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1.
Circulation ; 149(12): e964-e985, 2024 03 19.
Article in English | MEDLINE | ID: mdl-38344851

ABSTRACT

In 1924, the founders of the American Heart Association (AHA) envisioned an international society focused on the heart and aimed at facilitating research, disseminating information, increasing public awareness, and developing public health policy related to heart disease. This presidential advisory provides a comprehensive review of the past century of cardiovascular and stroke science, with a focus on the AHA's contributions, as well as informed speculation about the future of cardiovascular science into the next century of the organization's history. The AHA is a leader in fundamental, translational, clinical, and population science, and it promotes the concept of the "learning health system," in which a continuous cycle of evidence-based practice leads to practice-based evidence, permitting an iterative refinement in clinical evidence and care. This advisory presents the AHA's journey over the past century from instituting professional membership to establishing extraordinary research funding programs; translating evidence to practice through clinical practice guidelines; affecting systems of care through quality programs, certification, and implementation; leading important advocacy efforts at the federal, state and local levels; and building global coalitions around cardiovascular and stroke science and public health. Recognizing an exciting potential future for science and medicine, the advisory offers a vision for even greater impact for the AHA's second century in its continued mission to be a relentless force for longer, healthier lives.


Subject(s)
Cardiovascular Diseases , Heart Diseases , Stroke , United States , Humans , American Heart Association , Stroke/therapy , Stroke/epidemiology , Evidence-Based Practice , Mediastinum , Cardiovascular Diseases/therapy , Cardiovascular Diseases/epidemiology
2.
Circulation ; 148(14): 1113-1126, 2023 10 03.
Article in English | MEDLINE | ID: mdl-37782695

ABSTRACT

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.


Subject(s)
Heart Valve Prosthesis Implantation , Heart-Assist Devices , Humans , Shock, Cardiogenic/therapy , Shock, Cardiogenic/surgery , Research Design
4.
Resuscitation ; 168: 160-166, 2021 11.
Article in English | MEDLINE | ID: mdl-34384820

ABSTRACT

IMPORTANCE: Emergency research is challenging to do well as it involves time sensitive interventions in unstable patients. There is limited time to obtain informed consent from the patient or their legally authorized representative (LAR). Such research is permitted under exception from informed consent (EFIC) if specific criteria are met, including notification after enrollment. Some question whether the risks of EFIC outweighs its benefits. To date, there is limited empiric information about time to notification (TTN) and rates of withdrawal in such trials. OBJECTIVE: To describe variation in TTN and rates of withdrawal among that patients enrolled in EFIC trials over a twelve-year period. DESIGN: We performed post hoc descriptive analyses of data from five trials conducted under EFIC. SETTING: Emergency medical services and receiving hospitals participating in the Resuscitation Outcomes Consortium in the United States and Canada. PARTICIPANTS: Patients with out-of-hospital cardiac arrest or life-threatening traumatic injury. EXPOSURES: Notification strategies were specified at each site before initiation of enrollment by a local institutional review board. We monitored TTN within each site centrally throughout each study's enrollment period. OUTCOMES: TTN was defined as time from randomization to first-reported notification of patient or LAR of enrollment. Withdrawal was defined as patient or LAR opt out of ongoing participation at the time of notification. RESULTS: Of 35,442 patients enrolled in five trials, 33,805 had cardiac arrest; and 1636 had traumatic injury. TTN varied overall and by patient outcome. Among those with cardiac arrest, TTN ranged from median (5%ile, 95%ile) of 6 (1,27) days to 28 (2, 53) days across sites. 0.3% of notified patients with cardiac arrest withdrew. Among those with traumatic injury, TTN ranged from 0 (0, 5) days to 36 (5, 68) days across sites. 7.7% of notified patients with traumatic injury withdrew. CONCLUSIONS AND RELEVANCE: There is large variation in TTN in trials conducted under EFIC for emergency research. This may be due to several factors. It may or may not be modifiable. Overall rates of withdrawal are low, which suggests current practices related to EFIC are acceptable to those who have participated in emergency research.


