[
    {
        "Why prehospital research?": "In the early days of EMS, most clinical practices lacked objective supporting data from the field prior to implementation. Treatments and diagnostic modalities often were transferred from the hospital setting to the field or adopted with limited testing in a controlled setting. This resulted in widespread use of ineffective practices \u2013 for example, the first generation of esophageal obturator airways. Today EMS experts and providers agree that we have a duty to prove what works and what does not work using well-designed research methods.\n\nIn terms of direct benefits, the most important reason to do prehospital research is to improve patient care. This need exists not only for drug interventions (e.g. \u201cIs drug A or drug B better for the prehospital treatment of disease X?\u201d), but also for device use and other care opportunities, such as diagnostics and assessments, care algorithms, provider education, human interactions that can alter treatment, or unit deployment strategies. Classic experimental research designs examine a tightly focused question, using a small number of controlled observations in tightly monitored settings. EMS often has to rely on non-experimental approaches, surrogate settings, or systems research (involving complex interrelated questions, and large amounts of data from multiple agencies, collected in a poorly controlled environment). Spaite and colleagues provide an excellent overview of how the concepts of systems research, as borrowed from such fields as engineering, public administration, and social sciences, can be applied to EMS.\n\nAnother direct benefit of conducting research is that the patients enrolled in studies often have better outcomes than patients not enrolled in studies. This often holds true even for the patients in placebo or \u201cno treatment\u201d study arms or when the study intervention is not proven to be advantageous. There are a number of possible reasons for this: clinical information tends to be more closely followed, ancillary testing and care are optimized, and harm versus benefit is more closely monitored.\n\nResearch has a number of indirect benefits. First, the investigators and providers gain direct knowledge of the disease or issue being studied. By the time a study is designed, executed, presented, and published, the authors are experts on the topic. Second, both the researchers and the specialty gain academic recognition for well-done EMS research. Third, EMS physicians and field personnel who participate in a study may benefit from learning the scientific process and seeing how science can affect daily practice. Finally, research can facilitate improved teamwork within an EMS system. The interactions of EMS physicians, study coordinators, emergency department personnel, and field personnel can lead to an enhanced appreciation of the roles that each play and the problems each face.",
        "Ask a simple question": "Although it sounds simple, asking the wrong question \u2013 one that has little interest or utility to others or one that is not clear and focused \u2013 is one of the most common errors in research. Simply put, every research question should pass the \u201cSo what?\u201d test and be clear and focused. Although a study can involve some sub-topics or smaller questions related to the main question, the researcher must be able to state clearly in one or two sentences the main study question. Asking colleagues or a research mentor to review the question before starting the study will help ensure that the question is important, clear, and understandable and may also lead to additional ideas for conducting the project.\n\nIt is important that the researcher ask an important and focused question first and then design an approach to answering it, rather than the other way around. Searching through a mound of data (e.g. numbers generated by a quality improvement project or dumped out of a computer-aided dispatch system) for a question that could be addressed can result in either misleading or uninteresting results. Large databases are tempting to explore because it seems there must be a study lurking in the numbers, but care must be taken to ask a clear question before analyzing the data.",
        "Write a hypothesis or a clear, simple objective": "Once a research question has been formulated, a hypothesis or a clear objective must be composed. A hypothesis is a declaration to be proved or disproved. There are several types of hypotheses, depending on the phrasing. A null hypothesis states that no difference exists between two (or more) groups being studied. An example from a published study states, \u201cOur null hypothesis is no difference in survival exists between an EMS system using targeted response and one using a uniform or all advanced life support response model.\u201d The alternative hypothesis states that a difference between groups will exist. This difference can be directional, specifying a better/worse or higher/lower effect (e.g. \u201cWe hypothesized that 4-hour survival would be greater among patients randomized to load distributing band CPR compared with those randomized to manual CPR\u201d). It also can be non-directional, where no direction is specified for the sought-after difference.\n\nIt is important to recognize that not all studies can have traditional hypotheses, but every study should have a clear focus. For example, the following is a focused and clear objective: \u201cThe objective of the current study, the OPALS Respiratory Distress Study, was to assess the incremental benefit with respect to morbidity and mortality that results from the implementation of an advanced-life-support program for the evaluation and management of respiratory distress before patients arrive at the hospital.\u201d Many observational EMS studies observe patterns and operational features of systems rather than compare groups, and a formal hypothesis may not be appropriate. Such studies can refine a question and explore areas in need of future work rather than define an association.",
        "Review the current literature": "Reviewing the available literature on the topic to be studied is not glamorous or fun, but it is crucial. A review will confirm that the question is appropriate and important. If the question has already been studied, there may be no need for a trial. This is unlikely for a good clinical question \u2013 even if previous work exists, a confirmatory study or a study conducted in a different type of EMS system may be of value. More likely, a researcher will find work on a similar but different question. A review may also help identify problems that may be encountered or methods that may be better suited to the study question than those originally planned.\n\nTo ensure a comprehensive review of the literature, perform a computer search using at least two different databases. For the EMS literature, the MEDLINE and CINAHL (Cumulative Index to Nursing and Allied Health) databases are of particular value. MEDLINE is produced by the National Library of Medicine, indexes approximately 5,600 journals, and is generally considered to be the authoritative biomedical index. CINAHL indexes more than 5,400 journals and includes \u201cemergency services\u201d among the 17 allied health fields on which it focuses. Online abstracts are given for the majority of citations, and these can help screen for articles that need to be located and reviewed in their entirety. Online Google Scholar searches may also assist in identifying relevant published research. No matter which search engine is used, computerized searches will miss some papers, making a manual search of cited references from all relevant articles found in the computer search essential, although frequently tedious.\n\nAfter completing the literature review, the investigator should be an expert on the subject and have a clear idea of the direction the study is going to take. In fact, many investigators write review papers from this effort or are able to frame the introduction, methods, and even parts of the discussion section of the eventual study manuscript before beginning the study based on this gained expertise.",
        "Select a study design": "A study design is a general plan for testing the study hypothesis or approaching the objective. There are many designs, and the best choice will depend on the study question and available resources. The researcher must select a design that balances costs, time, feasibility, and ethics and will produce useful results.\n\nAlthough often perceived as the \u201cgold standard\u201d from an evidentiary strength view, a randomized controlled trial (RCT) is not always possible or even desirable. For example, some outcomes may occur so far in the future that it is not practical to wait for them to occur; similarly, an RCT may be unethical if clear benefit, harm, or a lack of supporting data for a particular therapy exists. New questions may require background work to define the magnitude of the problem or identify potential solutions, usually best accomplished using non-RCT designs.\n\nWhen choosing a study design, researchers must ask three questions.\n\n1. Can they follow participants over time?\n2. Can they intervene with participants (instead of simply observing)?\n3. Will they look at events that have already occurred or as they occur?\n\nThe first question determines if the study will be cross-sectional or longitudinal. Cross-sectional studies are those that measure all the study variables at the same point in time (or during a brief interval, perhaps a week or a month), providing a \u201csnapshot\u201d of data. Most surveys are cross-sectional, in that they gather data regarding the state of a particular problem or variable across a number of respondents, all at approximately the same time. A survey of all 9-1-1 communication centers in the state of North Carolina regarding dispatcher training and protocols for stroke and myocardial infarction is an example.\n\nIn contrast, longitudinal studies examine variables over time by following patients. Longitudinal studies are challenging in EMS, where patients generally do not maintain contact with the EMS system after their encounters. Although many out-of-hospital cardiac arrest studies follow survivors out to 1 year, very few studies follow patients through multiple EMS encounters over time. Some studies seem to have characteristics of both types, as with a study of changes in out-of-hospital cardiac arrest survival rates over an 11-year period. In this example, the investigators assembled sequential 1-year snapshots (rather than individual patients being followed over time) over more than a decade.\n\nThe second question determines if the study will be observational or interventional. An observational study monitors what is happening but makes no attempt to influence outcome or otherwise intervene in the events being studied. By comparison, an interventional design imposes a change or perturbation and studies the effects. Contrasting examples are a study by Hostler and colleagues examining blood samples from out-of-hospital cardiac arrest patients for the presence of thrombin/antithrombin complexes (an observational trial), and a randomized controlled trial by Rickard and colleagues comparing intranasal fentanyl to intravenous morphine for prehospital pain management (an interventional design).\n\nThe third question determines if the study will be prospective or retrospective. In a prospective study, the events of interest have not yet occurred when the patient is identified. For example, in the analgesia study by Rickard and colleagues, patients were enrolled before any pain medication was given. After enrollment, each patient randomly received one of the two study drugs, which was then administered, followed by outcome assessment (the amount of change in the patient's verbal rating score of the degree of pain). In a retrospective study, the events of interest have already occurred at the time of patient identification. A retrospective study might have reviewed the records of patients to see what pain medications they had received and compared outcomes.\n\nIn general, longitudinal, interventional, and prospective studies are of greater value in assessing causal relationships \u2013 \u201cthis affects/changes that\u201d \u2013 than are cross-sectional, observational, or retrospective studies. This benefit comes at an expense: the more powerful designs are generally harder to perform, are often more expensive, and are usually more time consuming.\n\nIn making the final choice, a researcher must match the specific needs and maturity of the question with available resources and ability to complete the project. For example, before embarking on an RCT to evaluate two different methods of limiting needle-stick exposure in EMS providers, a cross-sectional or observational design might help define the magnitude of the problem with provider needle-sticks and measure the current prevention practices. These data are key to planning an interventional trial.",
        "Descriptive studies": "The simplest research designs are descriptive and include the correlational, case report, case series, and cross-sectional survey study designs. Their primary use is to formulate hypotheses for more advanced work. These studies may not have hypotheses, but they should have clear and focused objectives.\n\nOne type of descriptive study is correlational, which can also be called aggregate or ecologic. Instead of comparing individuals, this design assesses rates for a population. For example, during the Vietnam War the survival rate for trauma patients increased and the average time to definitive care decreased when compared to the Korean War. This did not prove a causal relationship between survival and time to definitive care, but it suggested potential benefit. A major limitation for correlational designs is that the researcher cannot determine if individuals with the exposure (i.e. independent variable, or the factor being studied as a possible cause of some outcome) actually developed the disease (i.e. dependent variable, or the outcome itself). Using the previous example, it is impossible to determine if those soldiers who survived actually had short transport times. This is known as the ecological fallacy, where group characteristics are assumed for individual subjects. Another limitation of this design is the inability to control for any confounders in the analysis (e.g. injury severity, preexisting conditions, or ancillary care changes).\n\nIn contrast, the case report and case series are the simplest of study designs that analyze individuals. A case study looks at only one individual with a presentation or disease, whereas a case series looks at multiple patients with a presentation or disease. These studies describe in detail the identified individual(s), their treatment, and outcome. Although often seen as less valuable, case reports and series often give seminal insight into new diseases and treatments. For example, the 1981 case series by the Centers for Disease Control reporting on five homosexual men in Los Angeles who were diagnosed with Pneumocystis carinii pneumonia was the first published report of acquired immunodeficiency syndrome (AIDS).\n\nCase reports and case series may postulate a reason for the phenomenon that is being reported, but neither can be used to formally demonstrate an association. Therefore, the primary purpose of these designs is education (regarding the clinical scenario) and hypothesis formulation (regarding a possible causal link). It is important to note that case reports are the experience of only one person or group and may not be generalizable to other situations or patient populations. In the EMS world, case reports and case series are frequently used to describe not just clinical entities, such as a mass gammahydroxybutyrate intoxication or a perimortem Cesarean section by an air medical crew, but also operational issues such as a complex boat-dock collision rescue or an urban search and rescue training exercise.\n\nThe last of the descriptive study types is the cross-sectional survey, also known as the prevalence study. In these designs, the exposure (i.e. risk factor) and disease status (i.e. outcome) of the participants are measured at the same time. All measurements are made at one point in time, like taking a snapshot picture. The researcher only knows what happened at the time the question was asked and not what happened next. Surveys are the typical tool used for these analyses. The primary advantage of cross-sectional surveys is their ease because they are fast and inexpensive to conduct. The main disadvantage is that it is not usually possible to establish a cause\u2013effect relationship, although data from this design can help guide the next investigation seeking to define that relationship. Further, this design is called a prevalence study because it will measure only the number of existing cases of a disease (i.e. prevalence) as opposed to the number of new cases of the disease over a set period (i.e. incidence). An example is a survey of prehospital personnel regarding the amount, format, and content of training they had received in the past year regarding chemical, biological, nuclear/radiological, and other mass casualty events.",
