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1.
Pediatr Emerg Care ; 2024 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-38781459

RESUMO

OBJECTIVES: Boarding of adolescent patients with mental health concerns requiring ongoing observation and treatment is of increasing concern across US emergency departments. The objective was a proof of concept of developing an adolescent psychiatric emergency unit and assessment of the impact of this unit on lengths of stay (LOS). METHODS: We describe the creation of the unit designed to allow safe assessment and boarding of patients, and appropriate interventions and services, while arranging transfer to inpatient facility or safe discharge home. Using a precreation and postcreation analysis and comparison with a similar facility that did not create such a unit, we utilized linear regression to investigate the primary outcome of total length of stay and secondary outcomes of psychiatric emergency department and pediatric emergency department length of stay for both unit-eligible patients and all patients. RESULTS: The overall length of stay was not associated with a statistically significant change for unit-eligible patients; however, there was a significant decrease in the pediatric emergency department LOS for unit-eligible patients. This was associated with a decrease in beds lost to boarding in the pediatric emergency department of 544 hours per month. CONCLUSIONS: Creation of an adolescent psychiatric emergency unit without allotment of significant additional resources is an option to decrease pediatric emergency department boarding times for adolescent patients requiring ongoing emergent therapy for mental health concerns.

2.
Burns ; 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38582695

RESUMO

BACKGROUND: This study compared a novel topical hydrogel burn dressing (CI-PRJ012) to standard of care (silver sulfadiazine) and to untreated control in a swine thermal burn model, to assess for wound healing properties both in the presence and absence of concomitant bacterial inoculation. METHODS: Eight equal burn wounds were created on six Yorkshire swine. Half the wounds were randomized to post-burn bacterial inoculation. Wounds were subsequently randomized to three treatments groups: no intervention, CI-PRJ012, or silver sulfadiazine cream. At study end, a blinded pathologist evaluated wounds for necrosis and bacterial colonization. RESULTS: When comparing CI-PRJ012 and silver sulfadiazine cream to no treatment, both agents significantly reduced the amount of necrosis and bacteria at 7 days after wound creation (p < 0.01, independently for both). Further, CI-PRJ012 was found to be significantly better than silver sulfadiazine (p < 0.02) in reducing bacterial colonization. For wound necrosis, no significant difference was found between silver sulfadiazine cream and CI-PRJ012 (p = 0.33). CONCLUSIONS: CI-PRJ012 decreases necrosis and bacterial colonization compared to no treatment in a swine model. CI-PRJ012 appeared to perform comparably to silver sulfadiazine. CI-PRJ012, which is easily removed with the application of room-temperature water, may provide clinical advantages over silver sulfadiazine.

3.
J Surg Educ ; 81(3): 339-343, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38302298

RESUMO

OBJECTIVE: To determine whether participation in certain hobbies (e.g., participation in sports, playing musical instruments, or other hobbies requiring fine motor skills), preresidency, are associated with higher technical skills ratings at the time of residency graduation. DESIGN: Faculty members from 14 general surgery residency programs scored individual graduates from 2017 to 2020 on their technical skills using a 5-point Likert scale. Hobbies for these residents were collected from their Electronic Residency Application Service (ERAS) data. A single reviewer classified each ERAS hobby into predefined categories including musical instruments, sports requiring hand-eye coordination, team sports, and activities necessitating hand-eye coordination. Spearman correlation coefficients were calculated for the relationship between each category of hobby-as well as the total number of hobbies in each category-and the outcome of surgical faculty ratings of residents' technical surgical skills during their last year of residency. A proportional odds model including the above predictive variables was also fit to the data. SETTING: Fourteen general surgery residency programs. PARTICIPANTS: General surgery residency graduates from 14 different programs from 2017 to 2020. RESULTS: There were 296 residents across 14 institutions. The average ranking of residents' technical skills was 3.24 (SD 1.1). A total of 40% of residents played sports involving hand-eye coordination, 31% played team sports, 28% participated in nonsport hobbies that require eye-hand coordination, and 20% played musical instruments. Correlation coefficients were not statistically significant for any of the categories. In the proportional odds model, none of the variables were associated with statistically significant increased odds of a higher technical skills rating. CONCLUSIONS: There was no correlation between general surgery chief residents' technical skills as rated by faculty, and self-reported pre-residency hobbies on the ERAS application. These findings suggest such hobbies prior to residency are unlikely to predict future technical skills prowess.


