Clinical research and critical care transport: How to get started

Article Outline

• How research begins
• Sources of research questions
• Defining the research question
• Writing the research question
• Refining the research question
• Finalizing the research question
• Taking the next step
• References
• Copyright

Though we often do not consciously acknowledge it, most of our clinical decisions have their basis in previous published research studies. Melnyk and Fineout-Overholt¹ identify seven levels in a hierarchy of evidence to support clinical practice. All but one level relies on evidence generated from original research. Thus, research provides an important foundation for the provision of care during critical care transport. Clinical studies are potentially powerful tools for shaping the way in which care is delivered. Even a single article can radically change clinical practices or understanding of a disease process. It can influence clinical care on the other side of the country, or even the world.

Unfortunately, simply because a study is published within the medical literature does not ensure the quality of the research. Errors in design, data analysis, or author interpretation can slip through even with the best of editorial review. In other cases, a study may be of high quality but not applicable to your clinical care environment. The reader who has a solid understanding of the research process has a distinct advantage in best understanding a given study and applying the findings appropriately to their practice.

The trend toward evidence-based practice has made the ability to read and understand research an even more important skill, because all members of the medical team are expected to apply research findings to their practice. This includes those involved in critical care transport.

The articles in this series represent a revision of a series initially begun in 1995. The original articles are over 10 years old and will be updated with new knowledge and examples. When possible the original authors will be involved in the publication. In some cases, however, authorship will be reassigned.

The emphasis of the original publications was on the basics of conducting clinical research. The republication will continue to discuss the process of conducting research but will also add information relevant to the interpretation of research and the application of findings to practice. As with the originals, these articles will be directed at the novice. The series will cover the entire research process. It will start with formulating a research question, and continue through selecting a research design, fleshing out a protocol, understanding the basics of statistics, and, ultimately, presenting or publishing the results.

It is hoped that this series of articles will bring a better appreciation for the difficulty of doing research properly, while helping novices to avoid some of the known pitfalls. We also hope that novices will become more comfortable reading the research literature and making appropriate application to their practice.

There is certainly more than one way to approach a research project. This is obvious when reading multiple articles or textbooks on the subject. Different textbooks often have varying recommendations and sometimes even use different systems for categorizing the basic research designs. The important point is not to focus on a single classification system or approach but to understand the basic underlying principles and to learn to use the tools that are most relevant to your setting, background, and experience. Regardless of the system used, a systematic approach to research is important, and some fundamental “rules” have stood the test of time. This series of articles presents a relatively common accepted framework for approaching research and emphasizes a practical approach.

Back to Article Outline

How research begins 

A great irony of research is that at the beginning of one's career, one has the greatest amount of extra time because of fewer administrative responsibilities. However, novices also tend to have fewer good research ideas, because most clinical research ideas come from direct clinical experiences. As one becomes more experienced, often numerous research ideas appear, but there usually is not enough time to pursue even the most important ones. Properly performed research is much more work than most people anticipate and takes much longer than usually anticipated.

All research begins with a research question. The question reflects a desire to know something, a desire to know the truth, for example, to know whether Drug A truly works better than Drug B in patients with condition Y, or whether it works as well to measure a parameter (eg, blood pressure) using technique C versus technique D. No research project should begin without a clear understanding of the research question to be answered. Every published research study should make their purpose—the research question they attempted to answer—very apparent. In publications reporting the results of research studies, that purpose is usually stated in the last paragraph of the introduction section of the article. It is worth reading those sentences very carefully, because the rest of the manuscript should be considered in the context of the question being addressed.

Back to Article Outline

Sources of research questions 

Where do research questions come from? Everywhere! When we bring an evidence-based approach to our profession, we realize that clinical questions are all around us. This includes each of the following:

After some practice, appropriate research questions can be identified from almost every one of our patient encounters. What is required is an inquisitive mind, a willingness to question dogma, some knowledge of the medical literature, and an adequate base of experience from which to make observations.

