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Background: Non-melanoma skin cancer (NMSC) is the most common cancer globally in white ethinicity populations, and cutaneous squamous cell carcinoma (cSCC) is the second most common subtype. The COVID-19 pandemic severely impacted public and private healthcare systems. Many studies have reported reduced cancer diagnoses during the pandemic. The impact of the COVID-19 pandemic on global cSCC and NMSC incidence is poorly reported. Objectives: The aim was to conduct a systematic review and meta-analysis to assess the impact of the COVID-19 pandemic on global cSCC and NMSC incidence rates, compared with 2019 incidence rates. Two primary outcome measures were used: crude incidence rate ratios (CIRR) and age-standardised incidence rate ratios (ASIRR). Methods: A structured search was undertaken on 23 March 2023 using grey literature and four electronic databases: MEDLINE, CINAHL, EMBASE and Web of Science. Studies published before January 2020 were excluded. A quality assessment was undertaken using A. Lomas quality assessment tool. CIRR outcomes were synthesised in a meta-analysis, while ASIRR outcomes were narratively synthesised. Results: Fourteen cancer registries were included, capturing data from 13 countries across Europe. Variation was observed in NMSC and cSCC incidence across the cancer registries. Pooled cSCC crude incidence rates in 2020 were equal to crude incidence rates in 2019 (cSCC-CIRR 1.00 (95% confidence interval (CI) 0.94-1.06). In 2021, the pooled result indicated a non-significant 8% increase in cSCC crude incidence rates, compared with 2019 (cSCC-CIRR 1.08 (95% CI 0.98-1.19). Significant reductions were reported in NMSC incidence across all meta-analyses in 2020 and 2021 compared with 2019. Heterogeneity was observed across most pooled estimates (I 2>75%). Conclusion: There was a lack of high quality data on cSCC incidence rates recorded during the pandemic outside of Europe. The COVID-19 pandemic resulted in no significant changes in cSCC incidence across Europe. By contrast, NMSC incidence fell across Europe following the pandemic. Significant reductions in pooled NMSC incidence rates may reflect a delay in basal cell carcinoma presentation, diagnosis and treatment. Although annual incidence rates for cSCC were not affected by the pandemic, delays in treatment may still have occurred, which may result in poorer outcomes yet to be fully understood.
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OBJECTIVE: Reproducibly define CPAP Belly Syndrome (CBS) in preterm infants and describe associated demographics, mechanical factors, and outcomes. STUDY DESIGN: A retrospective case-control study was conducted in infants <32 weeks gestation in the Stanford Children's NICU from January 1, 2020 to December 31, 2021. CBS was radiographically defined by a pediatric radiologist. Data analysis included descriptive statistics and comparator tests. RESULTS: Analysis included 41 infants with CBS and 69 infants without. CBS was associated with younger gestational age (median 27.7 vs 30 weeks, p < 0.001) and lower birthweight (median 1.00 vs 1.31 kg, p < 0.001). Infants with CBS were more likely to receive bilevel respiratory support and higher positive end expiratory pressure. Infants with CBS took longer to advance enteral feeds (median 10 vs 7 days, p = 0.003) and were exposed to more abdominal radiographs. CONCLUSIONS: Future CBS therapies should target small infants, prevent air entry from above, and aim to reduce time to full enteral feeds and radiographic exposure.
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Fetal lower urinary tract obstruction (LUTO) is a severe malformation associated with an up to 80% mortality risk as well as significant renal and pulmonary morbidity in survivors. Fetal vesico-amniotic shunts (VAS) bypass the bladder obstruction, improve amniotic fluid volume and enhance in-utero pulmonary development. VAS has been shown to reduce respiratory morbidity and mortality in the neonatal period without proven benefit on long-term renal and bladder function. Clinically available shunts are associated with an up to 80% dislodgement rate, leading to repeat invasive procedures which increase fetal and maternal risks. We developed a novel "Vortex" shunt, which incorporates enhanced fixation to reduce dislodgement, a one-way valve to optimize in-utero bladder function, and enhanced sonographic echogenicity that optimizes the accurate deployment. Following the validation of these characteristics in initial benchtop experiments we have moved to feasibility studies in the fetal lamb model. We hope that the Vortex shunt may ultimately facilitate shunt deployment, reduce dislodgement risk, improve neonatal morbidity and mortality, and decrease the significant healthcare expenditures associated with long-term morbidity in LUTO survivors. In this manuscript, we review the natural history of LUTO, the risks and benefits of clinically available fetal shunts, and our development and early validation experiments.
