National EMS Research Agenda 

 2 

TABLE OF CONTENTS

Abstract ............................................................................................................................................................4

Dedication........................................................................................................................................................4

Preface ..............................................................................................................................................................5

Definition of EMS for this Document........................................................................................................5

Federal Agencies Can Help Advance EMS Research................................................................................5

Executive Summary........................................................................................................................................7

Develop Researchers..................................................................................................................................7

Facilitate Collaboration..............................................................................................................................8

Establish a Reliable Funding Stream .......................................................................................................8

Establish Alternative Funding Sources ...................................................................................................9

Recognize The Need for EMS Research ................................................................................................9

View Research as Necessary for the Improvement of Patient Care.................................................10

Create Reliable Information Systems ....................................................................................................10

Enhance Ethical Approaches to Research ...........................................................................................11

Conclusion.................................................................................................................................................12

Introduction...................................................................................................................................................13

EMS Impact ..............................................................................................................................................13

Is EMS Cost-effective?............................................................................................................................14

Need for Outcome Measurement..........................................................................................................14

Organized Research Effort Needed ......................................................................................................14

History of EMS Research............................................................................................................................16

Federal Involvement in EMS Begins.....................................................................................................16

Beginning of EMS Research...................................................................................................................17

A Case Study In EMS Research.............................................................................................................18

The Present State of EMS Research ..........................................................................................................19

Appeals for Advancement ......................................................................................................................19

Peer Review Journals ...............................................................................................................................19

Methodological Constraints and Concerns ..........................................................................................19

Current Literature in EMS ......................................................................................................................19

Research Domains....................................................................................................................................22

Clinical Research..................................................................................................................................22

Systems Research.................................................................................................................................22

Education..............................................................................................................................................23

Overcoming the Barriers to EMS Research..............................................................................................24

Primary Barriers: Developing Researchers ...........................................................................................24

Primary Barriers: Funding.......................................................................................................................26

Secondary Barriers: Recognizing the Need for EMS Research.........................................................28

The Culture of EMS............................................................................................................................29

EMS Systems........................................................................................................................................29

EMS Education....................................................................................................................................29

The Public and Policy Makers ...........................................................................................................30

EMS Professionals...............................................................................................................................31

Secondary Barriers: Information Systems.............................................................................................31

Data Definitions...................................................................................................................................32

Hardware and Software Infrastructure.............................................................................................32

Data Set Linkages ................................................................................................................................33
National EMS Research Agenda 

 3 

Statistical Implications of Large Databases......................................................................................34

Secondary Barriers: Ethical Concerns ...................................................................................................34

Principles...............................................................................................................................................34

Informed Consent ...............................................................................................................................35

IRBs and EMS Research.....................................................................................................................36

Valuing Individual Autonomy............................................................................................................37

Summary.........................................................................................................................................................38

Appendix A: The National EMS Research Agenda Writing Team.......................................................40

Appendix B: Organizations Invited to Participate in the National Review Team ..............................41

Appendix C: Ethical Standards and IRB Requirements..........................................................................43

Appendix D ...................................................................................................................................................44

Inclusion Of Women And Minorities In Research Study Populations Involving Human Subjects

.....................................................................................................................................................................44

Inclusion Of Children As Participants In Research Involving Human Subjects............................44

Appendix E: Bibliographic List of Internet Links ...................................................................................45

Appendix F: Published EMS Randomized Clinical Trials......................................................................47

Reference List................................................................................................................................................56
National EMS Research Agenda 

 4 

ABSTRACT

Now, more than ever before, the spirit of the emergency services professional is recognized by 

people everywhere. Individuals from every walk of life comprehend the reality of the job these 

professionals do each day. Placing the safety of others above their own is their acknowledged 

responsibility. Rescue and treatment of ill and injured patients is their purpose as well as their 

gratification. The men and women who provide prehospital care are well aware of the 

unpredictable nature of emergency medical service (EMS). Prehospital care is given when and 

where it is needed: in urban settings with vertical challenges and gridlock; in rural settings with 

limited access; in confined spaces; within entrapments; or simply in the street, exposed to the 

elements. Despite the challenges, EMS professionals rise to the occasion to do their best with the 

resources available. 

Despite more than 30 years of dedicated service by thousands of emergency medical service 

professionals, academic researchers, and public policy makers, the nation’s EMS system is treating 

victims of illness and injury with little or no evidence that the care they provide is optimal. A 

national investment in the EMS research infrastructure is necessary to overcome obstacles 

currently impeding the accumulation of essential evidence of the effectiveness of EMS practice. 

Funding is required to train new researchers and to help them establish their careers. Financial 

backing is needed to support the development of effective prehospital treatments for the diseases 

that drive the design of the EMS system, including injury and sudden cardiac arrest. Innovative 

strategies to make EMS research easier to accomplish in emergency situations must be 

implemented. Researchers must have access to patient outcome information in order to evaluate 

and improve prehospital care. New biomedical and technical advances must be evaluated using 

scientific methodology. Research is the key to maintaining focus on improving the overall health of 

the community in a competitive and cost conscious health care market. Most importantly, research 

is essential to ensure that the best possible patient care is provided in the prehospital setting. 

The bravery and dedication of EMS professionals cannot be underestimated. Images of 

firefighters, EMS personnel and others going into danger, while others are evacuating will remain 

burned in our collective consciousness. These professionals deserve the benefit of research to 

assist them in providing the best possible care in the challenging circumstances they encounter. 

With this document, we are seeking support for elevating the science of EMS and prehospital 

care to the next level. It is essential that we examine innovative ways to deliver prehospital care. 

Strategies to protect the safety of both the patient and the public safety worker must be devised 

and tested. There are many questions that remain to be asked, many practices to be evaluated, and 

many procedures to be improved. Research is the key to obtaining the answers. 

DEDICATION

During the writing of this document, we were devastated by the premature death of two 

colleagues who unselfishly gave of their energy, enthusiasm, time and wisdom to work toward 

improving emergency medical care, trauma care and health care access. The loss of their 

knowledge, friendship and concern for others leaves a void in the EMS community. In the spirit 

with which they made their contributions to this discipline, we dedicate this document to Scott 

Frame, MD, and Keith Neely, PhD. Their contributions as members of the writing team for the 

National EMS Research Agenda are treasured, and we remember them fondly.
National EMS Research Agenda 

 5 

PREFACE

This document, commissioned by the National Highway Traffic Safety Administration and the 

Maternal and Child Health Bureau, describes the history and current status of EMS research. 

Within its pages, impediments to the growth of scientific investigation in the field are identified; 

and strategies are suggested for improving the quality and quantity of EMS research with the goal 

of providing a scientific foundation upon which to base current and future prehospital care. We 

describe a culture of EMS that has been slow to respond to, recognize, and utilize the potential 

that exists in technology and science today. The time for major advancement in the science and 

practice of EMS is here. Emergency Medical Service providers must be able to deliver state of the 

art care based on sound scientific knowledge. A number of us, our families, or our friends will at 

some point turn to local EMS providers for assistance; and we expect that they will provide us with 

the best care possible. 

It is our intent that this document be used by policy makers, EMS professionals and 

administrators, academicians, and interested members of the public as a rationale for the allocation 

of resources to EMS research. We envision a not-too-distant future in which funding is available to 

enable collaboration between EMS professionals and academicians, support multi-center research, 

facilitate the development of new researchers, support the effective use of data from national 

databases, integrate education and training regarding research into EMS practice, and to promote 

the evaluation of important treatments in an efficient and highly productive manner. 

It is time for change, time to make a difference, and time to limit injury and suffering within 

our capacity to do so. This document is intended to provide direction for the steps that must be 

taken to improve prehospital care for all Americans. 

DEFINITION OF EMS FOR THIS DOCUMENT

Emergency medical service is widely regarded as including the full spectrum of emergency care 

from recognition of the emergency, telephone access of the system, provision of prehospital care, 

through definitive care in the hospital. It often also includes medical response to disasters, 

planning for and provision of medical coverage at mass gatherings, and interfacility transfers of 

patients. However, for the purposes of this document, the definition of EMS is limited to the more 

traditional, colloquial meaning: prehospital health care for patients with real or perceived 

emergencies from the time point of emergency telephone access until arrival and transfer of care to 

the hospital. 

FEDERAL AGENCIES CAN HELP ADVANCE EMS RESEARCH

We call on federal agencies for their assistance in implementing the recommendations in the 

National EMS Research Agenda to enhance EMS research. A variety of federal agencies have 

supported EMS operations and research in the past and most continue to do so now. We hope 

that agencies such as the National Highway Traffic Safety Administration (NHTSA), the Agency 

for Healthcare Research and Quality (AHRQ), the Centers for Disease Control (CDC), the Health 

Research and Services Administration (HRSA), the National Fire Academy, the Department of 

Defense, and the National Institutes of Health (NIH) will continue to support EMS research by 

providing funding for educational programs, supporting the development of Centers of 

Excellence, and by acknowledging their commitment to EMS research through the inclusion of 
National EMS Research Agenda 

 6 

EMS related research opportunities among their requests for proposals to solve health problems 

for Americans. 
National EMS Research Agenda 

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EXECUTIVE SUMMARY

Imagine if you will, the public outcry that would ensue if a jumbo jet filled with passengers 

crashed every day in the United States. Regrettably, Americans no longer need to imagine images 

of disasters that result in the tragic loss of lives. However, each day, more people die of sudden 

cardiac arrest than would fill a Boeing 747.1 The most effective way to improve the odds of 

survival for sudden cardiac arrest is rapid defibrillation in the prehospital setting. As high quality 

Emergency Medical Services (EMS) developed during the 1970s, cardiac arrest survival rates 

increased from near nothing to about 20% in a few progressive cities.2 However, essentially no 

additional progress in survival from cardiac arrest has occurred since 1980.3 For children, the odds 

of survival remain abysmal. Less than 2% of children with prehospital cardiac arrest survive to 

leave the hospital.4

Trauma systems developed during the 1970s to address the inadequacy of care for victims of 

traffic crashes. EMS began to transport patients directly to regional trauma centers, often 

bypassing closer community hospitals. With the establishment of these regional trauma centers the 

odds of survival from motor vehicle crashes improved.5 This reduction in mortality from injury 

illustrates the value of having EMS professionals who understand how to use the emergency care 

resources available in each community. 

The vast majority of patients cared for by EMS, however, are not victims of cardiac arrest or 

major injury. They have illnesses or injuries that are not life threatening yet require access to 

medical care. EMS spends about five billion dollars each year, most of which is used for the 

provision of care to patients without life threatening conditions. Essentially no research has been 

performed to evaluate the effectiveness of EMS care for this group of patients. 

Progress in prehospital emergency patient care is needed. There is not enough high quality 

EMS-related research to drive improvements in patient outcome and that vast amounts of money 

are being spent for patient care with little rigorous evaluation of the effectiveness of that care. 

Methodologically sound research must be incorporated into all facets of the EMS system. This 

document, The National EMS Research Agenda, discusses the reasons why EMS research is important 

and emphasizes that the responsibility for examining EMS practice lies with all stakeholders in 

EMS. 

Performance of high quality EMS research is hindered by five impediments: 1.) A paucity of 

highly skilled researchers; 2.) Inadequate funding; 3.) Failure of EMS professionals to understand 

the importance of conducting EMS research and translating the findings into clinical practice; 4.) A 

lack of integrated information systems that provide for meaningful linkage with patient outcomes; 

5.) Logistical problems in obtaining informed consent. However, these barriers can be overcome. 

Develop Researchers 

High quality research will not occur unless there are individuals with the training and 

experience to accurately answer important questions. Currently, there are few expert researchers 

with an interest in EMS-related problems who have an understanding of the special challenges of 

conducting research in the EMS setting. Researchers with a wide variety of backgrounds including 

physicians, nurses, EMS professionals, public health experts, and scientists from other disciplines 

need to be encouraged to perform EMS research. 
National EMS Research Agenda 

 8 

Recommendation 1.

A large cadre of career EMS investigators should be developed and supported 

in the initial stages of their careers. Highly structured training programs with 

content directed toward EMS research methodologies should be developed. 

• Fellowship training programs capable of producing at least five EMS researchers per year 

are needed. Federal agencies are potential funding sources for these fellowships. Ideally, 

fellowship programs should be at least two years in length and should produce individuals 

with training and expertise in both research methods and funding acquisition. A doctoral 

degree (PhD, MD, etc.) should be a prerequisite for entry into the training programs. 

Program funding that includes institutional overhead and provides funds to ensure that 

research projects can be accomplished during the fellowship is essential. Individual training 

grants specifically targeted to EMS specific topics and system evaluation should be 

available. 

Facilitate Collaboration 

Effective EMS research necessitates creating working relationships between EMS researchers 

and social scientists, economists, health services researchers, epidemiologists, operations experts, 

clinical scientists, basic scientists, and researchers from other disciplines. Building these 

relationships requires a dedicated and committed core research group with access to reliable 

funding sources. 

Recommendation 2.

Centers of Excellence should be created to facilitate EMS research. These 

Centers will bring together experienced investigators, institutional expertise, 

and resources such as budgetary and information systems support. Centers will 

develop and maintain strong working relationships with local and regional EMS 

providers. As the focal point of these resources, Centers of Excellence will be 

the catalyst for collaboration between EMS systems and investigators. Such an 

environment will enable quality research to flourish. 

• One or more federal agencies should encourage the submission of proposals to develop at 

least five EMS Centers of Excellence. Each successful applicant should be funded for five 

years and be evaluated for renewal in a competitive application process. At least $1M 

should be devoted to development of research programs and infrastructure at each Center 

every year. Each Center should be located within an academic institution with ties to 

fellowship programs, career faculty researchers, multidisciplinary expertise, training 

programs, and other resources necessary to create research infrastructure. 

• One or more federal agencies should issue requests for proposals for at least two regional 

EMS research centers. The centers will organize and manage multi-system studies. The 

centers will form a network to facilitate access to data. Each center should operate on a 

five-year funding cycle with a competitive renewal process at the end of each five-year 

phase. 

Establish a Reliable Funding Stream 

The absence of funding for major EMS research represents a huge obstacle to improving the 

health of the public. Researchers cannot perform research without financial support. Most research 

accomplished to date within EMS has been conducted on shoestring budgets using volunteer 

labor, surplus supplies, and in kind contributions from hospitals, medical schools, and EMS 

agencies. 
National EMS Research Agenda 

 9 

Researchers also need dedicated time to perform EMS research. Since investigators frequently 

have competing roles in their work, they are pressured by their institutions to spend time on 

projects with the best reimbursement. Institutions will release investigators from other 

responsibilities to concentrate on EMS research if there are incentives and advantages for the 

organization. Despite the lack of a concerted and focused effort, the advances in EMS that have 

occurred historically are remarkable. However, failing to intentionally plan for and fund EMS 

research will likely delay discoveries that have the potential to save untold numbers of lives. 

Additional annual funding in an amount equal to 1% of the annual expenditures on EMS 

systems should be allocated for research into the effectiveness of those systems. This would mean 

approximately $50 million would be available for research each year. 

Recommendation 3.

Federal agencies that sponsor research should acknowledge their 

commitment to EMS research. 

• The federal government should increase its commitment and support of EMS research. 

• A joint announcement, similar to that issued for EMS Research concerning children (PS01-044), should be issued to provide opportunities for conducting EMS research under the 

sponsorship of a group of Federal agencies and to broadly describe the areas in which 

research is warranted. Each sponsoring agency should delineate and prioritize specific areas 

of interest and provide detailed information regarding application upon request. 

• The number of fully federally funded controlled clinical trials conducted in the EMS setting 

should increase by 25% each year for five years beginning in FY 2003. 

Establish Alternative Funding Sources 

The federal government should not be the only organization funding EMS research. Charitable 

foundations often offer unique and flexible funding, some of which should be dedicated to EMS 

research. State EMS lead agencies traditionally have not performed EMS research, but they should 

develop a serious commitment to improve patient care based upon evidence generated by high 

quality research. Ideally, state agencies should collaborate with at least one academic institution 

with expertise in EMS research. This collaboration will give state regulators, provider agencies, and 

EMS professionals access to individuals with expertise regarding grant applications and local 

research related issues. This academic collaborator should also offer guidance to the state lead 

agency on EMS research policies. 

Recommendation 4.

States, corporations, and charitable foundations should be encouraged to 

support EMS research. 

• State lead EMS agencies should promote prehospital research and facilitate the 

development of relationships and resources necessary for such studies. 

• Corporations and charitable foundations should provide funds for EMS related research. 

Recognize The Need for EMS Research 

In most fields of human endeavor, there is a significant time delay from a new discovery until 

the new methods are integrated into practice. EMS has a similar delay in implementation of 

research results. This delay can negatively impact patient care by perpetuating erroneous or 

ineffective practices and by inhibiting timely implementation of new effective treatments. 
National EMS Research Agenda 

 10 

The problem of translating research into practice is especially difficult in EMS. Most EMS 

professionals are not trained to critically evaluate new treatments and so they do not possess the 

skills to decide whether evidence truly supports their use. Therefore, EMS agencies should employ 

physicians with the expertise to evaluate new treatments and with the ability to develop and 

improve patient care protocols based on scientific findings. These physicians should work to 

educate EMS providers about the scientific process of linking research findings to clinical care. 

This relationship will provide an environment in which EMS personnel will be able to adopt new 

protocols with an understanding of how decisions were made. The culture within EMS needs to 

change to promote research and demand evidence before implementing new system modifications, 

medications, or drug therapies. 

Recommendation 5.

The efforts of EMS professionals, delivery systems, academic centers, and 

public policy makers should be organized to support and apply the results of 

research. 

• NHTSA should adopt a curriculum for EMS educators that teaches critical review of the 

scientific literature. 

• The National Fire Academy should continue to offer courses that convey the importance 

of EMS research and detail specific strategies by which fire services can facilitate EMS 

research. 

• Federal agencies should adopt or develop a curriculum for EMS administrative officers that 

will instill the importance of evidence-based decision-making, reduction of medical errors, 

and introspection into the culture of EMS organizations. 

• Appropriate research principles should be included in the core content of EMS education 

of first responders, EMT-Basics, EMT-Intermediates, and EMT-Paramedics. 

• National and state accrediting agencies for EMS educational programs should require that 

familiarity with the scientific literature be an essential component of EMS education 

programs. 

