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Sample records for consent out-of-hospital clinical

  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

    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. ME......-reviewed journals and presented at relevant scientific symposia....

  2. Distinguishing in-hospital and out-of-hospital status epilepticus: clinical implications from a 10-year cohort study.

    Science.gov (United States)

    Sutter, R; Semmlack, S; Spiegel, R; Tisljar, K; Rüegg, S; Marsch, S

    2017-09-01

    The aim was to determine differences of clinical, treatment and outcome characteristics between patients with in-hospital and out-of-hospital status epilepticus (SE). From 2005 to 2014, clinical data were assessed in adults with SE treated in an academic medical care centre. Clinical characteristics, treatment and outcomes were compared between patients with in-hospital and out-of-hospital SE. Amongst 352 patients, 213 were admitted with SE and 139 developed in-hospital SE. Patients with in-hospital SE had more acute/fatal aetiologies (60% vs. 35%, P Status Epilepticus Severity Score (STESS) was an independent predictor for death in both groups, increased Charlson Comorbidity Index and treatment refractory SE were associated with death only in patients with in-hospital SE. Continuous anaesthesia for refractory SE was associated with increased mortality only in patients with out-of-hospital SE. The area under the receiver operating curve was 0.717 for prediction of death by STESS in patients with in-hospital SE and 0.811 in patients with out-of-hospital SE. Patients with in-hospital SE had more fatal aetiologies and comorbidities, refractory SE, less return to functional baseline, and increased mortality compared to patients with out-of-hospital SE. Whilst the STESS was a robust predictor for death in both groups, the association between continuous anaesthesia and death was limited to out-of-hospital SE. © 2017 EAN.

  3. 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...

  4. 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...

  5. Chest compressions before defibrillation for out-of-hospital cardiac arrest: A meta-analysis of randomized controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Meier Pascal

    2010-09-01

    Full Text Available Abstract Background Current 2005 guidelines for advanced cardiac life support strongly recommend immediate defibrillation for out-of-hospital cardiac arrest. However, findings from experimental and clinical studies have indicated a potential advantage of pretreatment with chest compression-only cardiopulmonary resuscitation (CPR prior to defibrillation in improving outcomes. The aim of this meta-analysis is to evaluate the beneficial effect of chest compression-first versus defibrillation-first on survival in patients with out-of-hospital cardiac arrest. Methods Main outcome measures were survival to hospital discharge (primary endpoint, return of spontaneous circulation (ROSC, neurologic outcome and long-term survival. Randomized, controlled clinical trials that were published between January 1, 1950, and June 19, 2010, were identified by a computerized search using SCOPUS, MEDLINE, BIOS, EMBASE, the Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts database, and Web of Science and supplemented by conference proceedings. Random effects models were used to calculate pooled odds ratios (ORs. A subgroup analysis was conducted to explore the effects of response interval greater than 5 min on outcomes. Results A total of four trials enrolling 1503 subjects were integrated into this analysis. No difference was found between chest compression-first versus defibrillation-first in the rate of return of spontaneous circulation (OR 1.01 [0.82-1.26]; P = 0.979, survival to hospital discharge (OR 1.10 [0.70-1.70]; P = 0.686 or favorable neurologic outcomes (OR 1.02 [0.31-3.38]; P = 0.979. For 1-year survival, however, the OR point estimates favored chest compression first (OR 1.38 [0.95-2.02]; P = 0.092 but the 95% CI crossed 1.0, suggesting insufficient estimate precision. Similarly, for cases with prolonged response times (> 5 min point estimates pointed toward superiority of chest compression first (OR 1.45 [0

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

    Science.gov (United States)

    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

  7. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest : rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    NARCIS (Netherlands)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    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.

  8. 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...... compared to patients with shockable rhythm. In the adjusted multivariable regression model, pre-existing non-cardiovascular disease and drug prescription were associated with a non-shockable rhythm e.g. chronic obstructive lung disease (OR 1.44 [95% CI: 1.32–1.58]); and the prescription for antidepressants...

  9. 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

    background frequency, and PD, suppressed voltage or burst-suppression) was associated with higher mortality (HR=1.62(1.09-2.41), p=0.02) after adjustment for known prognostic factors (false positive rate: 9%). CONCLUSION: EEG may be useful in work-up in prognostication of patients with OHCA. Findings......BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is associated with a poor prognosis and predicting outcome is complex with neurophysiological testing and repeated clinical neurological examinations as key components of the assessment. In this study we examine the association between different...... 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...

  10. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    Science.gov (United States)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    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. Methods and analysis We set up a large-scale prospective community-based registry (AmsteRdam Resuscitation Studies, ARREST) in which we prospectively include all resuscitation attempts from OHCA in a large study region in the Netherlands in collaboration with Emergency Medical Services. Of all OHCA 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 the resuscitation attempt since July 2007. Various study designs are employed to analyse the data of the ARREST registry, including case–control, cohort, case only and case-cross over designs. Ethics and dissemination We describe the rationale, outline and potential results of the ARREST registry. The design allows for a stable and reliable collection of multiple determinants of OHCA, while assuring that the patient, lay-caregiver or medical professional is not hindered in any way. Such comprehensive data collection is required to unravel the complex basis of OHCA. Results will be published in peer-reviewed journals and presented at relevant scientific symposia. PMID:25332818

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

    Science.gov (United States)

    Søholm, Helle; Kjær, Troels Wesenberg; Kjaergaard, Jesper; Cronberg, Tobias; Bro-Jeppesen, John; Lippert, Freddy K; Køber, Lars; Wanscher, Michael; Hassager, Christian

    2014-11-01

    Out-of-hospital cardiac arrest (OHCA) is associated with a poor prognosis and predicting outcome is complex with neurophysiological testing and repeated clinical neurological examinations as key components of the assessment. In this study we examine the association between different electroencephalography (EEG) patterns and mortality in a clinical cohort of OHCA-patients. From 2002 to 2011 consecutive patients were admitted to an intensive-care-unit after resuscitation from OHCA. Utstein-criteria for pre-hospital data and review of individual patients' charts for post-resuscitation care were used. EEG reports were analysed according to the 2012 American Clinical Neurophysiology Society's guidelines. 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 (36%) and Periodic Discharges (PD) in 100 patients (45%). Background EEG frequency of Alpha+ or Theta was noted in 107 patients (49%), and change in cerebral EEG activity to stimulation (reactivity) was found in 38 patients (17%). Suppression (all activity <10 μV) was found in 26 (12%) and burst-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 background frequency, and PD, suppressed voltage or burst-suppression) was associated with higher mortality (HR=1.62(1.09-2.41), p=0.02) after adjustment for known prognostic factors (false positive rate: 9%). EEG may be useful in work-up in prognostication of patients with OHCA. Findings 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. Copyright © 2014 Elsevier Ireland

  12. 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

    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...... 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...... in the control groups. The optimal target temperature management strategy is not known....

  13. 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.

  14. Out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Sondergaard, Kathrine B; Hansen, Steen Moller; Pallisgaard, Jannik L

    2018-01-01

    AIMS: Despite wide dissemination of automated external defibrillators (AEDs), bystander defibrillation rates remain low. We aimed to investigate how route distance to the nearest accessible AED was associated with probability of bystander defibrillation in public and residential locations. METHODS......: We used data from the nationwide Danish Cardiac Arrest Registry and the Danish AED Network to identify out-of-hospital cardiac arrests and route distances to nearest accessible registered AED during 2008-2013. The association between route distance and bystander defibrillation was described using...... in public locations, the probability of bystander defibrillation at 0, 100 and 200meters from the nearest AED was 35.7% (95% confidence interval 28.0%-43.5%), 21.3% (95% confidence interval 17.4%-25.2%), and 13.7% (95% confidence interval 10.1%-16.8%), respectively. The corresponding numbers for cardiac...

  15. 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.

    Science.gov (United States)

    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.

  16. 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.

  17. [The informed consent in international clinical trials including developing countries].

    Science.gov (United States)

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  18. 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......, completed the questions of the survey. A dedicated strategy for OHCA management is active in 85% of the centres. Shockable tachyarrhythmias such as initial OHCA rhythm are reported in >70% of the patients in 64% of the centres. In-hospital therapeutic hypothermia was applied in >50% of the patients in 53...... management strategy, including coronary angiography/PCI and implantable cardioverter defibrillator therapy, while therapeutic hypothermia appears to be underused....

  19. Pediatric out-of-hospital deaths following hospital discharge: a ...

    African Journals Online (AJOL)

    Background: Out-of-hospital death among children living in resource poor settings occurs frequently. Little is known about the location and circumstances of child death following a hospital discharge. Objectives: This study aimed to understand the context surrounding out-of-hospital deaths and the barriers to accessing ...

  20. Key factors in children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

    2015-01-01

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

  1. 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.

  2. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...

  3. Blockchain protocols in clinical trials: Transparency and traceability of consent

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

  4. Blockchain protocols in clinical trials: Transparency and traceability of consent.

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

  5. Implementation of a standardized out-of-hospital management method for Parkinson dysphagia.

    Science.gov (United States)

    Wei, Hongying; Sun, Dongxiu; Liu, Meiping

    2017-12-01

    Our objective is to explore the effectiveness and feasibility of establishing a swallowing management clinic to implement out-of-hospital management for Parkinson disease (PD) patients with dysphagia. Two-hundred seventeen (217) voluntary PD patients with dysphagia in a PD outpatient clinic were divided into a control group with 100 people, and an experimental group with 117 people. The control group was given dysphagia rehabilitation guidance. The experimental group was presented with the standardized out-of-hospital management method as overall management and information and education materials. Rehabilitation efficiency and incidence rate of dysphagia, as well as relevant complications of both groups were compared after a 6-month intervention. Rehabilitation efficiency and the incidence rate of dysphagia including relevant complications of patients treated with the standardized out-of-hospital management were compared with those seen in the control group. The differences have distinct statistics meaning (pdysphagia complications and improve the quality of life in patients with PD.

  6. [Out of hospital deliveries: incidence, obstetrical characteristics and perinatal outcome].

    Science.gov (United States)

    Zur, M; Hadar, A; Sheiner, E; Mazor, M

    2003-01-01

    Traditionally, women used to deliver their babies at home. In 1927, in England and Wales, 85% of births took place at home. By 1970 the position was reversed. The move from home to institutional delivery has been accompanied by changes in the institutions themselves and in the type of care provider. There are two kinds of out-of-hospital deliveries: 1. Planned home deliveries--women who decide to deliver in their home with the assistance of midwives or other consultant obstetric facilities. Few cases from this group, however, end up in the hospital; 2. Unplanned home deliveries or delivery en-route to the hospital--when women enter the active phase of labor rapidly, resulting in accidental out-of-hospital deliveries. The study aims to review the available literature and to describe the incidence, obstetrical characteristics and perinatal outcome of out-of-hospital deliveries.

  7. Use of altered informed consent in pragmatic clinical research.

    Science.gov (United States)

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

  8. The regulation of informed consent to participation in clinical ...

    African Journals Online (AJOL)

    participation in clinical research by mentally ill persons – the discussion on informed consent .... usually lay persons without scientific and medical knowledge. It is .... is not defined by the Mental Health Care Act; nor is it stated anywhere in the ...

  9. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Arab Journal of Nephrology and Transplantation ... in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to ...

  10. Implementation of a standardized out-of-hospital management method for Parkinson dysphagia

    OpenAIRE

    Wei, Hongying; Sun, Dongxiu; Liu, Meiping

    2017-01-01

    Summary Objective: Our objective is to explore the effectiveness and feasibility of establishing a swallowing management clinic to implement out-of-hospital management for Parkinson disease (PD) patients with dysphagia. Method: Two-hundred seventeen (217) voluntary PD patients with dysphagia in a PD outpatient clinic were divided into a control group with 100 people, and an experimental group with 117 people. The control group was given dysphagia rehabilitation guidance. The experimental gr...

  11. Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Ringh, Mattias; Rosenqvist, Mårten; Hollenberg, Jacob; Jonsson, Martin; Fredman, David; Nordberg, Per; Järnbert-Pettersson, Hans; Hasselqvist-Ax, Ingela; Riva, Gabriel; Svensson, Leif

    2015-06-11

    Cardiopulmonary resuscitation (CPR) performed by bystanders is associated with increased survival rates among persons with out-of-hospital cardiac arrest. We investigated whether rates of bystander-initiated CPR could be increased with the use of a mobile-phone positioning system that could instantly locate mobile-phone users and dispatch lay volunteers who were trained in CPR to a patient nearby with out-of-hospital cardiac arrest. We conducted a blinded, randomized, controlled trial in Stockholm from April 2012 through December 2013. A mobile-phone positioning system that was activated when ambulance, fire, and police services were dispatched was used to locate trained volunteers who were within 500 m of patients with out-of-hospital cardiac arrest; volunteers were then dispatched to the patients (the intervention group) or not dispatched to them (the control group). The primary outcome was bystander-initiated CPR before the arrival of ambulance, fire, and police services. A total of 5989 lay volunteers who were trained in CPR were recruited initially, and overall 9828 were recruited during the study. The mobile-phone positioning system was activated in 667 out-of-hospital cardiac arrests: 46% (306 patients) in the intervention group and 54% (361 patients) in the control group. The rate of bystander-initiated CPR was 62% (188 of 305 patients) in the intervention group and 48% (172 of 360 patients) in the control group (absolute difference for intervention vs. control, 14 percentage points; 95% confidence interval, 6 to 21; PCPR was associated with significantly increased rates of bystander-initiated CPR among persons with out-of-hospital cardiac arrest. (Funded by the Swedish Heart-Lung Foundation and Stockholm County; ClinicalTrials.gov number, NCT01789554.).

  12. 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...... 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...

  13. Out-of-hospital noninvasive ventilation: epidemiology, technology and equipment

    Directory of Open Access Journals (Sweden)

    John Scott Baird

    2012-04-01

    Full Text Available Noninvasive ventilation has been utilized successfully in the pre- and out-of-hospital settings for a variety of disorders, including respiratory distress syndrome in neonates, neurologic and pulmonary diseases in infants and children, and heart failure as well as chronic obstructive pulmonary disease in adults. A variety of interfaces as well as mechanical positive pressure devices have been used: simple continuous positive airway pressure devices are available which do not require sophisticated equipment, while a broad spectrum of ventilators have been used to provide bilevel positive airway pressure. Extensive training of transport teams may be important, particularly when utilizing bilevel positive airway pressure in infants and children.

  14. Key factors in children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-10-24

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that

  15. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    Science.gov (United States)

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  16. Implementation of a standardized out-of-hospital management method for Parkinson dysphagia

    Directory of Open Access Journals (Sweden)

    Hongying Wei

    Full Text Available Summary Objective: Our objective is to explore the effectiveness and feasibility of establishing a swallowing management clinic to implement out-of-hospital management for Parkinson disease (PD patients with dysphagia. Method: Two-hundred seventeen (217 voluntary PD patients with dysphagia in a PD outpatient clinic were divided into a control group with 100 people, and an experimental group with 117 people. The control group was given dysphagia rehabilitation guidance. The experimental group was presented with the standardized out-of-hospital management method as overall management and information and education materials. Rehabilitation efficiency and incidence rate of dysphagia, as well as relevant complications of both groups were compared after a 6-month intervention. Results: Rehabilitation efficiency and the incidence rate of dysphagia including relevant complications of patients treated with the standardized out-of-hospital management were compared with those seen in the control group. The differences have distinct statistics meaning (p<0.01. Conclusion: Establishing a swallowing management protocol for outpatient setting can effectively help the recovery of the function of swallowing, reduce the incidence rate of dysphagia complications and improve the quality of life in patients with PD.

  17. Out-of-hospital cardiac arrests in children and adolescents

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Wissenberg, Mads; Folke, Fredrik

    2015-01-01

    BACKGROUND: There is insufficient knowledge of out-of-hospital cardiac arrest (OHCA) in the very young. OBJECTIVES: This nationwide study sought to examine age-stratified OHCA characteristics and the role of parental socioeconomic differences and its contribution to mortality in the young...... 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...

  18. [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.

  19. Young man presenting with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Huang, Hans David; Lombardi, William L; Steinberg, Zachary Louis

    2018-06-22

    A man in his early 30s with remote history of a febrile rash as a toddler presented to the emergency room following an out-of-hospital cardiac arrest while riding his bicycle. He received bystander cardiopulmonary resuscitation and one shock from an automatic external defibrillator, successfully restoring sinus rhythm. On arrival, he was haemodynamically stable without ECG evidence of ST segment changes to suggest active ischaemia, and an initial troponin I was mildly elevated at 0.10 ng/mL (normal <0.04 ng/mL). A CT angiogram (CTA) was obtained showing a normal-appearing aorta and no abnormal extracardiac findings. Urgent coronary angiography was performed; images are shown in figure 1A-C. Echocardiogram revealed a mildly reduced left ventricular ejection fraction (45%) with a hypokinetic inferior wall.heartjnl;heartjnl-2018-312966v1/F1F1F1Figure 1(A) Right coronary artery angiogram in the left anterior oblique cranial projection. (B) Left coronary artery angiogram in the right anterior oblique caudal projection. (C) Left coronary artery angiogram in the right anterior oblique cranial projection. CAUD, caudal; CRAN, cranial; LAO, left anterior oblique; RAO, right anterior oblique. What is the next best step in the management of this patient at this time?Complete revascularisation via percutaneous coronary intervention (PCI).Referral for coronary artery bypass surgery (CABG).Initiation of high-dose steroids.Initiation of dual-antiplatelet therapy without planned revascularisation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

    Science.gov (United States)

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

    This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

  1. Community involvement in out of hospital cardiac arrest

    Science.gov (United States)

    Shams, Ali; Raad, Mohamad; Chams, Nour; Chams, Sana; Bachir, Rana; El Sayed, Mazen J.

    2016-01-01

    Abstract Out of hospital cardiac arrest (OHCA) is a leading cause of death worldwide. Developing countries including Lebanon report low survival rates and poor neurologic outcomes in affected victims. Community involvement through early recognition and bystander cardiopulmonary resuscitation (CPR) can improve OHCA survival. This study assesses knowledge and attitude of university students in Lebanon and identifies potential barriers and facilitators to learning and performing CPR. A cross-sectional survey was administered to university students. The questionnaire included questions regarding the following data elements: demographics, knowledge, and awareness about sudden cardiac arrest, CPR, automated external defibrillator (AED) use, prior CPR and AED training, ability to perform CPR or use AED, barriers to performing/learning CPR/AED, and preferred location for attending CPR/AED courses. Descriptive analysis followed by multivariate analysis was carried out to identify predictors and barriers to learning and performing CPR. A total of 948 students completed the survey. Participants’ mean age was 20.1 (±2.1) years with 53.1% women. Less than half of participants (42.9%) were able to identify all the presenting signs of cardiac arrest. Only 33.7% of participants felt able to perform CPR when witnessing a cardiac arrest. Fewer participants (20.3%) reported receiving previous CPR training. Several perceived barriers to learning and performing CPR were also reported. Significant predictors of willingness to perform CPR when faced with a cardiac arrest were: earning higher income, previous CPR training and feeling confident in one's ability to apply an AED, or perform CPR. Lacking enough expertise in performing CPR was a significant barrier to willingness to perform CPR. University students in Lebanon are familiar with the symptoms of cardiac arrest, however, they are not well trained in CPR and lack confidence to perform it. The attitude towards the importance of

  2. [Informed consent right of the appraised individuals in forensic clinical examination].

    Science.gov (United States)

    Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

    2015-02-01

    Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

  3. 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 home and in freestanding 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.

  4. Audit of the informed consent process as a part of a clinical research quality assurance program.

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

    Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

  5. 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)

  6. Radiation information and informed consent for clinical trials

    International Nuclear Information System (INIS)

    Caon, Martin

    2008-01-01

    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)

  7. Compression force-depth relationship during out-of-hospital cardiopulmonary resuscitation.

    Science.gov (United States)

    Tomlinson, A E; Nysaether, J; Kramer-Johansen, J; Steen, P A; Dorph, E

    2007-03-01

    Recent clinical studies reporting the high frequency of inadequate chest compression depth (compression depth in certain patients. Using a specially designed monitor/defibrillator equipped with a sternal pad fitted with an accelerometer and a pressure sensor, compression force and depth was measured during CPR in 91 adult out-of-hospital cardiac arrest patients. There was a strong non-linear relationship between the force of compression and depth achieved. Mean applied force for all patients was 30.3+/-8.2 kg and mean absolute compression depth 42+/-8 mm. For 87 of 91 patients 38 mm compression depth was obtained with less than 50 kg. Stiffer chests were compressed more forcefully than softer chests (pcompressed more deeply than stiffer chests (p=0.001). The force needed to reach 38 mm compression depth (F38) and mean compression force were higher for males than for females: 29.8+/-14.5 kg versus 22.5+/-10.2 kg (pcompression depth with age, but a significant 1.5 kg mean decrease in applied force for each 10 years increase in age (pcompressions performed. Average residual force during decompression was 1.7+/-1.0 kg, corresponding to an average residual depth of 3+/-2 mm. In most out-of-hospital cardiac arrest victims adequate chest compression depth can be achieved by a force<50 kg, indicating that an average sized and fit rescuer should be able to perform effective CPR in most adult patients.

  8. Syphilis screening in out-of-hospital care.

    Science.gov (United States)

    Marvez-Valls, E; Weiss, S J; Ernst, A A; Johnson, W D

    1995-07-01

    To estimate the rates of syphilis infection in inner-city patients managed by prehospital providers, a convenience sampling of prehospital patients who had intravenous lines initiated was screened for syphilis over a nine-month study period from February 1992 through October 1992. In a university-affiliated inner-city emergency department served by a city ambulance company, patients 18 years of age or older transported via ambulance who had had intravenous lines initiated at the scene or en route had a Venereal Disease Research Laboratory (VDRL) and microhemagglutination-Treponema pallidum (MHA-TP) drawn and performed by the state laboratory as a routine serological test. If the results were reactive with no previous history of syphilis recorded in the state registry, the state health department and/or one of the authors of this study contacted the patient for follow-up treatment. Age, race, sex, and diagnostic category (medical, surgical/obstetric, or neuropsychiatric) were recorded. Results were checked with the state syphilis registry. Latent syphilis was defined as a reactive VDRL and MHA-TP with no prior history of infection or record of infection in the state syphilis registry. Chi-squared test was used in statistical analysis for comparisons among ages, races, and sexes, with P > .05 considered significant. Three hundred two subjects 18 years of age and older consenting to a screening VDRL and MHA-TP had serum drawn. Two hundred seventy-nine patients were enrolled in the study after 23 patients were excluded because of improper data collection or insufficient serum collection. There were 174 men (63%) and 105 women (37%), with 73 white (26%) and 199 African-Americans (71%).(ABSTRACT TRUNCATED AT 250 WORDS)

  9. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  10. Revisiting the “Golden Hour”: An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury

    Science.gov (United States)

    Newgard, Craig D.; Meier, Eric N.; Bulger, Eileen M.; Buick, Jason; Sheehan, Kellie; Lin, Steve; Minei, Joseph P.; Barnes-Mackey, Roxy A.; Brasel, Karen

    2015-01-01

    Study Objective We evaluated shock and traumatic brain injury (TBI) patients previously enrolled in an out-of-hospital clinical trial to test the association between out-of-hospital time and outcome. Methods This was a secondary analysis of shock and TBI patients ≥ 15 years enrolled in a Resuscitation Outcomes Consortium out-of-hospital clinical trial by 81 EMS agencies transporting to 46 Level I and II trauma centers in 11 sites (May 2006 through May 2009). Inclusion criteria were: SBP ≤ 70 mmHg or SBP 71 - 90 mmHg with heart rate ≥ 108 beats per minute (shock cohort) and Glasgow Coma Scale score ≤ 8 (TBI cohort); patients meeting both criteria were placed in the shock cohort. Primary outcomes were 28-day mortality (shock cohort) and 6-month Glasgow Outcome Scale - Extended (GOSE) ≤ 4 (TBI cohort). Results There were 778 patients in the shock cohort (26% 28-day mortality) and 1,239 patients in the TBI cohort (53% 6-month GOSE ≤ 4). Out-of-hospital time > 60 minutes was not associated with worse outcomes after accounting for important confounders in the shock cohort (adjusted odds ratio [aOR] 1.42, 95% CI 0.77-2.62) or TBI cohort (aOR 0.80, 95% CI 0.52-1.21). However, shock patients requiring early critical hospital resources and arriving > 60 minutes had higher 28-day mortality (aOR 2.37, 95% CI 1.05-5.37); this finding was not observed among a similar TBI subgroup. Conclusions Among out-of-hospital trauma patients meeting physiologic criteria for shock and TBI, there was no association between time and outcome. However, the subgroup of shock patients requiring early critical resources arriving after 60 minutes had higher mortality. PMID:25596960

  11. Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

    Science.gov (United States)

    Mamotte, Nicole; Wassenaar, Douglas

    2017-09-01

    Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

  12. 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.

  13. 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.

  14. Colorimetric end-tidal CO2 detector for verification of endotracheal tube placement in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hayden, S R; Sciammarella, J; Viccellio, P; Thode, H; Delagi, R

    1995-06-01

    To evaluate the ability of a disposable, colorimetric end-tidal CO2 detector to verify proper endotracheal (ET) tube placement in out-of-hospital cardiac arrest, and to correlate semiquantitative CO2 measurements with the rate of return of spontaneous circulation (ROSC). Prospective, observational study using a convenience sample of intubated out-of-hospital cardiac arrest patients. A disposable, colorimetric end-tidal CO2 detector was attached to the ET tube after intubation. In the absence of a colorimetric change, the paramedics reassessed the tube placement and could reintubate the patient. Tube placement was verified at the hospital. Paramedics were instructed to contact the base station and report the colorimetric change upon hospital arrival. ROSC was defined as restoration of a self-sustaining pulse until hospital arrival. Between December 1990 and May 1993, ET tubes were placed in 566 victims of out-of-hospital cardiac arrest. 541 of the 566 intubations (95.6%) were associated with a color change. In one case with a color change and out-of-hospital clinical evidence of proper tube placement, the tube was determined to be in the esophagus at the hospital. Correct placement of the remaining 565 of 566 (99.8%) tubes was verified. Of the 566 patients who had a colorimetric change, 91 (16%) had ROSC vs one of 25 (4%) patients who did not have a color change. In one subgroup (n = 179), the degree of color change was highly associated with ROSC (p = 0.004). A disposable, colorimetric end-tidal CO2 detector appears reliable in verifying proper ET tube placement in victims of out-of-hospital cardiac arrest. The degree of color change correlates with the probability of ROSC.

  15. Chest compression rates and survival following out-of-hospital cardiac arrest.

    Science.gov (United States)

    Idris, Ahamed H; Guffey, Danielle; Pepe, Paul E; Brown, Siobhan P; Brooks, Steven C; Callaway, Clifton W; Christenson, Jim; Davis, Daniel P; Daya, Mohamud R; Gray, Randal; Kudenchuk, Peter J; Larsen, Jonathan; Lin, Steve; Menegazzi, James J; Sheehan, Kellie; Sopko, George; Stiell, Ian; Nichol, Graham; Aufderheide, Tom P

    2015-04-01

    Guidelines for cardiopulmonary resuscitation recommend a chest compression rate of at least 100 compressions/min. A recent clinical study reported optimal return of spontaneous circulation with rates between 100 and 120/min during cardiopulmonary resuscitation for out-of-hospital cardiac arrest. However, the relationship between compression rate and survival is still undetermined. Prospective, observational study. Data is from the Resuscitation Outcomes Consortium Prehospital Resuscitation IMpedance threshold device and Early versus Delayed analysis clinical trial. Adults with out-of-hospital cardiac arrest treated by emergency medical service providers. None. Data were abstracted from monitor-defibrillator recordings for the first five minutes of emergency medical service cardiopulmonary resuscitation. Multiple logistic regression assessed odds ratio for survival by compression rate categories (compression fraction and depth, first rhythm, and study site. Compression rate data were available for 10,371 patients; 6,399 also had chest compression fraction and depth data. Age (mean±SD) was 67±16 years. Chest compression rate was 111±19 per minute, compression fraction was 0.70±0.17, and compression depth was 42±12 mm. Circulation was restored in 34%; 9% survived to hospital discharge. After adjustment for covariates without chest compression depth and fraction (n=10,371), a global test found no significant relationship between compression rate and survival (p=0.19). However, after adjustment for covariates including chest compression depth and fraction (n=6,399), the global test found a significant relationship between compression rate and survival (p=0.02), with the reference group (100-119 compressions/min) having the greatest likelihood for survival. After adjustment for chest compression fraction and depth, compression rates between 100 and 120 per minute were associated with greatest survival to hospital discharge.

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

    DEFF Research Database (Denmark)

    Kragholm, Kristian; 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 repo...

  17. Outcome of out-of-hospital cardiac arrest--why do physicians withhold resuscitation attempts?

    DEFF Research Database (Denmark)

    Horsted, Tina I; Rasmussen, Lars S; Lippert, Freddy K

    2004-01-01

    To describe the outcome of out-of-hospital cardiac arrest (OHCA) with a focus on why physicians withhold resuscitation attempts.......To describe the outcome of out-of-hospital cardiac arrest (OHCA) with a focus on why physicians withhold resuscitation attempts....

  18. 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

  19. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Science.gov (United States)

    2013-05-09

    ... consent or the interactive computer-based program, will be assessed by face-to-face interview. In addition... Comment Request: Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with... other technological collection techniques or other forms of information technology. To Submit Comments...

  20. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    of South Africa (1996) and applicable legislation, it is apparent that voluntary informed ... Seoul, 2008);4 Ethics in Health Research: Principles, Structures and. Processes (Department of Health 2004 – 'ethical guidelines' for the purpose of this ... workers have a legal duty to obtain a patient's informed consent for any medical ...

  1. 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.

  2. Epinephrine in Out-of-hospital Cardiac Arrest: Helpful or Harmful?

    Science.gov (United States)

    Shao, Huan; Li, Chun-Sheng

    2017-09-05

    Epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest. The evidence for the use of adrenaline in out-of-hospital cardiac arrest (OHCA) and in-hospital resuscitation is inconclusive. We conducted a systematic review on the clinical efficacy of adrenaline in adult OHCA patients to evaluate whether epinephrine provides any overall benefit for patients. The EMBASE and PubMed databases were searched with the key words "epinephrine," "cardiac arrest," and variations of these terms. Data from clinical randomized trials, meta-analyses, guidelines, and recent reviews were selected for review. Sudden cardiac arrest causes 544,000 deaths in China each year, with survival occurring in CPR. There is currently insufficient evidence to support or reject epinephrine administration during resuscitation. We believe that epinephrine may have a role in resuscitation, as administration of epinephrine during CPR increases the probability of restoring cardiac activity with pulses, which is an essential intermediate step toward long-term survival. The administration of adrenaline was associated with improved short-term survival (ROSC). However, it appears that the use of adrenaline is associated with no benefit on survival to hospital discharge or survival with favorable neurological outcome after OHCA, and it may have a harmful effect. Larger placebo-controlled, double-blind, randomized control trials are required to definitively establish the effect of epinephrine.

  3. The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

    Directory of Open Access Journals (Sweden)

    A Nienaber

    2010-12-01

    Full Text Available The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft regulations, and the South African Constitution.

  4. Out-of-Hospital Hypertonic Resuscitation Following Severe Traumatic Brain Injury: A Randomized Controlled Trial

    Science.gov (United States)

    Bulger, Eileen M.; May, Susanne; Brasel, Karen J.; Schreiber, Martin; Kerby, Jeffrey D.; Tisherman, Samuel A.; Newgard, Craig; Slutsky, Arthur; Coimbra, Raul; Emerson, Scott; Minei, Joseph P.; Bardarson, Berit; Kudenchuk, Peter; Baker, Andrew; Christenson, Jim; Idris, Ahamed; Davis, Daniel; Fabian, Timothy C.; Aufderheide, Tom P.; Callaway, Clifton; Williams, Carolyn; Banek, Jane; Vaillancourt, Christian; van Heest, Rardi; Sopko, George; Hata, J. Steven; Hoyt, David B.

    2010-01-01

    Context Hypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury (TBI). Objective To determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. Design, Setting, and Participants Multicenter, double-blind, randomized, placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium, conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock. Planned enrollment was 2122 patients. Intervention A single 250-mL bolus of 7.5% saline/6% dextran 70 (hypertonic saline/dextran), 7.5% saline (hypertonic saline), or 0.9% saline (normal saline) initiated in the out-of-hospital setting. Main Outcome Measure Six-month neurologic outcome based on the Extended Glasgow Outcome Scale (GOSE) (dichotomized as >4 or ≤4). Results The study was terminated by the data and safety monitoring board after randomization of 1331 patients, having met prespecified futility criteria. Among the 1282 patients enrolled, 6-month outcomes data were available for 1087 (85%). Baseline characteristics of the groups were equivalent. There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ≤4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, −4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, −4.0% to 9.7%]; P=.67). There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group. Survival at 28 days was 74.3% with hypertonic saline

  5. Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan

    Directory of Open Access Journals (Sweden)

    M Kusunose

    2015-09-01

    Full Text Available Informed consent (IC is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency. 

  6. Doctors, Patients, and Nudging in the Clinical Context--Four Views on Nudging and Informed Consent.

    Science.gov (United States)

    Ploug, Thomas; Holm, Søren

    2015-01-01

    In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

  7. [Out-of-hospital pediatric emergencies. Perception and assessment by emergency physicians].

    Science.gov (United States)

    Eich, C; Roessler, M; Timmermann, A; Heuer, J F; Gentkow, U; Albrecht, B; Russo, S G

    2009-09-01

    Out-of-hospital (OOH) pediatric emergencies have a relatively low prevalence. In Germany the vast majority of cases are attended by non-specialized emergency physicians (EPs) for whom these are not routine procedures. This may lead to insecurity and fear. However, it is unknown how EPs perceive and assess pediatric emergencies and how they could be better prepared for them. All active EPs (n=50) of the Department of Anaesthesiology, Emergency and Intensive Care Medicine at the University Medical Centre of Göttingen were presented with a structured questionnaire in order to evaluate their perception and assessment of OOH pediatric emergencies. The 43 participating EPs made highly detailed statements on the expected characteristics of OOH pediatric emergencies. Their confidence level grew with the children's age (pemergencies. They felt the greatest deficits were in the care of infrequent but life-threatening emergencies. Three educational groups can be differentiated: knowledge and skills to be gained with children in hospital, clinical experience from adult care also applicable in children and rare diagnoses and interventions to be trained with manikins or simulators.

  8. Recent Trends in Out-of-Hospital Births in the United States.

    Science.gov (United States)

    MacDorman, Marian F; Declercq, Eugene; Mathews, T J

    2013-01-01

    Although out-of-hospital births are still relatively rare in the United States, it is important to monitor trends in these births, as they can affect patterns of facility usage, clinician training, and resource allocation, as well as health care costs. Trends and characteristics of home and birth center births are analyzed to more completely profile contemporary out-of-hospital births in the United States. National birth certificate data were used to examine a recent increase in out-of-hospital births. After a gradual decline from 1990 to 2004, the number of out-of-hospital births increased from 35,578 in 2004 to 47,028 in 2010. In 2010, 1 in 85 US infants (1.18%) was born outside a hospital; about two-thirds of these were born at home, and most of the rest were born in birth centers. The proportion of home births increased by 41%, from 0.56% in 2004 to 0.79% in 2010, with 10% of that increase occurring in the last year. The proportion of birth center births increased by 43%, from 0.23% in 2004 to 0.33% in 2010, with 14% of the increase in the last year. About 90% of the total increase in out-of hospital births from 2004 to 2010 was a result of increases among non-Hispanic white women, and 1 in 57 births to non-Hispanic white women (1.75%) in 2010 was an out-of-hospital birth. Most home and birth center births were attended by midwives. Home and birth center births in the United States are increasing, and the rate of out-of-hospital births is now at the highest level since 1978. There has been a decline in the risk profile of out-of-hospital births, with a smaller proportion of out-of-hospital births in 2010 than in 2004 occurring to adolescents and unmarried women and fewer preterm, low-birth-weight, and multiple births. © 2013 This article is a U.S. Government work and is in the public domain in the United States.

  9. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

    Science.gov (United States)

    Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

    2013-06-01

    A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND

  10. 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

    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......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...

  11. Improving outcomes from out-of-hospital cardiac arrest in young children and adolescents.

    Science.gov (United States)

    Atkins, Dianne L; Berger, Stuart

    2012-03-01

    Out-of-hospital cardiac arrest (OHCA) is an unusual but devastating occurrence in a young person. Years of life-lost are substantial and long-term health care costs of survivors can be high. However, there have been noteworthy improvements in cardiopulmonary resuscitation (CPR) standards, out-of hospital care, and postcardiac arrest therapies that have resulted in a several-fold improvement in resuscitation outcomes. Recent interest and research in resuscitation of children has the promise of generating improvements in the outcomes of these patients. Integrated and coordinated care in the out-of-hospital and hospital settings are required. This article will review the epidemiology of OHCA, the 2010 CPR guidelines, and developments in public access defibrillation for children.

  12. 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.

  13. 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...... in compliance with the PRISMA guidelines. We systematically searched MEDLINE, Embase and the Cochrane Library on 4 November 2015. Observational studies, reporting the proportion of clinically confirmed OHCAs that was recognised during the emergency call, were included. Two authors independently screened...

  14. Commence, continue, withhold or terminate?: a systematic review of decision-making in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Anderson, Natalie E; Gott, Merryn; Slark, Julia

    2017-04-01

    When faced with an out-of-hospital cardiac arrest patient, prehospital and emergency resuscitation providers have to decide when to commence, continue, withhold or terminate resuscitation efforts. Such decisions may be made difficult by incomplete information, clinical, resourcing or scene challenges and ethical dilemmas. This systematic integrative review identifies all research papers examining resuscitation providers' perspectives on resuscitation decision-making for out-of-hospital cardiac arrest patients. A total of 14 studies fulfilled the inclusion criteria: nine quantitative, four qualitative and one mixed-methods design. Five themes were identified, describing factors informing resuscitation provider decision-making: the arrest event; patient characteristics; the resuscitation scene; resuscitation provider perspectives; and medicolegal concerns. Established prognostic factors are generally considered important, but there is a lack of resuscitation provider consensus on other factors, indicating that decision-making is influenced by the perspective of resuscitation providers themselves. Resuscitation decision-making research typically draws conclusions from evaluation of cardiac arrest registry data or clinical notes, but these may not capture all salient factors. Future research should explore resuscitation provider perspectives to better understand these important decisions and the clinical, ethical, emotional and cognitive demands placed on resuscitation providers.

  15. High-Dose Citalopram and Escitalopram and the Risk of Out-of-Hospital Death.

    Science.gov (United States)

    Ray, Wayne A; Chung, Cecilia P; Murray, Katherine T; Hall, Kathi; Stein, C Michael

    2017-02-01

    Studies demonstrating that higher doses of citalopram (> 40 mg) and escitalopram (> 20 mg) prolong the corrected QT interval prompted regulatory agency warnings, which are controversial, given the absence of confirmatory clinical outcome studies. We compared the risk of potential arrhythmia-related deaths for high doses of these selective serotonin reuptake inhibitors (SSRIs) to that for equivalent doses of fluoxetine, paroxetine, and sertraline. The Tennessee Medicaid retrospective cohort study included 54,220 persons 30-74 years of age without cancer or other life-threatening illness who were prescribed high-dose SSRIs from 1998 through 2011. The mean age was 47 years, and 76% were female. Demographic characteristics and comorbidity for individual SSRIs were comparable. Because arrhythmia-related deaths are typically sudden and occur outside the hospital, we analyzed out-of-hospital sudden unexpected death as well as sudden cardiac deaths, a more specific indicator of proarrhythmic effects. The adjusted risk of sudden unexpected death for citalopram did not differ significantly from that for the other SSRIs. The respective hazard ratios (HRs) for citalopram versus escitalopram, fluoxetine, paroxetine, and sertraline were 0.84 (95% CI, 0.40-1.75), 1.24 (95% CI, 0.75-2.05), 0.75 (95% CI, 0.45-1.24), and 1.53 (95% CI, 0.91-2.55). There were no significant differences for sudden cardiac death or all study deaths, nor were there significant differences among high-risk patients (≥ 60 years of age, upper quartile baseline cardiovascular risk). Escitalopram users had no significantly increased risk for any study end point. We found no evidence that risk of sudden unexpected death, sudden cardiac death, or total mortality for high-dose citalopram and escitalopram differed significantly from that for comparable doses of fluoxetine, paroxetine, and sertraline. © Copyright 2016 Physicians Postgraduate Press, Inc.

