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Research in the clinical setting: Taking nursing to new heights
By Martha D. Buffum, PhD, RN, PMHCNS-BC
This course is 2 contact hours
Course must be completed by September 29, 2019
Goals and objectives: The goal of this program is to provide nurses with information about the steps for developing research projects in the clinical setting. After studying the information presented here, you will be able to: • Identify three methods for developing ideas for a research project • Describe a clinical problem in a researchable format • Discuss the steps involved in designing a study • Define three resources for facilitating the development and use of research
Nurse.com educational activities are provided by OnCourse Learning. For further information and accreditation statements, please visit Nurse.com/Accreditation. The planners and authors have declared no relevant conflicts of interest that relate to this educational activity. OnCourse Learning guarantees this educational activity is free from bias. See “How to Earn Continuing Education” to learn how to earn CE credit for this module or visit http://ce.nurse.com/instructions.aspx.
Have you ever thought that you may know of a better way to perform a clinical procedure? Or perhaps you’ve wondered about the subtle differences between patient populations. Or you’ve observed that certain treatments work better than others. Like any good detective, you must substantiate what you suspect, and research is the essential link to proving your case. Research provides the foundation for nursing science.
What is research?
Research is an organized and systematic quest for new knowledge. It’s based on curiosity or on perceived needs, and it may consist of observation or hypothesis testing and use of a preplanned research design, such as an experiment. The basic purposes of such systematic investigation are to discover new knowledge or new interpretations, revise facts or gain greater understanding of phenomena.2 From a nursing perspective, the purpose of research is to advance knowledge that may lead to practical application and improved patient care. Research involves general steps, including stating the problem; developing a question; reviewing the literature; establishing significance and explaining the need for the study; using research methods including design, sample, setting, instruments, and procedures for consenting; collecting data; analyzing data; interpreting findings; describing implications for practice; and disseminating the findings.

While topics for nursing research are plentiful, research often focuses on categories such as population (e.g., patients, caregivers, nursing staff, communities); nursing care (e.g., therapeutic interventions or processes of providing care); health (e.g., disease prevention or health promotion); and environment (e.g., hospitals, clinics, long-term care, or community settings). The Magnet program specifies that direct care nurses must be involved with research projects. Healthcare facilities applying for Magnet status must provide examples of how they integrate research into the clinical environment and operational processes through EBP and research projects. A structure, such as a nursing research council or committee, provides the resources and guidance for nurses to become involved in research. Meanwhile, a nursing department with a budget for nursing research can provide resources for conducting projects.

The Magnet program specifies that a healthcare facility demonstrate research integration through studies that identify nursing research questions and a nurse must be a principal investigator on such studies. This may mean an institutional review board approval or a waiver of review, and this is highly specific to each facility's requirements.3

Quality improvement projects and EBP projects often use formal methods; these can meet the requirement. The table (in the online version of this CE module) provides an overview of key research requirements for Magnet Recognition Program applicants along with examples and processes. Other examples are in the literature of clinical research projects used specifically for Magnet recognition.4
The research question is the most important part of a study because it guides the design and conduct of the investigation. Forming a question takes considerable time, thought, teamwork, persistence, and an ability to tolerate ambiguity. Some guidelines for selecting a topic, which leads to a question, include:
• Choose a topic you are passionate about that will sustain your interest • Pick a topic that is important for knowledge and patient care • Start small • Determine what others have done; be sure that data can be collected • Evaluate whether you can access the resources you’ll need The acronym FINER describes criteria relating to research studies and then formulating a good question. While other criteria can also be used, the FINER criteria are considered classic for both determining value of a project and guiding the research question. The study should be feasible (F), interesting (I), novel (N), ethical (E), and relevant (R).7

Feasible means practical in terms of the adequacy of numbers of subjects, access to subjects, availability of technical expertise, affordability, burdensomeness, and manageability. The question must be interesting to you, patients, colleagues, and the profession. Novel means the question should be refreshingly new, original, and unusual. This may be less desirable in nursing research because studies often need to be replicated in larger samples or with different populations; the question does not have to be original, but it should show promise for advancing knowledge.