Assuntos
Cirurgia Geral , Internato e Residência , Humanos , Passatempos , Cirurgia Geral/educação , Competência Clínica
4.
Prehosp Emerg Care ; 28(1): 98-106, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-36692410

RESUMO

OBJECTIVES: Rearrest after successful resuscitation from out-of-hospital cardiac arrest (OHCA) is common and is associated with worse patient outcomes. However, little is known about the effect of interventions designed to prevent rearrest. We assessed the association between a prehospital care protocol for immediate management after return of spontaneous circulation (ROSC) and rates of field rearrest and survival to discharge in patients with prehospital ROSC. METHODS: This was a retrospective study of adult patients with OHCA and field ROSC within a large EMS system before (April 2017-August 2018) and after (April 2019-February 2020) implementation of a structured prehospital post-ROSC care protocol. The protocol was introduced in September 2018 and provided on-scene stabilization direction including guidance on ventilation and blood pressure support. Field data and hospital outcomes were used to compare the frequency of field rearrest, hospital survival, and survival with good neurologic outcome before and after protocol implementation. Logistic regression was used to assess the association between the post-implementation period and these outcomes, and odds ratios were reported. The association between individual interventions on these outcomes was also explored. RESULTS: There were 2,706 patients with ROSC after OHCA in the pre-implementation period and 1,780 patients in the post-implementation period. The rate of prehospital rearrest was 43% pre-implementation vs 45% post-implementation (RD 2%, 95% CI -1, 4%). In the adjusted analysis, introduction of the protocol was not associated with decreased odds of rearrest (OR 0.87, 95% CI 0.73, 1.04), survival to hospital discharge (OR 1.01, 95% CI 0.81, 1.24), or survival with good neurologic outcome (OR 0.81, 95% CI 0.61, 1.06). Post-implementation, post-ROSC administration of saline and push-dose epinephrine increased from 11% to 25% (RD 14%, 95% CI 11, 17%) and from 3% to 12% (RD 9% 95% CI 7, 11%), respectively. In an exploratory analysis, push-dose epinephrine was associated with a decreased odds of rearrest (OR 0.68, 95% CI 0.50, 0.94). CONCLUSIONS: Introduction of a post-ROSC care protocol for patients with prehospital ROSC after OHCA was not associated with reduced odds of field rearrest. When elements of the care bundle were considered individually, push-dose epinephrine was associated with decreased odds of rearrest.


Assuntos
Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Pacotes de Assistência ao Paciente , Adulto , Humanos , Reanimação Cardiopulmonar/métodos , Estudos Retrospectivos , Parada Cardíaca Extra-Hospitalar/terapia , Serviços Médicos de Emergência/métodos , Epinefrina
5.
JAMA ; 330(9): 821-831, 2023 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-37668620

RESUMO

Importance: The effects of moderate systolic blood pressure (SBP) lowering after successful recanalization with endovascular therapy for acute ischemic stroke are uncertain. Objective: To determine the futility of lower SBP targets after endovascular therapy (<140 mm Hg or 160 mm Hg) compared with a higher target (≤180 mm Hg). Design, Setting, and Participants: Randomized, open-label, blinded end point, phase 2, futility clinical trial that enrolled 120 patients with acute ischemic stroke who had undergone successful endovascular therapy at 3 US comprehensive stroke centers from January 2020 to March 2022 (final follow-up, June 2022). Intervention: After undergoing endovascular therapy, participants were randomized to 1 of 3 SBP targets: 40 to less than 140 mm Hg, 40 to less than 160 mm Hg, and 40 to 180 mm Hg or less (guideline recommended) group, initiated within 60 minutes of recanalization and maintained for 24 hours. Main Outcomes and Measures: Prespecified multiple primary outcomes for the primary futility analysis were follow-up infarct volume measured at 36 (±12) hours and utility-weighted modified Rankin Scale (mRS) score (range, 0 [worst] to 1 [best]) at 90 (±14) days. Linear regression models were used to test the harm-futility boundaries of a 10-mL increase (slope of 0.5) in the follow-up infarct volume or a 0.10 decrease (slope of -0.005) in the utility-weighted mRS score with each 20-mm Hg SBP target reduction after endovascular therapy (1-sided α = .05). Additional prespecified futility criterion was a less than 25% predicted probability of success for a future 2-group, superiority trial comparing SBP targets of the low- and mid-thresholds with the high-threshold (maximum sample size, 1500 with respect to the utility-weighted mRS score outcome). Results: Among 120 patients randomized (mean [SD] age, 69.6 [14.5] years; 69 females [58%]), 113 (94.2%) completed the trial. The mean follow-up infarct volume was 32.4 mL (95% CI, 18.0 to 46.7 mL) for the less than 140-mm Hg group, 50.7 mL (95% CI, 33.7 to 67.7 mL), for the less than 160-mm Hg group, and 46.4 mL (95% CI, 24.5 to 68.2 mL) for the 180-mm Hg or less group. The mean utility-weighted mRS score was 0.51 (95% CI, 0.38 to 0.63) for the less than 140-mm Hg group, 0.47 (95% CI, 0.35 to 0.60) for the less than 160-mm Hg group, and 0.58 (95% CI, 0.46 to 0.71) for the high-target group. The slope of the follow-up infarct volume for each mm Hg decrease in the SBP target, adjusted for the baseline Alberta Stroke Program Early CT score, was -0.29 (95% CI, -0.81 to ∞; futility P = .99). The slope of the utility-weighted mRS score for each mm Hg decrease in the SBP target after endovascular therapy, adjusted for baseline utility-weighted mRS score, was -0.0019 (95% CI, -∞ to 0.0017; futility P = .93). Comparing the high-target SBP group with the lower-target groups, the predicted probability of success for a future trial was 25% for the less than 140-mm Hg group and 14% for the 160-mm Hg group. Conclusions and Relevance: Among patients with acute ischemic stroke, lower SBP targets less than either 140 mm Hg or 160 mm Hg after successful endovascular therapy did not meet prespecified criteria for futility compared with an SBP target of 180 mm Hg or less. However, the findings suggested a low probability of benefit from lower SBP targets after endovascular therapy if tested in a future larger trial. Trial Registration: ClinicalTrials.gov Identifier: NCT04116112.


