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BACKGROUND: With the availability of vaccines against SARS-COV-2, recommendations for vaccination of transplant candidates are widespread. At our institution, patients may receive liver transplant (LTx) regardless of vaccine status. The purpose of this study is to compare post-LTx outcomes between vaccinated (VAX) and unvaccinated (UNVAX) LTx recipients. METHODS: This is a retrospective, single-center study of LTx from January 1, 2021-March 30, 2022. The primary outcome is incidence of post-LTx COVID-19. Secondary outcomes include graft function, mortality, graft loss, and COVID-19 treatment. RESULTS: One hundred and seventy-seven LTx recipients were included, 57% [101/177] VAX and 43% [76/177] UNVAX. Baseline characteristics were similar between groups. Overall, 28 (36.8%) UNVAX and 34 (33.7%) VAX tested COVID-19 positive during the study period (p = .193) at a mean of 312.6 [255.4-369.8] days for UNVAX versus 254.6 [215.2-293.9] days for VAX (p = .084). COVID-19 treatment was administered in 15 (53.6%) of the UNVAX compared to 22 (64.7%) in the VAX (p = .374), although eight (28.6%) of UNVAX required hospital admission for treatment compared with two (5.9%) of VAX (p = .016). There were no statistically significant differences in death, and no COVID-19 related death or graft loss. There were no statistically significant differences in liver function tests at 3- and 12-months post LTx. CONCLUSION: In a series with a large percentage of UNVAX patients, LTx appears to be safe, with no difference in the rate of COVID-19 or transplant-related outcomes compared to VAX. While we encourage vaccination to prevent severe COVID, based on our results, vaccine status should not be reason to deny lifesaving transplant.
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COVID-19 , Trasplante de Hígado , Humanos , COVID-19/epidemiología , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19 , Vacunas contra la COVID-19 , Estudios Retrospectivos , Vacunación , Receptores de TrasplantesRESUMEN
INTRODUCTION: We assessed differences in the post-transplant outcomes between COVID-19 vaccinated and unvaccinated Kidney transplant (KTx) recipients. METHODS: We conducted a retrospective, single-center study of 400 KTx from 2/1/2021 to 4/30/2022 with 6-21 months follow-up. Primary outcomes included differences in the incidence of post-transplant COVID-19, ICU admission for COVID-19, death, and graft failure between the two groups. Secondary outcomes were inpatient floor admission, outpatient-management, length of hospital stay during COVID-19 admission. We also reported rejection, DGF, CMV needing treatment, and BK PCR >10 000 in baseline characteristics. RESULT: 70.5% (282/400) were fully vaccinated, and 29.5% (118/400) were unvaccinated. 33% (92/282) of vaccinated and 39% (46/118) of unvaccinated patients developed COVID-19 (p-value .03). In both groups, 16% received outpatient treatments for COVID-19. 3% (12/282) of the vaccinated and 8% (11/118) unvaccinated were admitted to the general floors (p-value .06), and 1% (3/282) of the vaccinated and 3.3% (4/118) of the unvaccinated patients needed admission to the ICU (p-value .2). The length of stay was 12 days in both groups. 13/282 (4.6%) vaccinated patients and 7/118 (5.93%) unvaccinated patients died during the follow-up period (p-value = .3). COVID-19 was deemed the etiology of death in 5/13 cases in the vaccinated and 3/7 in the unvaccinated. DGF, rejection, CMV requiring treatment, and BK PCR >10 000 were comparable between groups. CONCLUSION: The incidence of COVID-19 was higher in unvaccinated than in vaccinated KTx. The two groups were not statistically different for other primary outcomes, including the need for hospital admissions (outpatient, general floor, ICU), length of hospital stay, death, and graft failure.
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COVID-19 , Infecciones por Citomegalovirus , Trasplante de Riñón , Humanos , Tabú , COVID-19/epidemiología , Estudios Retrospectivos , Receptores de TrasplantesRESUMEN
BACKGROUND: There is limited literature describing the real-world practice of delayed initiation and shortened duration direct-acting antiviral (DAA) in kidney transplant recipients. We compared Hepatitis C virus (HCV) cure rates among kidney transplant recipients who received an HCV nucleic acid test positive (NAT +) kidney and were treated with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks or glecaprevir/pibrentasvir (G/P) for 8 weeks, a duration that is 4 weeks shorter than the guideline recommendation for treatment delay beyond 1-week post-transplant. METHODS: Retrospective study of HCV-negative adult patients who received a kidney transplant from an HCV NAT+ donor between April 2019 and April 2022 treated with either SOF/VEL for 12 weeks or G/P for 8 weeks. The primary outcome was sustained virologic response 12 weeks after completion of therapy (SVR12). Secondary outcomes included time to DAA initiation, renal function, graft loss, patient death, liver function tests, and opportunistic infections. RESULTS: 102 kidney transplant recipients were included with 36 treated with G/P and 66 treated with SOF/VEL. All 36 (100%) treated with G/P achieved SVR12. One patient in the SOF/VEL group failed to achieve SVR12 but received additional therapy and was cured. Time to DAA initiation was similar with a mean of 4 weeks. There was no difference in AST/ALT > 3x ULN or renal function. One rejection occurred in each group. No patient death or graft loss was observed. There was no difference in cytomegalovirus and BK viremia between groups. CONCLUSION: Delayed initiation of DAA therapy with 12 weeks of SOF/VEL or 8 weeks of G/P achieves SVR12 in kidney transplant recipients without significant adverse effects.
