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  1. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Blom, M T; van Hoeijen, D A; Bardai, A

    2014-01-01

    victims since June 2005, we prospectively collect medical history (through hospital and general practitioner), and current and previous medication use (through community pharmacy). In addition, we include DNA samples from OHCA victims with documented ventricular tachycardia/fibrillation during......INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA...

  2. Bystander Automated External Defibrillator Use and Clinical Outcomes after Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Holmberg, Mathias J; Vognsen, Mikael; Andersen, Mikkel S

    2017-01-01

    AIM: To systematically review studies comparing bystander automated external defibrillator (AED) use to no AED use in regard to clinical outcomes in out-of-hospital cardiac arrest (OHCA), and to provide a descriptive summary of studies on the cost-effectiveness of bystander AED use. METHODS: We...... randomized trials, and 13 cost-effectiveness studies were included. Meta-analysis of 6 observational studies without critical risk of bias showed that bystander AED use was associated with survival to hospital discharge (all rhythms OR: 1.73 [95%CI: 1.36, 2.18], shockable rhythms OR: 1.66 [95%CI: 1.54, 1.......79]) and favorable neurological outcome (all rhythms OR: 2.12 [95%CI: 1.36, 3.29], shockable rhythms OR: 2.37 [95%CI: 1.58, 3.57]). There was no association between bystander AED use and neurological outcome for non-shockable rhythms (OR: 0.76 [95%CI: 0.10, 5.87]). The Public-Access Defibrillation trial found higher...

  3. FENO and AHR mannitol in patients referred to an out-of-hospital asthma clinic

    DEFF Research Database (Denmark)

    Backer, Vibeke; Sverrild, Asger; Porsbjerg, Celeste

    2014-01-01

    between FENO and AHR to mannitol in unselected individuals with possible asthma. METHODS: A real-life study on patients with possible asthma referred to a specialized asthma clinic. Data on asthma history, FEV(1), FENO, atopy, smoking, treatment and AHR to mannitol were collected. RESULTS: In 217......OBJECTIVE: Ongoing airway inflammation measured by fractional exhaled nitric oxide (FENO) and airway hyperresponsiveness (AHR) to mannitol are associated in selected asthma patients, but no evidence exists of this association in unselected asthma patients. The aim was to investigate the association...... unselected patients with symptoms suggestive of asthma, FENO and response to mannitol were tested. Of the 141 who underwent both tests, 32 (23%) had FENO > 25 ppb, and 58 (41%) had AHR to mannitol. A significant association between high FENO and AHR was found (p 

  4. Electronic Versus Manual Data Processing: Evaluating the Use of Electronic Health Records in Out-of-Hospital Clinical Research

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    Newgard, Craig D.; Zive, Dana; Jui, Jonathan; Weathers, Cody; Daya, Mohamud

    2011-01-01

    Objectives To compare case ascertainment, agreement, validity, and missing values for clinical research data obtained, processed, and linked electronically from electronic health records (EHR), compared to “manual” data processing and record abstraction in a cohort of out-ofhospital trauma patients. Methods This was a secondary analysis of two sets of data collected for a prospective, population-based, out-of-hospital trauma cohort evaluated by 10 emergency medical services (EMS) agencies transporting to 16 hospitals, from January 1, 2006 through October 2, 2007. Eighteen clinical, operational, procedural, and outcome variables were collected and processed separately and independently using two parallel data processing strategies, by personnel blinded to patients in the other group. The electronic approach included electronic health record data exports from EMS agencies, reformatting and probabilistic linkage to outcomes from local trauma registries and state discharge databases. The manual data processing approach included chart matching, data abstraction, and data entry by a trained abstractor. Descriptive statistics, measures of agreement, and validity were used to compare the two approaches to data processing. Results During the 21-month period, 418 patients underwent both data processing methods and formed the primary cohort. Agreement was good to excellent (kappa 0.76 to 0.97; intraclass correlation coefficient 0.49 to 0.97), with exact agreement in 67% to 99% of cases, and a median difference of zero for all continuous and ordinal variables. The proportions of missing out-of-hospital values were similar between the two approaches, although electronic processing generated more missing outcomes (87 out of 418, 21%, 95% CI = 17% to 25%) than the manual approach (11 out of 418, 3%, 95% CI = 1% to 5%). Case ascertainment of eligible injured patients was greater using electronic methods (n = 3,008) compared to manual methods (n = 629). Conclusions In this

  5. Clinical profile, management, and outcome in patients with out of hospital cardiac arrest: insights from a 20-year registry

    Directory of Open Access Journals (Sweden)

    Patel AA

    2014-07-01

    Full Text Available Ashfaq Ahmad Patel, Abdul Rahman Arabi, Hakam Alzaeem, Jassim Al Suwaidi, Rajvir Singh, Hajar A Al BinaliDepartment of Cardiology, Heart Hospital, Hamad Medical Corporation, Doha, QatarBackground: There is limited information regarding the clinical characteristics and outcome of out of hospital cardiac arrest (OHCA in Middle Eastern patients. The aim of this study was to evaluate clinical characteristics, treatment, and outcomes in patients admitted following OHCA at a single center in the Middle East over a 20-year period.Methods: The data used for this hospital-based study were collected for patients hospitalized with OHCA in Doha, Qatar, between 1991 and 2010. Baseline clinical characteristics, in-hospital treatment, and outcomes were studied in comparison with the rest of the admissions.Results: A total of 41,453 consecutive patients were admitted during the study period, of whom 987 (2.4% had a diagnosis of OHCA. Their average age was 57±15 years, and 72.7% were males, 56.5% were Arabs, and 30.9% were South Asians. When compared with the rest of the admissions taken as a reference, patients with OHCA were more likely to have diabetes mellitus (42.8% versus 39.1%, respectively, P=0.02, prior myocardial infarction (21.8% versus 19.2%, P=0.04, and chronic renal failure (7.4% versus 3.9%, P=0.001, but were less likely to have dyslipidemia (16.9% versus 25.4%, P=0.001. Further, 52.6% of patients had preceding symptoms, the most common of which was chest pain (27.2% followed by dyspnea (24.8%. An initially shockable rhythm (ventricular fibrillation or ventricular tachycardia was present in 25.1% of OHCA patients, with ST segment elevation myocardial infarction documented in 30.0%. Severely reduced left ventricular systolic function (ejection fraction ≤35% was present in 53.2% of OHCA patients; 42.9% had cardiogenic shock requiring use of inotropes at presentation. An intra-aortic balloon pump was inserted in 3.6% of cases. Antiarrhythmic

  6. Clinical predictors of shockable versus non-shockable rhythms in patients with out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Granfeldt, Asger; Wissenberg, Mads; Hansen, Steen Møller

    2016-01-01

    Aim To identify factors associated with a non-shockable rhythm as first recorded heart rhythm. Methods Patients ≥18 years old suffering out-of-hospital cardiac arrest between 2001 and 2012 were identified in the population-based Danish Cardiac Arrest Registry. Danish administrative registries were...... used to identify chronic diseases (within 10 years) and drug prescriptions (within 180 days). A multivariable logistic regression model, including patient related and cardiac arrest related characteristics, was used to estimate odds ratios (OR) for factors associated with non-shockable rhythm. Results...

  7. The role of out-of-hospital cardiac arrest in predicting hospital mortality for percutaneous coronary interventions in the Clinical Outcomes Assessment Program.

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    Maynard, Charles; Rao, Sunil V; Gregg, Mary; Phillips, Richard C; Reisman, Mark; Tucker, Eben; Goss, J Richard

    2009-01-01

    Published mortality models for percutaneous coronary intervention (PCI), including the Clinical Outcomes Assessment Program (COAP) model, have not considered the effect of out-ofhospital cardiac arrest. The primary objective of this study was to determine if the inclusion of out-of-hospital cardiac arrest altered the COAP mortality model for PCI. The COAP PCI database contains extensive demographic, clinical, procedural and outcome information, including out-of-hospital cardiac arrest, which was added to the data collection form in 2006. This study included 15,586 consecutive PCIs performed in 31 Washington State hospitals in 2006. Using development and test sets, the existing COAP PCI logistic regression mortality model was examined to assess the effect of out-of-hospital arrest on in-hospital mortality. Overall, 2% of individuals undergoing PCI had cardiac arrest prior to hospital arrival. Among 8 hospitals with PCI volumes 120 cases per year did. In-hospital mortality was 19% in the arrest group and was 1.0% in remaining procedures (p < 0.0001). In the new multivariate model, out-of-hospital cardiac arrest was highly associated with mortality (odds ratio = 5.50; 95% confidence interval [CI] = 3.28-9.25). When evaluated in the test set, the new model had excellent discrimination (c-statistic = 0.89; 95% CI = 0.85-0.93). Out-of-hospital cardiac arrest is an important determinant of risk-adjusted in-hospital mortality for PCI, particularly for hospitals with low volumes and relatively high volumes of cardiac arrest cases.

  8. Clinical characteristics and vital and functional prognosis of out-of-hospital cardiac arrest survivors admitted to five cardiac intensive care units.

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    Loma-Osorio, Pablo; Aboal, Jaime; Sanz, Maria; Caballero, Ángel; Vila, Montserrat; Lorente, Victoria; Sánchez-Salado, José Carlos; Sionis, Alessandro; Curós, Antoni; Lidón, Rosa-Maria

    2013-08-01

    Survivors of out-of-hospital cardiac arrest constitute an increasing patient population in cardiac intensive care units. Our aim was to characterize these patients and determine their vital and functional prognosis in accordance with the latest evidence. A multicenter, prospective register was constructed with information from patients admitted to 5 cardiac intensive care units from January 2010 through January 2012 with a diagnosis of resuscitated out-of-hospital cardiac arrest. The information included clinical status, cardiac arrest characteristics, in-hospital course, and vital and neurologic status at discharge and at 6 months. A total of 204 patients were included. In 64% of cases, a first shockable rhythm was identified. The time to return of spontaneous circulation was 29 (18) min. An etiologic diagnosis was made in 86% of patients; 44% were discharged with no neurologic sequelae; 40% died in the hospital. At 6 months, 79% of survivors at discharge were still alive and neurologically intact with minimal sequelae. Short resuscitation time, first recorded rhythm, pH on admission >7.1, absence of shock, and use of hypothermia were the independent variables associated with a good neurologic prognosis. Half the patients who recovered from out-of-hospital cardiac arrest had good neurologic prognosis at discharge, and 79% of survivors were alive and neurologically intact after 6 months of follow-up. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  9. Association Between Chest Compression Interruptions and Clinical Outcomes of Ventricular Fibrillation Out-of-Hospital Cardiac Arrest.

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    Brouwer, Tom F; Walker, Robert G; Chapman, Fred W; Koster, Rudolph W

    2015-09-15

    Minimizing pauses in chest compressions during cardiopulmonary resuscitation is a focus of current guidelines. Prior analyses found that prolonged pauses for defibrillation (perishock pauses) are associated with worse survival. We analyzed resuscitations to characterize the association between pauses for all reasons and both ventricular fibrillation termination and patient survival. In 319 patients with ventricular tachycardia/fibrillation out-of-hospital cardiac arrest, we analyzed recordings from all defibrillators used during resuscitation and measured durations of all cardiopulmonary resuscitation pauses. Median durations were 32 seconds (25th and 75th percentile, 22 and 52 seconds) for the longest pause for any reason, 23 seconds (25th and 75th percentile, 14 and 34 seconds) for the longest perishock pause, and 24 seconds (25th and 75th percentile, 11 and 38 seconds) for the longest nonshock pause. Multivariable regression models showed lower odds for survival per 5-second increase in the longest overall pause (odds ratio, 0.89; 95% confidence interval, 0.83-0.95), longest perishock pause (odds ratio, 0.85; 95% confidence interval, 0.77-0.93), and longest nonshock pause (odds ratio, 0.83; 95% confidence interval, 0.75-0.91). In 36% of cases, the longest pause was a nonshock pause; this subgroup had lower survival than the group in whom the longest pause was a perishock pause (27% versus 44%, respectively; P<0.01) despite a higher chest compression fraction. Preshock pauses were 8 seconds (25th and 75th percentile, 4 and 17 seconds) for shocks that terminated ventricular fibrillation and 7 seconds (25th and 75th percentile, 4 and 13 seconds) for shocks that did not (P=0.18). Prolonged pauses have a negative association with survival not explained by chest compression fraction or decreased ventricular fibrillation termination rate. Ventricular fibrillation termination was not the mechanism linking pause duration and survival. Strategies shortening the longest

  10. Clinical Significance of J Waves in Patients Undergoing Therapeutic Hypothermia for Out-of-Hospital Cardiac Arrest.

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    Harhash, Ahmed; Gussak, Ihor; Cassuto, James; Winters, Stephen L

    2017-02-01

    Hypothermia is associated with the development of J waves. However, little is known about the impact of these electrocardiogram (ECG) findings on the development of ventricular arrhythmias and patient outcomes during therapeutic hypothermia (TH) postresuscitation from out-of-hospital cardiac arrest (OHCA). We investigated the prevalence of J waves in OHCA patients prior to and during TH. Additionally, we explored the incidence of atrial and ventricular arrhythmias and in-hospital mortality for patients with and without J waves either at baseline, during TH, or both. We conducted a retrospective analysis of patients who suffered OHCA and underwent TH (goal temperature of 32-34°C). Fifty-nine patients were stratified dependent upon the presence of or the development of J waves on surface ECGs. Descriptive analysis and logistic regression modeling were used to assess the population differences and mortality, respectively, between patients who developed J waves during TH and those who did not. There was no difference in the development of in-hospital atrial or ventricular arrhythmias between patients with J waves present during TH (16%) and those without (17.6%, P = 0.834). Compared to patients without J waves at baseline and during TH, those with J waves present both at baseline and during TH had significantly worse survival (hazard ratio = 12.42, P = 0.046). While J waves are common ECG findings during TH in patients resuscitated from OHCA, our study demonstrated an increase in mortality for patients with J waves present both at baseline and during TH. © 2016 Wiley Periodicals, Inc.

  11. A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

    DEFF Research Database (Denmark)

    Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville;

    2016-01-01

    BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients...... predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. TRIAL REGISTRATION: Clinical...

  12. Clinical research before informed consent.

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    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  13. Informed Consent (Clinical Trials)

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    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  14. A comprehensive regional clinical and educational ECPR protocol decreases time to ECMO in patients with refractory out-of-hospital cardiac arrest.

    Science.gov (United States)

    Grunau, Brian; Carrier, Sarah; Bashir, Jamil; Dick, William; Harris, Luke; Boone, Robert; Kalla, Dan; Scheuermeyer, Frank; Twaites, Brian; Straight, Ron; Abel, James; McDonald, Ken; MacRedmond, Ruth; Agulnik, David; Finkler, Joe; MacLeod, Jeanne; Christenson, Jim; Cheung, Anson

    2017-08-16

    Extracorporeal membrane oxygenation within CPR (ECPR) may improve survival for refractory out-of-hospital cardiac arrest (OHCA). We developed a prehospital, emergency department (ED), and hospital-based clinical and educational protocol to improve the key variable of time-to-ECPR (TTE). In a single urban health region we involved key prehospital, clinical, and administrative stakeholders over a 2-year period, to develop a regional ECPR program with destination to a single urban tertiary care hospital. We developed clear and reproducible inclusion criteria and processes, including measures of program efficiency. We conducted seminars and teaching modules to paramedics and hospital-based clinicians including monthly simulator sessions, and performed detailed reviews of each treated case in the form of report cards. In this before-and-after study we compared patients with ECPR attempted prior to, and after, protocol implementation. The primary outcome was TTE, defined as the time of initial professional CPR to establishment of extracorporeal circulation. We compared the median TTE for patients in the two groups using the Wilcoxon signed rank test. Four patients were identified prior to the protocol and managed in an ad hoc basis; for nine patients the protocol was utilized. Overall favourable neurological outcomes among ECPR-treated patients were 27%. The median TTE was 136 minutes (IQR 98 - 196) in the pre-protocol group, and 60 minutes (IQR 49 - 81) minutes in the protocol group (p=0.0165). An organized clinical and educational protocol to initiate ECPR for patients with OHCA is feasible and significantly reduces the key benchmark of time-to-ECPR flows.

  15. [Out-of-hospital births].

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    Fernández Domínguez, N; Leal Gómez, E; García Lavandeira, S; Vázquez Rodríguez, M

    2016-01-01

    Childbirth is a physiological process and, as such, there should be limited assistance for the woman to ensure that it follows its natural process, avoiding any possible complication and, if they do appear, attempting to resolve them. Health personnel should try to achieve a balance between safety and the least possible outside assistance. The out-of-hospital delivery is considered an emergency as it happens unexpectedly, that is, without being previously planned. Given that it has to be treated outside the ideal conditions of a maternity ward, it is considered as an emergency. Copyright © 2014 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf

    2012-01-01

    from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia......Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... in the control groups. The optimal target temperature management strategy is not known....

  17. Demographics and Clinical Features of Postresuscitation Comorbidities in Long-Term Survivors of Out-of-Hospital Cardiac Arrest: A National Follow-Up Study

    Directory of Open Access Journals (Sweden)

    Chih-Pei Su

    2017-01-01

    Full Text Available The outcome of patients suffering from out-of-hospital cardiac arrest (OHCA is very poor, and postresuscitation comorbidities increase long-term mortality. This study aims to analyze new-onset postresuscitation comorbidities in patients who survived from OHCA for over one year. The Taiwan National Health Insurance (NHI Database was used in this study. Study and comparison groups were created to analyze the risk of suffering from new-onset postresuscitation comorbidities from 2011 to 2012 (until December 31, 2013. The study group included 1,346 long-term OHCA survivors; the comparison group consisted of 4,038 matched non-OHCA patients. Demographics, patient characteristics, and risk of suffering comorbidities (using Cox proportional hazards models were analyzed. We found that urinary tract infections (n=225, 16.72%, pneumonia (n=206, 15.30%, septicemia (n=184, 13.67%, heart failure (n=111, 8.25% gastrointestinal hemorrhage (n=108, 8.02%, epilepsy or recurrent seizures (n=98, 7.28%, and chronic kidney disease (n=62, 4.61% were the most common comorbidities. Furthermore, OHCA survivors were at much higher risk (than comparison patients of experiencing epilepsy or recurrent seizures (HR = 20.83; 95% CI: 12.24–35.43, septicemia (HR = 8.98; 95% CI: 6.84–11.79, pneumonia (HR = 5.82; 95% CI: 4.66–7.26, and heart failure (HR = 4.88; 95% CI: 3.65–6.53. Most importantly, most comorbidities occurred within the first half year after OHCA.

  18. Demographics and Clinical Features of Postresuscitation Comorbidities in Long-Term Survivors of Out-of-Hospital Cardiac Arrest: A National Follow-Up Study

    Science.gov (United States)

    Su, Chih-Pei; Wu, Jr-Hau; Yang, Mei-Chueh; Liao, Ching-Hui; Hsu, Hsiu-Ying; Chang, Chin-Fu

    2017-01-01

    The outcome of patients suffering from out-of-hospital cardiac arrest (OHCA) is very poor, and postresuscitation comorbidities increase long-term mortality. This study aims to analyze new-onset postresuscitation comorbidities in patients who survived from OHCA for over one year. The Taiwan National Health Insurance (NHI) Database was used in this study. Study and comparison groups were created to analyze the risk of suffering from new-onset postresuscitation comorbidities from 2011 to 2012 (until December 31, 2013). The study group included 1,346 long-term OHCA survivors; the comparison group consisted of 4,038 matched non-OHCA patients. Demographics, patient characteristics, and risk of suffering comorbidities (using Cox proportional hazards models) were analyzed. We found that urinary tract infections (n = 225, 16.72%), pneumonia (n = 206, 15.30%), septicemia (n = 184, 13.67%), heart failure (n = 111, 8.25%) gastrointestinal hemorrhage (n = 108, 8.02%), epilepsy or recurrent seizures (n = 98, 7.28%), and chronic kidney disease (n = 62, 4.61%) were the most common comorbidities. Furthermore, OHCA survivors were at much higher risk (than comparison patients) of experiencing epilepsy or recurrent seizures (HR = 20.83; 95% CI: 12.24–35.43), septicemia (HR = 8.98; 95% CI: 6.84–11.79), pneumonia (HR = 5.82; 95% CI: 4.66–7.26), and heart failure (HR = 4.88; 95% CI: 3.65–6.53). Most importantly, most comorbidities occurred within the first half year after OHCA. PMID:28286775

  19. Prognostic value of electroencephalography (EEG) after out-of-hospital cardiac arrest in successfully resuscitated patients used in daily clinical practice

    DEFF Research Database (Denmark)

    Søholm, Helle; Kjær, Troels Wesenberg; Kjaergaard, Jesper;

    2014-01-01

    were used. EEG reports were analysed according to the 2012 American Clinical Neurophysiology Society's guidelines. RESULTS: A total of 1076 patients were included, and EEG was performed in 20% (n=219) with a median of 3(IQR 2-4) days after OHCA. Rhythmic Delta Activity (RDA) was found in 71 patients......-suppression in 17 (8%) patients. A favourable EEG pattern (reactivity, favourable background frequency and RDA) was independently associated with reduced mortality with hazard ratio (HR) 0.43 (95%CI: 0.24-0.76), p=0.004 (false positive rate: 31%) and a non-favourable EEG pattern (no reactivity, unfavourable...... such as Rhythmic Delta Activity (RDA) seem to be associated with a better prognosis, whereas suppressed voltage and burst-suppression patterns were associated with poor prognosis....

  20. [Informed consent in clinical practice: persistent doubts].

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    Kottow, Miguel

    2016-11-01

    Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

  1. Current practice in out-of-hospital cardiac arrest management

    DEFF Research Database (Denmark)

    Proclemer, Alessandro; Dobreanu, Dan; Pison, Laurent

    2012-01-01

    AIMS: The purpose of this EP wire is to examine clinical practice in the field of out-of-hospital cardiac arrest (OHCA) management, with special focus on in-hospital diagnostic and therapeutic strategies. METHODS AND RESULTS: Fifty-three European centres, all members of the EHRA-EP Research network...... management strategy, including coronary angiography/PCI and implantable cardioverter defibrillator therapy, while therapeutic hypothermia appears to be underused....

  2. Clinical value of ST-segment change after return of spontaneous cardiac arrest and emergent coronary angiography in patients with out-of-hospital cardiac arrest: Diagnostic and therapeutic importance of vasospastic angina.

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    Tateishi, Kazuya; Abe, Daisuke; Iwama, Tooru; Hamabe, Yuichi; Aonuma, Kazutaka; Sato, Akira

    2017-07-01

    We investigated the association between initial ST-segment change after return of spontaneous circulation (ROSC) and the incidence of acute coronary lesions in patients with out-of-hospital cardiac arrest (OHCA), and clinical outcomes of patients with OHCA caused by vasospastic angina pectoris (VSA). Among 2779 OHCA patients in our institution, all patients with ROSC underwent emergent coronary angiography (CAG) except for those with an obvious extra-cardiac cause of OHCA. Initial ST-segment changes after ROSC were reviewed, and 30-day survival and neurological outcome (Cerebral Performance Category) were evaluated. Of the 155 patients, 52 (34%) had ST-segment elevation (STE) and 103 (66%) had non-STE. Significant coronary culprit lesions were present in 81% of patients with STE and in 33% of patients with non-STE ( P<.001). Percutaneous coronary intervention (PCI) was successful in 60 patients (93.8%) and failed in 4 patients (6.2%). Among 155 patients, 74 patients (47.7%) had favorable neurological prognosis, and 104 patients (67.1%) were alive at 30 days. ST-segment analysis showed good positive predictive value (81%) but low negative predictive value (68%) in diagnosing the presence of acute coronary lesions. VSA was found in 5 patients (9.6%) in the STE group and in 12 patients (11.7%) in the non-STE group. Of these 17 patients, 9 (52.9%) had favorable neurological outcome and 14 (82.4%) were alive at 30 days. An acute culprit lesion may be the cause of OHCA even in the absence of STE. In survivors of OHCA with normal coronary arteries, spasm provocation testing should be performed to detect VSA as a cause of the arrest.

  3. Extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation or uncontrolled donation after the circulatory determination of death following out-of-hospital refractory cardiac arrest-An ethical analysis of an unresolved clinical dilemma.

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    Dalle Ave, Anne L; Shaw, David M; Gardiner, Dale

    2016-11-01

    The availability of extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation (E-CPR), for use in refractory out-of hospital cardiac arrest (OHCA), is increasing. In parallel, some countries have developed uncontrolled donation after circulatory determination of death (uDCDD) programs using ECMO to preserve organs for transplantation purposes. When facing a refractory OHCA, how does the medical team choose between initiating ECMO as part of an E-CPR protocol or ECMO as part of a uDCDD protocol? To answer these questions we conducted a literature review on E-CPR compared to uDCDD protocols using ECMO and analyzed the raised ethical issues. Our analysis reveals that the inclusion criteria in E-CPR and uDCDD protocols are similar. There may be a non-negligible risk of including patients in a uDCDD protocol, when the patient might have been saved by the use of E-CPR. In order to avoid the fatal error of letting a saveable patient die, safeguards are necessary. We recommend: (1) the development of internationally accepted termination of resuscitation guidelines that would have to be satisfied prior to inclusion of patients in any uDCDD protocol, (2) the choice regarding modalities of ongoing resuscitation during transfer should be focused on the primary priority of attempting to save the life of patients, (3) only centers of excellence in life-saving resuscitation should initiate or maintain uDCDD programs, (4) E-CPR should be clinically considered first before the initiation of any uDCDD protocol, and (5) there should be no discrimination in the availability of access to E-CPR. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Out-of-Hospital therapeutic hypothermia. A Systematic Review

    Directory of Open Access Journals (Sweden)

    María Nélida Conejo Pérez

    2012-07-01

    Full Text Available Recent studies have demonstrated therapeutic mild hypothermia improves neurological outcome of patients after suffering an out-of-hospital cardiac arrest.Other studies in animals suggest that the sooner hypothermia is started after return of spontaneous circulation, the lower neurological symptoms are suffered by patients.The aim of this work is to know the efficiency of the therapeutic moderated hipotermia after the cardiopulmonar resuscitation realized extra hospitable.Methods: We made a literature search in Medline (Pubmed, Cinahl, Cuiden, Cochrane Library and the Joanna Briggs Institute, combining mesh and free terms; and searched in the journals Circulation, Resuscitation and Emergency Medicine Journal manually last year. We selected systematic reviews and randomized and nonrandomized clinical trials which had contrasted in-hospital and out-of-hospital TMH with over 18 years patients.Results: Only 5 articles met the inclusion criteria of the 35 selected: four randomized clinical trials and one nonrandomized. They were then subjected to a critical methodological evaluation (CASPe and statistic evaluation (IDIPaz.Conclusions: Pre hospital TMH is an effective and safe technique in comatose patients after being resuscitated from cardiac arrest, improving the neurological status at hospital discharge.

  5. Out-of-hospital therapeutic hypothermia in cardiac arrest victims

    Directory of Open Access Journals (Sweden)

    Holzer Michael

    2009-10-01

    Full Text Available Abstract Despite many years of research, outcome after cardiac arrest is dismal. Since 2005, the European Resuscitation Council recommends in its guidelines the use of mild therapeutic hypothermia (32-34° for 12 to 24 hours in patients successfully resuscitated from cardiac arrest. The benefit of resuscitative mild hypothermia (induced after resuscitation is well established, while the benefit of preservative mild to moderate hypothermia (induced during cardiac arrest needs further investigation before recommending it for clinical routine. Animal data and limited human data suggest that early and fast cooling might be essential for the beneficial effect of resuscitative mild hypothermia. Out-of-hospital cooling has been shown to be feasible and safe by means of intravenous infusion with cold fluids or non-invasively with cooling pads. A combination of these cooling methods might further improve cooling efficacy. If out-of-hospital cooling will further improve functional outcome as compared with in-hospital cooling needs to be determined in a prospective, randomised, sufficiently powered clinical trial.

  6. AFEM Consensus Conference, 2013. AFEM Out-of-Hospital Emergency Care Workgroup Consensus Paper: Advancing Out-of-Hospital Emergency Care in Africa-Advocacy and Development

    Directory of Open Access Journals (Sweden)

    N.K. Mould-Millman

    2014-06-01

    Future directions of the AFEM Out-of-Hospital Emergency Care Workgroup include creating an online Toolkit. This will serve as a repository of template documents to guide implementation and development of clinical care, education, transportation, public access, policy and governance.

  7. Medical conditions associated with out-of-hospital endotracheal intubation.

    Science.gov (United States)

    Wang, Henry E; Balasubramani, G K; Cook, Lawrence J; Yealy, Donald M; Lave, Judith R

    2011-01-01

    While prior studies describe the clinical presentation of patients requiring paramedic out-of-hospital endotracheal intubation (ETI), limited data characterize the underlying medical conditions or comorbidities. To characterize the medical conditions and comorbidities of patients receiving successful paramedic out-of-hospital ETI. We used Pennsylvania statewide emergency medical services (EMS) clinical data, including all successful ETIs performed during 2003-2005. Using multiple imputation triple-match algorithms, we probabilistically linked EMS ETI to statewide death and hospital admission data. Each hospitalization record contained one primary and up to eight secondary diagnoses, classified according to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). We determined the proportion of patients in each major ICD-9-CM diagnostic group and subgroup. We calculated the Charlson Comorbidity Index score for each patient. Using binomial proportions with confidence intervals (CIs), we analyzed the data and combined imputed results using Rubin's method. Across the imputed sets, we linked 25,733 (77.7% linkage) successful ETIs to death or hospital records; 56.3% patients died before and 43.7% survived to hospital admission. Of the 14,478 patients who died before hospital admission, most (92.7%; 95% CI: 92.5-93.3%) had presented to EMS in cardiac arrest. Of the 11,255 hospitalized patents, the leading primary diagnoses were circulatory diseases (32.0%; 95% CI: 30.2-33.7%), respiratory diseases (22.8%; 95% CI: 21.9-23.7%), and injury or poisoning (25.2%; 95% CI: 22.7-27.8%). Prominent primary diagnosis subgroups included asphyxia and respiratory failure (15.2%), traumatic brain injury and skull fractures (11.3%), acute myocardial infarction and ischemic heart disease (10.9%), poisonings and drug and alcohol disorders (6.7%), dysrhythmias (6.7%), hemorrhagic and nonhemorrhagic stroke (5.9%), acute heart failure and cardiomyopathies

  8. Reasons for diagnostic delay in patient with out-of-hospital acute ischemic stroke

    Institute of Scientific and Technical Information of China (English)

    Tongge Wang; Qi Ma

    2006-01-01

    BACKGROUND:Time window is a common problem in various therapies of acute ischemic stroke,and diagnostic duration plays an important role in prognosis.OBJECTIVE:To analyze the main reasons for out-of-hospital diagnostic delay of patients with acute ischemic stroke.DESIGN:Survey and analysis.SETTING:Department of Neurology,the First Affiliated Hospital of Jinan University.PARTICIPANTS: A total of 116 patients with acute ischemic stroke were selected from the Department of Neurology,the First Affiliated Hospital of Jinan University from December 2002 to December 2005,including 79 males and 37 females aged fnom 35 to 90 years with the mean age of(65+10)years.All patients met the diagnostic criteda of "mainly diagnostic points of various cerebrovascular diseases"established by the 4th National Cerebrovascular Diseases Meeting in 1995.Patients having acute ischemic stroke in hospital were excluded.Moreover,32 nurses received questionnaires of partial items.All patients and nurses provided informed consent.METHODS:①Information,such as social Position,educational level and incomes,was added up based on questionnaires.②Out-of-hospital diagnostic delay was surveyed based on the recorded time of patients treated in emergency department and out-patient clinic or during hospitalization. ③Ability of patients and nurses to identify symptoms of stroke dudng an early period was evaluated:meanwhile,understanding concept of stroke and using emergent system of social medicine by patients were surveyed,Especially.whether Patients understood the emergent number"120" or not and how they used it practically were investigated further.④Attitude and behavior of patients to stroke were surveyed.⑤Whether patients were able to identify the symptoms of stroke or not was investigated;furthermore,identification of stroke by patients and nurses was dealt with semi-quantitative analysis.The scores ranged from-10 to 10.The higher the scores were,the better the identification was

  9. Out-of-Hospital Cardiac Arrest in Denmark

    DEFF Research Database (Denmark)

    Wissenberg Jørgensen, Mads

    challenges, due to the victim’s physical location, which brings an inherent risk of delay (or altogether absence) of recognition and treatment of cardiac arrest. A low frequency of bystander cardiopulmonary resuscitation and low 30-day survival after out-of-hospital cardiac arrest were identified nearly ten......BACK COVER TEXT Cardiac arrest is an emergency medical condition characterized by the cessation of cardiac mechanical activity; without immediate and decisive treatment, a victim’s chances of survival are minimal. Out-of-hospital cardiac arrest is a particular arrest subgroup that poses additional...... years ago in Denmark. These findings led to several national initiatives to strengthen bystander resuscitation attempts and advance care. Despite these nationwide efforts, it was unknown prior to this project whether these efforts resulted in changes in resuscitation attempts by bystanders and changes...

  10. Out-of-hospital births in the United States 2009-2014.

    Science.gov (United States)

    Grunebaum, Amos; Chervenak, Frank A

    2016-10-01

    To evaluate recent trends of out-of-hospital births in the US from 2009 to 2014. We accessed data for all live births occurring in the US from the National Vital Statistics System, Natality Data Files for 2009-2014 through the interactive data tool, VitalStats. Out-of-hospital (OOH) births in the US increased from 2009 to 2014 by 80.2% from 32,596 to 58,743 (0.79%-1.47% of all live births). Home births (HB) increased by 77.3% and births in freestanding birthing centers (FBC) increased by 79.6%. In 2014, 63.8% of OOH births were HB, 30.7% were in FBC, and 5.5% were in other places, physicians offices, or clinics. The majority of women who had an OOH birth in 2014 were non-Hispanic White (82.3%). About in one in 47 non-Hispanic White women had an OOH in 2014, up from 1 in 87 in 2009. Women with a HB were older compared to hospital births (age ≥35: 21.5% vs. 15.4%), had a higher live birth order(≥5: 18.9% vs. 4.9%), 3.48% had infants birthing centers has significantly increased in the US making it the country with the most out of hospital births among all developed countries. The root cause of the increase in planned OOH births should be identified and addressed by the medical community.

  11. Heat, heat waves, and out-of-hospital cardiac arrest.

    Science.gov (United States)

    Kang, Si-Hyuck; Oh, Il-Young; Heo, Jongbae; Lee, Hyewon; Kim, Jungeun; Lim, Woo-Hyun; Cho, Youngjin; Choi, Eue-Keun; Yi, Seung-Muk; Sang, Do Shin; Kim, Ho; Youn, Tae-Jin; Chae, In-Ho; Oh, Seil

    2016-10-15

    Cardiac arrest is one of the common presentations of cardiovascular disorders and a leading cause of death. There are limited data on the relationship between out-of-hospital cardiac arrest (OHCA) and ambient temperatures, specifically extreme heat. This study investigated how heat and heat waves affect the occurrence of OHCA. Seven major cities in Korea with more than 1 million residents were included in this study. A heat wave was defined as a daily mean temperature above the 98th percentile of the yearly distribution for at least two consecutive days. A total of 50,318 OHCAs of presumed cardiac origin were identified from the nationwide emergency medical service database between 2006 and 2013. Ambient temperature and OHCA had a J-shaped relationship with a trough at 28°C. Heat waves were shown to be associated with a 14-% increase in the risk of OHCA. Adverse effects were apparent from the beginning of each heat wave period and slightly increased during its continuation. Excess OHCA events during heat waves occurred between 3PM and 5PM. Subgroup analysis showed that those 65years or older were significantly more susceptible to heat waves. Ambient temperature and OHCA had a J-shaped relationship. The risk of OHCA was significantly increased with heat waves. Excess OHCA events primarily occurred during the afternoon when the temperature was high. We found that the elderly were more susceptible to the deleterious effects of heat waves. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Variation in Out-of-Hospital Cardiac Arrest Management

    Directory of Open Access Journals (Sweden)

    Jason M. Jones

    2016-01-01

    Full Text Available Objective. To evaluate variation in airway management strategies in one suburban emergency medical services system treating patients experiencing out-of-hospital cardiac arrest (OHCA. Method. Retrospective chart review of all adult OHCA resuscitation during a 13-month period, specifically comparing airway management decisions. Results. Paramedics demonstrated considerable variation in their approaches to airway management. Approximately half of all OHCA patients received more than one airway management attempt (38/77 [49%], and one-quarter underwent three or more attempts (25/77 [25%]. One-third of patients arrived at the emergency department with a different airway device than initially selected (25/77 [32%]. Conclusion. This study confirmed our hypothesis that paramedics’ selection of ventilation strategies in cardiac arrest varies considerably. This observation raises concern because airway management diverts time and energy from interventions known to improve outcomes in OHCA management, such as cardiopulmonary resuscitation and defibrillation. More research is needed to identify more focused airway management strategies for prehospital care providers.

  13. [Out of hospital emergencies towards a safety culture].

    Science.gov (United States)

    Cano-del Pozo, M I; Obón-Azuara, B; Valderrama-Rodríguez, M; Revilla-López, C; Brosed-Yuste, C; Fajardo-Trasobares, E; Garcés-Baquero, P; Mateo-Clavería, J; Molina-Estrada, I; Perona-Flores, N; Salcedo-de Dios, S; Tomé-Rey, A

    2014-01-01

    The aim of this study is to measure the degree of safety culture (CS) among healthcare professional workers of an out-of-hospital Emergency Medical Service. Most patient safety studies have been conducted in relation to the hospital rather than pre-hospital Emergency Medical Services. The objective is to analyze the dimensions with lower scores in order to plan futures strategies. A descriptive study using the AHRQ (Agency for Healthcare Research and Quality) questionnaire. The questionnaire was delivered to all healthcare professionals workers of 061 Advanced Life Support Units of Aragón, during the month of August 2013. The response rate was 55%. Main strengths detected: an adequate number of staff (96%), good working conditions (89%), tasks supported from immediate superior (77%), teamwork climate (74%), and non-punitive environment to report adverse events (68%). Areas for improvement: insufficient training in patient safety (53%) and lack of feedback of incidents reported (50%). The opportunities for improvement identified focus on the training of professionals in order to ensure safer care, while extending the safety culture. Also, the implementation of a system of notification and registration of adverse events in the service is deemed necessary. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  14. Anxiety and depression among out-of-hospital cardiac arrest survivors

    DEFF Research Database (Denmark)

    Lilja, G; Nilsson, G; Nielsen, N

    2015-01-01

    AIM: Survivors of out-of-hospital cardiac arrest (OHCA) may experience psychological distress but the actual prevalence is unknown. The aim of this study was to investigate anxiety and depression within a large cohort of OHCA-survivors. METHODS: OHCA-survivors randomized to targeted temperature....... Subjective cognitive problems were associated with an increased risk for psychological distress. Since psychological distress affects long-term prognosis of cardiac patients in general it should be addressed during follow-up of survivors with OHCA due to a cardiac cause. ClinicalTrials.gov NCT01020916/NCT...

  15. Radiation information and informed consent for clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: martin.caon@flinders.edu.au

    2008-09-01

    Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)

  16. Design and implementation of the AIRWAYS-2 trial: A multi-centre cluster randomised controlled trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest.

    Science.gov (United States)

    Taylor, Jodi; Black, Sarah; J Brett, Stephen; Kirby, Kim; Nolan, Jerry P; Reeves, Barnaby C; Robinson, Maria; Rogers, Chris A; Scott, Lauren J; South, Adrian; Stokes, Elizabeth A; Thomas, Matthew; Voss, Sarah; Wordsworth, Sarah; Benger, Jonathan R

    2016-12-01

    Health outcomes after out of hospital cardiac arrest (OHCA) are extremely poor, with only 7-9% of patients in the United Kingdom (UK) surviving to hospital discharge. Currently emergency medical services (EMS) use either tracheal intubation or newer supraglottic airway devices (SGAs) to provide advanced airway management during OHCA. Equipoise between the two techniques has led to calls for a well-designed randomised controlled trial. The primary objective of the AIRWAYS-2 trial is to assess whether the clinical effectiveness of the i-gel, a second-generation SGA, is superior to tracheal intubation in the initial airway management of OHCA patients in the UK. Paramedics recruited to the AIRWAYS-2 trial are randomised to use either tracheal intubation or i-gel as their first advanced airway intervention. Adults who have had a non-traumatic OHCA and are attended by an AIRWAYS-2 paramedic are retrospectively assessed against eligibility criteria for inclusion. The primary outcome is the modified Rankin Scale score at hospital discharge. Secondary objectives are to: (i) estimate differences between groups in outcome measures relating to airway management, hospital stay and recovery at 3 and 6 months; (ii) estimate the cost effectiveness of the i-gel compared to tracheal intubation. Because OHCA patient needs immediate treatment there are several unusual features and challenges to the design and implementation of this trial; these include level of randomisation, the automatic enrolment model, enrolment of patients that lack capacity and minimisation of bias. Patient enrolment began in June 2015. The trial will enrol 9070 patients over two years. The results are expected to influence future resuscitation guidelines. Trial Registration ISRCTN: 08256118. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

  17. Qualitative study of patient consent for health information exchange in an HIV clinic.

    Science.gov (United States)

    Ramos, S Raquel; Bakken, Suzanne

    2014-01-01

    Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.

  18. Readability and comprehensibility of informed consent forms for clinical trials

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

    A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

  19. Functional Outcome Trajectories After Out-of-Hospital Pediatric Cardiac Arrest.

    Science.gov (United States)

    Silverstein, Faye S; Slomine, Beth S; Christensen, James; Holubkov, Richard; Page, Kent; Dean, J Michael; Moler, Frank W

    2016-12-01

    To analyze functional performance measures collected prospectively during the conduct of a clinical trial that enrolled children (up to age 18 yr old), resuscitated after out-of-hospital cardiac arrest, who were at high risk of poor outcomes. Children with Glasgow Motor Scale score less than 5, within 6 hours of resuscitation, were enrolled in a clinical trial that compared two targeted temperature management interventions (THAPCA-OH, NCT00878644). The primary outcome, 12-month survival with Vineland Adaptive Behavior Scale, second edition, score greater or equal to 70, did not differ between groups. Thirty-eight North American PICUs. Two hundred ninety-five children were enrolled; 270 of 295 had baseline Vineland Adaptive Behavior Scale, second edition, scores greater or equal to 70; 87 of 270 survived 1 year. Targeted temperatures were 33.0°C and 36.8°C for hypothermia and normothermia groups. Baseline measures included Vineland Adaptive Behavior Scale, second edition, Pediatric Cerebral Performance Category, and Pediatric Overall Performance Category. Pediatric Cerebral Performance Category and Pediatric Overall Performance Category were rescored at hospital discharges; all three were scored at 3 and 12 months. In survivors with baseline Vineland Adaptive Behavior Scale, second edition scores greater or equal to 70, we evaluated relationships of hospital discharge Pediatric Cerebral Performance Category with 3- and 12-month scores and between 3- and 12-month Vineland Adaptive Behavior Scale, second edition, scores. Hospital discharge Pediatric Cerebral Performance Category scores strongly predicted 3- and 12-month Pediatric Cerebral Performance Category (r = 0.82 and 0.79; p Vineland Adaptive Behavior Scale, second edition, scores (r = -0.81 and -0.77; p Vineland Adaptive Behavior Scale, second edition, scores strongly predicted 12-month performance (r = 0.95; p Scale score less than 5 in the initial hours after out-of-hospital cardiac arrest resuscitation

  20. Temporal differences in out-of-hospital cardiac arrest incidence and survival

    DEFF Research Database (Denmark)

    Bagai, Akshay; McNally, Bryan F.; Al-Khatib, Sana M.

    2013-01-01

    Understanding temporal differences in the incidence and outcomes of out-of-hospital cardiac arrest (OHCA) has important implications for developing preventative strategies and optimizing systems for OHCA care.......Understanding temporal differences in the incidence and outcomes of out-of-hospital cardiac arrest (OHCA) has important implications for developing preventative strategies and optimizing systems for OHCA care....

  1. Therapeutic hypothermia after out-of-hospital cardiac arrest in children.

    Science.gov (United States)

    Moler, Frank W; Silverstein, Faye S; Holubkov, Richard; Slomine, Beth S; Christensen, James R; Nadkarni, Vinay M; Meert, Kathleen L; Clark, Amy E; Browning, Brittan; Pemberton, Victoria L; Page, Kent; Shankaran, Seetha; Hutchison, Jamie S; Newth, Christopher J L; Bennett, Kimberly S; Berger, John T; Topjian, Alexis; Pineda, Jose A; Koch, Joshua D; Schleien, Charles L; Dalton, Heidi J; Ofori-Amanfo, George; Goodman, Denise M; Fink, Ericka L; McQuillen, Patrick; Zimmerman, Jerry J; Thomas, Neal J; van der Jagt, Elise W; Porter, Melissa B; Meyer, Michael T; Harrison, Rick; Pham, Nga; Schwarz, Adam J; Nowak, Jeffrey E; Alten, Jeffrey; Wheeler, Derek S; Bhalala, Utpal S; Lidsky, Karen; Lloyd, Eric; Mathur, Mudit; Shah, Samir; Wu, Theodore; Theodorou, Andreas A; Sanders, Ronald C; Dean, J Michael

    2015-05-14

    Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest, but data about this intervention in children are limited. We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P=0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P=0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P=0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by

  2. An association between systolic blood pressure and stroke among patients with impaired consciousness in out-of-hospital emergency settings

    OpenAIRE

    Irisawa, Taro; Iwami, Taku; Kitamura, Tetsuhisa; Nishiyama, Chika; Sakai, Tomohiko; Tanigawa-Sugihara, Kayo; Hayashida, Sumito; Nishiuchi, Tatsuya; Shiozaki, Tadahiko; Tasaki, Osamu; Kawamura, Takashi; Hiraide, Atsushi; Shimazu, Takeshi

    2013-01-01

    Background: Stroke is difficult to diagnose when consciousness is disturbed. However few reports have discussed the clinical predictors of stroke in out-of-hospital emergency settings. This study aims to evaluate the association between initial systolic blood pressure (SBP) value measured by emergency medical service (EMS) and diagnosis of stroke among impaired consciousness patients. Methods: We included all patients aged 18 years or older who were treated and transported by EMS, and had imp...

  3. Out-of-hospital pediatric airway management in the United States.

    Science.gov (United States)

    Hansen, Matthew; Lambert, William; Guise, Jeanne-Marie; Warden, Craig R; Mann, N Clay; Wang, Henry

    2015-05-01

    The objective of this study was to characterize pediatric out-of-hospital airway management interventions, success rates, and complications in the United States using the 2012 National Emergency Medical Services Information System (NEMSIS) dataset. In 2012, NEMSIS collected data from Emergency Medical Services (EMS) encounters in 40 states. We included all patients less than 18 years of age and identified all patients who had airway interventions including endotracheal intubation (ETI), bag-valve-mask ventilation (BVM), continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) and alternate airways (Combitube, King LT, Laryngeal Mask Airway (LMA), esophageal obturator airway, and cricothyroidotomy). Success and complication rates were analyzed and compared across pediatric age groups, by race, ethnicity, clinical condition, and geographic region. We identified a total of 949,301 pediatric patient care events in the NEMSIS 2012 dataset. 4.5% had airway management procedures (42,936 events). Invasive airway management or ventilation (ETI, cricothyroidotomy, alternate airway, CPAP/BiPAP, BVM and other ventilation) took place in 1.5% of patient care events (14,107). Of those who had invasive airway management, 29.9% were less than 1 year of age, 58.1% were male, 42.3% were white, and 83.6% were in urban areas. ETI occurred in 3124 of patient care events (329 per 100,000; 95% CI 318-341). Overall success of ETI was 81.1% (95% CI 79.7-82.6). Lower success was noted in patients with cardiac arrest (75.5%, 95% CI 72.6-78.3) and those aged 1-12 months (72.1%, 95% CI 68.3-75.6). Out-of-hospital pediatric advanced airway procedures were infrequently performed. Success rates are lowest in patients aged 1-12 months. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  4. Functional Outcome Trajectories after Out-of Hospital Pediatric Cardiac Arrest

    Science.gov (United States)

    Silverstein, Faye S; Slomine, Beth; Christensen, James; Holubkov, Richard; Page, Kent; Dean, J. Michael; Moler, Frank

    2016-01-01

    Objective To analyze functional performance measures collected prospectively during the conduct of a clinical trial that enrolled children (up to age 18 years), resuscitated after out-of-hospital cardiac arrest, who were at high risk for poor outcomes. Design Children with Glasgow Motor Scales VABS-II) score ≥70, did not differ between groups. Setting 38 North American pediatric ICU’s. Participants 295 children were enrolled; 270/295 had baseline VABS-II scores ≥70; 87/270 survived one year. Interventions Targeted temperatures were 33.0°C and 36.8°C for hypothermia and normothermia groups. Measurements and Main Results Baseline measures included VABS-II, Pediatric Cerebral Performance Category(PCPC), and Pediatric Overall Performance Category (POPC). PCPC and POPC were rescored at hospital discharges; all three were scored at 3 and 12 months. In survivors with baseline VABS-II scores ≥70, we evaluated relationships of hospital discharge PCPC with 3 and 12 month scores, and between 3 and 12 month VABS-II scores. Hospital discharge PCPC scores strongly predicted 3 and 12 month PCPC (r=0.82,0.79; pVABS-II scores (r=−0.81,−0.77; pVABS-II scores strongly predicted 12 month performance (r=0.95, p<0.0001). Hypothermia treatment did not alter these relationships. Conclusions In comatose children, with Glasgow Motor Scales <5 in the initial hours after out-of-hospital cardiac arrest resuscitation, function scores at hospital discharge and at 3 months predicted 12-month performance well in the majority of survivors. PMID:27509385

  5. The role of effective communication in achieving informed consent for clinical trials.

    Science.gov (United States)

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

    Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

  6. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Sørensen, Kristian Dahl Kragholm; Wissenberg, Mads; Mortensen, Rikke N

    2017-01-01

    BACKGROUND: The effect of bystander interventions on long-term functional outcomes among survivors of out-of-hospital cardiac arrest has not been extensively studied. METHODS: We linked nationwide data on out-of-hospital cardiac arrests in Denmark to functional outcome data and reported the 1-year...... risks of anoxic brain damage or nursing home admission and of death from any cause among patients who survived to day 30 after an out-of-hospital cardiac arrest. We analyzed risks according to whether bystander cardiopulmonary resuscitation (CPR) or defibrillation was performed and evaluated temporal...... changes in bystander interventions and outcomes. RESULTS: Among the 2855 patients who were 30-day survivors of an out-of-hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1-year follow-up period...

  7. An audit of consent refusals in clinical research at a tertiary care center in India

    Directory of Open Access Journals (Sweden)

    S J Thaker

    2015-01-01

    Full Text Available Background and Rationale: Ensuring research participants′ autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the informed consent process. This audit examined consent refusals among Indian participants in clinical studies done at our center. Materials and Methods: The number of consent refusals and their reasons in 10 studies done at our center over a 5-year period were assessed. The studies were classified by the authors according to the type of participant (healthy vs patients, type of sponsor (investigator-initiated vs pharmaceutical industry, type of study (observational vs interventional, level of risk [based on the Indian Council of Medical Research (ICMR "Ethical Guidelines for Biomedical Research on Human Participants"], available knowledge of the intervention being studied, and each patient′s disease condition. Results: The overall consent refusal rate was 21%. This rate was higher among patient participants [23.8% vs. healthy people (14.9%; P = 0.002], in interventional studies [33.6% vs observational studies (7.5%; P < 0.0001], in pharmaceutical industry-sponsored studies [34.7% vs investigator-initiated studies (7.2%; P < 0.0001], and in studies with greater risk (P < 0.0001. The most common reasons for consent refusals were multiple blood collections (28%, inability to comply with the study protocol (20%, and the risks involved (20%. Conclusion: Our audit suggests the adequacy and reasonable quality of the informed consent process using consent refusals as a metric.

  8. Emergency medical service provider decision-making in out of hospital cardiac arrest: an exploratory study.

    Science.gov (United States)

    Brandling, J; Kirby, K; Black, S; Voss, S; Benger, J

    2017-07-25

    There are approximately 60,000 out-of-hospital cardiac arrests (OHCA) in the United Kingdom (UK) each year. Within the UK there are well-established clinical practice guidelines that define when resuscitation should be commenced in OHCA, and when resuscitation should cease. Background literature indicates that decision-making in the commencement and cessation of resuscitation efforts in OHCA is complex, and not comprehensively understood. No relevant research from the UK has been published to date and this research study seeks to explore the influences on UK Emergency Medical Service (EMS) provider decision-making when commencing and ceasing resuscitation attempts in OHCA. The aim of this research to explore the influences on UK Emergency Medical Services provider decision-making when commencing and ceasing resuscitation attempts in OHCA. Four focus groups were convened with 16 clinically active EMS providers. Four case vignettes were discussed to explore decision-making within the focus groups. Thematic analysis was used to analyse transcripts. This research found that there are three stages in the decision-making process when EMS providers consider whether to commence or cease resuscitation attempts in OHCA. These stages are: the call; arrival on scene; the protocol. Influential factors present at each of the three stages can lead to different decisions and variability in practice. These influences are: factual information available to the EMS provider; structural factors such as protocol, guidance and research; cultural beliefs and values; interpersonal factors; risk factors; personal values and beliefs. An improved understanding of the circumstantial, individual and interpersonal factors that mediate the decision-making process in clinical practice could inform the development of more effective clinical guidelines, education and clinical decision support in OHCA. These changes have the potential to lead to greater consistency. and EMS provider confidence, with

  9. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

    Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  10. Factors associated with the use of pharmacologic agents to facilitate out-of-hospital endotracheal intubation.

    Science.gov (United States)

    Wang, Henry E; Kupas, Douglas F; Paris, Paul M; Yealy, Donald M

    2004-01-01

    To identify a set of clinical factors most strongly associated with the use of drug-facilitated intubation (DFI) in the out-of-hospital setting. The authors used data from a prospective, multicentered endotracheal intubation (ETI) observational cohort trial, including patients from 45 emergency medical services in Pennsylvania. Providers reported clinical, physiologic, and anatomic factors associated with each ETI effort. The authors included only data from the 23 services using DFI. They identified all non-arrest (presence of a pulse) adult patients. They included both successful and failed ETIs. They defined DFI cases as patients who received a sedative or neuromuscular-blocking agent to facilitate ETI. The authors also classified patients who underwent nasotracheal intubation as DFI. They defined control subjects as patients undergoing conventional oral ETI. They performed multivariate logistic regression to identify the clinical, physiologic, and anatomic factors characteristic of DFI. They examined alternate forms of the final prediction model. The authors analyzed data from 208 nonarrest patients, including 92 DFIs and 116 control subjects. Of 34 factors potentially related to DFI, 17 were excluded on univariate analysis (likelihood ratio p>0.25). Multivariate logistic regression revealed the following as positively associated with DFI: presence of clenched jaw/trismus (odds ratio [OR], 2.33; 95% confidence interval [CI], 1.10-4.95; p=0.026); increased verbal Glasgow Coma Scale score (OR, 1.71; 95% CI, 1.29-2.26; ppredictors strongly associated with DFI. These data offer insight into the current use of DFI and support the development of consensus-based guidelines for this procedure.

  11. GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Wiberg, Sebastian; Hassager, Christian; Thomsen, Jakob Hartvig

    2016-01-01

    Background: Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous...... circulation to comatose patients resuscitated from out-of-hospital cardiac arrest. Methods/design: This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded...... one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined...

  12. Neuroprotective Effects of the Glucagon-Like Peptide-1 Analog Exenatide After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Wiberg, Sebastian; Hassager, Christian; Schmidt, Henrik

    2016-01-01

    BACKGROUND: In-hospital mortality in comatose patients resuscitated from out-of-hospital cardiac arrest (OHCA) is ≈50%. In OHCA patients, the leading cause of death is neurological injury secondary to ischemia and reperfusion. Glucagon-like peptide-1 analogs are approved for type 2 diabetes...... mellitus; preclinical and clinical data have suggested their organ-protective effects in patients with ischemia and reperfusion injury. The aim of this trial was to investigate the neuroprotective effects of the glucagon-like peptide-1 analog exenatide in resuscitated OHCA patients. METHODS: We randomly...

  13. Pharmacotherapy and hospital admissions before out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Weeke, Peter; Folke, Fredrik; Gislason, Gunnar Hilmar

    2010-01-01

    For out-of-hospital cardiac arrest (OHCA) to be predicted and prevented, it is imperative the healthcare system has access to those vulnerable before the event occurs. We aimed to determine the extent of contact to the healthcare system before OHCA.......For out-of-hospital cardiac arrest (OHCA) to be predicted and prevented, it is imperative the healthcare system has access to those vulnerable before the event occurs. We aimed to determine the extent of contact to the healthcare system before OHCA....