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Obstrucción Uretral , Obstrucción del Cuello de la Vejiga Urinaria , Femenino , Animales , Ovinos , Embarazo , Vejiga Urinaria/diagnóstico por imagen , Vejiga Urinaria/cirugía , Obstrucción Uretral/cirugía , Amnios/cirugía , Obstrucción del Cuello de la Vejiga Urinaria/cirugía , Líquido Amniótico , Ultrasonografía PrenatalRESUMEN
OBJECTIVE: Umbilical catheter malposition rate is high. We compared a Novel Umbilical Securement Device (NUSD) to standard methodologies for neonatal invasive care unit patients undergoing laparotomy. STUDY DESIGN: Retrospective study was performed on infants undergoing laparotomy from April 2019 to January 2023. Two neonatologists compared position of umbilical arterial catheter/umbilical venous catheter (UVC) on perioperative chest X-ray (CXRs) in patients with or without NUSD. RESULTS: Eighteen patients underwent laparotomy, of which 8 patients had NUSD (9 lines) and 10 patients did not (14 lines). In NUSD group, mean gestational age was 37 ± 4 weeks and mean birth weight was 2.3 ± 0.9 kg compared with 31 ± 8 weeks and 2.1 ± 1.4 kg in non-NUSD group, respectively. The mean age at surgery was 5 ± 7 and 5 ± 3 days, respectively. No malposition was seen in NUSD group, while 57% of UVCs (28% of lines) were malpositioned postoperatively in non-NUSD group (p = 0.048). CONCLUSION: NUSD is an umbilical catheter securement device with low malposition rate, specifically during perioperative period with heightened risk for dislodgement. KEY POINTS: · Umbilical catheters provide reliable access for neonates but have a high rate of malpositioning.. · NUSD is an umbilical catheter securement device with low malposition rate.. · NUSD can be kept in place during laparotomy and can decrease the risk of malpositioning..
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Many undergraduate educational experiences in biomedical design lack clinical immersion-based needs finding training for students. Convinced of the merits of this type of training for undergraduates, but unable to offer a quarter-long course due to faculty and administrative constraints, we developed an accelerated block-plan course, during which students were dedicated solely to our class for 3 weeks. The course focused on the earliest stages of the health technology innovation process-conducting effective clinical observations and performing comprehensive need research and screening. We grounded the course in experiential learning theory (with hands-on, collaborative, and immersive experiences) and constructivist learning theory (where students integrated prior knowledge with new material on need-driven innovation). This paper describes the design of this intensive block-plan course and the teaching methods intended to support the achievement of five learning objectives. We used pre- and post-course surveys to gather self-reported data about the effect of the course on student learning. Despite the accelerated format, we saw statistically significant gains for all but one sub-measure across the learning objectives. Our experience supports key benefits of the block-plan model, and the results indicate that specific course design choices were effective in achieving positive learning outcomes. These design decisions include (1) opportunities for students to practice observations before entering the clinical setting; (2) a framework for the curriculum that reinforced important concepts iteratively throughout the program; (3) balanced coverage of preparation, clinical immersion, and need research; (4) extensive faculty and peer coaching; and (5) providing hands-on prototyping opportunities while staying focused on need characterization rather than solution development. Based on our experience, we expect that this model is replicable across institutions with limited bandwidth to support clinical immersion opportunities.