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OBJECTIVE: Critical care transport is a high-risk environment ripe for patient safety incidents (PSIs). Disclosure is the process by which a PSI is communicated to a patient or substitute decision maker. Little is known on paramedic perceptions on disclosure PSIs. This study evaluated the impact of a disclosure training program on the perceptions of paramedics on disclosing PSIs. METHODS: This was a before-and-after mixed methods survey study on paramedic disclosure training at Ornge, the provincial critical care transport organization for Ontario, Canada. A paramedic disclosure training program was implemented at Ornge between 2020 and 2022. All paramedics were eligible for participation through pre- and posttraining surveys. RESULTS: In total, 54 and 69 paramedics completed the pretraining and posttraining surveys, respectively, representing 25% to 30% of all active paramedics. All of the paramedics (100%) expressed a moral and professional responsibility to disclose PSIs. All paramedics felt disclosure training was somewhat to extremely useful. After training, more paramedics felt comfortable disclosing PSIs, and more paramedics felt disclosure could occur at the time of transport. CONCLUSION: A training program on PSIs can improve paramedics' perceptions on disclosure. This study shows its feasible for paramedics to feel comfortable and participate in disclosure of PSIs within a critical care environment.
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Auxiliares de Urgencia , Paramédico , Humanos , Revelación , Seguridad del Paciente , Auxiliares de Urgencia/educación , Ontario , Técnicos Medios en SaludRESUMEN
OBJECTIVE: Timely access to a lead trauma hospital (LTH) saves lives; however, the vast geography of Northern Ontario creates a barrier to equitable access to an LTH. Paramedics in Ontario follow the field trauma triage standard (FTTS) to identify which patients should be directly brought to an LTH. A pilot project was launched using a fixed wing modified scene response (MSR) to transport patients from Northern Ontario who met the FTTS directly to an LTH. This study aimed to 1) explore the impact of the fixed wing MSR pilot program on the time to LTH arrival for injured patients in Northern Ontario compared with the traditional interfacility transfer (IFT) process and 2) determine the frequency and specific FTTS criteria that were fulfilled. METHODS: This was a retrospective cohort study of injured patients in Northern Ontario who were emergently transported to an LTH by the provincial air ambulance service between January 2016 and October 2021. Electronic patient care records were manually reviewed, and patient cases were grouped by their sending and receiving facilities to evaluate time differences between MSR and IFT. RESULTS: For same-distance transports, the average time from injury to trauma center arrival was reduced with MSR (292.8 minutes) compared with IFT (507.8 minutes), with a mean difference of 130.3 minutes. All MSR cases and 90% of IFT cases met at least 1 FTTS criterion. CONCLUSION: Fixed wing MSR improves access to timely definitive care for injured patients in Northern Ontario, and all patients transported in this pilot project met the trauma bypass criteria.
