Chapter 9 - Medical Terminology PDF

156 Part 1 Preparatory aspects important to the hospital. Another example is “patient dumping,” in which a patient who is not in stable condition is transferred or discharged from a hospital for financial reasons. Patient Advocacy and Paramedic Accountability While providing care, the paramedic...

156 Part 1 Preparatory aspects important to the hospital. Another example is “patient dumping,” in which a patient who is not in stable condition is transferred or discharged from a hospital for financial reasons. Patient Advocacy and Paramedic Accountability While providing care, the paramedic serves as the patient’s advocate. This advocacy may conflict at times with the paramedic’s accountability to the patient, the physician medical director, and the health care system (eg, health maintenance organization [HMO] protocols). In such a case, the paramedic should discuss all options with medical direction. As a rule, it is prudent and ethical to err on the side of providing for the needs of the patient when conflict arises. Examples of ways in which a paramedic can serve as the patient’s advocate include the following: • • • • • • Educating patients about the delivery of health care and the role they can play to help change the nation’s health care system Intervening when it is in the patient’s best interest, particularly when the patient cannot communicate10 Making sure health care decisions are made by patients and their physicians and are based on the patient’s medical needs, not financial considerations Informing patients of health care reform initiatives in the federal, state, and private sectors Promoting patient access to reliable information about state-of-the-art medical technologies and treatments Promoting fairness and equality in America’s health care system Paramedic’s Role as Physician Extender As a physician extender, the paramedic generally is responsible for following the orders of the medical director or the director’s designee. However, sometimes these orders may not seem appropriate. For example, the paramedic may believe that a medication order is contraindicated for the patient (such as giving narcotics when the patient is hypotensive). Or a medication may be medically acceptable but may not be in the patient’s best interest (eg, an order for an intravenous drug to treat asthma before the patient’s inhaler has been tried). The converse also can occur. For example, a paramedic might request treatment in a situation in which the field diagnosis is not certain, or the physician may lack information needed to approve the request. When a conflict occurs between medical direction and the paramedic, communication is the key to resolving short-term and long-term concerns. CRITICAL THINKING How are ethical issues involved in each of the following aspects of an EMS call? 1. Problems associated with finding an address 2. Stigmatization of patients 3. Interventions in dangerous situations 4. Safe driving 5. Dealing with difficult patients 6. Difference of opinion with other health care providers 7. Telling the truth to patients Modified from: Erbay H. Some ethical issues in prehospital emergency medicine. Turkish J Emerg Med. 2014;14(4):193-198. NOTE Moral Injury In their careers, paramedics witness cruelty, loss, and suffering that can take its toll on their own lives and emotional well-being. Moral injury, or moral suffering, is the “emotional and spiritual impact of participating in, witnessing, and/or being victimized by actions and behaviors which violate one’s core moral values and behavioral expectations of self or others.” The term was coined by the military, and in recent years the concept has been applied to the health care setting. Moral injury can be caused by merely seeing events that conflict with one’s own morals, or it may occur when paramedics feel as though they acted in a way that contradicts their personal morals. Unresolved feelings of anguish from moral injury can lead to depression and suicidal thoughts or actions. It is important that paramedics recognize moral injury and seek counseling to help work through the distress it causes. Modified from: Moral Injury Project. What is moral injury? Syracuse University website. http://moralinjuryproject.syr.edu /about-moral-injury/. Accessed January 16, 2018; and Butts JB, Rich KL. Nursing Ethics: Across the Curriculum and Into Practice. 4th ed. Burlington, MA: Jones & Bartlett Learning; 2016. Chapter 7 Ethics Ethical Leadership in Paramedicine Leadership is a key aspect of the paramedic role. Effective leaders are committed to ethical conduct. Ethical conduct applies to interactions with patients, the community, and other members of the EMS team. The community expects ethical behaviors from public safety professionals, and as leaders within that system, it is imperative that paramedics model those practices. Reflection on one’s own ethical life can begin by asking five questions: 1. Did I practice any virtues today? 2. Did I do more good than harm today? Summary • Ethics is the discipline relating to right and wrong, duty and obligation, moral principles and values, and moral character. Morals refers to standards that a person uses to distinguish right from wrong. Bioethics is the science of medical ethics. • Most ethical issues paramedics face in their careers deal with a patient’s right to self-determination and the paramedic’s duty to provide patient care. • Paramedics must meet a standard established by their level of training and regional practice. They must abide by the law when ethical conflicts occur. • Two concepts of ethical health care are to provide patient benefit and to do no harm. • The rapid approach to resolving ethical issues is a process that involves reviewing past experiences; deliberation (if possible); and/or performing the impartiality test, universalizability test, and interpersonal justifiability test to reach an acceptable decision. • All resources must be allocated fairly. This is an accepted bioethical value. References 1. 2. 3. 4. 5. Erbay H. Some ethical issues in prehospital emergency medicine. Turk J Emerg Med. 2014;14(4):193-198. Sanderson B. History of Ethics to 30 BC: Ancient Wisdom and Folly. Santa Barbara, CA: World Peace Communications; 2002. American Medical Association, Council on Ethical and Judicial Affairs. Code of Medical Ethics: Current Opinions With Annotations. Chicago, IL: American Medical Association; 2009. Veatch R. Medical Ethics. 2nd ed. Sudbury, MA: Jones & Bartlett Publishers; 1997. National Highway Traffic Safety Administration. EMT-Paramedic National Standard Curriculum. Washington, DC: US Department of Transportation; 1998. 157 3. Did I treat people with dignity and respect today? 4. Was I fair and just today? 