Keynote Address: Toward a Pragmatic Model for Community Consultation in Emergency Research

Under the Final Rule enacted in 1996 by the United States Food and Drug Administration and Office of Health and Human Services, community consultation and public notification are required when emergency research is to be conducted in the absence of prior informed consent by subjects. There is a dearth of published recommendations concerning the degree to which communities must be aware of the existence and parameters of a study for which informed consent might not be obtained prior to enrollment. It is argued that effective community consultation requires empirical measurement of the dynamics of community, and that ordinary notions of community may not capture the populations at greatest risk or those who might for other reasons figure most prominently in community consultation. A pragmatic approach to community consultation would establish benchmarks for such measures, and it is argued that such an approach is possible given the correct empirical measures.     

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.     

An Approach to Community Consultation Prior to Initiating an Emergency Research Study Incorporating a Waiver of Informed Consent

OBJECTIVES: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. METHODS: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. RESULTS: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. CONCLUSIONS: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.     

The Research on Community Consultation: An Annotated Bibliography

Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its intent is to provide an additional patient safeguard in emergency research circumstances when prospective informed consent is not possible. Investigators have reported that community consultation may be the most difficult aspect in implementing research trials using a wavier of or exception from informed consent. This article presents a brief overview of the sparse literature available on the process of community consultation since the inception of the current emergency research regulations. To determine if the process is meeting its goals, more research will be required.     

Implementation of Vertical Split Flow Model for Patient Throughput at a Community Hospital Emergency Department

BackgroundHospitals have implemented innovative strategies to address overcrowding by optimizing patient flow through the emergency department (ED). Vertical split flow refers to the concept of assigning patients to vertical chairs instead of horizontal beds based on patient acuity.ObjectiveEvaluate the impact of vertical split flow implementation on ED Emergency Severity Index (ESI) level 3, patient length of stay, and throughput at a community hospital.MethodsRetrospective cohort study of all ESI level 3 patients presenting to a community hospital ED over a 3-month period prior to and after vertical split flow implementation between 2018 and 2019.ResultsIn total, data were collected from 10,638 patient visits: 5262 and 5376 patient visits pre- and postintervention, respectively. There was a significant reduction in mean overall length of stay when ESI-3 patients were triaged with vertical split flow (251 min vs 283 min, p < 0.001).ConclusionsCommunity hospital ED implementation of vertical split flow for ESI level 3 patients was associated with a significant reduction in overall length of stay and improved throughput. This model provides a solution to increase the number of patients that can be simultaneously cared for in the ED without increasing staffing or physical space.     

Referral and Consultation in Emergency Medicine Practice

Since emergency physicians (EPs) frequently initiate referrals and consultations, accept patients in referral, and may provide consultation services, it is imperative that EPs fully understand these processes. Such an understanding improves communication and facilitates professional interactions and patient care. There is little published information concerning the significance and practice of referrals and consultations as they pertain to the EP. This article addresses referrals and consultations in relation to EPs. Specific recommendations are made for consultation initiation and execution. The dynamics and ethical/legal issues associated with initiating and accepting referrals and consultations are discussed.     

内分泌急诊会诊疾病分布及特点

  目的  探讨北京协和医院内分泌急诊会诊的疾病分布。  方法  回顾2010年3月1日至2011年2月28日北京协和医院内分泌科会诊医师处理的急诊会诊病例, 分析疾病分布情况及特点。  结果  内分泌急诊会诊患者共196例, 会诊病例最常见为电解质紊乱(69例, 35.2%), 其次为甲状腺疾病(56例, 28.6%)和糖代谢异常(49例, 25.0%)。电解质紊乱以低钠血症最为多见(65.2%)。冬春季节内分泌急诊会诊病例(110例)多于夏秋季节(86例), 电解质紊乱患者比例也高于夏秋季节(39.1%比30.2%)。重症医学科急诊会诊患者中, 甲状腺功能正常的病态综合征占28.6%。  结论  内分泌急诊会诊疾病谱发生一定变化, 电解质紊乱在内分泌急诊会诊中占重要地位, 应予高度重视。     

Patient Extrication Process for Urban Emergency Departments

ObjectivesThis project aimed to create and implement a safe and efficient role-based process to rapidly extricate traumatically injured persons transported to the emergency department via police transport or private vehicle.MethodsA simulation exercise was conducted with an interdisciplinary team of ED personnel, Philadelphia Police Department, and University of Pennsylvania police officers to identify the necessary steps to rapidly extricate traumatically injured individuals.ResultsThe simulation exercise identified several new processes needed to complete rapid extrications of traumatically injured individuals from private and police vehicles. These included a safe drop-off location, ED personnel role identification, proper personal protective equipment donning, 2 rapid extrication techniques, and a hard stop for weapon check by security before entering the emergency department.ConclusionsThrough simulation, the ED interdisciplinary team was able to develop a role-based safe and efficient rapid extrication process. Educating new ED personnel, security, and Pennsylvania police continues to facilitate ongoing safe rapid extrication practices in the emergency department.     

Patient Safety: A Curriculum for Teaching Patient Safety in Emergency Medicine

The last decade has witnessed a growing awareness of medical error and the inadequacies of our health care delivery systems. The Harvard Practice Study and subsequent Institute of Medicine Reports brought national attention to long-overlooked problems with health care quality and patient safety. The Committee on Quality of Health Care in America challenged professional societies to develop curriculums on patient safety and adopt patient safety teaching into their training and certification requirements. The Patient Safety Task Force of the Society for Academic Emergency Medicine (SAEM) was charged with that mission. The curriculum presented here offers an approach to teaching patient safety in emergency medicine.     

Models of Emergency Departments for Reducing Patient Waiting Times

In this paper, we apply both agent-based models and queuing models to investigate patient access and patient flow through emergency departments. The objective of this work is to gain insights into the comparative contributions and limitations of these complementary techniques, in their ability to contribute empirical input into healthcare policy and practice guidelines. The models were developed independently, with a view to compare their suitability to emergency department simulation. The current models implement relatively simple general scenarios, and rely on a combination of simulated and real data to simulate patient flow in a single emergency department or in multiple interacting emergency departments. In addition, several concepts from telecommunications engineering are translated into this modeling context. The framework of multiple-priority queue systems and the genetic programming paradigm of evolutionary machine learning are applied as a means of forecasting patient wait times and as a means of evolving healthcare policy, respectively. The models' utility lies in their ability to provide qualitative insights into the relative sensitivities and impacts of model input parameters, to illuminate scenarios worthy of more complex investigation, and to iteratively validate the models as they continue to be refined and extended. The paper discusses future efforts to refine, extend, and validate the models with more data and real data relative to physical (spatial–topographical) and social inputs (staffing, patient care models, etc.). Real data obtained through proximity location and tracking system technologies is one example discussed.     

EMS Providers and Exception from Informed Consent Research: Benefits, Ethics, and Community Consultation

Abstract Background. As attention to, and motivation for, emergency medical services (EMS)-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research. Objective. We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research. Methods. Using a qualitative design, 24 participants were interviewed including nationally registered paramedics and Virginia-certified emergency medical technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an EFIC trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation. Results. Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. The EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process. Conclusion. The EMS providers in our study valued research and were willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process.