Clinical research aims to deliver healthcare advancements that are safe, beneficial, and cost-effective (Ford & Norrie, 2016). Research requires a methodical approach to develop studies that generate high-quality evidence to support changes in clinical practice. The method is a step-wise process that attempts to limit the chances of errors, random and systematic, which can compromise conclusions (Cummings, 2013) and invalidate findings. As healthcare professionals, nurses need to be versed in understanding the vast amount of information and available research in their field (Pollock & Berge, 2018) to find the best evidence to guide their clinical practice and/or to develop their research. However, to effectively use the literature, it is imperative to understand the principles of critical appraisal and basic study designs.
There are many roles for nurses in research. Nurses can be consumers of research, by staying abreast of the current issues and trends in their specialty area; a nurse champion initiating quality improvement projects guided by the best clinical evidence (Luz, Shadmi, & Drach-Zahavy, 2019) (White, 2011); a member of an interprofessional research team helping to address a complex health problem; or an independent nurse scientist developing their scientific inquiry. Regardless of the nurse’s role in research, a common goal of clinical research is to understand health and illness and, to discover novel methods to detect, diagnose, treat, and prevent disease (NCI, 2018).
This column is the first in a series focusing on the concepts of clinical research using a step by step approach. Each column will build upon earlier columns to provide an overview of the essential components of clinical research. The goal of the columns is to discuss the concepts that underpin evidence-based practice from research designs to data interpretation. Each article can serve as a review of the elements used to develop clinical research. The focus of this inaugural column is how to start the research process, which involves the identification of the topic of interest and the development of a well-defined research question. This article also discusses methods of how to formulate quantitative and qualitative research questions.
The motivation to explore an area of inquiry often starts from an observation that leads one to question why does that occur or what if we did this instead? Speaking to patients and hearing their concerns about managing specific conditions or symptoms is another way to get inspired. Exploring new technologies, successful techniques, and procedures from other fields or disciplines and adapting them in a different area could be another source for new insights and discoveries (Cummings, 2013). For example, those working in a cardiac setting may take an interest in fitness watches to monitor adherence to a walking program to reduce blood pressure and body weight. The ease of use, cost, and availability of fitness watches may be the draw to this technology. Staying curious and willing to explore ideas to solve or understand clinical issues is vital in engaging in clinical research since the goal of research is to improve the lives of patients.
Developing a research project requires knowing in depth the chosen area of inquiry (i.e., etiology, and treatment of hypertension). Methods to get immersed in the topic of interest include speaking to experts in the field and conducting a comprehensive literature review. Reading narrative review (NR) articles is one approach for updates on the latest issues and trends in the area of interest. NRs can address clinical, background, or theoretical questions. It can also summarize current findings, identify the gaps in research, and provide suggestions for the next steps in research (Ferrari, 2015). On the downside, NRs can be biased based on the author(s) experience and interpretation of findings (Pae, 2015). Systematic reviews (SR), another summary paper, differs from NRs, in that it uses a systematic approach to select, appraise, and evaluate the published reports (Armstrong, Hall, Doyle, & Waters, 2011).
SRs start with a defined clinical question that is answered during the review (Hoffmann et al., 2017). SRs use specific strategies for the inclusion criteria of papers to include or not to include. SRs help to understand what works or do not work in terms of intervention based-research (Uman, 2011). SRs are excellent resources if your area of inquiry is leading towards an intervention based project. (See Table 1 for Classifications of Interventions).
Classifications Interventional Studies (Clinical Trials)
| Category of Interventional Studies | Examples for Each Category |
|---|---|
| Treatment Trials | Testing of new medications, combination medications, new surgical procedure, dietary intervention |
| Prevention Trials | Testing of lifestyle changes, vaccines, medications |
| Screening Trials | Testing best approaches to screen or detect for health conditions |
| Diagnostic Trials | Testing procedures to diagnose specific conditions |
| Quality of Life Trials | Explore methods to best support individuals with chronic illness |
Reviewing citations from published papers is another method to find relevant publications. Highly cited publications in a particular area could indicate a landmark paper, wherein the author(s) may have made an important discovery or identified a critical issue in the area. An essential goal of the literature review is to ensure that previously conducted studies are located and understood. Previous studies provide insight into recent discoveries, as well as dilemmas and challenges encountered in conducting the research.