5. Was my community better because I was in it? Was I better because I was in my community?11 On the surface, these seem like simple questions, and most people would readily respond in the affirmative to each. Faced with the complexities of the stressful EMS work environment, however, paramedics may find these questions more complicated. It requires work every day of a paramedic’s career to continue to confidently say, “Yes, I am leading an ethical life as a paramedic leader.” • A health care professional is not allowed to reveal details supplied by the patient to others without the patient’s consent. This is the principle of confidentiality. • Patients with decisional capacity have a legal right to decide on the medical care they will receive. In some cases, patients refuse lifesaving care. These cases can produce legal and ethical conflicts. • Advance directives, living wills, and other self-determination documents can help the paramedic make decisions about the appropriateness of resuscitation in the prehospital setting. • Other areas likely to raise ethical questions in the prehospital setting include error disclosure, providing care in futile situations, and the paramedic’s obligation to provide care. • While providing care, the paramedic serves as the patient’s advocate. The paramedic also serves the role of physician extender. • Ethical leadership is a key aspect of the paramedic role. 6. 7. 8. 9. Bourn S. Through traffic keep right. J Emerg Med Serv. 1996;21(5):26. Iserson KV, Sanders AB. Ethics in Emergency Medicine. 2nd ed. Tucson, AZ: Galen Press; 1995. Lu DW, Adams JG. Ethical challenges. In: Cone DC, Brice JH, Delbridge TR, Myers JB, eds. Emergency Medical Services: Clinical Practice and Systems Oversight. Vol 2. 2nd ed. West Sussex, England: Wiley and Sons; 2015. Mancini ME, Diekema DS, Hoadley TA, et al. 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care, part 3: ethical issues. Circulation. 2015;132(suppl):S383-S396. 158 10. Part 1 Preparatory Robertson B. A brief on patient rights. EMS Reference website. https://www.emsreference.com/articles/article/brief-patientrights. Published November 2, 2016. Updated January 5, 2017. Accessed February 9, 2018. Suggested Readings Awdish RLA. A view from the edge—creating a culture of caring. New Engl J Med. 2017;376(1):7-9. Breaux P. Leadership ethics in EMS. EMSWorld website. https:// www.emsworld.com/article/10712788/leadership-ethics-ems. Published May 10, 2012. Accessed February 9, 2018. 11. National Association of Emergency Medical Technicians. Ethics and Personal Leadership. Burlington, MA: Jones & Bartlett Learning; 2015: 36. Ethical challenges in emergency medical service. Prehosp Disaster Med. 1993 April-June;8(2):179-182. Malina D. Liberty versus need—our struggle to care for people with serious mental illness. New Engl J Med. 2016;375(15):1490-1495. Shapiro MF. Considering the common good—the view from seven miles up. New Engl J Med. 2016;374:2006-2007. © fStop /Getty Images Chapter 8 Research Principles and Evidence-Based Practice NATIONAL EMS EDUCATION STANDARD COMPETENCIES Preparatory Integrates comprehensive knowledge of the EMS system, safety/well-being of the paramedic, and medical/legal and ethical issues which is intended to improve the health of EMS personnel, patients, and the community. Research • Impact of research on emergency medical responder (EMR) care (p 161) • Data collection (pp 167–168, 170) • Evidence-based decision making (pp 169–171) • Research principles to interpret literature and advocate evidence-based practice (pp 161–169) OBJECTIVES Upon completion of this chapter, the paramedic student will be able to: 1. Explain the importance of EMS research. (p 161) 2. Outline the 10 steps in performing research. (pp 161–169) 3. Describe the differences between types of EMS research. (pp 163–165) 4. Define evidence-based practice. (pp 169–170) 5. Describe the criteria for evaluating a research paper. (pp 170–171) KEY TERMS alternative time sampling Sampling to prevent bias by assigning a treatment group based on the day, week, or month in which patients are encountered in a study. bias A systematic error introduced into sampling or testing that results in the deviation of the results of a study from the actual “truth.” blinding A research specification that dictates that parties are not made aware of the study, treatment, or outcome to be measured. confidence interval An estimate of the range of likely values in the source population (the true value) based on the given study sample value, where a narrow range indicates more certainty about the value than does a wide range. confounding variables Unmeasured variables that may affect the results of an experiment. convenience sampling The process of choosing the people who are easiest to reach, or sampling that is easily done. The sample does not represent the entire population. descriptive statistics A form of statistics that does not try to conclude (infer) anything about a subject that goes beyond the data; can be qualitative or quantitative. evidence-based medicine Medical practice that is based on current scientific evidence. 159 exclusion criteria Criteria that exclude a patient from eligibility for a particular research study; defined on a study-by-study basis. hypothesis A statement of the relationship between two or more variables. inclusion criteria Criteria that a patient must meet to be eligible for a particular research study; defined on a study-by-study basis. inferential statistics A form of statistics that enables the researcher to conclude (infer) whether the relationships seen in a sample are likely to occur in the larger population. institutional review board (IRB) A committee that performs critical oversight functions (scientific, ethical, and regulatory) for research conducted on human subjects. level of significance The likelihood that a finding in research data is due to chance; the probability of rejecting the null hypothesis if it is true. mean The arithmetic average of a group being studied. median A descriptive statistic that is found by first arranging the measurements according to size from smallest to largest, then choosing the measurement in the middle; the midpoint of a distribution score. mode The number that occurs more often than any other number in a set of data. nuisance variables Variables that can make drawing accurate conclusions from a study difficult. null hypothesis An exact statement that the results occur by chance (the opposite of the hypothesis). number needed to harm (NNH) The number of patients, on average, who need to be exposed to a treatment or risk factor for one person to have an adverse effect. number needed to treat (NNT) The number of patients, on average, who need to be treated to prevent one additional bad outcome. parameter An aspect of a population that is difficult or impossible to measure and so is estimated using a sample population. population A large group of people, places, or objects that are the main focus of a scientific query. power The ability of a study to detect difference if a difference really exists. It is based on the sample size (number of subjects) and effect size (difference in outcomes between the groups). qualitative analysis The non-numerical organization and interpretation of observations. quantitative analysis Research data that are measured and analyzed numerically. random sample A subset from the larger population of a study chosen randomly and entirely by chance. sampling error Error that results from observation of a sample rather than the whole population. selection bias A distortion of evidence or data that arises from the way the data are collected. standard deviation An estimate of the average deviation from the mean, measured in the same units as the original data. statistically significant