Subject(s)
Emergency Medical Services , Out-of-Hospital Cardiac Arrest , Emergencies , Humans , Informed Consent , Out-of-Hospital Cardiac Arrest/epidemiology , Out-of-Hospital Cardiac Arrest/therapy , Resuscitation , United States/epidemiology
5.
J Trauma Acute Care Surg ; 89(5): 900-907, 2020 11.
Article in English | MEDLINE | ID: mdl-33105308

ABSTRACT

BACKGROUND: No Food and Drug Administration-approved medication improves outcomes following traumatic brain injury (TBI). A forthcoming clinical trial that evaluated the effects of two prehospital tranexamic acid (TXA) dosing strategies compared with placebo demonstrated no differences in thromboelastography (TEG) values. We proposed to explore the impact of TXA on markers of coagulation and fibrinolysis in patients with moderate to severe TBI. METHODS: Data were extracted from a placebo-controlled clinical trial in which patients 15 years or older with TBI (Glasgow Coma Scale, 3-12) and systolic blood pressure of ≥90 mm Hg were randomized prehospital to receive placebo bolus/placebo infusion (placebo), 1 g of TXA bolus/1 g of TXA infusion (bolus maintenance), or 2 g of TXA bolus/placebo infusion (bolus only). Thromboelastography was performed, and coagulation measures including prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, D-dimer, plasmin-antiplasmin (PAP), thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1 were quantified at admission and 6 hours later. RESULTS: Of 966 patients receiving study drug, 700 had laboratory tests drawn at admission and 6 hours later. There were no statistically significant differences in TEG values, including LY30, between groups (p > 0.05). No differences between prothrombin time, activated partial thromboplastin time, international ratio, fibrinogen, thrombin antithrombin, tissue plasminogen activator, and plasminogen activator inhibitor 1 were demonstrated across treatment groups. Concentrations of D-dimer in TXA treatment groups were less than placebo at 6 hours (p < 0.001). Concentrations of PAP in TXA treatment groups were less than placebo on admission (p < 0.001) and 6 hours (p = 0.02). No differences in D-dimer and PAP were observed between bolus maintenance and bolus only. CONCLUSION: While D-dimer and PAP levels reflect a lower degree of fibrinolysis following prehospital administration of TXA when compared with placebo in a large prehospital trial of patients with TBI, TEG obtained on admission and 6 hours later did not demonstrate any differences in fibrinolysis between the two TXA dosing regimens and placebo. LEVEL OF EVIDENCE: Diagnostic test, level III.


Subject(s)
Antifibrinolytic Agents/administration & dosage , Blood Coagulation/drug effects , Brain Injuries, Traumatic/drug therapy , Fibrinolysis/drug effects , Tranexamic Acid/administration & dosage , Abbreviated Injury Scale , Adolescent , Adult , Blood Coagulation Disorders , Brain Injuries, Traumatic/blood , Brain Injuries, Traumatic/diagnosis , Female , Fibrin Fibrinogen Degradation Products/analysis , Fibrinolysin/analysis , Humans , Infusions, Intravenous , Injections, Intravenous , Male , Middle Aged , Thrombelastography/statistics & numerical data , Time-to-Treatment , Treatment Outcome , Young Adult , alpha-2-Antiplasmin/analysis
6.
JAMA ; 324(10): 961-974, 2020 09 08.
Article in English | MEDLINE | ID: mdl-32897344

ABSTRACT

Importance: Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI. Objective: To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. Design, Setting, and Participants: Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. Interventions: Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). Main Outcomes and Measures: The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. Results: Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16). Conclusions and Relevance: Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended. Trial Registration: ClinicalTrials.gov Identifier: NCT01990768.


