Understanding Clinical Research Design to Inform Healthcare

Study Designs - Kirsten Bibbins-Domingo, PhD, MD, MAS; Alka Kanaya, MD; Thomas B. Newman, MD, MPH

1. Define cohort studies
2. Distinguish between prospective and retrospective cohorts
3. Explain the nested case-control design and strategy
4. Describe the multiple-cohort design
5. Define cross-sectional studies
6. Explain why cross-sectional studies yield weaker evidence for causality than cohort studies
7. Define case-control studies and their benefits and problems
8. Describe case-crossover studies.

1. Define randomized blinded trials
2. Explain how to design RBTs
3. Describe how to choose the intervention and control conditions
4. Describe how to define outcomes and adverse effects
5. Describe how to select participants
6. Describe how to measure baseline and outcome variables
7. Evaluate approaches to randomizing and blinding.

1. Understand the definition of studies of a medical tests and how these studies differ from therapeutic intervention trials or studies to assess causality
2. Explain how to select subjects for a study of a medical test
3. Understand how to measure reproducibility of a test including use of kappa and the coefficient of variation
4. Define key metrics to use in studies that assess the accuracy of a diagnostic test including sensitivity, specificity, predictive value, ROC curves, and likelihood ratios
5. Understand how to design studies of clinical prediction rules and the associated limitations and challenges with this design.

1. READ Reading Assignments
2. VIEW Lecture Videos
3. COMPLETE Post-Module Assessments

• Fees: $75.00 per module, or $500.00 for the entire course.
• The estimated time to complete this activity is 3 - 5½ hours, which is equivalent to 3.0 - 5.5 credits.
• CME credit will be awarded through the module's expiration date of June 30, 2017.

This UCSF CME activity was planned and developed to uphold academic standards to ensure balance, independence, objectivity, and scientific rigor; adhere to requirements to protect health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA); and include a mechanism to inform learners when unapproved or unlabeled uses of therapeutic products or agents are discussed or referenced.

This activity has been reviewed and approved by members of the UCSF CME Governing Board in accordance with UCSF CME accreditation policies. Office of CME staff, planners, reviewers, and all others in control of content have disclosed they have no relevant financial relationships.

The speakers have disclosed they have NO financial interest/arrangement or affiliation with any commercial companies who have provided products or services relating to her presentation(s) or commercial support for this continuing medical education activity.

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