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Ambulancias Aéreas , Humanos , Proyectos Piloto , Ontario , Estudios Retrospectivos , Triaje , Centros TraumatológicosRESUMEN
WHAT IS KNOWN AND OBJECTIVE: Treatment of tacrolimus toxicity includes holding tacrolimus and supportive care. The objective is to describe considerations for pharmacologic induction of tacrolimus metabolism. CASE DESCRIPTION: A 52-year-old male with a failed renal transplant on chronic haemodialysis developed tacrolimus toxicity due to a drug-drug interaction with darunavir/ritonavir. Tacrolimus concentrations were >60 ng/mL for 10 days despite holding tacrolimus and darunavir/ritonavir. Development of encephalopathy prompted initiation of phenytoin to induce tacrolimus metabolism. Tacrolimus concentration was <2 ng/mL within 4 days and mental status normalized. WHAT IS NEW AND CONCLUSION: Phenytoin metabolic induction is a therapeutic option for prolonged tacrolimus toxicity.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/tratamiento farmacológico , Inmunosupresores/efectos adversos , Fenitoína/uso terapéutico , Tacrolimus/efectos adversos , Darunavir/uso terapéutico , Interacciones Farmacológicas , Humanos , Masculino , Persona de Mediana Edad , Diálisis Renal/métodos , Ritonavir/uso terapéuticoRESUMEN
BACKGROUND: Simulation-based medical education (SBME) is a cornerstone for procedural skill training in residency education. Multiple studies have concluded that SBME is highly effective, superior to traditional clinical education, and translates to improved patient outcomes. Additionally it is widely accepted that mastery learning, which comprises deliberate practice, is essential for expert level performance for routine skills; however, given that highly structured practice is more time and resource-intensive, it is important to assess its value for the acquisition of rarely performed technical skills. The bougie-assisted cricothyroidotomy (BAC), a rarely performed, lifesaving procedure, is an ideal skill for evaluating the utility of highly structured practice as it is relevant across many acute care specialties and rare - making it unlikely for learners to have had significant previous training or clinical experience. The purpose of this study is to compare a modified mastery learning approach with deliberate practice versus self-guided practice on technical skill performance using a bougie-assisted cricothyroidotomy model. METHODS: A multi-centre, randomized study will be conducted at four Canadian and one American residency programs with 160 residents assigned to either mastery learning and deliberate practice (ML + DP), or self-guided practice for BAC. Skill performance, using a global rating scale, will be assessed before, immediately after practice, and 6 months later. The two groups will be compared to assess whether the type of practice impacts performance and skill retention. DISCUSSION: Mastery learning coupled with deliberate practice provides systematic and focused feedback during skill acquisition. However, it is resource-intensive and its efficacy is not fully defined. This multi-centre study will provide generalizable data about the utility of highly structured practice for technical skill acquisition of a rare, lifesaving procedure within postgraduate medical education. Study findings will guide educators in the selection of an optimal training strategy, addressing both short and long term performance.
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Competencia Clínica/normas , Cartílago Cricoides/cirugía , Medicina de Emergencia/educación , Internado y Residencia , Intubación Intratraqueal/métodos , Cartílago Tiroides/cirugía , Traqueostomía/educación , Canadá , Educación Basada en Competencias , Simulación por Computador , Evaluación Educacional , Medicina de Emergencia/normas , Humanos , Internado y Residencia/normas , Intubación Intratraqueal/normas , Traqueostomía/normas , Estados UnidosRESUMEN
PURPOSE: Limited information is available regarding chronic treatment with pirfenidone, an anti-fibrotic drug. Effects of long-term open-label pirfenidone were evaluated in a small cohort with Hermansky-Pudlak syndrome (HPS), a rare autosomal recessive disorder with highly penetrant pulmonary fibrosis. RESULTS: Three patients with HPS pulmonary fibrosis treated with open-label pirfenidone and twenty-one historical controls randomized to placebo were studied at a single center. Mean duration of treatment with pirfenidone for 3 patients with HPS pulmonary fibrosis was 13.1â¯years. Annual changes in FVC and DLCO with pirfenidone treatment were 0.46 andâ¯-â¯0.93% predicted, respectively. In comparison, historical controls randomized to receive placebo experienced mean annual changes in FVC and DLCO of -4.4 andâ¯-â¯2.3% predicted, respectively. High-resolution computed tomography (HRCT) scans revealed improved ground glass opacities with development of minimal interstitial reticulations in 1 patient after 12.8â¯years of treatment with pirfenidone. Slowly progressive increase in bilateral interstitial fibrosis developed in a different patient, who received pirfenidone for 18.1â¯years and died at 73â¯years of age due to HPS pulmonary fibrosis. Another patient treated with pirfenidone for 8.4â¯years had attenuated ground glass opacification on HRCT scan and improved oxygenation; this patient died due to chronic complications from colitis, and not pulmonary fibrosis. Adverse effects were generally limited to mild gastrointestinal discomfort and transient elevations of alanine aminotransferase in one patient. CONCLUSIONS: Chronic treatment with pirfenidone may provide clinical benefit with few adverse effects for some patients with HPS pulmonary fibrosis. These results suggest that compassionate use of pirfenidone could be considered on a case-by-case basis for patients with HPS pulmonary fibrosis.
