Preparing and Designing Your Research Study or Case Report
Presented by Jean-Michel Brismée
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This course will describe a step-by-step process clinical practitioners can use to prepare and start their research projects. The course will include discussion of ethics/institutional review board requirements for clinical research, when trial registration is needed, and how to register a trial/case series. The process of preparing and reporting case studies, and the key ingredients needed to present or publish those, will be reviewed. Finally, the process of writing adequate research questions to guide methodology and design of a study will be explained.
Meet your instructor
Jean-Michel Brismée
Jean-Michel Brismée, PT, ScD, OCS, FAAOMPT, is a professor in the Doctor of Philosophy (PhD) and Doctor of Science (ScD) programs in physical therapy at Texas Tech University Health Sciences Center (TTUHSC) in Lubbock, Texas. Dr. Brismée teaches at TTUHSC in the areas of kinesiology and orthopedics and is involved in clinical…
Chapters & learning objectives
1. Preparing a Research Project
Before preparing a research project, it is important to perform a thorough literature review of existing publications on the topic. The chapter explains the importance of discussing your ideas about the case report or the research with others to review its originality and define what is innovative about your research. If there is existing research, this chapter discusses what can be improved about the design in regard to sampling (larger or different population), blinding and bias, and the use of validated measurement tools.
2. Ethics Requirements
Ethics requirements will be discussed in regard to case studies and cadaver studies, as well as studies involving humans or animal samples. The chapter will also address the steps to take for institutional review board clearance, both for researchers associated with academic institutions and for those who do not have affiliation. Writing of protocols to be submitted to institutional review boards will be discussed as well.
3. Trial Registration
The chapter will explain the process of trial registration, which is free of charge and needs to be completed prior to participants’ enrollment in the study. An important aim of prospective trial registration is to improve transparency and avoid research duplication. Publicly accessible databases, such as Primary Registries in the WHO Registry Network or ICMJE-approved registry where trials can be registered, will be reviewed, as well as which studies are considered prospective trials and should be registered.
4. Requirements for Case Studies
Case studies are usually not considered by institutional review boards to be research and do not require approval, although some journals can ask for a letter of exemption from an institutional review board. The need to obtain patient consent to publish their data/pictures/figures for presentations at conferences or use in publications will be reviewed. The CARE guidelines will also be discussed, as well as the ingredients necessary to make a case report publishable.
5. Writing Your Research Questions
This chapter will explain how to write research questions and will discuss how critical this process is for study design and statistical analysis. Writing research questions related to assessment of differences, associations, predictions, and reliability will be explained.
