Turning a Good Idea Into a Great Research Project: How to get Started

1. Turning a Good Idea Into a Great Research Project: How to get Started James R Miner MD Research Director Department of Emergency Medicine Hennepin County Medical Center John H. Burton, MD Chair Department of Emergency Medicine Carillion Clinic

2. Ideas: Research Questions • Its easy to think of good research questions in Emergency Medicine

3. Origins of the Research Question • Usually emerge based on the findings of previous work • “Although a fresh perspective can sometimes be useful by allowing a creative person to conceive new approaches to old problems, lack of experience is largely an impediment” Steven Hulley MD

4. Mastering the literature • Scholarship is an important part of good research • Research that does not recognize previous work in the area that applies to is very likely to be poorly done • The mastery of a subject also entails participating in meetings and building relationships with experts in the field

5. Being Alert to New Ideas • Have a skeptical attitude about prevailing beliefs • Remember that the application of new technologies often generates new insights and questions about familiar clinical problems • Attend conferences and listen to things you don’t agree with

6. Keep the Imagination Roaming • Carefully Observe your patients • Teach • Be Creative in your approach to old questions • Have Tenacity: Don’t give up on things that “can’t be done”

7. Everyone in Academic EM can claim slides #4-6

8. Characteristics of a Good Research Question • FINER • Feasible • Interesting • Novel • Ethical • Relevant

9. Feasible • Number of subjects • Technical expertise • Available time and money • Manageable in scope

10. Interesting • To the investigator • Is this a logical and important step in building a career or in getting to the truth of an important scientific matter? • To everyone else • Will anyone care to read this if its written up?

11. NOVEL • Can be determined by reviewing the literature and the CRISP database • Confirmatory studies are only necessary • To determine if a new methodology can be reproduced • to measure external validity in a different setting • to avoid weaknesses noted in previous studies

12. Ethical • This is a whole other lecture, but usually you don’t need a degree in ethics to tell

13. Relevant • Most important aspect • How will the various possible outcomes of a study advance knowledge, guide further research, or change clinical practice

14. Idea Summary

15. 1. Startwith a good idea2. Ask ifanyoneelse cares and ‘whowillpublishit?’3. Researchthe idea exhaustively4. Say ‘NO’ tounpublishable ideas Be Warren Buffett: Choose Your Investments/Ideas Wisely

16. Methods

17. Developing the Research Question and Study Plan • The question is not feasible • Too broad • Narrow the question • Not enough Subjects available • Expand inclusion criteria • Decrease the sample size you need • Methods beyond the skills of the investigator • Collaborate • Review the literature • Learn the skills • Too expensive • Decrease sample size and simplify measurements

18. Developing the Research Question • Not Novel • Modify the research question • Not Ethical • Modify the research question • Not relevant • You can’t fix this • Too Vague • Write the research question first • Stick to the question

19. Primary and Secondary Questions • Many studies have more than one question • One question needs to drive the study • Multiple questions don’t work for statistics as they are designed today • If you ask 20 random questions with random data and use the same test on all of them, one will be statistically significant

20. What is the Question? • The 4 elements of Well-built clinical Questions (PICO) • Patient or problem • Intervention (independent variable) • Comparison (measurement device) • Outcome (dependent variable)

21. A research question • What is the best treatment for acute asthma exacerbations?

22. What is the Study? Is continuous albuterol better than intermittent albuterol for the treatment of acute asthma exacerbations?

23. Who are the study subjects Is continuous albuterol better than intermittent albuterol for the treatment of adult ED patients with acute asthma exacerbations?

24. What is the intervention? Does continuous nebulized albuterol (10 mg/hr) results in better outcomes than intermittent nebulized albuterol (2.5 mg q 30 min) for the treatment of ED adult patients (18 – 40yrs.) with acute asthma exacerbation

25. What is the comparison and outcome? Does continuous nebulized albuterol (10 mg/hr) result in better outcomes, in terms of increased PEFR and admission rates at four hours, than intermittent nebulized albuterol (2.5mg q 30 min) for the treatment of ED adult patients (18 – 40 yrs) with an acute asthma exacerbation of less than 8 hours and presenting with a PEFR of <200, after one 2.5 mg albuterol treatment?

26. Funding • Cheaper is better! • It will take years to establish funding: • Department Discretionary Funds • Hospital/University Internal Grants/Funds • Local Organizations/Foundations • National Foundations • Government/NIH

27. Methods Summary Don’t be anEmergencyPhysician…,FOCUS

28. 1. Hypothesis, hypothesis, hypothesis2. Don’tstudythingsyoucan’tstudy3. Smaller/Tighterisbetter Focus

29. Research Design

30. Research Design • Know the basic types • Know the pros and cons of each • Look to the literature for good examples of each • Use reference texts

31. Design Implementation Research Question Study Plan Actual Study errors Truth in the Universe Truth in the Study Findings in the Study inference inference

32. Research Design • Errors in research design cause errors in the application of information from the study to reality (inference)

33. Conclusion • Appropriate Designs yield information that can be inferred to clinical practice • Inappropriate designs yield data

34. Design Summary You are a person of many great ideas…

35. Unfortunately, it’snotpracticalforallyourgreat ideas togetpublished….Maybe ONE every 2 years?

36. Hail Mary Passes are Rarely Caught

38. Study Execution

39. Practical Aspects of EM Research • Clinical research is always a form of a “natural” experiment as it involves trying to make measurements in the “real world” • Clinical research is always imperfect and limited by the lack of full control over study subjects • The ED environment is particularly difficult and presents unique challenges

40. Unique Aspects of EM Research • Lack of control over patients how present • Lack of control over patient care resources • Less time for staff to correctly apply I/X criteria • Usually less staff knowledge about the specific study subject area

41. The Natural History of a Research Project • Conception is easier than birth • The “birth” is often problematic if not planned • There is usually a honeymoon period when the project has the affection of the staff • Enthusiasm quickly wanes • After 6 months no one remembers its name • 2 years later the data forms languish in a drawer

42. The Study Conception Process • Question should be interesting and relevant to the staff • Modify the question until its feasible • Realistic numbers of patients to answer the question • Adequate resources and time to complete • Don’t try to get more data than is necessary to answer the study question • When you ask for more you often get less

43. Recommendations • Field test the project before it is implemented • Don’t start the study until its ready (call it a pilot study first) • Get most of the work done at the beginning • Remind everyone frequently • Keep the machinery working • Embrace Failure

44. Recommendations • Investigators lead by example • Modify the protocol as needed • Eliminate data or steps that are not working as planned • Send out notices when the study has ended • Publish the results – that’s the next lecture • Its easier to repeat a project with improvements than publish a bad study

45. Collaborate with others who have similar interests

46. 1. Try topushyourstudy DOWNHILL2. Capitalizeonsuccess3. Keepthemomentumgoing4. Admitfailure Study Execution Summary

47. Final Thoughts • If a senior investigator yells at you when you present your research you’re onto something good • Its amazing what you can get done when you don’t worry about whose going to get the credit for it • You’re a CLINICAL researcher, don’t let funding stand in your way

48. ThankYouCORD!