Preparing and Designing Your Research Study or Case Report

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.