1. Research Curriculum Session I – Developing A Research Question Jim Quinn MD MS Research Director, Division of Emergency Medicine Stanford University

2. Overview Review the purpose of the curriculum Review 5 page protocol concept Discuss the components of a good research question Becoming an “expert” Writing a significance section Homework for the next session Using EndNote

3. Research Curriculum Structure and Support to Develop Your Idea Curriculum (tried and tested) -12 hours – 6 sessions with core reading and homework designed to develop your project Textbook -“Designing Clinical Research” - Hulley and Cummings - small paperback readable Help identify mentors and sources of data

4. The Five Page Protocol Goal for the Research Curriculum Concise protocol -More concise than an NIH submission, but often sufficient for small intramural grants -Discipline your approach to planning the study -Provide the materials and answers for IRB submission -Completed by the end of first year

5. Organization- The Five Page Protocol Goal for the Research Curriculum Page One - Title, Specific objectives (Question), significance section Pages Two- Five DesignSubjectsVariables Statistical Issues -data management, timetable, ethical considerations ReferencesAppendices

6. Conceiving the Question Be alert -Read the literature -Conferences -New technologies -Have a skeptical attitude Master the literature – Become an “expert” -Find mentors with experience in the area you want to explore -EM “sub-specialist”

7. Characteristics of a Good Question Feasible Interesting Novel Ethical Relevant Must Pass the “So What” Test!

8. Feasible Is it Practical? Number of Subjects Technical expertise, resources AffordableScope -Narrow the question, strategies for sample size reduction, research training, mentors, appropriate follow-up

9. Interesting To the investigators To others - Consult with mentors, change the question

10. Novel Will it contribute new information Challenge old dogma -Important to review the literature “become an expert” -Consult with mentors who are experts For previously done studies -Can study be replicated in a different population? -Improved methodology, research techniques?

11. Ethical Does the study pose unacceptable physical risk? Risk to privacy? -Consult with IRB -Familiarize one self with HIPAA

12. Relevant How may the outcomes effect: -Clinical practice -Health Policy -Future Research

13. Question Format One - two sentence, clearly stated - It is what your study or conclusions should answer. “Does “X” “clearly defined” cause or associated by Y “clearly defined” E.g. “Do hand lacerations require suturing” Properly stated: “ Do simple (not involving joints tendons or fractures) hand lacerations (distal to volar crease) < 2 cm that present to the ED for treatment have similar cosmetic outcomes when treated conservatively (no sutures) compared to suture treatment.”

14. Significance Section (One Page, Four Paragraphs) 1) Magnitude of the problem - Number of individuals afflicted, cost to society 2) What is Known? - Previous studies, consensus panels, expert recommendations 3) What is Not Know? (Controversial) - Previous studies, experts 4) How your study will contribute answering what is not known?

15. Significance Section Thorough Literature Search (PubMed, article references) -Read relevant articles -Contact potential experts (local, national, international) Scholarly Writing Organizing literature search Reference Database Bibliographic Software (ProCite, EndNote)

16. Next Session - Assignment September 15 th, 2004 Come up with a research question Do a literature search Write a one page significance section - Hand in 1 page with question and referenced significance section 2 nd hour group discussion to review individual questions and sections Read section on subjects, variables and outcome measures – 1 st hour lecture