A descriptive term used when the observed phenomenon represents a significant departure from what might be expected by chance alone. statistics A summary of characteristics of numerical facts or data. systematic sampling A statistical method that involves the selection of a population from an ordered sampling so as to ensure equal probability. unblinding A research specification by which all parties are made aware of the study, treatment, and outcome to be measured. EMS systems are committed to providing effective and efficient health care to acutely ill and injured patients. As the National Highway Traffic Safety Administration has said, EMS agencies face a challenge today. Practices have been based on tradition and expert opinion. They need to be transformed into practices based on guidelines and protocols that have been developed through thoughtful, systematic examination of scientific evidence and data.1 Paramedics must have a basic knowledge of research principles. This knowledge is necessary for conducting research and interpreting published studies. Paramedics also must be willing to help collect research data, which provide important information for the continued development of EMS care. 160 Chapter 8 Research Principles and Evidence-Based Practice 161 CRITICAL THINKING What are your thoughts about research? NOTE © jurgenfr/Shutterstock. EMS Research Research is a desirable activity for an EMS system and is vital to improving patient care. This process involves gathering data to answer clinically valuable questions, such as which procedures, techniques, and equipment are clinically beneficial versus those that do not improve outcomes or cause patient harm. Thus, research is essential to the evolution of EMS. The National EMS Research Agenda, published in 2001, states, “Research is essential to ensure that the best possible care is provided in the prehospital setting.”1 The aims of this agenda2 were further advanced in a consensus research project in 2005 that developed target areas for clinical research in EMS. In 2014, the Federal Interagency Committee for Emergency Medical Services reaffirmed this focus in its strategic plan, which incorporated an objective to support data collection and research that leads to the development of evidence-based prehospital guidelines.3 Research is based on data and can improve patient care by leading to changes in professional standards, training, equipment, and procedures. In addition, EMS research increases respect for EMS professionals (BOX 8-1). BOX 8-1 Importance of Research in Emergency Medical Services • • • • • Production of outcome-based research New procedures, medications, and treatment Quality assurance Improved patient outcomes Professionalism The Longitudinal Emergency Medical Technician Attributes and Demographics Study (LEADS) project is hosted by the National Registry of Emergency Medical Technicians (NREMT) and is conducted each year. This study is designed to describe the EMS population in the United States, including their work activities, working conditions, and job satisfaction. LEADS, which began in August 1998, is led by a team of researchers made up of state EMS directors, state EMS training coordinators, EMS system managers, emergency physicians, EMS educators, survey researchers, and staff of the NREMT. The NREMT is a leader in the areas of research in EMS education and practice. For more information about the LEADS project, see www.nremt.org/rwd/public. Basic Principles of Research This chapter describes 10 basic steps for conducting research4 (FIGURE 8-1): 1. Prepare a question. 2. Write a hypothesis. 3. Decide what to measure and the best way to measure it. 4. Define the population. 5. Determine the study design. 6. Seek institutional review board (IRB) approval of the study. 7. Obtain informed consent if needed. 8. Gather data after conducting pilot trials. 9. Analyze the data with an awareness of the pitfalls in interpreting the data. 10. Determine what to do with the research product (publish, present, perform follow-up studies). NOTE Paramedics should search the medical literature for related research when seeking evidence or before undertaking their own studies. This research should be evaluated for validity and reliability (described later in this text). Reference sources for literature review include peer-reviewed studies, government publications, and literature searches on the Internet using reliable sources such as MEDLINE on PubMed (www.ncbi.nlm.nih.gov/pubmed/). 162 Part 1 Preparatory Prepare a question • • Write a hypothesis • Decide what to measure and the best way to measure it • • Define the population Determine the study design What is the incidence of violence in an EMS system? Does the paramedic’s shift length influence the number of medical errors? Does performance of prehospital electrocardiography change survival rates for patients with acute myocardial infarction? Does prehospital intubation improve outcomes for patients with traumatic brain injury? Does the use of mechanical cardiopulmonary resuscitation improve outcomes in prehospital cardiac arrest? When an area of clinical interest has been identified, it is of utmost importance to review the current literature to determine what is already known and optimize the objectives of the study. Seek study approval CRITICAL THINKING Obtain informed consent Gather data after conducting pilot trials Analyze the data with an awareness of the pitfalls in interpreting the data Determine what to do with the research product (publish, present, perform follow-up studies) FIGURE 8-1 Ten steps for conducting research. © Jones & Bartlett Learning. Prepare a Question EMS research begins with the identification of a specific problem or question. The research then is carried out using standard research methods. Examples of problems or questions specifically related to EMS might include the following: • • • Which factors predict success for paramedic students on the National Registry of Emergency Medical Technicians written examination? Is the incidence of complications greater with prehospital peripheral vascular access than with hospital peripheral vascular access? Does the paramedic uniform influence a patient’s satisfaction? Can you think of any EMS-related questions that you would be interested in studying? Write a Hypothesis After a problem or question to be studied has been identified, the researcher must define a statement to be tested by the study. This statement, which is called the hypothesis, proposes the relationship between two or more variables. A variable is any factor or entity that can vary in amount or type. For example, the problem might be the ability of one drug to lower a patient’s blood pressure more effectively than another drug. A hypothesis for the drug study might be that drug A lowers blood pressure better and with fewer side effects than drug B. The variables would include each drug being studied and the blood pressure. Other variables such as age and sex might also be considered. Decide What and How to Measure When the hypothesis has been defined, the next step is to decide what to measure and the best way to measure it. Using the previously described drug study, for example, the research may be focused on patients of a certain