Recruitment and Communication Process for Participation in the 2005 AEM Consensus Conference on the Ethical Conduct of Resuscitation Research: Methodology, Challenges, Lessons Learned

The 2005 Academic Emergency Medicine Consensus Conference, “Ethical Conduct of Resuscitation Research,” was designed with the goal of developing consensus on important issues for human subjects and researchers surrounding the 1996 federal regulations jointly published by the Department of Health and Human Services and the Food and Drug Administration and known as the Final Rule. These regulations, which guide the conduct of research using the emergency exception from informed consent or waiver of informed consent, have been the subject of much debate in the resuscitation research community. Therefore, the editorial board of Academic Emergency Medicine chose this topic as the subject of their annual consensus conference. This report outlines the methods by which individuals and organizations were recruited to participate, how the conference was advertised, and the way in which participants and nonparticipants were encouraged to communicate before and after the conference. The limitations and potential biases of these methods and activities are also presented.     

Confronting the Ethical Challenges to Informed Consent in Emergency Medicine Research

The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.     

DEFINING RESEARCH CRITERIA TO CHARACTERIZE MEDICAL NECESSITY IN EMERGENCY MEDICAL SERVICES: A CONSENSUS AMONG EXPERTS AT THE NEELY CONFERENCE

Objective. Researchers interested in ensuring appropriate use of emergency medical services (EMS) resources have attempted to define safe and effective protocols for triage either at the time of dispatch or after on-scene evaluation. Published work in this area is difficult to evaluate because protocols and outcome criteria vary from study to study. The goal of the Neely Conference was to bring together EMS experts to define a set of criteria to be used in research studies evaluating dispatch triage and field triage systems. Methods. Thirty-one experts in EMS systems and research attended a day-long workshop to assess the current literature regarding dispatch triage and field triage, and make recommendations to standardize methods used to evaluate future triage protocols. Participants were surveyed during the workshop; consensus analysis techniques were used to determine if a formal consensus was reached. A Bayesian posterior probability of 0.99 was required to consider responses a “consensus.” Results. Participants considered current evidence regarding the usefulness of EMS triage criteria to be “weak.” However, respondents agreed on a set of research criteria that could define the need for an EMS response and/or EMS transport. Field triage criteria were considered more plausible than dispatch criteria. Valid outcome criteria for assessing the effectiveness of triage protocols included ED assessment and the need for immediate surgery. Hospital admission, final diagnosis, and expert opinion were not considered adequate outcome measures. Conclusion. EMS experts agreed on a standard set of triage criteria and outcome measures for evaluating triage protocols supporting alternative forms of transport and care.     

Defining research criteria to characterize medical necessity in emergency medical services: a consensus among experts at the neely conference

Objective

Researchers interested in ensuring appropriate use of emergency medical services (EMS) resources have attempted to define safe and effective protocols for triage either at the time of dispatch or after on-scene evaluation. Published work in this area is difficult to evaluate because protocols and outcome criteria vary from study to study. The goal of the Neely Conference was to bring together EMS experts to define a set of criteria to be used in research studies evaluating dispatch triage and field triage systems.

Methods

Thirty-one experts in EMS systems and research attended a day-long workshop to assess the current literature regarding dispatch triage and field triage, and make recommendations to standardize methods used to evaluate future triage protocols. Participants were surveyed during the workshop; consensus analysis techniques were used to determine if a formal consensus was reached. A Bayesian posterior probability of 0.99 was required to consider responses a “consensus.”

Results

Participants considered current evidence regarding the usefulness of EMS triage criteria to be “weak.” However, respondents agreed on a set of research criteria that could define the need for an EMS response and/or EMS transport. Field triage criteria were considered more plausible than dispatch criteria. Valid outcome criteria for assessing the effectiveness of triage protocols included ED assessment and the need for immediate surgery. Hospital admission, final diagnosis, and expert opinion were not considered adequate outcome measures.

Conclusion

EMS experts agreed on a standard set of triage criteria and outcome measures for evaluating triage protocols supporting alternative forms of transport and care.     

Collaboration in Emergency Medicine Research: A Consensus Statement

The role of collaboration in medical research and how it applies to emergency medicine (EM) research are discussed. The guidance of the Division of Health Sciences Policy of the Institute of Medicine is reviewed. Application of the principles of collaborative efforts and recognition of each individual's contribution are overviewed. Emergency physicians can and should be invaluable contributors to collaborative research. Collaborative research relationships, whether established at individual institutions or through national clinical trials, must be developed deliberately. The specialty of EM must make the necessary commitment of time and resources to ensure that these occur.     