  14. Temporal variation of out-of-hospital cardiac arrests in an equatorial climate

    Directory of Open Access Journals (Sweden)

    Marcus EH Ong

    2010-04-01

    Full Text Available Marcus EH Ong1, Faith SP Ng2, Susan Yap1, Kok Leong Yong1, Mary A Peberdy3, Joseph P Ornato41Department of Emergency Medicine, Singapore General Hospital, Singapore; 2Clinical Trials and Epidemiology Research Unit (now known as Singapore Clinical Research Institute, Singapore; 3Division of Cardiology, Virginia Commonwealth University – Medical College of Virginia, Richmond, VA, USA; 4Department of Emergency Medicine, Virginia Commonwealth University – Medical College of Virginia, Richmond, VA, USAObjective: We aimed to determine whether there is a seasonal variation of out-of-hospital cardiac arrests (OHCA in an equatorial climate, which does not experience seasonal environmental change.Methods: We conducted an observational prospective study looking at the occurrence of OHCA in Singapore. Included were all patients with OHCA presented to Emergency Departments across the country. We examined the monthly, daily, and hourly number of cases over a threeyear period. Data was analyzed using analysis of variance (ANOVA.Results: From October, 1st 2001 to October, 14th 2004, 2428 patients were enrolled in the study. Mean age for cardiac arrests was 60.6 years with 68.0% male. Ethnic distribution was 69.5% Chinese, 15.0% Malay, 11.0% Indian, and 4.4% Others. There was no significant seasonal variation (spring/summer/fall/winter of events (ANOVA P = 0.71, monthly variation (P = 0.88 or yearly variation (P = 0.26. We did find weekly peaks on Mondays and a circadian pattern with daily peaks from 9–10 am.Conclusions: We did not find any discernable seasonal pattern of cardiac arrests. This contrasts with findings from temperate countries and suggests a climatic influence on cardiac arrest occurrence. We also found that sudden cardiac arrests follow a circadian pattern.Keywords: cardiopulmonary resuscitation, cardiac arrest, seasonal pattern, circadian pattern

  15. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

  16. [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

    Science.gov (United States)

    Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

    2016-10-01

    Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  17. The effect of targeted temperature management on coagulation parameters and bleeding events after out-of-hospital cardiac arrest of presumed cardiac cause

    DEFF Research Database (Denmark)

    Jacob, Marrit; Hassager, Christian; Bro-Jeppesen, John;

    2015-01-01

    AIMS: Targeted temperature management (TTM) is part of the standard treatment of comatose patients after out-of-hospital cardiac arrest (OHCA) to attenuate neurological injury. In other clinical settings, hypothermia promotes coagulopathy leading to an increase in bleeding and thrombosis tendency...

  18. Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research

    Directory of Open Access Journals (Sweden)

    Facio Flavia M

    2012-10-01

    Full Text Available Abstract Background Massively-parallel sequencing (MPS technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. Discussion We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. Summary The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants.

  19. Risky locations for out-of-hospital cardiopulmonary arrest in a typical urban city

    Directory of Open Access Journals (Sweden)

    Yoshihiro Moriwaki

    2014-01-01

    Full Text Available Background: The aim of this study is to clarify the circumstances including the locations where critical events resulting in out-of-hospital cardiopulmonary arrest (OHCPA occur. Materials and Methods: Subjects of this population-based observational case series study were the clinical records of patients with nontraumatic and nonneck-hanging OHCPA. Results: Of all 1546 cases, 10.3% occurred in a public place (shop, restaurant, workplace, stations, public house, sports venue, and bus, 8.3% on the street, 73.4% in a private location (victim′s home, the homes of the victims′ relatives or friends or cheap bedrooms, where poor homeless people live, and 4.1% in residential institutions. In OHCPA occurring in private locations, the frequency of asystole was higher and the outcome was poorer than in other locations. A total of 181 OHCPA cases (11.7% took place in the lavatory and 166 (10.7% in the bathroom; of these, only 7 (3.9% of OHCPA in the lavatory and none in the bath room achieved good outcomes. The frequencies of shockable initial rhythm occurring in the lavatory and in bath room were 3.7% and 1.1% (lower than in other locations, P = 0.011 and 0.002, and cardiac etiology in OHCPA occurring in these locations were 46.7% and 78.4% (the latter higher than in other locations, P < 0.001. Conclusions: An unignorable population suffered from OHCPA in private locations, particularly in the lavatory and bathroom; their initial rhythm was usually asystole and their outcomes were poor, despite the high frequency of cardiac etiology in the bathroom. We should try to treat OHCPA victims and to prevent occurrence of OHCPA in these risky spaces by considering their specific conditions.

  20. Neurobehavioral Outcomes in Children After Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Slomine, Beth S; Silverstein, Faye S; Christensen, James R; Holubkov, Richard; Page, Kent; Dean, J Michael; Moler, Frank W

    2016-04-01

    This study examined 12-month neurobehavioral outcomes in children who survived out-of-hospital cardiac arrest (OH-CA), were comatose after resuscitation, and were enrolled in a clinical trial to evaluate targeted temperature management to hypothermia (33.0°C) or normothermia (36.8°C) (Therapeutic Hypothermia after Pediatric Cardiac Arrest, Out-of-Hopsital [THAPCA-OH]; NCT00878644). Baseline functioning was assessed by caregiver responses on the Vineland Adaptive Behavior Scales-Second Edition (VABS-II) soon after OH-CA (based on functioning before OH-CA); children with broadly normal baseline functioning (VABS-II ≥70) were included in the THAPCA-OH primary outcome. VABS-II was completed again 12 months later. Then, face-to-face cognitive evaluations were completed. Analyses evaluated changes in VABS-II composite, domain, and subdomain scores and cognitive functioning at follow-up. Ninety-six of 295 enrolled children were alive at 12 months; 87 of 96 had broadly normal baseline functioning (VABS-II ≥70). Follow-up was obtained on 85/87. Forty-two of 85 had VABS-II ≥70 at 12 months. VABS-II composite, domain, and subdomain scores declined significantly between baseline and 12-month follow-up (P VABS-II scores were predictive of greater decline in neurobehavioral function. Treatment with hypothermia did not influence neurobehavioral outcomes. This is the largest study exploring long-term neurobehavioral outcomes in children surviving OH-CA who were comatose after resuscitation. Results revealed significant neurobehavioral morbidity across multiple functional domains, based both on caregiver reports and performance on objective cognitive measures, in survivors 1 year later. Copyright © 2016 by the American Academy of Pediatrics.

  1. Safety of Intranasal Fentanyl in the Out-of-Hospital Setting

    DEFF Research Database (Denmark)

    Karlsen, Anders P H; Pedersen, Danny M B; Trautner, Sven

    2014-01-01

    : In this prospective observational study, we administered intranasal fentanyl in the out-of-hospital setting to adults and children older than 8 years with severe pain resulting from orthopedic conditions, abdominal pain, or acute coronary syndrome refractory to nitroglycerin spray. Patients received 1 to 3 doses...

  2. Long-term prognosis after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Horsted, Tina I; Rasmussen, Lars S; Meyhoff, Christian S

    2007-01-01

    OBJECTIVE: In this study we aimed to report survival beyond 6 months, including quality of life, for patients after out-of-hospital cardiac arrest (OHCA) with a physician-based EMS in an urban area. METHODS: We collected data related to OHCA prospectively during a 2-year period. Long-term survival...

  3. Reperfusion therapy in out-of-hospital cardiac arrest: current insights.

    NARCIS (Netherlands)

    Keuper, W.; Dieker, H.J.; Brouwer, M.A.; Verheugt, F.W.A.

    2007-01-01

    Although early care in out-of-hospital cardiac arrest has been improved over the past decades, survival remains poor and neurological performance after survival is often impaired. Consequently, new therapies are needed to improve outcome. As thrombotic processes such as acute myocardial infarction o

  4. Trends in Out-of-Hospital Births in the United States, 1990-2012

    Science.gov (United States)

    ... influenced by differences in state laws pertaining to midwifery practice or out-of-hospital births ( 10–11 ), ... in the United States choose home birth. J Midwifery Womens Health 54(2):119–26. 2009. Health ...

  5. Perception of the informed consent form by participants in clinical trials

    OpenAIRE

    Meneguin, Silmara [UNESP; Ayres, Jairo Aparecido

    2014-01-01

    To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Some of the participa...

  6. Survival and Neurologic Outcome After Out-of-hospital Cardiac Arrest. Results of the Andalusian Out-of-hospital Cardiopulmonary Arrest Registry.

    Science.gov (United States)

    Rosell Ortiz, Fernando; Mellado Vergel, Francisco; López Messa, Juan Bautista; Fernández Valle, Patricia; Ruiz Montero, María M; Martínez Lara, Manuela; Vergara Pérez, Santiago; Vivar Díaz, Itziar; Caballero García, Auxiliadora; García Alcántara, Ángel; García Del Águila, Javier

    2016-05-01

    There is a paucity of data on prehospital cardiac arrest in Spain. Our aim was to describe the incidence, patient characteristics, and outcomes of out-of-hospital emergency care for this event. We conducted a retrospective analysis of a prospective registry of cardiopulmonary arrest handled by an out-of-hospital emergency service between January 2008 and December 2012. The registry included all patients considered to have a cardiac etiology as the cause of arrest, with a descriptive analysis performed of general patient characteristics and factors associated with good neurologic outcome at hospital discharge. A total of 4072 patients were included, with an estimated incidence of 14.6 events per 100000 inhabitants and year; 72.6% were men. The mean age was 62.0 ± 15.8 years, 58.6% of cases occurred in the home, 25% of patients had initial defibrillable rhythm, 28.8% of patients arrived with a pulse at the hospital (58.3% of the group with defibrillable rhythm), and 10.2% were discharged with good neurologic outcome. The variables associated with this recovery were: witnessed arrest (P=.04), arrest witnessed by emergency team (P=.005), previous life support (P=.04), initial defibrillable rhythm (P=.0001), and performance of a coronary interventional procedure (P=.0001). More than half the cases of sudden cardiac arrest occur at home, and the population was found to be relatively young. Although recovery was satisfactory in 1 out of every 10 patients, there is a need for improvement in the phase prior to emergency team arrival. Coronary interventional procedures had an impact on patient prognosis. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  7. Guidance for ambulance personnel on decisions and situations related to out-of-hospital CPR.

    Science.gov (United States)

    Ågård, Anders; Herlitz, Johan; Castrén, Maaret; Jonsson, Lars; Sandman, Lars

    2012-01-01

    Ethical guidelines on out-of-hospital cardio-pulmonary resuscitation (CPR) are designed to provide substantial guidance for the people who have to make decisions and deal with situations in the real world. The crucial question is whether it is possible to formulate practical guidelines that will make things somewhat easier for ambulance personnel. The aims of this article are to address the ethical aspects related to out-of-hospital CPR, primarily to decisions on not starting or terminating resuscitation attempts, using the views and experience of ambulance personnel as a starting point, and to summarise the key points in a practice guideline on the subject. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  8. To survive out-of-hospital cardiac arrest: a search for meaning and coherence.

    Science.gov (United States)

    Bremer, Anders; Dahlberg, Karin; Sandman, Lars

    2009-03-01

    The primary responsibility of prehospital emergency personnel at out-of-hospital cardiac arrests (OHCA) is to provide lifesaving care. Ethical considerations, decisions, and actions should be based in the patient's beliefs about health and well-being. In this article, we describe patients' experiences of surviving OHCA. By using a phenomenological approach, we focus on how OHCA influences patients' well-being over time. Nine survivors were interviewed. Out-of-hospital cardiac arrest is described as a sudden and elusive threat, an awakening in perplexity, and the memory gap as a loss of coherence. Survival means a search for coherence with distressing and joyful understanding, as well as existential insecurity exposed by feelings of vulnerability. Well-being is found through a sense of coherence and meaning in life. The study findings show survivors' emotional needs and a potential for prehospital emergency personnel to support them as they try to make sense of what has happened to them.

  9. Implementation of a titrated oxygen protocol in the out-of-hospital setting.

    Science.gov (United States)

    Bosson, Nichole; Gausche-Hill, Marianne; Koenig, William

    2014-08-01

    Oxygen is one of the most frequently-used therapeutic agents in medicine and the most commonly administered drug by prehospital personnel. There is increasing evidence of harm with too much supplemental oxygen in certain conditions, including stroke, chronic obstructive pulmonary disease (COPD), neonatal resuscitations, and in postresuscitation care. Recent guidelines published by the British Thoracic Society (BTS) advocate titrated oxygen therapy, but these guidelines have not been widely adapted in the out-of-hospital setting where high-flow oxygen is the standard. This report is a description of the implementation of a titrated oxygen protocol in a large urban-suburban Emergency Medical Services (EMS) system and a discussion of the practical application of this out-of-hospital protocol.

  10. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  11. An Unusual Cause of Out-of-Hospital Cardiac Arrest Recorded on a Heartrate Monitor.

    Science.gov (United States)

    Moore, Peter T; Ng, Arnold C T; Gould, Paul A; Wang, William Y S

    2016-10-01

    Coronary vasospasm is an uncommon, but perhaps under-recognised, cause of cardiac arrest. We present a novel case of an exercise-induced out-of-hospital cardiac arrest due to coronary vasospasm, captured on a heartrate monitor, and discuss the management options for this condition. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  12. A Manikin Model for Study of Wound Packing Interventions to Control Out-of-hospital Hemorrhage

    Science.gov (United States)

    2014-09-01

    SEP 2014 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE A manikin model for study of wound packing interventions to control...AirWrap. A manikin model for study of wound- packing interventions to control out-of-hospital hemorrhage☆,☆☆,★ To the Editor, With hemorrhage being the...primary cause of mortality on the battlefield [1 3], wound packing practice by US military medics in the wars since September 11, 2001, has changed from

  13. Association of Circulating MicroRNA-124-3p Levels With Outcomes After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Devaux, Yvan; Dankiewicz, Josef; Salgado-Somoza, Antonio

    2016-01-01

    cohort of comatose patients with out-of-hospital cardiac arrest. DESIGN, SETTING, AND PARTICIPANTS: This substudy of the Target Temperature Management After Cardiac Arrest (TTM) trial, a multicenter randomized, parallel-group, assessor-blinded clinical trial, compared the 6-month neurologic outcomes......IMPORTANCE: The value of microRNAs (miRNAs) as biomarkers has been investigated in various clinical contexts. Initial small-scale studies suggested that miRNAs might be useful indicators of outcome after cardiac arrest. OBJECTIVE: To address the prognostic value of circulating miRNAs in a large...... and survival of patients with cardiac arrest after targeted temperature management at 33°C or 36°C. Five hundred seventy-nine patients who survived the first 24 hours after the return of spontaneous circulation and who had blood samples available for miRNA assessment were enrolled from 29 intensive care units...

  14. Unmanned aerial vehicles (drones) in out-of-hospital-cardiac-arrest.

    Science.gov (United States)

    Claesson, A; Fredman, D; Svensson, L; Ringh, M; Hollenberg, J; Nordberg, P; Rosenqvist, M; Djarv, T; Österberg, S; Lennartsson, J; Ban, Y

    2016-10-12

    The use of an automated external defibrillator (AED) prior to EMS arrival can increase 30-day survival in out-of-hospital cardiac arrest (OHCA) significantly. Drones or unmanned aerial vehicles (UAV) can fly with high velocity and potentially transport devices such as AEDs to the site of OHCAs. The aim of this explorative study was to investigate the feasibility of a drone system in decreasing response time and delivering an AED. Data of Global Positioning System (GPS) coordinates from historical OHCA in Stockholm County was used in a model using a Geographic Information System (GIS) to find suitable placements and visualize response times for the use of an AED equipped drone. Two different geographical models, urban and rural, were calculated using a multi-criteria evaluation (MCE) model. Test-flights with an AED were performed on these locations in rural areas. In total, based on 3,165 retrospective OHCAs in Stockholm County between 2006-2013, twenty locations were identified for the potential placement of a drone. In a GIS-simulated model of urban OHCA, the drone arrived before EMS in 32 % of cases, and the mean amount of time saved was 1.5 min. In rural OHCA the drone arrived before EMS in 93 % of cases with a mean amount of time saved of 19 min. In these rural locations during (n = 13) test flights, latch-release of the AED from low altitude (3-4 m) or landing the drone on flat ground were the safest ways to deliver an AED to the bystander and were superior to parachute release. The difference in response time for EMS between urban and rural areas is substantial, as is the possible amount of time saved using this UAV-system. However, yet another technical device needs to fit into the chain of survival. We know nothing of how productive or even counterproductive this system might be in clinical reality. To use drones in rural areas to deliver an AED in OHCA may be safe and feasible. Suitable placement of drone systems can be designed by using GIS models

  15. Methylphenidate poisoning: an evidence-based consensus guideline for out-of-hospital management.

    Science.gov (United States)

    Scharman, Elizabeth J; Erdman, Andrew R; Cobaugh, Daniel J; Olson, Kent R; Woolf, Alan D; Caravati, E Martin; Chyka, Peter A; Booze, Lisa L; Manoguerra, Anthony S; Nelson, Lewis S; Christianson, Gwenn; Troutman, William G

    2007-01-01

    A review of US poison center data for 2004 showed over 8,000 ingestions of methylphenidate. A guideline that determines the conditions for emergency department referral and prehospital care could potentially optimize patient outcome, avoid unnecessary emergency department visits, reduce health care costs, and reduce life disruption for patients and caregivers. An evidence-based expert consensus process was used to create the guideline. Relevant articles were abstracted by a trained physician researcher. The first draft of the guideline was created by the lead author. The entire panel discussed and refined the guideline before distribution to secondary reviewers for comment. The panel then made changes based on the secondary review comments. The objective of this guideline is to assist poison center personnel in the appropriate out-of-hospital triage and initial out-of-hospital management of patients with suspected ingestions of methylphenidate by 1) describing the process by which a specialist in poison information should evaluate an exposure to methylphenidate, 2) identifying the key decision elements in managing cases of methylphenidate ingestion, 3) providing clear and practical recommendations that reflect the current state of knowledge, and 4) identifying needs for research. This review focuses on the ingestion of more than a single therapeutic dose of methylphenidate and the effects of an overdose and is based on an assessment of current scientific and clinical information. The expert consensus panel recognizes that specific patient care decisions may be at variance with this guideline and are the prerogative of the patient and the health professionals providing care, considering all of the circumstances involved. This guideline does not substitute for clinical judgment. Recommendations are in chronological order of likely clinical use. The grade of recommendation is in parentheses. 1) All patients with suicidal intent, intentional abuse, or in cases in which

  16. Mechanical CPR devices compared to manual CPR during out-of-hospital cardiac arrest and ambulance transport: a systematic review

    Directory of Open Access Journals (Sweden)

    Ong Marcus

    2012-06-01

    Full Text Available Abstract Aims The aim of this paper was to conduct a systematic review of the published literature to address the question: “In pre-hospital adult cardiac arrest (asystole, pulseless electrical activity, pulseless Ventricular Tachycardia and Ventricular Fibrillation, does the use of mechanical Cardio-Pulmonary Resuscitation (CPR devices compared to manual CPR during Out-of-Hospital Cardiac Arrest and ambulance transport, improve outcomes (e.g. Quality of CPR, Return Of Spontaneous Circulation, Survival”. Methods Databases including PubMed, Cochrane Library (including Cochrane database for systematic reviews and Cochrane Central Register of Controlled Trials, Embase, and AHA EndNote Master Library were systematically searched. Further references were gathered from cross-references from articles and reviews as well as forward search using SCOPUS and Google scholar. The inclusion criteria for this review included manikin and human studies of adult cardiac arrest and anti-arrhythmic agents, peer-review. Excluded were review articles, case series and case reports. Results Out of 88 articles identified, only 10 studies met the inclusion criteria for further review. Of these 10 articles, 1 was Level of Evidence (LOE 1, 4 LOE 2, 3 LOE 3, 0 LOE 4, 2 LOE 5. 4 studies evaluated the quality of CPR in terms of compression adequacy while the remaining six studies evaluated on clinical outcomes in terms of return of spontaneous circulation (ROSC, survival to hospital admission, survival to discharge and Cerebral Performance Categories (CPC. 7 studies were supporting the clinical question, 1 neutral and 2 opposing. Conclusion In this review, we found insufficient evidence to support or refute the use of mechanical CPR devices in settings of out-of-hospital cardiac arrest and during ambulance transport. While there is some low quality evidence suggesting that mechanical CPR can improve consistency and reduce interruptions in chest compressions, there is no

  17. Out-of-Hospital ICU Transfers to an Oncological Referral Center.

    Science.gov (United States)

    Gutierrez, Cristina; Cárdenas, Yenny R; Bratcher, Kristie; Melancon, Judd; Myers, Jason; Campbell, Jeannee Y; Feng, Lei; Price, Kristen J; Nates, Joseph L

    2016-01-01

    To determine resource utilization and outcomes of out-of-hospital transfer patients admitted to the intensive care unit (ICU) of a cancer referral center. Single-center cohort. A tertiary oncological center. Patients older than 18 years transferred to our ICU from an outside hospital between January 2013 and December 2015. A total of 2127 (90.3%) were emergency department (ED) ICU admissions and 228 (9.7%) out-of-hospital transfers. The ICU length of stay (LOS) was longer in the out-of-hospital transfers when compared to all other ED ICU admissions ( P = .001); however, ICU and hospital mortality were similar between both groups. The majority of patients were transferred for a higher level of care (77.2%); there was no difference in the amount of interventions performed, ICU LOS, and ICU mortality between nonhigher level-of-care and higher level-of-care patients. Factors associated with an ICU LOS ≥10days were a higher Sequential Organ Failure Assessment (SOFA) score, weekend admissions, presence of shock, need for mechanical ventilation, and acute kidney injury on admission or during ICU stay ( P transferred patients was 17.5% and associated risk factors were older age, higher SOFA score on admission, use of mechanical ventilation and vasopressors during ICU stay, and renal failure on admission ( P transfer such as LOS at the outside facility, time of transfer, delay in transfer, and longer distance traveled were not associated with increased LOS or mortality in our study. Organ failure severity on admission, and not transfer-related factors, continues to be the best predictor of outcomes of critically ill patients with cancer when transferred from other facilities to the ICU. Our data suggest that transferring critically ill patients with cancer to a specialized center does not lead to worse outcomes or increased resource utilization when compared to patients admitted from the ED.

  18. Antipsychotics and associated risk of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Weeke, Peter; Jensen, Aksel; Folke, Fredrik

    2014-01-01

    Antipsychotic drugs have been associated with sudden cardiac death, but differences in the risk of out-of-hospital cardiac arrest (OHCA) associated with different antipsychotic drug classes are not clear. We identified all OHCA in Denmark (2001-2010). Risk of OHCA associated with antipsychotic drug...... use was evaluated by conditional logistic regression analysis in case-time-control models. In total, 2,205 (7.6%) of 28,947 OHCA patients received treatment with an antipsychotic drug at the time of event. Overall treatment with any antipsychotic was associated with OHCA (odds ratio [OR]= 1.53, 95...

  19. Antidepressant Use and Risk of Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Weeke, P; Jensen, Aksel Karl Georg; Folke, F

    2012-01-01

    Treatment with some types of antidepressants has been associated with sudden cardiac death. It is unknown whether the increased risk is due to a class effect or related to specific antidepressants within drug classes. All patients in Denmark with an out-of-hospital cardiac arrest (OHCA) were...... identified (2001-2007). Association between treatment with specific antidepressants and OHCA was examined by conditional logistic regression in case-time-control models. We identified 19,110 patients with an OHCA; 2,913 (15.2%) were receiving antidepressant treatment at the time of OHCA, with citalopram...

  20. Interposed Abdominal Compression CPR for an Out-of-Hospital Cardiac Arrest Victim Failing Traditional CPR

    Directory of Open Access Journals (Sweden)

    Christian D. McClung

    2015-10-01

    Full Text Available Interposed abdominal compression cardiopulmonary resuscitation (IAC-CPR is an alternative technique to traditional cardiopulmonary resuscitation (CPR that can improve perfusion and lead to restoration of circulation in patients with chest wall deformity either acquired through vigorous CPR or co-morbidity such as chronic obstructive pulmonary disease. We report a case of out-of-hospital cardiac arrest where IAC-CPR allowed for restoration of spontaneous circulation and eventual full neurologic recovery when traditional CPR was failing to generate adequate pulses with chest compression alone.

  1. Advanced airway management does not improve outcome of out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hanif, M Arslan; Kaji, Amy H; Niemann, James T

    2010-09-01

    The goal of out-of-hospital endotracheal intubation (ETI) is to reduce mortality and morbidity for patients with airway and ventilatory compromise. Yet several studies, mostly involving trauma patients, have demonstrated similar or worse neurologic outcomes and survival-to-hospital discharge rates after out-of-hospital ETI. To date, there is no study comparing out-of-hospital ETI to bag-valve-mask (BVM) ventilation for the outcome of survival to hospital discharge among nontraumatic adult out-of-hospital cardiac arrest (OOHCA) patients. The objective was to compare survival to hospital discharge among adult OOHCA patients receiving ETI to those managed with BVM. In this retrospective cohort study, the records of all OOHCA patients presenting to a municipal teaching hospital from November 1, 1994, through June 30, 2008, were reviewed. The type of field airway provided, age, sex, race, rhythm on paramedic arrival, presence of bystander cardiopulmonary resuscitation (CPR), whether the arrest was witnessed, site of arrest, return of spontaneous circulation (ROSC), survival to hospital admission, comorbid illnesses, and survival to hospital discharge were noted. A univariate odds ratio (OR) was first computed to describe the association between the type of airway and survival to hospital discharge. A multivariable logistic regression analysis was performed, adjusting for rhythm, bystander CPR, and whether the arrest was witnessed. A cohort of 1,294 arrests was evaluated. A total of 1,027 (79.4%) received ETI, while 131 (10.1%) had BVM, 131 (10.1%) had either a Combitube or an esophageal obturator airway, and five (0.4%) had incomplete prehospital records. Fifty-five of 1,294 (4.3%) survived to hospital discharge; there were no survivors in the Combitube/esophageal obturator airway cohort. Even after multivariable adjustment for age, sex, site of arrest, bystander CPR, witnessed arrest, and rhythm on paramedic arrival, the OR for survival to hospital discharge for BVM

  2. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.

    Science.gov (United States)

    Bobrow, Bentley J; Clark, Lani L; Ewy, Gordon A; Chikani, Vatsal; Sanders, Arthur B; Berg, Robert A; Richman, Peter B; Kern, Karl B

    2008-03-12

    Out-of-hospital cardiac arrest is a major public health problem. To investigate whether the survival of patients with out-of-hospital cardiac arrest would improve with minimally interrupted cardiac resuscitation (MICR), an alternate emergency medical services (EMS) protocol. A prospective study of survival-to-hospital discharge between January 1, 2005, and November 22, 2007. Patients with out-of-hospital cardiac arrests in 2 metropolitan cities in Arizona before and after MICR training of fire department emergency medical personnel were assessed. In a second analysis of protocol compliance, patients from the 2 metropolitan cities and 60 additional fire departments in Arizona who actually received MICR were compared with patients who did not receive MICR but received standard advanced life support. Instruction for EMS personnel in MICR, an approach that includes an initial series of 200 uninterrupted chest compressions, rhythm analysis with a single shock, 200 immediate postshock chest compressions before pulse check or rhythm reanalysis, early administration of epinephrine, and delayed endotracheal intubation. Survival-to-hospital discharge. Among the 886 patients in the 2 metropolitan cities, survival-to-hospital discharge increased from 1.8% (4/218) before MICR training to 5.4% (36/668) after MICR training (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.1-8.9). In the subgroup of 174 patients with witnessed cardiac arrest and ventricular fibrillation, survival increased from 4.7% (2/43) before MICR training to 17.6% (23/131) after MICR training (OR, 8.6; 95% CI, 1.8-42.0). In the analysis of MICR protocol compliance involving 2460 patients with cardiac arrest, survival was significantly better among patients who received MICR than those who did not (9.1% [60/661] vs 3.8% [69/1799]; OR, 2.7; 95% CI, 1.9-4.1), as well as patients with witnessed ventricular fibrillation (28.4% [40/141] vs 11.9% [46/387]; OR, 3.4; 95% CI, 2.0-5.8). Survival

  3. Out-of-hospital cardiac arrest (OHCA) survival in rural Northwest Ireland: 17 years' experience.

    LENUS (Irish Health Repository)

    Masterson, Siobhán

    2011-05-01

    SAVES, the name used to describe a register of survivors of out-of-hospital cardiac arrest (OHCA), was established in rural Northwest Ireland in 1992. From 1992 to 2008, 80 survivors were identified (population 239,000 (2006)). Most incidents were witnessed (69\\/70) and all were in shockable rhythm at the time of first rhythm analysis (66\\/66). Of 66 patients who could be traced, 46 were alive in December 2008. Average survival rates appeared to increase over the lifetime of the database. SAVES has also contributed to the development of a national OHCA register.

  4. Long-term survival after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Holler, Nana G; Mantoni, Teit; Nielsen, Søren L;

    2007-01-01

    from the Danish Causes of Death Registry and the Danish Civil Registration System. We conducted a search to find out whether patients were still alive on 31 January 2005. RESULTS: Resuscitation was indicated and attempted in 1095 cases and 95 patients (8.7%) survived to discharge. Of these 75% had...... an initial rhythm of VF, 13% had asystole, 10% had PEA and 2% were unknown. Survival was 87% after one year and survival after 10 years was 46% with a significantly lower survival for patients over 60 years. CONCLUSION: Long-term survival after out-of-hospital cardiac arrest in a physician-staffed emergency...

  5. Survival after out-of-hospital cardiac arrest in relation to sex

    DEFF Research Database (Denmark)

    Wissenberg, Mads; Hansen, Carolina Malta; Folke, Fredrik;

    2014-01-01

    AIM: Crude survival has increased following an out-of-hospital cardiac arrest (OHCA). We aimed to study sex-related differences in patient characteristics and survival during a 10-year study period. METHODS: Patients≥12 years old with OHCA of a presumed cardiac cause, and in whom resuscitation...... was attempted, were identified through the Danish Cardiac Arrest Registry 2001-2010. A total of 19,372 patients were included. RESULTS: One-third were female, with a median age of 75 years (IQR 65-83). Compared to females, males were five years younger; and less likely to have severe comorbidities, e...

  6. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Kragholm, Kristian; Wissenberg, Mads; Mortensen, Rikke N; Hansen, Steen M; Malta Hansen, Carolina; Thorsteinsson, Kristinn; Rajan, Shahzleen; Lippert, Freddy; Folke, Fredrik; Gislason, Gunnar; Køber, Lars; Fonager, Kirsten; Jensen, Svend E; Gerds, Thomas A; Torp-Pedersen, Christian; Rasmussen, Bodil S

    2017-05-04

    The effect of bystander interventions on long-term functional outcomes among survivors of out-of-hospital cardiac arrest has not been extensively studied. We linked nationwide data on out-of-hospital cardiac arrests in Denmark to functional outcome data and reported the 1-year risks of anoxic brain damage or nursing home admission and of death from any cause among patients who survived to day 30 after an out-of-hospital cardiac arrest. We analyzed risks according to whether bystander cardiopulmonary resuscitation (CPR) or defibrillation was performed and evaluated temporal changes in bystander interventions and outcomes. Among the 2855 patients who were 30-day survivors of an out-of-hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1-year follow-up period. During the study period, among the 2084 patients who had cardiac arrests that were not witnessed by emergency medical services (EMS) personnel, the rate of bystander CPR increased from 66.7% to 80.6% (Pbystander defibrillation increased from 2.1% to 16.8% (Pbystander CPR was associated with a risk of brain damage or nursing home admission that was significantly lower than that associated with no bystander resuscitation (hazard ratio, 0.62; 95% confidence interval [CI], 0.47 to 0.82), as well as a lower risk of death from any cause (hazard ratio, 0.70; 95% CI, 0.50 to 0.99) and a lower risk of the composite end point of brain damage, nursing home admission, or death (hazard ratio, 0.67; 95% CI, 0.53 to 0.84). The risks of these outcomes were even lower among patients who received bystander defibrillation as compared with no bystander resuscitation. In our study, we found that bystander CPR and defibrillation were associated with risks of brain damage or nursing home admission and of death from any cause that were significantly lower than those associated with no bystander resuscitation. (Funded by Tryg

  7. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33°C versus 36°C

    DEFF Research Database (Denmark)

    Lilja, Gisela; Nielsen, Niklas; Friberg, Hans

    2015-01-01

    BACKGROUND: Target temperature management is recommended as a neuroprotective strategy after out-of-hospital cardiac arrest. Potential effects of different target temperatures on cognitive impairment commonly described in survivors have not been investigated sufficiently. The primary aim of this ...... survivors was also common in matched control subjects with ST-segment-elevation myocardial infarction not having had a cardiac arrest. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01946932....

  8. Return to Work in Out-of-Hospital Cardiac Arrest Survivors

    DEFF Research Database (Denmark)

    Sørensen, Kristian Dahl Kragholm; Wissenberg, Mads; Mortensen, Rikke Normark

    2015-01-01

    BACKGROUND: Data on long-term function of out-of-hospital cardiac arrest survivors are sparse. We examined return to work as a proxy of preserved function without major neurologic deficits in survivors. METHODS AND RESULTS: In Denmark, out-of-hospital cardiac arrests have been systematically...... reported to the Danish Cardiac Arrest Register since 2001. During 2001-2011, we identified 4354 patients employed before arrest among 12 332 working-age patients (18-65 years), of whom 796 survived to day 30. Among 796 survivors (median age, 53 years [quartile 1-3, 46-59 years]; 81.5% men), 610 (76.......6%) returned to work in a median time of 4 months [quartile 1-3, 1-19 months], with a median time of 3 years spent back at work. A total of 74.6% (N=455) remained employed without using sick leave during the first 6 months after returning to work. This latter proportion of survivors returning to work increased...

  9. Return to Work in Out-of-Hospital Cardiac Arrest Survivors

    DEFF Research Database (Denmark)

    Kragholm, K.; Wissenberg, M.; Mortensen, R. N.

    2015-01-01

    Background-Data on long-term function of out-of-hospital cardiac arrest survivors are sparse. We examined return to work as a proxy of preserved function without major neurologic deficits in survivors. Methods and Results-In Denmark, out-of-hospital cardiac arrests have been systematically reported...... to the Danish Cardiac Arrest Register since 2001. During 2001-2011, we identified 4354 patients employed before arrest among 12 332 working-age patients (18-65 years), of whom 796 survived to day 30. Among 796 survivors (median age, 53 years [quartile 1-3, 46-59 years]; 81.5% men), 610 (76.6%) returned to work...... in a median time of 4 months [quartile 1-3, 1-19 months], with a median time of 3 years spent back at work. A total of 74.6% (N=455) remained employed without using sick leave during the first 6 months after returning to work. This latter proportion of survivors returning to work increased over time (66...

  10. Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

    Science.gov (United States)

    Patel, Dipen Vasudev; Phatak, Ajay Gajanan

    2016-01-01

    Objective Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. Methods After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. Results Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents’ willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. Conclusion The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population’s motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base. PMID:27732680

  11. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

    Full Text Available Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF compliance with Good Clinical Practice (GCP guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.

  12. The readability of information and consent forms in clinical research in France.

    Directory of Open Access Journals (Sweden)

    Véronique Ménoni

    Full Text Available BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24, and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52% of the text in ICFs concerned medical information, and this information was statistically (p<0.05 more readable (Flesch: 28 than statutory information (Flesch: 21. CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use.

  13. Informed consent in clinical research; Do patients understand what they have signed?

    Directory of Open Access Journals (Sweden)

    Elena Villamañán

    2016-05-01

    Full Text Available Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial

  14. Informed consent in clinical research; Do patients understand what they have signed?

    Science.gov (United States)

    Villamañán, Elena; Ruano, Margarita; Fernández-de Uzquiano, Enma; Lavilla, Paz; González, Diana; Freire, Mercedes; Sobrino, Carmen; Herrero, Alicia

    2016-05-01

    Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

  15. Particulate matter and out-of-hospital coronary deaths in eight Italian cities.

    Science.gov (United States)

    Serinelli, Maria; Vigotti, Maria Angela; Stafoggia, Massimo; Berti, Giovanna; Bisanti, Luigi; Mallone, Sandra; Pacelli, Barbara; Tessari, Roberta; Forastiere, Francesco

    2010-05-01

    We evaluated the association between PM(10) concentration and out-of-hospital coronary deaths in eight Italian cities during 1997-2004. 16 989 subjects aged >35 years who died out-of-hospital from coronary causes were studied and hospital admissions in the previous 2 years identified. We studied the effect of the mean of current and previous day PM(10) values (lag 0-1). A city-specific case-crossover analysis was applied using a time-stratified approach considering as confounders weather, holidays, influenza epidemics, and summer decrease in population. The pooled percentage increase (95% CI) in mortality per 10 microg/m(3) increase in PM(10) was estimated. A statistically significant increase in out-of-hospital coronary deaths was related to a 10 microg/m(3) increase in PM(10): 1.46% (95% CI 0.50 to 2.43). Although no statistically significant effect modification by age was found, the effect was stronger among subjects aged >65 years (1.60%, 0.59 to 2.63), particularly those aged 65-74 (3.01%, 0.74 to 5.34). People in the lowest socio-economic category (3.34%, 1.28 to 5.45) had a stronger effect than those in the highest category. No clear effect modification was seen for gender, season or any specific comorbidity. An indication of negative effect modification was seen for previous admission for cardiac dysrhythmias. Subjects without hospital admissions in the previous 2 years were slightly more affected by PM(10) effects (1.91%, 0.28 to 3.47) than those with at least one previous hospital admission (1.44%, 0.09 to 2.82). Our results show that short term exposure to PM(10) is associated with coronary mortality especially among the elderly and socio-economically disadvantaged. No clear effect modification by previous hospitalisations was detected except for cardiac dysrhythmias, possibly due to protective treatment.

  16. Infectious complications after out-of-hospital cardiac arrest - a comparison between two target temperatures

    DEFF Research Database (Denmark)

    Dankiewicz, Josef; Nielsen, Niklas; Linder, Adam;

    2017-01-01

    temperature groups (sub-distribution hazard ratio [SHR] 0.88; 95%CI 0.75-1.03; p=0.12). PCT and CRP were significantly higher for patients with infections at all times (pshock after OHCA might......BACKGROUND: It has been suggested that target temperature management (TTM) increases the probability of infectious complications after cardiac arrest. We aimed to compare the incidence of pneumonia, severe sepsis and septic shock after out-of-hospital cardiac arrest (OHCA) in patients with two...... complications were recorded daily during the ICU-stay. Pneumonia, severe sepsis and septic shock were considered infectious complications. Procalcitonin (PCT) and C-reactive-protein (CRP) levels were measured at 24 h, 48 h and 72 h after cardiac arrest. RESULTS: There were 939 patients in the modified intention...

  17. Association between prehospital physician involvement and survival after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Hamilton, Annika; Steinmetz, Jacob; Wissenberg, Mads

    2016-01-01

    AIM: Sudden out-of-hospital cardiac arrest (OHCA) is an important public health problem. While several interventions are known to improve survival, the impact of physician-delivered advanced cardiac life support for OHCA is unclear. We aimed to assess the association between prehospital physician...... involvement and 30-day survival. METHODS: Observational study including persons registered with first-time OHCA of any cause in the Danish Cardiac Arrest Registry during 2005-2012. We used logistic regression analysis to assess the association between 30-day survival and involvement of a physician at any time...... before arrival at the hospital. Secondary outcomes were 1-year survival and return of spontaneous circulation (ROSC) before arrival at the hospital. The associations were explored in three multivariable models: a model with simple adjustment, a model with multiple imputation of missing variables...

  18. Improved survival after an out-of-hospital cardiac arrest using new guidelines

    DEFF Research Database (Denmark)

    Steinmetz, Jacob; Barnung, S.; Nielsen, S.L.

    2008-01-01

    BACKGROUND: An out-of-hospital cardiac arrest (OHCA) is associated with a poor prognosis. We hypothesized that the implementations of 2005 European Resuscitation Council resuscitation guidelines were associated with improved 30-day survival after OHCA. METHODS: We prospectively recorded data on all...... that 30-day survival increased after the implementation from 31/372 (8.3%) to 67/419 (16%), P=0.001. ROSC at hospital admission, as well as survival to hospital discharge, were obtained in a significantly higher proportion from 23.4% to 39.1%, P.... Treatment after implementation was confirmed as a significant predictor of better 30-day survival in a logistic regression analysis. CONCLUSION: The implementation of new resuscitation guidelines was associated with improved 30-day survival after OHCA Udgivelsesdato: 2008/8...

  19. Therapeutic Hypothermia and Out-of-Hospital Cardiac Arrest in a Child with Hypertrophic Obstructive Cardiomyopathy

    Directory of Open Access Journals (Sweden)

    Nancy Spurkeland

    2015-01-01

    Full Text Available Neurologic outcomes following pediatric cardiac arrest are consistently poor. Early initiation of cardiopulmonary resuscitation has been shown to have positive effects on both survival to hospital discharge, and improved neurological outcomes after cardiac arrest. Additionally, the use of therapeutic hypothermia may improve survival in pediatric cardiac arrest patients admitted to the intensive care unit. We report a child with congenital hypertrophic obstructive cardiomyopathy and an out-of-hospital cardiac arrest, in whom the early initiation of effective prolonged cardiopulmonary resuscitation and subsequent administration of therapeutic hypothermia contributed to a positive outcome with no gross neurologic sequelae. Continuing efforts should be made to promote and employ high-quality cardiopulmonary resuscitation, which likely contributed to the positive outcome of this case. Further research will be necessary to develop and solidify national guidelines for the implementation of therapeutic hypothermia in selected subpopulations of children with OHCA.

  20. Sinus bradycardia during hypothermia in comatose survivors of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Thomsen, Jakob Hartvig; Hassager, Christian; Bro-Jeppesen, John

    2015-01-01

    BACKGROUND: Bradycardia is a common finding in patients undergoing therapeutic hypothermia (TH) following out-of-hospital cardiac arrest (OHCA), presumably as a normal physiological response to low body temperature. We hypothesized that a normal physiological response with sinus bradycardia (SB......) indicates less neurological damage and therefore would be associated with lower mortality. METHODS: We studied 234 consecutive comatose survivors of OHCA with presumed cardiac etiology and shockable primary rhythm, who underwent a full 24-h TH-protocol (33°C) at a tertiary heart center (years: 2004......-2010). Primary endpoint was 180-day mortality; secondary endpoint was favorable neurological outcome (180-day cerebral performance category: 1-2). RESULTS: SB, defined as sinus rhythm arrest...

  1. Recognising out-of-hospital cardiac arrest during emergency calls increases bystander cardiopulmonary resuscitation and survival

    DEFF Research Database (Denmark)

    Viereck, Søren; Møller, Thea Palsgaard; Ersbøll, Annette Kjær

    2017-01-01

    BACKGROUND: Initiation of early bystander cardiopulmonary resuscitation (CPR) depends on bystanders' or medical dispatchers' recognition of out-of-hospital cardiac arrest (OHCA). The primary aim of our study was to investigate if OHCA recognition during the emergency call was associated...... with bystander CPR, return of spontaneous circulation (ROSC), and 30-day survival. Our secondary aim was to identify patient-, setting-, and dispatcher-related predictors of OHCA recognition. METHODS: We performed an observational study of all OHCA patients' emergency calls in the Capital Region of Denmark from...... the association between OHCA recognition and bystander CPR, ROSC, and 30-day survival. Univariable logistic regression analyses were applied to identify predictors of OHCA recognition. RESULTS: We included 779 emergency calls in the analyses. During the emergency calls, 70.1% (n=534) of OHCAs were recognised...

  2. Bystander Defibrillation for Out-of-Hospital Cardiac Arrest in Public vs Residential Locations

    DEFF Research Database (Denmark)

    Hansen, Steen Møller; Hansen, Carolina Malta; Folke, Fredrik

    2017-01-01

    Importance: Bystander-delivered defibrillation (hereinafter referred to as bystander defibrillation) of patients with out-of-hospital cardiac arrests (OHCAs) remains limited despite the widespread dissemination of automated external defibrillators (AEDs). Objective: To examine calendar changes...... in bystander defibrillation and subsequent survival according to a public or a residential location of the cardiac arrest after nationwide initiatives in Denmark to facilitate bystander-mediated resuscitative efforts, including bystander defibrillation. Design, Setting, and Participants: This nationwide study......, 2016. Exposures: Nationwide initiatives to facilitate bystander resuscitative efforts, including bystander defibrillation, consisted of resuscitation training of Danish citizens, dissemination of on-site AEDs, foundation of an AED registry linked to emergency medical dispatch centers, and dispatcher...

  3. Hospital admissions and pharmacotherapy before out-of-hospital cardiac arrest according to age

    DEFF Research Database (Denmark)

    Weeke, Peter; Folke, Fredrik; Gislason, Gunnar H;

    2012-01-01

    were identified in the nationwide Danish Cardiac Arrest Register and Copenhagen Medical Emergency Care Unit (2001-2006). We matched every OHCA patients with 10 controls on sex and age. Healthcare contacts were evaluated 30 days before event by individual-level-linkage of nationwide registers. RESULTS......BACKGROUND: The underlying etiology of sudden cardiac death varies with age and is likely to be reflected in type and number of healthcare contacts. We aimed to determine the specific type of healthcare contact shortly before out-of-hospital cardiac arrest (OHCA) across ages. METHODS: OHCA patients......: We identified 16,924 OHCA patients, median age 70.0 years (Q1-Q3: 59-80). OHCA patients had a higher number of hospitalizations and received more pharmacotherapy compared to the control population across all ages (p for difference 89) were...

  4. Evaluation of intensified prehospital treatment in out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Frandsen, F; Nielsen, J R; Gram, L;

    1991-01-01

    with doctors collaborating (advanced EMS) were used, and 11 (13%) patients were discharged. The intermediate EMS system was used in another area with 45,000 inhabitants/population density of 340/km2, and in this area 20 (18%) patients were discharged. Among the survivors a psychological assessment in form...... of a test for dementia was assessed in long-term survivors (n = 30) together with 28 patients surviving acute myocardial infarction and 11 control persons. The results of the investigation demonstrate that the more intensive the prehospital treatment of out-of-hospital cardiac arrest, the more patients...... survive and the more patients survive with good cerebral function. However, the ambulances with specially trained paramedics were only effective in the area with 340 inhabitants/km2....

  5. Barriers to recognition of out-of-hospital cardiac arrest during emergency medical calls

    DEFF Research Database (Denmark)

    Alfsen, David; Møller, Thea Palsgaard; Egerod, Ingrid;

    2015-01-01

    as influential factors. Though many of these factors are included in the algorithms used by medical dispatchers, many OHCA still remain not recognised. Qualitative studies investigating the communication between the caller and dispatcher are very scarce. There is a lack of knowledge about what influences...... the dispatchers' recognition of OHCA, focusing on the communication during the emergency call. The purpose of this study is to identify factors affecting medical dispatchers' recognition of OHCA during emergency calls in a qualitative analysis of calls. METHODS: An investigator triangulated inductive thematic...... analysis of recordings of out-of-hospital cardiac arrest emergency calls from December 2012. Participants were the callers (bystanders) and the emergency medical dispatchers. Data were analysed using a hermeneutic approach. RESULTS: Based on the concept of data saturation, 13 recordings of not recognised...

  6. Location of out-of-hospital cardiac arrest as a determinant in the survival of patients

    Directory of Open Access Journals (Sweden)

    Jokšić-Mazinjanin Radojka

    2016-01-01

    Full Text Available Introduction. Cardiac arrest (CA is defined as a sudden cessation of normal circulation of blood due to failure of the heart to contract effectively during systole. Objective. The aim of this study was to determine the difference in outcome among patients, depending on the location of out-of-hospital CA; to determine the influence of observed determinants on the survival rate. Methods. Observational and retrospective study was conducted in the Institute for Emergency Medical Service Novi Sad (IEMS NS. It included patients who underwent cardiopulmonary resuscitation (CPR by medical ambulance squads. Patients were divided into three groups, based on the location of CA: private place, public place, and medical institution. Results. CA occurred in private places in 151 cases (76.26%. The shortest duration of a phone call with the dispatcher and Reaction Time I was in the group of patients with CA in a public place (59.1 ± 36.4 seconds and 137.1 ± 89.8 seconds, respectively. CA was recognized in more than 80% of cases, but CPR was initiated in only 9.09% of patients in private places and in 19.35% of patients in public places. Though they initially presented with shockable rhythm in 57.14% of cases in public places, this group has the worst immediate outcome (11.43%, in contrast to the patients with CA in medical institutions (58.33%. Factors determining the survival of patients with CA were CPR attempted immediately after collapse, initial rhythm and eyewitnesses of CA. Conclusion. In order to improve survival of patients with out-of-hospital CA, both education of laymen and introduction of standard questioning protocol in the IEMS Call Centre are necessary. [Projekat Ministarstva nauke Republike Srbije, br. 175007

  7. Out-of-hospital combat casualty care in the current war in Iraq.

    Science.gov (United States)

    Gerhardt, Robert T; De Lorenzo, Robert A; Oliver, Jeffrey; Holcomb, John B; Pfaff, James A

    2009-02-01

    We describe outcomes for battle casualties receiving initial treatment at a US Army consolidated battalion aid station augmented with emergency medicine practitioners, advanced medic treatment protocols, and active medical direction. Battalion aid stations are mobile facilities integral to combat units, providing initial phases of advanced trauma life support and then evacuation. The setting was a forward base in central Iraq, with units engaged in urban combat operations. This was a retrospective observational study. Rates of battle casualties, mechanism, evacuations, and outcome were calculated. Corresponding Iraqi theater-wide US casualty rates were also calculated for indirect comparison. The study population consisted of 1.1% of the total US military population in the Iraqi theater. Data were available for all battle casualties. The study facility's battle casualty rate was 22.2%. The case fatality rate was 7.14%, and the out-of-theater evacuation rate was 27%. Analysis of evacuated patients revealed a study average Injury Severity Score of 10 (95% confidence interval [CI] 8 to 12). Concurrent theater aggregate US casualty rates are provided for contextual reference and include battle casualty rate of 6.7%, case fatality rate of 10.45%, out-of-theater evacuation rate of 18%, and average out-of-theater evacuation casualty Injury Severity Score of 10 (95% CI 9.5 to 10.5). The study battalion aid station experienced high casualty and evacuation rates while also demonstrating relatively low case fatality rates. A relatively high proportion of patients were evacuated out of the combat zone, reflecting both the battle casualty rate and number of patients surviving. Future effort should focus on improving out-of-hospital combat casualty data collection and prospective validation of emergency medicine-based out-of-hospital battlefield care and medical direction.

  8. Differences between out-of-hospital cardiac arrest in residential and public locations and implications for public-access defibrillation

    DEFF Research Database (Denmark)

    Folke, Fredrik; Gislason, Gunnar H; Lippert, Freddy

    2010-01-01

    The majority of out-of-hospital cardiac arrests (OHCAs) occur in residential locations, but knowledge about strategic placement of automated external defibrillators in residential areas is lacking. We examined whether residential OHCA areas suitable for placement of automated external...

  9. Understanding the informed consent process in HIV clinical trials in Uganda: a case study

    OpenAIRE

    Ssali, Agnes

    2014-01-01

    The regulatory guidelines on obtaining informed consent require that all protocols be reviewed by an ethics review committee; in addition study information must be presented to volunteers by the research teams in simple and understandable language, to ensure they are able to give informed consent for their participation. Despite the innovative methods that have been developed over the years to improve informed consent, the informed consent process is still a difficult subject and not fully un...

  10. Cardiopulmonary resuscitation (CPR) plus delayed defibrillation versus immediate defibrillation for out-of-hospital cardiac arrest.

    Science.gov (United States)

    Huang, Yu; He, Qing; Yang, Li J; Liu, Guan J; Jones, Alexander

    2014-09-12

    Sudden cardiac arrest (SCA) is a common health problem associated with high levels of mortality. Cardiac arrest is caused by three groups of dysrhythmias: ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT), pulseless electric activity (PEA) and asystole. The most common dysrhythmia found in out-of-hospital cardiac arrest (OHCA) is VF. During VF or VT, cardiopulmonary resuscitation (CPR) provides perfusion and oxygenation to the tissues, whilst defibrillation restores a viable cardiac rhythm. Early successful defibrillation is known to improve outcomes in VF/VT. However, it has been hypothesized that a period of CPR before defibrillation creates a more conducive physiological environment, increasing the likelihood of successful defibrillation. The order of priority of CPR versus defibrillation therefore remains in contention. As previous studies have remained inconclusive, we conducted a systematic review of available evidence in an attempt to draw conclusions on whether CPR plus delayed defibrillation or immediate defibrillation resulted in better outcomes in OHCA. To examine whether an initial one and one-half to three minutes of CPR administered by paramedics before defibrillation versus immediate defibrillation on arrival influenced survival rates, neurological outcomes or rates of return of spontaneous circulation (ROSC) in OHCA. We searched the following databases: the Cochrane Central Register of Controlled trials (CENTRAL) (2013, Issue 6); MEDLINE (Ovid) (1948 to May 2013); EMBASE (1980 to May 2013); the Institute for Scientific Information (ISI) Web of Science (1980 to May 2013) and the China Academic Journal Network Publishing Database (China National Knowledge Infrastructure (CNKI), 1980 to May 2013). We included studies published in all languages. We also searched the Current Controlled Trials and Clinical Trials databases for ongoing trials. We screened the references lists of studies included in our review against the reference

  11. Incidence and outcomes of out-of-hospital cardiac arrest in the eastern part of Yamaguchi prefecture.

    Science.gov (United States)

    Shiraki, Teruo; Osawa, Kazuhiro; Suzuki, Hideyuki; Yoshida, Masatoki; Takahashi, Natsuki; Takeuchi, Kazufumi; Tanakaya, Machiko; Kohno, Kunihisa; Saito, Daiji

    2009-07-01

    The aim of the present study was to evaluate the factors related to poor prognosis of out-of-hospital cardiac arrest patients in one local area of Japan. From May 1, 2002 to April 30, 2008, a total of 442 patients with cardiopulmonary arrest were transferred for resuscitation to the National Hospital Organization, Iwakuni Clinical Center. Of 325 patients with cardiopulmonary arrest of cardiac etiology, 126 patients were witnessed by a bystander. However, only 37 received bystander cardiopulmonary resuscitation, 13 had shockable cardiac rhythm, 3 survived 1 month, and 2 had a good neurological discharge. Multivariate analysis of overall cardiac arrest showed that 1-month survival and neurologically favorable discharge were associated with bystander cardiopulmonary resuscitation (P=0.049 and 0.013) and initial shockable cardiac rhythm (P=0.001 and 0.007). In this region, the survival rate for patients with cardiopulmonary arrest was lower than that reported in other areas, probably because fewer patients received bystander CPR or had shockable cardiac rhythm. This may result from CPR being less popularized in this region than in other areas, suggesting that raising the awareness of CPR would improve the survival rate.

  12. Experiencing out-of-hospital cardiac arrest: significant others' lifeworld perspective.

    Science.gov (United States)

    Bremer, Anders; Dahlberg, Karin; Sandman, Lars

    2009-10-01

    When patients suffer out-of-hospital cardiac arrests (OHCA), significant others find themselves with no choice about being there. After the event they are often left with unanswered questions about the life-threatening circumstances, or the patient's death, or emergency treatment and future needs. When it is unclear how the care and the event itself will affect significant others' well-being, prehospital emergency personnel face ethical decisions. In this article we describe the experiences of significant others present at OHCA, focusing on ethical aspects and values. Using a lifeworld phenomenological approach, 7 significant others were interviewed. The essence of the phenomenon of OHCA can be stated as unreality in the reality, which is characterized by overwhelming responsibility. The significant others experience inadequacy and limitation, they move between hope and hopelessness, and they struggle with ethical considerations and an insecurity about the future.The study findings show how significant others' sense of an OHCA situation, when life is trembling, can threaten values deemed important for a good life.

  13. Ambient air pollution, temperature and out-of-hospital coronary deaths in Shanghai, China.

    Science.gov (United States)

    Dai, Jinping; Chen, Renjie; Meng, Xia; Yang, Changyuan; Zhao, Zhuohui; Kan, Haidong

    2015-08-01

    Few studies have evaluated the effects of ambient air pollution and temperature in triggering out-of-hospital coronary deaths (OHCDs) in China. We evaluated the associations of air pollution and temperature with daily OHCDs in Shanghai, China from 2006 to 2011. We applied an over-dispersed generalized additive model and a distributed lag nonlinear model to analyze the effects of air pollution and temperature, respectively. A 10 μg/m(3) increase in the present-day PM10, PM2.5, SO2, NO2 and CO were associated with increases in OHCD mortality of 0.49%, 0.68%, 0.88%, 1.60% and 0.08%, respectively. A 1 °C decrease below the minimum-mortality temperature corresponded to a 3.81% increase in OHCD mortality on lags days 0-21, and a 1 °C increase above minimum-mortality temperature corresponded to a 4.61% increase over lag days 0-3. No effects were found for in-hospital coronary deaths. This analysis suggests that air pollution, low temperature and high temperature may increase the risk of OHCDs.

  14. Prevalence of Out-of-Hospital Sudden Cardiac Death in Moscow in 2005–2009

    Directory of Open Access Journals (Sweden)

    Leonid Makarov

    2015-01-01

    Full Text Available Background. The sudden out-of-hospital cardiac death (SOHCD in Russia is poorly investigated. The aim of study was to determine structure of SOHCD in Moscow. Methods. SOHCD were analyzed according to data for 2005–2009 from the 2nd Thanatology Department of Forensic Medicine of Moscow that serves 2502836 citizens in Moscow. Results. Prevalence of SOHCD was 49.1% of autopsies for all age groups and in 8.9% in the group aged 1–45 (22.3 cases per 100000 population/year. The frequency of SOHCD progressively increased with age. Most SOHCD victims (82% were males. The diagnosis of cardiomyopathy was prevalent (80–96% in the age 1–45 group; in 11–15 more 30% had normal heart; after 35 years of age, the role of ischaemic heart disease increased. In 67% of the people aged 19–25 SOHCD was associated with traces of alcohol (0.3–3.0 promile. Conclusion. The proportion of SOHCD in the Moscow population over all age groups has reached 123.2 per 100000 citizens annually. In the age group 1–45, the prevalence of SOHCD was 22.3 cases per 100000 citizens per year. The risk of SOHCD was greater in males. Possibly the role of alcohol in SOHCD in people older than 20 increased.