age, sex, or weight. It may also be limited to the effects of only a small number of antihypertensive drugs (eg, a specific angiotensin-converting enzyme inhibitor and a specific beta blocker.) Chapter 8 Research Principles and Evidence-Based Practice Define the Population The next step in the research process is to define the population for the study. For a study to be clinically relevant, the population should be carefully chosen based on the research question. The population is formally defined using inclusion criteria and exclusion criteria, which specify which people are and are not eligible to participate in the study. For example, a study to evaluate an intervention for cardiac arrest could include all patients who receive prehospital cardiopulmonary resuscitation in a specific region over a specific period. Exclusion criteria could include age younger than 18 years, nonshockable rhythm, return of spontaneous circulation prior to EMS arrival, and existence of a do not resuscitate order. Inclusion and exclusion criteria help minimize the influence of specific confounding variables. As it is typically impossible to research an entire population, research studies use a sample of the population to draw conclusions about the entire population. Ideally, to minimize bias, the sample is selected in such a way that every member of the population has an equal chance of being included in the sample. For example, drawing a random sample prevents selection bias (placing the best or worst patients in a study group). The researcher can ensure random sampling with the use of computer software programs, random digits, and even flipping a coin. Another way to limit bias is with systematic sampling. With this method, patients are put into groups in the order in which they are encountered in the prehospital setting. For example, the first patient seen is put into group A, the second into group B, the third into group A, and so on. The researcher also can use alternative time sampling to prevent bias by assigning a treatment group based on the day, week, or month in which patients are encountered in the study. Convenience sampling, which is based on choosing a readily available group, is the least preferred method. For example, patients might be assigned to groups when a particular person or crew is working. Even when researchers use carefully designed methods, however, sampling error may occur. Such errors result from the fact that even the best sample will not work perfectly to represent the population, because of the chance inclusion of one person in the study group rather than the chance inclusion of someone else. 163 NOTE A parameter is a numerical quantity or attribute of a population that is estimated using data collected from that population. For example, determining the exact age (hour of birth) of all patients in a group is nearly impossible; therefore, age is estimated using a sample population. Nuisance variables are issues that complicate the process of drawing accurate conclusions from a study by increasing background variability. An example is the use of audible and visual warning devices that can contribute to a rise in a patient’s blood pressure. Parameters and nuisance variables are difficult to identify, control, prevent, or eliminate. Determine the Study Design A study design is a plan for conducting a study. Not all research study designs are equally effective. Study designs vary in terms of their size, degree of bias, and ability to control for confounding variables. In turn, these designs lead to differences in how confidently the results of the research can be used in clinical practice. The goal is to select the experimental design that balances feasibility, cost, and usefulness (FIGURE 8-2). The first step in selecting a study design is to determine the study method. Study methods vary in terms of whether they follow patients over time, whether they study events as they occur or instead look backward in time, and whether they intervene with study subjects or instead simply observe them. The following study methods are widely used: • • Descriptive method. A research design in which events are monitored and analyzed without any attempt to manipulate or alter the outcome. Cross-sectional method. A research design in which a group of subjects is studied during a specified (usually short) period. Defi iti e Ho o e? Shoul • Polic e? evelopme t • mpleme tatio scie ce • Accepta ility • Prioriti atio • ost-effecti e ess a Suggesti e e? • ffecti e ess • fficacy FIGURE 8-2 Key considerations when selecting a study design. © Jones & Bartlett Learning. 164 • • • • Part 1 Preparatory Longitudinal method. A research design in which members of a sample population are followed forward over time. Retrospective method. A research design in which the specific question, hypothesis, and data collection are defined after the data already exist. Prospective method. A research design in which the specific question, hypothesis, and data collection are defined before the study begins. Experimental method. A research design in which an intervention is introduced and the effects are monitored for an outcome. The research method is intimately connected to the overall design because it determines whether the overall design is descriptive or analytical.5 Descriptive Designs Descriptive designs are the simplest of the study designs and are used primarily to generate hypotheses for future work. Because they do not control for confounding variables, descriptive studies are unable to draw a causal relationship between variables. For example, a descriptive study might identify that paramedics regularly experience fatigue while at work but not determine why they do. Although descriptive studies may use simple designs, they can have powerful results. The main types of descriptive studies include case reports/ series and cross-sectional designs. • • Case reports and case series analyze individual cases or events. They can give insight into new diseases or presentations. Because they review the experience of only one person or a few people, they do not represent a true sample of the population and their results cannot be extrapolated to the general population. Cross-sectional designs analyze data from a population at a specific point in time. Surveys are a typical example of a cross-sectional design. Analytical Designs Analytical designs collect data that are then evaluated for a cause-and-effect relationship between variables. The main types of analytical designs are observational designs and experimental designs. • Observational designs include case-control, cohort, and before–after studies. Case-control studies compare participants by their outcomes, • whereas cohort studies compare participants by exposure to a risk factor or intervention. For example, if a researcher designed an observational study to address the relationship between smoking and cancer, a case-control study might compare patients with lung cancer to patients without lung cancer on the basis of how much they had smoked, whereas a cohort study might compare patients who smoked with patients who did not smoke on the basis of how often lung cancer developed. A before–after study compares the same population before and after an intervention. This design is very