        "Analytical designs - Observational": "The two principal observational analytical study design types are case\u2013control studies and cohort studies. A third variety, the before\u2013after study, is an observational approach nested in a near- or \u201cquasi-\u201d experimental way.\n\nThe primary difference between the case\u2013control and cohort studies is the method of subject identification. Using the hypothetical question of whether intubation improves survival for major trauma patients, in a case\u2013control study patients are identified by their outcome (e.g. survivors versus non-survivors of major trauma), whereas in a cohort study they are selected by their exposure status (e.g. those intubated versus not intubated in the field).\n\nIn a case\u2013control study, after selecting the cases (i.e. those with the disease or outcome) and controls (i.e. those without the disease or outcome), the researcher looks to determine who was exposed to the risk factor of interest (e.g. to determine which patients had been intubated in the field). These studies are generally retrospective, but in some cases data can be gathered prospectively. This design is efficient in cost and time, especially for diseases with long latency periods, because it is not necessary to wait for the outcome. It is also the best design to use when studying a rare outcome, such as survival from out-of-hospital asystolic arrest, because participants are selected based on an outcome that has already happened. However, it is a poor choice for studying rare exposures (e.g. cricothyrotomy), because large numbers of subjects are needed to have enough participants who had the exposure of interest.\n\nCase\u2013control studies also have the advantage of allowing the researcher to look at several exposures at once. However, care must be taken to develop a hypothesis prior to analyzing the data. Conducting a data-driven analysis by testing multiple exposures without a specific hypothesis is an excellent way to develop new hypotheses, but it may result in spurious findings that are due solely to chance.\n\nThe other major disadvantages of case\u2013control studies are sampling and measurement bias. Sampling bias can occur when cases and controls are selected. Theoretically, cases should be selected from all patients with the disease. However, in practice subjects are usually identified through a single source (e.g. trauma patients from a single hospital trauma registry). This method may miss cases who do not present to that source (e.g. patients who die on the scene or are transported to another facility). Even more difficult is the identification of controls, who must be drawn from the same population as the cases and be at the same risk for the disease. Stated differently, controls should be the same as cases in all respects except presence of the disease. Another potential bias is measurement bias, where the presence of the disease influences the retrospective assessment of exposure. For instance, cases may be more likely to remember an exposure than controls because they are sick (known as recall bias). A final disadvantage of the case\u2013control design is difficulty establishing a temporal sequence (i.e. the exposure came before the disease) because the cases may have had unidentified disease prior to the exposure.\n\nIn a cohort study, patients are selected based on their exposure (e.g. field intubation). Two groups of patients are selected: one with and one without the exposure. The groups should be the same aside from the exposure \u2013 this is often a challenge and cannot be known with certainty, confounding observations. Also, none of the potential participants should have the outcome of interest at the time of selection. These subjects are followed to determine if they develop the outcome of interest (e.g. survival from major trauma). The military use of the word cohort, a group of soldiers who all march forward together, can be helpful in remembering the difference: in a cohort study, the group starts out together (with or without the exposure) and moves forward through time toward an objective (the outcome). Although usually prospective, cohort studies can also be done retrospectively.\n\nThe principal advantages of a cohort study are that the temporal sequence can typically be determined and all can be sure that the exposure came before the outcome. Further advantages are that the researcher can look at the exposure\u2019s effect on multiple outcomes, albeit with the same caution regarding data-driven analyses noted earlier. If done prospectively, the cohort design limits the bias being introduced into the measurement of the exposure or the outcome, as compared to a case\u2013control design. Cohort studies are good for studying rare exposures, because participants are selected based on exposure, but are best when the latency period is short. These studies can be expensive because contact with the subjects must be maintained throughout the follow-up period, and there is a risk of bias if participants are lost during the follow-up period. This design is a poor choice for rare outcomes because a large number of subjects is needed to have enough who develop the disease of interest.\n\nAn example of an EMS cohort study is one by Burstein and coworkers examining refusal of care. The study population was patients who refused EMS transport, the exposure was the level of assertiveness of the physician providing direct medical oversight who spoke directly to the patient, and the outcome was patient acceptance of hospital transport.\n\nThe before\u2013after study design is widely used in EMS research to study both clinical and operational topics. In this design, data are collected in two phases: before some sort of change is implemented in the system and after. The largest study of prehospital advanced life support, the Ontario Prehospital ALS Study (OPALS), utilized the before\u2013after design in several phases to study whether ALS improves patient outcomes overall and for a variety of clinical entities.\n\nThis design may be considered purely observational if the researchers have no role in implementing the change being studied. For example, a group of researchers may study motor vehicle crash fatalities before and after the implementation of a state-wide trauma system. However, if the researchers have some role in the change being implemented, this design can be considered quasi-experimental because the study will examine the effects of the changes that the researchers themselves implemented. As an example, a group of researchers participated in developing and implementing a dispatch protocol and then used the before\u2013after design to study the effects of this protocol on first responder utilization.",
        "Analytical designs - Experimental": "Experimental or clinical trials are constructed similarly to cohort studies, except that the researcher specifically assigns the exposure status in an experimental design. After identifying potential participants, measuring baseline characteristics, and checking to be certain the outcome does not already exist, the participants are each assigned to either receive or not receive the study treatment or intervention. Participants are followed over time to see which develop the outcome or disease of interest.\n\nThe participants in a clinical trial are typically assigned their exposure status randomly. Randomized assignment means that at the time each potential candidate is identified, he or she has an equal chance of being assigned to any treatment arm based on a non-systematic process, such as a random number generator. When done correctly, randomization to a study arm can limit the effect of both known and unknown factors that may influence the study outcome by distributing them equally between the groups. This process attempts to ensure that each group is similar at the start of the study.\n\nAlternatives to randomization exist and are used to simplify logistics, especially in the prehospital setting. These pseudo-randomization techniques include \u201cevery other time interval\u201d (e.g. every other day), use of end digits of a Social Security number, or other perceived non-systematic features. These alternatives often achieve the goal of each group having similar characteristics at the start of the study, but they may ultimately fail and produce groups that differ for a reason distinct from the exposure. For example, a study of intubation that gives group assignment based on day of the week may measure the skill differences of the providers (if EMS personnel work certain fixed schedules) or enroll varying populations (because injury and illness patterns often differ by day of week), rather than the target intervention (intubation).\n\nBlinding is used in clinical trials to limit assessment bias (beliefs held prior to or outside the experimental question that influence judgment regarding the subject\u2019s outcome). Specifically, blinding attempts to eliminate the distortions in variable measurement caused by the participant, care provider, or outcome assessor knowing which treatment arm the participant has been assigned. Single-blind studies generally try to ensure that the study subjects cannot tell which therapy is being used. Double-blind studies shroud both the subject and outcome assessor from the participant\u2019s group assignment. Triple-blind studies require the subject, assessor, and care provider to be unaware of the participant\u2019s group assignment.\n\nPlacebos or shams are substances or devices that are intended to be physiologically or functionally inactive but appear identical to the active therapy that is being studied. Using a placebo can allow the researcher to blind the participant, assessor, and caregiver to the participant\u2019s group assignment. The use of placebos also allows the researcher to separate the perceived effect of treatment from the actual effect of the specific treatment that is being studied. Placebos are generally used only when an accepted standard of care does not exist. In studies where a standard of care exists, it is unacceptable to use a placebo because the control subjects should receive the standard therapy, unless there are substantial questions regarding the effectiveness of that standard therapy. Blinding \u2013 whether the researchers or patients can distinguish between two active agents/interventions or a placebo and an active agent/intervention \u2013 can be unrealistic or difficult if there are obvious differences (e.g. color, smell, appearance).\n\nThere are several clinical trial design variations for assigning treatments. Clinical trials can range from simple two-arm studies (e.g. a study comparing active compression\u2013decompression CPR to standard CPR) to more complex designs with multiple arms (e.g. a study comparing intravenous diazepam, lorazepam, or placebo for adults with prolonged or repetitive seizures). Another option is to have each participant serve as his or her own control in a cross-over trial. In this design, each participant gets the treatment for a certain period of time and, after a washout period (i.e. a period of time where the effects of the treatment are removed), each enters the other arm of the study. An example is a 1998 study looking at the effect of melatonin on night-shift paramedics. Each paramedic in the study was randomly assigned to receive either melatonin or placebo for the first week of the study. After a washout period of several weeks where no treatment was given, each paramedic was given the opposite treatment. In this way, each subject was in each arm of the study and could serve as his or her own control. This design can also be used without a washout period. An example is a study by Woollard and colleagues examining the ability of field personnel to use two different types of airway devices. Each paramedic student randomly used one of the two devices, then was tested on the other device.\n\nOne advantage of clinical trials is that they can account for both known and unknown factors that might affect outcome.\n\nHowever, these studies are costly and time consuming, so they are typically only used after a hypothesis has been examined and refined using simpler study designs. Further, there may be ethical barriers to randomly assigning patients to a treatment group. To ethically conduct a randomized trial, a researcher must have clinical equipoise; in other words, he or she must be confident that there is not a clear benefit or harm from receiving the study intervention based on current knowledge (recognizing the trial may detect said difference).",
        "Conclusion": "High-quality research is important to the field of EMS. To conduct a meaningful study, the researcher must ask a clear and focused question, review the literature to determine what has been done in the past, and identify an appropriate study design. Typically when investigating a new area it is best to start simple and observe the phenomenon (case report or case series), review the past to see if there is a pattern (case\u2013control), watch the future to see if that pattern can be predicted (cohort), and finally manipulate participants to see if that pattern can be created (experimental)."
    },
    {
        "Introduction": "By its nature, EMS has been a reactive profession in that emergency responders have been prepared to respond quickly and work efficiently to attend to ill and injured individuals. A focus upon good health practices, including patient and family education and injury and illness prevention, has not yet become a vital mission in the profession. In addition, the lack of attention to social consequences of chronic illness in initial physician education and the psychosocial aspects of health and illness has produced a similar void in paramedic education. Although most EMS providers acquire familiarity with patient psychology through street experience, social issues such as those involving family, social isolation, bystanders, and cultural sensitivity have been given short shrift in the education of EMS professionals.",
        "Family support in patient care": "Communication with and inclusion of family members is a topic in medical education that has not previously been a significant focus. Hartmann et al. noted that training medical students and physicians in communicating with families is an essential task for the future. Families are increasingly involved in patient decision making. Similarly, family dynamics is usually not addressed in EMS education, particularly the differences in ethnic groups. Overall, EMS trainees rarely receive in-depth information regarding various cultural beliefs about health and illness, the sick role, and attitudes about health care providers. Emergency medical services students have been taught almost exclusively what to do to patients, suggesting that all are in extremis. However, patient care involves more than medical knowledge and technical expertise. Talking to patients has served the sole purpose of accessing the history and chief complaint and then for advising the patient of procedures that would be performed. Establishing rapport and reaching common ground were absent in the repertoire of yesterday's paramedics and EMTs. EMS courses similarly lacked information regarding communication with families. Providers were taught how to assertively inform family members that a loved one had died, but otherwise, interacting with and incorporating the family into patient care decisions has been limited to enlisting their help in convincing an unwilling patient who needed to go to the hospital or querying about history and medications in the unresponsive patient. EMS should now adopt trends seen in other medical settings. \u201cThe core features of family-centered health care are the acknowledgment of the unique strengths, resources and needs of all family members, and the emphasis placed on partnership between the patient, the family, the doctor and other service providers.\u201d No longer is the emphasis upon what is done to the patient, but what medical personnel can do for the patient, family, and other caregivers, all working as a team. The threshold for accessing EMS is lower than for other medical professionals, excepting perhaps family physicians and/or the emergency department. EMS may be the first and only contact with a medical professional for a variety of chronic and/or acute patient misfortunes and therefore is considered one component in the health care safety net. Even so, EMS providers tend to \u201cscoop and run\u201d and historically have not established short- or long-term relationships with their patients, families, and/or caregivers. However, as primary care providers have discovered, engaging the patient\u2019s family may be of assistance in several ways. First, it may engage those who can provide support to the patient, whether by monitoring diet and adherence to a medicine regime, serving as watchdogs for specific signs and symptoms of a worsening condition, or by creating a safer, more pleasant, and healthier environment for the patient. Second, acknowledging the family establishes trust and exhibits good will in caring for the patient. One of the normative cultural values in the Latino culture is personalismo, which refers to warm, personal relationships, including those expected with the physician or medical provider. Finally, family-centered involvement solidifies the continuum of care and creates a cohesive unit whereby strength is achieved through larger numbers of individuals focused upon the patient\u2019s best interest. In 2010, 56.7 million people or 18.7% of the US population were living with disabilities. In addition to coordination of care between medical providers, coordination of care should also include the families and other caretakers of these patients. EMS providers are frequently dependent upon families and caretakers of patients for information and history and occasionally must deal with multiple family members, not all of whom necessarily agree on their family member's care or who may not be equally informed. Coordination of patient care often requires medical personnel to interact with more than one family member, particularly for pediatric or impaired patients. Often, the EMS providers' management of the patient includes the decisions of the medical power of attorney. As a member of the health care team, EMS providers must work to improve communication in their arena of care. Even in an emergency setting, use of appropriate principles of interviewing and conversation with patients and their families can guide the EMT and paramedic toward relevant clinical decisions. For those patients who are technology dependent or have special needs, and for those with chronic or terminal illnesses being cared for at home, family members provide a rich resource of information regarding that which is normal for their loved one, including level of consciousness, color, respiratory status, or vital signs. Increasing numbers of patients are being cared for at home rather than in institutions, and their caretakers are taught how to perform skills and troubleshoot devices such as tracheostomies, IV pumps, urinary catheters, and ventilators. In addition, implanted devices such as defibrillators, pacemakers, and left ventricular assist devices and procedures such as peritoneal dialysis are increasingly encountered by EMS providers responding to 9-1-1 calls. Although in-depth knowledge of the technology that supports these patients may be out of the scope of training for the EMT and paramedic, he or she should rely upon family members or other caretakers for assistance in managing these devices and/or patients. As an integral member of the health care team, the EMS provider should not view requesting assistance or information from the patient or patient\u2019s care provider regarding unfamiliar technology as a point of incompetence, but rather as an overlap in the team approach to patient care. The inclusion of family members in patient decisions and care is paramount to improving a patient\u2019s health. However, the EMS professional should proceed cautiously while gathering patient information from the family or caregiver. Family members may insist that they are familiar with the patient\u2019s recent activities or medical history, and may possess inaccurate or irrelevant information for the current emergency problem, thus incorrectly shaping the paramedic\u2019s diagnosis and treatment. Therefore, the EMS provider must filter incoming information and temper the influence of family members in order to avoid tunnel vision. Finally, a dispute between the patient and some or all family members may create friction and disagreement at the scene. In this setting of conflict, the EMT or paramedic must make sense out of the dynamics, avoid taking sides, identify each person\u2019s agenda, and orchestrate the scene in order to reach common ground. Even with family present, a patient has rights of autonomy, confidentiality, and privacy. A frustrating situation for EMS providers includes the scenario where the family adamantly directs the EMS crew to treat and/or transport their loved one while the cognizant and competent patient refuses assistance. Furthermore, a patient may not want his health information or condition revealed to other family members. Adolescent patients may not wish to discuss their sexual or substance use histories in the presence of parents. Even pediatric patients may not admit the truth surrounding an incident for fear of punishment. A family member, just because of his or her relationship with the patient, is not automatically entitled to medical information regarding an ill or injured spouse and may not understand the legal ramifications involved. Conversely, the family may not want the patient\u2019s condition revealed to the patient him- or herself, such as in the case of late-stage cancer, as seen in some Asian, Jewish, Italian, Navajo, Pakistani, and Hispanic communities where cancer is seen as a curse and a social stigma. Many cultures value family-based decisions over autonomy for management of the patient, although patient autonomy is currently the prevailing norm in the United States. Familismo in the Latino culture is loyalty to the family and priority over the individual, a viewpoint seen also in Middle Eastern and Japanese cultures, among others. EMS providers should consider this cultural viewpoint when family members are present during patient contact. Despite the maturing of the EMS profession from its modern beginnings in the 1960s, this cohort remains mostly Anglo and male. Recent demographics for EMS providers in the United States include 75% Caucasians and 72% males. In contrast, by mid-century, Caucasian European descendants will begin to constitute a population minority. The current population majority in the United States is shifting toward a diverse mix of individuals from various cultures, ethnicities, races, and faiths. Understanding family relationships forms the foundation for integration of family into patient care. Family dynamics vary depending upon culture, ethnicity, socioeconomic and educational level, and even geographical location. In some families, love is synonymous with dependence and closeness while in other families, love is expressed by allowing members to be independent. The presence of family at the emergency scene simultaneously presents a unique opportunity and a challenge. Many EMS providers have felt frustration when attempting to interview and assess a patient while a roomful of chattering relatives looms at elbow\u2019s length and answers questions for the patient. Such behavior may result from the patient\u2019s culture and/or upbringing. Most patient-to-EMT contact occurs within a personal and intimate distance of 4 feet, which is the norm for the middle-class Anglo culture. However, other cultures and ethnic groups favor a much closer personal space, which may unnerve the EMT. Large, extended families such as the Roma (Gypsies) may cluster around the patient at arm\u2019s length to provide support. Family dynamics as well as health beliefs are affected by culture. Paternalism exists in many Middle Eastern and Latino cultures, and Asian and Romani cultures revere their elders. Therefore, the EMT may need to address the male figurehead or elder, while in certain matriarchal African cultures the oldest female may serve as the patient's spokesperson. In situations relating to women\u2019s problems, a female family member may be included in the history taking. The EMS provider should be aware that the cultural mores of a traditional Muslim female patient prohibit examination by a male medical provider. Cultural competency refers to possessing knowledge and awareness of and respect for other cultures and ethnic groups. An individual\u2019s culture has a direct effect upon health beliefs, values, and practices. Culture also shapes patients\u2019 and families\u2019 confidence in and viewpoint of modern medicine and health care professionals. The EMS medical director can promote cultural sensitivity and competency by encouraging EMS providers of different races and ethnicities to disseminate information about their culture/race to the other providers along with appropriate continuing education, exposure to, and discussion of different ethnicities and cultural beliefs.",