  15. Out-of-hospital cardiac arrest risk attributable to temperature in Japan

    Science.gov (United States)

    Onozuka, Daisuke; Hagihara, Akihito

    2017-01-01

    Several studies have estimated the associations between extreme temperatures and mortality and morbidity; however, few have investigated the attributable fraction for a wide range of temperatures on the risk of out-of-hospital cardiac arrest (OHCA). We obtained daily records of OHCA cases in the 47 Japanese prefectures between 2005 and 2014. We examined the relationship between OHCA and temperature for each prefecture using a Poisson regression model combined with a distributed lag non-linear model. The estimated prefecture-specific associations were pooled at the nationwide level using a multivariate random-effect meta-analysis. A total of 659,752 cases of OHCA of presumed-cardiac origin met the inclusion criteria. Overall, 23.93% (95% empirical confidence interval [eCI]: 20.15–26.19) of OHCA was attributable to temperature. The attributable fraction to low temperatures was 23.64% (95% eCI: 19.76–25.87), whereas that of high temperatures was 0.29% (95% eCI: 0.21–0.35). The attributable fraction for OHCA was related to moderate low temperature with an overall estimate of 21.86% (95% eCI: 18.10–24.21). Extreme temperatures were responsible for a small fraction. The majority of temperature-related OHCAs were attributable to lower temperatures. The attributable risk of extremely low and high temperatures was markedly lower than that of moderate temperatures.

  16. Improvements in logistics could increase survival after out-of-hospital cardiac arrest in Sweden.

    Science.gov (United States)

    Strömsöe, A; Afzelius, S; Axelsson, C; Södersved Källestedt, M L; Enlund, M; Svensson, L; Herlitz, J

    2013-06-01

    In a review based on estimations and assumptions, to report the estimated number of survivors after out-of-hospital cardiac arrest (OHCA) in whom cardiopulmonary resuscitation (CPR) was started and to speculate about possible future improvements in Sweden. An observational study. All ambulance organisations in Sweden. Patients included in the Swedish Cardiac Arrest Registry who suffered an OHCA between January 1, 2008 and December 31, 2010. Approximately 80% of OHCA cases in Sweden in which CPR was started are included. None In 11 005 patients, the 1-month survival rate was 9.4%. There are approximately 5000 OHCA cases annually in which CPR is started and 30-day survival is achieved in up to 500 patients yearly (6 per 100 000 inhabitants). Based on findings on survival in relation to the time to calling for the Emergency Medical Service (EMS) and the start of CPR and defibrillation, it was estimated that, if the delay from collapse to (i) calling EMS, (ii) the start of CPR, and (iii) the time to defibrillation were reduced to <2 min, <2 min, and <8 min, respectively, 300-400 additional lives could be saved. Based on findings relating to the delay to calling for the EMS and the start of CPR and defibrillation, we speculate that 300-400 additional OHCA patients yearly (4 per 100 000 inhabitants) could be saved in Sweden. © 2013 The Association for the Publication of the Journal of Internal Medicine.

  17. Oxygenation, Ventilation, and Airway Management in Out-of-Hospital Cardiac Arrest: A Review

    Directory of Open Access Journals (Sweden)

    Tomas Henlin

    2014-01-01

    Full Text Available Recently published evidence has challenged some protocols related to oxygenation, ventilation, and airway management for out-of-hospital cardiac arrest. Interrupting chest compressions to attempt airway intervention in the early stages of OHCA in adults may worsen patient outcomes. The change of BLS algorithms from ABC to CAB was recommended by the AHA in 2010. Passive insufflation of oxygen into a patent airway may provide oxygenation in the early stages of cardiac arrest. Various alternatives to tracheal intubation or bag-mask ventilation have been trialled for prehospital airway management. Simple methods of airway management are associated with similar outcomes as tracheal intubation in patients with OHCA. The insertion of a laryngeal mask airway is probably associated with worse neurologically intact survival rates in comparison with other methods of airway management. Hyperoxemia following OHCA may have a deleterious effect on the neurological recovery of patients. Extracorporeal oxygenation techniques have been utilized by specialized centers, though their use in OHCA remains controversial. Chest hyperinflation and positive airway pressure may have a negative impact on hemodynamics during resuscitation and should be avoided. Dyscarbia in the postresuscitation period is relatively common, mainly in association with therapeutic hypothermia, and may worsen neurological outcome.

  18. Oxygenation, ventilation, and airway management in out-of-hospital cardiac arrest: a review.

    Science.gov (United States)

    Henlin, Tomas; Michalek, Pavel; Tyll, Tomas; Hinds, John D; Dobias, Milos

    2014-01-01

    Recently published evidence has challenged some protocols related to oxygenation, ventilation, and airway management for out-of-hospital cardiac arrest. Interrupting chest compressions to attempt airway intervention in the early stages of OHCA in adults may worsen patient outcomes. The change of BLS algorithms from ABC to CAB was recommended by the AHA in 2010. Passive insufflation of oxygen into a patent airway may provide oxygenation in the early stages of cardiac arrest. Various alternatives to tracheal intubation or bag-mask ventilation have been trialled for prehospital airway management. Simple methods of airway management are associated with similar outcomes as tracheal intubation in patients with OHCA. The insertion of a laryngeal mask airway is probably associated with worse neurologically intact survival rates in comparison with other methods of airway management. Hyperoxemia following OHCA may have a deleterious effect on the neurological recovery of patients. Extracorporeal oxygenation techniques have been utilized by specialized centers, though their use in OHCA remains controversial. Chest hyperinflation and positive airway pressure may have a negative impact on hemodynamics during resuscitation and should be avoided. Dyscarbia in the postresuscitation period is relatively common, mainly in association with therapeutic hypothermia, and may worsen neurological outcome.

  19. Out-of-hospital cardiac arrests and outdoor air pollution exposure in Copenhagen, Denmark.

    Directory of Open Access Journals (Sweden)

    Janine Wichmann

    Full Text Available Cardiovascular disease is the number one cause of death globally and air pollution can be a contributing cause. Acute myocardial infarction and cardiac arrest are frequent manifestations of coronary heart disease. The objectives of the study were to investigate the association between 4 657 out-of-hospital cardiac arrests (OHCA and hourly and daily outdoor levels of PM(10, PM(2.5, coarse fraction of PM (PM(10-2.5, ultrafine particle proxies, NO(x, NO(2, O(3 and CO in Copenhagen, Denmark, for the period 2000-2010. Susceptible groups by age and sex was also investigated. A case-crossover design was applied. None of the hourly lags of any of the pollutants were significantly associated with OHCA events. The strongest association with OHCA events was observed for the daily lag4 of PM(2.5, lag3 of PM(10, lag3 of PM(10-2.5, lag3 of NO(x and lag4 of CO. An IQR increase of PM(2.5 and PM(10 was associated with a significant increase of 4% (95% CI: 0%; 9% and 5% (95% CI: 1%; 9% in OHCA events with 3 days lag, respectively. None of the other daily lags or other pollutants was significantly associated with OHCA events. Adjustment for O(3 slightly increased the association between OHCA and PM(2.5 and PM(10. No susceptible groups were identified.

  20. No difference in mortality between men and women after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Winther-Jensen, Matilde; Kjaergaard, Jesper; Wanscher, Michael

    2015-01-01

    AIM: Comparing the outcome after out-of-hospital cardiac arrest (OHCA) in men and women and to determine whether sex modifies the effect of targeted temperature management (TTM) at 33 or 36°C. METHODS: The TTM trial randomized 950 patients to TTM at 33 or 36°C for 24h. This predefined sub......-study of the TTM trial assessed survival and neurological outcome defined as Cerebral Performance Category (CPC) and modified Rankin Scale (mRS) using female sex as main predictor of outcome, in relation to level of TTM and other confounding factors. RESULTS: Compared to men, women more often had OHCA at home, p=0...... in univariate analysis, hazard ratio (HR)=1.29, CI=1.04-1.61, p=0.02 compared to men. Adjusting for demographic factors (age and comorbidity), arrest circumstances, pre-hospital findings, inclusion sites, treatments and status at admission reduced this: HR=1.11, CI=0. 87-1.41, p=0.42, and sex was no longer...

  1. Epinephrine (adrenaline) in the first-aid, out-of-hospital treatment of anaphylaxis.

    Science.gov (United States)

    Simons, F Estelle R

    2004-01-01

    Epinephrine (adrenaline), the initial treatment of choice for systemic anaphylaxis, is an alpha- and beta-adrenergic agonist with bidirectional, cyclic adenosine monophosphate-mediated pharmacological effects on target organs, and a narrow therapeutic index. In a recent study, 0.95% of a geographically-defined population was found to have had epinephrine dispensed for out-of-hospital use; dispensing rates within this population varied from 1.44% for individuals under age 17 years to 0.32% for those older than 65 years. Although epinephrine is widely available in the community, it is not necessarily given in a timely manner when anaphylaxis occurs. Individuals with anaphylaxis may fail to respond to first-aid treatment with epinephrine for a variety of reasons. These include: (1) delay in treatment (in an animal model, epinephrine injection at the nadir of shock fails to provide sustained haemodynamic recovery); (2) administration of epinephrine by sub-optimal routes such as subcutaneous injection or inhalation from a pressurized metered-dose inhaler instead of intramuscular injection; (3) administration of an inappropriately low epinephrine dose due to the limitations currently imposed by the availability of only two fixed-dose auto-injectors: EpiPen Jr 0.15 mg or EpiPen 0.3 mg; and (4) injection of 'outdated' epinephrine, with inadvertent administration of an inadequate dose. Additional fixed-dose formulations of epinephrine are needed to facilitate optimal first-aid dosing in patients of all ages and sizes.

  2. Drones may be used to save lives in out of hospital cardiac arrest due to drowning.

    Science.gov (United States)

    Claesson, A; Svensson, L; Nordberg, P; Ringh, M; Rosenqvist, M; Djarv, T; Samuelsson, J; Hernborg, O; Dahlbom, P; Jansson, A; Hollenberg, J

    2017-05-01

    Drowning leading to out-of-hospital cardiac arrest (OHCA) and death is a major public health concern. Submersion with duration of less than 10min is associated with favorable neurological outcome and nearby bystanders play a considerable role in rescue and resuscitation. Drones can provide a visual overview of an accident scene, their potential as lifesaving tools in drowning has not been evaluated. The aim of this simulation study was to evaluate the efficiency of a drone for providing earlier location of a submerged possible drowning victim in comparison with standard procedure. This randomized simulation study used a submerged manikin placed in a shallow (drone transmitting video to a tablet (intervention). Time from start to contact with the manikin was the primary endpoint. Twenty searches were performed in total, 10 for each group. The median time from start to contact with the manikin was 4:34min (IQR 2:56-7:48) for the search party (control) and 0:47min (IQR 0:38-0:58) for the drone-system (intervention) respectively (pdrone was 3:38min (IQR 2:02-6:38). A drone transmitting live video to a tablet is feasible, time saving in comparison to traditional search parties and may be used for providing earlier location of submerged victims at a beach. Drone search can possibly contribute to earlier onset of CPR in drowning victims. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Direct Transport to a Percutaneous Cardiac Intervention Center and Outcomes in Patients With Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Sørensen, Kristian Dahl Kragholm; Malta Hansen, Carolina; Dupre, Matthew E

    2017-01-01

    BACKGROUND: Practice guidelines recommend regional systems of care for out-of-hospital cardiac arrest. However, whether emergency medical services should bypass nonpercutaneous cardiac intervention (non-PCI) facilities and transport out-of-hospital cardiac arrest patients directly to PCI centers...... despite longer transport time remains unknown. METHODS AND RESULTS: Using the Cardiac Arrest Registry to Enhance Survival with geocoding of arrest location, we identified out-of-hospital cardiac arrest patients with prehospital return of spontaneous circulation and evaluated the association between direct...... transport to a PCI center and outcomes in North Carolina during 2012 to 2014. Destination hospital was classified according to PCI center status (catheterization laboratory immediately accessible 24/7). Inverse probability-weighted logistic regression accounting for age, sex, emergency medical services...

  4. Effect of prehospital advanced airway management for pediatric out-of-hospital cardiac arrest.

    Science.gov (United States)

    Ohashi-Fukuda, Naoko; Fukuda, Tatsuma; Doi, Kent; Morimura, Naoto

    2017-05-01

    Respiratory care may be important in pediatric out-of-hospital cardiac arrest (OHCA) due to the asphyxial nature of the majority of events. However, evidence of the effect of prehospital advanced airway management (AAM) for pediatric OHCA is scarce. This was a nationwide population-based study of pediatric OHCA in Japan from 2011 to 2012 based on data from the All-Japan Utstein Registry. We included pediatric OHCA patients aged between 1 and 17 years old. The primary outcome was one-month neurologically favorable survival defined as a Glasgow-Pittsburgh cerebral performance category (CPC) score of 1-2 (corresponding to a Pediatric CPC score of 1-3). A total of 2157 patients were included in the final cohort; 365 received AAM and 1792 received bag-valve-mask (BVM) ventilation only. Among the 2157 patients, 213 (9.9%) survived with favorable neurological outcomes (CPC of 1-2) one month after OHCA. There were no significant differences in neurologically favorable survival between the AAM and BVM groups after adjusting for potential confounders, although there was a tendency favoring BVM ventilation: propensity score matching, OR 0.74 (95%CI 0.35-1.59), and multivariable logistic regression modeling, ORadjusted 0.55 (95%CI 0.24-1.14). Subgroup analyses demonstrated that there were no subgroups in which AAM was associated with neurologically favorable survival, including the non-cardiac (primarily asphyxial) etiology group. In pediatric OHCA, prehospital AAM was not associated with an increased chance of neurologically favorable survival compared with BVM-only ventilation. However, careful consideration is required to interpret the findings, as there may be unmeasured residual confounders and selection bias. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Airway management and out-of-hospital cardiac arrest outcome in the CARES registry.

    Science.gov (United States)

    McMullan, Jason; Gerecht, Ryan; Bonomo, Jordan; Robb, Rachel; McNally, Bryan; Donnelly, John; Wang, Henry E

    2014-05-01

    Optimal out of hospital cardiac arrest (OHCA) airway management strategies remain unclear. We compared OHCA outcomes between patients receiving endotracheal intubation (ETI) versus supraglottic airway (SGA), and between patients receiving [ETI or SGA] and those receiving no advanced airway. We studied adult OHCA in the Cardiac Arrest Registry to Enhance Survival (CARES). Primary exposures were ETI, SGA, or no advanced prehospital airway placed. Primary outcomes were sustained ROSC, survival to hospital admission, survival to hospital discharge, and neurologically-intact survival to hospital discharge (cerebral performance category 1-2). Propensity scores characterized the probability of receiving ETI, SGA, or no advanced airway. We adjusted for Utstein confounders. Multivariable random effects regression accounted for clustering by EMS agency. We compared outcomes between (1) ETI vs. SGA, and (2) [no advanced airway] vs. [ETI or SGA]. Of 10,691 OHCA, 5591 received ETI, 3110 SGA, and 1929 had no advanced airway. Unadjusted neurologically-intact survival was: ETI 5.4%, SGA 5.2%, no advanced airway 18.6%. Compared with SGA, ETI achieved higher sustained ROSC (OR 1.35; 95%CI 1.19-1.54), survival to hospital admission (1.36; 1.19-1.55), hospital survival (1.41; 1.14-1.76) and hospital discharge with good neurologic outcome (1.44; 1.10-1.88). Compared with [ETI or SGA], patients receiving no advanced airway attained higher survival to hospital admission (1.31; 1.16-1.49), hospital survival (2.96; 2.50-3.51) and hospital discharge with good neurologic outcome (4.24; 3.46-5.20). In CARES, survival was higher among OHCA receiving ETI than those receiving SGA, and for patients who received no advanced airway than those receiving ETI or SGA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. Paediatric out-of-hospital resuscitation in an area with scattered population (Galicia-Spain

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    Cegarra-García María

    2007-05-01

    Full Text Available Abstract Background Cardiorespiratory arrest (CRA is a rare event in childhood. Our objective was to determine the characteristics of paediatric CRA and the immediate results of cardiopulmonary resuscitation (CPR in Galicia, a community with a very scattered population. Methods All children (aged from newborn to 16 years old who suffered an out-of-hospital CRA in Galicia and were assisted by the Public Foundation Medical Emergencies of Galicia-061 staff, from June 2002 to February 2005, were included in the study. Data were prospectively recorded following the Utstein's style guidelines. Results Thirty-one cases were analyzed (3.4 CRA annual cases per 100.000 paediatric population. The arrest was respiratory in 16.1% and cardiac in 83.9% of cases. CRA occurred at home in 58.1% of instances. Time CRA to initiation of CPR was shorter than 10 minutes in 32.2% and longer than 20 minutes in 29.0% of cases. 22.6% of children received bystander CPR. The first recorded rhythm was asystole in 67.7% of cases. Bag-mask ventilation was used in 67.7% and in 83.8% oro-tracheal intubation was done. A peripheral venous access was achieved in 67.7% and intraosseous access was used in 16.1% of patients. 93.5% of children were treated with adrenaline. After initial CPR, sustained restoration of spontaneous circulation was achieved in 38.7% of cases. Six children (19.4% survived until hospital discharge. Four of 5 children with respiratory arrest survived, whereas only 2 of 26 children with cardiac arrest survived until hospital discharge. Conclusion Despite the handicap of a highly disseminated population, paediatric CRA characteristics and CPR results in Galicia are comparable to references from other communities. Programs to increase bystander CPR, equip laypeople with basic CPR skills and to update life support knowledge of health staff are needed to improve outcomes.

  7. Laryngeal tube use in out-of-hospital cardiac arrest by paramedics in Norway

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    Sunde Geir A

    2012-12-01

    Full Text Available Abstract Background Although there are numerous supraglottic airway alternatives to endotracheal intubation, it remains unclear which airway technique is optimal for use in prehospital cardiac arrests. We evaluated the use of the laryngeal tube (LT as an airway management tool among adult out-of-hospital cardiac arrest (OHCA patients treated by our ambulance services in the Haukeland and Innlandet hospital districts. Methods Post-resuscitation forms and data concerning airway management in 347 adult OHCA victims were retrospectively assessed with regard to LT insertion success rates, ease and speed of insertion and insertion-related problems. Results A total of 402 insertions were performed on 347 OHCA patients. Overall, LT insertion was successful in 85.3% of the patients, with a 74.4% first-attempt success rate. In the minority of patients (n = 46, 13.3%, the LT insertion time exceeded 30 seconds. Insertion-related problems were recorded in 52.7% of the patients. Lack of respiratory sounds on auscultation (n = 100, 28.8%, problematic initial tube positioning (n = 85, 24.5%, air leakage (n = 61, 17.6%, vomitus/aspiration (n = 44, 12.7%, and tube dislocation (n = 17, 4.9% were the most common problems reported. Insertion difficulty was graded and documented for 95.4% of the patients, with the majority of insertions assessed as being “Easy” (62.5% or “Intermediate” (24.8%. Only 8.1% of the insertions were considered to be “Difficult”. Conclusions We found a high number of insertion related problems, indicating that supraglottic airway devices offering promising results in manikin studies may be less reliable in real-life resuscitations. Still, we consider the laryngeal tube to be an important alternative for airway management in prehospital cardiac arrest victims.

  8. Population density, call-response interval, and survival of out-of-hospital cardiac arrest

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    Ogawa Toshio

    2011-04-01

    Full Text Available Abstract Background Little is known about the effects of geographic variation on outcomes of out-of-hospital cardiac arrest (OHCA. The present study investigated the relationship between population density, time between emergency call and ambulance arrival, and survival of OHCA, using the All-Japan Utstein-style registry database, coupled with geographic information system (GIS data. Methods We examined data from 101,287 bystander-witnessed OHCA patients who received emergency medical services (EMS through 4,729 ambulatory centers in Japan between 2005 and 2007. Latitudes and longitudes of each center were determined with address-match geocoding, and linked with the Population Census data using GIS. The endpoints were 1-month survival and neurologically favorable 1-month survival defined as Glasgow-Pittsburgh cerebral performance categories 1 or 2. Results Overall 1-month survival was 7.8%. Neurologically favorable 1-month survival was 3.6%. In very low-density (2 and very high-density (≥10,000/km2 areas, the mean call-response intervals were 9.3 and 6.2 minutes, 1-month survival rates were 5.4% and 9.1%, and neurologically favorable 1-month survival rates were 2.7% and 4.3%, respectively. After adjustment for age, sex, cause of arrest, first aid by bystander and the proportion of neighborhood elderly people ≥65 yrs, patients in very high-density areas had a significantly higher survival rate (odds ratio (OR, 1.64; 95% confidence interval (CI, 1.44 - 1.87; p Conclusion Living in a low-density area was associated with an independent risk of delay in ambulance response, and a low survival rate in cases of OHCA. Distribution of EMS centers according to population size may lead to inequality in health outcomes between urban and rural areas.

  9. Recognising out-of-hospital cardiac arrest during emergency calls increases bystander cardiopulmonary resuscitation and survival.

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    Viereck, Søren; Møller, Thea Palsgaard; Ersbøll, Annette Kjær; Bækgaard, Josefine Stokholm; Claesson, Andreas; Hollenberg, Jacob; Folke, Fredrik; Lippert, Freddy K

    2017-06-01

    Initiation of early bystander cardiopulmonary resuscitation (CPR) depends on bystanders' or medical dispatchers' recognition of out-of-hospital cardiac arrest (OHCA). The primary aim of our study was to investigate if OHCA recognition during the emergency call was associated with bystander CPR, return of spontaneous circulation (ROSC), and 30-day survival. Our secondary aim was to identify patient-, setting-, and dispatcher-related predictors of OHCA recognition. We performed an observational study of all OHCA patients' emergency calls in the Capital Region of Denmark from 01/01/2013-31/12/2013. OHCAs were collected from the Danish Cardiac Arrest Registry and the Mobile Critical Care Unit database. Emergency call recordings were identified and evaluated. Multivariable logistic regression analyses were applied to all OHCAs and witnessed OHCAs only to analyse the association between OHCA recognition and bystander CPR, ROSC, and 30-day survival. Univariable logistic regression analyses were applied to identify predictors of OHCA recognition. We included 779 emergency calls in the analyses. During the emergency calls, 70.1% (n=534) of OHCAs were recognised; OHCA recognition was positively associated with bystander CPR (odds ratio [OR]=7.84, 95% confidence interval [CI]: 5.10-12.05) in all OHCAs; and ROSC (OR=1.86, 95% CI: 1.13-3.06) and 30-day survival (OR=2.80, 95% CI: 1.58-4.96) in witnessed OHCA. Predictors of OHCA recognition were addressing breathing (OR=1.76, 95% CI: 1.17-2.66) and callers located by the patient's side (OR=2.16, 95% CI: 1.46-3.19). Recognition of OHCA during emergency calls was positively associated with the provision of bystander CPR, ROSC, and 30-day survival in witnessed OHCA. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  10. Prognostic implications of conversion from nonshockable to shockable rhythms in out-of-hospital cardiac arrest.

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    Goto, Yoshikazu; Maeda, Tetsuo; Nakatsu-Goto, Yumiko

    2014-09-22

    The prognostic significance of conversion from nonshockable to shockable rhythms in patients with initial nonshockable rhythms who experience out-of-hospital cardiac arrest (OHCA) remains unclear. We hypothesized that the neurological outcomes in those patients would improve with subsequent shock delivery following conversion to shockable rhythms and that the time from initiation of cardiopulmonary resuscitation by emergency medical services personnel to the first defibrillation (shock delivery time) would influence those outcomes. We analyzed the data of 569,937 OHCA adults with initial nonshockable rhythms. The data were collected in a nationwide Utstein-style Japanese database between 2005 and 2010. Patients were divided into subsequently shocked (n =21,944) and subsequently not-shocked (n =547,993) cohorts. The primary study endpoint was 1-month favorable neurological outcome (Cerebral Performance Categories scale, category 1 or 2). In the subsequently shocked cohort, the ratio of 1-month favorable neurological outcome was significantly higher than that in the subsequently not-shocked cohort (1.79% versus 0.60%, P delivery time was less than 20 minutes, subsequent shock delivery was significantly associated with increased odds of 1-month favorable neurological outcomes (adjusted odds ratios (95% confidence interval), 6.55 (5.21 to 8.22) and 2.97 (2.58 to 3.43) for shock delivery times less than 10 minutes and from 10 to 19 minutes, respectively). However, when the shock delivery time was more than or equal to 20 minutes, subsequent shock delivery was not associated with increased odds of 1-month favorable neurological outcomes. In patients with an initial nonshockable rhythm after OHCA, subsequent conversion to shockable rhythms during emergency medical services resuscitation efforts was associated with increased odds of 1-month favorable neurological outcomes when the shock delivery time was less than 20 minutes.

  11. Spatial Variation and Resuscitation Process Affecting Survival after Out-of-Hospital Cardiac Arrests (OHCA.

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    Chien-Chou Chen

    Full Text Available Ambulance response times and resuscitation efforts are critical predictors of the survival rate after out-of-hospital cardiac arrests (OHCA. On the other hand, rural-urban differences in the OHCA survival rates are an important public health issue.We retrospectively reviewed the January 2011-December 2013 OHCA registry data of Kaohsiung City, Taiwan. With particular focus on geospatial variables, we aimed to unveil risk factors predicting the overall OHCA survival until hospital admission. Spatial analysis, network analysis, and the Kriging method by using geographic information systems were applied to analyze spatial variations and calculate the transport distance. Logistic regression was used to identify the risk factors for OHCA survival.Among the 4,957 patients, the overall OHCA survival to hospital admission was 16.5%. In the multivariate analysis, female sex (adjusted odds ratio:, AOR, 1.24 [1.06-1.45], events in public areas (AOR: 1.30 [1.05-1.61], exposure to automated external defibrillator (AED shock (AOR: 1.70 [1.30-2.23], use of laryngeal mask airway (LMA (AOR: 1.35 [1.16-1.58], non-trauma patients (AOR: 1.41 [1.04-1.90], ambulance bypassed the closest hospital (AOR: 1.28 [1.07-1.53], and OHCA within the high population density areas (AOR: 1.89 [1.55-2.32] were positively associated with improved OHCA survival. By contrast, a prolonged total emergency medical services (EMS time interval was negatively associated with OHCA survival (AOR: 0.98 [0.96-0.99].Resuscitative efforts, such as AED or LMA use, and a short total EMS time interval improved OHCA outcomes in emergency departments. The spatial heterogeneity of emergency medical resources between rural and urban areas might affect survival rate.

  12. Cost-utility analysis of treating out of hospital cardiac arrests in Jerusalem.

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    Ginsberg, Gary M; Kark, Jeremy D; Einav, Sharon

    2015-01-01

    Out-of-hospital cardiac arrest (OHCA) initiates a chain of responses including emergency medical service mobilization and medical treatment, transfer and admission first to a hospital Emergency Department (ED) and then usually to an intensive care unit and ward. Costly pre- and in-hospital care may be followed by prolonged post discharge expenditure on treatment of patients with severe neurological sequelae. We assessed the cost-effectiveness of treatment of OHCA by calculating the cost per Disability Adjusted Life Year (DALY) averted. We studied 3355 consecutive non-traumatic OHCAs (2005-2010) in Jerusalem, Israel, supplemented by hospital utilization data extracted from patient files (n = 570) and post-discharge follow-up (n = 196). Demographic, utilization and economic data were incorporated into a spreadsheet model to calculate the cost-utility ratio. Advanced life support was administered to 2264 of the 3355 OHCAs (67.5%) and 1048 (45.6%) patients were transferred to the ED. Of 676 (20.1%) patients who survived the ED and were admitted, there were 206 (6.1%) survivors to discharge, among them only 113 (3.4%) neurologically intact. Total cost ($39,100,000) per DALY averted (1353) was $28,864. The current package of OHCA interventions in Jerusalem appears to be very cost-effective as the cost per averted DALY of $28,864 is less than the Gross Domestic Product per capita ($33,261). This paper provides a basis for studying the effects of potential interventions that can be evaluated in terms of their incremental costs per averted DALY for treatment of OHCA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Role of blood gas analysis during cardiopulmonary resuscitation in out-of-hospital cardiac arrest patients.

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    Kim, Youn-Jung; Lee, You Jin; Ryoo, Seung Mok; Sohn, Chang Hwan; Ahn, Shin; Seo, Dong-Woo; Lim, Kyoung Soo; Kim, Won Young

    2016-06-01

    To determine the relationship between acid-base findings, such as pH, pCO2, and serum lactate levels, obtained immediately after starting cardiopulmonary resuscitation and the return of spontaneous circulation (ROSC).A prospective observational study of adult, nontraumatic out-of-hospital cardiac arrest (OHCA) patients was conducted at an urban academic teaching institution between April 1, 2013 and March 31, 2015. Arterial blood sample for acid-base data was taken from all OHCA patients on arrival to the emergency department. Of 224 OHCA patients, 88 patients with unavailable blood samples or delayed blood sampling or ROSC within 4 minutes were excluded, leaving 136 patients for analysis.The pH in the ROSC group was significantly higher than in the non-ROSC group (6.96 vs. 6.85; P = 0.009). pCO2 and lactate levels in the ROSC group were significantly lower than those in the non-ROSC group (74.0 vs. 89.5 mmHg, P < 0.009; 11.6 vs. 13.6 mmol/L, P = 0.044, respectively). In a multivariate regression analysis, pCO2 was the only independent biochemical predictor for sustained ROSC (OR 0.979; 95% CI 0.960-0.997; P = 0.025) and pCO2 of <75 mmHg was 3.3 times more likely to achieve ROSC (OR 0.302; 95% CI 0.146-0.627; P = 0.001).pCO2 levels obtained during cardiopulmonary resuscitation on ER arrival was associated with ROSC in OHCA patients. It might be a potentially marker for reflecting the status of the ischemic insult. These preliminary results need to be confirmed in a larger population.

  14. Association between dental caries and out-of-hospital cardiac arrests of cardiac origin in Japan.

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    Suematsu, Yasunori; Miura, Shin-Ichiro; Zhang, Bo; Uehara, Yoshinari; Ogawa, Masahiro; Yonemoto, Naohiro; Nonogi, Hiroshi; Nagao, Ken; Kimura, Takeshi; Saku, Keijiro

    2016-04-01

    Oral infection contributes to atherosclerosis and coronary heart disease. We hypothesized that dental caries may be associated with out-of-hospital cardiac arrests (OHCA) of cardiac origin, but not non-cardiac origin. We compared the age-adjusted incidence of OHCA (785,591 cases of OHCA: 55.4% of cardiac origin and 44.6% of non-cardiac origin) to the age-adjusted prevalence of dental caries between 2005 and 2011 in the 47 prefectures of Japan. In both the total population and males over 65 years, the number of cases of dental caries was significantly associated with the number of OHCA of total and cardiac origin from 2005 to 2011, but not those of non-cardiac origin. In the total population, the age-adjusted prevalence of dental caries was not significantly associated with the age-adjusted incidence of OHCA (total OHCA: r correlation coefficient=0.22, p=0.14; OHCA of cardiac origin: r=0.25, p=0.09; OHCA of non-cardiac origin: r=-0.002, p=0.99). Among male patients over 65 years, the age-adjusted prevalence of dental caries was significantly associated with OHCA of total and cardiac origin, but not non-cardiac origin (total OHCA: r=0.47, p<0.001; OHCA of cardiac origin: r=0.37, p=0.01; OHCA of non-cardiac origin: r=0.28, p=0.054). While oral hygiene is important in all age groups, it may be particularly associated with OHCAs of cardiac origin in males over 65 years. Copyright © 2015. Published by Elsevier Ltd.

  15. Etiology of out-of-hospital cardiac arrest diagnosed via detailed examinations including perimortem computed tomography

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    Yoshihiro Moriwaki

    2013-01-01

    Full Text Available Context: The spectrum of the etiology of out-of-hospital cardiopulmonary arrest (OHCPA has not been established. We have performed perimortem computed tomography (CT during cardiopulmonary resuscitation. Aims: To clarify the incidence of non-cardiac etiology (NCE, actual distribution of the causes of OHCPA via perimortem CT and its usefulness. Settings and Design: Population-based observational case series study. Materials and Methods: We reviewed the medical records of 1846 consecutive OHCPA cases and divided them into two groups: 370 showing an obvious cause of OHCPA with NCE (trauma, neck hanging, terminal stage of malignancy, and gastrointestinal bleeding and others. Results: Of a total OHCPA, perimortem CT was performed in 57.5% and 62.5% were finally diagnosed as NCE: Acute aortic dissection (AAD 8.07%, pulmonary thrombo-embolization (PTE 1.46%, hypoxia due to pneumonia 5.25%, asthma and acute worsening of chronic obstructive pulmonary disease 2.06%, cerebrovascular disorder (CVD 4.48%, airway obstruction 7.64%, and submersion 5.63%. The rates of patients who survived to hospital discharge were 6-14% in patients with NCE. Out of the 1476 cases excluding obvious NCE of OHCPA, 66.3% underwent perimortem CT, 14.6% of cases without obvious NCE and 22.1% of cases with perimortem CT were confirmed as having some NCE. Conclusions: Of the total OHCPA the incidences of NCE was 62.5%; the leading etiologies were AAD, airway obstruction, submersion, hypoxia and CVD. The rates of cases converted from cardiac etiology to NCE using perimortem CT were 14.6% of cases without an obvious NCE.

  16. Significance of the carboxyhemoglobin level for out-of-hospital cardiopulmonary arrest

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    Youichi Yanagawa

    2012-01-01

    Full Text Available Background: At low concentrations, carbon monoxide (CO can confer cyto and tissue-protective effects, such as endogenous Heme oxygenase 1 expression, which has antioxidative, anti-inflammatory, antiproliferative, and antiapoptotic effects. The level of carboxyhemoglobin in the blood is an indicator of the endogenous production of CO and inhaled CO. Aim of study: To investigate the significance of the value of carboxyhemoglobin for out-of-hospital (OH cardiopulmonary arrest (CPA. Materials and Methods: This study involved a medical chart review of cases treated from January to December 2005. The inclusion criteria included a patient who was transported to this department due to an OH CPA. The exclusion criteria included a patient who did not undergo blood gas analysis on arrival and who experienced CPA due to acute carbon monoxide intoxication. The subjects were divided into two groups based on their final outcome of either survival or non-survival. Results: There was no significant difference associated with the sex, age, frequency of witness collapse, bystander cardiopulmonary arrest, electrocardiogram at scene, cause of CPA, value of PCO 2 , HCO3 - , and methemoglobin. The frequency of OH return of spontaneous circulation and the value of pH, PO 2 , base excess, and carboxyhemoglobin in the survival group were greater than those values in the non-survival group. There were no subjects whose carboxyhemoglobin level was 0% on arrival in the survival groups. Conclusion: There appeared to be an association between higher carboxyhemoglobin levels and survival in comparison with non-survival patients.

  17. Access to out-of-hospital emergency care in Africa: Consensus conference recommendations

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    Christopher Stein

    2016-09-01

    Full Text Available Out-of-hospital emergency care (OHEC should be accessible to all who require it. However, available data suggests that there are a number of barriers to such access in Africa, mainly centred around challenges in public knowledge, perception and appropriate utilisation of OHEC. Having reached consensus in 2013 on a two-tier system of African OHEC, the African Federation for Emergency Medicine (AFEM OHEC Group sought to gain further consensus on the narrower subject of access to OHEC in Africa. The objective of this paper is to report the outputs and statements arising from the AFEM OHEC access consensus meeting held in Cape Town, South Africa in April 2015. The discussion was structured around six dimensions of access to care (i.e. awareness, availability, accessibility, accommodation, affordability and acceptability and tackled both Tier-1 (community first responder and Tier-2 (formal prehospital services and Emergency Medical Services OHEC systems. In Tier-1 systems, the role of community involvement and support was emphasised, along with the importance of a first responder system acceptable to the community in which it is embedded in order to optimise access. In Tier-2 systems, the consensus group highlighted the primacy of a single toll-free emergency number, matching of Emergency Medical Services resource demand and availability through appropriate planning and the cost-free nature of Tier-2 emergency care, amongst other factors that impact accessibility. Much work is still needed in prioritising the steps and clarifying the tools and metrics that would enable the ideal of optimal access to OHEC in Africa.

  18. An infant with out-of-hospital cardiac arrest secondary to enteroviral myocarditis surviving up to cardiac transplantation.

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    McGovern, Eimear; Ryan, Ethel; McMahon, Colin J

    2016-01-01

    We report the case of a 13-day-old infant with enteroviral myocarditis surviving an out-of-hospital cardiac arrest. She underwent orthotopic cardiac transplantation three months later. A year after the transplantation, she is alive and well. Enteroviral infection is common in neonates with high mortality in cases of enteroviral myocarditis. Cardiac transplantation is a treatment option for infants who fail to recover and remain dependent on inotropic support. This is the first report of an infant with out-of-hospital cardiac arrest secondary to enteroviral myocarditis surviving up to cardiac transplantation.

  19. Bystander Defibrillation for Out-of-Hospital Cardiac Arrest in Public vs Residential Locations.

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    Hansen, Steen Møller; Hansen, Carolina Malta; Folke, Fredrik; Rajan, Shahzleen; Kragholm, Kristian; Ejlskov, Linda; Gislason, Gunnar; Køber, Lars; Gerds, Thomas A; Hjortshøj, Søren; Lippert, Freddy; Torp-Pedersen, Christian; Wissenberg, Mads

    2017-05-01

    Bystander-delivered defibrillation (hereinafter referred to as bystander defibrillation) of patients with out-of-hospital cardiac arrests (OHCAs) remains limited despite the widespread dissemination of automated external defibrillators (AEDs). To examine calendar changes in bystander defibrillation and subsequent survival according to a public or a residential location of the cardiac arrest after nationwide initiatives in Denmark to facilitate bystander-mediated resuscitative efforts, including bystander defibrillation. This nationwide study identified 18 688 patients in Denmark with first-time OHCA from June 1, 2001, to December 31, 2012, using the Danish Cardiac Arrest Registry. Patients had a presumed cardiac cause of arrest that was not witnessed by emergency medical services personnel. Data were analyzed from April 1, 2015, to December 10, 2016. Nationwide initiatives to facilitate bystander resuscitative efforts, including bystander defibrillation, consisted of resuscitation training of Danish citizens, dissemination of on-site AEDs, foundation of an AED registry linked to emergency medical dispatch centers, and dispatcher-assisted guidance of bystander resuscitation efforts. The proportion of patients who received bystander defibrillation according to the location of the cardiac arrest and their subsequent 30-day survival. Of the 18 688 patients with OHCAs (67.8% men and 32.2% women; median [interquartile range] age, 72 [62-80] years), 4783 (25.6%) had a cardiac arrest in a public location and 13 905 (74.4%) in a residential location. The number of registered AEDs increased from 141 in 2007 to 7800 in 2012. The distribution of AED location was consistently skewed in favor of public locations. Bystander defibrillation increased in public locations from 3 of 245 (1.2%; 95% CI, 0.4%-3.5%) in 2001 to 78 of 510 (15.3%; 95% CI, 12.4%-18.7%) in 2012 (P bystander defibrillation increased in public locations from 8.3% (95% CI, 1.5%-35.4%) in 2001/2002 to 57

  20. Establishing the Aus-ROC Australian and New Zealand out-of-hospital cardiac arrest Epistry.

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    Beck, Ben; Bray, Janet; Smith, Karen; Walker, Tony; Grantham, Hugh; Hein, Cindy; Thorrowgood, Melanie; Smith, Anthony; Smith, Tony; Dicker, Bridget; Swain, Andy; Bailey, Mark; Bosley, Emma; Pemberton, Katherine; Cameron, Peter; Nichol, Graham; Finn, Judith

    2016-04-05

    Out-of-hospital cardiac arrest (OHCA) is a global health problem with low survival. Regional variation in survival has heightened interest in combining cardiac arrest registries to understand and improve OHCA outcomes. While individual OHCA registries exist in Australian and New Zealand ambulance services, until recently these registries have not been combined. The aim of this protocol paper is to describe the rationale and methods of the Australian Resuscitation Outcomes Consortium (Aus-ROC) OHCA epidemiological registry (Epistry). The Aus-ROC Epistry is designed as a population-based cohort study. Data collection started in 2014. Six ambulance services in Australia (Ambulance Victoria, SA Ambulance Service, St John Ambulance Western Australia and Queensland Ambulance Service) and New Zealand (St John New Zealand and Wellington Free Ambulance) currently contribute data. All OHCA attended by ambulance, regardless of aetiology or patient age, are included in the Epistry. The catchment population is approximately 19.3 million persons, representing 63% of the Australian population and 100% of the New Zealand population. Data are collected using Utstein-style definitions. Information incorporated into the Epistry includes demographics, arrest features, ambulance response times, treatment and patient outcomes. The primary outcome is 'survival to hospital discharge', with 'return of spontaneous circulation' as a key secondary outcome. Ethics approval was independently sought by each of the contributing registries. Overarching ethics for the Epistry was provided by Monash University HREC (Approval No. CF12/3938-2012001888). A population-based OHCA registry capturing the majority of Australia and New Zealand will allow risk-adjusted outcomes to be determined, to enable benchmarking across ambulance providers, facilitate the identification of system-wide strategies associated with survival from OHCA, and allow monitoring of temporal trends in process and outcomes to improve

  1. Out-of-hospital cardiac arrest: the teaching of experience at the SAMU of Lyon.

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    Gueugniaud, P Y; Vaudelin, T; Gaussorgues, P; Petit, P

    1989-01-01

    Because of the improvement resuscitation techniques have shown since the 1960s and because of the development of the out-of-hospital medical care, a cardiac arrest is no longer synonymous with death in every case. However the cardiac arrest resuscitation is only relevant if its adverse consequences can be limited. That is mainly the neurological after-effects and the cellular anoxia. Therefore, the "Service d'Aide Medicale Urgente" (SAMU) of Lyon has been concentrating its research aiming at: (a) Shortening the duration of cardiopulmonary resuscitation to limit the cerebral anoxia. (b) Analysing and treating some of the causes responsible for the aggravation of anoxia. On the basis of several studies in Lyon, here are some suggestions: (1) The use of high doses of epinephrine that unables a better percentage of primary recoveries (47.5% vs. 39%) (P less than 0.05) and secondary recoveries (21.3% vs. 14.8%) (P less than 0.01) without modifying the qualitative survival at long term. (On the basis of: 5 mg intravenous bolus repeated every 3 min in case of asystole instead of 1 mg every 5 min as it is usually recommended). (2) The choice of a peripheral intravenous line instead of a central intravenous line each time it is possible for the administration of drugs since it is as efficient as the second one. (40.7% vs. 33.4%) (P:NS). (3) The alkalinisation of the prolonged cardiac arrest in order to keep the acid-base balance. Most of the survivors show a pH equal or superior to the normal standard. (On the basis of 1 mmol/kg of sodium bicarbonate if the cardiac arrest lasts for more than 10 min). (4) The abolition of the dextrose solution as maintaining infusion the patients who are in a "coma depasse" (brain death) after the resuscitation have an average glycemia superior to the survivors without after-effects. (19.7 vs. 14.8 mmol/l) (P less than 0.05). (5) The monitoring at once at the hospital of the intra-cranial pressure. It reveals the frequency of high pression

  2. Exploring the safety and efficacy of targeted temperature management amongst infants with out-of-hospital cardiac arrest due to apparent life threatening events.

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    Meert, Kathleen; Telford, Russell; Holubkov, Richard; Slomine, Beth S; Christensen, James R; Dean, J Michael; Moler, Frank W

    2016-12-01

    To explore the safety and efficacy of targeted temperature management amongst infants with out-of-hospital cardiac arrest due to an apparent life threatening event (ALTE) recruited to the Therapeutic Hypothermia after Paediatric Cardiac Arrest Out-of-Hospital trial. Fifty-four infants (48h to VABS-II) score ≥70, 12-month survival, change in VABS-II score from pre-arrest to 12 months post-arrest, and select safety measures. Amongst infants with pre-arrest VABS-II ≥70 (n=52), there was no difference in 12-month survival with VABS-II ≥70 between therapeutic hypothermia and therapeutic normothermia groups (2/25 (8.0%) vs. 1/27 (3.7%); relative risk 2.16; 95% confidence interval 0.21-22.38, p=0.60). Amongst all evaluable infants (n=53), the change in VABS-II score from pre-arrest to 12 months post-arrest did not differ (p=0.078) between therapeutic hypothermia and therapeutic normothermia groups, nor did 12-month survival (5/26 (19.2%) vs. 1/27 (3.7%); relative risk 5.19; 95% confidence interval 0.65-41.50, p=0.10). Mortality was high amongst infants that were comatose after out-of-hospital cardiac arrest due to ALTE in both therapeutic hypothermia and therapeutic normothermia treated groups. Functional status was markedly reduced among survivors. (ClinicalTrials.gov, NCT00878644). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. Exploring informed consent in HIV clinical trials: A case study in Uganda

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    2016-11-01

    Conclusion: This study’s findings indicated that obtaining a volunteer’s signature or thumbprint on a consent form did not necessarily mean that the participant was fully-informed about the information relevant to their taking part nor that they understood all the information shared with them. Informed consent requires sufficient time in the research process to have staff trained well enough before research begins. Ensuring and gaining informed consent should be understood and treated as a relation-centred, dynamic supportive process throughout the duration of a research study.

  4. Hyperoxia Early After Hospital Admission in Comatose Patients with Non-Traumatic Out-of-Hospital Cardiac Arrest

    Science.gov (United States)

    Christ, Martin; von Auenmueller, Katharina Isabel; Brand, Michael; Amirie, Scharbanu; Sasko, Benjamin Michel; Trappe, Hans-Joachim

    2016-01-01

    Background The clinical effect of hyperoxia in patients with non-traumatic out-of-hospital cardiac arrest (OHCA) remains uncertain. We therefore initiated this study to find out whether there is an association between survival and hyperoxia early after return of spontaneous circulation (ROSC) in OHCA patients admitted to our hospital. Material/Methods All OHCA patients admitted to our hospital between 1 January 2008 and 30 June 2015 were identified by analysis of our central admission register. Data from individual patients were collected from patient health records and anonymously stored on a central database. Results Altogether, there were 280 OHCA patients admitted to our hospital between 1 January 2008 and 30 June 2015, including 35 patients (12.5%) with hyperoxia and 99 patients (35.4%) with normoxia. Comparison of these 2 groups showed lower pH values in OHCA patients admitted with normoxia compared to those with hyperoxia (7.10±0.18 vs. 7.21±0.17; p=0.001) but similar rates of initial lactate (7.92±3.87 mmol/l vs. 11.14±16.40 mmol/l; p=0.072). Survival rates differed between both groups (34.4% vs. 54.3%; p=0.038) with better survival rates in OHCA patients with hyperoxia at hospital admission. Conclusions Currently, different criteria are used to define hyperoxia following OHCA, but if the negative effects of hyperoxia in OHCA patients are a cumulative effect over time, hyperoxia < 60 min after hospital admission as investigated in this study would be equivalent to a short period of hyperoxia. It may be that the positive effect of buffering metabolic acidosis early after cardiac arrest maintains the negative effects of hyperoxia in general. PMID:27638399

  5. Determinants of unfavorable prognosis for out-of-hospital sudden cardiac arrest in Bielsko-Biala district

    Science.gov (United States)

    Nowak, Jolanta U.; Krzych, Łukasz J.

    2016-01-01

    Introduction The prognosis in out-of-hospital sudden cardiac arrest (OHCA) remains unfavorable and depends on a number of demographic and clinical variables, the reversibility of its causes and its mechanisms. Aim To investigate the risk factors of prehospital death in patients with OHCA in Bielsko County. Material and methods The study analyzed all dispatch cards of the National Emergency Medical Services (EMS) teams in Bielsko-Biala for the year 2013 (n = 23 400). Only the cards related to sudden cardiac arrest in adults were ultimately included in the study (n = 272; 190 men, 82 women; median age: 71 years). Results Sixty-seven victims (45 men, 22 women) were pronounced dead upon the arrival of the EMS team, and cardiopulmonary resuscitation (CPR) was not undertaken. In the remaining group of 205 subjects, CPR was commenced but was ineffective in 141 patients (97 male, 44 female). Although univariate analysis indicated 6 predictors of prehospital death, including OHCA without the presence of witnesses (odds ratio (OR) = 4.2), OHCA occurring in a public place (OR = 3.1), no bystander CPR (OR = 9.7), no bystander cardiac massage (OR = 13.1), initial diagnosis of non-shockable cardiac rhythm (OR = 7.0), and the amount of drugs used for CPR (OR = 0.4), logistic regression confirmed that only the lack of bystander cardiac massage (OR = 6.5) and non-shockable rhythm (OR = 4.6) were independent determinants of prehospital death (area under ROC curve = 0.801). Conclusions Non-shockable rhythm of cardiac arrest and lack of bystander cardiac massage are independent determinants of prehospital death in Bielsko-Biala inhabitants suffering from OHCA.

  6. Nonaccidental Out-of-Hospital Cardiac Arrest in an Urban Area as a Potential Source of Uncontrolled Organ Donors.

    Science.gov (United States)

    Pabisiak, Krzysztof; Krejczy, Arkadiusz; Dutkiewicz, Grażyna; Safranow, Krzysztof; Sienko, Jerzy; Bohatyrewicz, Romuald; Ciechanowski, Kazimierz

    2016-09-15

    BACKGROUND Donation after cardiac death offers the possibility of increasing the pool of organs for transplantation by up to 30%. Maastricht category type 3 (M3) dominates in most countries with active DCD programs. During preparations to introduce a permanent program for uncontrolled donation after circulatory death in Szczecin, Poland, the donor pool has been estimated. In Poland, Maastricht category type 2 (M2) is considered a basic source for organ recovery. MATERIAL AND METHODS This was a retrospective cohort study of out-of-hospital cardiac arrests (OHCA) reported to local Emergency Medical Services (EMS) between 1 December 2014 and 30 November 2015. The following inclusion criteria were used in the analysis: demographic (age 18-60 years, known identity), clinical (no chest or abdominal injury, no cachexia as an equivalent of wasting diseases), and organizational (weekdays from 8:00 am to 3:00 pm). RESULTS During 12-month period, 118 EMS interventions were recorded in response to sudden cardiac arrest. The stratification process mentioned above used criteria to establish potential, eligible, qualified, and actual donor pools (27 (30.3%), 24 (26.4%), 7 (7.3%), and 6 (6.7%), respectively). To establish a "virtual" actual number of uDCD, the nationwide average level of lack of authorization for donation was 12%. CONCLUSIONS Activation of a permanent program of organ recovery from uDCD would increase the donor pool by 6 cases. Compared to the number of brain-dead donors referred from regional hospitals, this increase would be equivalent to the formation of a new reporting center. The number of transplantable organs could increase by 22% per year.

  7. Characteristics of out-of-hospital paediatric emergencies attended by ambulance- and helicopter-based emergency physicians

    NARCIS (Netherlands)

    Eich, Christoph; Russo, Sebastian G.; Heuer, Jan F.; Timmermann, Arnd; Gentkow, Uta; Quintel, Michael; Roessler, Markus

    Background: In Germany, as in many other countries, for the vast majority of cases, critical out-of-hospital (OOH) paediatric emergencies are attended by non-specialised emergency physicians (EPs). As it is assumed that this may lead to deficient service we aimed to gather robust data on the

  8. Systematic downloading and analysis of data from automated external defibrillators used in out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Hansen, Marco Bo; Lippert, Freddy Knudsen; Rasmussen, Lars Simon

    2014-01-01

    BACKGROUND: Valuable information can be retrieved from automated external defibrillators (AEDs) used in victims of out-of-hospital cardiac arrest (OHCA). We describe our experience with systematic downloading of data from deployed AEDs. The primary aim was to compare the proportion of shockable...... to be witnessed (92% vs. 34%, p

  9. Characteristics of out-of-hospital paediatric emergencies attended by ambulance- and helicopter-based emergency physicians

    NARCIS (Netherlands)

    Eich, Christoph; Russo, Sebastian G.; Heuer, Jan F.; Timmermann, Arnd; Gentkow, Uta; Quintel, Michael; Roessler, Markus

    2009-01-01

    Background: In Germany, as in many other countries, for the vast majority of cases, critical out-of-hospital (OOH) paediatric emergencies are attended by non-specialised emergency physicians (EPs). As it is assumed that this may lead to deficient service we aimed to gather robust data on the charact

  10. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies

    NARCIS (Netherlands)

    J. Berdowski; R.A. Berg; J.G.P. Tijssen; R.W. Koster

    2010-01-01

    Aim: The aim of this investigation was to estimate and contrast the global incidence and outcome of out-of-hospital cardiac arrest (OHCA) to provide a better understanding of the variability in risk and survival of OHCA. Methods: We conducted a review of published English-language articles about inc

  11. Recognition of out-of-hospital cardiac arrest during emergency calls - a systematic review of observational studies

    DEFF Research Database (Denmark)

    Viereck, Søren; Møller, Thea Palsgaard; Rothman, Josephine Philip

    2017-01-01

    BACKGROUND: The medical dispatcher plays an essential role as part of the first link in the Chain of Survival, by recognising the out-of-hospital cardiac arrest (OHCA) during the emergency call, dispatching the appropriate first responder or emergency medical services response, performing...

  12. A clinical study of competency to consent to hospitalization and treatment in geriatric inpatients.

    Science.gov (United States)

    Billick, Stephen B; Perez, Dolores R; Garakani, Amir

    2009-07-01

    This study used a Competency Questionnaire modified for medical surgical patients (CQ-Med). Twenty-nine patients (ages 65-94 years) admitted to a geriatric medicine unit were studied. Along with the CQ-Med, patients were administered several WAIS-R subtests, the Blessed Dementia Scale (BDS), and Mini Mental State Exam (MMSE). Additionally, a blind forensic evaluation for competency to consent to hospitalization and treatment was performed for the purpose of validation of the CQ-Med. Results of the study found that, as expected, increased age was correlated with decreasing performance on the CQ-Med and decreased findings of competence by clinical exam. However, there was great variability within each age group, demonstrating individual differences in the progress of declining competency. CQ-Med scores also correlated well with the WAIS-R subtest raw and scaled scores. Scores on the MMSE and BDS were less well correlated. The CQ-Med may be a useful adjunct in assessing declining competency in geriatric patients.

  13. Impact of emergency percutaneous coronary intervention on outcomes of ST-segment elevation myocardial infarction patients complicated by out-of-hospital cardiac arrest.

    Science.gov (United States)

    Liu, Hong-wei; Pan, Wei; Wang, Lan-feng; Sun, Yan-ming; Li, Zhu-qin; Wang, Zhong-hua

    2012-04-01

    Cardiac arrest is one of the most serious complications of acute myocardial infarction (AMI), especially in the out-of-hospital patients. There is no general consensus as to whether percutaneous coronary intervention (PCI) is effective in treating ST-segment elevation myocardial infarction (STEMI) patients complicated by out-of-hospital cardiac arrest (OHCA). In our study, we evaluated the efficacy of PCI in treating STEMI patients complicated by OHCA through observing their clinical conditions in hospital; including total mortality, adverse cardiac events, stroke, acute renal failure, and gastrointestinal bleeding events. A total of 1827 STEMI patients were enrolled in this study, where 81 were STEMI with OHCA. Between the patients with and without OHCA, and the OHCA patients with and without PCI, we compared the clinical characteristics during hospitalization, including total mortality and incidences of adverse cardiac events, and stroke. Compared to the patients without OHCA, the OHCA patients had significantly lower systolic blood pressure (P Emergency PCI reduces the incidence of adverse events and decreases mortality during hospitalization, which is effective for treating STEMI with OHCA patients.

  14. Informed consent in clinical trials using stem cells: Sugges tions and ...

    African Journals Online (AJOL)

    2015-08-01

    Aug 1, 2015 ... Informed consent is an essential requirement of ethical research involving human .... is face with the prospect of closing her business. Therefore, she .... misconceptions), and participants' rights and duties, the patients and.

  15. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?

    Science.gov (United States)

    Chassany, Olivier; Bernard-Harlaut, Micheline; Guy, Gilles; Billon, Nathalie

    2009-01-01

    Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.

  16. Association between Prehospital CPR Quality and End-Tidal Carbon Dioxide Levels in Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Murphy, Ryan A; Bobrow, Bentley J; Spaite, Daniel W; Hu, Chengcheng; McDannold, Robyn; Vadeboncoeur, Tyler F

    2016-01-01

    International Guidelines recommend measurement of end-tidal carbon dioxide (EtCO2) to enhance cardiopulmonary resuscitation (CPR) quality and optimize blood flow during CPR. Numerous factors impact EtCO2 (e.g., ventilation, metabolism, cardiac output), yet few clinical studies have correlated CPR quality and EtCO2 during actual out-of-hospital cardiac arrest (OHCA) resuscitations. The purpose of this study was to describe the association between EtCO2 and CPR quality variables during OHCA. This is an observational study of prospectively collected CPR quality and capnography data from two EMS agencies participating in a statewide resuscitation quality improvement program. CPR quality and capnography data from adult (≥18 years) cardiac resuscitation attempts (10/2008-06/2013) were collected and analyzed on a minute-by-minute basis using RescueNet™ Code Review. Linear mixed effect models were used to evaluate the association between (log-transformed) EtCO2 level and CPR variables: chest compression (CC) depth, CC rate, CC release velocity (CCRV), ventilation rate. Among the 1217 adult OHCA cases of presumed cardiac etiology, 925 (76.0%) had a monitor-defibrillator file with CPR quality data, of which 296 (32.0%) cases had >1 minute of capnography data during CPR. After capnography quality review, 66 of these cases (22.3%) were excluded due to uninterpretable capnography, resulting in a final study sample of 230 subjects (mean age 68 years; 69.1% male), with a total of 1581 minutes of data. After adjustment for other CPR variables, a 10 mm increase in CC depth was associated with a 4.0% increase in EtCO2 (p < 0.0001), a 10 compression/minute increase in CC rate with a 1.7% increase in EtCO2 (p = 0.02), a 10 mm/second increase in CCRV with a 2.8% increase in EtCO2 (p = 0.03), and a 10 breath/minute increase in ventilation rate with a 17.4% decrease in EtCO2 (p < 0.0001). When controlling for known CPR quality variables, increases in CC depth, CC rate and CCRV

  17. Conventional Versus Compression-Only Versus No-Bystander Cardiopulmonary Resuscitation for Pediatric Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Fukuda, Tatsuma; Ohashi-Fukuda, Naoko; Kobayashi, Hiroaki; Gunshin, Masataka; Sera, Toshiki; Kondo, Yutaka; Yahagi, Naoki

    2016-12-20

    Conventional cardiopulmonary resuscitation (CPR) (chest compression and rescue breathing) has been recommended for pediatric out-of-hospital cardiac arrest (OHCA) because of the asphyxial nature of the majority of pediatric cardiac arrest events. However, the clinical effectiveness of additional rescue breathing (conventional CPR) compared with compression-only CPR in children is uncertain. This nationwide population-based study of pediatric OHCA patients was based on data from the All-Japan Utstein Registry. We included all pediatric patients who experienced OHCA in Japan from January 1, 2011, to December 31, 2012. The primary outcome was a favorable neurological state 1 month after OHCA defined as a Glasgow-Pittsburgh Cerebral Performance Category score of 1 to 2 (corresponding to a Pediatric Cerebral Performance Category score of 1-3). Outcomes were compared with logistic regression with uni- and multivariable modeling in the overall cohort and for a propensity-matched subset of patients. A total of 2157 patients were included; 417 received conventional CPR, 733 received compression-only CPR, and 1007 did not receive any bystander CPR. Among these patients, 213 (9.9%) survived with a favorable neurological status 1 month after OHCA, including 108/417 (25.9%) for conventional, 68/733 (9.3%) for compression-only, and 37/1007 (3.7%) for no-bystander CPR. In unadjusted analyses, conventional CPR was superior to compression-only CPR in neurologically favorable survival (odds ratio [OR] 3.42, 95% confidence interval [CI] 2.45-4.76; PCPR that was no longer statistically significant after multivariable adjustment (ORadjusted 1.52, 95% CI 0.93-2.49), and with further attenuation of the difference in a propensity-matched subset (OR 1.20, 95% CI 0.81-1.77). Both conventional and compression-only CPR were associated with higher odds for neurologically favorable survival compared with no-bystander CPR (ORadjusted 5.01, 95% CI 2.98-8.57, and ORadjusted 3.29, 95% CI 1

  18. Wilderness Medical Society practice guidelines for the out-of-hospital evaluation and treatment of accidental hypothermia: 2014 update.