Assuntos
Anti-Hipertensivos , Pressão Sanguínea , Infarto Encefálico , Procedimentos Endovasculares , Hipertensão , AVC Isquêmico , Idoso , Feminino , Humanos , Pressão Sanguínea/efeitos dos fármacos , Hipotensão , Infarto , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/cirurgia , Acidente Vascular Cerebral/cirurgia , Doença Aguda , Hipertensão/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Sístole , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/farmacologia , Anti-Hipertensivos/uso terapêutico , Infarto Encefálico/diagnóstico por imagem , Infarto Encefálico/tratamento farmacológico , Infarto Encefálico/cirurgia
6.
Prehosp Emerg Care ; 27(3): 281-286, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-34890522

RESUMO

OBJECTIVE: Subsequent to the Emergency Use Authorization (EUA) by the Food and Drug Administration, Gilead Sciences Inc. donated a supply of remdesivir to the United States government for immediate treatment of patients with COVID-19. The Los Angeles County Emergency Medical Services Agency (LAC-EMS) was tasked with the allocation. The objective of this study was to describe the process for allocation and the patients who were treated with the donated remdesivir in LAC. METHODS: LAC-EMS developed a strategic plan to distribute federal allocations of remdesivir to LAC hospitals based on the proportion of patients admitted with COVID-19 at each hospital. Criteria for treatment and its duration were based on the EUA at local hospital discretion. Data were collected on patients treated from May to December 2020. Variables included characteristics (age, sex, race/ethnicity), hospital care (level of care and respiratory support at start of treatment, ventilator support, total ventilator days), and outcomes (length of intensive care (ICU) and hospital stay, survival to discharge, disposition). We compared demographics of treated patients to the overall population of hospitalized patients in LAC. RESULTS: LAC-EMS distributed 34,250 vials of remdesivir in 7 allocations, which treated 5,376 patients. The median age was 60 (IQR 48-70); 62% were male, 59% Hispanic, 17% White, 6% Asian, 5% Black. Prior to remdesivir, 96% of patients required respiratory support including 49% supplemental oxygen, 35% high-flow nasal cannula, 3% continuous or bilevel positive airway pressure and 9% mechanical ventilation, with one quarter of patients in the ICU. Overall, 26% of patients were mechanically ventilated during the hospitalization, median 11 days (IQR 8-23), while 41% required ICU care, median 10 days (IQR 5-19). Median length of stay for all patients was 10 days (IQR 7-18) with 4,218 patients (74%) surviving to discharge and 80% of survivors discharged home. Compared with overall hospitalized patients with COVID-19, treated patients more likely to be male and middle-aged, and less likely to be Black. CONCLUSION: LAC-EMS's strategic plan to distribute donated remdesivir to hospitals based on the number of inpatients with COVID-19 resulted in the treatment of 5,376 patients of whom 74% survived to hospital discharge.