        "Social isolation": "Human beings are social creatures, even in individualistic societies such as the United States, which may be a survival mechanism lingering from the early days of mankind. Survival improved when individuals lived with and depended upon each other during times of duress and lack of food. Propagation of the species depended upon survival at least to reproductive age. In modern society, social ties continue to support survival in hard times and may also forestall morbidity and mortality. Compared to time spent on other daily activities, individuals report being happiest when socializing and relaxing with friends and intimate partners. The human desire for social interaction is so prevalent that people regularly devise perceived and non-reciprocal relationships with characters in books, movies, video games, and even deities. Interest in the effect of social ties upon health has experienced a dramatic surge since the mid-1970s although recognition of the social environment as a factor affecting health stems from Hippocrates. Clinical risk factors have long been associated with mortality, including modifiable factors such as tobacco use, hypertension, sedentary lifestyle, obesity, and hypercholesterolemia. However, social isolation has emerged as a contributory risk factor as overwhelming as unhealthy lifestyle choices and disease. Berkman and Syme found that the mortality risks for men and women who lacked social and community ties reached 2.3 and 2.8 respectively. A recent study with 16,849 non-institutionalized adult participants identified social isolation, determined by being unmarried, not affiliated with clubs or organizations, having infrequent social contact and infrequent participation in religious activities, as predicting early demise. Low levels of social support have been found to be associated with an increase of unhealthy lifestyles and a greater incidence of suicide ideation. Why do social ties mitigate morbidity and mortality? Social ties may simply help to buffer life\u2019s stresses, and social interaction may encourage individuals to follow socially accepted health principles such as regular doctor visits, preventive health practices, exercise, abstinence from tobacco use, and reduced ingestion of alcohol. What exactly is social isolation? Seeman defined it as disengagement from social ties, institutional connections, or community participation. The terms socially isolated and lonely are not necessarily synonymous; rather, loneliness may be more accurately synonymous with perceived social isolation. Loneliness has been described as the social equivalent of physical pain, hunger, and thirst. Several studies have identified perceived social isolation or loneliness as more contributory to poor health and increased mortality than physical social isolation. Whereas a socially isolated individual may not feel at all lonely, a lonely person may actually be surrounded by attentive family and friends. A patient\u2019s perception may predict negative health issues more closely than actual circumstances. Social isolation and poor physical health influence each other. Individuals may become socially isolated due to another cause such as increased age, frailty, immobilization, illness, mental deficiencies, disfigurement, social marginality, remote location, poverty, language barrier, or lack of education. Chronic conditions and worsening health may lead to social isolation as the patient becomes less mobile and less likely to participate in activities with others. Isolated patients may experience time distortion which affects their sleep-wake cycle, appetite and eating habits, or taking of prescribed medications, all of which ultimately worsen both physical and mental health. Physical barriers may also exacerbate social isolation. Factors such as stairs, heavy doors, inability to ambulate, lack of transportation, absence of nearby supermarkets and pharmacies, or residence in a high crime area or a remote location may further isolate an individual. Conversely, a patient\u2019s inherent social isolation or perception of loneliness may contribute to physical or mental illness which worsens and ultimately perpetuates into increased social isolation. The individual may ultimately feel social demise as he or she moves farther from fulfilling a valued role in the community and/or family. The population in the United States is aging; in 2011, 73.5% were under the age of 55 while 26.5% were 55 and over. Additionally, the number of persons 80 years old and over is projected to double by 2050. Hence, senior citizens are poised to represent the largest sector of socially isolated individuals due to their increased risk of health issues, potential lack of mobility, and loss of their social support system, whether it includes friends, family members, or work colleagues who reduce or curtail contact, move away, or die. In addition, the increasing number of special needs patients may represent a unique category of isolated individuals. In 2010, 56.7 million individuals in the US possessed a disability. Both patients with disabilities along with the families caring for them may become victims of social isolation, because of difficulty motivating, marginalization due to the disability, or lack of time to socialize due to continual or complex patient care. In 2009 in the US, there were an estimated 36,698,670 EMS responses. Emergency providers often represent the first point of contact in an individual's access of the health care system. In the EMS setting, exploration of a patient's social history has not been included in initial paramedic education curricula. However, the identification of sociological factors has now become one of the essential assessment steps of the responding EMT and/or paramedic. The National EMS Education Standards include psychosocial assessment for patients, specifically in the geriatric and other special patient populations. Assessment and management of sociological factors are becoming more important for improving and maintaining health. In 2011, the US continued to lead the world in health care costs per capita, at $8508. Costly hospital admissions and readmissions in addition to frequent non-essential summoning of the 9-1-1 EMS system are at last being addressed. The patient who appropriately manages his or her health and complies with prescribed diet, medications, and physical activity often does so with social support. Attentiveness and adherence to a prescribed medical regime represent the primary step in not only cost-cutting but also the patient's immediate and long-term well-being. Emergency medical services providers are in an opportune position to recognize social isolation while on scene of an emergency or during a home visit. Community paramedics can either access assistance for the patient or relate significant findings of the social history assessment to the receiving facility, which may ultimately lead to definitive management. EMS personnel have informally promoted health while operating on emergency runs, such as illustrating to parents how to secure their children in child safety seats, identifying household hazards to patients and their families, or correcting erroneous health myths. Health promotion may be achieved in a variety of ways. While O'Donnell identified health promotion as the science and art of assisting individuals in changing their lifestyles to promote optimum health, the Ottawa Charter for Health Promotion cites health promotion as creating environments conducive to healthy behaviors. Paramedics, in the mobile health care setting, are positioned to recognize both lifestyle and environmental obstacles to good health. The medical director sets the standard, culture, and environment for EMS providers in his or her system. Proactive steps taken by the medical director can prepare the providers for success in identifying socially isolated individuals in their community. The National EMS Education Standards include health screening and referrals as components of patient assessment along with knowledge of public health principles including epidemiology, health promotion, and illness and injury prevention. With the advent of expanded scope of care by providers such as community paramedics, interventions may be initiated at the level of street medicine. In non-critical emergency responses where life and death interventions are not required, EMS providers could assess the patient's social history with instruments such as the Berkman-Syme Social Network Index (SNI) or modified SNI scale that focuses upon marriage/partnership, frequency of contact with friends and family, group membership, and frequency of religious participation. The UCLA Loneliness Assessment is a brief 20-question research instrument that paramedics may also utilize during home visits in non-critical situations. Therapy for social isolation is beyond the current scope of training for EMS providers. The emergency setting in which EMS currently functions is not conducive to in-depth sociological or psychological interventions. However, EMS providers can communicate findings to appropriate contact persons who can then mobilize support services for those individuals who appear at high risk for undesired social isolation, with its physical and psychological ramifications. Referral should be made to community health workers, such as promotores who serve as community health workers in the Hispanic populations, or support groups such as Sisters in Support Together against Substances, Alcoholics Anonymous, Narcotics Anonymous, and Big Brothers Big Sisters. Most public health departments and hospitals maintain a list of social services available to community members in need. Finally, \u201c2-1-1 US\u201d is a system designed to assist individuals with access to health and human services in their communities. Services provided include basic human necessities, support for older and disabled persons, and physical and mental health resources. The EMS medical director should encourage development of assessment skills that encompass both the psyche as well as the physical self. In addition, observable clues to social isolation in the patient's affect and surroundings should be discussed. Finally, EMS providers should have opportunities to attend educational events and classes for exposure to specialists in the field of psychosocial health.",
        "Bystanders": "Nowhere in a medical delivery setting is the issue of bystanders more of a compelling consideration than in EMS. Unfortunately, bystander management is a topic that may not have been covered in initial EMS education. The unsecure setting of many EMS calls, including highways, businesses, schools, and street corners, lends itself to public involvement and potential interference in patient care. Providers may encounter difficulty in keeping bystanders out of the treatment area or scene. Safety concerns in EMS primarily focus upon the responders themselves and the patient. However, on-scene duties include the consideration of bystanders' safety and well-being. When a life hazard such as traffic, violence, or hazardous materials threatens the safety of onlookers, EMS personnel should summon law enforcement for assistance so that they may focus upon patient care. One of the most perplexing situations for EMS personnel is the offer of assistance for or direction of patient care by a physician bystander. Self-identified medical personnel often offer assistance at the scene of an accident or sick person which places the EMT and paramedic in a difficult situation as they are likely unfamiliar with the individual and his or her credentials. EMS providers, although functioning under the guidance of a medical director who is likely an emergency medicine specialist, are often poorly prepared to manage the conflict of their responsibilities with an individual who possesses a higher level of medical training. Many feel intimidated by an on-scene physician, whether it is in person or via telephone. In fact, many paramedics view sending an on-scene physician away while managing a critical patient to be an extremely risky act. To complicate matters further, despite position statements by the American Medical Association (AMA), American College of Emergency Physicians (ACEP), and National Association of EMT Physicians (NAEMSP) regarding unsolicited medical personnel at emergency scenes, a vast majority of physicians are unfamiliar with these guidelines and/or with the capabilities and responsibilities of EMS providers in general. Physicians who are not familiar with the EMS setting may not appreciate the Spartan nature of the prehospital environment. At times, the EMT and/or paramedic may be asked to follow orders by the patient\u2019s physician by telephone, which further complicates decision making. Consider an especially difficult scenario for the EMS provider who is called to a patient in cardiac arrest but lacking in any definitive signs of death. Both the family present and the individual on the phone stating that she is the patient\u2019s primary care provider state that the patient has a Do Not Resuscitate order but the document is not present. Both the family and the patient\u2019s physician on the telephone are requesting that you do not begin resuscitative efforts. The situation has both ethical and legal ramifications for the EMS provider. Physician presence on an EMS scene may also occur in clinic or office where the paramedics are summoned to transfer the patient to another facility such as the ED, nursing facility, or the patient\u2019s home. The physician may direct the EMS crew to perform patient procedures that are not in their standard of care or to transport the patient to a hospital which, in the EMTs\u2019 opinion, is not capable of managing the patient\u2019s condition or is not the closest appropriate facility. In some cases, the physician may advise the EMS crew to perform no patient care and to just transport the patient. A more disconcerting scenario is represented by a physician who is at a patient\u2019s side in a nonprofessional setting such as in a residence or on the golf course. Guidance for these types of scenarios should originate from the medical director and become part of the protocol or policies. Additionally, the medical director should guide EMS providers as to how to manage bystander medical providers with respect and tact. In some cases, consideration of the bystanders may affect the timing and/or location of detailed patient assessment and care. For example, injuries in settings such as restaurants, concerts, or public events may require quickly moving the patient to a more private area such as the ambulance before administering definitive care. Dramatic injuries occurring in front of sporting event crowds require EMTs to modify procedures in consideration of that which is not only best for the patient, but also for the coaches, team mates, family, and spectators. In settings such as rodeos and contact sports, the injured participant may insist upon walking out of the arena rather than being carried on a stretcher. In part, this action is for the benefit of the spectators and team mates. While it may be advantageous to dismiss bystanders, they may actually provide crucially needed assistance at an emergency scene. Much has been written about the bystander effect, a phenomenon where the presence of other bystanders decreases the probability that an individual will assist in a critical situation. However, Fischer et al. found that a bystander was more likely to assist if (a) there were larger numbers of bystanders, (b) the bystanders were all males, (c) the bystanders were strangers to each other, and (d) if the bystander perceived a high cost for intervening to him- or herself. However, a paucity of research exists regarding bystander involvement in conjunction with the presence of emergency responders. Anecdotally, most EMS providers could more likely recount situations where they had been inundated with helpful bystanders than not. If bystander assistance is enlisted, EMS providers must maintain patient confidentiality and privacy. Emergency personnel should remember that spectators often photograph or videotape scene activities. EMS should strive to protect patients\u2019 privacy, especially in the case where it may be impossible to move the patient to a more secure area. Bystanders may also be helpful in recounting the history of an event or in locating involved individuals who may have left the scene prior to the arrival of EMS. Neighbors may offer additional information about when a shut-in patient was last seen. If adequate rescue personnel are present, one of them should take charge of talking to bystanders to elicit information while other rescuers provide patient care. Using this approach will assist in bystander management and keep them out of the way of the rescuers. Bystanders, even though well-meaning, may be injured while wandering into a dangerous scene or into traffic. In any situation, an onlooker may become a patient him- or herself, due to injury or to fainting or suffering a medical emergency. Additionally, while potentially interfering with patient care, they may become hostile toward the rescuers, especially on a volatile or grisly scene or one involving extreme levels of grief. Bystander responses may be driven by their knowledge level and/or culture. Unfortunately, little written guidance exists regarding management of and communication with bystanders, including mobilizing and enlisting their cooperation. When appropriate, EMS providers should use the same principles of mutual respect, tolerance, and clear, concise communication that are used with patients and their families. Finally, bystander physicians and onlookers at emergency scenes present specific challenges for rescue personnel above and beyond their primary concern of patient care. Although bystanders may require management, organization, and, at times, removal from the scene, they may prove invaluable in settings with large numbers of sick or injured such as a natural or man-made disaster scene. EMS systems and medical directors should proactively prepare for integration of physicians and other medically trained bystanders to assist in these cases, and also to provide education regarding bystander management for the more routine EMS calls."