• Academic institutions should develop training pathways for EMS professionals interested 

in pursuing a research career. 

• EMS agencies should contribute to the research process by agreeing to collaborate with 

academic institutions. Collaboration should include assistance with field data collection and 

patient enrollment in research studies. 

View Research as Necessary for the Improvement of Patient Care 

EMS organizations and agencies of the federal government have an obligation to promote the 

development of a culture within EMS organizations that values and supports research. 

Recommendation 6.

EMS professionals of all levels should hold themselves to higher standards of 

requiring evidence before implementing new procedures, devices, or drugs. 

Create Reliable Information Systems 

EMS care delivery is unusual in that the patients are only under EMS care for a short time and 

may not be known by name. The lack of accurate patient identification presents a major challenge 

for the investigator wishing to measure outcomes. In addition because of the fragmented nature of 
National EMS Research Agenda 

 11 

the EMS delivery system, a given EMS agency may care for only a limited number of critically ill 

patients annually. Thus, the use of standardized data collection, data linkage, and reporting 

mechanisms are critical to allow patient outcomes to be compiled and meaningfully evaluated. 

Recommendation 7.

There should be standardized data collection methods at local, regional, state, 

and national levels. These data must be devoid of information that allows 

individual patient identification. All EMS provider agencies should adopt the 

Uniform Prehospital Data Elements for data collection. 

• NHTSA should sponsor a process to revise the Uniform Prehospital Data Elements at 

least every ten years. 

• State lead EMS agencies should require all EMS organizations in their jurisdictions to 

collect and submit to the state the Uniform Prehospital Data Elements at a minimum, and 

states should report that information to a national EMS data repository. 

• Federal agencies should promote the development and maintenance of a national EMS 

data repository to facilitate comparison of EMS system designs on the effectiveness of care 

delivery and improving patient safety. 

Enhance Ethical Approaches to Research 

In many emergency situations, time is inadequate to allow a critically ill patient or a surrogate 

decision maker to appropriately consider the risks and benefits of participating in a research study. 

There are two sets of regulations (Department of Health & Human Services and Food and Drug 

Administration) concerning the waiver of informed consent for medical research. These two sets 

of regulations have created some confusion among EMS researchers. Their implementation has 

exposed a fundamental problem associated with conducting research with subjects who cannot 

provide consent: There is a direct and irrevocable tension between protecting the rights of research 

subjects and the ability to investigate and improve the care rendered to future patients. The current 

federal regulations on research in emergency situations may have the unintended consequence of 

ensuring that EMS professionals will provide care that has not been scientifically validated. . New 

interventions to treat critical illness will continue to be introduced into the EMS environment, but 

difficulty in complying with the requirements of the consent regulations may impede the ability of 

EMS researchers to ensure that they have been studied appropriately first.

Recommendation 8.

The Food and Drug Administration (FDA) and the Office for Human Research 

Protections (OHRP) should work with EMS research stakeholders to evaluate the 

current requirements for exception from informed consent in emergency 

situations and to identify those requirements that are serious impediments to 

conducting EMS research. The FDA, OHRP, and EMS research stakeholders 

should work together to develop and propose EMS-specific consent strategies as 

well as appropriate revisions to the existing regulations to reduce the 

impediments to research while continuing to adequately protect research 

subjects. 

• There should be a national conference that brings together a large variety of EMS research 

stakeholders and regulators to recommend improvements to the emergency exception to 

informed consent procedures. 
National EMS Research Agenda 

 12 

• Based on the recommendations of the FDA and OHRP, Congress should amend the laws 

governing exception from informed consent for emergency research to reduce the 

regulatory burden and facilitate research while continuing to protect the rights of research 

subjects. 

• There should be educational programs that explain the consent process and recommend 

strategies by which EMS researchers can fulfill the requirements. 

• Educational programs that describe the difficulties in obtaining consent in the EMS 

environment, explain the emergency exception from consent process, and promote 

acceptance by and consistency among Institutional Review Board (IRBs) should be made 

available to IRB members and administrators.

Conclusion 

A national investment in EMS research infrastructure is necessary to overcome the obstacles 

currently impeding EMS research. Funding is needed to train new researchers and to establish their 

careers. Increased financial support is necessary to develop effective prehospital treatment for the 

diseases that drive the design of the EMS system, including injury and sudden cardiac arrest. 

Innovative strategies to make EMS research easier to accomplish in emergency situations must be 

legitimized and implemented. Researchers must have access to patient outcome information so 

that the impact of prehospital patient care can be evaluated and improved. Incorporating standard 

scientific methodology into the evaluation of biomedical and technical advances in prehospital care 

is crucial. Research is the key to maintaining an appropriate focus on improving the overall health 

of the community in a competitive and cost conscious health care market. Most importantly, 

research is essential to ensure that the best possible patient care is provided in the prehospital 

setting. 
National EMS Research Agenda 

 13 

INTRODUCTION

Medicine is primarily concerned with preventing and curing disease and relieving suffering. The 

Emergency Medical Service (EMS) is important part of the health care system, especially for 

people who suffer sudden and unexpected emergencies. In most communities, EMS is regarded as 

a public good. There are myriad approaches to offering EMS: it may be provided by the fire 

department, by another agency within the local government, by private entities that provide care 

within a local geographic area, by volunteer organizations, or by any number of other 

configurations. 

Emergency medical service is often regarded as including the full spectrum of emergency care 

from recognition of the emergency condition, requesting emergency medical aid, provision of 

prehospital care, through definitive care in the hospital. It may also include medical response to 

disasters, planning for and providing medical coverage at mass gatherings, and interfacility transfer 

of patients. However, for the purposes of this document, the examination of EMS is limited to the 

more traditional, colloquial definition: prehospital emergency care from the time of the request for 

medical aid until arrival at and transfer of care to the hospital. 

EMS care is provided by a variety of personnel, both paid and volunteer, who are trained at 

various levels of sophistication including first responders, EMT-Basic, EMT-Intermediate, and 

EMT-Paramedic. Basic level providers, trained in as little as 110 hours, provide services such as 

first aid, cardiopulmonary resuscitation, and patient stabilization. At the other end of the training 

spectrum, paramedics, who have acquired up to thousands of hours of training, bring highly 

sophisticated medical interventions that require critical thinking, such as endotracheal intubation 

and intravenous medication administration, to patients in the prehospital setting. EMS agencies 

often employ physicians with the expertise to evaluate new treatments and with the ability to 

develop and improve protocols based on scientific findings.6

EMS Impact 

While precise numbers are not available, EMS treats and transports approximately 25 to 30 

million patients per year. As an important point of entry into the healthcare system, EMS is in a 

unique position to impact those patients. It is logical to assume that prehospital intervention 

positively affects patient outcome, but this influence is difficult to quantify. For example, early 

defibrillation to victims of sudden cardiac arrest,7

 administration of nitroglycerin to patients with 

chest pain,8;9 and prehospital administration of fibrinolytic therapy to patients with myocardial 

infarction10 measurably saves lives. On the other hand, seemingly logical interventions such as the 

pneumatic anti-shock garment11 and endotracheal intubation of children12 may in fact cause harm. 

That so few EMS interventions have been subjected to outcome studies illustrates the lack of 

evidence for most prehospital therapies. More research is necessary to provide the evidence upon 

which EMS practices can be based. 

Misperceptions about EMS on the part of the public abound. In one study, fifteen percent of 

the patients in a hospital emergency department thought that paramedics were physicians.13 The 

entertainment media routinely depict cardiopulmonary resuscitation as resulting in good patient 

outcome, likely leading to unrealistic expectations among the lay public.14 Most members of the 

public believe that the use of warning lights and sirens saves clinically significant time in ambulance 

response and transport to the hospital, although several studies have suggested otherwise.15;16 No 

one has published an evaluation of the public’s perception of the importance of EMS research or 

the impact of research (or the lack thereof) on EMS practices. 
National EMS Research Agenda 

 14 

Is EMS Cost-effective? 

EMS systems are expensive to operate. The true economic burden of EMS is widely 

distributed and therefore well hidden from view. In the Medicare program alone, more than $2.5 

billion is spent for patient transportation. It is estimated that $5 billion is spent on EMS in the 

United States each year. More detail on the costs of the EMS system is available in the document 

describing the Negotiated Rule Making process on EMS reimbursement sponsored by the Health 

Care Financing Administration on the Internet at www.hcfa.gov/medicare/comstate.htm.17 The 

incremental costs and benefits of different levels of EMS care are poorly quantified18 and remain 

the subjects of ongoing studies.19;20

Need for Outcome Measurement 

Why are such large sums of money spent on a system with seemingly little evidence of 

efficacy?21 One reason is that efficacy information is difficult to define and obtain. Part of the 

problem lies in the uncertainty of how to measure patient outcome. An obvious outcome measure 

is mortality or lives saved. While seemingly easy to define, there is uncertainty over determining 

when a “save” occurs. Is it a “save” if a patient requiring CPR is admitted to the intensive care unit 

but dies after three days? Is it a “save” if that same patient dies in six months but was able to spend 

five of those months at home with his family? 

Mortality is often not a good measure of patient impact because it is an infrequent outcome in 

many disorders. Evaluation of an infrequent outcome requires either large numbers of patients, 

long periods of time, or sometimes both. EMS currently lacks the resources for these large 

research efforts. Disability, relief of suffering, utilization of health services, and costs may be better 

measures of outcome but are often even more complex to define and obtain. For example, 

attempting to answer a question such as, “what is the relative benefit of transporting a patient with 

a femur fracture to the hospital in the back of an ambulance with a leg splint versus by taxicab with 

no treatment?” can be challenging as one begins to define “benefit.” 

Accurately measuring outcome is made more challenging by the fact that the patient is 

delivered by EMS directly to a more comprehensive part of the health care system. Definitive care 

is seldom delivered in the field, but significant supportive care may take place there. Attribution of 

ultimate patient outcome to prehospital events is therefore confounded by the impact of 

interventions received by the patient later in the continuum of care. Measuring the impact of EMS 

patient care is further complicated by the concentration of specialized medical services such as 

major trauma care and tertiary pediatrics in a few experienced hospitals. When treating patients 

with problems such as major trauma, efficient transport to the optimal facility may be the most 

important prehospital intervention.22

Organized Research Effort Needed 

A well-organized EMS research effort is clearly needed to dramatically increase the evidence 

upon which prehospital patient care is based. “Public and private organizations responsible for 

EMS structures, processes and/or outcomes must collaborate to establish a national EMS research 

agenda. They should determine general research goals and assist with development of research 

funding sources.”23 

The authors of this document discussed the utility of creating a list of specific research topics 

that would be of value in EMS. However, there are compelling arguments against creating such a 

list. Individual investigators or research teams rather than committees usually generate the best 

new ideas. In addition, because of the rapid pace of change in the medical sciences, lists are usually 
National EMS Research Agenda 

 15 

out of date by the time they are published. The writing team agreed that valuable research topics 

would certainly include the following: 

• Ensuring proper and effective patient care. 

• Improving the quality of EMS care and systems. 

• Improving patient safety by reducing errors. 

• Analysis of the cost-effectiveness of systems and interventions. 

• Measuring the direct, indirect, and marginal costs of emergency medical services. 

• Providing information about the clinical aspects of emergency care, systems configuration 

and operation. 

• Encouraging effective injury prevention strategies and other public health measures. 

• Expanding the appropriate use of medical informatics in EMS. 

• Developing valid tools and methods for measuring the quality of EMS care and systems. 

• Learning effective ways to provide professional education, training, and retraining that will 

maximize skill acquisition and retention and improve practice patterns and patient 

outcomes. 

• Determining effective methods of public education that effect positive behavioral changes 

in the areas of injury prevention, basic emergency care skills, and the use of EMS systems. 

EMS systems must justify their role in the health care process. They must prove that the care 

and transportation they provide is necessary and delivered in an effective and economical manner. 

These mandates can only be achieved by true integration of the research process into the system. 

Research will lead to the development of more effective treatments, strategies for resource 

management that benefit the EMS system, and ultimately to improved patient care. 
National EMS Research Agenda 

 16 

HISTORY OF EMS RESEARCH

Modern EMS systems developed following the 1966 publication of a National Academy of 

Sciences paper entitled Accidental Death and Disability: The Neglected Disease of Modern Society24 and the 

work of J.F. Pantridge extending emergency cardiac care to the prehospital setting in the United 

Kingdom.25 Dr. Pantridge’s program in Northern Ireland inspired the pioneering efforts of 

physicians such as Eugene Nagel in Miami and Leonard Cobb in Seattle to extend emergency 

cardiac care to the patient’s home.26;27

Federal Involvement in EMS Begins 

Accidental Death and Disability called for improving prehospital trauma care.24 As a result, 

Congress passed the Highway Safety Act in 1966, which established the National Highway Traffic 

Safety Administration (NHTSA) within the Department of Transportation. Because motor vehicle 

crash injuries constituted a substantial proportion of the EMS patient load, NHTSA was charged 

with improving EMS systems by administering grants for ambulance purchases, communications 

systems, and training programs, and with supporting other traffic related system improvements. 

NHTSA furthered its role in the advancement of prehospital care by developing national standard 

curricula for the education of EMS personnel and by lending its foresight, leadership, and 

commitment to the development of EMS systems. 

In 1973, Congress enacted the EMS Systems Act (Public Law 93-154). This Act provided 

funding for the development of regional EMS systems and authorized a program of research in 

emergency techniques, methods, devices and delivery. The National Center for Health Services 

Research (NCHSR), predecessor to the Agency for Healthcare Research and Quality (AHRQ), was 

responsible for administering this applied research effort. Between 1974 and 1981, the NCHSR 

supported approximately 50 EMS demonstration projects. 

In 1984, Congress established the federal EMS for Children (EMSC) program as a 

demonstration grant co-sponsored by NHTSA and housed in the Maternal Child Health Bureau. 

The Institute of Medicine issued a 1993 report on EMS for children that identified several priority 

areas, including a call for additional data collection, evaluation and research.28 Since the report was 

issued, the EMSC program has played a valuable part in advancing the cause of EMS research and 

in establishing directions for the future of EMS for children. In addition to providing funding and 

leading EMS initiatives, the program has developed a consensus document of research priorities, 

including identifying appropriate outcomes.29

In January 2001, seven federal agencies participated on an interagency program announcement, 

PA-01-044, titled Emergency Medical Services for Children Research. The topics to be studied 

include asthma, traumatic brain injury, and violence prevention. HRSA’s other federal partners in 

this effort (besides the Agency for Healthcare Research and Quality) were the National Institute 

for Occupational Safety and Health at the Centers for Disease Control and Prevention, as well as 

the National Heart, Lung and Blood Institute, National Institute for Child Health and Human 

Development, National Institute on Drug Abuse, National Institute of Mental Health, and the 

National Institute of Nursing Research, all from the National Institutes of Health. 

Other EMSC initiatives providing funding for EMS research include the support of the 

development of a National EMS Database jointly with NHTSA, awards to promote pediatric 

patient safety research in EMS, and the EMSC Network Development Demonstration Project 

(NDDP) Cooperative Agreement Grant (CDA#93.127L). The $1.8 million NDDP grant is being 

supported by the EMSC program in collaboration with the Division of the Research, Training and 
National EMS Research Agenda 

 17 

Education of the Maternal and Child Health Bureau. NDDP will support the best proposals to 

create research networks for performing high quality collaborative research on EMSC topics. Each 

research node will collect data from participating EDs in its area in order to get answers to 

pediatric emergency care research questions which were previously difficult to obtain. 

Beginning of EMS Research

During the late 1960’s, a growing number of EMS organizations around the world recognized 

that their ambulance services required advancement.30-34 Improvements in these systems were 

generally implemented without undergoing unbiased evaluation. For example, in 1966 an editorial 

in the British Medical Journal suggested that patients were dying of suffocation because ambulance 

service personnel were inadequately trained in airway management.30 EMS systems responded by 

introducing airway interventions formerly reserved for the hospital emergency department directly 

into the field setting. The prevailing attitude was that if an intervention was useful and effective in 

the hospital then it would be similarly useful in the prehospital environment. 

However, study results from one particular environment do not necessarily translate 

successfully to other environments and may not apply to other populations. Studies of efficacy (i.e., 

does something work under ideal conditions) do not necessarily indicate effectiveness (i.e., does it 

work in the real world). Interventions that work in the emergency department might not work in 

the ambulance, interventions that work in an ambulance might not work in a helicopter, and 

interventions that work in a moderately busy suburban EMS system may not work in an 

overburdened urban system. While it makes intuitive sense to take the emergency department to 

the patient, the compressed time frame for patient evaluation, the lack of many medical 

technologies such as x-rays, and the limited training of EMS professionals sometimes alter the riskbenefit ratio.35 

The earliest scientific analyses of EMS practices were limited in scope and methodology. Only 

three EMS-related randomized, controlled clinical trials were published before 1980.36-38 The 

remaining published studies were observational, descriptive, or retrospective in nature. Many 

studies were designed simply to demonstrate that certain hospital interventions, such as inserting a 

peripheral intravenous line or performing defibrillation, could be extended to the prehospital 

environment.25;39 Often the results indicated that the intervention could be applied in the field but 

gave no clue as to whether the patient benefited. For example, the early studies of the pneumatic 

anti-shock garment (PASG) and the esophageal obturator airway (EOA) observed physiologic 

responses such as increased blood pressure but did not evaluate the relationship of the physiologic 

changes to patient outcome.40;41 

The science of EMS has been criticized for providing insufficient evidence to support many of 

its practices. In 1989, Ronald Stewart advised that EMS must begin to prove itself through 

research.42 Nearly a decade later, Michael Callaham repeated the sentiment and observed, “It is 

possible to document exactly how much scientific support there is for the efficacy of our present 

scope of EMS practice, and it is impressively deficient.”21 

Progress towards a scientific foundation for EMS practices is slow, in part due to the inherent 

difficulties in performing research in the field, but also because of the lack of research 

infrastructure in EMS systems and the absence of funded researchers working in this field. 

Thousands of people dedicated to improving prehospital care including physicians from a variety 

of specialties, EMS providers, allied health professionals, public leaders, and even the lay public 

have been working both individually and through myriad professional organizations toward 

creating that scientific basis. Most research accomplished to date within EMS has been conducted 
National EMS Research Agenda 

 18 

on shoestring budgets using volunteer labor, surplus supplies, and in kind contributions from 

hospitals, medical schools, and EMS agencies. 