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Innovation is essential to the advancement of the field of pediatric surgery. The natural skepticism toward new technologies in pediatrics leads to frequent confusion of surgical innovation and research. Using fluorescence-guided surgery as an archetype for this ethical discussion, we apply existing conceptual frameworks of surgical innovation to understand the distinction between innovation and experimentation, acknowledging the spectrum and "grey zone" in between. In this review, we discuss the role of Institutional Review Boards in evaluating surgical practice innovations, and the aspects of certain surgical innovations that are distinct from experimentation, including a thorough understanding of the risk profile, preexisting use in humans, and adaptation from related fields. Examining fluorescence-guided surgery through these existing frameworks as well as the concept of equipoise, we conclude that new applications of indocyanine green do not constitute human subjects research. Most importantly, this example gives practitioners a lens through which they may appraise potential surgical innovations to allow for a sensible and efficient improvement of the field of pediatric surgery. LEVEL OF EVIDENCE: V.
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Especialidades Quirúrgicas , Cirugía Asistida por Computador , Humanos , Niño , FluorescenciaAsunto(s)
Medicina Estatal , Evaluación de la Tecnología Biomédica , Niño , Humanos , Análisis Costo-Beneficio , Tecnología , Reino UnidoRESUMEN
OBJECTIVE: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. STUDY DESIGN: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. RESULTS: Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. CONCLUSION: During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. KEY POINTS: · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..
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OBJECTIVE: To determine whether market-based pricing could be coupled with surgeon integration into negotiation strategies to achieve lower pricing levels for orthopaedic trauma implants. A secondary aim was to identify specific types of implants that may offer larger opportunities for cost savings. METHODS: Market pricing levels were reviewed from 2 industry implant databases. This information was used by surgeons and supply chain management at our institution to select appropriate target pricing levels (25th percentile) for commonly used orthopaedic trauma implants. Target price values were provided to the existing 12 vendors used by our institution with a clear expectation that vendors meet these thresholds. RESULTS: Benchmark modeling projected a potential savings of 20.0% over our prior annual spend on trauma implants. After 2 rounds of negotiation, savings amounted to 23.0% of prior annual spend. Total savings exceeded 1,000,000 USD with 11 of 12 vendors (91.7%) offering net savings. Total percent savings were highest for external fixators, drill bits, and K-wires. Plates and screws comprised the greatest proportion of our prior annual spend and achieved similar savings. CONCLUSION: A surgeon and supply chain coordinated effort led to major cost savings without a need for consolidation of vendors. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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Ortopedia , Cirujanos , Humanos , Prótesis e Implantes , Ahorro de CostoRESUMEN
INTRODUCTION: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs. METHODS: A three-step approach was used to reduce costs through optimization of orthobiologics supply chain. First, surgeons with orthobiologics expertise were engaged in key supply chain purchasing decisions. Second, eight orthobiologics formulary categories were defined. Capitated pricing expectations were established for each product category. Capitated pricing expectations were established for each product using institutional invoice data and market pricing data. In comparison with similar institutions, products offered by multiple vendors were priced at a lower benchmark (10th percentile of market price) than more rare products priced at the 25th percentile of the market price. Pricing expectations were transparent to vendors. Third, a competitive bidding process required vendors to submit pricing proposals for products. Clinicians and supply chain leaders jointly awarded contracts to vendors that met pricing expectations. RESULTS: Compared with our projected estimate of $423,946 savings using capitated product prices, our actual annual savings was $542,216. Seventy-nine percent of savings came from allograft products. Although the number of total vendors decreased from 14 to 11, each of the nine returning vendors received a larger, three-year institutional contract. Average pricing decreased across seven of the eight formulary categories. DISCUSSION: This study demonstrates a three-step replicable approach to increase institutional savings for orthobiologic products, engaging clinician experts, and strengthening relationships with select vendors. Vendor consolidation permits a symbiotic win-win relationship: Health systems achieve increased value by reducing unnecessary complexity of multiple contracts, and vendors obtain larger contracts with increased market share. LEVEL OF EVIDENCE: Level IV study.