Subject(s)
Antifibrinolytic Agents/administration & dosage , Brain Injuries, Traumatic/drug therapy , Tranexamic Acid/administration & dosage , Adult , Antifibrinolytic Agents/adverse effects , Brain Diseases/etiology , Brain Injuries, Traumatic/complications , Brain Injuries, Traumatic/mortality , Double-Blind Method , Emergency Medical Services , Female , Follow-Up Studies , Glasgow Coma Scale , Humans , Infusions, Intravenous , Male , Middle Aged , Neuropsychological Tests , Patient Acuity , Survival Analysis , Time-to-Treatment , Tranexamic Acid/adverse effects
7.
Resuscitation ; 137: 168-174, 2019 04.
Article in English | MEDLINE | ID: mdl-30790694

ABSTRACT

BACKGROUND: An increasing proportion of patients with OHCA present with non-shockable rhythms, among whom the benefit from AED application is not known. METHODS: We performed a retrospective analysis of adults with non-traumatic, public, bystander-witnessed, non-shockable OHCA occurring between 2005-2015 at 9 locations participating in the Resuscitation Outcomes Consortium. Non-shockable arrest was defined as when no shock was administered by a bystander applied AED and confirmed by the initial rhythm on EMS arrival. Outcomes were compared between patients with non-shockable OHCA in whom a bystander AED was or was not applied. RESULTS: Among 2809 patients with non-shockable public, witnessed OHCA, 8.4% had an AED applied. CPR was more often performed in the AED-applied group (99% vs. 51% of patients, p < 0.001). Among patients in whom an AED was not applied, 39.8% had any pre-hospital ROSC, 29.6% had a pulse at ED arrival and 11.1% survived to hospital discharge compared to 44.1%, 29.6% and 9.7%, respectively with AED application. After adjustment for the Utstein variables excluding bystander CPR, the OR for survival to hospital discharge for AED application was 0.90 (95% CI:0.57-1.42); when adjusted for the higher frequency of CPR in the AED group the OR was 0.92 (95% CI:0.57-1.47). CONCLUSIONS: The application of an AED in non-shockable public witnessed OHCA was associated with a higher frequency of bystander CPR. The probabilities of pre-hospital ROSC, pulse at ED arrival, and survival to hospital discharge were not altered by the application of an AED.


Subject(s)
Bystander Effect , Defibrillators , Out-of-Hospital Cardiac Arrest/therapy , Adult , Aged , Aged, 80 and over , Cardiopulmonary Resuscitation , Emergency Medical Services , Female , Humans , Male , Middle Aged , North America , Out-of-Hospital Cardiac Arrest/mortality , Registries , Retrospective Studies
10.
JAMA ; 320(8): 769-778, 2018 08 28.
Article in English | MEDLINE | ID: mdl-30167699

ABSTRACT

Importance: Emergency medical services (EMS) commonly perform endotracheal intubation (ETI) or insertion of supraglottic airways, such as the laryngeal tube (LT), on patients with out-of-hospital cardiac arrest (OHCA). The optimal method for OHCA advanced airway management is unknown. Objective: To compare the effectiveness of a strategy of initial LT insertion vs initial ETI in adults with OHCA. Design, Setting, and Participants: Multicenter pragmatic cluster-crossover clinical trial involving EMS agencies from the Resuscitation Outcomes Consortium. The trial included 3004 adults with OHCA and anticipated need for advanced airway management who were enrolled from December 1, 2015, to November 4, 2017. The final date of follow-up was November 10, 2017. Interventions: Twenty-seven EMS agencies were randomized in 13 clusters to initial airway management strategy with LT (n = 1505 patients) or ETI (n = 1499 patients), with crossover to the alternate strategy at 3- to 5-month intervals. Main Outcomes and Measures: The primary outcome was 72-hour survival. Secondary outcomes included return of spontaneous circulation, survival to hospital discharge, favorable neurological status at hospital discharge (Modified Rankin Scale score ≤3), and key adverse events. Results: Among 3004 enrolled patients (median [interquartile range] age, 64 [53-76] years, 1829 [60.9%] men), 3000 were included in the primary analysis. Rates of initial airway success were 90.3% with LT and 51.6% with ETI. Seventy-two hour survival was 18.3% in the LT group vs 15.4% in the ETI group (adjusted difference, 2.9% [95% CI, 0.2%-5.6%]; P = .04). Secondary outcomes in the LT group vs ETI group were return of spontaneous circulation (27.9% vs 24.3%; adjusted difference, 3.6% [95% CI, 0.3%-6.8%]; P = .03); hospital survival (10.8% vs 8.1%; adjusted difference, 2.7% [95% CI, 0.6%-4.8%]; P = .01); and favorable neurological status at discharge (7.1% vs 5.0%; adjusted difference, 2.1% [95% CI, 0.3%-3.8%]; P = .02). There were no significant differences in oropharyngeal or hypopharyngeal injury (0.2% vs 0.3%), airway swelling (1.1% vs 1.0%), or pneumonia or pneumonitis (26.1% vs 22.3%). Conclusions and Relevance: Among adults with OHCA, a strategy of initial LT insertion was associated with significantly greater 72-hour survival compared with a strategy of initial ETI. These findings suggest that LT insertion may be considered as an initial airway management strategy in patients with OHCA, but limitations of the pragmatic design, practice setting, and ETI performance characteristics suggest that further research is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT02419573.