    Science.gov (United States)

    Zafren, Ken; Giesbrecht, Gordon G; Danzl, Daniel F; Brugger, Hermann; Sagalyn, Emily B; Walpoth, Beat; Weiss, Eric A; Auerbach, Paul S; McIntosh, Scott E; Némethy, Mária; McDevitt, Marion; Dow, Jennifer; Schoene, Robert B; Rodway, George W; Hackett, Peter H; Bennett, Brad L; Grissom, Colin K

    2014-12-01

    To provide guidance to clinicians, the Wilderness Medical Society (WMS) convened an expert panel to develop evidence-based guidelines for the out-of-hospital evaluation and treatment of victims of accidental hypothermia. The guidelines present the main diagnostic and therapeutic modalities and provide recommendations for the management of hypothermic patients. The panel graded the recommendations based on the quality of supporting evidence and the balance between benefits and risks/burdens according the criteria published by the American College of Chest Physicians. The guidelines also provide suggested general approaches to the evaluation and treatment of accidental hypothermia that incorporate specific recommendations. This is an updated version of the original Wilderness Medical Society Practice Guidelines for the Out-of-Hospital Evaluation and Treatment of Accidental Hypothermia published in Wilderness & Environmental Medicine 2014;25(4):425-445. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  19. Resuscitation and post resuscitation care of the very old after out-of-hospital cardiac arrest is worthwhile

    DEFF Research Database (Denmark)

    Winther-Jensen, Matilde; Kjaergaard, Jesper; Hassager, Christian;

    2015-01-01

    BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is associated with a poor prognosis. As comorbidity and frailty increase with age; ethical dilemmas may arise when OHCA occur in the very old. OBJECTIVES: We aimed to investigate mortality, neurological outcome and post resuscitation care in octog......BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is associated with a poor prognosis. As comorbidity and frailty increase with age; ethical dilemmas may arise when OHCA occur in the very old. OBJECTIVES: We aimed to investigate mortality, neurological outcome and post resuscitation care...... to 86% (n=317, p=0.03) in the younger patients. CONCLUSION: OHCA in octogenarians was associated with a significantly higher mortality rate after adjustment for prognostic factors. However, the majority of octogenarian survivors were discharged with a favorable neurological outcome. Withholding...

  20. Association of bystander cardiopulmonary resuscitation and survival according to ambulance response-times after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Wissenberg, Mads; Folke, Fredrik

    2016-01-01

    BACKGROUND: Bystander-initiated cardiopulmonary resuscitation (CPR) increases patient survival after out-of-hospital cardiac arrest, but it is unknown to what degree bystander CPR remains positively associated with survival with increasing time to potential defibrillation. The main objective...... was to examine the association of bystander CPR with survival as time to advanced treatment increases. METHODS: We studied 7623 out-of-hospital cardiac arrest patients between 2005 and 2011, identified through the nationwide Danish Cardiac Arrest Registry. Multiple logistic regression analysis was used...... to examine the association between time from 911 call to emergency medical service arrival (response time) and survival according to whether bystander CPR was provided (yes or no). Reported are 30-day survival chances with 95% bootstrap confidence intervals. RESULTS: With increasing response times, adjusted...

  1. Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Kirkegaard, Hans; Søreide, Eldar; de Haas, Inge

    2017-01-01

    Importance: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. Objective: To determine whether TTM at 33°C for 48....... Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. Results: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour......: In unconscious survivors from out-of-hospital cardiac arrest admitted to the ICU, targeted temperature management at 33°C for 48 hours did not significantly improve 6-month neurologic outcome compared with targeted temperature management at 33°C for 24 hours. However, the study may have had limited power...

  2. Factors Associated With Successful Resuscitation After Out-of-Hospital Cardiac Arrest and Temporal Trends in Survival and Comorbidity

    DEFF Research Database (Denmark)

    Søholm, Helle; Hassager, Christian; Lippert, Freddy;

    2015-01-01

    (multivariate odds ratio [OR]=3.9; 95% confidence interval [CI] 3.1 to 5.0), witnessed arrest (multivariate OR=3.5; 95% CI 2.7 to 4.6), and out-of-hospital cardiac arrest in a public area (multivariate OR=2.1; 95% CI 1.6 to 2.8), whereas no comorbidity (multivariate OR=1.1; 95% CI 0.8 to 1.45), sex...

  3. Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial

    OpenAIRE

    Perkins, Gavin D; Lall, Ranjit; Quinn, Tom; Deakin, Charles D; Cooke, Matthew W; Horton, Jessica; Lamb, Sarah E; Slowther, Anne-Marie; Woollard, Malcolm; Carson, Andy; Smyth, Mike; Whitfield, Richard; Williams, Amanda; Pocock, Helen; Black, John J. M.

    2015-01-01

    BACKGROUND: Mechanical chest compression devices have the potential to help maintain high-quality cardiopulmonary resuscitation (CPR), but despite their increasing use, little evidence exists for their effectiveness. We aimed to study whether the introduction of LUCAS-2 mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest. METHODS: The pre-hospital randomised assessment of a mechanical compression device in cardiac...

  4. Mortality and neurological outcome in the elderly after target temperature management for out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Winther-Jensen, Matilde; Pellis, Tommaso; Kuiper, Michael;

    2015-01-01

    AIM: To assess older age as a prognostic factor in patients resuscitated from out-of-hospital-cardiac arrest (OHCA) and the interaction between age and level of target temperature management. METHODS AND RESULTS: 950 patients included in the target temperature management (TTM) trial were randomly...... age groups, p = 0.001, the same was true for ST segment elevation on ECG at admission, p ....5-5.0, p target temperature...

  5. The Value of Arterial Blood Gas Parameters for Prediction of Mortality in Survivors of Out-of-hospital Cardiac Arrest.

    Science.gov (United States)

    von Auenmueller, Katharina Isabel; Christ, Martin; Sasko, Benjamin Michel; Trappe, Hans-Joachim

    2017-01-01

    Sudden cardiac death is one of the leading causes of death in Europe, and early prognostication remains challenging. There is a lack of valid parameters for the prediction of survival after cardiac arrest. This study aims to investigate if arterial blood gas parameters correlate with mortality of patients after out-of-hospital cardiac arrest. All patients who were admitted to our hospital after resuscitation following out-of-hospital cardiac arrest between January 1, 2008, and December 31, 2013, were included in this retrospective study. The patient's survival 5 days after resuscitation defined the study end-point. For the statistical analysis, the mean, standard deviation, Student's t-test, Chi-square test, and logistic regression analyses were used (level of significance P Arterial blood gas samples were taken from 170 patients. In particular, pH arterial blood gas parameters correlate with mortality of patients after out-of-hospital resuscitation. The most relevant parameters are pH and lactate because they are strongly and independently associated with mortality within the first 5 days after resuscitation. Despite this correlation, none of these parameters by oneself is strong enough to allow an early prognostication. Still, these parameters can contribute as part of a multimodal approach to assessing the patients' prognosis.

  6. The role of intraosseous vascular access in the out-of-hospital environment (resource document to NAEMSP position statement).

    Science.gov (United States)

    Fowler, Raymond; Gallagher, John V; Isaacs, S Marshal; Ossman, Eric; Pepe, Paul; Wayne, Marvin

    2007-01-01

    Thousands of critically ill emergency patients are treated in the out-of-hospital setting in the United States every year. In many patients intravenous (IV) therapy cannot be initiated because of inadequate access to peripheral veins. In some cases, this lack of vascular access may limit benefit of medications because of late administration.[1] Both speed and overall success of vascular access are important when evaluating potential methodologies for their use in the out-of-hospital environment. Insertion of an IV cannula has been reported to require substantial time in the prehospital environment, with a recent study reporting an average successful intravenous line placement time of 4.4+/-2.8 minutes.[2] In critically ill pediatric patients, vascular access may present substantial difficulties to the provide.[3] Intraosseous access may provide a significant time saving which may benefit many critically ill patients, both by decreasing the time to achieve access and by decreasing the time to administration of indicated medications.[4] Achieving rapid administration of medications may facilitate the care of critically ill patients.[1] Devices are now available that permit rapid, accurate access to the intraosseous space. Recent changes in the American Heart Association's resuscitation guidelines state that the intraosseous route should be the first alternative to difficult or delayed intravenous access.[5] With these considerations, the role of intraosseous vascular access in the out-of-hospital environment should be reemphasized.

  7. A randomised controlled trial of consent procedures for the use of residual tissues for medical research : Preferences of and implications for patients, research and clinical practice

    NARCIS (Netherlands)

    Rebers, S.; Vermeulen, E.; Brandenburg, A.P.; Stoof, T.J.; Zupan-Kajcovski, B.; Bos, W.J.W.; Jonker, M.J.; Bax, C.J.; van Driel, W.J.; Verwaal, V.J.; van den Brekel, M.W.; Grutters, J.C.; Tupker, R.A.; Plusjé, L.; de Bree, R.; Schagen van Leeuwen, J.H.; Vermeulen, E.G.J.; de Leeuw, R.A.; Brohet, R.M.; Aaronson, N.K.; van Leeuwen, F.E.; Schmidt, M.K.

    2016-01-01

    Background Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. Methods We conducted a

  8. A randomised controlled trial of consent procedures for the use of residual tissues for medical research : Preferences of and implications for patients, research and clinical practice

    NARCIS (Netherlands)

    Rebers, S.; Vermeulen, E.; Brandenburg, A. P.; Stoof, T. J.; Zupan-Kajcovski, B.; Bos, W. J W; Jonker, M. J.; Bax, C. J.; Van Driel, W. J.; Verwaal, V. J.; Van Den Brekel, M. W.; Grutters, J. C.; Tupker, R. A.; Plusjé, L.; De Bree, R.; Van Leeuwen, J. H Schagen; Vermeulen, E. G J; De Leeuw, R. A.; Brohet, R. M.; Aaronson, N. K.; Van Leeuwen, F. E.; Schmidt, M. K.

    2016-01-01

    Background: Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. Methods: We conducted a

  9. Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial

    DEFF Research Database (Denmark)

    Bro-Jeppesen, John; Kjaergaard, Jesper; Wanscher, Michael;

    2015-01-01

    OBJECTIVES: Whole-body ischemia during out-of-hospital cardiac arrest triggers immediate activation of inflammatory systems leading to a sepsis-like syndrome. The aim was to investigate the association between level of systemic inflammation and mortality in survivors after out-of-hospital cardiac...

  10. Licking as an out-of-hospital burns treatment-An isolated cultural phenomenon?

    LENUS (Irish Health Repository)

    Seoighe, Deirdre M

    2012-02-01

    Wound management in burns is a potentially complex issue. Salivary constituents have been shown experimentally to be of benefit in the treatment of thermal injuries. In our clinical experience we have encountered patients who have saliva directly applied to the burn wound prior to presenting to the national burns service. The practice is known as "Licking". We report two cases to illustrate the presentations we have encountered. We believe that these illustrate an isolated phenomenon unique to the Republic of Ireland.

  11. The value of arterial blood gas parameters for prediction of mortality in survivors of out-of-hospital cardiac arrest

    Directory of Open Access Journals (Sweden)

    Katharina Isabel von Auenmueller

    2017-01-01

    Full Text Available Context: Sudden cardiac death is one of the leading causes of death in Europe, and early prognostication remains challenging. There is a lack of valid parameters for the prediction of survival after cardiac arrest. Aims: This study aims to investigate if arterial blood gas parameters correlate with mortality of patients after out-of-hospital cardiac arrest. Materials and Methods: All patients who were admitted to our hospital after resuscitation following out-of-hospital cardiac arrest between January 1, 2008, and December 31, 2013, were included in this retrospective study. The patient's survival 5 days after resuscitation defined the study end-point. For the statistical analysis, the mean, standard deviation, Student's t-test, Chi-square test, and logistic regression analyses were used (level of significance P< 0.05. Results: Arterial blood gas samples were taken from 170 patients. In particular, pH < 7.0 (odds ratio [OR]: 7.20; 95% confidence interval [CI]: 3.11–16.69; P< 0.001 and lactate ≥ 5.0 mmol/L (OR: 6.79; 95% CI: 2.77–16.66; P< 0.001 showed strong and independent correlations with mortality within the first 5 days after hospital admission. Conclusion: Our study results indicate that several arterial blood gas parameters correlate with mortality of patients after out-of-hospital resuscitation. The most relevant parameters are pH and lactate because they are strongly and independently associated with mortality within the first 5 days after resuscitation. Despite this correlation, none of these parameters by oneself is strong enough to allow an early prognostication. Still, these parameters can contribute as part of a multimodal approach to assessing the patients' prognosis.

  12. Time-based partitioning model for predicting neurologically favorable outcome among adults with witnessed bystander out-of-hospital CPA.

    Directory of Open Access Journals (Sweden)

    Toshikazu Abe

    Full Text Available BACKGROUND: Optimal acceptable time intervals from collapse to bystander cardiopulmonary resuscitation (CPR for neurologically favorable outcome among adults with witnessed out-of-hospital cardiopulmonary arrest (CPA have been unclear. Our aim was to assess the optimal acceptable thresholds of the time intervals of CPR for neurologically favorable outcome and survival using a recursive partitioning model. METHODS AND FINDINGS: From January 1, 2005 through December 31, 2009, we conducted a prospective population-based observational study across Japan involving consecutive out-of-hospital CPA patients (N = 69,648 who received a witnessed bystander CPR. Of 69,648 patients, 34,605 were assigned to the derivation data set and 35,043 to the validation data set. Time factors associated with better outcomes: the better outcomes were survival and neurologically favorable outcome at one month, defined as category one (good cerebral performance or two (moderate cerebral disability of the cerebral performance categories. Based on the recursive partitioning model from the derivation dataset (n = 34,605 to predict the neurologically favorable outcome at one month, 5 min threshold was the acceptable time interval from collapse to CPR initiation; 11 min from collapse to ambulance arrival; 18 min from collapse to return of spontaneous circulation (ROSC; and 19 min from collapse to hospital arrival. Among the validation dataset (n = 35,043, 209/2,292 (9.1% in all patients with the acceptable time intervals and 1,388/2,706 (52.1% in the subgroup with the acceptable time intervals and pre-hospital ROSC showed neurologically favorable outcome. CONCLUSIONS: Initiation of CPR should be within 5 min for obtaining neurologically favorable outcome among adults with witnessed out-of-hospital CPA. Patients with the acceptable time intervals of bystander CPR and pre-hospital ROSC within 18 min could have 50% chance of neurologically favorable outcome.

  13. Association of serum lactate with outcome after out-of-hospital cardiac arrest treated with therapeutic hypothermia

    Science.gov (United States)

    Novain, Michaël; Cattet, Florian; Plattier, Rémi; Nefzaoui, Mohamed; Hyvernat, Hervé; Raguin, Olivier; Kaidomar, Michel; Kerever, Sébastien; Ichai, Carole

    2017-01-01

    Aims Lactate reflects hypoxic insult in many conditions and is considered as a prognosis factor. But, after cardiac arrest, its interest is still debated. Our study aimed to assess the prognosis value of lactate in out-of-hospital cardiac arrest patients treated with therapeutic hypothermia. Methods This retrospective observational study included out-of-hospital cardiac arrest patients treated with therapeutic hypothermia in four ICUs. Lactate levels were compared at different times during the first 24 hours according to outcome at ICU discharge and to the type of death (multiorgan or neurologic failure). Results Two hundred and seventy-two patients were included, 89 good outcome and 183 poor outcome. In the latter group, 171 patients died, from multiorgan failure in 30% and neurologic failure in 70%. Lactate levels were higher in the poor compared to the good outcome patients at admission (5.4 (3.3–9.4) vs. 2.2 (1.5–3.6) mmol/L; padmission (7.9 (3.9–12.0) vs. 5.2 (3.3–8.8) mmol/L; p<0.01), H12 (4.9 (2.1–8.9) vs. 2.2 (1.4–3.4) mmol/L; p<0.01) and H24 (3.3 (1.8–5.5) vs. 1.4 (1.1–2.5) mmol/L; p<0.01). Initial lactate levels showed an increasing proportion of poor outcome from the first to fourth quartile. Conclusions After out-of-hospital cardiac arrest treated with therapeutic hypothermia, lactate levels during the first 24 hours seem linked with ICU outcome. Patients dying from multiorgan failure exhibit higher initial lactate concentrations than patients succumbing from neurological failure. PMID:28282398

  14. Proportion of out-of-hospital adult non-traumatic cardiac or respiratory arrest among calls for seizure.

    Science.gov (United States)

    Dami, Fabrice; Rossetti, Andrea O; Fuchs, Vincent; Yersin, Bertrand; Hugli, Olivier

    2012-09-01

    To measure the proportion of adult non-traumatic cardiac or respiratory arrest among calls for seizure to an emergency medical dispatch centre and to record whether known epileptic patients present cardiac or respiratory arrest together with seizure. This 2-year prospective observational investigation involved the collection of tape recordings of all incoming calls to the emergency medical dispatch centre, in which an out-of-hospital non-traumatic seizure was the chief complaint in patients >18 years, in addition to the paramedics' records of all patients who presented with respiratory or cardiac arrest. The authors also recorded whether the bystander spontaneously mentioned to the dispatcher that the victim was known to have epilepsy. During the 24-month period, the call centre received 561 incoming calls for an out-of-hospital non-traumatic seizure in an adult. Twelve cases were classified as cardiac or respiratory arrest by paramedics. In one case, the caller spontaneously mentioned that the victim had a history of epilepsy. The proportion of cardiac or respiratory arrest among calls for seizure was 2.1%. Although these cases are rare, dispatchers should closely monitor seizure patients with the help of bystanders to exclude an out-of-hospital cardiac or respiratory arrest, in which case the dispatcher can offer telephone cardiopulmonary resuscitation advice until the paramedics arrive. Whenever the activity of the centre allows it and no new incoming call is on hold, this can be achieved by staying on the line with the caller or by calling back. A history of epilepsy should not modify the type of monitoring performed by the dispatcher as those patients may also have an arrest together with seizure.

  15. Non-steroidal anti-inflammatory drug use is associated with increased risk of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Sondergaard, Kathrine B; Weeke, Peter; Wissenberg, Mads

    2017-01-01

    AIMS: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used and have been associated with increased cardiovascular risk. Nonetheless, it remains unknown whether use of NSAIDs is associated with out-of-hospital cardiac arrest (OHCA). METHODS AND RESULTS: From the nationwide Danish Cardiac...... Arrest Registry, all persons with OHCA during 2001-2010 were identified. NSAID use 30 days before OHCA was categorized as follows: diclofenac, naproxen, ibuprofen, rofecoxib, celecoxib, and other. Risk of OHCA associated with use of NSAIDs was analyzed by conditional logistic regression in case...

  16. Prognostic implication of out-of-hospital cardiac arrest in patients with cardiogenic shock and acute myocardial infarction

    DEFF Research Database (Denmark)

    Ostenfeld, Sarah; Lindholm, Matias Greve; Kjaergaard, Jesper

    2015-01-01

    OBJECTIVES: To compare outcome in patients with acute myocardial infarction (MI) and cardiogenic shock (CS) presenting with and without out-of-hospital cardiac arrest (OHCA). BACKGROUND: Despite general improvement in outcome after acute MI, CS remains a leading cause of death in acute MI patients...... to a tertiary centre with the diagnosis of CS and acute MI were enrolled, 118 (48%) presented with OHCA and 130 (52%) without (non-OHCA patients). Mean lactate level at admission was significantly higher in OHCA patients compared with non-OCHA patients (9mmol/l (SD 6) vs. 6mmol/l (SD 4) p

  17. Recognition of out-of-hospital cardiac arrest by medical dispatchers in emergency medical dispatch centres in two countries

    DEFF Research Database (Denmark)

    Møller, Thea Palsgaard; Andréll, Cecilia; Viereck, Søren

    2016-01-01

    INTRODUCTION: Survival after out-of-hospital cardiac arrest (OHCA) remains low. Early recognition by emergency medical dispatchers is essential for an effective chain of actions, leading to early cardiopulmonary resuscitation, use of an automated external defibrillator and rapid dispatching...... of the emergency medical services. AIM: To analyse and compare the accuracy of OHCA recognition by medical dispatchers in two countries. METHOD: An observational register-based study collecting data from national cardiac arrest registers in Denmark and Sweden during a six-month period in 2013. Data were analysed...

  18. Targeted Temperature Management at 33°C Versus 36°C and Impact on Systemic Vascular Resistance and Myocardial Function After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Bro-Jeppesen, John; Hassager, Christian; Wanscher, Michael

    2014-01-01

    BACKGROUND: Cardiovascular dysfunction is common after out-of-hospital cardiac arrest as part of the postcardiac arrest syndrome, and hypothermia may pose additional impact on hemodynamics. The aim was to investigate systemic vascular resistance index (SVRI), cardiac index, and myocardial perform...... because of lower heart rate with unaffected left ventricular systolic function compared with 36°C. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01020916....

  19. Advanced airway management in an anaesthesiologist-staffed Helicopter Emergency Medical Service (HEMS): A retrospective analysis of 1047 out-of-hospital intubations.

    Science.gov (United States)

    Piegeler, Tobias; Neth, Philippe; Schlaepfer, Martin; Sulser, Simon; Albrecht, Roland; Seifert, Burkhardt; Spahn, Donat R; Ruetzler, Kurt

    2016-08-01

    Airway management in the out-of-hospital emergency setting is challenging. Failed and even prolonged airway management is associated with serious clinical consequences, such as desaturation, bradycardia, airway injuries, or aspiration. The overall success rate of tracheal intubation ranges between 77% and 99%, depending on the level of experience of the provider. Therefore, advanced airway management should only be performed by highly-skilled and experienced providers. 9765 patients were treated in the out-of-hospital emergency setting by the anaesthesiologist-staffed Helicopter Emergency Medical Services (HEMS) between 2002 and 2014. Patients successfully intubated upon the first attempt were compared to patients who required more than one intubation attempts regarding several potential confounding factors such as age, gender, on-going CPR, NACA Score, initial GCS, prior administration of anaesthetic drugs, neuromuscular blocking agents, and vasopressors. 1573 out of 9765 patients (16.1%) required advanced airway management. 459 patients had already been intubated upon arrival of the HEMS, whereas 1114 patients (11.4%) underwent advanced airway management by the HEMS physician. 67 patients had to be excluded. Data for the remaining 1047 patients (790 males and 257 females) were analyzed further. Primary use of an alternative airway device was reported in 59 patients (5.6%), whereas 988 patients (94.4%) underwent laryngoscopy-guided tracheal intubation. 952 patients (96.4%) could be intubated upon the first attempt and overall intubation success was 99.5% (983 out of 988). Our study demonstrates that HEMS physicians performed airway management frequently and that both the first attempt as well as the overall success rate of tracheal intubation was high. Together with the fact that all failed and difficult intubations were successfully recognized and handled and that no surgical airway had to be established, the current study once more underlines the importance of

  20. Out-of-Hospital Surgical Airway Management: Does Scope of Practice Equal Actual Practice?

    Directory of Open Access Journals (Sweden)

    Molly Furin

    2016-05-01

    Full Text Available Introduction: Pennsylvania, among other states, includes surgical airway management, or cricothyrotomy, within the paramedic scope of practice. However, there is scant literature that evaluates paramedic perception of clinical competency in cricothyrotomy. The goal of this project is to assess clinical exposure, education and self-perceived competency of ground paramedics in cricothyrotomy. Methods: Eighty-six paramedics employed by four ground emergency medical services agencies completed a 22-question written survey that assessed surgical airway attempts, training, skills verification, and perceptions about procedural competency. Descriptive statistics were used to evaluate responses. Results: Only 20% (17/86, 95% CI [11-28%] of paramedics had attempted cricothyrotomy, most (13/17 or 76%, 95% CI [53-90%] of whom had greater than 10 years experience. Most subjects (63/86 or 73%, 95% CI [64-82%] did not reply that they are well-trained to perform cricothyrotomy and less than half (34/86 or 40%, 95% CI [30-50%] felt they could correctly perform cricothyrotomy on their first attempt. Among subjects with five or more years of experience, 39/70 (56%, 95% CI [44-68%] reported 0-1 hours per year of practical cricothyrotomy training within the last five years. Half of the subjects who were able to recall (40/80, 50% 95% CI [39-61%] reported having proficiency verification for cricothyrotomy within the past five years. Conclusion: Paramedics surveyed indicated that cricothyrotomy is rarely performed, even among those with years of experience. Many paramedics felt that their training in this area is inadequate and did not feel confident to perform the procedure. Further study to determine whether to modify paramedic scope of practice and/or to develop improved educational and testing methods is warranted.

  1. [Informed consent].

    Science.gov (United States)

    Medina Castellano, Carmen Delia

    2009-10-01

    At present times, numerous complaints claiming defects produced at some point in the process of obtaining informed consent are filed in courts of justice; in these complaints there is an underlying comment element which is the roles that health professionals have in these processes. In obtaining this consent, one can see this more as a means to obtain judicial protection for professional practices rather than this process being a respectful exercise for the dignity and freedom which health service patients have. This article reflects on two basic rights related to informed consent: adequately obtaining this consent and the need to protect those people who lack, either partially or totally, the capacity to make this decision by themselves. Afterwards, the author makes some considerations about the necessity to obtain informed consent for nursing practices and treatment.

  2. Development of a Web GIS Application for Visualizing and Analyzing Community Out of Hospital Cardiac Arrest Patterns

    Science.gov (United States)

    Semple, Hugh; Qin, Han; Sasson, Comilla

    2013-01-01

    Improving survival rates at the neighborhood level is increasingly seen as a priority for reducing overall rates of out-of-hospital cardiac arrest (OHCA) in the United States. Since wide disparities exist in OHCA rates at the neighborhood level, it is important for public health officials and residents to be able to quickly locate neighborhoods where people are at elevated risk for cardiac arrest and to target these areas for educational outreach and other mitigation strategies. This paper describes an OHCA web mapping application that was developed to provide users with interactive maps and data for them to quickly visualize and analyze the geographic pattern of cardiac arrest rates, bystander CPR rates, and survival rates at the neighborhood level in different U.S. cities. The data comes from the CARES Registry and is provided over a period spanning several years so users can visualize trends in neighborhood out-of-hospital cardiac arrest patterns. Users can also visualize areas that are statistical hot and cold spots for cardiac arrest and compare OHCA and bystander CPR rates in the hot and cold spots. Although not designed as a public participation GIS (PPGIS), this application seeks to provide a forum around which data and maps about local patterns of OHCA can be shared, analyzed and discussed with a view of empowering local communities to take action to address the high rates of OHCA in their vicinity. PMID:23923097

  3. Prediction of successful defibrillation in human victims of out-of-hospital cardiac arrest: a retrospective electrocardiographic analysis.

    Science.gov (United States)

    Ristagno, G; Gullo, A; Berlot, G; Lucangelo, U; Geheb, E; Bisera, J

    2008-01-01

    In the present study we sought to examine the efficacy of an electrocardiographic parameter, 'amplitude spectrum area' (AMSA), to predict the likelihood that any one electrical shock would restore a perfusing rhythm during cardiopulmonary resuscitation in human victims of out-of-hospital cardiac arrest. AMSA analysis is not invalidated by artefacts produced by chest compression and thus it can be performed during CPR, avoiding detrimental interruptions of chest compression and ventilation. We hypothesised that a threshold value of AMSA could be identified as an indicator of successful defibrillation in human victims of cardiac arrest. Analysis was performed on a database of electrocardiographic records, representing lead 2 equivalent recordings from automated external defibrillators including 210 defibrillation attempts from 90 victims of out-of-hospital cardiac arrest. A 4.1 second interval of ventricular fibrillation or ventricular tachycardia, recorded immediately preceding the delivery of the shock, was analysed using the AMSA algorithm. AMSA represents a numerical value based on the sum of the magnitude of the weighted frequency spectrum between two and 48 Hz. AMSA values were significantly greater in successful defibrillation (restoration of a perfusing rhythm), compared to unsuccessful defibrillation (P electrical shocks, reducing thereby post-resuscitation myocardial injury.

  4. Development of a Web GIS Application for Visualizing and Analyzing Community Out of Hospital Cardiac Arrest Patterns.

    Science.gov (United States)

    Semple, Hugh; Qin, Han; Sasson, Comilla

    2013-01-01

    Improving survival rates at the neighborhood level is increasingly seen as a priority for reducing overall rates of out-of-hospital cardiac arrest (OHCA) in the United States. Since wide disparities exist in OHCA rates at the neighborhood level, it is important for public health officials and residents to be able to quickly locate neighborhoods where people are at elevated risk for cardiac arrest and to target these areas for educational outreach and other mitigation strategies. This paper describes an OHCA web mapping application that was developed to provide users with interactive maps and data for them to quickly visualize and analyze the geographic pattern of cardiac arrest rates, bystander CPR rates, and survival rates at the neighborhood level in different U.S. cities. The data comes from the CARES Registry and is provided over a period spanning several years so users can visualize trends in neighborhood out-of-hospital cardiac arrest patterns. Users can also visualize areas that are statistical hot and cold spots for cardiac arrest and compare OHCA and bystander CPR rates in the hot and cold spots. Although not designed as a public participation GIS (PPGIS), this application seeks to provide a forum around which data and maps about local patterns of OHCA can be shared, analyzed and discussed with a view of empowering local communities to take action to address the high rates of OHCA in their vicinity.

  5. [Nursing care of pulmonary embolism in out-of-hospital emergencies].

    Science.gov (United States)

    Carrión-Martínez, Aurora; Rivera-Caravaca, José Miguel

    2016-01-01

    Pulmonary embolism is one of the most severe venous thromboembolic diseases, both in mortality and the high number of associated complications and their impact on quality of life. The early hours are critical and proper management during this period can determine future sequels. Therefore, in the outpatient setting, nurses must have adequate knowledge and tools to act quickly and efficiently. In this paper, we present a case of a 77 year-old male in his home that after being discharged from a knee replacement surgery starts with symptoms compatible with pulmonary thromboembolism. A Nursing Care Process is performed, according to the functional patterns of Margory Gordon and a care plan is developed based on NNN taxonomy (NANDA, NOC, NIC). As main nursing diagnosis 'ineffective breathing pattern' is selected and as possible potential complication of the pulmonary embolism the 'pulmonary infarction' is chosen. The results obtained after conducting the care plan are satisfactory, improving the signs and symptoms presented by the patient, hence why we believe it is useful for nurses when facing similar clinical situations.

  6. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    Science.gov (United States)

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  7. Readability of informed consent documents (1987-2007) for clinical trials: a linguistic analysis.

    Science.gov (United States)

    Sand, K; Eik-Nes, N L; Loge, J H

    2012-10-01

    We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987-1992 and ten from 2006-2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: main themes, order of themes, rhetorical functions, the relationship between reader and writer, metadiscourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.

  8. Consent, Refusal, and Waivers in Patient-Centered Dysphagia Care: Using Law, Ethics, and Evidence to Guide Clinical Practice.

    Science.gov (United States)

    Horner, Jennifer; Modayil, Maria; Chapman, Laura Roche; Dinh, An

    2016-11-01

    When patients refuse medical or rehabilitation procedures, waivers of liability have been used to bar future lawsuits. The purpose of this tutorial is to review the myriad issues surrounding consent, refusal, and waivers. The larger goal is to invigorate clinical practice by providing clinicians with knowledge of ethics and law. This tutorial is for educational purposes only and does not constitute legal advice. The authors use a hypothetical case of a "noncompliant" individual under the care of an interdisciplinary neurorehabilitation team to illuminate the ethical and legal features of the patient-practitioner relationship; the elements of clinical decision-making capacity; the duty of disclosure and the right of informed consent or informed refusal; and the relationship among noncompliance, defensive practices, and iatrogenic harm. We explore the legal question of whether waivers of liability in the medical context are enforceable or unenforceable as a matter of public policy. Speech-language pathologists, among other health care providers, have fiduciary and other ethical and legal obligations to patients. Because waivers try to shift liability for substandard care from health care providers to patients, courts usually find waivers of liability in the medical context unenforceable as a matter of public policy.

  9. Association of Bystander Cardiopulmonary Resuscitation and Survival According to Ambulance Response Times After Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Rajan, Shahzleen; Wissenberg, Mads; Folke, Fredrik; Hansen, Steen Møller; Gerds, Thomas A; Kragholm, Kristian; Hansen, Carolina Malta; Karlsson, Lena; Lippert, Freddy K; Køber, Lars; Gislason, Gunnar H; Torp-Pedersen, Christian

    2016-12-20

    Bystander-initiated cardiopulmonary resuscitation (CPR) increases patient survival after out-of-hospital cardiac arrest, but it is unknown to what degree bystander CPR remains positively associated with survival with increasing time to potential defibrillation. The main objective was to examine the association of bystander CPR with survival as time to advanced treatment increases. We studied 7623 out-of-hospital cardiac arrest patients between 2005 and 2011, identified through the nationwide Danish Cardiac Arrest Registry. Multiple logistic regression analysis was used to examine the association between time from 911 call to emergency medical service arrival (response time) and survival according to whether bystander CPR was provided (yes or no). Reported are 30-day survival chances with 95% bootstrap confidence intervals. With increasing response times, adjusted 30-day survival chances decreased for both patients with bystander CPR and those without. However, the contrast between the survival chances of patients with versus without bystander CPR increased over time: within 5 minutes, 30-day survival was 14.5% (95% confidence interval [CI]: 12.8-16.4) versus 6.3% (95% CI: 5.1-7.6), corresponding to 2.3 times higher chances of survival associated with bystander CPR; within 10 minutes, 30-day survival chances were 6.7% (95% CI: 5.4-8.1) versus 2.2% (95% CI: 1.5-3.1), corresponding to 3.0 times higher chances of 30-day survival associated with bystander CPR. The contrast in 30-day survival became statistically insignificant when response time was >13 minutes (bystander CPR vs no bystander CPR: 3.7% [95% CI: 2.2-5.4] vs 1.5% [95% CI: 0.6-2.7]), but 30-day survival was still 2.5 times higher associated with bystander CPR. Based on the model and Danish out-of-hospital cardiac arrest statistics, an additional 233 patients could potentially be saved annually if response time was reduced from 10 to 5 minutes and 119 patients if response time was reduced from 7 (the median

  10. Consent for use of clinical leftover biosample: a survey among Chinese patients and the general public.

    Science.gov (United States)

    Ma, Yi; Dai, HuiLi; Wang, LiMin; Zhu, LiJun; Zou, HanBing; Kong, XianMing

    2012-01-01

    Storage of leftover biosamples generates rich biobanks for future studies, saving time and money and limiting physical impact to sample donors. To investigate the attitudes of Chinese patients and the general public on providing consent for storage and use of leftover biosamples. Cross-sectional surveys were conducted among randomly selected patients admitted to a Shanghai city hospital (n = 648) and members of the general public (n = 492) from May 2010 to July 2010. Face-to-face interviews collected respondents-report of their willingness to donate residual biosample, trust in medical institutions, motivation for donation, concerns of donated sample use, expectations for research results return, and so on. The response rate was 83.0%. Of the respondents, 89.1% stated that they completely understood or understood most of questions. Willingness to donate residual sample was stated by 64.7%, of which 16.7% desired the option to withdraw their donations anytime afterwards. Only 42.3% of respondents stated they "trust" or "strongly trust" medical institutions, the attitude of trusting or strongly trusting medical institutions were significantly associated with willingness to donate in the general public group.(p<0.05) The overall assent rate for future research without specific consents was also low (12.1%). Hepatitis B virus carriers were significantly less willing than non-carriers to donate biosamples (32.1% vs. 64.7%, p<0.001). Low levels of public trust in medical institutions become serious obstacle for biosample donation and biobanking in China. Efforts to increase public understanding of human medical research and biosample usage and trust in the ethical purposes of biobanking are urgently needed. These efforts will be greatly advanced by the impending legislation on biobanking procedures and intent, and our results may help guide the structure of such law.

  11. Consent for use of clinical leftover biosample: a survey among Chinese patients and the general public.

    Directory of Open Access Journals (Sweden)

    Yi Ma

    Full Text Available BACKGROUND: Storage of leftover biosamples generates rich biobanks for future studies, saving time and money and limiting physical impact to sample donors. OBJECTIVE: To investigate the attitudes of Chinese patients and the general public on providing consent for storage and use of leftover biosamples. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional surveys were conducted among randomly selected patients admitted to a Shanghai city hospital (n = 648 and members of the general public (n = 492 from May 2010 to July 2010. MAIN OUTCOME MEASURES: Face-to-face interviews collected respondents-report of their willingness to donate residual biosample, trust in medical institutions, motivation for donation, concerns of donated sample use, expectations for research results return, and so on. RESULTS: The response rate was 83.0%. Of the respondents, 89.1% stated that they completely understood or understood most of questions. Willingness to donate residual sample was stated by 64.7%, of which 16.7% desired the option to withdraw their donations anytime afterwards. Only 42.3% of respondents stated they "trust" or "strongly trust" medical institutions, the attitude of trusting or strongly trusting medical institutions were significantly associated with willingness to donate in the general public group.(p<0.05 The overall assent rate for future research without specific consents was also low (12.1%. Hepatitis B virus carriers were significantly less willing than non-carriers to donate biosamples (32.1% vs. 64.7%, p<0.001. CONCLUSIONS: Low levels of public trust in medical institutions become serious obstacle for biosample donation and biobanking in China. Efforts to increase public understanding of human medical research and biosample usage and trust in the ethical purposes of biobanking are urgently needed. These efforts will be greatly advanced by the impending legislation on biobanking procedures and intent, and our results may help guide the structure

  12. Tertiary centres have improved survival compared to other hospitals in the Copenhagen area after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Søholm, Helle; Wachtell, Kristian; Nielsen, Søren Loumann;

    2013-01-01

    AIMS: Out-of-hospital cardiac arrest (OHCA) has been reported to carry very varying morbidity and mortality. However, it remains unclear whether this is caused by intrinsic factors of the OHCA or due to the level of in-hospital care. The aim of this study is to compare 30-day and long......-term mortality after OHCA at tertiary heart centres and non-tertiary university hospitals. METHODS AND RESULTS: Data from the Copenhagen OHCA registry from June 2002 through December 2010 included a total of 1218 consecutive patients treated by the same mobile emergency care unit (MECU) with either return...... angiography. Therefore, patients with ST-elevation myocardial infarction (n=198) were excluded from the analysis. 30-day mortality was 56% vs. 76% and long term (up to 8years) mortality was 78% vs. 94% for tertiary and non-tertiary hospitals, respectively, both p...

  13. Wilderness Medical Society practice guidelines for the out-of-hospital evaluation and treatment of accidental hypothermia.

    Science.gov (United States)

    Zafren, Ken; Giesbrecht, Gordon G; Danzl, Daniel F; Brugger, Hermann; Sagalyn, Emily B; Walpoth, Beat; Weiss, Eric A; Auerbach, Paul S; McIntosh, Scott E; Némethy, Mária; McDevitt, Marion; Dow, Jennifer; Schoene, Robert B; Rodway, George W; Hackett, Peter H; Bennett, Brad L; Grissom, Colin K

    2014-12-01

    To provide guidance to clinicians, the Wilderness Medical Society (WMS) convened an expert panel to develop evidence-based guidelines for the out-of-hospital evaluation and treatment of victims of accidental hypothermia. The guidelines present the main diagnostic and therapeutic modalities and provide recommendations for the management of hypothermic patients. The panel graded the recommendations based on the quality of supporting evidence and the balance between benefits and risks/burdens according the criteria published by the American College of Chest Physicians. The guidelines also provide suggested general approaches to the evaluation and treatment of accidental hypothermia that incorporate specific recommendations. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  14. Prevalence and Prognostic Implications of Bundle Branch Block in Comatose Survivors of Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Grand, Johannes; Thomsen, Jakob Hartvig; Kjærgaard, Jesper

    2016-01-01

    This study reports the prevalence and prognostic impact of right bundle branch block (RBBB) and left bundle branch block (LBBB) in the admission electrocardiogram (ECG) of comatose survivors of out-of-hospital cardiac arrest (OHCA). The present study is part of the predefined electrocardiographic...... substudy of the prospective randomized target temperature management trial, which found no benefit of targeting 33°C over 36°C in terms of outcome. Six-hundred eighty-two patients were included in the substudy. An admission ECG, which defined the present study population, was available in 602 patients (88...... was directly associated with higher mortality and independently associated with higher odds of unfavorable neurologic outcome. RBBB is seemingly an early indicator of an unfavorable prognosis after OHCA....

  15. Advanced life support therapy and on out-of-hospital cardiac arrest patients: Applying signal processing and pattern recognition methods

    Directory of Open Access Journals (Sweden)

    Trygve Eftestøl

    2005-10-01

    Full Text Available In the US alone, several hundred thousands die of sudden cardiac arrests each year. Basic life support defined as chest compressions and ventilations and early defibrillation are the only factors proven to increase the survival of patients with out-of-hospital cardiac arrest, and are key elements in the chain of survival defined by the American Heart Association. The current cardiopulmonary resuscitation guidelines treat all patients the same, but studies show need for more individualiza- tion of treatment. This review will focus on ideas on how to strengthen the weak parts of the chain of survival including the ability to measure the effects of therapy, improve time efficiency, and optimize the sequence and quality of the various components of cardiopulmonary resuscitation.

  16. [Reminiscence on the municipal out-of-hospital maternity unit and the motherhood home in Novi Sad].

    Science.gov (United States)

    Dobanovacki, Dusanka; Breberina, Milan; Vujosević, Bozica; Pećanac, Marija; Zakula, Nenad; Trajković, Velicko

    2013-01-01

    In the mid-twentieth century, the health care of women and children was inadequate in the post-war Yugoslavia, including the city of Novi Sad, due to the severe post-war reality: poverty in the devastated country, shortage of all commodities and services and especially of medical supplies, equipment and educated staff. OUT-OF-HOSPITAL MATERNITY UNIT: One of the serious problems was parturition at home and morbidity and mortality of the newborns and women. Soon after the World War II the action programme of improving the women's health was realized on the state level by establishing out-of-hospital maternity units but under the expert supervision. The Maternity unit at 30 Ljudevita Gaja Street in Novi Sad played a great role in providing skilled birth attendance at mainly normal deliveries. With a minimal number of medical staff and modest medical equipment, about 2000 healthy babies were born in this house. After 5 years of functioning in that way, this unit was transformed into the Motherhood Home and became a social and medical institution for pregnant women and new mothers. Regardless of the redefined organization concept the curative and preventive health care as well as women and children social protection programmes were provided successfully for the next 12 years. Although the Motherhood Home was moved into the Women Health Centre of Novi Sad and later into the former Maternity Hospital in Sremski Karlovci, its great importance for women and children's health care remained unchanged. In 1979 the overall social situation and mostly economic issues led to its closing. The house in Gajeva Street is now used as the municipality office. However, this house with its story recommends itself to become a house for a special social function, such as a museum of medical history of Novi Sad. A small investment could make it possible to collect, preserve and display the valuable records of our past, which is something we do owe to the generations to come.

  17. Implantable cardioverter defibrillator and survival after out-of-hospital cardiac arrest due to acute myocardial infarction in Denmark in the years 2001-2012, a nationwide study

    DEFF Research Database (Denmark)

    Winther-Jensen, Matilde; Kjaergaard, Jesper; Lassen, Jens F

    2017-01-01

    AIM: The purpose of this study was to describe the implantation of implantable cardioverter defibrillator after out-of-hospital cardiac arrest caused by myocardial infarction in Denmark 2001-2012 and subsequent survival. METHODS: The Danish Cardiac Arrest Registry was used to identify patients ⩾18...... years surviving to discharge without prior implantable cardioverter defibrillator. Information on cardioverter defibrillator implantation was obtained from the National Patient Registry. RESULTS: We identified 974 myocardial infarction-out-of-hospital cardiac arrest patients surviving to hospital...... discharge, 130 of these patients (13%) had a cardioverter defibrillator implanted early (⩽40 days post-out-of-hospital cardiac arrest), 58 patients (6%) had late implantable cardioverter defibrillator (41-365 days post-out-of-hospital cardiac arrest). Odds of implantable cardioverter defibrillator...

  18. Association of out-of-hospital advanced airway management with outcomes after traumatic brain injury and hemorrhagic shock in the ROC hypertonic saline trial.

    Science.gov (United States)

    Wang, Henry E; Brown, Siobhan P; MacDonald, Russell D; Dowling, Shawn K; Lin, Steve; Davis, Daniel; Schreiber, Martin A; Powell, Judy; van Heest, Rardi; Daya, Mohamud

    2014-03-01

    Prior studies suggest adverse associations between out-of-hospital advanced airway management (AAM) and patient outcomes after major trauma. This secondary analysis of data from the Resuscitation Outcomes Consortium Hypertonic Saline Trial evaluated associations between out-of-hospital AAM and outcomes in patients suffering isolated severe traumatic brain injury (TBI) or haemorrhagic shock. This multicentre study included adults with severe TBI (GCS ≤8) or haemorrhagic shock (SBP ≤70 mm Hg, or (SBP 71-90 mm Hg and heart rate ≥108 bpm)). We compared patients receiving out-of-hospital AAM with those receiving emergency department AAM. We evaluated the associations between airway strategy and patient outcomes (28-day mortality, and 6-month poor neurologic or functional outcome) and airway strategy, adjusting for confounders. Analysis was stratified by (1) patients with isolated severe TBI and (2) patients with haemorrhagic shock with or without severe TBI. Of 2135 patients, we studied 1116 TBI and 528 shock; excluding 491 who died in the field, did not receive AAM or had missing data. In the shock cohort, out-of-hospital AAM was associated with increased 28-day mortality (adjusted OR 5.14; 95% CI 2.42 to 10.90). In TBI, out-of-hospital AAM showed a tendency towards increased 28-day mortality (adjusted OR 1.57; 95% CI 0.93 to 2.64) and 6-month poor functional outcome (1.63; 1.00 to 2.68), but these differences were not statistically significant. Out-of-hospital AAM was associated with poorer 6-month TBI neurologic outcome (1.80; 1.09 to 2.96). Out-of-hospital AAM was associated with increased mortality after haemorrhagic shock. The adverse association between out-of-hospital AAM and injury outcome is most pronounced in patients with haemorrhagic shock.

  19. [Human rights and informed consent in clinical practice: beyond the right to health].

    Science.gov (United States)

    Gonzalo, Gianella

    2013-04-01

    Providing medical care is us a complex process that requires a strict respect for human rights. In countries like Peru, despite of having regulations and specific laws, patient's autonomy is not a common currency and certainly paternalism and beneficence generally overrule in physicians decision making. In this type of reality the requirement to health care professionals for respecting fundamental rights should be considered crucial, far more than in societies where citizens are really empowered. But to achieve the full respect of human rights, especially when providing a health care service, there is the need to go much further than just advocating for appropriate legislation and regulatory frameworks. In this article I argue that the violation of certain rights as the informed consent process by health care providers, is rooted in how these professionals, specially medical doctors trained in the western tradition, establish priorities and arrive to moral judgments. In this scenario I consider the need of a change in the way the Human Rights framework is being used to improve fundamental rights respect in health care.

  20. Impact of emergency percutaneous coronary intervention on outcomes of ST-segment elevation myocardial infarction patients complicated by out-of-hospital cardiac arrest

    Institute of Scientific and Technical Information of China (English)

    LIU Hong-wei; PAN Wei; WANG Lan-feng; SUN Yan-ming; LI Zhu-qin; WANG Zhong-hua

    2012-01-01

    Background Cardiac arrest is one of the most serious complications of acute myocardial infarction (AMI),especially in the out-of-hospital patients.There is no general consensus as to whether percutaneous coronary intervention (PCI) is effective in treating ST-segment elevation myocardial infarction (STEMI) patients complicated by out-of-hospital cardiac arrest (OHCA).In our study,we evaluated the efficacy of PCI in treating STEMI patients complicated by OHCA through observing their clinical conditions in hospital; including total mortality,adverse cardiac events,stroke,acute renal failure,and gastrointestinal bleeding events.Methods A total of 1827 STEMI patients were enrolled in this study,where 81 were STEMI with OHCA.Between the patients with and without OHCA,and the OHCA patients with and without PCI,we compared the clinical characteristics during hospitalization,including total mortality and incidences of adverse cardiac events,and stroke.Results Compared to the patients without OHCA,the OHCA patients had significantly lower systolic blood pressure (P <0.05) and a faster heart rate (P<0.05),and a higher percentage of Killip class IV or Glasgow coma scale (GCS) ≤7 onadmission (P <0.001).And the in-hospital mortality was higher in the OHCA patients (55.6% vs.2.4%,P <0.001).Comparing the OHCA patients without PCI to the patients with PCI,there was no obvious difference of heart rate,blood pressure or the percentage of Killip class IV and GCS ≤7 on admission,but the incidences of cardiogenic shock,stroke were significantly lower in the with-PCI group during hospitalization (P <0.001,P <0.05).And the in-hospital mortality of the OHCA patients receiving PCI was significantly lower (36.7% vs.84.3%,P<0.001).Conclusions During hospitalization,the incidence of adverse events and mortality are higher in the STEMI with OHCA patients,comparing with the STEMI without OHCA.Emergency PCI reduces the incidence of adverse events and decreases mortality

  1. Impedance Threshold Device Combined With High-Quality Cardiopulmonary Resuscitation Improves Survival With Favorable Neurological Function After Witnessed Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Sugiyama, Atsushi; Duval, Sue; Nakamura, Yuji; Yoshihara, Katsunori; Yannopoulos, Demetris

    2016-09-23

    The quality of cardiopulmonary resuscitation (CPR) has been recently shown to affect clinical outcome. The Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Impedance Valve and Early Versus Delayed Analysis (PRIMED) trial showed no differences in outcomes with an active vs. sham impedance threshold device (ITD), a CPR adjunct that enhances circulation. It was hypothesized the active ITD would improve survival with favorable neurological outcomes in witnessed out-of-hospital cardiac arrest patients when used with high-quality CPR. Using the publicly accessible ROC PRIMED database, a post-hoc analysis was performed on all witnessed subjects with both compression rate and depth data (n=1,808) who received CPR within the study protocol definition of adequate CPR quality (compression rate 80-120/min and depth 4-6 cm; n=929). Demographics were similar between sham and active ITD groups. In witnessed subjects who received quality CPR, survival with favorable neurological function was 11.9% for the active ITD subjects (56/470) vs. 7.4% for the sham (34/459) (odds ratio 1.69 [95% confidence interval 1.08, 2.64]). There were no statistically significant differences for this primary outcome when CPR was performed outside the boundaries of the definition of adequate CPR quality. Multivariable models did not change these associations. An active ITD combined with adequate-quality conventional CPR has the potential to significantly improve survival after witnessed cardiac arrest. (Circ J 2016; 80: 2124-2132).

  2. The relationship between survival after out-of-hospital cardiac arrest and process measures for emergency medical service ambulance team performance.

    Science.gov (United States)

    Chen, Tsung-Tai; Ma, Matthew Huei-Ming; Chen, Fen-Ju; Hu, Fu-Chang; Lu, Yu-Cheng; Chiang, Wen-Chu; Ko, Patrick Chow-In

    2015-12-01

    International institutes have developed their own clinical performance indicators for ambulance services. It is unknown whether these process measures are related to survival of patients after out-of-hospital cardiac arrest (OHCA). We aimed to determine whether Emergency Medical Service (EMS)-related ambulance team process measures correlate with patient survival. Four years of observational data were collected from an urban EMS OHCA registry. The two process measures were achieving an EMS response time ≤4 min and prehospital ROSC (return of spontaneous circulation). The outcome measure was survival to discharge. We used the GLMM (generalised linear mixed model) with stepwise selection to examine this process-outcome link at the patient and EMS team levels, respectively. We analyzed 3856 OHCA patients distributed across forty-three EMS ambulance teams. Survival to discharge was observed in 193 (5%) patients. The two EMS team process measures were positively associated with an improvement in survival at the patient level after case-mix adjustment. However, they were not associated with improvement in the risk-adjusted survival rate. The EMS team-level process measures proposed by international institutes may not predict the risk-adjusted survival rate. Using these measures to motivate EMS teams to improve their quality performance would be questionable. Increased efforts should be devoted to constructing more pivotal EMS team-level process measures that are tightly linked to survival. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Informed Consent

    Directory of Open Access Journals (Sweden)

    Jean-Pierre CLÉRO

    2016-12-01

    Full Text Available Informed consent is one pillar of the nowadays’ medical relation; it is a main element of the Copernican revolution of the care ethics: where the doctor was at the centre of the system, the patient has now taken the place at the focus of the care’s process. The new deal with the doctor goes through the informed consent. The change is not always easily accepted. French people which just have a quiet revolution in endowing the patient with a large autonomy in the medical act – nevertheless speak of refus de soin (word for word: refusal of treatment when the patient wants his treatment to be stopped; whereas English-speaking people rightly draw a distinction between to waive and to refuse. There is no a slight difference between to waive and to refuse, between a waiver and a refusal even though a quick translation can take a word for another. A patient may decide to stop the treatment prescribed by the doctor, a treatment that he so far followed, without his waiver be a refusal. He is not necessarily somebody who is spoiling to a fight with the nursing staff. Even when they are Republican, the States are not at ease with the consent they try to restrain by all possible means. Caught between liberalism and republicanism, ethics seem, on the field of consent, prevented by the politics to take its autonomy.

  4. Out-of hospital cardiac arrest in Okayama city (Japan: outcome report according to the "Utsutein Style".

    Directory of Open Access Journals (Sweden)

    Hayashi,Hoei

    2005-04-01

    Full Text Available

    The purpose of this study was to evaluate the outcomes for out-of-hospital cardiac arrest (OHCA and cardiopulmonary resuscitation (CPR in the city of Okayama, Japan, during a 1-year period after the reorganization of defibrillation by Emergency Life-Saving Technicians (ELSTs with standing orders of CPR. The data were collected prospectively according to an Utstein style between June 1, 2003 and May 31, 2004; OHCA was confirmed in 363 patients. Cardiac arrest of presumed cardiac etiology (179 was witnessed by a bystander in 62 (34.6% cases. Of this group, ventricular fibrillation (VF was documented in 20 cases (32.3%, and 1 patient (5% was discharged alive without severe neurological disability. This outcome is average in Japan, but it is quite low level compared with Western countries because there is less VF in Japan. The Utstein style revealed that we must try to detect VF before the rhythm changes and to provide defibrillation as soon as possible in order to improve outcomes. Further research will be required to accurately evaluate OHCA in Okayama city.

  5. Reduced in-hospital survival rates of out-of-hospital cardiac arrest victims with obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Blom, M T; Warnier, M J; Bardai, A;

    2013-01-01

    AIM: Out-of-hospital cardiac arrest (OHCA) due to sustained ventricular tachycardia/fibrillation (VT/VF) is common and often lethal. Patient's co-morbidities may determine survival after OHCA, and be instrumental in post-resuscitation care, but are poorly studied. We aimed to study whether patients......, to hospital discharge, and at 30 days after OHCA, of OPD-patients and non-OPD patients, using logistic regression analysis. We also compared 30-day survival of patients who were admitted to hospital, using multivariate logistic regression analysis. RESULTS: OPD patients (n=178) and non-OPD patients (n=994...... admitted to hospital (OPD: n=100, no OPD: n=561) revealed that OPD was an independent determinant of reduced 30-day survival rate (39% vs. 59%, adjusted OR 0.6 [0.4-1.0, p=0.035]). CONCLUSION: OPD-patients had lower survival rates after OHCA than non-OPD patients. Survival to ER and to hospital admission...