Assuntos
COVID-19 , Serviços Médicos de Emergência , Pessoa de Meia-Idade , Humanos , Masculino , Estados Unidos , Feminino , SARS-CoV-2 , Pandemias , Los Angeles , Tratamento Farmacológico da COVID-19
7.
JAMA Surg ; 157(10): 918-924, 2022 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-35947371

RESUMO

Importance: Characteristics of outstanding graduating surgical residents are currently undefined. Identifying these qualities may be important in guiding resident selection and resident education. Objective: To determine characteristics that are most strongly associated with being rated as an outstanding graduating surgical resident. Design, Setting, and Participants: The multi-institutional study had 3 phases. First, an expert panel developed a list of characteristics embodied by top graduating surgical residents. Second, groups of faculty from 14 US general-surgery residency programs ranked 2017 through 2020 graduates into quartiles of overall performance. Third, faculty evaluated their graduates on each characteristic using a 5-point Likert scale. Data were analyzed using Spearman rank-order correlation to identify which individual characteristics were associated with overall graduate performance. A least absolute shrinkage and selection operator (LASSO) ordinal regression was performed to select a parsimonious model to predict the outcome of overall performance rating from individual characteristic scores. Main Outcome and Measures: Surgical educators' rankings of general surgery residency graduates' overall performance. Results: Fifty faculty from 14 US residency programs with a median of 13 (range, 5-30) years of surgical education experience evaluated 297 general surgery residency graduates. Surgical educators identified 21 characteristics that they believed outstanding graduating surgical residents possessed. Two hundred ninety-seven surgical residency graduates were evaluated. Higher scores in every characteristic correlated with better overall performance. Characteristics most strongly associated with higher overall performance scores were surgical judgment (r = 0.728; P < .001), leadership (r = 0.726; P < .001), postoperative clinical skills (r = 0.715; P < .001), and preoperative clinical skills (r = 0.707; P < .001). The remainder of the characteristics were moderately associated with overall performance. The LASSO regression model identified 3 characteristics from which overall resident performance could be accurately predicted without measuring other qualities: surgical judgment (odds ratio [OR] per 1 level of 5-level Likert scale OR, 1.27; 95% CI, 1.03-1.51), leadership (OR, 1.27; 95% CI, 1.06-1.48), and medical knowledge (OR, 1.16; 95% CI, 1.01-1.33). Conclusions and Relevance: All individual characteristics identified by surgical educators as being qualities of outstanding graduating surgical residents were positively associated with overall graduate performance. Surgical judgment and leadership skills had the strongest individual associations. Assessment of only 3 qualities (surgical judgment, leadership, and medical knowledge) were required to predict overall resident performance ratings. These findings highlight the importance of developing specific surgical judgment and leadership skills curricula and assessments during surgical residency.


Assuntos
Internato e Residência , Competência Clínica , Currículo , Educação de Pós-Graduação em Medicina , Humanos
9.
Clin Transplant ; 36(2): e14528, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34739731

RESUMO

BACKGROUND: Delayed graft function (DGF) after kidney transplantation is a common occurrence and correlates with poor graft and patient outcomes. Donor characteristics and care are known to impact DGF. We attempted to show the relationship between achievement of specific donor management goals (DMG) and DGF. METHODS: This is a retrospective case-control study using data from 14 046 adult kidney donations after brain death from hospitals in 18 organ procurement organizations (OPOs) which were transplanted to adult recipients between 2012 and 2018. Data on DMG compliance and donor, recipient, and ischemia-related factors were used to create multivariable logistic regression models. RESULTS: The overall rate of DGF was 29.4%. Meeting DMGs for urine output and vasopressor use were associated with decreased risk of DGF. Sensitivity analyses performed with different imputation methods, omitting recipient factors, and analyzing multiple time points yielded largely consistent results. CONCLUSIONS: The development of DMGs continues to show promise in improving outcomes in the kidney transplant recipient population. Studies have already shown increased kidney utilization in smaller cohorts, as well as other organs, and shown decreased rates of DGF. Additional research and analysis are required to assess interactions between meeting DMGs and correlation versus causality in DMGs and DGF.


Assuntos
Função Retardada do Enxerto , Transplante de Rim , Adulto , Estudos de Casos e Controles , Função Retardada do Enxerto/epidemiologia , Função Retardada do Enxerto/etiologia , Objetivos , Sobrevivência de Enxerto , Humanos , Transplante de Rim/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Doadores de Tecidos
10.
Prehosp Emerg Care ; 26(6): 772-781, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34369840

