggregate data from different systems can be cumbersome. Materials and methods: As part of an FDA Real-World Evidence demonstration project, we enriched routine care clinical data from our Cerner electronic health record (EHR) with PROMs collected using REDCap. We used SSIS, sFTP, and the REDCap Application Programming Interface to aggregate both data sources into the Cerner HealtheIntent Population Health Platform. Results: We successfully built dashboards, reports, and datasets containing both REDCap and EHR data collected prospectively. Discussion: This technically straightforward approach using commonly available clinical and research tools can be readily adopted and adapted by others to better integrate PROMs with clinical data sources.
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Introducción. A pesar de la importante presencia de la población haitiana en países de América Latina, existen pocos estudios que evalúen la salud mental en esta población; una de las razones es la falta de instrumentos psicométricos en kreyol (creole haitiano). Objetivo. Adaptar la versión en español de la Escala de Depresión del Centro de Estudios Epidemiológicos (CESD-R-20) al kreyol. Métodos. Estudio transversal de muestreo bietápico con 207 migrantes haitianos viviendo en Santiago de Chile, se tradujo y retrotradujo la Escala CESD-R-20 del español al kreyol. Resultados. 132 participantes respondieron la encuesta en kreyol y 75 en español. Las técnicas de detección de la dimensionalidad recomiendan retener un único componente y tres factores, con pocas excepciones a través de las muestras. Las soluciones factoriales llevan a retener un único factor, que presenta un Alfa de Cronbach =0.92 (IC: 0.90-0.94) adecuado. Estos resultados indican que se necesita un único factor. Discusión y conclusión. La adaptación del instrumento CESD-R-20 de español al kreyol obtiene evidencias de validez favorables y puede servir para iniciar nuevos estudios en población migrante haitiana en su trayecto por América Latina, si bien es necesario seguir ampliando el proceso de validación.
Introduction. Although the Haitian migrant population has a significant presence in Latin American countries, a few studies assess this population's mental health; one of the reasons is the lack of psychometric instruments in kreyol (Haitian Creole). Objective. Adapt the Spanish version of the Depression Scale of the Center for Epidemiological Studies (CESD-R-20) into kreyol. Methods. Based on a cross-sectional two-stage cluster sampling with 207 Haitian migrants living in Santiago de Chile, we conducted translation and back translation of the CESD-R-20 Scale from Spanish to kreyol; additionally, we reached an adapted version in Spanish. Results. In total, 132 participants answered the survey in Kreyol and 75 in Spanish. Dimensionality detection techniques recommend retaining a single component and three factors, with few exceptions across samples. Exploration of factor solutions leads to the retention of a single factor, which has an adequate Cronbach's alpha=0.92 (IC: 0.90;0.94). These results indicate that only one factor is needed. Discussion and conclusion. The adaptation of the Spanish CESD-R-20 instrument to Kreyol has obtained favorable validity evidence and can be used to initiate new studies on the Haitian migrant population on their journey through Latin America, although the validation process needs to be further extended.
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This commentary article discusses the benefits of utilizing telemedicine to conduct shared medical appointments for people with type 1 diabetes and type 2 diabetes. We conducted a literature review of articles about shared medical appointments or group medical visits in people with diabetes with associated clinical data. We identified 43 articles. Models of this approach to care have demonstrated positive outcomes in adults and children with type 1 diabetes. Shared telemedicine appointments also have the potential to improve diabetes self-management, reduce the treatment burden, and improve psychosocial outcomes in adults with type 2 diabetes. Ten key recommendations for implementation are presented to guide the development of shared telemedicine appointments for diabetes. These recommendations can improve care for diabetes.