The Research Process and the Scholarly Project (at UHCMC) an overview Vicken Y. Totten MD MS FACEP 1

Objectives: Give you an overview of how the process works Give you an overview of how the process works This is UHCMC specific This is UHCMC specific Moderately generalizable Moderately generalizable 2

All research starts with a question Well formed question Well formed question PICO PICO FINER FINER Other formats Other formats 3

What is known about the topic? Literature review Literature review A skill in itself A skill in itself You may refine your question after you search the database You may refine your question after you search the database 4

The literature search We will teach you more about it We will teach you more about it Where to look and how Where to look and how KEEP a record of your strategy KEEP a record of your strategy Keep copies of the citation, the abstract and the articles that you think are most relevant Keep copies of the citation, the abstract and the articles that you think are most relevant This is the “background and introduction” This is the “background and introduction” 5

Refine your question again. Why bother? – this is also part of your background and introduction. Why bother? – this is also part of your background and introduction. “Who cares?” test “Who cares?” test Written as the “Importance” Written as the “Importance” 6

Consider your study design. Prospective or retrospective? Prospective or retrospective? Patient contact or database contact? Patient contact or database contact? Control group? Control group? Statistics? Statistics? 7

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. 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. 8

Start writing your protocol There are a number of templates There are a number of templates Ask me. Ask me. Or use your own. Or use your own. This is your methods section This is your methods section 9

Resources What resources do you have? What resources do you have? What can you get? What can you get? Who can get you more? Who can get you more? 10

Ask your friends You would much rather have your friends tear apart your study than your enemies.] You would much rather have your friends tear apart your study than your enemies.] Start your study manual Start your study manual Gather your co-investigators and RAs. Gather your co-investigators and RAs. Make sure everyone has CITI and correct accesses Make sure everyone has CITI and correct accesses 11

Re-write your protocol Proof read it Proof read it Put it into UH IRB format Put it into UH IRB format By this tme, you have mostly written the final paper. 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 Put “we expect to find” instead of “we found” but put in the statistical tests and the tables and confidence ranges you want 12

Enter your protocol into iRIS You will be assigned a study reviewer You will be assigned a study reviewer It is reasonable to find out who that person is, and talk to them. It is reasonable to find out who that person is, and talk to them. Make nice. Make very nice. Make nice. Make very nice. 13

Wait. Wait. Wait. 14

Revise your protocol per “stipulations” Then do it again. Then do it again. 15

Get approved! DON’T gather any data until you have IRB approval. 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. 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. 16

Gather data This is where the EMRD can really help you This is where the EMRD can really help you 17

Once you have your data, what do you do with it all? Databases Databases RedCAP RedCAP Excell Excell Axess Axess The paper copies – keep ‘em forever The paper copies – keep ‘em forever 18

Analysis Now, aren't you glad you got your statistician's input early? Now, aren't you glad you got your statistician's input early? Run the analysis Run the analysis Interpret the analysis Interpret the analysis 19

Write up you work The exact format you may need depends on what journal you plan to send it to. 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. 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 “KISS” Keep it Short and Simple 20

Expect rejection 21

Re-submit. “There is no un-publishable article, just one that hasn’t found the right journal yet.” “There is no un-publishable article, just one that hasn’t found the right journal yet.” 22