1. I need a research study… Developing a study idea

2. Do you have any ideas? “I was thinking about the knee?” “I was thinking about the knee?” –What about the knee? –Arthroplasty? Fracture? Arthroscopy? –“I don’t know, just the knee…”

3. 2 important (and difficult) steps in designing a study Coming up with a study idea Coming up with a study idea Refining the idea Refining the idea

4. Coming up with a study idea PICO atients ntervention omparison utcome

5. Patients What is your patient population? What is your patient population? –Injury –Age –Gender –Treatment

6. Intervention Therapeutic? Treatment – technique, Therapeutic? Treatment – technique, device device Prognostic? Ability to predict outcome- Prognostic? Ability to predict outcome- smoking, diabetes smoking, diabetes Diagnostic? Define diagnostic Diagnostic? Define diagnostic procedure procedure

7. Comparison Is there a comparison group? Is there a comparison group? –Control group –Some studies may not have a comparison group

8. Outcome What outcomes are you looking for? What outcomes are you looking for? –Union –Infection –Complications –QOL

9. Refine your question Is the answer already known? Is the answer already known? –Literature Search Can I enroll enough patients? Can I enroll enough patients? –Based off of literature review, do sample size calculations Is the study ethical? Is the study ethical? –Risk/benefits, IRB approval

10. Refine your question Can we carry this out? Can we carry this out? –Does your study team have the expertise to do this study Do I have time to finish this study? Do I have time to finish this study? –What is your timeline Do you have the financial support? Do you have the financial support? –What is your budget

11. Is the answer already known? Literature Search

12. I couldn’t find anything on …. Or, there are 1000’s of articles on …

13. Variables Where did you look? Where did you look? What did you look for? What did you look for? How did you look? How did you look?

14. Where did you look? Standard Internet Searches Standard Internet Searches –Google –Yahoo Google Scholar Google Scholar Medline Medline –Ovid –PubMed Help from Library Help from Library

15. PubMed Free database, searchable from anywhere Free database, searchable from anywhere Links to full-text articles (if on campus, you can often link to the article through the library’s subscription) Links to full-text articles (if on campus, you can often link to the article through the library’s subscription) Can be very frustrating Can be very frustrating

16. Tips on Pubmed www.pubmed.gov www.pubmed.gov www.pubmed.gov Plain language searches Plain language searches Author Searches Author Searches Boolean: AND, OR, NOT Boolean: AND, OR, NOT MeSH – Subject Searches MeSH – Subject Searches GHS library offers beginner and advanced training in PubMed

17. How do I get full-text articles … GHSNet – A to Z GHSNet – A to Z GHSNet Request others from Library Request others from Library

18. Can I enroll enough patients? How many patients do you need? How many patients do you need? Based off of literature, need sample size calculation. (Talk with statistician) Based off of literature, need sample size calculation. (Talk with statistician) Need to know how many patients you may see. Would they enroll? Need to know how many patients you may see. Would they enroll?

19. Is the study ethical? Risk/Benefit Ratio Risk/Benefit Ratio –Does the benefit to the patient outweigh the risks? Benefit to society? Equitable selection Equitable selection IRB approval IRB approval

20. Can we carry this out? Is your study team knowledgeable about this study? Is your study team knowledgeable about this study? How much “work” will it take to enroll and follow a patient? Will your team be willing to enroll and follow patients? How much “work” will it take to enroll and follow a patient? Will your team be willing to enroll and follow patients? Can you change study plan to make it easier to carry out? Can you change study plan to make it easier to carry out?

21. Do I have time to finish this study? What is the reasonable timeline for finishing this study? What is the reasonable timeline for finishing this study? If I can’t finish it, is there someone else who can? Can you change study design? If I can’t finish it, is there someone else who can? Can you change study design?

22. Do you have the financial support? Are you requesting non-standard of care tests/procedures? Are you requesting non-standard of care tests/procedures? Who will pay for these? Who will pay for these? Grants?? Grants?? Can we adjust study idea to be a more economical study? Can we adjust study idea to be a more economical study?

23. Scope Now… Now… –What are the specific aims of you study?

24. Any questions?

25. Disclaimer: I may use examples from my experience with previous or current residents. I will take all precautions not to identify any resident. (And trust me, if used in this presentation, there is most likely more than one offender.