Evolution of European Ethical Resuscitation and End-of-Life Practices From 2014 to 2019: A Survey-based Comparative Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- END-OF-LIFE PRACTICES
研究概览
简要总结
In 2014, the authors conducted a survey of key opinion leaders on ethical resuscitation practices in 31 European Countries. The authors administered a comprehensive questionnaire to 1-2 "experts" from each country; subjectivity-related bias could not be excluded; however, the questionnaire was actually administered twice over a 6-month period to all participants, in order to confirm results' reproducibility. The questionnaire spanned across the following 4 domains: A: ethical practices (41 questions); B: access to best available care (39 questions); C: death diagnosis and organ donation (22 questions); and D: emergency care organization (40 questions). Accordingly, a 142-point scoring system of the responses of the participants was developed. Country-specific scores varied widely [e.g. score range of 1-41 for the ethical practices (domain A), and of 9-32 for emergency care organization (domain D)]. The authors also found a significant association between domain A and domain D scores (r2 = 0.42, P < 0.001).
The results of the 2014 survey highlighted variability across European countries in their approach to the ethics of resuscitation/end-of-life care. Results also indicated the presence of substantial need for improvements in all the aforementioned domains of practice and emergency care organization On the other hand, such evolution should be substantially augmented and accelerated by the above-described combination of new guidelines, RCT-based support of ACP, legislation / governmental policies, and educational activities.
With this study the authors undertake a methodologically improved version of the 2014 survey, in order to test the following hypotheses: 1) compared to 2014, there may be significant improvements in overall domain A to D scores for 2019, reflecting improved quality of ethical practice in the field of resuscitation/end-of-life care; 2) such progress, may be more marked in countries with "low" (i.e. below-average) domain A to D scores for 2014.
详细描述
Background and Rationale Recently published ethical practice guidelines focus on shared decision-making, patient-centred care, family-centred care, and prevention of patient distress after withdrawal of life-sustaining treatments (LSTs). Furthermore, several, recent randomized controlled trials (RCTs) have provided a robust evidence-base for complex and resource-demanding interventions such as advance care planning (ACP). ACP is also recommended by authors of major opinion articles. In addition, new laws, governmental statements, and educational activities across Europe support an autonomy-oriented end-of-life care.
In 2014, the authors conducted a survey of key opinion leaders on ethical resuscitation practices in 31 European Countries. The authors administered a comprehensive questionnaire to 1-2 "experts" from each country; subjectivity-related bias could not be excluded; however, the questionnaire was actually administered twice over a 6-month period to all participants, in order to confirm results' reproducibility. The questionnaire spanned across the following 4 domains: A: ethical practices (41 questions); B: access to best available care (39 questions); C: death diagnosis and organ donation (22 questions); and D: emergency care organization (40 questions). Accordingly, a 142-point scoring system of the responses of the participants was developed. Country-specific scores varied widely [e.g. score range of 1-41 for the ethical practices (domain A), and of 9-32 for emergency care organization (domain D)]. We also found a significant association between domain A and domain D scores (r2 = 0.42, P < 0.001).
The results of the 2014 survey highlighted variability across European countries in their approach to the ethics of resuscitation/end-of-life care. Results also indicated the presence of substantial need for improvements in all the aforementioned domains of practice and emergency care organization On the other hand, such evolution should be substantially augmented and accelerated by the above-described combination of new guidelines, RCT-based support of ACP, legislation / governmental policies, and educational activities.
With this study the authors undertake a methodologically improved version of the 2014 survey, in order to test the following hypotheses: 1) compared to 2014, there may be significant improvements in overall domain A to D scores for 2019, reflecting improved quality of ethical practice in the field of resuscitation/end-of-life care; 2) such progress, may be more marked in countries with "low" (i.e. below-average) domain A to D scores for 2014.