RESUMO

Objective: Within Emergency Medical Systems (EMS) regional systems, there may be significant differences in the approach to patient care despite efforts to promote standardization. Identifying hospital-level factors that contribute to variations in care can provide opportunities to improve patient outcomes. The purpose of this analysis was to evaluate variation in post-cardiac arrest care within a large EMS system and explore the contribution of hospital-level factors. Methods: This was a retrospective analysis from a regional cardiac system serving over 10 million persons. Patients with out-of-hospital cardiac arrest (OHCA) with return of spontaneous circulation (ROSC) are transported to 36 cardiac arrest centers with 24/7 emergent coronary angiography (CAG) capabilities and targeted temperature management (TTM) policies based on regional guidelines. We included adult patients ≥18 years with non-traumatic OHCA from 2016-2018. Patients with a Do-Not-Resuscitate order and those who died in the emergency department (ED) were excluded. For the TTM analysis, we also excluded patients who were alert in the ED. The primary outcome was receiving CAG or TTM after cardiac arrest. The secondary outcome was neurologic recovery (dichotomized to define a "good" outcome as cerebral performance category (CPC) 1 or 2). We used generalized estimating equations including patient-level factors (age, sex, witnessed arrest, initial rhythm) and hospital-level factors (academic status, hospital size based on licensed beds, annual OHCA patient volume) to estimate the odds ratios associated with these variables. Results: There were 7831 patients with OHCA during the study period; 4694 were analyzed for CAG and 3903 for TTM. The median and range for treatment with CAG and TTM after OHCA was 23% (12-49%) and 58% (17-92%) respectively. Hospital size was associated with increased likelihood of CAG, adjusted odds ratio 1.71, 95% CI 1.05-2.86, p = 0.03. Academic status approached significance in its association with TTM, adjusted odds ratio 1.69, 95% CI 0.98-2.91, p = 0.06. Overall, 28% of patients survived with good neurologic outcome, ranging from 17 to 43% across hospitals. Conclusion: Within this regional cardiac system, there was significant variation in use of CAG and TTM after OHCA, which was not fully explained by patient-level factors. Hospital size was associated with increased CAG.


Assuntos
Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Hipotermia Induzida , Parada Cardíaca Extra-Hospitalar , Humanos , Reanimação Cardiopulmonar/efeitos adversos , Estudos Retrospectivos , Parada Cardíaca Extra-Hospitalar/complicações
11.
JAMA ; 326(15): 1524-1525, 2021 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-34596661
12.
AEM Educ Train ; 5(4): e10650, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34568714

RESUMO

OBJECTIVES: Medical education fellowships in emergency medicine (EM) provide training in teaching, assessment, educational program administration, and scholarship. The longitudinal impact of this training is unknown. Our objective was to characterize the career outcomes of medical education fellowship graduates. METHODS: We solicited curriculum vitae (CV) from graduates of U.S. EM education fellowships by email. We abstracted data from CVs with a standard instrument that included program characteristics, employment history, leadership positions, awards, and scholarly productivity. We calculated and reported descriptive statistics. RESULTS: A total of 71 of 91 (78%) graduates participated. Thirty-three completed a 1-year fellowship and 38 completed a 2-year fellowship. Nineteen (27%) completed an advanced degree during fellowship. Median (range) graduation year was 2016 (1997-2020). The majority, 63 of 71 (89%), work in an academic setting. Graduates held leadership positions in continuing medical education, graduate medical education, and undergraduate medical education. Forty-eight (68%) served on national medical education committees. The mean ± SD number of national medical education awards was 1.27 ± 2.03. The mean ± SD number of national medical education presentations was 7.63 ± 10.83. Graduates authored a mean ± SD of 3.63 ± 5.81 book chapters and a mean ± SD of 4.99 ± 6.17 peer-reviewed medical education research publications. Ten (14%) served on journal editorial boards, 34 (48%) were journal reviewers, and 31 (44%) had received a medical education grant. CONCLUSION: EM medical education fellowship graduates are academically productive and hold education leadership positions.

13.
AEM Educ Train ; 5(2): e10464, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33796806

RESUMO

OBJECTIVES: Active learning techniques help with motivation, involvement, and retention during didactics. There are few studies comparing different active learning methods, and these have yielded mixed results. The objective of this study was to compare the effect of two active learning methods-small-group discussion and audience response system (ARS)-on immediate- and long-term knowledge gain. METHODS: This was a prospective experimental study of emergency medicine (EM) subinterns and residents. Participants were randomized into two groups, and baseline knowledge was assessed with a multiple-choice pretest. Didactic sessions on salicylate toxicity and ocular trauma were given to both groups utilizing either small-group discussion or ARS. A crossover design was utilized to ensure that both groups received instruction by each method. A multiple-choice posttest was administered following the didactics and again 2 months later. Pre- and posttests were identical. All test items were written by an academic faculty member with advanced training in medical education and item writing and were based on the goals and objectives of the session. Test items were piloted with a reference group of learners. Didactic instructors were blinded to test items. Data were analyzed using a linear mixed-effects model. RESULTS: Thirty-eight subinterns and residents participated in the study. Both instructional methods showed immediate- and long-term knowledge gain. The linear mixed-effects model did not demonstrate any significant difference between instructional methods on immediate knowledge gain (mean difference = 0.18, p = 0.62, 95% confidence interval [CI] = -0.52 to 0.88) or long-term knowledge gain (mean difference = -0.42, p = 0.36, 95% CI = -1.32 to 0.47). CONCLUSION: In this small study, there was no significant difference between instructional methods on immediate- and long-term knowledge gain in EM subinterns and residents.

