An On-line Statistics Course in a Bioethics Curriculum

1. An On-line Statistics Course in a Bioethics Curriculum Jane E. Oppenlander, Ph.D. Assistant Professor The Bioethics Program Union Graduate College-Mt. Sinai School of Medicine oppenlaj@uniongraduatecollege.edu

2. The Field of Bioethics • A relatively new field, bioethics deals with ethical issues that arise in biomedical research, clinical medicine and health policy. • Bioethics is interdisciplinary incorporating perspectives from medicine, law, philosophy, and religion. • Bioethicists are employed in health-related fields like administration, public policy, teaching, research, hospital and research ethics committees, and legal work. • Bioethics is largely a qualitative field, but there are opportunities for the application of quantitative methods.

3. “Empirical Research Methods in Bioethics” • Elective in a hybrid online-onsite 12-course Masters program designed for working professionals. • On-line course, delivered asynchronously over 11 weeks using a Moodle-based platform. • Class size of 2-8. • Great diversity in student backgrounds: • 40% work in clinical health care, 40% in administration, research, policy and law, and 20% are direct from undergraduate studies. • Wide variation in previous exposure to statistics, from no experience to published empirical research articles. • Global program with students residing in North America, Asia, and Europe. • Average age: 41

4. Course Objectives • Develop competence and confidence to read empirical literature in bioethics and medicine. • Solid understanding of descriptive statistics and basic statistical inference (tests of hypothesis and confidence intervals). • Develop skills to learn new quantitative methods independently. • Design studies and collect data to advance biomedical research, clinical medicine and health policy. • Become effective collaborators on research teams and consult with statisticians.

5. Course Content and Organization • Course follows the lifecycle of an empirical research study. • Organized into three sections: • Empirical Research Study Design (3 weeks) • Collecting Qualitative and Quantitative Data (3 weeks) • Analyzing Data and Interpreting Results (5 weeks) • Course activities emphasize “learning by doing” • Individual assignments • On-line discussions • Final project – empirical research study proposal • No exams or group assignments • Course resources: • Two required texts, abundant supplement material including on-line tutorials, published articles from bioethics and medicine

6. Getting Started • Pre-class survey to ascertain previous background and experience. • First assignment assesses student competency. • Read two bioethics empirical articles and make a list of all terms that are unfamiliar (medical and statistical). • Lists used to start a Wiki* of Empirical Research Terms. Students populate the wiki throughout the course. (See example) • First discussion motivates an appreciation for the difficulty of conducting empirical research. • Design and conduct an experiment from a vague problem statement. * A Web site developed collaboratively, allowing any participant to add and edit content.

7. Empirical Research Study Design • Topics Covered • Stages in the empirical research process, types of studies, problem specification, measurement, sampling. • Written Assignments • Proposal for final project • Read two journal articles – a randomized controlled trial and a cohort study. Compare and contrast the study populations and sampling methods. • Discussion Activity • Boiling water experiment – How long does it take to boil water?

8. Collecting Qualitative and Quantitative Data • Topics Covered • Question and response construction, techniques to maximize response, survey deployment and execution, ethical guidelines for handling data. • Written Assignment • Construct a 10-15 question survey and implement it in SurveyMonkey. • Discussion Activities • Conduct a structured interview. • Pilot surveys and provide feedback to classmates.

9. Analyzing Data and Interpreting Results • Topics Covered • Descriptive statistics, basic statistical inference (hypothesis testing and confidence intervals), evidence based medicine measures, critical evaluation of published literature • Written Assignments • Create two PowerPoint slides with descriptive statistics and graphs from a data set. • Problem set calculating evidence-based medicine measures • Read an empirical paper and summarize the statistical findings in lay language. • Discussion Activities • Wiki - Revisit papers read and continue to populate the Wiki. • Vioxx Meta-analysis

10. Challenges and Strategies to Address Them

11. The Future of a Statistics Course in a Bioethics Program • Anticipate growing use empirical methods to address issues in health care delivery and policy. • For example: “Does a clinical ethics consultation service reduce health care costs at end-of-life?” • This course prepares students for a growing and dynamic field by: • Providing a solid, practical foundation in basic statistical inference and data collection procedures. • Teaching skills to learn new quantitative methods independently. • Course content will need to evolve as the field of bioethics matures.