Evid Based Spine Care J. 2013 Oct; 4(2): 68–71. The most important step in conducting a high-quality research study is to create a study question that will provide the guidance for the planning, analysis, and reporting of your study. The process of generating a novel, answerable study question seems like it should be simple at first blush.
Perhaps your keen interest in a particular topic sparks an idea for a study that starts the creative process of hypothesizing and wondering “what if.” It is a wonderful experience to witness or be caught up in the joys of such a process. Finding inspiration for a study may, however, be a challenge, and the study idea emerges, instead, with time after thoughtful consideration of a topic. In either scenario, in order for you to design and execute your study, honing your idea and hypothesis into
questions that can be realistically studied is required, adding a level of complexity to what at first seemed simple. Creating the final study question is a formal and iterative process: You create an initial study question by answering questions, defining parameters, getting feedback from colleagues, and conducting a limited literature search. Then you refine your question and define major aspects of your study by using a Patients, Intervention, Comparison, and Outcomes (PICO)
table for treatment and diagnostic studies, or a Patients, Prognostic factors, and Outcomes (PPO) table for prognostic studies. By taking the time to complete these steps, you will have a good structure for your research study and will be able to proceed to the next part, a literature review. A study question reflects an uncertainty that you want to try to resolve, perhaps an uncertainty about the
effectiveness of an intervention or how well an intervention works in a specific patient population. It is the basis for your research study and presents the idea or ideas that are to be examined in your study. Everything included in your study must relate to your study question(s) and study objective. It gives information about the patients to be studied, interventions to be compared, and primary outcomes to focus on. Your general study question can come from several
places.1 You or others in your field might have observed a pattern of positive or poor outcomes or problems regarding a current treatment. Recent advances or technologies might spawn questions about their safety or applicability to different patient populations. Technologies in other fields might have potential for use in your clinical field. Or, you think that other
treatments might perform better than what is currently practiced. Unfortunately, high quality, novel, and answerable study questions do not usually just appear. The inspiration for the study may emerge with time as you confer with colleagues, listen to lectures at professional meetings, or even as you critically appraise literature on a given topic. Frequently, study ideas build on previous research and are honed by working collaboratively with mentors and colleagues. Once you have a general
idea of what you would like to research, the process of crafting your study begins with carefully forming and focusing an answerable question. The first step is to draft a simple clinical question you would like to answer or a hypothesis you would like to explore. What do you think the answer to
that clinical question might be? Why do you think it may be important to evaluate this question? Now you can start the process of focusing your question. The following is an example of creating a preliminary study question. Suppose you are interested in several treatments for cervical myelopathy.
Table 1 shows an example of progressing from a broad study question to one that is more focused. Note that in creating a more focused study question, we have been more specific on aspects of the diagnostic condition (myelopathy due to spondylosis) and the patient population (adults). Improving study question focus
Step 3: Complete a PICO or PPO TableAdd specifications to your study question using a PICO or PPO table to further refine it. While the more focused study question above is an improvement, there are some additional questions you should ask:
The PICO/PPO system provides a framework for further refinement based on these questions. A PICO/PPO table will help you to consider what should be included in your study and what should not be included. Your final PICO/PPO table is an aid to further refine your study question, define inclusion and exclusion criteria, highlight the interventions and outcomes you will measure, and provide the groundwork for a focused literature search. Note that a PICO table is used for treatment studies and a PPO table is used for prognostic studies. A PICO table is used as the example in this article. Consider the following issues when creating your PICO table:
Table 2 is an example of a PICO table for your study question, “What is the comparative effectiveness following laminoplasty versus laminectomy and fusion for adults with myelopathy due to spondylosis in the cervical spine?” Table 2Example of a PICO (Patients, Intervention, Comparator, Outcomes) table for formulating a study question
Step 4: Refine Study Question and Conduct Preliminary Literature SearchNow you can use your completed PICO table to refine your study question and to conduct a quick preliminary literature search. It is important to find out what is currently known and not known about your research topic, what has already been published on this topic, and what gaps exist that your research can fill, whether it be a type of intervention that has not been studied, a particular group of patients who have not previously been included in studies, or an outcome that has not been measured but is important to patients. This initial literature search helps you hone your study question further and may help you determine if it is realistic to answer in a single, focused study. The PICO framework is also helpful for getting feedback from potential co-investigators/colleagues to further refine your study question. Step 5: Consider Additional QuestionsBy this point, you should have not only a solid study question, but at least a preliminary idea of how you might approach answering it, and there are some additional questions to consider for another round of refinement. To be more specific in your study focus, consider these additional questions:
After considering the questions above, you can refine your study question further (Table 3). Table 3Final study question In symptomatic adults with cervical myelopathy due to spondylosis, does laminoplasty improve the severity of myelopathy (as measured by the JOA recovery rate) compared with laminectomy and fusion at 12 months? Step 6: Perform a More Complete Literature SearchNow that you have created a clear, focused, answerable study question and a PICO or PPO table as the framework for your study, you can proceed to a more complete literature search. It is important to solidify your understanding of what is known about your research topic, what gaps in knowledge need to be filled, and what is the best study design to answer your study question. The AO SMART Handbook for Spine Clinical Research2 is a good reference for planning your research study, including formulating your study question, conducting a literature search, and selecting an appropriate study design. Additionally, you can use a previously published EBSJ article as an aid to literature search.3 Conclusions
FundingThis article was funded by AOSpine. References1. Cummings S R, Browner W S, Hulley S B. Philadelphia: Lippincott Williams and Wilkins; 2007. Conceiving the research question; pp. 17–26. [Google Scholar] 2. Lee M J Norvell D C Dettori J R Skelly A C Chapman J R, eds. SMART Handbook for Spine Clinical Research New York: Thieme; 2013 [Google Scholar] 3. Ecker E D, Skelly A C. Conducting a winning literature search. Evid Based Spine Care J. 2010;1(1):9–14. [PMC free article] [PubMed] [Google Scholar] Articles from Evidence-Based Spine-Care Journal are provided here courtesy of Thieme Medical Publishers Why research is often considered as a process and not only as an outcome?Generally, research is the organised and systematic method of finding answers to questions. It is systematic because it is a process broken up into clear steps that lead to conclusions. Research is organised because there is a planned structure or method used to reach the conclusion.
Why research is considered to be an iterative process?Described in this way the research process is given the impression of linearity, yet research investigation is often an iterative process whereby the process of conducting the research will give rise to new ideas which, in turn, feed back into the data collection and analysis stage.
What is a research process and why is important?Research process consists of a series of steps or actions required for effectively conducting research while formulating the research problem, extensive literature survey, developing hypothesis, preparing the research design, determining sample design, collecting data, execution of the project, analysis of data, ...
What do you mean by research and explain its process?Definition: Research is defined as careful consideration of study regarding a particular concern or problem using scientific methods. According to the American sociologist Earl Robert Babbie, “research is a systematic inquiry to describe, explain, predict, and control the observed phenomenon.
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