Three pillars form the foundation of an academic trauma program: research, education, and clinical care. In a busy academic trauma practice, the unfortunate reality is that research is often a low priority in the frenzy of mandates for clinical productivity (no margin, no mission). With decreasing reimbursement for surgical procedures from the government and third-party payers, many surgical departments jettison outstanding research and education programs to bow down to the holy shrine of the relative value unit to make up for the volume of patient visits and procedures that are lacking in reimbursement. The net result is the exhaustion of providers and lost opportunities for improved patient care through research endeavors. In this monograph, we will provide a blueprint for starting up a modest trauma research program at your institution and how to motivate and incentivize providers on how to get involved with clinical research. Not everyone has the desire to do research, and that is perfectly reasonable. If clinical care is their forte, then have at it. However, if a practitioner wants to participate in research, this is where the department can look for opportunities to foster that interest without significantly impacting the overall clinical productivity of the department. That is the purpose of this report.

DEFINITIONS

In its simplest terms, medical research is the utilization of the scientific method to investigate ideas with the goal of improving patient care. There are 3 types of research: basic science research, translational research, and clinical research. Basic science research, or “bench” research, is commonly done at Level I university trauma centers that have specific facilities to support animal research and utilize both government and private grants for funding. Basic science research can be an extremely expensive and lengthy process. The entire career of a scientist may be devoted to a specific project, and investigators usually have “protected time” to work on their research. The second type of research is translational research. Translational research most often involves a partnership between MDs and PhDs to translate the findings of basic science research into medical practice. Translational research is usually done at Level I university trauma centers and is a new and rapidly evolving field with abundant funding available. The final type of research is clinical research. Clinical research can be categorized as either prospective or retrospective and is inexpensive in comparison to the other 2 types of research. Retrospective clinical research utilizes large database reviews to conduct medical record reviews of a topic. This type of research is useful for providing preliminary data or generating hypotheses to inform the direction of future research. Retrospective research cannot make causal claims and, as such, is most often used as a filter to guide the topics of the more costly, and time-consuming, prospective research (Tofthagen, 2012). Prospective clinical research is the most well-known type of clinical research. It involves following patients over time to assess the efficacy of an intervention involving these patients. Most types of prospective research cannot determine causation but can find association between interventions and outcomes (Andrade, 2014). The only type of clinical research that can determine causation are randomized controlled trials (RCTs) (Hariton & Locascio, 2018). RCTs lack the inherent biases of other study designs by randomizing patients into experimental or control groups. Informed consent from the patient must be obtained prior to enrolling a patient in a prospective research study. Clinical research is the most practical type of research as research ideas are informed directly by the lived experiences of the investigators conducting the research. Because of this, clinical research is immediately relevant to trauma patients and can be conducted at all levels of trauma centers.

LEVELS OF EVIDENCE

Not all clinical research is equivalent; it can be categorized into 6 types based on levels of evidence (Figure 1). The lowest levels of evidence are editorials and expert opinion. These publications do not have study outcome data to back claims; rather, they are opinion pieces that rely on the experiences of the writer to share their perspective on a topic. The next level of evidence is case series and case reports. These are single cases (case reports) or a group of similar cases (case series) that present an interesting finding in the studied patients. Case series and individual case reports suffer from a small sample size and do not provide statistically significant conclusions on a topic. Figure 1.:

Level of evidence for health/medical research.

Case–control studies are next in the hierarchy. These studies are usually retrospective, inexpensive, and provide rapid results in a relatively small patient population. Case–control studies compare 2 groups of subjects: those already with the problem being studied (case) and a similar group of patients without the problem (control). In this study type, a statistically significant relationship does not necessarily mean there is a causal relationship.

Cohort studies are often prospective, can be costly, take a long time to conduct, and involve a relatively large study population. Cohort studies are longitudinal to determine causal and risk factors for a disease. Study participants are compared to a group of participants who do not have the disease or receive a treatment to examine what may have caused the disease.

RCTs have the highest level of evidence from data collection. RCTs prospectively examine the efficacy of an intervention by randomizing or allocating patients into an experimental group (receives the intervention) or a control group (does not receive the intervention). These studies are expensive and require informed consent to be obtained from the patient before they are enrolled in the study.

The highest level of evidence in medical research are systematic reviews or meta-analyses. These studies are a compilation of all research done on the topic of interest. Systematic reviews or meta-analyses examine all studies as individual data points to determine if there is a clear outcome trend among all the research done on a topic. The level of evidence provided by systematic reviews or meta-analyses informs health-care policy changes and identifies best practices. Not all research models are appropriate for every situation (see Table 1 for the most appropriate study design for different situations). For example, while cohort studies provide a higher level of evidence than case–control studies, cohort studies are not appropriate for rare diseases, whereas case–control studies are. It is important to understand the types of research that can be performed to make an informed decision about the best study design to employ for a particular study question.