The two branches of research methods are experimental and observational. Under the experimental methods, randomized controlled trials and non-randomized controlled trials belong in this category, while the observational methods include analytical studies with control groups and descriptive studies with no control groups. The analytical studies are cohort and case-control studies and descriptive studies are ecological, cross-sectional and case reports. Despite the differences in research methods, the common thread among the various types of research is the research question. The question helps guide the study design and is the foundation for developing the study. In the health sciences, the question needs to pass the “So what?” test. In that, is the issue relevant and lead to the advancement of the field and feasible in terms of conducting the study? Cummings and colleagues (Cummings, 2013) use the mnemonic FINER (Feasible, Interesting, Novel, Ethical, Relevant) to define the characteristics of a good research question.
Feasibility is a critical element of research. Research questions must be answerable and focused on using methods to measure or quantify change or outcome. For example, assessing blood pressure for a study designed to lower hypertension is feasible, because methods to measure blood pressure and results associated with normal, and stages of hypertension are established. For studies requiring human study participants, approaches to recruiting and to enrolling them into the research need careful planning. Strategies must consider where and how to recruit the best study participants who fit the study population under investigation. An adequate number of study participants must be available to implement the study. The allotted timeframe to complete the study, the workforce to perform the study, and the budget to conduct the investigation must also be realistic. Research studies funded by private or public sponsors usually have timeframes to complete an investigation (2 years, three years). Funders can also request for a timeline showing when aspects of the research are achieved (institutional review board approval, recruitment of participants, data analysis).
Several reasons may drive interest in an area of inquiry. Cummings and colleagues (Cummings, 2013), use the term Interesting to refer to an area of importance for the investigator to examine. For some investigators, an experience or an observation drives them to evaluate the underpinnings of a situation or condition. While for some, obtaining financial support either through private or public funding is an important consideration, and for others, the research question is the logical next step in their program of research.
Novel research implies that new information contributes to or advances a field of inquiry. It can also mean that research confirms or refutes earlier results. Replicating past research is appropriate to validate scientific findings. When repeating studies, improving previously used research methods (i.e., increase sample size, outcome measures, increase follow-up period) can strengthen the project. For example, a study replicating a hypertension study may add a way to physiologically assess dietary sodium intake instead of only collecting dietary food records to determine sodium intake.
Ethical research is mandatory, from the protection of human and animal subjects to the data collection, storage, and reporting of research results (Applebaum, 2005; Grady, 2015). Research studies must obtain institutional review board (IRB) approval before proceeding with the investigation. IRB is known as an ethics committee. The committee reviews the proposed research plan to ensure that it has adequate safeguards for the well-being of the study participants, as well as evaluates the risk-benefits of the proposed study. If the level of the risk outweighs the benefits of the outcome, the IRB may require changes to the research plan to improve the safety profile or reject the study. For example, an IRB will not approve a study proposing to use a placebo when well-established and effective treatments are available. The National Institutes of Health (NIH) offers an excellent educational resource, titled, Clinical Research Training. This training is a free online tutorial for ethics, patient safety, protocol implementation, and regulatory research (https://crt.nihtraining.com/login.php). Registration is required to enter the NIH portal, and the course takes approximately three-four hours to complete.
Relevant research questions address critical issues. It will add to the current knowledge in the field. It may also change clinical practice or influence policy. The questions must be timely and appropriate for the study population under investigation. In continuing the hypertension example from above, for individuals diagnosed with hypertension, it is recognized that reducing the dietary intake of sodium and increasing potassium can lower blood pressure and reduce the risk for heart disease and stroke (McDonough, Veiras, Guevara, & Ralph, 2017). Therefore, an investigator should target both the dietary intakes of sodium and potassium if conducting a dietary study to reduce blood pressure. Focusing solely on lowering dietary sodium intake does not take into consideration the best available evidence in the field.