Resuscitation Research: Future Directions and Ethical Issues

Cardiopulmonary resuscitation research is a vital area of research that has made significant contributions to medical care over the last several decades. Abundant information currently exists in the medical literature, as a result of research in the areas of cardiac arrest and outcomes, physiology of cardiac arrest, pharmacologic treatments, mechanical interventions, and societal and ethical issues. Despite numerous clinical trials demonstrating physiologic benefit of various interventions, few interventions have had as much impact on outcomes of cardiac arrest as have improvements in out-of-hospital response times and rapid availability of medical treatment. Although abundant information exists regarding physiologic aspects of resuscitation, relatively little information exists about ethical, psychological, and social aspects of resuscitation. In addition to attempts to improve outcomes of cardiac arrest, researchers should also strive to improve the experiences of patients and families involved. These realities provide future strategies and directions for the best use of resuscitation research resources; although physiologic and pharmacologic research will always have significant roles in the improvement of medical care, the rapid delivery of out-of-hospital care and ethical issues will be indispensable areas of research focus in the future.     

A primer for clinical researchers in the emergency department: Part I: Ethical and regulatory background

Research is an important part of emergency medicine and provides the scientific underpinning for optimal patient care. Although increasing numbers of emergency physicians participate in research activities, formal research training is currently neither part of emergency physician training in Australia nor easily available for clinicians interested in clinical research. In a two‐part series, which is targeted at part‐time clinical researchers in the ED, we set out and explain the key elements for conducting high‐quality and ethical research. In Part I, we describe important underlying ethical principles for research in humans and explain key regulatory processes and documents pertaining to good clinical research practice in Australia. The ethics of research in children as a particularly vulnerable group will also be addressed. Part II will address important elements of research science and conduct.     

Research Directions in Emergency Medicine*

The goal of EM is to improve health while preventing and managing disease and illness in patients seeking emergency medical care. Improvements in emergency medical care and the delivery of this care can be achieved through credible and meaningful research efforts. Improved delivery of emergency medical care through research requires careful planning and the wise use of limited resources. To achieve this goal, EM must provide appropriate training of young investigators and attract support for their work. Promotion of multidisciplinary research teams will help the specialty fulfill its goals. The result will be the improvement of emergency medical care, which will benefit not only the patients whom EPs serve, but also, ultimately, the nation's health.     

Does the Emergency Exception from Informed Consent Process Protect Research Subjects?

Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define “protection”; therefore, it is not currently known whether or not subjects are protected under the current rules. 2) Care must be taken to protect not only the individual from harm during research but also to protect society from unregulated research in other countries and an inability to appropriately advance medical knowledge. 3) Some surrogate markers/methods of protection whose efficacies are debatable include data safety monitoring board activity, the community consultation and public notification (CC/PN) process, and institutional review board approval. 4) Minimal‐risk studies should be held to different standards of protection than those that involve more significant risk to the subject. 5) A handful of studies have been published regarding community consultation and notification, and the majority are case studies. Those that are specifically designed to discover the most successful methods are hindered by a lack of formal outcomes measures and tend to have negative results. 6) Follow‐up data from the CC/PN process should be disclosed to the Food and Drug Administration and incorporated into study designs. 7) Focus groups and/or random‐digit dialing have been suggested as promising methods for fulfilling the CC/PN requirements. 8) Studies need to be funded and performed that formally investigate the best means of CC/PN. 9) More funding for this research should be a priority in the emergency medicine and critical care communities. More data regarding terminated studies should be made available to the research community. 10) Quantifiable markers of success for CC/PN must be validated so that research may determine the most successful methods. 11) Data regarding subjects' and family members' experiences with exception from informed consent studies need to be obtained.     

Evaluating Professionalism in Emergency Medicine: Clinical Ethical Competence

While the teaching and assessing of technical skills have been an integral part of residency training, the demonstration of ethical and humanistic skills has been more or less left to chance. Only in the last two decades has the formal teaching of bioethics become an accepted component of Western medical education. In spite of the many ethics lectures, discussions, conferences, and courses, the clinical impact of this educational paradigm shift remains unclear. Most ethics assessments to date are conducted retrospectively by risk managers and attorneys. The few prospective evaluations of trainees have focused on single-researcher observations or student attitude surveys that are fraught with observer and recall biases, respectively. More reliable and valid methods of identifying clinical ethical competence are needed. This paper reviews a variety of evaluative tools and suggests a three-level approach to monitoring the ethical knowledge, capacity, and real-time performance of emergency medicine residents.     

Consensus statement: The role of emergency medical services in primary injury prevention

Injury is a leading cause of death and disability. Preventing injuries from ever occurring is primary injury prevention (PIP). The objective of this statement is to present the consensus of a 16-member panel of leaders from the out-of-hospital emergency medical services (EMS) community on essential and desirable EMS PIP activities. Essential PIP activities for leaders and decision makers of every EMS system include: protecting individual EMS providers from injury; providing education to EMS providers in PIP fundamentals; supporting and promoting the collection and utilization of injury data; obtaining support for PIP activities; networking with other injury prevention organizations; empowering individual EMS providers to conduct PIP activities; interacting with the media to promote injury prevention; and participating in community injury prevention interventions. Essential PIP knowledge areas for EMS providers include: PIP principles; personal injury prevention and role modeling; safe emergency vehicle operation; injury risk identification; documentation of injury data; and one-on-one safety education.     

