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Research Curriculum Session I – Developing A Research Question

Research Curriculum Session I – Developing A Research Question. Jim Quinn MD MS Research Director , Division of Emergency Medicine Stanford University. Overview. Review the purpose of the curriculum Review 5 page protocol concept Discuss the components of a good research question

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Research Curriculum Session I – Developing A Research Question

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  1. Research CurriculumSession 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 CurriculumStructure 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 ProtocolGoal 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 ProtocolGoal for the Research Curriculum • Page One - Title, Specific objectives (Question), significance section • Pages Two- Five • Design • Subjects • Variables • Statistical Issues • data management, timetable, ethical considerations • References • Appendices

  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. FeasibleIs it Practical? • Number of Subjects • Technical expertise, resources • Affordable • Scope • 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 - AssignmentSeptember 15th, 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 • 2nd hour group discussion to review individual questions and sections • Read section on subjects, variables and outcome measures – 1st hour lecture

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