A Case Study In EMS Research 

The experience with the pneumatic anti-shock garment (PASG) is illustrative of the early 

research experience in EMS. Many EMS physicians promoted its use in a wide variety of medical 

and surgical conditions with little evaluation of its effectiveness,43;44 while others were less 

convinced of its value.45 PASG use became widespread, with many jurisdictions requiring them as 

minimal equipment for ambulances at an expense of several thousand dollars per vehicle. Several 

years after gaining acceptance as a standard item to be stocked on ambulances, a single, 

randomized clinical trial found that application of the PASG to victims of truncal penetrating 

trauma in an urban environment actually worsened patient outcome.46 In the wake of that study, 

the popular sentiment rapidly shifted to renounce the use of the PASG. Yet, a comprehensive 

review of the literature established that some patients might in fact benefit from use of the 

PASG.11 This is but one example in which misinformation and the lack of scientific knowledge 

about optimal patient care has confused clinicians and left them floundering to provide the best 

care without the guidance of good science. 

Decisions about the effectiveness of any intervention must be based upon reliable evidence. 

This requires that there be enough studies to provide sufficient information upon which, among 

other things, effectiveness and generalizability of the intervention can be determined. Due to the 

paucity of available research, EMS decision makers have been forced to make judgments based 

upon limited evidence. Two current issues in which this problem is readily apparent are pediatric 

airway management, where one controlled trial has questioned the efficacy of endotracheal 

intubation;12 and the use of amiodarone for cardiac arrest, where another randomized controlled 

trial has suggested a positive effect.47 While both of these studies are examples of methodologically 

sound research and add to the overall understanding of their respective issues, additional high 

quality investigations are needed. 
National EMS Research Agenda 

 19 

THE PRESENT STATE OF EMS RESEARCH

Appeals for Advancement 

EMS research is still in an early stage of maturation. A concerted effort to improve the scant 

scientific knowledge that serves as the basis for EMS practice is now mandatory.23;48 There has 

been a strong plea for improving the science within the field.49 The leaders of the Future of 

Emergency Medicine Research conference, sponsored by the Emergency Medicine Foundation, the 

Society for Academic Emergency Medicine, and the Association for Academic Chairs of 

Emergency Medicine, emphasized the need for individual and program commitment to the process 

of advancing research in emergency medicine. The conference report called for the necessary 

resources to enhance emergency medicine research through training, academia, funding, national 

support, multi-center research and development of new outcome measures.50

The Society for Academic Emergency Medicine EMS Task Force published a paper in 1999 

entitled EMS Systems: Foundations for the Future, which called for the specialty of emergency medicine 

to foster the continued development of EMS administration, education, and research.48 The report 

pointed out, “The benefits of prehospital care never have been demonstrated scientifically in many 

medical and surgical conditions. The time has come to prove the value of field care and determine 

the most cost-effective and medically sound treatments.”51

Peer Review Journals

Several peer-review medical journals devoted to EMS are now in publication including 

Prehospital Emergency Care and Prehospital and Disaster Medicine. In addition, general emergency 

medicine journals, including Annals of Emergency Medicine, now contain sections devoted to EMS 

research. There are also subspecialty journals within emergency medicine, such as Pediatric 

Emergency Care and the Air Medical Journal, that publish material related to EMS and effectively 

reach an audience involved in at least some aspect of prehospital care of patients. The emergence 

of these journals holds an important position in the history of EMS. Their existence shows that 

EMS research is valuable to the readers of those publications. 

Methodological Constraints and Concerns 

Although the science of EMS has advanced, many concerns remain. Most of the problems are 

not very different than issues with which other fields of medicine have struggled. For example, 

there are not enough controlled clinical trials of new treatments for patient problems encountered 

by EMS professionals. 

One methodological concern in EMS research is that the best outcome measures for various 

study questions are not clear.51 While survival may be an appropriate outcome measurement for 

sudden cardiac arrest, it would not be a meaningful outcome measurement for studies of minor 

trauma or respiratory distress because almost all patients will survive independent of any EMS 

intervention. Further, appropriate measurements of pediatric patient outcomes are sometimes 

different from those that are commonly used for adults.29

Current Literature in EMS 

Several reviewers have evaluated the quality and quantity of EMS research over the last 30 

years. Figure 1 shows an appraisal of the number of EMS related manuscripts published each year 

since 1965. The data in the figure are the result of an extensive search of multiple National Library 

of Medicine (NLM) research databases including MEDLINE and CINAHL. Although the number 

of EMS publications is not vast, the volume has been increasing steadily over the years at a 

respectable rate. Since 1970, the quantity of published EMS literature increased at a rate of 
National EMS Research Agenda 

 20 

approximately 200 articles per decade. The increase is likely due to increased awareness of the need 

for study in this area and also the appearance of several new journals dedicated to the specialty. If 

this growth rate remains constant, about 900 articles will be published in the year 2010. 

There have been many pleas to increase the number of clinical trials,52;53 and some have made 

eloquent points about the dangers inherent in the existence of so few methodologically sound 

studies.21 Concern for the lack of scientific support for many pre-hospital interventions, lack of 

uniform reporting methods, monitoring of outcomes and adverse effects invokes the need for 

reexamination of EMS practice.48;54;55

While randomized controlled trials may be the gold standard for clinical studies, they are not 

appropriate for every question. For example, randomized trials are not appropriate for studies of 

harm, prognosis, or diagnostic devices.56;57 Randomized controlled trials can also be more 

challenging to implement in systems and educational settings. Indeed, very little educational 

research utilizes randomized-controlled designs.58 

Although the body of published EMS literature is growing steadily, there is much concern 

about the substance of the material. In a recent review of the EMS literature published between 

1985 and 1994, the most frequently used study design was the case series, which accounted for 44 

percent of the publications. The majority of EMS studies published during that ten-year period 

(53%) were retrospective in nature.55 
National EMS Research Agenda 

 21 

Figure 2 shows the results of an analysis conducted for the National EMS Research Agenda 

project in which the NLM designated study type was used to classify the 9,232 identified EMS 

related citations published between 1966 and 2000. These categorizations are estimates, as not all 

studies included a design designation. Despite this limitation in the analysis, it remains apparent 

that the overwhelming majority of the published EMS literature is not research reports but rather 

historical articles, editorials, consensus development pieces, biographies, monographs, or 

guidelines. Of those study types recognized as “research”, reviews (n=593; 6% of total) reigned 

over clinical trials (n=331; 4%) and meta-analyses (n=15; 0.1%). Evaluated on the basis of the 

strength of the study design, the majority of EMS studies published in peer-reviewed journals use 

unpersuasive methodology. The bulk of the published research can be characterized by its 

overwhelming propensity to use simple descriptive methods and retrospective techniques. 

With the understanding that randomized clinical trials may not always be the most appropriate 

design for scientific validation of prehospital treatments or system changes, the number of 

randomized trials conducted has been used as a surrogate marker for the level of sophistication in 

research. With this limitation in mind, the proportion of randomized trials out of all the clinical 

investigations published in EMS has been reported to range between 1%21, 5%59and 15%.55 As a 

point of reference, the proportion of randomized trials published in the entire specialty of 

emergency medicine has not changed much over the years, increasing from 10% in 1983, to 12% 

in 1989, and reaching 15% by 1997.60 This proportion is thought to be similar to the proportion of 

randomized trials estimated to exist in published internal medicine literatures.61 Appendix F of this 

document lists published randomized or pseudo-randomized clinical trials conducted in the EMS 

setting from 1966 through 2000 that could be identified by the writing team. 
National EMS Research Agenda 

 22 

Research Domains 

There are three domains within the spectrum of EMS research: clinical, systems, and 

educational. Clinical research involves the study of direct patient care activities. Systems research 

explores the effects of varying EMS system designs and operational methods on resource 

utilization. Educational research examines the appropriate methods for preparing prehospital care 

providers. 

While each domain can be approached independently, researchers must recognize the 

interactions between the three areas. Teaching a paramedic to apply a splint ultimately translates 

into a patient care practice: immobilizing a fracture. Determining the appropriate clinical use of 

narcotics for pain management ultimately becomes a systems issue: securing and tracking 

controlled substances. 

Clinical Research 

To date, investigators with little formal research training and minimal funding or other 

resources have contributed the substance of the literature in prehospital emergency care. Thus, 

most published research addresses the most austere questions involving single clinical 

interventions or health issues. Answers to major EMS issues such as cost-effectiveness, resource 

utilization, efficacy of field therapies, and injury prevention are conspicuous by their absence from 

the literature. In addition, as in other areas of medicine, there is little research demonstrating 

effective methods to improve patient safety in EMS by reducing medical errors. 

Despite the absence of evidence for the efficacy of almost all field interventions, progress is 

occurring in several areas. The Ontario Prehospital Advanced Life Support (OPALS) Study is the 

largest prehospital study ever conducted. It is enrolling more than 25,000 cardiac arrest, trauma, 

and critically ill patients over an 8-year period (1994-2002). The OPALS study uses a rigorous 

controlled methodology and a large sample size, and it is designed to measure the benefit in 

survival and morbidity that results from the introduction of prehospital ALS programs to 

communities of different sizes.19;20;62 While prehospital clinical studies of that magnitude have not 

been completed in the United States, some complex, well designed studies have been successfully 

implemented and completed. A clinical trial of the use of high dose epinephrine63and the pediatric 

intubation study from Los Angeles12 are notable examples. 

Systems Research 

In 1995, a systems analysis framework was suggested in order to accurately study the complex 

and interrelated questions that characterize EMS.64 Systems analysis research models are more 

commonly employed in disciplines such as engineering, economics, and epidemiology where they 

are used to evaluate complex questions, often involving computer simulation and mathematical 

models such as nonlinear or multivariate analysis.65;66 In the publication, EMS Systems: Foundations 

For The Future, members of the SAEM EMS Task Force reviewed the unique aspects of systemsbased questions and suggested a shift from the traditional EMS quality assurance model to one 

based on improving overall system performance.48 

An example of systems research is the investigation that showed providing defibrillators to 

police officers to augment EMS response to sudden cardiac arrest improved survival to hospital 

discharge.67;68 Another example demonstrated that pain is routinely under-treated in patients with 

extremity fractures.69 Although partially a clinical issue, certain components of the EMS system, 

such as the level of training for the caregivers and the procedures for replenishing medication 

supplies, contributed significantly to the problem. Researchers should approach EMS as a system 

of care, rather than as an isolated process. 
National EMS Research Agenda 

 23 

Education 

There have been a handful of studies designed to analyze the suitability of the curricula and 

training practices to the actual provision of services by EMTs.70-74 There seems to be very little in 

the way of actual evaluation of the relationship between curricula, educational methods and 

practice. For example, the core competencies expected of paramedics vary widely across the 

country, suggesting a lack of agreement on the appropriate set of skills for an entry-level 

paramedic. 

An example of educational research is the analysis to determine whether the advanced airway 

training module in the EMT-Basic National Standard Curriculum assured competency in 

performing endotracheal intubation, a complex skill. Two investigations found that most EMTBasic level providers did not achieve skill competency when asked to perform endotracheal 

intubation on actual patients in the field.75;76
National EMS Research Agenda 

 24 

OVERCOMING THE BARRIERS TO EMS RESEARCH

There are two primary barriers that have inhibited the development of a strong research 

program in EMS. They are a paucity of well-trained researchers with an interest in EMS research 

and a lack of reliable funding sources to support research. There are also three identifiable 

secondary barriers to EMS research. They are: a lack of recognizing the need for evidence-based 

practice; standardizing, accessing and sharing data; and complying with the current established 

ethical requirements for human research. 

To some extent, there is a chicken and egg phenomenon at work within the two primary 

barriers to developing a comprehensive EMS research program. For example, funding agencies 

understandably prefer to place their funds with researchers who have a track record of proven 

productivity. However, since there are not many proven researchers with interests in EMS 

problems, few funds flow into EMS-related research. On the other hand, academic institutions are 

reluctant to support the professional development of new, EMS-focused researchers because they 

cannot identify likely funding sources with a history of supporting EMS research. 

Primary Barriers: Developing Researchers 

As a discipline of medicine, EMS needs to develop a larger cadre of experienced investigators. 

Novice investigators need formal research training and the opportunity to work with experienced 

mentors. EMS researchers must collaborate with social scientists, economists, health services 

researchers, epidemiologists, operations researchers, and other clinical scientists to increase the 

expertise available for, to generate novel hypotheses in, and to improve the quality of 

investigations. 

Researchers affiliated with medical schools and large teaching hospitals perform most EMS 

studies because those institutions have the necessary research infrastructure. They offer 

Institutional Review Board review as well as assistance with obtaining grants and negotiating 

contracts. They have large libraries with many resources. Statisticians, epidemiologists, 

methodologists, database managers, and software engineers are available for consultation. 

Emergency physicians, cardiologists, surgeons, pediatricians, and other specialists who have 

interests in specific areas of EMS are available for collaboration. Opportunities exist for EMS 

researchers to collaborate with other disciplines and with industry in many different areas of 

scientific evaluation. Public health initiatives, injury prevention, development of new technologies, 

and health economics are examples of areas in which such opportunities exist. Prospective EMS 

researchers who do not have easy access to the traditional academic research setting may be able to 

establish relationships with public agencies or private corporations and build their research careers 

through those venues. 

Most EMS researchers have little or no formal training in research methodology.23 Many 

colleges and universities have programs that could provide training to interested EMS 

professionals. For example, graduate degree programs in research and public health are widely 

available and could easily be tailored to meet the needs of students with specific EMS interests. . 

One good model of such training programs is the Robert Wood Johnson Foundation Clinical 

Scholars Program. There are examples of successful collaboration between academic institutions 

and EMS agencies to provide EMS fellowship training to interested physicians. The Society for 

Academic Emergency Medicine and the Medtronic Physio-Control Corporation have supported an 

EMS fellowship program since 1990, and most graduates of that program have pursued careers in 

EMS research. Still, these training opportunities are limited in their availability. 
National EMS Research Agenda 

 25 

Recommendation 1.

A large cadre of career EMS investigators should be developed and supported 

in the initial stages of their careers. Highly structured training programs with 

content directed toward EMS research methodologies should be developed. 

• Fellowship training programs capable of producing at least five EMS researchers per year 

are needed. Federal agencies are potential funding sources for these fellowships. Ideally, 

fellowship programs should be at least two years in length and should produce individuals 

with training and expertise in both research methods and funding acquisition. A doctoral 

degree (PhD, MD, etc.) should be a prerequisite for entry into the training programs. 

Program funding that includes institutional overhead and provides funds to ensure that 

research projects can be accomplished during the fellowship is essential. Individual training 

grants specifically targeted to EMS specific topics and system evaluation should be 

available. 

Strong consideration should also be given to developing a few centers of excellence in EMS 

related research. These centers would use their financial resources to build the necessary 

infrastructure to successfully complete EMS related research. That infrastructure would necessarily 

include experienced investigators, information systems support, strong links with the local and 

regional EMS providers, and training opportunities for novice investigators. 

Protected time for faculty engaged in research is not adequate in most academic Departments 

of Emergency Medicine and degree granting institutions offering EMS provider education. 

Protected time is necessary to ensure research productivity. Developing faculty requires making an 

investment in them. Academic departments need to invest in EMS research by supporting 

adequate release time for researchers, and senior faculty should invest in EMS research by serving 

as mentors to novice researchers. EMS centers of excellence would provide support for release 

time to permit faculty to engage in research. 

Several important EMS problems have a relatively low frequency of events. This is true for 

clinical, systems and education issues. These questions will need to be addressed using a multicenter collaborative approach. While a number of such trials have been completed in recent years, 

these efforts need to be expanded.77 It would be useful to develop one or more EMS research 

coordinating centers to pull together the resources necessary to organize and manage multi-center 

clinical trials. 

Recommendation 2.

Centers of Excellence should be created to facilitate EMS research. These 

Centers will bring together experienced investigators, institutional expertise, 

and resources such as budgetary and information systems support. Centers will 

develop and maintain strong working relationships with local and regional EMS 

providers. As the focal point of these resources, Centers of Excellence will be 

the catalyst for collaboration between EMS systems and investigators. Such an 

environment will enable quality research to flourish. 

• One or more federal agencies should encourage the submission of proposals to develop at 

least five EMS Centers of Excellence. Each successful applicant should be funded for five 

years and be evaluated for renewal in a competitive application process. At least $1M 

should be devoted to development of research programs and infrastructure at each Center 

every year. Each Center should be located within an academic institution with ties to 
National EMS Research Agenda 

 26 

fellowship programs, career faculty researchers, multidisciplinary expertise, training 

programs, and other resources necessary to create research infrastructure. 

• One or more federal agencies should issue requests for proposals for at least two regional 

EMS research centers. The centers will organize and manage multi-system studies. The 

centers will form a network to facilitate access to data. Each center should operate on a 

five-year funding cycle with a competitive renewal process at the end of each five-year 

phase. 

As a unique body of knowledge is developed, EMS will become recognized as a medical 

subspecialty. Credentialing within the subspecialty will carry with it an obligation to advance the 

knowledge base of EMS. An increasing numbers of researchers will be drawn into the field, and 

academic institutions will develop the necessary infrastructure to support their activities. The 

resultant interactions between faculty, colleagues, fellows, and students will create a milieu resulting 

in an increased number of people with excellent EMS research skills. As these academic programs 

develop they will attract new researchers who will want to obtain advanced training and advanced 

degrees in research. The research produced by these well-trained EMS researchers will contribute 

to the continued growth of the subspecialty. 

Primary Barriers: Funding 

Improved monetary compensation for EMS research would help motivate researchers to look 

at EMS issues. Additional training grants would be useful to encourage the development of experts 

in both EMS research and a number of areas related to emergency medical systems, such as injury 

prevention, health services research, and operations management. As the number of well-trained 

researchers increases, a reliable stream of funding will be needed to support their activities. That 

stream of funding will necessarily come from a variety of sources. Public funds along with 

corporate and foundation support will all be needed. 