    },
    {
        "Introduction": "Emergency medical services providers make ethical decisions on a daily basis. They frequently deal with issues of patient refusal, confidentiality, the treatment of minors, and other challenging ethical dilemmas. The fast-paced prehospital work environment compounds the complexity because difficult decisions often need to be made without having all the necessary information and without sufficient time for extended consideration and debate. An understanding of the principles of medical ethics, however, can help guide EMS providers on the front lines when faced with ethical questions.\n\nEmergency medical services medical directors, physicians, and personnel should be familiar with the prevailing statutes of their respective state and local governments because ethical debate may be moot if the law renders a ready decision. However, because individual cases vary widely, the law leaves many ethical questions unanswered. There are important differences between ethics and the law. The law attempts to ensure order by establishing rules that are derived from social values. The law, however, does not attempt to enforce every moral value. Following legal rules alone, therefore, may be ethically insufficient. For example, EMS providers not infrequently encounter patients who refuse care. Although the minimal legal standard requires a signature of release by the informed patient, the signature alone may be ethically insufficient. From an ethical and professional standpoint, it is important to explore the patient's understanding, concerns, and perhaps alternative options for treatment in order to ensure that the patient is appropriately cared for. It is important to remember that the law establishes rules and regulations based on societal values but it does not mandate the full display of the highest ethical behaviors.\n\nThis chapter will introduce core medical ethics principles and demonstrate how they can be applied to common ethical dilemmas encountered in the prehospital setting.",
        "Refusal of treatment and transport": "Case #1: EMS responds to a 45-year-old unhelmeted man who was struck by a car while riding his bicycle with his two young sons. The patient is found thrashing about on the ground, with signs of head trauma. When EMS providers attempt to transport the patient to the ambulance, the patient repeatedly refuses care, instead only asking about the whereabouts of his children, who are unharmed and remain at his side. The patient is clearly disoriented and unable to engage the paramedics in any sustained manner. One of the EMS providers asks if the patient can be treated and transferred against his will.\n\nCase#2: EMS is dispatched to the home of a 90-year-old woman with known end-stage lung cancer who is complaining of shortness of breath. Upon their arrival, EMS intervention is refused by a cachectic but lucid patient who is very aware of her medical condition. She explains that she has been recently discharged from the hospital after extensive discussions with her oncologist regarding her preference to spend her remaining days at home. She understands that her progressive shortness of breath is a result of her end-stage lung cancer and that she will likely die from the disease in the near future. The patient's sons and daughters admit that they had initiated the 9-1-1 call because they felt their mother appeared extremely uncomfortable. The patient adamantly refuses any transfer to the hospital, while her family demands that EMS providers \u201cdo something\u201d to help her.\n\nAutonomy is a core principle of medical ethics. Individuals are assumed to have the right to self-determination, even if their decisions result in harm to themselves. Patient refusal of care may apply to a specific course of treatment (e.g. insertion of a peripheral IV) or plan for further care (e.g. patient refusing transportation to the closest hospital in favor of a different facility). For EMS providers, patients have capacity to make their own medical decisions when the following criteria are fulfilled:\n\n1. The patient must have sufficient information about his or her medical condition.\n2. The patient must understand the risks and benefits of available options, including the option not to act.\n3. The patient must have the ability to use the above information to make a decision in keeping with his or her personal values.\n4. The patient must be able to communicate his or her choices.\n5. The patient must have the freedom to act without undue influence from other parties, including family and friends.\n\nIf any of the above criteria are not met, EMS providers should balance their respect for the patient's limited decision-making capacity with their obligation to act in the patient's best interest. A great challenge for EMS providers is to expertly assess decision-making capacity in order to understand when a refusal is informed and when it is an impulsive gesture of a person who lacks capacity due to severe psychiatric disease, intoxication, or overwhelming medical illness. For example, medical conditions such as hypoglycemia, head trauma, and sepsis can make patients impulsive, restless, angry, and antagonistic such that there may be confusion regarding their ability to reason. If EMS providers believe a patient lacks decision-making capacity (as opposed to competence, which is a legal determination), actions should be taken to ensure the patient's safety and best interest. In this regard, EMS personnel must operate under the rubric of beneficence, another core principle of medical ethics.\n\nIn situations of refusal of care, providing unwanted treatment over the objection of a patient with sufficient decision-making capacity may render the EMS provider guilty of battery. Conversely, an impulsive or incompletely informed refusal leading to lack of treatment and transport leaves the provider liable for negligence. It is therefore strongly recommended that whenever EMS providers defer transport or treatment due to a patient's refusal of care, the patient's decision-making capacity should be explicitly documented in the medical record, with special attention to the information that was specifically communicated and understood by the patient. Similarly, when EMS providers act in the patient's best interest and treat or transport a patient who refuses care but who is deemed to have insufficient decision-making capacity, the conditions leading to this determination should be carefully documented. EMS providers must remember that it is not the responsibility of patients to prove they have decisional capacity; it is the responsibility of the provider to identify any impairment of such capacity.\n\nThe patient in case #1 clearly did not exhibit signs of decision-making capacity, likely secondary to the head trauma he sustained. EMS providers would be acting ethically to deny his refusal of care and instead act in his best interest by treating and transporting him to a hospital for definitive care.\n\nThe patient in case #2, though critically ill, still possessed full decision-making capacity when questioned by EMS personnel. She demonstrated that she sufficiently understood her medical condition, the risks and benefits of refusing further medical care, and how these decisions were in keeping with her personal values of wishing to die at home surrounded by her family and friends. For this patient, her decision to refuse further care is compatible with the EMS provider's ethical obligation to respect a patient's autonomy. Although the patient's family may disagree with the patient's decision, EMS responders would be acting ethically by respecting her wishes not to be transported to a hospital.",
        "Triage Decisions": "\n\nCase #3: EMS providers are en route to a patient who called 9-1-1 after falling down on the wet floor of a supermarket when they witness a motor vehicle collision at an intersection they had just crossed. It is clear to the paramedics that the occupants of the vehicles suffered injuries, although the severity of the injuries was still undetermined. Calls are just coming in regarding the current accident. One of the EMS providers in the ambulance asks if they should stop to assist at the accident because the 9-1-1 call they are responding to did not appear too serious.\n\nEmergency medical services systems are designed to encourage the best use of scarce and valuable resources in a given environment. They are operated by individuals with an organized and overarching view of the entire needs of a community at any given time. Paramedics dispatched to calls do not have the luxury of this knowledge and as such should not make triage and rationing decisions on an ad hoc basis. EMS providers should, however, report any unexpected events that they encounter and ask for appropriate instruction.\n\nIn case #3, the individual at the supermarket may have been much more seriously injured than the paramedics were led to believe. The ethically appropriate action would be for EMS personnel to ask if they should be reassigned to the motor vehicle accident, given their proximity to the incident, and await further instruction from dispatchers and supervisors, who likely have better information regarding other available resources. Of course, if EMS providers encounter a clear and immediate life threat outside their original assignment, it would be reasonable to render assistance. But other than in these extreme and rare circumstances, individual EMS personnel should refrain from varying from designated triage and response assignments.\n\nEmergency medical services providers should also refrain from dissuading patients from seeking transport to a hospital for definitive care. Paramedics may encounter patients who they feel are not ill enough to warrant care in an emergency department. EMS personnel, however, should be strongly cautioned against such action, because they are not trained to render formal medical diagnoses and decide if someone needs a formal medical evaluation. Comments to patients such as are unwise and outside the EMS scope of practice. EMS physicians, on the other hand, are in a better position to determine if no further care is needed than what is being provided at the scene. Depending on the nature of the EMS physician's role in the system, it may be reasonable for the physician to encourage non-transport in certain circumstances. This may be an expected role for the EMS physician in the case of a mass casualty event that involves fairly large numbers of uninjured or minimally injured patients. The physician may be able to assess and these patients at the scene, avoiding unnecessary transports that will burden both the EMS system and the receiving facilities.",
        "Confidentiality": "Case #4: Paramedics respond to a call from the home of a prominent local politician after he was found passed out in the bathroom by his wife. At the scene it becomes clear to the EMS providers that the individual is severely intoxicated. After transfer to a local hospital, EMS providers are asked to comment on the circumstances of the politician's hospital visit by reporters from the local media.\n\nHealth care providers, through the nature of their work, have unique access to the private lives of patients. In order to maintain an honest working patient-caregiver relationship, patient trust in his or her health care providers must not be breached. Although there may be exceptions to this rule (e.g. criminal investigations, patients who admit to suicidal or homicidal ideation, suspected child or elder abuse, and patients who pose a public health threat), health care providers should exercise caution in revealing information to those who do not share a therapeutic relationship with the patient.\n\nWhen EMS providers are asked to comment on the medical care delivered to any patient, they should exercise caution in what they reveal to media sources. EMS providers may do well to defer all questions to a specially designated media spokesperson, such as the agency's public information officer, who is well versed in sophisticated media relations. Had the EMS providers in case #4 stated that the patient \u201cwill be fine in a few hours,\u201d speculation would arise as to the nature of the hospital visit. Even seemingly benign comments about a patient\u2019s medical condition can be misconstrued. Likewise, health care providers should exercise restraint when asked by curious family members, friends, or colleagues about a prominent figure\u2019s medical condition. Not only would revealing such information represent a breach of patient confidentiality and trust, but strict and enforceable rules exist to discourage curious onlookers without a direct therapeutic relationship from accessing private patient information.",
        "Truth telling and error disclosure": "Case #5: EMS providers are called to a restaurant where a 55-year-old man with multiple food allergies complains of hives and itching. Intending to administer diphenhydramine, the EMS provider mistakenly administers 1 mg of 1:1,000 epinephrine IV, resulting in the patient\u2019s hospital admission for monitoring of multiple non-sustained runs of ventricular tachycardia. The patient is ultimately discharged without incident. The EMS provider asks the medical director if the error should be disclosed to the patient.\n\nTruth telling is important under all circumstances, but more so when upsetting news and information regarding medical errors are disclosed. Many professional societies, patient safety experts, and standard practice guidelines recommend disclosure. There are many reasons favoring the disclosure of harmful errors to patients. Disclosure supports truth telling, patient autonomy, and informed decision making, and is consistent with patients\u2019 preferences. Patients want to know about errors even when the harm is minor, and expect a full explanation and an apology. Patients also seek acknowledgment of the pain and suffering that was caused by the error, along with reassurance that recurrences will be prevented. In addition, disclosing errors promotes patient safety, as it enables the critical appraisal of the conditions leading to errors and the development of interventions to prevent recurrences.\n\nWhen errors are disclosed, the patient and family must sense honesty in the communication. Patients can often tolerate mistakes, but they will not tolerate providers who do not care. Information regarding errors must be explained to the patient in the proper context, even though the provider\u2019s natural instinct may be to cover up mistakes. This is a precarious maneuver both professionally and legally, especially if the patient or family later discovers the error. Many patients who file medical malpractice claims do so because they believe that disclosure was absent or inadequate and see legal action as their only option for finding out what happened.\n\nHistorically, providers were advised not to disclose errors to patients out of fear that offering an apology or an admission of fault would precipitate malpractice suits. Recent research suggests this assumption may be unfounded. Health care organizations that have adopted robust disclosure programs are reporting favorable outcomes in the number of claims filed, litigation costs, and time to resolution. In addition, 35 states and the District of Columbia have adopted laws making medical apology inadmissible as a statement of fault, with some states even requiring the disclosure of serious unanticipated outcomes to patients. These developments have led many risk managers and malpractice insurers to strongly advocate for disclosure.\n\nWhen disclosing a harmful medical error to a patient and his or her family, the provider should focus the conversation around the needs of the patient. The provider needs to present information in a fashion that the patient and family can comprehend. Patients should be told the facts surrounding the event, what steps have been taken to address any medical repercussions, and plans to prevent recurrences. Finally, the provider should apologize and express regret for the error. It takes expertise to know how to disclose errors and communicate them properly, and in case #5, EMS providers should work closely with their EMS system leadership in handling these sensitive issues.",
        "Personal risk": "Case #6: EMS responds to a call from a local bar where a man was reportedly assaulted during a brawl. On arrival, paramedics observe multiple intoxicated bystanders shouting angrily at each other, some of whom are wielding empty glass bottles. One such bystander calls to EMS providers to help the injured patient inside the bar. Police have not yet arrived on scene.\n\nEmergency medical services providers frequently encounter situations where the risk of physical harm is present. Although it is impossible to eliminate all potential dangers in the daily work of EMS personnel, reasonable caution can and should be exercised such that risks are minimized. Although the paramedics in case #6 may feel the need to attend to the injured individual, there is no moral requirement for health care providers to submit themselves to significant self-endangerment. The EMS responder should exercise proper judgment in determining what is reasonable and what is foolhardy. When possible, law enforcement officers should become involved to ensure a safe and secure scene. EMS providers have an ethical obligation to not place either themselves or others at undue additional harm.",
        "Training and research": "Case #7: EMS providers respond to a call from a nursing home and find a 75-year-old man who has been asystolic for an unknown period of time. EMS providers pronounce death at the scene after the patient begins showing early signs of rigor mortis and dependent lividity. En route to the hospital morgue, one of the paramedics asks if he can intubate the deceased patient using new equipment as part of a study on prehospital intubations conducted by a local academic medical center.\n\nContinued education for healthcare providers is essential for quality patient care. Standards of training should be followed to ensure proper use of time and resources. In the case of practicing procedures on the recently deceased, out of respect for patient autonomy and dignity even when the individual is no longer living, consent from appropriate family members or a designated proxy should be obtained. EMS providers operate with a significant level of trust from the public and all efforts should be undertaken to not compromise that confidence.\n\nSimilarly, caution should be exercised when performing research on patients who cannot give informed consent. In the prehospital and emergency setting, it is difficult, if not impossible, to obtain prospective informed consent from patients in order to enroll them in research trials. In recognition of the need for this type of research to take place while concurrently preserving patient autonomy, the Food and Drug Administration (FDA) in conjunction with the Department of Health and Human Services (DHHS) have established clear rules for how such research should be conducted. Among the many requirements for an exception from informed consent for research, the most prominent stipulation mandates that study investigators consult with the community in which the research will be conducted and that there will be close oversight of the clinical investigation by a data monitoring committee as well as an institutional review board. Moreover, study investigators should obtain informed consent from the patient or his or her next of kin whenever and as early as possible. These FDA/DHHS regulations are particularly stringent because when research can only be conducted without the informed consent of subjects, every effort must be made to ensure patient autonomy is protected.\n\nIn case #7, without having obtained prior consent from the patient\u2019s next of kin, it would be ethically inappropriate for the paramedic to practice intubating the deceased patient using the experimental equipment. In addition, had the patient even qualified for the research study, EMS personnel should ensure all procedures and protocols are closely followed in order to protect the patient\u2019s best interests.",
        "Treatment of minors": "Case #8: EMS providers are asked to respond to a call from a 15-year-old girl complaining of painful vaginal bleeding. Upon arrival to the house, the patient reports that her parents are both still at work and that they do not know about her approximately 3-month pregnancy. The paramedics discover a large amount of what appears to be active bleeding and the tearful patient is notably pale and diaphoretic. One of the EMS providers asks if they can treat and transport the patient to a hospital without first informing her parents.\n\nMinors, defined as persons under the age of 18, are legally incapable of giving consent. Instead, they rely on a parent or guardian for informed consent. The few exceptions to this rule apply to a special population of emancipated minors, which is a state-specific definition that usually includes those who are married or by legal decree separated from their parents; those who are pregnant or have had a child; and those who have served in the armed forces. Depending on state laws, EMS personnel can also treat non-emancipated minors without parental consent in special circumstances, such as when a minor seeks care for mental illness, substance abuse, pregnancy, or sexually transmitted diseases. In these potentially stigmat-laden situations, the risks in overriding parental consent are outweighed by concerns of individual privacy and benefits to public health. Each state operates under different policies and EMS personnel should be familiar with their local jurisdiction\u2019s conditions in which non-emancipated minors can seek care without parental consent.\n\nContinued education for health care providers is essential for quality patient care. Standards of training should be followed to ensure proper use of time and resources. In the case of practicing procedures on the recently deceased, out of respect for patient autonomy and dignity even when the individual is no longer living, consent from appropriate family members or a designated proxy should be obtained. EMS providers operate with a significant level of trust from the public and all efforts should be undertaken to not compromise that confidence.\n\nSimilarly, caution should be exercised when performing research on patients who cannot give informed consent. In the prehospital and emergency setting, it is difficult, if not impossible, to obtain prospective informed consent from patients in order to enroll them in research trials. In recognition of the need for this type of research to take place while concurrently preserving patient autonomy, the Food and Drug Administration (FDA) in conjunction with the Department of Health and Human Services (DHHS) have established clear rules for how such research should be conducted. Among the many requirements for an exception from informed consent for research, the most prominent stipulation mandates that study investigators consult with the community in which the research will be conducted and that there will be close oversight of the clinical investigation by a data monitoring committee as well as an institutional review board. Moreover, study investigators should obtain informed consent from the patient or his or her next of kin whenever and as early as possible. These FDA/DHHS regulations are particularly stringent because when research can only be conducted without the informed consent of subjects, every effort must be made to ensure patient autonomy is protected.\n\nTreat minors in a timely manner to prevent morbidity and mortality under the rubric of implied consent. Because definitions of conditions that deserve an emergency exception vary from case to case, when in doubt, it is usually preferable for EMS providers to treat and transfer the minor to a hospital when no parent is present. When possible, it is preferable to postpone major medical interventions until the minor\u2019s parents can be involved.\n\nIn case #8, EMS providers can ethically treat and transport the patient without prior parental consent. Not only is the patient critically ill and therefore appropriate for treatment under the emergency exception, but by virtue of her pregnancy the patient can be evaluated as an emancipated minor and seek care without parental consent.\n\nWhen the parent is present and disagrees with the medical decisions of EMS providers, the providers should remember to act first under the principle of the patient\u2019s best interest. If paramedics believe the minor is placed in significant and immediate risk by the parent\u2019s medical decisions, they can treat and transport the patient under a temporary protective custody. Protective custody of a minor should be taken only as a last resort and always in close consultation with the direct medical oversight physician and law enforcement personnel. If temporary protective custody of the patient is truly necessary, EMS personnel should remember that the parents do not subsequently lose all decision-making rights on behalf of their child. Paramedics should still involve and seek the consent of the parents in the remainder of the care of the patient as much as possible.\n\nWhen EMS providers and parents are in agreement over the medical care of the minor, providers should still inform the patient of the medical decision process as much as possible. Even young children can understand the basics of medical care and all efforts should be made to involve them on an age-appropriate level.",
        "Conclusion": "The cases provided in this chapter illustrate the wide variety of ethical issues that EMS providers encounter on a regular basis. EMS providers should become proficient with the basic principles of medical ethics. In addition, the exercise of ethical judgment should always be performed in conjunction with knowledge of local laws and professional guidelines. Finally, EMS providers must remember to practice excellent communication skills when dealing with potentially complicated issues of patient care."