Guidelines are available to help frame the research question that clarifies the concepts of interest; common frameworks include PICO and PEO. PICO is best suited for quantitative studies, while PEO for qualitative studies (Methley, Campbell, Chew-Graham, McNally, & Cheraghi-Sohi, 2014). Quantitative and qualitative methodologies view the research approach using different lenses. In quantitative research, numerical data is produced necessitating statistical analysis. While qualitative research generates themes using words, the outcome of interest for these studies is understanding phenomena and experiences. It is essential to recognize that some topics will not fit the PICO and PEO frameworks. Novice researchers should seek consultation from a mentor or academic research advisor to formulate the research question.
PICO incorporates the following components Population, Intervention, Comparison, and Outcomes. Population considers the persons or community affected with a specific health condition or problem (i.e., middle-aged adults, aged 45-65 with stage 1 hypertension; older adults, aged 65 and older with stage 1 hypertension living in nursing homes). Intervention is the process or action under investigation in a clinical study. Interventions include pharmaceutical agents, devices, and procedures, such as education about diet or exercise. The intervention under study can be investigational or already available to consumers or healthcare professionals for use (NLM, 2019). Comparison is the group assessed against the intervention (i.e., vegan diet versus the Mediterranean style diet). Outcome is the planned measure to determine the effect of an intervention on the population under study. Using the vegan versus Mediterranean style diet example, the Outcome of interest could be the percent of body weight loss and reduction of blood pressure.
PEO includes the following elements Population, Exposure, and Outcome. Population centers on those affected and their problems (i.e., middle-aged adults who smoke with hypertension). Exposure focuses on the area of interest (i.e., experience with smoking cessation programs; triggers of smoking). The Exposure viewpoint depends on the framing or wording of the research question and the goals of the project since qualitative studies can denote a broad area of research or specific sub-categories of topics (Creswell, 2013). Outcome using the PEO model might examine a person’s experience with smoking cessation and the themes associated with quitting and relapsing. Since the PEO model is best suited for qualitative studies, Outcome tends to have elements of defining a person’s experiences or discovering processes that happen in specific locations or context (Doody & Bailey, 2016). (See Table 2 for Sample Questions Using PICO and PEO).
Sample Questions Using PICO and PEO
| * PICO – Quantitative Designs | ||
|---|---|---|
| Component | Tip | Example |
| Population | Start by asking, “How would I describe the group of patients I want to study? What are their ages, symptoms, gender, etc.?” | Middle-aged adults with stage 1 hypertension |
| Intervention | Ask, “What intervention am I considering using?” | Lower Sodium (1,500 mg) Dietary Approaches to Stop Hypertension (DASH) diet with 4.7 mg of potassium. |
| Comparison | Ask, “What is the other comparative intervention I want to use?” | Standard (2,300 mg of sodium) DASH diet with 4.7 mg of potassium. |
| Outcome | Ask, “What do I want to accomplish?” | Reduction in blood pressure from the baseline level |
| PICO Question: How does the lower sodium DASH diet with 4.7 mg of potassium compared with the standard DASH diet with 4.7 mg of potassium in lowering blood pressure among middle-aged adults with stage 1 hypertension? | ||
| PEO – Qualitative Designs | ||
| Component | Tip | Example |
| Population | Start by asking, “How would I describe the group of patients or community I want to study? What are their ages, symptoms, gender, etc.?” | Middle-aged adults with stage 1 hypertension who smoke daily |
| Exposure | Ask, “What condition or action am I interested in studying?” | smoking behaviors |
| Outcome | Ask, “What experiences or themes do I want to understand?” | attitude towards quitting |
| PEO Question: What are the attitudes of middle-aged adults who smoke daily with stage 1 hypertension towards smoking cessation? | ||
To start in research, find an area of interest to study. For some, the inspiration for research comes from observations and experiences from the work-setting, colleagues, investigations from other fields, and past research. Before delving into developing a research protocol, master the subject of interest by speaking with experts, and understand the literature in the field. Use the FINER mnemonic as a guide to determine if the research question can pass the “So what?” test and use the PICO or PEO models to structure the research question. Formulating the appropriate research question is vital because the question is the starting point to select the design of the study, the population of interest, interventions, exposure, and outcomes.
This manuscript is supported in part by grant # UL1TR001866 from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program.