  16. 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.

  17. 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...

  18. Bystander efforts and 1-year outcomes in out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Kragholm, Kristian; Wissenberg, Mads; Mortensen, Rikke N.

    2017-01-01

    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...

  19. Defibrillation probability and impedance change between shocks during resuscitation from out-of-hospital cardiac arrest

    NARCIS (Netherlands)

    Walker, Robert G.; Koster, Rudolph W.; Sun, Charles; Moffat, George; Barger, Joseph; Dodson, Pamela P.; Chapman, Fred W.

    2009-01-01

    Objective: Technical data now gathered by automated external defibrillators (AEDs) allows closer evaluation of the behavior of defibrillation shocks administered during out-of-hospital cardiac arrest. We analyzed technical data from a large case series to evaluate the change in transthoracic

  20. 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...

  1. Quality of bystander cardiopulmonary resuscitation during real-life out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Gyllenborg, Tore; Granfeldt, Asger; Lippert, Freddy

    2017-01-01

    BACKGROUND: Cardiopulmonary resuscitation (CPR) can increase survival in out-of-hospital cardiac arrest (OHCA). However, little is known about bystander CPR quality in real-life OHCA. AIM: To describe bystander CPR quality based on automated external defibrillator (AED) CPR process data during OH...

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

    Science.gov (United States)

    ... to American Indian women, and 0.54% to Asian or Pacific Islander women. In 2012, out-of-hospital births comprised 3%– ... the United States choose home birth. J Midwifery Womens Health 54(2):119–26. 2009. Health Management Associates. Midwifery licensure and discipline program in Washington ...

  3. Circumstances and causes of out-of-hospital cardiac arrest in sudden death survivors

    NARCIS (Netherlands)

    de Vreede-Swagemakers, J. J.; Gorgels, A. P.; Dubois-Arbouw, W. I.; Dalstra, J.; Daemen, M. J.; van Ree, J. W.; Stijns, R. E.; Wellens, H. J.

    1998-01-01

    To study the circumstances and medical profile of out-of-hospital sudden cardiac arrest (SCA) patients in whom resuscitation was attempted by the ambulance service, and to identify causes of SCA in survivors and factors that influence resuscitation success rate. During a five year period (1991-95)

  4. Prolonged cardiopulmonary resuscitation and outcomes after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Folke, Fredrik; Kragholm, Kristian

    2016-01-01

    AIM: It is unclear whether prolonged resuscitation can result in successful outcome following out-of-hospital cardiac arrests (OHCA). We assessed associations between duration of pre-hospital resuscitation on survival and functional outcome following OHCA in patients achieving pre-hospital return...

  5. 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 o...

  6. Transforming Identities through Transforming Care: How People with Learning Disabilities Experience Moving out of Hospital

    Science.gov (United States)

    Head, Annabel; Ellis-Caird, Helen; Rhodes, Louisa; Parkinson, Kathie

    2018-01-01

    Background: People with learning disabilities are moving out of hospitals as part of the Transforming Care programme, although thus far their views on how they have experienced this have not been researched. Materials and Methods: A qualitative design was used to explore how people with learning disabilities experienced moving as part of…

  7. Early Head CT Findings Are Associated With Outcomes After Pediatric Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Starling, Rebecca M; Shekdar, Karuna; Licht, Dan; Nadkarni, Vinay M; Berg, Robert A; Topjian, Alexis A

    2015-07-01

    Head CT after out-of-hospital cardiac arrest is often obtained to evaluate intracranial pathology. Among children admitted to the PICU following pediatric out-of-hospital cardiac arrest, we hypothesized that loss of gray-white matter differentiation and basilar cistern and sulcal effacement are associated with mortality and unfavorable neurologic outcome. Retrospective, cohort study. Single, tertiary-care center PICU. Seventy-eight patients less than 18 years old who survived out-of-hospital cardiac arrest to PICU admission and had a head CT within 24 hours of return of spontaneous circulation were evaluated from July 2005 through May 2012. None. Median time to head CT from return of spontaneous circulation was 3.3 hours (1.0, 6.0). Median patient age was 2.3 years (0.4, 9.5). Thirty-nine patients (50%) survived, of whom 29 (74%) had favorable neurologic outcome. Nonsurvivors were more likely than survivors to have 1) loss of gray-white matter differentiation (Hounsfield unit ratios, 0.96 [0.88, 1.07] vs 1.1 [1.07, 1.2]; p pediatric out-of-hospital cardiac arrest. Select patients may have favorable outcomes despite these findings.

  8. Implementation of a consent for chart review and contact and its impact in one clinical centre.

    Science.gov (United States)

    Druce, Irena; Ooi, T C; McGuire, Debbie; Sorisky, Alexander; Malcolm, Janine

    2015-05-01

    Informed consent and protection of patient confidentiality are central to the conduction of clinical research. Consent for chart review and contact (CCRC) allows a patient chart to be screened for research by persons outside the direct circle-of-care and for the patient to be contacted regarding potential studies. This study describes the process of implementation and benefits of such a consent. We present a descriptive report of a CCRC document that was created and presented to patients over a 3.5-year period at a tertiary care Endocrinology and Metabolism centre. To assess the potential impact of such a document on patient recruitment, the basic demographics of patients who did and did not consent were compared. In addition, we compared the recruitment rate at our centre, using our novel approach, with that at other centres for an ongoing study of patients with type 1 diabetes. A large proportion (6501/8025, or 81%) of patients gave their consent for chart review. Patients who denied consent were more likely to be women and older. Compared with other centres, our centre recruited at the highest rate for a known study of patients with type 1 diabetes. The majority (46/60, or 76.7%) of patients were recruited via the novel approach. Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented. 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.

  9. GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wiberg, Sebastian; Hassager, Christian; Thomsen, Jakob Hartvig; Frydland, Martin; Høfsten, Dan Eik; Engstrøm, Thomas; Køber, Lars; Schmidt, Henrik; Møller, Jacob Eifer; Kjaergaard, Jesper

    2016-06-30

    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. 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 as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling. This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results. 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015.

  10. Truth telling and informed consent: is "primum docere" the new motto of clinical practice?

    Science.gov (United States)

    Byk, Christian

    2007-09-01

    Autonomy has become in many countries a key concept in the patient-physician relationship, leaving the old paternalistic medical attitude out of the realm of common good clinical practice. Consequently, the validity of the informed consent procedure which is related to any medical intervention, should imply that the information given is true. Raising the question as such obliges us to consider the truth not for itself but in regard to the validity of the consent to a medical intervention. Although a clinical approach reveals that loyalty should guide the patient-physician relationship, there are still some situations in which informed consent and truth telling may be controversial: in some circumstances, the physician should or may not tell the truth, in others he can simply forget to tell.

  11. Cost-effectiveness of Out-of-Hospital Continuous Positive Airway Pressure for Acute Respiratory Failure.

    Science.gov (United States)

    Thokala, Praveen; Goodacre, Steve; Ward, Matt; Penn-Ashman, Jerry; Perkins, Gavin D

    2015-05-01

    We determine the cost-effectiveness of out-of-hospital continuous positive airway pressure (CPAP) compared with standard care for adults presenting to emergency medical services with acute respiratory failure. We developed an economic model using a United Kingdom health care system perspective to compare the costs and health outcomes of out-of-hospital CPAP to standard care (inhospital noninvasive ventilation) when applied to a hypothetical cohort of patients with acute respiratory failure. The model assigned each patient a probability of intubation or death, depending on the patient's characteristics and whether he or she had out-of-hospital CPAP or standard care. The patients who survived accrued lifetime quality-adjusted life-years (QALYs) and health care costs according to their age and sex. Costs were accrued through intervention and hospital treatment costs, which depended on patient outcomes. All results were converted into US dollars, using the Organisation for Economic Co-operation and Development purchasing power parities rates. Out-of-hospital CPAP was more effective than standard care but was also more expensive, with an incremental cost-effectiveness ratio of £20,514 per QALY ($29,720/QALY) and a 49.5% probability of being cost-effective at the £20,000 per QALY ($29,000/QALY) threshold. The probability of out-of-hospital CPAP's being cost-effective at the £20,000 per QALY ($29,000/QALY) threshold depended on the incidence of eligible patients and varied from 35.4% when a low estimate of incidence was used to 93.8% with a high estimate. Variation in the incidence of eligible patients also had a marked influence on the expected value of sample information for a future randomized trial. The cost-effectiveness of out-of-hospital CPAP is uncertain. The incidence of patients eligible for out-of-hospital CPAP appears to be the key determinant of cost-effectiveness. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All

  12. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    Science.gov (United States)

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

  13. Informed consent for clinical trials: a review | Lema | East African ...

    African Journals Online (AJOL)

    Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding ...

  14. Informed consent in clinical trials: Perceptions and experiences of a ...

    African Journals Online (AJOL)

    It is recommended that more recognition be given to the important role of trial counsellors in clinical trials, and that they be given more formal training, support and ... Daar word aanbeveel dat meer erkenning gegee word aan die rol van proefvoorligters in kliniese proewe, dat hulle meer formele opleiding ondergaan, dat ...

  15. Informed Consent: Ethical Issues and Future Challenges in Clinical Education.

    Science.gov (United States)

    Angaran, David M.

    1989-01-01

    A look at pharmaceutical care needs in the future is the basis for discussion of the educational needs of clinical pharmacists. Issues discussed include the appropriate degree (bachelor's vs. doctoral), costs of instruction, faculty/student ratios, the pharmacy practice faculty as role models, and computer-assisted instruction. (MSE)

  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. Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

    NARCIS (Netherlands)

    Jansen-van der Weide, Marijke C.; Caldwell, Patrina H. Y.; Young, Bridget; de Vries, Martine C.; Willems, Dick L.; van't Hoff, William; Woolfall, Kerry; van der Lee, Johanna H.; Offringa, Martin

    2015-01-01

    Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in

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

    Science.gov (United States)

    Facio, Flavia M; Sapp, Julie C; Linn, Amy; Biesecker, Leslie G

    2012-10-10

    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. 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. 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. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  20. Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

    Science.gov (United States)

    Loh, Winnie Y; Butow, Phyllis N; Brown, Richard F; Boyle, Frances

    2002-12-01

    Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. The issues raised by these data managers have important implications for the successful conduct of

  1. Intravascular versus surface cooling for targeted temperature management after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Glover, Guy W; Thomas, Richard M; Vamvakas, George

    2016-01-01

    , maintenance and rewarming phases in addition to adverse events. All-cause mortality, as well as a composite of poor neurological function or death, as evaluated by the Cerebral Performance Category and modified Rankin scale were analysed. RESULTS: For patients managed at 33 °C there was no difference between......BACKGROUND: Targeted temperature management is recommended after out-of-hospital cardiac arrest and may be achieved using a variety of cooling devices. This study was conducted to explore the performance and outcomes for intravascular versus surface devices for targeted temperature management after...... out-of-hospital cardiac arrest. METHOD: A retrospective analysis of data from the Targeted Temperature Management trial. N = 934. A total of 240 patients (26%) managed with intravascular versus 694 (74%) with surface devices. Devices were assessed for speed and precision during the induction...

  2. Treatment of out-of-hospital supraventricular tachycardia: adenosine vs verapamil.

    Science.gov (United States)

    Brady, W J; DeBehnke, D J; Wickman, L L; Lindbeck, G

    1996-06-01

    To compare the use of adenosine and the use of verapamil as out-of-hospital therapy for supraventricular tachycardia (SVT). A period of prospective adenosine use (March 1993 to February 1994) was compared with a historical control period of verapamil use (March 1990 to February 1991) for SVT. Data were obtained for SVT patients treated in a metropolitan, fire-department-based paramedic system serving a population of approximately 1 million persons. Standard drug protocols were used and patient outcomes (i.e., conversion rates, complications, and recurrences) were monitored. During the adenosine treatment period, 105 patients had SVT; 87 (83%) received adenosine, of whom 60 (69%) converted to a sinus rhythm (SR). Vagal maneuvers (VM) resulted in restoration of SR in 8 patients (7.6%). Some patients received adenosine for non-SVT rhythms: 7 sinus tachycardia, 18 atrial fibrilation, 7 wide-complex tachycardia (WCT), and 2 ventricular tachycardia; no non-SVT rhythm converted to SR and none of these patients experienced an adverse effect. Twenty-five patients were hemodynamically unstable (systolic blood pressure fibrillation). Recurrence of SVT was noted in 2 adenosine patients and 2 verapamil patients in the out-of-hospital setting and in 23 adenosine patients and 15 verapamil patients after ED arrival, necessitating additional therapy (p = 0.48 and 0.88, for recurrence rates and types of additional therapies, respectively). Hospital diagnoses, outcomes, and ED dispositions were similar for the 2 groups. Adenosine and verapamil were equally successful in converting out-of-hospital SVT in patients with similar etiologies responsible for the SVT. Recurrence of SVT occurred at similar rates for the 2 medications. Rhythm misidentification remains a common issue in out-of-hospital cardiac care in this emergency medical services system.

  3. Time to standardise levels of care amongst Out-of-Hospital Emergency Care providers in Africa

    OpenAIRE

    Mould-Millman, N.K.; Stein, C.; Wallis, L.A.

    2016-01-01

    The African Federation for Emergency Medicine’s Out-of-Hospital Emergency Care (OHEC) Committee convened 15 experts from various OHEC systems in Africa to participate in a consensus process to define levels of care within which providers in African OHEC systems should safely and effectively function. The expert panel concluded that four provider levels were relevant for African OHEC systems: (i) first aid, (ii) basic life support, (iii) intermediate life support, and (iv) advanced life suppor...

  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

    During a period of 3 years three different types of emergency medical service (EMS) systems were evaluated in a city with about 238,000 inhabitants/population density of 570/km2. Included were 393 out-of-hospital cardiac arrest patients in whom prehospital cardiopulmonary resuscitation was provid...... 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. Outcomes after out-of-hospital cardiac arrest treated by basic vs advanced life support.

    Science.gov (United States)

    Sanghavi, Prachi; Jena, Anupam B; Newhouse, Joseph P; Zaslavsky, Alan M

    2015-02-01

    Most out-of-hospital cardiac arrests receiving emergency medical services in the United States are treated by ambulance service providers trained in advanced life support (ALS), but supporting evidence for the use of ALS over basic life support (BLS) is limited. To compare the effects of BLS and ALS on outcomes after out-of-hospital cardiac arrest. Observational cohort study of a nationally representative sample of traditional Medicare beneficiaries from nonrural counties who experienced out-of-hospital cardiac arrest between January 1, 2009, and October 2, 2011, and for whom ALS or BLS ambulance services were billed to Medicare (31,292 ALS cases and 1643 BLS cases). Propensity score methods were used to compare the effects of ALS and BLS on patient survival, neurological performance, and medical spending after cardiac arrest. Survival to hospital discharge, to 30 days, and to 90 days; neurological performance; and incremental medical spending per additional survivor to 1 year. Survival to hospital discharge was greater among patients receiving BLS (13.1% vs 9.2% for ALS; 4.0 [95% CI, 2.3-5.7] percentage point difference), as was survival to 90 days (8.0% vs 5.4% for ALS; 2.6 [95% CI, 1.2-4.0] percentage point difference). Basic life support was associated with better neurological functioning among hospitalized patients (21.8% vs 44.8% with poor neurological functioning for ALS; 23.0 [95% CI, 18.6-27.4] percentage point difference). Incremental medical spending per additional survivor to 1 year for BLS relative to ALS was $154,333. Patients with out-of-hospital cardiac arrest who received BLS had higher survival at hospital discharge and at 90 days compared with those who received ALS and were less likely to experience poor neurological functioning.

  6. Perinatal outcomes of unplanned out-of-hospital deliveries: a case-control study.

    Science.gov (United States)

    Pasternak, Yael; Wintner, Eliana Muskin; Shechter-Maor, Gil; Pasternak, Yehonatan; Miller, Netanella; Biron-Shental, Tal

    2018-04-01

    To compare the pregnancy and perinatal outcomes of unplanned home or car births vs. in-hospital deliveries. A retrospective, case-control study of women who underwent unplanned out-of-hospital deliveries vs. in-hospital deliveries from 2004 through 2014. Matching was based on gestational age and parity in a ratio of 2:1. There were no significant differences between the groups regarding demographic criteria, prenatal care and delivery complications. Women who delivered out of hospital (n = 90) had significantly fewer cesarean deliveries (1.1 vs. 10.6%; p = 0.05) and operative deliveries (2.2 vs. 13.3%; p = 0.004) in their obstetrical history than did the control group (n = 180). Significantly more newborns delivered out of the hospital had polycythemia (25.6 vs. 1.7%; p unplanned out-of-hospital deliveries tend to have fewer complications in their previous deliveries. Higher rates of polycythemia and hypothermia require attention for neonates born out of the hospital.

  7. Dextrose 10% in the treatment of out-of-hospital hypoglycemia.

    Science.gov (United States)

    Kiefer, Matthew V; Gene Hern, H; Alter, Harrison J; Barger, Joseph B

    2014-04-01

    Prehospital first responders historically have treated hypoglycemia in the field with an IV bolus of 50 mL of 50% dextrose solution (D50). The California Contra Costa County Emergency Medical Services (EMS) system recently adopted a protocol of IV 10% dextrose solution (D10), due to frequent shortages and relatively high cost of D50. The feasibility, safety, and efficacy of this approach are reported using the experience of this EMS system. Over the course of 18 weeks, paramedics treated 239 hypoglycemic patients with D10 and recorded patient demographics and clinical outcomes. Of these, 203 patients were treated with 100 mL of D10 initially upon EMS arrival, and full data on response to treatment was available on 164 of the 203 patients. The 164 patients' capillary glucose response to initial infusion of 100 mL of D10 was calculated and a linear regression line fit between elapsed time and difference between initial and repeat glucose values. Feasibility, safety, and the need for repeat glucose infusions were examined. The study cohort included 102 men and 62 women with a median age of 68 years. The median initial field blood glucose was 38 mg/dL, with a subsequent blood glucose median of 98 mg/dL. The median time to second glucose testing was eight minutes after beginning the 100 mL D10 infusion. Of 164 patients, 29 (18%) required an additional dose of IV D10 solution due to persistent or recurrent hypoglycemia, and one patient required a third dose. There were no reported adverse events or deaths related to D10 administration. Linear regression analysis of elapsed time and difference between initial and repeat glucose values showed near-zero correlation. In addition to practical reasons of cost and availability, theoretical risks of using 50 mL of D50 in the out-of-hospital setting include extravasation injury, direct toxic effects of hypertonic dextrose, and potential neurotoxic effects of hyperglycemia. The results of one local EMS system over an 18-week

  8. 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

  9. 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

  10. Clinical psychology service users' experiences of confidentiality and informed consent: a qualitative analysis.

    Science.gov (United States)

    Martindale, S J; Chambers, E; Thompson, A R

    2009-12-01

    To explore and describe the experience of clinical psychology service users in relation to the processes associated with confidentiality and the generation of informed consent in individual therapy. A qualitative interview-based study employing interpretative phenomenological analysis was conducted with service users. User researchers were active collaborators in the study. A focus group of four users was convened to explore issues related to confidentiality and consent, which then informed the development of the semi-structured interview schedule. Twelve users of community mental health clinical psychology services were interviewed by user researchers. A user researcher and a clinical psychologist undertook joint analysis of the data. A second clinical psychologist facilitated reflexivity and wider consideration of validity issues. Four main themes were identified from the data: being referred; the participant's feelings, mental health difficulties, and their impact; relationships with workers and carers; and autonomy. The meaningfulness of processes of discussing confidentiality, and generating informed consent, can be improved by psychologists placing a greater emphasis on choice, control, autonomy, individual preferences, and actively involving the user in dialogue on repeated occasions.

  11. [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.

  12. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  13. Patient satisfaction in out-of-hospital emergency care: a multicentre survey.

    Science.gov (United States)

    Neumayr, Agnes; Gnirke, André; Schaeuble, Joerg C; Ganter, Michael T; Sparr, Harald; Zoll, Adolf; Schinnerl, Adolf; Nuebling, Matthias; Heidegger, Thomas; Baubin, Michael

    2016-10-01

    There is only limited information on patient satisfaction with emergency medical services (EMS). The aim of this multicentre survey was to evaluate patient satisfaction in five out-of-hospital physician-based EMS in Austria and Switzerland. The psychometrically tested and standardized questionnaire 'patient satisfaction in out-of-hospital emergency care' was used for this survey. The recruitment of the patients was carried out on the basis of inclusion and exclusion criteria. All questionnaires were sent together with an invitation letter and a prepaid return envelope, followed by a reminder 2 weeks later. The descriptive statistical analysis was carried out by an external organization to maintain anonymity. The response rate of all EMS was 46.7%. High satisfaction rates were achieved for the four quality scales 'emergency call, emergency treatment, transport and hospital admission'. A significant difference was found between the Swiss and the Austrian dispatch centres in the judgement of the call takers' social skills. Patient satisfaction with the emergency treatment, for example, reduction of pain, was high in all EMS, independent of whether the EMS is physician (Austria) or physician and emergency medical assistant based (Switzerland). Lowest satisfaction rates were found for items of social skills. Patient satisfaction in out-of-hospital physician-based EMS is generally high. There is room for improvement in areas such as the social skills of dispatchers and EMS-team members and the comfort of the patients during transport. A checklist should be developed for basic articles that patients should take along to hospital and for questions on responsibilities for children, dependent people or pets.

  14. Association of Ambient Fine Particles With Out-of-Hospital Cardiac Arrests in New York City

    Science.gov (United States)

    Silverman, Robert A.; Ito, Kazuhiko; Freese, John; Kaufman, Brad J.; De Claro, Danilynn; Braun, James; Prezant, David J.

    2010-01-01

    Cardiovascular morbidity has been associated with particulate matter (PM) air pollution, although the relation between pollutants and sudden death from cardiac arrest has not been established. This study examined associations between out-of-hospital cardiac arrests and fine PM (of aerodynamic diameter ≤2.5 μm, or PM2.5), ozone, nitrogen dioxide, sulfur dioxide, and carbon monoxide in New York City. The authors analyzed 8,216 out-of-hospital cardiac arrests of primary cardiac etiology during the years 2002–2006. Time-series and case-crossover analyses were conducted, controlling for season, day-of-week, same-day, and delayed/apparent temperature. An increased risk of cardiac arrest in time-series (relative risk (RR) = 1.06, 95% confidence interval (CI): 1.02, 1.10) and case-crossover (RR = 1.04, 95% CI: 0.99, 1.08) analysis for a PM2.5 increase of 10 μg/m3 in the average of 0- and 1-day lags was found. The association was significant in the warm season (RR = 1.09, 95% CI: 1.03, 1.15) but not the cold season (RR = 1.01, 95% CI: 0.95, 1.07). Associations of cardiac arrest with other pollutants were weaker. These findings, consistent with studies implicating acute cardiovascular effects of PM, support a link between PM2.5 and out-of-hospital cardiac arrests. Since few individuals survive an arrest, air pollution control may help prevent future cardiovascular mortality. PMID:20729350

  15. Platelet aggregation during targeted temperature management after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Jeppesen, Anni Nørgaard; Hvas, Anne-Mette; Grejs, Anders Morten

    2017-01-01

    Some studies conclude that mild hypothermia causes platelet dysfunction leading to an increased bleeding risk, whereas others state that platelet aggregation is enhanced during mild hypothermia. Therefore, the aim of this study was to clarify whether standard or prolonged duration of targeted...... temperature management affected platelet aggregation. We randomised 82 comatose patients resuscitated after out-of-hospital cardiac arrest to either 24 hours (standard group) or 48 hours (prolonged group) of targeted temperature management at 33±1°C. Blood samples were collected 22 hours, 46 hours and 70......® decreased by 14% (95% CI -8%;-20%), p management....

  16. 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

  17. 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...... the hypothermia phase of TH had a 17% 180-day mortality rate compared to 38% in no-SB patients (phypothermia was directly associated with lower odds of unfavorable...... neurological outcome (ORunadjusted=0.42 (0.23-0.75, phypothermia is independently associated with a lower 180-day mortality rate and may thus be a novel, early marker of favorable outcome in comatose survivors of OHCA....

  18. 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.

  19. Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

    Science.gov (United States)

    Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

    2017-05-01

    To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Withholding or termination of resuscitation in pediatric out-of-hospital traumatic cardiopulmonary arrest.

    Science.gov (United States)

    Fallat, Mary E

    2014-04-01

    This multiorganizational literature review was undertaken to provide an evidence base for determining whether or not recommendations for out-of-hospital termination of resuscitation could be made for children who are victims of traumatic cardiopulmonary arrest. Although there is increasing acceptance of out-of-hospital termination of resuscitation for adult traumatic cardiopulmonary arrest when there is no expectation of a good outcome, children are routinely excluded from state termination-of-resuscitation protocols. The decision to withhold resuscitative efforts in a child under specific circumstances (decapitation or dependent lividity, rigor mortis, etc) is reasonable. If there is any doubt as to the circumstances or timing of the traumatic cardiopulmonary arrest, under the current status of limiting termination of resuscitation in the field to persons older than 18 years in most states, resuscitation should be initiated and continued until arrival to the appropriate facility. If the patient has arrested, resuscitation has already exceeded 30 minutes, and the nearest facility is more than 30 minutes away, involvement of parents and family of these children in the decision-making process with assistance and guidance from medical professionals should be considered as part of an emphasis on family-centered care, because the evidence suggests that either death or a poor outcome is inevitable.

  1. Out-of-hospital emergency care providers' work and challenges in a changing care environment.

    Science.gov (United States)

    Mikkola, Riitta; Paavilainen, Eija; Salminen-Tuomaala, Mari; Leikkola, Päivi

    2018-03-01

    Acutely ill patients are often treated on site instead of being transported to hospital, so wide-ranging professional competence is required from staff. The aim of this study was to describe and produce new information about out-of-hospital emergency care providers' competence, skills and willingness to engage in self-development activities, and to uncover challenges experienced by care providers in the midst of changing work practices. A quantitative questionnaire was sent to out-of-hospital emergency care providers (N = 142, response rate 53%) of one Finnish hospital district. Data were analysed using spss for Windows 22 software. Almost all respondents found their work interesting and their ability to work independently sufficient. The majority found the work meaningful. Almost 20% felt that work was dominated by constant rush, and 40%, more than half of 25-year-olds but <10% of over 45-years-olds, found the work physically straining. The majority indicated that they had a sufficient theoretical-practical basis to perform their regular duties, and more than one-third felt that they had sufficient skills to deal with multiple patient or disaster situations. Over 20% stated that they were unsure about performing new or infrequent procedures. A number of factors experienced as challenging were revealed. The results provide a basis for improving care providers' initial and further training. © 2017 Nordic College of Caring Science.

  2. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-11-09

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents

  3. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  4. Survival after Out-of-Hospital Cardiac Arrest in Nursing Homes

    DEFF Research Database (Denmark)

    Pape, Marianne; Rajan, Shahzleen; Hansen, Steen Møller

    2018-01-01

    BACKGROUND: Survival among nursing home residents who suffers out-of-hospital cardiac arrest (OHCA) is sparsely studied. Deployment of automated external defibrillators (AEDs) in nursing home facilities in Denmark is unknown. We examined 30-day survival following OHCA in nursing and private home...... residents. METHODS: This register-based, nationwide, follow-up study identified OHCA-patients ≥18 years of age with a resuscitation attempt in nursing homes and private homes using Danish Cardiac Arrest Register data from June 1, 2001 to December 31, 2014. The primary outcome measure was 30-day survival....... Multiple logistic regression analyses were used to assess factors potentially associated with survival among nursing and private home residents separately. RESULTS: Of 26,999 OCHAs, 2516 (9.3%) occurred in nursing homes, and 24,483 (90.7%) in private homes. Nursing home residents were older (median 83 (Q1...

  5. 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....... 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...... patients with OHCA treated by the Mobile Emergency Care Unit of Copenhagen in two periods: 1 June 2004 until 31 August 2005 (before implementation) and 1 January 2006 until 31 March 2007 (after implementation), separated by a 4-month period in which the above-mentioned change took place. RESULTS: We found...

  6. 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...

  7. 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...

  8. 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

    ); and in females (4.8% in 2001 to 6.7% in 2010), psexes in patients with a non-shockable rhythm (OR 1.00; CI 0.72-1.40), while female sex was positively associated...... characteristics in females with a lower proportion of shockable rhythm. In an adjusted model, female sex was positively associated with survival in patients with a shockable rhythm.......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...

  9. 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

    -to-treat population. Five-hundred patients (53%) developed pneumonia, severe sepsis or septic shock which was associated with mortality in multivariate analysis (Hazard ratio [HR] 1.39; 95%CI 1.13-1.70; p=0.001). There was no statistically significant difference in the incidence of infectious complications between......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 24h, 48h and 72h after cardiac arrest. RESULTS: There were 939 patients in the modified intention...

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

    International Nuclear Information System (INIS)

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

    2015-01-01

    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 PM 10 , PM 2.5 , SO 2 , NO 2 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. - Highlights: • Few studies have evaluated the effects of air pollution and temperature on OHCDs in China. • The present-day concentrations of air pollution were associated with OHCDs. • The effect of high temperatures on OHCDs was more immediate than low temperatures. • No significant effects were found for in-hospital coronary deaths. - Ambient air pollution and temperature may trigger out-of-hospital coronary deaths but not in-hospital coronary deaths

  11. Prognostic value of relative adrenal insufficiency after out-of-hospital cardiac arrest.

    Science.gov (United States)

    Pene, Frédéric; Hyvernat, Hervé; Mallet, Vincent; Cariou, Alain; Carli, Pierre; Spaulding, Christian; Dugue, Marie-Annick; Mira, Jean-Paul

    2005-05-01

    To assess the prevalence of relative adrenal insufficiency in patients successfully resuscitated after cardiac arrest, and its prognostic role in post-resuscitation disease. A prospective observational single-center study in a medical intensive care unit. 64 patients hospitalised in the intensive care unit after successful resuscitation for out-of-hospital cardiac arrest. A corticotropin-stimulation test was performed between 12 and 24 h following admission: serum cortisol level was measured before and 60 min after administration of tetracosactide 250 microg. Patients with an incremental response less than 9 microg/dl were considered to have relative adrenal insufficiency (non-responders). Variables were expressed as medians and interquartile ranges. 33 patients (52%) had relative adrenal insufficiency. Baseline cortisol level was higher in non-responders than in responders (41 [27.2-55.5] vs. 22.8 [15.7-35.1] microg/dl respectively, P=0.001). A long interval before initiation of cardiopulmonary resuscitation was associated with relative adrenal insufficiency (5 [3-10] vs. 3 [3-5] min, P=0.03). Of the 38 patients with post-resuscitation shock, 13 died of irreversible multiorgan failure. The presence of relative adrenal insufficiency was identified as a poor prognostic factor of shock-related mortality (log-rank P=0.02). A trend towards higher mortality in non-responders was identified in a multivariate logistic regression analysis (odds ratio 6.77, CI 95% 0.94-48.99, P=0.058). Relative adrenal insufficiency occurs frequently after successful resuscitation of out-of-hospital cardiac arrest, and appears to be associated with a poor prognosis in cases of post-resuscitation shock. The role of corticosteroid supplementation should be evaluated in this setting.

  12. Resuscitation outcomes of reproductive-age females who experienced out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hagihara, Akihito; Onozuka, Daisuke; Hasegawa, Manabu; Nagata, Takashi; Abe, Takeru; Nabeshima, Yoshihiro

    2017-03-01

    Although some studies have shown that women in their reproductive years have better resuscitation outcomes of out-of-hospital cardiac arrest (OHCA), conflicting results and methodological problems have also been noted. Thus, we evaluated the resuscitation outcomes of OHCA of females by age. This was a prospective observational study using registry data from all OHCA cases between 2005 and 2012 in Japan. The subjects were females aged 18-110 years who suffered an out-of-hospital cardiac arrest. Logistic regression analyses were performed using total and propensity-matched patients. There were 381,123 OHCA cases that met the inclusion criteria. Among propensity-matched patients, females aged 18-49 and 50-60 years of age had similar rates of return of spontaneous circulation before hospital arrival and 1-month survival (all p>0.60). In contrast, females aged 18-49 years of age had significantly lower rates of 1-month survival with minimal neurological impairment than did females aged 50-60 years of age (after adjusting for selected variables: Cerebral Performance Category scale 1 or 2 (CPC (1, 2)), OR=0.45, p=0.020; Overall Performance Category scale 1 or 2 (OPC (1, 2)): OR=0.42, p= 0.014; after adjustment for all variables: CPC (1, 2), OR=0.27, p= 0.008; OPC (1, 2), OR=0.29, p=0.009). Women of reproductive age did not show improved resuscitation outcomes in OHCA. Additionally, women in their reproductive years showed worse neurological outcomes one month after the event, which may be explained by the negative effects of estrogen. These findings need to be verified in further studies.

  13. 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.

  14. Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

    Science.gov (United States)

    Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

    2012-05-01

    Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

  15. 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

  16. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

    OpenAIRE

    Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.

    2017-01-01

    Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request ...

  17. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

    Science.gov (United States)

    Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

    2017-05-01

    In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

  18. Impact of Early Vasopressor Administration on Neurological Outcomes after Prolonged Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Hubble, Michael W; Tyson, Clark

    2017-06-01

    Introduction Vasopressors are associated with return of spontaneous circulation (ROSC), but no long-term benefit has been demonstrated in randomized trials. However, these trials did not control for the timing of vasopressor administration which may influence outcomes. Consequently, the objective of this study was to develop a model describing the likelihood of favorable neurological outcome (cerebral performance category [CPC] 1 or 2) as a function of the public safety answering point call receipt (PSAP)-to-pressor-interval (PPI) in prolonged out-of-hospital cardiac arrest. Hypothesis The likelihood of favorable neurological outcome declines with increasing PPI. This investigation was a retrospective study of cardiac arrest using linked data from the Cardiac Arrest Registry to Enhance Survival (CARES) database (Centers for Disease Control and Prevention [Atlanta, Georgia USA]; American Heart Association [Dallas, Texas USA]; and Emory University Department of Emergency Medicine [Atlanta, Georgia USA]) and the North Carolina (USA) Prehospital Medical Information System. Adult patients suffering a bystander-witnessed, non-traumatic cardiac arrest between January 2012 and June 2014 were included. Logistic regression was used to calculate the adjusted odds ratio (OR) of neurological outcome as a function of PPI, while controlling for patient age, gender, and race; endotracheal intubation (ETI); shockable rhythm; layperson cardiopulmonary resuscitation (CPR); and field hypothermia. Of the 2,100 patients meeting inclusion criteria, 913 (43.5%) experienced ROSC, 618 (29.4%) survived to hospital admission, 187 (8.9%) survived to hospital discharge, and 155 (7.4%) were discharged with favorable neurological outcomes (CPC 1 or 2). Favorable neurological outcome was less likely with increasing PPI (OR=0.90; PCPR, and ETI were not independent predictors of favorable neurological outcome. In this evaluation, time to vasopressor administration was significantly associated with

  19. Out-of-hospital mortality among patients receiving methadone for noncancer pain.

    Science.gov (United States)

    Ray, Wayne A; Chung, Cecilia P; Murray, Katherine T; Cooper, William O; Hall, Kathi; Stein, C Michael

    2015-03-01

    Growing methadone use in pain management has raised concerns regarding its safety relative to other long-acting opioids. Methadone hydrochloride may increase the risk for lethal respiratory depression related to accidental overdose and life-threatening ventricular arrhythmias. To compare the risk of out-of-hospital death in patients receiving methadone for noncancer pain with that in comparable patients receiving sustained-release (SR) morphine sulfate. A retrospective cohort study was conducted using Tennessee Medicaid records from 1997 through 2009. The cohort included patients receiving morphine SR or methadone who were aged 30 to 74 years, did not have cancer or another life-threatening illness, and were not in a hospital or nursing home. At cohort entry, 32 742 and 6014 patients had filled a prescription for morphine SR or methadone, respectively. The patients' median age was 48 years, 57.9% were female, and comparable proportions had received cardiovascular, psychotropic, and other musculoskeletal medications. Nearly 90% of the patients received the opioid for back pain or other musculoskeletal pain. The median doses prescribed for morphine SR and methadone were 90 mg/d and 40 mg/d, respectively. The primary study end point was out-of-hospital mortality, given that opioid-related deaths typically occur outside the hospital. There were 477 deaths during 28 699 person-years of follow-up (ie, 166 deaths per 10 000 person-years). After control for study covariates, patients receiving methadone had a 46% increased risk of death during the follow-up period, with an adjusted hazard ratio (HR) of 1.46 (95% CI, 1.17-1.83; P Methadone doses of 20 mg/d or less, the lowest dose quartile, were associated with an increased risk of death (HR, 1.59; 95% CI, 1.01-2.51, P = .046) relative to a comparable dose of morphine SR (methadone in this retrospective cohort study, even for low doses, supports recommendations that it should not be a drug of first choice for

  20. Finding a vein or obtaining consent: a qualitative study of hepatitis C testing in GP methadone clinics.

    Science.gov (United States)

    Perry, Mark; Chew-Graham, Carolyn

    2003-10-01

    Informed consent is a professional norm, but the promotion of testing for infectious disease in organized clinics and the introduction of targets for uptake, such as those for human immunodeficiency virus (HIV) testing in antenatal clinics, might impair truly voluntary consent. Hepatitis C virus (HCV) is highly prevalent among intravenous drug users (IDUs) and the 'offer' of a serological test for HCV antibodies is now seen as a national standard within drug misuse services, including GP methadone clinics. We hoped that GPs' descriptions of the context and offer of HCV testing could provide an exploratory study of consent within primary care clinics. The aim of this study was to understand GPs' ethical practice when negotiating consent to HCV testing with IDUs. A qualitative semi-structured interview study of 20 GPs in Greater Manchester was carried out. GPs reported that they or their attached drug workers commonly tested for HCV, and many stressed the need for good teamwork and building relationships with 'stable' IDUs before testing. GPs' views on the beneficence of testing and their practices in obtaining consent were diverse. GPs' discourse highlighted important management problems: (i) the adequacy of preparation of some IDUs for testing; (ii) 'opportunistic' HCV testing; and (iii) GPs' recognition of denial after testing. While GPs offered little explicit ethical reflection, occasionally they remarked on tendencies to control a patient's decision, and a deviant case analysis demonstrates how poor teamwork can be associated with coercion. GPs' descriptions suggest that an effective informed consent process is the norm for HCV testing within GP methadone clinics. Importantly, a minority of GPs alluded to the directive effect of team protocols or other problems in obtaining valid consent. We offer recommendations for managing testing to ensure voluntary choice.

  1. 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.

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

    Science.gov (United States)

    Ong, Marcus Eh; Ng, Faith Sp; Yap, Susan; Yong, Kok Leong; Peberdy, Mary A; Ornato, Joseph P

    2010-01-01

    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. 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 three-year period. Data was analyzed using analysis of variance (ANOVA). 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. 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.

  3. Assessment of muscle tissue oxygen saturation after out-of-hospital cardiac arrest.

    Science.gov (United States)

    Orban, Jean-Christophe; Scarlatti, Audrey; Danin, Pierre-Eric; Dellamonica, Jean; Bernardin, Gilles; Ichai, Carole

    2015-12-01

    Pathophysiology of cardiac arrest corresponds to an ischemia-reperfusion syndrome with deep impairment of microcirculation. Muscular tissue oxygen saturation (StO2) is a noninvasive method of evaluation of microcirculation. Our study was aimed at assessing the prognosis value of muscular StO2 in patients admitted for out-of-hospital cardiac arrest (OHCA) and treated with hypothermia. We conducted a prospective bicentric observational study including OHCA patients treated with therapeutic hypothermia. Baseline StO2, derived variables (desaturation and resaturation slopes), and lactate levels were compared at different times between patients with good and poor outcomes. Prognosis was assessed by the Cerebral Performance Category (CPC) score at 6 months after admission (CPC 1-2, good outcome; CPC 3-5, poor outcome). Forty-four patients were included, 17 good and 27 poor outcomes at 6 months. At admission, StO2 and lactate levels were lower in good outcome patients. Desaturation and resaturation slopes did not differ between groups. After an OHCA treated with therapeutic hypothermia, StO2 was correlated with outcome. Further research is needed to better understand the pathophysiological process underlying our results. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Surviving out-of-hospital cardiac arrest: just a matter of defibrillators?

