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This guide outlines essential steps for designing a research study focusing on knee interventions, such as knee arthroplasty and arthroscopy. It highlights the importance of generating study ideas, refining them using the PICO framework (Patients, Intervention, Comparison, Outcome), and conducting thorough literature reviews. Key aspects include determining the patient population, evaluating ethical considerations, ensuring team expertise, and assessing financial support. Additionally, tips for effective literature searches, patient enrollment strategies, and study timeline management are discussed to facilitate a successful research project.
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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.