Ethical means that the question has scientific value, and the risk-benefit ratio must be favorable so that risks are minimized. Human subjects’ protections must be in place (i.e., subjects must be selected fairly, informed consent must be appropriate, an institutional review board must conduct an independent review, and respect for subjects’ privacy and autonomy must be evident).

All staff involved in research must complete training in the protection of human subjects participating in research. Relevant means that the question and results of a study will advance scientific knowledge and have the potential to influence policy and future research.
Wording of questions
How to earn continuing education
THIS COURSE IS 2 CONTACT HOUR
1.
Read the Continuing Education article.
2.
Go online to https://www.nurse.com/ce/research-in-the-clinical-setting-taking-nursing-to-new-heights to take the test for $15. If you are an Unlimited CE subscriber, you can take this test for only $7.50. You can sign up for an Unlimited CE membership at https://www.nurse.com/sign-up for $49.95 per year.
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If the course you have chosen to take includes a clinical vignette, you will be asked to review the vignette and answer 3 or 4 questions. You must answer all questions correctly to proceed. If you answer a question incorrectly, we will provide a clue to the correct answer.
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Once you successfully complete the short test associated with the clinical vignette (if there is one), proceed to the course posttest. To earn contact hours, you must achieve a score of 75%. You may retake the test as many times as necessary to pass the test.
5.
All users must complete the evaluation process to complete the course. You will be able to view a certificate on screen and print or save it for your records.
In support of improving patient care, OnCourse Learning is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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The PICO model: Asking questions
A frequent challenge is converting a problem into a clinically relevant and answerable question. PICO is a model for creating the elements of a question.8 P stands for patient or population, I is intervention, C is comparison, and O is outcome. Using the gastroenterology diagnostic arena example cited earlier, P is the diabetic population, I is a special prep, C is comparing one type of prep with another, and O is the prep result. The question can then be framed: “What is the difference in bowel cleanliness between experimental or standard prep in patients with diabetes undergoing colonoscopy?” This model works best for studies that have comparisons for interventions or populations. Another example involves choosing whether the same patients are compared with themselves or with another group. Suppose nursing home patients with dementia are eating poorly. The staff would like to try using music to accompany meals because the literature shows that music might be beneficial.

Applying PICO, P is patients with dementia, I is music during eating, C is no music during eating, and O is eating pattern. The question is: “What is the effect of music during a meal on the eating patterns of patients with dementia in the nursing home?” This question is vague enough that it could mean comparing the effects of music versus no music in the same patients or comparing a group of patients that gets music with a group that does not. “Are patients with dementia in the nursing home more likely to eat better when listening to music or when not listening to music while eating?” This wording offers more specifics in that it reflects that the same patients will be exposed to both music and no music while eating. Other authors offer ways to apply PICO to research questions and designs.8 Some authors use PICOT, where T is time. Time is not always applicable but can be useful if evaluating whether an intervention is more effective at one time point than at another. Using the above example, P is patients with dementia, I is music during eating, C is no music during eating, O is eating pattern, and T is at breakfast or at dinner. Or, patients’ eating patterns could be compared with their own baseline before any intervention. Asking questions using PICO (T) depends on the specific investigation.9,10
Different problems call for different types of wording. When the problem is to explore, investigate, search for or learn perceptions or opinions, the wording of the question is “What happens when ... ?” “How do they feel?” “Why do patients react this way?” Types of studies emerging from these questions are descriptive or exploratory. This is often a first stage of research because the question has not been asked before with the specific population. When characteristics, reasons, phenomena, or outcomes are known, wording becomes “What is going on here?” “What is the relationship between … ?” “What is the difference between …?” “Are patient characteristics associated with restraint use in ICU?” Studies emerging from these types of questions establish relationships and correlation but not cause and effect. When prior research has been done and an intervention is being tested, a question can be asked that compares groups: “What is the effect of this intervention on that outcome?” An example of this type of question is: “What is the difference in patient adherence to medication when explanations are given with each refill or only with the first prescription?” This type of question leads to an experiment that can establish cause and effect. Several wording patterns are problematic for research questions. These questions suggest a yes or no answer, pose a rhetorical question, use vague or ambiguous language, start with “How can I?” or combine two or more issues into one question. A common problem when beginning to develop research questions is posing too big a question.