Back to Article Outline

Defining the research question 

Research questions can take many forms. Generating rules that will cover every potential research question or area of investigation is not possible. However, most clinical research questions will fit one of the following categories:

Once you have initially identified an area of research interest or a preliminary research question, the experience of a stream of ideas is very common. Instead of just one research question, several related questions may come to mind. Should you look at the research question this way or that way, in this patient population or in that patient population? Is it more important to look at prior history and potential cause or natural course and outcome? For an evaluation of Drug A, should it be at high dose or standard dose? Alternatively, should it be in combination with another medication, or alone? Several related or “tagalong” type research questions may occur to you. This process is important in helping to sort through options, better understanding the basis of interest in the topic, and further defining the exact nature of the research question.

At this stage you may experience a great temptation to broaden the research question, and this should be resisted. Sorting through competing research ideas is important and helps to focus the research question on a specific area. Too often researchers start out with an ill-defined project, which lacks a clear research question and therefore has no testable hypotheses. If this is not rectified in the early stages, the entire study will tend to wander without a clear focus. It will waste precious investigator time and resources.

Another potential obstacle, at this point, is the inability to proceed from a general area of interest/concern and convert it into a specific research question. For example, one has a general interest in studying emergency airway management. Before further research efforts can proceed, the study must have a single, primary focus. One way to achieve this is to break the topic area into constituent parts. Separately write down each aspect of the topic and transform each of those into individual questions. Then rank the questions in order of importance or greatest interest. Early in their career, researchers should concentrate on studies with a single, primary question. One or two secondary questions may occasionally be identified, but maintaining the quality of the study is easiest if the investigator has a single focus for the investigation. Secondary questions, if chosen, are meant to be complementary and should not be allowed to detract from the primary research question itself.

Back to Article Outline

Writing the research question 

After the initial brainstorming about your research question, it is time to become more structured. At this point, prepare to write down the exact proposed research question in a single, understandable sentence. If you cannot do this, you do not yet have a clear understanding of the purpose of the proposed study. The research question is the objective of the study, the gap in medical knowledge that one hopes to resolve. Writing a properly formatted research question can be much harder than anticipated. It is not simply any sentence with a question mark on the end. This is a formidable stumbling block for many novice researchers.

One approach to help with this process is the “PICO” approach. It breaks the research question down into four common elements. By first defining these elements, the investigator can better focus on the intent and purpose of the study. The four elements are then combined into a single sentence. Table 1 lists these elements and provides a template for generating research questions.

Table 1. Using a PICO Format to Generate a Properly Formatted Research Question

PICO stands for “patients,” “intervention,” “comparison,” and “outcome.” Patients means the intended study subjects, for example, “adults with acute chest pain” or “pediatric patients with blunt trauma” Epidemiologists refer to these as “subjects” rather than patients, because often they are looking at large population-based studies. Intervention generally means the aspect of those patients that is the main object of the study. It should be interpreted broadly as the independent variable, that is, simply the parameter of interest between the two study groups. It could be an active intervention (eg, giving a blood transfusion to one group, but not to the other) or it could be a passive characteristic (eg, the group that has pre-hospital hypotension vs. those that do not). Epidemiologists commonly refer to this as the “exposure.” It could be exposure to cigarette smoke or to cocaine use or even to a gunshot wound. Either way, when two groups are being compared in a study, it is that characteristic, or parameter that varies between the two groups. Comparison refers to the other group being compared with the main study group. In the examples above, it is the group that does not get the blood transfusion or does not have prehospital hypotension. Outcome is fairly straightforward. It is the resultant measure (ie, the outcome) that is being used to assess the effect of the intervention. It is often referred to as the “dependent variable.” It could be death rates, admission rates, hospital length-of-stay, changes in mean blood pressure, etc. With an understanding of the four PICO elements, they can be combined into a research question. For example, “In blunt trauma patients with hypotension, does pre-hospital blood transfusion, versus standard intravenous fluid, result in lower mortality rates?”

The question should be relatively simple, a single sentence, and written in the present tense.² Although the PICO format works for most research questions, it is not universally applicable. Sometimes investigators desire a simple descriptive summary of observations. For example, summarizing the county emergency medical services (EMS) transport experience for the year. How many were pediatric versus adult, trauma versus medical, etc.? Such observations can have investigative value. However, even such studies should have some underlying research question. Otherwise, what is the point? The investigator should have a purpose for taking the time and energy to collect and analyze the observations. For a research study, that purpose must be stated in a research question.