    },
    {
        "Introduction": "Performing well-designed and properly analyzed clinical and systems research is the essential first step in improving out-of-hospital medical care, and only through such research can we better understand the effectiveness of both current and new practices. Data handling procedures and appropriate use of statistics are critical aspects of high-quality out-of-hospital research. The purpose of this chapter is to present and explore concepts underlying data handling and statistical analysis for clinical research in the out-of-hospital setting. Once the null and alternative hypotheses have been defined, the study is conducted and the data are obtained. During analysis of the results, the null hypothesis is \u201ctested\u201d to determine which hypothesis (null or alternative) will be accepted as true. Testing the null hypothesis consists of calculating the probability of obtaining the results observed, or results more inconsistent with the null hypothesis, assuming the null hypothesis is true. This probability is the p value. For example, it may be determined that the median response time was 6 minutes for the new dispatch system and 7 minutes for the old system. Testing is done to determine the probability that the 1-minute decrease in response time is due solely to chance and is not a reflection of improvements in the dispatch system.",
        "Classical hypothesis testing": "Historically, research data have been analyzed using p values and classical hypothesis testing, although there has been an increasing emphasis on the use of confidence intervals in the presentation of results. In classical hypothesis testing, two hypotheses or conclusions that might be supported by the data are considered. The first, called the null hypothesis, is the idea that there is no difference between two or more groups, with respect to the measured quantity of interest. For example, in a study examining the effect of a new EMS dispatch system on response time (response interval), the null hypothesis might be that there is no difference between the median response times before and after implementation of the new system. The alternative hypothesis is the idea that the groups being compared are different with respect to the quantity of interest and, ideally, the alternative hypothesis defines the size of that difference. For example, the alternative hypothesis might be that the new EMS dispatch system decreases the median response time by 1 minute or more compared to the old dispatch system. The difference between the two groups defined by the alternative hypothesis is called the \u201ctreatment effect\u201d or \u201ceffect size.\u201d The size of the difference implied by the alternative hypothesis, the treatment effect, must be defined prior to data collection. If the p value is less than some predefined value, denoted \u03b1, then the null hypothesis is rejected and the alternative hypothesis is accepted as true. In other words, if results like those obtained would occur less than \u03b1 percent of the time (where \u03b1 is usually 5% or 0.05) assuming the null hypothesis to be true, then the null hypothesis is rejected as false. Using our previous example, the researcher might state that he or she is willing to accept a 5% probability (\u03b1) of falsely concluding that there is a difference between dispatch systems when in reality there is no difference. If a 1-minute difference between the dispatch systems were observed, this difference could be due solely to chance, especially if the p value is greater than 0.05. However, using a p value of less than 0.05 as a cut-off (i.e. \u201cstatistically significant\u201d), the probability of saying there is a difference between the systems when there really is not (called a type I error \u2013 see later in the chapter) is less than 1 in 20. Rather than proving the alternative hypothesis that a difference exists between the groups, we eliminate from consideration the null hypothesis that there is no difference. Although the p value provides evidence for rejecting the null hypothesis, it does not provide information regarding the magnitude of the treatment effect or precision of the estimated treatment effect. Furthermore, the investigator arbitrarily assigns \u03b1, the \u201clevel of significance.\u201d A level of \u03b1 equal to 0.05 is most often used and represents nothing more than medical convention. Probabilities above this level (e.g. 0.06) may still suggest an important difference in measured outcome between treatment groups, although not reaching a generally accepted level of proof. P values should be interpreted as only one piece of statistical information and are best interpreted in the context of the study design, the sample size, and the credibility of the hypotheses being tested.",
        "Type I error": "A type I error occurs when one concludes that a difference has been demonstrated between two groups of patients when, in fact, no such difference really exists. It is a type of \u201cfalse positive.\u201d Using p values, a type I error occurs if a statistically significant p value is obtained when there is no underlying difference between the groups being compared. The risk of a type I error is equal to the maximum p value considered statistically significant or alpha, typically set at a level of 0.05.",
        "Type II error and power": "A type II error occurs when a difference does exist between the two groups that is as large as, or larger than that defined by the alternative hypothesis, yet a non-significant p value is obtained. That is, the researcher states there is no difference between the groups because the p value is greater than \u03b1, when in reality there is a difference. A type II error is a type of \u201cfalse negative.\u201d A common cause of a type II error is an inadequate sample size. The \u201cpower\u201d of a trial is the chance of detecting a treatment effect of the size defined by the alternative hypothesis, if one truly exists. Studies are usually designed to have a power of 0.80, 0.90, or 0.95. Because the power of a trial is the chance of finding a true treatment effect, the value \u03b2 (1 \u2013 power) is the chance of missing a true treatment effect (i.e. the risk of committing a type II error) if a true difference equal to the effect size actually exists. The value of \u03b1, the power, and the magnitude of the treatment effect sought (defined by the alternative hypothesis) are all used to determine the sample size required for a study.",
        "Power analysis and sample size determination": "Determining the required sample size for a clinical study is an essential step in the statistical design of a project. An adequate sample size helps ensure that the study will yield reliable information. If the final data suggest that no clinically important treatment effect exists, an adequate sample size is needed to reduce the chance that a type II error has occurred and a clinically important difference has been missed. If the final result is positive, an adequate sample size is needed to ensure the treatment effect is measured with appropriate precision. In addition to the basic study design and planned analysis method, four parameters influence the power of a study: the sample size, the effect size defined by the alternative hypothesis, the variability of the results from patient to patient, and \u03b1. For each method of statistical analysis and type of study design (unpaired samples, case-control studies, etc.) there is a different formula relating sample size to power. Because the treatment effect size sought by the study is a major determinant of the sample size required, choosing an appropriate effect size is the first step in sample size determination. Optimally, one designs clinical studies to reliably detect the minimum clinically relevant treatment effect (i.e. the smallest treatment effect that would result in a change in clinical practice). Defining the minimum clinically significant treatment effect is a medical and scientific judgment, not a statistical decision. For example, what difference in response times is large enough to warrant changing a dispatch system (e.g. 4 minutes, 2 minutes, 1 minute, or 30 seconds)? The researcher has the responsibility of proposing an effect size that he or she believes would be clinically or operationally relevant. The decision about the effect size to be studied should be based on the researcher's judgment, available resources (sample size feasibility), and relevant information from similar published studies. The smaller the treatment effect sought by a study, the larger the sample size required. Frequently, available time and resources do not allow a clinical trial large enough to reliably detect the smallest clinically significant treatment effect. In these cases, one may choose to define a larger treatment effect size, with the realization that should the trial result be negative, it will not reliably exclude the possibility that a smaller but clinically important treatment difference exists. One frequently faces the problem of interpreting data from a negative study in which no power calculation was initially performed. Although tempting, performing a post hoc (i.e. after the study is concluded) power analysis in which one calculates the effect size that could have been found with the actual sample size and a given power is invalid and should never be done. The correct approach to analyzing such data is to calculate the 95% confidence interval for the difference in the outcome of interest, based on the final data. Because there is some risk in participating in clinical research, it is unethical to enroll patients in a trial that has an inadequate sample size and therefore is unlikely to yield useful information. Such a study would have little chance of generating meaningful information about the hypothesis and may waste time and resources, as well as expose subjects to risk with a low likelihood of benefit to society. This issue warrants special consideration during the design of phase I and so-called \u201cpilot\u201d studies. Studies involving human subjects (or laboratory animals) should be designed with a large enough sample size so it is highly likely they will yield useful information. Historically, learning the techniques of sample size determination and power analysis has been difficult because of relatively complex mathematical considerations and numerous formulas. There has been tremendous improvement in the availability, ease of use, and capability of commercially available sample size determination software. These programs now allow the determination of sample size and the resulting power for a wide variety of research designs and analysis methods.",
        "Statistical tests": "Before reviewing some common statistical tests, it is useful to define the different types of characteristics, or variables, we may wish to compare. The ability to differentiate the types of variables and measurements is critical to selecting appropriate analysis methods. There are two general scales of measurement: numerical and categorical. With a numerical (or quantitative) scale, the size of differences between numbers has meaning. Variables measured in a numerical scale may be continuous, having values measured along a continuum (e.g. age, height, weight, time), or discrete, taking on only specific values (e.g. number of paramedic calls per shift). The mean and median of variables measured using a numeric scale are often used to summarize results or to compare characteristics between groups. Categorical variables are used for measuring qualitative characteristics. The simplest form of a categorical variable is termed a nominal scale, in which observations fit into discrete categories that have no inherent order (e.g. race, sex, hospital name). When there are only two categories (e.g. male or female), the variable is termed dichotomous or binary. If there are more than two categories, (e.g. blood types A, B, AB, and O), the variable is polychotomous (or polytomous). One common, but potentially ill-advised, practice is to categorize continuous variables (e.g. systolic blood pressure \u226490 mmHg or age by decades) for statistical analyses. Although this may simplify the interpretation of the variable, this practice substantially reduces the available information in the data, frequently requires an arbitrary selection of the appropriate cut-point(s), and may reduce study power as well as introduce residual confounding. When a variable is ordinal, there is an inherent order among different categories. Examples include the Glasgow Coma Scale (GCS) score and the Apgar scores. Although an order exists among categories (each possible score is a category) in an ordinal scale, the relationship between categories may differ throughout the scale (i.e. the clinical implication of a difference between a GCS of 4 versus 3 is not the same as a difference of 15 versus 14). Many statistical tests exist for both continuous and categorical data. Depending on the type of data being analyzed, different statistical tests are used to determine the p value. The most common statistical tests and their assumptions are described in Table 50.2. Selecting the appropriate statistical test requires identifying the type of variable to be analyzed and making reasonable assumptions regarding the underlying distribution of the data and the standard deviation or variance of the data in each group. Parametric tests require more assumptions about the data \u2013 typically that numeric data follow a normal distribution and that different groups yield data with equal variance. Non-parametric tests do not require these assumptions. Considering the low power of available tests used to detect deviations from the normal distribution, it is prudent to use non-parametric methods of analysis when there is any doubt as to the underlying distribution of the data.",
        "Parametric tests": "Parametric tests are used to analyze numerical data and require both that the data follow a normal distribution and that the variance of the data from each group is equal. For example, the Student\u2019s t test (also called \u201ct test\u201d) is used to compare the means of numerical variables (e.g. serum glucose, respiratory rate) between two groups of patients. If there are three or more groups of patients, one-way analysis of variance (ANOVA) can be used to compare means between the groups. A form of Student\u2019s t test for paired data can also be used to compare mean differences between pairs of matched data points. Such data frequently result from studies in which baseline and posttreatment measurements are performed on each patient or experimental animal.",
        "Non-parametric tests": "When the data to be analyzed cannot be assumed to be normally distributed, then the p value should be obtained using a non-parametric test. Non-parametric tests can be used for normally or non-normally distributed numerical data and provide a more robust estimate of the *p* value (i.e. an estimate less affected by the underlying distribution of the data than would be obtained with a parametric test). The trade-off for not requiring data to be normally distributed is a slight loss of power for detecting a true difference between groups (i.e. greater chance of type II error). This difference in power is usually of little practical significance but may require a slightly larger sample size to achieve the same desired power (e.g. an additional 10% more subjects).\n\nThe non-parametric alternative to a student\u2019s *t* test for unpaired samples is the Wilcoxon rank sum test (also called the Mann-Whitney U test). For a statistical comparison of paired measurements, one can use the Wilcoxon signed rank test. The non-parametric alternative to one-way ANOVA is the Kruskal-Wallis test. These methods compare the medians between groups (as opposed to a comparison of means with similar parametric tests).\n\nThe chi-square test and Fisher\u2019s exact test are non-parametric tests used to detect associations between treatment (or exposure) and outcome when both variables are categorical (e.g. placebo versus active drug, lived versus died, admitted versus discharged). For these analyses, the data are arranged by creating a table with individual cells representing all possible combinations of the variables (the most basic being a 2 \u00d7 2 table; Figure 50.1). The chi-square test requires that each cell in the table have five or more expected observations. If your data do not fulfill this assumption, Fisher\u2019s exact test may be used. \n\nMany common statistical software packages (e.g. SAS, Stata, SPSS) may be used for database management and analysis. Although these software programs are efficient and generally provide a wide range of options for optimal analysis, a general statistical background and thorough understanding of the appropriate tests, the assumptions required, and associated limitations are necessary to accurately interpret the results and avoid drawing invalid conclusions. A given statistical program may not warn the user if an invalid approach to the analysis is being used.",