common in EMS quality improvement research, where outcomes are compared before and after a protocol or equipment change. Experimental designs are studies in which the researcher assigns an intervention (exposure) to a participant and then follows the participants to measure specific outcomes. Ideally, patients are randomly assigned to their intervention arm to minimize selection bias. NOTE Correlation and Causation: What Do They Mean? When a researcher finds a connection or association between two or more variables, it is called a correlation. The correlation can be in a positive direction where all variables go up (eg, as texting while driving increases, crashes increase), or it can be in a negative direction where some variables go up and some go down (eg, as seat belt use increases, fatal crashes decrease). However, in order to prove causation (ie, that one variable directly causes the other), the variables must be properly controlled and measured using methods that are statistically valid. An example would be studying seat belt use and distracted driving data obtained from patient interviews following a vehicle crash. It is much more difficult to prove causation than it is to prove correlation. When reading media reports or scientific papers, the paramedic should critically question whether the correlation between two variables can be treated as having a causal relationship. As mentioned earlier, each study is likely to contain some form of bias, and the goal of good study design is to minimize this influence on the results. One technique for minimizing bias is blinding, which is used to limit the effects of the researchers’ or participants’ beliefs on the results of the study (assessment bias). Chapter 8 Research Principles and Evidence-Based Practice In a single-blind method, one party (the patient, the paramedic, or the person gathering the data) is unaware of (blinded to) the treatment at the time it is given. For example, in a study to evaluate the effectiveness of a drug to treat nausea, some patients may be given the study drug, and others a placebo (ie, an inactive substance that is physically indistinguishable from the study drug). The paramedic, but not the patient, would know if the patient received a placebo or study drug, which would eliminate some bias. In a double-blind study, both the parties administering the intervention and the research subject (in the previous example the patient and the paramedic) are unaware of which intervention is being administered. Note that in the double-blind scenario, there is still a party, the researcher, who knows which intervention is being administered. In a triple-blind study, the study participant, the care provider, and the researcher are all unaware of which intervention the participant received. The outcomes of the study cannot be evaluated until the researcher is unblinded. Unblinding refers to making all parties aware of the study, treatment, and outcome to be measured. When a research report is evaluated, the study design should be considered before drawing conclusions based on the results. The strength of evidence that research provides can range from very weak (expert opinion) to very strong (meta-analysis) (FIGURE 8-3). CRITICAL THINKING Why might experimental trials be difficult to perform in EMS? Why is it important to conduct such trials? Seek Institutional Review Board Approval of the Study When planning for research involving human subjects, researchers use an institutional review board (IRB) as a touchstone for advice and a source of approval for the study. IRBs (also known as independent ethics committees or ethical review boards) came into widespread use as a result of a mandate from the US Public Health Services in 1966.6 This mandate required a review by a “committee of institutional associates” for any federally funded research that used human subjects. In the United States, regulations have empowered IRBs to approve research, require modifications in planned research before approval, or disapprove research. These regulations were Strongest evidence 165 Meta-analysis (quantitative synthesis) of randomized clinical trials Large randomized experimental studies with control groups Small randomized experiments with control groups Nonrandomized trials with control groups Nonrandomized studies without control groups Descriptive, correlational, qualitative studies Weakest evidence Case studies FIGURE 8-3 Quality of evidence ranges from very weak (expert opinion) to very strong (meta-analysis). © Jones & Bartlett Learning. developed by the US Food and Drug Administration and the Department of Health and Human Services (specifically the Office for Human Research Protections). An IRB performs critical oversight functions for research conducted on human subjects to protect their safety. To receive IRB approval, the research is required to be scientific, ethical, and regulatory. CRITICAL THINKING Why do you think the development of IRBs was needed for research? Obtain Informed Consent A subject who voluntarily agrees to take part in the research project gives informed consent. Informed consent recognizes that the subject has decisional capacity and understands what is being presented. With respect to EMS research and the problems associated with obtaining informed consent in emergency 166 Part 1 Preparatory situations, alternatives to informed consent have been developed, including the following:4 • • • • Consent at a distance. The base station physician educates and obtains informed consent from the subject by radio or telephone. Consent by proxy. The paramedic obtains informed consent from a surrogate who is authorized to give medical consent on behalf of the patient, such as a medical power of attorney, a relative on behalf of an unconscious patient, or a parent on behalf of a child. Stepped consent. The paramedic provides the subject with a brief overview of the experimental therapy. Full informed consent is obtained at the hospital. Cohort consent. Permission is obtained to enter the study at some future time (eg, during an asthma exacerbation or sickle cell crisis). • • • Deferred consent. This type of consent is used during resuscitation; the subject’s condition is stabilized and the person receives experimental therapy without permission, after which the family is approached for traditional informed consent. Surrogate consent. Surrogate consent is consent from someone other than the patient. It varies by state, but if the patient has no designated medical power of attorney, most states use a hierarchy starting with a spouse, proceeding to an adult child, and ending with a close friend. The surrogate consents to whether the patient will participate in the treatment based on the surrogate’s desires and wishes and not by evaluating the treatment as to its appropriateness. Consent jury. A lay panel determines certain aspects of the experimental protocol, particularly potential risks and complications that must be presented during a request for consent. DID YOU KNOW? Institutional Review Boards Currently most IRBs involved in EMS research consist of physicians, attorneys, psychologists, ethicists, allied health professionals, and lay members of the community. In fact, most peer-reviewed EMS journals ask for a record that the research was approved by an IRB. IRBs seek to reduce the risk of patients unknowingly entering into research that could harm them in any way. In 2016, the US Department of Health and Human Services updated the regulations for research practice (CFR title 21, part 56; revised, 2016). These regulations are observed by most IRBs. 1. Risks to subjects are minimized by using procedures consistent with sound research design that do not unnecessarily expose subjects to risk and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (eg, the possible effects of the research on public policy) as among the research risks that fall within the purview of its responsibility. 3. Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, people with mental disability, and economically or educationally disadvantaged people. 4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative in accordance with and to the extent required by federal regulations related to protection of human subjects. 5. Informed consent will be appropriately documented in accordance with and to the extent required by federal regulations related to protection of human subjects. 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. 7. When appropriate, adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data. 8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence (eg, children, prisoners, pregnant women, people with mentally disability, or economically or educationally disadvantaged people), additional safeguards are included in the study to protect the rights and welfare of these subjects. Modified from: Code of Federal Regulations title 21, part 56. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch .cfm?CFRPart=56&showFR=1. US Food and Drug Administration website. Updated August 14, 2017. Accessed December 1, 2017. Chapter 8 Research Principles and Evidence-Based Practice NOTE Exceptions to obtaining informed consent may be permitted in some emergency research. To be granted this waiver, the researchers must prove that they have informed the community about the research and must solicit feedback from the community about the proposed research. This process is known as community consultation and public disclosure. It can be accomplished in a number of ways, depending on the community and the specific group targeted for the research. In 2010, the National Registry of Emergency Medical Technicians surveyed more than 65,000 EMS providers to seek their opinions on this type of consent. Almost all of the 36% of survey respondents agreed that EMS research is important; however, only one-third thought that it was acceptable to enroll patients without their consent to learn about a new treatment, and less than half were willing to enroll in a similar study. The researchers suggested that the opinions of this group meant that it would be important to meet with EMS providers and address these concerns before conducting prehospital research involving exceptions from informed consent. Modified from: Jasti J, Fernandez AR, Schmidt TA, Lerner EB. EMS provider attitudes and perceptions of enrolling patients without consent in prehospital emergency research. Prehosp Emerg Care. 2015;20(1):22-27. SHOW ME THE EVIDENCE The following study demonstrates an example of community consultation to perform research. Nelson and colleagues collected a cross-sectional, standardized survey conducted by two sets of random-digit telephone surveys, paper surveys at community meetings, and web-based surveys. Their goal was to comply with federal law that allows research to be conducted using very strict criteria without having prior consent of the patient. The surveys were done to fulfill the law’s requirement for community consultation and public disclosure. The authors found that community meetings were poorly attended and that phone surveys were effective for gauging public opinion. However, they recommended targeted surveys to reach special populations. Modified from: Nelson M, Schmidt TA, DeIorio NM, McConnell KJ, Griffiths DE, McClure KB. Community consultation methods in a study using exception to informed consent. Prehosp Emerg Care. 2009;12:417-425. Gather and Analyze Data Data from the research study should be gathered after conducting pilot trials and analyzed using statistical methods. The term statistics refers to numerical facts or data. These facts or data are classified into groups and are 167 often organized into charts to present key details about a subject. Statistics can be descriptive or inferential. Descriptive Statistics Descriptive statistics does not try to conclude (infer) anything about a subject that goes beyond the data. This type of statistics describes the sample of objects or people being studied. It does not infer anything from the data, but simply reports the data. Descriptive statistics can be qualitative or quantitative. Qualitative analysis is the organization and interpretation of observations; it is non-numerical, using text and few numbers to describe the research findings. The sample size in qualitative research usually is very small. Interviews, analysis of written text, and focus groups are often used to gather data in this type of research. The conclusions reveal key underlying dimensions and patterns in a group, allowing the researcher to propose themes, trends, or theories related to the group. Findings from qualitative studies can provide rich detail not obtainable through pure numerical data analysis. For example, in 2012 Leonard et al. tried to understand factors that influenced EMS partnerships in prehospital research.7 To answer their research question, the team conducted focus group interviews using a structured interview process. During their data analysis of the transcripts of these interviews, they identified 17 barriers and 12 motivators for EMS personnel participation in research. Their findings provided the foundation for a model to plan and facilitate prehospital research. Quantitative analysis in descriptive statistics uses the mean, median, and mode to describe numeric data such as the most commonly occurring values in a sample. The mean is the arithmetic average of the group (eg, the average age of the people in the sample). The median (also called the 50th percentile) is found by first arranging the measurement according to size from smallest to largest and then choosing the one in the middle (or the mean of the two measurements that are nearest to the middle). The median frequently is used to divide a sample into two halves. The mode is the number that occurs more often than any other number in a set of data. The following is an example of quantitative analysis: Your sample has 13 participants. Their ages are 53, 53, 53, 54, 55, 55, 56, 57, 59, 60, 64, 71, and 79. The mean (average) age of the group is 59.15 years; the median (middle) age is 56; and the mode age is 53. 