Turning a clinical question Turning a clinical question into a testable hypothesis into a testable hypothesis Lauren A. Trepanier, DVM, PhD Lauren A. Trepanier, DVM, PhD Diplomate ACVIM, Diplomate ACVCP Diplomate ACVIM, Diplomate ACVCP Department of Medical Sciences Department of Medical Sciences School of Veterinary Medicine School of Veterinary Medicine University of Wisconsin-Madison University of Wisconsin-Madison ?? ?? ? ?
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Turning a clinical question into a testable hypothesis Lauren A. Trepanier, DVM, PhD Diplomate ACVIM, Diplomate ACVCP Department of Medical Sciences School.
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Turning a clinical question Turning a clinical question into a testable hypothesisinto a testable hypothesis
Turning a clinical question Turning a clinical question into a testable hypothesisinto a testable hypothesis
Lauren A. Trepanier, DVM, PhDLauren A. Trepanier, DVM, PhD
• Trust your clinical experienceTrust your clinical experience• Common diseasesCommon diseases• Clinical controversiesClinical controversies• Standards of practice in Standards of practice in
•Discussions with senior Discussions with senior facultyfaculty
Define the state of knowledge Define the state of knowledge Define the state of knowledge Define the state of knowledge
• Literature searchLiterature search• Multiple search termsMultiple search terms• Reference lists from papersReference lists from papers• Read full papers!!Read full papers!!•Beware abstracts that never Beware abstracts that never made it to peer reviewed pubsmade it to peer reviewed pubs
Define the knowledge gapDefine the knowledge gapDefine the knowledge gapDefine the knowledge gap
• Major conclusions from each paperMajor conclusions from each paper• Organize as a logical storyOrganize as a logical story•Why it is importantWhy it is important•What is known in humansWhat is known in humans•What is known in veterinary What is known in veterinary
species of interestspecies of interest
Refining the clinical questionRefining the clinical questionRefining the clinical questionRefining the clinical question
• What remains to be answered?What remains to be answered?• Does your question need Does your question need
revising?revising?• What do you think you will What do you think you will
find (your hypothesis)?find (your hypothesis)?
Framing your research approachFraming your research approachFraming your research approachFraming your research approach
• Research objectives, or aims, to Research objectives, or aims, to specifically test your hypothesisspecifically test your hypothesis• To compareTo compare• To determineTo determine• To evaluateTo evaluate• To characterizeTo characterize
• Drug treatmentDrug treatment• Surgical procedureSurgical procedure• Diagnostic assayDiagnostic assay
• What other care is allowed?What other care is allowed?•Avoid “clinician discretion” Avoid “clinician discretion” without guidelineswithout guidelines
InterventionInterventionInterventionIntervention
• Blinded vs. double blindedBlinded vs. double blinded• Applies to all evaluatorsApplies to all evaluators• OwnersOwners• Managing cliniciansManaging clinicians• Techs administering Techs administering
• Define a primary outcomeDefine a primary outcome• ObjectiveObjective• Easily measuredEasily measured• Clinically availableClinically available• Validated for your speciesValidated for your species• Relevant to clinical responseRelevant to clinical response
Dr. Noel Moens, GuelphDr. Noel Moens, Guelph
OutcomesOutcomesOutcomesOutcomes
• Subjective primary outcomesSubjective primary outcomes• Validated scoring systemValidated scoring system• Complement with objective Complement with objective
Dr. Duncan Lascelles, NCStateDr. Duncan Lascelles, NCState
OutcomesOutcomesOutcomesOutcomes
• Secondary outcomesSecondary outcomes• Less important?Less important?• May be harder to proveMay be harder to prove•Can generate further Can generate further hypotheseshypotheses• Add depthAdd depth
Sample size and powerSample size and powerSample size and powerSample size and power
• Both prospective and Both prospective and retrospective designsretrospective designs
• Need enough cases to Need enough cases to overcome variability overcome variability withinwithin groups to show groups to show a difference a difference betweenbetween groupsgroups
Healthy Dog GSH Sick Dog GSH0
1
2
3
4PP = 0.0004 = 0.0004
Viviano et al. Viviano et al. J Vet Intern MedJ Vet Intern Med. 2009 . 2009
Finalized PICOT research planFinalized PICOT research planFinalized PICOT research planFinalized PICOT research plan
• Still addresses the hypothesisStill addresses the hypothesis• Still relevantStill relevant• Feasible!Feasible!• Clinical expertiseClinical expertise• CaseloadCaseload• Support staffSupport staff• FundsFunds• Career time frameCareer time frame
Finalized PICOT research planFinalized PICOT research planFinalized PICOT research planFinalized PICOT research plan
• Question is of interest to pet Question is of interest to pet ownersowners• Intervention is low riskIntervention is low risk• Follow-up is convenientFollow-up is convenient• Incentives are consideredIncentives are considered
Common roadblocksCommon roadblocksCommon roadblocksCommon roadblocks
• Disease is uncommonDisease is uncommon• Studied outcome is rareStudied outcome is rare• Data collection too labor Data collection too labor
intensiveintensive
Common roadblocksCommon roadblocksCommon roadblocksCommon roadblocks
• Samples banked without Samples banked without validated assays (!)validated assays (!)• Case identification out Case identification out
of your controlof your control• Collaborators Collaborators
unmotivatedunmotivated
Key pointsKey pointsKey pointsKey points
• Study what you knowStudy what you know• Choose straight-forward Choose straight-forward
aims using available aims using available assays/proceduresassays/procedures• Define the approach Define the approach
using PICOTusing PICOT
Key pointsKey pointsKey pointsKey points
• Make sure you would Make sure you would volunteer your own pet volunteer your own pet to participateto participate• Results should be Results should be
publishable no matter publishable no matter what the outcomewhat the outcome