    Science.gov (United States)

    Zorzi, Alessandro; Gasparetto, Nicola; Stella, Federica; Bortoluzzi, Andrea; Cacciavillani, Luisa; Basso, Cristina

    2014-08-01

    Out-of-hospital sudden cardiac arrest (OHCA) is a leading cause of death all over the world. Although the outcome of OHCA resulting from 'nonshockable' rhythms (asystole and pulseless electrical activity) is poor regardless of resuscitation efforts, 'shockable' rhythms such as ventricular tachycardia or fibrillation may carry a good prognosis if early defibrillation is performed. At present, simplified cardiopulmonary resuscitation techniques (hands-only cardiopulmonary resuscitation) and automated external defibrillators (AEDs) offer lay people the possibility to provide lifesaving treatment to OHCA victims in the critical minutes before the arrival of the emergency medical system. Programs aimed at increasing provision of cardiopulmonary resuscitation and use of AEDs by lay people have been set up in different countries, including Italy, and have contributed to improve survival rates. However, success of these programs critically depends on appropriate planning and design, and on cultural predisposition of witnesses to undertake immediate measures of resuscitation in the case of OHCA. Placement of a large number of AEDs may carry high costs and little benefits if it is uncoordinated and not preceded by educational campaigns to spread widely the 'culture of resuscitation' in the population.

  5. 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.

  6. Therapeutic hypothermia following out-of-hospital cardiac arrest; does it start in the emergency department?

    Science.gov (United States)

    Galloway, R; Sherren, P B

    2010-12-01

    The use of therapeutic hypothermia after cardiac arrest is a well-practised treatment modality in the intensive care unit (ICU). However, recent evidence points to advantages in starting the cooling process as soon as possible after the return of spontaneous circulation (ROSC). There are no data on implementation of this treatment in the emergency department. A telephone survey was conducted of the 233 emergency departments in the UK. The most senior available clinician was asked if, in cases where they have a patient with a ROSC after an out-of-hospital cardiac arrest, would therapeutic hypothermia be started in the emergency department. Of the 233 hospitals called, 230 responded, of which 35% would start cooling in the emergency department. Of this 35%, over half (56%) said the decision to start cooling was made by the emergency physician before consultation with the ICU. Also, of the 35% who would begin cooling in the emergency department, 55% would cool only for ventricular fibrillation/ventricular tachycardia, 66% would monitor temperature centrally, and 14% would use specialised cooling equipment. There is often a delay in getting patients to ICU from the emergency department, and thus the decision not to start cooling in the emergency department may impact significantly on patient outcome. The dissemination of these data may persuade emergency physicians that starting treatment in the emergency department is an appropriate and justifiable decision that is becoming a more accepted practice throughout the UK.

  7. Cardiopulmonary resuscitation duration and survival in out-of-hospital cardiac arrest patients.

    Science.gov (United States)

    Adnet, Frederic; Triba, Mohamed N; Borron, Stephen W; Lapostolle, Frederic; Hubert, Hervé; Gueugniaud, Pierre-Yves; Escutnaire, Josephine; Guenin, Aurelien; Hoogvorst, Astrid; Marbeuf-Gueye, Carol; Reuter, Paul-Georges; Javaud, Nicolas; Vicaut, Eric; Chevret, Sylvie

    2017-02-01

    Relationship between cardiopulmonary arrest and resuscitation (CPR) durations and survival after out-of-hospital cardiac arrest (OHCA) remain unclear. Our primary aim was to determine the association between survival without neurologic sequelae and cardiac arrest intervals in the setting of witnessed OHCA. We analyzed 27,301 non-traumatic, witnessed OHCA patients in France included in the national registry from June 1, 2011 through December 1, 2015. We analyzed cardiac arrest intervals, designated as no-flow (NF; from collapse to start of CPR) and low-flow (LF; from start of CPR to cessation of resuscitation) in relation to 30-day survival without sequelae. We determined the influence of recognized prognostic factors (age, gender, initial rhythm, location of cardiac arrest) on this relation. For the entire cohort, the area delimited by a value of NF greater than 12min (95% confidence interval: 11-13min) and LF greater than 33min (95% confidence interval: 29-45min), yielded a probability of 30-day survival of less than 1%. These sets of values were greatly influenced by initial cardiac arrest rhythm, age, sex and location of cardiac arrest. Extended CPR duration (greater than 40min) in the setting of initial shockable cardiac rhythm is associated with greater than 1% survival with NF less than 18min. The NF interval was highly influential on the LF interval regardless of outcome, whether return of spontaneous circulation (padvanced techniques. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. 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.

  9. 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.

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

    Science.gov (United States)

    Weeke, P; Jensen, A; Folke, F; Gislason, G H; Olesen, J B; Fosbøl, E L; Wissenberg, M; Lippert, F K; Christensen, E F; Nielsen, S L; Holm, E; Kanters, J K; Poulsen, H E; Køber, L; Torp-Pedersen, C

    2014-10-01

    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 OHCAs in Denmark (2001-2010). The 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 the event. Overall, treatment with any antipsychotic drug was associated with OHCA (odds ratio (OR) = 1.53, 95% confidence interval (CI): 1.23-1.89), as was use with typical antipsychotics (OR = 1.66, CI: 1.27-2.17). By contrast, overall, atypical antipsychotic drug use was not (OR = 1.29, CI: 0.90-1.85). Two individual typical antipsychotic drugs, haloperidol (OR = 2.43, CI: 1.20-4.93) and levomepromazine (OR = 2.05, CI: 1.18-3.56), were associated with OHCA, as was one atypical antipsychotic drug, quetiapine (OR = 3.64, CI: 1.59-8.30).

  11. Debriefing bystanders of out-of-hospital cardiac arrest is valuable.

    Science.gov (United States)

    Møller, Thea Palsgaard; Hansen, Carolina Malta; Fjordholt, Martin; Pedersen, Birgitte Dahl; Østergaard, Doris; Lippert, Freddy K

    2014-11-01

    To explore the concept of debriefing bystanders after participating in an out-of-hospital cardiac arrest resuscitation attempt including (1) bystanders' most commonly addressed reactions after participating in a resuscitation attempt when receiving debriefing from medical dispatchers; (2) their perception of effects of receiving debriefing and (3) bystanders' recommendations for a systematic debriefing concept. Qualitative study based on telephone debriefing to bystanders and interviews with bystanders who received debriefing. Data was analyzed using the phenomenological approach. Six themes emerged from analysis of debriefing audio files: (1) identification of OHCA; (2) emotional and perceptual experience with OHCA; (3) collaboration with healthcare professionals; (4) patients outcome; (5) coping with the experience and (6) general reflections. When evaluating the concept, bystanders expressed positive short term effect of receiving debriefing and a retention of this effect after two months. Recommendations for a future debriefing concept were given. Debriefing by emergency medical dispatchers to OHCA bystanders stimulates reflection, positively influencing the ability to cope with the emotional reactions and the cognitive perception of own performance and motivates improvement of CPR skills. Importantly, it increases confidence to provide CPR in the future. Implementation of telephone debriefing to bystanders at Emergency Medical Dispatch Centres is a low complexity and a low cost intervention though the logistic challenges have to be considered. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  12. The time dependent association of adrenaline administration and survival from out-of-hospital cardiac arrest.

    Science.gov (United States)

    Ewy, Gordon A; Bobrow, Bentley J; Chikani, Vatsal; Sanders, Arthur B; Otto, Charles W; Spaite, Daniel W; Kern, Karl B

    2015-11-01

    Recommended for decades, the therapeutic value of adrenaline (epinephrine) in the resuscitation of patients with out-of-hospital cardiac arrest (OHCA) is controversial. To investigate the possible time-dependent outcomes associated with adrenaline administration by Emergency Medical Services personnel (EMS). A retrospective analysis of prospectively collected data from a near statewide cardiac resuscitation database between 1 January 2005 and 30 November 2013. Multivariable logistic regression was used to analyze the effect of the time interval between EMS dispatch and the initial dose of adrenaline on survival. The primary endpoints were survival to hospital discharge and favourable neurologic outcome. Data from 3469 patients with witnessed OHCA were analyzed. Their mean age was 66.3 years and 69% were male. An initially shockable rhythm was present in 41.8% of patients. Based on a multivariable logistic regression model with initial adrenaline administration time interval (AATI) from EMS dispatch as the covariate, survival was greatest when adrenaline was administered very early but decreased rapidly with increasing (AATI); odds ratio 0.94 (95% Confidence Interval (CI) 0.92-0.97). The AATI had no significant effect on good neurological outcome (OR=0.96, 95% CI=0.90-1.02). In patients with OHCA, survival to hospital discharge was greater in those treated early with adrenaline by EMS especially in the subset of patients with a shockable rhythm. However survival rapidly decreased with increasing adrenaline administration time intervals (AATI). Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  13. How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

    Science.gov (United States)

    Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

    2018-01-01

    Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

  14. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    OpenAIRE

    Mehdi Benchoufi; Raphael Porcher; Philippe Ravaud

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a...

  15. A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

    Science.gov (United States)

    Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

    2015-02-01

    Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

  16. Sex differences in the prehospital management of out-of-hospital cardiac arrest.

    Science.gov (United States)

    Mumma, Bryn E; Umarov, Temur

    2016-08-01

    Sex differences exist in the diagnosis and treatment of several cardiovascular diseases. Our objective was to determine whether sex differences exist in the use of guideline-recommended treatments in out-of-hospital cardiac arrest (OHCA). We included adult patients with non-traumatic OHCA treated by emergency medical services (EMS) in the Resuscitation Outcomes Consortium Prehospital Resuscitation using an IMpedance valve and Early versus Delayed (ROC PRIMED) database during 2007-2009. Outcomes included prehospital treatment intervals, procedures, and medications. Data were analysed using multivariable linear and logistic regression models that adjusted for sex, age, witnessed arrest, public location, bystander cardiopulmonary resuscitation (CPR), and first known rhythm of ventricular tachycardia/fibrillation. We studied 15,584 patients; 64% were male and median age was 68 years (interquartile range 55-80). In multivariable analyses, intervals from EMS dispatch to first rhythm capture (p=0.001) and first EMS CPR (p=0.001) were longer in women than in men. Women were less likely to receive successful intravenous or intraosseous access (OR 0.78, 95% CI 0.71-0.86) but equally likely to receive a successful advanced airway (OR 0.94, 95% CI 0.86-1.02). Women were less likely to receive adrenaline (OR 0.81, 95% CI 0.74-0.88), atropine (OR 0.86, 95% CI 0.80-0.92), and lidocaine or amiodarone (OR 0.68, 95% CI 0.61-0.75). Women were less likely than men to receive guideline-recommended treatments for OHCA. The reasons for these differences require further exploration, and EMS provider education and training should specifically address these sex differences in the treatment of OHCA. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Solar radiation and out-of-hospital cardiac arrest in Japan.

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    Onozuka, Daisuke; Hagihara, Akihito

    2017-11-01

    Although several studies have estimated the effects of temperature on mortality and morbidity, little is known regarding the burden of out-of-hospital cardiac arrest (OHCA) attributable to solar radiation. We obtained data for all cases of OHCA and meteorological data reported between 2011 and 2014 in 3 Japanese prefectures: Hokkaido, Ibaraki, and Fukuoka. We first examined the relationship between daily solar radiation and OHCA risk for each prefecture using time-varying distributed lag non-linear models and then pooled the results in a multivariate random-effects meta-analysis. The attributable fractions of OHCA were calculated for low and high solar radiation, defined as solar radiation below and above the minimum morbidity solar radiation, respectively. The minimum morbidity solar radiation was defined as the specific solar radiation associated with the lowest morbidity risk. A total of 49,892 cases of OHCA occurred during the study period. The minimum morbidity solar radiation for each prefecture was the 100th percentile (72.5 MJ/m 2 ) in Hokkaido, the 83rd percentile (59.7 MJ/m 2 ) in Ibaraki, and the 70th percentile (53.8 MJ/m 2 ) in Fukuoka. Overall, 20.00% (95% empirical confidence interval [eCI]: 10.97-27.04) of the OHCA cases were attributable to daily solar radiation. The attributable fraction for low solar radiation was 19.50% (95% eCI: 10.00-26.92), whereas that for high solar radiation was 0.50% (95% eCI: -0.07-1.01). Low solar radiation was associated with a substantial attributable risk for OHCA. Our findings suggest that public health efforts to reduce OHCA burden should consider the solar radiation level. Large prospective studies with longitudinal collection of individual data is required to more conclusively assess the impact of solar radiation on OHCA. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. 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.

  19. 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.

  20. Outcomes of Basic Versus Advanced Life Support for Out-of-Hospital Medical Emergencies.

    Science.gov (United States)

    Sanghavi, Prachi; Jena, Anupam B; Newhouse, Joseph P; Zaslavsky, Alan M

    2015-11-03

    Most Medicare patients seeking emergency medical transport are treated by ambulance providers trained in advanced life support (ALS). Evidence supporting the superiority of ALS over basic life support (BLS) is limited, but some studies suggest ALS may harm patients. To compare outcomes after ALS and BLS in out-of-hospital medical emergencies. Observational study with adjustment for propensity score weights and instrumental variable analyses based on county-level variations in ALS use. Traditional Medicare. 20% random sample of Medicare beneficiaries from nonrural counties between 2006 and 2011 with major trauma, stroke, acute myocardial infarction (AMI), or respiratory failure. Neurologic functioning and survival to 30 days, 90 days, 1 year, and 2 years. Except in cases of AMI, patients showed superior unadjusted outcomes with BLS despite being older and having more comorbidities. In propensity score analyses, survival to 90 days among patients with trauma, stroke, and respiratory failure was higher with BLS than ALS (6.1 percentage points [95% CI, 5.4 to 6.8 percentage points] for trauma; 7.0 percentage points [CI, 6.2 to 7.7 percentage points] for stroke; and 3.7 percentage points [CI, 2.5 to 4.8 percentage points] for respiratory failure). Patients with AMI did not exhibit differences in survival at 30 days but had better survival at 90 days with ALS (1.0 percentage point [CI, 0.1 to 1.9 percentage points]). Neurologic functioning favored BLS for all diagnoses. Results from instrumental variable analyses were broadly consistent with propensity score analyses for trauma and stroke, showed no survival differences between BLS and ALS for respiratory failure, and showed better survival at all time points with BLS than ALS for patients with AMI. Only Medicare beneficiaries from nonrural counties were studied. Advanced life support is associated with substantially higher mortality for several acute medical emergencies than BLS. National Science Foundation, Agency for

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Extreme temperatures and out-of-hospital coronary deaths in six large Chinese cities.

    Science.gov (United States)

    Chen, Renjie; Li, Tiantian; Cai, Jing; Yan, Meilin; Zhao, Zhuohui; Kan, Haidong

    2014-12-01

    The seasonal trend of out-of-hospital coronary death (OHCD) and sudden cardiac death has been observed, but whether extreme temperature serves as a risk factor is rarely investigated. We therefore aimed to evaluate the impact of extreme temperatures on OHCDs in China. We obtained death records of 126,925 OHCDs from six large Chinese cities (Harbin, Beijing, Tianjin, Nanjing, Shanghai and Guangzhou) during the period 2009-2011. The short-term associations between extreme temperature and OHCDs were analysed with time-series methods in each city, using generalised additive Poisson regression models. We specified distributed lag non-linear models in studying the delayed effects of extreme temperature. We then applied Bayesian hierarchical models to combine the city-specific effect estimates. The associations between extreme temperature and OHCDs were almost U-shaped or J-shaped. The pooled relative risks (RRs) of extreme cold temperatures over the lags 0-14 days comparing the 1st and 25th centile temperatures were 1.49 (95% posterior interval (PI) 1.26-1.76); the pooled RRs of extreme hot temperatures comparing the 99th and 75th centile temperatures were 1.53 (95% PI 1.27-1.84) for OHCDs. The RRs of extreme temperature on OHCD were higher if the patients with coronary heart disease were old, male and less educated. This multicity epidemiological study suggested that both extreme cold and hot temperatures posed significant risks on OHCDs, and might have important public health implications for the prevention of OHCD or sudden cardiac death. 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.

  3. Out-of-hospital cardiac arrest: the prospect of E-CPR in the Maastricht region.

    Science.gov (United States)

    Sharma, A S; Pijls, R W M; Weerwind, P W; Delnoij, T S R; de Jong, W C; Gorgels, A P M; Maessen, J G

    2016-02-01

    The current outcome of out-of-hospital cardiac arrest (OHCA) patients in the Maastricht region was analysed with the prospect of implementing extracorporeal cardiopulmonary resuscitation (E-CPR). A retrospective analysis of adult patients who were resuscitated for OHCA during a 24-month period was performed. 195 patients (age 66 [57-75] years, 82 % male) were resuscitated for OHCA by the emergency medical services and survived to admission at the emergency department. Survival to hospital discharge was 46.2 %. Notable differences between non-survivors and survivors were observed and included: age (70 [58-79] years) vs. (63 [55-72] years, p = 0.01), chronic heart failure (18 vs. 7 %, p = 0.02), shockable rhythm (67 vs. 99 %, p < 0.01), and return of spontaneous circulation (ROSC) at departure from the site of the arrest (46 vs. 99 %, p < 0.01) and on arrival to the emergency department (43 vs. 98 %, p < 0.01), respectively. Acute coronary syndrome was diagnosed in 32 % of non-survivors vs. 59 % among survivors, p < 0.01. Therapeutic hypothermia was provided in non-survivors (20 %) vs. survivors (43 %), p < 0.01. Percutaneous coronary intervention (PCI) was performed in 14 % of non-survivors while 52 % of survivors received PCI (p < 0.01). No statistical significance was observed in terms of gender, witnessed arrest, bystander CPR, or automated external defibrillator deployed among the cohort. At hospital discharge, moderately severe neurological disability was present in six survivors. These observations are compatible with the notion that a shockable rhythm, ROSC, and post-arrest care improve survival outcome. Potentially, initiating E-CPR in the resuscitation phase in patients with a shockable rhythm and no ROSC might serve as a bridge to definite treatment and improve survival outcome.

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Work factors associated with return to work in out-of-hospital cardiac arrest survivors.

    Science.gov (United States)

    Descatha, Alexis; Dumas, Florence; Bougouin, Wulfran; Cariou, Alain; Geri, Guillaume

    2018-07-01

    Although the survival rate after out-of-hospital cardiac arrest (OHCA) has increased over time, little is known about the return to work of OHCA survivors. We aim to evaluate prevalence and factors associated with return to work (RTW) in OHCA survivors. All consecutive OHCA survivors aged 18-65 years and discharged alive from a Paris tertiary intensive care unit between 2000 and 2013 were included. Pre-hospital care, in-hospital care, and after-hospital discharge data, such as work description (work location, job classification, nature of the job) were compared relative to work status and RTW. Factors associated with RTW were evaluated using multivariable logistic regression. 153 OHCA survivors were included in the analysis. Among them, 96 (62.8%) returned to work an average of 714 days after OHCA (SD 1031); mostly to the same job (n = 72, 75%). Six patients changed jobs (4%) and 12 reduced their activity (10.6%). Factors associated with RTW were younger age (adjusted odds ratio (aOR) 3.64 [1.10; 12.02]), being managers and professionals, and service and sales workers (compared to technicians and associate professionals, clerical support workers, respectively aOR 3.43 [1.05; 11.22] and 4.69 [1.14; 19.37]), and workplace occurrence (aOR 11.72 [1.37; 99.93]). Two thirds of OHCA survivors, in the present study, returned to work. Patients with a higher-level job, and with the arrest occurring in the workplace, were more likely to return to work. Further research should include more details of job contents, evolution, financial consequences, as well as prevention practices related to work location. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Out-of-hospital cardiac arrest attributable to sunshine: a nationwide, retrospective, observational study.

    Science.gov (United States)

    Onozuka, Daisuke; Hagihara, Akihito

    2017-04-01

    To investigate the population attributable risk of out-of-hospital cardiac arrest (OHCA) from non-optimal sunshine duration and the relative contribution of daily sunshine hours. National registry data of all cases of OHCA occurred between 2005 and 2014 in the 47 Japanese prefectures were obtained. We examined the relationship between daily duration of sunshine and OHCA risk for each prefecture in Japan using a Poisson regression model combined with a distributed lag non-linear model, adjusting for confounding factors. The estimated associations for each prefecture were pooled at the nationwide level using a multivariate random-effects meta-analysis. A total of 658 742 cases of OHCA of presumed cardiac origin met our inclusion criteria. The minimum morbidity sunshine duration varied from the 21st percentile in Okayama to the 99th percentile in Hokkaido, Gifu, and Hyogo. Overall, 5.78% [95% empirical confidence interval (eCI): 3.57-7.16] of the OHCA cases were attributable to daily sunshine duration. The attributable fraction for short sunshine duration (below the minimum morbidity sunshine duration) was 4.18% (95% eCI: 2.64-5.38), whereas that for long sunshine duration (above the minimum morbidity sunshine duration) was 1.59% (95% eCI: 0.81-2.21). Daily sunshine duration was responsible for OHCA burden, and a greater number of OHCA cases occurred in patients who were only exposed to sunshine for short periods of time each day. Our findings suggest that public health efforts to reduce OHCA burden should take sunshine level into account. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For Permissions, please email: journals.permissions@oup.com.

  7. Dispatcher-assisted bystander cardiopulmonary resuscitation and survival in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hagihara, Akihito; Onozuka, Daisuke; Shibuta, Hidetoshi; Hasegawa, Manabu; Nagata, Takashi

    2018-04-19

    Bystander cardiopulmonary resuscitation (CPR) is critical to the survival of patients with out-of-hospital cardiac arrest (OHCA). However, it is unknown whether bystander CPR with or without dispatcher assistance is more effective or why. Thus, we evaluated the association between dispatcher-assisted bystander CPR (vs. bystander CPR without dispatcher assistance) and survival of patients with OHCA. This is a retrospective, nonrandomized, observational study using national registry data for all OHCAs. We performed a propensity analysis. Patients with OHCA of cardiac origin were 18-100 years of age and received bystander chest compression in Japan between 2005 and 2014. Outcome measures were bystander rescue breathing, return of spontaneous circulation (ROSC) before hospital arrival, and survival and Cerebral Performance Category (CPC) 1 or 2 at 1 month after the event. During the study period, 1,176,351 OHCAs occurred, and 87,400 cases met the inclusion criteria. Among propensity-matched patients, a negative association was observed between dispatcher-assisted bystander CPR and outcome measures in a fully-adjusted model [odds ratio (OR) (95% CI) for ROSC = 0.87 (0.78-0.97), P < 0.05; OR (95% CI) for 1-month survival = 0.81 (0.65-1.00), P < 0.05; OR (95% CI) for CPC 1 or 2 = 0.64 (0.43-0.93), P < 0.05]. OR of survival for dispatcher-assisted bystander CPR tended to decrease as the emergency medical services response time increased. Survival benefit was less for dispatcher-assisted bystander CPR with dispatcher assistance than without dispatcher assistance. Low quality is hypothesized to be the cause of the reduced benefit. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Out-of-Hospital Cardiac Arrests During the Japanese Professional Baseball Championship Series.

    Science.gov (United States)

    Onozuka, Daisuke; Hagihara, Akihito

    2018-03-14

    Because the Japan Professional Baseball Championship Series (Japan Series) is a stressful sports event, it is possible that watching Japan Series matches may increase the risk of cardiovascular events. Therefore, we investigated the potential association between the Japan Series and the incidence of out-of-hospital cardiac arrest (OHCA) events. National registry data for all cases of OHCA between 2005 and 2014 from 47 prefectures of Japan were obtained. We used a time-stratified case-crossover design with a conditional Poisson regression model to compare OHCA events during the Japan Series with those events that occurred during the periods except for dates of the Japan Series. The estimated associations for each prefecture were pooled at the nationwide level using a random-effects meta-analysis. In total, 666,020 OHCAs of presumed cardiac origin were reported during the study period. On days of Japan Series matches, the pooled relative risk of OHCA was 1.033 (95% confidence interval 1.012 to 1.055; p = 0.002; I 2  = 3.5%, P for heterogeneity = 0.405). Stratified analyses by gender revealed that the substantial increase in OHCA during the events was observed for men, whereas we found no significant increase for women. We also found a considerable rise in OHCA among patients aged ≥65 years; however, there was no significant evidence of increased risk in those aged 18 to 64 years. In conclusion, stressful baseball match is associated with an increased risk of OHCA. Prevention measures for severe emotional stress-related OHCA should be implemented, particularly for elderly men. Copyright © 2018 Elsevier Inc. All rights reserved.

  9. Extracorporeal cardiopulmonary resuscitation after out-of-hospital cardiac arrest in a Danish health region.

    Science.gov (United States)

    Fjølner, J; Greisen, J; Jørgensen, M R S; Terkelsen, C J; Ilkjaer, L B; Hansen, T M; Eiskjaer, H; Christensen, S; Gjedsted, J

    2017-02-01

    Extracorporeal Cardiopulmonary Resuscitation (ECPR) has emerged as a feasible rescue therapy for refractory, normothermic out-of-hospital cardiac arrest (OHCA). Reported survival rates vary and comparison between studies is hampered by heterogeneous study populations, differences in bystander intervention and in pre-hospital emergency service organisation. We aimed to describe the first experiences, treatment details, complications and outcome with ECPR for OHCA in a Danish health region. Retrospective study of adult patients admitted at Aarhus University Hospital, Denmark between 1 January 2011 and 1 July 2015 with witnessed, refractory, normothermic OHCA treated with ECPR. OHCA was managed with pre-hospital advanced airway management and mechanical chest compression during transport. Relevant pre-hospital and in-hospital data were collected with special focus on low-flow time and ECPR duration. Survival to hospital discharge with Cerebral Performance Category (CPC) of 1 and 2 at hospital discharge was the primary endpoint. Twenty-one patients were included. Median pre-hospital low-flow time was 54 min [range 5-100] and median total low-flow time was 121 min [range 55-192]. Seven patients survived (33%). Survivors had a CPC score of 1 or 2 at hospital discharge. Five survivors had a shockable initial rhythm. In all survivors coronary occlusion was the presumed cause of cardiac arrest. Extracorporeal cardiopulmonary resuscitation is feasible as a rescue therapy in normothermic refractory OHCA in highly selected patients. Low-flow time was longer than previously reported. Survival with favourable neurological outcome is possible despite prolonged low-flow duration. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  10. A second chance at life: people's lived experiences of surviving out-of-hospital cardiac arrest.

    Science.gov (United States)

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

    2017-12-01

    There is more to illuminate about people's experiences of surviving out-of-hospital cardiac arrest (OHCA) and how such an event affects people's lives over time. This study aimed to elucidate meanings of people's lived experiences and changes in everyday life during their first year after surviving OHCA. A qualitative, longitudinal design was used. Eleven people surviving OHCA from northern Sweden agreed to participate and were interviewed 6 and 12 months after the event. A phenomenological hermeneutic interpretation was used to analyse the transcribed texts. The structural analysis resulted in two themes: (i) striving to regain one's usual self and (ii) a second chance at life, and subthemes (ia) testing the body, (ib) pursuing the ordinary life, (ic) gratitude for help to survival, (iia) regaining a sense of security with one's body, (iib) getting to know a new self, and (iic) seeking meaning and establishing a future. To conclude, we suggest that people experienced meanings of surviving OHCA over time as striving to regain their usual self and getting a second chance at life. The event affected them in many ways and resulted in a lot of emotions and many things to think about. Participants experienced back-and-forth emotions, when comparing their present lives to both their lives before cardiac arrest and those lives they planned for the future. During their first year, participants' daily lives were still influenced by 'being dead' and returning to life. As time passed, they wanted to resume their ordinary lives and hoped for continued lives filled with meaning and joyous activities. © 2017 Nordic College of Caring Science.

  11. Electrocardiographic Findings in Patients With Acute Coronary Syndrome Presenting With Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Sarak, Bradley; Goodman, Shaun G; Brieger, David; Gale, Chris P; Tan, Nigel S; Budaj, Andrzej; Wong, Graham C; Huynh, Thao; Tan, Mary K; Udell, Jacob A; Bagai, Akshay; Fox, Keith A A; Yan, Andrew T

    2018-02-01

    We sought to characterize presenting electrocardiographic findings in patients with acute coronary syndromes (ACSs) and out-of-hospital cardiac arrest (OHCA). In the Global Registry of Acute Coronary Events and Canadian ACS Registry I, we examined presenting and 24- to 48-hour follow-up ECGs (electrocardiogram) of ACS patients who survived to hospital admission, stratified by presentation with OHCA. We assessed the prevalence of ST-segment deviation and bundle branch blocks (assessed by an independent ECG core laboratory) and their association with in-hospital and 6-month mortality among those with OHCA. Of the 12,040 ACS patients, 215 (1.8%) survived to hospital admission after OHCA. Those with OHCA had higher presenting rates of ST-segment elevation, ST-segment depression, T-wave inversion, precordial Q-waves, left bundle branch block (LBBB), and right bundle branch block (RBBB) than those without. Among patients with OHCA, those with ST-segment elevation had significantly lower in-hospital mortality (20.9% vs 33.0%, p = 0.044) and a trend toward lower 6-month mortality (27% vs 39%, p = 0.060) compared with those without ST-segment elevation. Conversely, among OCHA patients, LBBB was associated with significantly higher in-hospital and 6-month mortality rates (58% vs 22%, p presenting ECG resolved by 24 to 48 hours. In conclusion, compared with ACS patients without cardiac arrest, those with OHCA had higher rates of ST-segment elevation, LBBB, and RBBB on admission. Among OHCA patients, ST-segment elevation was associated with lower in-hospital mortality, whereas LBBB was associated with higher in-hospital and 6-month mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Ambulance cardiopulmonary resuscitation: outcomes and associated factors in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Rosell Ortiz, Fernando; García Del Águila, Javier; Fernández Del Valle, Patricia; J Mellado-Vergel, Francisco; Vergara-Pérez, Santiago; R Ruiz-Montero, María; Martínez-Lara, Manuela; J Gómez-Jiménez, Francisco; Gonzáez-Lobato, Ismael; García-Escudero, Guillermo; Ruiz-Bailén, Manuel; Caballero-García, Auxiliadora; Vivar-Díaz, Itziar; Olavarría-Govantes, Luis

    2018-06-01

    To assess factors associated with survival of out-of-hospital cardiac arrest (OHCA) in patients who underwent cardiopulmonary resuscitation (CPR) during ambulance transport. Retrospective analysis of a registry of OHCA cases treated between 2008 and 2014. We included patients who had not recovered circulation at the time it was decided to transport to a hospital and who were rejected as non-heart-beating donors. Multivariate analysis was used to explore factors associated with the use of ambulance CPR, survival, and neurologic outcome. Out of a total of 7241 cases, 259 (3.6%) were given CPR during emergency transport. The mean (SD) age was 51.6 (23.6) years; 27 (10.1%) were aged 16 years or younger. The following variables were associated with the use of CPR during transport: age 16 years or under (odds ratio [OR], 6.48; 95% CI, 3.91-10.76); P<.001)], witnessed OHCA (OR, 1.62; 95% CI, 1.16-2.26; P=.004), cardiac arrest outside the home (OR, 3.17; 95% CI, 2.38-4.21; P<.001), noncardiac cause (OR, 1.47; 95% CI, 1.07-2.02; P=.019], initially shockable rhythm (OR, 1.67; 95% CI, 1.17-2.37; P=.004), no prior basic life support (OR, 3.48; 95% CI, 2.58-4.70; P<.001), and orotracheal intubation (OR, 1.93; 95% CI, 1.24-2.99; P=.003). One patient (0.38%) survived to discharge with good neurologic outcome. Ambulance CPR by a physician on board is applied in few OHCA cases. Young patient age, cardiac arrest outside the home, the presence of a witness, lack of a shockable rhythm on responder arrival, lack of basic life support prior to responder arrival, noncardiac cause, and orotracheal intubation are associated with the use of ambulance CPR, a strategy that can be considered futile.

  13. Effects of adrenaline on rhythm transitions in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Neset, Andres; Nordseth, Trond; Kramer-Johansen, Jo; Wik, Lars; Olasveengen, Theresa M

    2013-11-01

    We wanted to study the effects of intravenous (i.v.) adrenaline (epinephrine) on rhythm transitions during cardiac arrest with initial or secondary ventricular fibrillation/tachycardia (VF/VT). Post hoc analysis of patients included in a randomised controlled trial of i.v. drugs in adult, non-traumatic out-of-hospital cardiac arrest patients who were defibrillated and had a readable electrocardiography recording. Patients who received adrenaline were compared with patients who did not. Cardiac rhythms were annotated manually using the defibrillator data. Eight hundred and forty-nine patients were included in the randomised trial of which 223 were included in this analysis; 119 in the adrenaline group and 104 in the no-adrenaline group. The proportion of patients with one or more VF/VT episodes after temporary return of spontaneous circulation (ROSC) was higher in the adrenaline than in the no-adrenaline group, 24% vs. 12%, P = 0.03. Most relapses from ROSC to VF/VT in the no-adrenaline group occurred during the first 20 min of resuscitation, whereas patients in the adrenaline group experienced such relapses even after 20 min. Fibrillations from asystole or pulseless electrical activity, shock resistant VF/VT and the number of rhythm transitions per patient was higher in the adrenalin group compared with the no-adrenalin group: 90% vs. 69%, P adrenaline had more rhythm transitions from ROSC and non-shockable rhythms to VF/VT. © 2013 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    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.

  15. A smartphone application for dispatch of lay responders to out-of-hospital cardiac arrests.

    Science.gov (United States)

    Berglund, Ellinor; Claesson, Andreas; Nordberg, Per; Djärv, Therese; Lundgren, Peter; Folke, Fredrik; Forsberg, Sune; Riva, Gabriel; Ringh, Mattias

    2018-05-01

    Dispatch of lay volunteers trained in cardiopulmonary resuscitation (CPR) and equipped with automated external defibrillators (AEDs) may improve survival in cases of out-of-hospital cardiac arrest (OHCA). The aim of this study was to investigate the functionality and performance of a smartphone application for locating and alerting nearby trained laymen/women in cases of OHCA. A system using a smartphone application activated by Emergency Dispatch Centres was used to locate and alert laymen/women to nearby suspected OHCAs. Lay responders were instructed either to perform CPR or collect a nearby AED. An online survey was carried out among the responders. From February to August 2016, the system was activated in 685 cases of suspected OHCA. Among these, 224 cases were Emergency Medical Services (EMSs)-treated OHCAs (33%). EMS-witnessed cases (n = 11) and cases with missing survey data (n = 15) were excluded. In the remaining 198 OHCAs, lay responders arrived at the scene in 116 cases (58%), and prior to EMSs in 51 cases (26%). An AED was attached in 17 cases (9%) and 4 (2%) were defibrillated. Lay responders performed CPR in 54 cases (27%). Median distance to the OHCA was 560 m (IQR 332-860 m), and 1280 m (IQR 748-1776 m) via AED pick-up. The survey-answering rate was 82%. A smartphone application can be used to alert CPR-trained lay volunteers to OHCAs for CPR. Further improvements are needed to shorten the time to defibrillation before EMS arrival. Copyright © 2018 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

    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.

  17. Out-of-hospital births, U.S., 1978: birth weight and Apgar scores as measures of outcome.

    OpenAIRE

    Declercq, E R

    1984-01-01

    An examination of 1978 natality data for the United States disclosed that low birth weight was less common among 30,819 infants born out of hospital than among 3,294,101 infants born in hospital in that year. When controls were applied for birth attendant, infants' race, and mothers' education, age, nativity, and parity, the data revealed that white, well-educated women between 25 and 39 years of age, who were having their second babies and were attended by midwives out of hospital, were at l...

  18. Full recovery two months after therapeutic hypothermia following cardiopulmonary resuscitation in a patient with out-of-hospital cardiac arrest

    International Nuclear Information System (INIS)

    Ahn, J.; Cha, K.S.; Oh, J.H.; Lee, H.C.

    2013-01-01

    Neurologic impairments are very common among patients who get a recovery of spontaneous circulation after suffering from out-of-hospital cardiac arrest. Therapeutic hypothermia is established as a standardized therapeutic strategy for those patients in whom it decreases mortality rate and improves neurologic outcome. Herein, we report a case of patient who experienced out-of-hospital cardiac arrest with ischaemic heart disease and ventricular arrhythmia and got a full recovery without any neurologic impediments 2 months after being managed with therapeutic hypothermia. (author)

  19. Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

    Science.gov (United States)

    D'Cruz, L

    2010-07-24

    Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

  20. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia.

    Science.gov (United States)

    Chappuy, H; Baruchel, A; Leverger, G; Oudot, C; Brethon, B; Haouy, S; Auvrignon, A; Davous, D; Doz, F; Tréluyer, J M

    2010-10-01

    To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.

  1. Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies.

    Science.gov (United States)

    Brown, Richard; Bylund, Carma L; Siminoff, Laura A; Slovin, Susan F

    2011-04-01

    Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies. Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies. Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences. Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions. Copyright © 2010 John Wiley & Sons, Ltd.

  2. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

    Science.gov (United States)

    Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

    2012-02-01

    Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

  3. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Jocelyne R Benatar

    Full Text Available OBJECTIVE: Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. METHODS: 21 currently used informed consent forms (ICF from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK. To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. RESULTS: Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs. 41 respectively, p = 0.0003. The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42. Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI 56 to 67 correct, or simplified ICF 62% (CI 58 to 68 correct compared to 52%, (CI 47 to 57 correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008. Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64

  4. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Science.gov (United States)

    Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

    2012-01-01

    Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet

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

    Science.gov (United States)

    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

  6. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

    Science.gov (United States)

    Armstrong, Stephanie; Langlois, Adele; Laparidou, Despina; Dixon, Mark; Appleton, Jason P; Bath, Philip M; Snooks, Helen; Siriwardena, A Niroshan

    2017-09-16

    We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  7. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stephanie Armstrong

    2017-09-01

    Full Text Available Abstract Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Conclusions Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent. Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  8. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

    Science.gov (United States)

    Chima, Sylvester C

    2013-01-01

    Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while

  9. 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 defibrillat...... defibrillators could be identified on the basis of demographic characteristics and characterized individuals with OHCA in residential locations....

  10. Prevention of deterioration of ventricular fibrillation by basic life support during out-of-hospital cardiac arrest

    NARCIS (Netherlands)

    Waalewijn, Reinier A.; Nijpels, Marië A.; Tijssen, Jan G.; Koster, Rudolph W.

    2002-01-01

    Survival of cardiac arrest is improved by basic life support (BLS). This study investigated the relationship between ventricular fibrillation (VF) characteristics and survival. In a 2-year prospective study out-of-hospital witnessed non-traumatic cardiac arrests were observed. The probabilities of

  11. A case-crossover analyses of fine particulate matter and out-of-hospital sudden unexpected death

    Science.gov (United States)

    Out-of-hospital sudden unexpected deaths (OHSUD) are natural deaths that occur without obvious underlying causes and account for nearly 1 in 6 deaths in the United States. Ambient air pollution is known to be causally related to overall mortality, therefore, we hypothesized that ...

  12. 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

  13. Serum Potassium Changes During Therapeutic Hypothermia After Out-of-Hospital Cardiac Arrest-Should It Be Treated?

    DEFF Research Database (Denmark)

    Soeholm, Helle; Kirkegaard, Hans

    2012-01-01

    Background: Therapeutic hypothermia (TH) after out-of-hospital cardiac arrest (OHCA) is associated with adverse events, for example hypokalemia and arrhythmias. In the present study, we report the impact of serum potassium changes related to the rate of cardiac arrhythmias, and the advantages...

  14. Assessment of quality of life and cognitive function after out-of-hospital cardiac arrest with successful resuscitation

    NARCIS (Netherlands)

    van Alem, Anouk P.; Waalewijn, Reinier A.; Koster, Rudolph W.; de Vos, Rien

    2004-01-01

    This prospective cohort study evaluated the impact of the time-related elements of the "chain of survival" on the quality of life of patients, taking their characteristics into account. Between 1995 and 2002, consecutive, out-of-hospital cardiac arrest patients from Amsterdam and the surrounding

  15. Comorbidity and favorable neurologic outcome after out-of-hospital cardiac arrest in patients of 70 years and older

    NARCIS (Netherlands)

    Beesems, Stefanie G.; Blom, Marieke T.; van der Pas, Martine H. A.; Hulleman, Michiel; van de Glind, Esther M. M.; van Munster, Barbara C.; Tijssen, Jan G. P.; Tan, Hanno L.; van Delden, Johannes J. M.; Koster, Rudolph W.