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Comercio , Negociación , Humanos , Costos y Análisis de CostoRESUMEN
BACKGROUND: Per-oral endoscopic myotomy (POEM) has is an alternative treatment to laparoscopic Heller myotomy for children with achalasia. The EndoFLIP functional luminal imaging system is used to measure esophagogastric junction (EGJ) distensibility pre- and post-POEM. Previous adult studies have established a correlation between obstructive symptoms and Distensibility Index (DI). Here we analyze the utility of EndoFLIP in diagnosis and management of achalasia in the largest study on pediatric POEM patients and hypothesize that DI may aid diagnosis and treatment of pediatric achalasia. METHODS: Demographics, preoperative basal and residual pressures measured on manometry, and EndoFLIP measurements pre- and post-POEM were recorded for children that underwent POEM. Pearson correlation coefficient and T-scores were used to assess for correlation between manometry measurements and pre-POEM DI. Linear regression was conducted to analyze the relationship between pre-POEM DI, Eckardt scores, and manometry pressures. RESULTS: Of 33 patients that underwent POEM and EndoFLIP since 2014 (21 male, 12 female), the median pre-POEM Eckardt score decreased from 7 to 1 post-POEM. The median basal pressure was 50 ± 25 mmHg, pre-POEM DI was 0.9 (0.8-1.6) mm2/mmHg and the post-POEM DI was 3.8 (3.2-4.4) mm2/mmHg. There was no correlation between DI and basal pressure or residual pressure, though there was a strong negative correlation between Eckardt scores and DI. CONCLUSION: The EndoFLIP system is a valuable tool in adult patients in diagnosing achalasia and defining the endpoint of the POEM procedure. We find that there is a role for EndoFLIP in the pediatric population in diagnosis and management of the disease. TYPE OF STUDY & LEVEL OF EVIDENCE: Study of diagnostic test; Level IV.
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Acalasia del Esófago , Cirugía Endoscópica por Orificios Naturales , Adulto , Humanos , Masculino , Niño , Femenino , Acalasia del Esófago/diagnóstico por imagen , Acalasia del Esófago/cirugía , Esofagoscopía/métodos , Unión Esofagogástrica , Manometría , Cirugía Endoscópica por Orificios Naturales/métodos , Resultado del Tratamiento , Esfínter Esofágico Inferior/cirugíaRESUMEN
BACKGROUND: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature. PURPOSE: We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding. RESEARCH DESIGN: We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results. STUDY SAMPLE AND DATA COLLECTION: We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation. RESULTS: Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely. CONCLUSIONS: Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.
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Equipos y Suministros , Cirugía General , Estados Unidos , Cirugía General/instrumentación , Publicaciones , IndustriasRESUMEN
Medically unexplained dermatologic symptoms, such as pruritus, numbness and burning are known as somatization. These cutaneous symptoms can be very difficult to treat because of an absence of an objective explanation and they may not fit neatly into any known dermatological or psychiatric condition. These disorders are more commonly encountered in primary care and in dermatology, rather than in psychiatry. Certain skin disorders, for example, pruritus, could be a manifestation of somatization and others may predispose to somatic symptoms, for example, atopic dermatitis and psoriasis. Although there has been increasing research in the interconnection between psychiatry and dermatology, psychodermatology is a relatively new crossover discipline in clinical practice and recognition of psychodermatological conditions, such as cutaneous somatic disorders, can be difficult. Somatization may occur with or without the existence of a dermatological disease. When a dermatological disorder is present, somatization should be considered when the patient is worrying too much about their skin, spending too much time and energy on it and especially if the patient also complains of many non-cutaneous symptoms. Purely cutaneous somatic conditions include for example, the genital pain syndromes or Gardner-Diamond syndrome, characterized by unexplained bruising, which usually affects women. Effective management tools may include mindfulness therapies, pharmacotherapy with selective serotonin reuptake inhibitors, tricyclic antidepressants and cognitive conduct therapy. Electroconvulsive therapy can also be considered in extremely rare cases for treatment of severe somatization on a background of mood disorders. This paper discusses somatization, its relationship to immunodermatoses and its relevance to clinical practice.
