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 1

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. 2

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 3

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. 4

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 5

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. 6

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? 7

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. 8

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 9

10. Challenges and Strategies to Address Them ChallengesStrategies Student diversity in statistical backgroundOffer advanced students the option to learn statistical software (JMP) or pursue advanced topics independently in lieu of basic statistics. Student diversity in work experience and profession - Wikis for research terms and resources (both medical and statistical). - Discussions allow sharing of experiences and discipline-specific knowledge. Replacing classroom interaction in an on- line asynchronous format Five on-line graded discussions evaluated on timeliness, frequency, and quality. How can non-statisticians discuss statistics on-line? Discussions center on experiences with data collection activities, not statistical methods. Experienced statistics teacher learning the bioethics field Shadow a clinical ethicist, frequent interaction with colleagues, attend bioethics workshops. Very small classes make on-line discussion difficult Tailor discussion topics to student needs when there are only 2-3 students. 10

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. 11