14.
Resuscitation ; 158: 185-192, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33221363

RESUMO

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (ECPR) is a promising therapy for out-of-hospital cardiac arrest (OHCA) that is refractory to standard therapy, but no multicenter randomized clinical trials have been conducted to establish its efficacy. We report the design and operating characteristics of a proposed randomized Bayesian adaptive "enrichment" clinical trial designed to determine whether ECPR is effective for refractory OHCA and, if effective, to define the interval after arrest during which patients derive benefit. METHODS: Through iterative trial simulation and trial design modification, we developed a Bayesian adaptive trial of ECPR for adults who experience non-traumatic out-of-hospital cardiac arrest. Our proposed trial design addresses the threats to trial success identified during the design process, which were (1) the uncertainty surrounding the cardiac arrest (CA)-to-ECPR interval within which clinical benefit might be preserved (2) the difference in prognosis between patients with an initial rhythm that is non-shockable vs. shockable. Trial subjects will be randomized 1:1 to receive either standard care or expedited transport to a hospital for potential ECPR. The CA-to-ECPR interval will be estimated in real time based on the sum of the estimated paramedic response time (911 call to scene arrival), paramedic scene time, and transport time to hospital. A Bayesian decreasing step function will be used to estimate the efficacy of the treatment with an outcome of the 90-day utility-weighted Modified Rankin Scale (uwmRS) for each rhythm subgroup and estimated CA-to-ECPR interval at pre-specified interims. The trial will adaptively lengthen the estimated CA-to-ECPR eligibility window if the treatment appears effective at the upper limit of initial eligibility window. If ECPR appears ineffective at longer estimated CA-to-ECPR intervals, the upper limit of the window for enrollment eligibility will be shortened. The analysis will be stratified by rhythm subgroup. RESULTS: With a maximum total sample size of 400, and a cap on the maximum sample size of 300 for the non-shockable rhythm subgroup, the trial design has power ranging from 91-100% to detect a benefit from ECPR for non-shockable rhythms under the various efficacy scenarios simulated and power ranging from 69-98% for shockable rhythms under the same scenarios. The trial design also has a high probability of correctly identifying the maximum CA-to-ECPR interval within which ECPR produces a clinically significant benefit of 0.2 on the uwMRS. If ECPR is equivalent to standard CA care, the type I error is 2.5% with a 99% probability of stopping enrollment early for futility in the non-shockable subgroup and a 97% probability of stopping enrollment early for futility in the shockable subgroup. CONCLUSION: This proposed adaptive trial design helps to ensure the population of patients who are most likely to benefit from treatment-as defined both by rhythm subgroup and estimated CA-to-ECPR interval-is enrolled. The design promotes early termination of the trial if continuation is likely to be futile.


Assuntos
Reanimação Cardiopulmonar , Auxiliares de Emergência , Oxigenação por Membrana Extracorpórea , Parada Cardíaca Extra-Hospitalar , Adulto , Teorema de Bayes , Humanos , Parada Cardíaca Extra-Hospitalar/terapia
15.
Prehosp Disaster Med ; 35(4): 388-396, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32430085