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Síndrome de Hermanski-Pudlak/tratamiento farmacológico , Fibrosis Pulmonar/tratamiento farmacológico , Piridonas/administración & dosificación , Adulto , Anciano , Femenino , Síndrome de Hermanski-Pudlak/complicaciones , Síndrome de Hermanski-Pudlak/diagnóstico por imagen , Síndrome de Hermanski-Pudlak/patología , Humanos , Pulmón/diagnóstico por imagen , Pulmón/patología , Masculino , Persona de Mediana Edad , Fibrosis Pulmonar/complicaciones , Fibrosis Pulmonar/diagnóstico por imagen , Fibrosis Pulmonar/patología , Piridonas/efectos adversos , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Diagnosing acute heart failure (AHF) in undifferentiated dyspneic emergency department (ED) patients can be challenging. We prospectively studied a validated diagnostic prediction model for AHF that uses patient age, clinician pretest probability for AHF, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) as a continuous value to determine its utility and performance. METHODS AND RESULTS: This was a multicenter randomized controlled trial of undifferentiated dyspneic patients with an indeterminate pretest probability of AHF as assessed by the treating emergency physician (EP). After recording its components, the calculated model results with validated treatment threshold guidelines were provided to EPs for patients randomized to the intervention arm. Final diagnoses with the use of 60-day follow-up information were adjudicated by 2 independent cardiologists. The primary outcomes were accuracy of the model and of physician diagnosis comparing intervention and standard care arms. A total of 197 patients were randomized and had outcome data recorded; 41% were determined to have had heart failure. Final EP diagnostic accuracy was 76% (sensitivity 68.2%, specificity 83.9%) with no significant difference between exposed versus blinded arms (accuracy 77% vs 74%; P = .77). Area under the model receiver operating characteristic curve was 0.93. Using the model treatment thresholds would have redirected 48% of patients with 95% accuracy. CONCLUSIONS: This study prospectively validated the diagnostic accuracy of our AHF model in a significant proportion of indeterminate dyspneic ED patients, but provision of this information did not improveEP diagnostic accuracy. Future studies should determine how such a clinical prediction tool could be effectively integrated into routine practice and improve early management of suspected AHF patients in the ED.
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Disnea/diagnóstico , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/mortalidad , Mortalidad Hospitalaria , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Enfermedad Aguda , Anciano , Biomarcadores/sangre , Disnea/etiología , Servicio de Urgencia en Hospital , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/complicaciones , Humanos , Masculino , Persona de Mediana Edad , Ontario , Valor Predictivo de las Pruebas , Estudios Prospectivos , Reproducibilidad de los Resultados , Medición de Riesgo , Índice de Severidad de la Enfermedad , Tasa de Supervivencia , Factores de TiempoRESUMEN
BACKGROUND: The emergency department (ED) is an environment fraught with increasing patient volumes, competing priorities, fluctuating information, and ad hoc interprofessional clinical teams. Limited time is available to reflect on and discuss clinical experiences, policies, or research with others on the involved team. Online resources, such as webcasts and blogs, offer an accessible platform for emergency shift workers to engage in interprofessional discussion and education. OBJECTIVE: Our objective was to explore the current opportunities for shared learning and discussion and to discover the potential of online resources to foster and facilitate interprofessional education within an academic tertiary emergency department community. METHODS: A qualitative study using semistructured interviews was conducted to solicit participants' views of the current culture of IPE in the ED, the potential value of introducing new online resources and technology in support of IPE, and possible barriers to uptake. Participation was voluntary and participants provided verbal informed consent. RESULTS: Online resources discussed included webcasts, interactive discussion forums, websites, and dashboard with links to central repositories. Identified barriers to uptake of new online resources were an unwillingness to "work" off-shift, a dislike of static one-directional communication, concerns with confidentiality, and the suggestion that new resources would be used by only a select few. CONCLUSIONS: Owing to the sensitive dynamics of emergency medicine-and the preference among its professional staff to foster interprofessional discussion and education through personal engagement, in an unhurried, non-stressful environment-introducing and investing in online resources should be undertaken with caution.
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Actitud del Personal de Salud , Medicina de Emergencia/educación , Comunicación Interdisciplinaria , Internet , Centros Médicos Académicos , Educación Continua , Medicina de Emergencia/organización & administración , Humanos , Relaciones Interprofesionales , Aprendizaje , Evaluación de Necesidades , Ontario , Investigación CualitativaRESUMEN
Mental practice is an effective method for skill acquisition in medicine. We describe the integration of interview-derived sensory cues with a list of procedural steps into a cohesive script to facilitate mental practice for a High Acuity, Low-Occurrence procedure, the bougie-assisted cricothyrotomy. Data collection occurred through interviews with emergency physicians. Interview transcripts were analyzed on a coding framework based on a previously published list of procedural steps. These cues were integrated with procedural steps to create a narrative script. Eight interview transcripts were analyzed. A total of 328 cues were identified. On average, each participant identified 13.7 cues per procedure. This represents the first attempt to combine cues identified by practitioners along with procedural steps with the aim of supporting rich mental representations of a procedure. We expect that this script will be useful to physicians seeking to improve their skills in this rare procedure.
RéSUMé: La pratique mentale est une méthode efficace d'acquisition de compétences en médecine. Nous décrivons l'intégration d'indices sensoriels dérivés de l'entrevue avec une liste d'étapes procédurales dans un scénario cohésif pour faciliter la pratique mentale pour une procédure de haute acuité, de faible occurrence, la cricothyrotomie assistée par bougie. La collecte de données s'est faite au moyen d'entrevues avec des médecins urgentistes. Les transcriptions des entrevues ont été analysées selon un cadre de codage fondé sur une liste d'étapes procédurales déjà publiée. Ces indices ont été intégrés aux étapes procédurales pour créer un scénario narratif. Huit transcriptions d'entrevues ont été analysées. Au total, 328 indices ont été identifiés. En moyenne, chaque participant a identifié 13,7 indices par procédure. Il s'agit de la première tentative de combiner des indices identifiés par les praticiens avec des étapes procédurales dans le but de soutenir des représentations mentales riches d'une procédure. Nous nous attendons à ce que ce texte soit utile aux médecins qui cherchent à améliorer leurs compétences dans cette procédure rare.