        "Confidence intervals": "Suppose we wish to determine whether a new dispatch system decreases response times, as in our previous example. In our study, we observe a median response time of 6 minutes for patients transported under a new dispatch system and 7 minutes for patients transported under the previous dispatch system. The observed treatment difference is \u20131 minute. If the *p* value associated with the null hypothesis that the median response times are equal (a difference of zero) is less than 0.05, we reject the null hypothesis as false and we conclude that our study demonstrates a statistically significant difference in median response times. That the *p* value is less than 0.05 implies the treatment difference is statistically different from zero. The *p* value does not tell us the magnitude of the treatment difference, which determines whether the difference is clinically important, nor how precisely our trial was able to estimate the true treatment difference. The true treatment difference is the difference that would be observed if an infinite number of patients could be included in the study.\n\nThe treatment difference identified in a study (e.g. \u20131 minute) estimates the \u201ctrue\u201d treatment difference between the groups and is called a \u201cpoint estimate.\u201d It is also possible to estimate a range of values between which the true treatment difference will lie with some degree of certainty (e.g. 95%). This \u201cinterval estimate\u201d is called a confidence interval [11]. If, instead of reporting only a *p* value as the result of a study, the researcher reports the point estimate and the corresponding confidence interval around it, he or she will communicate whether the measured treatment difference was likely due solely to chance, plus information on the size of the treatment difference (and therefore its clinical importance) and the precision of the estimated difference.\n\nThe p value answers the question, \u201cIs there a statistically significant difference between the two treatments?\u201d The point estimate and its confidence interval answer the questions, \u201cWhat is the size of the treatment difference?\u201d and \u201cHow precisely did this study determine the true treatment difference?\u201d The effect of a study on clinical practice should depend on whether the study has definitively demonstrated a treatment difference and whether that treatment difference is large enough to be clinically important. Even if a trial does not show a statistically significant difference, the confidence interval enables us to distinguish whether there really is no difference between the treatments or the trial simply did not have enough patients to reliably demonstrate the difference.\n\nReturning to our example, a treatment difference (i.e. the calculated difference in response time between the two dispatch systems) of zero is equivalent to the null hypothesis that there is no difference in median response time between patients transported under either of the two dispatch systems. If a treatment difference of \u22121 minute were calculated with a 95% confidence interval of \u22120.5 to \u22122.5 minutes, an interval that excludes zero, it would imply that a true treatment difference of zero is not statistically consistent with our observed data. We would conclude that the null hypothesis is not consistent with our findings and would reject the null hypothesis. If a 95% confidence interval does not include a zero treatment difference, this is equivalent to a p value less than 0.05. \n\nOur point estimate of a 1-minute decrease in response times for two dispatch systems gives an estimate of the size of treatment effect. However, the confidence interval (i.e. between \u22120.5 and \u22122.5 minutes) is statistically consistent with the true treatment difference being any value between \u22120.5 and \u22122.5. In other words, the true effect of the new dispatch system on response time may be a decrease of as little as 30 seconds or as much as 2.5 minutes. If the newer dispatch system requires significant purchase and recurring costs, an EMS medical director may conclude that even a 2.5-minute reduction in response time does not warrant the associated costs, although the difference is statistically significant. Another EMS medical director may feel that even a decrease of 30 seconds would be beneficial, despite the costs. When authors report p values alone, they often leave the reader with little basis for drawing conclusions relevant to their clinical practice. With confidence intervals, the reader can decide what treatment difference is clinically important and can reach conclusions appropriate to his or her system. \n\nWe may also use confidence intervals to interpret information from studies that did not achieve statistical significance (so-called \u201cnegative\u201d trials). Suppose we found the 95% confidence interval for the difference in median response time to extend from \u22123.5 minutes to +0.5 minutes, with the same point estimate for the difference in response times (\u22121 minute). This confidence interval indicates that the new dispatch system could decrease response times by as much as 3.5 minutes over the current dispatch system, or it could increase times by as much as 30 seconds. Because the confidence interval includes 0, the results are not statistically significant, and p is greater than 0.05. Because p is greater than 0.05, it is tempting to conclude that there is no advantage to using the new EMS dispatch system. However, our data are also consistent with the new dispatch system decreasing response time by as much as 3.5 minutes. Although p is greater than 0.05, there remains the possibility that an important difference exists in the two dispatch systems. \n\nNegative trials whose results are still consistent with a clinically important difference usually occur because the sample size is too small, resulting in inadequate power to detect an important treatment difference. A larger sample size will decrease the width of the confidence interval, allowing greater certainty of either no clinically important difference or determination of a difference that was not uncovered by an analysis of the smaller sample size. \n\nIt is important to know how precisely the study data define the true difference between the groups. The width of the confidence interval gives us information on the precision of the point estimate. The larger the sample size, the more precise the point estimate and the narrower the confidence interval. As mentioned earlier, a trial that uses an inadequate sample size may not show a statistically significant result, yet may not be able to exclude a clinically important treatment difference. In this case, the confidence interval will be wide and imprecise, including both zero (no treatment difference) and clinically important treatment differences. Conversely, a positive trial that uses a very large sample size may result in a statistically significant treatment difference that is not clinically important (e.g. demonstrating a decrease in response time of 5 seconds). \n\nIf a confidence interval includes either zero or clinically unimportant treatment differences, as well as clinically important treatment differences, we cannot make any definitive conclusions. If this is the case, it will be necessary to repeat the study with a larger sample size, a more homogeneous population, or a more statistically efficient study design in order to narrow the width of the confidence interval and to provide more definitive conclusions.",
        "Multiple comparisons": "Whenever a characteristic of two groups of patients is compared statistically, even if the groups are fundamentally identical (i.e. they were randomly selected from the same larger population), there is a chance that a statistically significant p value will be obtained. If the maximum significant p value (\u03b1) is 0.05, then there is a 5% chance that a statistically significant p value will be obtained, even if there is fundamentally no true difference between the two patient populations. This risk of a false-positive p value occurs each time a statistical test is performed. If multiple comparisons are performed, the risk of at least one false-positive p value is increased because the risk associated with each test is incurred multiple times. This increased risk occurs whether the multiple comparisons are pairwise comparisons of more than two groups of patients or comparisons of many different characteristics between two groups of patients. The risk of obtaining at least one false-positive p value when comparing two groups of fundamentally identical patients and assuming each result is statistically independent is shown in Table 50.3 as a function of the number of comparisons made. The overall or \u201cstudywise\u201d risk of at least one type I error is roughly equal to the maximum significant p value used for each individual test multiplied by the total number of tests performed. This rough equality is the basis for the Bonferroni correction. The Bonferroni correction is one method for reducing the overall type I error risk for the whole study (the studywise risk) by reducing the maximum p value considered statistically significant (\u03b1) for each of the individual tests (the testwise risk). The overall risk of a type I error that is desired (usually 0.05) is divided by the number of statistical tests to be performed, and this value is used as the maximum significant p value for each individual test. For example, if five comparisons are to be made, then a maximum significant p value of 0.01 would be used as the cut-off for each of the five statistical tests. The Bonferroni correction controls the overall (studywise) risk of a type I error, at the expense of an increased risk of a type II error. Because each statistical test is conducted using more stringent criteria for a statistically significant p value (i.e. a smaller \u03b1), there is an increased risk that each test will miss a difference as big as that defined by its associated alternative hypothesis by yielding a p value that is non-significant using the new criteria for p. Some investigators consider correction factors, such as the Bonferroni correction, for multiple comparison analyses to be controversial. Certain statistical tests can be used to compare three or more groups of patients simultaneously, without the need to control for multiple comparisons. Examples include ANOVA, the Kruskal-Wallis test, the chi-square test, and Fisher\u2019s exact test. These tests, which do not use the Bonferroni correction, have relatively high power, while controlling the overall risk of a type I error. Their disadvantage is that, although they may detect a difference among three or more groups of patients, they do not define which pairwise differences are statistically significant. Once an overall difference is demonstrated, additional statistical tests can be used to determine where the differences exist.",
        "Interim data analyses": "During the conduct of a clinical trial, data accumulate sequentially, gradually containing more and more information on the relative effectiveness of the treatments being compared. Often, however, the data are not analyzed until all patients have been enrolled. This type of fixed sample size design has the disadvantage that more patients than necessary to obtain a clinically important result may be enrolled, raising ethical concerns that \u201cextra\u201d participants were denied or subjected to a treatment that may have been proved advantageous or harmful, respectively. It is prudent to plan for one or more interim analyses of the data, which are conducted before the full sample size has been reached, to see if a final conclusion may be drawn from the data and the trial terminated early. Such interim analyses of the data must be planned in advance to avoid increasing the type I error rate because this is a type of multiple comparison.",
        "Subgroup analysis": "Any group of patients is heterogeneous. This is especially true for patients treated by EMS systems. Some patients within a group defined by an out-of-hospital complaint or dispatch category may have a more severe form of the disease in question or no disease at all, and some patients may have a coexisting disease that modifies the primary disease process. Because of this heterogeneity, a treatment effect detected using the entire group in an EMS study may or may not exist for a particular subgroup of the original population. To detect this heterogeneity in treatment effect, the data from subgroups of patients are often analyzed separately. In some circumstances, this is important to determine which interventions are most effective in important subgroups of patients. This concept is exemplified in a clinical trial on prehospital pediatric intubation where the effect of intubation on clinical outcome was compared by diagnosis groups. Unfortunately, several problems can occur when subgroups of patients are analyzed separately. First, analyzing subgroups of patients involves the use of multiple statistical comparisons, increasing the chance of a type I error. Second, because each subgroup is smaller than the entire study population, the statistical tests used in comparing subgroups may have low statistical power, increasing the chance of a type II error. These problems arise whether or not the subgroups were defined prior to the acquisition of the clinical trial data, unless such planned analyses were integrated into the selection of \u03b1 for each comparison and into the sample size calculations. Additional problems may occur if the subgroups of patients are not defined properly. A \u201cproper\u201d subgroup of patients is defined by signs, symptoms, or other characteristics available at the initial presentation (e.g. on the arrival of EMS personnel) that are not modified by the interventions being compared. Signs, symptoms, or other characteristics, which in principle can be modified by the interventions being evaluated, define an \u201cimproper\u201d subgroup of patients. For example, in a study comparing different volumes of fluid resuscitation for patients with undifferentiated shock, an improper subgroup of patients might be defined by a low systolic blood pressure after fluid administration. A proper subgroup would, however, be defined by a low systolic blood pressure prior to any fluid administration. In this example, because of the possible influence of the fluid administered on the final subgroup assignment (if the postresuscitation blood pressure is used to define the subgroup), there is no way to accurately assess the effect of fluids on blood pressure in this subgroup. Unfortunately, many retrospective studies inappropriately compare such improper subgroups of patients. The limitations of subgroup analyses should be recognized so that appropriate strategies for such analyses (e.g. a priori identification of meaningful and properly defined subgroups, limits on the number of planned subgroup analyses, and sample size calculations that account for such analyses) can be integrated into the study design before studies are begun and to assure that results from subgroup analyses are interpreted appropriately.",
        "Intention-to-treat analysis": "The effectiveness of a therapy in practice is determined both by the therapy\u2019s inherent efficacy and by one\u2019s ability to administer the therapy to the patient. For example, an intravenous medication will be completely ineffective if it cannot be given because no intravenous line can be established in the field. Similarly, an invasive procedure will be less effective on average if it can only be successfully performed in a minority of patients. To accurately estimate the effectiveness of an intervention in the out-of-hospital setting, one must properly account for those patients in a study for whom a procedure is initiated but cannot be completed or those for whom the medication is ordered but cannot be administered. This is the purpose of an \u201cintention-to-treat\u201d analysis. In an intention-to-treat analysis, patients are considered to be members of the treatment group to which they were originally assigned, regardless of whether the appropriate therapy or intervention was successfully administered. For example, in a study examining paramedic use of endotracheal intubation in children, a patient would be considered to be part of the intubation group if he or she was originally randomized to that group, even if the patient could not be intubated.",
        "Multivariable analyses": "When multiple patient characteristics or variables potentially influence a given outcome, or if there are differences between groups that must be \u201ccontrolled for\u201d to obtain a valid estimate of the treatment effect (e.g. crash severity in assessing airbag-related injuries among pediatric passengers), multivariable analyses can be very useful. The goal of a multivariable analysis is to quantify the separate effect of each multiple predictor (or \u201cindependent\u201d) variable on the outcome of interest (the \u201cdependent\u201d variable). The type of multivariable analytic technique selected depends on the types of variables to be analyzed (e.g. numerical versus categorical), the goals of the analysis, and other assumptions regarding the data. The two general types of multivariable analytic methods are mathematical modeling and stratified analysis. Multivariable modeling provides a mechanism for integrating several variables into the same analysis to account for the variety of factors that may influence a given outcome and to increase comparability between patient groups. Stratification involves separating the sample into two (or more) groups, based on a given variable (frequently a confounder), and analyzing these groups in parallel. Because a detailed discussion of multivariable analysis is beyond the scope of this chapter, we will focus our attention on one of the most common methods found in the biomedical literature: multivariable logistic regression. Multivariable logistic regression is a form of mathematical modeling used with a categorical outcome and multiple predictor or confounding variables. The outcome is generally dichotomous or binary (e.g. survival versus death). The predictor variables can be numerical or categorical. Additional assumptions must be fulfilled for this statistical technique to be valid. This type of modeling allows an investigator to assess how a single predictor affects the outcome of interest, while assuming one could hold all other variables in the analysis constant (i.e. controlling for the effect of these additional variables). This technique is very useful when certain confounding variables must be controlled for in order to generate a valid estimate of the association between one variable and the outcome of interest. Generally, a measure of association (odds ratio) is calculated for each predictor variable, along with the confidence interval and p value for the null hypothesis that the odds ratio is 1 (i.e. no independent association).",
        "Clustering": "refers to correlated data and represents the tendency of subjects who have some features in common (e.g. the EMS agency that responds to their 9-1-1 calls) to have other characteristics in common as well (e.g. hospital disposition or receiving certain types of hospital care). This effect leads to correlated observations that violate the assumption of statistical independence required by most common statistical tests. When clustering is present, subjects within groups that show common features tend to be more alike than subjects drawn from different patient groups. Some prehospital examples of clustering include patients evaluated by the same EMS agency, ambulance crew, or hospital. These \u201cclusters\u201d may exhibit similarity in patient characteristics, EMS care (e.g. a certain EMS agency or crew may have more or less experience with certain procedures than other crews), or hospital care (e.g. treatments and outcomes at certain hospitals may be better or worse than other hospitals). The phenomenon of clustering may exist at multiple levels simultaneously, a situation that represents hierarchical clustering. Although appropriately accounting for clustering in statistical analyses can be complicated, the important point is that failing to account for these correlations can result in inappropriately narrow confidence intervals and artificially low p values (i.e. increased type I error rates). Standard analyses do not properly account for the smaller variance between subjects in a cluster as well as the variance between clusters. Ignoring clustering may also bias results of the analysis. Fortunately, some analytic methods appropriately account for clustered observations.",
        "Missing data": "Even in rigorous, prospective out-of-hospital research, it is typically impossible to gather every intended data element from every patient. Thus, even in well-executed studies, some data values will be missing in the final dataset. Although sometimes regarded as a simple nuisance or minor distraction, the inappropriate handling of missing values in statistical analyses can introduce substantial bias in study results, decrease the precision of estimates, and reduce study power, potentially leading to invalid conclusions. There are valid methods for analyzing data with missing values (e.g. multiple imputation, maximum likelihood estimation, Bayesian estimation), provided certain assumptions are met. One important assumption is that the underlying mechanism of missingness is \u201cignorable.\u201d That is, the probability that values are missing must be either independent of both observed and unobserved values (a situation called \u201cmissing completely at random\u201d) or must be entirely explained by the observed values (a situation called \u201cmissing at random\u201d). One key strategy underlying many valid methods for handling missing data is to use observed values to predict plausible values for missing data, while appropriately accounting for the uncertainty (i.e. variance) inherent in this process. Ideally, an investigator would provide a plan for handling missing values (including appropriate adjustment for sample size) before initiating a research project.",