The challenge is to think of small steps, specific issues, and the information truly wanted from the research. As people who operate in the practical realm, nurses often think about what we can do (to make research happen) before we think of what is important to know.
The growth of the nursing profession depends on developing scientific principles on which to base practice. Nursing urgently needs sound studies to advance knowledge. In the 1990s, a scholarly effort in nursing termed “research utilization” focused on applying study findings to practice to improve care. With nursing science growing continually, nursing is now better equipped to go beyond this limit to improve patient care. That is, improving patient outcomes depends on establishing, applying, and evaluating the use of the strongest possible evidence — evidence-based practice (EBP) — to advance changes in policies and procedures.1

With these terms in the nursing vernacular, many hospitals have made efforts in the past three decades to incorporate research into practice. The prestigious Magnet Recognition Program, developed and continually updated by the American Nurses Credentialing Center to recognize healthcare organizations that demonstrate nursing excellence, has provided recommendations for incorporating research into nursing culture within organizations. Hence, the focus of this program is the development and conduct of nursing research in the clinical setting for direct bedside application.
Where to begin
Questions come from several sources. Often clinical practice is the best place for brewing ideas and discovering problems. Typically, research questions come from clinical problems. Staff conversations about patient problems are usually a rich source of ideas. The problem must be clearly stated before a question can be established. For example, in the gastroenterology diagnostic arena, staff nurses may wonder why one prep cleans the bowel better than another.

The problem may be that because one prep is not sufficiently cleaning the bowel, colonoscopies cannot proceed, and the consequences include increasing patient discomfort/risk with repeat and delayed procedures and rescheduling patients into an existing busy schedule. However, the problem may be multifaceted. Perhaps the prep itself is not effective, or maybe there are intrinsic patient characteristics that interfere with effective cleansing, or maybe the patients are nonadherent with instructions. You need more information to clarify the problem.

Patients with diabetes have more difficulty achieving a clean bowel after usual preps because of physiological aspects of the disease and may be a population of interest. Thus, the issue is clearer, and the question then becomes “Which bowel prep cleanses the bowel more effectively in patients with diabetes?” Another source of ideas for questions is research literature. As you search through articles related to a topic of interest, you’ll notice what work others have done to advance the topic. From the review of articles, you can determine whether studies need replication because methods need to be improved, such as need for a larger sample size. With information from the review, your original question may already have been sufficiently answered.

The body of knowledge may show that another question will advance the topic to yet another level. Or perhaps findings should be applied to practice with a new study that seeks to learn more about patient outcomes. When undertaking research projects, flexibility and openness to new inquiries are critical personality characteristics while obtaining more information. Other sources of ideas are activities already under way in healthcare organizations. For instance, quality improvement or performance improvement studies provide focus for topics, institution/organization (used interchangeably) or unit-specific processes, objective and systematic data collection and monitoring, and data analysis.

While these activities are not research investigations per se, they do provide the pilot data for determining that a problem exists. For example, when data collection for a facility demonstrates a high rate of restraint use in the ICU, questions arise about how high is high, what the reasons are, and how the situation can be changed. Again, more information is needed about numbers, reasons, and patient and staff characteristics.