  6. Association between bystander cardiopulmonary resuscitation and redeemed prescriptions for antidepressants and anxiolytics in out-of-hospital cardiac arrest survivors

    DEFF Research Database (Denmark)

    Bundgaard, Kristian; Hansen, Steen M; Mortensen, Rikke Nørmark

    2017-01-01

    AIM: This study aimed to examine rates of redeemed prescriptions of antidepressants and anxiolytics, used as markers for cerebral dysfunction in out-of-hospital cardiac arrest (OHCA) survivors, and examine the association between bystander CPR and these psychoactive drugs. METHODS: We included all....... Among survivors who received bystander CPR, prescriptions for antidepressants and anxiolytics were redeemed in 11.1% [95% CI 9.2-13.3%] and 6.3% [95% CI 4.9-8.0%] of the cases, respectively, versus 17.2% [95% CI 13.9-21.1%] and 13.4% [95% CI 10.5-17.0%], respectively, among patients who had not received...... bystander CPR. Adjusted for age, sex, year of arrest, comorbidity, witnessed status and socioeconomic status, bystander CPR was associated with significant reductions in redeemed prescriptions for antidepressants, Hazard Ratio (HR) 0.71 [95% CI 0.52-0.98], P=0.031; and anxiolytics, HR 0.55 [95% CI 0...

  7. Characteristics and outcome among patients suffering from out-of-hospital cardiac arrest: Factors associated with survival

    Directory of Open Access Journals (Sweden)

    Trpković S.

    2014-01-01

    Full Text Available The aim was to define factors associated with an improved outcome among patients suffering out-of-hospital cardiac arrest (OHCA using the Utstain style data collection. We examined 200 patients suffering from OHCA in a prospective study in a two years period. We determined survival from cardiac arrest (CA to discharge from hospital and the factors associated with survival. 78% of CA patients had a cardiac aetiology, 65% occurred at home, 3.7% received bystander CPR. 36% were found in VF/VT, 64% in asystole/PEA. 52% of patients were intubated in the field, survival to discharge from hospital was significantly higher among patients who were intubated in the field. The mean response time was 6.6 minutes. 66.7% of patients were given the shock after 4 minutes. 131 (65.5% were pronounced dead in the field, 69 patients were transported to the hospital. 53 (76.8% patients of them died during the transport or in the ED, 7 died after hospital admission and 9 survived to hospital discharge. Multivariate logistic regression analysis showed that variables significantly associated with survival to hospital discharge were: age, endotracheal intubation in the field and mean response time. The outcome of CPR was better in patients who were younger, who were intubated in the field and when the response time was shorter.

  8. Assessment of cardiopulmonary resuscitation practices in emergency departments for out-of-hospital cardiac arrest victims in Lebanon

    Directory of Open Access Journals (Sweden)

    Samar Noureddine

    2016-01-01

    Full Text Available Background: The survival rate of out-of-hospital cardiac arrest (OHCA victims in Lebanon is low. A national policy on resuscitation practice is lacking. This survey explored the practices of emergency physicians related to the resuscitation of OHCA victims in Lebanon. Methods: A sample of 705 physicians working in emergency departments (EDs was recruited and surveyed using the LimeSurvey software (Carsten Schmitz, Germany. Seventy-five participants responded, yielding 10.64% response rate. Results: The most important factors in the participants' decision to initiate or continue resuscitation were presence of pulse on arrival (93.2%, underlying cardiac rhythm (93.1%, the physician's ethical duty to resuscitate (93.2%, transport time to the ED (89%, and down time (84.9%. The participants were optimistic regarding the survival of OHCA victims (58.1% reporting > 10% survival and reported frequent resuscitation attempts in medically futile situations. The most frequently reported challenges during resuscitation decisions were related to pressure or presence of victim's family (38.8% and lack of policy (30%. Conclusion: In our setting, physicians often rely on well-established criteria for initiating/continuing resuscitation; however, their decisions are also influenced by cultural factors such as victim's family wishes. The findings support the need for a national policy on resuscitation of OHCA victims.

  9. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.

    Science.gov (United States)

    Vanderpool, Harold Y

    2009-01-01

    This essay explores the meaning and implications of informed consent in xenotransplantation clinical trials from both ethically justifiable and international perspectives. In international and national codes and guidelines involving human subject research and in the laws of many nations, the informed consent of research subjects is obligatory. Its moral foundations include and also extend beyond respect for individual persons as autonomous agents in Western nations. Axioms regarding the value of human life and duties to protect innocent and vulnerable persons from harm, duress, and deceit underlie Western individualism and are broadly shared in many non-Western cultures. Accents on family and/or community consent in China and other nations are compatible with individual consent as long as family and community consent supplement, rather than replace, individual consent. Reflecting its moral foundations, informed consent in medical research is rightly characterized as "voluntary" or "freely given" informed consent because it encompasses researchers' disclosure and subjects' comprehension of all the relevant information about the protocol that reasonable persons would want to know in order to freely and affirmatively enroll in the research. The interplay between these conceptual foundations of informed consent and the realities of xenotransplantation research defines what the nature and functions of consent should be in xenotransplantation clinical trials. Because these trials involve a complex body of medical information, numerous procedures, numerous risks (associated with failure rates, immunosuppression, xenogeneic infections, and so on) and the subject's obligation to abide by extensive national and international precautionary guidelines, informed consent should be enacted as an organized, sequential, thoughtfully paced, jargon-free process of communication. The features and functions of consent forms or consent documents should accord with this process. Rather

  10. Variation in recruitment across sites in a consent-based clinical data registry: lessons from the Canadian Stroke Network

    Directory of Open Access Journals (Sweden)

    Richards Janice A

    2006-05-01

    Full Text Available Abstract Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%, and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%. Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for

  11. Pregnancy in HIV clinical trials in Sub Saharan Africa: failure of consent or contraception?

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    Full Text Available OBJECTIVE: Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa. METHODS: Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP; and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO. 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use. RESULTS: All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may

  12. CPR Induced Consciousness During Out-of-Hospital Cardiac Arrest: A Case Report on an Emerging Phenomenon.

    Science.gov (United States)

    Pound, Joshua; Verbeek, P Richard; Cheskes, Sheldon

    2017-01-01

    High quality cardiopulmonary resuscitation (CPR) has produced a relatively new phenomenon of consciousness in patients with vital signs absent. Further research is necessary to produce a viable treatment strategy during and post resuscitation. To provide a case study done by paramedics in the field illustrating the need for sedation in a patient whose presentation was consistent with CPR induced consciousness. Resuscitative challenges are provided as well as potential future treatment options to minimize harm to both patients and prehospital providers. A 52-year-old male presented as a witnessed out-of-hospital cardiac arrest (OHCA). During CPR the patient began to exhibit signs of life including severe agitation and thrashing of his limbs while CPR was ongoing for ventricular fibrillation prior to defibrillation. Resuscitation became considerably more complicated due to the violent and counterintuitive motions done by the patient during their own resuscitation. Despite the atypical presentation of cardiac arrest the patient was successfully resuscitated employing high quality CPR, standard advanced life support (ALS) care as well as two double sequential external defibrillation shocks. The patient underwent emergency percutaneous coronary intervention (PCI) for a 100% occlusion of his left anterior descending artery (LAD). The patient returned home 3 days later fully recovered with a Cerebral Performance Score of 1. CPR induced consciousness is emerging as a new phenomenon challenging providers of high quality CPR during cardiac arrest resuscitation. Our case report describes the manifestations of CPR induced consciousness as well as the resuscitative challenges which occur during resuscitation. Further research is required to determine the true frequency of this condition as well as treatment algorithms that would allow for appropriate and safe management for both the patient and EMS providers.

  13. Comparison of supraglottic airway versus endotracheal intubation for the pre-hospital treatment of out-of-hospital cardiac arrest

    Science.gov (United States)

    2011-01-01

    Introduction Both supraglottic airway devices (SGA) and endotracheal intubation (ETI) have been used by emergency life-saving technicians (ELST) in Japan to treat out-of-hospital cardiac arrests (OHCAs). Despite traditional emphasis on airway management during cardiac arrest, its impact on survival from OHCA and time dependent effectiveness remains unclear. Methods All adults with witnessed, non-traumatic OHCA, from 1 January 2005 to 31 December 2008, treated by the emergency medical services (EMS) with an advanced airway in Osaka, Japan were studied in a prospective Utstein-style population cohort database. The primary outcome measure was one-month survival with neurologically favorable outcome. The association between type of advanced airway (ETI/SGA), timing of device placement and neurological outcome was assessed by multiple logistic regression. Results Of 7,517 witnessed non-traumatic OHCAs, 5,377 cases were treated with advanced airways. Of these, 1,679 were ETI while 3,698 were SGA. Favorable neurological outcome was similar between ETI and SGA (3.6% versus 3.6%, P = 0.95). The time interval from collapse to ETI placement was significantly longer than for SGA (17.2 minutes versus 15.8 minutes, P predictor (AOR 0.71, 95% CI 0.39 to 1.30) but the presence of an ETI certified ELST (AOR, 1.86, 95% CI 1.04 to 3.34) was a significant predictor for favorable neurological outcome. Conclusions There was no difference in neurologically favorable outcome from witnessed OHCA for ETI versus SGA. Early airway management with advanced airway regardless of type and rhythm was associated with improved outcomes. PMID:21985431

  14. Regions of High Out-Of-Hospital Cardiac Arrest Incidence and Low Bystander CPR Rates in Victoria, Australia

    Science.gov (United States)

    Straney, Lahn D.; Bray, Janet E.; Beck, Ben; Finn, Judith; Bernard, Stephen; Dyson, Kylie; Lijovic, Marijana; Smith, Karen

    2015-01-01

    Background Out-of-hospital cardiac arrest (OHCA) remains a major public health issue and research has shown that large regional variation in outcomes exists. Of the interventions associated with survival, the provision of bystander CPR is one of the most important modifiable factors. The aim of this study is to identify census areas with high incidence of OHCA and low rates of bystander CPR in Victoria, Australia Methods We conducted an observational study using prospectively collected population-based OHCA data from the state of Victoria in Australia. Using ArcGIS (ArcMap 10.0), we linked the location of the arrest using the dispatch coordinates (longitude and latitude) to Victorian Local Government Areas (LGAs). We used Bayesian hierarchical models with random effects on each LGA to provide shrunken estimates of the rates of bystander CPR and the incidence rates. Results Over the study period there were 31,019 adult OHCA attended, of which 21,436 (69.1%) cases were of presumed cardiac etiology. Significant variation in the incidence of OHCA among LGAs was observed. There was a 3 fold difference in the incidence rate between the lowest and highest LGAs, ranging from 38.5 to 115.1 cases per 100,000 person-years. The overall rate of bystander CPR for bystander witnessed OHCAs was 62.4%, with the rate increasing from 56.4% in 2008–2010 to 68.6% in 2010–2013. There was a 25.1% absolute difference in bystander CPR rates between the highest and lowest LGAs. Conclusion Significant regional variation in OHCA incidence and bystander CPR rates exists throughout Victoria. Regions with high incidence and low bystander CPR participation can be identified and would make suitable targets for interventions to improve CPR participation rates. PMID:26447844

  15. Regions of High Out-Of-Hospital Cardiac Arrest Incidence and Low Bystander CPR Rates in Victoria, Australia.

    Directory of Open Access Journals (Sweden)

    Lahn D Straney

    Full Text Available Out-of-hospital cardiac arrest (OHCA remains a major public health issue and research has shown that large regional variation in outcomes exists. Of the interventions associated with survival, the provision of bystander CPR is one of the most important modifiable factors. The aim of this study is to identify census areas with high incidence of OHCA and low rates of bystander CPR in Victoria, Australia.We conducted an observational study using prospectively collected population-based OHCA data from the state of Victoria in Australia. Using ArcGIS (ArcMap 10.0, we linked the location of the arrest using the dispatch coordinates (longitude and latitude to Victorian Local Government Areas (LGAs. We used Bayesian hierarchical models with random effects on each LGA to provide shrunken estimates of the rates of bystander CPR and the incidence rates.Over the study period there were 31,019 adult OHCA attended, of which 21,436 (69.1% cases were of presumed cardiac etiology. Significant variation in the incidence of OHCA among LGAs was observed. There was a 3 fold difference in the incidence rate between the lowest and highest LGAs, ranging from 38.5 to 115.1 cases per 100,000 person-years. The overall rate of bystander CPR for bystander witnessed OHCAs was 62.4%, with the rate increasing from 56.4% in 2008-2010 to 68.6% in 2010-2013. There was a 25.1% absolute difference in bystander CPR rates between the highest and lowest LGAs.Significant regional variation in OHCA incidence and bystander CPR rates exists throughout Victoria. Regions with high incidence and low bystander CPR participation can be identified and would make suitable targets for interventions to improve CPR participation rates.

  16. Meanings of people's lived experiences of surviving an out-of-hospital cardiac arrest, 1 month after the event.

    Science.gov (United States)

    Forslund, Ann-Sofie; Zingmark, Karin; Jansson, Jan-Håkan; Lundblad, Dan; Söderberg, Siv

    2014-01-01

    The out-of-hospital cardiac arrest (OHCA) survival rate has been poor and stable for a long time, but more recent studies describe its increase. However, there are few studies in which people narrate their experiences from surviving. The aim of this study was to elucidate meanings of people's lived experiences of surviving an OHCA with validated myocardial infarction (MI) etiology, 1 month after the event. A purposive sample of 2 women and 9 men was interviewed between February 2011 and May 2012. A phenomenological hermeneutical method was used for analysis, which involved 3 steps: naive reading and understanding, structural analysis, and comprehensive understanding. There were 2 themes, (1) returning to life and (2) revaluing life, and five subthemes, (1a) waking up and missing the whole picture, (1b) realizing it was not time to die, (2a) wondering why and seeking explanations, (2b) feeling ambiguous in relations, and (2c) wondering whether life will be the same. All were constructed from the analysis. Surviving an OHCA with validated MI etiology meant waking up and realizing that one had experienced a cardiac arrest and had been resuscitated. These survivors had memory loss and a need to know what had happened during the time they were dead/unconscious. They searched for a reason why they experienced an MI and cardiac arrest and had gone from being "heart-healthy" to having a lifelong illness. They all had the experience of passing from life to death and back to life again. For the participants, these differences led to a revaluation of what is important in life.

  17. Effects of bystander CPR following out-of-hospital cardiac arrest on hospital costs and long-term survival.

    Science.gov (United States)

    Geri, Guillaume; Fahrenbruch, Carol; Meischke, Hendrika; Painter, Ian; White, Lindsay; Rea, Thomas D; Weaver, Marcia R

    2017-06-01

    Bystander cardiopulmonary resuscitation (CPR) is associated with a greater likelihood of survival to hospital discharge after out-of-hospital cardiac arrest (OHCA). However the long-term survival benefits in relationship to cost have not been well-studied. We evaluated bystander CPR, hospital-based costs, and long-term survival following OHCA in order to assess the potential cost-effectiveness of bystander CPR. We conducted a retrospective cohort study of consecutive EMS-treated OHCA patients >=12years who arrested prior to EMS arrival and outside a nursing facility between 2001 and 2010 in greater King County, WA. Utstein-style information was obtained from the EMS registry, including 5-year survival. Costs from the OHCA hospitalization were obtained from the Washington State Comprehensive Hospital Abstract Reporting System. Cost effectiveness was based on hospital costs divided by quality-adjusted life years (QALYs) for a 5-year follow-up window. Of the 4448 eligible patients, 18.5% (n=824) were discharged alive from hospital and 12.1% (n=539) were alive at 5 years. Five-year survival was higher in patients who received bystander CPR (14.3% vs. 8.7%, pbystander CPR. The average (SD) total cost of the initial acute care hospitalization was USD 19,961 (40,498) for all admitted patients and USD 75,175 (52,276) for patients alive at year 5. The incremental cost-effectiveness ratio associated with bystander CPR was USD 48,044 per QALY. Based on this population-based investigation, bystander CPR was positively associated with long-term survival and appears cost-effective. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Association between bystander cardiopulmonary resuscitation and redeemed prescriptions for antidepressants and anxiolytics in out-of-hospital cardiac arrest survivors.

    Science.gov (United States)

    Bundgaard, Kristian; Hansen, Steen M; Mortensen, Rikke Nørmark; Wissenberg, Mads; Hansen, Malta; Lippert, Freddy; Gislason, Gunnar; Køber, Lars; Nielsen, Jimmi; Torp-Pedersen, Christian; Rasmussen, Bodil Steen; Kragholm, Kristian

    2017-06-01

    This study aimed to examine rates of redeemed prescriptions of antidepressants and anxiolytics, used as markers for cerebral dysfunction in out-of-hospital cardiac arrest (OHCA) survivors, and examine the association between bystander CPR and these psychoactive drugs. We included all 30-day survivors of OHCA in Denmark between 2001 and 2011, who had not redeemed prescriptions for antidepressants or anxiolytics in the last six months prior to OHCA. Main outcome measures were redeemed prescriptions of antidepressants and anxiolytics within one year after OHCA. Among 2,001 30-day survivors, 174 (8.6% died and 12.0% redeemed a first prescription for an antidepressant and 8.2% for an anxiolytic drug within one year after arrest. The corresponding frequencies for redeemed prescribed drugs among age- and sex-matched population controls were 7.5% and 5.2%, respectively. Among survivors who received bystander CPR, prescriptions for antidepressants and anxiolytics were redeemed in 11.1% [95% CI 9.2-13.3%] and 6.3% [95% CI 4.9-8.0%] of the cases, respectively, versus 17.2% [95% CI 13.9-21.1%] and 13.4% [95% CI 10.5-17.0%], respectively, among patients who had not received bystander CPR. Adjusted for age, sex, year of arrest, comorbidity, witnessed status and socioeconomic status, bystander CPR was associated with significant reductions in redeemed prescriptions for antidepressants, Hazard Ratio (HR) 0.71 [95% CI 0.52-0.98], P=0.031; and anxiolytics, HR 0.55 [95% CI 0.38-0.81], P=0.002. Relative to no bystander CPR, redeemed prescriptions for antidepressants and anxiolytics were significantly lower among 30-day survivors of OHCA who received bystander CPR, suggesting a cerebral dysfunction-lowering potential of bystander CPR. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Regions of High Out-Of-Hospital Cardiac Arrest Incidence and Low Bystander CPR Rates in Victoria, Australia.

    Science.gov (United States)

    Straney, Lahn D; Bray, Janet E; Beck, Ben; Finn, Judith; Bernard, Stephen; Dyson, Kylie; Lijovic, Marijana; Smith, Karen

    2015-01-01

    Out-of-hospital cardiac arrest (OHCA) remains a major public health issue and research has shown that large regional variation in outcomes exists. Of the interventions associated with survival, the provision of bystander CPR is one of the most important modifiable factors. The aim of this study is to identify census areas with high incidence of OHCA and low rates of bystander CPR in Victoria, Australia. We conducted an observational study using prospectively collected population-based OHCA data from the state of Victoria in Australia. Using ArcGIS (ArcMap 10.0), we linked the location of the arrest using the dispatch coordinates (longitude and latitude) to Victorian Local Government Areas (LGAs). We used Bayesian hierarchical models with random effects on each LGA to provide shrunken estimates of the rates of bystander CPR and the incidence rates. Over the study period there were 31,019 adult OHCA attended, of which 21,436 (69.1%) cases were of presumed cardiac etiology. Significant variation in the incidence of OHCA among LGAs was observed. There was a 3 fold difference in the incidence rate between the lowest and highest LGAs, ranging from 38.5 to 115.1 cases per 100,000 person-years. The overall rate of bystander CPR for bystander witnessed OHCAs was 62.4%, with the rate increasing from 56.4% in 2008-2010 to 68.6% in 2010-2013. There was a 25.1% absolute difference in bystander CPR rates between the highest and lowest LGAs. Significant regional variation in OHCA incidence and bystander CPR rates exists throughout Victoria. Regions with high incidence and low bystander CPR participation can be identified and would make suitable targets for interventions to improve CPR participation rates.

  20. Cerebral oximetry and cerebral blood flow monitoring in 2 pediatric survivors with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Abramo, Thomas; Aggarwal, Nitin; Kane, Ian; Crossman, Kristen; Meredith, Mark

    2014-04-01

    In pediatric out-of-hospital cardiac arrest (POHCA), cardiovascular monitoring tools have improved resuscitative endeavors and cardiovascular outcomes but with still poor neurologic outcomes. Regarding cardiac arrest in patients with congenital heart disease during surgery, the application of cerebral oximetry with blood volume index (BVI) during the resuscitation has shown significant results and prognostic significance. We present 2 POHCA patients who had cerebral oximetry with BVI monitoring during their arrest and postarrest phase in the emergency department and its potential prognostic aspect.Basic procedures include left and right cerebral oximetry with BVI monitoring at every 5-second interval during cardiac arrest, resuscitation, and postarrest in 2 POHCA patients in the pediatric emergency department.Regional cerebral tissue oxygen saturation (rSo2) with BVI readings in these 2 POHCA survivors demonstrated interesting cerebral physiology, blood flow, and potential prognostic outcome. In 1 patient, the reference range of cerebral rSo2 with positive blood flow during arrest and postarrest phases consistently occurred. This neurologic monitoring had its significance when the resuscitation effectiveness was used and end-tidal CO2 changes were lost. The other patient's cerebral rSo2 with simultaneous BVI readings and trending showed the effectiveness of the emergency medical services (EMS) resuscitation.Cerebral oximetry with cerebral blood flow index monitoring in these POHCA survivors demonstrates compelling periarrest and postarrest cerebral physiology information and prognostication. Cerebral oximetry with cerebral BVI monitoring during these arrest phases has potential as a neurologic monitor for the resuscitative intervention's effectiveness and its possible neurologic prognostic application in the pediatric OCHA patients.

  1. Positive trend in survival to hospital discharge after out-of-hospital cardiac arrest: a quantitative review of the literature.

    Science.gov (United States)

    Savastano, Simone; Klersy, Catherine; Raimondi, Maurizio; Langord, Karen; Vanni, Vincenzo; Rordorf, Roberto; Vicentini, Alessandro; Petracci, Barbara; Landolina, Maurizio; Visconti, Luigi Oltrona

    2014-08-01

    Seven editions of cardiopulmonary resuscitation (CPR) and emergency cardiovascular care guidelines have been published with many changes, in particular, about CPR. The aim of our study was to evaluate the temporal trend of survival to hospital discharge after out-of-hospital cardiac arrest (OHCA) as a possible effect of guidelines changes. We searched PubMed for observational studies on 'survival to hospital discharge after OHCA'. Survival to discharge was the primary outcome; prehospital return of spontaneous circulation and survival to hospital admission were our secondary endpoints. All data were analyzed according to the year of inclusion: group 1 before 2000; group 2 between 2000 and 2005; and group 3 after 2005. Mortality rates were compared between groups by means of a group frequency-weighted log-linear model. We considered 38 of 201 studies for a total of 156 301 patients. Survival to hospital discharge rate was 5.0% [95% confidence interval (CI) 4.9-5.2) in group 1; 6.1% (95% CI 5.9-6.4) in group 2; and 9.1% (95% CI 8.9-9.4) in group 3 (P < 0.001). A statistically significant decrease in risk of mortality in group 2 vs. group 1 (risk ratio 0.988, 95% CI 0. 985-0.0.992, P < 0.001) and in group 3 vs. group 2 (risk ratio 0.967, 95% CI 0.964-0.971, P < 0.001) was observed. Similar trends were observed for return of spontaneous circulation and survival to hospital admission. Survival to hospital discharge after OHCA has significantly improved. Many aspects may influence survival, but surely, the reduction of time and an early and good quality CPR have positively influenced the outcome.

  2. Intrapartum and Postpartum Transfers to a Tertiary Care Hospital from Out-of-Hospital Birth Settings: A Retrospective Case Series.

    Science.gov (United States)

    Lundeen, Tiffany

    2016-01-01

    This study describes the reasons for and outcomes of maternal transfers from private homes and freestanding birthing suites to a large academic hospital in order to better understand and meet the needs of transferring women and their families. The convenience sample included all adult women admitted to the labor and birth unit or emergency room within a 5-year period who: 1) had planned to give birth out-of-hospital but developed complications at term before the onset of labor and were admitted to the hospital for labor induction; 2) had planned to give birth at home or in a birthing suite but transferred to the hospital during labor; or 3) arrived at the hospital for care within 24 hours after a planned birth at home or in a birthing suite. Descriptive data for each transfer were obtained from the medical record. Fifty-one transfers were identified: 11 prior to labor, 38 during labor, and 2 postpartum. Only 4 transfers were considered urgent by the referring provider. The most common reasons for intrapartum transfer were prolonged labor (n = 19) and desire for epidural analgesia (n = 10). Only 25% of the medical records had documentation that the referring provider accompanied the woman to the hospital during the care transition or was involved in her hospital course; however, the prenatal and/or intrapartum records had been delivered by the referring provider, were referenced in the hospital admission note, and had become part of the permanent hospital medical record for 85% of the women. On average, one transfer per year was complicated by neonatal morbidity, and one transfer per year involved significant disagreement between hospital providers and the women presenting for care. Collecting and reviewing data about a facility's perinatal transfer events can help the local multi-stakeholder group appraise current practice and plan for quality improvement. © 2016 by the American College of Nurse-Midwives.

  3. Rates of organ donation in a UK tertiary cardiac arrest centre following out-of-hospital cardiac arrest.

    Science.gov (United States)

    Cheetham, Olivia V; Thomas, Matthew J C; Hadfield, John; O'Higgins, Fran; Mitchell, Claire; Rooney, Kieron D

    2016-04-01

    To ascertain the rate of successful organ donation (OD) within patients who sustained an out of hospital cardiac arrest (OHCA) with initial return of spontaneous circulation (ROSC) and survival to hospital admission, but whom subsequently do not survive to hospital discharge. A retrospective audit of ambulance service and hospital databases from January 2010 to January 2015 was undertaken in a United Kingdom tertiary-referral regional cardiac arrest centre. Crude denominator data for cardiac arrests was obtained from the regional ambulance service; the ICU database was interrogated for OHCA patient admissions and outcomes. Patients who died were cross-referenced against the local Organ Donation service database. Five hundred and fourteen {514} patients were admitted to ICU following OHCA over this five year period. Two hundred and forty-one {241} patients (47%) survived to hospital discharge and 273 (53%) died of whom 106 (39%) were referred to a Specialist Nurse for Organ Donation (SNOD). The conversion rate after the family was approached was 64%. Twenty-eight {28} patients proceeded to donation and 25 patients (24%) successfully donated at least one organ. On average, a patient proceeding to donation provided 1.9 organs. A proactive, systematic approach to OD in OHCA patients can provide a good conversion rate and substantial number of donors. Most donations occur after death from circulatory criteria. There is a positive socio-economic benefit with nearly £4m in savings to the health service within the next 5 years potentially being realised during this period by liberating patients from dialysis. Copyright © 2016. Published by Elsevier Ireland Ltd.

  4. Characteristics of out-of-hospital paediatric emergencies attended by ambulance- and helicopter-based emergency physicians.

    Science.gov (United States)

    Eich, Christoph; Russo, Sebastian G; Heuer, Jan F; Timmermann, Arnd; Gentkow, Uta; Quintel, Michael; Roessler, Markus

    2009-08-01

    In Germany, as in many other countries, for the vast majority of cases, critical out-of-hospital (OOH) paediatric emergencies are attended by non-specialised emergency physicians (EPs). As it is assumed that this may lead to deficient service we aimed to gather robust data on the characteristics of OOH paediatric emergencies. We retrospectively evaluated all OOH paediatric emergencies (0-14 years) within a 9-year period and attended by physician-staffed ground- or helicopter-based emergency medical service (EMS or HEMS) teams from our centre. We identified 2271 paediatric emergencies, making up 6.3% of all cases (HEMS 8.5%). NACA scores IV-VII were assigned in 27.3% (HEMS 32.0%). The leading diagnosis groups were age dependent: respiratory disorders (infants 34.5%, toddlers 21.8%, school children 15.0%), convulsions (17.2%, 43.2%, and 16.0%, respectively), and trauma (16.0%, 19.5%, and 44.4%, respectively). Endotracheal intubation was performed in 4.2% (HEMS 7.6%) and intraosseous canulation in 0.7% (HEMS 1.0%) of children. Cardiopulmonary resuscitation (CPR) was commenced in 2.3% (HEMS 3.4%). Thoracocentesis, chest drain insertion and defibrillation were rarities. HEMS physicians attended a particularly high fraction of drowning (80.0%), head injury (73.9%) and SIDS (60.0%) cases, whereas 75.6% of all respiratory emergencies were attended by ground-based EPs. Our data suggest that EPs need to be particularly confident with the care of children suffering respiratory disorders, convulsions, and trauma. The incidence of severe paediatric OOH emergencies requiring advanced interventions is higher in HEMS-attended cases. However, well-developed skills in airway management, CPR, and intraosseous canulation in children are essential for all EPs.

  5. Increasing first responder CPR during resuscitation of out-of-hospital cardiac arrest using automated external defibrillators.

    Science.gov (United States)

    Shah, Sachita; Garcia, Michele; Rea, Thomas D

    2006-10-01

    Evidence supports that increasing the balance of "hands-on" CPR may improve survival in ventricular fibrillation out-of-hospital cardiac arrest (OHCA). We assessed whether training and/or AED reconfiguration was associated with an increase in the proportion of time during which CPR was performed between first and second stacks of shocks. The investigation was a cohort study of 291 persons who suffered ventricular fibrillation OHCA and were treated with at least two stacks of AED shocks by emergency medical services (EMS) first-tier responders. In January 2003, first-tier providers were retrained regarding the importance of CPR. In addition, a subset of AEDs was reconfigured to remove continuous fibrillation detection and its associated voice prompts as to be comparable with other AED models. The amount of time spent on CPR was assessed through review of AED electronic and audio recordings to compare the pre-intervention (n = 241) and post-intervention periods (n = 50). The proportion of time spent performing hands-on CPR between first and second stacks of shocks was 0.40 in the pre-intervention period compared to 0.51 in the post-intervention period (p = 0.001). The difference was greatest for AEDs where EMS was retrained and the AED reconfigured (0.33 versus 0.50, p = 0.01). No difference in survival was detected between the pre- and post-intervention periods (24.9% versus 28.0%, p = 0.65). An intervention consisting of retraining and AED reconfiguration was associated with an increase in the proportion of time spent performing CPR between first and second stacks of shocks by first-tier EMS. Whether this increase improves patient outcomes requires additional study.

  6. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hasegawa, Kohei; Hiraide, Atsushi; Chang, Yuchiao; Brown, David F M

    2013-01-16

    It is unclear whether advanced airway management such as endotracheal intubation or use of supraglottic airway devices in the prehospital setting improves outcomes following out-of-hospital cardiac arrest (OHCA) compared with conventional bag-valve-mask ventilation. To test the hypothesis that prehospital advanced airway management is associated with favorable outcome after adult OHCA. Prospective, nationwide, population-based study (All-Japan Utstein Registry) involving 649,654 consecutive adult patients in Japan who had an OHCA and in whom resuscitation was attempted by emergency responders with subsequent transport to medical institutions from January 2005 through December 2010. Favorable neurological outcome 1 month after an OHCA, defined as cerebral performance category 1 or 2. Of the eligible 649,359 patients with OHCA, 367,837 (57%) underwent bag-valve-mask ventilation and 281,522 (43%) advanced airway management, including 41,972 (6%) with endotracheal intubation and 239,550 (37%) with use of supraglottic airways. In the full cohort, the advanced airway group incurred a lower rate of favorable neurological outcome compared with the bag-valve-mask group (1.1% vs 2.9%; odds ratio [OR], 0.38; 95% CI, 0.36-0.39). In multivariable logistic regression, advanced airway management had an OR for favorable neurological outcome of 0.38 (95% CI, 0.37-0.40) after adjusting for age, sex, etiology of arrest, first documented rhythm, witnessed status, type of bystander cardiopulmonary resuscitation, use of public access automated external defibrillator, epinephrine administration, and time intervals. Similarly, the odds of neurologically favorable survival were significantly lower both for endotracheal intubation (adjusted OR, 0.41; 95% CI, 0.37-0.45) and for supraglottic airways (adjusted OR, 0.38; 95% CI, 0.36-0.40). In a propensity score-matched cohort (357,228 patients), the adjusted odds of neurologically favorable survival were significantly lower both for

  7. The role of prehospital advanced airway management on outcomes for out-of-hospital cardiac arrest patients: a meta-analysis.

    Science.gov (United States)

    Jeong, Seungmin; Ahn, Ki Ok; Shin, Sang Do

    2016-11-01

    The objective of this meta-analysis was to compare the benefits of prehospital advanced airway management (AAM) and basic airway management (BAM) for out-of-hospital cardiac arrest (OHCA) patients. Two investigators performed a systematic review of PubMed, EMBASE, and the Cochrane Database to identify all peer-reviewed articles relevant to this meta-analysis. We included all articles describing emergency medical system-treated nontraumatic OHCAs; specifically, all articles that described intervention of the prehospital AAM type were considered. The primary outcome was survival to discharge, whereas the secondary outcome was neurologic recovery after an OHCA event. For subgroup analysis, we compared the clinical outcome of endotracheal intubation (ETI), a specific type of AAM, vs BAM. We reviewed 1452 studies, 10 of which satisfied all the inclusion criteria and involved 17 380 patients subjected to AAM and 67 525 subjected to BAM. Based on the full random effects model, patients who received AAM had lower odds of survival (odds ratio [OR], 0.51; 95% confidence interval [CI], 0.29-0.90) compared with BAM. Subgroup analysis for ETI vs BAM showed no significant association with respect to survival (OR, 0.44; 95% CI, 0.16-1.23). There were no significant differences in the odds of neurologic recovery between AAM and BAM (OR, 0.64; 95% CI, 0.03-1.37). Our results reveal decreased survival odds for OHCA patients treated with AAM by emergency medical service personnel compared with BAM. However, the role of prehospital AAM, especially ETI, on achieving neurologic recovery remains unclear. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. The impact of first responder turnout and curb-to-care intervals on survival from out-of-hospital cardiac arrest.

    Science.gov (United States)

    DeRuyter, Nicolaas P; Husain, Sofia; Yin, Lihua; Olsufka, Michele; McCoy, Andrew M; Maynard, Charles; Cobb, Leonard A; Rea, Thomas D; Sayre, Michael R

    2017-04-01

    Patients with out-of-hospital cardiac arrest (OHCA) more likely survive when emergency medical services (EMS) arrive quickly. We studied time response elements in OHCA with attention to EMS intervals before wheels roll and after wheels stop to understand their contribution to total time response and clinical outcome. We analyzed EMS responses to OHCA from 2009-2014 in an urban, fire department based system. The Call-to-Care Interval, from call receipt to hands-on EMS care, was comprised of four time intervals: 1) call received to EMS notification (Activation), 2) EMS notification to vehicle wheels rolling (Turnout), 3) wheels rolling to arrival at scene (Travel), and 4) arrival at scene to hands-on EMS care (Curb-to-Care). We created a new time interval (On-Feet) comprised of the turnout and curb-to-care intervals. Using logistic regression, we evaluated whether the total EMS response interval and discrete time intervals were related to survival to discharge. Of 1,831 cases, 1,806 (98.6%) had complete information. The mean lengths for the intervals were 7.2±3.6min. (call-to-care), 58±39s (activation), 63±29s (turnout), 2.5±1.3min (travel), 2.4±1.6min (curb-to-care), and 3.5±1.7min (on-feet). After adjustment, "On Feet" interval was associated with OHCA survival (OR=0.91 [95% CI=0.83-1.00] for each additional minute). Turnout and curb-to-care intervals were half of the total response interval in our EMS system. Measurement should incorporate these two intervals to accurately characterize and possibly reduce the professional response interval. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Quality of cardiopulmonary resuscitation in out-of-hospital cardiac arrest is hampered by interruptions in chest compressions--a nationwide prospective feasibility study

    DEFF Research Database (Denmark)

    Krarup, Niels Henrik; Terkelsen, Christian Juhl; Johnsen, Søren Paaske

    2011-01-01

    Quality of cardiopulmonary resuscitation (CPR) is a critical determinant of outcome following out-of-hospital cardiac arrest. The aim of our study was to evaluate the quality of CPR provided by emergency medical service providers (Basic Life Support (BLS) capability) and emergency medical service...

  10. Quality of cardiopulmonary resuscitation in out-of-hospital cardiac arrest is hampered by interruptions in chest compressions-A nationwide prospective feasibility study

    DEFF Research Database (Denmark)

    Krarup, Niels Henrik; Terkelsen, Christian Juhl; Johnsen, Søren Paaske

    2010-01-01

    Quality of cardiopulmonary resuscitation (CPR) is a critical determinant of outcome following out-of-hospital cardiac arrest. The aim of our study was to evaluate the quality of CPR provided by emergency medical service providers (Basic Life Support (BLS) capability) and emergency medical service...

  11. Ventricular ectopic burden in comatose survivors of out-of-hospital cardiac arrest treated with targeted temperature management at 33°C and 36°C

    DEFF Research Database (Denmark)

    Thomsen, Jakob Hartvig; Kjaergaard, Jesper; Graff, Claus

    2016-01-01

    PURPOSE: Life threatening arrhythmias are increasingly frequent with lower body temperature. While targeted temperature management (TTM) with mild hypothermia following out-of-hospital cardiac arrest (OHCA) is generally considered safe and has been suggested as a potential antiarrhythmic add...... in ventricular ectopic activity (pincidence of ventricular ectopic...

  12. Incidence, Causes, and Outcomes of Out-of-Hospital Cardiac Arrest in Children A Comprehensive, Prospective, Population-Based Study in the Netherlands

    NARCIS (Netherlands)

    Bardai, Abdennasser; Berdowski, Jocelyn; van der Werf, Christian; Ceelen, Manon; van Langen, Irene M.; Tijssen, Jan G. P.; Wilde, Arthur A. M.; Koster, Rudolph W.; Tan, Hanno L.; Blom, Marieke T.

    2011-01-01

    Objectives This study sought to determine comprehensively the incidence of pediatric out-of-hospital cardiac arrest (OHCA) and its contribution to total pediatric mortality, the causes of pediatric OHCA, and the outcome of resuscitation of pediatric OHCA patients. Background There is a paucity of

  13. Hemodynamics and vasopressor support during targeted temperature management at 33°C Versus 36°C after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Bro-Jeppesen, John; Annborn, Martin; Hassager, Christian

    2015-01-01

    OBJECTIVE: To investigate the hemodynamic profile associated with different target temperatures and to assess the prognostic implication of inotropic/vasopressor support and mean arterial pressure after out-of-hospital cardiac arrest. There is a lack of information how different target temperatures...

  14. Incidence, Causes, and Outcomes of Out-of-Hospital Cardiac Arrest in Children A Comprehensive, Prospective, Population-Based Study in the Netherlands

    NARCIS (Netherlands)

    A. Bardai; J. Berdowski; C. van der Werf; M.T. Blom; M. Ceelen; I.M. van Langen; J.G.P. Tijssen; A.A.M. Wilde; R.W. Koster; H.L. Tan

    2011-01-01

    Objectives This study sought to determine comprehensively the incidence of pediatric out-of-hospital cardiac arrest (OHCA) and its contribution to total pediatric mortality, the causes of pediatric OHCA, and the outcome of resuscitation of pediatric OHCA patients. Background There is a paucity of co

  15. Age-specific prognostication after out-of-hospital cardiac arrest - The ethical dilemma between 'life-sustaining treatment' and 'the right to die' in the elderly.

    Science.gov (United States)

    Sulzgruber, Patrick; Sterz, Fritz; Poppe, Michael; Schober, Andreas; Lobmeyr, Elisabeth; Datler, Philip; Keferböck, Markus; Zeiner, Sebastian; Nürnberger, Alexander; Hubner, Pia; Stratil, Peter; Wallmueller, Christian; Weiser, Christoph; Warenits, Alexandra-Maria; van Tulder, Raphael; Zajicek, Andreas; Buchinger, Angelika; Testori, Christoph

    2017-03-01

    While prognostic values on survival after out-of-hospital cardiac arrest have been well investigated, less attention has been paid to their age-specific relevance. Therefore, we aimed to identify suitable age-specific early prognostication in elderly patients suffering out-of-hospital cardiac arrest in order to reduce the burden of unnecessary treatment and harm. In a prospective population-based observational trial on individuals suffering out-of-hospital cardiac arrest, a total of 2223 patients receiving resuscitation attempts by the local emergency medical service in Vienna, Austria, were enrolled. Patients were stratified according to age as follows: young and middle-aged individuals (85 years). There was an increasing rate of 30-day mortality (+21.8%, p 85-year-olds. Frailty was directly associated with mortality (HR 1.22, 95% CI 1.01-1.51, p = 0.049), showing a 30-day survival of 5.6% and a favourable neurological outcome of 1.1% among elderly individuals. An initially shockable electrocardiogram proved to be a suitable tool for risk assessment and decision making in order to predict a successful outcome in elderly victims of out-of-hospital cardiac arrest. However, the outcomes of elderly patients seemed to be exceptionally poor in frail individuals and need to be considered in order to reduce unnecessary treatment decisions.

  16. Out-of-hospital cardiac arrests in an urban/rural area during 1991 and 1996 : have emergency medical service changes improved outcome?

    NARCIS (Netherlands)

    Absalom, AR; Bradley, P; Soar, J

    1999-01-01

    Survival after out-of-hospital cardiac arrest is influenced by pre-hospital emergency medical care. This study compares outcome of cardiac arrest victims presenting to an emergency department serving a mixed urban/rural area (Norfolk, UK) in 1991 with 1996. Between these years the regional emergency

  17. Distance to invasive heart centre, performance of acute coronary angiography, and angioplasty and associated outcome in out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Tranberg, Tinne; Knudsen Lippert, Freddy; Christensen, Erika F

    2017-01-01

    Aims: To evaluate whether the distance from the site of event to an invasive heart centre, acute coronary angiography (CAG)/percutaneous coronary intervention (PCI) and hospital-level of care (invasive heart centre vs. local hospital) is associated with survival in out-of-hospital cardiac arrest...

  18. A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice

    Science.gov (United States)

    Rebers, S.; Vermeulen, E.; Brandenburg, A. P.; Stoof, T. J.; Zupan-Kajcovski, B.; Bos, W. J. W.; Jonker, M. J.; Bax, C. J.; van Driel, W. J.; Verwaal, V. J.; van den Brekel, M. W.; Grutters, J. C.; Tupker, R. A.; Plusjé, L.; de Bree, R.; Schagen van Leeuwen, J. H.; Vermeulen, E. G. J.; de Leeuw, R. A.; Brohet, R. M.; Aaronson, N. K.; Van Leeuwen, F. E.; Schmidt, M. K.

    2016-01-01

    Background Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. Methods We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded. Results We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus. Conclusion We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent

  19. A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice.

    Directory of Open Access Journals (Sweden)

    S Rebers

    Full Text Available Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus, and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients' tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms, 71%, 69%, and 31%, respectively, indicated being (very well informed. By questionnaire, the majority (53% indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%. Health care providers (N = 35 were more likely to be (very satisfied with opt-out plus than with informed consent (p = 0.002 or opt-out (p = 0.039; the majority (66% preferred opt-out plus.We conclude that opt-out with information (opt-out plus is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in

  20. Points to consider in the clinical use of NGS panels for mitochondrial disease: an analysis of gene inclusion and consent forms.

    Science.gov (United States)

    Platt, Julia; Cox, Rachel; Enns, Gregory M

    2014-08-01

    Mitochondrial next generation sequencing (NGS) panels offer single-step analysis of the numerous nuclear genes involved in the structure, function, and maintenance of mitochondria. However, the complexities of mitochondrial biology and genetics raise points for consideration in clinical use of these tests. To understand the current status of mitochondrial genetic testing, we assessed the gene offerings and consent forms of mitochondrial NGS panels available from seven US-based clinical laboratories. The NGS panels varied markedly in number of genes (101-1204 genes), and the proportion of genes causing "classic" mitochondrial diseases and their phenocopies ranged widely between labs (18 %-94 % of panel contents). All panels included genes not associated with classic mitochondrial diseases (6 %-28 % of panel contents), including genes causing adult-onset neurodegenerative disorders, cancer predisposition, and other genetic syndromes or inborn errors of metabolism. Five of the panels included genes that are not listed in OMIM to be associated with a disease phenotype (5 %-49 % of panel contents). None of the consent documents reviewed had options for patient preference regarding receipt of incidental findings. These findings raise points of discussion applicable to mitochondrial diagnostics, but also to the larger arenas of exome and genome sequencing, including the need to consider the boundaries between clinical and research testing, the necessity of appropriate informed consent, and the responsibilities of clinical laboratories and clinicians. Based on these findings, we recommend careful evaluation by laboratories of the genes offered on NGS panels, clear communication of the predicted phenotypes, and revised consent forms to allow patients to make choices about receiving incidental findings. We hope that our analysis and recommendations will help to maximize the considerable clinical utility of NGS panels for the diagnosis of mitochondrial disease.

  1. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

    Science.gov (United States)

    Diemert, David J; Lobato, Lucas; Styczynski, Ashley; Zumer, Maria; Soares, Amanda; Gazzinelli, Maria Flávia

    2017-01-01

    Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants' understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there

  2. Balancing between closeness and distance: emergency medical services personnel's experiences of caring for families at out-of-hospital cardiac arrest and sudden death.

    Science.gov (United States)

    Bremer, Anders; Dahlberg, Karin; Sandman, Lars

    2012-02-01

    Out-of-hospital cardiac arrest (OHCA) is a lethal health problem that affects between 236,000 and 325,000 people in the United States each year. As resuscitation attempts are unsuccessful in 70-98% of OHCA cases, Emergency Medical Services (EMS) personnel often face the needs of bereaved family members. Decisions to continue or terminate resuscitation at OHCA are influenced by factors other than patient clinical characteristics, such as EMS personnel's knowledge, attitudes, and beliefs regarding family emotional preparedness. However, there is little research exploring how EMS personnel care for bereaved family members, or how they are affected by family dynamics and the emotional contexts. The aim of this study is to analyze EMS personnel's experiences of caring for families when patients suffer cardiac arrest and sudden death. The study is based on a hermeneutic lifeworld approach. Qualitative interviews were conducted with 10 EMS personnel from an EMS agency in southern Sweden. The EMS personnel interviewed felt responsible for both patient care and family care, and sometimes failed to prioritize these responsibilities as a result of their own perceptions, feelings and reactions. Moving from patient care to family care implied a movement from well-structured guidance to a situational response, where the personnel were forced to balance between interpretive reasoning and a more direct emotional response, at their own discretion. With such affective responses in decision-making, the personnel risked erroneous conclusions and care relationships with elements of dishonesty, misguided benevolence and false hopes. The ability to recognize and respond to people's existential questions and needs was essential. It was dependent on the EMS personnel's balance between closeness and distance, and on their courage in facing the emotional expressions of the families, as well as the personnel's own vulnerability. The presence of family members placed great demands on mobility

  3. Prognostic Implications of Level-of-Care at Tertiary Heart Centers Compared With Other Hospitals After Resuscitation From Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Søholm, Helle; Kjaergaard, Jesper; Bro-Jeppesen, John

    2015-01-01

    . The adjusted odds of predefined markers of level-of-care were higher in tertiary centers: admission to intensive care unit (odds ratio [OR], 1.8 [95% confidence interval, 1.2-2.5]), temporary pacemaker (OR, 6.4 [2.2-19]), vasoactive agents (OR, 1.5 [1.1-2.1]), acute (...-segment-elevation myocardial infarction in the Copenhagen area even after adjustment for prognostic factors including comorbidity. Level-of-care seems higher in tertiary centers both in the early phase, during the intensive care unit admission, and in the workup before discharge. The varying level-of-care may contribute......BACKGROUND: Studies have found higher survival rates after out-of-hospital cardiac arrest and admission to tertiary heart centers. The aim was to examine the level-of-care at tertiary centers compared with nontertiary hospitals and the association with outcome after out-of-hospital cardiac arrest...

  4. Continuous chest compression versus interrupted chest compression for cardiopulmonary resuscitation of non-asphyxial out-of-hospital cardiac arrest.

    Science.gov (United States)

    Zhan, Lei; Yang, Li J; Huang, Yu; He, Qing; Liu, Guan J

    2017-03-27

    Out-of-hospital cardiac arrest (OHCA) is a major cause of death worldwide. Cardiac arrest can be subdivided into asphyxial and non asphyxial etiologies. An asphyxia arrest is caused by lack of oxygen in the blood and occurs in drowning and choking victims and in other circumstances. A non asphyxial arrest is usually a loss of functioning cardiac electrical activity. Cardiopulmonary resuscitation (CPR) is a well-established treatment for cardiac arrest. Conventional CPR includes both chest compressions and 'rescue breathing' such as mouth-to-mouth breathing. Rescue breathing is delivered between chest compressions using a fixed ratio, such as two breaths to 30 compressions or can be delivered asynchronously without interrupting chest compression. Studies show that applying continuous chest compressions is critical for survival and interrupting them for rescue breathing might increase risk of death. Continuous chest compression CPR may be performed with or without rescue breathing. To assess the effects of continuous chest compression CPR (with or without rescue breathing) versus conventional CPR plus rescue breathing (interrupted chest compression with pauses for breaths) of non-asphyxial OHCA. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1 2017); MEDLINE (Ovid) (from 1985 to February 2017); Embase (1985 to February 2017); Web of Science (1985 to February 2017). We searched ongoing trials databases including controlledtrials.com and clinicaltrials.gov. We did not impose any language or publication restrictions. We included randomized and quasi-randomized studies in adults and children suffering non-asphyxial OHCA due to any cause. Studies compared the effects of continuous chest compression CPR (with or without rescue breathing) with interrupted CPR plus rescue breathing provided by rescuers (bystanders or professional CPR providers). Two authors extracted the data and summarized the effects as risk ratios (RRs), adjusted risk

  5. Physician presence in an ambulance car is associated with increased survival in out-of-hospital cardiac arrest: a prospective cohort analysis.

    Directory of Open Access Journals (Sweden)

    Akihito Hagihara

    Full Text Available The presence of a physician seems to be beneficial for pre-hospital cardiopulmonary resuscitation (CPR of patients with out-of-hospital cardiac arrest. However, the effectiveness of a physician's presence during CPR before hospital arrival has not been established. We conducted a prospective, non-randomized, observational study using national data from out-of-hospital cardiac arrests between 2005 and 2010 in Japan. We performed a propensity analysis and examined the association between a physician's presence during an ambulance car ride and short- and long-term survival from out-of-hospital cardiac arrest. Specifically, a full non-parsimonious logistic regression model was fitted with the physician presence in the ambulance as the dependent variable; the independent variables included all study variables except for endpoint variables plus dummy variables for the 47 prefectures in Japan (i.e., 46 variables. In total, 619,928 out-of-hospital cardiac arrest cases that met the inclusion criteria were analyzed. Among propensity-matched patients, a positive association was observed between a physician's presence during an ambulance car ride and return of spontaneous circulation (ROSC before hospital arrival, 1-month survival, and 1-month survival with minimal neurological or physical impairment (ROSC: OR = 1.84, 95% CI 1.63-2.07, p = 0.00 in adjusted for propensity and all covariates; 1-month survival: OR = 1.29, 95% CI 1.04-1.61, p = 0.02 in adjusted for propensity and all covariates; cerebral performance category (1 or 2: OR = 1.54, 95% CI 1.03-2.29, p = 0.04 in adjusted for propensity and all covariates; and overall performance category (1 or 2: OR = 1.50, 95% CI 1.01-2.24, p = 0.05 in adjusted for propensity and all covariates. A prospective observational study using national data from out-of-hospital cardiac arrests shows that a physician's presence during an ambulance car ride was independently associated with

  6. Interactive informed consent: randomized comparison with paper consents.

    Directory of Open Access Journals (Sweden)

    Michael C Rowbotham

    Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

  7. Iatrogenic Perforations During Colonoscopy In a Portuguese Population: A Study Including In and Out-Of-Hospital Procedures

    Directory of Open Access Journals (Sweden)

    Sara Campos

    2016-07-01

    Conclusion: Perforations in colonoscopy are rare in our clinical practice. Endoscopic closure was effective, though limited to perforations found during the procedure. The mortality was relatively low and endoscopic management did not seem to worsen it. An additional effort is necessary in order to detect perforations during colonoscopy.

  8. Therapeutic hypothermia for out-of-hospital cardiac arrest: An analysis comparing cooled and not cooled groups at a Canadian center

    Directory of Open Access Journals (Sweden)

    D Alex MacLean

    2012-01-01

    Full Text Available Background: Out of hospital cardiac arrest is a devastating event and is associated with poor outcomes; however, therapeutic hypothermia (TH is a novel treatment which may improve neurological outcome and decrease mortality. Despite this, TH is not uniformly implemented across Coronary Care and Intensive Care Units in Canada. Objective: The purpose of this study was to compare cerebral recovery and mortality rates between patients in our Coronary Care Unit who received TH with a historical control group. Materials and Methods: A retrospective chart review was performed of patients admitted to a tertiary care center with out-of-hospital cardiac arrest. Twenty patients who were admitted and cooled after December 2006 were compared with 29 noncooled patients admitted in the 5 years prior as a historical control group. The primary outcomes of interest were in-hospital mortality and neurological outcome. Results: Eleven of 20 (11/20, 55% patients who were cooled as per protocol survived to hospital discharge, all having a good neurological outcome. Eleven of 29 (11/29, 38% noncooled patients survived to hospital discharge (Odds Ratio: 0.50, 95% CI: 0.16- 1.60, P=0.26. Eleven of 20 patients who were cooled had a good neurological outcome (CPS I-II, 11/20, 55%, versus 7 of 29 (7/29, 24% of noncooled patients (Odds ratio: 3.84, 95% CI: 1.13- 13.1, P=0.03. One hundred percent (11/11 of survivors in the cooled group had a good neurological outcome. Conclusion: In our center, the use of TH in out-of-hospital cardiac arrest survivors was associated with improved neurological outcome.

  9. [Conditions for the survival of combat casualties in overseas operations: procedure and experience from the Afghan out-of-hospital theater].

    Science.gov (United States)

    Palmier, Bruno

    2012-01-01

    Recent conflicts have led the French Army Health Service to specify the setting condition for the survival of combat casualties in overseas operations. The majority of them are victims of explosion injuries, and an early and effective control of bleeding is the primary means of improving survival. A procedure called "Combat Rescue" is taught. This chronological procedure favours external haemostasis and led to specific equipment, in particular a tourniquet and a haemostatic bandage of high efficiency. It is applied in recent years on the Afghan out-of-hospital theatre. A very front medical presence, which is systematic during evacuations, is a feature of the French Army Health Service operations support.

  10. Myocardial infarction is a frequent cause of exercise-related resuscitated out-of-hospital cardiac arrest in a general non-athletic population

    DEFF Research Database (Denmark)

    Søholm, Helle; Kjaergaard, Jesper; Thomsen, Jakob Hartvig;

    2014-01-01

    performed (88% vs. 54%, pCardiac etiology was the predominant cause of OHCA in both exercise and non-exercise patients......BACKGROUND: Performing exercise is shown to prevent cardiovascular disease, but the risk of an out-of-hospital cardiac arrest (OHCA) is temporarily increased during strenuous activity. We examined the etiology and outcome after successfully resuscitated OHCA during exercise in a general non......: OHCA occurring during exercise was associated with a significantly lower mortality in successfully resuscitated patients even after adjusting for confounding factors. Acute coronary syndrome was more common among exercise-related cardiac arrest patients....

  11. Informed consent in pediatric research.

    Science.gov (United States)

    Leibson, Tom; Koren, Gideon

    2015-02-01

    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

  12. Circadian variation of transient myocardial ischemia in the early out-of-hospital period after first acute myocardial infarction

    DEFF Research Database (Denmark)

    Mickley, H; Pless, P; Nielsen, J R

    1991-01-01

    Circadian rhythms have been demonstrated in acute myocardial infarction (AMI) and in other clinical cardiac dysfunctions. The purpose of this study was to elucidate whether a circadian pattern of transient myocardial ischemia exists after first AMI. Prospectively, 24-hour ambulatory ST......-segment monitoring was initiated at discharge on day 11 +/- 5 in 123 consecutive survivors of first AMI. A total of 93 ischemic episodes (91 asymptomatic) occurred in 21 of the 123 patients (17%) (mean duration of 30 minutes, range 4 to 292). A significant circadian rhythm of transient myocardial ischemia was found...... was significantly higher during morning episodes (p less than 0.02). Patients with transient myocardial ischemia had a diurnal distribution similar to the circadian variation displayed during ischemic activity. Thus, 16 of the 21 patients had ischemic episodes from 6 P.M. to 12 midnight versus 10 patients from 6 A...

  13. Prolonged closed cardiac massage using LUCAS device in out-of-hospital cardiac arrest with prolonged transport time

    Directory of Open Access Journals (Sweden)

    Edouard Matevossian

    2009-04-01

    Full Text Available Edouard Matevossian1, Dietrich Doll4, Jakob Säckl1, Inga Sinicina5, Jürgen Schneider2, Gerhard Simon3, Norbert Hüser11Department of Surgery, 2Department of Anesthesiology and Intensive-Care Medicine; 3Department of Radiology, Technische Universität of Munich, Germany; 4Department of Visceral, Vascular and Thoracic Surgery, Philips University of Marburg, Marburg, Germany; 5Institute of Clinical Forensic Medicine, Ludwig-Maximilian University of Munich, Munich, GermanyAbstract: Saving more human lives through more effective reanimation measures is the goal of the new international guidelines on cardiopulmonary resuscitation as the decisive aspect for survival after cardiovascular arrest is that basic resuscitation should start immediately. According to the updated guidelines, the greatest efficacy in cardiac massage is only achieved when the right compression point, an adequate compression depth, vertical pressure, the correct frequency, and equally long phases of compression and decompression are achieved. The very highest priority is placed on restoring continuous circulation. Against this background, standardized continuous chest compression with active decompression has contributed to a favorable outcome in this case. The hydraulically operated and variably adjustable automatic Lund University Cardiac Arrest System (LUCAS device (Jolife, Lund, Sweden undoubtedly meets these requirements. This case report describes a 44-year-old patient who – approximately 15 min after the onset of clinical death due to apparent ventricular fibrillation – received cardiopulmonary resuscitation, initially by laypersons and then by the emergency medical team (manual chest compressions followed by situation-adjusted LUCAS compressions. Sinus rhythm was restored after more than 90 min of continuous resuscitation, with seven defibrillations. Interventional diagnostic workup did not reveal a causal morphological correlate for the condition on coronary

  14. Misguided presumptions: British Medical Association (BMA) and National Institute for Health and Clinical Excellence (NICE) guidance on organ retrieval and 'opt out' or 'presumed consent'.

