I need a research study… Developing a study idea
Do you have any ideas? • “I was thinking about the knee?” • What about the knee? • Arthroplasty? Fracture? Arthroscopy? • “I don’t know, just the knee…”
2 important (and difficult) steps in designing a study • Coming up with a study idea • Refining the idea
P I C O atients ntervention omparison utcome Coming up with a study idea
Patients • What is your patient population? • Injury • Age • Gender • Treatment
Intervention • Therapeutic? Treatment – technique, device • Prognostic? Ability to predict outcome- smoking, diabetes • Diagnostic? Define diagnostic procedure
Comparison • Is there a comparison group? • Control group • Some studies may not have a comparison group
Outcome • What outcomes are you looking for? • Union • Infection • Complications • QOL
Refine your question • Is the answer already known? • Literature Search • Can I enroll enough patients? • Based off of literature review, do sample size calculations • Is the study ethical? • Risk/benefits, IRB approval
Refine your question • Can we carry this out? • Does your study team have the expertise to do this study • Do I have time to finish this study? • What is your timeline • Do you have the financial support? • What is your budget
Is the answer already known? Literature Search
I couldn’t find anything on …. Or, there are 1000’s of articles on …
Variables • Where did you look? • What did you look for? • How did you look?
Where did you look? • Standard Internet Searches • Google • Yahoo • Google Scholar • Medline • Ovid • PubMed • Help from Library
PubMed • 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) • Can be very frustrating
Tips on Pubmed • www.pubmed.gov • Plain language searches • Author Searches • Boolean: AND, OR, NOT • MeSH – Subject Searches GHS library offers beginner and advanced training in PubMed
How do I get full-text articles … • GHSNet – A to Z • Request others from Library
Can I enroll enough patients? • How many patients do you need? • Based off of literature, need sample size calculation. (Talk with statistician) • Need to know how many patients you may see. Would they enroll?
Is the study ethical? • Risk/Benefit Ratio • Does the benefit to the patient outweigh the risks? Benefit to society? • Equitable selection • IRB approval
Can we carry this out? • 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? • Can you change study plan to make it easier to carry out?
Do I have time to finish 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?
Do you have the financial support? • Are you requesting non-standard of care tests/procedures? • Who will pay for these? • Grants?? • Can we adjust study idea to be a more economical study?
Scope • Now… • What are the specific aims of you study?
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.