A strong argument can be made that the government should fund the majority of the research 

into the effectiveness of EMS since EMS is largely paid for with taxpayer monies and since there is 

almost certainly a pay off in terms of improved efficiency and effectiveness of care. Of the 794 

papers identified as likely related to EMS published in 1999 and cited on PubMed, only 30 (3.8%) 

had at least some support from the United States Public Health Service (PHS). Indeed, 1999 was a 

record year for PHS support of published EMS research (Figure 3). 
National EMS Research Agenda 

 27 

Other areas of medicine appear to get more governmental research support than EMS. For 

example, in 1999 there were 5862 articles with a MeSH heading of breast neoplasms; 892 (15.2%) 

were PHS supported. There were 1468 articles cited in PubMed in 1999 with a MeSH heading of 

acquired immunodeficiency syndrome. Of those, 209 (14.2%) were at least partially supported by 

the PHS. There were 3003 articles with a MeSH heading of myocardial infarction, and 230 (7.7%) 

of them were PHS supported. 

Two diseases with a large impact on both the general health of the public and the design of 

EMS systems are sudden cardiac arrest and major traumatic injuries. In 1999, there were 13,430 

articles with a MeSH heading of heart arrest, of which 828 (6.1%) were PHS supported. There 

were 4776 articles with a MeSH heading of multiple trauma, and only 86 (1.8%) of those were PHS 

supported. It is clear that the amount of current funding is inadequate to support real progress in 

reducing the morbidity and mortality from both of these diseases that kill a large number of 

Americans each year. The NIH has begun to recognize this fact and held the PULSE Conference 

in June 2000 to explore ways to increase the funding devoted to attacking the problem of sudden 

cardiac arrest. A similar initiative is needed to increase funding for research on treatment of injury. 

Recommendation 3.

Federal agencies that sponsor research should acknowledge their 

commitment to EMS research. 

• The federal government should increase its commitment and support of EMS research. 

• A joint announcement, similar to that issued for EMS Research concerning children (PS01-044), should be issued to provide opportunities for conducting EMS research under the 

sponsorship of a group of Federal agencies and to broadly describe the areas in which 

research is warranted. Each sponsoring agency should delineate and prioritize specific areas 

of interest and provide detailed information regarding application upon request. 
National EMS Research Agenda 

 28 

• The number of fully federally funded controlled clinical trials conducted in the EMS setting 

should increase by 25% each year for five years beginning in FY 2003. 

EMS researchers must also begin to compete for funding that is not specifically earmarked for 

prehospital care. Because EMS has the potential to provide services to individuals experiencing 

almost every disease process, the pool of appropriate funding sources may be quite large. 

The federal government should not be the only organization funding EMS research. Charitable 

foundations often offer unique and flexible funding, some of which should be dedicated to EMS 

research. State EMS lead agencies traditionally have not performed EMS research, but they should 

develop a serious commitment to improve patient care based upon evidence generated by high 

quality research. Ideally, they should collaborate with at least one academic institution with 

expertise in EMS research. This collaboration will give state regulators, provider agencies, and 

EMS professionals access to individuals with expertise regarding grant applications and local 

research related issues. This academic collaborator should also offer guidance to the state lead 

agency on EMS research policies. 

Recommendation 4.

States, corporations, and charitable foundations should be encouraged to 

support EMS research. 

• State lead EMS agencies should promote prehospital research and facilitate the 

development of relationships and resources necessary for such studies. 

• Corporations and charitable foundations should provide funds for EMS related research. 

To successfully compete for both public and private funding, whether earmarked for EMS or 

not, it will be important for the specialty of EMS to develop a cadre of qualified peer reviewers for 

granting agencies. As more researchers with EMS backgrounds gain experience with major 

granting agencies, they will be selected as peer reviewers. This will help facilitate EMS research in 

the long run as these qualified reviewers will be able to educate other members of grant application 

review committees about the importance of EMS research programs. A full description of the 

process of peer review is available on the NIH web site at 

http://www.drg.nih.gov/review/peerrev.htm. 

Secondary Barriers: Recognizing the Need for EMS Research 

Although it may not be similar in magnitude to the other barriers to EMS research, the lack of 

appreciation for the importance of EMS research can be detected throughout all aspects of the 

EMS system. There is a common belief that EMS research is not important as a basis for system 

evaluation and improvement. This belief is detrimental to efforts to improve the system based on 

scientific evaluation. 

Recommendation 5.

The efforts of EMS professionals, delivery systems, academic centers, and 

public policy makers should be organized to support and apply the results of 

research. 

• NHTSA should adopt a curriculum for EMS educators that teaches critical review of the 

scientific literature. 

• The National Fire Academy should continue to offer courses that convey the importance 

of EMS research and detail specific strategies by which fire services can facilitate EMS 

research. 
National EMS Research Agenda 

 29 

• Federal agencies should adopt or develop a curriculum for EMS administrative officers that 

will instill the importance of evidence-based decision-making, reduction of medical errors, 

and introspection into the culture of EMS organizations. 

• Appropriate research principles should be included in the core content of EMS education 

of first responders, EMT-Basics, EMT-Intermediates, and EMT-Paramedics. 

• National and state accrediting agencies for EMS educational programs should require that 

familiarity with the scientific literature be an essential component of EMS education 

programs. 

• Academic institutions should develop training pathways for EMS professionals interested 

in pursuing a research career. 

• EMS agencies should contribute to the research process by agreeing to collaborate with 

academic institutions. Collaboration should include assistance with field data collection and 

patient enrollment in research studies. 

The Culture of EMS 

The misunderstanding within the EMS community of the importance of research is multifactorial. EMS professionals often view research as an academic exercise with little applicability to 

patient care. EMS administrators have difficulty understanding the links between research and 

system operations. EMS education programs frequently do not emphasize the role of research in 

shaping EMS practices, perhaps because instructors themselves do not understand the significance 

of research. The general public and most policy makers have little understanding about the actual 

services provided by EMS agencies, and thus they are also unlikely to recognize the need for 

research to improve those services. 

An organized effort on the part of EMS professionals, delivery systems, education centers and 

public policy makers is needed to take advantage of the available EMS research opportunities and 

to support research endeavors for the benefit of the public. Adoption of a new mindset must be 

followed by specific actions designed to encourage the integration of research into the framework 

of EMS. Providers must see practical applications of the concepts gleaned from field research. 

EMS administrators must support research if the use of evidence based decision making is to 

become integrated throughout the system. EMS educational programs must show students the 

need for collecting and analyzing data in order to provide a scientific basis for EMS patient care. 

Finally, regulatory agencies must encourage collaboration, use of technology for data capture, 

linkage with outcomes and analysis, and self-evaluation as means to improve EMS systems. 

EMS Systems 

EMS agencies need to provide appropriate mechanisms for interested individuals to use their 

research skills. EMS systems must also commit to collaborating with academic centers. Academic 

collaboration is a crucial link in creating a process that can translate research into improvements in 

patient care and system efficiency. In essence, society needs the EMS equivalent of the teaching 

hospital: the teaching EMS system. Unfortunately, there are few, if any, incentives for participating 

in such an arrangement. 

EMS Education 

Insufficient academic commitment to EMS research has also been identified as an important 

impediment to progress in the development of a body of scientific knowledge necessary for the 

support of EMS practices.23 Those educational institutions that chose to offer EMS training 

programs must integrate research into the process of developing entry-level EMS professionals. 
National EMS Research Agenda 

 30 

Successful integration requires using scientific evidence as the basis for education and fulfilling the 

traditional academic role of contributing to the evidence base. 

The amount of education about research principles currently provided to EMS professionals is 

limited at best. Education about EMS research is virtually non-existent in most EMT-Basic 

programs. Although research methodology is part of the National Standard Curriculum for EMTParamedics, most EMS educational institutions provide little time for it in their training programs. 

Some degree granting paramedic education programs do include a research component in their 

curricula, and a few require students to complete a research project prior to completion of the 

program. 

Educational programs are not teaching research principles because many EMS educators are 

not knowledgeable about the process of research and therefore are unable to teach others. There 

are few resources available to assist EMS educators in teaching this material. Two national efforts 

aimed at improving the research education of prehospital providers are the EMS research 

workshops offered by National Association of EMS Physicians and the Prehospital Care Research 

Forum. These entry level one or two day courses are offered at national EMS conferences or by 

themselves for interested sponsoring organizations. 

Education programs for EMS providers must keep pace with the evolving basis for clinical 

practice. The curricula developed by the U.S. Department of Transportation National Highway 

Traffic Safety Administration which provide the basis for education of first responders, EMTBasics, EMT-Intermediates, and EMT-Paramedics should be revised to include improved 

objectives regarding research principles. These objectives must emphasize the need to teach the 

importance of research as well as the principles involved in conducting EMS-related research, and 

should become a part of the routine education of EMS field providers and managers. The 

objective is not to develop every EMS provider into an EMS researcher but to help all personnel 

understand the need for research to enable them to be supportive.23 These educational efforts 

should provide a working understanding of the research process and not simply encourage 

memorization of methodological criteria and statistical terminology. 

 Exposure to the scientific literature should also be an essential component of EMS education 

programs. The curricula should include an introduction to the critical appraisal of scientific articles 

and methods for asking and answering clinical questions. The curricula should also introduce the 

student to the methods that practicing health care professionals use to update their knowledge and 

practice patterns, including routine reading of scientific journals. 

EMS education systems must be compatible with an academically based approach to EMS 

education that parallels the education process of other allied health professions. These concepts 

have been addressed in the EMS Education Agenda. Academic institutions that sponsor EMS 

education programs must make a commitment to supporting EMS research. 

The process of teaching a novice EMS professional, including skill and knowledge acquisition 

and retention, has not been adequately studied. EMS educators in traditional academic settings are 

uniquely positioned to evaluate both the content of EMS curricula adequacy and the effectiveness 

of teaching techniques. 

The Public and Policy Makers 

Public policy makers must also participate in the cultural changes necessary to establish an 

evidence base for EMS practices. State lead EMS agencies should support statutory changes that 

encourage evidence based prehospital care. They should promote public health services research 
National EMS Research Agenda 

 31 

and facilitate the development of relationships and resources necessary for such studies.23 States 

need to adopt standardized data collection strategies and use technology to link prehospital patient 

care information with outcome data. 

State lead agencies must move away from a role focused on regulating the processes of 

delivering care and evolve into agencies providing insightful leadership and technical assistance. 

One way to accomplish this is by participating in the evaluation of patient and system outcomes. 

One example of how a regulatory body can evolve is the Joint Commission on Accreditation of 

Healthcare Organizations. That organization is changing its focus from process regulation to 

outcomes measurement. These changes are controversial, and they are not easy to implement. 

However, they ought to lead to significant improvements in patient outcomes.78

Finally, as competition for health care dollars increases, individual, corporate, or governmental 

purchasers of health care services are interested in documentation of the effectiveness of the 

system and the impact of EMS on public health. The public’s knowledge of EMS-related issues, 

including funding, level of care provided, equipment, system expectations and standards must be 

increased. These issues should become key factors driving EMS research. 

EMS Professionals 

Individual providers need to embrace research as the basis for prehospital practices, and at 

least some of those providers should become active participants in the research process. EMS 

agencies should encourage and support participation of their employees in these endeavors. A 

research career track should be developed for those EMS professionals who have the desire to 

participate in research, and systems can actively work to support researchers by creating researchrelated positions. Likewise a commitment to supporting the research process should be an integral 

part of the responsibilities identified in the medical director’s job description. 

Recommendation 6.

EMS professionals of all levels should hold themselves to higher standards of 

requiring evidence before implementing new procedures, devices, or drugs. 

Secondary Barriers: Information Systems 

There are a number of problems in storage and retrieval of information that impede EMS 

research. These include differing data definitions, inadequate hardware and software infrastructure, 

database linkages, and statistical implications of large databases.79

Recommendation 7.

There should be standardized data collection methods at local, regional, state, 

and national levels. These data must be devoid of information that allows 

individual patient identification. All EMS provider agencies should adopt the 

Uniform Prehospital Data Elements for data collection. 

• NHTSA should sponsor a process to revise the Uniform Prehospital Data Elements at 

least every ten years. 

• State lead EMS agencies should require all EMS organizations in their jurisdictions to 

collect and submit to the state the Uniform Prehospital Data Elements at a minimum, and 

states should report that information to a national EMS data repository. 

• Federal agencies should promote the development and maintenance of a national EMS 

data repository to facilitate comparison of EMS system designs on the effectiveness of care 

delivery and improving patient safety. 
National EMS Research Agenda 

 32 

Data Definitions

An EMS researcher may need to obtain information from a number of different EMS agencies 

and hospitals. This makes research more difficult because different organizations will often use the 

same terms in different ways. In technical terms, they are using different data definitions. 

An example may help to make this clear. A researcher who is interested in the care of victims 

of motor vehicle crashes would like to know the total time interval from the occurrence of a crash 

until the driver arrived at the hospital. This researcher wishes to compare patients in suburban 

areas with those in rural areas. Since the time of the crash is not recorded automatically, the 

researcher decides to use the time that the first person called 911 as a surrogate marker for the time 

of the crash. In one community, the computer aided dispatch system saves the time at which a call 

begins to ring at the public safety answering point and labels that data point as the “911 call time”. 

In another community, the computer aided dispatch system records the time at which the call is 

answered by the EMS dispatcher after the call was transferred from an operator at the public safety 

answering point. That agency also uses the label “911 call time”. A researcher who did not know 

the specific mechanisms for collecting and labeling data used by these two EMS agencies could be 

easily misled into thinking that both agencies were recording the same event, when in fact these are 

two distinct time points. 

Clinical research activities have been enhanced by efforts to standardize prehospital data 

acquisition. Standardized templates and definitions for the reporting of prehospital cardiac arrest 

data have been developed.80 Similar reporting standards have been developed for pediatric cardiac 

arrest81 and trauma data.82 

There are two major federally sponsored data definitions that describe data points that could 

be collected on each patient encounter. These are the Uniform Prehospital Data Elements 

developed by NHTSA83 and the Data Elements for Emergency Department Systems (DEEDS) 

developed by the Centers for Disease Control.84 The development of the Uniform Prehospital 

Data Elements and Definitions in 1993 was a crucial step to structure evidence about the efficacy 

of prehospital care.83 Sadly, few EMS systems have adopted these criteria; and most agencies are 

still unable to link prehospital data with outcome information. Only 25 states require EMS 

provider agencies to use most or all of these data elements. The DEEDS document was developed 

by the Centers for Disease Control to address the same data labeling issues for emergency 

department encounters.84 Despite evidence that these data-standardization tools may not be used 

to their full potential, their existence is encouraging.85

Widespread use of both the DEEDS data definitions and the Uniform Prehospital Data 

Elements would enhance EMS research. The challenge is in convincing EMS agencies to embrace 

a new system. While administrators may benefit from the ability to advance the quality 

improvement process and perform system benchmarking, implementation of these systems is 

costly. At this time, there is not a compelling advantage to using the newer systems for those 

actually providing care to patients. 

Hardware and Software Infrastructure 

The computer revolution is happening in medicine. The Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) will prompt a massive investment in electronic 

documentation. The regulations implementing HIPAA require additional security measures for 

medical record information, including medical records held by EMS agencies. Research review is 

permitted under these regulations, but HIPAA imposes new requirements in addition to existing 

privacy regulations. See the Code of Federal Regulations 164.514(i) for additional information. 
National EMS Research Agenda 

 33 

Most EMS agencies and emergency departments still use paper records with multiple copies. 

Paper records present many problems for researchers. Both the originals and the copies are often 

illegible. Some of the time points recorded, which may be considered as hard data by researchers, 

are actually estimates by the caregivers.86 If a patient is transferred between hospitals, the paper 

records may not make the trip with the patient. 

Electronic medical record systems are being developed for use in emergency medicine and 

EMS. However, the design of these products will unquestionably affect the quality of the data. If 

the products are cumbersome to use, then the health care providers operating them may provide 

incomplete data in order to simply achieve their immediate goal of completing the data entry 

process.87 As the process of product development continues, software designers will likely 

incorporate standardized data definitions like the DEEDS data dictionary and the Uniform 

Prehospital Data Elements. So, as less documentation is done on paper and more is automated, the 

use of these established data definitions will increase and the ability of EMS researchers to abstract 

patient data will be enhanced. 

Data Set Linkages 

EMS systems should track patient outcomes into the hospital and beyond. One method for 

obtaining patient outcome data in EMS is to link together large databases that describe different 

stages of the continuum of patient care. For example, a statewide EMS database might be linked 

with a financial dataset that describes inpatient hospital charges, and that database may in turn be 

linked to a death registry. In theory, such linkages allow researchers to follow a patient from the 

prehospital phase, through hospitalization, and after discharge. In fact, such linkages are 

challenging to create. The patient’s name is often stripped out of datasets to preserve 

confidentiality and other identifying information, such as the patient’s home address, may be 

missing because those providing care did not have it at the time the records were created. To tackle 

this problem, enterprising researchers developed a technique called probabilistic matching.88 The 

probabilistic system is often able to match 95% or more of records in different databases.89 EMS 

investigations have used this technique, including examination of the impact of EMS on children 

with special needs90 and linking hospital trauma registry data with prehospital records.91 

In addition to the technical challenges posed by incomplete data, the best outcome variables 

may not be recorded in available data sets. Since medical records and database structures are 

designed independent of specific research questions, key information is often incomplete or simply 

altogether absent. One temptation is to use the information that is present in the database in an 

attempt to get as close to the answer as possible. The problem is that this approach can give results 

that are not meaningful because the most appropriate outcome variables have not been measured. 

Another problem is that elements of the health care system may be reluctant to share 

information. Maintaining patient confidentiality is a major issue. For example, matching a zip code 

and date of birth in a large database can uniquely identify about 15% of subjects. Some privacy 

advocates maintain that if a researcher can use a data set to violate the privacy of even one person, 

then the data should not be collected. 

Patient privacy is an important issue in EMS research. Recently the Department of Health and 

Human Services has developed recommendations to protect against the disclosure of identifiable 

patient information. The impact of these new privacy regulations on the linking of patient data and 

its availability for research purposes remains to be seen. These rules may become an additional 

obstacle to the effective evaluation of prehospital interventions; or they may establish a level of 
National EMS Research Agenda 

 34 

privacy protection that adequately alleviates concerns among the public, thus facilitating advances 

in clinical research. 