Table 1. - What Study Design Is Right for Your Research? Type of Question Suggested Best Type of Study Therapy RCT > Cohort > Case–control > Case series Diagnosis Prospective, blind comparison to a gold standard Etiology/harm RCT > Cohort > Case–control > Case series Prognosis Cohort study > Case–control > Case series Prevention RCT > Cohort study > Case–control > Case series Clinical exam Prospective, blind comparison to gold standard

The Agency of Healthcare Research and Quality (AHRQ) released a grading scale to categorize the level of evidence available to inform best practices for patients (Clair, 2005). The AHRQ scale ranges from strongly recommend (A), meaning there is substantial evidence to support a study results integration into clinical practice, to finding evidence that is insufficient to allow a recommendation (E), meaning there is simply not enough evidence to make any claims for a clinical practice change on the topic, or the evidence available is of poor quality. The grading scale developed by the AHRQ is a standardized way to determine if there is enough evidence on a topic to warrant a clinical practice change or if more research is needed.

THE INSTITUTIONAL REVIEW BOARD (IRB)

Before research can begin at any institution, an IRB must be created. The IRB acts as an independent entity to assure that all research involving human participants is ethical. All research study protocols involving human subjects must be submitted to and approved by the IRB before initiation. The idea of an impartial review board was not widely utilized until the 1974 National Research Act and subsequent Belmont Report were published in response to some of the heinous research abuses of the 20th century (Grady, 2015), most notably the Tuskegee Syphilis Study. The Belmont Report set the standards for ethical research that all IRBs operate under today. The 3 pillars of ethical research are defined as respect for persons, beneficence (benefit to participants outweighs risks), and justice (Khin-Maung-Gyi, 2009). All research must abide by these core values, and the IRB has the authority to accept, reject, or declare a pause of any research if there is concern that the research is not abiding by any of these 3 pillars.

INSTILLING MOTIVATION TO DO RESEARCH AT YOUR INSTITUTION

The foundation for creating a strong research program is pride. Because one is proud to work at an excellent trauma center, clinicians have a moral imperative to share the expertise of their institution with the rest of the trauma community. Taking care of patients is the easy part of trauma care, the hard part is doing research, writing papers, and presenting them. After a long day of patient care, doing research is the last thing a provider may want to do. Often, there is no protected time for research, so projects are completed in addition to regular duties. Significant commitment is needed to start a research project, but often the hardest part of research is simply deciding to do it.

There are 4 elements (in order of importance) that are mandatory for creating a research program at your institution: (1) a zealot, (2) institutional commitment and support, (3) a statistician, and (4) registry access. The first, and most important, element needed is what we call a zealot. This is a research coordinator whose sole role at your institution will be to initiate and oversee projects, obtain IRB approval, write manuscripts, present research at conferences, and manage the general day-to-day operations of the research program without the added responsibility of patient care. The second mandatory element is a strong commitment from your home institution to support the research department. This does not mean that your department will need the limitless funds of an academic medical center but minimally to commit to hire a research coordinator who can focus on research without any clinical commitments. Many Level I and II trauma programs have a requirement that they must produce 10 or more peer-reviewed research publications to maintain their verification status. A trauma director can leverage this requirement in negotiations with hospital administrators to hire a research coordinator. Another benefit to incentivize providers to do research is to get a commitment from administration that if a paper is accepted for publication at a national trauma society meeting, the institution will cover the cost for the presenter to attend the meeting (over and above their annual CME distribution). The third mandatory element for creating a strong research department is a good statistician. You can collect all the data in the world, but without the ability to determine significance, detect correlation, and provide meaning to your data, your institution will never publish it. Having a statistician in house without the need to contract for statistical input not only saves money but increases the rate at which you can publish your results. Furthermore, it is important that your statistician can present the results of a project in a way that can be understood by those not involved in the research. Understandable results are published; incomprehensible results are disregarded. Ideally, your statistician should be a trauma provider or someone with a solid understanding of trauma care. This person would understand the trauma issues you are trying to address with your research and at the same time be able to provide the study model and analysis the research project requires. Finally, access to a registry of patients is mandatory to conduct research. At a minimum, you should have a home-grown registry of patients from your institution that can be utilized for outcome reviews. Ideally, your team will obtain access to large, statewide, or multi-institutional registries like the Trauma Quality Improvement Program (TQIP), American Association for the Surgery of Trauma (AAST), or Eastern Association for the Surgery of Trauma (EAST) multi-institutional trials, etc. After creation of your research team, you should begin networking with other hospitals to develop a consortium of local investigators to share data on patient populations.

OTHER ELEMENTS OF A STRONG RESEARCH PROGRAM

There are 2 more elements to create a research department at your home institution that are not mandatory but are ideal to have. The first is a grant writer. A grant writer is responsible for finding funding opportunities for the trauma service related to the current research they are conducting. Grant writers collaborate with trauma providers who serve as principal investigators on projects and write polished proposals to seek external financial support for projects. Their duties might include identifying deadlines, understanding which grant types your institution is competitive for, and finding seed grant proposals for new researchers.

