Course Description
This 4-week distance learning elective designed to introduce 3rd and 4th year medical students to the concepts and methods of clinical research.
Course Objectives
- Explain the difference between internal and external validity and how each relates to the research question, study plan, and actual study.
- Analyze the components of a research question in terms of study design, predictor, outcome, and population and evaluate using the FINER criteria.
- Compare the different probability and nonprobability sampling methods.
- Analyze a study design in terms of target population, accessible population, sampling scheme, and generalizability.
- Explain the difference between dichotomous, nominal, ordinal, continuous and discrete numerical variables.
- Explain the difference between precision and accuracy, how they are related to different types of bias, and how this affects validity.
- Analyze the difference between cross-sectional, cohort, and case-control studies and the strengths and weaknesses of each.
- Select a study design that is appropriate a clinical research question.
- Analyze the components of a randomized trial and design one to answer a hypothetical research question.
- Explain the concept of the null hypothesis, alternative hypothesis, one-sided and two-sided tests, and power.
- Estimate sample size for a desired power and statistical significance.
- Compare explain different statistical methods, including Student’s T test, ANOVA, Chi square, linear correlation, simple and multiple regression.
- Develop a research question and perform a relevant literature search.
- Optional: start writing manuscript for a case report
Student Learning Outcomes
- Apply understanding of the material covered to answer weekly questions.
- Apply the concepts of this course to critically analyze medical literature.
- Perform basic statistical analysis and power calculations.
Student Expectations
- Turn in assignments on time.
- Attend weekly virtual meetings.
Evaluation Methods
- Weekly questions and practice problems
- Writing assignment – case report
Textbook Information: Hulley, Stephen. Designing Clinical Research, 4th Edition, Lippincott Williams & Wilkins, 2013.
Course Calendar
Week 1: Process of Research
- Learning objectives 1-6
- Topics:
- Developing a research question
- Introduction to study design
- Choosing study subjects: specification, sampling, recruitment
- Planning measurements: precision, accuracy, and validity
- Reading assignments: DCR, ch. 1-4
Week 2: Types of Studies
- Learning objectives 7-9
- Topics:
- Cross-sectional studies
- Case-control studies
- Clinical trials
- Types of studies
- Reading: DCR, ch. 7,8,10
Week 3 – Statistical Methods
- Learning objectives 10-12
- Topics:
- Estimating sample size and power
- Statistical methods
- Reading: DCR, ch. 5,6 and additional content provided by instructor
Week 4 – Literature Searches, Paper Writing, Grant Writing
- Learning objectives 13-14
- Topics:
- Literature searches
- Writing the manuscript
- Submitting for publication
- Grant writing
- Reading: DCR, ch. 19 and additional content provided by instructor
How to Apply
Instructor
Edward Durant, MD, MPH, FACEP
For more information and to apply to this elective, contact Sherry Sandoval – Program Coordinator – sherry.a.sandoval@kp.org