RESUMO

HYPOTHESIS: Emergency Medical Services (EMS) systems have developed protocols for prehospital activation of the cardiac catheterization laboratory for patients with suspected ST-elevation myocardial infarction (STEMI) to decrease first-medical-contact-to-balloon time (FMC2B). The rate of "false positive" prehospital activations is high. In order to decrease this rate and expedite care for patients with true STEMI, the American Heart Association (AHA; Dallas, Texas USA) developed the Mission Lifeline PreAct STEMI algorithm, which was implemented in Los Angeles County (LAC; California USA) in 2015. The hypothesis of this study was that implementation of the PreAct algorithm would increase the positive predictive value (PPV) of prehospital activation. METHODS: This is an observational pre-/post-study of the effect of the implementation of the PreAct algorithm for patients with suspected STEMI transported to one of five STEMI Receiving Centers (SRCs) within the LAC Regional System. The primary outcome was the PPV of cardiac catheterization laboratory activation for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). The secondary outcome was FMC2B. RESULTS: A total of 1,877 patients were analyzed for the primary outcome in the pre-intervention period and 405 patients in the post-intervention period. There was an overall decrease in cardiac catheterization laboratory activations, from 67% in the pre-intervention period to 49% in the post-intervention period (95% CI for the difference, -14% to -22%). The overall rate of cardiac catheterization declined in post-intervention period as compared the pre-intervention period, from 34% to 30% (95% CI, for the difference -7.6% to 0.4%), but actually increased for subjects who had activation (48% versus 58%; 95% CI, 4.6%-15.0%). Implementation of the PreAct algorithm was associated with an increase in the PPV of activation for PCI or CABG from 37.9% to 48.6%. The overall odds ratio (OR) associated with the intervention was 1.4 (95% CI, 1.1-1.8). The effect of the intervention was to decrease variability between medical centers. There was no associated change in average FMC2B. CONCLUSIONS: The implementation of the PreAct algorithm in the LAC EMS system was associated with an overall increase in the PPV of cardiac catheterization laboratory activation.


Assuntos
Protocolos Clínicos/normas , Laboratórios/normas , Avaliação de Resultados em Cuidados de Saúde , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Algoritmos , American Heart Association , Serviços Médicos de Emergência , Reações Falso-Positivas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Estados Unidos
17.
PLoS One ; 15(1): e0226332, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31923203

RESUMO

BACKGROUND: Approximately half of hospitalized patients suffer functional decline due to spending the vast majority of their time in bed. Previous studies of early mobilization have demonstrated improvement in outcomes, but the interventions studied have been resource-intensive. We aimed to decrease the time hospital inpatients spend in bed through a pragmatic mobilization protocol. METHODS: This prospective, non-blinded, controlled clinical trial assigned inpatients to the study wards per routine clinical care in an urban teaching hospital. All subjects on intervention wards were provided with a behavioral intervention, consisting of educational handouts, by the nursing staff. Half of the intervention wards were supplied with recliner chairs in which subjects could sit. The primary outcome was hospital length of stay. The secondary outcome was the '6-Clicks' functional score. RESULTS: During a 6-month study period, 6082 patient encounters were included. The median length of stay was 84 hours (IQR 44-175 hours) in the control group, 80 hours (IQR 44-155 hours) in the group who received the behavioral intervention alone, and 88 hours (IQR 44-185 hours) in the group that received both the behavioral intervention and the recliner chair. In the multivariate analysis, neither the behavioral intervention nor the provision of a recliner chair was associated with a significant decrease in length of stay or increase in functional status as measured by the '6-Clicks' functional score. CONCLUSION: The program of educational handouts and provision of recliner chairs to discourage bed rest did not increase functional status or decrease length of stay for inpatients in a major urban academic center. Education and physical resources must be supplemented by other active interventions to reduce time spent in bed, functional decline, and length of stay. TRIAL REGISTRATION: ClinicalTrials.gov, HS-16-00804.


Assuntos
Terapia Comportamental/métodos , Tempo de Internação , Adulto , Idoso , Repouso em Cama/métodos , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos
18.
Prehosp Disaster Med ; 35(1): 46-54, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31806058

RESUMO

OBJECTIVE: Low rates of bystander cardiopulmonary resuscitation (CPR) were identified as a shortcoming in the "chain of survival" for out-of-hospital cardiac arrest (OHCA) care in the Korean city of Ansan. This study sought to evaluate the effect of an initiative to increase bystander CPR and quality of out-of-hospital resuscitation on outcome from OHCA. The post-intervention data were used to determine the next quality improvement (QI) target as part of the "Plan-Do-Study-Act" (PDSA) model for QI. HYPOTHESIS: The study hypothesis was that bystander CPR, return of spontaneous circulation (ROSC), and survival to discharge after OHCA would increase in the post-intervention period. METHODS: This was a retrospective pre/post study. The data from the pre-intervention period were abstracted from 2008-2011 and the post-intervention period from 2012-2013. The effect of the intervention on the odds of ROSC and survival to hospital discharge was determined using a generalized estimating equation to account for confounders and the effect of clustering within medical centers. The analysis was then used to identify other factors associated with outcomes to determine the next targets for intervention in the chain of survival for cardiac arrest in this community. RESULTS: Rates of documented bystander CPR increased from 13% in the pre-intervention period to 37% in the post-intervention period. The overall rate of ROSC decreased from 18.4% to 14.3% (risk difference -4.1%; 95% CI, -7.1%-1.0%), whereas survival to hospital discharge increased from 3.9% to 5.0% (risk difference 1.1%; 95% CI, -1.8%-3.8%), and survival with good neurologic outcome increased from 0.8% to 1.6% (risk difference 0.8%; 95% CI, -0.8%-2.4%). In multivariable analyses, there was no association between the intervention and the rate of ROSC or survival to hospital discharge. The designated level of the treating hospital was a significant predictor of both survival and ROSC. CONCLUSION: In this case study, there were no observed improvements in outcomes from OHCA after the targeted intervention to improve out-of-hospital CPR. However, utilizing the PDSA model for QI, the designated level of the treating hospital was found to be a significant predictor of survival in the post-period, identifying the next target for intervention.