    2015-01-01

    Advanced age is reported to be associated with lower survival after out-of-hospital cardiac arrest (OHCA). We aimed to establish survival rate and neurological outcome at hospital discharge after OHCA in older patients and evaluated whether pre-OHCA comorbidity was associated with favorable

  16. Comorbidity and favorable neurologic outcome after out-of-hospital cardiac arrest in patients of 70 years and older

    NARCIS (Netherlands)

    Beesems, Stefanie G.; Blom, Marieke T.; van der Pas, Martine H. A.; Hulleman, Michiel; van de Glind, Esther M. M.; van Munster, Barbara C.; Tijssen, Jan G. P.; Tan, Hanno L.; van Delden, Johannes J. M.; Koster, Rudolph W.

    Introduction: Advanced age is reported to be associated with lower survival after out-of-hospital cardiac arrest (OHCA). We aimed to establish survival rate and neurological outcome at hospital discharge after OHCA in older patients and evaluated whether pre-OHCA comorbidity was associated with

  17. 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.

  18. Evaluation of an impedance threshold device in patients receiving active compression-decompression cardiopulmonary resuscitation for out of hospital cardiac arrest.

    Science.gov (United States)

    Plaisance, Patrick; Lurie, Keith G; Vicaut, Eric; Martin, Dominique; Gueugniaud, Pierre-Yves; Petit, Jean-Luc; Payen, Didier

    2004-06-01

    The purpose of this multicentre clinical randomized controlled blinded prospective trial was to determine whether an inspiratory impedance threshold device (ITD), when used in combination with active compression-decompression (ACD) cardiopulmonary resuscitation (CPR), would improve survival rates in patients with out-of-hospital cardiac arrest. Patients were randomized to receive either a sham (n = 200) or an active impedance threshold device (n = 200) during advanced cardiac life support performed with active compression-decompression cardiopulmonary resuscitation. The primary endpoint of this study was 24 h survival. The 24 h survival rates were 44/200 (22%) with the sham valve and 64/200 (32%) with the active valve (P = 0.02). The number of patients who had a return of spontaneous circulation (ROSC), intensive care unit (ICU) admission, and hospital discharge rates was 77 (39%), 57 (29%), and 8 (4%) in the sham valve group versus 96 (48%) (P = 0.05), 79 (40%) (P = 0.02), and 10 (5%) (P = 0.6) in the active valve group. Six out of ten survivors in the active valve group and 1/8 survivors in the sham group had normal neurological function at hospital discharge (P = 0.1). The use of an impedance valve in patients receiving active compression-decompression cardiopulmonary resuscitation for out-of-hospital cardiac arrest significantly improved 24 h survival rates.

  19. Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

    The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

  20. The Extent of Myocardial Injury During Prolonged Targeted Temperature Management After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Grejs, Anders Morten; Gjedsted, Jakob; Thygesen, Kristian

    2017-01-01

    AIM: The aim of this study is to evaluate the extent of myocardial injury by cardiac biomarkers during prolonged targeted temperature management of 24 hours vs 48 hours after out-of-hospital cardiac arrest. METHODS: This randomized Scandinavian multicenter study compares the extent of myocardial...... injury estimated by hs-cTnTAUC of prolonged targeted temperature management of 48 hours vs 24 hours, although the CK-MBAUC was significantly higher during 48 hours vs 24 hours. Hence, it seems unlikely that the duration of targeted temperature management has a beneficial effect on the extent...... injury quantified by area under the curve (AUC) of cardiac biomarkers during prolonged targeted temperature management at 33°C ± 1°C of 24 hours and 48 hours, respectively. Through a period of 2.5 years, 161 comatose out-of-hospital cardiac arrest patients were randomized to targeted temperature...

  1. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

  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. Order-specific fertility estimates based on perinatal statistics and statistics on out-of-hospital births

    OpenAIRE

    Kreyenfeld, Michaela; Peters, Frederik; Scholz, Rembrandt; Wlosnewski, Ines

    2014-01-01

    Until 2008, German vital statistics has not provided information on biological birth order. We have tried to close part of this gap by providing order-specific fertility rates generated from Perinatal Statistics and statistics on out-of-hospital births for the period 2001-2008. This investigation has been published in Comparative Population Studies (CPoS) (see Kreyenfeld, Scholz, Peters and Wlosnewski 2010). The CPoS-paper describes how data from the Perinatal Statistics and statistics on out...

  4. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    Science.gov (United States)

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  5. Informed Consent in Dentistry.

    Science.gov (United States)

    Reid, Kevin I

    2017-03-01

    A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

  6. Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo).

    Science.gov (United States)

    Kudenchuk, Peter J; Leroux, Brian G; Daya, Mohamud; Rea, Thomas; Vaillancourt, Christian; Morrison, Laurie J; Callaway, Clifton W; Christenson, James; Ornato, Joseph P; Dunford, James V; Wittwer, Lynn; Weisfeldt, Myron L; Aufderheide, Tom P; Vilke, Gary M; Idris, Ahamed H; Stiell, Ian G; Colella, M Riccardo; Kayea, Tami; Egan, Debra; Desvigne-Nickens, Patrice; Gray, Pamela; Gray, Randal; Straight, Ron; Dorian, Paul

    2017-11-28

    Out-of-hospital cardiac arrest (OHCA) commonly presents with nonshockable rhythms (asystole and pulseless electric activity). It is unknown whether antiarrhythmic drugs are safe and effective when nonshockable rhythms evolve to shockable rhythms (ventricular fibrillation/pulseless ventricular tachycardia [VF/VT]) during resuscitation. Adults with nontraumatic OHCA, vascular access, and VF/VT anytime after ≥1 shock(s) were prospectively randomized, double-blind, to receive amiodarone, lidocaine, or placebo by paramedics. Patients presenting with initial shock-refractory VF/VT were previously reported. The current study was a prespecified analysis in a separate cohort that initially presented with nonshockable OHCA and was randomized on subsequently developing shock-refractory VF/VT. The primary outcome was survival to hospital discharge. Secondary outcomes included discharge functional status and adverse drug-related effects. Of 37 889 patients with OHCA, 3026 with initial VF/VT and 1063 with initial nonshockable-turned-shockable rhythms were treatment-eligible, were randomized, and received their assigned drug. Baseline characteristics among patients with nonshockable-turned-shockable rhythms were balanced across treatment arms, except that recipients of a placebo included fewer men and were less likely to receive bystander cardiopulmonary resuscitation. Active-drug recipients in this cohort required fewer shocks, supplemental doses of their assigned drug, and ancillary antiarrhythmic drugs than recipients of a placebo ( P discharge ( P =0.24). No significant interaction between treatment assignment and discharge survival occurred with the initiating OHCA rhythm (asystole, pulseless electric activity, or VF/VT). Survival in each of these categories was consistently higher with active drugs, although the trends were not statistically significant. Adjusted absolute differences (95% confidence interval) in survival from nonshockable-turned-shockable arrhythmias

  7. Advanced vs. Basic Life Support in the Treatment of Out-of-Hospital Cardiopulmonary Arrest in the Resuscitation Outcomes Consortium.

    Science.gov (United States)

    Kurz, Michael Christopher; Schmicker, Robert H; Leroux, Brian; Nichol, Graham; Aufderheide, Tom P; Cheskes, Sheldon; Grunau, Brian; Jasti, Jamie; Kudenchuk, Peter; Vilke, Gary M; Buick, Jason; Wittwer, Lynn; Sahni, Ritu; Straight, Ronald; Wang, Henry E

    2018-04-30

    Prior observational studies suggest no additional benefit from advanced life support (ALS) when compared with providing basic life support (BLS) for patients with out-of-hospital cardiac arrest (OHCA). We compared the association of ALS care with OHCA outcomes using prospective clinical data from the Resuscitation Outcomes Consortium (ROC). Included were consecutive adults OHCA treated by participating emergency medical services (EMS) agencies between June 1, 2011, and June 30, 2015. We defined BLS as receipt of cardiopulmonary resuscitation (CPR) and/or automated defibrillation and ALS as receipt of an advanced airway, manual defibrillation, or intravenous drug therapy. We compared outcomes among patients receiving: 1) BLS-only; 2) BLS + late ALS; 3) BLS + early ALS; and 4) ALS-first care. Using multivariable logistic regression, we evaluated the associations between level of care and return of spontaneous circulation (ROSC), survival to hospital discharge, and survival with good functional status, adjusting for age, sex, witnessed arrest, bystander CPR, shockable initial rhythm, public location, EMS response time, CPR quality, and ROC site. Among 35,065 patients with OHCA, characteristics were median age 68 years (IQR 56-80), male 63.9%, witnessed arrest 43.8%, bystander CPR 50.6%, and shockable initial rhythm 24.2%. Care delivered was: 4.0% BLS-only, 31.5% BLS + late ALS, 17.2% BLS + early ALS, and 47.3% ALS-first. ALS care with or without initial BLS care was independently associated with increased adjusted ROSC and survival to hospital discharge unless delivered greater than 6 min after BLS arrival (BLS + late ALS). Regardless of when it was delivered, ALS care was not associated with significantly greater functional outcome. ALS care was associated with survival to hospital discharge when provided initially or within six minutes of BLS arrival. ALS care, with or without initial BLS care, was associated with increased ROSC, however it was

  8. The influence of scenario-based training and real-time audiovisual feedback on out-of-hospital cardiopulmonary resuscitation quality and survival from out-of-hospital cardiac arrest.

    Science.gov (United States)

    Bobrow, Bentley J; Vadeboncoeur, Tyler F; Stolz, Uwe; Silver, Annemarie E; Tobin, John M; Crawford, Scott A; Mason, Terence K; Schirmer, Jerome; Smith, Gary A; Spaite, Daniel W

    2013-07-01

    We assess whether an initiative to optimize out-of-hospital provider cardiopulmonary resuscitation (CPR) quality is associated with improved CPR quality and increased survival from out-of-hospital cardiac arrest. This was a before-after study of consecutive adult out-of-hospital cardiac arrest. Data were obtained from out-of-hospital forms and defibrillators. Phase 1 included 18 months with real-time audiovisual feedback disabled (October 2008 to March 2010). Phase 2 included 16 months (May 2010 to September 2011) after scenario-based training of 373 professional rescuers and real-time audiovisual feedback enabled. The effect of interventions on survival to hospital discharge was assessed with multivariable logistic regression. Multiple imputation of missing data was used to analyze the effect of interventions on CPR quality. Analysis included 484 out-of-hospital cardiac arrest patients (phase 1 232; phase 2 252). Median age was 68 years (interquartile range 56-79); 66.5% were men. CPR quality measures improved significantly from phase 1 to phase 2: Mean chest compression rate decreased from 128 to 106 chest compressions per minute (difference -23 chest compressions; 95% confidence interval [CI] -26 to -19 chest compressions); mean chest compression depth increased from 1.78 to 2.15 inches (difference 0.38 inches; 95% CI 0.28 to 0.47 inches); median chest compression fraction increased from 66.2% to 83.7% (difference 17.6%; 95% CI 15.0% to 20.1%); median preshock pause decreased from 26.9 to 15.5 seconds (difference -11.4 seconds; 95% CI -15.7 to -7.2 seconds), and mean ventilation rate decreased from 11.7 to 9.5/minute (difference -2.2/minute; 95% CI -3.9 to -0.5/minute). All-rhythms survival increased from phase 1 to phase 2 (20/231, 8.7% versus 35/252, 13.9%; difference 5.2%; 95% CI -0.4% to 10.8%), with an adjusted odds ratio of 2.72 (95% CI 1.15 to 6.41), controlling for initial rhythm, witnessed arrest, age, minimally interrupted cardiac resuscitation

  9. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2018-02-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  10. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-12-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-07-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

  12. 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......, thrombelastography (TEG), bleeding, and stent thrombosis events. Platelet counts were lower in the TTM33-group compared to TTM36 (p=0.009), but neither standard coagulation nor TEG-parameters showed any difference between the groups. TEG revealed a normocoagulable state in the majority of patients, while...... approximately 20% of the population presented as hypercoagulable. Adverse events included 38 bleeding events, one stent thrombosis, and one reinfarction, with no significant difference between the groups. CONCLUSIONS: There was no evidence supporting the assumption that TTM at 33°C was associated with impaired...

  13. The Glucagon-Like Peptide-1 Analog Exenatide Increases Blood Glucose Clearance, Lactate Clearance, and Heart Rate in Comatose Patients After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Wiberg, Sebastian; Kjaergaard, Jesper; Schmidt, Henrik

    2018-01-01

    the first 6 hours from study drug initiation: lactate level, blood glucose level, heart rate, mean arterial pressure, and combined dosage of norepinephrine and dopamine. MEASUREMENTS AND MAIN RESULTS: The population consisted of 106 patients receiving either exenatide or placebo. During the first 6 hours...... from study drug initiation, the levels of blood glucose and lactate decreased 17% (95% CI, 8.9-25%; p = 0.0004) and 21% (95% CI, 6.0-33%; p = 0.02) faster in patients receiving exenatide versus placebo, respectively. Exenatide increased heart rate by approximately 10 beats per minute compared......OBJECTIVES: To investigate the effects of the glucagon-like peptide-1 analog exenatide on blood glucose, lactate clearance, and hemodynamic variables in comatose, resuscitated out-of-hospital cardiac arrest patients. DESIGN: Predefined post hoc analyzes from a double-blind, randomized clinical...

  14. 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.

  15. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial.

    Science.gov (United States)

    Bohn, Andreas; Weber, Thomas P; Wecker, Sascha; Harding, Ulf; Osada, Nani; Van Aken, Hugo; Lukas, Roman P

    2011-03-01

    Chest compression quality is a determinant of survival from out-of-hospital cardiac arrest (OHCA). ERC 2005 guidelines recommend the use of technical devices to support rescuers giving compressions. This prospective randomized study reviewed influence of different feedback configurations on survival and compression quality. 312 patients suffering an OHCA were randomly allocated to two different feedback configurations. In the limited feedback group a metronome and visual feedback was used. In the extended feedback group voice prompts were added. A training program was completed prior to implementation, performance debriefing was conducted throughout the study. Survival did not differ between the extended and limited feedback groups (47.8% vs 43.9%, p = 0.49). Average compression depth (mean ± SD: 4.74 ± 0.86 cm vs 4.84 ± 0.93 cm, p = 0.31) was similar in both groups. There were no differences in compression rate (103 ± 7 vs 102 ± 5 min(-1), p=0.74) or hands-off fraction (16.16% ± 0.07 to 17.04% ± 0.07, p = 0.38). Bystander CPR, public arrest location, presenting rhythm and chest compression depth were predictors of short term survival (ROSC to ED). Even limited CPR-feedback combined with training and ongoing debriefing leads to high chest compression quality. Bystander CPR, location, rhythm and chest compression depth are determinants of survival from out of hospital cardiac arrest. Addition of voice prompts does neither modify CPR quality nor outcome in OHCA. CC depth significantly influences survival and therefore more focus should be put on correct delivery. Further studies are needed to examine the best configuration of feedback to improve CPR quality and survival. ClinicalTrials.gov (NCT00449969), http://www.clinicalTrials.gov. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  16. Use of implantable cardioverter defibrillators after out-of-hospital cardiac arrest: a prospective follow-up study

    Science.gov (United States)

    Parkash, Ratika; Tang, Anthony; Wells, George; Blackburn, Josée; Stiell, Ian; Simpson, Christopher; Dorian, Paul; Yee, Raymond; Cameron, Doug; Connolly, Stuart; Birnie, David; Nichol, Graham

    2004-01-01

    Background Survivors of out-of-hospital cardiac arrest are at high risk of recurrent arrests, many of which could be prevented with implantable cardioverter defibrillators (ICDs). We sought to determine the ICD insertion rate among survivors of out-of-hospital cardiac arrest and to determine factors associated with ICD implantation. Methods The Ontario Prehospital Advanced Life Support (OPALS) study is a prospective, multiphase, before–after study assessing the effectiveness of prehospital interventions for people experiencing cardiac arrest, trauma or respiratory arrest in 19 Ontario communities. We linked OPALS data describing survivors of cardiac arrest with data from all defibrillator implantation centres in Ontario. Results From January 1997 to April 2002, 454 patients in the OPALS study survived to hospital discharge after experiencing an out-of-hospital cardiac arrest. The mean age was 65 (standard deviation 14) years, 122 (26.9%) were women, 398 (87.7%) had a witnessed arrest, 372 (81.9%) had an initial rhythm of ventricular tachycardia or ventricular fibrillation (VT/VF), and 76 (16.7%) had asystole or another arrhythmia. The median cerebral performance category at discharge (range 1–5, 1 = normal) was 1. Only 58 (12.8%) of the 454 patients received an ICD. Patients with an initial rhythm of VT/VF were more likely than those with an initial rhythm of asystole or another rhythm to undergo device insertion (adjusted odds ratio [OR] 9.63, 95% confidence interval [CI] 1.31–71.50). Similarly, patients with a normal cerebral performance score were more likely than those with abnormal scores to undergo ICD insertion (adjusted OR 12.52, 95% CI 1.74–92.12). Interpretation A minority of patients who survived cardiac arrest underwent ICD insertion. It is unclear whether this low usage rate reflects referral bias, selection bias by electrophysiologists, supply constraint or patient preference. PMID:15505267

  17. 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.

  18. Trends and characteristics of home and other out-of-hospital births in the United States, 1990-2006.

    Science.gov (United States)

    MacDorman, Marian F; Menacker, Fay; Declercq, Eugene

    2010-03-03

    This report examines trends and characteristics of out-of-hospital and home births in the United States. Descriptive tabulations of data are presented and interpreted. In 2006, there were 38,568 out-of-hospital births in the United States, including 24,970 home births and 10,781 births occurring in a freestanding birthing center. After a gradual decline from 1990 to 2004, the percentage of out-of-hospital births increased by 3% from 0.87% in 2004 to 0.90% in 2005 and 2006. A similar pattern was found for home births. After a gradual decline from 1990 to 2004, the percentage of home births increased by 5% to 0.59% in 2005 and remained steady in 2006. Compared with the U.S. average, home birth rates were higher for non-Hispanic white women, married women, women aged 25 and over, and women with several previous children. Home births were less likely than hospital births to be preterm, low birthweight, or multiple deliveries. The percentage of home births was 74% higher in rural counties of less than 100,000 population than in counties with a population size of 100,000 or more. The percentage of home births also varied widely by state; in Vermont and Montana more than 2% of births in 2005-2006 were home births, compared with less than 0.2% in Louisiana and Nebraska. About 61% of home births were delivered by midwives. Among midwife-delivered home births, one-fourth (27%) were delivered by certified nurse midwives, and nearly three-fourths (73%) were delivered by other midwives. Women may choose home birth for a variety of reasons, including a desire for a low-intervention birth in a familiar environment surrounded by family and friends and cultural or religious concerns. Lack of transportation in rural areas and cost factors may also play a role.

  19. Eccentric apical hypertrophic cardiomyopathy unmasked by multimodality imaging: an uncommon but missed cause of out of hospital cardiac arrest

    Science.gov (United States)

    Towe, Eric; Sharma, Saurabh; Geske, Jeffrey; Ackerman, Michael J

    2015-01-01

    A woman in her late 50s experienced a witnessed, sudden out of hospital cardiac arrest. Initial workup included coronary angiography, transthoracic echocardiogram and a CT scan of the chest to rule out pulmonary embolus. She was subsequently discharged home without an implantable cardioverter defibrillator (ICD) or a life vest. On follow-up at another facility, an ICD was placed and a Holter monitor showed no ventricular ectopy. Further transthoracic echocardiographic images were obtained, which were suggestive of apical hypertrophic cardiomyopathy. A limited transthoracic echocardiogram with contrast was performed, which did not elucidate the hypertrophy. However, eccentric left ventricular apical wall hypertrophy was visualised by a coronary CT scan. PMID:26153133

  20. Time Trends and Educational Inequalities in Out-of-Hospital Coronary Deaths in Norway 1995-2009

    DEFF Research Database (Denmark)

    Sulo, Enxhela; Nygård, Ottar; Vollset, Stein Emil

    2017-01-01

    using Poisson regression analysis with year as the independent, continuous variable. Information on the highest achieved education was obtained from The National Education Database and classified as primary (up to 10 years of compulsory education), secondary (high school or vocational school......BACKGROUND: Recent time trends and educational gradients characterizing out-of-hospital coronary deaths (OHCD) are poorly described. METHODS AND RESULTS: We identified all deaths from coronary heart disease occurring outside the hospital in Norway during 1995 to 2009. Time trends were explored......), or tertiary (college/university). Educational gradients in OHCD were explored using Poisson regression, stratified by sex and age (

  1. 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.

  2. Trends and Characteristics of United States Out-of-Hospital Births 2004-2014: New Information on Risk Status and Access to Care.

    Science.gov (United States)

    MacDorman, Marian F; Declercq, Eugene

    2016-06-01

    Out-of-hospital births are increasing in the United States. Our purpose was to examine trends in out-of-hospital births from 2004 to 2014, and to analyze newly available data on risk status and access to care. Newly available data from the revised birth certificate for 47 states and Washington, DC, were used to examine out-of-hospital births by characteristics and to compare them with hospital births. Trends from 2004 to 2014 were also examined. Out-of-hospital births increased by 72 percent, from 0.87 percent of United States births in 2004 to 1.50 percent in 2014. Compared with mothers who had hospital births, those with out-of-hospital births had lower prepregnancy obesity (12.5% vs 25.0%) and smoking (2.8% vs 8.5%) rates, and higher college graduation (39.3% vs 30.0%) and breastfeeding initiation (94.3% vs 80.8%) rates. Among planned home births, 67.1 percent were self-paid, compared with 31.9 percent of birth center and 3.4 percent of hospital births. Vaginal births after cesarean (VBACs) comprised 4.6 percent of planned home births and 1.6 percent of hospital and birth center births. Sociodemographic and medical risk status of out-of-hospital births improved substantially from 2004 to 2014. Improvements in risk status of out-of-hospital births from 2004 to 2014 suggest that appropriate selection of low-risk women is improving. High rates of self-pay for the costs of out-of-hospital birth suggest serious gaps in insurance coverage, whereas higher-than-average rates of VBAC could reflect lack of access to hospital VBACs. Mandating private insurance and Medicaid coverage could substantially improve access to out-of-hospital births. Improving access to hospital VBACs might reduce the number of out-of-hospital VBACs. © 2016 Wiley Periodicals, Inc.

  3. Increase in cerebral oxygenation during advanced life support in out-of-hospital patients is associated with return of spontaneous circulation.

    Science.gov (United States)

    Genbrugge, Cornelia; Meex, Ingrid; Boer, Willem; Jans, Frank; Heylen, René; Ferdinande, Bert; Dens, Jo; De Deyne, Cathy

    2015-03-24

    By maintaining sufficient cerebral blood flow and oxygenation, the goal of cardiopulmonary resuscitation (CPR) is to preserve the pre-arrest neurological state. To date, cerebral monitoring abilities during CPR have been limited. Therefore, we investigated the time-course of cerebral oxygen saturation values (rSO₂) during advanced life support in out-of-hospital cardiac arrest. Our primary aim was to compare rSO₂ values during advanced life support from patients with return of spontaneous circulation (ROSC) to patients who did not achieve ROSC. We performed an observational study to measure rSO₂ using Equanox (Nonin, Plymouth, MI) from the start of advanced life support in the pre-hospital setting. rSO₂ of 49 consecutive out-of-hospital cardiac arrest patients were analyzed. The total increase from initial rSO₂ value until two minutes before ROSC or end of advanced life support efforts was significantly larger in the group with ROSC 16% (9 to 36) compared to the patients without ROSC 10% (4 to 15) (P = 0.02). Mean rSO₂ from the start of measurement until two minutes before ROSC or until termination of advanced life support was higher in patients with ROSC than in those without, namely 39% ± 7 and 31% ± 4 (P = 0.05) respectively. During pre-hospital advanced life support, higher increases in rSO₂ are observed in patients attaining ROSC, even before ROSC was clinically determined. Our findings suggest that rSO₂ could be used in the future to guide patient tailored treatment during cardiac arrest and could therefore be a surrogate marker of the systemic oxygenation state of the patient.

  4. Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Jacobs, Ian G; Finn, Judith C; Jelinek, George A; Oxer, Harry F; Thompson, Peter L

    2011-09-01

    There is little evidence from clinical trials that the use of adrenaline (epinephrine) in treating cardiac arrest improves survival, despite adrenaline being considered standard of care for many decades. The aim of our study was to determine the effect of adrenaline on patient survival to hospital discharge in out of hospital cardiac arrest. We conducted a double blind randomised placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. Identical study vials containing either adrenaline 1:1000 or placebo (sodium chloride 0.9%) were prepared. Patients were randomly allocated to receive 1 ml aliquots of the trial drug according to current advanced life support guidelines. Outcomes assessed included survival to hospital discharge (primary outcome), pre-hospital return of spontaneous circulation (ROSC) and neurological outcome (Cerebral Performance Category Score - CPC). A total of 4103 cardiac arrests were screened during the study period of which 601 underwent randomisation. Documentation was available for a total of 534 patients: 262 in the placebo group and 272 in the adrenaline group. Groups were well matched for baseline characteristics including age, gender and receiving bystander CPR. ROSC occurred in 22 (8.4%) of patients receiving placebo and 64 (23.5%) who received adrenaline (OR=3.4; 95% CI 2.0-5.6). Survival to hospital discharge occurred in 5 (1.9%) and 11 (4.0%) patients receiving placebo or adrenaline respectively (OR=2.2; 95% CI 0.7-6.3). All but two patients (both in the adrenaline group) had a CPC score of 1-2. Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  5. Cardiopulmonary resuscitation of out-of-hospital traumatic cardiac arrest in Qatar: A nationwide population-based study.

    Science.gov (United States)

    Irfan, Furqan B; Consunji, Rafael; El-Menyar, Ayman; George, Pooja; Peralta, Ruben; Al-Thani, Hassan; Thomas, Stephen Hodges; Alinier, Guillaume; Shuaib, Ashfaq; Al-Suwaidi, Jassim; Singh, Rajvir; Castren, Maaret; Cameron, Peter A; Djarv, Therese

    2017-08-01

    Traumatic cardiac arrest studies have reported improved survival rates recently, ranging from 1.7-7.5%. This population-based nationwide study aims to describe the epidemiology, interventions and outcomes, and determine predictors of survival from out-of-hospital traumatic cardiac arrest (OHTCA) in Qatar. An observational retrospective population-based study was conducted on OHTCA patients in Qatar, from January 2010 to December 2015. Traumatic cardiac arrest was redefined to include out-of-hospital traumatic cardiac arrest (OHTCA) and in-hospital traumatic cardiac arrest (IHTCA). A total of 410 OHTCA patients were included in the 6-year study period. The mean annual crude incidence rate of OHTCA was 4.0 per 100,000 population, in Qatar. OHTCA mostly occurred in males with a median age of 33. There was a preponderance of blunt injuries (94.3%) and head injuries (66.3%). Overall, the survival rate was 2.4%. Shockable rhythm, prehospital external hemorrhage control, in-hospital blood transfusion, and surgery were associated with higher odds of survival. Adrenaline (Epinephrine) lowered the odds of survival. The incidence of OHTCA was less than expected, with a low rate of survival. Thoracotomy was not associated with improved survival while Adrenaline administration lowered survival in OHTCA patients with majority blunt injuries. Interventions to enable early prehospital control of hemorrhage, blood transfusion, thoracostomy and surgery improved survival. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest: The State of the Evidence and Framework for Application.

    Science.gov (United States)

    Grunau, Brian; Hornby, Laura; Singal, Rohit K; Christenson, Jim; Ortega-Deballon, Ivan; Shemie, Sam D; Bashir, Jamil; Brooks, Steve C; Callaway, Clifton W; Guadagno, Elena; Nagpal, Dave

    2018-02-01

    Out-of-hospital cardiac arrest (OHCA) affects 134 per 100,000 citizens annually. Extracorporeal cardiopulmonary resuscitation (ECPR), providing mechanical circulatory support, may improve the likelihood of survival among those with refractory OHCA. Compared with in-hospital ECPR candidates, those in the out-of-hospital setting tend to be sudden unexpected arrests in younger and healthier patients. The aims of this review were to summarize, and identify the limitations of, the evidence evaluating ECPR for OHCA, and to provide an approach for ECPR program application. Although there are many descriptions of ECPR-treated cohorts, we identified a paucity of robust data showing ECPR effectiveness compared with conventional resuscitation. However, it is highly likely that ECPR, provided after a prolonged attempt with conventional resuscitation, does benefit select patient populations compared with conventional resuscitation alone. Although reliable data showing the optimal patient selection criteria for ECPR are lacking, most implementations sought young previously healthy patients with rapid high-quality cardiopulmonary resuscitation. Carefully planned development of ECPR programs, in high-performing emergency medical systems at experienced extracorporeal membrane oxygenation centres, may be reasonable as part of systematic efforts to determine ECPR effectiveness and globally improve care. Protocol evaluation requires regional-level assessment, examining the incremental benefit of survival compared with standard care, while accounting for resource utilization. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  7. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

    Science.gov (United States)

    Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

    2016-01-01

    To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

  8. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, I.M.; de Vries, M.C.; Troost, P.W.; Meynen, G.; van Goudoever, J.B.; Lindauer, R.J.

    2015-01-01

    Background: For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that

  9. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; de Vries, Martine C.; Troost, Pieter W.; Meynen, Gerben; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

    2015-01-01

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's

  10. Early Outcomes of Out-of-Hospital Cardiac Arrest after Early Defibrillation: a 24 Months Retrospective Analysis

    Directory of Open Access Journals (Sweden)

    Paolo Terranova

    2006-10-01

    Full Text Available Introduction: Cardiovascular disease remains the most common cause of death in the United States and most other Western nations. Among these deaths, sudden, out-of-hospital cardiac arrest claims approximately 1000 lives each day in the United States alone. Most of these cardiac arrests are due to ventricular fibrillation. Though highly reversible with the rapid application of a defibrillator, ventricular fibrillation is otherwise fatal within minutes, even when cardiopulmonary resuscitation is provided immediately. The overall survival rate in the United States is estimated to be less than 5 percent. Recent developments in automated-external-defibrillator technology have provided a means of increasing the rate of prompt defibrillation after out-of-hospital cardiac arrest. After minimal training, nonmedical personnel (e.g., flight attendants and casino workers are also able to use defibrillators in the workplace, with lifesaving effects. Nonetheless, such programs have involved designated personnel whose job description includes assisting persons who have had sudden cardiac arrest. Data are still lacking on the success of programs in which automated external defibrillators have been installed in public places to be used by persons who have no specific training or duty to act. Materials and Methods: All patients who had an out-of-hospital cardiac arrest between January 2003 and December 2004 and who received early defibrillation for ventricular fibrillation were included. We conducted a 24 months retrospective population-based analysis of the outcome in our population. Results: Over a 24 month period, 446 people had non–traumatic cardiac arrest, and in all of them it was observed to be ventricular fibrillation. In a very few cases, the defibrillator operators were good Samaritans, acting voluntarily. Eighty-nine patients (about 19% with ventricular fibrillation were successfully resuscitated, including eighteen who regained consciousness before

  11. 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

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

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available 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.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.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.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.Clinicaltrials.gov NCT01772511.

  13. Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

    Science.gov (United States)

    Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

    2014-01-10

    The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p s name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

  14. Association of public health initiatives with outcomes for out-of-hospital cardiac arrest at home and in public locations

    DEFF Research Database (Denmark)

    Christopher B., Fordyce; Carolina M., Hansen; Kragholm, Kristian

    2017-01-01

    Importance  Little is known about the influence of comprehensive public health initiatives according to out-of-hospital cardiac arrest (OHCA) location, particularly at home, where resuscitation efforts and outcomes have historically been poor.Objective  To describe temporal trends in bystander...... cardiopulmonary resuscitation (CPR) and first-responder defibrillation for OHCAs stratified by home vs public location and their association with survival and neurological outcomes.Design, Setting, and Participants  This observational study reviewed 8269 patients with OHCAs (5602 [67.7%] at home and 2667 [32.......3%] in public) for whom resuscitation was attempted using data from the Cardiac Arrest Registry to Enhance Survival (CARES) from January 1, 2010, through December 31, 2014. The setting was 16 counties in North Carolina.Exposures  Patients were stratified by home vs public OHCA. Public health initiatives...

  15. 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...... rhythm from AEDs used by laypersons with the corresponding proportion recorded by the Emergency Medical Services (EMS) on arrival. METHODS: In a 20-month study, we collected data on OHCAs in the Capital Region of Denmark where an AED was deployed prior to arrival of EMS. The AEDs were brought...... to the emergency medical dispatch centre for data downloading and rhythm analysis. Patient data were retrieved from the medical records from the admitting hospital, whereas data on EMS rhythm analyses were obtained from the Danish Cardiac Arrest Register between 2001 and 2010. RESULTS: A total of 121 AEDs were...

  16. 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

    in two steps; registry data were merged with electronically registered emergency call data from the emergency medical dispatch centres in the two regions. Cases with missing or non-OHCA dispatch codes were analysed further by auditing emergency call recordings using a uniform data collection template......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...

  17. 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.

  18. Out-of-hospital cardiac arrest: Probability of bystander defibrillation relative to distance to nearest automated external defibrillator.

    Science.gov (United States)

    Sondergaard, Kathrine B; Hansen, Steen Moller; Pallisgaard, Jannik L; Gerds, Thomas Alexander; Wissenberg, Mads; Karlsson, Lena; Lippert, Freddy K; Gislason, Gunnar H; Torp-Pedersen, Christian; Folke, Fredrik

    2018-03-01

    Despite wide dissemination of automated external defibrillators (AEDs), bystander defibrillation rates remain low. We aimed to investigate how route distance to the nearest accessible AED was associated with probability of bystander defibrillation in public and residential locations. We used data from the nationwide Danish Cardiac Arrest Registry and the Danish AED Network to identify out-of-hospital cardiac arrests and route distances to nearest accessible registered AED during 2008-2013. The association between route distance and bystander defibrillation was described using restricted cubic spline logistic regression. We included 6971 out-of-hospital cardiac arrest cases. The proportion of arrests according to distance in meters (≤100, 101-200, >200) to the nearest accessible AED was: 4.6% (n=320), 5.3% (n=370), and 90.1% (n=6281), respectively. For cardiac arrests in public locations, the probability of bystander defibrillation at 0, 100 and 200m from the nearest AED was 35.7% (95% confidence interval 28.0%-43.5%), 21.3% (95% confidence interval 17.4%-25.2%), and 13.7% (95% confidence interval 10.1%-16.8%), respectively. The corresponding numbers for cardiac arrests in residential locations were 7.0% (95% confidence interval -2.1%-16.1%), 1.5% (95% confidence interval 0.002%-2.8%), and 0.9% (95% confidence interval 0.0005%-1.7%), respectively. In public locations, the probability of bystander defibrillation decreased rapidly within the first 100m route distance from cardiac arrest to nearest accessible AED whereas the probability of bystander defibrillation was low for all distances in residential areas. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. [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.

  20. [Informed consent].

    Science.gov (United States)

    López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

    2003-11-01

    Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

  1. 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.

  2. 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...... providers assisted by paramedics, nurse anesthetists or physician-manned ambulances (Advanced Life Support (ALS) capability) in a nationwide, unselected cohort of out-of-hospital cardiac arrest cases....

  3. 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...... providers assisted by paramedics, nurse anesthetists or physician-manned ambulances (Advanced Life Support (ALS) capability) in a nationwide, unselected cohort of out-of-hospital cardiac arrest cases....

  4. Assessment of mental capacity to consent to treatment in anorexia nervosa: A comparison of clinical judgment and MacCAT-T and consequences for clinical practice.

    Science.gov (United States)

    Elzakkers, Isis F F M; Danner, Unna N; Grisso, Thomas; Hoek, Hans W; van Elburg, Annemarie A

    Informed consent requires adequate mental capacity to consent to treatment. Mental capacity (MC) to consent to treatment refers to the ability to make medical decisions. MC is assessed in a general psychiatric interview, but this clinical assessment is known to overestimate mental capacity in patients and the inter rater reliability is low. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) has emerged as the gold standard to assess mental capacity to consent to treatment. The MacCAT-T is a semi-structured interview designed to aid clinicians in this assessment and has shown good inter rater reliability in patients with schizophrenia and other mental disorders, but has hardly been studied in patients with anorexia nervosa. Patients with anorexia nervosa (AN) regularly avoid treatment, even when severely ill and discussion includes assessing MC to consent to treatment. The aim of this study is to compare clinical judgment and the MacCAT-T in evaluating MC in patients with AN which in turn may influence use of the MacCAT-T in daily practice. In a sample of 70 consecutively referred severely ill patients with AN with a mean BMI of 15.5 kg/m 2 and a mean duration of illness of 8.6 years, clinical assessment of MC by experienced psychiatrists and the outcome of the MacCAT-T interview were compared. Agreement (κ-value) was calculated. Agreement between clinical assessment and outcome of the MacCAT-T was questionable (κ 0.23). Unlike in other psychiatric populations, clinicians judged a high proportion of patients with AN as having diminished MC. The MacCAT-T can be useful in assessing MC in AN when used in addition to clinical judgment to aid clinicians in complex cases. Why clinicians judge a relatively high proportion of patients with AN as having diminished MC, in contrast to lower proportions in other psychiatric disorders, is an area in need of further research. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.

    Science.gov (United States)

    Gates, Simon; Lall, Ranjit; Quinn, Tom; Deakin, Charles D; Cooke, Matthew W; Horton, Jessica; Lamb, Sarah E; Slowther, Anne-Marie; Woollard, Malcolm; Carson, Andy; Smyth, Mike; Wilson, Kate; Parcell, Garry; Rosser, Andrew; Whitfield, Richard; Williams, Amanda; Jones, Rebecca; Pocock, Helen; Brock, Nicola; Black, John Jm; Wright, John; Han, Kyee; Shaw, Gary; Blair, Laura; Marti, Joachim; Hulme, Claire; McCabe, Christopher; Nikolova, Silviya; Ferreira, Zenia; Perkins, Gavin D

    2017-03-01

    Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical

  6. Home Discharge and Out-of-Hospital Follow-Up of Total Artificial Heart Patients Supported by a Portable Driver System

    Science.gov (United States)

    2014-01-01

    To enhance ambulation and facilitate hospital discharge of total artificial heart (TAH)–supported patients, we adapted a mobile ventricular assistance device (VAD) driver (Excor) for TAH use and report on the performance of Excor-driven TAH patients discharged home. Ten patients stabilized on a TAH, driven by the CSS (“Circulatory Support System”), were progressively switched over to the Excor in hospital over 14 days as a pilot, with daily hemodynamics and laboratory parameters measured. Twenty-two stable TAH patients were subsequently placed on the Excor, trained, and discharged home. Clinical and hemodynamic parameters were followed. All pilot study patients were clinically stable on the Excor, with no decrease in TAH output noted (6.3 + 0.3 L/min [day 1] vs. 5.8 + 0.2 L/min [day 14], p = 0.174), with a trend suggesting improvement of both hepatic and renal function. Twenty-two TAH patients were subsequently successfully discharged home on the portable driver and were supported out of hospital for up to 598 days (range, 2–598; mean = 179 ± 140 days), remaining ambulatory, New York Heart Association (NYHA) class I or II, and free of readmission for 88.5% of the time of support. TAH patients may be effectively and safely supported by a mobile drive system. As such, the utility of the TAH may be extended to support patients beyond the hospital, at home, with overall ambulatory freedom. PMID:24577369

  7. Effect of initial lactate level on short-term survival in patients with out-of-hospital cardiac arrest

    Directory of Open Access Journals (Sweden)

    Tuba Sarıaydın, MD

    2017-12-01

    Full Text Available Purpose: This study evaluated whether serum lactate levels (SLL at admission in patients with cardiac arrest (CA can predict successful return of spontaneous circulation (ROSC or short-term survival, especially within the first 24 h. Materials and methods: This prospective, observational study was conducted in the emergency department (ED of a training and research hospital from April 2015 through February 2016. It included all patients older than 18 years who presented to the ED during the study period with non-traumatic out-of-hospital cardiac arrest (OHCA. The study measured two outcomes: whether ROSC was achieved and whether short-term survival was achieved. ROSC was defined as the presence of spontaneous circulation for the first hour after cardiopulmonary resuscitation (CPR. Survival was defined as having survived for a minimum of 24 h after ROSC. Results: The study included 140 patients who were admitted to the ED with OHCA. ROSC was achieved in 55 patients (39.3%, and survival for 24 h following CA was achieved in 42 patients (30%. The mean SLL in the ROSC (+ and ROSC (- groups were 9.1 ± 3.2 mmol/L and 9.8 ± 2.9 mmol/L, respectively. The mean SLL in the survivor and non-survivor groups were 8.6 ± 2.9 mmol/L and 10 ± 3.1 mmol/L, respectively. These differences were not statistically significant (p = 0.1. A multivariate regression model assessing the factors that predicted both ROSC and 24-h survival showed the odds ratio (OR of initial SLL was 1.3 (95% CI: 1.05–1.6 and 1.1 (95% CI: 0.9–1.3, respectively. Conclusions: This study showed that in OHCA patients, SLL on admission was not associated with increased ROSC achievement or 24-h survival. Keywords: Cardiac arrest, Out-of-hospital cardiac arrest (OHCA, Return of spontaneous circulation (ROSC, Serum lactate, Emergency department

  8. Relationship Between Emergency Medical Services Response Time and Bystander Intervention in Patients With Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Goto, Yoshikazu; Funada, Akira; Goto, Yumiko

    2018-04-27

    The response time of emergency medical services (EMS) is an important determinant of survival after out-of-hospital cardiac arrest. We sought to identify upper limits of EMS response times and bystander interventions associated with neurologically intact survival. We analyzed the records of 553 426 patients with out-of-hospital cardiac arrest in a Japanese registry between 2010 and 2014. The primary study end point was 1-month neurologically intact survival (Cerebral Performance Category scale 1 or 2). Increased EMS response time was associated with significantly decreased adjusted odds of 1-month neurologically intact survival (adjusted odds ratio [aOR] for each 1-minute increase, 0.89; 95% confidence interval [CI], 0.89-0.90), although this relationship was modified by bystander interventions. The bystander interventions and the ranges of EMS response times that were associated with increased adjusted 1-month neurologically intact survival were as follows: bystander defibrillation, from ≤2 minutes (aOR, 3.10 [95% CI, 1.25-7.31]) to 13 minutes (aOR, 5.55 [95% CI, 2.66-11.2]); bystander conventional cardiopulmonary resuscitation, from 3 minutes (aOR 1.48 [95% CI, 1.02-2.12]) to 11 minutes (aOR 2.41 [95% CI, 1.61-3.56]); and bystander chest-compression-only cardiopulmonary resuscitation, from ≤2 minutes (aOR 1.57 [95% CI, 1.01-2.25]) to 11 minutes (aOR 1.92 [95% CI, 1.45-2.56]). However, the increase in neurologically intact survival of those receiving bystander interventions became statistically insignificant compared with no bystander interventions when the EMS response time was outside these ranges. The upper limits of the EMS response times associated with improved 1-month neurologically intact survival were 13 minutes when bystanders provided defibrillation (typically with cardiopulmonary resuscitation) and 11 minutes when bystanders provided cardiopulmonary resuscitation without defibrillation. © 2018 The Authors. Published on behalf of the

  9. Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

    Science.gov (United States)

    Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

    2014-02-01

    for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the

  10. 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.

