I need a research I need a research study…study…

Developing a study ideaDeveloping a study idea

Do you have any Do you have any ideas?ideas? ““I was thinking about the knee?”I was thinking about the knee?”

– What about the knee?What about the knee?– Arthroplasty? Fracture? Arthroscopy?Arthroplasty? Fracture? Arthroscopy?– ““I don’t know, just the knee…” I don’t know, just the knee…”

2 important (and 2 important (and difficult) steps in difficult) steps in designing a studydesigning a study Coming up with a study ideaComing up with a study idea Refining the ideaRefining the idea

Coming up with a Coming up with a study ideastudy idea

PP

II

CC

OO

atientsatients

nterventionntervention

omparisonomparison

utcomeutcome

PatientsPatients

What is your patient population?What is your patient population?– InjuryInjury– AgeAge– GenderGender– TreatmentTreatment

InterventionIntervention

Therapeutic? Treatment – Therapeutic? Treatment – technique, technique,

devicedevice Prognostic? Ability to predict Prognostic? Ability to predict

outcome-outcome-

smoking, diabetessmoking, diabetes Diagnostic? Define diagnostic Diagnostic? Define diagnostic

procedure procedure

ComparisonComparison

Is there a comparison group?Is there a comparison group?– Control groupControl group– Some studies may not have a Some studies may not have a

comparison groupcomparison group

OutcomeOutcome

What outcomes are you looking What outcomes are you looking for?for?– UnionUnion– InfectionInfection– ComplicationsComplications– QOLQOL

Refine your questionRefine your question

Is the answer already known?Is the answer already known?– Literature Search Literature Search

Can I enroll enough patients?Can I enroll enough patients?– Based off of literature review, do Based off of literature review, do

sample size calculationssample size calculations Is the study ethical?Is the study ethical?

– Risk/benefits, IRB approvalRisk/benefits, IRB approval

Refine your questionRefine your question

Can we carry this out?Can we carry this out?– Does your study team have the Does your study team have the

expertise to do this studyexpertise to do this study Do I have time to finish this study?Do I have time to finish this study?

– What is your timelineWhat is your timeline Do you have the financial support?Do you have the financial support?

– What is your budgetWhat is your budget

Is the answer already Is the answer already known?known?

Literature SearchLiterature Search

I couldn’t find I couldn’t find anything on ….anything on ….

Or, there are 1000’s of Or, there are 1000’s of articles on …articles on …

VariablesVariables

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?

Where did you look?Where did you look?

Standard Internet SearchesStandard Internet Searches– GoogleGoogle– YahooYahoo

Google ScholarGoogle Scholar MedlineMedline

– OvidOvid– PubMedPubMed

Help from LibraryHelp from Library

PubMedPubMed

Free database, searchable from Free database, searchable from anywhereanywhere

Links to full-text articles (if on Links to full-text articles (if on campus, you can often link to the campus, you can often link to the article through the library’s article through the library’s subscription)subscription)

Can be very frustratingCan be very frustrating

Tips on PubmedTips on Pubmed

www.pubmed.govwww.pubmed.gov Plain language searchesPlain language searches Author SearchesAuthor Searches Boolean: AND, OR, NOTBoolean: AND, OR, NOT MeSH – Subject SearchesMeSH – Subject Searches

GHS library offers beginner and GHS library offers beginner and advanced training in PubMedadvanced training in PubMed

How do I get full-text How do I get full-text articles …articles … GHSNetGHSNet – A to Z – A to Z Request others from LibraryRequest others from Library

Can I enroll enough Can I enroll enough patients?patients? How many patients do you need?How many patients do you need? Based off of literature, need Based off of literature, need

sample size calculation. (Talk with sample size calculation. (Talk with statistician)statistician)

Need to know how many patients Need to know how many patients you may see. Would they enroll?you may see. Would they enroll?

Is the study ethical?Is the study ethical?

Risk/Benefit RatioRisk/Benefit Ratio– Does the benefit to the patient Does the benefit to the patient

outweigh the risks? Benefit to outweigh the risks? Benefit to society?society?

Equitable selectionEquitable selection IRB approvalIRB approval

Can we carry this out? Can we carry this out?

Is your study team Is your study team knowledgeable about this study? knowledgeable about this study?

How much “work” will it take to How much “work” will it take to enroll and follow a patient? Will enroll and follow a patient? Will your team be willing to enroll and your team be willing to enroll and follow patients?follow patients?

Can you change study plan to Can you change study plan to make it easier to carry out?make it easier to carry out?

Do I have time to finish Do I have time to finish this study? this study? What is the reasonable timeline What is the reasonable timeline

for finishing this study?for finishing this study? If I can’t finish it, is there If I can’t finish it, is there

someone else who can? Can you someone else who can? Can you change study design?change study design?

Do you have the Do you have the financial support?financial support? Are you requesting non-standard Are you requesting non-standard

of care tests/procedures?of care tests/procedures? Who will pay for these?Who will pay for these? Grants??Grants?? Can we adjust study idea to be a Can we adjust study idea to be a

more economical study?more economical study?

ScopeScope

Now…Now…– What are the specific aims of you What are the specific aims of you

study?study?

Any questions?Any questions?

Disclaimer:Disclaimer:

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