Research inclusion and exclusion criteria DrMajdi

Research inclusion and exclusion criteria. Different types of population. Target population, Eligible population

1. Dr. MajdiN. Al-Jasim
Consultant Family Medicine
Research Inclusion and
Exclusion Criteria

2. OBJECTIVES
Bytheendofthislecture,youshouldbeableto:
Identifythedifferenttypesofpopulation.
Explainthedifferentbetween inclusionand
exclusioncriteria.

3. Population:
Aparticulargroupofindividualswhoarethefocusofthe
research.
TargetPopulation–StudyPopulation:
Anentiresetofindividualswhomeetthesampling
criteria.
EligiblePopulation:
Theportionofthetargetpopulationthatmetcertain
criteriaandfromwhichtheresearcherdrawsthesample.
Basic Concepts

4. Sample:
Groupofindividualsfromtheeligiblepopulationwhoparticipate
inthestudy.
Basic Concepts
A: General Population
B: Target Population
C: Eligible Population
D: Sample
B
C
D
A

5. Example:
YouwanttoknowtheprevalenceofDM-2inmaleswhoare45-75
yearsold,wholiveinAl-Ahsa,KSA.
❑Thetargetpopulationwillbe:
Al-Ahsapopulation
❑Theeligiblepopulationwillbe:
DM-2maleswhoare45-75yearsoldONLYfromAl-Ahsa
population
Basic Concepts
Eligiblepopulation is a part
of target population who
fulfil certain criteria

6. Rrepresentativesample:
Representativesamplehasallcharacteristicsofthepopulationit
isdrawnfrom.
Itisonlywhenthesampleisrepresentativetheresultsofthestudy
canbegeneralizedtothatpopulation.
Howtogetrepresentativesample?
Bypropersamplingtechnique.
Basic Concepts

7. Example:
Youneedtoknowtheglucoselevelinyourblood.Thebestand
exactwaytoknowthatistotakeyourWHOLEBLOODand
measureglucoselevel,right?!!!
Basic Concepts
ForthatyoutakejustaSAMPLE
OFBLOODandtheresultofthat
samplerepresentsyourwhole
bloodandcanbegeneralized.

8. Afteryoudefinedyoursamplesize,sampling
techniqueanddatacollectiontoolaspre-made
questionnaire,oneofyoursamplewas2-year
oldboy.
Scenario
Howareyougoingtomakehimfillyour
questionnaire?

9. Inclusionandexclusioncriteriaareusedforfurtherfilteringofyour
targetpopulation.Bydoingso,youwillhavecontrolonsome
biases.
Theresultantpopulationoutofinclusionandexclusioncriteriais
called“ELIGIBLEPOPULATION”.
ThesecriteriashouldbesetBEFOREsamplingtakesplace.Once
studyisstarted,nofurthereditingtothesecriteriaisallowed.
Inclusion / Exclusion Criteria

10. The Main Target Population
Eligible Population
Sample
Inclusion Criteria
Exclusion Criteria

11. InclusionCriteria:
Arethosecharacteristicsthatfulfilltheneedsoftheresearcherfor
thestudy.
ThePurposeofInclusionCriteria:
Usedtofocuson:
▪Certaindemographicparameters.
▪Certainclinicalcharacteristic.
▪Certaingeographicconsideration.
Inclusion Criteria

12. Canyougiveexampleof:
❑Certaindemographicsparameters:
Likeonlycertainagegroup,onlycertainweightrange,onlyfemales,
onlysmokers,onlymarried…etc.
❑Certainclinicalcharacteristics:
Likeonlystage2CHF,onlystage3-5CKD…etc.
❑Certaingeographicconsideration:
OnlythosewhoarelivinginAl-Ahsaatthetimeofstudy.
OnlythosevisitedAl-AhsaPHCsfromMarch2018untilJuly2018.
Inclusion Criteria

13. Example:
Anewdrugusedintreatingstep4and5bronchialasthmain
pediatricpatientsunder5-year-old.
Whatwillbeyourinclusioncriteria?
Inclusion Criteria
➀Age:All under 5 year-old patients.
➁Clinical characteristic:
-Moderately severe cases of bronchial asthma.
-Severe cases of bronchial asthma.

14. ExclusionCriteria:
Arethosecharacteristicsthatdisqualifyprospectivesubjectsfrom
inclusioninthestudy.
ThePurposeofExclusionCriteria:
Usedtopredictandeliminateexpected:
▪Biaseslikeconfounderbias,incompletedata…etc.
▪Certainethicalproblemslikeinabilitytogiveconsent.
▪Certainharmeffect.
Exclusion Criteria

15. Example:
Anewdrugusedintreatingstep4and5bronchialasthmain
pediatricpatientsunder5-year-old.
Whatwillbeyourexclusioncriteria?
Exclusion Criteria
➀Age:5 years old and more.
➁Clinical characteristic:
-Mild cases of bronchial asthma.
-No history of bronchial asthma.

16. Example:
Anewdrugusedtotreatstage-2hypertensioncameoutandyou
areinterestedtouseitinyourupcomingresearch,butoneofits
sideeffectisacuterenalimpairmentinthosewithestablished
CKDandthosewithlowBMI.
WhatwillbeyourExclusioncriteria?
Exclusion Criteria
➀GFR:Less than 60 ml/min/1.73m
2
➁Blood creatinine level: More than 1.5mg/dl
➂Proteinuria: Positive
➃BMI:Less than18 kg/m
2
➄Ethical:Inability to give consent
➅Clinical:No hypertension or stage-1 hypertension

17. Keep in mind
Toomuchinclusion:
Thestudywillenrollmoreheterogenoussamplethatresemblereal
life.Thisiscalled“EFFECTIVENESS”inwhichtheresultsarebroadly
generalizable.However,thiscanputthestudyatgreaterriskfor
confoundingvariables.

18. Keep in mind
Toomuchexclusion:
Thestudywillonlyenrollatightlycontrolled,homogenoussample.
Thisiscalledan“EFFICACY”.Butsuchstrictcriteriamakeenrolling
sufficientnumbersofsubjectsmoredifficult,andthefinalresults
arenotasapplicabletorealclinicalpractice.

19. Target Population
Anentiresetofindividualswhomeetthesampling
criteria.
Summary
Eligible Population
Theportionofthetargetpopulationthatmetcertain
criteriafromwhichtheresearcherdrawsthesample.

20. Inclusion Criteria
Arethosecharacteristicsthatfulfilltheneedsofthe
researcherforthestudy.
Summary
Exclusion Criteria
Arethosecharacteristicsthatdisqualifyprospective
subjectsfrominclusioninthestudy.