  11. 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...

  12. 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.......5%; 95% CI, -16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour...

  13. 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.

  14. Influence of chest compression artefact on capnogram-based ventilation detection during out-of-hospital cardiopulmonary resuscitation.

    Science.gov (United States)

    Leturiondo, Mikel; Ruiz de Gauna, Sofía; Ruiz, Jesus M; Julio Gutiérrez, J; Leturiondo, Luis A; González-Otero, Digna M; Russell, James K; Zive, Dana; Daya, Mohamud

    2018-03-01

    Capnography has been proposed as a method for monitoring the ventilation rate during cardiopulmonary resuscitation (CPR). A high incidence (above 70%) of capnograms distorted by chest compression induced oscillations has been previously reported in out-of-hospital (OOH) CPR. The aim of the study was to better characterize the chest compression artefact and to evaluate its influence on the performance of a capnogram-based ventilation detector during OOH CPR. Data from the MRx monitor-defibrillator were extracted from OOH cardiac arrest episodes. For each episode, presence of chest compression artefact was annotated in the capnogram. Concurrent compression depth and transthoracic impedance signals were used to identify chest compressions and to annotate ventilations, respectively. We designed a capnogram-based ventilation detection algorithm and tested its performance with clean and distorted episodes. Data were collected from 232 episodes comprising 52 654 ventilations, with a mean (±SD) of 227 (±118) per episode. Overall, 42% of the capnograms were distorted. Presence of chest compression artefact degraded algorithm performance in terms of ventilation detection, estimation of ventilation rate, and the ability to detect hyperventilation. Capnogram-based ventilation detection during CPR using our algorithm was compromised by the presence of chest compression artefact. In particular, artefact spanning from the plateau to the baseline strongly degraded ventilation detection, and caused a high number of false hyperventilation alarms. Further research is needed to reduce the impact of chest compression artefact on capnographic ventilation monitoring. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lin, Steve; Callaway, Clifton W; Shah, Prakesh S; Wagner, Justin D; Beyene, Joseph; Ziegler, Carolyn P; Morrison, Laurie J

    2014-06-01

    The evidence for adrenaline in out-of-hospital cardiac arrest (OHCA) resuscitation is inconclusive. We systematically reviewed the efficacy of adrenaline for adult OHCA. We searched in MEDLINE, EMBASE, and Cochrane Library from inception to July 2013 for randomized controlled trials (RCTs) evaluating standard dose adrenaline (SDA) to placebo, high dose adrenaline (HDA), or vasopressin (alone or combination) in adult OHCA patients. Meta-analyses were performed using random effects modeling. Subgroup analyses were performed stratified by cardiac rhythm and by number of drug doses. The primary outcome was survival to discharge and the secondary outcomes were return of spontaneous circulation (ROSC), survival to admission, and neurological outcome. Fourteen RCTs (n=12,246) met inclusion criteria: one compared SDA to placebo (n=534), six compared SDA to HDA (n=6174), six compared SDA to an adrenaline/vasopressin combination (n=5202), and one compared SDA to vasopressin alone (n=336). There was no survival to discharge or neurological outcome differences in any comparison group, including subgroup analyses. SDA showed improved ROSC (RR 2.80, 95%CI 1.78-4.41, padrenaline. There was no benefit of adrenaline in survival to discharge or neurological outcomes. There were improved rates of survival to admission and ROSC with SDA over placebo and HDA over SDA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  16. The association of emergency department administration of sodium bicarbonate after out of hospital cardiac arrest with outcomes.

    Science.gov (United States)

    Chen, Yi-Chuan; Hung, Ming-Szu; Liu, Chia-Yen; Hsiao, Cheng-Ting; Yang, Yao-Hsu

    2018-03-05

    Sodium bicarbonate administration is mostly restricted to in-hospital use in Taiwan. This study was conducted to investigate the effect of sodium bicarbonate on outcomes among patients with out-of-hospital cardiac arrest (OHCA). This population-based study used a 16-year database to analyze the association between sodium bicarbonate administration for resuscitation in the emergency department (ED) and outcomes. All adult patients with OHCA were identified through diagnostic and procedure codes. The primary outcome was survival to hospital admission and secondary outcome was the rate of death within the first 30days of incidence of cardiac arrest. Cox proportional-hazards regression, logistic regression, and propensity analyses were conducted. Among 5589 total OHCA patients, 15.1% (844) had survival to hospital admission. For all patients, a positive association was noted between sodium bicarbonate administration during resuscitation in the ED and survival to hospital admission (adjusted odds ratio [OR]: 4.47; 95% confidence interval [CI]: 3.82-5.22, p<0.001). In propensity-matched patients, a positive association was also noted (adjusted OR, 4.61; 95% CI: 3.90-5.46, p<0.001). Among patients with OHCA in Taiwan, administration of sodium bicarbonate during ED resuscitation was significantly associated with an increased rate of survival to hospital admission. Copyright © 2018. Published by Elsevier Inc.

  17. Effectiveness of dispatcher training in increasing bystander chest compression for out-of-hospital cardiac arrest patients in Japan.

    Science.gov (United States)

    Tsunoyama, Taichiro; Nakahara, Shinji; Yoshida, Masafumi; Kitamura, Maki; Sakamoto, Tetsuya

    2017-10-01

    The Japanese government has developed a standardized training program for emergency call dispatchers to improve their skills in providing oral guidance on chest compression to bystanders who have witnessed out-of-hospital cardiac arrests (OHCAs). This study evaluated the effects of such a training program for emergency call dispatchers in Japan. The analysis included all consecutive non-traumatic OHCA patients transported to hospital by eight emergency medical services, where the program was implemented as a pilot project. We compared the provision of oral guidance and the incidence of chest compression applications by bystanders in the 1-month period before and after the program. Data collection was undertaken from October 2014 to March 2015. The 532 non-traumatic OHCA cases were used for analysis: these included 249 cases before and 283 after the guidance intervention. Most patients were over 75 years old and were men. After the program, provision of oral guidance to callers slightly increased from 63% of cases to 69% ( P = 0.13) and implementation of chest compression on patients by bystanders significantly increased from 40% to 52% ( P = 0.01). Appropriate chest compression also increased from 34% to 47% ( P = 0.01). In analysis stratified by the provision of oral guidance, increased chest compressions were observed only under oral guidance. We found increased provision of oral guidance by dispatchers and increased appropriate chest compressions by bystanders after the training program for dispatchers had been rolled out. Long-term observation and further data analysis, including patient outcomes, are needed.

  18. Effects of modifiable prehospital factors on survival after out-of-hospital cardiac arrest in rural versus urban areas.

    Science.gov (United States)

    Mathiesen, Wenche Torunn; Bjørshol, Conrad Arnfinn; Kvaløy, Jan Terje; Søreide, Eldar

    2018-04-18

    The modifiable prehospital system factors, bystander cardiopulmonary resuscitation (CPR), emergency medical services (EMS), response time, and EMS physician attendance, may affect short- and long-term survival for both rural and urban out-of-hospital cardiac arrest (OHCA) patients. We studied how such factors influenced OHCA survival in a mixed urban/rural region with a high survival rate after OHCA. We analyzed the association between modifiable prehospital factors and survival to different stages of care in 1138 medical OHCA patients from an Utstein template-based cardiac arrest registry, using Kaplan-Meier type survival curves, univariable and multivariable logistic regression and mortality hazard plots. We found a significantly higher probability for survival to hospital admission (OR: 1.84, 95% CI 1.43-2.36, p rural group. In patients receiving bystander CPR before EMS arrival, the odds of survival to hospital discharge increased more than threefold (OR: 3.05, 95% CI 2.00-4.65, p rural areas, patients with EMS physician attendance had an overall better survival to hospital discharge (survival probability 0.17 with EMS physician vs. 0.05 without EMS physician, p = 0.019). Adjusted for modifiable factors, the survival differences remained. Overall, OHCA survival was higher in urban compared to rural areas, and the effect of bystander CPR, EMS response time and EMS physician attendance on survival differ between urban and rural areas. The effect of modifiable factors on survival was highest in the prehospital stage of care. In patients surviving to hospital admission, there was no significant difference in in-hospital mortality or in 1 year mortality between OHCA in rural versus urban areas.

  19. Effect of Inpatient Dobutamine versus Milrinone on Out-of-Hospital Mortality in Patients with Acute Decompensated Heart Failure.

    Science.gov (United States)

    King, Jordan B; Shah, Rashmee U; Sainski-Nguyen, Amy; Biskupiak, Joseph; Munger, Mark A; Bress, Adam P

    2017-06-01

    To determine the effect of dobutamine versus milrinone on out-of-hospital mortality in the treatment of patients with acute decompensated heart failure (ADHF). Propensity score weighted retrospective cohort study with mortality as the primary outcome. An academic health care system. Five hundred adult patients with a prior history of heart failure who survived a hospitalization for ADHF that included treatment with dobutamine or milrinone between January 1, 2006, and April 30, 2014. ADHF events were defined as a hospitalization with receipt of an intravenous loop diuretic or a brain-type natriuretic peptide (BNP) value greater than 400 pg/ml during the hospitalization. Patients were followed until death or 180 days from hospital discharge. Risk ratios (RRs) for mortality associated with dobutamine compared with milrinone were calculated at 15, 30, and 180 days postdischarge using Poisson regression with robust error variance. Mean age was 62.7 years, 65.4% were male, and 48.2% had a mean left ventricular ejection fraction (LVEF) of 40% or lower. Overall, 55 (18%) of dobutamine-treated versus 23 (12%) of milrinone-treated patients died during follow-up (RR 1.27, 95% confidence interval [CI] 0.76-2.13, p=0.360). For death from cardiovascular causes, the RR for dobutamine was 1.49 (95% CI 0.79-2.82, p=0.214). For death from worsening heart failure, the RR for dobutamine was 2.55 (95% CI 1.07-6.10, p=0.035). A trend toward significance was observed at day 15 after discharge for all mortality analyses (all p values milrinone in patients with ADHF. These results replicate and extend prior associations with mortality and should be confirmed in a prospective study. © 2017 Pharmacotherapy Publications, Inc.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Diagnostic value and prognostic implications of early cardiac magnetic resonance in survivors of out-of-hospital cardiac arrest.

    Science.gov (United States)

    Zorzi, Alessandro; Susana, Angela; De Lazzari, Manuel; Migliore, Federico; Vescovo, Giovanni; Scarpa, Daniele; Baritussio, Anna; Tarantini, Giuseppe; Cacciavillani, Luisa; Giorgi, Benedetta; Basso, Cristina; Iliceto, Sabino; Bucciarelli Ducci, Chiara; Corrado, Domenico; Marra, Martina Perazzolo

    2018-03-15

    In patients who survived out-of-hospital cardiac arrest (OHCA), it is crucial to establish the underlying cause and its potential reversibility. The purpose of this study was to assess the incremental diagnostic and prognostic role of early cardiac magnetic resonance (CMR) in survivors of OHCA. Among 139 consecutive OHCA patients, the study enrolled 44 patients (median age 43 years; 84% male) who underwent coronary angiography and CMR ≤7 days after admission. The CMR protocol included T2-weighted sequences for myocardial edema and late gadolinium enhancement (LGE) sequences for myocardial fibrosis. Coronary angiography identified obstructive coronary artery disease in 18 of 44 patients in whom CMR confirmed the diagnosis of ischemic heart disease by demonstrating subendocardial or transmural LGE. The presence of myocardial edema allowed differentiation between acute myocardial ischemia (n = 12) and postinfarction myocardial scar (n = 6). Among the remaining 26 patients without obstructive coronary artery disease, CMR in 19 (73%) showed dilated cardiomyopathy in 5, myocarditis in 4, mitral valve prolapse associated with LGE in 3, ischemic scar in 2, idiopathic nonischemic scar in 2, arrhythmogenic cardiomyopathy in 1, hypertrophic cardiomyopathy in 1, and takotsubo cardiomyopathy in 1. In this subgroup of 26 patients, 6 (23%) had myocardial edema. During mean follow-up of 36 ± 17 months, all 18 patients with myocardial edema had an uneventful outcome, whereas 9 of 26 (35%) without myocardial edema experienced sudden arrhythmic death (n = 1), appropriate defibrillator interventions (n = 5), and nonarrhythmic death (n = 3; P = .006). In survivors of OHCA, early CMR with a comprehensive tissue characterization protocol provided additional diagnostic and prognostic value. The identification of myocardial edema was associated with a favorable long-term outcome. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  5. Associations of day-to-day temperature change and diurnal temperature range with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Onozuka, Daisuke; Hagihara, Akihito

    2017-01-01

    Background Although the impacts of temperature on mortality and morbidity have been documented, few studies have investigated whether day-to-day temperature change and diurnal temperature range (DTR) are independent risk factors for out-of-hospital cardiac arrest (OHCA). Design This was a prospective, population-based, observational study. Methods We obtained all OHCA data from 2005-2013 from six major prefectures in Japan: Hokkaido, Tokyo, Kanagawa, Aichi, Kyoto, and Osaka. We used a quasi-Poisson regression analysis with a distributed-lag non-linear model to assess the associations of day-to-day temperature change and DTR with OHCA for each prefecture. Results In total, 271,698 OHCAs of presumed cardiac origin were reported during the study period. There was a significant increase in the risk of OHCA associated with cold temperature in five prefectures, with relative risks (RRs) ranging from 1.298 (95% confidence interval (CI) 1.022-1.649) in Hokkaido to 3.893 (95% CI 1.713-8.845) in Kyoto. DTR was adversely associated with OHCA on hot days in Aichi (RR 1.158; 95% CI 1.028-1.304) and on cold days in Tokyo (RR 1.030; 95% CI 1.000-1.060), Kanagawa (RR 1.042; 95% CI 1.005-1.082), Kyoto (RR 1.060; 95% CI 1.001-1.122), and Osaka (RR 1.050; 95% CI 1.014-1.088), whereas there was no significant association between day-to-day temperature change and OHCA. Conclusion We found that associations between day-to-day temperature change and DTR and OHCA were generally small compared with the association with mean temperature. Our findings suggest that preventative measures for temperature-related OHCA may be more effective when focused on mean temperature and DTR.

  6. Within-summer variation in out-of-hospital cardiac arrest due to extremely long sunshine duration.

    Science.gov (United States)

    Onozuka, Daisuke; Hagihara, Akihito

    2017-03-15

    Although several studies have reported the impacts of extremely high temperatures on cardiovascular diseases, no studies have examined whether variation in out-of-hospital cardiac arrest (OHCA) due to extremely long sunshine duration changes during the summer. We obtained daily data on all cases of OHCA and weather variations for all 47 prefectures of Japan during the summer (June to September) between 2005 and 2014. A distributed lag non-linear model combined with a quasi-Poisson regression model was used to estimate within-summer variation in OHCA due to extremely long sunshine duration for each prefecture. Then, multivariate random-effects meta-analysis was performed to derive overall effect estimates of sunshine duration at the national level. A total of 166,496 OHCAs of presumed cardiac origin met the inclusion criteria. The minimum morbidity percentile (MMP) was the 0th percentile of sunshine duration at the national level. The overall cumulative relative risk (RR) at the 99th percentile vs. the MMP was 1.15 (95% CI: 1.05-1.27) during the summer. The effect of extremely long sunshine duration on OHCA in early summer was acute and did not persist, whereas an identical effect was observed in late summer, but it was delayed and lasted for several days. During summer periods, excessive sunshine duration could increase the risk of OHCA. Timely preventive measures to reduce the OHCA risk due to extremely long sunshine duration are important in early summer, whereas these measures could include a wider time window of several days to reduce the risk in late summer. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. Age × Gender Interaction Effect on Resuscitation Outcomes in Patients With Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Hagihara, Akihito; Onozuka, Daisuke; Ono, Junko; Nagata, Takashi; Hasegawa, Manabu

    2017-08-01

    Although an interaction between gender and age has been shown to influence resuscitation outcomes in patients with out-of-hospital cardiac arrest (OHCA), this interaction has not been investigated in Asian populations. In this prospective, observational study, data from all cases of OHCA in Japan between 2005 and 2012 were obtained from the Japanese National Registry. We determined the relative excess risk due to interaction and the ratio of odds ratios (ORs) to assess the interaction effect of gender and age on the incidence of return of spontaneous circulation (ROSC) before hospital arrival, 1-month survival, and neurologically intact survival 1 month after OHCA. Male gender was associated with decreased ROSC and lower 1-month survival rates in patients with OHCA of presumed cardiac origin. Older age was associated with lower 1-month and neurologically intact survival rates in male patients with OHCA of presumed cardiac and noncardiac origin and with increased ROSC in male patients with OHCA of presumed cardiac origin. The relative excess risk due to interaction for ROSC in patients with OHCA of presumed cardiac origin was statistically significant (OR 0.19, 95% confidence interval [CI] 0.06 to 0.32). The ratio of ORs for ROSC was statistically significant in patients with OHCA of presumed cardiac origin (OR 1.25, 95% CI 1.05 to 1.47) and of noncardiac origin (OR 0.40, 95% CI 0.17 to 0.92). In conclusion, the interaction effect between age and gender on ROSC was positive in OHCA cases of presumed cardiac origin and negative in those of noncardiac origin. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Neighborhood characteristics, bystander automated external defibrillator use, and patient outcomes in public out-of-hospital cardiac arrest.

    Science.gov (United States)

    Andersen, Lars W; Holmberg, Mathias J; Granfeldt, Asger; Løfgren, Bo; Vellano, Kimberly; McNally, Bryan F; Siegerink, Bob; Kurth, Tobias; Donnino, Michael W

    2018-05-01

    Automated external defibrillators (AEDs) can be used by bystanders to provide rapid defibrillation for patients with out-of-hospital cardiac arrest (OHCA). Whether neighborhood characteristics are associated with AED use is unknown. Furthermore, the association between AED use and outcomes has not been well characterized for all (i.e. shockable and non-shockable) public OHCAs. We included public, non-911-responder witnessed OHCAs registered in the Cardiac Arrest Registry to Enhance Survival (CARES) between 2013 and 2016. The primary patient outcome was survival to hospital discharge with a favorable functional outcome. We first assessed the association between neighborhood characteristics and bystander AED use using logistic regression and then assessed the association between bystander AED use and patient outcomes in a propensity score matched cohort. 25,182 OHCAs were included. Several neighborhood characteristics, including the proportion of people living alone, the proportion of white people, and the proportion with a high-school degree or higher, were associated with bystander AED use. 5132 OHCAs were included in the propensity score-matched cohort. Bystander AED use was associated with an increased risk of a favorable functional outcome (35% vs. 25%, risk difference: 9.7% [95% confidence interval: 7.2%, 12.2%], risk ratio: 1.38 [95% confidence interval: 1.27, 1.50]). This was driven by increased favorable functional outcomes with AED use in patients with shockable rhythms (58% vs. 39%) but not in patients with non-shockable rhythms (10% vs. 10%). Specific neighborhood characteristics were associated with bystander AED use in OHCA. Bystander AED use was associated with an increase in favorable functional outcome. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Extracorporeal cardiopulmonary resuscitation versus conventional cardiopulmonary resuscitation in adults with out-of-hospital cardiac arrest: a prospective observational study.

    Science.gov (United States)

    Sakamoto, Tetsuya; Morimura, Naoto; Nagao, Ken; Asai, Yasufumi; Yokota, Hiroyuki; Nara, Satoshi; Hase, Mamoru; Tahara, Yoshio; Atsumi, Takahiro

    2014-06-01

    A favorable neurological outcome is likely to be achieved in out-of-hospital cardiac arrest (OHCA) patients with ventricular fibrillation or pulseless ventricular tachycardia (VF/VT) on the initial electrocardiogram (ECG). However, in patients without pre-hospital restoration of spontaneous circulation despite the initial VF/VT, the outcome is extremely low by conventional cardiopulmonary resuscitation (CPR). Extracorporeal CPR (ECPR) may enhance cerebral blood flow and recovery of neurological function. We prospectively examined how ECPR for OHCA with VF/VT would affect neurological outcomes. The design of this trial was a prospective, observational study. We compared differences of outcome at 1 and 6 months after OHCA between ECPR group (26 hospitals) and non-ECPR group (20 hospitals). Primary endpoints were the rate of favorable outcomes defined by the Glasgow-Pittsburgh Cerebral Performance and Overall Performance Categories (CPC) 1 or 2 at 1 and 6 months after OHCA. Based on intention-to-treat analysis, CPC 1 or 2 were 12.3% (32/260) in the ECPR group and 1.5% (3/194) in the non-ECPR group at 1 month (P<0.0001), and 11.2% (29/260) and 2.6% (5/194) at 6 months (P=0.001), respectively. By per protocol analysis, CPC 1 or 2 were 13.7% (32/234) in the ECPR group and 1.9% (3/159) in the non-ECPR group at 1 month (P<0.0001), and 12.4% (29/234) and 3.1% (5/159) at 6 months (P=0.002), respectively. In OHCA patients with VF/VT on the initial ECG, a treatment bundle including ECPR, therapeutic hypothermia and IABP was associated with improved neurological outcome at 1 and 6 months after OHCA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. Barriers and facilitators to public access defibrillation in out-of-hospital cardiac arrest: a systematic review.

    Science.gov (United States)

    Smith, Christopher M; Lim Choi Keung, Sarah N; Khan, Mohammed O; Arvanitis, Theodoros N; Fothergill, Rachael; Hartley-Sharpe, Christopher; Wilson, Mark H; Perkins, Gavin D

    2017-10-01

    Public access defibrillation initiatives make automated external defibrillators available to the public. This facilitates earlier defibrillation of out-of-hospital cardiac arrest victims and could save many lives. It is currently only used for a minority of cases. The aim of this systematic review was to identify barriers and facilitators to public access defibrillation. A comprehensive literature review was undertaken defining formal search terms for a systematic review of the literature in March 2017. Studies were included if they considered reasons affecting the likelihood of public access defibrillation and presented original data. An electronic search strategy was devised searching MEDLINE and EMBASE, supplemented by bibliography and related-article searches. Given the low-quality and observational nature of the majority of articles, a narrative review was performed. Sixty-four articles were identified in the initial literature search. An additional four unique articles were identified from the electronic search strategies. The following themes were identified related to public access defibrillation: knowledge and awareness; willingness to use; acquisition and maintenance; availability and accessibility; training issues; registration and regulation; medicolegal issues; emergency medical services dispatch-assisted use of automated external defibrillators; automated external defibrillator-locator systems; demographic factors; other behavioural factors. In conclusion, several barriers and facilitators to public access defibrillation deployment were identified. However, the evidence is of very low quality and there is not enough information to inform changes in practice. This is an area in urgent need of further high-quality research if public access defibrillation is to be increased and more lives saved. PROSPERO registration number CRD42016035543. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions

  11. Daily FOUR score assessment provides accurate prognosis of long-term outcome in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Weiss, N; Venot, M; Verdonk, F; Chardon, A; Le Guennec, L; Llerena, M C; Raimbourg, Q; Taldir, G; Luque, Y; Fagon, J-Y; Guerot, E; Diehl, J-L

    2015-05-01

    The accurate prediction of outcome after out-of-hospital cardiac arrest (OHCA) is of major importance. The recently described Full Outline of UnResponsiveness (FOUR) is well adapted to mechanically ventilated patients and does not depend on verbal response. To evaluate the ability of FOUR assessed by intensivists to accurately predict outcome in OHCA. We prospectively identified patients admitted for OHCA with a Glasgow Coma Scale below 8. Neurological assessment was performed daily. Outcome was evaluated at 6 months using Glasgow-Pittsburgh Cerebral Performance Categories (GP-CPC). Eighty-five patients were included. At 6 months, 19 patients (22%) had a favorable outcome, GP-CPC 1-2, and 66 (78%) had an unfavorable outcome, GP-CPC 3-5. Compared to both brainstem responses at day 3 and evolution of Glasgow Coma Scale, evolution of FOUR score over the three first days was able to predict unfavorable outcome more precisely. Thus, absence of improvement or worsening from day 1 to day 3 of FOUR had 0.88 (0.79-0.97) specificity, 0.71 (0.66-0.76) sensitivity, 0.94 (0.84-1.00) PPV and 0.54 (0.49-0.59) NPV to predict unfavorable outcome. Similarly, the brainstem response of FOUR score at 0 evaluated at day 3 had 0.94 (0.89-0.99) specificity, 0.60 (0.50-0.70) sensitivity, 0.96 (0.92-1.00) PPV and 0.47 (0.37-0.57) NPV to predict unfavorable outcome. The absence of improvement or worsening from day 1 to day 3 of FOUR evaluated by intensivists provides an accurate prognosis of poor neurological outcome in OHCA. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

    Hansen, Marco Bo; Lippert, Freddy Knudsen; Rasmussen, Lars Simon; Nielsen, Anne Møller

    2014-12-01

    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 rhythm from AEDs used by laypersons with the corresponding proportion recorded by the Emergency Medical Services (EMS) on arrival. In a 20-month study, we collected data on OHCAs in the Capital Region of Denmark where an AED was deployed prior to arrival of EMS. The AEDs were brought to the emergency medical dispatch centre for data downloading and rhythm analysis. Patient data were retrieved from the medical records from the admitting hospital, whereas data on EMS rhythm analyses were obtained from the Danish Cardiac Arrest Register between 2001 and 2010. A total of 121 AEDs were deployed, of which 91 cases were OHCAs with presumed cardiac origin. The prevalence of initial shockable rhythm was 55.0% (95% CI [44.7-64.8%]). This was significantly greater than the proportion recorded by the EMS (27.6%, 95% CI [27.0-28.3%], p<0.0001). Shockable arrests were significantly more likely to be witnessed (92% vs. 34%, p<0.0001) and the bystander CPR rate was higher (98% vs. 85%, p=0.04). More patients with initial shockable rhythm achieved return of spontaneous circulation upon hospital arrival (88% vs. 7%, p<0.0001) and had higher 30-day survival rate (72% vs. 5%, p<0.0001). AEDs used by laypersons revealed a higher proportion of shockable rhythms compared to the EMS rhythm analyses. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  13. Survival after out-of-hospital cardiac arrest in relation to sex: a nationwide registry-based study.

    Science.gov (United States)

    Wissenberg, Mads; Hansen, Carolina Malta; Folke, Fredrik; Lippert, Freddy K; Weeke, Peter; Karlsson, Lena; Rajan, Shahzleen; Søndergaard, Kathrine Bach; Kragholm, Kristian; Christensen, Erika Frischknecht; Nielsen, Søren L; Køber, Lars; Gislason, Gunnar H; Torp-Pedersen, Christian

    2014-09-01

    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. 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. 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.g., chronic obstructive pulmonary disease (12.8% vs. 16.5%); but more likely to have arrest outside of the home (29.4% vs. 18.7%), receive bystander CPR (32.9% vs. 25.9%), and have a shockable rhythm (32.6% vs. 17.2%), all p<0.001. Thirty-day crude survival increased in males (3.0% in 2001 to 12.9% in 2010); and in females (4.8% in 2001 to 6.7% in 2010), p<0.001. Multivariable logistic regression analyses adjusted for patient characteristics including comorbidities, showed no survival difference between sexes in patients with a non-shockable rhythm (OR 1.00; CI 0.72-1.40), while female sex was positively associated with survival in patients with a shockable rhythm (OR 1.31; CI 1.07-1.59). Analyses were rhythm-stratified due to interaction between sex and heart rhythm; there was no interaction between sex and calendar-year. Temporal increase in crude survival was more marked in males due to poorer prognostic characteristics in females with a lower proportion of shockable rhythm. In an adjusted model, female sex was positively associated with survival in patients with a shockable rhythm. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

    Science.gov (United States)

    Winther-Jensen, Matilde; Kjaergaard, Jesper; Hassager, Christian; Bro-Jeppesen, John; Nielsen, Niklas; Lippert, Freddy K; Køber, Lars; Wanscher, Michael; Søholm, Helle

    2015-12-15

    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. We aimed to investigate mortality, neurological outcome and post resuscitation care in octogenarians (≥80) to assess whether resuscitation and post resuscitation care should be avoided. During 2007-2011 consecutive OHCA-patients were attended by the physician-based Emergency Medical Services-system in Copenhagen. Pre-hospital data based on Utstein-criteria, and data on post resuscitation care were collected. Primary outcome was successful resuscitation; secondary endpoints were 30-day mortality and neurological outcome (Cerebral Performance Category (CPC)). 2509 OHCA-patients with attempted resuscitation were recorded, 22% (n=558) were octogenarians/nonagenarians. 166 (30% of all octogenarians with resuscitation attempted) octogenarians were successfully resuscitated compared to 830 (43% with resuscitation attempted) patients <80 years. 30-day mortality in octogenarians was significantly higher after adjustment for prognostic factors (HR=1.61 CI: 1.22-2.13, p<0.001). Octogenarians received fewer coronary angiographies (CAG) (14 vs. 37%, p<0.001), and had lower odds of receiving CAG by multivariate logistic regression (OR: 0.19, CI: 0.08-0.44, p<0.001). A favorable neurological outcome (CPC 1/2) in survivors to discharge was found in 70% (n=26) of octogenarians compared to 86% (n=317, p=0.03) in the younger patients. 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 resuscitation and post resuscitation care in octogenarians does not seem justified. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Analysis of bystander CPR quality during out-of-hospital cardiac arrest using data derived from automated external defibrillators.

    Science.gov (United States)

    Fernando, Shannon M; Vaillancourt, Christian; Morrow, Stanley; Stiell, Ian G

    2018-07-01

    Little is known regarding the quality of cardiopulmonary resuscitation (CPR) performed by bystanders in out-of-hospital cardiac arrest (OHCA). We sought to determine quality of bystander CPR provided during OHCA using CPR quality data stored by Automated External Defibrillators (AEDs). We used the Resuscitation Outcomes Consortium database to identify OHCA cases of presumed cardiac etiology where an AED was utilized. We then matched AED data to each case identified. AED data was analyzed using manufacturer software in order to determine overall measures of bystander CPR quality, changes in bystander CPR quality over time, and adherence to existing 2010 Resuscitation Quality Guidelines. 100 cases of OHCA of presumed cardiac etiology involving bystander CPR and with corresponding AED data. Mean age was 62.3 years, and 75% were male. Bystanders demonstrated high-quality CPR over all minutes of resuscitation, with a chest compression fraction of 76%, a compression depth of 5.3 cm, and a compression rate of 111.2 compressions/min. Mean perishock pause was 26.8 s. Adherence rates to 2010 Resuscitation Guidelines for compression rate and depth were found to be 66% and 55%, respectively. CPR quality was lowest in the first minute, resulting from increased delay to rhythm analysis (mean 40.7 s). In cases involving shock delivery, latency from initiation of AED to shock delivery was 59.2 s. We found that bystanders perform high-quality CPR, with strong adherence rates to existing Resuscitation Guidelines. High-quality CPR is maintained over the first five minutes of resuscitation, but was lowest in the first minute. Copyright © 2018 Elsevier B.V. All rights reserved.

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

    African Journals Online (AJOL)

    2015-08-01

    Aug 1, 2015 ... research. The correlated results showed the need for continuous training and education of elucidators in order to make sure that they acquire and maintain ... in the recommendations show that improving IC related to stem cell research is a .... of this clinical trial. • Contact information and consultation service.

  17. 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 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.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.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 alter over time.

  18. 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

  19. No Benefit in Neurologic Outcomes of Survivors of Out-of-Hospital Cardiac Arrest with Mechanical Compression Device.

    Science.gov (United States)

    Newberry, Ryan; Redman, Ted; Ross, Elliot; Ely, Rachel; Saidler, Clayton; Arana, Allyson; Wampler, David; Miramontes, David

    2018-01-01

    Out-of-hospital cardiac arrest (OHCA) is a major cause of death and morbidity in the United States. Quality cardiopulmonary resuscitation (CPR) has proven to be a key factor in improving survival. The aim of our study was to investigate the outcomes of OHCA when mechanical CPR (LUCAS 2 Chest Compression System™) was utilized compared to conventional CPR. Although controlled trials have not demonstrated a survival benefit to the routine use of mechanical CPR devices, there continues to be an interest for their use in OHCA. We conducted a retrospective observational study of OHCA comparing the outcomes of mechanical and manual chest compressions in a fire department based EMS system serving a population of 1.4 million residents. Mechanical CPR devices were geographically distributed on 11 of 33 paramedic ambulances. Data were collected over a 36-month period and outcomes were dichotomized based on utilization of mechanical CPR. The primary outcome measure was survival to hospital discharge with a cerebral performance category (CPC) score of 1 or 2. This series had 3,469 OHCA reports, of which 2,999 had outcome data and met the inclusion criteria. Of these 2,236 received only manual CPR and 763 utilized a mechanical CPR device during the resuscitation. Return of spontaneous circulation (ROSC) was attained in 44% (334/763) of the mechanical CPR resuscitations and in 46% (1,020/2,236) of the standard manual CPR resuscitations (p = 0.32). Survival to hospital discharge was observed in 7% (52/763) of the mechanical CPR resuscitations and 9% (191/2,236) of the manual CPR group (p = 0.13). Discharge with a CPC score of 1 or 2 was observed in 4% (29/763) of the mechanical CPR resuscitation group and 6% (129/2,236) of the manual CPR group (p = 0.036). In our study, use of the mechanical CPR device was associated with a poor neurologic outcome at hospital discharge. However, this difference was no longer evident after logistic regression adjusting for confounding variables

  20. 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

  1. The number of prehospital defibrillation shocks and 1-month survival in patients with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hasegawa, Manabu; Abe, Takeru; Nagata, Takashi; Onozuka, Daisuke; Hagihara, Akihito

    2015-04-17

    The relationship between the number of pre-hospital defibrillation shocks and treatment outcome in patients with out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation (VF) is unknown currently. We examined the association between the number of pre-hospitalization defibrillation shocks and 1-month survival in OHCA patients. We conducted a prospective observational study using national registry data obtained from patients with OHCA between January 1, 2009 and December 31, 2012 in Japan. The study subjects were ≥ 18-110 years of age, had suffered from an OHCA before arrival of EMS personnel, had a witnessed collapse, had an initial rhythm that was shockable [VF/ventricular tachycardia (pulseless VT)], were not delivered a shock using a public automated external defibrillator (AED), received one or more shocks using a biphasic defibrillator by EMS personnel, and were transported to a medical institution between January 1, 2009 and December 31, 2012. There were 20,851 OHCA cases which met the inclusion criteria during the study period. Signal detection analysis was used to identify the cutoff point in the number of prehospital defibrillation shocks most closely related to one-month survival. Variables related to the number of defibrillations or one-month survival in OHCA were identified using multiple logistic regression analysis. A cutoff point in the number of pre-hospital defibrillation shocks most closely associated with 1-month OHCA survival was between two and three (χ(2) = 209.61, p < 0.0001). Among those patients who received two shocks or less, 34.48% survived for at least 1 month, compared with 24.75% of those who received three shocks or more. The number of defibrillations (odds ratio [OR] = 1.19, 95% CI: 1.03, 1.38), OHCA origin (OR = 2.81, 95% CI: 2.26, 3.49), use of ALS devices (OR = 0.68, 95% CI: 0.59, 0.79), use of epinephrine (OR = 0.33, 95% C: 0.28, 0.39), interval between first defibrillation and first ROSC (OR = 1.45, 95

  2. Forest Fire Smoke Exposures and Out-of-Hospital Cardiac Arrests in Melbourne, Australia: A Case-Crossover Study.

    Science.gov (United States)

    Dennekamp, Martine; Straney, Lahn D; Erbas, Bircan; Abramson, Michael J; Keywood, Melita; Smith, Karen; Sim, Malcolm R; Glass, Deborah C; Del Monaco, Anthony; Haikerwal, Anjali; Tonkin, Andrew M

    2015-10-01

    Millions of people can potentially be exposed to smoke from forest fires, making this an important public health problem in many countries. In this study we aimed to measure the association between out-of-hospital cardiac arrest (OHCA) and forest fire smoke exposures in a large city during a severe forest fire season, and estimate the number of excess OHCAs due to the fire smoke. We investigated the association between particulate matter (PM) and other air pollutants and OHCA using a case-crossover study of adults (≥ 35 years of age) in Melbourne, Australia. Conditional logistic regression models were used to derive estimates of the percent change in the rate of OHCA associated with an interquartile range (IQR) increase in exposure. From July 2006 through June 2007, OHCA data were collected from the Victorian Ambulance Cardiac Arrest Registry. Hourly air pollution concentrations and meteorological data were obtained from a central monitoring site. There were 2,046 OHCAs with presumed cardiac etiology during our study period. Among men during the fire season, greater increases in OHCA were observed with IQR increases in the 48-hr lagged PM with diameter ≤ 2.5 μm (PM2.5) (8.05%; 95% CI: 2.30, 14.13%; IQR = 6.1 μg/m(3)) or ≤ 10 μm (PM10) (11.1%; 95% CI: 1.55, 21.48%; IQR = 13.7 μg/m(3)) and carbon monoxide (35.7%; 95% CI: 8.98, 68.92%; IQR = 0.3 ppm). There was no significant association between the rate of OHCA and air pollutants among women. One hundred seventy-four "fire-hours" (i.e., hours in which Melbourne's air quality was affected by forest fire smoke) were identified during 12 days of the 2006/2007 fire season, and 23.9 (95% CI: 3.1, 40.2) excess OHCAs were estimated to occur due to elevations in PM2.5 during these fire-hours. This study found an association between exposure to forest fire smoke and an increase in the rate of OHCA. These findings have implications for public health messages to raise community awareness and for planning of emergency

  3. Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2014-12-01

    An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver

  4. A Smartphone Application to Reduce the Time to Automated External Defibrillator Delivery After a Witnessed Out-of-Hospital Cardiac Arrest: A Randomized Simulation-Based Study.