168 Part 1 Preparatory To further explore how the mean describes the sample, the researcher calculates the standard deviation. The standard deviation measures how much variability there is from the mean in the research data. Inferential Statistics Inferential statistics is a type of quantitative analysis used to infer whether the relationships seen in a sample are likely to occur in the larger population. The researcher can use these statistics to decide whether the results of the study support or contradict the initial hypothesis. To do this, the researcher states a null hypothesis. A null hypothesis is a default position, such as that a specific treatment has no effect or that the results are a chance of variation (the opposite of what the researcher expects to prove). In US courts, the null hypothesis is that the accused person is assumed to be innocent until proved guilty beyond a reasonable doubt. If this assumption cannot be rejected, the accused goes free—which does not always mean that the accused is actually innocent, just that guilt has not been definitively proven. A research hypothesis is the opposite of the null hypothesis—the finding that the research expects to prove. In the court system, the research hypothesis would be that the accused person is guilty until proved innocent. NOTE The level of sureness with which a null hypothesis can be rejected is called the confidence interval, which measures the probability that the true value of a measurement lies within the range of two values. The confidence increases as the confidence interval narrows. Confidence intervals are often stated at the 95% level, which means that 95% of the time the confidence interval will contain the true value of a measurement for the population of interest. For example, if large random samples are repeatedly taken from the same population and used to create 95% confidence intervals for the population average, approximately 95% of the intervals should contain the true population average. When a statistical test reveals that the probability is rare that a set of results is attributable to chance alone, this result is called statistically significant. Statistically significant means that the observed phenomenon represents a significant departure from what might be expected by chance alone. Generally, the level of significance refers to the probability of the event occurring as a result of chance. The level of significance is the acceptable risk of sampling errors and is established through mathematical equations. The level of significance (P value) is usually designated as 0.05 (1 chance in 200) or 0.01 (1 chance in 100) that the difference between two groups is larger than expected as a result of chance alone (too large to be reasonably attributed to chance). Researchers must set their level of significance before they begin their research. The power of a study reflects its ability to detect a difference between groups when such a difference exists. In EMS research, the power of a study is determined by the incidence of a disease or outcome and by the number of participants (sample size). For example, if a particular outcome is rare, a very large sample size would be needed to determine whether an intervention changes outcomes. NOTE Increasingly, EMS research in which an intervention is evaluated includes the number needed to treat (NNT) and the number needed to harm (NNH) in the results. The NNT is the number of patients who need to be treated to prevent one additional bad outcome. It is the estimated number of patients who need to be treated with the proposed intervention rather than the standard treatment before one additional patient will benefit when there are two possible outcomes. The NNH is the number of patients, on average, who need to be exposed to a treatment or risk factor before one person will have an adverse effect. Modified from: Altman DG. Confidence intervals for the number needed to treat. BMJ. 1998;317(7168):1309-1312. https://www.ncbi .nlm.nih.gov/pmc/articles/PMC1114210/. Accessed September 15, 2017; and Centre for Evidence-Based Medicine. Number needed to treat (NNT). August 14, 2012. http://www.cebm.net /number-needed-to-treat-nnt/. Determine What to Do With the Results The final step in EMS research is to determine what to do with the results of the study. Several options are available, including publishing the results, presenting the results, and performing follow-up studies. Publishing the Results The findings from research may be published in a professional journal for peer evaluation. Publication in a peer-reviewed journal means that several experts Chapter 8 Research Principles and Evidence-Based Practice in the field being studied have reviewed the research to assess its quality. The peer reviewers may recommend the article be accepted as written, accepted with minor or major revisions, or rejected. Most medical peer-reviewed journals require evidence that an IRB has approved any research involving human subjects. Examples of EMS-related peer-reviewed journals are Prehospital Emergency Care, Annals of Emergency Medicine, and Prehospital and Disaster Medicine. (Sometimes just an abstract, or summary, of the research is published. Published abstracts have not always gone through the same rigorous peer-review process as a full article.) The format for writing a manuscript for scientific literature typically has five basic sections: 1. The introduction provides a brief historical background of the research and describes any previously published research. The introduction provides both a rationale for the study and the research hypothesis (or hypotheses). 2. The methods section describes how the experiment was done so that it can be replicated by other researchers and so that readers can assess the validity of the methodology. This section should identify the inclusion or exclusion criteria for the study (how patients were chosen) as well as the statistical methods used to analyze the data. It is important to read this section carefully to determine how to interpret the results and to decide whether they are transferrable to another system. 3. The results section contains the research findings. It provides answers to the study questions and summarizes the data obtained by the researcher (eg, tables and figures). 169 4. The discussion section includes the author’s interpretation of the research findings and implications of the findings. Limitations of the project are also given here. This section frequently offers suggestions for improving the study through follow-up research. 5. The conclusion provides a succinct summary of the four preceding sections (BOX 8-2). Presenting the Results and Performing Follow-Up Studies Clinical studies can lead to improvements in patient outcomes. Presenting the results of a study—to peers, professional organizations, and higher education institutions—can help put research into practice. Follow-up studies may be done through, and funded by, collaborative efforts with public agencies, corporations, and foundations. They may also be funded and supported by state and federal government programs that support research consortia. (A consortium is a group of people and/or organizations that pool resources and information to achieve a common goal.) Examples of such consortia in the EMS field include the Pediatric Emergency Care Applied Research Network (PECARN), which focuses on pediatric emergency care, and the Resuscitation Outcomes Consortium (ROC), which focuses on research related to prehospital cardiopulmonary arrest and severe traumatic injury. Evidence-Based Practice For too long, prehospital care has been driven more by intuitive thinking about what is right rather than by evidence.8 A system-wide process is needed to BOX 8-2 Fifteen Steps for Evaluating and Interpreting Research 1. Was the research peer reviewed? 