From CRMDA
Randomized Controlled Trials (RCT) for Clinical and Behavioral Settings
Five-day Course • June 3 - 7, 2013• Lawrence, Kansas
Presented by the Quantitative Training Program of Psychology and the Center for Research Methods and Data Analysis at the University of Kansas.
Institute Overview
Topics include study design, control of confounds, sample selection, best methods for the analysis of RCT data including intent to treat and related analyses.
Objectives
After completing this workshop participants should be able to:
- Describe and discuss key concepts in the design, implementation, and data analysis of Randomized Controlled Trials (RCT) in the educational, behavioral and clinical/biomedical sciences.
- Discuss and critique how these key concepts apply to examples of existing trials used in the educational, behavioral and clinical/biomedical settings.
- Describe the advantages, disadvantages, and ethical issues associated with RCT methodology.
- Discuss the merits of alternatives to RCTs, such as regression discontinuity design, and extensions to RCTs such as embedded qualitative design elements.
- Gain a general understanding of when and how to implement a cluster-randomized trial and how and why Structural Equation Modeling can be useful when analyzing results from RCTs.
Audience
If you are interested in learning more about Randomized Control Trials and have a basic statistical background, this course is for you. You should have a good working knowledge of the principles and practice of ANOVA, multiple regression, and elementary statistical inference.
Participants from a variety of fields, including psychology, education, human development, biology, and medicine will benefit from the course.
The course will emphasize the practical issues related to design of Randomized Control Trials in the behavioral sciences and medical fields. This course focuses on the design and implementation of RCTs, and does not provide in-depth statistical training; however, some assistance will be available for questions related to analytic issues.
Instructors
Amber Watts, Ph.D., is an Assistant Professor of Psychology and Research Associate at the Center for Research Methods and Data Analysis and the Lifespan Institute, Gerontology Center, at the University of Kansas. Dr. Watts completed her Ph.D. in Gerontology at the University of Southern California and has advanced training in quantitative methodology with a particular focus on longitudinal research. She has been involved in clinical trials research in hospital settings since 2001 included those funded by pharmaceutical companies and NIH. Dr. Watts has worked extensively in interdisciplinary environments including biomedical, behavioral, and social sciences.
Chantelle Dowsett, Ph.D., is Research Assistant at the University of Kansas. She holds a Ph.D. in Human Development and Family Sciences at the University of Texas at Austin. Chantelle has been involved with designing, implementing, and analyzing results from randomized control trials funded by the U.S.Department of Education, Institute for Educational Sciences and The National Institutes of Health, National Institute for Child Health and Human Development.
Software and Computer Support
Optimal Design (http://sitemaker.umich.edu/group-based/optimal_design_software) and R (http://www.r-project.org/)
Syllabus
Randomized Controlled Trials (RCT) for Clinical and Behavioral Settings
Amber Watts and Chantelle Dowsett
University of Kansas
| Monday | June 3, 2013 |
| 9:00-9:20 | Welcome and Introductions |
| 9:20-10:00 | Overview of Basic Issues in RCT |
| 10:00-10:15 | Break |
| 10:15-11:00 | Bias, Confounds, Internal/External Validity |
| 11:00-11:30 | Principles of Experimental Design |
| 11:30-12:00 | Selecting a Study Population |
| 12:00-1:30 | Lunch * |
| 1:30-2:30 | Random Assignment, Randomization Activity & Discussion |
| 2:30-3:15 | Controls and Blinding |
| 3:15 – 3:30 | Break |
| 3:30 – 4:15 | Control Groups Activity & Discussion |
| 4:15 – 4:45 | Q&A, Further discussion of participant Research Questions/Hypotheses |
| 5:00 – 8:30 | Free BBQ (burgers, veggie burgers, brats) and open beer/wine bar at Holiday Inn |
| Tuesday | June 4, 2013 |
| 9:00-10:00 | Introduction to Design Types, Activity & Discussion |
| 10:00-10:15 | BREAK |
| 10:15-10:30 | Sample Size and Power |
| 10:30-12:00 | Group activity: Examples using free software; Power for group randomized trials, multi-site trials, repeated measures studies, and combinations of these, especially, multi site group randomized - common in Educational interventions; Using design and statistical adjustment to increase power |
| 12:00 – 1:30 | Lunch * |
| 1:30-2:15 | Issues in Trial Implementation |
| 2:15-2:35 | Group Discussion: In Theory vs. In Practice: The Research Pipeline |
| 2:35- 2:45 | BREAK |
| 2:45-3:15 | Introduction to Analytic Issues |
| 3:15-3:30 | Embedded Designs (Focus Groups, Mixed Methods) |
| 3:30-4:15 | Issues Specific to Clinical Trials - Optional Attendance |
| 4:15-4:45 | Q&A |
| 5:45 | Free Bus to Downtown Departs |
| 8:45 | Free Bus returns from Downtown |
| Wednesday | June 5, 2013 |
| 9:00-9:15 | Brief Introduction to Analysis of RCTs |
| 9:15-9:45 | RCT Analysis Examples (Basic) |
| 9:45-10:00 | RCT Analysis Examples (Intermediate) |
| 10:00-10:15 | RCT Analysis Examples (Advanced) |
| 10:15-10:30 | BREAK |
| 10:30-10:45 | Advanced Topics: Meta Analysis, Group Activity |
| 10:45-12:00 | Advanced Topics: RCTs and SEM (Guest Lecture) |
| 12:00 – 1:30 | Lunch * |
| 1:30-2:15 | Advanced Topics: RCTs and SEM, testing mediation (continued) |
| 2:15-2:30 | BREAK |
| 2:30-3:00 | Group Activity: Study Design |
| 3:00-4:15 | Ethical Issues & Group Discussion |
| 4:15-4:45 | Q&A |
| 5:45 | Free Bus to Downtown Departs |
| 8:45 | Free Bus returns from Downtown |
| Thursday | June 6, 2013 |
| 9:00-12:00 | Guest Speaker 1 |
| 12:00 – 1:00 | Lunch * |
| 1:30-4:30 | Guest Speaker 2 |
| 4:15-4:45 | Q&A |
| 5:45 | Free Bus to Downtown Departs |
| 8:45 | Free Bus returns from Downtown |
| Friday | June 7, 2013 |
| 9:00-9:15 | Overview of alternatives for RCTs |
| 9:15-10:15 | Regression Discontinuity (Guest lecture) |
| 10:15-10:30 | BREAK |
| 10:30-11:30 | Modern Missing Data Approaches and Missing Data Design for RCTs |
| 11:30-12:00 | Writing & Reporting |
| 12:00 – 1:30 | Lunch * |
| 1:30-3:00 | Wrap up, Conclude, Individual consultations |
* Our group lunch is included in the Holiday Inn room rate and tickets for the group lunch are also available for purchase for those not staying at the Holiday Inn. There are other lunch options in Lawrence as well.
Course Files
Below are links to course files for those who enrolled in the course. The files are password protected to respect the intellectual property rights of the instructors. By using your login information you agree not to share your login information or the content protected by it.
Coming soon.
Contact Information
For information on course content, contact Amber Watts or Chantelle Dowsett.
A full list of prices and fellowship opportunities for this course and all the courses offered at this year's Summer Institutes in Statistics can be found on the Fees and Registration Page.