If the literature or a comparative data set or experience in the same hospital reveals a consistently lower restraint rate, the question can focus on one of several topics: “What are the reasons for restraining patients in the ICU?” “Which patient characteristics are associated with the need for restraints?” “What alternatives do staff have for restraints in the ICU?” “Which staffing pattern will reduce restraint use in the ICU?” Each of these questions can become a research project. Another source of ideas is evaluations of innovations ready to be implemented in clinical settings. Program evaluation is a specific research design that lends itself to studying change during implementation of new ideas. For example, a psychiatric inpatient unit has noted that patients taking the newer antipsychotics are rapidly gaining large amounts of weight and putting themselves at high risk for diabetes.

Staff members want to create a unit program that addresses this problem. To do this, staff members have decided to begin the Healthy Living Program, which involves a new way of thinking and behaving — truly a culture change on the unit. Staff will role model behaviors, facilitate activities and dietary changes, and lead classes for patients about diet, exercise, symptom management, coping skills, and stress management.

A review of the literature may reveal successful programs or findings about dosages of antipsychotics and their relationship to weight gain. To determine the effectiveness of their program, staff members want to measure whether patients gain weight while hospitalized and then each month after discharge for the next six months. Such a program lends itself to objective outcome measures, such as weight and length of time in exercise activity, and subjective measures, such as patient and staff satisfaction. Often, ideas for studies come from multiple sources. It’s helpful to discuss the topic with peers, colleagues, subject experts, patients, and nurse researchers to determine whether the issue merits investigation. An important lesson when beginning a research project is to recognize that research cannot be done in isolation. Clinical research requires the involvement of many people from the earliest phase of development. Hence, a communication plan needs to be established early in the research process for keeping all stakeholders informed of meetings, tasks, and progress.
Where do questions come from
Literature review
  • Identify the study by design and type (descriptive, correlational, experimental, single study, review article)
  • Identify the major research questions and their clarity
  • Identify the structure of the article (e.g., introduction, background, methods, results, discussion, implications for practice and research)
  • Identify any theoretical approach, concepts, and definitions of terms
  • Identify instruments used to measure the concepts, which should include descriptions of validity and reliability (e.g., depression scale and score)
  • Make notations about concepts that need clarity; define them
  • Describe methods (e.g., design, sample, procedures, consent, data analyses)
  • Identify findings from tables and charts
  • Evaluate whether research questions were answered
  • Evaluate usefulness of the findings and recommendations for further research
Researchers review the literature several times during a project. First, they review prior research to find what has been done and with which populations. This search enables them to identify gaps that need investigation, determine the significance of the question, and establish the need for further research. Often this search helps clarify the question, provides ideas for theoretical approaches and conceptual definitions, and informs the researcher about methods used before.

Researchers do another literature review during the course of the study and at each annual institutional review board renewal. These reviews ensure that the study is on target with respect to sound, safe, and appropriate methods. They do a final review at the end of the study to compare past with current findings and to set the stage for applying the findings in practice and future research recommendations. Components of the literature review involve searching for and retrieving articles, critiquing research and establishing meaningful syntheses. Literature reviewing is the perfect time to engage consultants and resources. The medical librarian’s expertise is invaluable for searching specific topics in databases, such as PubMed, MEDLINE, PubMed Central, the Cumulative Index to Nursing and Allied Health Literature, the Virginia Henderson Global Nursing e-Repository, the Joanna Briggs Library of Systematic Reviews (qualitative and quantitative syntheses) and the Cochrane Library.