2. What was the research hypothesis? 3. Was the study approved by an IRB and conducted ethically? 4. What was the population studied? 5. What were the inclusion and exclusion criteria for the study? 6. Which method was used to draw a sample of patients? 7. How many patient groups participated? 8. How were patients assigned to groups? 9. Which type of data was gathered? 10. Does the study appear to have enrolled a sufficient number of patients? 11. Does the study fail to account for any potential confounding variables? 12. Were the data properly analyzed? 13. Is the author’s conclusion logical and based on the data? 14. Could the results apply in local EMS systems? 15. Are the patients in the study similar to those seen in the local EMS system? 170 Part 1 Preparatory ensure that prehospital care is based on current and scientific evidence—that is, to facilitate evidence-based practice, also known as evidence-based medicine. Evidence-based medicine involves translating the best science into EMS clinical policies and individual paramedic decision making. Already, many medical specialties have developed evidence-based guidelines (EBGs) for specific conditions, such as traumatic brain injury, spinal injury, and ST-segment elevation myocardial infarction. (These conditions are addressed in other chapters in the text.) In 2016, the National Association of EMS Physicians developed a consensus document to establish a process to create EBGs for EMS.9 Its framework includes the establishment of a guidelines consortium that connects researchers to various EMS groups; promotion of research to support EBGs; development of EBGs for EMS; education of EMS providers about the EBGs; implementation of EMS EBGs; evaluation of prehospital EBGs; and identification of funding sources for the process. Research Education Modified from: National Guideline Clearinghouse, Agency for Healthcare Research and Quality, US Department of Health and Human Services. https://www.guideline.gov. Accessed December 1, 2017. High-quality patient care requires use of procedures that have been proven useful in improving patient outcomes.10 To obtain this evidence, paramedics should participate in EMS research, data collection, and sharing of information obtained through research. These efforts aid in the design of a system-wide process for prehospital care that reflects the current state of scientific evidence (FIGURE 8-4). Reviewing Research Paramedics should read research articles critically to determine whether the findings are relevant Practice Theory FIGURE 8-4 Relationship of the review of the literature to theory, research, education, and practice. Modified from: LoBiondo-Wood G, Haber J. Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice. 8th ed. St. Louis, MO: Elsevier/Mosby; 2010. to their practice. When reviewing research articles, the following components should be carefully studied:11 • NOTE The National Guideline Clearinghouse (NGC) is a public resource for evidence-based, clinical practice guidelines and expert commentaries, which can be found using the NGC’s research tools. The mission of the NGC is to provide physicians and other health professionals with an accessible means of obtaining objective, detailed information on clinical practice guidelines. Another goal of the NGC is to disseminate practice guidelines for implementation and use. Review of literature • • • • Population. Is the sample adequate and is it similar to your practice? For example, a study that evaluates response times without lights and sirens conducted in a rural setting may not be relevant to an urban EMS system. Similarly, if a study is conducted in an area that has a significantly different ethnic makeup than your practice area, this setting could influence the results if the study subject involves disease processes that are more prevalent in certain ethnic communities. Inclusion and exclusion criteria. A study of patients with chest pain that did not include patients older than age 65 years, for example, would eliminate a key group at risk for heart disease and death. Data collection. Is there anything that could have influenced the data collection? If the study used the experimental method, how were the groups randomized? Was the method clearly described? Could the method have varied based on the person delivering care? Were the conditions in the control group and the experimental group the same? Results. Are the numbers presented clearly? When percentages are presented, are the underlying numbers reported? If a statistically significant difference was seen in the outcome, is it also clinically significant? Discussion and conclusion. Is the conclusion consistent with the results reported? Did the Chapter 8 Research Principles and Evidence-Based Practice • authors properly report correlations and relationships, rather than predictions? Did they link the research to relevant literature? Were the limitations of the study pointed out clearly? Did the researchers make specific suggestions for future research? Did you identify any major flaws in the conclusion? Relation of the research to your practice. Does the research suggest an area of improvement for your system? Does it suggest an area that should be monitored in your quality improvement program? Is there a reason to seek out more literature on the same subject to propose a change in your system? Summary • The paramedic must be familiar with research principles. This knowledge is needed to conduct research, collect research data, and interpret published studies. • Research is essential to improving patient care. • The 10 steps for conducting EMS research are (1) prepare a question, (2) write a hypothesis, (3) decide what to measure and how to measure it, (4) define the population, (5) determine the study design, (6) seek IRB approval, (7) obtain informed consent, (8) gather data after conducting pilot trials, (9) analyze the data, and (10) present the data. • The two main types of research designs are descriptive designs and analytical designs. References 1. 2. 3. 4. 5. 6. National Highway Traffic Safety Administration, Maternal and Child Health Bureau. National EMS Research Agenda. Washington, DC: Health Resources Administration; 2001. Sayre MR, White LJ, Brown LH, McHenry S. National EMS research agenda. Prehosp Emerg Care. 2001;6(suppl 3):S1-S43. Federal Interagency Committee on Emergency Medical Services. FICEMS Strategic Plan (DOT HS 811 990). Washington, DC: Federal Interagency Committee on Emergency Medical Services; 2014. Menegazzi J. Research: The Who, What, Why, When and How. Wilmington, OH: Ferno-Washington; 1994. Lerner EB, Cone DC, Yealy DM. EMS research basics. In: Cone D, Brice JH, Delbridge TR, Myers JB, eds. Emergency Medical Services: Clinical Practice and Systems Oversight. 2nd ed. Hoboken, NJ: John Wiley & Sons; 2015:401-409. Hicks S. How the Past Influenced Human Research Protection Legislation. Washington, DC: US Department of Health and Human Services; 2007. 171 NOTE It is important that researchers not overstate their findings. The journal peer review process evaluates the study findings and may suggest that the authors revise their