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Formulating a researchable question: A critical step for facilitating good clinical research

Objectives of this article

❶By the end of this article, the reader will be able to appreciate the significance of constructing a good research question and developing hypotheses and research objectives for the successful design of a research study.

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INTRODUCTION

According to this principle, a clinical or surgical trial is ethical only if the expert community is uncertain about the relative therapeutic merits of the experimental and control groups being evaluated. Designing a research hypothesis is supported by a good research question and will influence the type of research design for the study.

Acting on the principles of appropriate hypothesis development, the study can then confidently proceed to the development of the research objective. The primary objective should be coupled with the hypothesis of the study. Study objectives define the specific aims of the study and should be clearly stated in the introduction of the research protocol.

Note that the study objective is an active statement about how the study is going to answer the specific research question. Objectives can and often do state exactly which outcome measures are going to be used within their statements.

They are important because they not only help guide the development of the protocol and design of study but also play a role in sample size calculations and determining the power of the study. For example, the most methodologically sound randomized controlled trial comparing 2 techniques of distal radial fixation would have little or no clinical impact if the primary objective was to determine the effect of treatment A as compared to treatment B on intraoperative fluoroscopy time. However, if the objective was to determine the effect of treatment A as compared to treatment B on patient functional outcome at 1 year, this would have a much more significant impact on clinical decision-making.

Second, more meaningful surgeon—patient discussions could ensue, incorporating patient values and preferences with the results from this study. The following is an example from the literature about the relation between the research question, hypothesis and study objectives:.

Low-intensity pulsed ultrasound for chronic patellar tendinopathy: How does low-intensity pulsed ultrasound LIPUS compare with a placebo device in managing the symptoms of skeletally mature patients with patellar tendinopathy? The development of the research question is the most important aspect of a research project. A research project can fail if the objectives and hypothesis are poorly focused and underdeveloped.

Useful tips for surgical researchers are provided in Box 3. Designing and developing an appropriate and relevant research question, hypothesis and objectives can be a difficult task. The critical appraisal of the research question used in a study is vital to the application of the findings to clinical practice. Focusing resources, time and dedication to these 3 very important tasks will help to guide a successful research project, influence interpretation of the results and affect future publication efforts.

No funding was received in preparation of this paper. National Center for Biotechnology Information , U. Journal List Can J Surg v. DeGroote School of Medicine, the. Bhandari, Wellington St. Accepted Jan This article has been cited by other articles in PMC. Objectives of this article In this article, we discuss important considerations in the development of a research question and hypothesis and in defining objectives for research. Research question Interest in a particular topic usually begins the research process, but it is the familiarity with the subject that helps define an appropriate research question for a study.

Open in a separate window. Research hypothesis The primary research question should be driven by the hypothesis rather than the data. Research objective The primary objective should be coupled with the hypothesis of the study. The following is an example from the literature about the relation between the research question, hypothesis and study objectives: Conclusion The development of the research question is the most important aspect of a research project.

Box 3 Tips for developing research questions, hypotheses and objectives for research studies Perform a systematic literature review if one has not been done to increase knowledge and familiarity with the topic and to assist with research development. Seek careful input from experts, mentors, colleagues and collaborators to refine your research question as this will aid in developing the research question and guide the research study.

Ensure that the research question and objectives are answerable, feasible and clinically relevant. Lippincott Williams and Wilkins; Introduction to and techniques of evidence-based medicine.

Guyatt G, Rennie D. AMA Press Printing; Designing, conducting and reporting clinical research. A step by step approach.

One and two sided tests of significance. Equipoise and the ethics of clinical research. N Engl J Med. Support Center Support Center. Please review our privacy policy. Adequate number of subjects Adequate technical expertise Affordable in time and money Manageable in scope. Getting the answer intrigues investigator, peers and community. Confirms, refutes or extends previous findings. Amenable to a study that institutional review board will approve. CSTAR is available to assist with defining and planning a study.

This includes constructing primary and secondary research questions, identifying experimental designs which address the proposed questions, developing a data dictionary for the variables to be studied and a statistical plan outlining how the data collected will be analysed. What is the difference between primary and secondary research questions? Particularly in experiments with an intervention, there is generally one primary question the study intends to answer.

As part of the study, ancillary data is often collected and studied to answer secondary questions. These questions generally are instrumental in defining future research projects. The study design is centered on the primary question and any causal claims of the study are specifically in regards to the primary question. What type of study meets my objectives?

There are many classes of studies which meet a variety of objectives. CSTAR has analysts trained in a broad variety of quantitative and qualitative research methods and can assist with selecting an approach appropriate to your objective. This includes identifying if an observational study is sufficient or if an experiment with an intervention is necessary. These types of decisions can be made based on whether the objective is to make observations about a specific case, describe a group of individuals, or generalize results to a population.

CSTAR can help researchers estimate the power of a study being proposed. Power calculations estimate how sensitive an experiment is expected to be based on an effect size and the proposed sample sizes.

As such, it is based on what a researcher expects to happen during a study. Optimally, the researcher has an estimate of the effect size anticipated in the study. The effect size is a function of the expected change in response and the variability of the measures of interest.

Often, if the ranges of scores for the various treatment groups are available, estimates can be made leading to an estimate of the power expected for a study. Power calculations have three components; power, effect size and sample size. Therefore, if the sample size and power are fixed, a minimum detectable effect size can be determined. This can often give a sense of whether or not a study will have sufficient power to be worthwhile.

Similarly, if the desired effect size and power are known, the required sample sizes can be established.

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The question that describes the main specific objective of this type of research is known as primary study question. Types of data collection methods include personal observation, interviews, questionnaires, focus groups, mystery shopping etc.

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Sep 11,  · Primary questions are important because how well a researcher meets the goals of the primary question will often be the criteria by which the research will be evaluated. The primary question should be a carefully worded phrase that states exactly the focus of the study.

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Any additional questions should never compromise the primary question because it is the primary research question that forms the basis of the hypothesis and study objectives. Primary Research Question and Definition of Endpoints Mario Chen, PhD. Clinical Research Workshop January Research Questions zUncertainty that the investigator wants to resolve. the primary question or to other hypotheses Primary and Secondary Questions/Objectives.

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A research question is the initial step in a research project and is an inquiry into a specific concern or issue. It forms the groundwork that the entire research project is based on later, and. • Primary vs. secondary questions o Primary questions: a question that introduces a new topic or a new idea within a topic o Secondary questions: • List and explain the 3 rules for communication research in your presentation. This is the end of the preview%(5).