    Science.gov (United States)

    Hatakeyama, Toshihiro; Nishiyama, Chika; Shimamoto, Tomonari; Kiyohara, Kosuke; Kiguchi, Takeyuki; Chida, Izumi; Izawa, Junichi; Matsuyama, Tasuku; Kitamura, Tetsuhisa; Kawamura, Takashi; Iwami, Taku

    2018-04-13

    We developed a new smartphone application to deliver an automated external defibrillator (AED) to out-of-hospital cardiac arrest scene. The aim of this study was to evaluate whether an AED could be delivered earlier with or without an application in a simulated randomized controlled trial. Participants, who were asked to work as bystanders, were randomly assigned to either an application group or control group and were asked to bring an AED in both groups. The bystanders in the application group sent a signal notification using the application to two responders, who were stationed within 200 meters of the arrest scene, to carry an AED. The primary outcome was the AED delivery time by either the bystander or his/her responder. In total, 61 bystanders were eligible and randomized to either the application group (32) or the control group (29). The 52 with time data were available and analyzed. The AED delivery time by either the bystander or his/her responder was significantly shorter in the application group than in the control group [133.6 (44.4) seconds vs. 202.2 (122.2) seconds, P = 0.01]. In this simulation-based trial, AED delivery time was shortened by our newly developed smartphone application for the bystander to ask nearby responders to find and bring an AED to the cardiac arrest scene (UMIN-Clinical Trials Registry 000016506).This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  5. Prehospital sodium bicarbonate use could worsen long term survival with favorable neurological recovery among patients with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Kawano, Takahisa; Grunau, Brian; Scheuermeyer, Frank X; Gibo, Koichiro; Dick, William; Fordyce, Christopher B; Dorian, Paul; Stenstrom, Robert; Straight, Ronald; Christenson, Jim

    2017-10-01

    Sodium bicarbonate (SB) is widely used for resuscitation in out-of- hospital cardiac arrest (OHCA); however, its effect on long term outcomes is unclear. From 2005-2016, we prospectively conducted a province-wide population-based observational study including adult non-traumatic OHCA patients managed by paramedics. SB was administered by paramedics based on their clinical assessments. To examine the association of SB administration and survival and favorable neurological outcome to hospital discharge, defined as modified Rankin scale of 3 or less, we performed a multivariable logistic regression analysis: (1) within propensity score matched comparison groups, and; (2) within the full cohort with missing variables addressed by multiple imputation techniques. Of 15 601 OHCA patients, 13,865 were included in this study with 5165 (37.3%) managed with SB. In the SB treated group, 118 (2.3%) patients survived and 62 (1.2%) had favorable neurological outcomes to hospital discharge, compared to 1699 (19.8%) and 831 (10.6%) in the non-SB treated group, respectively. In the 1:1 propensity matched cohort including 5638 OHCA patients, SB was associated with decreased probability of outcomes (adjusted OR for survival: 0.64, 95% CI 0.45-0.91, and adjusted OR for favorable neurological outcome: 0.59, 95% CI 0.39-0.88, respectively). The association remained consistent in the multiply imputed cohort (adjusted OR 0.48, 95 CI 0.36-0.64, and adjusted OR 0.54, 95% CI 0.38-0.76, respectively). In OHCA patients, prehospital SB administration was associated with worse survival rate and neurological outcomes to hospital discharge. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Early cardiopulmonary resuscitation and use of Automated External Defibrillators by laypersons in out-of-hospital cardiac arrest using an SMS alert service

    NARCIS (Netherlands)

    Scholten, Annemieke C.; van Manen, Jeanette Gabrielle; van der Worp, Wim E.; IJzerman, Maarten Joost; Doggen, Catharina Jacoba Maria

    2011-01-01

    Aim: To evaluate an SMS service (SMS = short message service = text message) with which laypersons are alerted to go to patients with suspected out-of-hospital cardiac arrest and perform early cardiopulmonary resuscitation (CPR) and use an Automated External Defibrillator (AED). This study is the

  7. 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.

  8. 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-on t...

  9. A prospective, randomised and blinded comparison of first shock success of monophasic and biphasic waveforms in out-of-hospital cardiac arrest

    NARCIS (Netherlands)

    van Alem, Anouk P.; Chapman, Fred W.; Lank, Paula; Hart, Augustinus A. M.; Koster, Rudolph W.

    2003-01-01

    Background: Evidence suggests that biphasic waveforms are more effective than monophasic waveforms for defibrillation in out-of-hospital cardiac arrest (OHCA), yet their performance has only been compared in un-blinded studies. Methods and results: We compared the success of biphasic truncated

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

    NARCIS (Netherlands)

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

    2001-01-01

    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

  11. Apples to apples or apples to oranges? International variation in reporting of process and outcome of care for out-of-hospital cardiac arrest

    NARCIS (Netherlands)

    Nishiyama, Chika; Brown, Siobhan P.; May, Susanne; Iwami, Taku; Koster, Rudolph W.; Beesems, Stefanie G.; Kuisma, Markku; Salo, Ari; Jacobs, Ian; Finn, Judith; Sterz, Fritz; Nürnberger, Alexander; Smith, Karen; Morrison, Laurie; Olasveengen, Theresa M.; Callaway, Clifton W.; Shin, Sang Do; Gräsner, Jan-Thorsten; Daya, Mohamud; Ma, Matthew Huei-Ming; Herlitz, Johan; Strömsöe, Anneli; Aufderheide, Tom P.; Masterson, Siobhán; Wang, Henry; Christenson, Jim; Stiell, Ian; Davis, Dan; Huszti, Ella; Nichol, Graham

    2014-01-01

    Survival after out-of-hospital cardiac arrest (OHCA) varies between communities, due in part to variation in the methods of measurement. The Utstein template was disseminated to standardize comparisons of risk factors, quality of care, and outcomes in patients with OHCA. We sought to assess whether

  12. Informed consent

    International Nuclear Information System (INIS)

    Bundy, A.L.

    1988-01-01

    Numerous articles on informed consent have appeared in medical and legal journals over the past few years. Many of these have been in the radiological literature. This chapter presents an overview of the legal principles behind this controversial topic. Recent articles are reviewed and specific suggestions are made where applicable. The doctrine of informed consent is both a product of and the basis for the physician-patient relationship. Their communications to each other establish the relationship, but once established, heightened degrees of expectations on the patient's part have dictated the need for a more sophisticated level of communication. Since patients and physicians often expect different things of each other, it is imperative that the relationship leads to effective and respectful conversation

  13. 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

    BACKGROUND: Current guidelines recommend that comatose out-of-hospital cardiac arrest patients with ST-segment elevations (STEs) following return of spontaneous circulation (ROSC) should be referred for an acute coronary angiography. We sought to investigate the diagnostic value of the pre......-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...... interval (CI) 62-84), specificity of 65% (95% CI 53-75) and a positive and negative predictive value of 65% (95% CI 54-76) and 73% (95% CI 61-83) in predicting STEMI. Time to ROSC was significantly longer (24 minutes vs. 19 minutes, P=0.02) in STE compared with no STE patients. Percutaneous coronary...

  14. Prehospital critical care for out-of-hospital cardiac arrest: An observational study examining survival and a stakeholder-focused cost analysis.

    Science.gov (United States)

    von Vopelius-Feldt, Johannes; Powell, Jane; Morris, Richard; Benger, Jonathan

    2016-12-07

    Survival rates from out-of-hospital cardiac arrest (OHCA) remain low, despite remarkable efforts to improve care. A number of ambulance services in the United Kingdom (UK) have developed prehospital critical care teams (CCTs) which attend critically ill patients, including OHCA. However, current scientific evidence describing CCTs attending OHCA is sparse and research to date has not demonstrated clear benefits from this model of care. This prospective, observational study will describe the effect of CCTs on survival from OHCA, when compared to advanced-life-support (ALS), the current standard of prehospital care in the UK. In addition, we will describe the association between individual critical care interventions and survival, and also the costs of CCTs for OHCA. To examine the effect of CCTs on survival from OHCA, we will use routine Utstein variables data already collected in a number of UK ambulance trusts. We will use propensity score matching to adjust for imbalances between the CCT and ALS groups. The primary outcome will be survival to hospital discharge, with the secondary outcome of survival to hospital admission. We will record the critical care interventions delivered during CCT attendance at OHCA. We will describe frequencies and aim to use multiple logistic regression to examine possible associations with survival. Finally, we will undertake a stakeholder-focused cost analysis of CCTs for OHCA. This will utilise a previously published Emergency Medical Services (EMS) cost analysis toolkit and will take into account the costs incurred from use of a helicopter and the proportion of these costs currently covered by charities in the UK. Prehospital critical care for OHCA is not universally available in many EMS. In the UK, it is variable and largely funded through public donations to charities. If this study demonstrates benefit from CCTs at an acceptable cost to the public or EMS commissioners, it will provide a rationale to increase funding and service

  15. Is hospital care of major importance for outcome after out-of-hospital cardiac arrest? Experience acquired from patients with out-of-hospital cardiac arrest resuscitated by the same Emergency Medical Service and admitted to one of two hospitals over a 16-year period in the municipality of Göteborg.

    Science.gov (United States)

    Engdahl, J; Abrahamsson, P; Bång, A; Lindqvist, J; Karlsson, T; Herlitz, J

    2000-02-01

    To describe patient characteristics, hospital investigations and interventions and early mortality among patients being hospitalized after out-of-hospital cardiac arrest in two hospitals. Municipality of Göteborg, Sweden. All patients suffering an out-of-hospital cardiac arrest who were successfully resuscitated and admitted to hospital between 1 October 1980 and 31 December 1996. All patients were resuscitated by the same Emergency Medical Service and admitted alive to one of the two city hospitals in Göteborg. Of 579 patients admitted to Sahlgrenska Hospital, 253 (44%) were discharged alive and of 459 patients admitted to Ostra Hospital, 152 (33%) were discharged alive (P percentage of patients admitted to Sahlgrenska Hospital underwent coronary angiography (P < 0.001), electrophysiological testing (P < 0.001), Holter recording (P < 0.001), echocardiography (P = 0.004), percutaneous transluminal coronary angioplasty (PTCA, P = 0.009), implantation of automatic implantable cardioverter defibrillator (AICD, P = 0.03) and exercise stress tests (P = 0.003). Inhabitants in the catchment area of Ostra Hospital had a less favourable socio-economic profile. Survival after out-of-hospital cardiac arrest may be affected by the course of hospital management. Other variables that might influence survival are socio-economic factors and cardiorespiratory status on admission to hospital. Further investigation is called for as more patients are being hospitalised alive after out-of-hospital cardiac arrest.

  16. Dynamic effects of adrenaline (epinephrine) in out-of-hospital cardiac arrest with initial pulseless electrical activity (PEA).

    Science.gov (United States)

    Nordseth, Trond; Olasveengen, Theresa Mariero; Kvaløy, Jan Terje; Wik, Lars; Steen, Petter Andreas; Skogvoll, Eirik

    2012-08-01

    In cardiac arrest, pulseless electrical activity (PEA) is a challenging clinical syndrome. In a randomized study comparing intravenous (i.v.) access and drugs versus no i.v. access or drugs during advanced life support (ALS), adrenaline (epinephrine) improved return of spontaneous circulation (ROSC) in patients with PEA. Originating from this study, we investigated the time-dependent effects of adrenaline on clinical state transitions in patients with initial PEA, using a non-parametric multi-state statistical model. Patients with available defibrillator recordings were included, of whom 101 received adrenaline and 73 did not. There were significantly more state transitions in the adrenaline group than in the no-adrenaline group (rate ratio = 1.6, pAdrenaline markedly increased the rate of transition from PEA to ROSC during ALS and slowed the rate of being declared dead; e.g. by 20 min 20% of patients in the adrenaline group had been declared dead and 25% had obtained ROSC, whereas 50% in the no-adrenaline group have been declared dead and 15% had obtained ROSC. The differential effect of adrenaline could be seen after approx. 10 min of ALS for most transitions. For both groups the probability of deteriorating from PEA to asystole was highest during the first 15 min. Adrenaline increased the rate of transition from PEA to ventricular fibrillation or -tachycardia (VF/VT), and from ROSC to VF/VT. Adrenaline has notable clinical effects during ALS in patients with initial PEA. The drug extends the time window for ROSC to develop, but also renders the patient more unstable. Further research should investigate the optimal dose, timing and mode of adrenaline administration during ALS. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  17. [New medical approach to out-of-hospital treatment of psychomotor agitation in psychiatric patients: a report of 14 cases].

    Science.gov (United States)

    Cester-Martínez, Armando; Cortés-Ramas, José Antonio; Borraz-Clares, Diego; Pellicer-Gayarre, Marta

    2017-06-01

    This case series explored the usefulness of an inhaled dose of 9.1 mg of loxapine administered outside the hospital to treat psychomotor agitation related to schizophrenia, bipolar disorder, or schizoaffective disorder. The Clinical Global Impression Scale and the Positive and Negative Syndrome Scale (excitement component) were used to assess the effects of treatment in 14 patients. The treatment was useful in 12 patients, who showed significant improvement (Pagitation related to a psychiatric disorder. Mechanical restraint and parenteral medication can be avoided after use of this drug. Loxapine treatment shortens the agitation episode and attenuates the impact on the patient, facilitating ambulance transfer.

  18. Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

    Science.gov (United States)

    Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

    2017-09-02

    Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

  19. Factors Promoting Survival After Prolonged Resuscitation Attempts: A Case of Survival With Good Neurological Outcome Following 60 Minutes of Downtime After Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Bell, Douglas; Gluer, Robert; Murdoch, Dale

    2018-03-01

    Sudden cardiac arrest is a significant cause of death affecting approximately 25,000 people in Australia annually. We present an out-of-hospital cardiac arrest (OHCA) with prolonged down time and recurrent ventricular arrhythmias treated with extra-corporeal membrane oxygenation. The patient survived to hospital discharge with good neurological outcome. The patient's excellent outcome was a result of immediate good quality CPR, high level premorbid function, reversible cause of arrest and rapid access to an ECMO centre. Copyright © 2017 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.

  20. Influence of mannan-binding lectin and MAp44 on outcome in comatose survivors of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Bro-Jeppesen, John; Kjaergaard, Jesper; Thiel, Steffen

    2016-01-01

    as an endogenous inhibitor of MBL-mediated activities. The aim of this study was to investigate the possible association between MBL deficiency, MAp44 levels and outcome in comatose survivors of out-of-hospital cardiac arrest (OHCA). Methods: In a single center post hoc analysis of the prospective multicenter...... assessed by Cerebral Performance Category (CPC1-2) and modified Rankin Scale (mRS0-3) 180 days after OHCA. Results: Patients with MBL deficiency (defined as plasma levels ≤100 ng ml-1 at baseline) (n = 22) carried a 30-day mortality of 41% compared to 32% in MBL sufficient patient (n = 147), p = 0...

  1. 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

  2. Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture

    Science.gov (United States)

    2014-01-01

    Background The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures. Methods We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues. Results Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met. PMID:24406055

  3. 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.

  4. Informed consent in surgical trials.

    Science.gov (United States)

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  5. 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...... in comatose patient resuscitated from NSR. METHODS: Hundred and seventy-eight patients out of 950 in the TTM trial with an initial NSR were randomly assigned to targeted temperature management at either 33°C (TTM33, n=96) or 36°C (TTM36, n=82). We assessed mortality, neurologic function (Cerebral Performance...... 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...

  6. Ambulatory care sensitive conditions at out-of-hospital emergence services in Croatia: a longitudinal study based on routinely collected data.

    Science.gov (United States)

    Kostanjšek, Diana; Benčić, Miro; Keglević, Mladenka Vrcić

    2014-12-01

    Conditions for which a hospital and emergency utilization can be considered avoidable are often referred as ambulatory care sensitive conditions (ACSCs). Until now, there has been no published research related to ACSCs in Croatia. This study was undertaken with the aim of determining the trends relating to ACSCs in out-of-hospital ES from 1995-2012. The study is based on data from the Croatian Health Service Yearbooks. Five chronic and three acute conditions were chosen: diabetes, hypertension, congestive heart failure, angina pectoris, asthma and COPD, bacterial pneumonia, urinary tract infections and skin infections. The results indicate that the ES in Croatia is overused, and consequently ACSCs are over-represented; 23.3% Croatian citizens visited the ES and around 15% of all diagnoses belonged to the ACSCs, with decreased trend. The leading diagnosis is hypertension, followed by asthma and COPD. For a better understanding of the importance of ACSC within the Croatian context, further research is needed.

  7. Similar long-term survival of consecutive in-hospital and out-of-hospital cardiac arrest patients treated with targeted temperature management

    DEFF Research Database (Denmark)

    Engsig, Magaly; Søholm, Helle; Folke, Fredrik

    2016-01-01

    OBJECTIVE: The long-term survival of in-hospital cardiac arrest (IHCA) patients treated with targeted temperature management (TTM) is poorly described. The aim of this study was to compare the outcomes of consecutive IHCA with out-of-hospital cardiac arrest (OHCA) patients treated with TTM. DESIGN...... SETTING AND PATIENTS: Retrospectively collected data on all consecutive adult patients treated with TTM at a university tertiary heart center between 2005 and 2011 were analyzed. MEASUREMENTS: Primary endpoints were survival to hospital discharge and long-term survival. Secondary endpoint was neurological...... time to return of spontaneous circulation (ROSC). Survival to hospital discharge was 54% for OHCA and 53% for IHCA (adjusted odds ratio 0.98 [95% confidence interval {CI}; 0.43-2.24]). Age ≤60 years, bystander CPR, time to ROSC ≤10 min, and shockable rhythm at presentation were associated with survival...

  8. 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

    assessed with tests for memory (Rivermead Behavioural Memory Test), executive functions (Frontal Assessment Battery), and attention/mental speed (Symbol Digit Modalities Test). A control group of 119 matched patients hospitalized for acute ST-segment-elevation myocardial infarction without cardiac arrest...... was more affected among cardiac arrest patients, but results for memory and executive functioning were similar. CONCLUSIONS: Cognitive function was comparable in survivors of out-of-hospital cardiac arrest when a temperature of 33°C and 36°C was targeted. Cognitive impairment detected in cardiac arrest...... performed the same assessments. Half of the cardiac arrest survivors had cognitive impairment, which was mostly mild. Cognitive outcome did not differ (P>0.30) between the 2 temperature groups (33°C/36°C). Compared with control subjects with ST-segment-elevation myocardial infarction, attention/mental speed...

  9. 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...... may affect hemodynamics. DESIGN: Post hoc analysis of a prospective randomized study. SETTING: Thirty-six ICUs in 10 countries. PATIENTS: Nine hundred twenty patients (97%) with available vasopressor data out of 950 patients from the Target Temperature Management trial randomly assigned patients...... to a targeted temperature management at 33 °C or 36 °C. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Mean arterial pressure, heart rate, and lactate were registered at prespecified time points. The population was stratified according to cardiovascular Sequential Organ Failure Assessment = 4 defining...

  10. 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

    categorized according to their recorded body temperature on arrival and also categorized to groups of patients being actively cooled or passively rewarmed. RESULTS: OHCA patients having a temperature ≤34.0°C on arrival at hospital had a significantly higher mortality compared to the OHCA patients...... with a higher temperature on arrival. A low body temperature on arrival was associated with a longer time to return of spontaneous circulation (ROSC) and duration of transport time to hospital. Patients who were actively cooled or passively rewarmed during the first 4h had similar mortality. In a multivariate......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...

  11. Impact of an educational video as a consent tool on knowledge about cure research among patients and caregivers at HIV clinics in South Africa.

    Science.gov (United States)

    Hendricks, Melany; Nair, Gonasagrie; Staunton, Ciara; Pather, Michael; Garrett, Nigel; Baadjies, Dianno; Kidd, Martin; Moodley, Keymanthri

    2018-04-01

    Despite increasing access to antiretroviral therapy in low- and middle-income countries, only 54% of eligible individuals were receiving treatment in Africa by 2015. Recent developments in HIV cure research have been encouraging. However, the complex science and procedures of cure research render the informed consent process challenging. This study evaluates the impact of a video tool on educating participants about HIV cure. A questionnaire assessing the content of the video was administered to adults recruited from two clinics in South Africa. Patients and their care partners, who provided voluntary informed consent, were included in the study. The questionnaire was administered in each participant's home language before, immediately after and at 3 months after viewing the video, in an uncontrolled quasi-experimental 'one group pre-test-post-test' design. Scoring was carried out according to a predetermined scoring grid, with a maximum score of 22. A total of 88 participants, median age 32.0 years and 86% female, were enrolled and completed the pre- and post-video questionnaires. Twenty-nine (33%) completed the follow-up questionnaire 3 months later to assess retention of knowledge. Sixty-three (72%) participants had a known HIV-positive status. A significant increase (10.1 vs 15.1, P =0.001) in knowledge about HIV and HIV cure immediately after viewing the video was noted. No statistically significant difference in knowledge between HIV-positive and -negative patients was noted at baseline. After 3 months, a decrease in performance participation (14 vs 13.5, P =0.19) was noted. However, knowledge scores achieved after 3 months remained significantly higher than scores at baseline (13.5 vs 9.5, P HIV, HIV cure research and ethics, and the improvement was sustained over 3 months. Video intervention may be a useful tool to add to the consent process when dealing with complex medical research questions.

  12. 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

  13. From Informed Consent to Negotiated Consent.

    Science.gov (United States)

    Moody, Harry R.

    1988-01-01

    Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from…

  14. Is Distance to the Nearest Registered Public Automated Defibrillator Associated with the Probability of Bystander Shock for Victims of Out-of-Hospital Cardiac Arrest?

    Science.gov (United States)

    Neves Briard, Joel; de Montigny, Luc; Ross, Dave; de Champlain, François; Segal, Eli

    2018-04-01

    Introduction Rapid access to defibrillation is a key element in the management of out-of-hospital cardiac arrests (OHCAs). Public automated external defibrillators (PAEDs) are becoming increasingly available, but little information exists regarding the relation between the proximity to the arrest and their usage in urban areas. This study is a retrospective, observational, cross-sectional analysis of non-traumatic OHCA during a 24-month period in the greater Montreal area (Quebec, Canada). Using logistic regression, bystander shock odds are described with regards to distance from the OHCA scene to the nearest PAED, adjusted for prehospital care arrival delay and time of day, and stratifying for type of location. Out of a total of 2,443 OHCA victims identified, 77 (3%) received bystander PAED shock, 622 (26%) occurred out-of-home, and 743 (30%) occurred during business hours. When controlling for time (business hours versus other hours) and minimum response delay for prehospital care arrival, a marginal negative association was found between bystander shock and distance to the nearest PAED in logged meters (aOR=0.80; CI, 0.64-0.99) for out-of-home cardiac arrests. No significant association was found between distance and bystander shock for at-home arrests. Out-of-home victims had significantly higher odds of receiving bystander shock up to 175 meters of distance to a PAED inclusively (aOR=2.52; CI, 1.07-5.89). For out-of-home cardiac arrests, proximity to a PAED was associated with bystander shock in the greater Montreal area. Strategies aiming to increase accessibility and use of these life-saving devices could further expand this advantage by assisting bystanders in rapidly locating nearby PAEDs. Neves Briard J , de Montigny L , Ross D , de Champlain F , Segal E . Is distance to the nearest registered public automated defibrillator associated with the probability of bystander shock for victims of out-of-hospital cardiac arrest? Prehosp Disaster Med. 2018;33(2):153-159.

  15. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

    provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent...

  16. 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

  17. Frequency of rib and sternum fractures associated with out-of-hospital cardiopulmonary resuscitation is underestimated by conventional chest X-ray.

    Science.gov (United States)

    Lederer, Wolfgang; Mair, Dieter; Rabl, Walter; Baubin, Michael

    2004-02-01

    Fractured ribs and sternum are frequent complications of thoracic compression during CPR in adults. This study was conducted to determine whether findings of plain chest radiography (CXR) correlate with post-mortem findings in patients who underwent cardiopulmonary resuscitation (CPR) after out-of-hospital cardiac arrest. CXR findings and autopsy results of CPR-related chest injuries comprising rib and sternum fractures were compared prospectively in 19 patients. Fractures were diagnosed in nine of 19 patients by means of radiology and in 18 of 19 patients by autopsy (rib fractures in 6/19 versus 17/19, P=0.002; sternum fractures in 5/19 versus in 9/19, P=0.227. The total number of isolated bone fractures detected by CXR was 18 (12 rib and six sternum fractures) and by autopsy 92 (83 rib and nine sternum fractures). The majority of rib fractures was located in the anterior part of the thoracic cage. Sternum fractures predominantly occurred in the lower third. Eight of 19 patients received either thrombolytic or antithrombotic treatment during CPR but no major bleeding complication associated with CPR was detected by autopsy. The findings of this study indicate that fractures associated with CPR are underreported in conventional radiographic investigations. No major bleeding complications related to CPR-associated fractures was detected.

  18. 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.

  19. Mobile phone technology identifies and recruits trained citizens to perform CPR on out-of-hospital cardiac arrest victims prior to ambulance arrival.

    Science.gov (United States)

    Ringh, Mattias; Fredman, David; Nordberg, Per; Stark, Tomas; Hollenberg, Jacob

    2011-12-01

    In a two-parted study, evaluate a new concept were mobile phone technology is used to dispatch lay responders to nearby out-of-hospital cardiac arrests (OHCAs). Mobile phone positioning systems (MPS) can geographically locate selected mobile phone users at any given moment. A mobile phone service using MPS was developed and named Mobile Life Saver (MLS). Simulation study: 25 volunteers named mobile responders (MRs) were connected to MLS. Ambulance time intervals from 22 consecutive OHCAs in 2005 were used as controls. The MRs randomly moved in Stockholm city centre and were dispatched to simulated OHCAs (identical to controls) if they were within a 350 m distance. Real life study: during 25 weeks 1271-1801 MRs trained in CPR were connected to MLS. MLS was activated at the dispatch centre in parallel with ambulance dispatch when an OHCA was suspected. The MRs were dispatched if they were within 500 m from the suspected OHCA. Simulation study: mean response time for the MRs compared to historical ambulance time intervals was reduced by 2 min 20s (44%), pMobile phone technology can be used to identify and recruit nearby CPR-trained citizens to OHCAs for bystander CPR prior to ambulance arrival. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  20. Hospital costs and revenue are similar for resuscitated out-of-hospital cardiac arrest and ST-segment acute myocardial infarction patients.

    Science.gov (United States)

    Swor, Robert; Lucia, Victoria; McQueen, Kelly; Compton, Scott

    2010-06-01

    Care provided to patients who survive to hospital admission after out-of-hospital cardiac arrest (OOHCA) is sometimes viewed as expensive and a poor use of hospital resources. The objective was to describe financial parameters of care for patients resuscitated from OOHCA. This was a retrospective review of OOHCA patients admitted to one academic teaching hospital from January 2004 to October 2007. Demographic data, length of stay (LOS), and discharge disposition were obtained for all patients. Financial parameters of patient care including total cost, net revenue, and operating margin were calculated by hospital cost accounting and reported as median and interquartile range (IQR). Groups were dichotomized by survival to discharge for subgroup analysis. To provide a reference group for context, similar financial data were obtained for ST-segment elevation myocardial infarction (STEMI) patients admitted during the same time period, reported with medians and IQRs. During the study period, there were 72 admitted OOCHA patients and 404 STEMI patients. OOCHA and STEMI groups were similar for age, sex, and insurance type. Overall, 27 (38.6%) OOHCA patients survived to hospital discharge. Median LOS for OOHCA patients was 4 days (IQR = 1-8 days), with most of those hospitalized for Financial parameters for OOHCA patients are similar to those of STEMI patients. Financial issues should not be a negative incentive to providing care for these patients. (c) 2010 by the Society for Academic Emergency Medicine.

  1. Efficacy of vasopressin-epinephrine compared to epinephrine alone for out of hospital cardiac arrest patients: A systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Qiang; Liu, Bo; Zhao, Lianxing; Qi, Zhijiang; Shao, Huan; An, Le; Li, Chunsheng

    2017-10-01

    The aim of this study was to conduct a meta-analysis to evaluate the efficacy of vasopressin-epinephrine compared to epinephrine alone in patients who suffered out-of-hospital cardiac arrest (OHCA). Relevant studies up to February 2017 were identified by searching in PubMed, EMBASE, the Cochrane Library, Wanfang for randomized controlled trials(RCTs) assigning adults with cardiac arrest to treatment with vasopressin-epinephrine (VEgroup) vs adrenaline (epinephrine) alone (E group). The outcome point was return of spontaneous circulation (ROSC) for patients suffering from OHCA. Heterogeneity, subgroup analysis, sensitivity analysis and publication bias were explored. Individual patient data were obtained from 5047 participants who experienced OHCA in nine studies. Odds ratios (ORs) were calculated using a random-effects model and results suggested that vasopressin-epinephrine was associated with higher rate of ROSC (OR=1.67, 95% CI=1.13-2.49, Padrenaline can improve ROSC of OHCA from Asia, but patients from other regions who suffered from OHCA cannot benefit from combination of vasopressin and epinephrine. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. 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.

  3. Usefulness of Serum B-Type Natriuretic Peptide Levels in Comatose Patients Resuscitated from Out-of-Hospital Cardiac Arrest to Predict Outcome

    DEFF Research Database (Denmark)

    Frydland, Martin; Kjaergaard, Jesper; Erlinge, David

    2016-01-01

    N-terminal pro-B-type natriuretic (NT-proBNP) is expressed in the heart and brain, and serum levels are elevated in acute heart and brain diseases. We aimed to assess the possible association between serum levels and neurological outcome and death in comatose patients resuscitated from out......-of-hospital cardiac arrest (OHCA). Of the 939 comatose OHCA patients enrolled and randomized in the Targeted Temperature Management (TTM) trial to TTM at 33°C or 36°C for 24 hours, 700 were included in the biomarker substudy. Of these, 647 (92%) had serum levels of NT-proBNP measured 24, 48, and 72 hours after return...... of spontaneous circulation (ROSC). Neurological outcome was evaluated by the Cerebral Performance Category (CPC) score and modified Rankin Scale (mRS) at 6 months. Six hundred thirty-eight patients (99%) had serum NT-proBNP levels ≥125 pg/ml. Patients with TTM at 33°C had significantly lower NT-proBNP serum...

  4. Evaluating the Efficacy of a Registry linked to a Consent to Re-Contact Program and Communication Strategies for Recruiting and Enrolling Participants into Clinical Trials.

    Science.gov (United States)

    Flood-Grady, Elizabeth; Clark, Virginia C; Bauer, Angie; Morelli, Lauren; Horne, Patrick; Krieger, Janice L; Nelson, David R

    2017-12-01

    Although registries can rapidly identify clinical study participants, it is unknown which follow up methods for recruiting are most effective. Our goal is to examine the efficacy of three communication strategies for recruiting and enrolling patients who were identified via a contact registry (i.e., registry linked to a consent to re-contact program). Patients who met the study criteria were identified via the contact registry and targeted for recruitment. In condition 1, patients established in the university hepatology specialty clinics were contacted one time via phone call by the study coordinator and asked to participate (C1). In condition 2, non-established specialty clinic patients were mailed an IRB-approved letter with study information and instructions for calling the study coordinator to participate (C2). Condition 2A included patients who called within two weeks of receiving the letter (C2A); condition 2B included patients who did not call after receiving the letter but were subsequently contacted via phone call. A registry identified 1,060 patients, of which 661were eligible and targeted for recruiting. All 37 patients were reached in C1 and 17 (45.9%) were recruited. Nineteen of the 624 patients in C2A were reached and 10 were recruited whereas 120 of the 605 patients in C2B were reached and 53 (8.7%) were recruited. Seventy patients enrolled with C2B being the most effective (total, cost) recruitment strategy ( n = 50) ( p recruiting.

  5. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials

    NARCIS (Netherlands)

    Aaronson, N. K.; Visser-Pol, E.; Leenhouts, G. H.; Muller, M. J.; van der Schot, A. C.; van Dam, F. S.; Keus, R. B.; Koning, C. C.; ten Bokkel Huinink, W. W.; van Dongen, J. A.; Dubbelman, R.

    1996-01-01

    PURPOSE: Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS: During a 12-month period, 180

  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. Comparison of health-related quality of life and functional recovery measurement tools in out-of-hospital cardiac arrest survivors.

    Science.gov (United States)

    Andrew, Emily; Nehme, Ziad; Bernard, Stephen; Smith, Karen

    2016-10-01

    Although a number of validated health-related quality of life (HR-QOL) instruments exist for critical care populations, a standardised approach to assessing the HR-QOL of out-of-hospital cardiac arrest (OHCA) survivors has not been developed. We sought to compare the responses of 12-month OHCA survivors to three HR-QOL and functional recovery instruments, and assess instrument validity. The Victorian Ambulance Cardiac Arrest Registry invited 12-month OHCA survivors to participate in telephone follow-up between January 2011 and December 2015. Responders provided answers to the 12 Item Short Form Health Survey (SF-12), Three-Level EuroQol-5D (EQ-5D-3L) and the Glasgow Outcome Scale-Extended (GOSE). The SF-12 was also used to derive the SF-6D. Responses were used to assess the interpretability and construct validity of the instruments. A total of 1188 patients and proxies responded. Large ceiling effects were observed for the EQ-5D-3L (patients=46%, proxies=23%). Substantial variability was also observed in SF-6D responses for patients who reported full health according to the EQ-5D-3L. For patient responders, the strongest correlations were observed between the EQ-5D-3L index score and SF-6D (ρ=0.65, pGOSE outcome and lower or upper good recovery (pGOSE suggest that these may be useful measures of HR-QOL and functional recovery in OHCA survivors. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Public awareness and self-efficacy of cardiopulmonary resuscitation in communities and outcomes of out-of-hospital cardiac arrest: A multi-level analysis.

    Science.gov (United States)

    Ro, Young Sun; Shin, Sang Do; Song, Kyoung Jun; Hong, Sung Ok; Kim, Young Taek; Lee, Dong-Woo; Cho, Sung-Il

    2016-05-01

    This study aims to test the association between capacity of cardiopulmonary resuscitation (CPR) at community level and survival after out-of-hospital cardiac arrest (OHCA). Emergency medical service (EMS)-treated OHCAs with cardiac etiology in Korea between 2012 and 2013 were analyzed, excluding cases witnessed by EMS providers. Exposure variables were five indexes of community CPR capacity: awareness of CPR (CPR-Awareness), any training experience of CPR (CPR-Any-Training), recent CPR training within the last 2 years (CPR-Recent-Training), CPR training with a manikin (CPR-Manikin-Training), and CPR self-efficacy (CPR-Self-Efficacy). All measures of capacity were calculated as aggregated values for each county level using the national Korean Community Health Survey database of 228,921 responders sampled representatively from 253 counties in 2012. Endpoints were bystander CPR (BCPR) and survival to discharge. We calculated adjusted odds ratios (AORs) per 10% increment in community CPR capacity using multi-level logistic regression models, adjusting for potential confounders at individual levels. Of 29,052 eligible OHCAs, 11,079 (38.1%) received BCPR. Patients were more likely to receive BCPR in communities with higher proportions of residents with CPR-Awareness, CPR-Any-Training, CPR-Recent-Training, CPR-Manikin-Training, and CPR-Self-Efficacy (all pCPR-Awareness, 1.10 (1.04-1.15) for CPR-Any-Training, and 1.08 (1.03-1.13) for CPR-Self-Efficacy. For survival to discharge, AORs (95% CIs) were 1.34 (1.23-1.47) per 10% increment in CPR-Awareness, 1.36 (1.20-1.54) for CPR-Any-Training, and 1.29 (1.15-1.45) for CPR-Self-Efficacy. Higher CPR capacity at community level was associated with higher bystander CPR and survival to discharge rates after OHCA. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. 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.

  10. 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.

  11. Neurologic outcome in comatose patients resuscitated from out-of-hospital cardiac arrest with prolonged downtime and treated with therapeutic hypothermia

    Science.gov (United States)

    Kim, Won Young; Giberson, Tyler A.; Uber, Amy; Berg, Katherine; Cocchi, Michael N.; Donnino, Michael W.

    2014-01-01

    Background Previous reports have shown that prolonged duration of resuscitation efforts in out-of-hospital cardiac arrest (OHCA) is associated with poor neurologic outcome. This concept has recently been questioned with advancements in post-cardiac arrest care including the use of therapeutic hypothermia (TH). The aim of this study was to determine the rate of good neurologic outcome based on the duration of resuscitation efforts in OHCA patients treated with TH. Methods This prospective, observational, study was conducted between January 2008 and September 2012. Inclusion criteria consisted of adult non-traumatic OHCA patients who were comatose after return of spontaneous circulation (ROSC) and received TH. The primary endpoint was good neurologic outcome defined as a cerebral performance category score of 1 or 2. Downtime was calculated as the length of time between the patient being recognized as pulseless and ROSC. Results 105 patients were treated with TH and 19 were excluded due to unknown downtime, leaving 86 patients for analysis. The median downtime was 18.5 (10.0–32.3) minutes and 33 patients (38.0%) had a good neurologic outcome. When downtime was divided into four groups (≤10 min, 11-20 min, 21-30 min, > 30 min), good neurologic outcomes were 62.5%, 37%, 25%, and 21.7%, respectively (p=0.02). However, even with downtime >20 minutes, 22.9% had a good neurologic outcome, and this percentage increased to 37.5% in patients with an initial shockable rhythm. Conclusions Although longer downtime is associated with worse outcome in OHCA patients, we found that comatose patients who have been successfully resuscitated and treated with TH have neurologically intact survival rates of 23% even with downtime > 20 minutes. PMID:24746783

  12. Neurologic outcome in comatose patients resuscitated from out-of-hospital cardiac arrest with prolonged downtime and treated with therapeutic hypothermia.

    Science.gov (United States)

    Kim, Won Young; Giberson, Tyler A; Uber, Amy; Berg, Katherine; Cocchi, Michael N; Donnino, Michael W

    2014-08-01

    Previous reports have shown that prolonged duration of resuscitation efforts in out-of-hospital cardiac arrest (OHCA) is associated with poor neurologic outcome. This concept has recently been questioned with advancements in post-cardiac arrest care including the use of therapeutic hypothermia (TH). The aim of this study was to determine the rate of good neurologic outcome based on the duration of resuscitation efforts in OHCA patients treated with TH. This prospective, observational, study was conducted between January 2008 and September 2012. Inclusion criteria consisted of adult non-traumatic OHCA patients who were comatose after return of spontaneous circulation (ROSC) and received TH. The primary endpoint was good neurologic outcome defined as a cerebral performance category score of 1 or 2. Downtime was calculated as the length of time between the patient being recognized as pulseless and ROSC. 105 patients were treated with TH and 19 were excluded due to unknown downtime, leaving 86 patients for analysis. The median downtime was 18.5 (10.0-32.3)min and 33 patients (38.0%) had a good neurologic outcome. When downtime was divided into four groups (≤10min, 11-20min, 21-30min, >30min), good neurologic outcomes were 62.5%, 37%, 25%, and 21.7%, respectively (p=0.02). However, even with downtime >20min, 22.9% had a good neurologic outcome, and this percentage increased to 37.5% in patients with an initial shockable rhythm. Although longer downtime is associated with worse outcome in OHCA patients, we found that comatose patients who have been successfully resuscitated and treated with TH have neurologically intact survival rates of 23% even with downtime >20min. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Association of initial rhythm with neurologically favorable survival in non-shockable out-of-hospital cardiac arrest without a bystander witness or bystander cardiopulmonary resuscitation.

    Science.gov (United States)

    Fukuda, Tatsuma; Ohashi-Fukuda, Naoko; Matsubara, Takehiro; Doi, Kent; Kitsuta, Yoichi; Nakajima, Susumu; Yahagi, Naoki

    2016-05-01

    Out-of-hospital cardiac arrest (OHCA) has a predominantly non-shockable rhythm. Non-shockable rhythm, and the absence of a bystander witness or bystander cardiopulmonary resuscitation (CPR) are associated with poor outcomes. However, the association between the type of non-shockable rhythm and outcomes is not well known. To examine the association between the initial rhythm and neurologically favorable outcomes after non-shockable OHCA without a bystander witness or bystander CPR. In a nationwide, population-based, cohort study, we analyzed 213,984 adult OHCA patients with a non-shockable rhythm who had neither a bystander witness nor bystander CPR. They were identified through the Japanese national OHCA registry data from January 1, 2005 to December 31, 2010. The primary outcome was neurologically favorable survival. Among 213,984 patients, the initial rhythm was Pulseless Electrical Activity (PEA) in 31,179 patients (14.6%) and Asystole in 182,805 patients (85.4%). The neurological outcome was more favorable in PEA than in Asystole (1.4% vs. 0.2%, padvanced airway management, time from call to contact with patient, and calendar year, PEA was associated with an increased neurologically favorable survival rate (odds ratio 7.86; 95% confidence interval 6.81-9.07). In subgroup analysis stratified by age group (18-64, 65-84, or ≥85years), the neurologically favorable survival rate was ≥1% in PEA, even for patients aged ≥85years, but <1% in Asystole among all age groups. PEA and Asystole should not be considered to be identical to non-shockable rhythm, but rather should be clearly distinguished from each other from the perspective of quantitative medical futility. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  14. The combined use of mechanical CPR and a carry sheet to maintain quality resuscitation in out-of-hospital cardiac arrest patients during extrication and transport.