Research questions may be categorized many ways, but the system is not as important as understanding the general principles. In one classification system, Burns and Grove² identify four types of research questions: those that are descriptive, those that identify differences, those that examine relationships, and those that attempt to predict outcomes. See Table 2 for examples of each of these types of research questions.

Table 2. Examples of Types of Research Questions

Back to Article Outline

Refining the research question 

Once you have defined your research question, the next step is to “refine” it and determine whether it is a practical project to undertake. An investigator could have an absolutely brilliant and properly formatted research question, but one that is not appropriate for an actual research project. Several aspects must be considered at this stage. The characteristics of a good research question, appropriate for a research project, have been well described by Drs Stephen Hulley and Steven Cummings³ in their book, Designing Clinical Research, in which they use the acronym of a FINER research question (Table 3):

Table 3. The FINER Elements of a Research Question

Back to Article Outline

Finalizing the research question 

If you have not already done so, after defining your proposed research question, applying the FINER criteria, and deciding that you are headed in the right direction, it is time to discuss it with experienced and respected colleagues. Are they able to understand your question? Can they correctly identify the main variables that you will measure? Is a specific research design suggested by your question? If the answer to any of these questions is “no,” work with your colleagues to clarify and strengthen your questions.

Having a proper research question, as discussed, is sufficient to move forward with developing a research project. However, defining the research-related hypotheses is also useful at this stage. A hypothesis is an intellectual exercise that predicts the outcome of the research, that is, the predicted answer to the research question. A research hypothesis may not be appropriate for studies that are entirely descriptive. However, it is always helpful in studies that are examining differences or relationships, or that attempt to predict outcomes. It helps organize the investigator's understanding of the project and forms the basis for subsequent classical statistical testing. Hypotheses can be tested, using statistical tests, whereas questions generally cannot be directly tested.

A research hypothesis may predict the presence or absence of a relationship. When a presence is predicted, it also may predict the direction of a relationship, or not. Hypotheses also may provide additional information such as the sample in which the relationship will be found and specific details regarding the circumstances under which the relationship will be demonstrated. An example of a non-directional hypothesis would be: There will be a relationship between family satisfaction with a transport and time spent with the family before the transport. An example of a similar hypothesis, but one that is directional, would be: Family satisfaction with transport will increase as time spent with the family before the transport increases.

These hypotheses are often referred to as the “alternative” hypothesis when they predict a relationship or that an intervention will have an effect. In contrast, a “null” hypothesis proposes no relationship. For example: Family satisfaction with transport will not increase with an increase in time spent with the family before transport.

The null hypothesis is an important statistical concept and is used as the basis for the statistical analysis to be used at the conclusion of the study. This will be discussed in greater detail in a future part of this series.

Back to Article Outline

Taking the next step 

Now you have a research question that is well defined, refined, and highly specific. However, it may not be completely finalized. You have started the planning process that is the most important part of any research study. In research endeavors, more time should be spent on planning rather than rushing into actually performing the study. The next step is to research the topic further, including a systematic review of the literature relevant to your focused research question. The process of reviewing the literature will be discussed in an upcoming part in this series.

Congratulations on taking the first and most important step to better understanding the medical literature, or to becoming a researcher yourself. Although there are many roadblocks in the research process, there is tremendous personal satisfaction in performing credible research. This series will try to help with each of the steps and point out some of the pitfalls. In addition, if you want to read about this subject in greater depth, a number of excellent textbooks are available. Listed below are some of the best for the beginning researcher.

Back to Article Outline

References 

1. Melnyk BM , Fineout-Overholt E . Evidence-Based Practice in Nursing & Healthcare . Philadelphia: Lippincott Williams & Wilkins; 2005;
   • View In Article
2. Burns N , Grove SK . The Practice of Nursing Research: Conduct, Critique & Utilization . 5th ed.. Philadelphia: Saunders; 2004;
   • View In Article
3. Hulley SB , Cummings SR , Browner WS , Grady D , Hearst N , Newman TB . Designing Clinical Research: An Epidemiologic Approach . 2nd ed.. Philadelphia: Lippincott Williams & Wilkins; 2001;
   • View In Article