Subject(s)
Airway Management/methods , Intubation, Intratracheal/methods , Larynx , Out-of-Hospital Cardiac Arrest/therapy , Aged , Airway Management/instrumentation , Cardiopulmonary Resuscitation , Cross-Over Studies , Female , Humans , Intubation, Intratracheal/instrumentation , Male , Middle Aged , Out-of-Hospital Cardiac Arrest/mortality , Survival Rate , Treatment Outcome
11.
JAMA Cardiol ; 3(10): 989-999, 2018 10 01.
Article in English | MEDLINE | ID: mdl-30267053

ABSTRACT

Importance: Emergency medical services (EMS) deliver essential initial care for patients with out-of-hospital cardiac arrest (OHCA), but the extent to which patient outcomes vary between different EMS agencies is not fully understood. Objective: To quantify variation in patient outcomes after OHCA across EMS agencies. Design, Setting, and Participants: This observational cohort study was conducted in the Resuscitation Outcomes Consortium (ROC) Epistry, a prospective multicenter OHCA registry at 10 sites in North America. Any adult with OHCA treated by an EMS from April 2011 through June 2015 was included. Data analysis occurred from May 2017 to March 2018. Exposure: Treating EMS agency. Main Outcomes and Measures: The primary outcome was survival to hospital discharge. Secondary outcomes were return of spontaneous circulation at emergency department arrival and favorable functional outcome at hospital discharge (defined as a modified Rankin scale score ≤3). Multivariable hierarchical logistic regression models were used to adjust confounders and clustering of patients within EMS agencies, and calculated median odds ratios (MORs) were used to quantify the extent of residual variation in outcomes between EMS agencies. Results: We identified 43 656 patients with OHCA treated by 112 EMS agencies. At EMS agency level, we observed large variations in survival to hospital discharge (range, 0%-28.9%; unadjusted MOR, 1.43 [95% CI, 1.34-1.54]), return of spontaneous circulation on emergency department arrival (range, 9.0%-57.1%; unadjusted MOR, 1.53 [95% CI, 1.43-1.65]), and favorable functional outcome (range, 0%-20.4%; unadjusted MOR, 1.54 [95% CI, 1.40-1.73]). This variation persisted despite adjustment for patient-level and EMS agency-level factors known to be associated with outcomes (adjusted MOR for survival 1.56 [95% CI 1.44-1.73]; adjusted MOR for return of spontaneous circulation at emergency department arrival, 1.50 [95% CI, 1.41-1.62]; adjusted MOR for functionally favorable survival, 1.53 [95% CI, 1.37-1.78]). After restricting analysis to those who survived more than 60 minutes after hospital arrival and including hospital treatment characteristics, the variation persisted (adjusted MOR for survival, 1.49 [95% CI, 1.36-1.69]; adjusted MOR for functionally favorable survival, 1.34 [95% CI, 1.20-1.59]). Conclusions and Relevance: We found substantial variations in patient outcomes after OHCA between a large group of EMS agencies in North America that were not explained by documented patient-level and EMS agency-level variables.