    Science.gov (United States)

    Lyon, Richard M; Crawford, Anna; Crookston, Colin; Short, Steven; Clegg, Gareth R

    2015-08-01

    Quality of manual cardiopulmonary resuscitation (CPR) during extrication and transport of out-of-hospital cardiac arrest victims is known to be poor. Performing manual CPR during ambulance transport poses significant risk to the attending emergency medical services crew. We sought to use pre-hospital video recording to objectively analyse the impact of introducing mechanical CPR with an extrication sheet (Autopulse, Zoll) to an advanced, second-tier cardiac arrest response team. The study was conducted prospectively using defibrillator downloads and analysis of pre-hospital video recording to measure the quality of CPR during extrication from scene and ambulance transport of the OHCA patient. Adult patients with non-traumatic OHCA were included. The interruption to manual CPR to during extrication and to deploy the mechanical CPR device was analysed. In the manual CPR group, 53 OHCA cases were analysed for quality of CPR during extrication. The median time that chest compression was interrupted to allow the patient to be carried from scene to the ambulance was 270 s (IQR 201-387 s). 119 mechanical CPR cases were analysed. The median time interruption from last manual compression to first Autopulse compression was 39 s (IQR 29-47 s). The range from last manual compression to first Autopulse compression was 14-118 s. Mechanical CPR used in combination with an extrication sheet can be effectively used to improve the quality of resuscitation during extrication and ambulance transport of the refractory OHCA patient. The time interval to deploy the mechanical CPR device can be shortened with regular simulation training. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Therapeutic Hypothermia for Asphyxial Out-of-Hospital Cardiac Arrest Due to Drowning: A Systematic Review of Case Series and Case Reports.

    Science.gov (United States)

    Suen, K-F; Leung, Reynold; Leung, Ling-Pong

    2017-12-01

    The objective of this review was to summarize published evidence of the effectiveness of therapeutic hypothermia in patients with drowning-associated asphyxial out-of-hospital cardiac arrest (OHCA) and to explore any preliminary favorable factors in the management of therapeutic hypothermia to improve survival and neurological outcome. Drowning may result in asphyxial OHCA or hypothermic OHCA, but the former does not provide any potential neuroprotective effect as the latter may do. Electronic literature searches of Ovid Medline, Embase, Cochrane Library, and Scopus were performed for all years from inception to July 2016. Primary studies in the form of case reports, letters to the editor, and others with higher quality are included, but guidelines, reviews, editorials, textbook chapters, conference abstracts, and nonhuman studies are excluded. Non-English articles are excluded. Relevant studies are then deemed eligible if the drowning OHCA patient's initial temperature was above 28°C, which implies asphyxial cardiac arrest, and intentional therapeutic hypothermia was instituted. Because of the narrow scope of interest and strict definition of the condition, limited studies addressed it, and no randomized controlled trials (RCT) could be selected. Thirteen studies covering 35 patients are included. No quantitative synthesis, assessment of study quality, or assessment of bias was performed. It is conjectured that extended therapeutic hypothermia of 48-72 hours might help prevent reperfusion injury during the intermediate phase of postcardiac arrest care to benefit patients of drowning-associated asphyxial OHCA, but this finding only serves as preliminary observation for future research. No conclusive recommendation could be made regarding the duration of and the time of onset of therapeutic hypothermia. Future research should put effort on RCT, particularly the effect of extended duration of 48-72 hours. Important parameters should be reported in detail. Asphyxial

  16. Out-of-hospital cardiac arrests during exercise among urban inhabitants in Japan: Insights from a population-based registry of Osaka City.

    Science.gov (United States)

    Kiyohara, Kosuke; Sado, Junya; Matsuyama, Tasuku; Nishiyama, Chika; Kobayashi, Daisuke; Kiguchi, Takeyuki; Hayashida, Sumito; Kitamura, Yuri; Sobue, Tomotaka; Nakata, Ken; Iwami, Taku; Kitamura, Tetsuhisa

    2017-08-01

    The patient characteristics, pre-hospital interventions, and outcomes of out-of-hospital cardiac arrests (OHCA) occurring during exercise, have not been sufficiently investigated among the general population. OHCA data from 2009 to 2015 were obtained from the population-based OHCA registry in Osaka City, Japan. Patients who suffered OHCA, which occurred during exercise before the arrival of emergency medical service personnel, were included. The primary endpoint was one-month survival with a favourable neurological outcome after OHCA, defined using the Glasgow-Pittsburgh cerebral performance category scale 1 or 2. During the 7-year study period, 16,278 OHCAs were observed, and 52 (0.3%) occurred during exercise (male, n=41 [79%]; median age, 62 years). These incidents occurred mainly during running activities (n=14), followed by swimming (n=8), dance/social dance (n=6), tennis (n=4), and weight training (n=3). Within these exercise-related OHCAs, 47 (90%) were of cardiac origin, 45 (87%) were bystander-witnessed cardiac arrests, 49 (94%) received bystander-initiated cardiopulmonary resuscitation, and 30 (57%) received public-access defibrillation (PAD). Overall, 56% (29/52) had one-month survival with a favourable neurological outcome after OHCA, which was significantly higher among OHCAs of cardiac origin with PAD (77%, 23/30) than among those of cardiac origin without PAD (35%, 6/17) and among those of non-cardiac origin (0%, 0/5) (pexercise represented a small subset of the overall OHCA burden, but occurred during a wide variety of exercise activities. Patients with OHCA of cardiac origin had a good prognosis, and PAD played an important role in improving patient outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Impact of community-wide police car deployment of automated external defibrillators on survival from out-of-hospital cardiac arrest.

    Science.gov (United States)

    Myerburg, Robert J; Fenster, Jeffrey; Velez, Mauricio; Rosenberg, Donald; Lai, Shenghan; Kurlansky, Paul; Newton, Starbuck; Knox, Melenda; Castellanos, Agustin

    2002-08-27

    Disappointing survival rates from out-of-hospital cardiac arrests encourage strategies for faster defibrillation, such as use of automated external defibrillators (AEDs) by nonconventional responders. AEDs were provided to all Miami-Dade County, Florida, police. AED-equipped police (P-AED) and conventional emergency medical rescue (EMS) responders are simultaneously deployed to possible cardiac arrests. Times from 9-1-1 contact to the scene were compared for P-AED and concurrently deployed EMS, and both were compared with historical EMS experience. Survival with P-AED was compared with outcomes when EMS was the sole responder. Among 420 paired dispatches of P-AED and EMS, the mean+/-SD P-AED time from 9-1-1 call to arrival at the scene was 6.16+/-4.27 minutes, compared with 7.56+/-3.60 minutes for EMS (P<0.001). Police arrived first to 56% of the calls. The time to first responder arrival among P-AED and EMS was 4.88+/-2.88 minutes (P<0.001), compared with a historical response time of 7.64+/-3.66 minutes when EMS was the sole responder. A 17.2% survival rate was observed for victims with ventricular fibrillation or pulseless ventricular tachycardia (VT/VF), compared with 9.0% for standard EMS before P-AED implementation (P=0.047). However, VT/VF benefit was diluted by the observation that 61% of the initial rhythms were nonshockable, reducing the absolute survival benefit among the total study population to 1.6% (P-AED, 7.6%; EMS, 6.0%). P-AED establishes a layer of responders that generate improved response times and survival from VT/VF. There was no benefit for victims with nonshockable rhythms.

  18. Distance to invasive heart centre, performance of acute coronary angiography, and angioplasty and associated outcome in out-of-hospital cardiac arrest: a nationwide study.

    Science.gov (United States)

    Tranberg, Tinne; Lippert, Freddy K; Christensen, Erika F; Stengaard, Carsten; Hjort, Jakob; Lassen, Jens Flensted; Petersen, Frants; Jensen, Jan Skov; Bäck, Caroline; Jensen, Lisette Okkels; Ravkilde, Jan; Bøtker, Hans Erik; Terkelsen, Christian Juhl

    2017-06-01

    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 (OHCA) patients. Nationwide historical follow-up study of 41 186 unselected OHCA patients, in whom resuscitation was attempted between 2001 and 2013, identified through the Danish Cardiac Arrest Registry. We observed an increase in the proportion of patients receiving bystander CPR (18% in 2001, 60% in 2013, P acute CAG/PCI (5% in 2001, 27% in 2013, P acute CAG/PCI annually in each region was defined as the CAG/PCI index. The following variables were associated with lower mortality in multivariable analyses: direct admission to invasive heart centre (HR 0.91, 95% CI: 0.89-0.93), CAG/PCI index (HR 0.33, 95% CI: 0.25-0.45), population density above 2000 per square kilometre (HR 0.94, 95% CI: 0.89-0.98), bystander CPR (HR 0.97, 95% CI: 0.95-0.99) and witnessed OHCA (HR 0.87, 95% CI: 0.85-0.89), whereas distance to the nearest invasive centre was not associated with survival. Admission to an invasive heart centre and regional performance of acute CAG/PCI were associated with improved survival in OHCA patients, whereas distance to the invasive centre was not. These results support a centralized strategy for immediate post-resuscitation care in OHCA patients. © The Author 2017. Published on behalf of the European Society of Cardiology.

  19. A comparison of the universal TOR Guideline to the absence of prehospital ROSC and duration of resuscitation in predicting futility from out-of-hospital cardiac arrest.

    Science.gov (United States)

    Drennan, Ian R; Case, Erin; Verbeek, P Richard; Reynolds, Joshua C; Goldberger, Zachary D; Jasti, Jamie; Charleston, Mark; Herren, Heather; Idris, Ahamed H; Leslie, Paul R; Austin, Michael A; Xiong, Yan; Schmicker, Robert H; Morrison, Laurie J

    2017-02-01

    The Universal Termination of Resuscitation (TOR) Guideline accurately identifies potential out-of-hospital cardiac arrest (OHCA) survivors. However, implementation is inconsistent with some Emergency Medical Service (EMS) agencies using absence of return of spontaneous circulation (ROSC) as sole criterion for termination. To compare the performance of the Universal TOR Guideline with the single criterion of no prehospital ROSC. Second, to determine factors associated with survival for patients transported without a ROSC. Lastly, to compare the impact of time to ROSC as a marker of futility to the Universal TOR Guideline. Retrospective, observational cohort study. Non-traumatic, adult (≥18 years) OHCA patients of presumed cardiac etiology treated by EMS providers. ROC-PRIMED and ROC-Epistry post ROC-PRIMED databases between 2007 and 2011. Primary outcome was survival to hospital discharge and the secondary outcome was functional survival. We used multivariable regression to evaluate factors associated with survival in patients transported without a ROSC. 36,543 treated OHCAs occurred of which 9467 (26%) were transported to hospital without a ROSC. Patients transported without a ROSC who met the Universal TOR Guideline for transport had a survival of 3.0% (95% CI 2.5-3.4%) compared to 0.7% (95% CI 0.4-0.9%) in patients who met the Universal TOR Guideline for termination. The Universal TOR Guideline identified 99% of survivors requiring continued resuscitation and transportation to hospital including early identification of survivors who sustained a ROSC after extended durations of CPR. Using absence of ROSC as a sole predictor of futility misses potential survivors. The Universal TOR Guideline remains a strong predictor of survival. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

    Science.gov (United States)

    Søholm, Helle; Kjaergaard, Jesper; Thomsen, Jakob Hartvig; Bro-Jeppesen, John; Lippert, Freddy K; Køber, Lars; Wanscher, Michael; Hassager, Christian

    2014-11-01

    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-athletic population. Consecutive patients with OHCA were admitted with return of spontaneous circulation (ROSC) or on-going resuscitation at hospital arrival (2002-2011). Patient charts were reviewed for post-resuscitation data. Exercise was defined as moderate/vigorous physical activity. A total of 1393 OHCA-patients were included with 91(7%) arrests occurring during exercise. Exercise-related OHCA-patients were younger (60 ± 13 vs. 65 ± 15, p<0.001) and predominantly male (96% vs. 69%, p<0.001). The arrest was more frequently witnessed (94% vs. 86%, p=0.02), bystander CPR was more often performed (88% vs. 54%, p<0.001), time to ROSC was shorter (12 min (IQR: 5-19) vs. 15 (9-22), p=0.007) and the primary rhythm was more frequently shock-able (91% vs. 49%, p<0.001) compared to non-exercise patients. Cardiac etiology was the predominant cause of OHCA in both exercise and non-exercise patients (97% vs. 80%, p<0.001) and acute coronary syndrome was more frequent among exercise patients (59% vs. 38%, p<0.001). One-year mortality was 25% vs. 65% (p<0.001), and exercise was even after adjustment associated with a significantly lower mortality (HR=0.40 (95%CI: 0.23-0.72), p=0.002). 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. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Direct transport to a PCI-capable hospital is associated with improved survival after adult out-of-hospital cardiac arrest of medical aetiology.

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    McKenzie, Nicole; Williams, Teresa A; Ho, Kwok M; Inoue, Madoka; Bailey, Paul; Celenza, Antonio; Fatovich, Daniel; Jenkins, Ian; Finn, Judith

    2018-05-02

    To compare survival outcomes of adults with out-of-hospital cardiac arrest (OHCA) of medical aetiology directly transported to a percutaneous-coronary-intervention capable (PCI-capable) hospital (direct transport) with patients transferred to a PCI-capable hospital via another hospital without PCI services available (indirect transport) by emergency medical services (EMS). This retrospective cohort study used the St John Ambulance Western Australia OHCA Database and medical chart review. We included OHCA patients (≥18 years) admitted to any one of five PCI-capable hospitals in Perth between January 2012 and December 2015. Survival to hospital discharge (STHD) and survival up to 12-months after OHCA were compared between the direct and indirect transport groups using multivariable logistic and Cox-proportional hazards regression, respectively, while adjusting for so-called "Utstein variables" and other potential confounders. Of the 509 included patients, 404 (79.4%) were directly transported to a PCI-capable hospital and 105 (20.6%) transferred via another hospital to a PCI-capable hospital; 274/509 (53.8%) patients STHD and 253/509 (49.7%) survived to 12-months after OHCA. Direct transport patients were twice as likely to STHD (adjusted odds ratio 1.97, 95% confidence interval [CI] 1.13-3.43) than those transferred via another hospital. Indirect transport was also associated with a possible increased risk of death, up to 12-months, compared to direct transport (adjusted hazard ratio 1.36, 95% CI 1.00-1.84). Direct transport to a PCI-capable hospital for post-resuscitation care is associated with a survival advantage for adults with OHCA of medical aetiology. This has implications for EMS transport protocols for patients with OHCA. Copyright © 2018 Elsevier B.V. All rights reserved.

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

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    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.

  3. Prompt prediction of successful defibrillation from 1-s ventricular fibrillation waveform in patients with out-of-hospital sudden cardiac arrest.

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    Endoh, Hiroshi; Hida, Seiji; Oohashi, Satomi; Hayashi, Yusuke; Kinoshita, Hidenori; Honda, Tadayuki

    2011-02-01

    Ventricular fibrillation (VF) is a common cardiac arrest rhythm that can be terminated by electrical defibrillation. During cardiopulmonary resuscitation, there is a strong need for a prompt and reliable predictor of successful defibrillation because myocardial damage can result from repeated futile defibrillation attempts. Continuous wavelet transform (CWT) provides excellent time and frequency resolution of signals. The purpose of this study was to evaluate whether features based on CWT could predict successful defibrillation. VF electrocardiogram (ECG) waveforms stored in ambulance-located defibrillators were collected. Predefibrillation waveforms were divided into 1.0- or 5.12-s VF waveforms. Indices in frequency domain or nonlinear analysis were calculated on the 5.12-s waveform. Simultaneously, CWT was performed on the 1.0-s waveform, and total low-band (1-3 Hz), mid-band (3-10 Hz), and high-band (10-32 Hz) energy were calculated. In 152 patients with out-of-hospital cardiac arrest, a total of 233 ECG predefibrillation recordings, consisting of 164 unsuccessful and 69 successful episodes, were analyzed. Indices of frequency domain analysis (peak frequency, centroid frequency, and amplitude spectral area), nonlinear analysis (approximate entropy and Hurst exponent, detrended fluctuation analysis), and CWT analysis (mid-band and high-band energy) were significantly different between unsuccessful and successful episodes (P centroid frequency and total mid-band energy were effective predictors (P < 0.01 for both). Energy spectrum analysis based on CWT as short as a 1.0-s VF ECG waveform enables prompt and reliable prediction of successful defibrillation.

  4. Effect of rescue breathing by lay rescuers for out-of-hospital cardiac arrest caused by respiratory disease: a nationwide, population-based, propensity score-matched study.

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    Fukuda, Tatsuma; Ohashi-Fukuda, Naoko; Kondo, Yutaka; Sera, Toshiki; Yahagi, Naoki

    2017-06-01

    The importance of respiratory care in cardiopulmonary resuscitation may vary depending on the cause of cardiac arrest. No previous study has investigated the effects of rescue breathing performed by a lay rescuer on the outcomes of patients with out-of-hospital cardiac arrest (OHCA) caused by intrinsic respiratory diseases. The aim of this study was to investigate whether rescue breathing performed by a lay rescuer is associated with outcomes after respiratory disease-related OHCA. In a nationwide, population-based, propensity score-matched study in Japan, among adult patients with OHCA caused by respiratory disease who received bystander cardiopulmonary resuscitation from January 1, 2005 to December 31, 2010, we compared patients with rescue breathing to those without rescue breathing. The primary outcome was neurologically favorable survival 1 month after OHCA. Of the eligible 14,781 patients, 4970 received rescue breathing from a lay rescuer and 9811 did not receive rescue breathing. In a propensity score-matched cohort (4897 vs. 4897 patients), the neurologically favorable survival rate was similar between patients with and without rescue breathing from a lay rescuer [0.9 vs. 0.7 %; OR 1.23 (95 % CI 0.79-1.93)]. Additionally, in subgroup analyses, rescue breathing was not associated with neurological outcome regardless of the type of rescuer [family member: adjusted OR 0.83 (95 % CI 0.39-1.70); or non-family member: adjusted OR 1.91 (95 % CI 0.79-5.35)]. Even among patients with OHCA caused by respiratory disease, rescue breathing performed by a lay rescuer was not associated with neurological outcomes, regardless of the type of lay rescuer.

  5. Reactions and coping strategies in lay rescuers who have provided CPR to out-of-hospital cardiac arrest victims: a qualitative study.

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    Mathiesen, Wenche Torunn; Bjørshol, Conrad Arnfinn; Braut, Geir Sverre; Søreide, Eldar

    2016-05-25

    Cardiopulmonary resuscitation (CPR) provided by community citizens is of paramount importance for out-of-hospital cardiac arrest (OHCA) victims' survival. Fortunately, CPR rates by community citizens seem to be rising. However, the experience of providing CPR is rarely investigated. The aim of this study was to explore reactions and coping strategies in lay rescuers who have provided CPR to OHCA victims. This is a qualitative study of 20 lay rescuers who have provided CPR to 18 OHCA victims. We used a semistructured interview guide focusing on their experiences after providing CPR. The study was conducted in the Stavanger region of Norway, an area with very high bystander CPR rates. Three themes emerged from the interview analysis: concern, uncertainty and coping strategies. Providing CPR had been emotionally challenging for all lay rescuers and, for some, had consequences in terms of family and work life. Several lay rescuers experienced persistent mental recurrences of the OHCA incident and had concerns about the outcome for the cardiac arrest victim. Unknown or fatal outcomes often caused feelings of guilt and were particularly difficult to handle. Several reported the need to be acknowledged for their CPR attempts. Health-educated lay rescuers seemed to be less affected than others. A common coping strategy was confiding in close relations, preferably the health educated. However, some required professional help to cope with the OHCA incident. Lay rescuers experience emotional and social challenges, and some struggle to cope in life after providing CPR in OHCA incidents. Experiencing a positive patient outcome and being a health-educated lay rescuer seem to mitigate concerns. Common coping strategies are attempts to reduce uncertainty towards patient outcome and own CPR quality. Further studies are needed to determine whether an organised professional follow-up can mitigate the concerns and uncertainty of lay rescuers. Published by the BMJ Publishing Group

  6. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants.

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    Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A

    2010-04-05

    To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

  7. 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 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.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.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 fundamental rationale underpinning placebo controlled

  8. Termination of Resuscitation Rules to Predict Neurological Outcomes in Out-of-Hospital Cardiac Arrest for an Intermediate Life Support Prehospital System.

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    Cheong, Randy Wang Long; Li, Huihua; Doctor, Nausheen Edwin; Ng, Yih Yng; Goh, E Shaun; Leong, Benjamin Sieu-Hon; Gan, Han Nee; Foo, David; Tham, Lai Peng; Charles, Rabind; Ong, Marcus Eng Hock

    2016-01-01

    Futile resuscitation can lead to unnecessary transports for out-of-hospital cardiac arrest (OHCA). The Basic Life Support (BLS) and Advanced Life Support (ALS) termination of resuscitation (TOR) guidelines have been validated with good results in North America. This study aims to evaluate the performance of these two rules in predicting neurological outcomes of OHCA patients in Singapore, which has an intermediate life support Emergency Medical Services (EMS) system. A retrospective cohort study was carried out on Singapore OHCA data collected from April 2010 to May 2012 for the Pan-Asian Resuscitation Outcomes Study (PAROS). The outcomes of each rule were compared to the actual neurological outcomes of the patients. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and predicted transport rates of each test were evaluated. A total of 2,193 patients had cardiac arrest of presumed cardiac etiology. TOR was recommended for 1,411 patients with the BLS-TOR rule, with a specificity of 100% (91.9, 100.0) for predicting poor neurological outcomes, PPV 100% (99.7, 100.0), sensitivity 65.7% (63.6, 67.7), NPV 5.6% (4.1, 7.5), and transportation rate 35.6%. Using the ALS-TOR rule, TOR was recommended for 587 patients, specificity 100% (91.9, 100.0) for predicting poor neurological outcomes, PPV 100% (99.4, 100.0), sensitivity 27.3% (25.4, 29.3), NPV 2.7% (2.0, 3.7), and transportation rate 73.2%. BLS-TOR predicted survival (any neurological outcome) with specificity 93.4% (95% CI 85.3, 97.8) versus ALS-TOR 98.7% (95% CI 92.9, 99.8). Both the BLS and ALS-TOR rules had high specificities and PPV values in predicting neurological outcomes, the BLS-TOR rule had a lower predicted transport rate while the ALS-TOR rule was more accurate in predicting futility of resuscitation. Further research into unique local cultural issues would be useful to evaluate the feasibility of any system-wide implementation of TOR.

  9. Comparison of team-focused CPR vs standard CPR in resuscitation from out-of-hospital cardiac arrest: Results from a statewide quality improvement initiative.

    Science.gov (United States)

    Pearson, David A; Darrell Nelson, R; Monk, Lisa; Tyson, Clark; Jollis, James G; Granger, Christopher B; Corbett, Claire; Garvey, Lee; Runyon, Michael S

    2016-08-01

    Team-focused CPR (TFCPR) is a choreographed approach to cardiopulmonary resuscitation (CPR) with emphasis on minimally interrupted high-quality chest compressions, early defibrillation, discourages endotracheal intubation and encourages use of the bag-valve-mask (BVM) and/or blind-insertion airway device (BIAD) with a ventilation rate of 8-10 breaths/min to minimize hyperventilation. Widespread incorporation of TFCPR in North Carolina (NC) EMS agencies began in 2011, yet its impact on outcomes is unknown. To determine whether TFCPR improves survival with good neurological outcome in out-of-hospital cardiac arrest (OHCA) patients compared to standard CPR. This retrospective cohort analysis of NC EMS agencies reporting data to the Cardiac Arrest Registry for Enhanced Survival (CARES) database from January 2010 to June 2014 included adult, non-traumatic OHCA with presumed cardiac etiology where EMS performed CPR or patient received defibrillation. Exclusions were arrest terminated per EMS policy or DNR. EMS agencies self-reported the TFCPR implementation dates. Patients were categorized as receiving either TFCPR or standard CPR. The primary outcome was good neurologic outcome at time of hospital discharge defined as Pittsburgh Cerebral Performance Category (CPC) 1-2. Of 14,994 OHCAs, 14,129 patients were included for analysis with a mean age 65 (IQR 50-81) years, 61% male, 7.3% with good neurologic outcome, 24.3% with shockable initial rhythm, and 71.5% receiving TFCPR. Of the 3427 (24.3%) with an initial shockable rhythm, 739 (71.9%) had a good neurological outcome. Good neurologic outcome was higher with TFCPR [836 (8.3%, 95%CI 7.7-8.8%)] vs. standard CPR [193 (4.8%, 95%CI 4.2-5.5%)]. Logistic regression controlling for demographic and arrest characteristics revealed TFCPR (OR 1.5), witnessed arrest (OR 4.3), initial shockable rhythm (OR 7.1), and in-hospital hypothermia (OR 3.3) were associated with good neurologic outcome. Mechanical CPR device (OR 0.68), CPR

  10. Similar long-term survival of consecutive in-hospital and out-of-hospital cardiac arrest patients treated with targeted temperature management

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    Engsig M

    2016-11-01

    Full Text Available Magaly Engsig,1 Helle Søholm,2 Fredrik Folke,3,4 Peter J Gadegaard,1 Julie Therese Wiis,5 Rune Molin,6 Thomas Mohr,1 Frederik N Engsig7 1Department of Anaesthesiology and Intensive Care, Copenhagen University Hospital, Hellerup, 2Department of Cardiology, Copenhagen University Hospital, Herlev, 3Department of Cardiology, Copenhagen University Hospital, Hellerup, 4Pre-Hospital Emergency Medical Services, Capital Region of Denmark, Ballerup, 5Department of Intensive Care, Copenhagen University Hospital, Copenhagen, 6Department of Anaesthesiology, Copenhagen University Hospital, Hillerød, 7Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark Objective: The long-term survival of in-hospital cardiac arrest (IHCA patients treated with targeted temperature management (TTM is poorly described. The aim of this study was to compare the outcomes of consecutive IHCA with out-of-hospital cardiac arrest (OHCA patients treated with TTM. Design, setting, and patients: Retrospectively collected data on all consecutive adult patients treated with TTM at a university tertiary heart center between 2005 and 2011 were analyzed. Measurements: Primary endpoints were survival to hospital discharge and long-term survival. Secondary endpoint was neurological outcome assessed using the Pittsburgh cerebral performance category (CPC. Results: A total of 282 patients were included in this study; 233 (83% OHCA and 49 (17% IHCA. The IHCA group presented more often with asystole, received bystander cardiopulmonary resuscitation (CPR in all cases, and had shorter time to return of spontaneous circulation (ROSC. Survival to hospital discharge was 54% for OHCA and 53% for IHCA (adjusted odds ratio 0.98 [95% confidence interval {CI}; 0.43–2.24]. Age ≤60 years, bystander CPR, time to ROSC ≤10 min, and shockable rhythm at presentation were associated with survival to hospital discharge. Good neurologic outcome among survivors was achieved by 86

  11. Interaction of defibrillation waveform with the time to defibrillation or the number of defibrillation attempts on survival from out-of-hospital cardiac arrest.

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    Hagihara, Akihito; Onozuka, Daisuke; Ono, Junko; Nagata, Takashi; Hasegawa, Manabu

    2018-01-01

    Early biphasic defibrillation is effective in out-of-hospital cardiac arrest (OHCA) cases. In the resuscitation of patients with OHCA, it is not clear how the defibrillation waveform interacts with the time to defibrillation to influence patient survival. The second, and any subsequent, shocks need to be administered by an on-line physician in Japan. Thus, we investigated the interaction between the defibrillation waveform and time to or the number of defibrillation on resuscitation outcomes. This prospective observational study used data for all OHCAs that occurred between 2005 and 2014 in Japan. To investigate the interaction effect between the defibrillation waveform and the time to defibrillation or the number of defibrillations on the return to spontaneous circulation (ROSC), 1-month survival, and cerebral performance category (CPC) (1, 2), we assessed the modifying effects of the defibrillation waveform and the time to or the number of defibrillation on additive scale (i.e., the relative excessive risk due to interaction, RERI) and multiplicative scale (i.e., ratio of odds ratios (ORs)). In total, 71,566 cases met the inclusion criteria. For the measure of interaction between the defibrillation waveform and the time to defibrillation, ratio of ORs for ROSC was 0.84 (0.75-0.94), implying that the effect of time to first defibrillation on ROSC was negatively modified by defibrillation waveform. For the interaction between the defibrillation waveform and the number of defibrillations, RERI and ratio of ORs for CPC (1, 2) was -0.25 (-0.47 to -0.06) and 0.79 (0.67-0.93), respectively. It is implied that the effect of number of defibrillation on CPC (1, 2) was negatively modified by defibrillation waveform. An increased number of defibrillations was associated with a decreased ROSC in the case of biphasic and monophasic defibrillation, while an increased number of defibrillations was related to an increased 1-month survival rate and CPC (1, 2) only in the case of

  12. Diurnal variations in incidence and outcome of out-of-hospital cardiac arrest including prior comorbidity and pharmacotherapy: a nationwide study in Denmark.

    Science.gov (United States)

    Karlsson, Lena I M; Wissenberg, Mads; Fosbøl, Emil L; Hansen, Carolina Malta; Lippert, Freddy K; Bagai, Akshay; McNally, Bryan; Granger, Christopher B; Christensen, Erika Frischknecht; Folke, Fredrik; Rajan, Shahzleen; Weeke, Peter; Nielsen, Søren L; Køber, Lars; Gislason, Gunnar H; Torp-Pedersen, Christian

    2014-09-01

    To investigate diurnal variations in incidence and outcomes following out-of-hospital cardiac arrest (OHCA). OHCA of presumed cardiac etiology were identified through the nationwide Danish Cardiac Arrest Registry (2001-2010). Time of day was divided into three time periods: daytime 07.00-14.59; evening 15.00-22.59; and nighttime 23.00-06.59. We identified 18,929 OHCA patients, aged ≥18 years. The median age was 72 years (IQR 62-80) and the majority were male (67.5%). OHCA occurrence varied across time periods, with 43.9%, 35.7% and 20.6% occurring during daytime, evening and nighttime, respectively. Nighttime patients were more likely to have: severe comorbidity (i.e. COPD), arrest in private home (87.2% vs. 69.0% and 73.0% daytime and evening, respectively), non-witnessed arrest (51.2% vs. 48.4% and 43.7%), no bystander CPR (75.9% vs. 68.4% and 66.1%), longer time interval from recognition of OHCA to rhythm analysis (12 min vs. 11 min and 11 min), and non-shockable heart rhythm (80.1% vs. 70.3% and 69.4%), all p<0.0001. Nighttime patients were less likely to achieve return of spontaneous circulation on arrival at the hospital (7.5% vs. 14.8% and 15.1%) and 1-year survival (2.8% vs. 7.2% and 7.1%), p<0.0001. Overall, the lower 1-year survival rate persisted after adjusting for patient-related and cardiac-arrest related characteristics mentioned above (OR 0.47, 95%CI 0.37-0.59; OR 0.51, 95%CI 0.40-0.65, compared to daytime and evening, respectively). We found nighttime patients to have a lower survival compared to daytime and evening that persisted when adjusting for patient-related and cardiac-arrest related characteristics including comorbidities. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. The Effects of Public Access Defibrillation on Survival After Out-of-Hospital Cardiac Arrest: A Systematic Review of Observational Studies.

    Science.gov (United States)

    Bækgaard, Josefine S; Viereck, Søren; Møller, Thea Palsgaard; Ersbøll, Annette Kjær; Lippert, Freddy; Folke, Fredrik

    2017-09-05

    Despite recent advances, the average survival after out-of-hospital cardiac arrest (OHCA) remains 50%. Accordingly, placement of automated external defibrillators in the community as part of a public access defibrillation program (PAD) is recommended by international guidelines. However, different strategies have been proposed on how exactly to increase and make use of publicly available automated external defibrillators. This systematic review aimed to evaluate the effect of PAD and the different PAD strategies on survival after OHCA. PubMed, Embase, and the Cochrane Library were systematically searched on August 31, 2015 for observational studies reporting survival to hospital discharge in OHCA patients where an automated external defibrillator had been used by nonemergency medical services. PAD was divided into 3 groups according to who applied the defibrillator: nondispatched lay first responders, professional first responders (firefighters/police) dispatched by the Emergency Medical Dispatch Center (EMDC), or lay first responders dispatched by the EMDC. A total of 41 studies were included; 18 reported PAD by nondispatched lay first responders, 20 reported PAD by EMDC-dispatched professional first responders (firefighters/police), and 3 reported both. We identified no qualified studies reporting survival after PAD by EMDC-dispatched lay first responders. The overall survival to hospital discharge after OHCA treated with PAD showed a median survival of 40.0% (range, 9.1-83.3). Defibrillation by nondispatched lay first responders was associated with the highest survival with a median survival of 53.0% (range, 26.0-72.0), whereas defibrillation by EMDC-dispatched professional first responders (firefighters/police) was associated with a median survival of 28.6% (range, 9.0-76.0). A meta-analysis of the different survival outcomes could not be performed because of the large heterogeneity of the included studies. This systematic review showed a median overall

  14. Dynamic axes of informed consent in Japan.

    Science.gov (United States)

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials.

    Science.gov (United States)

    Behrendt, C; Gölz, T; Roesler, C; Bertz, H; Wünsch, A

    2011-02-01

    Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent.

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

    Science.gov (United States)

    Ramos, S Raquel

    2017-11-01

    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 health information. Comprehension is key factor in the ability to make informed decisions.

  17. 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

  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. Informed consent in clinical trials

    African Journals Online (AJOL)

    2009-08-27

    Aug 27, 2009 ... Founded upon the principle of respect for the autonomy of persons, IC seeks to ... Debates and controversies driven by cultural considerations in IC have been ... from an individualistic notion of personhood specific to Western.

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

    Directory of Open Access Journals (Sweden)

    Hammami Muhammad M

    2012-11-01

    Full Text Available Abstract 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 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 vs. 8[4,9], p vs. 5[2,7], p  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.

  1. Evaluation of pre-hospital administration of adrenaline (epinephrine) by emergency medical services for patients with out of hospital cardiac arrest in Japan: controlled propensity matched retrospective cohort study.

    Science.gov (United States)

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

    2013-12-10

    To evaluate the effectiveness of pre-hospital adrenaline (epinephrine) administered by emergency medical services to patients with out of hospital cardiac arrest. Controlled propensity matched retrospective cohort study, in which pairs of patients with or without (control) adrenaline were created with a sequential risk set matching based on time dependent propensity score. Japan's nationwide registry database of patients with out of hospital cardiac arrest registered between January 2007 and December 2010. Among patients aged 15-94 with out of hospital cardiac arrest witnessed by a bystander, we created 1990 pairs of patients with and without adrenaline with an initial rhythm of ventricular fibrillation or pulseless ventricular tachycardia (VF/VT) and 9058 pairs among those with non-VF/VT. Overall and neurologically intact survival at one month or at discharge, whichever was earlier. After propensity matching, pre-hospital administration of adrenaline by emergency medical services was associated with a higher proportion of overall survival (17.0% v 13.4%; unadjusted odds ratio 1.34, 95% confidence interval 1.12 to 1.60) but not with neurologically intact survival (6.6% v 6.6%; 1.01, 0.78 to 1.30) among those with VF/VT; and higher proportions of overall survival (4.0% v 2.4%; odds ratio 1.72, 1.45 to 2.04) and neurologically intact survival (0.7% v 0.4%; 1.57, 1.04 to 2.37) among those with non-VF/VT. Pre-hospital administration of adrenaline by emergency medical services improves the long term outcome in patients with out of hospital cardiac arrest, although the absolute increase of neurologically intact survival was minimal.

  2. Futility, autonomy, and informed consent.

    Science.gov (United States)

    Trau, J M

    1994-03-01

    If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

  3. Consent ain't anything

    DEFF Research Database (Denmark)

    Di Nucci, Ezio

    2016-01-01

    I argue against various versions of the 'attitude' view of consent and of the 'action' view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic ...

  4. Learning Ethics through Everyday Problems: Informed Consent

    Science.gov (United States)

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  5. Informed consent in psychotherapy.

    Science.gov (United States)

    Beahrs, J O; Gutheil, T G

    2001-01-01

    The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

  6. Ventricular ectopic activity is reduced in comatose survivors of out of hospital cardiac arrest treated with target temperature management at 36 degrees C compared to 33 degrees C

    DEFF Research Database (Denmark)

    Thomsen, J. H.; Kjaergaard, J.; Graff, Claus

    2015-01-01

    Introduction: The classification of myocardial infarction (MI) into five types was introduced in 2007 as a component of the Universal definition. However, data outlining clinical symptoms in different MI types are limited. Purpose: To describe the presenting symptoms in patients with type 1 MI vs....... type 2 MI. Methods: During January 2010-January 2011 unselected patients admitted to a single hospital with a catchment area of 300.000 residents were studied. All patients having cardiac troponin I measured on clinical indication were considered and had a supplementary history taken with focus...

  7. 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

  8. Click here to consent forever: Expiry dates for informed consent

    Directory of Open Access Journals (Sweden)

    Bart Custers

    2016-01-01

    Full Text Available The legal basis for processing personal data and some other types of Big Data is often the informed consent of the data subject involved. Many data controllers, such as social network sites, offer terms and conditions, privacy policies or similar documents to which a user can consent when registering as a user. There are many issues with such informed consent: people get too many consent requests to read everything, policy documents are often very long and difficult to understand and users feel they do not have a real choice anyway. Furthermore, in the context of Big Data refusing consent may not prevent predicting missing data. Finally, consent is usually asked for when registering, but rarely is consent renewed. As a result, consenting once often implies consent forever. At the same time, given the rapid changes in Big Data and data analysis, consent may easily get outdated (when earlier consent no longer reflects a user’s preferences. This paper suggests expiry dates for consent, not to settle questions, but to put them on the table as a start for further discussion on this topic. Although such expiry dates may not solve all the issues of informed consent, they may be a useful tool in some situations.

  9. Consent to research by mentally ill children and adolescents: The ...

    African Journals Online (AJOL)

    , the Act's statutory requirements relating to the informed consent to participation in clinical research by mentally ill children and adolescents in South Africa are examined. The necessity of doing clinical research in mentally ill children and ...

  10. Testing an alternate informed consent process.

    Science.gov (United States)

    Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

    2009-01-01

    One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

  11. Aspects of vulnerable patients and informed consent in clinical trials [Aspekte schutzbedürftiger Patienten sowie der Einwilligung nach Aufklärung in klinischen Prüfungen

    Directory of Open Access Journals (Sweden)

    Hundt, Ferdinand

    2013-01-01

    Full Text Available [english] Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google.Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. [german] Ziel: Diskussion der Aspekte der Einwilligung schutzbedürftiger Patienten nach Aufklärung zur Teilnahme an klinischen Prüfungen aus europäischem und deutschem Blick.Methoden: Wissenschaftliche Literaturrecherche via PubMed, Medline und Google. Ergebnis: Das

  12. 42 CFR 35.15 - Consent to operative procedures.

    Science.gov (United States)

    2010-10-01

    ... emergencies when the patient is physically or mentally incapable of consenting and the delay required to... operative procedure shall be undertaken unless the patient or, in the case of a minor or incompetent, his... or refusal of consent shall be made a part of the clinical record. ...

  13. Informed consent for braces.

    Science.gov (United States)

    Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-05-01

    The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

  14. Nudging and informed consent.

    Science.gov (United States)

    Cohen, Shlomo

    2013-01-01

    Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

  15. Cardiopulmonary resuscitation by trained responders versus lay persons and outcomes of out-of-hospital cardiac arrest: A community observational study.