        "Using statistical consultants": "Statistical consultants can be extremely valuable in designing, implementing, and analyzing clinical research and should be involved early in the course of planning a research study. The consultant's expertise may be helpful in anticipating potential problems with the proposed study, allowing changes in design or data collection methods before unnecessary effort and time are wasted. If several guidelines are followed, statistical consultation will be more efficient and productive. First, the investigator should clearly define the focus and purpose of the study, as well as the single most important question to be answered, in quantitative terms. Such quantification might include the response time for each of two patient groups transported under different dispatch systems or the change in systolic blood pressure after a pharmacological intervention. For a comparative study, the proposed effect size should be clearly defined and judged to be clinically important. Next, you should retrieve as much information as possible about what you expect to find in the control group. Estimates of the standard deviation of important continuous outcome variables or percentages of a specific outcome (e.g. survival) in the control group, are necessary for sample size calculations. These values may be found in previous studies, preferably those carried out in the same (or a similar) sample population, or in existing data from the same sampling frame (e.g. the county served by a given EMS agency). The investigator should attempt to identify potentially important subgroups of the study population and identifiers that could be used to specify those subgroups during the course of the study. Specification of the need for multiple comparisons and the number of comparisons that will be performed in the analysis should be made at the beginning of the study to avoid confusion in the correction for multiple comparisons. Examples of previously published studies that illustrate aspects of what the researcher is trying to accomplish with the planned study can be very helpful, especially to further refine the purpose of the project for a statistical consultant. Anticipated rates of missing values for key variables (e.g. outcomes), plus appropriate methods for handling missing values, should be specified before initiating a study and should be accounted for when doing sample size calculations. Finally, for interventional studies of clinical conditions with significant morbidity or mortality, one should consider performing interim analyses of accumulating data, so the study may be stopped as soon as a reliable conclusion can be drawn (i.e. definite benefit or harm from the intervention)."
    },
    {
        "Introduction": "Economic evaluations of medical technologies assess the effectiveness and cost of the technologies so that physicians, policy makers, and the general public can decide which technologies offer sufficient value for the money. The cost-effectiveness of health care interventions including EMS must be demonstrated definitively if claims of their public health benefit are to have scientific credibility. Since some experts question the merits of interventions to improve resuscitation care, while others endorse such interventions, we believe that economic evaluations of EMS provide critical information to inform public policy.\n\nMany important outcomes must be considered when evaluating the effectiveness of an intervention. A key outcome consideration is cost (\u201cdestitution\u201d in the framework of the \u201csix Ds of outcome\u201d). Although it can be intellectually difficult to consider cost as a health care constraint, the reality is that even when it comes to health care, all resources are finite and selecting the most cost-effective intervention is an important decision.\n\nThis chapter will discuss conducting economic evaluation of health interventions in the out-of-hospital setting and will describe a methodology for determining the cost of an EMS intervention to the community it serves that was developed by the EMS Cost Analysis Project (EMSCAP), sponsored by the National Highway Traffic Safety Administration (NHTSA).",
        "State of cost analysis research in EMS": "Although EMS research is an emerging field, some projects have worked to establish effectiveness, such as the Ontario Prehospital Life Support Study (OPALS). Interventions such as treatment of non-traumatic cardiac arrest and use of a formalized system of care for severe trauma are known to be effective. However, little is known about the cost-effectiveness of most EMS interventions.\n\nA structured literature review found that from 2003 to 2013 there were only 60 published economic evaluations of EMS interventions. Only 14 of these evaluations were considered full economic evaluations. Further, using a published checklist for evaluating the quality of an economic evaluation, the authors found that most of these studies were of poor quality. They also determined that there were inconsistencies in how EMS costs were measured, indicating the need for a standardized approach to calculating the cost of EMS.",
        "Types of cost analyses": "In general, there are four types of cost analyses that are full economic evaluations. The term full economic evaluation means that the costs and the consequences of two or more interventions are compared. The primary difference between the four types of full economic evaluations is how the outcome is measured.\n\nA cost-benefit analysis measures the outcome, or the effect of an intervention, in dollars. For example, Riediger and Fleischmann-Sperber estimated that the annual cost for their EMS system was $8.3 million and that the outcome from providing EMS care was $44.3 million in socioeconomic cost savings to the community.\n\nCost-effectiveness analysis measures a common effect, such as lives saved, between two interventions and reports the result in terms of effect per unit of cost. The effect is measured in natural units such as the amount of disability or health care resources consumed. A common example is the reporting of cost per life saved. For example, Forrer et al. assessed the cost-effectiveness of implementing a police automated external defibrillator program and estimated the cost per life saved ranged from $23,542 to $70,342 and the cost per year of life saved ranged from $1,582 to $16,060.\n\nIn a cost-utility analysis the effect is measured in quality-adjusted life-years. For example, Nichol et al. found that the mean incremental cost per quality-adjusted life-year for lay responder defibrillation was $46,700 (95% confidence interval (CI) $23,100 to $68,600).\n\nFinally, a cost-minimization analysis compares two equivalent treatments and determines which has the lowest cost. De Wing et al. used this method and found that burn patients transported by helicopter who could have also been safely transported by ground ambulance had a sevenfold to eightfold increase in transportation charges (assumed to be the actual cost, which is not always a valid assumption in health care research \u2013 see later) compared to burn patients transported by ground ambulance.",
        "Conducting a full economic evaluation": "Extensive literature can be found on how to conduct economic analyses in health care settings. A key factor in ensuring external validity is that standardized guidelines be followed. This allows comparisons to be made across studies and between systems. The Panel on Cost-Effectiveness in Health and Medicine published guidelines for standardizing economic analyses in health care. These guidelines recommend that the costs and consequences of an intervention always be considered. However, calculating EMS system costs is complicated and is not specifically addressed in existing textbooks apart from the first edition of this book. In addition, a comparison of the existing cost-analysis literature in EMS found that there was no standard approach to calculating EMS system costs. NHTSA-sponsored EMSCAP project created a standardized guideline for what to include when calculating the cost of EMS. This guideline accounts for all the costs of the EMS system regardless of who pays for them. Thus, this approach determines the cost of the EMS system from the community\u2019s perspective.\n\nThe consequences of an EMS intervention are the downstream effects. These can include what occurs in the emergency department, in the hospital (if the patient is admitted), and during rehabilitation as well as the effect on the patient\u2019s life once the initial period of medical care is complete (e.g. lost wages, inability to return to work). Although calculating these costs is complicated, the methods are similar to those used in any health care environment. Thus, the foundations for determining the economic consequences of an EMS intervention are similar to those that have been developed already for application to candidate interventions in other settings. The reader is referred to health economic textbooks for more information on these aspects of a cost analysis.",
        "Charges versus costs": "An important distinction to make when considering an economic evaluation is the difference between costs and charges. Costs are the actual resources consumed to produce a good or service, whereas a charge includes the cost as well as taxes and any profit gained from providing the good or service. The charge is frequently more than the cost. For example, the charge (i.e. bill) for a meal at a restaurant is usually more than the cost of what was consumed and the effort of preparing and serving it because it includes local taxes as well as some profit for the owner. The charge can also be less than the cost of the good or service. For example, an EMS agency medical director may have a contract that does not accurately reflect the number of hours spent working for the agency or it may not include administrative costs; thus, he or she may be charging the agency less than the fair value of his or her efforts and time.\n\nWhen conducting an economic evaluation from the societal perspective, costs must be used instead of charges, regardless of who pays them. This can make calculating the cost for providers difficult when EMS providers are volunteers because, although they do not charge for their time, there is an associated cost. The EMSCAP project recommended that the local prevailing wage be used for volunteer time. Another issue is determining the cost of buildings used as stations for ambulances or fire trucks when they are provided by the local municipality \u201cfree of charge.\u201d The cost of obtaining and maintaining these buildings should still be accounted for because there is an associated cost even though it is not being paid for by the agency that is using it.",
        "Perspective": "The cost of a given service can be very different depending on the perspective of who is paying. A patient who is transported by ambulance for an injury may consider the cost to be that of the bills he or she receives from the EMS service, the hospital, and the rehabilitation center, as well as any wages lost during recuperation. The patient\u2019s insurance company will consider the cost to be the amount it pays for all health care related to the event. The EMS service will consider the cost to be its actual costs for providing services to that patient, including a proportion of the cost of acquiring and maintaining the response/transport vehicles, the cost of the EMS personnel who responded to the event, the cost of administering the response system, etc.\n\nThe broadest and most comprehensive view of the cost of this patient\u2019s treatment is the community\u2019s perspective. This is typically referred to as the \u201csocietal perspective.\u201d This accounts for all costs, regardless of who pays them. A societal perspective would include the cost for EMS agency response, the first responder agency response, communications infrastructure including dispatch, administration of the EMS system, medical oversight, training, on call and direct patient care, and so forth. The cost will also include \u201cdownstream\u201d costs of the patient\u2019s hospital care, rehabilitative care, lost wages, etc.\n\nThe inclusion of downstream costs is not simple. However, they must be considered because, when determining the cost of an EMS intervention, the EMS costs are not necessarily independent of the health care beyond the EMS setting. For example, it has been shown that transporting a severely injured patient to a regional trauma center will reduce that patient's risk of mortality. Therefore, an ambulance transporting an injured patient directly to a regional trauma center may increase the patient's chances of survival and reduce the need to transfer that patient to the regional trauma center for specialized treatment, thus decreasing the overall cost of the patient's care. In addition, if the patient has less injury-related morbidity because he or she was transported to a regional trauma center, that patient may be able to return to work sooner and, in turn, incur fewer lost wages.\n\nThe Panel on Cost-Effectiveness in Health and Medicine recommended that all health economic evaluations be conducted from a societal perspective. This means any cost analysis should account for all costs, regardless of who pays them or when they occur. Using a societal perspective means that when the costs of the EMS system are calculated, they are always greater than the cost of maintaining a single EMS agency in a community. Further, using the societal perspective allows for comparisons across studies and communities. When the entire cost is considered regardless of who pays, this negates the risk of unintentionally biasing the results based on a limited perspective.",
        "Framework for EMS costs": "The key EMS cost components that should be considered when 'costing' an EMS system are shown in Table 49.1. These components are shown in alphabetical order because no component is considered more important than the others. They should all be considered when calculating EMS system costs.\n\nWhen the costs of human resources are considered, they must include the cost of salary, overtime, and benefits. The cost of resources that are used multiple times such as vehicles, buildings, and durable equipment must include their acquisition, operation, maintenance, and replacement costs. The acquisition and replacement costs of items that can be used only once should be included regardless of whether they are used for patient care or discarded due to expiration. When identifying what resources to include, it is important to remember that they may not be directly related to patient care. Examples of this are buildings that house EMS administration and information systems. Any cost required to run or maintain the EMS system must be considered part of the cost of EMS.\n\nIn considering the cost of an EMS system, some costs should be excluded. These include taxes because they are a charge rather than a true cost. Tax payments are simply a revenue transfer; money is exchanged without any services relevant to EMS being provided. The actual cost of providing a given EMS system response is identical whether taxes are being paid by entities within the system or not. Medical errors and adverse event costs should be included in the downstream costs rather than the EMS system costs, but the costs for liability coverage and legal costs should be included because they are direct costs for running the EMS system. 'Sunk' costs to society should not be included because they would be costs to the society regardless of whether EMS is provided. For example, the cost of building and maintaining highways used by ambulances to travel to and from emergencies in the out-of-hospital setting should not be included in the cost of an EMS system because highways would still be there if there were no ambulances.\n\nCosts for revenue generation (i.e. billing) should not be included because that is a transfer rather than a cost of providing EMS care.\n\nOther possible considerations when costing an EMS system are whether to include prevention costs (e.g. bicycle safety courses or fall prevention programs). A working definition of EMS is \u201cacute, unscheduled health care delivered outside the hospital within the setting of a system that deploys health resources in response to a request for emergency medical care \u2026\u2026\u201d The authors of this definition determined that prevention was not within their definition of EMS and recommended that prevention costs be excluded from EMS system costs. Further, if a community sends mutual aid assistance outside of its borders, those costs should not be considered as part of the cost to provide EMS within that community. Therefore, when considering the cost of disaster preparation, the costs related to disaster preparation and response within the community served should be counted as an EMS system cost, but the cost of responses outside the community should not be included.\n\nFinally, the decision of when to include the cost of deploying EMS services to \u201cspecial events\u201d in EMS system costs can be confusing. The EMSCAP project recommended that the cost of deploying system resources to an event when there is a high likelihood of resource need should be included in any EMS system cost calculation regardless of who pays the costs. However, if EMS coverage is provided to a facility or event simply because the owners or planners have requested extra coverage, these costs should not be considered part of EMS system costs.",
        "Joint prduction": "Determining the cost of an EMS system is further complicated by the two aspects of EMS cost: the cost of the actual response (i.e. the equipment and personnel required to provide care to a specific patient) and the cost of readiness (i.e. the cost for personnel and equipment that must remain idle so that they are available whenever a request for emergency aid occurs). Since the need for emergency response is largely unpredictable, there must always be idle equipment and personnel available. When considering the cost of an ambulance agency, it is easy to conclude that the time spent waiting to be requested is a cost that should be attributed to the EMS system. This includes providing extra assets to a location that is likely to have a high need for resources (e.g. a local festival or sporting event).\n\nWhen considering the costs related to an agency that plays multiple roles in a community, such as a fire department or police agency, it may be difficult to determine how to attribute the cost of the time these agencies have staff or equipment waiting for an emergency request for aid. In the economics literature this is referred to as a \u201cjoint production\u201d problem, and, to date, there has been no consensus or definitive decision on how to fairly attribute the cost of these activities. It is common for a proportion of resources used to be allocated to the various activities in which an agency is engaged. When considering agencies that are part of the EMS system, there are several methods for determining this proportion, such as the proportion of calls that are EMS-related, the proportion of time engaged in responses that is related to EMS, or not attributing the cost of readiness from that agency at all. There is no single solution that could fit every agency and system type. For instance, it has been suggested that the percentage of calls be used for dispatch agencies and that percentage of time on EMS calls be used for fire departments. The decision of how to allocate these costs across different functions is very important because it can result in an overestimation or underestimation of cost. This area remains controversial, and work is needed to find an equitable solution.",
        "Conclusion": "The calculation of EMS system costs is challenging and requires the consideration of many aspects of the EMS system. The health economics literature strongly supports using the societal perspective when evaluating cost. This identifies the actual cost of the provision of care, regardless of who pays for it, and includes \u201cdownstream\u201d costs (and potential savings). Any attempt to identify the cost of EMS should use standardized methods to calculate EMS system costs, such as those recommended by the EMSCAP project. Only through the use of standardized costing methods will it be possible to compare results across studies or across jurisdictions. When a cost analysis is undertaken, it is also imperative that a full economic analysis be performed to provide reliable and meaningful conclusions."