One potential solution to the problem of maintaining patient confidentiality is to assign a 

longitudinal patient identifier. For example, in the State of Washington, trauma patients are given a 

bracelet with a unique identifying number that remains with the patient throughout the process of 

care. That number is kept with the medical record but the patient’s name and address is not 

maintained at the state level, thus preserving confidentiality since the unique number but not 

patient identifying data moves from the hospital or EMS agency to the state. 

Another important regulatory issue that needs to be considered by researchers is a proposed 

change in the freedom of information law that would allow requests for access to raw research data 

collected for federally funded research projects. This proposal has several implications. For one, 

the confidentiality of the study subjects might be compromised. There is also a potential problem 

with protection of the raw research data from a legal discovery process. If EMS systems and health 

care providers are going to undertake serious evaluations of their practices in order to improve the 

care they provide to their patients, they must be assured that the information gathered in that 

process won’t subsequently be used to support litigation against them.92 One possible solution to 

this problem would be the availability of a “federal certificate of confidentiality” issued by the 

Office of Management and Budget. 

It is useful to link outside data, like law enforcement records about motor vehicle crashes, to 

EMS and hospital data. 93 It is also sometimes helpful to link to payment data sets, such as those 

used in the medical expenditure panel study or the payment databases of health insurance plans. 

These linkages also raise confidentiality concerns that must be addressed by EMS researchers. 

Statistical Implications of Large Databases 

Since there are only one or two large datasets of EMS patients in any state, there are important 

statistical implications. As more questions are asked, it is increasingly likely that a result will be 

positive based upon chance alone and not a real difference. Since there is not a second dataset with 

which to validate the results, it becomes impossible to tell which positive results are meaningful 

and which are statistical flukes. When EMS researchers conduct studies involving large state-based 

data sets, they will need to validate those studies by repeating them in other states or at a different 

time. 

Secondary Barriers: Ethical Concerns 

Principles 

Adhering to ethical research principles results in higher quality research, ensures that all 

individuals are respected, and protects vulnerable people. The ethics of conducting research in the 

EMS environment are sometimes complicated by time urgency and decreased patient 

competency.94 Despite these challenges, EMS related research has to follow the same basic ethical 

guidelines as any other human subjects research. 

The Federal government has assumed the lead role in protecting the rights of human research 

subjects. The Office of the Inspector General of the Department of Health and Human Services 

(HHS) recently published a report on the status of protecting the rights of research subject. The 

Office of Human Research Protections (OHRP) is charged with assuring compliance with ethical 

guidelines. Grant reviewers, funding agency staff, clinicians, journal editors, and other researchers 

all share in the responsibility to protect human subjects. 
National EMS Research Agenda 

 35 

EMS researchers must fulfill all of the requirements for human research delineated at the 

federal, state, local, and institutional level. Federal regulations have been developed with hospital 

and outpatient based clinical research in mind. As a result, researchers may often view these 

requirements as impediments to conducting prehospital research. While burdensome to the 

researcher, the process of ethical review often will result in an improved research plan because of 

the structure provided by the process and by suggestions from the reviewers. 

Informed Consent 

One particular concern expressed by EMS researchers is the requirement to obtain written 

informed consent. Two ethical principles underlying informed consent are that it is free from 

coercion and that the prospective research subject has time to contemplate whether or not to 

participate. It may be, particularly in emergency research where therapy has to be initiated in 

minutes, that neither principle is true. 95

 In the mid-1990’s, the FDA and HHS agreed that there needed to be a method for allowing 

emergency resuscitation research to occur even when the subject was unable to give consent. Two 

sets of federal rules were modified within the Department of Health and Human Services 

regulating obtaining informed consent for medical research. The “General Requirements for 

Informed Consent” (45 CFR 46.116) are administered by the Office for Human Research 

Protections (OHRP) and include provisions for the waiver of consent in certain circumstances. 

New regulations providing for “Exception from Informed Consent Requirement for 

Emergency Research” (21 CFR 50.24) were developed for activities regulated by the Food and 

Drug Administration (FDA).96 The FDA regulations, CFR 21 Part 50, section 50.24, specify the 

requirements for exception from informed consent for emergency research. The FDA recently 

released a draft document providing guidance for implementing the rules. 

These regulations have created some confusion among EMS researchers. Their 

implementation has exposed a fundamental problem associated with conducting research with 

subjects who cannot provide consent: There is a direct and irrevocable tension between the 

standards of protecting the rights of research subjects and the ability to investigate and improve 

the care rendered to future patients. 

The current federal regulations on research in emergency situations may have the unintended 

consequence of ensuring that EMS professionals will continue to provide care that has not been 

properly evaluated. New interventions to treat critical illness will continue to be introduced into the 

EMS environment, but difficulty in complying with the requirements of the consent regulations 

may impede the ability of EMS researchers to ensure that they have been studied appropriately 

first.

Recommendation 8.

The Food and Drug Administration (FDA) and the Office for Human Research 

Protections (OHRP) should work with EMS research stakeholders to evaluate the 

current requirements for exception from informed consent in emergency 

situations and to identify those requirements that are serious impediments to 

conducting EMS research. The FDA, OHRP, and EMS research stakeholders 

should work together to develop and propose EMS-specific consent strategies as 

well as appropriate revisions to the existing regulations to reduce the 

impediments to research while continuing to adequately protect research 

subjects. 
National EMS Research Agenda 

 36 

• There should be a national conference that brings together a large variety of EMS research 

stakeholders and regulators to recommend improvements to the emergency exception to 

informed consent procedures. 

• Based on the recommendations of the FDA and OHRP, Congress should amend the laws 

governing exception from informed consent for emergency research to reduce the 

regulatory burden and facilitate research while continuing to protect the rights of research 

subjects. 

• There should be educational programs that explain the consent process and recommend 

strategies by which EMS researchers can fulfill the requirements. 

• Educational programs that describe the difficulties in obtaining consent in the EMS 

environment, explain the emergency exception from consent process, and promote 

acceptance by and consistency among Institutional Review Board (IRBs) should be made 

available to IRB members and administrators. 

In those circumstances in which waiver of the written consent requirement is not appropriate, 

other strategies for streamlining the consent process might be possible. The consent form does not 

necessarily need to be a multi-page document and using a shorter form may facilitate giving 

information to the patient. Some researchers have had success with a two-step process in which a 

structured verbal consent is obtained in the field followed by written consent once the patient 

arrives at the emergency department.97;98

It is important to note that some patients, such as those in coma, will never be able to give 

informed consent. Further, those patients who may be able to give informed consent may still be 

unduly influenced by the emergent nature of their condition.95 EMS researchers must work with 

their IRBs to develop consent mechanisms that account for these issues and protect these patients 

while not unfairly excluding them from the research process and the potential benefits of those 

efforts. 

Many areas of prehospital care in need of research involve patients who are competent and not 

in extremis. Obtaining consent from such patients is comparable to obtaining consent from 

patients in any other clinical setting. One difference is that the process of obtaining consent from 

an EMS patient may take place in a public environment and therefore those enrolling the patient in 

research must take steps to protect confidential patient information. 

Certain research populations may continue to be underrepresented in research studies due to 

real or perceived impediments in obtaining informed consent. These excluded groups can include 

children, domestic violence victims, sexual assault victims, illiterate and non-English speaking 

patients, elderly people, potentially pregnant women, mentally or behaviorally challenged 

individuals, and the drug or alcohol impaired. EMS systems care for a disproportionate share of 

these patients.99 Investigators and institutional review boards should consider this concern when 

determining the consent requirements for any study and take steps to avoid the inappropriate 

exclusion of such subjects. Federal policies on the inclusion of women, minorities and children as 

research subjects are detailed in appendix D. 

IRBs and EMS Research 

Some institutional review boards are unfamiliar with the scope of prehospital emergency 

medical care and thus may have difficulty understanding the issues associated with conducting 

research in that environment. The prospective EMS investigator needs to become familiar with the 

local IRB guidelines and process. Through positive interactions with the IRB, a researcher can help 
National EMS Research Agenda 

 37 

educate the members about EMS issues; and, together, the researcher and the IRB can develop 

study or consent methodologies that meet the needs of the investigator while fulfilling current legal 

requirements. 

One possible concern that might be raised by an IRB is that study enrollment will delay patient 

transport. It is incumbent upon the investigator to determine the risks associated with such a delay. 

For most prehospital patients, those risks are minimal. The researcher may have to overcome 

preconceptions among IRB members that all patients who call EMS need rapid response and 

transport. 

An IRB might also express concern about altering the existing standard of care for a 

prehospital study. Yet, little that is considered “standard care” has ever been rigorously evaluated 

in the prehospital setting. It is considered ethical to alter or remove a non-evidence-based pattern 

of care in order to evaluate prehospital practices, so long as such studies are designed to minimize 

the risks to subjects. Two notable examples of this practice are the study of pneumatic anti-shock 

garments in which the garments, long part of standard care for trauma patients, were removed 

from ambulances as part of a study evaluating their efficacy 46 and the pediatric intubation study in 

which children were allocated to receive either bag-valve-mask ventilation or endotracheal 

intubation.12

Concerns about altering standard of care can be addressed, at least in part, through the use of 

data and safety monitoring boards.100 Such entities are set up as part of the study design and review 

the data at predetermined interim periods to assess for any untoward affects of the study. This can 

be accomplished without breaking the blinding scheme and without giving the researchers any 

indication of the study results. If it appears that a study is resulting in unacceptable risks to 

patients, the data and safety monitoring board can stop it. The concept of such boards is not new; 

their use by EMS researchers is simply one technique that might be successful for addressing IRB 

concerns. 

Valuing Individual Autonomy 

Current ethical guidelines, as written, value individual autonomy over other competing values. 

At the same time, the only way to ensure public and government support for research activities is 

to ensure the safety of all research subjects. In overcoming the barriers to EMS research posed by 

ethical constraints, EMS researchers must follow the federal law while at the same time 

championing rational revision of the regulations. Reaching this goal will require consensus among 

regulators, researchers, clinicians and the general public. 

Sources for complete information about ethical standards and IRB requirements are listed in 

appendix C of this document. 
National EMS Research Agenda 

 38 

SUMMARY

The National EMS Research Agenda makes the following recommendations: 

1. A large cadre of career EMS investigators should be developed and supported in the initial 

stages of their careers. Highly structured training programs with content directed toward 

EMS research methodologies should be developed. 

2. Centers of Excellence should be created to facilitate EMS research. These Centers will 

bring together experienced investigators, institutional expertise and resources such as 

budgetary and information systems support. Centers will develop and maintain strong 

working relationships with local and regional EMS providers. As the focal point of these 

resources, Centers of Excellence will be the catalyst for collaboration between EMS 

systems and investigators. Such an environment will enable collaborative research to 

flourish. 

3. Federal agencies that sponsor research should acknowledge their commitment to EMS 

research. 

4. States, corporations, and charitable foundations should be encouraged to support EMS 

research. 

5. The efforts of EMS professionals, delivery systems, academic centers, and public policy 

makers should be organized to support and apply the results of research. 

6. EMS professionals of all levels should hold themselves to higher standards of requiring 

evidence before implementing new procedures, devices, or drugs. 

7. There should be standardized data collection methods at local, regional, state, and national 

levels. These data must be devoid of information that allows individual patient 

identification. All EMS provider agencies should adopt the Uniform Prehospital Data 

Elements for data collection. 

8. The Food and Drug Administration (FDA) and the Office for Human Research 

Protections (OHRP) should work with EMS research stakeholders to evaluate the current 

requirements for exception from informed consent in emergency situations and to identify 

those requirements that are serious impediments to conducting EMS research. The FDA, 

OHRP, and EMS research stakeholders should work together to develop and propose 

EMS-specific consent strategies as well as appropriate revisions to the existing regulations 

to reduce the impediments to research while continuing to adequately protect research 

subjects. 

An investment in EMS research infrastructure is necessary to overcome the obstacles currently 

impeding EMS research. Funding is needed to train new researchers and to establish their careers. 

Increased financial support is necessary to develop effective prehospital treatment for the diseases 

that drive the design of the EMS system, including injury and sudden cardiac arrest. Innovative 

strategies to make EMS research easier to accomplish in emergency situations must be legitimized 

and implemented. Researchers must have access to patient outcome information so that the impact 

of prehospital patient care can be evaluated and improved. Incorporating standard scientific 

methodology into the evaluation of biomedical and technical advances in prehospital care is 

crucial. Research is the key to maintaining an appropriate focus on improving the overall health of 
National EMS Research Agenda 

 39 

the community in a competitive and cost conscious health care market. Most importantly, research 

is essential to ensure that the best possible patient care is provided in the prehospital setting. 
National EMS Research Agenda 

 40 

APPENDIX A: THE NATIONAL EMS RESEARCH AGENDA WRITING TEAM

Role Name Affiliation 

Principal Investigator Michael R. Sayre, MD University of Chicago 

Co- Investigators Lynn White, MS Akron General Medical Center 

 Lawrence H. Brown, EMT-P Upstate Medical University 

Administrative Staff Dede Gish Panjada, MBA NAEMSP 

 Jennifer Kimzey NAEMSP 

Writing Team Members Michael Armacost, MA, NREMT-P Colorado Department of Health

 J. Michael Dean, MD, MBA University of Utah 

 Scott B. Frame, MD, FACS (dec.) University of Cincinnati 

 Baxter Larmon, PhD, MICP UCLA School of Medicine 

 Susan MacLean, RN, PhD Emergency Nurses Association 

 N. Clay Mann, PhD, MS University of Utah 

 Gregg Margolis, MS, NREMT-P George Washington University 

 Isabelle Melese-d’Hospital, PhD Emergency Medical Services for 

Children National Resource 

Center 

 Keith Neely, MPA, EMT-P (dec.) Oregon Health Sciences Univ. 

 Michael O’Keefe Vermont Department of Health

 Daniel W. Spaite, MD, FACEP University of Arizona 

Ex-Officio Jon R. Krohmenr, MD NAEMSP 

Contracting Office 

Technical Representative 

Susan D. McHenry, MS National Highway Traffic Safety 

Administration 

Federal Partners Timothy B. Davis, MD National Center for Injury 

Prevention & Control (CDC) 

 Elinor Walker Agency for Healthcare Research 

and Quality 
National EMS Research Agenda 

 41 

APPENDIX B: ORGANIZATIONS INVITED TO PARTICIPATE IN THE NATIONAL REVIEW 

TEAM

Organization Representative Web Site 

Committee on Accreditation of 

Educational Programs for the 

EMS Professions (CoAEMSP, 

formerly the JRCEMT-P) 

James M. Atkins, MD www.coaemsp.org 

Prehospital Care Research 

Forum (PCRF) 

Elizabeth Criss, RN, CEN, 

MAEd 

www.pcrf.mednet.ucla.edu 

American College of 

Osteopathic Emergency 

Physicians (ACOEP) 

John W. Becher, DO, FACOEP www.acoep.org 

Health Resources and Services 

Administration/ 

Maternal and Child Health 

Bureau/Emergency Medical 

Services for Children 

(HRSA/MCHB/EMSC) 

Cindy Doyle, RN, MA www.mchb.hrsa.gov 

www.ems-c.org 

American College of 

Surgeons/Committee on 

Trauma (ACS/COT) 

Scott Frame, MD, FACS (dec.) www.facs.org 

National Association of EMS 

Quality Professionals 

(NAEMSQP) 

Todd Hatley, MBA, MHA, 

REMT-P 

www.naemsqp.org 

National Association of EMS 

Physicians (NAEMSP) 

Richard Hunt, MD, FACEP www.naemsp.org 

American College of 

Emergency Physicians (ACEP) 

Alan Katz, MD, FACEP www.acep.org 

National Volunteer Fire 

Council (NVFC) 

Kenneth R. Knipper, EMT-B www.nvfc.org 

American Ambulance 

Association (AAA) 

Kurt Krumperman, EMT-P www.the-aaa.org 

American Academy of 

Pediatrics (AAP) 

Nate Kuppermann, MD, MPH www.aap.org 
National EMS Research Agenda 

 42 

American Public Health 

Association (APHA) 

Richard Levinson, MD, DrPH www.apha.org 

National Association of State 

EMS Directors (NASEMSD) 

Kevin McGinnis www.nasemsd.org 

International Association of 

Fire Fighters (IAFF) 

Lori Moore, MPH, EMT-P www.iaff.org 

Society for Academic 

Emergency Medicine (SAEM) 

Robert O’Connor, MD www.saem.org 

Association of Air Medical 

Services (AAMS) 

Jeff Plant, MD, FRCP www.aams.org 

American Academy of 

Orthopaedic Surgeons (AAOS) 

Andrew Pollak, MD, FAAOS www.aaos.org 

Emergency Nurses Association 

(ENA) 

Kathy Robinson, RN www.ena.org 

National Association of EMS 

Educators (NAEMSE) 

Judith A. Ruple, PhD, RN, 

NREMT-P 

www.naemse.org 

National Association of EMT’s 

(NAEMT) 

Jay Scott, BS, NREMT-P www.naemt.org 

International Association of 

Fire Chiefs (IAFC) 

Chief John Sinclair, EMT-P www.iafc.org 

American Academy of Family 

Physicians (AAFP) 

Jeffrey Susman, MD www.aafp.org 

National Registry of EMT’s 

(NREMT) 

Howard Werman, MD www.nremt.org 

Air Medical Physicians 

Association (AMPA) 

Kenneth Williams, MD, FACEP www.ampa.org 

National Council of State EMS 

Training Coordinators 

(NCSEMSTC) 

Don Wood www.sni.net/ncsemstc 
National EMS Research Agenda 

 43 

APPENDIX C: ETHICAL STANDARDS AND IRB REQUIREMENTS

• Complete information about ethical standards and IRB requirements can be found at both 

the National Academies of Science IRB home page and the U.S. Department of Health 

and Human Services’ (DHHS) Office of Human Research Protections (OHRP) website 

(http://ohrp.osophs.dhhs.gov/). That website also has links to sites with additional 

information. 

• The Federal Policy for the Protection of Human Subjects (45 CFR 46) is available at 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm 

• Food and Drug Administration Requirements for Human Research, including 

Requirements for Exemption from Informed Consent for Emergency Research (21 CFR 

50) is available here: http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html. 

