Study Designs for Intervention Research in Real-World Settings

EPI 241 Spring 2021 (2 unit)
Course Directors:
Margaret Handley, PhD, MPH
Professor
Department of Epidemiology and Biostatistics
Starley Shade, PhD
Associate Professor
Department of Epidemiology and Biostatistics

OBJECTIVES

This course provides a foundation for the design of studies that are alternatives to individual participant-level randomization for the evaluation of interventions in real-world settings. An overview of the history of experimental and observational design will set the stage to understand these design variants. For each randomized (e.g., cluster-randomized and stepped-wedge randomized trials) and quasi-experimental design (e.g., pre-post and interrupted time series) presented, students will assess key features, common pitfalls, and possible strategies to improve internal and external validity. Scholars will be also introduced to implications of design decisions for data analysis. Focus will be placed on determining which design is best suited to a range of 'real world' implementation settings.

At the end of the course, students will be able to:

  • Describe the rationale for using common randomized and non-randomized group-level study design alternatives to individual participant-level randomized trials;
  • Understand key characteristics of cluster-randomized trials, stepped-wedge randomized trials, and selected quasi-experimental designs;
  • Identify specific threats to internal validity and strategies to mitigate these threats;
  • Develop design elements that incorporate the implementation process, including hybrid effectiveness implementation designs; and
  • Prepare a plan for discussing issues of sampling, sample size, and analysis with methodologic experts for cluster-randomized trials, stepped-wedge randomized trials, and selected quasi-experimental designs.
PREREQUISITES

Familiarity with basic individual-level study designs.

FACULTY
Course Directors:

Margaret Handley, PhD, MPH
Phone: 415-206-5333
email: margaret.handley@ucsf.edu

 

Starley Shade, PhD
Phone: 415-476-5798
email: starley.shade@ucsf.edu

Lecturers: Courtney Lyles, PhD
email: courtney.lyles@ucsf.edu
  Valy Fontil, MD, MAS, MPH
email: valy.fontil@ucsf.edu
  Chris Miller-Rosales, MSPH
email: TBA
FORMAT

Aside from the first class in which a lecture will be delivered by the course director, most of the didactic material will be delivered through a series of videos which students will watch prior to the classroom sessions. Classroom time will mainly be used to have students reflect on the material they viewed prior to class as well as the associated reading.

MATERIALS

All course materials and handouts will be posted on the course's online syllabus.

GRADING

Evaluation of student performance will be based on successful completion of weekly homework assignments, class participation, and attendance.

Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.

UCSF Graduate Division Policy on Disabilities

TO ENROLL

To apply for this course, please fill out and submit the application below. The deadline for application is March 1, 2021. Only one application needs to be completed for all courses desired during the quarter.

The application is best completed using the latest version of Firefox, Chrome or Safari.

APPLICATION