Subject(s)
Cardiopulmonary Resuscitation/methods , Emergency Medical Services/organization & administration , Out-of-Hospital Cardiac Arrest/therapy , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Logistic Models , Male , Middle Aged , Out-of-Hospital Cardiac Arrest/epidemiology , Patient Discharge/statistics & numerical data , Prospective Studies , Registries , Survival Analysis
12.
Card Electrophysiol Clin ; 9(4): 551-557, 2017 12.
Article in English | MEDLINE | ID: mdl-29173401

ABSTRACT

Public access defibrillation is particularly valuable in witnessed cardiac arrests that occur in public places. Bystander and police use of automated external defibrillators (AEDs) has increased over the past 15 years, resulting in improved survival with normal or near-normal neurologic function. There is great promise for increasing bystander use of defibrillators as the technology is applied to linking patients with shockable arrests to volunteers committed to bringing AEDs to the patients. There continues to be controversy as to the value of epinephrine, antiarrhythmic drugs, hypothermia, and mechanical chest compression in resuscitative efforts.


Subject(s)
Cardiopulmonary Resuscitation , Defibrillators , Out-of-Hospital Cardiac Arrest , Cardiopulmonary Resuscitation/methods , Cardiopulmonary Resuscitation/standards , Cardiopulmonary Resuscitation/statistics & numerical data , Emergency Medical Services , Humans , Out-of-Hospital Cardiac Arrest/epidemiology , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/therapy , Volunteers
13.
Circulation ; 136(22): 2119-2131, 2017 Nov 28.
Article in English | MEDLINE | ID: mdl-28904070

ABSTRACT

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) commonly presents with nonshockable rhythms (asystole and pulseless electric activity). It is unknown whether antiarrhythmic drugs are safe and effective when nonshockable rhythms evolve to shockable rhythms (ventricular fibrillation/pulseless ventricular tachycardia [VF/VT]) during resuscitation. METHODS: Adults with nontraumatic OHCA, vascular access, and VF/VT anytime after ≥1 shock(s) were prospectively randomized, double-blind, to receive amiodarone, lidocaine, or placebo by paramedics. Patients presenting with initial shock-refractory VF/VT were previously reported. The current study was a prespecified analysis in a separate cohort that initially presented with nonshockable OHCA and was randomized on subsequently developing shock-refractory VF/VT. The primary outcome was survival to hospital discharge. Secondary outcomes included discharge functional status and adverse drug-related effects. RESULTS: Of 37 889 patients with OHCA, 3026 with initial VF/VT and 1063 with initial nonshockable-turned-shockable rhythms were treatment-eligible, were randomized, and received their assigned drug. Baseline characteristics among patients with nonshockable-turned-shockable rhythms were balanced across treatment arms, except that recipients of a placebo included fewer men and were less likely to receive bystander cardiopulmonary resuscitation. Active-drug recipients in this cohort required fewer shocks, supplemental doses of their assigned drug, and ancillary antiarrhythmic drugs than recipients of a placebo (P<0.05). In all, 16 (4.1%) amiodarone, 11 (3.1%) lidocaine, and 6 (1.9%) placebo-treated patients survived to hospital discharge (P=0.24). No significant interaction between treatment assignment and discharge survival occurred with the initiating OHCA rhythm (asystole, pulseless electric activity, or VF/VT). Survival in each of these categories was consistently higher with active drugs, although the trends were not statistically significant. Adjusted absolute differences (95% confidence interval) in survival from nonshockable-turned-shockable arrhythmias with amiodarone versus placebo were 2.3% (-0.3, 4.8), P=0.08, and for lidocaine versus placebo 1.2% (-1.1, 3.6), P=0.30. More than 50% of these survivors were functionally independent or required minimal assistance. Drug-related adverse effects were infrequent. CONCLUSIONS: Outcome from nonshockable-turned-shockable OHCA is poor but not invariably fatal. Although not statistically significant, point estimates for survival were greater after amiodarone or lidocaine than placebo, without increased risk of adverse effects or disability and consistent with previously observed favorable trends from treatment of initial shock-refractory VF/VT with these drugs. Together the findings may signal a clinical benefit that invites further investigation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01401647.