The Belmont Report, which was an important basis for the development of ethical 

research standards in the U.S., can be found at 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm. A tutorial on ethical 

requirements for research that was designed for employees of the NIH but available to 

anyone is available here: http://ohsr.od.nih.gov/ 

• The National Association of EMS Physicians website contains information on ethical 

challenges in emergency medical services at 

http://www.naemsp.org/sw/Resources/EthicalChlng.html 

• Suggested Reading: Mahon NE, Yarcheski A: Ethical concerns in research with 

adolescents. Journal of Pediatric Nursing 1988; 3(5): 341-344. 
National EMS Research Agenda 

 44 

APPENDIX D 

Inclusion Of Women And Minorities In Research Study Populations Involving 

Human Subjects 

• It is the policy of Federal agencies that women and members of minority groups and their 

sub-populations must be included in all Federal agency-supported research projects 

involving human subjects, unless clear and compelling rationale and justification is 

provided that inclusion is inappropriate with respect to the health of the subjects or the 

purpose of the research. This policy results from the NIH Revitalization Act of 1993 

(Section 492B of Public law 103-43). 

• All investigators proposing research involving human subjects should read the “NIH 

Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research” 

which have been published in the Federal Register of March 28, 1994 (FR 59 14508-

14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 

available on the web at the following URL address: http://grants.nih.gov/grants/noticfiles/not94-100.html. To the extent possible, AHRQ requires adherence to these NIH 

Guidelines.

Inclusion Of Children As Participants In Research Involving Human Subjects 

• It is the policy of NIH that children (i.e., individuals under the age of 21) must be included 

in all human subjects research, conducted or supported by the NIH, unless there are 

scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) 

applications submitted for receipt dates after October 1, 1998. 

• All investigators proposing research involving human subjects should read the “NIH 

Policy and Guidelines on the Inclusion of Children as Participants in Research Involving 

Human Subjects” that was published in the NIH Guide for Grants and Contracts, March 

6, 1998, and is available at the following address: 

http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
National EMS Research Agenda 

 45 

APPENDIX E: BIBLIOGRAPHIC LIST OF INTERNET LINKS

Page Name Website Description of Site Linked 

3,4 EMS Agenda for the 

Future 23

www.nhtsa.dot.gov/people/injur

y/ems/agenda/emsman.html 

Link to National Highway Traffic Safety Administration 

site and posted copy of the EMS Agenda for the 

Future. 

4 EMS Agenda for the 

Future Implementation 

Guide 101

www.nhtsa.dot.gov/people/injur

y/ems/agenda/index.html 

Link to the National Highway Traffic Safety 

Administration site and posted copy of the EMS 

Agenda for the Future Implementation Guide. 

4 Technology Assessment 

and Practice Guidelines 

Forum 102

odp.od.nih.gov/consensus/about

/process.htm 

Guidelines for the Planning and Management of NIH 

Consensus Development Conferences. This site provides 

guidelines for organizing major conferences that 

produce consensus statements on important and 

controversial topics in medicine. 

5 Research Agenda Home www.ResearchAgenda.org Web site with pertinent information relating to the 

National EMS Research Agenda Project 

6 Breaking the Scientific 

Bottleneck 

www.aamc.org/newsroom/clinre

s 

The Association of American Medical Colleges Research 

Statement: Breaking the Scientific Bottleneck. 

Clinical Research: A National Call to Action 

9 Negotiated Rule Making 17 www.hcfa.gov/medicare/comstat

e.htm 

Document (2-14-2000) regarding Medicare 

expenditures for ambulance services. Health Care 

Financing Administration. Department of Health and 

Human Services

12 National Academy of 

Sciences 24

www4.nationalacademies.org/nas

/nashome.nsf/ 

Link to National Academy of Sciences’ web site. For 

reference to paper entitled Accidental Death and 

Disability: The Neglected Disease of Modern Society. 

13 Agency for Healthcare 

Research and Quality 

www.ahrq.gov Link to Agency for Healthcare Research and Quality web 

site. The AHRQ provides evidence-based 

information on health care outcomes, quality and 

cost, use and access. 

23 Uniform Prehospital Data 

Elements and Definitions. 

83

www.nhtsa.dot.gov/people/injur

y/ems/pub/def.zip 

Link to the National Highway Traffic Safety 

Administration’s web site and electronic copy of the 

data elements (criteria written to facilitate 

standardization of prehospital data). 

23 Privacy regulations aspe.hhs.gov/adminsimp Health and Human Services web site. Privacy rules 

here: aspe.hhs.gov/admnsimp/bannerps.htm final 

rule (Federal Register) Dec 28, 2000. 

26, 40 EMS Education Agenda 

For The Future: A Systems 

Approach 48;54

www.nhtsa.dot.gov/people/injur

y/ems/EdAgenda/final/index.ht

ml 

National Highway Traffic Safety Administration’s web 

site and link to the EMS Education Agenda for the 

Future Document 

33 Robert Wood Johnson 

Foundation Clinical 

Scholars Program 

www.rwjf.org/library/clin2000.ht

m 

The Robert Wood Johnson Foundation 

Homepage. Describes the mission of the RWJ 

foundation and the direction toward which their 

philanthropic grant making efforts are aimed. 

35 PULSE conference www.nhlbi.nih.gov/meetings/pul

se/index.htm 

Proceedings of June 2000conference. “NHLBI 

Workshop on Post-Resuscitation and Initial Utility 

in Life Saving Efforts” (PULSE). The goal of the 

workshop was to provide novel research 

recommendations in the area of cardiopulmonary 

resuscitation. 
National EMS Research Agenda 

 46 

Page Name Website Description of Site Linked 

39 Curricula 

First Responders, EMTBasics, EMTIntermediates, EMTParamedics. 

www.nhtsa.dot.gov/people/injur

y/ems/nsc.htm 

www.nhtsa.dot.gov/people/injur

y/ems/pub/emtbnsc.pdf 

The Curricula developed by the U.S. Department of 

Transportation National Highway Traffic Safety 

Administration 

Individual content for each of the EMT levels. 

41 Outcomes measurement 78 www.jcaho.org/perfmeas/nextev

ol.html 

Facts about ORYX: The Next Evolution in 

Accreditation. In February 1997, the Joint 

Commission announced the health care 

organization requirements for the ORYX initiative, 

which integrates outcomes and other performance 

measurement data into the accreditation process. 

43 Prehospital Uniform Data 

Elements 

www.nhtsa.dot.gov/people/injur

y/ems/pub/def.zip 

Link to the National Highway Traffic Safety 

Administration’s web site and electronic copy of the 

Prehospital uniform data elements (criteria written 

to facilitate standardization of prehospital data). 

43 DEEDS 84 www.cdc.gov/ncipc/pubres/deedspage.htm Data Elements for Emergency Department 

Systems. 

41 The NIH web site www.drg.nih.gov/review/peerrev

.htm 

Link to NIH Web Site and discussion of the peer 

review process used to evaluate grant proposals. “A 

Straightforward Description of What Happens to 

Your Research Project Grant Application 

(R01/R21) After it is Received for Peer Review” 

43 Regulations implementing 

CFR 164.514(i) 

www.hhs.gov/ocr/hipaa 

www.hhs.gov/ocr/regtext.html 

HIPAA will require additional security of medical 

record information including medical records held 

by EMS agencies. 

 Research review is permitted under these 

regulations, but additional requirements are added 

to previously existing regulations. See CFR 

164.514(i) 

48 Belmont Report 

Office of Human Research 

Protections 

www.dhhs.gov/progorg/oei/rep

orts/a447.pdf 

ohrp.osophs.dhhs.gov 

Text of the report “Protecting the Rights of 

Research Subjects” 

Link to the Department of Health and Human 

Services home page. 

49 CFR 21 Part 50, section 

50.24 

Exception to informed 

consent implementation 

guide draft document 

www.fda.gov/opacom/morechoi

ces/fed996.html 

www.fda.gov/ora/compliance_re

f/bimo/err_guide.htm 

Section of the Federal Register document 

containing the legislation concerning the process 

required for exception from informed consent for 

emergency research. 

Draft document released by the FDA 
National EMS Research Agenda 

 47 

APPENDIX F: PUBLISHED EMS RANDOMIZED CLINICAL TRIALS

The following table is a listing of major randomized or pseudo-randomized clinical trials 

completed in the prehospital setting. It is a modification of a table by Brazier et al.,59 that is 

available on the Internet at http://www.rcsi.ie/library/prehospital_care.html. 

Trial Patients Setting N Intervention Main Result 

Valentine 

1974 36

Adults younger 

than 70 with high 

suspicion for acute 

myocardial 

infarction 

Multicenter, 

Australia 

269 Physician intramuscular 

injection of (a) lidocaine 

or (b) placebo 

During first two hours 

after injection, 5% 

absolute reduction in 

mortality (p<0.04) 

Hampton 

1978 37

Adult patients 

without motorvehicle trauma 

Nottingham, 

England 

3340 (a) Transport by mobile 

coronary care unit or (b) 

routine transport 

2% absolute reduction in 

mortality from heart 

attacks (NS) 

Diederich 

1979 38

Acute myocardial 

infarction patients 

younger than 70 

Lubeck, Germany Intramuscular injection 

of (a) lidocaine or (b) 

placebo 

Mortality lower in 

lidocaine group. 

Mahoney 

1983 103

Cardiac arrest 

patients older than 

20 

Minneapolis, 

Minnesota, USA 

136 (a) Pneumatic antishock 

garments or (b) usual 

care 

Survival to hospital 

discharge was 9% in (a) 

and 4% in (b) (NS). 

Mateer 1984 

104

Cardiac arrest 

patients 

Milwaukee, 

Wisconsin, USA 

140 After endotracheal 

intubation either (a) 

interposed abdominal 

compression CPR (IACCPR) or (b) standard 

CPR is begun 

4% absolute increase in 

patients admitted to ED 

with a pulse (NS) 

Olson 1984 

105

Ventricular 

fibrillation 

persisting after 

initial shocks 

Milwaukee, 

Wisconsin, USA 

92 (a) Bretylium and then, 

if VF persists, lidocaine 

or (b) lidocaine and 

then, if VF persists, 

bretylium 

Survival to hospital 

discharge was 5% in 

bretylium first group vs 

10% in lidocaine first 

group (NS) 

Paris 1984 

106

Cardiac arrest 

patients with 

pulseless 

idioventricular 

rhythm 

Pittsburgh, 

Pennsylvania, 

USA 

86 (a) Dexamethasone 100 

mg or (b) saline placebo 

No long term survivors in 

either group 

Stueven 

1984 107

Witnessed nontraumatic adult 

cardiac arrest 

patients with 

asystole and not 

responding to 

epinephrine, 

bicarbonate, or 

atropine 

Milwaukee, 

Wisconsin, USA 

32 (a) Calcium chloride or 

(b) saline placebo 

No long term survivors in 

either group 

Bickell 1985 

108

Injured patients 

with hypotension 

Houston, Texas, 

USA 

68 (a) Pneumatic antishock 

garments or (b) usual 

care 

No difference in 

presenting emergency 

department trauma score 
National EMS Research Agenda 

 48 

Trial Patients Setting N Intervention Main Result 

Mateer 1985 

109

Same as Mateer 

1984 104

Milwaukee, 

Wisconsin, USA 

291 After endotracheal 

intubation either (a) 

interposed abdominal 

compression CPR (IACCPR) or (b) standard 

CPR is begun 

3% absolute decrease in 

patients admitted to ED 

with a pulse (NS) 

Silfvast 1985 

110

Patients with 

cardiac arrest 

Helsinki, Finland 65 (a) Phenylephrine 1 mg 

or (b) epinephrine 0.5 

mg intravenously 

3% absolute increase in 

patients with “successful” 

resuscitation (NS) 

Stueven 

1985a 111

Cardiac arrest 

patients with 

asystole as in 

Stueven 1984 107

Milwaukee, 

Wisconsin, USA 

73 (a) Calcium chloride or 

(b) saline placebo 

No long term survivors in 

either group 

Stueven 

1985b 112 

Cardiac arrest 

patients with 

electromechanical 

dissociation who 

did not respond to 

epinephrine and 

bicarbonate 

Milwaukee, 

Wisconsin, USA 

90 (a) Calcium chloride or 

(b) saline placebo 

16% of patients receiving 

calcium were admitted to 

the emergency department 

with a pulse vs 5% of 

controls. Only one patient 

was a long term survivor. 

Goldenberg 

1986 113

Cardiac arrest 

patients 

St. Paul, 

Minnesota, USA 

175 Airway managed with 

either (a) esophageal 

gastric tube airway 

(EGTA) or (b) 

endotracheal intubation 

(ETI) 

Training in use of EGTA 

cost less than ETI. 

Survival to hospital 

discharge 12.9% vs 

11.1%. 

Hargarten 

1986 114

Stable patients with 

chest pain 

Milwaukee, 

Wisconsin, USA 

446 (a) Lidocaine or (b) 

usual care 

1.4% absolute decrease in 

hospital mortality (NS). 

Four patients with sudden 

death in each group (NS). 

Mattox 1986 

115

Injured patients 

with systolic BP < 

90mm Hg 

Houston, Texas, 

USA 

352 (a) Pneumatic antishock 

garments or (b) usual 

care 

No difference in mortality 

(NS). 

Baxt 1987 

116

Trauma patients 

requiring 

resuscitation 

transported by 

helicopter 

San Diego, 

California, USA 

545 Helicopter staffed by (a) 

flight nurse and 

paramedic or (b) flight 

nurse and physician 

Mortality of patients 

treated by flight nurse / 

physician team was lower 

than that of patients 

treated by flight nurse / 

paramedic (p<0.05), and 

lower than predicted by 

TRISS (p<0.05) 

Bickell 1987 

117

Victims of gunshot 

or stab wounds to 

anterior abdomen 

with a systolic BP 

<90mm Hg 

Houston, Texas, 

USA 

201 (a) Pneumatic antishock 

garments or (b) usual 

care 

8.8% absolute increase in 

mortality at hospital 

discharge (NS) 

Castaigne 

1987 118

Patients seen 

within three hours 

of symptoms 

suggesting AMI 

who had a 

qualifying ECG 

Val de Marne, 

France 

25 Administration by noncardiologist staffed 

mobile care unit of (a) 

anisoylated plasminogen 

streptokinase activator 

complex (APSAC) or 

(b) placebo 

Thrombolytic drug 

treatment started 56 

minutes sooner after onset 

of pain in mobile care unit 

group than in control 

group. 
National EMS Research Agenda 

 49 

Trial Patients Setting N Intervention Main Result 

Cummins 

1987 119

Patients in cardiac 

arrest 

Seattle, 

Washington, 

USA 

321 Use by EMT of (a) 

automated external 

defibrillator (AED) or 

(b) standard defibrillator 

7% absolute reduction in 

mortality at hospital 

discharge (NS). Time 

from power on to first 

shock 0.9 minutes faster 

in AED group. 

Hedges 1987 

120

Patients in asystole 

or with 

hemodynamically 

significant 

bradycardia 

Thurston County, 

Washington, 

USA 

202 (a) Prehospital 

transcutaneous cardiac 

pacing or (b) usual care 

1.9% absolute reduction 

in mortality at hospital 

discharge (NS) 

Hoffman 

1987 121

Patients whose 

chief complaint 

was dyspnea and 

who had a 

presumed diagnosis 

of cardiogenic 

pulmonary edema 

Los Angeles 

County, USA 

57 Administration by 

paramedic of (a) sl 

nitroglycerin and iv 

furosemide, or (b) iv 

morphine and 

furosemide, or (c) all 

three, or (d) iv morphine 

and sl nitroglycerin 

No difference at hospital 

discharge. 

Barthell 

1988 122

Patients in asystole 

or with 

hemodynamically 

significant 

bradycardia 

Milwaukee, 

Wisconsin, USA 

239 (a) External cardiac 

pacing device or (b) 

usual care 

2.4% absolute reduction 

in mortality at hospital 

discharge (NS) 

DuBoiseRande 1989 

123

Castaigne 

1989 124

Patients seen 

within three hours 

of symptoms who 

had a qualifying 

ECG 

Val de Marne, 

France 

93 (a) Administration of 

APSAC by 

anaesthesiologist staffed 

mobile care unit or (b) 

inhospital treatment 

0.3% (NS) reduction in 

mortality in the 

prehospital group at 

hospital discharge. 

Krischer 

1989 125 

Adults with nontraumatic out of 

hospital cardiac 

arrest 

Florida, USA 702 (a) Simultaneous 

compression-ventilation 

(SC-V) CPR or (b) 

standard CPR 

6.8% increase in mortality 

(p<0.01) at hospital 

discharge 

Mattox 1989 

46 

Injured patients 

with systolic BP < 

90mm Hg 

Houston, Texas, 

USA 

911 (a) Pneumatic antishock 

garment or (b) usual 

care 

6% absolute increase in 

mortality at hospital 

discharge (p=0.05) 

Olson 1989 

126

Pulseless, 

nonbreathing 

patients with initial 

cardiac rhythm of 

ventricular 

fibrillation 

Milwaukee, USA 102 Administration by 

paramedic of repeated iv 

doses of (a) epinephrine 

or (b) methoxamine 

11.8% (NS) at hospital 

discharge 

Barbash 

1990 127

AMI patients seen 

within four hours 

of symptoms who 

had a qualifying 

ECG and 

confirmed for 

inclusion by 

remote physician 

Israel 87 (a) Administration of 

recombinant tissue-type 

plasminogen activator 

(rt-PA) by physician and 

paramedic staffed 

mobile coronary care 

unit or (b) inhospital 

treatment 

4.5% (NS) reduction in 

mortality in (a) at 60 days. 
National EMS Research Agenda 

 50 

Trial Patients Setting N Intervention Main Result 

Hargarten 

1990 128

Patients seen with 

symptoms 

suggestive of AMI 

and confirmed for 

inclusion by 

remote physician 

after ECG review 

Milwaukee, USA 1,427 Administration by 

paramedic of (a) iv 

lidocaine bolus and 

infusion or (b) placebo 

1.5% increase in mortality 

(NS) at hospital discharge 

Karagounis 

1990 129

Patients clinically 

suspected of 

having an AMI 

Salt Lake City, 

Utah, USA 

71 (a) Prehospital cellular 

transmission of 12-lead 

ECG or (b) no 

prehospital ECG 

In-field ECG caused 

negligible delays in onscene and transport time 

Roine 1990 

130

Patients 

resuscitated from 

ventricular 

fibrillation 

Helsinki, Finland 155 (a) Initiation of IV 

nimodipine 10 mcg/kg 

with 24 hour infusion or 

(b) placebo by physician 

staffed advance life 

support unit 

4% reduction in mortality 

at one year in nimodipine 

group (NS) 

Schofer 

1990 131

Mathey 1990 

132

AMI patients seen 

within four hours 

of symptoms who 

had a qualifying 

ECG 

Hamburg, 

Germany 

78 (a) Administration of iv 

urokinase by physician 

and emergency medical 

technician staffed 

mobile coronary care 

unit or (b) inhospital 

treatment 

2.8% (NS) reduction in 

mortality in (a) at hospital 

discharge. 