Communicating with Subjects: Special Challenges for Resuscitation Research

In May 2005, Academic Emergency Medicine sponsored a one‐day consensus conference held in association with the 2005 Society for Academic Emergency Medicine meeting in New York City. The conference, entitled “Ethical Conduct of Resuscitation Research,” addressed a variety of issues regarding the successful conduct of research in acute care settings. A number of important breakout sessions were convened based on challenges specific to resuscitation research. “Communicating with Subjects” was one such session, dedicated toward perfecting the conduct of informed consent for research. The breakout session was attended by 15 insightful emergency medicine investigators, administrators, and ethicists. Issues of research information disclosure, subject comprehension, and the voluntariness of research participation were addressed. Consensus statements were developed and are discussed within this report.     

Ethical relationships in paediatric emergency medicine: Moving beyond the dyad

Most areas of health‐services research concentrate on a dyadic relationship between doctor and patient. In paediatric emergency medicine it may be necessary to focus on a more complicated relationship because the parents of the child play an important role in the delivery of medical services. This paper discusses the ethical principles in paediatric emergency medicine from the perspective of five disciplines: health economics, paediatrics, medical ethics, law and mental health. The general consensus is that the traditional dyadic model is inadequate and that a more complicated relationship is needed for the paediatric emergency setting, such as triadic, multiple‐dyadic or polyadic. Such models allow the inclusion of the parents and possibly other family members, medical providers and community members. If the paediatric setting is considered in such a framework, it may be possible to deliver a more socially beneficial medical service.     

Emergency medicine and futile care: Taking the road less travelled

Debate around medical futility has produced a vast literature that continues to grow. Largely absent from the broader literature is the role of emergency medicine in either starting measures that prove to be futile, withholding treatment or starting the end of life communication process with patients and families. In this discussion we review the status of the futility debate in general, identify some of the perceived barriers in managing futile care in the ED including the ethical and legal issues, and establish the contribution of emergency medicine in this important debate. We conclude that emergency physicians have the clinical ability and the legal and moral standing to resist providing futile treatment. In these situations they can take a different path that focuses on comfort care thereby initiating the process of the much sought after ‘good death’.     

Development of Geriatric Competencies for Emergency Medicine Residents Using an Expert Consensus Process

Background: The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource‐intensive. Evidence indicates that emergency physicians fail to provide consistent high‐quality care for elder ED patients, resulting in poor clinical outcomes. Objectives: The objective was to develop a consensus document, “Geriatric Competencies for Emergency Medicine Residents,” by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. Methods: This consensus‐based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. Results: In Phase I, participants (n = 363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n = 24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. Conclusions: The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. ACADEMIC EMERGENCY MEDICINE 2010; 17:316–324 © 2010 by the Society for Academic Emergency Medicine     

Establishing the Scope and Methodological Approach to Out-of-hospital Outcomes and Effectiveness Research

Outcomes research offers out-of-hospital medicine a valuable methodology for studying the effectiveness of services provided in the out-of hospital setting. A clear understanding of the history and constructs of outcomes research is necessary for its integration into emergency medical services research. This report describes the conceptual framework of outcomes research and key methodological considerations for the successful implementation of out-of-hospital outcomes research. Illustrations of the specific applications of outcomes research and implications to existing methodologies are given, as well as suggestions for improved interdisciplinary research.     

Ethical Controversies Surrounding the Management of Potential Organ Donors in the Emergency Department

Background

On a daily basis, emergency physicians are confronted by patients with devastating neurological injuries and insults. Some of these patients, despite our best efforts, will not survive. However, from these tragedies, there may be benefit given to others who are awaiting organ transplantation. Steps taken in the emergency department (ED) can be critical to preserving the option of organ donation in patients whose neurologic insult places them on a potential path to declaration of brain death. Much of the literature on this subject has focused on the utilitarian value of clinical interventions in the potential organ donor to optimize the likelihood of effective organ procurement.

Case Presentation

In this article, we present an actual case that reveals additional ethical perspectives to consider in how emergency physicians manage patients in the ED who can be confidently predicted to progress to death, as attested by neurologic criteria, and become organ donors. The case involves a patient with a devastating, nonsurvivable intracerebral hemorrhage who rapidly progressed to hemodynamic instability.

Discussion

This case reveals how the current organ donor referral and maintenance system raises ethical tensions for emergency physicians and ED personnel.

Conclusion

This process imposes limitations on communication with patient surrogate decision-makers while calling for interventions with the primary purpose of benefiting off-site patients awaiting transplantation.