    Science.gov (United States)

    Randall, Fiona; Downie, Robin

    2012-12-01

    Three documents have been produced in an attempt to increase the number of organs available for transplant: a National Institute for Health and Clinical Excellence (NICE) clinical guideline, a British Medical Association (BMA) report and a Welsh Government white paper. All three are ethically flawed: NICE and the BMA recommend that whenever there is intention to withdraw life-sustaining treatment and death is expected, patients should instead be stabilised to assess for donation. This is contrary to patients' best interests, the principles of mental capacity legislation and current criteria for accessing intensive care units. Regarding consent, the BMA and Welsh Government recommend an 'opt-out' policy, but consent in law requires information and cannot be 'presumed' or 'deemed' on the basis of failure to express or register 'opting out'. The language of all three proposals is manipulative, and patient trust may be undermined because the doctor's attention must move from the interests of the patient to those of the unknown organ recipients.

  15. 儿童用药临床试验中的知情同意获得%Informed consent on clinical trail of drug for children

    Institute of Scientific and Technical Information of China (English)

    唐燕; 奚益群

    2015-01-01

    儿童用药临床试验的开展是儿童用药安全的重要保障,知情同意则是保障受试者权益的关键环节。与成年人相比,处于生长发育期的儿童在生理、心理等方面均有其特殊性。因此,对儿童参与临床试验的知情同意获得有特殊要求。%Clinical trail of drug for children is an important guarantee for the safety of children medication. Informed consent is the key link in the protection of the rights and interests of the subjects. Compared with adults, children in the growth and development are special in physiological, psychological and other aspects. Therefore, there are special requirements in the acquisition of informed consent for children participating in clinical trail.

  16. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

    This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we...... on the character of the information exchanged, and we uncover a range of causes of routinisation. Finally, the article discusses possible ways of countering the problem of routinisation of informed consent....

  17. Survival models for out-of-hospital cardiopulmonary resuscitation from the perspectives of the bystander, the first responder, and the paramedic.

    Science.gov (United States)

    Waalewijn, R A; de Vos, R; Tijssen, J G; Koster, R W

    2001-11-01

    Survival from out-of-hospital resuscitation depends on the strength of each component of the chain of survival. We studied, on the scene, witnessed, nontraumatic resuscitations of patients older than 17 years. The influence of the chain of survival and potential predictors on survival was analyzed by logistic regression modeling. From 1030 patients, 139 survived to hospital discharge. Three prediction models of survival were developed from the perspective of the different contributors active in out-of-hospital resuscitation: model I, bystanders; model II, first responders; and model III, paramedics. Predictors for survival (with odds ratio) were: in model I (bystanders): emergency medical service (EMS) witnessed arrest (0.50), delay to basic cardiopulmonary resuscitation (CPR) (0.74/min) and delay to EMS arrival (0.87/min); in model II (first responders): initial recorded heart rhythm (0.02 for nonshockable rhythm), delay to basic CPR (0.71/min and 0.87/min for shockable and nonshockable rhythms) and to defibrillation (0.89/min), and in model III (paramedics): need for advanced CPR (4.74 for advanced CPR not-needed), initial recorded heart rhythm (0.05 for nonshockable rhythm), and delay to basic CPR (0.77/min and 0.72/min for shockable and nonshockable rhythms), to defibrillation and to advanced CPR for shockable rhythms (0.85/min), and to advanced CPR for nonshockable rhythm (0.85/min). The area under the receiver-operator characteristic curve for model I was 0.763, for model II was 0.848, and for model III was 0.896. Of survivors, 50% had restoration of circulation without need for advanced CPR. Three survival models for witnessed nontraumatic out-of-hospital resuscitation based on the information known by bystanders, first responders and paramedics explained survival with increasing precision. Early defibrillation can restore circulation without the need for advanced CPR. When advanced CPR is needed, its delay leads to a markedly reduced survival.

  18. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

    This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we...

  19. Risk of seizures in transcranial magnetic stimulation: a clinical review to inform consent process focused on bupropion

    Directory of Open Access Journals (Sweden)

    Dobek CE

    2015-11-01

    involved in a percentage of the seizures. None of these seizures reported had patients taking bupropion in the literature review. One rTMS-induced seizure was reported from the Food and Drug Administration in a sleep-deprived patient who was concurrently taking bupropion, sertraline, and amphetamine.Conclusion: During the consent process, potential risk factors for an rTMS-induced seizure should be carefully screened for and discussed. Data do not support considering concurrent bupropion treatment as contraindication to undergo rTMS.Keywords: repetitive transcranial magnetic stimulation, seizures, bupropion, consent process, interaction

  20. Consenting to Heteronormativity: Assumptions in Biomedical Research

    NARCIS (Netherlands)

    Cottingham, M.D.; Fisher, J.A.

    2015-01-01

    The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormati

  1. Consenting to Heteronormativity: Assumptions in Biomedical Research

    NARCIS (Netherlands)

    Cottingham, M.D.; Fisher, J.A.

    2015-01-01

    The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormati

  2. A low body temperature on arrival at hospital following out-of-hospital-cardiac-arrest is associated with increased mortality in the TTM-study

    DEFF Research Database (Denmark)

    Hovdenes, Jan; Røysland, Kjetil; Nielsen, Niklas

    2016-01-01

    logistic regression model mortality was significantly related to time from OHCA to ROSC, time from OHCA to advanced life support (ALS), age, sex and first registered rhythm. None of the temperature related variables (included the TTM-groups) were significantly related to mortality. CONCLUSION: OHCA...... patients with a temperature ≤34.0°C on arrival have a higher mortality than patients with a temperature ≥34.1°C on arrival. A low temperature on arrival is associated with a long time to ROSC. Temperature changes and TTM-groups were not associated with mortality in a regression model.......AIM: To investigate the association of temperature on arrival to hospital after out-of-hospital-cardiac arrest (OHCA) with the primary outcome of mortality, in the targeted temperature management (TTM) trial. METHODS: The TTM trial randomized 939 patients to TTM at 33 or 36°C for 24h. Patients were...

  3. Target temperature management of 33°C and 36°C in patients with out-of-hospital cardiac arrest with initial non-shockable rhythm

    DEFF Research Database (Denmark)

    Frydland, Martin; Kjaergaard, Jesper; Erlinge, David

    2015-01-01

    PURPOSE: Despite a lack of randomized trials in comatose survivors of out-of-hospital cardiac arrest (OHCA) with an initial non-shockable rhythm (NSR), guidelines recommend induced hypothermia to be considered in these patients. We assessed the effect on outcome of two levels of induced hypothermia...... Score (CPC) and modified Rankin Scale (mRS)), and organ dysfunction (Sequential Organ Failure Assessment (SOFA) score). RESULTS: Patients with NSR were older, had longer time to ROSC, less frequently had bystander CPR and had higher lactate levels at admission compared to patients with shockable rhythm...... prognosis. We found no effect of targeted temperature management at 33°C compared to 36°C in these patients....

  4. The need to immobilise the cervical spine during cardiopulmonary resuscitation and electric shock administration in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Desroziers, Milene; Mole, Sophie; Jost, Daniel; Tourtier, Jean-Pierre

    2016-06-13

    In cases of out-of hospital cardiac arrest (OHCA), falling to the ground can cause brain and neck trauma to the patient. We present a case of a man in his mid-60s who suffered from an OHCA resulting in a violent collapse. The patient received immediate cardiopulmonary resuscitation, but his spine was immobilised only after a large frontal haematoma was found. The resuscitation efforts resulted in return of spontaneous circulation and discharge from hospital. After this, doctors performed angioplasty, followed by a cardiopulmonary bypass. Later, CT scan examination reported a displaced and unstable fracture of the 6th vertebra without bone marrow involvement. The patient underwent a second operation. 40 days later, he was able to return home without sequela. This case shows the importance of analysing the circumstances of a fall, considering the possibility of two concomitant diagnoses and prioritising investigations and treatment.

  5. Is the pre-hospital ECG after out-of-hospital cardiac arrest accurate for the diagnosis of ST-elevation myocardial infarction?

    DEFF Research Database (Denmark)

    Salam, Idrees; Hassager, Christian; Thomsen, Jakob Hartvig

    2016-01-01

    -hospital ROSC-ECG in predicting ST-elevation myocardial infarction (STEMI). METHOD: ROSC-ECGs of 145 comatose survivors of out-of-hospital cardiac arrest, randomly assigned in the Target Temperature Management trial, were classified according to the current STEMI ECG criteria (third universal definition...... of myocardial infarction). RESULTS: STEs were present in the pre-hospital ROSC-ECG of 78 (54%) patients. A final diagnosis revealed that 69 (48%) patients had STEMI, 31 (21%) patients had non-STEMI and 45 (31%) patients had no myocardial infarction. STE in ROSC-ECGs had a sensitivity of 74% (95% confidence...... intervention was successful in 68% versus 36% (PECG is a suboptimal diagnostic tool to predict STEMI...

  6. Informed Consent and Clinical Research Involving Children and Adolescents: Implications of the Revised APA Ethics Code and HIPAA

    Science.gov (United States)

    Fisher, Celia B.

    2004-01-01

    In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part…

  7. Locating Automated External Defibrillators in a Complicated Urban Environment Considering a Pedestrian-Accessible Network that Focuses on Out-of-Hospital Cardiac Arrests

    Directory of Open Access Journals (Sweden)

    Pil Kwon

    2017-02-01

    Full Text Available Automated external defibrillators (AEDs are portable devices that defibrillate and diagnose sudden-cardiac-arrest patients. Therefore, AEDs are widely installed in public places such as airports, schools, sport complexes, etc., and the installation of AEDs is required by law in these places. However, despite their usefulness, AEDs are mostly installed indoors with limited coverage outdoors. Hence, this study conducts research in the placement of AEDs in outdoor locations. This study considers a complicated urban environment using a pedestrian network dataset and network barriers. We draw on the Teitz and Bart’s (1968 heuristic method that was built in the location-allocation solver in ArcMap. The results of this study found that a total of 455 AEDs, including 227 pre-installed AEDs, could be placed in the study area, thus providing an additional 228 devices. Compared with 10 different installation methods that were set as experimental groups, our test results found that additional installations were able to cover 10% to 30% more actual out-of-hospital cardiac-arrest cases. The main contribution of this study is the proposal of a new method in locating AEDs in optimal areas while considering complicated urban environments. We predict that the cardiac-arrest-related mortality rate would be reduced through implementing the findings of this study.

  8. Mild therapeutic hypothermia in patients resuscitated from out-of-hospital cardiac arrest: A meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pedro A Villablanca

    2016-01-01

    Full Text Available Aims: Guidelines recommend mild therapeutic hypothermia (MTH for survivors of out-of-hospital cardiac arrest (OHCA. However, there is little literature demonstrating a survival benefit. We performed a meta-analysis of randomized controlled trials (RCTs assessing the efficacy of MTH in patients successfully resuscitated from OHCA. Materials and Methods: Electronic databases were searched for RCT involving MTH in survivors of OHCA, and the results were put through a meta-analysis. The primary endpoint was all-cause mortality, and the secondary endpoint was favorable neurological function. Odds ratios (ORs and 95% confidence intervals (CIs were computed using the Mantel-Haenszel method. A fixed-effect model was used and, if heterogeneity (I2 was >40, effects were analyzed using a random model. Results: Six RCT (n = 1400 patients were included. Overall survival was 50.7%, and favorable neurological recovery was 45.5%. Pooled data demonstrated no significant all-cause mortality (OR, 0.81; 95% CI 0.55-1.21 or neurological recovery (OR, 0.77; 95% CI 0.47-1.24. No evidence of publication bias was observed. Conclusion: This meta-analysis demonstrated that MTH did not confer benefit on overall survival rate and neurological recovery in patients resuscitated from OHCA.

  9. A qualitative study about experiences and emotions of emergency medical technicians and out-of-hospital emergency nurses after performing cardiopulmonary resuscitation resulting in death.

    Science.gov (United States)

    Fernández-Aedo, I; Pérez-Urdiales, I; Unanue-Arza, S; García-Azpiazu, Z; Ballesteros-Peña, S

    To explore the experiences, emotions and coping skills among emergency medical technicians and emergency nurses after performing out-of-hospital cardiopulmonary resuscitation manoeuvres resulting in death. An exploratory qualitative research was performed. Seven emergency medical technicians and six emergency nurses were selected by non-probability sampling among emergency medical system workers. The meetings took place up to information saturation, achieved after six individual interviews and a focal group. The meetings were then transcribed and a manual and inductive analysis of the contents performed. After a failed resuscitation several short and long-term reactions appear. They can be negatives, such as sadness or uncertainty, or positives, such as the feeling of having done everything possible to save the patient's life. Emotional stress increases when ambulance staff have to talk with the deceased's family or when the patient is a child. The workers don't know of a coping strategy other than talking about their emotions with their colleagues. Death after a failed resuscitation can be viewed as a traumatic experience for rescuers. Being in contact with the suffering of others is an emotional, stress-generating factor with direct repercussions on the working and personal lives of emergency staff. Nevertheless, structured coping techniques are not common among those professionals. Copyright © 2016 Sociedad Española de Enfermería Intensiva y Unidades Coronarias (SEEIUC). Publicado por Elsevier España, S.L.U. All rights reserved.

  10. Ventricular ectopic burden in comatose survivors of out-of-hospital cardiac arrest treated with targeted temperature management at 33°C and 36°C.

    Science.gov (United States)

    Thomsen, Jakob Hartvig; Kjaergaard, Jesper; Graff, Claus; Pehrson, Steen; Erlinge, David; Wanscher, Michael; Køber, Lars; Bro-Jeppesen, John; Søholm, Helle; Winther-Jensen, Matilde; Hassager, Christian

    2016-05-01

    Life threatening arrhythmias are increasingly frequent with lower body temperature. While targeted temperature management (TTM) with mild hypothermia following out-of-hospital cardiac arrest (OHCA) is generally considered safe and has been suggested as a potential antiarrhythmic add-on therapy, it is unknown whether the level of TTM affects the burden of ventricular ectopic activity. We sought to assess the ventricular ectopic burden between patients treated with TTM at 33°C or 36°C for 24h. Continuous 12-lead digital Holter electrocardiograms performed during the intervention were analyzed blinded to treatment allocation in 115 comatose OHCA-survivors from a single center of the TTM-trial. The main study showed no difference with regards to mortality. Fifty-eight patients were randomized to 33°C and 57 to 36°C. Cardiac arrest characteristics were similar between the groups. The number of isolated ventricular ectopic beats (VEB) per hour was similar at the beginning of the maintenance phase of TTM and decreased over time in both groups (both ptimeectopic activity in the 36°C-group (pinteractionectopic activity (pectopic activity was reduced in comatose OHCA-survivors treated with TTM at 36°C compared to 33°C. Higher numbers of pre-hospital defibrillations were associated with higher incidence of ventricular ectopic activity. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. [Informed consent in psychosomatic medicine].

    Science.gov (United States)

    Satohisa, E

    1998-01-01

    Obtaining informed consent perfectly is very difficult from the view of psychosomatic medicine. Medical education regarding informed consent is generally of a low level. However as it is important to defend patients' human rights, we must educate them as to the precise meaning of both "informed" and "consent". In this report I have tried to demonstrate that both the education of medical students and their social consciousness are very important. I examined students' opinions regarding the care of a sudden case of hysterectomy (Porro's emergent operation). The following students were involved: 1st year medical students (N = 73), 4th year (N = 85) and 6th year (N = 119), and 3rd year nursing students (N = 42) and midwife students (N = 27). I examined their answers by transactional analysis. The answers of the 1st year medical students reflecting the view of the child ego state were significantly greater than those of the other students (P students altered to reflect the view of the adult ego more (P Japan" in our clinic two years ago. Since then we have talked every month to people in general about various women's diseases, and also discussed various problems of the doctor-patient relationships during these talks. I feel that public awareness concerning informed consent has increased gradually recently in Japan.

  12. Culture clash on consent.

    Science.gov (United States)

    2010-07-01

    All research on human subjects requires their informed consent. Obtaining valid consent from isolated minorities can be particularly challenging, but scientists need to avoid the temptingly easy way out, so as to prevent further exclusion of these vulnerable populations from biomedical research.

  13. Prognostic value of reduced discrimination and oedema on cerebral computed tomography in a daily clinical cohort of out-of-hospital cardiac arrest patients

    DEFF Research Database (Denmark)

    Langkjær, Sandra; Hassager, Christian; Kjaergaard, Jesper

    2015-01-01

    bleeding' in 4(3%), 'new cerebral infarction' in 10(7%), and 'reduced discrimination between white and grey matter and/or oedema' in 45(30%) patients. 'Reduced discrimination and/or oedema' by late cCT was independently associated with higher 30-day mortality compared to patients with a normal late CT (HR......(adjusted) = 2.6 (95%CI: 1.4-4.8, p = 0.002). CONCLUSION: Our observations suggest that a cCT may be useful as part of the neurological prognostication in patients with OHCA. 'Reduced discrimination between white and grey matter and/or oedema' on cCT was independently associated with a poor prognosis....

  14. 儿童药物临床试验研究知情同意的伦理审查%Ethic review of informed consent in pediatric medicine clinical and trial study

    Institute of Scientific and Technical Information of China (English)

    李艺影; 潘岳松; 任佩娟

    2013-01-01

    The significant difference between children and adult have been identified in physiology, pharmacology, psychology, recognition and autonomy. There was different characteristics among different children age group. Besides complying with the basic principle of general clinical and trial study, informed consent in clinical and trial study involving children has special requirements in informed information, informed consent procedure, and consent decision. This paper focused on the ethic issues and specificity of informed consent in pediatric clinical and trial study involving children. The paper might provide guidance on the ethic review of informed consent in pediatric clinical and trial study.%由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求.文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查.

  15. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

    Directory of Open Access Journals (Sweden)

    Felicity L Bishop

    Full Text Available BACKGROUND: Placebo groups are used in randomised clinical trials (RCTs to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects. METHODS AND FINDINGS: We conducted a content analysis of 45 Participant Information Leaflets (PILs using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database. Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%, but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001 and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001 or adverse effects (4 vs. 39, p<001. 8 PILs (18% explicitly stated that the placebo treatment was either undesirable or ineffective. CONCLUSIONS: PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the

  16. Association of Bystander and First-Responder Intervention With Survival After Out-of-Hospital Cardiac Arrest in North Carolina, 2010-2013.

    Science.gov (United States)

    Malta Hansen, Carolina; Kragholm, Kristian; Pearson, David A; Tyson, Clark; Monk, Lisa; Myers, Brent; Nelson, Darrell; Dupre, Matthew E; Fosbøl, Emil L; Jollis, James G; Strauss, Benjamin; Anderson, Monique L; McNally, Bryan; Granger, Christopher B

    2015-07-21

    Out-of-hospital cardiac arrest is associated with low survival, but early cardiopulmonary resuscitation (CPR) and defibrillation can improve outcomes if more widely adopted. To examine temporal changes in bystander and first-responder resuscitation efforts before arrival of the emergency medical services (EMS) following statewide initiatives to improve bystander and first-responder efforts in North Carolina from 2010-2013 and to examine the association between bystander and first-responder resuscitation efforts and survival and neurological outcome. We studied 4961 patients with out-of-hospital cardiac arrest for whom resuscitation was attempted and who were identified through the Cardiac Arrest Registry to Enhance Survival (2010-2013). First responders were dispatched police officers, firefighters, rescue squad, or life-saving crew trained to perform basic life support until arrival of the EMS. Statewide initiatives to improve bystander and first-responder interventions included training members of the general population in CPR and in use of automated external defibrillators (AEDs), training first responders in team-based CPR including AED use and high-performance CPR, and training dispatch centers in recognition of cardiac arrest. The proportion of bystander and first-responder resuscitation efforts, including the combination of efforts between bystanders and first responders, from 2010 through 2013 and the association between these resuscitation efforts and survival and neurological outcome. The combination of bystander CPR and first-responder defibrillation increased from 14.1% (51 of 362; 95% CI, 10.9%-18.1%) in 2010 to 23.1% (104 of 451; 95% CI, 19.4%-27.2%) in 2013 (P bystander-initiated CPR. Adjusting for age and sex, bystander and first-responder interventions were associated with higher survival to hospital discharge. Survival following EMS-initiated CPR and defibrillation was 15.2% (30 of 198; 95% CI, 10.8%-20.9%) compared with 33.6% (38 of 113; 95% CI

  17. Impact of the Great East Japan earthquake on out-of-hospital cardiac arrest with cardiac origin in non-disaster areas [corrected].

    Science.gov (United States)

    Kiyohara, Kosuke; Kitamura, Tetsuhisa; Iwami, Taku; Nishiyama, Chika; Kawamura, Takashi

    2015-02-01

    To examine changes in the incidence of out-of-hospital cardiac arrest (OHCA) with cardiac origin in the non-disaster areas of Japan before and after the Great East Japan Earthquake of 11 March 2011. The 35 prefectures in Japan with no dead or missing caused directly by the earthquake were defined as the non-disaster areas. Data of adult OHCA patients in the non-disaster areas from March 4 to 24 each year from 2005 to 2011 were obtained from the All-Japan Utstein Registry. Risk ratios (RRs) of OHCA incidence and 95% CIs were estimated for three specific weeks in 2011 (1 week before and 2 weeks after the earthquake) by applying multivariable Poisson regression model. Incidence in the corresponding periods of March 4-24 from 2005 to 2010 was set as the baseline risk. In the analyses from a total of 17,353 OHCA patients, the incidence statistically significantly increased in the first week after the earthquake in all adults (adjusted-RR=1.13, 95% CI=1.05 to 1.22, p=0.001) and in elderly women (adjusted-RR=1.23, 95% CI=1.11 to 1.37, pJapan Earthquake caused the increase of OHCA among elderly women even in the non-disaster areas. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Role of coronary angiography for out-of-hospital cardiac arrest survivors according to postreturn of spontaneous circulation on an electrocardiogram

    Science.gov (United States)

    Lee, Tae Rim; Hwang, Sung Yeon; Cha, Won Chul; Shin, Tae Gun; Sim, Min Seob; Jo, Ik Joon; Song, Keun Jeong; Rhee, Joong Eui; Jeong, Yeon Kwon

    2017-01-01

    Abstract Survivors of out-of-hospital cardiac arrest (OHCA) have high mortality and morbidity. An acute coronary event is the most common cause of sudden cardiac death. For this reason, coronary angiography is an important diagnostic and treatment strategy for patients with postcardiac arrest. This study aimed to identify the correlation between postreturn of spontaneous circulation (ROSC) on an electrocardiogram (ECG) and results of coronary angiography of OHCA survivors. We collected data from our OHCA registry from January 2010 to November 2014. We categorized OHCA survivors into 2 groups according to post-ROSC ECG results. Emergent coronary artery angiography (CAG) (CAG performed within 12 hours after cardiac arrest) was performed in patients who showed ST segment elevation or new onset of left bundle branch block (LBBB) in post-ROSC ECG. For other patients, the decision for performing CAG was made according to agreement between the emergency physician and the cardiologist. During the study period, 472 OHCA victims visited our emergency department and underwent cardiopulmonary resuscitation. Among 198 OHCA survivors, 82 patients underwent coronary artery intervention. Thirty-one (70.4%) patients in the ST segment elevation or LBBB group and 10 (24.4%) patients in the nonspecific ECG group had coronary artery lesions (P < .01). Seven (18.4%) patients in the nonspecific ECG group showed coronary spasm. OHCA survivors without ST segment elevation or new onset LBBB still have significant coronary lesions in CAG. If there is no other obvious arrest cause in patients without significant changes in post ROSC ECG, CAG should be considered to rule out the possibility of coronary artery problems, including coronary spasm. PMID:28207539

  19. Does Pre-hospital Endotracheal Intubation Improve Survival in Adults with Non-traumatic Out-of-hospital Cardiac Arrest? A Systematic Review

    Directory of Open Access Journals (Sweden)

    Ling Tiah

    2014-11-01

    Full Text Available Introduction: Endotracheal intubation (ETI is currently considered superior to supraglottic airway devices (SGA for survival and other outcomes among adults with non-traumatic out-of-hospital cardiac arrest (OHCA. We aimed to determine if the research supports this conclusion by conducting a systematic review. Methods: We searched the MEDLINE, Scopus and CINAHL databases for studies published between January 1, 1980, and 30 April 30, 2013, which compared pre-hospital use of ETI with SGA for outcomes of return of spontaneous circulation (ROSC; survival to hospital admission; survival to hospital discharge; and favorable neurological or functional status. We selected studies using pre-specified criteria. Included studies were independently screened for quality using the Newcastle-Ottawa scale. We did not pool results because of study variability. Study outcomes were extracted and results presented as summed odds ratios with 95% CI. Results: We identified five eligible studies: one quasi-randomized controlled trial and four cohort studies, involving 303,348 patients in total. Only three of the five studies reported a higher proportion of ROSC with ETI versus SGA with no difference reported in the remaining two. None found significant differences between ETI and SGA for survival to hospital admission or discharge. One study reported better functional status at discharge for ETI versus SGA. Two studies reported no significant difference for favorable neurological status between ETI and SGA. Conclusion: Current evidence does not conclusively support the superiority of ETI over SGA for multiple outcomes among adults with OHCA. [West J Emerg Med. 2014;15(7:-0.

  20. Duration of Prehospital Cardiopulmonary Resuscitation and Favorable Neurological Outcomes for Pediatric Out-of-Hospital Cardiac Arrests: A Nationwide, Population-Based Cohort Study.

    Science.gov (United States)

    Goto, Yoshikazu; Funada, Akira; Goto, Yumiko

    2016-12-20

    The appropriate duration of cardiopulmonary resuscitation (CPR) for pediatric out-of-hospital cardiac arrests (OHCAs) remains unclear and may differ based on initial rhythm. We aimed to determine the relationship between the duration of prehospital CPR by emergency medical services (EMS) personnel and post-OHCA outcomes. We analyzed the records of 12 877 pediatric patients who experienced OHCAs (CPR duration was defined as the time from CPR initiation by EMS personnel to prehospital return of spontaneous circulation (ROSC) or to hospital arrival when prehospital ROSC was not achieved during prehospital CPR efforts. The rates of 30-day survival and 30-day CPC 1 to 2 were 9.1% (n=1167) and 2.5% (n=325), respectively. Prehospital EMS-initiated CPR duration was significantly and inversely associated with 30-day outcomes (adjusted odds ratio for 1-minute increments: 0.94, 95% confidence interval: 0.93-0.95 for survival; adjusted odds ratio: 0.90, 95% confidence interval: 0.88-0.92 for CPC 1-2). The duration of prehospital EMS-initiated CPR, beyond which the chance for favorable outcomes diminished to CPR durations beyond which the chance for 30-day survival with CPC 1 to 2 diminished to CPR, the prehospital CPR duration, beyond which the chance for favorable outcome diminished to CPR duration for pediatric OHCAs was independently and inversely associated with 30-day favorable outcomes. The duration of prehospital EMS-initiated CPR, beyond which the chance for 30-day favorable outcomes diminished to CPR duration to achieve this proportion of outcomes differed based on initial rhythm. Further research is required to elucidate appropriate CPR duration for pediatric OHCAs, including in-hospital CPR time. URL: https://clinicaltrials.gov. Unique identifier: NCT02432196. © 2016 American Heart Association, Inc.

  1. Effect of pre-hospital advanced airway management for out-of-hospital cardiac arrest caused by respiratory disease: a propensity score-matched study.

    Science.gov (United States)

    Ohashi-Fukuda, N; Fukuda, T; Yahagi, N

    2017-05-01

    Optimal pre-hospital care for out-of-hospital cardiac arrest (OHCA) caused by respiratory disease may differ from that for OHCA associated with other aetiologies, especially with respect to respiratory management. We aimed to investigate whether pre-hospital advanced airway management (AAM) was associated with favourable outcomes after OHCA caused by intrinsic respiratory disease. This nationwide, population-based, propensity score-matched study of adult patients in Japan with OHCA due to respiratory disease from 1 January 2005 to 31 December 2012 compared patients with and without pre-hospital AAM. The primary outcome was neurologically favourable survival at one month after the OHCA. Of 49,534 eligible patients, 20,458 received pre-hospital AAM and 29,076 did not. In a propensity score-matched cohort (18,483 versus 18,483 patients), the odds of neurologically favourable survival were significantly lower for patients receiving pre-hospital AAM (0.6% versus 1.5%; odds ratio [OR] 0.42 [95% confidence interval {CI} 0.34 to 0.52]). The results from multivariable logistic regression analysis also showed that pre-hospital AAM was significantly associated with a decreased chance of neurologically favourable survival (adjusted OR 0.43 [95% CI 0.35 to 0.52]). Similar findings were observed for one-month survival and pre-hospital return of spontaneous circulation. In subgroup analyses, pre-hospital AAM was associated with poor neurological outcomes, regardless of the type of airway device used (laryngeal mask airway, adjusted OR 0.35 [95% CI 0.19 to 0.57]; oesophageal obturator airway, adjusted OR 0.44 [95% CI 0.35 to 0.55]; and endotracheal tube, adjusted OR 0.47 [95% CI 0.30 to 0.69]). In conclusion, pre-hospital AAM was associated with poor neurological outcome among patients with OHCA caused by intrinsic respiratory disease.

  2. Combining Amplitude Spectrum Area with Previous Shock Information Using Neural Networks Improves Prediction Performance of Defibrillation Outcome for Subsequent Shocks in Out-Of-Hospital Cardiac Arrest Patients.

    Directory of Open Access Journals (Sweden)

    Mi He

    Full Text Available Quantitative ventricular fibrillation (VF waveform analysis is a potentially powerful tool to optimize defibrillation. However, whether combining VF features with additional attributes that related to the previous shock could enhance the prediction performance for subsequent shocks is still uncertain.A total of 528 defibrillation shocks from 199 patients experienced out-of-hospital cardiac arrest were analyzed in this study. VF waveform was quantified using amplitude spectrum area (AMSA from defibrillator's ECG recordings prior to each shock. Combinations of AMSA with previous shock index (PSI or/and change of AMSA (ΔAMSA between successive shocks were exercised through a training dataset including 255shocks from 99patientswith neural networks. Performance of the combination methods were compared with AMSA based single feature prediction by area under receiver operating characteristic curve(AUC, sensitivity, positive predictive value (PPV, negative predictive value (NPV and prediction accuracy (PA through a validation dataset that was consisted of 273 shocks from 100patients.A total of61 (61.0% patients required subsequent shocks (N = 173 in the validation dataset. Combining AMSA with PSI and ΔAMSA obtained highest AUC (0.904 vs. 0.819, p<0.001 among different combination approaches for subsequent shocks. Sensitivity (76.5% vs. 35.3%, p<0.001, NPV (90.2% vs. 76.9%, p = 0.007 and PA (86.1% vs. 74.0%, p = 0.005were greatly improved compared with AMSA based single feature prediction with a threshold of 90% specificity.In this retrospective study, combining AMSA with previous shock information using neural networks greatly improves prediction performance of defibrillation outcome for subsequent shocks.

  3. Thromboelastometric analysis of the risk factors for return of spontaneous circulation in adult patients with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Koami, Hiroyuki; Sakamoto, Yuichiro; Sakurai, Ryota; Ohta, Miho; Imahase, Hisashi; Yahata, Mayuko; Umeka, Mitsuru; Miike, Toru; Nagashima, Futoshi; Iwamura, Takashi; Yamada, Kosuke Chris; Inoue, Satoshi

    2017-01-01

    It is well known that coagulopathy is observed in patients with out-of-hospital cardiac arrest (OHCA). Thrombolytic therapy for those patients has been controversial until now. The purpose of this study was to identify a significant predictor for return of spontaneous circulation (ROSC) of OHCA patients in the emergency department (ED) using whole blood viscoelastic testing. Adult non-trauma OHCA patients transported to our hospital that underwent thromboelastometry (ROTEM) during cardiopulmonary resuscitation between January 2013 and December 2015 were enrolled in this study. We divided patients into two groups based on the presence or absence of ROSC, and performed statistical analysis utilizing patient characteristics, prehospital data, laboratory data, and ROTEM data. Seventy-five patients were enrolled. The ROSC group and non-ROSC group included 23 and 52 patients, respectively. The logistic regression analysis, utilizing significant parameters by univariate analysis, demonstrated that lactate level [odds ratio (OR) 0.880, 95% confidence interval (CI) 0.785-0.986, p = 0.028] and A30 of EXTEM test [OR 1.039, 95% CI 1.010-1.070, p = 0.009] were independent risk factors for ROSC. The cut-off values of lactate and A30 in EXTEM were 12.0 mmol/L and A 48.0 mm, respectively. We defined a positive prediction for ROSC if the patient presented lower lactate level (<12.0 mmol/L) and higher A30 of EXTEM (≥48.0 mm) with high specificity (94.7%) and accuracy (75.0%). The present study showed that lactate level and ROTEM parameter of clot firmness were reliable predictors of ROSC in the ED for adult patients with OHCA.

  4. Potential association of bystander-patient relationship with bystander response and patient survival in daytime out-of-hospital cardiac arrest.

    Science.gov (United States)

    Tanaka, Yoshio; Maeda, Tetsuo; Kamikura, Takahisa; Nishi, Taiki; Omi, Wataru; Hashimoto, Masaaki; Sakagami, Satoru; Inaba, Hideo

    2015-01-01

    To investigate whether the bystander-patient relationship affects bystander response to out-of-hospital cardiac arrest (OHCA) and patient outcomes depending on the time of day. This population-based observational study in Japan involving 139,265 bystander-witnessed OHCAs (90,426 family members, 10,479 friends/colleagues, and 38,360 others) without prehospital physician involvement was conducted from 2005 to 2009. Factors associated with better bystander response [early emergency call and bystander cardiopulmonary resuscitation (BCPR)] and 1-month neurologically favourable survival were assessed. The rates of dispatcher-assisted CPR during daytime (7:00-18:59) and nighttime (19:00-6:59) were highest in family members (45.6% and 46.1%, respectively, for family members; 28.7% and 29.2%, respectively, for friends/colleagues; and 28.1% and 25.3%, respectively, for others). However, the BCPR rates were lowest in family members (35.5% and 37.8%, respectively, for family members; 43.7% and 37.8%, respectively, for friends/colleagues; and 59.3% and 50.0%, respectively, for others). Large delays (≥ 5 min) in placing emergency calls and initiating BCPR were most frequent in family members. The overall survival rate was lowest (2.7%) for family members and highest (9.1%) for friends/colleagues during daytime. Logistic regression analysis revealed that the effect of bystander relationship on survival was significant only during daytime [adjusted odds ratios (95% CI) for survival from daytime OHCAs with family as reference were 1.51 (1.36-1.68) for friends/colleagues and 1.23 (1.13-1.34) for others]. Family members are least likely to perform BCPR and OHCAs witnessed by family members are least likely to survive during daytime. Different strategies are required for family-witnessed OHCAs. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. The linguistic and interactional factors impacting recognition and dispatch in emergency calls for out-of-hospital cardiac arrest: a mixed-method linguistic analysis study protocol.

    Science.gov (United States)

    Riou, Marine; Ball, Stephen; Williams, Teresa A; Whiteside, Austin; O'Halloran, Kay L; Bray, Janet; Perkins, Gavin D; Cameron, Peter; Fatovich, Daniel M; Inoue, Madoka; Bailey, Paul; Brink, Deon; Smith, Karen; Della, Phillip; Finn, Judith

    2017-07-09

    Emergency telephone calls placed by bystanders are crucial to the recognition of out-of-hospital cardiac arrest (OHCA), fast ambulance dispatch and initiation of early basic life support. Clear and efficient communication between caller and call-taker is essential to this time-critical emergency, yet few studies have investigated the impact that linguistic factors may have on the nature of the interaction and the resulting trajectory of the call. This research aims to provide a better understanding of communication factors impacting on the accuracy and timeliness of ambulance dispatch. A dataset of OHCA calls and their corresponding metadata will be analysed from an interdisciplinary perspective, combining linguistic analysis and health services research. The calls will be transcribed and coded for linguistic and interactional variables and then used to answer a series of research questions about the recognition of OHCA and the delivery of basic life-support instructions to bystanders. Linguistic analysis of calls will provide a deeper understanding of the interactional dynamics between caller and call-taker which may affect recognition and dispatch for OHCA. Findings from this research will translate into recommendations for modifications of the protocols for ambulance dispatch and provide directions for further research. The study has been approved by the Curtin University Human Research Ethics Committee (HR128/2013) and the St John Ambulance Western Australia Research Advisory Group. Findings will be published in peer-reviewed journals and communicated to key audiences, including ambulance dispatch professionals. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Impact of in or out of office hours at admission time on outcome in out-of-hospital cardiac arrest patients.

    Science.gov (United States)

    Genbrugge, Cornelia; Viaene, Els; Meex, Ingrid; De Vadder, Katrien; Eertmans, Ward; Boer, Willem; Jans, Frank; De Deyne, Cathy; Dens, Jo; Ferdinande, Bert

    2017-08-01

    In out-of-hospital cardiac arrest (OHCA), neurological outcome is determined by the severity of neurological injury, early percutaneous coronary intervention, and application of neuroprotective temperature management. As this is a very time-intensive and manpower-intensive protocol, we hypothesized that there would be a difference in outcome between OHCA patients admitted during and out of office hours. We prospectively collected demographic data of OHCA patients in two hospitals. All patients included were treated at 33°C for 24 h, followed by a rewarming phase until 36.6°C. During office hours were defined as arriving between 8:00 a.m. and 5:00 p.m. on weekdays. Neurological outcome at 180 days was assessed following the Cerebral Performance Category scale. Forty-seven (31%) patients were admitted during office hours and 105 (69%) out of office hours (P=0.199). Patients admitted during office hours were significantly older, respectively, 66±14 and 59±15 years (P=0.014). There was no significant difference between both groups in the number of patients who underwent coronary angiography, door to angiography time, and number of affected vessels. The median time spent in the target range of PaO2, PaCO2, and lactate was also not significantly different. We found no significant difference in survival until 180 days between both groups (P=0.599), even after adjustment for age (95% confidence interval: 0.44-1.90, hazard ratio: 0.912). Survival until 180 days between OHCA patients admitted during office hours or out of office hours was not significantly different in two hospitals with a fixed protocol for neuroprotection and 24/7 streamlined access to coronary angiography.

  7. Saving the On-Scene Time for Out-of-Hospital Cardiac Arrest Patients: The Registered Nurses' Role and Performance in Emergency Medical Service Teams

    Science.gov (United States)

    Lin, Ming-Wei; Wu, Che-Yu; Pan, Chih-Long; Tian, Zhong; Wen, Jyh-Horng

    2017-01-01

    For out-of-hospital cardiac arrest (OHCA) patients, every second is vital for their life. Shortening the prehospital time is a challenge to emergency medical service (EMS) experts. This study focuses on the on-scene time evaluation of the registered nurses (RNs) participating in already existing EMS teams, in order to explore their role and performance in different EMS cases. In total, 1247 cases were separated into trauma and nontrauma cases. The nontrauma cases were subcategorized into OHCA (NT-O), critical (NT-C), and noncritical (NT-NC) cases, whereas the trauma cases were subcategorized into collar-and-spinal board fixation (T-CS), fracture fixation (T-F), and general trauma (T-G) cases. The average on-scene time of RN-attended cases showed a decrease of 21.05% in NT-O, 3.28% in NT-C, 0% in NT-NC, 18.44% in T-CS, 13.56% in T-F, and 3.46% in T-G compared to non-RN-attended. In NT-O and T-CS cases, the RNs' attendance can notably save the on-scene time with a statistical significance (P = .016 and .017, resp.). Furthermore, the return of spontaneous circulation within two hours (ROSC2 h) rate in the NT-O cases was increased by 12.86%. Based on the findings, the role of RNs in the EMTs could save the golden time in the prehospital medical care in Taiwan. PMID:28280734

  8. Saving the On-Scene Time for Out-of-Hospital Cardiac Arrest Patients: The Registered Nurses’ Role and Performance in Emergency Medical Service Teams

    Directory of Open Access Journals (Sweden)

    Ming-Wei Lin

    2017-01-01

    Full Text Available For out-of-hospital cardiac arrest (OHCA patients, every second is vital for their life. Shortening the prehospital time is a challenge to emergency medical service (EMS experts. This study focuses on the on-scene time evaluation of the registered nurses (RNs participating in already existing EMS teams, in order to explore their role and performance in different EMS cases. In total, 1247 cases were separated into trauma and nontrauma cases. The nontrauma cases were subcategorized into OHCA (NT-O, critical (NT-C, and noncritical (NT-NC cases, whereas the trauma cases were subcategorized into collar-and-spinal board fixation (T-CS, fracture fixation (T-F, and general trauma (T-G cases. The average on-scene time of RN-attended cases showed a decrease of 21.05% in NT-O, 3.28% in NT-C, 0% in NT-NC, 18.44% in T-CS, 13.56% in T-F, and 3.46% in T-G compared to non-RN-attended. In NT-O and T-CS cases, the RNs’ attendance can notably save the on-scene time with a statistical significance (P=.016 and .017, resp.. Furthermore, the return of spontaneous circulation within two hours (ROSC2 h rate in the NT-O cases was increased by 12.86%. Based on the findings, the role of RNs in the EMTs could save the golden time in the prehospital medical care in Taiwan.

  9. Use of an intubating laryngeal mask airway on out-of-hospital cardiac arrest patients in a developing emergency medical service system.

    Science.gov (United States)

    Chien, Li-Chien; Hsu, Hsiang-Chin; Lin, Chih-Hao; Cheng, Ching-Fa; Tung, Yung-Chuang; Hung, Hsien-Cheng; Yeh, Yu-Ching; Tsai, Ming-Che

    2012-01-01

    An intubating laryngeal mask airway (ILMA) is an alternative device for airway control, capable of providing effective ventilation in various situations. The purpose of this study is to compare the effects of the ILMA and bag-valve-mask (BVM) ventilation devices on out-of-hospital cardiac arrest (OHCA) patients. An ILMA training course was conducted by emergency medical technicians (EMTs). Before training, OHCA patients had received BVM ventilation; these patients were defined as the BVM group. After training, all EMTs in the area being served were instructed to immediately use an ILMA on OHCA patients when possible; these patients were defined as the ILMA group. Demographics, transport time, first arterial blood gas data, and the short-term outcomes of these two groups were analyzed. A total of 398 OHCA patients (89 in the BVM group and 309 in the ILMA group) were analyzed. All of the EMTs passed the training course, and ILMAs were used in the emergency settings. The ILMA was applied to each OHCA patient for a longer-than-average field time than the BVM (9.5 vs. 7.8 minutes, p = 0.006). The 24-hour survival rate of the ILMA-treated patients was significantly higher than BVM-treated patients (36.2% vs. 24.7%, p = 0.033). Well-trained EMTs were able to insert the ILMA and ventilate OHCA patients properly in prehospital settings, and ILMA-treated OHCA patients had better short-term outcomes than BVM-treated patients. Copyright © 2012. Published by Elsevier B.V.

  10. Manual Cardiopulmonary Resuscitation Versus CPR Including a Mechanical Chest Compression Device in Out-of-Hospital Cardiac Arrest: A Comprehensive Meta-analysis From Randomized and Observational Studies.

    Science.gov (United States)

    Bonnes, Judith L; Brouwer, Marc A; Navarese, Eliano P; Verhaert, Dominique V M; Verheugt, Freek W A; Smeets, Joep L R M; de Boer, Menko-Jan

    2016-03-01

    Mechanical chest compression devices have been developed to facilitate continuous delivery of high-quality cardiopulmonary resuscitation (CPR). Despite promising hemodynamic data, evidence on clinical outcomes remains inconclusive. With the completion of 3 randomized controlled trials, we conduct a meta-analysis on the effect of in-field mechanical versus manual CPR on clinical outcomes after out-of-hospital cardiac arrest. With a systematic search (PubMed, Web of Science, EMBASE, and the Cochrane Libraries), we identified all eligible studies (randomized controlled trials and nonrandomized studies) that compared a CPR strategy including an automated mechanical chest compression device with a strategy of manual CPR only. Outcome variables were survival to hospital admission, survival to discharge, and favorable neurologic outcome. Twenty studies (n=21,363) were analyzed: 5 randomized controlled trials and 15 nonrandomized studies, pooled separately. For survival to admission, the pooled estimate of the randomized controlled trials did not indicate a difference (odds ratio 0.94; 95% confidence interval 0.84 to 1.05; P=.24) between mechanical and manual CPR. In contrast, meta-analysis of nonrandomized studies demonstrated a benefit in favor of mechanical CPR (odds ratio 1.42; 95% confidence interval 1.21 to 1.67; PCPR guidelines (2000 versus 2005) and the CPR strategy (P=.27). Survival to discharge and neurologic outcome did not differ between strategies. Although there are lower-quality, observational data that suggest that mechanical CPR used at the rescuer's discretion could improve survival to hospital admission, the cumulative high-quality randomized evidence does not support a routine strategy of mechanical CPR to improve survival or neurologic outcome. These findings are irrespective of the endorsed CPR guidelines during the study periods. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  11. User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in a HIV Clinic.

    Science.gov (United States)

    Ramos, S Raquel

    2017-05-05

    Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share medical records. Comprehension is key factor in the ability to make informed decisions.

  12. Consent for organ donation

    National Research Council Canada - National Science Library

    Vincent, A; Logan, L

    2012-01-01

    Summary Improving the consent rate for solid organ donation from deceased donors is a key component of strategies in the UK and other countries to increase the availability of organs for transplantation...

  13. Electroconvulsive therapy without consent.

    Science.gov (United States)

    Moksnes, Kjell Martin

    2013-10-15

    In principle, electroconvulsive therapy (ECT) can only be administered to patients who consent to the treatment. If the patient does not consent, the treatment can be given in exceptional cases, in situations where a plea of necessity can be made. The purpose of this study was to investigate whether the issue of consent was documented in the patient records at Dikemark Hospital in the period 1960-95, and to study the outcomes for patients who were given ECT treatment without having consented. The article is based on a review of the ECT protocols and the records of patients who were given this treatment during the period 1960-95 in three psychiatric wards at Dikemark Hospital. We registered whether the issue of consent had been documented, and if so, whether consent had been provided or not. The material encompasses 241 ECT series administered to 141 patients. The issue of consent had been documented for 107 of a total of the 241 series. Seven patients were given the therapy against their wishes. The median age of these seven was 68 years (range 56-82 years). All of them had been diagnosed with depressive psychosis and were given electroconvulsive therapy on a vital indication under a plea of necessity. Insufficient intake of nourishment was described as the main reason for the vital indication in all the seven patients. According to their records, they showed signs of improvement on the day after the first treatment. Their lifespan after the treatment varied from three to 19 years. On the basis of the records in which it was documented that the patient had not provided consent, electroconvulsive therapy was administered exclusively as a life-saving intervention.

  14. Association of ozone and particulate air pollution with out-of-hospital cardiac arrest in Helsinki, Finland: evidence for two different etiologies.

    Science.gov (United States)

    Rosenthal, Frank S; Kuisma, Markku; Lanki, Timo; Hussein, Tareq; Boyd, James; Halonen, Jaana I; Pekkanen, Juha

    2013-01-01

    Out-of-hospital cardiac arrest (OHCA) has been previously associated with exposure to particulate air pollution. However, there is uncertainty about the agents and mechanisms that are involved. We aimed to determine the association of gases and particulates with OHCA, and differences in pollutant effects on OHCAs due to acute myocardial infarction (AMI) vs those due to other causes. Helsinki Emergency Medical Services provided data on OHCAs of cardiac origin (OHCA_Cardiac). Hospital and autopsy reports determined whether OHCAs were due to AMI (OHCA_MI) or other cardiac causes (OHCA_Other). Pollutant data was obtained from central ambient monitors. A case-crossover analysis determined odds ratios (ORs) for hourly lagged exposures (Lag 0-3) and daily lagged exposures (Lag 0d-3d), expressed per interquartile range of pollutant level. For OHCA_Cardiac, elevated ORs were found for PM(2.5) (Lag 0, 1.07; 95% confidence interval (CI): 1.01-1.13) and ozone (O(3)) (Lag 2d, 1.18; CI: 1.03-1.35). For OHCA_MI, elevated ORs were found for PM(2.5) (Lag 0, 1.14; CI: 1.03-1.27; Lag 0d, 1.17; CI: 1.03-1.33), accumulation mode particulate (Acc) (Lag 0d, 1.19; CI: 1.04-1.35), NO (Lag 0d, 1.07; CI: 1.01-1.13), and ultrafine particulate (Lag 0d, 1.27; CI: 1.05-1.54). For OHCA_Other, elevated ORs were found only for O(3) (Lag 1d, 1.26; CI: 1.07-1.48; Lag 2d, 1.30; CI: 1.11-1.53). Results from two-pollutant models, with one of the pollutants either PM(2.5) or O(3), suggested that associations were primarily due to effects of PM(2.5) and O(3), rather than other pollutants. The results suggest that air pollution triggers OHCA via two distinct modes: one associated with particulates leading to AMI and one associated with O(3) involving etiologies other than AMI, for example, arrhythmias or respiratory insufficiency.

  15. Common Problems of Informed Consent in Medical Equipment Clinical Trials and Relevant Solutions%医疗器械临床试验中知情同意常见的问题与对策

    Institute of Scientific and Technical Information of China (English)

    杨春梅; 袁丹江

    2015-01-01

    This paper analyzed the problems of informed consent during medical equipment clinical trials, including the poor writing, nonstandard signing, formalized content and loss of signed informed consent. Moreover, this paper also discussed relevant solutions to improve the writing of informed consent, ethical reviews and file management, regulate the researchers’ behavior and strengthen the awareness of protecting the right of informed consent.%本文就目前医疗器械临床试验中知情同意存在的:知情同意书撰写质量不高、签署欠规范,告知与知情同意流于形式、签署的知情同意书发生丢失等问题进行分析;就如何提高知情同意书撰写质量、伦理审查质量及档案管理水平,如何规范研究者行为、强化受试者知情同意权的保护意识等措施进行了探讨。

  16. Protein S100 as outcome predictor after out-of-hospital cardiac arrest and targeted temperature management at 33 °C and 36 °C

    DEFF Research Database (Denmark)

    Stammet, Pascal; Dankiewicz, Josef; Nielsen, Niklas

    2017-01-01

    BACKGROUND: We aimed to investigate the diagnostic performance of S100 as an outcome predictor after out-of-hospital cardiac arrest (OHCA) and the potential influence of two target temperatures (33 °C and 36 °C) on serum levels of S100. METHODS: This is a substudy of the Target Temperature...

  17. Reduced pre-hospital and in-hospital survival rates after out-of-hospital cardiac arrest of patients with type-2 diabetes mellitus : An observational prospective community-based study

    NARCIS (Netherlands)

    Van Hoeijen, Daniel A.; Blom, Marieke T.; Bardai, Abdennasser; Souverein, Patrick C.|info:eu-repo/dai/nl/243074948; De Boer, Anthonius|info:eu-repo/dai/nl/075097346; Tan, Hanno L.

    2015-01-01

    Aims Out-of-hospital cardiac arrest (OHCA) remains a major cause of death. We aimed to determine whether type-2 diabetes mellitus (T2DM) is associated with reduced pre-hospital and in-hospital survival rates after OHCA. Methods and results An observational community-based cohort study was performed

  18. Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia “Face to Face”

    Directory of Open Access Journals (Sweden)

    O. I. Zvonareva

    2016-01-01

    Full Text Available Introduction. Currently, clinical trials (CT remain the only technology, which provides proof of efficacy and safety of new drugs and their subsequent release to the market. Medical researcher and informed consent (IC are the main (and often the only source of information for the patient about the upcoming clinical trials, and thus have a direct impact on the perception of clinical trials, and on the patient’s decision about participation. However, the degree of influence of these factors on the clinical trials participants still remains unclear.Materials and methods. A multicenter cross-sectional study was conducted in different cities of the Russian Federation. Patients who had previous experience in CTs (or were enrolled in a CT at the time of this study were asked to complete a questionnaire.Results. To assess the impact of researcher, all respondents were divided into 2 groups: patients that acquainted with IC in collaboration with the researcher, and the other group, which reviewed IC form independently. We evaluated the importance of the factors influencing the decision-making process on participation in clinical trials. According to our data, the most important factors were professional monitoring services (3,72 ± 1,00, regular condition monitoring (3,66 ± 0,98, and better medical care (3,62 ± 1,00. These factors were evaluated at significantly lower score by group of patients that acquainted with IC together with the researcher (3,55 ±0,94, vs 4,01 ± 0,90, p = 0,002; 3,52 ± 1,01 vs 3,87 ± 0,90, p = 0,040; 3,49 ± 0,94, vs 3,83 ± 1,06, p = 0,020 respectively. In assessing the factors that had negative impact on the interest in participating in a clinical trial, the most significant were risk of side effects (3,01 ± 1,27, study of new medication (2,68 ± 1,21, and the risk of getting into the placebo group (2,64 ± 1,34 (so-called “objective” risk factors. At the same time, risk of side effects and risk of

  19. Consenting options for posthumous organ donation: presumed consent and incentives are not favored

    Science.gov (United States)

    2012-01-01

    Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p organ donor or recipient. Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. PMID:23173834

  20. Informed consent & ethical issues in paediatric psychopharmacology.

    Science.gov (United States)

    Malhotra, Savita; Subodh, B N

    2009-01-01

    Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

  1. Association of Bystander Interventions With Neurologically Intact Survival Among Patients With Bystander-Witnessed Out-of-Hospital Cardiac Arrest in Japan.

    Science.gov (United States)

    Nakahara, Shinji; Tomio, Jun; Ichikawa, Masao; Nakamura, Fumiaki; Nishida, Masamichi; Takahashi, Hideto; Morimura, Naoto; Sakamoto, Tetsuya

    2015-07-21

    Neurologically intact survival after out-of-hospital cardiac arrest (OHCA) has been increasing in Japan. However, associations between increased prehospital care, including bystander interventions and increases in survival, have not been well estimated. To estimate the associations between bystander interventions and changes in neurologically intact survival among patients with OHCA in Japan. Retrospective descriptive study using data from Japan's nationwide OHCA registry, which started in January 2005. The registry includes all patients with OHCA transported to the hospital by emergency medical services (EMS) and recorded patients' characteristics, prehospital interventions, and outcomes. Participants were 167,912 patients with bystander-witnessed OHCA of presumed cardiac origin in the registry between January 2005 and December 2012. Prehospital interventions by bystander, including defibrillation using public-access automated external defibrillators and chest compression. Neurologically intact survival was defined as Glasgow-Pittsburgh cerebral performance category score 1 or 2 and overall performance category scores 1 or 2 at 1 month or at discharge. The association between the interventions and neurologically intact survival was evaluated. From 2005 to 2012, the number of bystander-witnessed OHCAs of presumed cardiac origin increased from 17,882 (14.0 per 100,000 persons [95% CI, 13.8-14.2]) to 23,797 (18.7 per 100,000 persons [95% CI, 18.4-18.9]), and neurologically intact survival increased from 587 cases (age-adjusted proportion, 3.3% [95% CI, 3.0%-3.5%]) to 1710 cases (8.2% [95% CI, 7.8%-8.6%]). The rates of bystander chest compression increased from 38.6% to 50.9%, bystander-only defibrillation increased from 0.1% to 2.3%, bystander defibrillation combined with EMS defibrillation increased from 0.1% to 1.4%, and EMS-only defibrillation decreased from 26.6% to 23.5%. Performance of bystander chest compression, compared with no bystander chest compression

  2. Informed consent comprehension in African research settings.

    Science.gov (United States)

    Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

    2014-06-01

    Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

  3. Visual informed consent

    NARCIS (Netherlands)

    Lie, Rico; Witteveen, Loes

    2015-01-01

    The notion of visual informed consent (VIC) is developed in the context of capturing on film the clarification of the purpose of data collection, the use of information obtained, and the rights, risks and benefits of participation on the one hand, and the registration of the participant’s underst

  4. Study on the priority of coronary arteriography or therapeutic hypothermia after return of spontaneous circulation in patients with out-of-hospital cardiac arrest: results from the SOS-KANTO 2012 study.

    Science.gov (United States)

    Hagiwara, Shuichi

    2016-06-01

    Many emergency physicians struggle with the clinical question of whether to perform therapeutic hypothermia (TH) or coronary angiography (CAG) first after return of spontaneous circulation (ROSC) in patients with out-of-hospital cardiac arrest (OHCA). We analyzed the results of the SOS-KANTO 2012 study, which is a prospective, multicenter (67 emergency hospitals), observational study about OHCA conducted between January 2012 and March 2013 (n = 16,452). We compared two groups: the group in which TH was first performed (TH group), and the group in which CAG was performed first (CAG group) within 24 h after arrival. Two hundred and twenty-one patients were treated TH and CAG (TH group, 76 patients; CAG group, 145 patients). In addition, we selected patients who underwent coronary treatment. 164 patients underwent coronary treatment after CAG (TH group, 52 patients; CAG group, 112 patients). In patients in whom TH and CAG and coronary artery treatment were done, 42 patients (55.3 %) in the TH group and 86 patients (59.3 %) in the CAG group survived at 90 days. The cerebral performance category (CPC) 1 and 2 were 26.3 % (20 patients) in TH group, and 31.0 % (45 patients) in CAG group. In patients in whom TH and CAG with coronary artery treatment were performed, 29 patients (55.8 %) in the TH group and 64 patients (57.1 %) in the CAG group survived at 90 days. The rates of CPC 1 and 2 were 26.9 % (14 patients) in TH group, and 23.2 % (26 patients) in CAG group. There was no significant difference in 90-day survival between the two groups although it tended to be better in the CAG group than in the TH group. Whether TH or CAG was performed first did not affect the 90-day survival and 30-day neurological situation among patients with ROSC after OHCA.

