• Choosing a Research Question
• Formulating Hypotheses
• Identifying/Selecting Endpoints or Outcomes
• Choosing a Study Design

Research Question

A well thought out and specific research question paired with an appropriate study design is crucial to obtaining meaningful results.   

Formulating a specific and concise research question can be complicated and will often be a multi-step process. We encourage collaboration with a statistician early and often to ensure the research question is specific and answerable through data collection and statistical analyses. 

The below table gives a brief example of this process 

   SOURCE

Formulating Hypotheses

Along with a specific and concise research question, hypothesis questions will need to be formed.   Research questions in nature are more inquisitive or interrogative. Hypotheses are more predictive and are usually made with preexisting knowledge of the subject. Hypotheses should always be written declaratively instead of interrogatively, like a research question. A hypothesis statement should be developed prior to any data collection.

Do you need help distinguishing between  research questions and hypotheses? Visit the following  link for in text descriptions of each and a video distinguishing the characteristics between the two provided by Center for Innovation in Research and Testing.

https://cirt.gcu.edu/research/developmentresources/research_ready/quantresearch/question_hypoth

The following link from UCLA provides a nice introduction to hypothesis testing. 

http://www.stat.ucla.edu/~rgould/110as02/hypoverview.pdf

Identifying/Selecting Endpoints or Outcomes

Endpoints need to be established immediately after forming a research question as is steers the user in the right direction when establishing whether an outcome will be quantitatively or qualitatively determined.

Study Design

Choosing the Correct Study Design

It is critical to choose the correct study design for your question to obtain meaningful results.  Because some research questions can often be answered by more than one method/design, the choice of design depends on a variety of considerations, including: availability of time, resources, and data.  We encourage a discussion with a statistician early in the research process to ensure a successful study design plan.  According to Byrne (Byrne 2017 – Publishing your medical research), study design is the single most common type of flaw that results in outright rejection of a submitted manuscript. 

And more importantly, a flawed design may lead to spurious results that cannot answer your research questions.

Basic Study Design Options

The figure below gives basic study design options as well as considerations in selecting each.