The second additional element is an editor. An editor is a third-party person knowledgeable in grammar and composition to review a manuscript prior to publication. In the absence of a defined editor, all contributing authors are required to read a paper several times over for grammar and syntax errors. It cannot be emphasized enough that mistakes are frequently found in the third, fourth, or even fifth iteration of the manuscript. Furthermore, it is often hard for the researchers who have read their manuscript dozens of times during the writing process to identify grammar and syntax errors, as they are simply “too close” to the project. This is where your editor is most useful.

HOW TO GET YOUR PROJECT STARTED

Now that your institution has an established research program, it is time to start your research. All research begins with a question. To help develop a question that is relevant to the patient population of interest, we recommend using the PICO strategy. The PICO approach provides a format for a well-developed clinical question, specifically one that makes searching for a precise answer possible. The 4 criteria are outlined in Table 2 (Richardson et al., 1995). The PICO approach allows for the identification of best evidence in the construction of a research question and promotes a clear understanding of the topic of a study. After you identify your PICO criteria, a study begins with a literature review on the topic. This step is essential for making sure your research is filling a relevant gap in the scientific literature, not just reproducing prior results. Literature reviews also provide different perspectives on similar topics that may inform study design. Then one must determine which of the 6 study design types best fits a particular study. After identification of the proper study design, data collection can begin. To reduce the risk of bias in your research, we recommend that data be abstracted and then validated (preferably by an independent reviewer) to confirm accuracy. After collection, the study data are ready to be sent to your statistician for analysis. Following analysis, the results should be written into an abstract to be submitted/presented at a medical conference. It is important to note that all abstracts presented at a conference should be developed into a manuscript for publication. A good rule of thumb is that if a researcher from your institution wants to present at a conference, they must have a completed manuscript in hand that is published/ready to be published. It is considered academic dilettantism to expend money and labor on a research project with only an abstract, not a published manuscript, to show for it. In addition, since a literature review has already been completed, a review article can also be published on the study topic, allowing for 2 publications per research project (see Figure 2 for steps to conduct research). Figure 2.:

Steps to conduct research.

Acronym Definition Description P Patient/Population Can be only one patient, or a group of patients with a particular condition or a health problem I Intervention Intervention of interest. Can be therapeutic, preventive, diagnostic, prognostic, administrative, or related to economic issues C Control/Comparison Standard intervention, the most used intervention, or no intervention (placebo) O Outcome Expected result (primary and secondary)
ABSTRACT SUBMISSION

Submitting an abstract to a conference is a competitive process, with only a few abstracts accepted and even fewer accepted for a coveted presentation spot “on the podium.” The most important step in abstract preparation is having a great idea. The idea should be novel, entertaining, and controversial. Conferences love to choose hot button abstracts for podium presentations that will simulate conversation and friendly debate. This is particularly true for small trauma centers; for your research to be noticed, you must “think outside the box.” Next, it is crucial that your abstract follows all directions and adheres to the submission deadline. Follow all directions to the letter, or your abstract will not be considered. Third, always state your hypothesis, that is, provide a statement of expectation(s), which is used to explain a scientific phenomenon. Your hypothesis should go in the introduction, and it should be clear that your study was designed to test your hypothesis. Make sure your results are presented in a simple manner that is easy to understand. What may seem intuitively obvious to you, the researcher, may be quite complicated to someone not close to the research. Field test abstracts with colleagues unfamiliar with your work. Finally, finish the abstract with a strong conclusion. Make sure to state whether the hypothesis was accepted or rejected, and state the implications of this research on trauma care. The last sentence of your abstract needs to be memorable. Reviewers will read hundreds of abstracts; a strong closing statement will make your abstract stand out.

TIPS TO SUSTAINING A RESEARCH PROGRAM

Here are some practical tips for sustaining your research program. First, conduct a monthly research meeting that takes minutes and has a clear agenda. This meeting should include an open invitation to all staff (MDs, APCs, residents, nurses, NPs, pharmacists, PT/OT, medical students, ERTs, etc.) to capitalize on the professional experience at your institution. Next, develop a “wall of fame.” This could be a bulletin board of all recent publications by your group in a high traffic area with a display of all presented posters around the office. Establish yourself as an institution that is frequently published and serious about research. Remind providers of all meeting and abstract deadlines by printing out a schedule and placing it in the staff meeting area. There is success in numbers. The more abstracts you submit, the greater the probability of acceptance and subsequent paper publication. There is a journal for every paper; be persistent and do not accept reject. If your submission is rejected, use the reviewers’ comments, then resubmit. Aim to be published in journals with a high impact factor; this is how you will be put on the map as a research institution.

CONCLUSION

Research is a lot of hard (extra) work. But it is an intellectually stimulating and extremely satisfying process that can vastly improve patient care. A robust research program is essential to being certified as a Level I trauma center and allows for your institution to have a footprint in the academic trauma community.