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Intubación , Humanos , Cartílago Cricoides , Intubación/métodos , Señales (Psicología) , Médicos , Educación MédicaRESUMEN
INTRODUCTION: Direct transport from the scene of injury to a trauma centre reduces saves lives. In Ontario, paramedics use the field trauma triage standard (FTTS) to determine if a patient meets trauma bypass criteria. Recent studies have questioned the efficacy of the FTTS in identifying severely injured patients. The objective of this study was to determine the predictive performance of the FTTS on the need for trauma center care in patients who were transported to a trauma center. METHODS: This was a single-center health records study of patients transported by ambulance directly to a level 1 trauma center. Hospital based trauma center need and injury severity score-based need were defined. Bivariate associations with one or more FTTS criteria were tested using the Wilcoxon two-sample test for continuous variables, and the Chi-square or Fisher's exact test for categorical indicators. The sensitivity and specificity of each category of the FTTS were calculated. RESULTS: There were 1427 patients included in the study, with 76% men, mean age of 40, and 76% had a blunt mechanism. The overall sensitivity and specificity of the FTTS was 90.9% and 20.8% for hospital-based need and 91.6% and 20.3 for injury severity need. The most sensitive variable for hospital-based need was physiologic criteria (53.7). Mechanism of injury was the most sensitive criteria for injury severity need (54.8). Physiological criteria had the highest association with hospital-based and injury severity need (adjusted odds ratios 7.5 [95% CI 5.8-9.8] and 5.1 [95% CI 3.9-6.7]). CONCLUSIONS: The FTTS has fair performance in identifying the need for hospital-based and injury severity need. Systolic blood pressure less than 90 mmHg, Glasgow Coma Scale (motor) less than 6, and falls greater than 6 m were most predictive of trauma center need. Improving prehospital trauma triage is critical to ensure timely transport to a trauma centre.
RéSUMé: INTRODUCTION: Le transport direct de la scène de la blessure à un centre de traumatologie permet de sauver des vies. En Ontario, les ambulanciers paramédicaux utilisent la norme de triage des traumatismes sur le terrain (FTTS) pour déterminer si un patient répond aux critères de pontage traumatique. Des études récentes ont remis en question l'efficacité du FTTS dans l'identification des patients gravement blessés. L'objectif de cette étude était de déterminer la performance prédictive du FTTS sur le besoin de soins en centre de traumatologie chez les patients qui ont été transportés dans un centre de traumatologie. MéTHODES: Il s'agissait d'une étude des dossiers médicaux d'un seul centre portant sur des patients transportés par ambulance directement à un centre de traumatologie de niveau 1. Les besoins des centres de traumatologie hospitaliers et les besoins basés sur le score de gravité des blessures ont été définis. Les associations bivariées avec un ou plusieurs critères FTTS ont été testées à l'aide du test à deux échantillons de Wilcoxon pour les variables continues et du test de Fisher pour les indicateurs catégoriels. La sensibilité et la spécificité de chaque catégorie du FTTS ont été calculées. RéSULTATS: Il y avait 1427 patients inclus dans l'étude, avec 76% d'hommes, âge moyen de 40, et 76% avaient un mécanisme émoussé. La sensibilité et la spécificité globales du FTTS étaient de 90,9 % et de 20,8 % pour les besoins hospitaliers et de 91,6 % et de 20,3 % pour les besoins de gravité des blessures. La variable la plus sensible pour les besoins hospitaliers était les critères physiologiques (53,7). Le mécanisme de blessure était le critère le plus sensible pour le besoin de gravité de la blessure (54,8). Les critères physiologiques étaient les plus associés aux besoins hospitaliers et aux besoins en matière de gravité des blessures (rapports de cotes ajustés de 7,5 [IC à 95 % 5,8-9,8] et 5,1 [IC à 95 % 3,9-6,7]). CONCLUSION: Le FTTS a un rendement équitable pour ce qui est de déterminer le besoin de soins hospitaliers et de gravité des blessures. La pression artérielle systolique inférieure à 90mmHg, l'échelle de coma de Glasgow (moteur) inférieure à 6 et les chutes supérieures à 6m étaient les plus prédictives des besoins du centre de traumatologie. L'amélioration du triage des traumatismes avant l'hospitalisation est essentielle pour assurer un transport rapide vers un centre de traumatologie.
