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7. CourseWebsite http://weill.cornell.edu/education_and_training/foundations/

8. The Answer is the Question: identifying research question and hypothesesAl Mushlin, MD, ScMDepartment of Public HealthWeill Cornell Medical Center Sept 9, 2013

9. What’s the ? that “the ?” is the answer to? the answer: What is the most important part of clinical research?: “the ?”

10. The topics for this session • Most important : asking research question and identifying hypotheses • ………next most important? • prioritizing and selecting research questions • ……….and the third? • Turning research questions into testable hypotheses

11. Outline • Define clinical and translational research • Locate CR within spectrum of biomedical research • Asking research ?’s • Going from ?’s to hypotheses………and then to research

12. Patient Oriented Research “investigator directly interacts with human subjects…..” excluded are in vitro studies that utilize human tissues that cannot be linked to a living individual Epidemiological and behavioral studies Outcomes and health services research ………….to answer a clinical question The(NIH) Definition of Clinical Research

13. Spectrum of Clinical Research Care Delivery, Financing, Organization Biomedical/bench Outcomes research & clinical epidemiology or etiologic Epidemiology Health services research Controlled clinical trials molecule population What causes diseases and why? What might work? Under ideal circumstances, does the intervention work? What works best in “real world”? How much Does it cost? How can care be provided best and cost contained? Note: same ? sequence for prevention, dx, or management

14. Clinicaland Translational Research Laboratory Research Population Research T1 T3 &4 T2 Clinical Research

15. The Stages of Translational Research • making discoveries that impact health T1 • applying discoveries to studies in humans T2 • Logistics, feasibility, and cost-effectiveness of prevention, diagnosis, and treatment strategiesT3 • enhancing the adoption of best practices in the community T4

16. Spectrum of Clinical Research Care Delivery, Financing, Organization Biomedical/bench Outcomes research & clinical epidemiology or etiologic Epidemiology Health services research Controlled clinical trials molecule population What causes diseases and why? What might work? T1 Under ideal circumstances, does the intervention work? T2 What works best in “real world”? How much Does it cost? T2/T3 How can care be provided best and cost contained? T3 Note: same ? sequence for prevention, dx, or management

17. Good Research Questions Require: • Inquisitiveness/creativity/imagination • Focus, i.e., concern about the ‘big picture”+ an area of interest within it • Knowledge of the study topic • Literature review • Experience • Mentorship

18. The first step in asking questions is identifying the “problem in the universe” • Central issue that needs addressing • This drives the development of research questions • Related but more specific ?’s • Provides new insights/answers • Makes investigations possible

19. The Research Questionan example • Research questions should be: • a part of the puzzle and a part of the solution

20. FINER Criteria • F easible • I nteresting • N ovel • E thical • R elevant

21. Feasible • Adequate number of subjects • Adequate technical expertise • Affordable in time and money • Manageable in scope

22. Interesting • To the field • To you, the investigator

23. Novel • Confirms or refutes previous findings • Extends previous findings • Provides new insights

24. Ethical • Value of new knowledge justifies the study • Minimizes likelihood of harm to study subjects • Maintains confidentiality of data • Avoids conflicts of interest

25. Relevant • To scientific knowledge • To clinical and health policy • To future research • To you, the investigator

26. Going from good research questions to testable hypotheses • Frames the specific research question in ways that can be measured • specifies the interventions or factors of interest; the independent variables • Identifies the outcomes; the dependent variables • States the question in a way that is based on current scientific knowledge and, when answered, adds to that knowledge

27. A Hypothesis > H: The revision rate will be statistically and clinically higher for MOM than POM THRs Ho: no difference

28. Designing and Implementing a Research Project Sets the Stage for Drawing Conclusions RESEARCH QUESTION design implement Designing and implementing STUDY PLAN ACTUAL STUDY TRUTH IN THE UNIVERSE Drawing conclusions TRUTH IN THE STUDY FINDINGS IN THE STUDY infer infer

29. Clinical Research Designs

30. Key Steps In Research • Identify the “problem in the universe” • Define, prioritize, and select the research question and hypotheses • Choose the study design • Specify the study population • Develop astudy protocol • Construct an operations manual • Do the study/collect data • Analyze data • Communicate results

31. Outline of the Study Protocol