  5. Evaluación de la práctica clínica del Consentimiento Informado en los ensayos clínicos Evaluation of the clinical practice of Informed Consent in clinical trials

    Directory of Open Access Journals (Sweden)

    J. Gost

    2003-04-01

    Full Text Available Sobre la base de las publicaciones existentes parece lícito suponer que en un ensayo clínico (EC, las dificultades inherentes al proceso de comunicación investigador-participante son en la práctica mayores que las deseadas. Se asume asimismo la hipótesis de que existen deficiencias en la legibilidad formal de los documentos de consentimiento informado. Se presentan los resultados de un estudio transversal realizado en una muestra aleatoria (n= 160 de los EC aprobados por el CEIC de Navarra durante los años 1995-1999. Los resultados encontrados (en el 69,7% de los casos el investigador archiva la documentación correspondiente al EC, el CI aparece firmado por el investigador en el 56,6% de los EC, y en más del 83% de los casos la información escrita presenta una deficiente legibilidad confirman la bondad de la hipótesis y detectan áreas de mejora a desarrollar.On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160 of the CTs approved by the Ethical Committee of Clinical Research (CEIC of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

  6. Manual Cardiopulmonary Resuscitation Versus CPR Including a Mechanical Chest Compression Device in Out-of-Hospital Cardiac Arrest: A Comprehensive Meta-analysis From Randomized and Observational Studies

    NARCIS (Netherlands)

    Bonnes, J.L.; Brouwer, M.A.; Navarese, E.P.; Verhaert, D.V.; Verheugt, F.W.; Smeets, J.L.; Boer, M.J. de

    2016-01-01

    STUDY OBJECTIVE: Mechanical chest compression devices have been developed to facilitate continuous delivery of high-quality cardiopulmonary resuscitation (CPR). Despite promising hemodynamic data, evidence on clinical outcomes remains inconclusive. With the completion of 3 randomized controlled

  7. Medical informed consent: general considerations for physicians.

    Science.gov (United States)

    Paterick, Timothy J; Carson, Geoff V; Allen, Marjorie C; Paterick, Timothy E

    2008-03-01

    Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.

  8. [Parental Information and Consent in Neonatology].

    Science.gov (United States)

    Ehlen, M; Budde, A

    2015-06-01

    Careful analysis of current adjudication reveals increasing demand of adequate record-keeping as well as meticulously documented informed consent forms regarding all aspects of medicine. Although standardized informed consent forms or explicit guidelines for obtaining procedural consent already exist in surgical disciplines there is strong evidence that, however, in neonatology (and paediatric intensive care) these processes are still incomplete and qualitatively insufficiently implemented. Therefore the author discussed all existing information prescriptions with the legal department and quality management of a large German clinic group especially in terms of relevant legislation, recent case law and specialist literature in order to obtain potential for improvement. Based on the results of this audit of expert opinions improved recommendations could be implemented in the daily practise of a department of neonatology and paediatric intensive care on a tertiary level.

  9. [Informed consent in emergency medicine].

    Science.gov (United States)

    Ersoy, Nermin; Ozcan Senses, Müesser; Aydin Er, Rahime

    2010-01-01

    Informed consent is a prerequisite for the ethical and legal validity of the emergency intervention in emergency medicine, since it protects the fiduciary relationship between the physician and patient; the principle of honesty that grounds this relationship; the principle of autonomy that necessitates right of self-determination; and the principle of respect for persons. Informed consent in emergency medicine, which is supposed to include the nature, benefits and risks of emergency medical intervention, differentiates with respect to definite groups of patients: (1) conscious patients, (2) unconscious patients, and (3) children and mature minors. In addition, informed consent differentiates between medical, psychological and even social circumstances of the patients, referred to as valid consent, expressed-explicit consent, blanket consent, presumed consent, tacit consent, proxy consent, and parental consent. There are a few exceptions in which emergency medical intervention is administered without informed consent. In addition to the exceptions of life-saving interventions, when a patient can not decide for herself/himself, intervention of the physician in the best interest of the patient or children is based on the "therapeutic privilege" of the physician. As an ethically defensible right, since therapeutic privilege may open a door to hard paternalistic approaches, in those situations, emergency physicians should be cautious not to violate a patient's autonomy.

  10. Adolescents and consent to treatment.

    Science.gov (United States)

    Dickens, B M; Cook, R J

    2005-05-01

    Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

  11. Informed consent process: Foundation of the researcher–participant bond

    Directory of Open Access Journals (Sweden)

    Amrita Sil

    2017-01-01

    Full Text Available Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of “autonomy” in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF; and they have to be approved by the Institutional Ethics Committee (IEC before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability or is illiterate, it has be obtained from a legally acceptable representative (LAR. If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years informed assent should be obtained.

  12. What are the essential ingredients to successful delivery of integrated care to help keep frail and complex patients well, and out of hospital?

    OpenAIRE

    Burns, Philip Robert; Elliott, Claudette

    2016-01-01

    Introduction: In conjunction with the Northwest leadership academy, clinical and managerial leaders in South Manchester, UK observed and interrogated successful models of integrated health and social care in Washington DC, USA before the introduction of an innovative local model, and afterwards in Barcelona, Spain. The observation of others successful systems were a useful mirror to analyse, evaluate and implement the elements needed to make integration work. Our subsequent visit to Barcelona...

  13. Endothelial activation/injury and associations with severity of post-cardiac arrest syndrome and mortality after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Bro-Jeppesen, John; Johansson, Pär I; Hassager, Christian

    2016-01-01

    BACKGROUND: Post-cardiac arrest syndrome (PCAS) is characterized by whole-body ischemia triggering systemic inflammation and damage of the endothelium. This study investigated the relationship between systemic inflammation, endothelial damage and severity of PCAS and the association between endot...... compared to 33°C after OHCA was associated with lower endothelial activation, but not endothelial damage. CLINICAL TRIAL REGISTRATION: URL: clinicaltrials.gov/ct2/show/NCT01020916. Unique identifier: NCT01020916....

  14. Impact of time to return of spontaneous circulation on neuroprotective effect of targeted temperature management at 33 or 36 degrees in comatose survivors of out-of hospital cardiac arrest

    DEFF Research Database (Denmark)

    Kjaergaard, Jesper; Nielsen, Niklas; Winther-Jensen, Matilde

    2015-01-01

    AIM: Time to Return of Spontaneous Circulation (ROSC) has a plausible relation to severity of hypoxic injury before and during resuscitation in Out-of-Hospital Cardiac Arrest (OHCA), and has consistently been associated with adverse outcome. The effect of Targeted Temperature Management (TTM) may....... CONCLUSION: Time to ROSC remains a significant prognostic factor in comatose OHCA patients with regards to risk of death and risk of adverse neurological outcome. For any time to ROSC, targeting 33°C in TTM was not associated with benefit with regards to reducing mortality or risk of adverse neurological...

  15. [Guidelines for uniform reporting of data from out-of-hospital and in-hospital cardiac arrest and resuscitation in the pediatric population: the pediatria utstein-style].

    Science.gov (United States)

    Tormo Calandín, C; Manrique Martínez, I

    2002-06-01

    Children who require cardiopulmonary resuscitation present high mortality and morbidity. The few studies that have been published on this subject use different terminology and methodology in data collection, which makes comparisons, evaluation of efficacy, and the performance of meta-analyses, etc. difficult. Consequently, standardized data collection both in clinical studies on cardiorespiratory arrest and in cardiopulmonary resuscitation in the pediatric age group are required. The Spanish Group of Pediatric Cardiopulmonary Resuscitation emphasizes that recommendations must be simple and easy to understand. The first step in the elaboration of guidelines on data collection is to develop uniform definitions (glossary of terms). The second step comprises the so-called time intervals that include time periods between two events. To describe the intervals of cardiorespiratory arrest different clocks are used: the patient's watch, that of the ambulance, the interval between call and response, etc.Thirdly, a series of clinical results are gathered to determine whether the efforts of cardiopulmonary resuscitation have a positive effect on the patient, the patient's family and society. With the information gathered a registry of data that includes the patient's personal details, general data of the cardiopulmonary resuscitation, treatment, times of performance and definitive patient outcome is made.

  16. Teleconsent: A novel approach to obtain informed consent for research

    Directory of Open Access Journals (Sweden)

    Brandon M. Welch

    2016-08-01

    Full Text Available Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called “teleconsent”, which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.

  17. Informed Consent in Adult Psychiatry

    Directory of Open Access Journals (Sweden)

    Ahmed Bait Amer

    2013-07-01

    Full Text Available This article addresses some of the groundwork of informed consent in people with mental illness whose decision-making capacity has obviously been compromised. This article examines four crucial aspects in particular, namely: i the main elements of informed consent; ii difficulties pertaining to psychiatric illnesses; iii the effect of psychiatric disorders on the patient’s capability; iv how to assess situations in which consents may not be required.

  18. O processo de consentimento na pesquisa clínica: da elaboração à obtenção The process of consent in clinical trials: from elaboration to accomplishment

    Directory of Open Access Journals (Sweden)

    Luci Meire Pereira da Silva

    2005-10-01

    Full Text Available O termo de consentimento é um documento recomendado por declarações internacionais, códigos de ética, resoluções e leis específicas para ser utilizado no cotidiano de pesquisas em saúde. A prática ou a obtenção do consentimento informado no exercício da medicina e da pesquisa em seres humanos é própria das últimas décadas e caracteriza o aperfeiçoamento da ética biomédica, constitui um requerimento legal e ético na pesquisa clínica envolvendo seres humanos. O principal desafio do processo de consentimento é garantir a compreensão adequada do indivíduo, entretanto os aspectos sociais, culturais e intelectuais dos indivíduos, ou mesmo a relação existente entre médico e paciente, às vezes, podem comprometer esse processo. O objetivo desse trabalho é apresentar critérios importantes no processo de consentimento que merecem ser destacados e abordados de acordo com normas e resoluções específicas.The consent form is a document recommended for international declarations, resolutions and specific laws currently used in research on health. The practice or the accomplishment of the informed consent in the exercise of the medicine and the research in human beings is pertains to the last decades and characterizes the perfectioning of biomedical ethics, constitutes a legal and ethical requirement in clinical research involving human beings. The main challenge of the consent process is to guarantee the adequate understanding of the individual, however the social, cultural and intellectual aspects as well as the relationship between physician and patient, sometimes, can affect this process. The purpose of this paper is to present important criteria in the consent process that need to be highlighted in accordance with specific tenets and resolutions, such as Resolution 196/96 of the National Council of Health.

  19. Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order

    Science.gov (United States)

    Under section 4 of the Toxic Substances Control Act (TSCA), EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with the Aceto Corporation, E.I. du Pont de Nemours and Company, and Solutia Inc.

  20. Alzheimer disease ethics--informed consent and related issues in clinical trials: results of a survey among the members of the Research Ethics Committees in Sweden.

    Science.gov (United States)

    Peterson, Gunbrith; Wallin, Anders

    2003-06-01

    The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity. We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.

  1. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    Science.gov (United States)

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Where no consent = death.

    Science.gov (United States)

    1977-01-01

    Men must be made to understand the value of family planning - particularly in societies where men hold the power of decision in the family. Dr. Kotha Pannikar, chairman of the Kedah Family Planning Association (FPA) in Malaysia, illustrated this point in discussion which followed the Consultation of Medical and Communication Fieldworkers conference in Kuala Lumpur in August, with a story about 1 of her own patients. When the girl, who had a rheumatic heart, was 16, Dr. Pannikar advised the parents that she needed cardiac surgery if she were to be a healthy wife and mother. But the parents lived some distance from Dr. Pannikar's surgery and did not heed the advice. The girl was married to a carpenter from a traditional Chinese family, in which "the man is lord and master." Her new home had no piped water, and in additional to normal domestic tasks she had to carry water from a source 1 1/2 miles agay. In the 7th month of her 1st pregnancy, she went into cardiac failure. After the 3rd pregnancy and a 3rd cardiac failure, Dr. Pannikar tried to arrange a sterilization "but we could not get consent - her husband refused to turn up at the hospital." When the girl was admitted to hospital 6 months into her 4th pregnancy, Dr. Pannikar got hold of her patient's mother-in-law. "I told her if she wanted a servant in the house, it was easy to get one. But no servant would look after her grandchildren the way their mother would. I told her if she wanted to save the girl's life she had better speak to her son." During the 4th delivery, the girl went into cardiac arrest and spent 2 weeks in intensive care. The mother-in-law prevailed upon her son to at least consent, and the girl was sterilized before she left hospital. But "it was a very near thing," Dr. Pannikar recalls "and it wouldn't have happened if the husband had felt he was responsible in parenthood." The Kedah FPA makes special efforts to reach men. Dr. Pannikar herself talks to men's organizations like the Lions and

  3. The association of targeted temperature management at 33 and 36 °C with outcome in patients with moderate shock on admission after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Annborn, Martin; Bro-Jeppesen, John; Nielsen, Niklas

    2014-01-01

    ). Primary outcome was 180-day mortality. Secondary outcomes were intensive care unit (ICU) and 30-day mortality, severity of circulatory shock assessed by mean arterial pressure, serum lactate, fluid balance and the extended Sequential Organ Failure assessment (SOFA) score. RESULTS......PURPOSE: We hypothesized that a targeted temperature of 33 °C as compared to that of 36 °C would increase survival and reduce the severity of circulatory shock in patients with shock on admission after out-of-hospital cardiac arrest (OHCA). METHODS: The recently published Target Temperature...... Management trial (TTM-trial) randomized 939 OHCA patients with no difference in outcome between groups and no difference in mortality at the end of the trial in a predefined subgroup of patients with shock at admission. Shock was defined as a systolic blood pressure of 30 min or the need...

  4. Interprofessional cooperation by midwives in the field of out-of-hospital obstetrical care: an integrative review / Interprofessionelle Kooperation von Hebammen im Handlungsfeld der ambulanten geburtshilflichen Versorgung: ein integratives Review

    Directory of Open Access Journals (Sweden)

    Schlüter-Cruse Martina

    2016-12-01

    Full Text Available The central objective of early prevention in Germany is an improved cooperation between professional groups of the health services and child and youth welfare in interprofessional networks. This objective derives from the realisation that proper care for families with infants can only be achieved if the various groups act in close integration. The ‘Federal Initiative early prevention’ explicitly calls for freelance midwives to be integrated in this context. However, only a few scientific findings on midwives’ cooperation in networks of early prevention have been published to date. This integrative review aims to identify the central themes of interprofessional cooperation of midwives in out-of-hospital obstetrical care from national and international research literature.

  5. 34 CFR 303.404 - Parent consent.

    Science.gov (United States)

    2010-07-01

    ... DISABILITIES Procedural Safeguards General § 303.404 Parent consent. (a) Written parental consent must be... given. (Authority: 20 U.S.C. 1439) Note 1: In addition to the consent requirements in this section...

  6. Informed consent in dental extractions.

    Directory of Open Access Journals (Sweden)

    José Luis Capote Femenías

    2009-07-01

    Full Text Available When performing any oral intervention, particularly dental extractions, the specialist should have the oral or written consent of the patient. This consent includes the explanation of all possible complications, whether typical, very serious or personalized associated with the previous health condition, age, profession, religion or any other characteristic of the patient, as well as the possi.ble benefits of the intervention. This article is related with the bioethical aspects related with dental extractions, in order to determine the main elements that the informed consent should include.

  7. Consent to organ donation part 2: alternative modes of consent.

    Science.gov (United States)

    Griffith, Richard; Tengnah, Cassam

    2010-01-01

    In the December 2009 issue of British Journal of Community Nursing Richard Griffith and Cassam Tengnah reviewed the system of consent for non-beating heart organ donation at the centre of the Human Tissue Act 2004. This article considers the benefits and risks of alternative systems of consent being proposed to overcome the United Kingdom's poor organ donation rate that is the worst in Western Europe.

  8. Medical ghostwriting and informed consent.

    Science.gov (United States)

    Almassi, Ben

    2014-11-01

    Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.

  9. Informing egg donors of the potential for embryonic research: a survey of consent forms from U.S. in vitro fertilization clinics

    National Research Council Canada - National Science Library

    Schaefer, Gerald Owen; Sinaii, Ninet; Grady, Christine

    2012-01-01

    To understand whether and to what extent U.S. IVF clinics inform egg donors that resultant embryos initially intended to be implanted for reproductive purposes may in fact be used for research instead...

  10. Changing trends in informed consent

    Directory of Open Access Journals (Sweden)

    Victor Lim

    2014-01-01

    Full Text Available Abstract: Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decision making. The paternalistic approach by doctors is no longer acceptable. Today the patient has the right to receive and the doctor the obligation to give sufficient and appropriate information so that the patient can make an informed decision to accept or refuse a treatment option. This has led to higher standards of practice in the process of informed consent taking. Consent taking is both a legal and moral requirement. Failure to comply with standards of practice can result in criminal prosecution, civil litigation or disciplinary action by the relevant professional authority. Consent taking is a process and not merely a one-off affixation of the patient’s signature on a consent form. It involves a continuous discussion to reflect the evolving nature of treatment from before the treatment is given to the post-operative or discharge period. The regulatory authorities in many countries have established standards for consent taking which would include the capacity of the patient, the person who should seek consent, the information to be provided and the necessary documentation.

  11. [Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

    Science.gov (United States)

    Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

    2013-01-01

    The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

  12. The Influence of Age, Health Literacy, and Affluence on Adolescents' Capacity to Consent to Research.

    Science.gov (United States)

    Nelson, Lance R; Stupiansky, Nathan W; Ott, Mary A

    2016-04-01

    While adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents' capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents' capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents' capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.

  13. Communication and informed consent in elderly people.

    Science.gov (United States)

    Giampieri, M

    2012-02-01

    Physician-patient relationship is the key-point for an optimal management of any medical procedure. Before performing any diagnostic or therapeutic procedure, clinical communication with patients is necessary. It should regard the nature and purpose of a proposed procedure including potential risks and benefits. During physician-patient communication, alternatives, as well as the risks and benefits of not receiving or undergoing a procedure should also be disclosed. Thus, a complete physician-patient clinical communication is the basis of "shared decision-making" and plays a clinical-therapeutic role in the informed consent process in order to improve patient care. Informed consent is a delicate process of communication between a patient and physician necessary for patient authorization for any medical intervention. The success of achieving good informed consent procedure depends on the strength of the relationship between the doctor and the patient. For this reason, the traditional paternalistic relationship, in which decisions were made by the doctor, is no longer appropriate. Therefore, the use of a model which allows for a greater patient involvement in the decision making process is fundamental. This approach allows for a clearer impact on patient values. The aspects of the procedure related to these values, combined with the technical and scientific considerations of the doctor, are the basis of a shared decision making process, in which the patient is actively involved. Therefore, an informed consent is not simply the acquisition of the patient's signature, but a real process based on the dialogue between doctor and patient. This dialogue is particularly delicate in some circumstances, such as geriatric medicine and anesthesiology. Seeking consent is part of a respectful relationship with an older person. Adults are almost always considered capable of making personal healthcare decisions. Older adults should also be considered capable of handling their own

  14. Age-specific differences in prognostic significance of rhythm conversion from initial non-shockable to shockable rhythm and subsequent shock delivery in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Funada, Akira; Goto, Yoshikazu; Tada, Hayato; Teramoto, Ryota; Shimojima, Masaya; Hayashi, Kenshi; Yamagishi, Masakazu

    2016-11-01

    Early rhythm conversion from an initial non-shockable to a shockable rhythm and subsequent shock delivery in patients with out-of-hospital cardiac arrest (OHCA) has been associated with favourable neurological outcome (Cerebral Performance Category score 1 or 2; CPC 1-2). We hypothesized that the prognostic significance of rhythm conversion and subsequent shock delivery differs by age and time from initiation of cardiopulmonary resuscitation (CPR) by emergency medical service (EMS) providers to first defibrillation (shock delivery time). We analysed 430,443 OHCA patients with an initial non-shockable rhythm using a prospective Japanese Utstein-style database from 2011 to 2014. The primary endpoint was 1-month CPC 1-2. Multivariate logistic regression revealed that rhythm conversion and subsequent shock delivery is positively associated with 1-month CPC 1-2: the adjusted odds ratio was 6.09 (95% confidence interval: 3.65-9.75) for shock delivery time delivery time of 20-59min in patients aged 75-84 years (0.55; 0.27-0.98) and ≥85 years (0.17; 0.03-0.53). Early rhythm conversion from an initial non-shockable to a shockable rhythm and subsequent shock delivery is associated with increased odds of 1-month CPC 1-2 in OHCA patients aged 18-74 years but not in those aged ≥75 years. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Consent - a new era begins.

    Science.gov (United States)

    D'Cruz, L; Kaney, H

    2015-07-24

    The law in relation to consent has changed following the handing down of the Supreme Court judgement in Montgomery vs Lanarkshire in March this year. Legally, clinicians, including dentists, must now take reasonable care to ensure that patients are aware of any material risks involved in a proposed treatment and of reasonable alternatives. This case now brings the law in relation to the disclosure of risks when obtaining consent to treatment in line with the guidance issued by regulatory bodies such as the GMC and GDC.

  16. Personal autonomy and informed consent.

    Science.gov (United States)

    Ursin, Lars Oystein

    2009-03-01

    Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.

  17. Optimizing the HIV/AIDS informed consent process in India

    Directory of Open Access Journals (Sweden)

    Shrotri A

    2004-08-01

    Full Text Available Abstract Background While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low. Methods In this study, we examined pregnant women's understanding of group education and counseling (GEC about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues. Results We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%. Conclusions This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.

  18. Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258

    Directory of Open Access Journals (Sweden)

    Weeks Andrew

    2006-05-01

    Full Text Available Abstract Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled.

  19. Improved understanding and satisfaction with a modified informed consent document: a randomized study

    Directory of Open Access Journals (Sweden)

    Raich PC

    2012-05-01

    Full Text Available Peter C Raich1,2, Ralph L Kennedy1, Chris Vanoni1, William Thorland2, Naamon Owens1, Charles L Bennett31AMC Cancer Research Center, University of Colorado Comprehensive Cancer Center, Denver, 2Denver Health Medical Center, Denver, Colorado, USA; 3Center for Management of Complex Chronic Care, Hines Veterans Administration Hospital, Hines, IL, USABackground: Informed consent documents need to convey crucial information to prospective study participants. We assessed the impact of an informed consent process designed to be understood by persons with low health literacy skills.Methods: We conducted a randomized controlled trial with ethnically and racially diverse male veterans. Participants were randomly assigned to receive and read the standard consent document for the Selenium and Vitamin E Cancer Prevention Trial prostate cancer prevention trial or a culturally tailored, easy-to-read consent document. Telephone interviews were conducted 2 weeks following consent, assessing comprehension, satisfaction, consent anxiety, state anxiety, decisional conflict, and cultural sensitivity.Results: Of 162 male veterans completing the initial telephone interview, 49.7% were African American, 44.1% were Caucasian, and 6.2% were Hispanic. The mean comprehension score for the consent document and process was significantly increased in the intervention arm participants (17.08 versus the standard consent arm (15.06, P < 0.0001. The satisfaction score with the consent information was higher in participants in the intervention arm (3.67 vs 3.42, P = 0.0009, while the consent anxiety score was reduced (1.31 vs 1.56, P = 0.0067.Conclusion: Modifications in the reading level, format, appearance, interactivity, and cultural sensitivity of an informed consent document in the cancer prevention setting significantly improved comprehension of and satisfaction with the consent document, while decreasing consent anxiety.Keywords: health literacy, informed consent, clinical

  20. Consenting to uncertainty: challenges for informed consent to disease screening--a case study.

    Science.gov (United States)

    Greene, Mark; Smith, Suzanne M

    2008-01-01

    This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health.

  1. The continuous quality improvement project for telephone-assisted instruction of cardiopulmonary resuscitation increased the incidence of bystander CPR and improved the outcomes of out-of-hospital cardiac arrests.

    Science.gov (United States)

    Tanaka, Yoshio; Taniguchi, Junro; Wato, Yukihiro; Yoshida, Yutaka; Inaba, Hideo

    2012-10-01

    In 2007, the Ishikawa Medical Control Council initiated the continuous quality improvement (CQI) project for telephone-assisted cardiopulmonary resuscitation (telephone-CPR), which included instruction on chest-compression-only CPR, education on how to recognise out-of-hospital cardiac arrests (OHCAs) with agonal breathing, emesis and convulsion, recommendations for on-line or redialling instructions and feedback from emergency physicians. This study aimed to investigate the effect of this project on the incidence of bystander CPR and the outcomes of OHCAs. The baseline data were prospectively collected on 4995 resuscitation-attempted OHCAs, which were recognised or witnessed by citizens rather than emergency medical technicians during the period of February 2004 to March 2010. The incidence of telephone-CPR and bystander CPR, as well as the outcomes of the OHCAs, was compared before and after the project. The incidence of telephone-CPR and bystander CPR significantly increased after the project (from 42% to 62% and from 41% to 56%, respectively). The incidence of failed telephone-CPR due to human factors significantly decreased from 30% to 16%. The outcomes of OHCAs significantly improved after the projects. A multiple logistic regression analysis revealed that the CQI project is one of the independent factors associated with one-year (1-Y) survival with favourable neurological outcomes (odds ratio=1.81, 95% confidence interval=1.20-2.76). The CQI project for telephone-CPR increased the incidence of bystander CPR and improved the outcome of OHCAs. A CQI project appeared to be essential to augment the effects of telephone-CPR. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  2. Predictors of survival and favorable functional outcomes after an out-of-hospital cardiac arrest in patients systematically brought to a dedicated heart attack center (from the Harefield Cardiac Arrest Study).

    Science.gov (United States)

    Iqbal, M Bilal; Al-Hussaini, Abtehale; Rosser, Gareth; Salehi, Saleem; Phylactou, Maria; Rajakulasingham, Ramyah; Patel, Jayna; Elliott, Katharine; Mohan, Poornima; Green, Rebecca; Whitbread, Mark; Smith, Robert; Ilsley, Charles

    2015-03-15

    Despite advances in cardiopulmonary resuscitation (CPR), survival remains low after out-of-hospital cardiac arrest (OOHCA). Acute coronary ischemia is the predominating precipitant, and prompt delivery of patients to dedicated facilities may improve outcomes. Since 2011, all patients experiencing OOHCA in London, where a cardiac etiology is suspected, are systematically brought to heart attack centers (HACs). We determined the predictors for survival and favorable functional outcomes in this setting. We analyzed 174 consecutive patients experiencing OOHCA from 2011 to 2013 brought to Harefield Hospital-a designated HAC in London. We analyzed (1) all-cause mortality and (2) functional status using a modified Rankin scale (mRS 0 to 6, where mRS0-3(+) = favorable functional status). The overall survival rates were 66.7% (30 days) and 62.1% (1 year); and 54.5% had mRS0-3(+) at discharge. Patients with mRS0-3(+) had reduced mortality compared to mRS0-3(-): 30 days (1.2% vs 72.2%, p <0.001) and 1 year (5.3% vs 77.2%, p <0.001). Multivariate analyses identified lower patient comorbidity, absence of cardiogenic shock, bystander CPR, ventricular tachycardia/ventricullar fibrillation as initial rhythm, shorter duration of resuscitation, prehospital advanced airway, absence of adrenaline and inotrope use, and intra-aortic balloon pump use as predictors of mRS0-3(+). Consistent predictors of increased mortality were the presence of cardiogenic shock, advanced airway use, increased duration of resuscitation, and absence of therapeutic hypothermia. A streamlined delivery of patients experiencing OOHCA to dedicated facilities is associated with improved functional status and survival. Our study supports the standardization of care for such patients with the widespread adoption of HACs.

  3. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    Science.gov (United States)

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  4. Why we should not seek individual informed consent for participation in health services research.

    Science.gov (United States)

    Cassell, J; Young, A

    2002-10-01

    Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.

  5. 7 CFR 1.420 - Consent recommendation.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation....

  6. Consent for Genetic Research in the Framingham Heart Study

    Science.gov (United States)

    Levy, Daniel; Splansky, Greta Lee; Strand, Nicolle K.; Atwood, Larry D.; Benjamin, Emelia J.; Blease, Susan; Cupples, L. Adrienne; D’Agostino, Ralph B.; Fox, Caroline S.; Kelly-Hayes, Margaret; Koski, Greg; Larson, Martin G.; Mutalik, Karen M.; Oberacker, Elizabeth; O’Donnell, Christopher J.; Sutherland, Patrice; Valentino, Maureen; Vasan, Ramachandran S.; Wolf, Philip A.; Murabito, Joanne M.

    2010-01-01

    Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease; including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. PMID:20425830

  7. [Consent to genetic paternity testing].

    Science.gov (United States)

    Lach, Arkadiusz; Linkowska, Katarzyna; Grzybowski, Tomasz

    2010-01-01

    The present article aims at reviewing the legislation in Poland and other countries concerning the consent to DNA sample collection, with the special reference to genetic relatedness analyses (including paternity tests) in anonymous samples of biological materials. The Polish legislator has not regulated this issue in a direct manner. Therefore, in view of progressing commercialization of genetic paternity tests, it is necessary to undertake legislative actions towards regulation of DNA tests admissibility, both in civil proceedings and by commission of private individuals.

  8. Chest Compression Fraction between Mechanical Compressions on a Reducible Stretcher and Manual Compressions on a Standard Stretcher during Transport in Out-of-Hospital Cardiac Arrests: The Ambulance Stretcher Innovation of Asian Cardiopulmonary Resuscitation (ASIA-CPR) Pilot Trial.

    Science.gov (United States)

    Kim, Tae Han; Shin, Sang Do; Song, Kyoung Jun; Hong, Ki Jeong; Ro, Young Sun; Song, Sung Wook; Kim, Chu Hyun

    2017-01-01

    Cardiopulmonary resuscitation (CPR) with the use of mechanical devices is recommended during ambulance transport. However, the CPR quality en route and while in transfer to the emergency department (ED) for out-of-hospital cardiac arrests (OHCAs) remains uncertain. We developed a mechanical CPR device outfitted on a reducible stretcher (M-CPR) and compared with standard manual CPR on a standard stretcher (S-CPR) to evaluate CPR quality. Adult OHCAs transported by five ambulances in a metropolitan area with a population of 3.5 million (many of whom lived in high-rise buildings) from September to October (before-phase) and November to December (after-phase) in 2015 were collected. The reducible stretcher was developed for use in a small elevator during the transfer from scene to ambulance, and the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA) was used for M-CPR. Chest compression fraction (CCF) was measured by transthoracic impedance data using an X-series® cardiac monitor (ZOLL Medical) during time from attachment to patient to arrival to the ED. A comparison of CCF using a Wilcoxon signed-rank test evaluated the difference between the before- and after-phases. Of the eligible 49 OHCAs, 31 (21 in the before-phase and 10 in the after-phase) were analyzed, excluding patients for whom CCF was not measured, for whom M-CPR was not used, who had a return of spontaneous circulation in the field before transport, or who collapsed during transport. There were no differences in demographic data. Median total CCF (median, q1-q3) was significantly higher in the after-phase M-CPR group (85.2, 83.4-86.3) than in the before-phase S-CPR group (80.1, 68.0-85.2) (p = 0.03). Mechanical CPR on the reducible stretcher during the transport of OHCAs to the ED showed a much higher chest compression fraction than standard manual CPR.

  9. One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial).

    Science.gov (United States)

    Selker, Harry P; Udelson, James E; Massaro, Joseph M; Ruthazer, Robin; D'Agostino, Ralph B; Griffith, John L; Sheehan, Patricia R; Desvigne-Nickens, Patrice; Rosenberg, Yves; Tian, Xin; Vickery, Ellen M; Atkins, James M; Aufderheide, Tom P; Sayah, Assaad J; Pirrallo, Ronald G; Levy, Michael K; Richards, Michael E; Braude, Darren A; Doyle, Delanor D; Frascone, Ralph J; Kosiak, Donald J; Leaming, James M; Van Gelder, Carin M; Walter, Gert-Paul; Wayne, Marvin A; Woolard, Robert H; Beshansky, Joni R

    2014-05-15

    The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.

  10. Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

    Science.gov (United States)

    Mellado, J M

    2016-01-01

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. An audit cycle of consent form completion: A useful tool to improve junior doctor training

    Directory of Open Access Journals (Sweden)

    Catherine Leng

    2016-01-01

    Full Text Available Background: Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. Methods: An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008 and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Results: Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91–100% and additional procedures (0–7.5%. Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. Conclusion: The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

  12. Monetary incentives improve recall of research consent information: it pays to remember.

    Science.gov (United States)

    Festinger, David S; Marlowe, Douglas B; Croft, Jason R; Dugosh, Karen L; Arabia, Patricia L; Benasutti, Kathleen M

    2009-04-01

    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, the authors randomly assigned 31 drug court clients participating in a clinical research trial to a control group that received a standard informed consent procedure or to a group that received the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1 week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the control group (65% vs. 42%, p<.01). Findings from this study have important implications for the ethical conduct of human subject research. The incentivized consent procedure may be useful for improving consent recall in research studies, particularly those involving potentially serious side effects. The results also provide an important "proof of concept" regarding the utility of motivational procedures for improving recall of consent information.

  13. Obstetrics and gynaecology residents' knowledge of the informed consent process and its practice in their training institutions.

    Science.gov (United States)

    Okonta, P I

    2015-01-01

    The ethical principle of autonomy as expressed in the practice of informed consent is a core tenet of clinical practice and good patient physician relationship. The aim was to identify specific gaps in the knowledge of trainee obstetricians and gynecologists in Nigeria about the informed consent process and its content. It also sought to describe the practice of informed consent in their respective institutions. A survey of Residents in obstetrics and gynecology attending the revision course of the Faculty of obstetrics and gynecology of the national postgraduate medical college was done to determine their knowledge of the informed consent process and its practice in their institutions. None of the residents was able to give responses that contained all five conditions for informed consent to be valid. Furthermore, only 3 (2.22%) Residents mentioned that the name of the surgeon to perform the surgery should be part of the information provided to patients during the informed consent process. Similarly, only 8 (5.93%) mentioned that consequences of not having the surgery should be part of the informed consent process. The concept of the 'emancipated minor' being competent to give consent was known by 38% of the residents. Although Residents in obstetrics and gynecology in Nigeria have some knowledge of the informed consent process, this knowledge is deficient in key areas such as competence to give consent, content and scope of information to be disclosed to patients for surgery. There is a need to teach residents the rudiments of informed consent and bioethics in general.

  14. [The origin of informed consent].

    Science.gov (United States)

    Mallardi, V

    2005-10-01

    The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised

  15. What is presumed when we presume consent?

    Directory of Open Access Journals (Sweden)

    Pierscionek Barbara K

    2008-04-01

    Full Text Available Abstract Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable

  16. Value of informed consent in surgical orthodontics.

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, atten

  17. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, atten

  18. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, atten

  19. The changing face of informed surgical consent.

    LENUS (Irish Health Repository)

    Oosthuizen, J C

    2012-03-01

    To determine whether procedure-specific brochures improve patients\\' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed \\'Request for Treatment\\' consenting process is viable on a large scale.

  20. 16 CFR 312.5 - Parental consent.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Parental consent. 312.5 Section 312.5 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or...

  1. Informed consent in experimentation involving mentally impaired persons: ethical issues.

    Science.gov (United States)

    Petrini, Carlo

    2010-01-01

    The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  2. Informed consent in experimentation involving mentally impaired persons: ethical issues

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2010-12-01

    Full Text Available The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  3. Collective informed consent and decision power.

    Science.gov (United States)

    Varelius, Jukka

    2009-03-01

    It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent.

  4. Anesthesiological ethics: can informed consent be implied?

    Science.gov (United States)

    Spike, Jeffrey R

    2012-01-01

    Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.

  5. Informed consent, dementia and oral health care provision.

    Science.gov (United States)

    Ting, Graeme

    2012-04-01

    Managing patients with dementia requires a practitioner to exercise diverse skills. Communicating with the patient (as their dementia allows), relatives, caregivers and medical personnel are essential elements in the care process. Diagnosis of oral health problems may not be straightforward, clinical examination and treatment planning may be hampered by poor cooperation from the person with dementia. Practitioners must view any treatment from the patient's perspective and balance this with the requirements for sound clinical care. The consent process must be approached in a manner that fulfils the ethical responsibilities that acknowledge patient rights. This can be difficult when managing a patient with dementia. This paper will explore issues surrounding the consent process and the provision of oral health care to people suffering from dementia. It is hoped that readers will be stimulated to review their practice; especially related to informed consent, whether they routinely manage patients with dementia or not. Such practice evaluation should consider the wants and needs of patients and families on a broader than clinical basis and thus enhance the care that is brought to this group of interesting and often challenging patients.

  6. Informed Consent in Complementary and Alternative Medicine

    Directory of Open Access Journals (Sweden)

    Opher Caspi

    2011-01-01

    Full Text Available The objective of this study was to examine complementary and alternative medicine (CAM practitioners’ (i attitudes toward informed consent and (ii to assess whether standards of practice exist with respect to informed consent, and what these standards look like. The design and setting of the study constituted face-to-face qualitative interviews with 28 non-MD, community-based providers representing 11 different CAM therapeutic modalities. It was found that there is great deal of variability with respect to the informed consent process in CAM across providers and modalities. No unique profession-based patterns were identified. The content analysis yielded five major categories related to (i general attitude towards the informed consent process, (ii type and amount of information exchange during that process, (iii disclosure of risks, (iv discussions of alternatives, and (v potential benefits. There is a widespread lack of standards with respect to the practice of informed consent across a broad range of CAM modalities. Addressing this problem requires concerted and systematic educational, ethical and judicial remedial actions. Informed consent, which is often viewed as a pervasive obligation is medicine, must be reshaped to have therapeutic value. Acknowledging current conceptions and misconception surrounding the practice of informed consent may help to bring about this change. More translational research is needed to guide this process.

  7. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  8. Informed consent for radiotherapy: Our responsibility

    Energy Technology Data Exchange (ETDEWEB)

    Colyer, Hazel [Canterbury Christ Church University College, North Holmes Road, Canterbury, Kent CT1 1QU (United Kingdom)]. E-mail: h.m.colyer@canterbury.ac.uk

    2007-08-15

    This article describes and contextualises the findings from an email survey of cancer centres in the United Kingdom (UK) conducted early in 2005. It sought to discover how widely the model consent policy and process, published in 2001 [Department of Health. Good practice in consent. Achieving the NHS Plan commitment to patient-centred consent practice. HSC 2001/023. NHS Executive; November 2001], had been implemented and, more controversially, which professional groups gained the consent of patients to radiotherapy. The survey was sent on the author's behalf by the Society and College of Radiographers (SCoR) to all cancer centres in the UK, including five private sector facilities (n = 63). Forty-eight responses were received (76%). A majority of cancer centres have implemented the new procedures and these are undertaken most commonly by consultant oncologists and trained specialist registrars. In 10 centres, therapeutic radiographers (radiographers) are among the team gaining consent to radiotherapy and other centres have radiographers in training. There is widespread adherence to government guidance for obtaining consent and a growing number of centres are implementing radiographer-led consent. However, this is controversial from both medical and radiographic professional perspectives despite guidance indicating that the person who is actually treating the patients should seek their consent [Department of Health. 12 Key points on consent: the law in England. March 2001]. In the context of creating person-centred services, the significance for the development of the profession of therapeutic radiography is evaluated. In particular, the implications of radiographers both capitalising on and failing to assume this professional responsibility were explored.

  9. Informed Consent for Reconstructive Pelvic Surgery.

    Science.gov (United States)

    Alam, Pakeeza; Iglesia, Cheryl B

    2016-03-01

    Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery.

  10. Consent in crisis: the need to reconceptualize consent to tissue banking research.

    Science.gov (United States)

    Lipworth, W; Ankeny, R; Kerridge, I

    2006-02-01

    The issues surrounding consent to tissue banking research in Australia are complex and have created a forum of intense debate, thus providing a window of opportunity to critically appraise and challenge standard models of consent for research in general and for tissue banking research in particular. The usual practical difficulties associated with meeting the criteria for valid consent to research (including adequate information provision and voluntariness) are amplified in the case of tissue banking research. A number of models, based on widely accepted ethical principles, have been proposed to improve the process of obtaining consent to tissue banking research, all of which assume that the consent of individual tissue donors is needed to meet the criteria for valid consent. Feminist and communitarian theories use many of the same criteria for valid consent but interpret these criteria differently and de-emphasize the importance of individual autonomy as the central criterion for valid consent. An enriched model of consent incorporating feminist and communitarian ideas could satisfy the currently accepted criteria for valid consent while also furthering a broader range of community values.

  11. Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

    Science.gov (United States)

    Obeid, Jihad S; Gerken, Katherine; Madathil, Kapil Chalil; Rugg, Daniel; Alstad, Colin E; Fryar, Katrina; Alexander, Randall; Gramopadhye, Anand K; Moskowitz, Jay; Sanderson, Iain C

    2013-01-01

    Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

  12. Use of deferred consent for severely ill children in a multi-centre phase III trial

    Directory of Open Access Journals (Sweden)

    Boga Mwamvua

    2011-03-01

    Full Text Available Abstract Background Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrolment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. Methods We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. Results Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrolment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. Conclusions In light of the controversy around guidance and regulations in this area we report how and why we have used a

  13. Parents, adolescents, and consent for research participation.

    Science.gov (United States)

    Iltis, Ana S

    2013-06-01

    Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

  14. Click yes to consent: Acceptability of incorporating informed consent into an internet-based testing program for sexually transmitted and blood-borne infections.

    Science.gov (United States)

    Gilbert, Mark; Bonnell, Amanda; Farrell, Janine; Haag, Devon; Bondyra, Mark; Unger, David; Elliot, Elizabeth

    2017-09-01

    Autonomous use of online health care services without interaction with a health care provider challenges existing models for achieving informed consent (IC); current examinations of this issue have focused on commercial direct-to-consumer genetic testing. As IC is integral to publicly funded clinical testing services, we incorporated pre-test concepts necessary for IC in GetCheckedOnline (GCO), British Columbia's online sexually transmitted and blood-borne infection (STBBI) testing service. We assessed the acceptability of this IC step and its design options among potential users during usability testing of GCO. English-speaking participants≥19years were recruited from Craigslist and among provincial STI clinic clients for usability testing of an early version of GCO, which included a consent webpage presenting 8 pre-test statements for review prior to completing testing. Participants were interviewed regarding their acceptability, perceptions, and understanding of the consent page; transcripts were analyzed thematically. We conducted 13 interviews (9 males, 4 females; 9 self-identified as heterosexual; all had previously tested for STBBI). We identified three main themes: i) the meaning of IC (consent page viewed as important and for protection of individual and organization; participants demonstrated varying understandings of specific components); ii) the impact of previous experience on understanding IC (participants understood difference between online and in-person testing; IC concepts were better understood by participants with more testing experience); iii) the role of website design on achieving IC (design of page to disrupt speedy click-throughs was valued and demonstrated seriousness of the consent page). Our careful attention to both content and design of the consent page of GCO was highly valued by potential users of the service, and effective in disrupting routinization of consent on websites. We argue that principles of IC apply equally in online

  15. A linguistic model of informed consent.

    Science.gov (United States)

    Marta, J

    1996-02-01

    The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.

  16. Human dignity and consent in research biobanking

    African Journals Online (AJOL)

    2012-12-02

    Dec 2, 2012 ... Research biobanking raises numerous ethical questions.1 This ... ethical and legal reflections on the notion of informed consent in ... Faculty of Theology and Philosophy, Australian Catholic University, Brisbane, Australia.

  17. Testing Consent Order for Sodium Cyanide

    Science.gov (United States)

    This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).

  18. Testing Consent Order on Refractory Ceramic Fibers

    Science.gov (United States)

    This notice announces that EPA has signed signed an enforceable testing consent order under the Toxic Substances Control Act (TSCA), 15 U.S.C. section 2601 at seq., with three of the primary producers of refractory ceramic fibers (RCF).

  19. A descriptive study of consent documentation.

    LENUS (Irish Health Repository)

    Murphy, K

    2011-09-01

    The aim of this study was to observe the error rate in the consent process of a university hospital and to illicit the opinions of the consenting doctors on the process. A prospective observational review of theatre consent forms was performed along with an anonymous survey of non-consultant hospital doctors (NCHD\\'s). No potential risks were documented in 95.3% of the 64 scrutinized consents and late alterations were required in 9%. Respondents to the NCHD survey estimated that they were unsure of the procedure or risks involved in an average of 29% of occasions. Interns admitted to being unsure of the details of the procedure in almost a third (32%) of cases, making them less well informed than their senior colleagues (p=0.024). This study highlights the difficulties encountered by consenting doctors, an issue which may lead to patient dissatisfaction, threaten the efficient running of a surgical unit and potentially expose its staff to avoidable litigation. It also recommends the use of multimedia adjuncts to facilitate both patient and doctor education in the consent process.

  20. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

    Science.gov (United States)

    Fields, Lindy Marie; Calvert, James Douglas

    2015-08-01

    The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to 'informed consent' and 'cognitive impairment' published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed. We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount. © 2015 The Authors. Psychiatry and Clinical Neurosciences © 2015 Japanese Society of Psychiatry and Neurology.

  1. Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

    Science.gov (United States)

    Keel, Isabelle; Immer, Franz F.; Jüni, Peter

    2014-01-01

    Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

  2. Informed Consent in Medical Decision-Making in Commercial Gestational Surrogacy: A Mixed Methods Study in New Delhi, India

    DEFF Research Database (Denmark)

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi;

    2015-01-01

    OBJECTIVE: To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. DESIGN: Mixed methods study employing observations, an interview-guide and semi-structured interviews. SETTING: Fertility clinics and agenc...

  3. Dimensions of informed consent to treatment.

    Science.gov (United States)

    Dickens, B M; Cook, R J

    2004-06-01

    Modern law approaches patients' consent to treatment not only through liability for unauthorized touching, namely criminal assault and/or civil (non-criminal) battery, but also through liability for negligence. Physicians must exercise appropriate skill in conducting procedures, and in providing patients with information material to the choices that patients have to make. The doctrine of informed consent serves the ethical goal of respecting patients' rights of self-determination. Information is initially pitched at the reasonable, prudent person in the patient's circumstances, and then fine-tuned to what is actually known about the particular patient's needs for information. Elements to be disclosed include the patient's prognosis if untreated, alternative treatment goals and options, the success rate of each option, and its known effects and material risks. Risks include medical risks, but also risks to general well-being such as economic and similar reasonable interests. Consent is a continuing process, not an event or signed form.

  4. Informed consent: an international researchers' perspective.

    Science.gov (United States)

    Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence; Wong, Emelita

    2007-01-01

    We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

  5. Does parental consent for birth control affect underage pregnancy rates? The case of Texas.

    Science.gov (United States)

    Girma, Sourafel; Paton, David

    2013-12-01

    Previous work based on conjectural responses of minors predicted that the 2003 Texas requirement for parental consent for state-funded birth control to minors would lead to a large increase in underage pregnancies. We use state- and county-level data to test this prediction. The latter allow us to compare the impact of parental consent in counties with and without state-funded family planning clinics. We control for characteristics systematically correlated with the presence of state-funded clinics by combining difference-in-difference estimation with propensity score-weighted regressions. The evidence suggests that the parental consent mandate led to a large decrease in attendance at family planning clinics among teens but did not lead to an increase in underage pregnancies.

  6. Variability in the Perception of Informed Consent for IV-tPA during TeleStroke Consultation

    Directory of Open Access Journals (Sweden)

    Lisa Elizabeth Thomas

    2012-08-01

    Full Text Available OBJECTIVE: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving IV-tPA.METHODS: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by 5 raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. RESULTS: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all 5 raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k< 0.20. Similarly, the quality of the physician consent process was poor for agreement between all 5 raters (k=0.07 or between the subgroup of the 3 non-physician raters (k=-0.06 and fair between the 2 physician raters (k=0.24. The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. CONCLUSION: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.

  7. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

  8. RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER HEALTH SERVICES.

    Science.gov (United States)

    Spector-Bagdady, Kayte

    2015-01-01

    The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the

  9. Uso do desfibrilador automático externo no ambiente pré-hospitalar peruano: melhorando a resposta a emergências na América Latina Use of automated external defibrillator in Peruvian out-of-hospital environment: improving emergency response in Latin America

    Directory of Open Access Journals (Sweden)

    Pablo Lister

    2009-08-01

    Full Text Available Este relato de caso reporta o atendimento pré-hospitalar de um paciente com fatores de risco atendido pelo serviço pré-hospitalar ao ser acometido por uma parada cardíaca e apresentar fibrilação ventricular. O paciente foi atendido seguindo os padrões de suporte básico de vida e suporte cardiovascular avançado. Um desfibrilador automático externo (DAE foi aplicado com resultados favoráveis e o paciente se recuperou do quadro de perigo de vida com sucesso. Este é o primeiro relato documentado com resultados favoráveis no Peru, na área de atendimento pré-hospitalar e enfatiza a necessidade de serem adotadas políticas de acesso público à desfibrilação precoce.El presente reporte de caso, relata la atencion prehospitalaria de un paciente con factores de riesgo atendido en el area prehospitalaria al sufrir arresto cardiaco y presentar fibrilacion ventricular. El paciente fue atendido bajo estandares de Soporte Basico Vital y Soporte Cardiovascular Avanzado Vital, se aplico un Desfibrilador Automatizado Externo (DEA con resultado favorable y exito al recuperar al paciente de su condicion de compromiso de vida. Este es el primer reporte documentado con resultado favorable en el pais, en el area prehospitalaria y refuerza la conveniencia de adoptar politicas de Acceso Publico a la Desfibrilacion Temprana.This case report relates out-of-hospital care to a patient with risk factors treated in the out-of-hospital services after cardiac arrest and ventricular fibrillation. The patient was treated according to the standards of basic life support and advanced cardiovascular life support; by applying an automated external defibrillator (AED with favorable outcome and successful recovery of the patient from his risk of life condition. This is the first documented report with a favorable outcome in Peru, in out-of-hospital services and stresses the desirability of adopting policies for public access to early defibrillation.

  10. 12 CFR 347.119 - Specific consent.

    Science.gov (United States)

    2010-01-01

    ... processing procedure. (d) Specific consent. Direct or indirect investments in or activities of foreign... control such organization as a result of a foreign investment; or (ii) A bank would be establishing a... foreign country. (1) Applicable law or practice in the foreign country where the foreign organization...

  11. Students' Consent to a Teacher's Pedagogical Authority

    Science.gov (United States)

    Harjunen, Elina

    2011-01-01

    In this paper student comments are examined to identify a typology of demands for granting their consent to a teacher's pedagogical authority. The data for this study (136 written responses and 66 interviews) have been collected from students in a Finnish comprehensive school and examined by means of a theory-bounded content analysis. The results…

  12. 48 CFR 2944.203 - Consent limitations.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Consent limitations. 2944.203 Section 2944.203 Federal Acquisition Regulations System DEPARTMENT OF LABOR CONTRACT MANAGEMENT... rationale), signed by the contracting officer, and included in the contract file....

  13. Electronic registration of out-of-hospital cardiac arrests

    DEFF Research Database (Denmark)

    Nielsen, Niels Dalsgaard; Dahl, Michael; Gade, John;

    2007-01-01

    is uncertain. As the first region in the country, North Denmark Region has introduced a prehospital electronic healthcare record (designated amPHI™) in all of its 50 emergency ambulances. We used data from amPHI™ to examine the incidence of OHCA in the region.   Methods: We extracted patient data from the am...... %) had ventricular fibrillation, 32 (10 %) had other arrhythmias, 21 (7 %) had sinus rhythm and a single patient (0.3 %) had ventricular tachycardia.   Conclusions: We have shown amPHI™ to be a valuable tool for accessing information about OHCA. By a stringent electronic registration we found...

  14. ECPR for Refractory Out-Of-Hospital Cardiac Arrest

    Science.gov (United States)

    2017-05-17

    Cardiac Arrest; Heart Arrest; Sudden Cardiac Arrest; Cardiopulmonary Arrest; Death, Sudden, Cardiac; Cardiopulmonary Resuscitation; CPR; Extracorporeal Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation

  15. Electronic registration of out-of-hospital cardiac arrests

    DEFF Research Database (Denmark)

    Nielsen, Niels Dalsgaard; Dahl, Michael; Gade, John

    2007-01-01

    is uncertain. As the first region in the country, North Denmark Region has introduced a prehospital electronic healthcare record (designated amPHI™) in all of its 50 emergency ambulances. We used data from amPHI™ to examine the incidence of OHCA in the region.   Methods: We extracted patient data from the am...... %) had ventricular fibrillation, 32 (10 %) had other arrhythmias, 21 (7 %) had sinus rhythm and a single patient (0.3 %) had ventricular tachycardia.   Conclusions: We have shown amPHI™ to be a valuable tool for accessing information about OHCA. By a stringent electronic registration we found...

  16. What accounting leaves out of hospital financial management.

    Science.gov (United States)

    Boles, K E; Glenn, J K

    1986-01-01

    As PPS and other fixed-price initiatives replace cost-based reimbursement in the hospital industry, the burden of assuming the risk for business success or failure shifts from the payor to the hospital. As a consequence, theories of risk to the business firm which have found application in other industries now deserve attention by hospital management. Incorporating such risk concepts into hospital strategies and actions requires a view of financial management that goes beyond the generally accepted accounting principles of managing and assigning costs for maximum revenue and profitability. This article examines the financial theory of risk in business firms, illustrates the various components of risk as they apply to a hospital business, and discusses how the hospital management strategies of cost-reduction, marketing, diversification, and multiorganizational affiliation can alter the risk characteristics of a hospital business.

  17. Out-of-hospital treatment in case of drowning

    Directory of Open Access Journals (Sweden)

    Popović Vladan

    2011-01-01

    Full Text Available Introduction. Drowning is a leading preventable cause of unintentional morbidity and mortality. The dominant pathophysiological mechanism of drowning includes the development of acute hypoxia. First aid. The rescue procedure of a drowning person includes careful pulling the victim out of the water, examination, maintenance of the airways passable and urgent transfer to hospital. Basic life support. The first and most important treatment option of a drowning victim is the provision of ventilation which increases the chances of survival. As soon as the unresponsive victim is removed from the water, the lay rescuer should immediately begin chest compressions and provide cycles of ventilations and compressions. Some recent investigations have revealed that exterior compression of the chest is a necessary measure even in a situation when by­standers cannot provide airway. It is recommended to train by­standers to provide basic life support and apply automated external defibrillator in a drowning person whenever indicated and as early as possible. Advanced life support. In drowning, the victim with cardiac arrest requires advanced life support, including an early intubation. Extended medical measures, which are primarily provided by medical professionals, include cervical spine immobilization in case a spinal injury is suspected, or, establishment of the ventilation with oxygen, emergency transport, application of reanimation and advanced vital support measures.

  18. [Out-of-hospital resuscitation in Israel 2000].

    Science.gov (United States)

    Canetti, M; Feigenberg, Z; Caspi, A; Leor, J; Hod, H; Green, M; Hasin, Y; Battler, A; Garty, M; Mittelman, M; Porath, A; Grossman, E; Behar, S

    2004-11-01

    The aim of the study was to evaluate the impact of pre-hospital cardio-pulmonary resuscitation, performed by mobile intensive cardiac care units of Magen David Adom (MDA) teams in the framework of a national survey conducted in the period February and March 2000. During the survey, MDA performed 539 resuscitations, 485 of which were performed by mobile intensive care units of MDA, and they constitute the study population of the present analysis. The average age of the patients was 70.5 years, and 68% were men. The mean response time of the mobile intensive care units was 10.3 minutes. In 14% of the cases, a bystander initiated basic cardiac life support before the arrival of the MDA team. Upon arrival of the resuscitation team, 242 patients (50%) had asystole, 19% ventricular tachycardia (VT)/ventricular fibrillation (VF), 13% pulseless electrical activity (PEA), and 18% had other severe arrhythmias. One hundred and ninety-nine patients (41%) were transferred alive to the hospital after successful resuscitation. Hospital summaries were obtained for 148 of these patients. The cause of cardiac arrest was cardiac in 64% of the cases and 48% of the patients who reached the hospital had a previous history of heart disease. Fifty-three patients (11%) were discharged alive from the hospital. Patients discharged alive were younger, more promptly resuscitated, 78% had a cardiac cause of death and 38% of them were in ventricular tachycardia/fibrillation when first seen by the resuscitation team. The rate of successful resuscitation to discharge in the sub-group with VT/VF was 21%, and only 4% for patients in asystole, which is in line with other studies. However, the rate of initiation of resuscitation by bystanders is low in Israel. These data may help the medical staff and the health policy providers in Israel.

  19. Out-of-Hospital Cardiac Arrests in Children and Adolescents

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Wissenberg, Mads; Folke, Fredrik

    2015-01-01

    population. METHODS: All OHCA patients in Denmark, ≤21 years of age, were identified from 2001 to 2010. The population was divided into infants (adolescents/young adults (16-21 years). Multivariate logistic regression......-school children, school children and high school adolescents were 11.5, 3.5, 1.3 and 5.3 per 100,000 inhabitants. Overall bystander CPR rate was 48.8%, and for age groups: 55.4%, 41.2%, 44.9% and 63.0%, respectively. Overall 30-day survival rate was 8.1%, and for age groups: 1.4%, 4.5%, 16.1% and 9...

