1. Biostatistics and Research Design, #6350 Introduction, Housekeeping

2. ’10-11Introduction and Overview Background: Jerry R. Paugh, O.D., Ph.D. OD, TOSU, 1979 MSc. TOSU, 1981 SCCO, ‘81-’88 Private Practice, ‘84- ’88 Allergan R&D, ‘87- ’93 PhD, Australia, ‘93- ’98 Allergan Surgical, ‘98-’01 SCCO, ‘01 to Present –Assoc Dean for Research To Date: –> 39 personal studies –> 32 student studies

3. ’10-11Introduction and Overview

4. ’10-11Introduction and Overview Philosophical Issues: What I Have Learned in 30+ years of research? 1.Never be afraid to get your hands dirty 2.Never be afraid to say “I don’t know” 3.Try to ask a good question!

5. ’10-11Introduction and Overview Instructor of Record: J Paugh Room 205 C; 2 nd floor, academic building (across from Drs. Ridder and LaMotte) Office hours: –Mondays: 11:00 – 12:00 – Thursdays: 11:00 – 12:00 Telephone: DO NOT CALL!!!!! –make an appointment!! Email: jpaugh@scco.edujpaugh@scco.edu Generally on campus: M-F, 8:15-5:00

6. ’10-11Introduction and Overview 6350: Grading Two midterms (25% each for 50% ), & final (30%; (cumulative!!!) –Multiple choice, some short answer –May read an abstract Pop (unscheduled) Quizzes: 5% (cumulative!!!) –To keep up, take load off big tests Homework: 15% –Only Two Assignments!: Find a project idea, and undertake a literature review –To take load off tests

7. ’10-11Introduction and Overview “Testable” Materials What Materials Will I Test From? –Lecture PPTs –Lecture handouts –The EndNote session and handouts –Written material (e.g. article pdfs) that I place in the student folder –Materials from ALL guest lecturers –Homework assignments What Materials Will I NOT Test From? –Board examples; these are to help illustrate the concepts –The reserve texts

8. ’10-11Introduction and Overview 6350: References Principal: Dawson and Trapp, Basic and Clinical Biostatistics, Fourth Edition, 2004 Supplemental: –Hatch, Ophthal. Res. And Epidemiology, 1998 –Greenberg et al., Med Epidemiology, 3 rd Ed., 2001 All: on reserve in the Library

9. ’10-11Introduction and Overview Housekeeping: Important!!! Lecture Switches; Attendance is Mandatory Dates: 1.March 16, Wednesday : EndNote Session: 1.Will use attendance here to help your grade if necessary 2.TBD : Dr. Schornack will lecture on Capstones and Surveys

10. ’10-11Introduction and Overview Overall Course Goals: To provide information that will directly apply to your student research requirements To provide research and epidemiological information to target NBEO requirements To provide tools for life-long learning

11. ’10-11Introduction and Overview 6350: Overview Provide the major components to assist the student research requirement Introduction to epidemiology Introduction to (review of) statistical methods Critical literature review (errors, bias, etc.) Understanding Study Design

12. ’10-11Introduction and Overview 6350: Core Competencies Finding and analyzing the ophthalmic literature (critique and properly cite) Generating a viable research question Designing a viable study-design Study validity: bias etc. Biostatistics-review Epidemiology: quantitative measures Research ethics and regulatory issues Major ophthalmic epidemiological studies Research in action: guest speakers, real examples

13. ’10-11Introduction and Overview Choose the Research Idea and Meet with Faculty Homework 1: Choose the Research Idea and Meet with Faculty Designed to help the research requirement process Choose a good/viable/nice partner; work is done in teams Choose an area of interest to you; if not interesting, it’s difficult to stay motivated Some ideas at the end of the first HW assignment Find this assignment in Student Shared Folder Due: March 16, 2011 (NB: Short timeframe!!!)

14. ’10-11Introduction and Overview Homework 2: Literature Review Why? Because most literature reviews for student projects are sub-par Because, if you are wise, you can use that as the beginning of your real student project Grading: –25%: style and flow (broad to narrow) –25%: appropriateness to topic –25%: did you critique the prior literature? Where are the gaps? –25%: proper literature citations (no non-peer reviewed references)

15. ’10-11Introduction and Overview Literature Review Homework 2: Literature Review Homework 2 is due on April 13, to Dr. Paugh’s mailbox (basic science building, main mailroom) Find this assignment in Student Shared Folder Work in Pairs Follows EndNote Seminar Topics: some suggested; ask Dr. Paugh if you have other ideas These skills are vital to Student Research Requirement

16. ’10-11Introduction and Overview Literature Review: Components Keep a narrow focus (vital; otherwise too much time wasted) Must critique the literature: –What was said in a given article? –What was not said, or not investigated? – , what are the unknowns? These can turn into a productive area of research Structure: start broad, narrow focus to one key issue or problem –Look at any article introduction for form

17. ’10-11Introduction and Overview Literature Review: Examples VT: Convergence Insufficiency and Home-based Therapy: –What procedures commonly used? –Evidence for efficacy? –Will children stay with the program to achieve success? –Are there different measures of “success” (e.g., symptom reduction, improved school performance, improved reading performance?) –Which are best? –As effective as office therapy?

18. ’10-11Introduction and Overview Literature Review: Examples Contact Lenses: Topic = Keratoconus and Best RGP Fit Approach –What fitting approaches are commonly used? –Evidence for efficacy or not?

19. ’10-11Introduction and Overview Literature Review: Examples Ocular Disease: Topic = Does gatifloxacin induce more or less corneal toxicity than moxifloxacin? –What evidence in general for either? –What methods were used to demonstrate? –Was there bias in any of the work (e.g., poor study design, industry sponsored, etc.)? –Were there methodological issues for the “proof”?

20. ’10-11Introduction and Overview Dr. Paugh’s Expectations Attend class Keep up Make an effort: learning is an active process

21. ’10-11Introduction and Overview Dr. Paugh’s Hopes That you will appreciate research a little more following this class That you will strive for the best possible research project: “to be the best that you can be” Goals: we tend to hit what we aim at

22. ’10-11Introduction and Overview “Chance Favors the Prepared Mind”, Louis Pasteur

23. ’10-11Introduction and Overview Next Lecture: Please look over Paugh et al., “Can a Pre-application Drop….. See Two-Page handout and pdf in Student Folder (anatomy of a research project)