    Science.gov (United States)

    Park, Yoo Mi; Shin, Sang Do; Lee, Yu Jin; Song, Kyoung Jun; Ro, Young Sun; Ahn, Ki Ok

    2017-09-01

    The study aims to compare bystander processes of care (cardiopulmonary resuscitation (CPR) and defibrillation) and outcomes for witnessed presumed cardiac etiology in OHCA patients in whom initial resuscitation was provided by dedicated trained responder (TR) versus lay person (LP) bystanders. Data on witnessed and presumed cardiac OHCA in adults (15 years or older) from 2011 to 2015 in a metropolitan city with 10 million persons were collected, excluding cases in which the information on TRs, bystander CPR, defibrillation, and clinical outcomes was unknown. Exposure variables were TRs who were legally designated with CPR education and response and LPs who were bystanders who witnessed the OHCA by chance. The primary/secondary/tertiary outcomes were a good cerebral performance category (CPC) of 1 or 2, survival to discharge, and bystander defibrillation. A multivariable logistic regression analysis was used to calculate the adjusted odds ratio (AOR) with 95% confidence intervals (CIs), adjusting for potential confounders. Of 20,984 OHCA events, 6475 cases were ultimately analyzed. The TR group constituted 6.4% of the cases, and the patients showed significantly better survival and a good CPC. From the multivariable logistic regression analysis of the outcomes, by comparing the TR group with the LP group, the AOR (95% CIs) was 1.49 (1.04-2.15) for a good CPC, 1.59 (1.20-2.11) for survival to discharge, and 10.02 (7.04-14.26) for bystander defibrillation. The TR group witnessed a relatively low proportion of OHCA but was associated with better survival outcomes and good neurological recovery through higher CPR rates and defibrillation of adults older than 15 years with witnessed OHCA in a metropolitan city. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. More care out of hospital? A qualitative exploration of the factors influencing the development of the district nursing workforce in England.

    Science.gov (United States)

    Drennan, Vari M

    2018-01-01

    Objectives Many countries seek to improve care for people with chronic conditions and increase delivery of care outside of hospitals, including in the home. Despite these policy objectives in the United Kingdom, the home visiting nursing service workforce, known as district nursing, is declining. This study aimed to investigate the factors influencing the development of district nursing workforces in a metropolitan area of England. Methods A qualitative study in a metropolitan area of three million residents in diverse socio-economic communities using semi-structured interviews with a purposive sample of senior nurses in provider and commissioning organizations. Thematic analysis was framed by theories of workforce development. All participants reported that the context for the district nursing service was one of major reorganizations in the face of wider National Health Service changes and financial pressures. The analysis identified five themes that can be seen to impact the ways in which the district nursing workforce was developed. These were: the challenge of recruitment and retention, a changing case-mix of patients and the requirement for different clinical skills, the growth of specialist home visiting nursing services and its impact on generalist nursing, the capacity of the district nursing service to meet growing demand, and the influence of the short-term service commissioning process on the need for long-term workforce development. Conclusion There is an apparent paradox between health policies which promote more care within and closer to home and the reported decline in district nursing services. Using the lens of workforce development theory, an explanatory framework was offered with factors such as the nature of the nursing labour market, human resource practices, career advancement opportunities as well as the contractual context and the economic environment.

  17. Consent in escrow.

    Science.gov (United States)

    Van der Loos, Kiah I; Longstaff, Holly; Virani, Alice; Illes, Judy

    2015-02-01

    Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.

  18. Placebo Effects and Informed Consent.

    Science.gov (United States)

    Alfano, Mark

    2015-01-01

    The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

  19. 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.

  20. 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.

  1. Informed consent and the readability of the written consent form.

    Science.gov (United States)

    Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

    2017-11-01

    Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

  2. 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 < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-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 < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

  3. Single versus Serial Measurements of Neuron-Specific Enolase and Prediction of Poor Neurological Outcome in Persistently Unconscious Patients after Out-Of-Hospital Cardiac Arrest - A TTM-Trial Substudy

    DEFF Research Database (Denmark)

    Wiberg, Sebastian; Hassager, Christian; Stammet, Pascal

    2017-01-01

    were included from sites participating in the TTM-trial biobank sub study. NSE was measured at 24, 48 and 72 hours after ROSC and follow-up was concluded after 180 days. The primary end point was poor neurological function or death defined by a cerebral performance category score (CPC-score) of 3 to 5...... of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA. In addition....... RESULTS: A total of 685 (73%) patients participated in the study. At day three after OHCA 63 (9%) patients had died and 473 (69%) patients were not awake. In these patients, a single NSE measurement at 48 hours predicted poor outcome with an area under the receiver operating characteristics curve (AUC...

  4. 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...... not be similar over the full spectrum of time to ROSC. This study investigated the possible beneficial effect of targeting 33°C over 36°C on the prognostic importance of time to ROSC. METHODS: In predefined sub-study of the TTM-trial (NEJM 2013) we investigated the relationship between time to ROSC, level of TTM...... and mortality and neurological outcome as assessed by the Cerebral Performance Category (CPC) scale and modified Rankin Scale (mRS) after 180 days. RESULTS: Prolonged time to ROSC was significantly associated with increased mortality with a hazard ratio (HR) of 1.02 per minute (95% CI 1.01-1.02). Level of TTM...

  5. 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.

  6. Informed consent -- Building consensus

    International Nuclear Information System (INIS)

    Lovenheim, R.

    1990-01-01

    The author shares his observations and offers an approach to 'building consensus' for what he believes is the only environmentally sound option, i.e., safe, permanent disposal of low-level radioactive waste (LLRW). Consensus does not mean unanimity, acceptance, or harmony. The low-level radioactive waste disposal issue is fraught with fear and hysteria. The paper discusses major emotions that fracture public opinion regarding this issue. The author defines consensus as the informed consent of LLRW disposal strategies by a majority of citizens whose cooperation is required to achieve the goals of environmentally sound solution. The political aspects are reviewed. The need for US Department of Energy to fulfill its importance technical assistance role is discussed

  7. Evaluating nurse understanding and participation in the informed consent process.

    Science.gov (United States)

    Axson, Sydney A; Giordano, Nicholas A; Hermann, Robin M; Ulrich, Connie M

    2017-01-01

    Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. This study examines hospital-based nurses' experiences and understandings of the informed consent process. This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of

  8. Nudging, informed consent and bullshit.

    Science.gov (United States)

    Simkulet, William

    2017-11-18

    Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © 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.

  9. 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.

  10. 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

  11. Making a difference: incorporating theories of autonomy into models of informed consent.

    Science.gov (United States)

    Delany, C

    2008-09-01

    Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

  12. Informed Consent and Capacity to Give Consent in Mental Disorders

    OpenAIRE

    Zeynep Mackali

    2014-01-01

    Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interacti...

  13. Informed Consent and Capacity to Give Consent in Mental Disorders

    Directory of Open Access Journals (Sweden)

    Zeynep Mackali

    2014-09-01

    Full Text Available Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2014; 6(3.000: 227-242

  14. Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

    Science.gov (United States)

    Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

    2017-11-01

    The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

  15. Are regional variations in activity of dispatcher-assisted cardiopulmonary resuscitation associated with out-of-hospital cardiac arrests outcomes? A nation-wide population-based cohort study.

    Science.gov (United States)

    Nishi, Taiki; Kamikura, Takahisa; Funada, Akira; Myojo, Yasuhiro; Ishida, Tetsuya; Inaba, Hideo

    2016-01-01

    Dispatcher-assisted cardiopulmonary resuscitation (DA-CPR) impacts the rates of bystander CPR (BCPR) and survival after out-of-hospital cardiac arrests (OHCAs). This study aimed to elucidate whether regional variations in indexes for BCPR and emergency medical service (EMS) may be associated with OHCA outcomes. We conducted a population-based observational study involving 157,093 bystander-witnessed, resuscitation-attempted OHCAs without physician involvement between 2007 and 2011. For each index of BCPR and EMS, we classified the 47 prefectures into the following three groups: advanced, intermediate, and developing regions. Nominal logit analysis followed by multivariable logistic regression including OHCA backgrounds was employed to examine the association between neurologically favourable 1-month survival, and regional classifications based on BCPR- and EMS-related indexes. Logit analysis including all regional classifications revealed that the number of BLS training course participants per population or bystander's own performance of BCPR without DA-CPR was not associated with the survival. Multivariable logistic regression including the OHCA backgrounds known to be associated with survival (BCPR provision, arrest aetiology, initial rhythm, patient age, time intervals of witness-to-call and call-to-arrival at patient), the following regional classifications based on DA-CPR but not on EMS were associated with survival: sensitivity of DA-CPR [adjusted odds ratio (95% confidence intervals) for advanced region; those for intermediate region, with developing region as reference, 1.277 (1.131-1.441); 1.162 (1.058-1.277)]; the proportion of bystanders to follow DA-CPR [1.749 (1.554-1.967); 1.280 (1.188-1.380)]. Good outcomes of bystander-witnessed OHCAs correlate with regions having higher sensitivity of DA-CPR and larger proportion of bystanders to follow DA-CPR. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Use of cardiocerebral resuscitation or AHA/ERC 2005 Guidelines is associated with improved survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis.

    Science.gov (United States)

    Salmen, Marcus; Ewy, Gordon A; Sasson, Comilla

    2012-01-01

    To determine whether the use of cardiocerebral resuscitation (CCR) or AHA/ERC 2005 Resuscitation Guidelines improved patient outcomes from out-of-hospital cardiac arrest (OHCA) compared to older guidelines. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases. We also hand-searched study references and consulted experts. Design: randomised controlled trials and observational studies. OHCA patients, age >17 years. 'Control' protocol versus 'Study' protocol. 'Control' protocol defined as AHA/ERC 2000 Guidelines for cardiopulmonary resuscitation (CPR). 'Study' protocol defined as AHA/ERC 2005 Guidelines for CPR, or a CCR protocol. Survival to hospital discharge. High-quality or medium-quality studies, as measured by the Newcastle Ottawa Scale using predefined categories. Twelve observational studies met inclusion criteria. All the three studies using CCR demonstrated significantly improved survival compared to use of AHA 2000 Guidelines, as did five of the nine studies using AHA/ERC 2005 Guidelines. Pooled data demonstrate that use of a CCR protocol has an unadjusted OR of 2.26 (95% CI 1.64 to 3.12) for survival to hospital discharge among all cardiac arrest patients. Among witnessed ventricular fibrillation/ventricular tachycardia (VF/VT) patients, CCR increased survival by an OR of 2.98 (95% CI 1.92 to 4.62). Studies using AHA/ERC 2005 Guidelines showed an overall trend towards increased survival, but significant heterogeneity existed among these studies. We demonstrate an association with improved survival from OHCA when CCR protocols or AHA/ERC 2005 Guidelines are compared to use of older guidelines. In the subgroup of patients with witnessed VF/VT, there was a threefold increase in OHCA survival when CCR was used. CCR appears to be a promising resuscitation protocol for Emergency Medical Services providers in increasing survival from OHCA. Future research will need to be conducted to directly compare AHA/ERC 2010

  17. Chest compression-only versus conventional cardiopulmonary resuscitation for bystander-witnessed out-of-hospital cardiac arrest of medical origin: A propensity score-matched cohort from 143,500 patients.

    Science.gov (United States)

    Kitamura, Tetsuhisa; Kiyohara, Kosuke; Nishiyama, Chika; Kiguchi, Takeyuki; Kobayashi, Daisuke; Kawamura, Takashi; Iwami, Taku

    2018-05-01

    Current cardiopulmonary resuscitation (CPR) guidelines do not define the optimal type of CPR (chest compression-only CPR [CCCPR] or conventional CPR with rescue breathing [CCRB]) to be performed by bystanders when they witness someone collapse. Using a nationwide database of 1.17 million patients who underwent out-of-hospital cardiac arrest (OHCA) in Japan, we enrolled consecutive bystander-witnessed OHCAs of medical origin with resuscitation attempts from January 2005 through December 2014. Multivariable logistic regression analysis was used to assess the association between the type of bystander CPR and the OHCA outcome after one-to-one propensity score matching for CCCPR versus CCRB. The primary outcome measure was one-month survival with a favorable neurological outcome, defined as a cerebral performance category of 1 or 2. Among 143,500 eligible patients with bystander-witnessed OHCAs receiving bystander-initiated CPR, 71.4% received CCCPR and 28.6% received CCRB. In the univariate analysis, the proportion of one-month survival cases with favorable neurological outcome was lower in the CCCPR group than the CCRB group (5.6% [5749/102,487] vs. 6.5% [2682/41,013], odds ratio [OR]; 0.85 [95% confidence interval {CI}; 0.81-0.89]). However, in the multivariate analysis, the CCCPR group showed a more favorable neurological outcome than the CCRB group (adjusted OR 1.12, 95% CI; 1.06-1.19). In the propensity-matched cohort, the CCCPR group also showed a more favorable neurological outcome than the CCRB group (7.2% [2894/40,096] vs. 6.5% [2610/40,096], adjusted OR 1.14, 95% CI; 1.09-1.22). CCCPR is an acceptable resuscitation technique for lay-rescuers responding to bystander witnessed OHCA of presumed medical origin. Copyright © 2018 Elsevier B.V. All rights reserved.

  18. 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.

    Science.gov (United States)

    Kjaergaard, Jesper; Nielsen, Niklas; Winther-Jensen, Matilde; Wanscher, Michael; Pellis, Tommaso; Kuiper, Michael; Hartvig Thomsen, Jakob; Wetterslev, Jørn; Cronberg, Tobias; Bro-Jeppesen, John; Erlinge, David; Friberg, Hans; Søholm, Helle; Gasche, Yvan; Horn, Janneke; Hovdenes, Jan; Stammet, Pascal; Wise, Matthew P; Åneman, Anders; Hassager, Christian

    2015-11-01

    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 not be similar over the full spectrum of time to ROSC. This study investigated the possible beneficial effect of targeting 33°C over 36°C on the prognostic importance of time to ROSC. In predefined sub-study of the TTM-trial (NEJM 2013) we investigated the relationship between time to ROSC, level of TTM and mortality and neurological outcome as assessed by the Cerebral Performance Category (CPC) scale and modified Rankin Scale (mRS) after 180 days. Prolonged time to ROSC was significantly associated with increased mortality with a hazard ratio (HR) of 1.02 per minute (95% CI 1.01-1.02). Level of TTM did not modify the association of time to ROSC and mortality, pinteraction=0.85. Prolonged time to ROSC was associated with reduced odds of surviving with a favorable neurological outcome for CPC (p=0.008 for CPC 1-2) and mRS (p=0.17, mRS 0-3) with no significant interaction with level of TTM. 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 outcome compared to targeting 36°C. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Effects of the administration of 2,3-butanedione monoxime during conventional cardiopulmonary resuscitation on ischaemic contracture and resuscitability in a pig model of out-of-hospital cardiac arrest.

    Science.gov (United States)

    Lee, Byung Kook; Jeung, Kyung Woon; Choi, Sung Soo; Park, Sang Wook; Yun, Seong Woo; Lee, Sung Min; Kim, Nan Yeol; Heo, Tag; Min, Yong Il

    2015-02-01

    Ischaemic contracture compromises the haemodynamic effectiveness of cardiopulmonary resuscitation and resuscitability. 2,3-Butanedione monoxime (BDM) reduced ischaemic contracture by inhibiting actin-myosin crossbridge formation in an isolated heart model. We investigated the effects of BDM on ischaemic contracture and resuscitation outcomes in a pig model of out-of-hospital cardiac arrest (OHCA). After 15min of untreated ventricular fibrillation, followed by 8min of basic life support, 16 pigs were randomised to receive either 2mlkg(-1) of BDM solution (25gl(-1)) or 2mlkg(-1) of saline during advanced cardiac life support (ACLS). During the ACLS, the control group showed an increase in left ventricular (LV) wall thickness from 10.0mm (10.0-10.8) to 13.0mm (13.0-13.0) and a decrease in LV chamber area from 8.13cm(2) (7.59-9.29) to 7.47cm(2) (5.84-8.43). In contrast, the BDM group showed a decrease in the LV wall thickness from 10mm (9.0-10.8) to 8.5mm (7.0-9.8) and an increase in the LV chamber area from 9.86cm(2) (7.22-12.39) to 12.15 cm(2) (8.02-14.40). Mixed model analyses of the LV wall thickness and LV chamber area revealed significant group effects and group-time interactions. Spontaneous circulation was restored in four (50%) animals in the control group and in eight (100%) animals in the BDM group (p=0.077). All the resuscitated animals survived during an intensive care period of 4h. BDM administered during cardiopulmonary resuscitation reversed ischaemic contracture in a pig model of OHCA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Augmented survival of out-of-hospital cardiac arrest victims with the use of mobile phones for emergency communication under the DA-CPR protocol getting information from callers beside the victim.

    Science.gov (United States)

    Maeda, Tetsuo; Yamashita, Akira; Myojo, Yasuhiro; Wato, Yukihiro; Inaba, Hideo

    2016-10-01

    To investigate the impacts of emergency calls made using mobile phones on the quality of dispatcher-assisted cardiopulmonary resuscitation (DA-CPR) and survival from out-of-hospital cardiac arrests (OHCAs) that were not witnessed by emergency medical service (EMS). In this prospective study, we collected data for 2530 DA-CPR-attempted medical emergency cases (517 using mobile phones and 2013 using landline phones) and 2980 non-EMS-witnessed OHCAs (600 using mobile phones and 2380 using landline phones). Time factors and quality of DA-CPR, backgrounds of callers and outcomes of OHCAs were compared between mobile and landline phone groups. Emergency calls are much more frequently placed beside the arrest victim in mobile phone group (52.7% vs. 17.2%). The positive predictive value and acceptance rate of DA-CPR in mobile phone group (84.7% and 80.6%, respectively) were significantly higher than those in landline group (79.2% and 70.9%). The proportion of good-quality bystander CPR in mobile phone group was significantly higher than that in landline group (53.5% vs. 45.0%). When analysed for all non-EMS-witnessed OHCAs, rates of 1-month survival and 1-year neurologically favourable survival in mobile phone group (7.8% and 3.5%, respectively) were higher than those in landline phone group (4.6% and 1.9%; pmobile phone calls were associated with increased 1-month survival in the subgroup of OHCAs receiving bystander CPR (adjusted odds ratio, 1.84; 95% CI, 1.15-2.92). Emergency calls made using mobile phones are likely to augment the survival from OHCAs by improving DA-CPR. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. [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.

  2. An approach to radiotherapy under informed consent

    International Nuclear Information System (INIS)

    Okazaki, Atsushi; Maehara, Tadayuki; Baba, Sadaaki; Nakamura, Yuji; Kamitani, Hiroshi

    1996-01-01

    Over the past two years, we have attempted to practice radiotherapy in accordance with the principle of informed consent. The procedure used in our radiotherapy, which consists of informing the patient of the seriousness of his or her disease (malignant and benign) and receiving signed consent forms, is a new system in Japan. This is a report of our experience with this system and its advantages and disadvantages. We are satisfied with the clinical results of the attempt. Radiotherapy in accordance with informed consent has now become routine at our hospital. We feel that this practice will produce the mutual enhancement of our responsibility to patients and their trust in us, and improve cure rates. In promoting mutual understanding between our patients and ourselves, we must keep in mind that we, radiation oncologists, are not only radiotherapists but also health-care providers in our capacity as medical and surgical doctors. It is also necessary to achieve the best radiotherapeutic system in Japan. (author)

  3. Informed consent: is it a myth?

    Science.gov (United States)

    Herz, D A; Looman, J E; Lewis, S K

    1992-03-01

    The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.

  4. Consented Autopsy and the Middle-East.

    Science.gov (United States)

    Kharoshah, Magdy A; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

    2017-02-01

    Consented autopsy is almost non-existent in the Middle-East where established social and cultural beliefs regarding the procedure might discourage family members from requesting a consented autopsy. Evidence suggests that new information is obtained from consented autopsies. It would not be in the best interest of medicine if social and cultural misconceptions succeed in erasing the existence of consented autopsies entirely.

  5. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-09-18

    Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Mixed method survey, interview and focus group study. 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). 12 UK children's hospitals. Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions

  6. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-01-01

    Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication

  7. Neurologic Function and Health-Related Quality of Life in Patients Following Targeted Temperature Management at 33°C vs 36°C After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial

    NARCIS (Netherlands)

    Cronberg, Tobias; Lilja, Gisela; Horn, Janneke; Kjaergaard, Jesper; Wise, Matt P.; Pellis, Tommaso; Hovdenes, Jan; Gasche, Yvan; Åneman, Anders; Stammet, Pascal; Erlinge, David; Friberg, Hans; Hassager, Christian; Kuiper, Michael; Wanscher, Michael; Bosch, Frank; Cranshaw, Julius; Kleger, Gian-Reto; Persson, Stefan; Undén, Johan; Walden, Andrew; Winkel, Per; Wetterslev, Jørn; Nielsen, Niklas

    2015-01-01

    Brain injury affects neurologic function and quality of life in survivors after cardiac arrest. To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest. In this multicenter, international, parallel group, assessor-masked

  8. Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

    Science.gov (United States)

    Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

    2017-05-24

    Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for

  9. Use of a geographic information system to identify differences in automated external defibrillator installation in urban areas with similar incidence of public out-of-hospital cardiac arrest: a retrospective registry-based study.

    Science.gov (United States)

    Fredman, David; Haas, Jan; Ban, Yifang; Jonsson, Martin; Svensson, Leif; Djarv, Therese; Hollenberg, Jacob; Nordberg, Per; Ringh, Mattias; Claesson, Andreas

    2017-06-02

    Early defibrillation in out-of-hospital cardiac arrest (OHCA) is of importance to improve survival. In many countries the number of automated external defibrillators (AEDs) is increasing, but the use is low. Guidelines suggest that AEDs should be installed in densely populated areas and in locations with many visitors. Attempts have been made to identify optimal AED locations based on the incidence of OHCA using geographical information systems (GIS), but often on small datasets and the studies are seldom reproduced. The aim of this paper is to investigate if the distribution of public AEDs follows the incident locations of public OHCAs in urban areas of Stockholm County, Sweden. OHCA data were obtained from the Swedish Register for Cardiopulmonary Resuscitation and AED data were obtained from the Swedish AED Register. Urban areas in Stockholm County were objectively classified according to the pan-European digital mapping tool, Urban Atlas (UA). Furthermore, we reclassified and divided the UA land cover data into three classes (residential, non-residential and other areas). GIS software was used to spatially join and relate public AED and OHCA data and perform computations on relations and distance. Between 1 January 2012 and 31 December 2014 a total of 804 OHCAs occurred in public locations in Stockholm County and by December 2013 there were 1828 AEDs available. The incidence of public OHCAs was similar in residential (47.3%) and non-residential areas (43.4%). Fewer AEDs were present in residential areas than in non-residential areas (29.4% vs 68.8%). In residential areas the median distance between OHCAs and AEDs was significantly greater than in non-residential areas (288 m vs 188 m, p<0.001). The majority of public OHCAs occurred in areas classified in UA as 'residential areas' with limited AED accessibility. These areas need to be targeted for AED installation and international guidelines need to take geographical location into account when suggesting

  10. Collaborative effects of bystander-initiated cardiopulmonary resuscitation and prehospital advanced cardiac life support by physicians on survival of out-of-hospital cardiac arrest: a nationwide population-based observational study.

    Science.gov (United States)

    Yasunaga, Hideo; Horiguchi, Hiromasa; Tanabe, Seizan; Akahane, Manabu; Ogawa, Toshio; Koike, Soichi; Imamura, Tomoaki

    2010-01-01

    There are inconsistent data about the effectiveness of prehospital physician-staffed advanced cardiac life support (ACLS) on the outcomes of out-of-hospital cardiac arrest (OHCA). Furthermore, the relative importance of bystander-initiated cardiopulmonary resuscitation (BCPR) and ACLS and the effectiveness of their combination have not been clearly demonstrated. Using a prospective, nationwide, population-based registry of all OHCA patients in Japan, we enrolled 95,072 patients whose arrests were witnessed by bystanders and 23,127 patients witnessed by emergency medical service providers between 2005 and 2007. We divided the bystander-witnessed arrest patients into Group A (ACLS by emergency life-saving technicians without BCPR), Group B (ACLS by emergency life-saving technicians with BCPR), Group C (ACLS by physicians without BCPR) and Group D (ACLS by physicians with BCPR). The outcome data included 1-month survival and neurological outcomes determined by the cerebral performance category. Among the 95,072 bystander-witnessed arrest patients, 7,722 (8.1%) were alive at 1 month, including 2,754 (2.9%) with good performance and 3,171 (3.3%) with vegetative status or worse. BCPR occurred in 42% of bystander-witnessed arrests. In comparison with Group A, the rates of good-performance survival were significantly higher in Group B (odds ratio (OR), 2.23; 95% confidence interval, 2.05 to 2.42; P < 0.01) and Group D (OR, 2.80; 95% confidence interval, 2.28 to 3.43; P < 0.01), while no significant difference was seen for Group C (OR, 1.18; 95% confidence interval, 0.86 to 1.61; P = 0.32). The occurrence of vegetative status or worse at 1 month was highest in Group C (OR, 1.92; 95% confidence interval, 1.55 to 2.37; P < 0.01). In this registry-based study, BCPR significantly improved the survival of OHCA with good cerebral outcome. The groups with BCPR and ACLS by physicians had the best outcomes. However, receiving ACLS by physicians without preceding BCPR significantly

  11. Informed consent in neurosurgery--translating ethical theory into action.

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-09-01

    Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

  12. Informed consent in neurosurgery—translating ethical theory into action

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-01-01

    Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

  13. Changing trends in informed consent

    OpenAIRE

    Victor Lim

    2014-01-01

    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 decisi...

  14. Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

    Science.gov (United States)

    Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

    2017-01-01

    Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

  15. Customising informed consent procedures for people with schizophrenia in India.

    Science.gov (United States)

    Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

    2015-10-01

    There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

  16. 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.

  17. An Alternative Consent Process for Minimal Risk Research in the ICU.

    Science.gov (United States)

    Terry, Melissa A; Freedberg, Daniel E; Morris, Marilyn C

    2017-09-01

    Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Prospective cohort study. Five ICUs within a tertiary care hospital. Newly admitted ICU patients 18 years old or older. We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

  18. Organ procurement: let's presume consent

    OpenAIRE

    Moustarah, F

    1998-01-01

    IN WINNING FIRST PRIZE in the Logie Medical Ethics Essay Contest in 1997, Dr. Fady Moustarah made a strong and compelling argument in favour of presumed consent in the procurement of donor organs. He stressed that a major education campaign will be needed when such a policy is adopted lest some people begin to regard physicians as "organ vultures."

  19. Informed consent for and regulation of critical care research.

    Science.gov (United States)

    Lemaire, François

    2008-12-01

    Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

  20. Pattern of informed consent acquisition in patients undergoing emergent endovascular treatment for acute ischemic stroke

    Science.gov (United States)

    Qureshi, Adnan I; Gilani, Sarwat; Adil, Malik M; Majidi, Shahram; Hassan, Ameer E; Miley, Jefferson T; Rodriguez, Gustavo J

    2014-01-01

    Background Telephone consent and two physician consents based on medical necessity are alternate strategies for time sensitive medical decisions but are not uniformly accepted for clinical practice or recruitment into clinical trials. We determined the rate of and associated outcomes with alternate consenting strategies in consecutive acute ischemic stroke patients receiving emergent endovascular treatment. Methods We divided patients into those treated based on in-person consent and those based on alternate strategies. We identified clinical and procedural differences and differences in hospital outcomes: symptomatic ICH and favorable outcome (defined by modified Rankin Scale of 0–2 at discharge) based on consenting methodology. Results Of a total of 159 patients treated, 119 were treated based on in-person consent (by the patient in 27 and legally authorized representative in 92 procedures). Another 40 patients were treated using alternate strategies (20 telephone consents and 20 two physician consents based on medical necessity). There was no difference in the mean ages and proportion of men among the two groups based on consenting methodology. There was a significantly greater time interval incurred between CT scan and initiation of endovascular procedure in those in whom in-person consent was obtained (117 ± 65 min versus 101 ± 45 min, p = 0.01). There was no significant difference in rates of ICH (9% versus 8%, p = 0.9), or favorable outcome at discharge (28% versus 30%, p = 0.8). Conclusions Consent through alternate strategies does not adversely affect procedural characteristics or outcome of patients and may be more time efficient than in-person consenting process. PMID:25132906

  1. Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

    Science.gov (United States)

    Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

    2014-04-01

    Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: pmotivational consent procedure for enhancing recall of study information and human research protections.

  2. 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.

  3. 32 CFR 634.8 - Implied consent.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Implied consent. 634.8 Section 634.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent to blood, breath, or urine tests....

  4. Consent to research by mentally ill children and adolescents: The ...

    African Journals Online (AJOL)

    2013-03-01

    Mar 1, 2013 ... permissible in minors be stated in terms of well-defined risk standards. Finally, the ... The assessment of a mentally ill child's or adolescent's capacity to consent to ... 'mental healthcare' may include research; furthermore its repeated ..... Clinical response and risk of reported suicidal ideation and suicide ...

  5. 42 CFR Appendix to Subpart B of... - Required Consent Form

    Science.gov (United States)

    2010-10-01

    ... final paragraphs: Use the first paragraph below except in the case of premature delivery or emergency... information about sterilization from _______ (doctor or clinic). When I first asked for the information, I was... signature on the consent form. In those cases, the second paragraph below must be used. Cross out the...

  6. Remote preenrollment checking of consent forms to reduce nonconformity.

    Science.gov (United States)

    Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

    2013-01-01

    In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information

  7. Should we nudge informed consent ?

    OpenAIRE

    Brooks, Thom

    2013-01-01

    Critics argue that nudge theory manipulates rather than respects the informed consent of patients. Cohen (2013) convincingly argues that this criticism falls short of the mark. But we might go one step further: nudges are not only defensible, there are also inescapable. Cohen’s defence should be more robust and recognize the importance of context and unavoidable framing effects. The question is not whether nudges are acceptable, but rather how they might be better employed to improve informed...

  8. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  9. Informed consent: a socio-legal study.

    Science.gov (United States)

    Rathor, M Y; Rani, Mohammad Fauzi Abdul; Shah, Azarisman Mohammad; Akter, Sheikh Fariuddin

    2011-12-01

    Informed consent [IC] is a recognized socio-legal obligation for the medical profession. The doctrine of IC involves the law, which aims to ensure the lawfulness of health assistance and tends to reflect the concept of autonomy of the person requiring and requesting medical and/or surgical treatment. Recent changes in the health care delivery system and the complex sociological settings, in which it is practiced, have resulted in an increase in judicial activity and medical negligence lawsuits for physicians. While IC is a well-established practice, it often fails to meet its stated purpose. In the common law, the standard of medical care to disclose risks has been laid down by the Bolam test- a familiar concept to most physicians, but it has been challenged recently in many jurisdictions. This paper aims to discuss some important judgments in cases of alleged medical negligence so as to familiarize doctors regarding their socio-legal obligations. We also propose to discuss some factors that influence the quality of IC in clinical practice. Literature review. The law of medical consent has been undergoing changes in recent years. Case law appears to be evolving towards a more patient centered standard of disclosure. Patient's expectations are higher and they are aware of the power of exercising their rights. Failure to obtain IC is one of the common allegations in medical malpractice suits. The medical professionals need to change their mindset and avoid claims of negligence by providing information that is "reasonable" in the eyes of the court.

  10. No Understanding, No Consent: The Case Against Alternative Medicine.

    Science.gov (United States)

    Shahvisi, Arianne

    2016-02-01

    The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

  11. Improving participant comprehension in the informed consent process.

    Science.gov (United States)

    Cohn, Elizabeth; Larson, Elaine

    2007-01-01

    To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

  12. Enhancing informed consent for research and treatment.

    Science.gov (United States)

    Dunn, L B; Jeste, D V

    2001-06-01

    Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

  13. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

    Science.gov (United States)

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2014-09-01

    Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

  14. 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.

  15. An audit cycle of consent form completion: A useful tool to improve junior doctor training.

    Science.gov (United States)

    Leng, Catherine; Sharma, Kavita

    2016-01-01

    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. 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. 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. 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.

  16. Clinical Trials

    Medline Plus

    Full Text Available ... What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might ... enroll in a clinical trial, a doctor or nurse will give you an informed consent form that ...

  17. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

    Science.gov (United States)

    Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

    2018-02-01

    Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

  18. Why persons choose to opt out of an exception from informed consent cardiac arrest trial.

    Science.gov (United States)

    Nelson, Maria J; Deiorio, Nicole M; Schmidt, Terri A; Zive, Dana M; Griffiths, Denise; Newgard, Craig D

    2013-06-01

    We sought to characterize persons who requested to opt out of an exception from informed consent (EFIC) cardiac arrest trial and their reasons for opting out. At one site of a multi-site, out-of-hospital, cardiac arrest EFIC trial (September 2007 - June 2009), persons who did not want to participate in the study could request an opt-out "NO STUDY" bracelet to prevent trial enrollment. We surveyed all persons who requested a bracelet by phone interview, web or mail. Opt-out bracelets were advertised in all public communication about the study, including community consultation and public disclosure efforts. Survey questions included demographics, Likert scale items about attitudes toward the trial and research in general, plus open-ended questions. We used descriptive statistics for standardized questions and qualitative analysis to identify common themes from open-ended questions. Sixty bracelets were requested by 50 individuals. Surveys were completed by 46 persons (92% response rate). Seventy percent of respondents agreed emergency research is important, but 87% objected to any research without consent. In the qualitative analysis, 5 overlapping themes emerged: questioning the ethics of EFIC research; concerns about how the study would impact end-of-life preferences; subjective emotions including sarcasm, anger, and allusions to past unethical research; negative reference to unrelated public health controversies; and objections to the study protocol based on misinformation. A primary reason for opting out from this EFIC trial was opposition to all research without informed consent, despite stated support for emergency research. Understanding the demographics and beliefs of persons opting out may aid researchers planning EFIC studies and help provide clarity in future EFIC-related community education efforts. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  19. Unanimous Constitutional Consent and the Immigration Problem

    OpenAIRE

    Josten, Stefan D.; Zimmermann, Klaus W.

    2004-01-01

    This paper utilizes the cross-cutting cleavages approach to evaluate the probability of a unanimous constitutional consent and, based on these results, discusses the implications of immigration on an existing constitutional consent. It is shown that previous conclusions of beneficial effects stemming from a multitude of political dimensions for a unanimous constitutional consent crucially depend on the assumption of an extreme mode of intrapersonal compensation of constitutional majority and ...

  20. Obtaining consent to oral and maxillofacial surgery.

    Science.gov (United States)

    Poswillo, D

    1989-09-01

    The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

  1. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

    Science.gov (United States)

    Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

  2. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

    Directory of Open Access Journals (Sweden)

    Go Yoshizawa

    2017-07-01

    Full Text Available The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in

  3. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

    Science.gov (United States)

    Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

  4. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    OpenAIRE

    Borello Alessandro; Ferrarese Alessia; Passera Roberto; Surace Alessandra; Marola Silvia; Buccelli Claudio; Niola Massimo; Di Lorenzo Pierpaolo; Amato Maurizio; Di Domenico Lorenza; Solej Mario; Martino Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a grap...

  5. 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

    -specific enolase (NSE) did not further improve the AUC. CONCLUSIONS: The allocated target temperature did not affect S100 to a clinically relevant degree. High S100 values are predictive of poor outcome but do not add value to present prognostication models with or without NSE. S100 measured at 24 h and afterward...

  6. [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

  7. The limits of informed consent.

    Science.gov (United States)

    1975-09-01

    The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

  8. 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

  9. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Borello Alessandro

    2016-01-01

    Full Text Available Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

  10. Informed consent and medical ordeal: a qualitative study.

    Science.gov (United States)

    Little, M; Jordens, C F C; McGrath, C; Montgomery, K; Lipworth, W; Kerridge, I

    2008-08-01

    Informed consent is a mainstay of clinical practice, with both moral and legal forces. Material disclosure about extreme treatments, however, is unlikely to convey the full impact of the experience of treatment. Informed consent may be flawed under such circumstances. The aims of this study were to compare expressed satisfaction with pretreatment information to satisfaction after experiencing autologous stem cell transplantation for recurrent lymphoma. A qualitative, narrative-based cohort study was conducted in a bone-marrow transplant unit of a teaching hospital at Westmead Hospital, Sydney, Australia. The cohort consisted of 10 transplant recipients and 9 of their nominated lay carers. The outcome measure was satisfaction expressed in narrative interviews at the time of transplantation and 3 months later. We used discourse-analytic techniques to examine the narratives. Both patients and carers expressed high satisfaction with the information given by individual clinicians and by speakers at a formal Information Day held before transplantation. At the first interview, neither patients nor carers commented much on the forthcoming ordeal of chemotherapy and bone marrow ablation, although all patients had undergone previous chemotherapy. At the second interview, the ordeal dominated the narratives and retrospective dissatisfaction with information was common. This study suggests that information about treatment theories and protocols can be satisfactorily communicated, but personal experience of suffering defies communication. This finding has serious implications for the practices involved in obtaining informed consent and for the very notion of informed consent.

  11. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent.

    Science.gov (United States)

    Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

    2008-08-01

    Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient's so-called "informed consent". Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as "complete information". In this report, a specific form for informed consent to FEES procedures, is proposed.

  12. Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

    Science.gov (United States)

    Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

    2011-01-01

    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, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to 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 standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

  13. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    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. 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. 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%. 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.

  14. Predicting Participant Consent in mHealth Trials – A Caregiver’s Perspective

    Directory of Open Access Journals (Sweden)

    Yvonne O'Connor

    2017-11-01

    Full Text Available Informed consent is sought prior to conducting a healthcare intervention on a person. When a healthcare intervention involves a young child, their caregiver is required to provide informed consent on their behalf. However, little is known on the behavioural intentions of participants to provide consent when a mobile health (mHealth intervention is involved in a clinical trial scenario. Understanding this phenomenon is important, without consent appropriate data may not be collected to empirically examine the implications of mHealth initiatives when delivering healthcare services to children in a ‘real world context’. The objective of this paper is to explore the behavioural intentions of caregivers to provide consent for children (under five years of age to participate in mHealth Randomised Control Trials (RCT in developing countries and subsequently develop a predictive model for consent giving. Data was captured vis-à-vis interviews with Malawian caregivers in Africa. The findings reveal that emotional response stimuli play a major role during the participant informed consent process resulting in the involvement (or not of a child within an RCT. The study contributes to, and opens up, avenues for critical research on the role of informed consent as part of RCT-related projects, especially concerning the involvement of children. This new knowledge may be leveraged to address participant uncertainties and subsequently improve the rate of paediatric recruitment in mHealth trial scenarios.

  15. 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.

  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,

  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,

  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,

  19. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, Sander; Becking, Alfred G.; Tuinzing, D. Bram

    2009-01-01

    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, attention was

  20. Use of informed consent with therapeutic paradox.

    Science.gov (United States)

    Farkas, M M

    1992-01-01

    Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

  1. 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.

  2. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    donation; and the protection of third parties, including the health care worker. .... closest available relative or, in the case of a minor, the consent of the medical ... case informed consent to the taking of blood is obviously mandatory. . Blood ...

  3. The History and Current Status of Informed Consent

    OpenAIRE

    Abimbola Farinde

    2014-01-01

    The purpose of this article is to examine the process of informed consent as it relates to the practice of psychology and as a part of Human relations Standards (3.10) of the American Psychological Association Ethical Principles of Psychologists and Code of Conduct. Before a psychologist provides any type of psychological service to a client/patient, whether it involves conducting research, administering a test or assessment/ therapy, counseling, clinical supervision, or providing consulting ...

  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. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

    Science.gov (United States)

    Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

    2015-02-07

    Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

  6. Informed consent in paediatric critical care research--a South African perspective.

    Science.gov (United States)

    Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

    2015-09-09

    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

  7. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

    Science.gov (United States)

    Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

    2015-08-01

    Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

  8. 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.

  9. Competence for Contract and Competence to Consent to Treatment

    OpenAIRE

    前田, 泰

    2008-01-01

    This paper analyzes assessing competence to consent to treatment. It focuses on problems of competence for contract and competence to consent to treatment. Finally, it discusses the degree of assessing competence to consent to treatment.

  10. Informed consent - a survey of doctors' practices in South Africa ...

    African Journals Online (AJOL)

    Informed consent - a survey of doctors' practices in South Africa. ... whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent ...

  11. 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

    of supportive measures to maintain a blood pressure ≥90 mmHg and/or clinical signs of end-organ hypoperfusion. In this post hoc analysis reported here, we further analyzed the 139 patients with shock at admission; all had been randomized to receive intervention at 33 °C (TTM33; n = 71) or 36 °C (TTM36; n = 68......). 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......: There was no significance difference between targeted temperature management at 33 °C or 36 °C on 180-day mortality [log-rank test, p = 0.17, hazard ratio 1.33, 95 % confidence interval (CI) 0.88-1.98] or ICU mortality (61 vs. 44 %, p = 0.06; relative risk 1.37, 95 % CI 0.99-1.91). Serum lactate and the extended...

  12. Improving the Proficiency of Research Consent Administrators

    Science.gov (United States)

    Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

    2015-01-01

    Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061