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Puntaje de Gravedad del Traumatismo , Centros Traumatológicos , Triaje , Heridas y Lesiones , Humanos , Triaje/métodos , Triaje/normas , Masculino , Estudios Retrospectivos , Femenino , Adulto , Ontario , Heridas y Lesiones/terapia , Heridas y Lesiones/diagnóstico , Heridas y Lesiones/epidemiología , Persona de Mediana Edad , Servicios Médicos de Urgencia/normas , Servicios Médicos de Urgencia/organización & administraciónRESUMEN
Overly restrictive clinical trial eligibility criteria can reduce generalizability, slow enrollment, and disproportionately exclude historically underrepresented populations. The eligibility criteria for 196 Alzheimer's Disease and Related Dementias (AD/ADRD) trials funded by the National Institute on Aging were analyzed to identify common criteria and their potential to disproportionately exclude participants by race/ethnicity. The trials were categorized by type (48 Phase I/II pharmacological, 7 Phase III/IV pharmacological, 128 non-pharmacological, 7 diagnostic, and 6 neuropsychiatric) and target population (51 AD/ADRD, 58 Mild Cognitive Impairment, 25 at-risk, and 62 cognitively normal). Eligibility criteria were coded into the following categories: Medical, Neurologic, Psychiatric, and Procedural. A literature search was conducted to describe the prevalence of disparities for eligibility criteria for African Americans/Black (AA/B), Hispanic/Latino (H/L), American Indian/Alaska Native (AI/AN) and Native Hawaiian/Pacific Islander (NH/PI) populations. The trials had a median of 15 criteria. The most frequent criterion were age cutoffs (87% of trials), specified neurologic (65%), and psychiatric disorders (61%). Underrepresented groups could be disproportionately excluded by 16 eligibility categories; 42% of trials specified English-speakers only in their criteria. Most trials (82%) contain poorly operationalized criteria (i.e., criteria not well defined that can have multiple interpretations/means of implementation) and criteria that may reduce racial/ethnic enrollment diversity.
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Enfermedad de Alzheimer , Ensayos Clínicos como Asunto , Selección de Paciente , Humanos , Enfermedad de Alzheimer/epidemiología , Enfermedad de Alzheimer/diagnóstico , Disfunción Cognitiva/epidemiología , Demencia/epidemiología , Determinación de la Elegibilidad , Etnicidad , National Institute on Aging (U.S.) , Estados Unidos/epidemiología , Negro o Afroamericano , Hispánicos o Latinos , Indio Americano o Nativo de Alaska , Nativos de Hawái y Otras Islas del PacíficoRESUMEN
OBJECTIVE: The diagnosis of multiple sclerosis (MS) rests on confirmation of central nervous system inflammatory disease that is disseminated in space and time, as evidenced clinically or by magnetic resonance imaging (MRI). The 2010 McDonald criteria simplified MRI requirements, and newly proposed that the criteria are also suitable for the diagnosis of pediatric MS. METHODS: In a national prospective incident cohort study of children with acute demyelination observed for a minimum of 24 months, baseline and serial clinical and MRI examinations were used to retrospectively evaluate the 2010 and 2005 McDonald criteria using clinically relapsing disease as the gold standard. RESULTS: Of 212 eligible participants, 34 experienced 2 or more clinical attacks, 58 met the 2010 criteria, and 42 met 2005 McDonald criteria. The 2010 criteria demonstrated high sensitivity (100%), specificity (86%), positive predictive value (76%), and negative predictive value (100%) for children older than 11 years with non-acute disseminated encephalomyelitis (ADEM) presentations, as did the 2005 McDonald criteria. In younger children with a non-ADEM presentation, PPV of the 2010 criteria was only 55%. None of the 50 children with ADEM met clinical criteria for MS, but 10 met 2010 and 4 met 2005 criteria. INTERPRETATION: Both 2005 and 2010 McDonald criteria identify children with relapsing-remitting MS, although caution is suggested when applying these criteria in younger children. The 2010 McDonald criteria are simple and enable an early diagnosis of MS, but are not suited for application in the context of ADEM-like presentations.