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OBJECTIVES: Amid continuously rising US healthcare costs, particularly for inpatient and surgical services, strategies to more effectively manage supply chain expenses are urgently necessary. Across industries, the 'economy of scale' principle indicates that larger purchasing volumes should correspond to lower prices due to 'bulk discounts'. Even as such advantages of scale have driven health system mergers in the USA, it is not clear whether they are being achieved, including for specialised products like surgical implants which may be more vulnerable to cost inefficiency. The objective of this observational cross-sectional study was to investigate whether purchasing volumes for spinal implants was correlated with price paid. SETTING: USA. PARTICIPANTS: Market data based on pricing levels for spine implants were reviewed from industry implant price databases. Filters were applied to narrow the sample to include comparable institutions based on procedural volume, patient characteristics and geographical considerations. Information on the attributes of 619 health systems representing 12 471 provider locations was derived from national databases and analytics platforms. PRIMARY OUTCOME MEASURE: Institution-specific price index paid for spinal implants, normalised to the national average price point achieved. RESULTS: A Spearman's correlation test indicated a weak relationship between purchasing volume and price index paid (ρ=-0.35, p<0.001). Multivariable linear regression adjusting for institutional characteristics including type of hospital, accountable care organisation status, payer-mix, geography, number of staffed beds, number of affiliated physicians and volume of patient throughput also did not exhibit a statistically significant relationship between purchasing volume and price index performance (p=0.085). CONCLUSIONS: National supply chain data revealed that there was no significant relationship between purchasing volume and price paid by health systems for spinal implants. These findings suggest that factors other than purchasing or patient volume are responsible for setting prices paid by health systems to surgical vendors and/or larger healthcare systems are not negotiating in a way to consistently achieve optimal pricing.
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Prótesis e Implantes , Salarios y Beneficios , Estudios Transversales , Bases de Datos Factuales , Costos de la Atención en Salud , HumanosRESUMEN
OBJECTIVES: To develop and test a novel vesicoamniotic shunt (VAS) to treat fetal lower urinary tract obstruction (LUTO), decrease dislodgement and optimize shunt deployment in-vitro. METHODS: Vesicoamniotic shunt design objectives included: (1) robust and atraumatic fixation elements, (2) kink resistant conduit to adjust to fetal movement and growth, (3) one-way pressure valve to facilitate bladder cycling, and (4) echogenic deployment visualization aids. The force to dislodge the novel Vortex shunt was compared with existing commercially available shunts in a bench-top porcine bladder model. Sonographic echogenicity was evaluated with ultrasound-guided deployment, and the shunt valve pressure measured. RESULTS: A prototype novel Vortex shunt was developed using braided nitinol "umbrella-type" ends with a kink-resistant stem incorporating an internal one-way valve. The peak force required to dislodge the Vortex shunt was significantly higher than commercially available shunts (p < 0.01). Shunt deployment in the bench-top model was easily confirmed with ultrasound guidance and the brisk decompression of the inflated porcine bladder thereafter. In-vitro valve gauge pressure testing mirrored bladder pressures in human LUTO cases. CONCLUSION: In-vitro testing shows that the Vortex shunt may improve deployment, sonographic visualization, kink resistance, and dynamic size adjustment. Validation in preclinical animal models are warranted and currently underway.
