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The Research Process and the Scholarly Project (at UHCMC) an overview. Vicken Y. Totten MD MS FACEP. Objectives:. Give you an overview of how the process works This is UHCMC specific Moderately generalizable. All research starts with a question. Well formed question PICO FINER
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The Research Processand the Scholarly Project(at UHCMC)an overview Vicken Y. Totten MD MS FACEP
Objectives: • Give you an overview of how the process works • This is UHCMC specific • Moderately generalizable
All research starts with a question • Well formed question • PICO • FINER • Other formats
What is known about the topic? • Literature review • A skill in itself • You may refine your question after you search the database
The literature search • We will teach you more about it • Where to look and how • KEEP a record of your strategy • Keep copies of the citation, the abstract and the articles that you think are most relevant • This is the “background and introduction”
Refine your question again. • Why bother? – this is also part of your background and introduction. • “Who cares?” test • Written as the “Importance”
Consider your study design. • Prospective or retrospective? • Patient contact or database contact? • Control group? • Statistics?
Consult your statistician • You should know what variables you want to gather, how you want to code them and how you plan to analyze them before you even consider submitting a protocol to the IRB.
Start writing your protocol • There are a number of templates • Ask me. • Or use your own. • This is your methods section
Resources • What resources do you have? • What can you get? • Who can get you more?
Ask your friends • You would much rather have your friends tear apart your study than your enemies.] • Start your study manual • Gather your co-investigators and RAs. • Make sure everyone has CITI and correct accesses
Re-write your protocol • Proof read it • Put it into UH IRB format • By this tme, you have mostly written the final paper. • Put “we expect to find” instead of “we found” but put in the statistical tests and the tables and confidence ranges you want
Enter your protocol into iRIS • You will be assigned a study reviewer • It is reasonable to find out who that person is, and talk to them. • Make nice. Make very nice.
Revise your protocol per “stipulations” • Then do it again.
Get approved! • DON’T gather any data until you have IRB approval. • You MAY, however, perform “activities preparatory to research” including refining your survey, creating your database, gathering the opinion of various potential subjects and so on.
Gather data • This is where the EMRD can really help you
Once you have your data, what do you do with it all? • Databases • RedCAP • Excell • Axess • The paper copies – keep ‘em forever
Analysis • Now, aren't you glad you got your statistician's input early? • Run the analysis • Interpret the analysis
Write up you work • The exact format you may need depends on what journal you plan to send it to. • Ask a couple of friends to help you cut it down. Whatever you wrote, half those words are unnecessary. • “KISS” Keep it Short and Simple
Re-submit. • “There is no un-publishable article, just one that hasn’t found the right journal yet.”