Subject(s)
Amiodarone/therapeutic use , Anti-Arrhythmia Agents/therapeutic use , Cardiopulmonary Resuscitation , Electric Countershock , Lidocaine/therapeutic use , Out-of-Hospital Cardiac Arrest/therapy , Tachycardia, Ventricular/therapy , Ventricular Fibrillation/therapy , Aged , Aged, 80 and over , Amiodarone/adverse effects , Anti-Arrhythmia Agents/adverse effects , Cardiopulmonary Resuscitation/adverse effects , Cardiopulmonary Resuscitation/mortality , Double-Blind Method , Electric Countershock/adverse effects , Electric Countershock/mortality , Female , Hospital Mortality , Humans , Lidocaine/adverse effects , Male , Middle Aged , North America , Out-of-Hospital Cardiac Arrest/diagnosis , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/physiopathology , Patient Discharge , Prospective Studies , Recovery of Function , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/mortality , Tachycardia, Ventricular/physiopathology , Time Factors , Treatment Outcome , Ventricular Fibrillation/diagnosis , Ventricular Fibrillation/mortality , Ventricular Fibrillation/physiopathology
14.
N Engl J Med ; 376(6): 578-579, 2017 02 09.
Article in English | MEDLINE | ID: mdl-28121490
16.
N Engl J Med ; 374(18): 1711-22, 2016 May 05.
Article in English | MEDLINE | ID: mdl-27043165

ABSTRACT

BACKGROUND: Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit. METHODS: In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock. RESULTS: In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P=0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P=0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P=0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P=0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo. CONCLUSIONS: Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT01401647.).


Subject(s)
Amiodarone/therapeutic use , Anti-Arrhythmia Agents/therapeutic use , Lidocaine/therapeutic use , Out-of-Hospital Cardiac Arrest/drug therapy , Adult , Aged , Amiodarone/adverse effects , Anti-Arrhythmia Agents/adverse effects , Cardiopulmonary Resuscitation/methods , Central Nervous System Diseases/epidemiology , Combined Modality Therapy , Double-Blind Method , Electric Countershock , Emergency Medical Services , Female , Humans , Intention to Treat Analysis , Lidocaine/adverse effects , Male , Middle Aged , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/therapy , Patient Discharge , Survival Rate , Tachycardia, Ventricular/complications , Ventricular Fibrillation/complications , Ventricular Fibrillation/therapy
17.
Resuscitation ; 100: 76-81, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26705971

ABSTRACT

INTRODUCTION: This study examined the relationship between gender and outcomes of non-traumatic out-of-hospital cardiac arrest (OHCA). METHODS: All eligible, consecutive, non-traumatic Emergency Medical Services (EMS) treated OHCA patients in the Resuscitation Outcomes Consortium between December 2005 and May 2007. Patient age was analyzed as a continuous variable and stratified in two age cohorts: 15-45 and >55 years of age (yoa). Unadjusted and adjusted (based on Utstein characteristics) chi square tests and logistic regression models were employed to examine the relationship between gender, age, and survival outcomes. RESULTS: This study enrolled 14,690 patients: of which 36.4% were women with a mean age of 68.3 and 63.6% of them men with a mean age of 64.2. Women survived to hospital discharge less often than men (6.4% vs. 9.1%, p<0.001); the unadjusted OR was 0.69, 95%CI: 0.60, 0.77 whereas when adjusted for all Utstein predictors the difference was not significant (OR: 1.16, 95%CI: 0.98, 1.36, p=0.07). The adjusted survival rate for younger women (15-45 yoa) was 11.1% vs. 9.8% for younger men (OR: 1.66, 95%CI: 1.04, 2.64, p=0.03) but no difference in discharge rates was observed in the >55 cohort (OR: 0.94, 95%CI: 0.78, 1.15, p=0.57). CONCLUSIONS: Women who suffer OHCAs have lower rates of survival and have unfavourable Utstein predictors. When survival is adjusted for these predictors survival is similar between men and women except in younger women suggesting that age modifies the association of gender and survival from OHCA; a result that supports a protective hormonal effect among premenopausal women.