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Diseño de Equipo/métodos , Enfermedades Fetales/cirugía , Terapias Fetales/instrumentación , Obstrucción Uretral/cirugía , Procedimientos Quirúrgicos Urológicos/instrumentación , Anastomosis Quirúrgica/instrumentación , Anastomosis Quirúrgica/métodos , Animales , Femenino , Terapias Fetales/métodos , Técnicas In Vitro , Embarazo , Porcinos , Procedimientos Quirúrgicos Urológicos/métodosRESUMEN
The combination of computing power, connectivity, and big data has been touted as the future of innovation in many fields, including medicine. There has been a groundswell of companies developing tools for improving patient care utilizing healthcare data, but procedural specialties, like surgery, have lagged behind in benefitting from data-based innovations, given the lack of data that is well structured. While many companies are attempting to innovate in the surgical field, some have encountered difficulties around collecting surgical data, given its complex nature. As there is no standardized way in which to interact with healthcare systems to purchase these data, the authors attempt to characterize the various ways in which surgical data are collected and shared. By surveying and conducting interviews with various surgical technology companies, at least 3 different methods to collect surgical data were identified. From this information, the authors conclude that an attempt to outline best practices should be undertaken that benefits all stakeholders.
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Inteligencia Artificial , HumanosRESUMEN
BACKGROUND: Many nursing contexts have introduced bedside handover, where the person in care participates in the transfer of clinical information, with benefits for person, carers, and clinicians. This type of handover has been implemented across a number of mental health settings, but there is limited evidence regarding implementation approaches or of practice change. This study reports the development and evaluation of a co-produced education and support package. AIM: To evaluate changes in nurses' practice regarding bedside (person-side) handover following implementation of a structured education and support package. DESIGN: Multi-method design incorporating nurse surveys and chart audit. METHODS: The survey and audit were conducted in 2019-2020 on two inpatient mental health units in a metropolitan health service immediately prior to, and 6 months after, implementation, with 70 survey responses and 52 files audited. Non-parametric tests assessed change, and text comments were reported. RESULTS: Significant improvements were observed in nurses' reports of confidence, the ability to maintain privacy, identified benefits for the person and in information transfer. In contrast, the chart audit identified no change in documentation of this practice. CONCLUSIONS: The implementation of a co-produced education and support package demonstrated positive practice change in engaging people receiving care in handover. This approach to handover provides increased opportunity for nurses to work in partnership with people receiving mental healthcare, facilitating collaborative person-centred care and shared decision making.
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Pacientes Internos , Pase de Guardia , Servicios de Salud , Humanos , Salud Mental , Atención Dirigida al PacienteRESUMEN
OBJECTIVE: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. METHODS: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.
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Atención a la Salud , Niño , Humanos , Estados UnidosRESUMEN
Importance: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. Objective: To identify and characterize high-risk devices with pediatric age indications derived from PMA statements. Design, Setting, and Participants: In this cross-sectional study of PMA statements, those statements containing the words indicated or intended for medical devices listed in the FDA PMA database as of February 2020 were retrieved. Age indications were manually annotated in these approval statements via PubAnnotation. Based on the PMA identification from the PMA statements, device metadata including product codes, regulation numbers, advisory panels, and approval dates were queried. Main Outcomes and Measures: The main outcome was discernment of the distribution of devices indicated for the pediatric population (neonate, infant, child, and adolescent). Secondary measures included outlining the clinical specialties, device types, and lag time between the initial approval date and the first date of an approval statement with a pediatric indication for generic device categories. Results: A total of 297 documents for 149 unique devices were analyzed. Based on the manual age annotations, 102 devices with a pediatric indication, 10 with a neonate age indication, 32 with an infant age indication, 60 with a child age indication, and 94 with an adolescent age indication were identified. For indications for patients from age 17 to 18 years, the number of devices available nearly doubled from 42 devices to 81 devices. Although more than half of the surveyed devices had a pediatric age indication, many were available only for a limited range of the pediatric population (age 18-21 years). For indications for patients from age 0 to 17 years, the mean (SD) number of clinical specialties at each age was 7.27 (1.4), and 12 clinical specialties were represented from ages 18 to 21 years. Conclusions and Relevance: In this cross-sectional study on device PMA statements, a gap was identified in both quantity and diversity of high-risk devices indicated for the pediatric population. Because the current scarcity of pediatric devices may limit therapeutic possibilities for children, this study represents a step toward quantifying this scarcity and identifying clinical specialties with the greatest need for pediatric device innovation and may help inform future device development efforts.