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Sistema Nervioso Central/patología , Evaluación de la Discapacidad , Esclerosis Múltiple/diagnóstico , Pediatría , Adolescente , Factores de Edad , Niño , Estudios de Cohortes , Diagnóstico Diferencial , Femenino , Humanos , Imagen por Resonancia Magnética/métodos , Imagen por Resonancia Magnética/normas , Masculino , Evaluación de Resultado en la Atención de Salud , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de TiempoAsunto(s)
Servicio de Urgencia en Hospital , Oftalmopatías/diagnóstico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Derivación y Consulta/estadística & datos numéricos , Tomografía Computarizada por Rayos X/estadística & datos numéricos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Selección de Paciente , Estudios RetrospectivosRESUMEN
PURPOSE: The STAT (Safety Threats and Adverse Events in Trauma) taxonomy was developed through expert consensus, and groups 65 identified trauma resuscitation adverse events (AEs) into nine distinct categories. It provides a framework for standardized analysis of trauma resuscitations and creates a foundation for targeted quality improvement and patient safety initiatives. This study aims to evaluate the reliability of the STAT taxonomy in identifying AEs during video-recorded trauma resuscitations. METHODS: High-definition audiovisual data from 30 trauma resuscitations were reviewed. Videos were assessed and scored by four independent reviewers (two trainees and two staff). The STAT taxonomy was used to identify AEs based on binary responses: yes and no. Inter-rater reliability was calculated using Gwet's AC1. The frequencies of AEs were tallied and reported as counts and percentages. RESULTS: The most common AEs identified in the videos were failure to measure temperature (86.7%) and inadequate personal protective equipment (86.7%), followed by inability to use closed-loop communication (76.7%). The agreement on all AEs between reviewers was 0.94 (95% CI: 0.93-0.95). The Gwet's AC1 agreement across the 9 AE categories was paramedic handover (0.82), airway and breathing (0.99), circulation (0.95), assessment of injuries (0.91), management of injuries (0.96), procedure-related (0.97), patient monitoring and IV access (0.99), disposition (0.98), team communication and dynamics (0.87). CONCLUSION: The STAT taxonomy demonstrated excellent inter-rater reliability between reviewers and can be used to identify AEs in video-recorded trauma resuscitations. These results provide a foundation for adapting video review to objectively quantify and assess AEs in the trauma bay.
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OBJECTIVES: Simulation-based technical skills training is now ubiquitous in medicine, particularly for high acuity, low occurrence (HALO) procedures. Mastery learning and deliberate practice (ML + DP) are potentially valuable educational methods, however, they are resource intensive. We sought to compare the effect of deliberate practice and mastery learning versus self-guided practice on skill performance of the rare, life-saving procedure, a bougie-assisted cricothyroidotomy (BAC). METHODS: We conducted a multi-center, randomized study at five North American emergency medicine (EM) residency programs. We randomly assigned 176 EM residents to either the ML + DP or self-guided practice groups. Three blinded airway experts independently evaluated BAC skill performance by video review before (pre-test), after (post-test) and 6-12 months (retention) after the training session. The primary outcome was post-test skill performance using a global rating score (GRS). Secondary outcomes included performance time and skill performance at the retention test. RESULTS: Immediately following training, GRS scores were significantly higher as mean performance improved from pre-test, (22, 95% CI = 21-23) to post-test (27, 95% CI = 26-28), (p < 0.001) for all participants. However, there was no difference between the groups on GRS scores (p = 0.2) at the post-test or at the retention test (p = 0.2). At the retention test, participants in the ML + DP group had faster performance times (66 s, 95% CI = 57-74) compared to the self-guided group (77 s, 95% CI = 67-86), (p < 0.01). CONCLUSIONS: There was no significant difference in skill performance between groups. Residents who received deliberate practice and mastery learning demonstrated an improvement in skill performance time.
ABSTRAIT: OBJECTIFS: La formation aux compétences techniques fondée sur la simulation est maintenant omniprésente en médecine, en particulier pour les procédures de grande acuité et de faible occurrence (HALO). L'apprentissage de la maîtrise et la pratique délibérée (ML+DP) sont des méthodes éducatives potentiellement précieuses, mais elles exigent beaucoup de ressources. Nous avons cherché à comparer l'effet de la pratique délibérée et de l'apprentissage de la maîtrise par rapport à la pratique autoguidée sur le rendement des compétences de la rare intervention de sauvetage, une cricothyroïdotomie à la bougie. MéTHODES: Nous avons mené une étude multicentrique randomisée dans le cadre de cinq programmes nord-américains de résidence en médecine d'urgence. Nous avons affecté au hasard 176 résidents en SE aux groupes de ML+DP ou de pratique autoguidée. Trois experts des voies respiratoires aveuglés ont évalué de façon indépendante la performance des compétences en BAC par examen vidéo avant (pré-test), après (post-test) et 6 à 12 mois (rétention) après la séance de formation. Le principal résultat a été le rendement des compétences après le test au moyen d'une cote globale (SRC). Les résultats secondaires comprenaient le temps consacré au rendement et le rendement des compétences au test de rétention. RéSULTATS: Immédiatement après la formation, les résultats des SRC étaient beaucoup plus élevés, car le rendement moyen s'est amélioré entre le prétest (22, IC à 95 % = 21 à 23) et le post-test (27, IC à 95 % = 26 à 28), (p < 0,001) pour tous les participants. Cependant, il n'y avait aucune différence entre les groupes sur les scores GRS (p = 0,2) au post-test ou au test de rétention (p = 0,2). Au test de rétention, les participants du groupe ML+DP avaient des temps de performance plus rapides (66 secondes, IC à 95 % = 57 à 74) que ceux du groupe autoguidé (77 secondes, IC à 95 % = 67 à 86) (p < 0,01). CONCLUSIONS: Il n'y avait pas de différence significative dans le rendement des compétences entre les groupes. Les résidents qui ont bénéficié d'une pratique délibérée et d'un apprentissage de la maîtrise ont démontré une amélioration du temps consacré aux compétences.