Mattox 1991 

133

Trauma patients 

with systolic BP 

<90mm Hg 

Multicenter, USA 359 Administration of (a) 

7.5% NaCl with 6% 

Dextran or (b) lactated 

Ringers 

Absolute reduction in 

mortality of 3.3% (NS); 

7.5% NaCl/Dextran 

significantly increased BP 

(p<0.05) 

Risenfors 

1991 134

AMI patients seen 

within 2.75 hours 

of symptoms 

Göteborg, 

Sweden 

101 Administration by 

cardiologist staffed 

mobile coronary care 

unit of (a) rt-PA or (b) 

placebo 

8.7% (NS) reduction in 

mortality in (a) at hospital 

discharge 

Vassar 1991 

135

Trauma patients 

transported by 

helicopter with 

systolic BP 

<100mm Hg 

Sacramento 

California, USA 

166 Administration of (a) 

7.5% NaCl with 4.2% 

Dextran or (b) lactated 

Ringers 

Absolute reduction in 

mortality of 4.8% (NS); 

7.5% NaCl/Dextran 

significantly increased BP 

(p<0.05) 

Berntsen 

1992 136

Patients seen 

within six hours of 

symptoms 

suggestive of AMI 

Norway 204 Administration by 

general practitioner of 

(a) IV bolus and IM 

injection of lidocaine or 

(b) placebo 

4.8% (NS) at hospital 

discharge; 0.9% (NS) 

absolute reduction in 

ventricular fibrillation 

Brown 1992 

137

Adult cardiac arrest 

patients 

Multicenter, USA 1280 Administration by 

paramedic of (a) high 

dose epinephrine or (b) 

standard dose 

epinephrine 

1% absolute reduction in 

mortality at hospital 

discharge (NS). 
National EMS Research Agenda 

 51 

Trial Patients Setting N Intervention Main Result 

Callaham 

1992 138

Nontraumatic 

cardiac arrest 

patients 

San Francisco, 

USA 

816 Administration by 

paramedic of (a) high 

dose epinephrine or (b) 

high dose epinephrine 

bitartrate or (c) standard 

dose epinephrine 

No difference at hospital 

discharge 

GREAT 

Group 1992 

139

Patients with acute 

myocardial 

infarction seen at 

home by general 

practioners within 

4 hours of 

symptom onset 

Grampian region, 

Scotland 

311 (a) APSAC 30 units at 

home and placebo in 

hospital or (b) placebo 

at home and APSAC 30 

units in hospital 

7.6% absolute reduction 

in 3 month mortality for 

group with thrombolysis 

started at home (95% 

confidence interval 14.7% 

to 0.4%). 

Kereiakes 

1992 140

Patients with AMI 

confirmed by serial 

ECGs and enzyme 

analysis 

Cincinnati, Ohio, 

USA 

22 (a) Prehospital cellular 

transmission of 12-lead 

ECG or (b) no 

prehospital ECG 

Significant reduction in 

hospital delay to initiation 

of thrombolytic therapy 

(p<0.005) 

Karpov 1992 

141

Patients with 

suspected AMI 

Russia 200 (a) Prehospital 

administration of iv 

streptokinase and 

heparin by cardiologist 

or (b) inhospital 

administration or (c) 

usual care 

6% (NS) reduction in 

mortality for (a) vs. (b) at 

30 days; 10% (p<0.05) for 

(a) vs. (c) at 30 days 

McAleer 

1992 142

AMI patients seen 

within six hours of 

symptoms who had 

a qualifying ECG 

Enniskillen, 

Northern Ireland 

145 (a) Administration of iv 

streptokinase by 

physician staffed mobile 

coronary care unit or (b) 

inhospital treatment 

21.5% (p<0.05) reduction 

in mortality in (a) at two 

years 

Stiell 1992 

143

Patients with 

cardiac arrest 

Ottawa, Ontario, 

Canada 

335 Administration of (a) 

high-dose epinephrine 

or (b) standard dose 

epinephrine 

2% absolute increase in 

mortality at hospital 

discharge (NS) 

Bertini 1993 

144

Patients seen 

within six hours of 

symptoms 

suggestive of AMI 

who had a 

qualifying ECG 

Florence, Italy 60 Administration by 

cardiologist and 

paramedic staffed 

mobile coronary care 

unit of (a) lidocaine 

bolus and infusion or (b) 

placebo 

4.1% (NS) at hospital 

discharge; 15.2% 

(p<0.05) absolute 

reduction in ventricular 

fibrillation 

EMIP Group 

1993 145

Boissel 1995 

146

Patients seen 

within six hours of 

symptoms who had 

a qualifying ECG 

Europe and 

Canada 

5,469 Administration by 

emergency medical 

personnel of (a) iv 

anistreplase or (b) 

placebo 

1.4% (NS) reduction in 

mortality in (a) at 30 days 

Longstreth 

1993 147

Cardiac arrest 

patients 

Seattle, 

Washington, 

USA 

748 Administration of 

intravenous 

maintenance solutions 

containing either (a) 5% 

dextrose in water 

(D5W) or (b) half 

normal saline 

1.8% reduction in 

mortality in the D5W 

group at hospital 

discharge (NS) 
National EMS Research Agenda 

 52 

Trial Patients Setting N Intervention Main Result 

Vassar 1993 

148

Trauma patients 

transported by 

helicopter, with 

systolic BP <90 

mm Hg 

Multicenter, USA 194 Administration of (a) 

lactated Ringers or (b) 

7.5% NaCl or (c) 7.5% 

NaCl with 6% Dextran 

or (d) 7.5%NaCl with 

12% Dextran 

Mortality in the 7.5% 

NaCl group was 

significantly lower than 

predicted by TRISS 

(p<0.001); adding 

Dextran made no 

difference. 

Vassar 1993 

149

Trauma patients 

with systolic BP 

<90 mm Hg 

Sacramento 

California, USA 

258 Administration of (a) 

normal saline or (b) 

7.5% NaCl or (c) 7.5% 

NaCl with 6% Dextran 

Mortality in the 7.5% 

NaCl group was 

significantly lower than 

predicted by TRISS 

(p<0.025); adding 

Dextran made no 

difference. 

Weaver 

1993 150

Patients seen 

within six hours of 

symptoms who had 

a qualifying ECG 

and confirmed for 

inclusion by 

remote physician 

Seattle, 

Washington, 

USA 

360 (a) Administration of 

aspirin and alteplase by 

paramedic or (b) 

inhospital treatment 

2.4% (NS) reduction in 

mortality in (a) at 30 days 

Bickell 1994 

151

Adults with 

penetrating torso 

injuries and 

systolic BP < 

90mm Hg 

Houston, Texas, 

USA 

598 (a) Immediate fluid 

resuscitation in field or 

(b) delayed fluid 

resuscitation in 

operating suite 

8% absolute reduction in 

mortality at hospital 

discharge for the group 

receiving delayed fluid 

resuscitation (OR 0.70, 

95% confidence interval 

0.50 – 0.99, P = 0.04) 

Ellinger 

1994 152

Patients in cardiac 

arrest 

Mannheim, 

Germany 

56 (a) Active compression 

decompression CPR 

(ACD-CPR) or (b) 

standard CPR 

1.8% increase in mortality 

in ACD-CPR group at 

hospital discharge (NS). 

EMIP-BB 

Group 1994 

153

Patients seen 

within two hours of 

symptoms 

suggestive of AMI 

who had a 

qualifying ECG 

Lyon, France 77 Administration by 

emergency medical 

personnel of (a) IV 

atenolol or (b) placebo 

0.7% difference in 

mortality at hospital 

discharge (NS) 

Rhee 1994 

154

Injured adults with 

GCS <8 

transported by 

helicopter 

Sacramento, 

California, USA 

77 Performance by flight 

nurses of (a) 

nasotracheal intubation 

or (b) neuromuscular 

blockade-assisted oral 

intubation 

No difference in success 

rate; nasotracheal 

intubation required 

significantly less time to 

perform (p<0.01) 

Staudinger 

1994 155

Out of hospital 

cardiac arrests 

Valparaiso, USA 80 Intubation with (a) 

‘Combitube’ combined 

endotracheal and 

esophageal obturator 

airway adjunct or (b) 

standard endotracheal 

tube 

0.5% absolute reduction 

in mortality at hospital 

discharge (NS) 
National EMS Research Agenda 

 53 

Trial Patients Setting N Intervention Main Result 

Choux 1995 

156

Prehospital cardiac 

arrest patients 

Paris, France 536 (a) High-dose 

epinephrine or (b) 

standard dose 

epinephrine 

3.6% increase in 

admission to hospital in 

(a) and 3.7% increase in 

survival at 6 months in (a) 

(NS). 

Dybvik 1995 

157 

Dybvik 1996 

158

Adult cardiac arrest 

patients with 

asystole or 

ventricular 

fibrillation 

persisting after one 

shock 

Oslo, Norway 502 (a) 250 ml of sodium 

bicarbonate-trometamolphosphate mixture with 

buffering capacity 500 

mmol/l or (b) 250 ml of 

0.9% saline 

4% decrease in survival 

to hospital discharge in 

buffer therapy group 

(NS).

Quadrel 

1995 159

Known adult 

asthmatics with 

wheeze 

New Jersey, USA 154 Administration by 

paramedic of (a) sc 

epinephrine, or (b) 

nebulized 

metaproterenol or (c) sc 

epinephrine and 

nebulized 

metaproterenol 

Nebulized metaproterenol 

is as effective as sc 

epinephrine; the 

combination of the two 

drugs offered no 

additional benefit 

Schwab 

1995 160

Normothermic 

adult victims of 

out-of- hospital, 

nontraumatic 

cardiac arrest on 

whom CPR was 

performed by first 

responders 

San Francisco 

and Fresno, 

California, USA 

860 First responders did 

either (a) active 

compressiondecompression CPR 

(ACD-CPR) or (b) 

standard CPR 

1% decrease in survival to 

hospital discharge in 

ACD-CPR group (NS). 

Weiss 1995 

161

Patients transported 

by paramedical 

ambulance service 

New Orleans, 

Louisiana, USA 

182 (a) Tympanic membrane 

thermometry or (b) 

usual care 

Acceptable correlation 

with gold standard 

Zehner 1995 

98

Adults with 

respiratory distress 

Syracuse, New 

York, USA 

83 Paramedics 

administered either (a) 

albuterol aerosol and 

saline injection or (b) 

saline aerosol and 

terbutaline injection 

Albuterol group had 

greater improvement in 

respiratory distress score 

by hospital arrival. 

Brouwer 

1996 162

As in Weaver 150 Seattle, USA 360 As in Weaver 150 2% increase in mortality 

(NS) at two years. 

Luiz 1996 163 Out of hospital 

cardiac arrests 

Mannheim, 

Germany 

56 (a) Active compressiondecompression (ACD) 

or (b) standard CPR 

1.8% increase in mortality 

(NS) at hospital discharge 

Mauer D 

1996 164

Out of hospital 

cardiac arrest 

patients 

Mainz, Germany 220 (a) Active compressiondecompression CPR 

(ACD-CPR) or (b) 

standard CPR 

2% decrease in mortality 

(NS) at hospital discharge 

Sayre 1996 

165

Helicopter 

transported and 

intubated patients 

with a head injury 

Cincinnati, Ohio, 

USA 

41 Administration by 

emergency physician of 

(a) iv 20% mannitol or 

(b) 0.9% saline 

No change in systolic BP 

over a 2-hour period 

Stiell 1996 

166

Out of hospital 

cardiac arrests 

Ontario, Canada 1,011 (a) ACD or (b) standard 

CPR 

1.7% (NS) absolute 

reduction in mortality in 

(a) at 1 hour; 0.9% (NS) 

at hospital discharge 
National EMS Research Agenda 

 54 

Trial Patients Setting N Intervention Main Result 

Lindner 

1997 167

Cardiac arrest 

patients in 

ventricular 

fibrillation 

unresponsive to 

defibrillation 

Ulm, Germany 40 (a) epinephrine or (b) 

vasopressin 

At 24 hours, 40% 

absolute reduction in 

mortality (P < 0.02); at 

hospital discharge, 25% 

absolute reduction in 

mortality (NS). 

Mader 1997 

168

Nontraumatic, 

asystolic cardiac 

arrest patients 

Springfield, 

Massachusetts, 

USA 

22 (a) aminophylline or (b) 

placebo 

Half of aminophylline 

patients had organized 

rhythm compared with 

none of the placebo 

patients (P=0.02). 

Plaisance 

1997 169

Out of hospital 

cardiac arrests 

confirmed by ECG 

France 512 (a) ACD or (b) standard 

CPR 

12.4% (p<0.005) absolute 

reduction in mortality (a) 

at 24 hours; 3.2% (NS) at 

1 month 

Rosen 1997 

170

Male combative 

patients 

Denver, 

Colorado, USA 

46 Administration by 

paramedics of (a) IV 

droperidol or (b) 

placebo 

Patients significantly less 

agitated (p<0.001) after 

10 minutes 

Rumball 

1997 171

Patients requiring 

advanced airway 

management 

Canada 470 Three different airway 

management techniques 

– pharyngeal tracheal 

lumen airway (PTL); 

combitube (Combi), and 

laryngeal mask airway 

(LMA) 

Successful insertion and 

ventilation: Combi, 86%; 

PTL, 82%; LMA, 73% (p 

= 0.048) 

Gueugniaud 

1998 172

Adult cardiac arrest 

patients 

Multicenter, 

Europe 

3327 (a) High dose 

epinephrine or (b) 

standard dose 

epinephrine 

0.5% absolute increase in 

mortality at hospital 

discharge (NS). 

Gardtman 

1999 173

Suspected acute 

myocardial 

infarction patients 

with ongoing chest 

pain 

Göteborg, 

Sweden 

262 Morphine 5 mg IV 

followed by (a) 

metoprolol 5 mg IV x 3 

with 2 minute intervals 

or (b) placebo IV x 3 

Arbitrary 10 point chest 

pain score decreased by 3 

units in (a) and 2.6 units 

in (b) (NS). 

Kudenchuk 

1999 174

Cardiac arrest 

patients with 

ventricular 

fibrillation not 

responding to three 

shocks 

Seattle, 

Washington, 

USA 

504 (a) IV amiodarone or (b) 

placebo 

10% absolute decrease in 

mortality at hospital 

admission (P=0.03); no 

difference at hospital 

discharge (NS). 

Mader 1999 

175

Nontraumatic, 

asystolic cardiac 

arrest 

Springfield, 

Massachusetts, 

USA 

82 (a) aminophylline or (b) 

placebo 

7% increase in return of 

spontaneous circulation 

(NS). 

Plaisance 

1999 77

Cardiac arrest 

patients 

Paris and 

Thionville, 

France 

750 (a) ACD-CPR or (b) 

standard CPR 

4% absolute decrease in 

mortality at hospital 

discharge (P=0.01) and 

3% absolute decrease in 

mortality at one year 

(P=0.03). 

Skogvoll 

1999 176

Cardiac arrest 

patients of 

presumed cardiac 

origin 

Trondheim, 

Norway 

302 (a) ACD-CPR or (b) 

standard CPR 

1% absolute decrease in 

mortality at hospital 

discharge (NS). 
National EMS Research Agenda 

 55 

Trial Patients Setting N Intervention Main Result 

Gausche 

2000 12 Pediatric patients ≤

12 years of age or 

40 kg bodyweight 

requiring 

prehospital airway 

management 

Los Angeles and 

Orange Counties, 

California, USA 

830 Scope of paramedic 

practice alternates 

between (a) bag-mask 

ventilation with 

endotracheal intubation 

(ETI) or (b) bag-mask 

ventilation alone 

Absolute mortality in ETI 

group was 4% higher than 

bag-mask ventilation 

alone group (NS). 

Plaisance 

2000 177

Nontraumatic 

cardiac arrest 

patients 

Paris, France 21 (a) ACD-CPR with an 

impedance threshold 

valve or (b) ACD-CPR 

Maximal end-tidal CO2, 

coronary perfusion 

pressure, and diastolic 

blood pressure were all 

higher in group (a) 

(P<0.01). 

Schneider 

2000 178

Ventricular 

fibrillation patients 

with an AED used 

Multicenter, 

Europe 

115 (a) AED using 150 j 

biphasic waveform or 

(b) 200 j to 260 j 

monophasic waveform 

98% defibrillated in first 

three shocks using 

biphasic waveform vs 

69% using monophasic 

waveform (P<0.0001). 

Turner 2000 

179

Adult trauma 

patients 

Multicenter, 

England 

1309 (a) IV fluids started at 

scene or (b) no 

prehospital IV fluids 

Absolute mortality was 

0.4% lower in the group 

not getting prehospital IV 

fluids (NS). 

 
National EMS Research Agenda 

 56 

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group judgment method. Int J Technol Assess Health Care 1992; 8(2):289-300. 

103. Mahoney BD, Mirick MJ. Efficacy of pneumatic trousers in refractory prehospital 

cardiopulmonary arrest. Ann Emerg Med 1983; 12(1):8-12. 

104. Mateer JR, Stueven HA, Thompson BM, Aprahamian C, Darin JC. Interposed abdominal 

compression CPR versus standard CPR in prehospital cardiopulmonary arrest: preliminary 

results. Ann Emerg Med 1984; 13(9 Pt 2):764-766. 

105. Olson DW, Thompson BM, Darin JC, Milbrath MH. A randomized comparison study of 

bretylium tosylate and lidocaine in resuscitation of patients from out-of-hospital ventricular 

fibrillation in a paramedic system. Ann Emerg Med 1984; 13(9 Pt 2):807-810. 

106. Paris PM, Stewart RD, Deggler F. Prehospital use of dexamethasone in pulseless 

idioventricular rhythm. Ann Emerg Med 1984; 13(11):1008-1010. 

