From clinical observation to research study design: THINKING LIKE A SCIENTIST. What can I get published??. Objectives for the day: By the end of the seminar the participant will have Applied the 5 Why’s to a clinical research question. Developed an innovative and novel research question.
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From clinical observation to research study design:THINKING LIKE A SCIENTIST
What can I get published??
Objectives for the day: By the end of the seminar the participant will have
Applied the 5 Why’s to a clinical research question.
Developed an innovative and novel research question.
Begun the process of moving from a research question to designing a research project.
The Problem: Your car will not start.
1- Why? - The battery is dead.
2- Why? - The alternator is not functioning.
3- Why? - The alternator belt has broken.
4- Why? - The alternator belt was well beyond its useful service life and not replaced.
5- Why? - The vehicle was not maintained according to the recommended service schedule. (a root cause)
6- Why? - Replacement parts are not available because of the extreme age of the vehicle. (next step)
Start maintaining the vehicle according to the recommended service schedule. (5th Why solution)
Purchase a different vehicle that is maintainable. (6th Why solution)
The Problem: Children with severe sickle cell disease are not aggressively managed until after they have several re-current VOCs.
1- Why? – There is no way to identify them pre-emptively.
2- Why? – There are no serum or genetic markers identified.
3- Why? – The focus has been on vascular components of the disease and pain has been ignored as an expected downstream event instead of as a active event.
4- Why? – There has been an under-appreciation of the role of the nervous system peptidergic afferents in an over-lapping manner with vascular reactivity and pain.
5- Why? – Dogma was that peptidergic nervous system afferents have little to do with acute VOCs. (root cause)
So we have a novel and innovative area of research study if we look at VOCs and genetic markers from a pain-centric perspective.
Caveat: Getting funded can be hard if you are too far outside of the dogma.
1. Target Disorder
Step 1:Create a search strategy
Scenario: A 64 year old obese male who has tried many ways to lose weight presents with a newspaper article about ‘fat-blazer’ (chitosan). He asks for your advice.
PICO Question: In obsese patients, does chitosan, compared to a placebo, decrease weight.
Step 2: Convert PICO question into a search strategy
‘*’ is a truncation symbol that means further letters can be added to the word OR finds studies containing either of the specified words/phrases, and broadens your search AND finds studies containing both specified words/phrases, and narrows your search
Step 3: Searching
Comparison groups similar in prognostic factors
Follow –up complete
Analyzed according to starting allocation
How large was the treatment effect?
What was the relative risk reduction?
What was the absolute risk reduction?
How precise was the estimate of the treatment effect?
What were the confidence intervals?
Were the study patients similar to my population of interest? Does your population match the study inclusion criteria?If not, are there compelling reasons why the results should not apply to your population?
Were all clinically important outcomes considered? What were the primary and secondary endpoints studied?Were surrogate endpoints used?Are the likely treatment benefits worth the potential harm and costs?What is the number needed to treat (NNT) to prevent one adverse outcome or produce one positive outcome?Is the reduction of clinical endpoints worth the increase of cost and risk of harm?
Step 5: Study Design
How do you turn it into a fundable research project?
Identify potential funding sourceS.
Go after low hanging fruit first!
Use your new investigator advantage!
Identify your specific aims (typically 2-3)
Identify the key preliminary data you need to generate!
Plan to get your biggest BANG for your Buck!