Get started on a new research project by bouncing ideas off of colleagues, mentors, and reviewing the literature to see what has already been completed. Identify gaps in the literature that could be filled by the proposed study.

Prior to your initial meeting with an SDBC collaborator, prepare a few relevant articles or examples of existing measures/surveys from your literature review and ideas on some of the following study design aspects:

  1. Develop your research question(s) and corresponding hypotheses – See Study Design Resources below
  2. Study design – Experimental or observational? Prospective or retrospective? Survey or focus group?
  3. Inclusion/exclusion criteria
  4. Sample size availability
  5. Potential outcome and predictor variables
    1. Major outcome variable(s): For example, a primary outcome could be mortality, secondary could be complications and/or adverse events.
    2. Major predictor/grouping variable(s): For example, Cases vs. Controls, Treatment A vs. Treatment B.
    3. Potential confounders: Variables associated with both predictor and outcome variable of interest. For example, age and time since procedure.
    4. Potential effect modifiers: Variables that exhibit different associations with the outcome within different strata of a predictor variable (i.e., variables that exhibit significant interactions with your predictor variable). For example, hip fractures are more common in young males (via trauma) than young females, but elderly females have a higher risk of hip fracture (due to osteoporosis) than elderly males. Thus the relationship between sex and hip fracture is modified by age (Methods in Observational Epidemiology, Kelsey, et al second edition).

Study Design Resources

Developing your Research Question

Observational Studies Guidelines

Experimental Study Guidelines

Study Design/Statistics Training - Lancet & BMJ

Lancet

BMJ

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Contact

Camie Derricott
Phone: 801-587-5212
Fax: 801-581-3623

ACKNOWLEDGING THE SDBC

Please use the following text to acknowledge the CCTS Study Design and Biostatistics Center:

"This investigation was supported by the University of Utah Population Health Research (PHR) Foundation, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant 5UL1TR001067-05 (formerly 8UL1TR000105 and UL1RR025764)."