    },
    {
        "Development of uniform requirements for the protection of human objects": "Today's vast medical knowledge is built upon years of research efforts involving human subjects to delineate the causes and most effective treatments for injury and disease. Regulations regarding the ethical conduct of human subject research in the United States have developed over recent decades, informed largely by multiple instances of research misconduct. The 1974 National Research Act was the first public bioethics policy in the United States. It was, in part, a response to the atrocities uncovered in the Tuskegee syphilis study, an experiment in Tuskegee, Alabama, in which treatment was withheld from 400 African American men with syphilis so that scientists could study the course of the disease. The National Research Act was the impetus for the creation of the Belmont Report which led to the development of the first guidelines for human subject research and also defined institutional review boards (IRBs).",
        "The Belmont Report": "The Belmont Report, published in 1979, identified the ethical principles of beneficence, justice, and respect for persons as the primary concepts comprising ethical research conduct. Today's informed consent and research subjects selection process are based on these principles. Respect for persons, beneficence, and justice were the principles used to inform development of the US Department of Health and Human Services (HHS) human subject protection regulations. They continue to define ethical conduct for both biomedical and behavioral research involving human subjects.",
        "The Common Rule": "Harmonization of the many different federal human subject protection rules authored by various federal departments and agencies was accomplished in 1991. Fourteen agencies adopted a uniform set of rules for the protection of human subjects that were identical to the human subjects guidance set forth in the HHS regulations. Known as the \u201cCommon Rule,\u201d this uniform set of regulations is the defining federal policy for the protection of human subjects. The Common Rule is the standard of ethics to which nearly all academic institutions hold their researchers regardless of funding source. The US Food and Drug Administration (FDA) also has regulations for protection of human subjects which conform in large part to the HHS regulations; however, research involving drugs or devices may be subject to additional FDA regulations.",
        "The role of the institutional review board": "All research involving human subjects must be reviewed by an IRB. The main purpose of the IRB review is to assure that the rights of human subjects are protected and that research is conducted ethically. Although human subject protections are a shared responsibility of the IRB, investigators, and personnel involved in the research, the IRB is the primary mechanism responsible for carrying out the DHHS and FDA regulations. There are defined categories of research with correspondingly rigorous levels of regulation. While some studies may not require IRB approval, investigators cannot self-exempt their human participant research projects. Determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff. Likewise, a protocol may be deemed to be of minimal risk, and may qualify for an expedited review process; again this is determined by the IRB based on the qualities of the study. By design, each IRB is charged with establishing its own local processes for complying with federal regulations delineated in the Common Rule. Local IRBs generally offer good guidance to researchers to take them through the processes required.",
        "Issues affecting prehospital research": "Research conducted in the prehospital setting can be a challenge both for the researcher to design and for IRBs to review and understand. Many IRBs may be most familiar with research that occurs within the confines of the institution, and may not have had experience with prehospital studies. They may not fully understand the limitations placed on research that occurs in the field. Additionally, special provisions for research into emergency conditions for which consent is not feasible have not been widely used and therefore may not be fully understood by many IRBs across the country.\n\nOnly a modest evidence base exists to support many prehospital treatments, and often the lack of evidence for some practices currently in place makes defining a standard of care difficult for many conditions. This is sometimes accompanied by practitioner bias for existing therapies or new unproven devices, which further affects the goal of achieving clinical equipoise in research.",
        "Informed consent": "Informed consent for research participation is one of the most sensitive issues in prehospital research because these patients are considered vulnerable, due to their reliance on EMS professionals for emergency treatment, and therefore may feel coerced when asked to consent to participate in research. More difficult still is the issue of conducting emergency research when subjects may not be able to consent to participate due to the nature of their illness or injury. Human subjects research carried out in the prehospital setting for emergency conditions where a patient is unable to provide informed consent (e.g. during cardiac arrest) is possible, but a series of additional regulations designed to provide extra protection to these vulnerable subjects must be followed. This process is called the exception from informed consent in emergency research (EICER).",
        "Public perceptions of prehospital care": "The public has an \u201cillusion of efficacy\u201d regarding the availability of current and future medical treatments for emergency conditions such as sudden cardiac arrest, trauma, and stroke. The fact that there is very little scientific evidence supporting much of what is done in resuscitation and trauma care is generally unrecognized. Similarly, the public is unaware that many emergency therapies currently in use have not been rigorously tested. Public awareness exists mainly to the extent that the media sensationalize accounts of research misconduct. There is little public understanding about the need for scientific evidence upon which to base new therapies or about the barriers facing researchers as they attempt to develop and test new emergency treatments. Acquiring knowledge about treatment efficacy, while assuring that reasonable ethical actions are in place, remains a complicated task. In spite of obstacles facing prehospital researchers, the progress in prehospital research methodology and knowledge in the last decade has been impressive.",
        "History of the exception from informed consent for emergency research": "During the mid 1970s, articles began to appear in the medical literature debating the issues fundamental to informed consent. These articles proposed a spectrum of ideological issues ranging from questions of whether consent during emergencies is necessary at all, to introspective treatises on the ethics and morality invoked when researching treatments for subjects who cannot give permission. For emergency medicine researchers, this debate was largely an interesting philosophical issue that did not affect research to a great degree. Little emergency medicine research was being conducted for conditions that today present the greatest challenge in this arena, such as resuscitation from sudden cardiac arrest, preservation of life and organ function in major trauma, and salvage of the brain during stroke. Even fewer studies were under way in the prehospital setting. Research pioneers in these fields generally obtained consent for participation in their studies retrospectively from the subjects' family members following the administration of emergency treatment, typically after families had been located or presented to the hospital. Several different consent strategies, all retrospective, were in use including deferred or implied consent and a two-tiered strategy. These methods were used for several more years, particularly in resuscitation research that was sometimes conducted in the prehospital setting. In 1993, a series of incidents raised concerns about research misconduct and prompted a presidential directive to investigate these offenses which resulted in the Office of Protection from Research Risks (now the Office for Human Research Protection) issuing a call for IRBs to stop all federally funded studies that did not involve obtaining prospective informed consent. An excellent review of the issues that led up to this action and the research implicated is detailed in Michelle Biros\u2019 article \u201cResearch without consent: current status, 2003\u201d. The FDA also halted all resuscitation research in the United States for almost 4 years. Some researchers believe that this significantly affected the progress of resuscitation research, which was just beginning to gain momentum in the United States, and outcries were heard from the researchers. This was accompanied by a flurry of communication between the FDA, HHS, emergency researchers, and professional societies with research missions. Released in 1996, the Final Rule provides a mechanism by which prospective research can occur in emergency situations that meet certain conditions. Some researchers argued that the requirements added excessive regulatory burden and were overly restrictive to the conduct of research in areas where scientific evidence was sorely needed in order to establish effective new therapies, particularly in emergency and trauma care. Others believed that the regulations provided appropriate safeguards to human subjects but that further refinement and standardization of the process were necessary to adequately facilitate resuscitation research. The Final Rule was criticized for being too vague in sections to adequately advise IRBs on how to proceed, and for adding regulatory requirements without evidence as to their efficacy. Part of the imprecision inherent in the Final Rule is purposeful, with the intent of leaving many decisions to the authority of the local IRB; however, when an IRB has little or no experience using the concepts of the EICER, this latitude can be viewed as more problematic than helpful. ",
        "EMS research during the 1990s": "Although there was an increase in the number of prehospital publications evident during the 1990s, the majority of these were retrospective reviews. In an analysis of the literature published between 1985 and 1994, Brice et al. found that only 15% of the studies (42 in total) were clinical trials and 53% were retrospective in design [20]. Overall, the scientific rigor of the prehospital studies during that period was limited, and it was suggested that a strengthening of study designs would benefit EMS research progress. Following the release of the Final Rule in 1996, there have been several successful examples of prehospital studies successfully negotiating the EICER rules. The first was the study of diaspirin cross-linked hemoglobin in severe traumatic hemorrhagic shock. Others, including the large, multicenter study of public access defibrillation, soon followed, with varying experiences in the time invested in the process, expense, and perceived success of the exception of the process.",
        "Additional protections required when using the exception from informed consent for emergency research - Community consultation": "The most debated portion of the Final Rule is the requirement for community consultation and public disclosure. Community consultation refers to discourse between investigators and a wide variety of community members and representatives and addresses multiple issues, including an opportunity for input from the community, ensuring transparency in the research process, and engendering trust in the research process and the proposed study. Community consultation also provides a mechanism by which community members may opt out of enrollment. Community consultation must occur prior to the enrollment of any subjects. Local IRBs assess the adequacy of plans for community consultation prior to study implementation and consider the results of the community consultation before making a decision about whether the research may proceed. Researchers are advised to work closely with their IRBs to determine an appropriate community consultation plan. The specific requirements for the scope of this activity were purposely left vague in the Final Rule so that local IRBs could ensure that community consultation activities were appropriate, based on their knowledge of their own communities. In the past, many researchers have chosen to conduct community consultation by holding town hall meetings. At these meetings, the investigator presents information about the study and exception from informed consent. These presentations are typically scripted, with the IRB approving the script prior to the first presentation. Sometimes an IRB representative will also be present to monitor the consultation process and occasionally to provide additional information about the protection of human subjects to the attendees. Attendees are then given an opportunity to ask questions, and surveys are sometimes used to formally report the demographics of the attendees and their support or lack of support for the study. Other strategies used to conduct community consultation prior to implementation of an EICER study include population-based telephone surveys and social media.",
        "Additional protections required when using the exception from informed consent for emergency research - Public disclosure": "Public disclosure is a one-way transfer of information to the community. It generally includes a notice that the study is planned, describes the nature and purpose of the research including the fact that consent will not be prospectively obtained, and presents the possible risks and expected benefits that might result. Public disclosure must be performed prior to the start of the study and after the study is complete. The intended purpose of public disclosure before the study is to inform the community, the public and other researchers about the details of the upcoming study. This should include the following elements. The intent to conduct the research without prospective informed consent A description of the treatment under study as well as its risks and benefits A synopsis of the protocol and study design Information about how subjects will be identified A list of sites participating in the research A description of the attempts that will be made to contact each subject\u2019s legally authorized representative Public disclosure to the community and to other researchers following completion of the study should include the following. Aggregate demographic information (age, sex, and race) about the population that participated Results of the study Many researchers have found that submitting press releases to local media outlets is an effective way of initiating public disclosure. These typically also result in newspaper and radio interviews that allow study information to be relayed to the public. Further, the placement of classified ads and the release of public service announcements have also been used for public disclosure. These announcements also include references to websites and the researcher\u2019s phone number so that those who are interested can obtain more information. These announcements are typically approved by the local IRB prior to their release. Some institutions will allow or even require researchers to work with their public relations office to produce high-quality press releases. Disclosures to other researchers can be accomplished through the publication of the study in a scientific journal.",
        "Additional protections required when using the exception from informed consent for emergency research - Meeting the requirements": "Most researchers agree that regulatory guidance such as the Final Rule is necessary and helpful to ensure that research maintains an ethical standard. However, the complexity of the rules, combined with inexperience of both researchers and IRBs in applying the guidelines, continues to impose financial and time costs which are considered barriers to conducting resuscitation research in the United States. For example, among the 24 sites and 101 IRBs participating in the multicenter Public Access Defibrillation Trial, there were nearly 12,000 activities conducted to achieve community consultation and public disclosure. Clearly, investigators must consider the time and cost of these activities in both planning and budgeting an EICER study. The researcher who needs to apply these guidelines should become familiar with the rules, seek guidance from colleagues who have participated in this process, and establish early and regular communication with the IRB. This will help the parties to work through the regulations together and to design and conduct emergency research in an ethical manner and with every opportunity for success.",
        "Conclusion": "It is often said that EMS research is challenging to carry out. Conducting any research study requires meticulous planning to ensure that methodological issues are considered and also that ethical treatment of the human subjects who make research possible is adequately addressed. When conducting EICER research, it is helpful to become familiar with the regulations, to communicate early and often with your IRB, and to seek input from other researchers who have had experience with the process."
    }
]