Turning a Good Idea Into a Great Research Project: How to get Started
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Transcript of Turning a Good Idea Into a Great Research Project: How to get Started
Turning a Good Idea Into a Great Research Project:
How to get StartedJames R Miner MDResearch DirectorDepartment of Emergency MedicineHennepin County Medical Center
John H. Burton, MDChairDepartment of Emergency MedicineCarillion Clinic
Its easy to think of good research questions in Emergency Medicine
Ideas: Research Questions
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
Origins of the Research Question
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
Mastering the literature
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
Being Alert to New Ideas
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”
Keep the Imagination Roaming
Everyone in Academic EM can claim slides #4-6
FINER◦ Feasible◦ Interesting◦ Novel◦ Ethical◦ Relevant
Characteristics of a Good Research Question
Number of subjects Technical expertise Available time and money Manageable in scope
Feasible
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?
Interesting
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
NOVEL
This is a whole other lecture, but usually you don’t need a degree in ethics to tell
Ethical
Most important aspect How will the various possible outcomes of a
study advance knowledge, guide further research, or change clinical practice
Relevant
Idea Summary
1. Start with a good idea2. Ask if anyone else cares and ‘who will publish it?’3. Research the idea exhaustively4. Say ‘NO’ to unpublishable ideas
Be Warren Buffett:Choose Your
Investments/Ideas Wisely
Methods
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
Developing the Research Question and Study Plan
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
Developing the Research Question
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
Primary and Secondary Questions
The 4 elements of Well-built clinical Questions (PICO)◦ Patient or problem◦ Intervention (independent variable)◦ Comparison (measurement device)◦ Outcome (dependent variable)
What is the Question?
What is the best treatment for acute asthma exacerbations?
A research question
Is continuous albuterol better than intermittent albuterol for the treatment of acute asthma exacerbations?
What is the Study?
Is continuous albuterol better than intermittent albuterol for the treatment of adult ED patients with acute asthma exacerbations?
Who are the study subjects
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
What is the intervention?
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?
What is the comparison and outcome?
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
Funding
Don’t be an Emergency Physician…,
FOCUS
Methods Summary
1. Hypothesis, hypothesis, hypothesis2. Don’t study things you can’t study3. Smaller/Tighter is better
Focus
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
Research Design
Research Question Study Plan Actual Study
Truth in the Universe
Truth in the Study
Findings in the Study
Design Implementation
inferenceinference
errors
Errors in research design cause errors in the application of information from the study to reality (inference)
Research Design
Appropriate Designs yield information that can be inferred to clinical practice
Inappropriate designs yield data
Conclusion
Design SummaryYou are a person of many great ideas…
Unfortunately, it’s not practical for all your great ideas to get published….
Maybe ONE every 2 years?
Hail Mary Passes are Rarely Caught
Study Execution
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
Practical 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
Unique Aspects of EM Research
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
The Natural History of a Research Project
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
The Study Conception Process
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
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
Recommendations
Collaborate with others who have similar interests
Study Execution Summary1. Try to push your
study DOWNHILL2. Capitalize on success 3. Keep the momentum going4. Admit failure
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
Final Thoughts
Thank You CORD!