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Research: The Journey Begins

Research: The Journey Begins. MAJ Chad Asplund, MD, MD U.S. Army Eisenhower Army Medical Center. Objectives. Where does research start? Clinical Question Research Question Pitfalls Tips for success. Research Process. Step 1 – Come up with an idea (Clinical Question)

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Research: The Journey Begins

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  1. Research: The Journey Begins MAJ Chad Asplund, MD, MD U.S. Army Eisenhower Army Medical Center

  2. Objectives • Where does research start? • Clinical Question • Research Question • Pitfalls • Tips for success

  3. Research Process • Step 1 – Come up with an idea (Clinical Question) • Step 2 - Formulate a rough research question • Step 3 - Search the literature (What has been done?) • Step 4 - Focus the research question • Step 5 - Design the study • Step 6 - Refine the specific aims and objectives of the study

  4. RESEARCH IDEA Why should women take HRT after menopause… • The fun part • Research ideas should occur frequently and be pursued rarely. • “Every great advance in science has issued from a new audacity of imagination.” John Dewey

  5. IDEA CREATIVE IMPULSIVE EXCITING UNDEFINED UNVERIFIED UNVALIDATED NO LIMITS QUESTION METHODICAL CONSIDERED RESERVED FINITE VERIFIABLE VALIDATED LIMITED TIME PERIOD FIXED BUDGET MOVING THE RESEARCH IDEA TO A QUESTION

  6. Question Should women take hormones after menopause? • Uncertainty about something in the population that you want to study • Difficulty in finding an important question that can be transformed into a feasible and valid study plan

  7. Question – Then What • Master the literature – what is already out there • Find a mentor for help • Use your imagination • Once imagined – use the PICO criteria.

  8. PICO Criteria • Population– How would I describe a group of patients similar to mine? • Intervention (exposure) – Which intervention am I considering? • Comparisons– What is the main alternative to the intervention? • Outcomes – What do I hope to accomplish? What does the intervention affect?

  9. Detective Work • Review and evaluation of literature. • allows you to ask a better question • defines the questions that came before • provides insights and methodology • identifies potential mentors/collaborators • tells you what their next questions were

  10. Literature Review • MEDLINE • EMBASE • Google • Librarian • Secondary resources: • ACP Journal Club • POEMS • FPIN • The Cochrane Library

  11. MEDLINE Strategy: Does taking estrogen after menopause lower the likelihood of developing CHD?

  12. RESEARCH QUESTION • The challenge is to ask a research question that is important, specific, and answerable by an investigation or experiment. • In order to ask a good question, carry out the study in your mind. • The Virtual Investigation - essential for refining the research question and moving toward an hypothesis. • Involve a statistician early – BEFORE starting to collect data • The Columbus Dispatch, April 16th: • “Lack of Brains Hinders Research”

  13. FINER Criteria F-I-N-E-R • FEASIBLE - it can be answered. • INTERESTING - you are enthusiastic. • NOVEL - it breaks new ground. • ETHICAL - no harm to subjects. • RELEVANT - the “So What” test. Hulley, Newman and Cummings, 1988

  14. FINER Criteria • Feasible • • Adequate number of subjects • • Adequate technical expertise • • Affordable in time and money • • Manageable in scope • Interesting • • Interesting to the investigator

  15. FINER Criteria • Novel • • Confirms or refutes previous findings • • Extends previous findings • • Provides new findings • Ethical • Relevant • • To scientific knowledge • • To clinical and health policy • • To future research directions

  16. So What? • What is the benefit of answering your research question? • Who will it help (and how)? • If you cannot make a definitive statement about the purpose of your research, think again….forget about it…

  17. Focused Research Question What are the effects of treatment with estrogen plus progesterone on LDL levels in post menopausal women? • • Aids in the development of hypotheses • • Aids in the development of a • conceptual or theoretical framework • • Aids in clarifying relationships among • variables

  18. Research Hypothesis There will be a greater decrease in LDL levels in the hormone treated group than in the placebo group. • Derived from the research question • Declarative statement • Predicts how phenomena are related • Can be subjected to empirical study

  19. Study Design • Complex part • Seek assistance • Passive – observational • Apply intervention – clinical trial

  20. Study Design • Useful to characterize design: • “This is a cross-sectional study of the prevalence of estrogen treatment among women aged 50-69 years, followed by a prospective cohort study of whether estrogen is associated with low risk of subsequent heart attacks”

  21. Keys to a Good Research Experience • Qualified, interested, experienced mentor. • Stable, nurturing research environment. • Given independence - • But, highly supported. • Realistic expectations. • Stable funding. • Opportunity for continuing involvement.

  22. Pitfalls • Don’t make a simple study difficult • Unwanted questions • Have sufficient commitment • Genuine interest • Assess practicality • Think about likely difficulties

  23. Questions?

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