[Medicolegal aspects in emergency medical care : Analysis of the frequency of advance health care directives and the influence on decision making in emergency medicine]. / Medizinrechtliche Aspekte bei der notärztlichen Versorgung : Analyse zur Häufigkeit von Patientenverfügungen und deren Einfluss auf notärztliche Entscheidungsprozesse.

BACKGROUND: Medical decisions in an emergency medical services (EMS) situation are always extremely time- critical and sensitive, potentially leading to medicolegal consequences. Advance health care directives (AHCDs) are crucial components in the patients' participative decision making. When a patient refuses resuscitation, and/or other life-extending treatments, emergency physicians face possible ethical, medical, and medicolegal conflicts. METHODS: As part of the RIMANO II Study [Risk Management Präklinische (prehospital) Notfallmedizin (emergency medicine)], all 18 "emergency physician bases" of the Berlin Fire Department were polled regarding the influence of AHCDs in regard to emergency medical decision making. The assessment was based on anonymous questionnaires. Furthermore, emergency medical suggestions for improvement of AHCDs were gathered. Descriptive statistics and qualitative methods were used for evaluation. RESULTS: A total of 112 responses from emergency physicians could be incorporated into the study. Anesthesiologists represented the largest group (n = 55, 49 %), followed by internists (n = 40, 36 %). The median length of experience in EMS was 7 years [interquartile range (IQR) 4-14 years]. Patients' "do not resuscitate" orders were obeyed in 78/112 cases (70 %, 95 % CI 69-78 %). In 49/112 cases (44 %, 95 % CI 34-53 %), the request to not be hospitalized was granted. The length of EMS experience, type of medical specialty, the number of EMS cases and ways in which AHCDs were handled were all contributing factors to the various emergency medical interventions. CONCLUSION: AHCDs appear to have an influence in the emergency medical decision process. However, it is presently unclear as to what a standardized and universally comprehensible AHCD should look like, in order to provide a framework that is both acceptable and necessary in a prehospital emergency medicine environment, ensuring medicolegal certainty for the parties involved.

[Enrolment of intensive care patients in clinical studies. Ethical, legal and organizational problems from an interdisciplinary point of view]. / Der Einschluss von Intensivpatienten in klinische Studien. Ethische, rechtliche und organisatorische Probleme aus interdisziplinärer Sicht.

Nowadays, most patients in hospital die in the intensive care unit from sepsis and multiple organ failure. Clinical research in this critically ill and vulnerable patient population bears a lot of ethical and legal problems; however, it remains a must in order to develop evidence-based diagnostic and therapeutic strategies for life-threatening diseases with special respect to limited health care resources. With regard to the Declaration of Helsinki, good clinical practice guidelines (GCP) from the European Medicines Agency (EMA) and the German medical drug law (AMG) this article discusses ethical and legal aspects of patient inclusion for clinical trials as well as incentives for appropriate patient recruitment from an interdisciplinary point of view.