Subject(s)
Cardiopulmonary Resuscitation/methods , Out-of-Hospital Cardiac Arrest/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Cardiopulmonary Resuscitation/statistics & numerical data , Cohort Studies , Emergency Medical Services/statistics & numerical data , Female , Humans , Logistic Models , Male , Middle Aged , North America , Out-of-Hospital Cardiac Arrest/mortality , Patient Discharge/statistics & numerical data , Sex Factors , Survival Rate , Treatment Outcome , Young Adult
18.
J Womens Health (Larchmt) ; 24(11): 933-9, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26291588

ABSTRACT

BACKGROUND: National data suggest that women are overall less likely than men to attain independent research funding. However, it remains unclear whether such sex differences are also observed in academic institutions that have integrated diversity in the workplace as a priority. METHODS: During 1999-2008, all National Institutes of Health (NIH) Career Development (K01, K08, or K23) awardees in the Department of Medicine at Johns Hopkins University School of Medicine were identified to investigate differences in the attainment of independent funding by sex, including NIH Research Project Grant (R01) or equivalent awards, (U01, P01, P50), and any R award (also R03, R21, R34) through 2012. RESULTS: A similar number of men (n = 49) and women (n = 43) received a K award. There were no significant sex differences in attaining an R01/equivalent award or any R award. The median time to attaining the first R01/equivalent award was similar for men and women (5.6 vs. 5.3 years, p = 0.93). The actuarial rate of R01/equivalent award attainment at 10 years was 64% overall (56% among men vs. 74% among women; log-rank p = 0.41). For any R award, the rate was 72% overall (70% among men vs. 76% among women; log-rank p = 0.63). In Cox proportional hazards models, adjusting for race/ethnicity, age, Doctor of Medicine (MD) degree, and funding period, sex was not an independent predictor of R01/equivalent or any R award attainment. Interestingly, black race and/or Hispanic ethnicity significantly predicted any R award attainment (adjusted hazard ratio [HR] = 2.34, 95% confidence interval [CI] 1.02-5.37). CONCLUSIONS: No sex differences were found in the attainment of independent funding by K awardees in our study. Future studies to investigate the impact of specific diversity initiatives on subsequent success in attaining independent research funding are needed.


Subject(s)
Awards and Prizes , Biomedical Research , Career Mobility , Physicians , Research Support as Topic/statistics & numerical data , Biomedical Research/economics , Female , Humans , Male , Prejudice , Proportional Hazards Models , Sex Factors , United States , Universities , Workforce
20.
Acad Med ; 88(11): 1747-53, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24072121

ABSTRACT

PURPOSE: In 1995, the American Board of Internal Medicine (ABIM) formalized an integrated residency curriculum including both clinical and research training (the Research Pathway), designed to develop careers of physician-scientists. Individuals who completed Pathway training between 1995 and 2007 were surveyed to determine the extent to which graduates established research-oriented careers. METHOD: In 2012, the authors used a Web-based, 56-question, multiple-choice electronic survey of 813 participants in Research Pathway programs who completed their residency training between the years of 1995 and 2007. Survey questions addressed source and type of funding, research productivity, and job title/content. Descriptive and inferential analyses were performed. RESULTS: Forty-seven percent of solicited Pathway graduates participated in the survey. Ninety-seven percent of the respondents completed Pathway training. Ninety-one percent reported some research effort, with a group average of 58.6% of total professional effort spent in research. Seventy-two percent currently hold positions in academic medicine; 8.6% in the biomedical industry; and 2.1% in government medical service. Over 85% reported extramural research funding, with 81.4% receiving research support from federal sources. Among the variables positively correlated with the highest level of research engagement were previous graduate-level research training, any first-author publications arising from the Pathway research experience, and the receipt of extramural career development funding supporting the Pathway research. CONCLUSIONS: On the basis of a very high level of active research engagement reported by 385 ABIM Research Pathway graduates, this special research training track appears to be effectively meeting its goal of training biomedical scientists.


Subject(s)
Curriculum , Internal Medicine/education , Research Personnel , Cross-Sectional Studies , Curriculum/trends , Humans , Research Support as Topic , United States
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