107. Stueven HA, Thompson BM, Aprahamian C, Tonsfeldt DJ. Calcium chloride: reassessment 

of use in asystole. Ann Emerg Med 1984; 13(9 Pt 2):820-822. 

108. Bickell WH, Pepe PE, Wyatt CH, Dedo WR, Applebaum DJ, Black CT et al. Effect of 

antishock trousers on the trauma score: a prospective analysis in the urban setting. Ann Emerg 

Med 1985; 14(3):218-222. 

109. Mateer JR, Stueven HA, Thompson BM, Aprahamian C, Darin JC. Pre-hospital IAC-CPR 

versus standard CPR: paramedic resuscitation of cardiac arrests. Am J Emerg Med 1985; 

3(2):143-146. 

110. Silfvast T, Saarnivaara L, Kinnunen A, Erosuo J, Nick L, Pesonen P et al. Comparison of 

adrenaline and phenylephrine in out-of-hospital cardiopulmonary resuscitation. A doubleblind study. Acta Anaesthesiol Scand 1985; 29(6):610-613. 
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111. Stueven HA, Thompson B, Aprahamian C, Tonsfeldt DJ, Kastenson EH. Lack of 

effectiveness of calcium chloride in refractory asystole. Ann Emerg Med 1985; 14(7):630-632. 

112. Stueven HA, Thompson B, Aprahamian C, Tonsfeldt DJ, Kastenson EH. The effectiveness 

of calcium chloride in refractory electromechanical dissociation. Ann Emerg Med 1985; 

14(7):626-629. 

113. Goldenberg IF, Campion BC, Siebold CM, McBride JW, Long LA. Esophageal gastric tube 

airway vs endotracheal tube in prehospital cardiopulmonary arrest. Chest 1986; 90(1):90-96. 

114. Hargarten KM, Aprahamian C, Stueven HA, Thompson BM, Mateer JR, Darin J. 

Prophylactic lidocaine in the prehospital patient with chest pain of suspected cardiac origin. 

Ann Emerg Med 1986; 15(8):881-885. 

115. Mattox KL, Bickell WH, Pepe PE, Mangelsdorff AD. Prospective randomized evaluation of 

antishock MAST in post-traumatic hypotension. J Trauma 1986; 26(9):779-786. 

116. Baxt WG, Moody P. The differential survival of trauma patients. J Trauma 1987; 27(6):602-

606. 

117. Bickell WH, Pepe PE, Bailey ML, Wyatt CH, Mattox KL. Randomized trial of pneumatic 

antishock garments in the prehospital management of penetrating abdominal injuries. Ann 

Emerg Med 1987; 16(6):653-658. 

118. Castaigne AD, Duval AM, Dubois-Rande JL, Herve C, Jan F, Louvard Y. Prehospital 

administration of anisoylated plasminogen streptokinase activator complex in acute 

myocardial infarction. Drugs 1987; 33 Suppl 3:231-234. 

119. Cummins RO, Eisenberg MS, Litwin PE, Graves JR, Hearne TR, Hallstrom AP. Automatic 

external defibrillators used by emergency medical technicians. A controlled clinical trial. 

JAMA 1987; 257(12):1605-1610. 

120. Hedges JR, Syverud SA, Dalsey WC, Feero S, Easter R, Shultz B. Prehospital trial of 

emergency transcutaneous cardiac pacing. Circulation 1987; 76(6):1337-1343. 

121. Hoffman JR, Reynolds S. Comparison of nitroglycerin, morphine and furosemide in 

treatment of presumed pre-hospital pulmonary edema. Chest 1987; 92(4):586-593. 

122. Barthell E, Troiano P, Olson D, Stueven HA, Hendley G. Prehospital external cardiac 

pacing: a prospective, controlled clinical trial [see comments]. Ann Emerg Med 1988; 

17(11):1221-1226. 

123. Dubois-Rande JL, Herve C, Duval-Moulin AM, Gaillard M, Boesch C, Louvard Y et al. 

[Prehospital thrombolysis. Evaluation of preliminary experiences at Val- de-Marne]. Arch Mal 

Coeur Vaiss 1989; 82(12):1963-1966. 

124. Castaigne AD, Herve C, Duval-Moulin AM, Gaillard M, Dubois-Rande JL, Boesch C et al. 

Prehospital use of APSAC: results of a placebo-controlled study. Am J Cardiol 1989; 

64(2):30A-33A. 
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125. Krischer JP, Fine EG, Weisfeldt ML, Guerci AD, Nagel E, Chandra N. Comparison of 

prehospital conventional and simultaneous compression- ventilation cardiopulmonary 

resuscitation. Crit Care Med 1989; 17(12):1263-1269. 

126. Olson DW, Thakur R, Stueven HA, Thompson B, Gruchow H, Hendley GE et al. 

Randomized study of epinephrine versus methoxamine in prehospital ventricular fibrillation 

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127. Barbash GI, Roth A, Hod H, Miller HI, Modan M, Rath S et al. Improved survival but not 

left ventricular function with early and prehospital treatment with tissue plasminogen 

activator in acute myocardial infarction. Am J Cardiol 1990; 66(3):261-266. 

128. Hargarten KM, Stueven HA, Waite EM, Olson DW, Mateer JR, Aufderheide TP et al. 

Prehospital experience with defibrillation of coarse ventricular fibrillation: a ten-year review. 

Ann Emerg Med 1990; 19(2):157-162. 

129. Karagounis L, Ipsen SK, Jessop MR, Gilmore KM, Valenti DA, Clawson JJ et al. Impact of 

field-transmitted electrocardiography on time to in-hospital thrombolytic therapy in acute 

myocardial infarction. Am J Cardiol 1990; 66(10):786-791. 

130. Roine RO, Kaste M, Kinnunen A, Nikki P, Sarna S, Kajaste S. Nimodipine after resuscitation 

from out-of-hospital ventricular fibrillation. A placebo-controlled, double-blind, randomized 

trial. JAMA 1990; 264(24):3171-3177. 

131. Schofer J, Buttner J, Geng G, Gutschmidt K, Herden HN, Mathey DG et al. Prehospital 

thrombolysis in acute myocardial infarction. Am J Cardiol 1990; 66(20):1429-1433. 

132. Mathey DG, Buttner J, Geng G, Gutschmidt HJ, Herden HN, Moecke H et al. [The 

thrombolysis treatment of acute myocardial infarct at the site of the emergency. A 

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133. Mattox KL, Maningas PA, Moore EE, Mateer JR, Marx JA, Aprahamian C et al. Prehospital 

hypertonic saline/dextran infusion for post-traumatic hypotension. The U.S.A. Multicenter 

Trial. Ann Surg 1991; 213(5):482-491. 

134. Risenfors M, Gustavsson G, Ekstrom L, Hartford M, Herlitz J, Karlson BW et al. 

Prehospital thrombolysis in suspected acute myocardial infarction: results from the 

TEAHAT Study. J Intern Med Suppl 1991; 734:3-10. 

135. Vassar MJ, Perry CA, Gannaway WL, Holcroft JW. 7.5% sodium chloride/dextran for 

resuscitation of trauma patients undergoing helicopter transport. Arch Surg 1991; 

126(9):1065-1072. 

136. Berntsen RF, Rasmussen K. Lidocaine to prevent ventricular fibrillation in the prehospital 

phase of suspected acute myocardial infarction: the North-Norwegian Lidocaine Intervention 

Trial. Am Heart J 1992; 124(6):1478-1483. 

137. Brown CG, Martin DR, Pepe PE, Stueven H, Cummins RO, Gonzalez E et al. A 

comparison of standard-dose and high-dose epinephrine in cardiac arrest outside the 
National EMS Research Agenda 

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hospital. The Multicenter High-Dose Epinephrine Study Group. N Engl J Med 1992; 

327(15):1051-1055. 

138. Callaham M, Madsen CD, Barton CW, Saunders CE, Pointer J. A randomized clinical trial of 

high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital 

cardiac arrest [see comments]. JAMA 1992; 268(19):2667-2672. 

139. Feasibility, safety, and efficacy of domiciliary thrombolysis by general practitioners: 

Grampian region early anistreplase trial. GREAT Group [see comments]. BMJ 1992; 

305(6853):548-553. 

140. Kereiakes DJ, Gibler WB, Martin LH, Pieper KS, Anderson LC. Relative importance of 

emergency medical system transport and the prehospital electrocardiogram on reducing 

hospital time delay to therapy for acute myocardial infarction: a preliminary report from the 

Cincinnati Heart Project. Am Heart J 1992; 123(4 Pt 1):835-840. 

141. Karpov RS, Markov VA, Danilenko AM, Varvarenko VI, Zakharova RM, Dzhavadov KI et 

al. [Effectiveness of pre-hospital thrombolytic therapy in acute myocardial infarction]. 

Kardiologiia 1992; 32(9-10):23-26. 

142. McAleer B, Ruane B, Burke E, Cathcart M, Costello A, Dalton G et al. Prehospital 

thrombolysis in a rural community. Cardiovasc Drugs Ther 1992; 6(4):369-372. 

143. Stiell IG, Hebert PC, Weitzman BN, Wells GA, Raman S, Stark RM et al. High-dose 

epinephrine in adult cardiac arrest [see comments]. N Engl J Med 1992; 327(15):1045-1050. 

144. Bertini G, Giglioli C, Rostagno C, Conti A, Russo L, Taddei T et al. Early out-of-hospital 

lidocaine administration decreases the incidence of primary ventricular fibrillation in acute 

myocardial infarction [see comments]. J Emerg Med 1993; 11(6):667-672. 

145. Prehospital thrombolytic therapy in patients with suspected acute myocardial infarction. The 

European Myocardial Infarction Project Group [see comments]. N Engl J Med 1993; 

329(6):383-389. 

146. Boissel JP. The European Myocardial Infarction Project: an assessment of pre- hospital 

thrombolysis. Int J Cardiol 1995; 49 Suppl:S29-S37. 

147. Longstreth WT, Jr., Copass MK, Dennis LK, Rauch-Matthews ME, Stark MS, Cobb LA. 

Intravenous glucose after out-of-hospital cardiopulmonary arrest: a community-based 

randomized trial. Neurology 1993; 43(12):2534-2541. 

148. Vassar MJ, Fischer RP, O'Brien PE, Bachulis BL, Chambers JA, Hoyt DB et al. A 

multicenter trial for resuscitation of injured patients with 7.5% sodium chloride. The effect 

of added dextran 70. The Multicenter Group for the Study of Hypertonic Saline in Trauma 

Patients. Arch Surg 1993; 128(9):1003-1011. 

149. Vassar MJ, Perry CA, Holcroft JW. Prehospital resuscitation of hypotensive trauma patients 

with 7.5% NaCl versus 7.5% NaCl with added dextran: a controlled trial. J Trauma 1993; 

34(5):622-632. 
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150. Weaver WD, Cerqueira M, Hallstrom AP, Litwin PE, Martin JS, Kudenchuk PJ et al. 

Prehospital-initiated vs hospital-initiated thrombolytic therapy. The Myocardial Infarction 

Triage and Intervention Trial [see comments]. JAMA 1993; 270(10):1211-1216. 

151. Bickell WH, Wall MJ, Jr., Pepe PE, Martin RR, Ginger VF, Allen MK et al. Immediate versus 

delayed fluid resuscitation for hypotensive patients with penetrating torso injuries [see 

comments]. N Engl J Med 1994; 331(17):1105-1109. 

152. Ellinger K, Luiz T, Denz C, van Ackern K. [Randomized use of an active compressiondecompression technique within the scope of preclinical resuscitation]. Anasthesiol Intensivmed 

Notfallmed Schmerzther 1994; 29(8):492-500. 

153. Pre-hospital treatment of patients with suspected acute myocardial using a beta-blocking 

agent: a double-blind feasibility study. EMIP-BB Pilot Study Group. Clin Trials Metaanal

1994; 29(2-3):125-138. 

154. Rhee KJ, O'Malley RJ. Neuromuscular blockade-assisted oral intubation versus nasotracheal 

intubation in the prehospital care of injured patients. Ann Emerg Med 1994; 23(1):37-42. 

155. Staudinger T, Brugger S, Roggla M, Rintelen C, Atherton GL, Johnson JC et al. [Comparison 

of the Combitube with the endotracheal tube in cardiopulmonary resuscitation in the 

prehospital phase]. Wien Klin Wochenschr 1994; 106(13):412-415. 

156. Choux C, Gueugniaud PY, Barbieux A, Pham E, Lae C, Dubien PY et al. Standard doses 

versus repeated high doses of epinephrine in cardiac arrest outside the hospital. Resuscitation

1995; 29(1):3-9. 

157. Dybvik T, Strand T, Steen PA. Buffer therapy during out-of-hospital cardiopulmonary 

resuscitation [see comments]. Resuscitation 1995; 29(2):89-95. 

158. Dybvik T, Strand T, Steen PA. [Out-of-hospital buffer therapy in heart arrest]. Tidsskr Nor 

Laegeforen 1996; 116(27):3212-3214. 

159. Quadrel M, Lavery RF, Jaker M, Atkin S, Tortella BJ, Cody RP. Prospective, randomized trial 

of epinephrine, metaproterenol, and both in the prehospital treatment of asthma in the adult 

patient. Ann Emerg Med 1995; 26(4):469-473. 

160. Schwab TM, Callaham ML, Madsen CD, Utecht TA. A randomized clinical trial of active 

compression-decompression CPR vs standard CPR in out-of-hospital cardiac arrest in two 

cities [see comments]. JAMA 1995; 273(16):1261-1268. 

161. Weiss SJ, Hanhart EJ, McBride R, Johnson H, Denninghof K, Johnson WD. Tympanic 

membrane thermometry in the care of out-of-hospital patients [see comments]. Ann Emerg 

Med 1995; 25(1):41-47. 

162. Brouwer MA, Martin JS, Maynard C, Wirkus M, Litwin PE, Verheugt FW et al. Influence of 

early prehospital thrombolysis on mortality and event-free survival (the Myocardial Infarction 

Triage and Intervention [MITI] Randomized Trial). MITI Project Investigators. Am J Cardiol

1996; 78(5):497-502. 
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163. Luiz T, Ellinger K, Denz C. Active compression-decompression cardiopulmonary 

resuscitation does not improve survival in patients with prehospital cardiac arrest in a 

physician-manned emergency medical system [see comments]. J Cardiothorac Vasc Anesth

1996; 10(2):178-186. 

164. Mauer D, Schneider T, Dick W, Withelm A, Elich D, Mauer M. Active compressiondecompression resuscitation: a prospective, randomized study in a two-tiered EMS system 

with physicians in the field. Resuscitation 1996; 33(2):125-134. 

165. Sayre MR, Daily SW, Stern SA, Storer DL, van Loveren HR, Hurst JM. Out-of-hospital 

administration of mannitol to head-injured patients does not change systolic blood pressure. 

Acad Emerg Med 1996; 3(9):840-848. 

166. Stiell IG, Hebert PC, Wells GA, Laupacis A, Vandemheen K, Dreyer JF et al. The Ontario 

trial of active compression-decompression cardiopulmonary resuscitation for in-hospital and 

prehospital cardiac arrest [see comments]. JAMA 1996; 275(18):1417-1423. 

167. Lindner KH, Dirks B, Strohmenger HU, Prengel AW, Lindner IM, Lurie KG. Randomised 

comparison of epinephrine and vasopressin in patients with out-of-hospital ventricular 

fibrillation. Lancet 1997; 349(9051):535-537. 

168. Mader TJ, Gibson P. Adenosine receptor antagonism in refractory asystolic cardiac arrest: 

results of a human pilot study. Resuscitation 1997; 35(1):3-7. 

169. Plaisance P, Adnet F, Vicaut E, Hennequin B, Magne P, Prudhomme C et al. Benefit of 

active compression-decompression cardiopulmonary resuscitation as a prehospital advanced 

cardiac life support. A randomized multicenter study. Circulation 1997; 95(4):955-961. 

170. Rosen CL, Ratliff AF, Wolfe RE, Branney SW, Roe EJ, Pons PT. The efficacy of intravenous 

droperidol in the prehospital setting. J Emerg Med 1997; 15(1):13-17. 

171. Rumball CJ, MacDonald D. The PTL, Combitube, laryngeal mask, and oral airway: a 

randomized prehospital comparative study of ventilatory device effectiveness and costeffectiveness in 470 cases of cardiorespiratory arrest [see comments]. Prehosp Emerg Care 1997; 

1(1):1-10. 

172. Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C et al. A comparison 

of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside 

the hospital. European Epinephrine Study Group [see comments]. N Engl J Med 1998; 

339(22):1595-1601. 

173. Gardtman M, Dellborg M, Brunnhage C, Lindkvist J, Waagstein L, Herlitz J. Effect of 

intravenous metoprolol before hospital admission on chest pain in suspected acute 

myocardial infarction. Am Heart J 1999; 137(5):821-829. 

174. Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE et al. 

Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular 

fibrillation [see comments]. N Engl J Med 1999; 341(12):871-878. 
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175. Mader TJ, Smithline HA, Gibson P. Aminophylline in undifferentiated out-of-hospital 

asystolic cardiac arrest. Resuscitation 1999; 41(1):39-45. 

176. Skogvoll E, Wik L. Active compression-decompression cardiopulmonary resuscitation: a 

population-based, prospective randomised clinical trial in out-of- hospital cardiac arrest. 

Resuscitation 1999; 42(3):163-172. 

177. Plaisance P, Lurie KG, Payen D. Inspiratory impedance during active compressiondecompression cardiopulmonary resuscitation: a randomized evaluation in patients in cardiac 

arrest. Circulation 2000; 101(9):989-994. 

178. Schneider T, Martens PR, Paschen H, Kuisma M, Wolcke B, Gliner BE et al. Multicenter, 

randomized, controlled trial of 150-J biphasic shocks compared with 200- to 360-J 

monophasic shocks in the resuscitation of out-of-hospital cardiac arrest victims. Optimized 

Response to Cardiac Arrest (ORCA) Investigators. Circulation 2000; 102(15):1780-1787. 

179. Turner J, Nicholl J, Webber L, Cox H, Dixon S, Yates D. A randomised controlled trial of 

prehospital intravenous fluid replacement therapy in serious trauma. Health Technol Assess

2000; 4(31):1-57.