  20. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  1. Investigation and evaluation on nutrition status of pulmonary tuberculosis and nutritional support guidance effects out of hospital%肺结核患者营养状况调查分析及院外营养支持指导的效果评价

    Institute of Scientific and Technical Information of China (English)

    孙俊波; 汤敏; 凌国瑞

    2011-01-01

    Objective To discusses nutritive condition of tuberculosis patients and evaluation the recuperative effect of nutritional support guidance out of hospital. Method Detecting the first time peripheral blood total lymphocyte count (TLC) , seralbumin and body mass index ( BMI) of 98 tuberculosis patients who were first diagnosed before and after tuberculosis treatment and nutritional support guidance out of hospital after 3 months, and the results carried out statistical a-nalysis. Results The nutrition condition of primary tuberculosis patients was poor, it accounted for 88.04% , only 8.7% patients did not appear serious malnutrition. After tuberculosis treatment and nutritional support guidance out of hospital, all the patients nutritive condition obviously took a favorable turn, and the results snowed significant deviation ( P < 0.01) . Conclusions The nutritional status of tuberculosis patients was widespread poor, but after 3 month regular and effective tuberculosis treatment and nutritional support guidance, most patients can be recovered to satisfactory nutritional status, so nutritional support guidance out of hospital had considerable significance to help patients rehabilitation.%目的 探讨初发肺结核患者的营养状况,评价院外营养支持指导对肺结核患者营养恢复的效果.方法 通过对92例初发肺结核患者首次外周血总淋巴细胞数(TLC)、血清白蛋白(ALB)及患者体质量指数( BMI)的检测结果与抗结核治疗并院外营养支持治疗指导3月后复查结果进行统计分析.结果 初发肺结核患者营养状况差,占本组88.04%,仅约8.7%的患者未出现较为严重的营养不良,院外营养支持与抗结核治疗后,所有患者营养状况均有明显好转,差异有统计学意义(P<0.01).结论 肺结核患者营养状况普遍较差,通过正规有效的抗痨治疗及营养支持指导,多数患者可在3月内恢复良好的营养状况,院外营养支持指导对肺结核患者的迅

  2. Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire - a brave new world?

    Science.gov (United States)

    Mchale, Jean V

    2017-10-01

    The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

  3. Ethical issues in implementation research: a discussion of the problems in achieving informed consent

    Directory of Open Access Journals (Sweden)

    Eccles Martin P

    2008-12-01

    Full Text Available Abstract Background Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research. Discussion The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research. Summary While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of

  4. Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Thornton, J Daryl; Sullivan, Catherine; Albert, Jeffrey M; Cedeño, Maria; Patrick, Bridget; Pencak, Julie; Wong, Kristine A; Allen, Margaret D; Kimble, Linda; Mekesa, Heather; Bowen, Gordon; Sehgal, Ashwini R

    2016-08-01

    Low organ donation rates remain a major barrier to organ transplantation. We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider. This was a randomized controlled trial between February 2013 and May 2014. The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio. The study included 915 patients over 15.5 years of age who had not previously consented to organ donation. Just prior to their clinical encounter, intervention patients (n = 456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n = 459) visited their provider per usual routine. The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter. Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10-2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1-20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61-1.25). How the observed increases in organ donation consent might translate into a greater organ supply is unclear. Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected. clinicaltrials.gov Identifier: NCT01697137.

  5. Readability of patient information and consent documents in rheumatological studies

    DEFF Research Database (Denmark)

    Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

    2016-01-01

    BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands...

  6. The doctrine of informed consent in surgical practice

    African Journals Online (AJOL)

    had acted reasonably by asking the doctor to disclose his HIV status.[9] .... Conclusion. The concept of consent is continuously evolving, ... A citizen's right cannot be abridged with the intention of ... Consent A guide for Canadian. Physicians.

  7. Informed consent - a survey of doctors' practices in South Africa

    African Journals Online (AJOL)

    To examine doctors' practices with regard to informed consent. ... difficulties inherent in the concept of informed consent.'2 ... A systematic analysis of findings was undertaken to ..... this issue.20 However, the SAMDC21 supports a policy of.

  8. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications, and Consent

    Science.gov (United States)

    Horst, Jeremy A; Ellenikiotis, Hellene; Milgrom, Peter M

    2016-01-01

    The Food and Drug Administration recently cleared silver diamine fluoride for reducing tooth sensitivity. Clinical trials document arrest and prevention of dental caries by silver diamine fluoride; this off-label use is now permissible and appropriate under U.S. law. A CDT code was approved for caries arresting medicaments for 2016 to facilitate documentation and billing. We present a systematic review, clinical indications, clinical protocol, and consent procedure to guide application for caries arrest treatment. PMID:26897901

  9. 12 CFR 980.6 - Finance Board consent.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank...

  10. 26 CFR 25.2513-3 - Revocation of consent.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 14 2010-04-01 2010-04-01 false Revocation of consent. 25.2513-3 Section 25... GIFT TAXES GIFT TAX; GIFTS MADE AFTER DECEMBER 31, 1954 Transfers § 25.2513-3 Revocation of consent. (a... consent by filing in duplicate a signed statement of revocation, but only if the statement is filed on...

  11. 7 CFR 1c.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  12. Failing the vulnerable: Three new consent norms that will undermine ...

    African Journals Online (AJOL)

    2014-06-02

    Jun 2, 2014 ... completion of a questionnaire is commonly regarded as consent.[25] It ... concerns that: (i) children would not be prepared to seek parental consent, or (ii) ... Section 71 of the NHA limits the authority to provide proxy consent to.

  13. Vulnerable Subjects: Why Does Informed Consent Matter?

    Science.gov (United States)

    Goodwin, Michele

    2016-09-01

    This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term "bioethics" provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent.

  14. The nocebo effect of informed consent.

    Science.gov (United States)

    Cohen, Shlomo

    2014-03-01

    The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent (NEIC). This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis.

  15. Is informed consent effective in trauma patients?

    Science.gov (United States)

    Bhangu, A; Hood, E; Datta, A; Mangaleshkar, S

    2008-11-01

    Informed consent in the modern era is a common and important topic both for the well-informed patient and to prevent unnecessary litigation. However, the effectiveness of informed consent in trauma patients is an under-researched area. This paper aims to assess the differences in patient recall of the consent process and desire for information by performing a comparative analysis between orthopaedic trauma and elective patients. Information from 41 consecutive elective operations and 40 consecutive trauma operations was collected on the first post-operative day. 100% of elective patients and 90% of trauma patients knew what operation they had received (p = 0.06). Overall recall of complications was poor, but was significantly lower in trauma patients compared with elective patients (62% vs 22%, p<0.001). 30% of trauma patients desired more information about their operation compared to 12% of elective patients (p = 0.049), although only 35% of trauma patients wanted written as well as verbal explanations, compared to 85% of elective patients p<0.001). Overall 100% of elective and 90% of trauma patients were happy with the consent process (p = 0.06). Subset analysis of neck of femur compared to other trauma patients showed that the above factors were not significantly different between the two groups. Recall of complications in the trauma patients is significantly lower than in elective patients, although both groups scored poorly overall. Repeated verbal explanations should be reinforced with the option of additional information leaflets for trauma operations. Further research into the usefulness of DVDs for commonly performed operations is warranted, although official internet resources may be more cost-effective.

  16. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

    NARCIS (Netherlands)

    Kinnersley, P.; Phillips, K.; Savage, K.; Kelly, M.J.; Farrell, E.; Morgan, B.; Whistance, R.; Lewis, V.; Mann, M.K.; Stephens, B.L.; Blazeby, J.; Elwyn, G.; Edwards, A.G.

    2013-01-01

    BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken. However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their optio

  17. Modernity: A Myth That Manufactures Consent

    Directory of Open Access Journals (Sweden)

    Mehmet Atif Ergun

    2014-10-01

    Full Text Available This paper argues that “modernity”, as a process, a temporality, a category, and so on, is akin to Orientalism in that those who speak of it produce it as their ideology, their stereotyping of themselves and their others. The first section, on time, employs Kristeva’s work in “Women’s Time” in regards to the gendered politics of chaos and ordering. The second section, on alterity, pulls from various “times” and “spaces”, where multiple authors from, at times, conflicting backgrounds converge on the politics of othering. The third section, on consent, is on structuring the limits of imaginable alternatives of discourse. The final section draws from the previous three in order to deconstruct “modernity” as a mythology of temporal, spacial and societal orderliness, producing forms of alterity to manufacture the consent of whomever speaks of modernity towards creating a convenient history and setting a hegemony-laden agenda. As such, modernity takes the place of “the real” to consolidate and augment hegemony by way of self-naturalization. It is a manufactured consent, of those who speak of, to and about it, to colonial aggression and arrogance by evacuating colonial relations of power from the limits of the debate.

  18. Informed consent: Do not be afraid.

    Science.gov (United States)

    Sprumont, Dominique

    2017-04-01

    Informed consent is the cornerstone of the doctor-patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients. Copyright © 2015. Published by Elsevier B.V.

  19. Informed consent: Do not be afraid

    Directory of Open Access Journals (Sweden)

    Dominique Sprumont

    2017-04-01

    Full Text Available Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

  20. Relevance of information in informed consent to digestive endoscopy.

    Science.gov (United States)

    Stroppa, I

    2000-09-01

    In the field of instrumental methodologies, digestive endoscopy is widely applied diagnostic and therapeutic investigation, involving ethical and medico-legal problems connected with its performance. So, in the light of the present doctor-patient relationship, we therefore wished to reconsider the relevant meaning of preventive information which is indispensable for obtaining the patient's consent to the doctor's action. The aim of this present paper is to provide adequate knowledge, for who ever is about to undergo endoscopic examination, by introducing new informative forms and a new system for their distribution, without negatively affecting the patient's state of anxiety. We have tried to attribute greater responsibility to the person of the doctor requesting the examination, in providing information for the patient, and to underline, in the case of complications, the important conduct of the endoscopic specialist, who must not fail to obtain new informed consent before submitting the patient to any action directed towards treatment of the specific complication. If ignored, these medico-legal aspects can formulate the responsibility of the doctor both in clinical or penal context.

  1. Hope and persuasion by physicians during informed consent.

    Science.gov (United States)

    Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

    2014-10-10

    To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

  2. Legal sanctity of consent for surgical procedures in India

    Directory of Open Access Journals (Sweden)

    Gauri Sharma

    2012-01-01

    Full Text Available As surgeons, we are morally committed to respecting the right of self-determination of patients, thus an informed consent is necessary before any operative intervention. Many neurosurgical patients are incapable of giving consent because of impaired consciousness. Moreover, neurosurgical procedures involve high risks and often are time sensitive; therefore obtaining consent is a challenging job. Patients and their family members need immense courage, understanding, and trust before giving consent for a surgical procedure to a doctor. Lawsuits against doctors are on the rise and it is important to understand "what is consent?" in legal parlance.

  3. Law on consent and confidentiality in India: a need for clarity.

    Science.gov (United States)

    Mathiharan, Karunakaran

    2014-01-01

    The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.

  4. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

    2015-06-01

    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

  5. Informed Consent in Otolaryngologic Surgery: Case Scenario from a Nigerian Specialist Hospital

    Directory of Open Access Journals (Sweden)

    O. A. Afolabi

    2014-01-01

    Full Text Available Informed consent is a foundational concept necessary for ethical conduct of clinical research and practice. It is a technical tool that shifts the autonomy to decide whether a medical procedure should be performed—from the doctor to the patient. However there is an ongoing discussion in bioethical circles on the level of comprehension of the informed consent process by the patients and research participants. We present this case vignette and the discussion afterwards to explore the question of to what extent a patient comprehends the information given to him/her before a surgical procedure is carried out. In other words, the question being asked here is how informed is informed consent in the context of oto-laryngological practice.

  6. Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials.

    Science.gov (United States)

    Kimmelman, Jonathan; Levenstadt, Aaron

    2005-04-01

    The therapeutic misconception arises wherever human subjects misinterpret the primary purpose of a clinical trial as therapeutic. Such misconceptions are particularly prevalent in trials involving severely ill subjects or novel and well-publicized investigational agents. In order to identify possible sources of the therapeutic misconception in gene transfer trials, 286 phase 1 human gene transfer consent documents were analyzed for their description of purpose, alternatives, and their use of the term gene transfer. We report that 20% of trials fail to explain their purpose as safety and dosage, only 41% of oncology trials identify comfort care as an alternative to participation, and that the term gene therapy is used with twice the frequency of the term gene transfer. Trends and coherence in consent form language were analyzed as well. Our results indicate that consent forms used in gene transfer phase 1 trials often contain language that promotes, or does little to deter, therapeutic misconceptions.

  7. On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

    Science.gov (United States)

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

    Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

  8. Transboundary Resources, Consent and Customary Law - Comment

    Directory of Open Access Journals (Sweden)

    Graham Dutfield

    2013-09-01

    Full Text Available This brief commentary focuses on the unresolved access and benefit sharing (ABS challenges of transboundary resources and situations where getting prior informed consent is not possible. In the absence of the global mechanism envisaged by the Nagoya Protocol, satisfactory ABS deals can still be struck but these are unlikely to be either common or effective in generating substantial benefits for the indigenous peoples. The commentary closes by underlining the moral imperative of ensuring that traditional knowledge and genetic resource users comply with the laws and customary practices established by indigenous groups rather than simply impose their own norms. However, there are many legal and conceptual obstacles to be overcome first.

  9. Children’s competence to consent to medical treatment or research

    OpenAIRE

    Hein, I.M.

    2015-01-01

    In this study, we have explored the issue of children’s abilities to meaningfully decide on complex and important medical options, of which, until recently, little was known except that it often proved difficult to assess a child’s competence in some clinical settings. Nor was there empirical evidence on children’s competence to consent to treatment or clinical research to underpin these problematic areas. Yet problems did arise, when, for instance, pediatric patients did not agree with a rec...

  10. Role of the treating surgeon in the consent process for elective refractive surgery

    Directory of Open Access Journals (Sweden)

    Schallhorn SC

    2016-11-01

    Full Text Available Steven C Schallhorn,1–3 Stephen J Hannan,3 David Teenan,3 Julie M Schallhorn1 1Department of Ophthalmology, University of California, San Francisco, San Francisco, 2Roski Eye Institute, University of Southern California, Los Angeles, CA, USA; 3Optical Express, Glasgow, UK Purpose: To compare patient’s perception of consent quality, clinical and quality-of-life outcomes after laser vision correction (LVC and refractive lens exchange (RLE between patients who met their treating surgeon prior to the day of surgery (PDOS or on the day of surgery (DOS. Design: Retrospective, comparative case series. Setting: Optical Express, Glasgow, UK. Methods: Patients treated between October 2015 and June 2016 (3972 LVC and 979 RLE patients who attended 1-day and 1-month postoperative aftercare and answered a questionnaire were included in this study. All patients had a thorough preoperative discussion with an optometrist, watched a video consent, and were provided with written information. Patients then had a verbal discussion with their treating surgeon either PDOS or on the DOS, according to patient preference. Preoperative and 1-month postoperative visual acuity, refraction, preoperative, 1-day and 1-month postoperative questionnaire were compared between DOS and PDOS patients. Multivariate regression model was developed to find factors associated with patient’s perception of consent quality. Results: Preoperatively, 8.0% of LVC and 17.1% of RLE patients elected to meet their surgeon ahead of the surgery day. In the LVC group, 97.5% of DOS and 97.2% of PDOS patients indicated they were properly consented for surgery (P=0.77. In the RLE group, 97.0% of DOS and 97.0% of PDOS patients stated their consent process for surgery was adequate (P=0.98. There was no statistically significant difference between DOS and PDOS patients in most of the postoperative clinical or questionnaire outcomes. Factors predictive of patient’s satisfaction with consent quality

  11. [Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

    Science.gov (United States)

    de los Reyes López, M; Iñíguez Romo, A; Goicolea de Oro, A; Funes López, B; Castro Beiras, A

    1998-10-01

    In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations.

  12. Alternatives to project-specific consent for access to personal information for health research: insights from a public dialogue.

    Science.gov (United States)

    Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

    2008-11-19

    The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for

  13. Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

    Directory of Open Access Journals (Sweden)

    Abelson Julia

    2008-11-01

    for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.

  14. Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

    Science.gov (United States)

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

    This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data

  15. The accompanying adult: authority to give consent in the UK.

    Science.gov (United States)

    Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

    2007-05-01

    Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

  16. Seeking consent for research with indigenous communities: a systematic review.

    Science.gov (United States)

    Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J

    2016-10-22

    When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

  17. 77 FR 61640 - Notice of Lodging Proposed Consent Decree

    Science.gov (United States)

    2012-10-10

    ..., Richard C. Lee Federal Building, 141 Church Street, New Haven, CT 06510. In addition, the proposed Consent.... Rogers, Assistant Section Chief, Environmental Defense Section, Environment and Natural...

  18. Adherence to informed consent standards in Shiraz hospitals: matrons' perspective

    National Research Council Canada - National Science Library

    Mohsenian Sisakht, Alireza; Karamzade Ziarati, Najme; Kouchak, Farideh; Askarian, Mehrdad

    ...) to informed consent standards defined by Joint Commission International (JCI) Accreditation, USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons...

  19. A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research.

    Science.gov (United States)

    Blackford, Martha G; Falletta, Lynn; Andrews, David A; Reed, Michael D

    2012-09-01

    To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research. Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study. Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research. To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform "hard-to-reach" populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community. Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

  20. [Informed consent in aesthetic plastic surgery].

    Science.gov (United States)

    Fenger, H

    2006-02-01

    The informed consent plays a very decisive part in aesthetic plastic surgery. As there is often no medical indication in plastic surgery, the patient has to be informed about all the facts of an operation, especially about the possible risks. The legal requests for therapeutic and economic clarification gain in importance. The jurisdiction in Germany demands a merciless clarification for the patient. The patient needs to be clarified about all facts early enough so that he has a sufficient amount of time to weigh-up the pros und cons of the operation and if necessary to take advice from someone else. The sufficient documentation is very important at the sight of the extensive burden of proof at the expense of the physician.

  1. A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent

    Directory of Open Access Journals (Sweden)

    Kitchener Henry C

    2007-02-01

    Full Text Available Abstract Background The first vaccine to prevent human papillomavirus (HPV and cervical cancer has been licensed, and in future, vaccination may be routinely offered to 10–14 year old girls. HPV is a sexually transmitted virus and some parents may refuse consent for vaccination. Under-16s in the UK have a right to confidential sexual health care without parental consent. We investigated parents' views on making available HPV vaccination to adolescent minors at sexual health clinics without parental consent. Methods This was a semi-qualitative analysis of views of parents of 11–12 year old school children collected as part of a population-based survey of parental attitudes to HPV vaccination in Manchester. Parents were firstly asked if they agreed that a well-informed child should be able to request vaccination at a sexual health clinic without parental consent, and secondly, to provide a reason for this answer. Ethical perspectives on adolescent autonomy provided the framework for descriptive analysis. Results 307 parents answered the question, and of these, 244 (80% explained their views. Parents with views consistent with support for adolescent autonomy (n = 99 wanted to encourage responsible behaviour, protect children from ill-informed or bigoted parents, and respected confidentiality and individual rights. In contrast, 97 parents insisted on being involved in decision-making. They emphasised adult responsibility for a child's health and guidance, erosion of parental rights, and respect for cultural and moral values. Other parents (n = 48 wanted clearer legal definitions governing parental rights and responsibilities or hoped for joint decision-making. Parents resistant to adolescent autonomy would be less likely to consent to future HPV vaccination, (67% than parents supporting this principle (89%; p Conclusion In the UK, the principle of adolescent autonomy is recognised and logically should include the right to HPV vaccination, but

  2. A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

    Science.gov (United States)

    Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

    2017-02-01

    Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and

  3. The regulation of informed consent to participation in clinical ...

    African Journals Online (AJOL)

    in research or experimentation became a statutory imperative. Section 71(1) .... Chichester: John Wiley & Sons, 1994: 63-64, where he presents Kant's argument in ... Rather than a categorical approach which predicates that people should be.

  4. Termo de consentimento livre e esclarecido aos usuários de clínicas odontológicas brasileiras: aspectos éticos e legais Terms of informed consent for users of dental clinics in Brazil: legal and ethical issues

    Directory of Open Access Journals (Sweden)

    Sílvia Helena de Carvalho Sales-Peres

    2011-01-01

    Full Text Available O consentimento do paciente antes do início de qualquer procedimento é uma condição a ser respeitada pelos profissionais da odontologia, sem nenhuma exceção. É necessário que o paciente esteja ciente de seu status de saúde, de suas necessidades específicas, do propósito de cada tratamento, conheça os planejamentos alternativos (incluindo o não tratamento, saiba do seu prognóstico, riscos, consequências, limitações e se conscientize das suas responsabilidades e as do seu cirurgião-dentista, proporcionando o sucesso do tratamento. O termo de consentimento livre e esclarecido (TCLE visa fortalecer e esclarecer a posição do paciente, estabelecendo os direitos e deveres de ambas as partes paciente e profissional. O conhecimento integral do tratamento diminuirá a ansiedade do paciente e as complicações de tratamento, promoverá maior qualidade dos serviços odontológicos e maior satisfação do dentista e do paciente. Entretanto, no Brasil, poucos artigos são encontrados e existem alguns problemas éticos envolvendo as clínicas odontológicas, no que diz respeito a este documento de esclarecimento para o paciente. Diante disso, este trabalho tem por objetivo realizar uma revisão crítica sobre o tema abordado, demonstrando a importância do TCLE na clínica odontológica brasileira e na vida profissional dos cirurgiões-dentistas.The consent of patient before the beginning of any procedure has to be a respected condition, without any exception. It is necessary the patients to be aware of their health status, their specific needs, the intention of each treatment, the alternatives plans (including no treatment, to know their prognostic, risks, consequences, limitations, and to be aware of their responsibilities and those of your dentist, resulting in the success of the treatment. The Informed Consent (TCLE aims to fortify and to clarify the position of the patient, being established the rights and duties of both parts

  5. Changes in capacity to consent over time in patients involved in psychiatric research

    Science.gov (United States)

    Palmer, Barton W.; Savla, Gauri N.; Roesch, Scott C.; Jeste, Dilip V.

    2013-01-01

    Background Informed consent is a key element of ethical clinical research. Patients with serious mental illness may be at risk for impaired consent capacity. Corrective feedback improves within-session comprehension of consent-relevant information, but little is known about the trajectory of patients’ comprehension after the initial enrolment session. Aims To examine whether within-session gains in understanding after feedback were maintained between study visits and to examine stability of decisional capacity over time. Method This was a longitudinal, within-participants comparison of decisional capacity assessed at baseline, 1 week, 3 months, 12 months and 24 months in 161 people with schizophrenia or bipolar disorder. Results Within-session gains from corrective feedback generally dissipated over each follow-up interval. Decisional capacity showed a general pattern of stability, but there was significant between-participant heterogeneity. Better neuropsychological performance was associated with better decisional capacity across time points. Positive symptoms of schizophrenia did not predict any aspects of decisional capacity, but general psychopathology, negative symptoms and depression evidenced some modest associations with certain subdomains of decisional capacity. Conclusions Informed consent may be most effectively construed as an ongoing dialogue with participants at each study visit. PMID:23661766

  6. Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

    Science.gov (United States)

    Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie

    2012-01-01

    Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

  7. Between personal and relational privacy: understanding the work of informed consent in cancer genetics in Brazil.

    Science.gov (United States)

    Goldim, José Roberto; Gibbon, Sahra

    2015-07-01

    Drawing from perspectives of both bioethics and anthropology, this article explores how the boundaries between personal and relational privacy are negotiated by patients and practitioners in the context of an emerging domain of cancer genetics in Brazil. It reflects on the place of informed consent in the history of bioethics in North America in contrast to the development of bioethics in Brazil and the particular social cultural context in which consent is sought in Brazilian public health care. Making use of empirical research with families and individuals receiving genetic counselling related to increased genetic risk for cancer, in genetic clinics in southern Brazil, it examines how informed consent is linked to the necessary movement between personal and relational privacy. The paper illustrates the value of a particular tool known as a 'sociogram' to examine the complex interpersonal dynamics that arise in negotiating informed consent at the interface between the family and the individual in Brazil. The paper, therefore, points to the scope of further interdisciplinary exchanges between anthropology and bioethics, confronting the new challenges that arise in the context of medical genetics in developing country.

  8. Different Diagnosis, Shared Vulnerabilities: The Value of Cross Disorder Validation of Capacity to Consent.

    Science.gov (United States)

    Rosen, Allyson; Weitlauf, Julie C

    2015-01-01

    A screening measure of capacity to consent can provide an efficient method of determining the appropriateness of including individuals from vulnerable patient populations in research, particularly in circumstances in which no caregiver is available to provide surrogate consent. Seaman et al. (2015) cross-validate a measure of capacity to consent to research developed by Jeste et al. (2007). They provide data on controls, caregivers, and patients with mild cognitive impairment and dementia. The study demonstrates the importance of validating measures across disorders with different domains of incapacity, as well as the need for timely and appropriate follow-up with potential participants who yield positive screens. Ultimately clinical measures need to adapt to the dimensional diagnostic approaches put forward in DSM 5. Integrative models of constructs, such as capacity to consent, will make this process more efficient by avoiding the need to test measures in each disorder. Until then, cross-validation studies, such as the work by Seaman et al. (2015) are critical.

  9. "Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

    Science.gov (United States)

    Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

    2016-01-01

    This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

  10. Who is the patient? Disclosure of information and consent in anesthesia and intensive care (informed consent).

    Science.gov (United States)

    Korusić, Andelko; Merc, Vlasta; Duzel, Viktor; Tudorić-Djeno, Ivana; Zidak, Davorka; Brundula, Ana; Sojcić, Natasa; Milanović, Rudolf; Barić, Ada; Beslić, Gabrijela

    2013-09-01

    Physicians have always strived to uphold all the ethical postulates of the medical profession in all aspects of the practice, however with the vast advances in science and technology, numerous ethical dilemmas regarding all aspects of life and ultimately death have emerged. Medical decisions however, are no longer in the sole jurisdiction of traditional Hippocratic medicine but are now deliberated and delivered by the patient and they are comprised of a number of additional determining aspects such as psychological, social, legal, religious, esthetic, administrative etc., which all together represent the complete best interest of the patient. This is the basic goal of the "Informed Consent". The widening of legal boundaries regarding professional liability may consequentially lead to a "defensive medicine" and a deterioration in the quality of healthcare. In the Republic of Croatia there a four types of liability and the hyperproduction of laws which regulate healthcare geometrically increase the hazards to which physicians are exposed to on a daily basis. When evaluating the Croatian informed consent for anesthesia, we can come to the conclusion that it is completely impractical and as such entirely unnecessary. Anesthesiologists should concentrate on an informed consent which would in brief explain all the necessary information a "reasonable" anesthesiologist would disclose to a "reasonable" patient so that a patient could undertake a diagnostic or therapeutic procedure unburdened and with complete confidence in the physicians who are involved in the treatment of the respective patient.

  11. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    Science.gov (United States)

    Laubach, Marty

    2005-01-01

    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  12. Consent to tissue banking for research: qualitative study and recommendations.

    Science.gov (United States)

    Soto, Carmen; Tarrant, Carolyn; Pritchard-Jones, Kathy; Dixon-Woods, Mary

    2012-07-01

    To explore how families of children with cancer experience giving consent for tissue banking and to produce recommendations on good practice. 79 participants from 42 families (41 mothers, 18 fathers, 20 children and young people with cancer) took part in semistructured interviews to explore their experiences of being approached for consent to tissue banking. Tertiary care facilities for childhood cancer. Families are generally supportive of tissue banking, although they report that it may be difficult for them to consider all the implications when asked for consent. They typically do not want detailed information when consent is sought close to diagnosis, preferring to see tissue banking as part of routine practice. Families often recognise that their consent may not be fully informed, but are content to give consent based on their understanding at the time. Some may want a chance to go over the information and revisit their decision when things have settled. Families' views can inform practical recommendations for optimising the experience of consent for tissue banking. Current guidelines for obtaining consent should be revisited to take account of families' preferences.

  13. Consent for Dental Therapy in Severely Ill Patients.

    Science.gov (United States)

    Litch, C. Scott; Liggett, Martha L.

    1992-01-01

    Legal standards for informed consent are discussed in the context of dental care for the elderly and severely ill. Variations in state common law and legislation are analyzed, focusing on differences between practitioner-oriented and patient-oriented approaches to informed consent. Implications for educators and practitioners are examined.…

  14. Revocation of Parental Consent: State Approaches. inForum

    Science.gov (United States)

    Muller, Eve

    2010-01-01

    The purpose of this document is to determine whether revocation of parental consent is currently posing a challenge for states and to describe how states are responding to this new provision. Although parental consent has always played a central role in Individuals with Disabilities Education Act, the new provision allowing revocation of parental…

  15. 40 CFR 26.1117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent....

  16. Informed Consent in Research on Second Language Acquisition

    Science.gov (United States)

    Thomas, Margaret; Pettitt, Nicole

    2017-01-01

    The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

  17. The Social Construction of Consent: Sexual Scripts and Acquaintance Rape.

    Science.gov (United States)

    White, Jacquelyn W.; Niles, Patricia

    The decision whether a woman has consented to sexual intercourse is rarely determined by the woman herself. Often, instead, a woman's consent, and ultimately her sexuality, is determined for her by others--her partner, the community, or the court system. Women in this culture have traditionally had very little power to control their own bodies and…

  18. Alcohol and Sexual Consent Scale: Development and Validation

    Science.gov (United States)

    Ward, Rose Marie; Matthews, Molly R.; Weiner, Judith; Hogan, Kathryn M.; Popson, Halle C.

    2012-01-01

    Objective: To establish a short measure of attitudes toward sexual consent in the context of alcohol consumption. Methods: Using a multistage and systematic measurement development process, the investigators developed the Alcohol and Sexual Consent Scale using a sample of college students. Results: The resulting 12-item scale, the Alcohol and…

  19. 42 CFR 50.205 - Consent form requirements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Consent form requirements. 50.205 Section 50.205 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form...

  20. Black Boxing Restraints: The Need for Full Disclosure and Consent

    Science.gov (United States)

    Mohr, Wanda K.; Nunno, Michael A.

    2011-01-01

    In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

  1. Black Boxing Restraints: The Need for Full Disclosure and Consent

    Science.gov (United States)

    Mohr, Wanda K.; Nunno, Michael A.

    2011-01-01

    In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

  2. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    Science.gov (United States)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  3. Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

    LENUS (Irish Health Repository)

    2012-02-29

    Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

  4. Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents

    Science.gov (United States)

    2016-01-01

    Background In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. Methods We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Results Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Conclusions Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers. PMID:27689046

  5. Manufacturing Consent revisited Manufacturing Consent revisité Una nueva aproximación a Manufacturing Consent

    Directory of Open Access Journals (Sweden)

    Michael Burawoy

    2012-12-01

    Full Text Available Cet article présente rapidement Manufacturing Consent publié en 1979 dans lequel la direction d’Allis Chalmer organisait la discipline du travail ouvrier par la coercition et par le consentement, en particulier à travers l’établissement des quotas de production qui fondait une sorte de jeu social entre ouvriers (the game of making out. L’auteur revient sur la méthode ethnographique utilisée alors pour la critiquer et il propose de la remplacer par « l’étude de cas élargie » (the extented case method qui prend en compte le contexte du travail dont les trajectoires des acteurs, les transformations des marchés et du rôle de l’État, sans négliger les éléments spatio-temporels facteurs de changement. C’est l’occasion pour l’auteur de passer en revue les publications récentes qui ont élargi les objets de recherches à la question du genre, au travail domestique, aux travailleurs migrants, aux services, au syndicalisme, etc. L’article suggère que l’enjeu des luttes passerait de l’exploitation à la marchandisation (commodification avec les luttes consuméristes qui l’accompagneraient ; lesquelles inaugureraient une nouvelle ère de mobilisations transnationales étendues à l’Europe de l’Est et à l’Asie. Ce qui conduit l’auteur à reprendre les thèses de Polanyi sur La Grande Transformation en les actualisant avec l’avènement présent d’une troisième vague ultra-libérale qui étend la marchandisation à la nature (terre, eau et air et aux connaissances : les mouvements « d’occupation » (“occupy” movements en seraient les premières ripostes.The article briefly presents Manufacturing Consent, a 1979 publication directed by Allis Chalmer that deals with the way in which work discipline for manual labourers is organised through coercion and consent, based in particular on the establishment of production quota creating a kind of "game of making out" between works. The author reviews

  6. Manufacturing Consent revisité Manufacturing Consent revisited Una nueva aproximación a Manufacturing Consent

    Directory of Open Access Journals (Sweden)

    Michael Burawoy

    2012-12-01

    Full Text Available Cet article présente rapidement Manufacturing Consent publié en 1979 dans lequel la direction d’Allis Chalmer organisait la discipline du travail ouvrier par la coercition et par le consentement, en particulier à travers l’établissement des quotas de production qui fondait une sorte de jeu social entre ouvriers (the game of making out. L’auteur revient sur la méthode ethnographique utilisée alors pour la critiquer et il propose de la remplacer par « l’étude de cas élargie » (the extented case method qui prend en compte le contexte du travail dont les trajectoires des acteurs, les transformations des marchés et du rôle de l’État, sans négliger les éléments spatio-temporels facteurs de changement. C’est l’occasion pour l’auteur de passer en revue les publications récentes qui ont élargi les objets de recherches à la question du genre, au travail domestique, aux travailleurs migrants, aux services, au syndicalisme, etc. L’article suggère que l’enjeu des luttes passerait de l’exploitation à la marchandisation (commodification avec les luttes consuméristes qui l’accompagneraient ; lesquelles inaugureraient une nouvelle ère de mobilisations transnationales étendues à l’Europe de l’Est et à l’Asie. Ce qui conduit l’auteur à reprendre les thèses de Polanyi sur La Grande Transformation en les actualisant avec l’avènement présent d’une troisième vague ultra-libérale qui étend la marchandisation à la nature (terre, eau et air et aux connaissances : les mouvements « d’occupation » (“occupy” movements en seraient les premières ripostes.The article briefly presents Manufacturing Consent, a 1979 publication directed by Allis Chalmer that deals with the way in which work discipline for manual labourers is organised through coercion and consent, based in particular on the establishment of production quota creating a kind of "game of making out" between works. The author reviews

  7. [Readability of surgical informed consent in Spain].

    Science.gov (United States)

    San Norberto, Enrique María; Gómez-Alonso, Daniel; Trigueros, José M; Quiroga, Jorge; Gualis, Javier; Vaquero, Carlos

    2014-03-01

    To assess the readability of informed consent documents (IC) of the different national surgical societies. During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

  8. [Informed consent in the patients' rights law].

    Science.gov (United States)

    Figueroa G, Rodolfo

    2012-10-01

    The new regulation of patients' rights creates the right to informed consent, which allows accepting or refusing any medical treatment. Also, the patient has the right to be appropriately informed about a variety of aspects determined by the law. Patient's autonomy has limits. Artificial acceleration of death, euthanasia or assisted suicide are not permitted. The problem is that the law does not define those situations. The law provides the intervention of Ethics Committees when the doctor considers that the patient exposes himself to severe harm or the risk of death which would be avoided. This intervention impinges on patient's autonomy. Patients have the right to request discharge and medical facilities could discharge patients against their will if they do not accept medical recommendations. These limitations on autonomy should be explained because the law apparently makes the distinction between killing, letting die and the Double Effect Doctrine. There is plenty of literature questioning the validity of both. The law fails to regulate part of the medical practice, regarding life and death decisions. A lack of consensus could explain this omission. Doctors have a right to conscientious objection to some patient's requests.

  9. Análisis de la inclusión de la policía en la respuesta de emergencias al paro cardiorrespiratorio extrahospitalario Analysis of the inclussion of police personnel on the out of hospital cardiac arrest emergency response

    Directory of Open Access Journals (Sweden)

    Andrea Aguilera-Campos

    2012-02-01

    Full Text Available OBJETIVO: El presente estudio busca analizar una alternativa al pronóstico de paro cardiorrespiratorio extrahospitalario (PCE como problema de salud pública al involucrar a los cuerpos policiacos en la respuesta de emergencias. MATERIAL Y MÉTODOS: Se analizó retrospectivamente un registro de PCE iniciado en junio de 2009. Se contrastó un modelo basado en un número limitado de ambulancias con primera respuesta por la policía. RESULTADOS: La mortalidad fue de 100%, tiempos de respuesta elevados y 10.8% recibió reanimación cardiopulmonar (RCP por testigos presenciales. En 63.7% de los eventos la policía llegaba antes que la ambulancia y en 1.5% el policía dio RCP. El costo por vida salvada fue 5.8-60 millones de pesos en un modelo sólo con ambulancias vs. 0.5-5.5 millones de pesos en un modelo con primera respuesta policiaca. CONCLUSIONES: La intervención de la policía en la ciudad de Querétaro facilitaría la disminución de la mortalidad por PCE a un menor costo.OBJETIVE: Out-of-hospital cardiac arrest (OCHA is a public health problem in which survival depends on community initial response among others. This study tries to analyze what's the proportional cost of enhancing such response by involving the police corps in it. MATERIALS AND METHODS: We analyzed retrospectively an OCHA registry started on June 2009. We contrasted a model with limited number of ambulances and police based first response. RESULTS: Mortality was 100%, response times high and 10.8% of the victims were receiving cardiopulmonary resuscitation (CPR by bystanders. In 63.7% of the events the police arrived before the ambulance, in 1.5% of these cases the police provided CPR. The cost for each saved life was of 5.8-60 million Mexican pesos per life with only ambulance model vs 0.5-5.5 million Mexican pesos on a police first response model with 12 ambulances. CONCLUSIONS: In Queretaro interventions can be performed taking advantage of the response capacity of the

  10. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Science.gov (United States)

    2011-10-19

    ... Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent Orders... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl...

  11. USign--a security enhanced electronic consent model.

    Science.gov (United States)

    Li, Yanyan; Xie, Mengjun; Bian, Jiang

    2014-01-01

    Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

  12. Informed Consent Documentation for Lumbar Puncture in the Emergency Department

    Directory of Open Access Journals (Sweden)

    Pankaj B. Patel

    2014-05-01

    Full Text Available Introduction: Informed consent is a required process for procedures performed in the emergency department (ED, though it is not clear how often or adequately it is obtained by emergency physicians. Incomplete performance and documentation of informed consent can lead to patient complaints, medico-legal risk, and inadequate education for the patient/guardian about the procedure. We undertook this study to quantify the incidence of informed consent documentation in the ED setting for lumbar puncture (LP and to compare rates between pediatric (<18 years and adult patients. Methods: In this retrospective cohort study, we reviewed the ED electronic health records (EHR for all patients who underwent successful LPs in three EDs between April 2010 and June 2012. Specific elements of informed consent documentation were reviewed. These elements included the presence of general ED and LP-specific consent forms, signatures of patient/guardian, witness, and physician, documentation of purpose, risks, benefits, alternatives, and explanation of the LP. We also reviewed the use of educational material about the LP and LP-specific discharge information. Results: Our cohort included 937 patients; 179 (19.1% were pediatric. A signed general ED consent form was present in the EHR for 809 (86% patients. A consent form for the LP was present for 524 (56% patients, with signatures from 519 (99% patients/guardians, 327 (62% witnesses, and 349 (67% physicians. Documentation rates in the EHR were as follows: purpose (698; 74%, risks (742; 79%, benefits (605; 65%, alternatives (635; 68%, and explanation for the LP (57; 6%. Educational material about the LP was not documented as having been given to any of the patients and LP-specific discharge information was documented as given to 21 (2% patients. No significant differences were observed in the documentation of informed consent elements between pediatric and adult patients. Conclusion: General ED consent was obtained in

  13. The Consent Solution to Punishment and the Explicit Denial Objection

    Directory of Open Access Journals (Sweden)

    Miroslav Imbrisevic

    2010-06-01

    Full Text Available Recently, David Boonin has put forward several objections to Carlos S. Nino's 'Consensual Theory of Punishment'. In this paper I will defend Nino against the 'explicit denial objection'. I will discuss whether Boonin's interpretation of Nino as a tacit consent theorist is right. I will argue that the offender's consent is neither tacit nor express, but a special category of implicit consent. Further, for Nino the legal-normative consequences of an act (of crime are 'irrevocable', i.e. one cannot (expressly and successfully deny liability to them. I will suggest an explanation for Nino's irrevocability claim.

  14. The current status analysis of medical priority dispatching system in out-of-hospital cardiac arrest event%医疗优先分级调派系统在院前心脏骤停事件中应用现况分析

    Institute of Scientific and Technical Information of China (English)

    张晓凡; 陈洁莲; 陈卡佳

    2015-01-01

    Objective To analyze the application status of medical priority dispatch system ( MPDS) in out-of-Hospital Cardiac Arrest ( OHCA) .Methods According to the answering records of the dispatchers we totally collected 1658 OHCA cases in Wuxi Pre -hospital Center from June 26, 2012 to December 26, 2013.Results Among 1658 cases, 958 patients were assessed and of these 370 cases were given assistance cardio -pulmonary resuscitation ( CPR) by the dispatcher.The sensitivity of MPDS in detecting cardiac arrest was 49.1%and specificity was 99.9%.Accident location (χ2 =2.872, P=0.000;χ2 =1.772, P=0.000), alarm people gender (χ2 =9.763, P=0.002;χ2 =8.308, P=0.004), the relationship with the patients (χ2 =2.660, P =0.000; χ2 =1.461, P=0.000), whether belonging to 110 linkage events (χ2 =4.414, P=0.000; χ2 =1.169, P=0.000) were not statistic significant difference with implementing MPDS to accessing the condition of the patient and giving assistant CPR respectively.Conclusion The specificity of MPDS in detecting cardiac arrest is high but the sensitivity is low.There are weak links to be improved by enforcing management of implement, public training, training subjects, carrying out scientific research for the MPDS.%目的:分析医疗优先分级调派系统( medical priority dispatch system, MPDS)在院前心脏骤停( out of hospital cardiac arrest, OHCA)事件中的应用现况。方法对照2012-06-26~2013-12-26院前直属分站出诊的1658份现场心脏骤停病历,听取相关调度员接警录音,收集相关数据。结果1658例心脏骤停事件中,调度员应用MPDS判断病情958例,电话医学指导370例;MPDS对院前心脏骤停事件的识别特异度为99.9%,敏感度为49.1%;发病地点(χ2=2.872,P=0.000;χ2=1.772,P=0.000)、报警人性别(χ2=9.763,P=0.002;χ2=8.308,P=0.004)与是否为患者家属(χ2=2.660,P=0.000;χ2=1.461

  15. Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-01-01

    Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

  16. ECT in the treatment of a patient with catatonia: consent and complications.

    Science.gov (United States)

    Zisselman, Marc H; Jaffe, Richard L

    2010-02-01

    Acute catatonia in an adolescent or young adult can present complex clinical challenges. Prominent issues include those involving diagnosis, timely and effective treatment, and diminished capacity to provide consent. The authors describe a 19-year-old woman presenting initially with manic excitement followed by a lengthy period of mutism, immobility, and food and fluid refusal. Elevated temperature, an elevated creatine phosphokinase level, and autonomic dysfunction led to consideration of a malignant catatonic syndrome. The patient manifested rigidity accompanied by posturing and waxy flexibility. Neurologic, medical, and laboratory evaluations failed to identify an organic cause for the likely catatonia. Treatment with amantadine, bromocriptine, and lorazepam was unsuccessful. ECT was deemed appropriate but required emergency guardianship because of the patient's inability to provide consent. At the initial ECT session, the elicited seizure was followed by an episode of torsade de pointes requiring immediate cardioversion. In reviewing the ECT complication, it appeared that muscle damage due to catatonic immobility led to acute hyperkalemia with the administration of succinylcholine. Discussions were held with the patient's guardian outlining the clinical issues and the risks of additional ECT. The patient responded to eight subsequent ECT sessions administered with rocuronium, a nondepolarizing muscle relaxant. The authors provide a brief review of the diagnosis and treatment of catatonia and address issues surrounding ECT, cardiac effects, use of muscle relaxants, and the consent process.

  17. Informed Consent in Medical Decision-Making in Commercial Gestational Surrogacy: A Mixed Methods Study in New Delhi, India

    DEFF Research Database (Denmark)

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi

    2015-01-01

    in the surrogacy process were coded to identify categories of ethical concern. Numerical and grounded theory-oriented analyses were used. MAIN OUTCOME MEASURES: Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. RESULTS: None of the 14 surrogate......OBJECTIVE: To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. DESIGN: Mixed methods study employing observations, an interview-guide and semi-structured interviews. SETTING: Fertility clinics...

  18. The Informed Consent in Allergology from a Scientific, Technological and Social Perspective

    Directory of Open Access Journals (Sweden)

    Marisela Luisa Pérez Pacaréu

    2015-11-01

    Full Text Available This paper reviews the application of the informed consent within the specialty of allergology in procedures (skin tests, therapeutic interventions (immunotherapy and research (clinical trials from a scientific, technological and social perspective, based on the advances achieved in Cuba in recent years to obtain better allergenic extracts for testing, high-quality vaccines and new drugs to benefit the allergic patient. It is demonstrated that when applying the informed consent in this specialty, the humanistic social precepts are respected by directing health actions to respect the integrity of the patients against possible risks, offering the option to use immunotherapy and respecting their autonomy in research. It benefits the patients by improving their lifestyles to control the allergic disease, improve their health and quality of life. Furthermore, it promotes social justice by making available these services to the entire population.

  19. Customary international rule and the consent of the States

    Directory of Open Access Journals (Sweden)

    Rodrigo Díaz Inverso

    2015-10-01

    Full Text Available This paper analyzes the relationship between custom, one of the main sources of public international law, and the need of consent of the State to which the customary rule should apply. The two main answers that the authors gave in connection to that relationship are reviewed: on the one hand, the authors who require consent as a condition for enforceability of the customary law and, on the other hand, the authors who deny the need of such consent. We adopt the doctrinal opinion that international customary law is compulsory only for those States that had, expressly or tacitly, consented to it.

  20. Informed consent - a survey of doctors' practices in South Africa ...

    African Journals Online (AJOL)

    ... that patients and parents were fully informed about diagnostic and therapeutic interventions. ... Language, inadequate communication skills and lack of time were, ... Doctors who treat children were significantly less likely to obtain consent for

  1. 'guardian'? Practical strategies for consent to child research in

    African Journals Online (AJOL)

    dianship consent strategy means the following: • Researchers should be aware of the current definition of 'parent',. 'guardian' ... do not meet the strict legal definition. As set out in a ..... trials: Evolution of the field and opportunities for growth.

  2. Impact of informed consent on patient decisions regarding third ...

    African Journals Online (AJOL)

    2015-06-22

    Jun 22, 2015 ... The Amsterdam Preoperative Anxiety and Information. Scale and ... Key words: Anxiety, informed consent, third molar extraction ..... Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative. Anxiety and ...

  3. 21 CFR 1316.08 - Consent to inspection.

    Science.gov (United States)

    2010-04-01

    ... constitutional right not to have an administrative inspection made without an administrative inspection warrant; (2) That he has right to refuse to consent to such an inspection; (3) That anything of...

  4. Informed consent: attitudes, knowledge and information concerning prenatal examination

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone

    2006-01-01

    Background: Providing women with information enabling an informed consent to prenatal examinations has been widely recommended. Objective: The primary purpose of this review is to summarise current knowledge of the pregnant woman's expectations and attitudes concerning prenatal examinations, as w...

  5. Assessing children’s competence to consent in research by a standardized tool: a validity study

    Directory of Open Access Journals (Sweden)

    Hein Irma M

    2012-09-01

    Full Text Available Abstract Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s. It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In

  6. Informed Consent in Lumbar Puncture: ¿a Systematic Practice?

    Directory of Open Access Journals (Sweden)

    Ivonne Martín Hernández

    2011-08-01

    Full Text Available Background: the lumbar puncture is an invasive procedure doesn't exempt of risks and for its realization it is necessary to request the patient or family's informed consent. However, this practice is even controversial among our physicians. Objective: to identify how the process of informed consent works for the lumbar puncture in our means and its importance for our professionals. Methods: this study involved 90 physicians who were underwent a validated questionnaire. For the processing of numerical data was used frequency analysis and relative percent. SPSS 11.5 on Windows was employed as statistical system. Results: it was found that informed consent doesn't constitute a systematic practice in our means and was evidenced the deficiencies that even exist in its quality and application. This has been only carried out oral and the informative interest prevails above the respect to the patient's will. The physicians offer insufficient information in aspects like the explanation of the procedure, the contraindications and the complications of proceeding. For most of those interviewed the informed consent is important, but regrettably still some fear that it becomes obstacle for the realization of this to proceed. Conclusions: although most of our physicians value the importance positively of offering the informed consent when they execute the lumbar puncture, many carry out it improperly or they don't still carry out it. Lack of knowledge on the informed consent's ethical foundation and practical aspects is denoted among the physicians interviewed.

  7. The Age of Consent and the Ending of Queer Theory

    Directory of Open Access Journals (Sweden)

    Sarah Beresford

    2014-10-01

    Full Text Available This article uses the debates surrounding the age of consent as a broad umbrella to question the continued usefulness of Queer Theory. The debates surrounding the age of consent illustrate that Queer Theory has not fulfilled its original promise and that it is not (and possibly never been, “fit for purpose”. Towards the end of 2013, the topic of lowering the age of consent in England and Wales was once again much in the news. This article suggests that much of that debate focused expressly or impliedly on the age of which men and boys have sexual intercourse (whether gay or straight, rather than when people have sexual intercourse. Queer Theory (originating from feminism, was intended to be a liberating phenomenon, but contrary to these hopes and intentions, Queer Theory evolved to become synonymous with white gay men, thus denying its origins and becoming distinctly anti-feminist. Those who argue for a reduction in the age of consent have used (whether knowingly or not an approach which is consistent with this evolved version of Queer Theory. Consequently, the debate on the age of consent has ignored, or given insufficient attention to, the effect(s a lowering of the age of consent will have on girls and women. This article, therefore, seeks to question, disrupt and unsettle, what Queer Theory has become, suggesting that, in several significant aspects, it fails to fully acknowledge patriarchy; render (lesbian women visible; acknowledge and accommodate the lived experiences of women.

  8. Patients' consent to the measure of medical treatment

    Directory of Open Access Journals (Sweden)

    Sjeničić Marta Ž.

    2009-01-01

    Full Text Available Consent to medical treatment is a patient right. The patient right to give or withhold consent to some treatment procedure arises from the principle of free will of each person, that is, the principle of self-determination. The patient consent is valid only in case he/she has previously been provided by the physician with the relevant information on the intended medical measure. The scope of information is generally regulated. However, the physician is obliged to estimate each patient's need and the ability to receive information. Treatment can have desired results only with patients' compliance. Apart from being patient right, giving of consent to medical treatment is also his/her legal duty, the fulfillment of which is expected prior to beginning of treatment. By non-complicance, a patient unable the treatment procedure and damages his/her own health. However, the duty to give the consent is not the real legal obligation. It cannot be the subject of claim, nor can it be coercively enforced. For this reason, consent to medical treatment, as well as the other subsidiary duties of patients, is named duty of the patient in his own interest. Its non full filament does not lead to the liability of the patient. It can, under certain circumstances, reduce or exclude the physicians share in damage and his liability or, under certain circumstances, give the possibility to the physician to cancel further rendering of health care to the patient.

  9. Adherence to Informed Consent Standards in Shiraz Hospitals: Matrons Perspective

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    Alireza Mohsenian Sisakht

    2015-01-01

    Full Text Available Background Informed consent is an important part of the patients’ rights and hospitals are assigned to obtain informed consent before any diagnostic or therapeutic procedures. Obtaining an informed consent enables patients to accept or reject their care or treatments and prevent future contentions among patients and medical staff. Methods This survey was carried out during 2011-2. We assessed adherence of 33 Shiraz hospitals (governmental and non-governmental to informed consent standards defined by Joint Commission International (JCI Accreditation, USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons. We calculated valid percent frequency for each part of the questionnaire and compared these frequencies in governmental and nongovernmental hospitals using analytical statistics. Results Considering 63% of the hospitals that filled out the questionnaire, no statistically significant difference was observed between the governmental and non-governmental hospitals in adherence to informed consent standards. Conclusion This study shows a relatively acceptable adherence to standards about informed consent in Shiraz hospitals but the implementation seems not to be as satisfactory.

  10. 76 FR 256 - Informed Consent Elements

    Science.gov (United States)

    2011-01-04

    ... elements which align with various ethics codes and apply to all clinical investigations regulated by FDA and clinical investigations that support applications for research or marketing permits for products... ethical research, patient advocacy organizations, health care attorneys, pharmacy and law students,...

  11. "Informed" Consent: An Audit of Informed Consent of Cesarean Section Evaluating Patient Education and Awareness.

    Science.gov (United States)

    Kirane, Akhilesh G; Gaikwad, Nandkishor B; Bhingare, Prashant E; Mule, Vidya D

    2015-12-01

    Better diagnosis and early referral due to increased health care coverage have increased the cesarean deliveries at tertiary-care hospitals of India. Improvements in the health care system raise many concerns and need of cross-checking system in place to counter the problems pertaining to patient education and participation of patient. While most of the cesarean sections are done in good faith for the patient, it does not escape the purview of consumer awareness and protection. This cross-sectional study was undertaken at a tertiary level government institution to understand the level of awareness of 220 patients regarding the various aspects of cesarean delivery which are essential for women to know before giving an informed consent. 71 % of the women had knowledge about the indication and need to do cesarean delivery. Of these, only one-third (25 % of total women) were properly explained about procedure and complications. Other demographic and social characteristics were also evaluated. While the health care schemes have had their improved results, the onus lies upon the caregivers to improve and maintain the quality of health care in these tertiary-care government hospitals in proportion to the increase in patient load. The results of this study highlight the need for proper counseling of patients regarding complications of cesarean section. The fact that only 25 % of total cases were explained proper procedure and complication as opposed to 71 % of patients having proper knowledge about the indication of cesarean section points out the lack of information in seemingly "informed" consent. To bring about awareness about the risks and complications of cesarean section, there is a need that patients be counseled during the antenatal visits, specifically when patients visit near term for antenatal check up.

  12. How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review.

    Science.gov (United States)

    Munung, Nchangwi Syntia; Che, Chi Primus; Ouwe-Missi-Oukem-Boyer, Odile; Tangwa, Godfrey B

    2011-09-01

    We assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 full-length articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.

  13. Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent.

    Science.gov (United States)

    Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan

    2016-10-26

    Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient's personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness - their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications - constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process.

  14. Health literacy predicts participant understanding of orally-presented informed consent information.

    Science.gov (United States)

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

  15. Interpreter accuracy and informed consent among Spanish-speaking families with cancer.

    Science.gov (United States)

    Simon, Christian M; Zyzanski, Stephen J; Durand, Ellen; Jimenez, Xavier F; Jimenez, Xavier; Kodish, Eric D

    2006-01-01

    Language interpreters mediate a growing number of health care communication events, including the informed consent process, which underlies the ethical conduct of clinical research. This article explores a key interpretive outcome, accuracy, in 21 Spanish/English informed consent consultations. Discussions were transcribed, translated, and coded according to established techniques. Most (74%) discussion was accurately interpreted (range: 47%-98%; std. deviation: .137). Accuracy was lower in the more technical portions of the discussion when compared with nontechnical portions such as discussion of coping and quality-of-life issues (p = .024). The concept of "randomization" often was poorly communicated and interpreted. These differences may be due in part to the use of long, uninterrupted, and jargon-filled sentences by clinicians explaining research, among other factors. The article concludes that accuracy may be promoted if clinicians used less technical language and shorter sentences, and are more "process driven." Interpreters may need to be better informed about research-related concepts such as randomization. Further research is needed to determine the effects of interpretive accuracy on the informed consent process, the decision to participate in research, and other outcomes.

  16. Health literacy predicts participant understanding of orally-presented informed consent information

    Science.gov (United States)

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    2016-01-01

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants’ recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects’ levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate. PMID:26767117

  17. Non-consent to a wrist-worn accelerometer in older adults: the role of socio-demographic, behavioural and health factors.

    Directory of Open Access Journals (Sweden)

    Maliheh Hassani

    Full Text Available Accelerometers, initially waist-worn but increasingly wrist-worn, are used to assess physical activity free from reporting-bias. However, its acceptability by study participants is unclear. Our objective is to assess factors associated with non-consent to a wrist-mounted accelerometer in older adults.Data are from 4880 Whitehall II study participants (1328 women, age range = 60-83, requested to wear a wrist-worn accelerometer 24 h every day for 9 days in 2012/13. Sociodemographic, behavioral, and health-related factors were assessed by questionnaire and weight, height, blood pressure, cognitive and motor function were measured during a clinical examination.210 participants had contraindications and 388 (8.3% of the remaining 4670 participants did not consent. Women, participants reporting less physical activity and less favorable general health were more likely not to consent. Among the clinical measures, cognitive impairment (Odds Ratio = 2.21, 95% confidence interval: 1.22-4.00 and slow walking speed (Odds Ratio = 1.38, 95% confidence interval: 1.02-1.86 were associated with higher odds of non-consent.The rate of non-consent in our study of older adults was low. However, key markers of poor health at older ages were associated with non-consent, suggesting some selection bias in the accelerometer data.

  18. Surgical informed consent in children: a systematic review.

    Science.gov (United States)

    Chotai, Pranit N; Nollan, Richard; Huang, Eunice Y; Gosain, Ankush

    2017-06-01

    The purpose of the article was to analyze current literature on surgeon and parents' understanding and role in the informed consent process for children undergoing surgery. A systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non-English-language articles, review articles, case reports and/or series, letters-commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. One hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents' ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. Studies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon-patient relationship and to optimize the informed consent process in children undergoing surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Informed consent and nurses' roles: a survey of Indonesian practitioners.

    Science.gov (United States)

    Susilo, Astrid P; van Dalen, Jan; Chenault, Michelene N; Scherpbier, Albert

    2014-09-01

    In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses' roles therein and whether there is a difference between ideal and experienced practice (reality), and whether this differs across hospitals. A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: 'nurses' roles', 'barriers in informed consent', and 'adequacy of information'. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses' roles varied across professions, while barriers in informed consent differed between hospitals. The differences between ideal and reality indicated that improvement in the informed consent process and nurses' roles therein is called for. Varying views between physicians and nurses on nurses' roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Views on nurses' roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent

  20. Consent Processes for Mobile App Mediated Research: Systematic Review.

    Science.gov (United States)

    Moore, Sarah; Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

    2017-08-30

    Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. This review advocates the importance of participant informedness in a novel and largely unregulated research setting.