Assuntos
Reanimação Cardiopulmonar/estatística & dados numéricos , Serviços Médicos de Emergência/estatística & dados numéricos , Parada Cardíaca Extra-Hospitalar/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Serviços Médicos de Emergência/normas , Feminino , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/mortalidade , Parada Cardíaca Extra-Hospitalar/terapia , Melhoria de Qualidade , República da Coreia/epidemiologia , Estudos Retrospectivos
19.
West J Emerg Med ; 21(1): 108-114, 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31913829

RESUMO

INTRODUCTION: The optimal method to train novice learners to perform endotracheal intubation (ETI) is unknown. The study objective was to compare two models: unembalmed cadaver vs simulation manikin. METHODS: Fourth-year medical students, stratified by baseline ETI experience, were randomized 1:1 to train on a cadaver or simulation manikin. Students were tested and video recorded on a separate cadaver; two reviewers, blinded to the intervention, assessed the videos. Primary outcome was time to successful ETI, analyzed with a Cox proportional hazards model. Authors also compared percentage of glottic opening (POGO), number of ETI attempts, learner confidence, and satisfaction. RESULTS: Of 97 students randomized, 78 were included in the final analysis. Median time to ETI did not differ significantly (hazard ratio [HR] 1.1; 95% CI [confidence interval], 0.7-1.8): cadaver group = 34.5 seconds (interquartile ratio [IQR]: 23.3-55.8) vs manikin group = 35.5 seconds (IQR: 23.8-80.5), with no difference in first-pass success (odds ratio [OR] = 1; 95% CI, 0.1-7.5) or median POGO: 80% cadaver vs 90% manikin (95% CI, -14-34%). Satisfaction was higher for cadavers (median difference = 0.5; p = 0.002; 95% CI, 0-1) as was change in student confidence (median difference = 0.5; p = 0.03; 95% CI, 0-1). Students rating their confidence a 5 ("extremely confident") demonstrated decreased time to ETI (HR = 4.2; 95% CI, 1.0-17.2). CONCLUSION: Manikin and cadaver training models for ETI produced similar time to ETI, POGO, and first-pass success. Cadaver training was associated with increased student satisfaction and confidence; subjects with the highest confidence level demonstrated decreased time to ETI.


Assuntos
Educação de Graduação em Medicina/métodos , Intubação Intratraqueal/métodos , Ensino , Cadáver , Feminino , Glote , Humanos , Los Angeles , Masculino , Manequins , Estudos Prospectivos , Estudantes de Medicina , Gravação em Vídeo
20.
J Trauma Acute Care Surg ; 84(6S Suppl 1): S28-S34, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29554037

RESUMO

The traditional approach to clinical trial design requires assuming precise values for multiple unknown parameters, resulting in a trial design that is unlikely to perform well if one or more of those assumptions turn out to be incorrect. During conduct of the trial, trial characteristics are often held fixed, even if incoming data suggest that one or more design assumptions were incorrect. This leads to an increased risk of a failed trial. In contrast, an adaptive clinical trial is designed to take advantage of partial, incoming data during the conduct of the trial, modifying key clinical trial characteristics according to prespecified rules, in order to avoid a failed or inconclusive trial, improve statistical efficacy, better treat patients within the trial, or achieve other scientific or ethical goals. The concept of an adaptive trial can be expanded to a platform trial, a clinical trial that is intended to evaluate multiple treatments or combinations of treatments, often for patients with any of a group of related diseases, and to continue beyond the evaluation of any particular treatment. Platform trial design strategies can be applied to the problem of finding the best treatment strategy for patients suffering from posttraumatic hemorrhagic shock. We present the rationale and considerations surrounding adaptive and platform trial design and apply these concepts to the problem of investigating strategies for remote damage control resuscitation.


Assuntos
Ensaios Clínicos Adaptados como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ressuscitação/métodos , Humanos , Distribuição Aleatória , Projetos de Pesquisa
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