METHODS Ethics Committee Approval The study protocol will be submitted for approval to the Regional Ethics and Scientific Committee of Evaggelismos General Hospital of Athens, the Athens Eye Clinic, and the Athens Polyclinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
END-OF-LIFE PRACTICES
时间窗: Within one year of occurrence of cardiac arrest or need for treatment of an acute illness
Do-not-attempt-Cardiopulmonary Resuscitation; Advance Directives; Advance Care Planning; Terminal Analgesia; Termination of Resuscitation; Treatment Limitation; Euthanasia; Resuscitation continuation in the prospect of higher-level treatment (e.g. extracorporeal membrane oxygenation) or organ donation
END-OF-LIFE DECISIONS
时间窗: Within one year of occurrence of cardiac arrest or need for treatment of an acute illness
For both Adults and Children: Family participating in end-of-life decisions; End-of-life decisions are reached through processes of shared decision making
EMERGENCY CARE: Level of care provided by out-of-hospital emergency services
时间窗: Within 60 min of onset of cardiac arrest
Is there an alert system for lay rescuers? Is dispatcher assisted bystander cardiopulmonary resuscitation (CPR) practiced? Do ambulances offer basic life support and defibrillation, or advanced life support? is arrest resuscitation for traumatic cardiac arrest undertaken by specifically qualified personnel - are there specific criteria for withholding or terminating resuscitation?
EMERGENCY CARE: Registry reporting of cardiac arrest
时间窗: Within 24 hours of onset of cardiac arrest
Is there registry reporting of out-of-hospital and in-hospital cardiac arrest data?
EMERGENCY CARE: Enrollment in Emergency Research and Informed Consent
时间窗: Within 4 hours of onset of cardiac arrest
Is enrollment of adults in emergency observational or interventional (drug or non-drug) research legally allowed?
Organization of in-hospital resuscitation services
时间窗: Within 24 hours of onset of cardiac arrest
Are in-hospital Rapid Response Teams in place?; Is cardiopulmonary resuscitation (CPR) feedback, debriefing, audit applied? Is CPR training on the recently dead allowed / applied?
Family presence during Cardiopulmonary Resuscitation (CPR)
时间窗: Wtihin 6 hours of onset of cardiac arrest
Adults: Family present during CPR; Children: Parents present during CPR? Adults / Children: Other family members present during CPR?
ACCESS TO BEST RESUSCITATION AND POSTRESUSCITATION CARE
时间窗: Within 10 days of onset of cardiac arrest
Is access to best available care (including extracorporeal CPR wherever available) affected by age? race? religion? comorbidity? socioeconomic status? urban-rural (area of occurrence)? type of receiving hospital (out-of-hospital setting) or type of treating hospital (inhospital setting)? minority? language? high-risk presentation (e.g. Acute Physiology and Chronic Health Evaluation Score II score\>25 corresponding to \>50% mortality probability)? suicide attempt? knowledge of patient's wish against undergoing CPR? other?
EMERGENCY CARE: Education
时间窗: Within the preceding and subsequent 5-year period
Are there ongoing, theoretical and or practice training educational programs in the field of Ethics? Is certified cardiopulmonary resuscitation training mandatory for healthcare providers?
DIAGNOSIS OF DEATH AND ORGAN DONATION
时间窗: Within 60 min of cessation of resuscitaiton efforts
Who is legally allowed to diagnose death? Diagnostic criteria for death: Brain death criteria or Cardiorespiratory death criteria?
Organ donation
时间窗: Within 24 hours of surgical harvesting of organs
Is organ donation allowed? Is heart beating or non-heart beating organ donation applied?
EMERGENCY CARE: Access to resuscitation care in case of cardiac arrest in different areas / settings
时间窗: Within 60 min of onset of cardiac arrest
Availability of emergency numbers; ambulance arrival within 10 min in the out-of-hospital settings; resuscitation team arrival within 10 min in the inhospital setting
EMERGENCY CARE: Defibrillation
时间窗: Within 60 min of onset of cardiac arrest
Who is legally allowed to defibrillate? Are automated external defibrillators (AEDs) available in ambulances? other emergency service vehicles? different kinds of public places? Are AED data available in patient record? Are there specific, ongoing, public-access AED programs (e.g home AED? school AED? in-hospital AED)? Are there AED registries?
次要结局
未报告次要终点
研究者
Spyros D. Mentzelopoulos
Professor of Intensive Care Medicine
University of Athens