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Aprendizaje , Medicina , Humanos , Capacitación en Servicio , Simulación por ComputadorRESUMEN
Background: Latent safety threats (LSTs) in healthcare are hazards or conditions that risk patient safety but are not readily apparent without system stress. In situ simulation (ISS), followed by post-scenario debriefing is a common method to identify LSTs within the clinical environment. The function of post-ISS debriefing for LST identification is not well understood. Objectives: This study aims to qualitatively characterise the types of LSTs identified during ISS debriefing. Methods: We conducted 12 ISS trauma scenarios followed by debriefing at a Canadian, Level 1 trauma centre. We designed the scenarios and debriefing for 15 and 20 min, respectively. Debriefings focused on LST identification, and each session was audio recorded and transcribed. We used an inductive approach with qualitative content analysis to code text data into an initial coding tree. We generated refined topics from the coded text data. Results: We identified five major topics: (1) communication and teamwork challenges, (2) system-level issues, (3) resource constraints, (4) positive team performance and (5) potential improvements to the current systems and processes. Conclusions: During simulation debriefing sessions for LST identification, participants discussed threats related to communication and interpersonal issues. Safety issues relating to equipment, processes and the physical space received less emphasis. These findings may guide health system leaders and simulation experts better understanding of the strengths and limitations of simulation debriefing for LST identification. Further studies are required to compare ISS-based LST identification techniques.
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OBJECTIVES: Successful implementation of any new technology requires extensive engagement with front-line staff. We explored the perceptions of emergency department and trauma staff about a trauma video review program (TVR) prior to implementation of the first such program in Canada at our level I trauma center. METHODS: We conducted semi-structured individual interviews and in situ small group interviews with 35 multidisciplinary ED and trauma staff members of a teaching and research hospital in Toronto, Canada. We sought maximum variation in the sample of purposively selected participants. Interviews were recorded with audiotapes or detailed field notes, transcribed verbatim, coded, and analyzed using standard thematic analysis techniques. RESULTS: Participants expressed overall support for the concept of TVR, but there is a core sense of unease that influenced overall staff perceptions. Despite several departmental presentations, very few participants actually had a solid understanding of how the TVR worked. Many were apprehensive about their own professional privacy, deeply concerned about vulnerable patients being filmed without consent, and questioned how video data would be used. Despite significant hesitancy, ED and trauma staff identified positive opportunities that TVR could bring, including providing an evidence base for quality improvement. CONCLUSIONS: TVR is an evolving approach to evaluate quality and patient safety in the trauma bay. As such it brings with it natural concerns and apprehension from staff regarding privacy, confidentiality, and how data will be captured and used. There is opportunity for these types of concerns to be addressed with a robust knowledge translation plan and engagement of staff throughout the implementation process.
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INTRODUCTION: Trauma resuscitation is a complex and time-sensitive endeavour with significant risk for error. These errors can manifest from sequential system, team and knowledge-based failures, defined as latent safety threats (LSTs). In situ simulation (ISS) provides a novel prospective approach to recreate clinical situations that may manifest LSTs. Using ISS coupled with a human factors-based video review and modified framework analysis, we sought to identify and quantify LSTs within trauma resuscitation scenarios. METHODS: At a level 1 trauma centre, we video recorded 12 monthly unannounced ISS to prospectively identify trauma-related LSTs. The on-call multidisciplinary trauma team participated in the study. Using a modified framework analysis, human factors experts transcribed and coded the videos. We identified LST events, categorised them into themes and subthemes and used a hazard matrix to prioritise subthemes requiring intervention. RESULTS: We identified 843 LST events during 12 simulations, categorised into seven themes and 38 subthemes, of which 23 are considered critical. The seven themes relate to physical workspace, mental model formation, equipment, unclear accountability, demands exceeding individuals' capacity, infection control and task-specific issues. The physical workspace theme accounted for the largest number of critical LST events (n=152). We observed differences in LST events across the four scenarios; complex scenarios had more LST events. CONCLUSIONS: We identified a diverse set of critical LSTs during trauma resuscitations using ISS coupled with video-based framework analysis. The hazard matrix scoring, in combination with detailed LST subthemes, supported identification of critical LSTs requiring intervention and enhanced efforts intended to improve patient safety. This approach may be useful to others who seek to understand the contributing factors to common LSTs and design interventions to mitigate them.