The librarian can help with naming keywords for searching and with finding references of varying types, such as single studies, reviews spanning many years, and practice guidelines. Once references are identified, retrieval is the next step. Many libraries have online journal access or interlibrary loan programs. Some public libraries are part of a community network that enable electronic access to materials at local universities. Hence, the librarian is the best resource for retrieving articles, and you should allot enough time for the acquisition of articles. After the librarian retrieves articles, a problem frequently emerges: how to determine the scientific merit of the work. Therefore, another resource vital to the literature review is a nurse researcher in the nursing department or at an affiliated academic institution. While many nurses prepared at the master’s degree level can critically review research articles, guidance from those more experienced in research methods and statistical techniques will enhance the critical review process. Sometimes, a statistician consultant is useful when the data analyses are complex. Several people should review together and compile lists of questions for their consultants. Research texts and university library websites offer guidance for critiquing articles. Critical reviewing varies by research design and often by discipline. Specific to nursing, the American Nurses Association offers an online research toolkit that addresses critiquing a research article and appraising the evidence.11,12 The table provides one style that has been useful for journal club critiques at the author's hospital. The following points offer tips for critiquing the literature:
Collating articles can be helpful when the search reveals a large body of information. Articles can be categorized in many ways, including groupings based on methods (e.g., all experimental design); populations (e.g., all frail elderly older than 65); setting (e.g., hospital, healthcare center, home); type of interventions (e.g., all patient education studies); particular theoretical application (e.g., self-care model); or theme (e.g., disease or diagnosis, symptoms, type of opinion, or type of intervention). Each article can be entered sequentially into a table to organize the process and enable later synthesis. The table presents a matrix for recording information when creating a literature review summary.
  An essential part of the research critique is establishing the strength of the evidence. This requires knowledge of the kind of research being reviewed and a standard by which to rate its strength. Because different evidence tables are applicable to different types of healthcare issues (i.e., preventive interventions, disease treatments), multiple organizations have created their own tables.13,14

The “Levels of Evidence” table below depicts evidence ratings from OnCourse Learning recommendation based on collaboration from nursing research experts and usefulness for nursing.15 The “Grades of Recommendation” table depicts the GRADES system for recommendations for use in clinical practice. Varying schemas of evidence ratings and practice recommendations are provided by recent systematic review articles; methods of reviews (systematic, meta-analysis, meta-syntheses); textbooks; and national task forces.

Of note is that often more attention is given to the strength of evidence of quantitative studies; the Joanna Briggs Institute Library describes how to evaluate the evidence for meta-syntheses (a method of review of qualitative studies on a particular topic). Once the literature review has established the strength of evidence already existing for the specific problem and question, the next step flows easily: to decide what needs to be studied to advance the topic. Much of the discussion thus far has focused on developing the research question. When the question is soundly based on literature and the need for clinical knowledge, the research process proceeds to designing the methodology of the study. However, an intermediate step within the literature review is examining the role of theory.

Theory, theoretical models, and conceptual frameworks are valuable because they form the foundation underlying the project. Nursing theories are often used in guiding research projects.17 Specifically, theory is an explanation of phenomena and proposes relationships between concepts. Proposed relationships can be questioned and tested in a research project. An example of the use of a theoretical framework is Everett Rogers’ theory of diffusion of innovations, which describes how people may come to accept or refuse a new idea or practice.18 (Rogers was an influential professor of communication studies.) The five stages for deciding happen in relation to the people involved and the actual innovation. The stages are knowledge (learning about the change), persuasion (developing a positive or negative attitude and sharing with others), decision (making a choice to try the new practice), implementation (testing the change in the specific setting) and confirmation (deciding whether to adopt the change based on evaluations and opinions of those involved).

Two nursing projects involving dissemination of an evidence-based course used to teach behavioral techniques for self-management of auditory hallucinations in patients with schizophrenia illustrate use of Rogers’ framework. The projects describe specific staff behaviors and activities characterizing each of Rogers’ stages of diffusion as staff decided to continue, make adaptations, or reject the new program in their settings.19 (Level B),20 (Level B)
Nurse researchers should be good detectives
Earn 2 credit hours with this continuing education course
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EDITOR'S NOTE: Martha Buffum, PhD, RN, PMHCNS-BC, is a nurse researcher (without compensation [WOC]) at the VA San Francisco Health Care System and is a clinical professor in the School of Nursing at the University of California, San Francisco.
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DAISY meaningful recognition guide
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